As filed with the Securities and
Exchange Commission on August 24, 2016
Registration Statement No. 333-210582
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM S-1
AMENDMENT NO.
3 TO
REGISTRATION STATEMENT UNDER
THE SECURITIES ACT OF 1933
OPIANT PHARMACEUTICALS, INC.
(Exact name of registrant in its charter)
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Nevada
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2834
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46-4744124
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(State or other
jurisdiction of
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(Primary Standard
Industrial
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(IRS Employer
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incorporation
or organization)
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Classification
Code Number)
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Identification
Number)
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401 Wilshire Blvd., 12
th
Floor
Santa Monica, CA 90401
(424) 252-4756
(Address, including
zip code, and telephone number,
including area code, of registrant’s
principal executive offices)
Kevin Pollack
Opiant Pharmaceuticals, Inc.
401 Wilshire Blvd., 12
th
Floor
Santa Monica,
CA 90401
(424) 252-4756
(Name, address,
including zip code, and telephone number,
including area
code, of agent for service)
Copies of communications
to:
David C. Schwartz,
Esq.
DLA Piper LLP (US)
51 John F. Kennedy
Parkway, Suite 120
Short Hills,
New Jersey 07078-2704
(973)
520-2550
Approximate date of commencement of proposed
sale to the public: As soon as practicable after this Registration Statement becomes effective.
If any of the securities being registered
on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the
following box.
x
If
this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act of 1933,
please check the following box and list the Securities Act registration statement number of the earlier effective registration
statement for the same offering.
¨
If
this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act of 1933, check the following box
and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.
¨
If
this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act of 1933, check the following box
and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.
¨
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions
of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule
12b-2 of the Exchange Act.
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Large accelerated filer
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¨
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Accelerated filer
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¨
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Non-accelerated filer
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¨
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Smaller reporting company
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þ
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(Do not check if a smaller reporting
company)
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CALCULATION OF REGISTRATION FEE
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Title
of Each Class of Securities to be Registered
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Amount
to be
Registered(1)
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Proposed
Maximum
Offering
Price Per
Share(2)
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Proposed
Maximum
Aggregate
Offering
Price
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Amount
of
Registration
Fee (3)
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Common Stock, par value
$0.001 per share
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15,715
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$
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10.08
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158,407
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$
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15.96
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Common Stock, par value $0.001 per share,
issuable pursuant to the exercise of warrants
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45,000
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$
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10.08
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$
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453,600
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$
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45.68
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Common Stock, par value $0.001 per share,
issuable pursuant to the exercise of options
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2,000,000
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$
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10.08
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$
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20,160,000
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$
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2,030.12
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Total
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2,060,715
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$
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10.08
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$
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20,772,007
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$
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2,091.76
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(1)
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Pursuant
to Rule 416 under the Securities Act of 1933, as amended, this registration statement shall be deemed to cover the additional
securities (i) to be offered or issued in connection with any provision of any securities purported to be registered hereby
to be offered pursuant to terms which provide for a change in the amount of securities being offered or issued to prevent
dilution resulting from stock splits, stock dividends or similar transactions and (ii) of the same class as the securities
covered by this registration statement issued or issuable prior to completion of the distribution of the securities covered
by this registration statement as a result of a split of, or a stock dividend on, the registered securities.
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(2)
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Estimated solely for purposes
of calculating the registration fee pursuant to Rule 457(c) of the Securities Act of 1933, as amended, based on the average
of the high and low prices of the common stock of the registrant as reported on the OTC Markets on March 30, 2016.
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(3)
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The Registrant previously submitted
$5,714.27 on the original filing of this registration statement filed on April 4, 2016.
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THE REGISTRANT
HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT
SHALL FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN
ACCORDANCE WITH SECTION 8(a) OF THE SECURITIES ACT OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME EFFECTIVE ON SUCH DATE
AS THE COMMISSION, ACTING PURSUANT TO SUCH SECTION 8(a), MAY DETERMINE.
The information
in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement
filed with the U.S. Securities and Exchange Commission (“SEC”) is effective. This preliminary prospectus is not an
offer to sell these securities and it is not soliciting an offer to buy these securities in any jurisdiction where the offer or
sale is not permitted.
The information in this prospectus is not complete and may
be changed. The Company may not sell these securities until the registration statement filed with the Securities and Exchange
Commission is effective. This prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these
securities in any state where the offer or sale is not permitted.
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PRELIMINARY
PROSPECTUS
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SUBJECT
TO COMPLETION, as of August 24, 2016
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OPIANT PHARMACEUTICALS, INC.
2,060,715 Shares of Common Stock
This prospectus relates to the resale
of up to 2,060,715 shares of common stock of Opiant Pharmaceuticals, Inc. (the “Company”), par value $0.001 per share
(the “common stock”), consisting of 15,715 shares of common stock, 45,000 shares of common stock upon the exercise
of warrants and 2,000,000 shares of common stock upon exercise of options. The total amount of shares of common stock which may
be sold pursuant to this prospectus would constitute approximately 101.94% of the Company’s issued and outstanding common
stock as of August 18, 2016, assuming that the selling security holders will exercise all of the warrants and options and sell
all of the shares offered for sale.
The selling security holders may offer
all or part of the shares for resale from time to time through public or private transactions, at either prevailing market prices
or at privately negotiated prices
The Company’s common stock is quoted
on the OTC Markets, under the ticker symbol “OPNT.” On March 30, 2016, the closing price of the Company’s
common stock was $10.08 per share.
Investing in the Company’s
common stock involves a high degree of risk. See “Risk Factors” beginning on page 10 to read about factors you should
consider before investing in shares of the Company’s common stock.
NEITHER THE SECURITIES AND EXCHANGE
COMMISSION NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED OF THESE SECURITIES OR DETERMINED IF THIS PROSPECTUS
IS TRUTHFUL OR COMPLETE. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
The date of this prospectus is August
24, 2016.
TABLE OF CONTENTS
PROSPECTUS SUMMARY
This summary highlights selected information
contained elsewhere in this prospectus. This summary does not contain all the information that you should consider before investing
in the common stock of Opiant Pharmaceuticals, Inc. (referred to herein as “we,” “our,” “us,”
“Opiant” or the “Company”). You should carefully read the entire prospectus, including “Risk Factors,”
“Management’s Discussion and Analysis of Financial Condition and Results of Operations” and the accompanying
financial statements and the related notes to the Financial Statements before making an investment decision.
General Information
Opiant Pharmaceuticals, Inc. (“Opiant”
or the “Company”) is a specialty pharmaceutical company developing pharmacological treatments for substance use, addictive
and eating disorders. The Company was incorporated in the State of Nevada on June 21, 2005, as Madrona Ventures, Inc. and on September
16, 2009, the Company changed its name to Lightlake Therapeutics Inc. On January 28, 2016, the Company changed its name to Opiant
Pharmaceuticals, Inc. The Company’s fiscal year end is July 31.
The Company’s strategy is to
develop pharmacological treatments for substance use, addictive and eating disorders based on the Company’s expertise using
opioid antagonists. The Company has worked on developing a treatment for reversing opioid overdoses in collaboration with the
National Institute on Drug Abuse (“NIDA”), part of the National Institutes of Health (“NIH”). This treatment,
now known as NARCAN® (naloxone hydrochloride) Nasal Spray, was approved by the U.S. Food and Drug Administration (“FDA”)
in November 2015, and is marketed by Adapt Pharma.
In December 2014, the Company effected
a one-for-one hundred reverse stock split of its common stock (the “1:100 Reverse Stock Split”) which decreased the
number of common shares issued and outstanding from approximately 191 million shares to approximately 1.91 million shares as of
March 30, 2016. Unless otherwise noted, all shares amounts listed in this Report been retroactively adjusted for the 1:100 Reverse
Stock Split as if such stock splits occurred prior to the issuance of such shares.
The Company has been focused on developing:
(i) a treatment to reverse opioid overdoses, (ii) a treatment for overweight and obese patients with Binge Eating Disorder (“BED”),
and (iii) a treatment for Cocaine Use Disorder.
Principal Products or Services and Markets
Opioid Overdose Reversal
Naloxone is a medicine that can
reverse the overdose of prescription and illicit opioids and that historically has been available through injection. Opiant’s
intranasal delivery system of naloxone could widely expand its availability and use in preventing opioid overdose deaths.
On March 14, 2014, the Company filed U.S.
Provisional Application No. 61/953,379. This application addresses delivery devices and methods of treating opioid overdoses through
the administration of intranasal naloxone.
On May 15, 2014, the Company entered
into an agreement and subsequently received funding from an individual investor in the amount of $300,000 for use by the Company
for any purpose. In exchange for this funding, the Company agreed to provide the investor with a 1.5% interest in the net profit
as related to the Company’s treatment to reverse opioid overdoses. Net profit is defined as the pre-tax profit generated
from the product after the deduction of all expenses incurred by and payments made by the Company in connection with the product,
including but not limited to an allocation of Company overhead. The investor also has rights with respect to its 1.5% interest
if the treatment is sold or the Company is sold. If the product is not introduced to the market and not approved for marketing
within 24 months, the investor will have a 60 day option to receive 37,500 shares of common stock in lieu of the 1.5% interest
in the product. The product was approved by the FDA during the six month period ended January 31, 2016 and as result the investor
will not receive the option to receive shares. During the nine months ended April 30, 2016, specifically, during the Company’s
second fiscal quarter that ended on January 31, 2016, the Company recognized $300,000 as revenue because the option to receive
the shares of common stock was removed, and the research and development work related to the product was completed.
On July 9, 2014, the Company filed U.S.
Provisional Application No. 62/022,268 with respect to the Company’s treating opioid overdoses through the administration
of intranasal naloxone.
On July 22, 2014, the Company received
a $3,000,000 commitment, from which the Company has the right to make capital calls, from a foundation for the research, development,
marketing, commercialization, and any other activities connected to the Company’s treatment to reverse opioid overdoses,
certain operating expenses, and any other purpose consistent with the goals of the foundation. In exchange for funds invested
by the foundation the Company agreed to provide the foundation with pro-rata share up to a 6.0% interest in the net profit as
related to the Company’s treatment to reverse opioid overdoses. Net profit is defined as the pre-tax profit generated from
the product after the deduction of all expenses incurred by and payments made by the Company in connection with the product, including
but not limited to an allocation of Company overhead. The foundation also has rights with respect to its up to 6.0% interest if
the treatment is sold or the Company is sold. Additionally, the Company may buyback interests from the foundation within two and
one half years or after two and a half years of the initial investment at a price of two times or three and a half times, respectively,
the relevant investment amount represented by the interests to be bought back. Such buyback can be for a portion of the interest
rather than for the entire interest. If the product is not approved by the U.S. Food and Drug Administration or an equivalent
body in Europe for marketing and is not actually marketed within 24 months the foundation will have a 60 day option to receive
shares of the Company’s common stock in lieu of the interest in the treatment at a rate of 10 shares for every dollar of
its investment. On July 28, 2014 the Company received an initial investment of $111,470 from the foundation in exchange for a
0.22294% interest. On August 13, 2014, September 8, 2014, November 13, 2014, and February 17, 2015, the Company made capital calls
of $422,344, $444,530, $1,033,614, and $988,043, respectively, from the foundation in exchange for 0.844687%, 0.888906%, 2.067228%,
and 1.976085% interests, respectively, in the net profit as related to the Company’s treatment to reverse opioid overdoses.
The product was approved by the FDA during the nine month period ended April 30, 2016 and as result the investor will not receive
the option to receive shares. During the nine months ended April 30, 2016, specifically, during the Company’s second fiscal
quarter that ended on January 31, 2016, the Company recognized $3,000,000 as revenue because the option to receive the shares
of common stock was removed, and the research and development work related to the product was completed.
On September 9, 2014, the Company entered
into an agreement and subsequently received funding from an individual investor in the amount of $500,000 for use by the Company
for any purpose. In exchange for this funding, the Company agreed to provide the investor with a 0.98% interest in the net profit
as related to the Company’s treatment to reverse opioid overdoses. Net profit includes the pre-tax profit received by the
Company derived from the sale of the product after the deduction of all expenses incurred by and payments made by the Company
in connection with the product, including but not limited to an allocation of Company overhead. The investor also has rights with
respect to its 0.98% interest if the treatment is sold or the Company is sold. Additionally, the Company may buyback interests
from the investor within two and one half years or after two and a half years but no later than four years of the initial investment
at a price of two times or three and a half times, respectively, the relevant investment amount represented by the interests to
be bought back. Such buyback can be for a portion of the interest rather than for the entire interest. If the product is not introduced
to the market and not approved by the FDA or an equivalent body in Europe and not marketed within 24 months the investor will
have a 60 day option to receive 50,000 shares of common stock in lieu of the interest in the product. The product was approved
by the FDA during the three month period ended January 31, 2016 and as result the investor will not receive the option to receive
shares. During the nine months ended April 30, 2016, specifically, during the Company’s second fiscal quarter that ended
on January 31, 2016, the Company recognized $500,000 as revenue because the option to receive the shares of common stock was removed,
and the research and development work related to the product was completed.
On October 31, 2014, the Company entered
into an agreement and subsequently received funding from an individual investor in the amount of $500,000 for use by the Company
for any purpose. In exchange for this funding, the Company agreed to provide the investor with a 0.98% interest in the net profit
as related to the Company’s treatment to reverse opioid overdoses. Net profit includes the pre-tax profit received by the
Company derived from the sale of the product after the deduction of all expenses incurred by and payments made by the Company
in connection with the product, including but not limited to an allocation of Company overhead. The investor also has rights with
respect to its 0.98% interest if the treatment is sold or the Company is sold. Additionally, the Company may buyback interests
from the investor within two and one half years or after two and a half years but no later than four years of the initial investment
at a price of two times or three and a half times, respectively, the relevant investment amount represented by the interests to
be bought back. Such buyback can be for a portion of the interest rather than for the entire interest. If the product is not introduced
to the market and not approved by the FDA or an equivalent body in Europe and not marketed within 24 months the investor will
have a 60 day option to receive 50,000 shares of common stock in lieu of the interest in the product. The product was approved
by the FDA during the three month period ended January 31, 2016 and as result the investor will not receive the option to receive
shares. During the nine months ended April 30, 2016, specifically, during the Company’s second fiscal quarter that ended
on January 31, 2016, the Company recognized $500,000 as revenue because the option to receive the shares of common stock was removed,
and the research and development work related to the product was completed.
On December 15, 2014, the Company and
Adapt Pharma Operations Limited, a wholly owned subsidiary of Adapt Pharma Limited (“Adapt”), an Ireland-based pharmaceutical
company, entered into a license agreement (the “Adapt Agreement”). Pursuant to the agreement Adapt has received from
the Company a global license to develop and commercialize the Company’s intranasal naloxone opioid overdose reversal treatment.
In exchange for licensing its treatment to Adapt, the Company could receive total potential regulatory and sales milestone payments
of more than $55 million, plus up to double-digit percentage royalties on net sales. The Adapt Agreement provided for an upfront
and nonrefundable payment of $500,000, and monthly payments for up to one year for participation in joint development committee
calls and the production and submission of an initial development plan. The Adapt Agreement also required the Company to contribute
$2,500,000 of development, regulatory, and commercialization costs, some of which was credited for costs incurred by the Company
prior to the execution of the Adapt Agreement. The Company fulfilled its requirement to contribute $2,500,000 during the three
months ended October 31, 2015.
On February 17, 2015, the Company announced
that Adapt received Fast Track designation by the FDA.
On April 22, 2015, the Company announced
that Adapt successfully completed a pharmacokinetic study of intranasal naloxone. This study had been designed and conducted by
Opiant in collaboration with NIDA. The pharmacokinetic study compared intranasal naloxone with an injectable formulation of naloxone.
The study met its objectives and demonstrated the intranasal formulation of naloxone delivered the targeted naloxone dose as expected.
On June 3, 2015, the Company announced
that Adapt commenced a rolling submission of a New Drug Application (“NDA”) to the FDA for a nasal spray formulation
of naloxone. A rolling submission allows completed portions of the NDA to be submitted and reviewed by the FDA on an ongoing
basis.
On July 29, 2015, the Company announced
that Adapt has submitted a NDA to the FDA for NARCAN® (naloxone hydrochloride) Nasal Spray, an investigational drug intended
to treat opioid overdose.
On November 18, 2015, the FDA approved
NARCAN® (naloxone hydrochloride) Nasal Spray for the emergency treatment of known or suspected opioid overdose, to be marketed
by Adapt.
On December 8, 2015, the Company entered
into an agreement with an individual investor to receive $500,000 for use by the Company for any purpose, which $500,000 shall
be invested by December 18, 2015. In exchange for this funding, the Company has agreed to provide the investor with a 0.75% interest
in the Net Profit as related to the Company’s treatment to reverse opioid overdoses. Net Profit includes the pre-tax profit
received by the Company derived from the sale of the product after the deduction of all expenses incurred by and payments made
by the Company in connection with the product, including but not limited to an allocation of Company overhead. The investor also
has rights with respect to its 0.75% interest if the treatment is sold or the Company is sold. Additionally, the Company may buyback
interests from the investor within two and one half years or after two and a half years but no later than four years of the initial
investment at a price of two times or three and a half times, respectively, the relevant investment amount represented by the
interests to be bought back. Such buyback can be for a portion of the interest rather than for the entire interest. The investor
also had an option to invest an additional $1,000,000 by February 29, 2016 for use by the Company for any purpose in exchange
for a 1.50% interest in the Net Profit as related to the Company’s treatment to reverse opioid overdoses. If such investment
were made, then the investor also would have rights with respect to its 1.50% interest if the treatment were sold or the Company
were sold. Additionally, the Company would be able to buyback interests from the investor within two and one half years or after
two and a half years but no later than four years of the initial investment at a price of two times or three and a half times,
respectively, the relevant investment amount represented by the interests to be bought back. Such buyback could be for a portion
of the interest rather than for the entire interest. This option expired unexercised. During the nine months ended April 30, 2016,
specifically, during the Company’s second fiscal quarter that ended on January 31, 2016, the Company recognized $500,000
as revenue because the investment did not contain an option to receive shares, and the research and development work related to
the product was completed.
On December 15, 2015, the Company announced
that it received a $2 million milestone payment from Adapt. This milestone payment was triggered by the FDA approval of NARCAN®
(naloxone hydrochloride) Nasal Spray.
On January 19, 2016, the Company announced
that Adapt announced that it has reached an agreement to facilitate the purchase of NARCAN® (naloxone hydrochloride) Nasal
Spray by offering its discounted public interest price to 62,000 agencies in state and local government and the non-profit sector.
Adapt, in partnership with the National Association of Counties, National Governors Association, National League of Cities, and
United States Conference of Mayors, will offer NARCAN® (naloxone hydrochloride) Nasal Spray at a discounted public interest
price of $37.50 per dose ($75 for a 2 pack carton) through the U.S. Communities Purchasing Alliance and Premier, Inc. Adapt’s
discounted public interest price has been available to qualifying group purchasers, such as law enforcement, firefighters, first
responders, departments of health, local school districts, colleges and universities, and community-based organizations.
On January 27, 2016, the Company announced
that Adapt announced two national programs at the Clinton Health Matters Initiative Activation Summit to assist in efforts to
address the growing risk of opioid overdose among American high school students. Adapt offered a free carton of NARCAN® (naloxone
hydrochloride) Nasal Spray to all high schools in the U.S. through the state departments of education. This program will collaborate
with the Clinton Health Matters Initiative, an initiative of the Clinton Foundation, as part of its work to scale naloxone access
efforts nationally. In addition, Adapt has provided a grant to the National Association of School Nurses (NASN) to support their
educational efforts concerning opioid overdose education materials.
On March 7, 2016, the Company announced the receipt of a $2.5
million milestone payment from Adapt. This milestone payment was triggered by the first commercial sale of NARCAN® (naloxone
hydrochloride) Nasal Spray in the U.S.
On April 29, 2016, the Company received $105,097 in royalty
payments due from Adapt Pharma Operations Limited from commercial sales of NARCAN® (naloxone hydrochloride) Nasal Spray in
the U.S during the first quarter of Adapt Pharma Operations Limited’s fiscal year.
On May 6, 2016, the Company announced that Adapt submitted
a new drug submission (NDS) for NARCAN® (naloxone hydrochloride) Nasal Spray to Health Canada.
Binge Eating Disorder
The Company is developing a treatment
for BED. The Company considers naloxone to be a potentially compelling drug for the pharmacological treatment of BED. It has a
well-known safety profile and has the potential to block the reward that patients experience from bingeing.
On May 23, 2013, the Company presented
the results of the Company’s Phase II clinical trial of its nasal spray treatment for BED at the American Psychiatric Association
(“APA”) Annual Meeting in San Francisco. BED has been added to the fifth edition of the APA’s Diagnostic and
Statistical Manual of Mental Disorders (“DSM-5”), which was launched at the APA Annual Meeting. DSM-5 is used by clinicians
and researchers to diagnose and classify mental disorders in order to improve diagnoses, treatment, and research. BED is defined
in the DSM-5 chapter on Feeding and Eating Disorders as a diagnosis for individuals who experience persistent, recurrent episodes
of overeating, marked by loss of control and significant clinical distress.
On December 17, 2013, the Company entered
into an agreement and subsequently received additional funding totaling $250,000 for use by the Company for any purpose. In exchange
for this funding, the Company agreed to provide the investor with a 0.5% interest in the net profit as related to the Company’s
BED treatment. Net profit is defined as the pre-tax profit generated from the product after the deduction of all expenses incurred
by and payments made by the Company in connection with the product, including but not limited to an allocation of Company overhead.
The investor also has rights with respect to its 0.5% interest if the treatment is sold or the Company is sold. If the product
is not approved by the U.S. Food and Drug Administration within 36 months the investor will have a 60 day option to receive 31,250
shares of common stock in lieu of the 0.5% interest in the product.
On September 17, 2014, the Company entered
into an agreement and subsequently received funding totaling $500,000 for use by the Company for any purpose. In exchange for
this funding, the Company agreed to provide the investor with a 1.0% interest in the Company’s BED treatment product and
pay the investor 1.0% of the net profit generated from this treatment in perpetuity. Net profit is defined as the pre-tax profit
generated from the product after the deduction of all expenses incurred by and payments made by the Company in connection with
the product, including but not limited to an allocation of Company overhead. If the product is not approved by the FDA within
36 months the investor will have a sixty day option to receive 62,500 shares of common stock in lieu of the 1.0% interest in the
product.
On July 20, 2015, the Company entered
into an agreement and subsequently received additional funding totaling $250,000 for use by the Company for any purpose. In exchange
for this funding, the Company agreed to provide the investor with a 0.5% interest in the Company’s BED treatment product
and pay the investor 0.5% of the net profit generated from this treatment in perpetuity. Net profit is defined as the pre-tax
profit generated from the product after the deduction of all expenses incurred by and payments made by the Company in connection
with the product, including but not limited to an allocation of Company overhead. If the product is not approved by the FDA within
36 months the investor will have a sixty day option to receive 25,000 shares of common stock in lieu of the 0.5% interest in the
product.
The Company now aims to collaborate with
other parties and progress its drug development program for BED.
Cocaine Use Disorder
The Company is developing a treatment
for Cocaine Use Disorder (“CocUD”). There are approximately 1.5 million current cocaine users in the U.S., as
reported by The Substance Abuse and Mental Health Services Administration (SAMHSA).
Cocaine is often used in a binge pattern.
Taking the drug repeatedly within a relatively short period of time, at increasingly higher doses, can easily lead to addiction,
a chronic relapsing disease caused by changes in the brain and characterized by uncontrollable drug-seeking no matter the consequences.
Cocaine is a strong central nervous system stimulant that increases levels of the neurotransmitter dopamine in brain circuits regulating
pleasure and movement, with the opioid system strongly linked to the dopamine reward circuitry.
Any route of administration can lead to
absorption of toxic amounts of cocaine. Most seriously, in the short-term cocaine users can suffer from heart attacks, strokes,
and convulsions, which can result in sudden death. Repeated use of cocaine can lead to long-term harmful changes in the brain
and other parts of the body, including decreases in appetite, weight loss, and malnourishment. Snorting cocaine can lead to loss
of sense of smell and difficulty in swallowing, ingesting cocaine can cause severe bowel gangrene due to reduced blood flow, and
injecting cocaine can lead to puncture marks called “tracks” and possible allergic reactions. Cocaine users are also
at high risk of contracting HIV and viral hepatitis from sharing contaminated needles and engaging in risky sexual behaviors.
The extraordinary cost of cocaine addiction,
financially, medically and socially, is directly related to the stubborn clinical problem of relapse. Relapse rates have remained
discouragingly high for decades: up to 80% of addicted individuals relapse within six months of treatment. Finding effective interventions,
psychosocial or pharmacologic, has proven difficult.
On December 23, 2015, the Company announced
that an opioid antagonist drug will be tested in patients with CocUD at the University of Pennsylvania. The study has been conducted
by the Department of Psychiatry at the Perelman School of Medicine at the University of Pennsylvania, and began recruitment in
December 2015. Funded by a Medications Development Centers of Excellence Cooperative (U54) Program from NIDA, the study plans
to use functional Magnetic Resonance Imaging (fMRI) to better understand the impact of an opioid antagonist drug in the brain
of patients with CocUD. The study plans to test its impact on brain networks related to addiction-relevant processes, such as
reward and inhibition.
Other Activities
On December 1, 2014, the Company and Aegis
Therapeutics, LLC (“Aegis”), entered into a Material Transfer, Option and Research License Agreement (the “Aegis
Agreement”) that provides the Company with an exclusive royalty-free research license for a period of time to Aegis’
proprietary delivery enhancement and stabilization agents, including Aegis’ ProTek® and Intravail® technologies
(collectively, the “Technology”) to enable the Company to conduct a feasibility study of opioid antagonists when used
with the Technology. During this period of time, the Company may also evaluate its interest in having an exclusive license to
the Technology for use with opioid antagonists to treat, diagnose, predict, detect or prevent any disease, disorder, state, condition
or malady in humans (the “Possible License”). Aegis has granted the Company an exclusive option to obtain the Possible
License for a certain period after the study is completed. In consideration of the license granted to the Company pursuant to
the Aegis Agreement, the Company is required to pay to Aegis a nonrefundable study fee.
On October 6, 2015, the Company entered
into an amendment to the Aegis Agreement. This amendment had an effective date of May 19, 2015 and allowed the Company to evaluate
Aegis’ Technology until August 17, 2015. The amendment also provided an opportunity for the Company to elect to further
extend the period of time during which the Company could evaluate the Technology until February 13, 2016. The Company elected
to further extend the period during which the Company could evaluate the Technology through August 11, 2016.
On September 22, 2015, the Company received
a $1,600,000 commitment from a foundation, from which the Company has the right to make capital calls, for the research, development,
any other activities connected to the Company’s opioid antagonist treatments for addictions and related disorders that materially
rely on certain studies funded by the foundation’s investment, certain operating expenses, and any other purpose consistent
with the goals of the foundation. In exchange for funds invested by the foundation the Company agreed to provide the foundation
with pro-rata share up to a 2.1333% interest in the Net Profit as related to the Company’s opioid antagonist treatments
for addictions and related disorders that materially rely on certain studies funded by the foundation’s investment. Net
profit is defined as any pre-tax revenue received by the Company that was derived from the sale of the products less any and all
expenses incurred by and payments made by the Company in connection with the products, including but not limited to an allocation
of Company overhead. The foundation also has rights with respect to its up to 2.1333% interest if the products are sold or the
Company is sold. Additionally, the Company may buyback interests from the foundation within two and one half years or after two
and a half years of the initial investment at a price of two times or three and a half times, respectively, the relevant investment
amount represented by the interests to be bought back. Such buyback can be for a portion of the interest rather than for the entire
interest. If a product is not introduced to the market within 36 months the foundation will have a 60 day option to receive shares
of the Company’s common stock in lieu of the interest in the product at a rate of one-tenth of a share for every dollar
of its investment. On October 6, 2015, and December 23, 2015, the Company received $618,000 and $715,500 from the foundation in
exchange for a 0.824% and 0.954% interests, respectively, in the Company’s treatments covered by the commitment agreement. The
Company will defer recording revenue until such time as the option expires or milestones are achieved that eliminates the investor’s
right to exercise the option. Upon expiration of the exercise option, the deliverables of the arrangement will be reviewed and
evaluated under ASC 605. In the event the investor chooses to convert interests into shares of common stock, that transaction
will be accounted for similar to a sale of shares of common stock for cash.
On April 26, 2016 (the “Amendment
Date”), the Company and Aegis entered into the Amended and Restated Material Transfer, Option and Research License Agreement
(the “Restated License Agreement”) which amends and restates in its entirety the Initial Aegis Agreement. Under the
Restated License Agreement, the Company has been granted an exclusive royalty-free research license to Aegis’ Technology,
for a period of time (the “Compound Research Period”), to enable the Company to conduct the Study and evaluate the
Company’s interest in licensing the Technology through use of the Compound in additional studies.
The Company agreed to pay Aegis
(i) an aggregate of $300,000, of which the Company may elect to pay up to 50% by issuing shares of the Company’s common
stock, par value $0.001 per share, to Aegis, with the number of shares to be issued equal to 75% of the average closing price
of the Company’s common stock over the 20 trading days preceding the date of payment as consideration for extending the
Compound Research Period pursuant to two separate extension payments of $150,000 each, and (ii) 50,000 shares of common stock
as partial consideration for entering into the Restated License Agreement. The Company exercised such extensions through
payment of the first and second extension fees prior to October 13, 2015 and prior to February 13, 2016, respectively. The
Restated License Agreement shall expire on the earlier of (i) the expiration of the “Opiant Negotiation Periods”
(as defined in the Restated License Agreement) and (ii) on 30 days prior written notice by the Company;
provided
,
however
,
that Aegis shall have the right to terminate the license granted in the event the Company does not pursue commercially
reasonable efforts to exploit a “Product”, defined as (i) pharmaceutical formulations containing the Compound as
an active ingredient and (ii) Aegis’s proprietary chemically synthesizable excipient(s), including without limitation
the Intravail® excipients pharmaceutical formulations containing certain ingredients of Aegis’ proprietary
technology.
During the term of the Restated License
Agreement, the Company has a right of first refusal and option to add any, or all of the “Additional Compounds” (as
defined in the Restated License Agreement), which the Company may exercise at any time upon written notice to Aegis. The Company
has granted Aegis a co-exclusive license with the Company to use the data from the Company’s Studies under the Restated
License Agreement for certain purposes. Pursuant to the Restated License Agreement, Aegis granted the Company an exclusive option
(the “Opiant Option”) to obtain an exclusive, worldwide, royalty-bearing license (with the right to grant sublicenses
through multiple tiers) under Aegis’s interests in the Technology and any “Joint Invention” (as such term is
defined in the Restated License Agreement) to the Technology to research, develop, make, have made, use, sell, offer for sale,
and import products containing the “Compound” (as defined in the Restated License Agreement) or an Additional Compound.
The Company may exercise such Opiant Option with respect to the Compounds by written notice to Aegis within 90 days of the completion
of the Study for (i) the Compounds or (ii) the Additional Compounds. In the event the Company exercises the Opiant Option, the
parties have 120 days to negotiate and execute a definitive license agreement. The terms of such license agreement have been contemplated
and agreed upon by the parties under a letter agreement (the “Letter Agreement”). As partial consideration for exercising
the Option, the Company shall pay Aegis a nonrefundable and noncreditable license issuance fee of $300,000 as of the effective
date of the license agreement entered into by Company and Aegis, of which the Company may elect to pay up to 50% by issuing shares
of the Company’s common stock to Aegis, with the number of shares to be issued equal to 75% of the average closing price
of the Company’s stock over the prior 20 trading days. In the event the Company exercises the Opiant Option specific to
the “Opioid Field” (as defined in Exhibit 1 to the Letter Agreement), the Company shall pay Aegis an additional $100,000
fee and any such products in the Opioid Field shall be subject to the same milestones, royalties and other monetary obligations
set forth in the Letter Agreement and summarized below.
Under the Letter Agreement containing
the terms of such license, the Company will pay Aegis upon the achievement of each development milestone for a particular Compound
or Additional Compound, ranging from $250,000 to $4,000,000 per achievement. Additionally, the Company is required to make minimum
quarterly nonrefundable payments to Aegis in the amount of $25,000 (the “Quarterly Payments”), which Quarterly Payments
are fully creditable and treated as a prepayment against future milestones or royalties. During the “Royalty Term”
(as defined in Exhibit 1 to the Letter Agreement), the Company shall pay Aegis royalties (the “Royalties”) on annual
net sales of (i) pharmaceutical formulations containing the Compound as an active ingredient and (ii) Aegis’s proprietary
chemically synthesizable excipient(s), including without limitation the Intravail® excipients ((i) and (ii) together, the
“Products”), ranging from (A) low single digits for Products with an aggregate annual “Net Sales” (as
defined in Exhibit 1 to the Letter Agreement) during a calendar year of $50 million or less to (B) mid-single digits for Products
with Net Sales of greater than $1 billion. Such Royalties are subject to reduction as provided in Exhibit 1 to the Restated Agreement
but shall not be reduced by more than 50% of the regularly scheduled royalty payment.
The foregoing description of the Restated
License Agreement and the Letter Agreement is qualified in its entirety by reference to the complete text of the Restated License
Agreement and the Letter Agreement which were filed as exhibits to our Form 10-Q for the quarter ended April 30, 2016 which was
filed on June 8, 2016. The Company is seeking confidential treatment for certain terms and provisions of the Restated License
Agreement and the Letter Agreement.
On February 17, 2016, the Company announced
the first convening of its medical advisory board in 2016 to discuss its development programs in substance use, addictive and
eating disorders.
Where You Can Find Us
The Company’s principal executive offices are located
at 401 Wilshire Blvd., 12
th
Floor, Santa Monica, CA 90401.
The Company’s telephone number is (424) 252-4756.
THE OFFERING
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Common
Stock Offered by Selling Security Holders
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2,060,715
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Common Stock
Outstanding Before the Offering
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2,021, 577
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Common Stock
Outstanding After the Offering (includes the issuance of the warrant and option shares)
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4,066,577
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Use of Proceeds
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The
Company will not receive any proceeds from the sale of the shares of the Company’s common stock offered under this prospectus
by the selling security holders. Rather, the selling security holder will receive those proceeds directly
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OTC Markets Trading
Symbol
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OPNT
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Risk Factors
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The
common stock offered hereby involves a high degree of risk and should not be purchased by investors who cannot afford the
loss of their entire investment. See “Risk Factors”.
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RISK
FACTORS
You should carefully consider the risks
described below together with all of the other information included in this prospectus before making an investment decision with
regard to the Company’s securities. The statements contained in or incorporated into this prospectus that are not historic
facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially
from those set forth in or implied by forward-looking statements. If any of the following risks actually occurs, the Company’s
business, financial condition or results of operations could be harmed. In that case, the trading price of the Company’s
common stock could decline, and you may lose all or part of your investment.
Risks Related to The Company’s
Business and Industry
The Company has generated limited
revenue to date and expect to incur significant operating losses for the foreseeable future.
The Company was incorporated on June 21,
2005. The Company operates as a specialty pharmaceutical company developing treatments for substance use, addictive and eating
disorders. The Company has generated limited revenues from inception through the date of this report. The likelihood of success
must be considered in light of the problems, expenses, difficulties, complications, and delays encountered in connection with the
clinical trials that will be conducted and on the development of new solutions to common addictions and related disorders. These
potential problems include, but are not limited to, unanticipated problems relating to the clinical trials, changes in the regulatory
and competitive landscape, and additional costs and expenses that may exceed current budget estimates for the completion of the
trials. In order to complete certain clinical trials, the Company anticipates that the Company will incur increased operating expenses.
The Company expects to incur significant losses into the foreseeable future. The Company recognizes that if the Company is unable
to generate funding or sufficient revenues, the Company will not be able to earn profits or continue operations. There is no history
upon which to base any assumption as to the likelihood that the Company will prove successful. If the Company is unsuccessful in
addressing these risks, then the Company will most likely fail.
The Company may not succeed in completing
the development of the Company’s products, commercializing the Company’s products, and generating significant revenues.
Since commencing operations, the Company
has focused on the research and development of using opioid antagonists to: (i) reverse opioid overdoses, (ii) for BED; and (iii)
treat Cocaine Use Disorder. The Company’s products have generated limited revenues. The Company’s ability to generate
significant revenues and achieve profitability depends on the Company’s ability to successfully complete the development
of its products, obtain market approval, and generate significant revenues. On December 15, 2014, the Company and Adapt entered
into the Adapt Agreement that provides Adapt with a global license to develop and commercialize the Company’s intranasal
naloxone opioid overdose reversal treatment, now known as NARCAN® (naloxone hydrochloride) Nasal Spray. The loss for any reason
of Adapt as a key partner could have a significant and adverse impact on the Company’s business. If the Company is unable
to retain Adapt as a partner on commercially acceptable terms, the Company may not be able to commercialize the Company’s
treatment as planned and the Company may experience delays in or suspension of the marketing of the treatment.
The future success of the Company’s
business cannot be determined at this time, and the Company does not anticipate generating significant revenues from product sales
for the foreseeable future. Notwithstanding the foregoing, the Company expects to generate revenues from NARCAN® (naloxone
hydrochloride) Nasal Spray, for which the Company is dependent on many factors, including the performance of the Company’s
licensing partner Adapt and competition in the market. In addition, the Company has no experience in commercializing its treatments
on its own and faces a number of challenges with respect to its commercialization efforts, including, among others, that:
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the Company may
not have adequate financial or other resources to complete the development of its products;
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the Company may
not be able to manufacture its products in commercial quantities, at an adequate quality, or at an acceptable cost;
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the Company may
not be able to establish adequate sales, marketing, and distribution channels;
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healthcare professionals
and patients may not accept the Company’s treatments;
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the Company may not be aware of possible complications
from the continued use of its products since the Company has limited clinical experience with respect to the actual use of its
products;
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technological breakthroughs in reversing opioid overdoses,
treating overweight and obese patients with BED and treating Cocaine Use Disorder may reduce the demand for the Company’s
products;
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changes in the market for reversing opioid overdoses,
treating overweight and obese patients with BED, and treating Cocaine Use Disorder, new alliances between existing market participants,
and the entrance of new market participants may interfere with the Company’s market penetration efforts;
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third-party payors may not agree to reimburse patients
for any or all of the purchase price of the Company’s products, which may adversely affect patients’ willingness to
purchase the Company’s products;
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uncertainty as to
market demand may result in inefficient pricing of the Company’s products;
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the Company may
face third-party claims of intellectual property infringement;
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the Company may fail to obtain or maintain regulatory
approvals for its products in the Company’s target markets or may face adverse regulatory or legal actions relating to its
products even if regulatory approval is obtained; and
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the Company is dependent upon the results of clinical
studies relating to its products and the products of its competitors. If data from a clinical trial is unfavorable then the Company
would be reluctant to advance the specific product for the indication for which it was being developed.
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If the Company is unable to meet any one
or more of these challenges successfully, the Company’s ability to effectively commercialize its products could be limited,
which in turn could have a material adverse effect on its business, financial condition, and results of operations.
Given the Company’s lack of
revenue and cash flow, the Company may need to raise additional capital, which may be unavailable to the Company or, even if consummated,
may cause dilution or place significant restrictions on the Company’s ability to operate.
Since the Company may be unable to generate
sufficient revenue or cash flow to fund its operations for the foreseeable future, the Company may need to seek additional equity
or debt financing to provide the capital required to maintain or expand its operations. The Company may also need additional funding
to continue the development of its products, increase its sales and marketing capabilities, promote brand identity, or develop
or acquire complementary companies, technologies and assets, as well as for working capital requirements and other operating and
general corporate purposes.
The Company does not currently have any
arrangements or credit facilities in place as a source of funds, and there can be no assurance that the Company will be able to
raise sufficient additional capital if needed on acceptable terms, or at all. If such financing is not available on satisfactory
terms, or is not available at all, the Company may be required to delay, scale back, or eliminate the development of business
opportunities and its ability to achieve its business objectives, its competitiveness, and its operations and financial condition
may be materially adversely affected. The Company’s inability to fund its business could thus lead to the loss of your investment.
If the Company raises additional capital
by issuing equity securities and/or equity-linked securities, the percentage ownership of the Company’s existing stockholders
may be reduced, and accordingly these stockholders may experience substantial dilution. The Company may also issue equity securities
and/or equity-linked securities that provide for rights, preferences, and privileges senior to those of its common stock. Given
the Company’s need for cash and that equity and equity-linked issuances are very common types of fundraising for companies
like the Company, the risk of dilution is particularly significant for stockholders of the Company.
Debt financing, if obtained, may involve
agreements that include liens on the Company’s assets and covenants limiting or restricting the Company’s ability
to take specific actions such as incurring additional debt. Debt financing could also be required to be repaid regardless of the
Company’s operating results.
If the Company raises additional funds
through collaborations and licensing arrangements, the Company may be required to relinquish some rights to its products, or to
grant licenses on terms that are not favorable to the Company.
The Company’s current and
future operations substantially depend on the Company’s management team and the Company’s ability to hire other key
personnel, the loss of any of whom could disrupt the Company’s business operations.
The Company’s business depends and
will continue to depend in substantial part on the continued service of Dr. Roger Crystal and Kevin Pollack. The loss of the services
of either of these individuals would significantly impede implementation and execution of the Company’s business strategy
and may result in the failure to reach its goals. The Company does not carry key person life insurance on any of its management,
which would leave the Company uncompensated for the loss of any of its management.
The Company’s future viability and
ability to achieve sales and profits will also depend on the Company’s ability to attract, train, retain, and motivate highly
qualified personnel in the diverse areas required for continuing its operations. There is a risk that the Company will be unable
to attract, train, retain, or motivate qualified personnel, both near term or in the future, and the Company’s failure to
do so may severely damage its prospects.
The Company’s independent
auditor has issued an audit opinion for the Company which includes a statement describing the company’s going concern status.
The Company’s financial status creates a doubt whether the Company will continue as a going concern.
Based on the Company’s financial
history since inception, the Company’s independent registered public accounting firm has expressed substantial doubt as
to the Company’s ability to continue as a going concern. The Company has generated limited revenue to date.
The Company’s products may
have undesirable side effects which may delay or prevent marketing approval, or, if approval is received, require it to be taken
off the market, require it to include safety warnings or otherwise limit sales of the product.
Unforeseen side effects from the Company’s
products could arise either during clinical development or, if approved, after the Company’s products has been marketed.
This could cause regulatory approvals for, or market acceptance of, the Company’s products harder and more costly to obtain.
To date, no serious adverse events have
been attributed to the Company’s products. The results of the Company’s planned or any future clinical trials may
show that the Company’s products causes undesirable or unacceptable side effects, which could interrupt, delay or halt clinical
trials, and result in delay of, or failure to obtain, marketing approval from the FDA and other regulatory authorities, or result
in marketing approval from the FDA and other regulatory authorities with restrictive label warnings. If the Company’s
products receive marketing approval and the Company or others later identify undesirable or unacceptable side effects caused by
the use of the Company’s products:
• regulatory authorities may withdraw
their approval of the products, which would force the Company to remove its products from the market;
• regulatory authorities may require
the addition of labeling statements, specific warnings, a contraindication, or field alerts to physicians, pharmacies, and others;
• the Company may be required to
change instructions regarding the way the products are administered, conduct additional clinical trials, or change the labeling
of the products;
• the Company may be subject to limitations
on how it may promote the products;
• sales of the products may decrease
significantly;
• the Company may be subject to litigation
or product liability claims; and
• the Company’s reputation
may suffer.
Any of these events could prevent the
Company or its potential future collaborators from achieving or maintaining market acceptance of the Company’s products
or could substantially increase commercialization costs and expenses, which in turn could delay or prevent the Company from generating
significant revenues from the sale of its products.
The Company currently has no marketing
and sales organization and has no experience as a company in marketing pharmaceutical products. If the Company is unable to establish
its own marketing and sales capabilities, or enter into agreements with third parties, to market and sell the Company’s
products after they are approved, the Company may not be able to generate product revenues.
The Company does not have a sales organization
for the marketing, sales, and distribution of any pharmaceutical products. In order to commercialize the Company’s products
or any other product candidate the Company may develop or acquire in the future, the Company must develop these capabilities on
its own or make arrangements with third parties for the marketing, sales, and distribution of its products. The establishment
and development of the Company’s own sales force would be expensive and time consuming and could delay any product launch,
and the Company cannot be certain that it would be able to successfully develop this capability. As a result, the Company may
seek one or more licensing partners to handle some or all of the sales and marketing of its products in the U.S. and elsewhere.
There also may be certain markets within the U.S. and elsewhere for the Company’s products for which the Company may seek
a co-promotion arrangement. However, the Company may not be able to enter into arrangements with third parties to sell its products
on favorable terms or at all. In the event the Company is unable to develop its own marketing and sales force or collaborate with
a third-party marketing and sales organization, the Company would not be able to commercialize its products or any other product
candidates that it develops, which would negatively impact its ability to generate product revenues. Furthermore, whether the
Company commercializes products on its own or relies on a third party to do so, the Company’s ability to generate revenue
would be dependent on the effectiveness of the sales force. In addition, to the extent the Company relies on third parties to
commercialize its approved products, the Company would likely receive less revenues than if the Company commercialized these products
itself.
The Company relies heavily on Adapt
Pharma Operations Limited license to develop and commercialize the Company’s intranasal naloxone opioid overdose reversal
treatment.
On December 15, 2014, the Company and
Adapt entered into a License Agreement that provides Adapt with a global license to develop and commercialize the Company’s
intranasal naloxone opioid overdose reversal treatment, now known as NARCAN® (naloxone hydrochloride) Nasal Spray. The Company
may be unable to establish or maintain this relationship on a commercially reasonable basis, if at all. In addition, Adapt may
have similar or more established relationships with the Company’s competitors or larger customers. Moreover, the loss for
any reason of Adapt as a key partner could have a significant and adverse impact on the Company’s business. If the Company
is unable to retain Adapt as a partner on commercially acceptable terms, the Company may not be able to commercialize the Company’s
products as planned and the Company may experience delays in or suspension of the marketing of the Company’s products. The
same could apply to other product candidates the Company may develop or acquire in the future. The Company’s dependence
upon third parties may adversely affect the Company’s ability to generate profits or acceptable profit margins and the Company’s
ability to develop and deliver such products on a timely and competitive basis.
The Company is exposed to product
liability, non-clinical and clinical liability risks which could place a substantial financial burden upon the Company, should
lawsuits be filed against the Company.
The Company’s business exposes the
Company to potential product liability and other liability risks that are inherent in the testing, manufacturing, and marketing
of pharmaceutical formulations and products. The Company expects that such claims are likely to be asserted against the Company
at some point. In addition, the use in the Company’s clinical trials of pharmaceutical formulations and products and the
subsequent sale of these formulations or products by the Company or the Company’s potential collaborators may cause the
Company to bear a portion of or all product liability risks. Any claim under any existing insurance policies or any insurance
policies secured in the future may be subject to certain exceptions, and may not be honored fully, in part, in a timely manner,
or at all, and may not cover the full extent of liability the Company may actually face. Therefore, a successful liability claim
or series of claims brought against the Company could have a material adverse effect on the Company’s business, financial
condition, and results of operations.
Risks Related to the Company’s Common Stock
The trading in the Company’s
shares is regulated by Securities and Exchange Commission rule 15g-9 which established the definition of a “penny stock.”
Although the Company’s shares are
currently traded at a price higher than $5.00, the Company’s shares have frequently traded in the past at a price lower
than $5.00. If the Company’s share price goes below $5.00, the shares will be defined as a “Penny Stock” under
the Securities and Exchange Act of 1934, as amended (the “Exchange Act”) and rules of the Commission. Penny stocks
generally are equity securities with a price of less than $5.00 (other than securities registered on certain national securities
exchanges or quoted on the NASDAQ system). Penny stock rules require a broker-dealer, prior to a transaction in a penny stock
not otherwise exempt from the rules, to deliver a standardized risk disclosure document that provides information about penny
stocks and the risks in the penny stock market. The broker-dealer also must provide the customer with current bid and offer quotations
for the penny stock, the compensation of the broker-dealer and its salesperson in the transaction, and monthly account statements
showing the market value of each penny stock held in the customer’s account. The broker-dealer must also make a special
written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser’s written
agreement to the transaction. These requirements may have the effect of reducing the level of trading activity, if any, in the
secondary market for a security that becomes subject to the penny stock rules. The additional burdens imposed upon broker-dealers
by such requirements may discourage broker-dealers from effecting transactions in the Company’s securities, which could
severely limit the market price and liquidity of the Company’s securities. These requirements may restrict the ability of
broker-dealers to sell the Company’s common stock and may affect your ability to resell Company’s common stock.
The Company will incur ongoing costs and
expenses for SEC reporting and compliance. Without revenue the Company may not be able to remain in compliance, making it difficult
for investors to sell their shares, if at all.
The Company’s shares are quoted
on the OTCQB Market under the symbol “OPNT.” To be eligible for quotation, issuers must remain current in their filings
with the SEC. In order for the Company to remain in compliance the Company will require cash to cover the cost of these filings,
which could comprise a substantial portion of the Company’s available cash resources. If the Company is unable to remain
in compliance it may be difficult for the Company’s stockholders to resell any shares, if at all.
The Company does not anticipate
declaring any cash dividends on the Company’s common stock.
The Company currently intends to retain any future earnings
for use in the operation and expansion of the Company’s business. Accordingly, the Company does not expect to pay any dividends
in the foreseeable future, but will review this policy as circumstances dictate.
The Company is registering an
aggregate of 15,715 shares of common stock, 45,000 shares of common stock underlying warrants and 2,000,000 shares of common stock
underlying options. The sales of such shares could depress the market price of the Company’s common stock.
The Company is registering aggregate
of 15,715 shares of common stock, 45,000 shares of common stock underlying warrants and 2,000,000 shares of common stock underlying
options under this prospectus. The 2,060,715 total shares would represent approximately 101.94% of the Company’s shares
of common stock outstanding held by non-affiliates, assuming that all the security holders exercised all of their warrants and
options. The sale of these shares into the public market could depress the market price of the Company’s common stock.
As an “emerging growth company”
under applicable law, the Company is subject to lessened disclosure requirements, which could leave the Company’s stockholders
without information or rights available to stockholders of more mature companies.
For as long as the Company remains an
“emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 (which we refer to herein
as the JOBS Act), the Company has elected to take advantage of certain exemptions from various reporting requirements that are
applicable to other public companies that are not “emerging growth companies” including, but not limited to:
• not being required to comply with
the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act;
• taking advantage of an extension
of time to comply with new or revised financial accounting standards;
• reduced disclosure obligations
regarding executive compensation in the Company’s periodic reports and proxy statements; and
• exemptions from the requirements
of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not
previously approved.
The Company expects to take advantage
of these reporting exemptions until the Company is no longer an “emerging growth company.” Because of these lessened
regulatory requirements, the Company’s stockholders would be left without information or rights available to stockholders
of more mature companies.
Because the Company has elected
to use the extended transition period for complying with new or revised accounting standards for an “emerging growth company”
its financial statements may not be comparable to companies that comply with public company effective dates.
The Company has elected to use the extended
transition period for complying with new or revised accounting standards under Section 102(b)(1) of the JOBS Act. This election
allows the Company to delay the adoption of new or revised accounting standards that have different effective dates for public
and private companies until those standards apply to private companies. As a result of this election, the Company’s financial
statements may not be comparable to companies that comply with public company effective dates, and thus investors may have difficulty
evaluating or comparing the Company’s business, performance or prospects in comparison to other public companies, which
may have a negative impact on the value and liquidity of the Company’s common stock.
The Company will incur ongoing costs
and expenses for SEC reporting and compliance. Without significant revenue the Company may not be able to remain in compliance,
making it difficult for investors to sell their shares, if at all.
The Company’s shares are quoted
on the OTCQB Market under the symbol “OPNT”. To be eligible for quotation, issuers must remain current in their filings
with the SEC. In order for the Company to remain in compliance the Company will require cash to cover the cost of these filings,
which could comprise a substantial portion of the Company’s available cash resources. If the Company is unable to remain
in compliance it may be difficult for the Company’s shareholders to resell any shares, if at all.
SPECIAL NOTE REGARDING
FORWARD-LOOKING STATEMENTS
Certain information contained in this
Registration Statement includes forward-looking statements. The statements herein which are not historical reflect the Company’s
current expectations and projections about the Company’s future results, performance, liquidity, financial condition, prospects
and opportunities and are based upon information currently available to the Company and its management and management’s
interpretation of what is believed to be significant factors affecting the business, including many assumptions regarding future
events. Such forward-looking statements include statements regarding, among other things, (i) the Company’s projected sales
and profitability; (ii) the Company’s growth strategies; (iii) anticipated trends in the Company’s industry; (iv)
the Company’s future financing plans; and (v) the Company’s anticipated needs for working capital. Forward-looking
statements, which involve assumptions and describe the Company’s future plans, strategies, and expectations, are generally
identifiable by use of the words “will,” “shall,” “may,” “should,” “expect,”
“anticipate,” “estimate,” “believe,” “intend,” “plan,” or “project”
or the negative of these words or other variations on these words or comparable terminology. Actual results, performance, liquidity,
financial condition, prospects and opportunities could differ materially from those expressed in, or implied by, these forward-looking
statements as a result of various risks, uncertainties and other factors, including the ability to raise sufficient capital to
continue the Company’s operations. Actual events or results may differ materially from those discussed in forward-looking
statements as a result of various factors, including, without limitation, the risks outlined under “Risk Factors”
and matters described in this Registration Statement generally. In light of these risks and uncertainties, there can be no assurance
that the forward-looking statements contained in this Registration Statement will in fact occur.
Prospective investors should not place
undue reliance on any forward-looking statements. Except as expressly required by the federal securities laws, there is no undertaking
to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changed circumstances
or any other reason.
The specific discussions herein about
the Company include financial projections and future estimates and expectations about the Company’s business. The projections,
estimates and expectations are presented in this Registration Statement only as a guide about future possibilities and do not
represent actual amounts or assured events. All the projections and estimates are based exclusively on the Company management’s
own assessment of its business, the industry in which it works and the economy at large and other operational factors, including
capital resources and liquidity, financial condition, fulfillment of contracts and opportunities. The actual results may differ
significantly from the projections.
Prospective investors should not make an investment decision
based solely on the Company’s projections, estimates or expectations.
USE OF PROCEEDS
The Company will not receive any proceeds
from the sale of the shares of the Company’s common stock offered under this prospectus by the selling security holders.
Rather, the selling security holder will receive those proceeds directly. The Company has agreed to bear the expenses (other
than any underwriting discounts or selling commissions or any legal expenses incurred by any selling security holder) in connection
with the registration of the shares of the Company’s common stock being offered for resale hereunder by the selling security
holders.
DETERMINATION OF
OFFERING PRICE
The Company determined the offering price
based on the average of the high and low prices of the common stock as reported on the OTC Markets on March 30, 2016.
SELLING SECURITY
HOLDERS
The shares of common stock being offered
for resale by the selling security holders consist of 15,715 shares of common stock, 45,000 shares of common stock underlying
warrants and 2,000,000 shares of common stock underlying options.
The table below lists the following information
with respect to the selling security holders: (i) the number of outstanding shares of common stock beneficially owned by the selling
security holders prior to this offering assuming all of the eligible options and warrants held by such security holders had been
exercised; (ii) the number of shares of common stock offered by the selling security holders in this offering; (iii) the number
of shares of common stock to be beneficially owned by the selling security holders after the completion of this offering, assuming
the sale of all of the shares of common stock offered by the selling security holders; and (iv) the percentage of outstanding
shares of common stock to be beneficially owned by the selling security holders after the completion of this offering, assuming
the sale of all of the shares of common stock offered by the selling security holders.
Information presented in the table below
is from the selling security holders and the Company’s stock ownership records.
The aggregate number of shares of the
Company’s common stock in this offering constitutes approximately 101.94% of the outstanding shares of the Company’s
common stock based on 2,021,577 shares of common stock outstanding as of August 18, 2016, and assuming that all of the selling
security holders exercise their warrants and options.
The selling security holders may, from
time to time, sell all, some or none of their shares in this offering. See “Plan of Distribution” below. No estimate
can be given as to the number of shares that will be held by the selling security holders after completion of this offering, because
the selling security holders may offer some or all of the shares, and, to the Company’s knowledge, there are currently no
agreements, arrangements or understandings with respect to the sale of any of the shares. The shares numbers provided below reflect
the share numbers after the December 2014 reverse stock split.
|
Name
*
|
|
Shares of
Common Stock
Beneficially
Owned Prior to
Offering
|
|
|
Common
Stock to be Registered
|
|
|
Option
Shares to be
Registered
|
|
|
Warrant
Shares to
be
Registered
|
|
|
Number of
Shares of
Common Stock
Beneficially
Owned After
Offering
|
|
|
Percentage
Ownership After
Offering (+)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Michael Sinclair (1)
|
|
|
1,066,670
|
|
|
|
|
|
|
|
475,000
|
|
|
|
|
|
|
|
591,670
|
|
|
|
20.18
|
%
|
|
Roger Crystal (2)
|
|
|
1,430,000
|
|
|
|
|
|
|
|
500,000
|
|
|
|
-
|
|
|
|
930,000
|
|
|
|
26.98
|
%
|
|
Kevin Pollack (3)
|
|
|
1,460,000
|
|
|
|
|
|
|
|
500,000
|
|
|
|
|
|
|
|
960,000
|
|
|
|
27.57
|
%
|
|
Geoffrey Wolf (4)
|
|
|
381,000
|
|
|
|
|
|
|
|
187,500
|
|
|
|
|
|
|
|
193,500
|
|
|
|
17.25
|
%
|
|
Gerald Amato
|
|
|
15,715
|
|
|
|
15,715
|
|
|
|
|
|
|
|
|
|
|
|
0
|
|
|
|
0
|
%
|
|
Arvind Agrawal (5)
|
|
|
175,000
|
|
|
|
|
|
|
|
175,000
|
|
|
|
|
|
|
|
0
|
|
|
|
0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Phax Limited (6)
|
|
|
40,000
|
|
|
|
|
|
|
|
40,000
|
|
|
|
|
|
|
|
0
|
|
|
|
0
|
%
|
|
Pacific Link Consulting (7)
|
|
|
15,000
|
|
|
|
|
|
|
|
15,000
|
|
|
|
|
|
|
|
0
|
|
|
|
0
|
%
|
|
Brad Miles (8)
|
|
|
142,500
|
|
|
|
|
|
|
|
97,500
|
|
|
|
45,000
|
|
|
|
0
|
|
|
|
0
|
%
|
|
Mary Farrell
(9)
|
|
|
10,000
|
|
|
|
|
|
|
|
10,000
|
|
|
|
|
|
|
|
0
|
|
|
|
0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
|
15,715
|
|
|
|
2,000,000
|
|
|
|
45,000
|
|
|
|
|
|
|
|
|
|
* The security holders
own options or warrants and underlying such options or warrants are shares of common stock of the Company. Such underlying shares
are set forth in the table above and are the shares being registered hereto. For purposes of this table, the Company has assumed
that the security holders exercised all of their options and warrants with respect to all of the shares underlying such options
and warrants set forth in the table as of the date hereof.
+ Based on 2,021,577
shares of common stock issued and outstanding as of August 18, 2016 and on a fully-diluted basis. Beneficial ownership percentage
is determined under the rules of the SEC and includes investment power with respect to common stock. The number of shares beneficially
owned by a person includes shares of common stock underlying warrants, stock options and other derivative securities to acquire
our common stock held by that person that are currently exercisable or convertible within 60 days after August 18, 2016. The shares
issuable under these securities are treated as outstanding for computing the percentage ownership of the person holding these
securities, but are not treated as outstanding for the purposes of computing the percentage ownership of any other person.
|
(1)
|
Michael Sinclair is registering
150,000 shares of common stock underlying options with an exercise price of $5.00 per share, vested on June 15, 2014, with
an expiration date of June 14, 2024; 75,000 shares of common stock underlying options with an exercise price of $6.00 per
share, vested on December 31, 2013, with an expiration date of December 30, 2023; and 250,000 shares of common stock underlying
options with an exercise price of $7.25 per share, vested on October 27, 2015, with an expiration date of October 26, 2025. All
option grant dates are the same dates as the vesting dates.
|
|
|
|
|
|
For purposes of calculating beneficial ownership,
Mr. Sinclair beneficially owns 156,670 shares of common stock, 910,000 options and 0
warrants that are exercisable within 60 days after August 18, 2016.
|
|
|
|
|
(2)
|
Roger Crystal is registering 150,000
shares of common stock underlying options with an exercise price of $5.00 per share, vested on June 15, 2014, with an expiration
date of June 14, 2024; 75,000 shares of common stock underlying options with an exercise price of $6.00 per share, vested
on December 31, 2013, with an expiration date of December 30, 2023; and 275,000 shares of common stock underlying options
with an exercise price of $7.25 per share, vested on October 27, 2015, with an expiration date of October 26, 2025. All
option grants dates are the same dates as the vesting dates.
|
|
|
|
|
|
For purposes of calculating beneficial ownership,
Mr. Crystal beneficially owns 5,000 shares of common stock, 1,425,000 options and 0 warrants
that are exercisable within 60 days after August 18, 2016.
|
|
|
|
|
(3)
|
Kevin Pollack is
registering 150,000 shares of common stock underlying options with an exercise price of $5.00 per share, vested on June
15, 2014, with an expiration date of June 14, 2024; 75,000 shares of common stock underlying options with an exercise
price of $6.00 per share, vested on December 31, 2013, with an expiration date of December 30, 2023; and 220,000 shares
of common stock underlying options with an exercise price of $7.25 per share, vested on October 27, 2015, with an expiration
date of October 26, 2025. All option grant dates are the same dates as the vesting dates.
Mr. Pollack is also
registering 2,500 shares of common stock underlying options with an exercise price of $10.00 per share, granted on April
17, 2012, vested on April 17, 2012, with an expiration date of April 16, 2017; 2,500 shares of common stock underlying
options with an exercise price of $10.00 per share, granted on April 17, 2012, vested on July 17, 2012, with an expiration
date of July 16, 2017; 2,500 shares of common stock underlying options with an exercise price of $10.00 per share, granted
on April 17, 2012, vested on October 17, 2012, with an expiration date of October 16, 2017; and 2,500 shares of common
stock underlying options with an exercise price of $10.00 per share, granted on April 17, 2012, vested on January 17,
2013, with an expiration date of January 16, 2018.
In addition, Mr.
Pollack is also registering 1,250 shares of common stock underlying options with an exercise price of $10.00 per share,
granted on April 17, 2012, vested on April 17, 2013, with an expiration date of April 16, 2018, 1,250 shares of common
stock underlying options with an exercise price of $10.00 per share, granted on April 17, 2012, vested on July 17, 2013,
with an expiration date of July 16, 2018; 1,250 shares of common stock underlying options with an exercise price of $10.00
per share, granted on April 17, 2012, vested on October 17, 2013, with an expiration date of October 16, 2018; 1,250 shares
of common stock underlying options with an exercise price of $10.00 per share, granted on April 17, 2012, vested on January
17, 2014, with an expiration date of January 16, 2019; 1,250 shares common stock underlying options with an exercise price
of $10.00 per share, granted on April 17, 2012, vested on April 17, 2014, with an expiration date of April 16, 2019; 1,250
shares of common stock underlying options with an exercise price of $10.00 per share, granted on April 17, 2012, vested
on July 17, 2014, with an expiration date of July 16, 2019; 1,250 shares of common stock underlying options with an exercise
price of $10.00 per share, granted on April 17, 2012, vested on October 17, 2014, with an expiration date of October 16,
2019; and 1,250 of common shares underlying options with an exercise price of $10.00 per share, granted on April 17, 2012,
vested on January 17, 2015, with an expiration date of January 16, 2020.
In addition, Mr.
Pollack is also registering 18,125 shares of common stock underlying options with an exercise price of $12.00 per share,
granted on November 26, 2012, vested on November 26, 2012, with an expiration date of November 25, 2022; 5,625 shares
of common stock underlying options with an exercise price of $12.00 per share, granted on November 26, 2012, vested on
February 26, 2013, with an expiration date of February 25, 2023; 5,625 shares of common stock underlying options with
an exercise price of $12.00 per share, granted on November 26, 2012, vested on May 26, 2013, with an expiration date of
May 25, 2023; and 5,625 shares of common stock underlying options with an exercise price of $12.00 per share, granted
on November 26, 2012, vested on August 26, 2013, with an expiration date of August 25, 2023.
For purposes of calculating
beneficial ownership, Mr. Pollack beneficially owns 0 shares of common stock, 1,460,000 options and 0 warrants that are
exercisable within 60 days after August 18, 2016.
|
|
(4)
|
Geoffrey
Wolf is registering 75,000 shares of common stock underlying options with an exercise price of $5.00 per share, granted on
June 15, 2014, vested on June 15, 2014, with an expiration date of June 14, 2024; 62,500 shares of common stock underlying
options with an exercise price of $7.25 per share, granted on October 27, 2015, vested on October 27, 2015, with an expiration
date of October 26, 2025; and 50,000 shares of common stock underlying options with an exercise price of $8.00 per share,
granted on June 15, 2014, vested on June 15, 2014, with an expiration date of June 14, 2024.
|
|
|
|
|
|
For purposes of calculating beneficial ownership, Mr. Wolf
beneficially owns 56,500 shares of common stock, 187,500 options and 137,000 warrants that are exercisable within 60 days
after August 18, 2016.
|
|
|
|
|
(5)
|
Arvind
Agrawal is registering 125,000 shares of common stock underlying options with an exercise price of $7.25 per share, granted
on October 27, 2015, vested on October 27, 2015, with an expiration date of October 26, 2025; 30,000 shares of common stock
underlying options with an exercise price of $10.00 per share, granted on November 12, 2014, with varying vesting dates, with
an expiration date of November 11, 2019; and 20,000 shares of common stock underlying options with an exercise price of $15.00
per share, granted on November 12, 2014, with varying vesting dates, with an expiration of November 11, 2019.
|
|
|
|
|
(6)
|
Phax Limited is registering
30,000 shares of common stock underlying options with an exercise price of $10.00 per share, granted on August 2, 2014,
vested on August 2, 2014, with an expiration date of August 1, 2019; and 10,000 shares of common stock underlying options
with an exercise price of $10.00 per share, granted on January 25, 2015, vested on January 25, 2015, with an expiration
date of January 24, 2020.
Mark Ellison has
sole voting and investment control with respect to the shares underlying options offered by Phax Limited.
|
|
|
|
|
(7)
|
Pacific Link Consulting
is registering 15,000 shares of common stock underlying options with an exercise price of $10.00 per share, granted and
vested on January 9, 2015, with an expiration date of January 8, 2020.
Richard Lowenthal
has sole voting and investment control with respect to the shares offered by Pacific Link Consulting.
|
|
|
|
|
(8)
|
Brad
Miles is registering 45,000 shares of common stock underlying warrants with an exercise price of $10.00 per share, granted
and vested on March 19, 2015, with an expiration date of March 18, 2020; 48,000 shares of common stock underlying options
with an exercise price of $10.00 per share, granted and vested on March 19, 2015, with an expiration date of March 18, 2020;
17,500 shares of common stock underlying options with an exercise price of $15.00 per share, granted and vested on January
22, 2013, with an expiration date of January 22, 2018; and 32,000 shares of common stock underlying options with an exercise
price of $15.00 per share, granted and vested on March 19, 2015, with an expiration date of March 18, 2020.
|
|
|
|
|
(9)
|
Mary Farrell is registering
10,000 shares of common stock underlying options with an exercise price of $10.00 per share, granted and vested on July
15, 2015, with an expiration date of July 14, 2018.
|
PLAN
OF DISTRIBUTION
The shares
of common stock being offered for resale by the selling security holders consist of 15,715 shares of common stock, 45,000 shares
of common stock underlying warrants and 2,000,000 shares of common stock underlying options. The Company registering the shares
of common stock issued to the selling security holders to permit the resale of these shares of common stock by the holders of
the shares of common stock from time to time after the date of this prospectus. The Company will not receive any of the proceeds
from the sale by the selling security holders of the shares of common stock. The Company will bear all fees and expenses incident
to the Company’s obligation to register the shares of common stock.
The selling security
holders may sell all or a portion of the shares of common stock beneficially owned by them and offered hereby from time to time
directly or through one or more underwriters, broker-dealers or agents. If the shares of common stock are sold through underwriters
or broker-dealers, the selling security holders will be responsible for underwriting discounts or commissions or agent’s
commissions. The shares of common stock may be sold in one or more transactions, which may involve crosses or block transactions,
and may be sold on any national securities exchange or quotation service on which the Company’s common stock may be listed
or quoted at the time of sale, in the over-the-counter market, or in transactions otherwise than on these exchanges or systems.
Sales of the common stock to be registered hereunder could be made at prevailing market prices at the time of the sale, at fixed
prices, at negotiated prices, or at varying prices determined at the time of sale. As a result, the Company cannot know the price
at which any of the Company’s common stock to be registered hereunder may ultimately be sold by the holders thereof.
The selling security
holders may use any one or more of the following methods when selling shares:
|
|
•
|
ordinary
brokerage transactions and transactions in which the broker-dealer solicits purchasers;
|
|
|
|
|
|
|
•
|
block
trades in which the broker-dealer will attempt to sell the shares as agent but may position and resell a portion of the block
as principal to facilitate the transaction;
|
|
|
|
|
|
|
•
|
purchases
by a broker-dealer as principal and resale by the broker-dealer for its account;
|
|
|
|
|
|
|
•
|
an
exchange distribution in accordance with the rules of the applicable exchange;
|
|
|
|
|
|
|
•
|
privately
negotiated transactions;
|
|
|
|
|
|
|
•
|
settlement
of short sales entered into after the effective date of the registration statement of which this prospectus is a part;
|
|
|
|
|
|
|
•
|
broker-dealers
may agree with the selling security holders to sell a specified number of such shares at a stipulated price per share;
|
|
|
|
|
|
|
•
|
through
the writing or settlement of options or other hedging transactions, whether such options are listed on an options exchange
or otherwise;
|
|
|
|
|
|
|
•
|
a
combination of any such methods of sale; and
|
|
|
|
|
|
|
•
|
any
other method permitted pursuant to applicable law.
|
The selling security
holders also may resell all or a portion of the shares in open market transactions in reliance upon Rule 144 under the Securities
Act, as permitted by that rule, or Section 4(a)(1) under the Securities Act, if available, rather than under this prospectus,
provided that they meet the criteria and conform to the requirements of those provisions, including the requirements of Rule 144(i)
applicable to former “shell companies.”
Broker-dealers
engaged by the selling security holders may arrange for other broker-dealers to participate in sales. If the selling security
holders effect such transactions by selling shares of common stock to or through underwriters, broker-dealers or agents, such
underwriters, broker-dealers or agents may receive commissions in the form of discounts, concessions or commissions from the selling
security holders or commissions from purchasers of the shares of common stock for whom they may act as agent or to whom they may
sell as principal. Such commissions will be in amounts to be negotiated, but, except as set forth in a supplement to this prospectus,
in the case of an agency transaction will not be in excess of a customary brokerage commission in compliance with FINRA Rule 5110.
In connection
with sales of the shares of common stock or otherwise, the selling security holders may enter into hedging transactions with broker-dealers
or other financial institutions, which may in turn engage in short sales of the shares of common stock in the course of hedging
in positions they assume. The selling security holders may also sell shares of common stock short and if such short sale shall
take place after the date that this registration statement is declared effective by the SEC, the selling security holders may
deliver shares of common stock covered by this prospectus to close out short positions and to return borrowed shares in connection
with such short sales. The selling security holders may also loan or pledge shares of common stock to broker-dealers that in turn
may sell such shares, to the extent permitted by applicable law. The selling security holders may also enter into option or other
transactions with broker-dealers or other financial institutions or the creation of one or more derivative securities which require
the delivery to such broker-dealer or other financial institution of shares offered by this prospectus, which shares such broker-dealer
or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).
Notwithstanding the foregoing, the selling security holders have been advised that they may not use shares registered pursuant
to this registration statement to cover short sales of the Company’s common stock made prior to the date the registration
statement of which this prospectus forms a part is declared effective by the SEC.
The selling security
holders may, from time to time, pledge or grant a security interest in some or all of the shares of common stock owned by them
and, if they default in the performance of their secured obligations, the pledgees or secured parties may offer and sell the shares
of common stock from time to time pursuant to this prospectus or any amendment to this prospectus under Rule 424(b)(3) or other
applicable provision of the Securities Act, amending, if necessary, the list of selling security holders to include the pledgee,
transferee or other successors in interest as selling security holders under this prospectus. The selling security holders also
may transfer and donate the shares of common stock in other circumstances in which case the transferees, donees, pledgees or other
successors in interest will be the selling beneficial owners for purposes of this prospectus.
The selling security
holders and any broker-dealer or agents participating in the distribution of the shares of common stock offered hereby may be
deemed to be “underwriters” within the meaning of Section 2(11) of the Securities Act in connection with such
sales. In such event, any commissions paid, or any discounts or concessions allowed to, any such broker-dealer or agent and any
profit on the resale of the shares purchased by them may be deemed to be underwriting commissions or discounts under the Securities
Act. Selling security holders who are “underwriters” within the meaning of Section 2(11) of the Securities Act
will be subject to the prospectus delivery requirements of the Securities Act and may be subject to certain statutory liabilities
of, including but not limited to, Sections 11, 12 and 17 of the Securities Act and Rule 10b-5 under the Exchange Act.
Each selling
stockholder has informed the Company that it is not a registered broker-dealer and does not have any written or oral agreement
or understanding, directly or indirectly, with any person to distribute the common stock. Upon the Company being notified in writing
by a selling stockholder that any material arrangement has been entered into with a broker-dealer for the sale of common stock
through a block trade, special offering, exchange distribution or secondary distribution or a purchase by a broker-dealer, a supplement
to this prospectus will be filed, if required, pursuant to Rule 424(b) under the Securities Act, disclosing (i) the name
of each such selling stockholder and of the participating broker-dealer(s), (ii) the number of shares involved, (iii) the
price at which such the shares of common stock were sold, (iv) the commissions paid or discounts or concessions allowed to
such broker-dealer(s), where applicable, (v) that such broker-dealer(s) did not conduct any investigation to verify the information
set out or incorporated by reference in this prospectus, and (vi) other facts material to the transaction. In no event shall
any broker-dealer receive fees, commissions and markups, which, in the aggregate, would exceed eight percent (8%).
Under the securities
laws of some states, the shares of common stock may be sold in such states only through registered or licensed brokers or dealers.
In addition, in some states the shares of common stock may not be sold unless such shares have been registered or qualified for
sale in such state or an exemption from registration or qualification is available and is complied with in all respects.
Any selling stockholder
may sell some, all or none of the shares of common stock to be registered pursuant to the registration statement of which this
prospectus forms a part.
Each selling
stockholder and any other person participating in such distribution will be subject to applicable provisions of the Exchange Act
and the rules and regulations thereunder, including, without limitation, Regulation M of the Exchange Act, which may limit the
timing of purchases and sales of any of the shares of common stock by the selling stockholder and any other participating person.
Regulation M may also restrict the ability of any person engaged in the distribution of the shares of common stock to engage in
market-making activities with respect to the shares of common stock. All of the foregoing may affect the marketability of the
shares of common stock and the ability of any person or entity to engage in market-making activities with respect to the shares
of common stock.
The Company will
pay all expenses of the registration of the shares of common stock, including, without limitation, SEC filing fees and expenses
of compliance with state securities or “blue sky” laws;
provided
,
however
, that each selling
stockholder will pay all underwriting discounts and selling commissions, if any, and any legal expenses incurred by it. The Company
will indemnify the selling security holders against certain liabilities, including some liabilities under the Securities Act or
the selling security holders will be entitled to contribution. The Company may be indemnified by the selling security holders
against civil liabilities, including liabilities under the Securities Act, that may arise from any written information furnished
to the Company by the selling security holders specifically for use in this prospectus or the Company may be entitled to contribution.
DESCRIPTION OF SECURITIES
TO BE REGISTERED
Authorized Capital Stock
The authorized capital stock of the
Company consists of one billion shares of common stock of which, as of August 18, 2016, 2,021,577 shares are issued and outstanding.
In the event that the warrants and options held by the security holders selling under this offering were to exercise all of their
warrants and options, there would be 4,066,577 shares issued and outstanding. The Company does not have any other class of stock
authorized to be issued.
In December 2014, the Company effected
a one-for-one hundred reverse stock split of its common stock did not affect the number of authorized shares of common stock and
preferred stock.
Common Stock
On August 10,
2009, the Company amended its Articles to increase the number of shares of common stock, par value $0.001 per share, that the Company
is authorized to issue from 75,000,000 to 200,000,000.
On November 26,
2014, the Company amended its Articles of incorporation (the “Articles”) to increase the number of shares of common
stock, par value $0.001 per share, that the Company is authorized to issue from 200,000,000 to 1,000,000,000.
As
of August 18, 2016, 2,021,577 shares of common stock are issued and outstanding. In the event that the warrants and options held
by the security holders selling under this offering were to exercise all of their warrants and options, there would be 4,066,577
shares issued and outstanding.
In December 2014,
the Company effected a one-for-one hundred reverse stock split of its common stock, which decreased the number of common shares
issued and outstanding from approximately 182.0 million shares to approximately 1.82 million shares as of December 29, 2015.
The holders of the Company’s common
stock have equal ratable rights to dividends from funds legally available if and when declared by the Company’s board of
directors (the “Board”) and are entitled to share ratably in all of the Company’s assets available for distribution
to holders of common stock upon liquidation, dissolution or winding up of the Company’s affairs. The Company’s common
stock does not provide the right to a preemptive, subscription or conversion rights and there are no redemption or sinking fund
provisions or rights. The Company’s common stock holders are entitled to one non-cumulative vote per share on all matters
on which stockholders may vote.
All shares of common stock now outstanding
are fully paid for and non-assessable. The Company refers you to its Articles of Incorporation, Bylaws, and the relevant provisions
of the Nevada Revised Statutes (“NRS”) for a more complete description of the rights and liabilities of holders of
the Company’s securities. All material terms of the Company’s common stock have been addressed in this section.
Holders of shares of the Company’s
common stock do not have cumulative voting rights, which means that the holders of more than 50% of the outstanding shares, voting
for the election of directors, can elect all of the directors to be elected, if they so choose, and, in that event, the holders
of the remaining shares will not be able to elect any of the Company’s directors.
Dividends
Under NRS 78.288,
the directors of a Nevada corporation may authorize, and the corporation may make, distributions (including cash dividends) to
stockholders, but no such distribution may be made if, after giving it effect:
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the
corporation would not be able to pay its debts as they become due in the usual course of business; or
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the
corporation’s total assets would be less than the sum of (x) its total liabilities plus (y) the amount that
would be needed, if the corporation were to be dissolved at the time of distribution, to satisfy the preferential rights upon
dissolution of stockholders whose preferential rights are superior to those receiving the distribution.
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The NRS prescribes
the timing of the determinations above depending on the nature and timing of payment of the distribution. For cash dividends paid
within 120 days after the date of authorization, the determinations above must be made as of the date the dividend is authorized.
When making their determination that a distribution is not prohibited by NRS 78.288, directors may consider:
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financial
statements prepared on the basis of accounting practices that are reasonable in the circumstances;
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a
fair valuation, including, but not limited to, unrealized appreciation and depreciation; and/or
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any
other method that is reasonable in the circumstances.
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Declaration and payment of any dividend
will be subject to the discretion of the Company’s Board, however, the time and amount of such dividends, if any, will be
dependent upon the Company’s financial condition, operations, compliance with applicable law, cash requirements and availability,
debt repayment obligations, capital expenditure needs and restrictions in the Company’s debt instruments, contractual restrictions,
business prospects, industry trends, the provisions of Nevada law affecting the payment of distributions, and any other factors
the Company’s Board may consider relevant.
Anti-Takeover Effects of the Company’s
Articles of Incorporation, as Amended, Bylaws, and Certain Provisions of Nevada Law
The Company’s Articles of Incorporation,
as amended, Bylaws, and the NRS contain provisions that may have the effect of maintaining continuity and stability in the composition
of the Company’s Board. These provisions may help the Company avoid costly takeover battles, reduce the Company’s
vulnerability to a hostile change of control and enhance the ability of the Company’s Board to effectively evaluate and
negotiate in connection with any unsolicited offer to acquire the Company. However, these provisions may have an anti-takeover
effect and may delay, deter or prevent a merger or acquisition of the Company’s company by means of a tender offer, a proxy
contest or other takeover attempt that a stockholder might consider to be in its best interest, including attempts that might
result in a premium over the prevailing market price for the shares of common stock held by stockholders.
Business Combinations and Acquisition
of Control Shares
Nevada’s “combinations with
interested stockholders” statutes (NRS 78.411 through 78.444, inclusive) prohibit specified types of business “combinations”
between certain Nevada corporations and any person deemed to be an “interested stockholder” for two years after such
person first becomes an “interested stockholder” unless the corporation’s board of directors approves the combination
(or the transaction by which such person becomes an “interested stockholder”) in advance, or unless the combination
is approved by the board of directors and sixty percent of the corporation’s voting power not beneficially owned by the
interested stockholder, its affiliates and associates. Furthermore, in the absence of prior approval certain restrictions may
apply even after such two-year period. For purposes of these statutes, an “interested stockholder” is any person who
is (1) the beneficial owner, directly or indirectly, of ten percent or more of the voting power of the outstanding voting
shares of the corporation, or (2) an affiliate or associate of the corporation and at any time within the two previous years
was the beneficial owner, directly or indirectly, of ten percent or more of the voting power of the then-outstanding shares of
the corporation. The definition of the term “combination” is sufficiently broad to cover most significant transactions
between a corporation and an “interested stockholder.” These laws generally apply to Nevada corporations with 200
or more stockholders of record, but a Nevada corporation may elect in its articles of incorporation not to be governed by these
particular laws. The Company has not made such an election.
Nevada’s
“acquisition of controlling interest” statutes (NRS 78.378 through 78.3793, inclusive) contain provisions governing
the acquisition of a controlling interest in certain Nevada corporations. These “control share” laws provide generally
that any person that acquires a “controlling interest” in certain Nevada corporations may be denied voting rights,
unless a majority of the disinterested stockholders of the corporation elects to restore such voting rights. These laws will only
apply to the Company if we were to have 200 or more stockholders of record (at least 100 of whom have addresses in Nevada appearing
on the Company’s stock ledger) and do business in the State of Nevada directly or through an affiliated corporation, unless
the Company’s articles of incorporation or bylaws in effect on the tenth day after the acquisition of a controlling interest
provide otherwise. These laws provide that a person acquires a “controlling interest” whenever a person acquires shares
of a subject corporation that, but for the application of these provisions of the NRS, would enable that person to exercise (i) one-fifth
or more, but less than one-third, (ii) one-third or more, but less than a majority or (iii) a majority or more, of all
of the voting power of the corporation in the election of directors. Once an acquirer crosses one of these thresholds, shares
which it acquired in the transaction taking it over the threshold and within the 90 days immediately preceding the date when the
acquiring person acquired or offered to acquire a controlling interest become “control shares” to which the voting
restrictions described above apply.
In addition, NRS 78.139 also provides
that directors may resist a change or potential change in control if the directors, by majority vote of a quorum, determine that
the change is opposed to, or not in, the best interest of the corporation.
Transfer Agent and Registrar
The Company’s transfer agent and
registrar is VStock Transfer, LLC, 18 Lafayette Place, Woodmere, New York 11598. Their telephone number is (212) 828-8436.
Liability and Indemnification of Directors
and Officers
The NRS empower
the Company to indemnify the Company’s directors and officers against expenses relating to certain actions, suits or proceedings
as provided for therein. In order for such indemnification to be available, the applicable director or officer must not have acted
in a manner that constituted a breach of his or her fiduciary duties and involved intentional misconduct, fraud or a knowing violation
of law and was material to the action, or must have acted in good faith and reasonably believed that his or her conduct was in,
or not opposed to, the Company’s best interests. In the event of a criminal action, the applicable director or officer must
not have had reasonable cause to believe his or her conduct was unlawful.
Under applicable
provisions of the NRS, the Company’s Articles of Incorporation, as amended, Bylaws or any separate agreement may provide
for the Company’s payment of expenses incurred by any such director or officer in advance of the final disposition of the
applicable action, suit or proceeding, upon delivery by such director or officer of an undertaking to repay all amounts so advanced
if it is ultimately determined that the director or officer is not entitled to be indemnified by the Company.
The Company’s
Bylaws provide for indemnification of the Company’s directors and officers substantially identical in scope to that permitted
under applicable Nevada law. The Company’s Bylaws also provide that the expenses of the Company’s directors and officers
incurred in defending any applicable action, suit or proceeding may be paid by the Company as they are incurred and in advance
of the final disposition of the action, suit or proceeding, provided that the required undertaking by the director or officer
is delivered to the Company.
The Company also
maintains a customary insurance policy that indemnifies the Company’s directors and officers against various liabilities,
including liabilities arising under the Securities Act of 1933, as amended (the “Securities Act”) that may be incurred
by any director or officer in his or her capacity as such.
At present, there
is no pending litigation or proceeding involving any of the Company’s directors or officers for which indemnification is
sought, nor is the Company aware of any threatened litigation that is likely to result in claims for indemnification.
Insofar as indemnification
for liabilities arising under the Securities Act may be permitted for the Company’s directors, officers and controlling
persons pursuant to the foregoing provisions, or otherwise, the Company been informed that in the opinion of the SEC such indemnification
is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event a claim for indemnification
against such liabilities (other than payment by the Company for expenses incurred or paid by a director, officer or controlling
person of ours in successful defense of any action, suit, or proceeding) is asserted by a director, officer or controlling person
in connection with the securities being registered, the Company will, unless in the opinion of the Company’s counsel the
matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction, the question of whether such
indemnification by it is against public policy in the Securities Act and will be governed by the final adjudication of such issue.
INTERESTS OF NAMED
EXPERTS AND COUNSEL
No expert or counsel named in this prospectus
as having prepared or certified any part of this prospectus or having given an opinion upon the validity of the securities being
registered or upon other legal matters in connection with the registration or offering of the common stock was employed on a contingency
basis, or had, or is to receive, in connection with the offering, a substantial interest, direct or indirect, in the registrant
or any of its parents or subsidiaries. Nor was any such person connected with the registrant or any of its parents or subsidiaries
as a promoter, managing or principal underwriter, voting trustee, director, officer, or employee.
DLA Piper LLP
(US), located at 51 John F. Kennedy Parkway, Suite 120, Short Hills, New Jersey 07078-2704, will pass on the validity of the common
stock being offered pursuant to this registration statement.
The financial statements of the Company
as of and for the years ended July 31, 2015 and 2014, incorporated in this registration statement, have been audited by MaloneBailey,
LLP, independent registered public accounting firm, as stated in their report which is incorporated herein, which report includes
an explanatory paragraph about the existence of a substantial doubt concerning the Company’s ability to continue as a going
concern, in reliance upon the report of such firm, given upon their authority as experts in accounting and auditing.
DESCRIPTION OF BUSINESS
General Information
Opiant Pharmaceuticals, Inc. (“the
Company” or the “Company”) is a specialty pharmaceutical company developing pharmacological treatments for substance
use, addictive and eating disorders. The Company was incorporated in the State of Nevada on June 21, 2005, as Madrona Ventures,
Inc. and on September 16, 2009, the Company changed its name to Lightlake Therapeutics Inc. On January 28, 2016, the Company changed
its name to Opiant Pharmaceuticals, Inc. The Company’s fiscal year end is July 31.
The Company’s strategy is to develop
treatments for substance use, addictive and eating disorders. The Company has developed a treatment for reversing opioid overdoses
in collaboration with the National Institute on Drug Abuse (“NIDA”), part of the National Institutes of Health (“NIH”).
This treatment, now known as NARCAN® (naloxone hydrochloride) Nasal Spray, was approved by the U.S. Food and Drug Administration
(“FDA”) in November 2015.
In December 2014, the Company effected
a one-for-one hundred reverse stock split of its common stock (the “1:100 Reverse Stock Split”) which decreased the
number of common shares issued and outstanding from approximately 182.0 million shares to approximately 1.82 million shares. Unless otherwise noted, all shares amounts listed in this Report been retroactively adjusted for the 1:100 Reverse
Stock Split as if such stock splits occurred prior to the issuance of such shares.
The Company has been focused on developing:
(i) a treatment to reverse opioid overdoses, (ii) a treatment for Binge Eating Disorder (“BED”), and (iii) a treatment
for Cocaine Use Disorder.
Principal Products or Services and Markets
Opioid Overdose Reversal
Naloxone is a medicine that can rapidly
reverse the overdose of prescription and illicit opioids and that historically has been available through injection. The Company’s
intranasal delivery system of naloxone could widely expand its availability and use in preventing opioid overdose deaths.
On March 14, 2014, the Company filed U.S.
Provisional Application No. 61/953,379. This application addresses delivery devices and methods of treating opioid overdoses through
the administration of intranasal naloxone.
On May 15, 2014, the Company entered
into an agreement and subsequently received funding from an individual investor in the amount of $300,000 for use by the Company
for any purpose. In exchange for this funding, the Company agreed to provide the investor with a 1.5% interest in the net profit
as related to the Company’s treatment to reverse opioid overdoses. Net profit is defined as the pre-tax profit generated
from the product after the deduction of all expenses incurred by and payments made by the Company in connection with the product,
including but not limited to an allocation of Company overhead. The investor also has rights with respect to its 1.5% interest
if the treatment is sold or the Company is sold. If the product is not introduced to the market and not approved for marketing
within 24 months, the investor will have a 60 day option to receive 37,500 shares of common stock in lieu of the 1.5% interest
in the product. The product was approved by the FDA during the six month period ended January 31, 2016 and as result the investor
will not receive the option to receive shares. During the nine months ended April 30, 2016, specifically, during the Company’s
second fiscal quarter that ended on January 31, 2016, the Company recognized $300,000 as revenue because the option to receive
the shares of common stock was removed, and the research and development work related to the product was completed.
On July 9, 2014, the Company filed U.S.
Provisional Application No. 62/022,268 with respect to the Company’s treating opioid overdoses through the administration
of intranasal naloxone.
On July 22, 2014,
the Company received a $3,000,000 commitment, from which the Company has the right to make capital calls, from a foundation for
the research, development, marketing, commercialization, and any other activities connected to the Company’s treatment to
reverse opioid overdoses, certain operating expenses, and any other purpose consistent with the goals of the foundation. In exchange
for funds invested by the foundation the Company agreed to provide the foundation with pro-rata share up to a 6.0% interest in
the net profit as related to the Company’s treatment to reverse opioid overdoses. Net profit is defined as the pre-tax profit
generated from the product after the deduction of all expenses incurred by and payments made by the Company in connection with
the product, including but not limited to an allocation of Company overhead. The foundation also has rights with respect to its
up to 6.0% interest if the treatment is sold or the Company is sold. Additionally, the Company may buyback interests from the
foundation within two and one half years or after two and a half years of the initial investment at a price of two times or three
and a half times, respectively, the relevant investment amount represented by the interests to be bought back. Such buyback can
be for a portion of the interest rather than for the entire interest. If the product is not approved by the U.S. Food and Drug
Administration or an equivalent body in Europe for marketing and is not actually marketed within 24 months the foundation will
have a 60 day option to receive shares of the Company’s common stock in lieu of the interest in the treatment at a rate
of 10 shares for every dollar of its investment. On July 28, 2014 the Company received an initial investment of $111,470 from
the foundation in exchange for a 0.22294% interest. On August 13, 2014, September 8, 2014, November 13, 2014, and February 17,
2015, the Company made capital calls of $422,344, $444,530, $1,033,614, and $988,043, respectively, from the foundation in exchange
for 0.844687%, 0.888906%, 2.067228%, and 1.976085% interests, respectively, in the net profit as related to the Company’s
treatment to reverse opioid overdoses.The product was approved by the FDA during the nine month period ended April 30, 2016 and
as result the investor will not receive the option to receive shares. During the nine months ended April 30, 2016, specifically,
during the Company’s second fiscal quarter that ended on January 31, 2016, the Company recognized $3,000,000 as revenue
because the option to receive the shares of common stock was removed, and the research and development work related to the product
was completed.
On September 9, 2014, the Company entered
into an agreement and subsequently received funding from an individual investor in the amount of $500,000 for use by the Company
for any purpose. In exchange for this funding, the Company agreed to provide the investor with a 0.98% interest in the net profit
as related to the Company’s treatment to reverse opioid overdoses. Net profit includes the pre-tax profit received by the
Company derived from the sale of the product after the deduction of all expenses incurred by and payments made by the Company
in connection with the product, including but not limited to an allocation of Company overhead. The investor also has rights with
respect to its 0.98% interest if the treatment is sold or the Company is sold. Additionally, the Company may buyback interests
from the investor within two and one half years or after two and a half years but no later than four years of the initial investment
at a price of two times or three and a half times, respectively, the relevant investment amount represented by the interests to
be bought back. Such buyback can be for a portion of the interest rather than for the entire interest. If the product is not introduced
to the market and not approved by the FDA or an equivalent body in Europe and not marketed within 24 months the investor will
have a 60 day option to receive 50,000 shares of common stock in lieu of the interest in the product. The product was approved
by the FDA during the nine month period ended April 30, 2016 and as result the investor will not receive the option to receive
shares. During the nine months ended April 30, 2016, specifically, during the Company’s second fiscal quarter that ended
on January 31, 2016, the Company recognized $500,000 as revenue because the option to receive the shares of common stock was removed,
and the research and development work related to the product was completed.
On October 31, 2014, the Company entered
into an agreement and subsequently received funding from an individual investor in the amount of $500,000 for use by the Company
for any purpose. In exchange for this funding, the Company agreed to provide the investor with a 0.98% interest in the net profit
as related to the Company’s treatment to reverse opioid overdoses. Net profit includes the pre-tax profit received by the
Company derived from the sale of the product after the deduction of all expenses incurred by and payments made by the Company
in connection with the product, including but not limited to an allocation of Company overhead. The investor also has rights with
respect to its 0.98% interest if the treatment is sold or the Company is sold. Additionally, the Company may buyback interests
from the investor within two and one half years or after two and a half years but no later than four years of the initial investment
at a price of two times or three and a half times, respectively, the relevant investment amount represented by the interests to
be bought back. Such buyback can be for a portion of the interest rather than for the entire interest. If the product is not introduced
to the market and not approved by the FDA or an equivalent body in Europe and not marketed within 24 months the investor will
have a 60 day option to receive 50,000 shares of common stock in lieu of the interest in the product. The product was approved
by the FDA during the nine month period ended April 30, 2016 and as result the investor will not receive the option to receive
shares. During the nine months ended April 30, 2016, specifically, during the Company’s second fiscal quarter that ended
on January 31, 2016, the Company recognized $500,000 as revenue because the option to receive the shares of common stock was removed,
and the research and development work related to the product was completed.
On December 15, 2014, the Company and
Adapt Pharma Operations Limited, a wholly owned subsidiary of Adapt Pharma Limited (“Adapt”), an Ireland-based pharmaceutical
company, entered into a license agreement (the “Adapt Agreement”). Pursuant to the agreement Adapt has received from
the Company a global license to develop and commercialize the Company’s intranasal naloxone opioid overdose reversal treatment.
In exchange for licensing its treatment to Adapt, the Company could receive total potential regulatory and sales milestone payments
of more than $55 million, plus up to double-digit percentage royalties on net sales. The Adapt Agreement provided for an upfront
and nonrefundable payment of $500,000, and monthly payments for up to one year for participation in joint development committee
calls and the production and submission of an initial development plan. The Adapt Agreement also required the Company to contribute
$2,500,000 of development, regulatory, and commercialization costs, some of which was credited for costs incurred by the Company
prior to the execution of the Adapt Agreement. The Company fulfilled its requirement to contribute $2,500,000 during the three
months ended October 31, 2015.
On February 17, 2015, the Company announced
that Adapt received Fast Track designation by the FDA.
On April 22, 2015, the Company announced
that Adapt successfully completed a clinical study of intranasal naloxone. The pharmacokinetic study compared intranasal naloxone
with an injectable formulation of naloxone. The study met its objectives and demonstrated the intranasal formulation of naloxone
delivered the targeted naloxone dose as expected.
On June 3, 2015, the Company announced
that Adapt commenced a rolling submission of a New Drug Application (“NDA”) to the FDA for a nasal spray formulation
of naloxone, a drug intended to treat opioid overdose. A rolling submission allows completed portions of the NDA to be submitted
and reviewed by the FDA on an ongoing basis.
On July 29, 2015, the Company announced
that Adapt has submitted a NDA to the FDA for NARCAN® (naloxone hydrochloride) Nasal Spray, an investigational drug intended
to treat opioid overdose.
On November 18, 2015, the FDA approved
NARCAN® (naloxone hydrochloride) Nasal Spray for the emergency treatment of known or suspected opioid overdose, to be marketed
by Adapt.
On December 8, 2015, the Company entered
into an agreement with an individual investor to receive $500,000 for use by the Company for any purpose, which $500,000 shall
be invested by December 18, 2015. In exchange for this funding, the Company has agreed to provide the investor with a 0.75% interest
in the Net Profit as related to the Company’s treatment to reverse opioid overdoses. Net Profit includes the pre-tax profit
received by the Company derived from the sale of the product after the deduction of all expenses incurred by and payments made
by the Company in connection with the product, including but not limited to an allocation of Company overhead. The investor also
has rights with respect to its 0.75% interest if the treatment is sold or the Company is sold. Additionally, the Company may buyback
interests from the investor within two and one half years or after two and a half years but no later than four years of the initial
investment at a price of two times or three and a half times, respectively, the relevant investment amount represented by the
interests to be bought back. Such buyback can be for a portion of the interest rather than for the entire interest. The investor
also had an option to invest an additional $1,000,000 by February 29, 2016 for use by the Company for any purpose in exchange
for a 1.50% interest in the Net Profit as related to the Company’s treatment to reverse opioid overdoses. If such investment
were made, then the investor also would have rights with respect to its 1.50% interest if the treatment were sold or the Company
were sold. Additionally, the Company would be able to buyback interests from the investor within two and one half years or after
two and a half years but no later than four years of the initial investment at a price of two times or three and a half times,
respectively, the relevant investment amount represented by the interests to be bought back. Such buyback could be for a portion
of the interest rather than for the entire interest. This option expired unexercised. During the nine months ended April 30, 2016,
specifically, during the Company’s second fiscal quarter that ended on January 31, 2016, the Company recognized $500,000
as revenue because the investment did not contain an option to receive shares, and the research and development work related to
the product was completed.
On December 15, 2015, the Company announced
that it received a $2 million milestone payment from Adapt. This milestone payment was triggered by the FDA approval of NARCAN®
(naloxone hydrochloride) Nasal Spray.
On January 19, 2016, the Company announced
that Adapt announced that it has reached an agreement to facilitate the purchase of NARCAN® (naloxone hydrochloride) Nasal
Spray by offering its discounted public interest price to 62,000 agencies in state and local government and the non-profit sector.
Adapt, in partnership with the National Association of Counties, National Governors Association, National League of Cities, and
United States Conference of Mayors, will offer NARCAN® (naloxone hydrochloride) Nasal Spray at a discounted public interest
price of $37.50 per dose ($75 for a 2 pack carton) through the U.S. Communities Purchasing Alliance and Premier, Inc. Adapt’s
discounted public interest price has been available to qualifying group purchasers, such as law enforcement, firefighters, first
responders, departments of health, local school districts, colleges and universities, and community-based organizations.
On January 27, 2016, the Company announced
that Adapt announced two national programs at the Clinton Health Matters Initiative Activation Summit to assist in efforts to
address the growing risk of opioid overdose among American high school students. Adapt offered a free carton of NARCAN® (naloxone
hydrochloride) Nasal Spray to all high schools in the U.S. through the state departments of education. This program will collaborate
with the Clinton Health Matters Initiative, an initiative of the Clinton Foundation, as part of its work to scale naloxone access
efforts nationally. In addition, Adapt has provided a grant to the National Association of School Nurses (NASN) to support their
educational efforts concerning opioid overdose education materials.
On March 7, 2016, the Company announced the receipt of a $2.5
million milestone payment from Adapt. This milestone payment was triggered by the first commercial sale of NARCAN® (naloxone
hydrochloride) Nasal Spray in the U.S.
On April 29, 2016, the Company received $105,097 in royalty
payments due from Adapt Pharma Operations Limited from commercial sales of NARCAN® (naloxone hydrochloride) Nasal Spray in
the U.S during the first quarter of Adapt Pharma Operations Limited’s fiscal year.
On May 6, 2016, the Company announced that Adapt submitted
a new drug submission (NDS) for NARCAN® (naloxone hydrochloride) Nasal Spray to Health Canada.
Binge Eating Disorder
The Company is developing a treatment for
BED.
The Company considers naloxone to be
a potentially compelling drug for the pharmacological treatment of BED. It has a well-known safety profile and has the potential
to block the reward that patients experience from bingeing.
On May 23, 2013, the Company presented
the results of the Company’s Phase II clinical trial of its nasal spray treatment for BED at the American Psychiatric Association
(“APA”) Annual Meeting in San Francisco. BED has been added to the fifth edition of the APA’s Diagnostic and
Statistical Manual of Mental Disorders (“DSM-5”), which was launched at this APA Annual Meeting. DSM-5 is used by
clinicians and researchers to diagnose and classify mental disorders in order to improve diagnoses, treatment, and research. BED
is defined in the DSM-5 chapter on Feeding and Eating Disorders as a diagnosis for individuals who experience persistent, recurrent
episodes of overeating, marked by loss of control and significant clinical distress.
On December 17, 2013, the Company entered
into an agreement and subsequently received additional funding totaling $250,000 for use by the Company for any purpose. In exchange
for this funding, the Company agreed to provide the investor with a 0.5% interest in the net profit as related to the Company’s
BED treatment. Net profit is defined as the pre-tax profit generated from the product after the deduction of all expenses incurred
by and payments made by the Company in connection with the product, including but not limited to an allocation of Company overhead.
The investor also has rights with respect to its 0.5% interest if the treatment is sold or the Company is sold. If the product
is not approved by the U.S. Food and Drug Administration within 36 months the investor will have a 60 day option to receive 31,250
shares of common stock in lieu of the 0.5% interest in the product.
On September 17, 2014, the Company entered
into an agreement and subsequently received funding totaling $500,000 for use by the Company for any purpose. In exchange for this
funding, the Company agreed to provide the investor with a 1.0% interest in the Company’s BED treatment product and pay the
investor 1.0% of the net profit generated from this treatment in perpetuity. Net profit is defined as the pre-tax profit generated
from the product after the deduction of all expenses incurred by and payments made by the Company in connection with the product,
including but not limited to an allocation of Company overhead. If the product is not approved by the FDA within 36 months the
investor will have a sixty day option to receive 62,500 shares of common stock in lieu of the 1.0% interest in the product.
On July 20, 2015, the Company entered into
an agreement and subsequently received additional funding totaling $250,000 for use by the Company for any purpose. In exchange
for this funding, the Company agreed to provide the investor with a 0.5% interest in the Company’s BED treatment product
and pay the investor 0.5% of the net profit generated from this treatment in perpetuity. Net profit is defined as the pre-tax profit
generated from the product after the deduction of all expenses incurred by and payments made by the Company in connection with
the product, including but not limited to an allocation of Company overhead. If the product is not approved by the FDA within 36
months the investor will have a sixty day option to receive 25,000 shares of common stock in lieu of the 0.5% interest in the product.
The Company now aims to collaborate with
other parties and progress its drug development program for BED.
Cocaine Use Disorder
The Company is developing a treatment for
Cocaine Use Disorder (“CocUD”). There are approximately 1.5 million current cocaine users in the U.S., as reported
by The Substance Abuse and Mental Health Services Administration (SAMHSA).
Cocaine is often used in a binge pattern.
Taking the drug repeatedly within a relatively short period of time, at increasingly higher doses, can easily lead to addiction,
a chronic relapsing disease caused by changes in the brain and characterized by uncontrollable drug-seeking no matter the consequences.
Cocaine is a strong central nervous system stimulant that increases levels of the neurotransmitter dopamine in brain circuits regulating
pleasure and movement, with the opioid system strongly linked to the dopamine reward circuitry.
Any route of administration can lead to
absorption of toxic amounts of cocaine. Most seriously, in the short-term cocaine users can suffer from heart attacks, strokes,
and convulsions, which can result in sudden death. Repeated use of cocaine can lead to long-term harmful changes in the brain and
other parts of the body, including decreases in appetite, weight loss, and malnourishment. Snorting cocaine can lead to loss of
sense of smell and difficulty in swallowing, ingesting cocaine can cause severe bowel gangrene due to reduced blood flow, and injecting
cocaine can lead to puncture marks called “tracks” and possible allergic reactions. Cocaine users are also at high
risk of contracting HIV and viral hepatitis from sharing contaminated needles and engaging in risky sexual behaviors.
The extraordinary cost of cocaine addiction,
financially, medically and socially, is directly related to the stubborn clinical problem of relapse. Relapse rates have remained
discouragingly high for decades: up to 80% of addicted individuals relapse within six months of treatment. Finding effective interventions,
psychosocial or pharmacologic, has proven difficult.
Other Activities
On December 1, 2014, the Company and Aegis
Therapeutics, LLC (“Aegis”), entered into a Material Transfer, Option and Research License Agreement (the “Aegis
Agreement”) that provides the Company with an exclusive royalty-free research license for a period of time to Aegis’
proprietary delivery enhancement and stabilization agents, including Aegis’ ProTek® and Intravail® technologies
(collectively, the “Technology”) to enable the Company to conduct a feasibility study of opioid antagonists when used
with the Technology. During this period of time, the Company may also evaluate its interest in having an exclusive license to
the Technology for use with opioid antagonists to treat, diagnose, predict, detect or prevent any disease, disorder, state, condition
or malady in humans (the “Possible License”). Aegis has granted the Company an exclusive option to obtain the Possible
License for a certain period after the study is completed. In consideration of the license granted to the Company pursuant to
the Aegis Agreement, the Company is required to pay to Aegis a nonrefundable study fee.
On October 6, 2015, the Company entered
into an amendment to the Aegis Agreement. This amendment had an effective date of May 19, 2015 and allowed the Company to evaluate
Aegis’ Technology until August 17, 2015. The amendment also provided an opportunity for the Company to elect to further
extend the period of time during which the Company could evaluate the Technology until February 13, 2016. The Company elected
to further extend the period during which the Company could evaluate the Technology through August 11, 2016.
On September 22, 2015, the Company received
a $1,600,000 commitment from a foundation, from which the Company has the right to make capital calls, for the research, development,
any other activities connected to the Company’s opioid antagonist treatments for addictions and related disorders that materially
rely on certain studies funded by the foundation’s investment, certain operating expenses, and any other purpose consistent
with the goals of the foundation. In exchange for funds invested by the foundation the Company agreed to provide the foundation
with pro-rata share up to a 2.1333% interest in the Net Profit as related to the Company’s opioid antagonist treatments
for addictions and related disorders that materially rely on certain studies funded by the foundation’s investment. Net
profit is defined as any pre-tax revenue received by the Company that was derived from the sale of the products less any and all
expenses incurred by and payments made by the Company in connection with the products, including but not limited to an allocation
of Company overhead. The foundation also has rights with respect to its up to 2.1333% interest if the products are sold or the
Company is sold. Additionally, the Company may buyback interests from the foundation within two and one half years or after two
and a half years of the initial investment at a price of two times or three and a half times, respectively, the relevant investment
amount represented by the interests to be bought back. Such buyback can be for a portion of the interest rather than for the entire
interest. If a product is not introduced to the market within 36 months the foundation will have a 60 day option to receive shares
of the Company’s common stock in lieu of the interest in the product at a rate of one-tenth of a share for every dollar
of its investment. On October 6, 2015, and December 23, 2015, the Company received $618,000 and $715,500 from the foundation in
exchange for a 0.824% and 0.954% interests, respectively, in the Company’s treatments covered by the commitment agreement. The
Company will defer recording revenue until such time as the option expires or milestones are achieved that eliminates the investor’s
right to exercise the option. Upon expiration of the exercise option, the deliverables of the arrangement will be reviewed and
evaluated under ASC 605. In the event the investor chooses to convert interests into shares of common stock, that transaction
will be accounted for similar to a sale of shares of common stock for cash.
On February 17, 2016, the Company announced
the first convening of its medical advisory board in 2016 to discuss its development programs in substance use, addictive and
eating disorders.
On April 26, 2016 (the “Amendment
Date”), the Company and Aegis entered into the Amended and Restated Material Transfer, Option and Research License Agreement
(the “Restated License Agreement”) which amends and restates in its entirety the Initial Aegis Agreement. Under the
Restated License Agreement, the Company has been granted an exclusive royalty-free research license to Aegis’ Technology,
for a period of time (the “Compound Research Period”), to enable the Company to conduct the Study and evaluate the
Company’s interest in licensing the Technology through use of the Compound in additional studies.
The Company agreed to pay Aegis
(i) an aggregate of $300,000, of which the Company may elect to pay up to 50% by issuing shares of the Company’s common
stock, par value $0.001 per share, to Aegis, with the number of shares to be issued equal to 75% of the average closing price
of the Company’s common stock over the 20 trading days preceding the date of payment as consideration for extending the
Compound Research Period pursuant to two separate extension payments of $150,000 each, and (ii) 50,000 shares of common stock
as partial consideration for entering into the Restated License Agreement. The Company exercised such extensions through
payment of the first and second extension fees prior to October 13, 2015 and prior to February 13, 2016, respectively. The
Restated License Agreement shall expire on the earlier of (i) the expiration of the “Opiant Negotiation Periods”
(as defined in the Restated License Agreement) and (ii) on 30 days prior written notice by the Company;
provided
,
however
,
that Aegis shall have the right to terminate the license granted in the event the Company does not pursue commercially
reasonable efforts to exploit a “Product”, defined as (i) pharmaceutical formulations containing the Compound as
an active ingredient and (ii) Aegis’s proprietary chemically synthesizable excipient(s), including without limitation
the Intravail® excipients pharmaceutical formulations containing certain ingredients of Aegis’ proprietary
technology.
During the term of the Restated License
Agreement, the Company has a right of first refusal and option to add any, or all of the “Additional Compounds” (as
defined in the Restated License Agreement), which the Company may exercise at any time upon written notice to Aegis. The Company
has granted Aegis a co-exclusive license with the Company to use the data from the Company’s Studies under the Restated
License Agreement for certain purposes. Pursuant to the Restated License Agreement, Aegis granted the Company an exclusive option
(the “Opiant Option”) to obtain an exclusive, worldwide, royalty-bearing license (with the right to grant sublicenses
through multiple tiers) under Aegis’s interests in the Technology and any “Joint Invention” (as such term is
defined in the Restated License Agreement) to the Technology to research, develop, make, have made, use, sell, offer for sale,
and import products containing the “Compound” (as defined in the Restated License Agreement) or an Additional Compound.
The Company may exercise such Opiant Option with respect to the Compounds by written notice to Aegis within 90 days of the completion
of the Study for (i) the Compounds or (ii) the Additional Compounds. In the event the Company exercises the Opiant Option, the
parties have 120 days to negotiate and execute a definitive license agreement. The terms of such license agreement have been contemplated
and agreed upon by the parties under a letter agreement (the “Letter Agreement”). As partial consideration for exercising
the Option, the Company shall pay Aegis a nonrefundable and noncreditable license issuance fee of $300,000 as of the effective
date of the license agreement entered into by Company and Aegis, of which the Company may elect to pay up to 50% by issuing shares
of the Company’s common stock to Aegis, with the number of shares to be issued equal to 75% of the average closing price
of the Company’s stock over the prior 20 trading days. In the event the Company exercises the Opiant Option specific to
the “Opioid Field” (as defined in Exhibit 1 to the Letter Agreement), the Company shall pay Aegis an additional $100,000
fee and any such products in the Opioid Field shall be subject to the same milestones, royalties and other monetary obligations
set forth in the Letter Agreement and summarized below.
Under the Letter Agreement containing
the terms of such license, the Company will pay Aegis upon the achievement of each development milestone for a particular Compound
or Additional Compound, ranging from $250,000 to $4,000,000 per achievement. Additionally, the Company is required to make minimum
quarterly nonrefundable payments to Aegis in the amount of $25,000 (the “Quarterly Payments”), which Quarterly Payments
are fully creditable and treated as a prepayment against future milestones or royalties. During the “Royalty Term”
(as defined in Exhibit 1 to the Letter Agreement), the Company shall pay Aegis royalties (the “Royalties”) on annual
net sales of (i) pharmaceutical formulations containing the Compound as an active ingredient and (ii) Aegis’s proprietary
chemically synthesizable excipient(s), including without limitation the Intravail® excipients ((i) and (ii) together, the
“Products”), ranging from (A) low single digits for Products with an aggregate annual “Net Sales” (as
defined in Exhibit 1 to the Letter Agreement) during a calendar year of $50 million or less to (B) mid-single digits for Products
with Net Sales of greater than $1 billion. Such Royalties are subject to reduction as provided in Exhibit 1 to the Restated Agreement
but shall not be reduced by more than 50% of the regularly scheduled royalty payment.
The foregoing description of the Restated
License Agreement and the Letter Agreement is qualified in its entirety by reference to the complete text of the Restated License
Agreement and the Letter Agreement which were filed as exhibits to our Form 10-Q for the quarter ended April 30, 2016 which was
filed on June 8, 2016. The Company is seeking confidential treatment for certain terms and provisions of the Restated License
Agreement and the Letter Agreement.
Employees
As of the date hereof, the Company has
six (6) permanent employees, five (5) full time and one (1) part time. In addition, the Company has numerous outside
consultants that are not on the Company’s payroll.
DESCRIPTION OF PROPERTY
The Company does not currently own any physical property. The Company leases
space on the 12
th
Floor of 401 Wilshire Blvd., Santa Monica, CA 90401 for $2,801 per month. The lease expires on August
31, 2016.
Additionally, the Company leases space
in Suite 100 of 1180 North Town Center Drive, Las Vegas, NV 89144 for $299 per month. The lease expires on July 31, 2017.
The Company believes that the current
premises are sufficient for the Company’s needs at this time.
LEGAL PROCEEDINGS
The Company is currently not involved
in any litigation that the Company believes could have a materially adverse effect on the Company’s financial condition
or results of operations. There is no action, suit, proceeding, inquiry or investigation before or by any court, public board,
government agency, self-regulatory organization or body pending or, to the knowledge of the executive officers of the Company
or any of the Company’s subsidiaries, threatened against or affecting the Company, the Company’s common stock, any
of the Company’s subsidiaries or the Company’s or the Company’s subsidiaries’ officers or directors in
their capacities as such, in which an adverse decision could have a material adverse effect.
MARKET PRICE OF
AND DIVIDENDS ON THE REGISTRANT’S COMMON EQUITY
AND RELATED STOCKHOLDER MATTER
Market Information
Since April 2007, the Company’s
common stock has been listed for quotation on the OTCQB under the symbol “LLTP” and currently, “OPNT”.
Price Range of common stock
The following table shows, for the periods
indicated, the high and low bid prices per share of the Company’s common stock as reported by the OTCQB quotation service.
The quotations reflect inter-dealer prices, without retail mark-up, mark-down or commissions, and may not represent actual transactions.
|
|
|
High
|
|
|
Low
|
|
|
Fiscal Year 2014
|
|
|
|
|
|
|
|
|
|
First quarter ended October 31, 2013
|
|
$
|
11.29
|
|
|
$
|
2.80
|
|
|
Second quarter ended January 31, 2014
|
|
$
|
7.00
|
|
|
$
|
3.30
|
|
|
Third quarter ended April 30, 2014
|
|
$
|
6.00
|
|
|
$
|
3.10
|
|
|
Fourth quarter ended July 31, 2014
|
|
$
|
6.10
|
|
|
$
|
1.97
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Year
2015
|
|
|
|
|
|
|
|
|
|
First quarter ended October 31, 2014
|
|
$
|
6.10
|
|
|
$
|
3.20
|
|
|
Second quarter ended January 31, 2015
|
|
$
|
6.00
|
|
|
$
|
3.16
|
|
|
Third quarter ended April 30, 2015
|
|
$
|
10.99
|
|
|
$
|
3.43
|
|
|
Fourth quarter ended July 31, 2015
|
|
$
|
8.10
|
|
|
$
|
6.09
|
|
Approximate Number of Equity Security Holders
As of August 18, 2016, there were
approximately 90 stockholders of record. Because shares of the Company’s common stock are held by depositaries,
brokers and other nominees, the number of beneficial holders of the Company’s shares is substantially larger than the
number of stockholders of record.
Dividends
There are no restrictions in the Company’s
Articles of Incorporation or bylaws that prevent the Company from declaring dividends. The Nevada Revised Statutes,
however, do prohibit the Company from declaring dividends where, after giving effect to the distribution of the dividend:
|
|
1.
|
the
Company would not be able to pay the Company’s debts as they become due in the usual course of business; or
|
|
|
2.
|
the
Company’s total assets would be less than the sum of the Company’s total liabilities plus the amount that would
be needed to satisfy the rights of shareholders who have preferential rights superior to those receiving the distribution.
|
The Company has not declared any dividends, and the Company
does not plan to declare any dividends in the foreseeable future.
Securities Authorized for Issuance under Equity Compensation
Plans
The Company does
not have in effect any compensation plans under which the Company’s equity securities are authorized for issuance.
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis
of the results of operations and financial condition for the three and nine months ended April 30, 2016 and 2015, and the fiscal
years ended July 31, 2015 and 2014. It should be read in conjunction with our financial statements and the notes to those financial
statements that are included in this report.
Overview
Opiant Pharmaceuticals, Inc. (“the
Company” or the “Company”) is a specialty pharmaceutical company developing pharmacological treatments for substance
use, addictive and eating disorders. The Company was incorporated in the State of Nevada on June 21, 2005, as Madrona Ventures,
Inc. and on September 16, 2009, the Company changed its name to Lightlake Therapeutics Inc. On January 28, 2016, the Company changed
its name to Opiant Pharmaceuticals, Inc. The Company’s fiscal year end is July 31.
The Company’s strategy is to develop
treatments for substance use, addictive and eating disorders. The Company has worked on developing a treatment for reversing opioid
overdoses in collaboration with the National Institute on Drug Abuse (“NIDA”), part of the National Institutes of Health
(“NIH”). This treatment, now known as NARCAN® (naloxone hydrochloride) Nasal Spray, was approved by the U.S. Food
and Drug Administration (“FDA”) in November 2015. The Company also is developing treatments for Cocaine Use Disorder
and Binge Eating Disorder (“BED”).
In December 2014, the Company effected
a one-for-one hundred reverse stock split of its common stock (the “1:100 Reverse Stock Split”) which decreased the
number of common shares issued and outstanding from approximately 182.0 million shares to approximately 1.82 million shares as
of March 12, 2015. Unless otherwise noted, all shares amounts listed in this Report been retroactively adjusted for the 1:100
Reverse Stock Split as if such stock splits occurred prior to the issuance of such shares.
The Company has been focused on developing:
(i) a treatment to reverse opioid overdoses, (ii) a treatment for BED, and (iii) a treatment for Cocaine Use Disorder.
Principal Products or Services and Markets
Opioid Overdose Reversal
Naloxone is a medicine that can rapidly
reverse the overdose of prescription and illicit opioids and that historically has been available through injection. The Company’s
intranasal delivery system of naloxone could widely expand its availability and use in preventing opioid overdose deaths.
On March 14, 2014, the Company filed U.S.
Provisional Application No. 61/953,379. This application addresses delivery devices and methods of treating opioid overdoses through
the administration of intranasal naloxone.
On May 15, 2014, the Company entered
into an agreement and subsequently received funding from an individual investor in the amount of $300,000 for use by the Company
for any purpose. In exchange for this funding, the Company agreed to provide the investor with a 1.5% interest in the net profit
as related to the Company’s treatment to reverse opioid overdoses. Net profit is defined as the pre-tax profit generated
from the product after the deduction of all expenses incurred by and payments made by the Company in connection with the product,
including but not limited to an allocation of Company overhead. The investor also has rights with respect to its 1.5% interest
if the treatment is sold or the Company is sold. If the product is not introduced to the market and not approved for marketing
within 24 months, the investor will have a 60 day option to receive 37,500 shares of common stock in lieu of the 1.5% interest
in the product. The product was approved by the FDA during the nine month period ended April 30, 2016 and as result the investor
will not receive the option to receive shares. During the nine months ended April 30, 2016, specifically, during the Company’s
second fiscal quarter that ended on January 31, 2016, the Company recognized $300,000 as revenue because the option to receive
the shares of common stock was removed, and the research and development work related to the product was completed.
On July 9, 2014, the Company filed U.S.
Provisional Application No. 62/022,268 with respect to the Company’s treating opioid overdoses through the administration
of intranasal naloxone.
On July 22, 2014, the Company received
a $3,000,000 commitment, from which the Company has the right to make capital calls, from a foundation for the research, development,
marketing, commercialization, and any other activities connected to the Company’s treatment to reverse opioid overdoses,
certain operating expenses, and any other purpose consistent with the goals of the foundation. In exchange for funds invested
by the foundation the Company agreed to provide the foundation with pro-rata share up to a 6.0% interest in the net profit as
related to the Company’s treatment to reverse opioid overdoses. Net profit is defined as the pre-tax profit generated from
the product after the deduction of all expenses incurred by and payments made by the Company in connection with the product, including
but not limited to an allocation of Company overhead. The foundation also has rights with respect to its up to 6.0% interest if
the treatment is sold or the Company is sold. Additionally, the Company may buyback interests from the foundation within two and
one half years or after two and a half years of the initial investment at a price of two times or three and a half times, respectively,
the relevant investment amount represented by the interests to be bought back. Such buyback can be for a portion of the interest
rather than for the entire interest. If the product is not approved by the U.S. Food and Drug Administration or an equivalent
body in Europe for marketing and is not actually marketed within 24 months the foundation will have a 60 day option to receive
shares of the Company’s common stock in lieu of the interest in the treatment at a rate of 10 shares for every dollar of
its investment. On July 28, 2014 the Company received an initial investment of $111,470 from the foundation in exchange for a
0.22294% interest. On August 13, 2014, September 8, 2014, November 13, 2014, and February 17, 2015, the Company made capital calls
of $422,344, $444,530, $1,033,614, and $988,043, respectively, from the foundation in exchange for 0.844687%, 0.888906%, 2.067228%,
and 1.976085% interests, respectively, in the net profit as related to the Company’s treatment to reverse opioid overdoses.
The product was approved by the FDA during the nine month period ended April 30, 2016 and as result the investor will not receive
the option to receive shares. During the nine months ended April 30, 2016, specifically, during the Company’s second fiscal
quarter that ended on January 31, 2016, the Company recognized $3,000,000 as revenue because the option to receive the shares
of common stock was removed, and the research and development work related to the product was completed.
On September 9, 2014, the Company entered
into an agreement and subsequently received funding from an individual investor in the amount of $500,000 for use by the Company
for any purpose. In exchange for this funding, the Company agreed to provide the investor with a 0.98% interest in the net profit
as related to the Company’s treatment to reverse opioid overdoses. Net profit includes the pre-tax profit received by the
Company derived from the sale of the product after the deduction of all expenses incurred by and payments made by the Company
in connection with the product, including but not limited to an allocation of Company overhead. The investor also has rights with
respect to its 0.98% interest if the treatment is sold or the Company is sold. Additionally, the Company may buyback interests
from the investor within two and one half years or after two and a half years but no later than four years of the initial investment
at a price of two times or three and a half times, respectively, the relevant investment amount represented by the interests to
be bought back. Such buyback can be for a portion of the interest rather than for the entire interest. If the product is not introduced
to the market and not approved by the FDA or an equivalent body in Europe and not marketed within 24 months the investor will
have a 60 day option to receive 50,000 shares of common stock in lieu of the interest in the product. The product was approved
by the FDA during the nine month period ended April 30, 2016 and as result the investor will not receive the option to receive
shares. During the nine months ended April 30, 2016, specifically, during the Company’s second fiscal quarter that ended
on January 31, 2016, the Company recognized $500,000 as revenue because the option to receive the shares of common stock was removed,
and the research and development work related to the product was completed.
On October 31, 2014, the Company entered
into an agreement and subsequently received funding from an individual investor in the amount of $500,000 for use by the Company
for any purpose. In exchange for this funding, the Company agreed to provide the investor with a 0.98% interest in the net profit
as related to the Company’s treatment to reverse opioid overdoses. Net profit includes the pre-tax profit received by the
Company derived from the sale of the product after the deduction of all expenses incurred by and payments made by the Company
in connection with the product, including but not limited to an allocation of Company overhead. The investor also has rights with
respect to its 0.98% interest if the treatment is sold or the Company is sold. Additionally, the Company may buyback interests
from the investor within two and one half years or after two and a half years but no later than four years of the initial investment
at a price of two times or three and a half times, respectively, the relevant investment amount represented by the interests to
be bought back. Such buyback can be for a portion of the interest rather than for the entire interest. If the product is not introduced
to the market and not approved by the FDA or an equivalent body in Europe and not marketed within 24 months the investor will
have a 60 day option to receive 50,000 shares of common stock in lieu of the interest in the product. The product was approved
by the FDA during the nine month period ended April 30, 2016 and as result the investor will not receive the option to receive
shares. During the nine months ended April 30, 2016, specifically, during the Company’s second fiscal quarter that ended
on January 31, 2016, the Company recognized $500,000 as revenue because the option to receive the shares of common stock was removed,
and the research and development work related to the product was completed.
On December 15, 2014, the Company and
Adapt Pharma Operations Limited, a wholly owned subsidiary of Adapt Pharma Limited (“Adapt”), an Ireland-based pharmaceutical
company, entered into a license agreement (the “Adapt Agreement”). Pursuant to the agreement Adapt has received from
the Company a global license to develop and commercialize the Company’s intranasal naloxone opioid overdose reversal treatment.
In exchange for licensing its treatment to Adapt, the Company could receive total potential regulatory and sales milestone payments
of more than $55 million, plus up to double-digit percentage royalties on net sales. The Adapt Agreement provided for an upfront
and nonrefundable payment of $500,000, and monthly payments for up to one year for participation in joint development committee
calls and the production and submission of an initial development plan. The Adapt Agreement also required the Company to contribute
$2,500,000 of development, regulatory, and commercialization costs, some of which was credited for costs incurred by the Company
prior to the execution of the Adapt Agreement. The Company fulfilled its requirement to contribute $2,500,000 during the three
months ended October 31, 2015.
On February 17, 2015, the Company announced
that Adapt received Fast Track designation by the FDA.
On April 22, 2015, the Company announced
that Adapt successfully completed a clinical study of intranasal naloxone. The pharmacokinetic study compared intranasal naloxone
with an injectable formulation of naloxone. The study met its objectives and demonstrated the intranasal formulation of naloxone
delivered the targeted naloxone dose as expected.
On June 3, 2015, the Company announced
that Adapt commenced a rolling submission of a New Drug Application (“NDA”) to the FDA for a nasal spray formulation
of naloxone, a drug intended to treat opioid overdose. A rolling submission allows completed portions of the NDA to be submitted
and reviewed by the FDA on an ongoing basis.
On July 29, 2015, the Company announced
that Adapt has submitted a NDA to the FDA for NARCAN® (naloxone hydrochloride) Nasal Spray, an investigational drug intended
to treat opioid overdose.
On November 18, 2015, the FDA approved
NARCAN® (naloxone hydrochloride) Nasal Spray for the emergency treatment of known or suspected opioid overdose, to be marketed
by Adapt.
On December 8, 2015, the Company entered
into an agreement with an individual investor to receive $500,000 for use by the Company for any purpose, which $500,000 shall
be invested by December 18, 2015. In exchange for this funding, the Company has agreed to provide the investor with a 0.75% interest
in the Net Profit as related to the Company’s treatment to reverse opioid overdoses. Net Profit includes the pre-tax profit
received by the Company derived from the sale of the product after the deduction of all expenses incurred by and payments made
by the Company in connection with the product, including but not limited to an allocation of Company overhead. The investor also
has rights with respect to its 0.75% interest if the treatment is sold or the Company is sold. Additionally, the Company may buyback
interests from the investor within two and one half years or after two and a half years but no later than four years of the initial
investment at a price of two times or three and a half times, respectively, the relevant investment amount represented by the
interests to be bought back. Such buyback can be for a portion of the interest rather than for the entire interest. The investor
also had an option to invest an additional $1,000,000 by February 29, 2016 for use by the Company for any purpose in exchange
for a 1.50% interest in the Net Profit as related to the Company’s treatment to reverse opioid overdoses. If such investment
were made, then the investor also would have rights with respect to its 1.50% interest if the treatment were sold or the Company
were sold. Additionally, the Company would be able to buyback interests from the investor within two and one half years or after
two and a half years but no later than four years of the initial investment at a price of two times or three and a half times,
respectively, the relevant investment amount represented by the interests to be bought back. Such buyback could be for a portion
of the interest rather than for the entire interest. This option expired unexercised. During the nine months ended April 30, 2016,
specifically, during the Company’s second fiscal quarter that ended on January 31, 2016, the Company recognized $500,000
as revenue because the investment did not contain an option to receive shares, and the research and development work related to
the product was completed.
On December 15, 2015, the Company announced
that it received a $2 million milestone payment from Adapt. This milestone payment was triggered by the FDA approval of NARCAN®
(naloxone hydrochloride) Nasal Spray for the emergency treatment of known or suspected opioid overdose.
On January 19, 2016, the Company announced
that Adapt announced that it has reached an agreement to facilitate the purchase of NARCAN® (naloxone hydrochloride) Nasal
Spray by offering its discounted public interest price to agencies in state and local government and the non-profit sector. Adapt,
in partnership with the National Association of Counties, National Governors Association, National League of Cities, and United
States Conference of Mayors, will offer NARCAN® (naloxone hydrochloride) Nasal Spray at a discounted public interest price
of $37.50 per dose ($75 for a 2 pack carton) through the U.S. Communities Purchasing Alliance and Premier, Inc. Adapt’s discounted
public interest price has been available to qualifying group purchasers, such as law enforcement, firefighters, first responders,
departments of health, local school districts, colleges and universities, and community-based organizations.
On January 27, 2016, the Company announced
that Adapt announced two national programs at the Clinton Health Matters Initiative Activation Summit to assist in efforts to
address the growing risk of opioid overdose among American high school students. Adapt offered a free carton of NARCAN® (naloxone
hydrochloride) Nasal Spray to all high schools in the U.S. through the state departments of education. This program will collaborate
with the Clinton Health Matters Initiative, an initiative of the Clinton Foundation, as part of its work to scale naloxone access
efforts nationally. In addition, Adapt has provided a grant to the National Association of School Nurses (NASN) to support their
educational efforts concerning opioid overdose education materials.
On March 7, 2016, the Company announced the receipt of a $2.5
million milestone payment from Adapt. This milestone payment was triggered by the first commercial sale of NARCAN® (naloxone
hydrochloride) Nasal Spray in the U.S.
On April 29, 2016, the Company received $105,097 in royalty
payments due from Adapt Pharma Operations Limited from commercial sales of NARCAN® (naloxone hydrochloride) Nasal Spray in
the U.S during the first quarter of Adapt Pharma Operations Limited’s fiscal year.
On May 6, 2016, the Company announced that Adapt submitted
a new drug submission (NDS) for NARCAN® (naloxone hydrochloride) Nasal Spray to Health Canada.
Binge Eating Disorder
The Company is developing a treatment for
BED.
The Company considers naloxone to be
a potentially compelling drug for the pharmacological treatment of BED. It has a well-known safety profile and has the potential
to block the reward that patients experience from bingeing.
On May 23, 2013, the Company presented
the results of the Company’s Phase II clinical trial of its nasal spray treatment for BED at the American Psychiatric Association
(“APA”) Annual Meeting in San Francisco. BED has been added to the fifth edition of the APA’s Diagnostic and
Statistical Manual of Mental Disorders (“DSM-5”), which was launched at this APA Annual Meeting. DSM-5 is used by clinicians
and researchers to diagnose and classify mental disorders in order to improve diagnoses, treatment, and research. BED is defined
in the DSM-5 chapter on Feeding and Eating Disorders as a diagnosis for individuals who experience persistent, recurrent episodes
of overeating, marked by loss of control and significant clinical distress.
On December 17, 2013, the Company entered
into an agreement and subsequently received additional funding totaling $250,000 for use by the Company for any purpose. In exchange
for this funding, the Company agreed to provide the investor with a 0.5% interest in the net profit as related to the Company’s
BED treatment. Net profit is defined as the pre-tax profit generated from the product after the deduction of all expenses incurred
by and payments made by the Company in connection with the product, including but not limited to an allocation of Company overhead.
The investor also has rights with respect to its 0.5% interest if the treatment is sold or the Company is sold. If the product
is not approved by the U.S. Food and Drug Administration within 36 months the investor will have a 60 day option to receive 31,250
shares of common stock in lieu of the 0.5% interest in the product.
On September 17, 2014, the Company entered
into an agreement and subsequently received funding totaling $500,000 for use by the Company for any purpose. In exchange for this
funding, the Company agreed to provide the investor with a 1.0% interest in the Company’s BED treatment product and pay the
investor 1.0% of the net profit generated from this treatment in perpetuity. Net profit is defined as the pre-tax profit generated
from the product after the deduction of all expenses incurred by and payments made by the Company in connection with the product,
including but not limited to an allocation of Company overhead. If the product is not approved by the FDA within 36 months the
investor will have a sixty day option to receive 62,500 shares of common stock in lieu of the 1.0% interest in the product.
On July 20, 2015, the Company entered into
an agreement and subsequently received additional funding totaling $250,000 for use by the Company for any purpose. In exchange
for this funding, the Company agreed to provide the investor with a 0.5% interest in the Company’s BED treatment product
and pay the investor 0.5% of the net profit generated from this treatment in perpetuity. Net profit is defined as the pre-tax profit
generated from the product after the deduction of all expenses incurred by and payments made by the Company in connection with
the product, including but not limited to an allocation of Company overhead. If the product is not approved by the FDA within 36
months the investor will have a sixty day option to receive 25,000 shares of common stock in lieu of the 0.5% interest in the product.
The Company now aims to collaborate with
other parties and progress its drug development program for BED.
Cocaine Use Disorder
The Company is developing a treatment for
Cocaine Use Disorder (“CocUD”). There are approximately 1.5 million current cocaine users in the U.S., as reported
by The Substance Abuse and Mental Health Services Administration (SAMHSA).
Cocaine is often used in a binge pattern.
Taking the drug repeatedly within a relatively short period of time, at increasingly higher doses, can easily lead to addiction,
a chronic relapsing disease caused by changes in the brain and characterized by uncontrollable drug-seeking no matter the consequences.
Cocaine is a strong central nervous system stimulant that increases levels of the neurotransmitter dopamine in brain circuits regulating
pleasure and movement, with the opioid system strongly linked to the dopamine reward circuitry.
Any route of administration can lead to
absorption of toxic amounts of cocaine. Most seriously, in the short-term cocaine users can suffer from heart attacks, strokes,
and convulsions, which can result in sudden death. Repeated use of cocaine can lead to long-term harmful changes in the brain and
other parts of the body, including decreases in appetite, weight loss, and malnourishment. Snorting cocaine can lead to loss of
sense of smell and difficulty in swallowing, ingesting cocaine can cause severe bowel gangrene due to reduced blood flow, and injecting
cocaine can lead to puncture marks called “tracks” and possible allergic reactions. Cocaine users are also at high
risk of contracting HIV and viral hepatitis from sharing contaminated needles and engaging in risky sexual behaviors.
The extraordinary cost of cocaine addiction,
financially, medically and socially, is directly related to the stubborn clinical problem of relapse. Relapse rates have remained
discouragingly high for decades: up to 80% of addicted individuals relapse within six months of treatment. Finding effective interventions,
psychosocial or pharmacologic, has proven difficult.
Other Activities
On December 1, 2014, the Company and Aegis
Therapeutics, LLC (“Aegis”), entered into a Material Transfer, Option and Research License Agreement (the “Aegis
Agreement”) that provides the Company with an exclusive royalty-free research license for a period of time to Aegis’
proprietary delivery enhancement and stabilization agents, including Aegis’ ProTek® and Intravail® technologies
(collectively, the “Technology”) to enable the Company to conduct a feasibility study of opioid antagonists when used
with the Technology. During this period of time, the Company may also evaluate its interest in having an exclusive license to
the Technology for use with opioid antagonists to treat, diagnose, predict, detect or prevent any disease, disorder, state, condition
or malady in humans (the “Possible License”). Aegis has granted the Company an exclusive option to obtain the Possible
License for a certain period after the study is completed. In consideration of the license granted to the Company pursuant to
the Aegis Agreement, the Company is required to pay to Aegis a nonrefundable study fee.
On October 6, 2015, the Company entered
into an amendment to the Aegis Agreement. This amendment had an effective date of May 19, 2015 and allowed the Company to evaluate
Aegis’ Technology until August 17, 2015. The amendment also provided an opportunity for the Company to elect to further
extend the period of time during which the Company could evaluate the Technology until February 13, 2016. The Company elected
to further extend the period during which the Company could evaluate the Technology through August 11, 2016.
On September 22, 2015, the Company received
a $1,600,000 commitment from a foundation, from which the Company has the right to make capital calls, for the research, development,
any other activities connected to the Company’s opioid antagonist treatments for addictions and related disorders that materially
rely on certain studies funded by the foundation’s investment, certain operating expenses, and any other purpose consistent
with the goals of the foundation. In exchange for funds invested by the foundation the Company agreed to provide the foundation
with pro-rata share up to a 2.1333% interest in the Net Profit as related to the Company’s opioid antagonist treatments
for addictions and related disorders that materially rely on certain studies funded by the foundation’s investment. Net
profit is defined as any pre-tax revenue received by the Company that was derived from the sale of the products less any and all
expenses incurred by and payments made by the Company in connection with the products, including but not limited to an allocation
of Company overhead. The foundation also has rights with respect to its up to 2.1333% interest if the products are sold or the
Company is sold. Additionally, the Company may buyback interests from the foundation within two and one half years or after two
and a half years of the initial investment at a price of two times or three and a half times, respectively, the relevant investment
amount represented by the interests to be bought back. Such buyback can be for a portion of the interest rather than for the entire
interest. If a product is not introduced to the market within 36 months the foundation will have a 60 day option to receive shares
of the Company’s common stock in lieu of the interest in the product at a rate of one-tenth of a share for every dollar
of its investment. On October 6, 2015, and December 23, 2015, the Company received $618,000 and $715,500 from the foundation in
exchange for a 0.824% and 0.954% interests, respectively, in the Company’s treatments covered by the commitment agreement. The
Company will defer recording revenue until such time as the option expires or milestones are achieved that eliminates the investor’s
right to exercise the option. Upon expiration of the exercise option, the deliverables of the arrangement will be reviewed and
evaluated under ASC 605. In the event the investor chooses to convert interests into shares of common stock, that transaction
will be accounted for similar to a sale of shares of common stock for cash.
On February 17, 2016, the Company announced
the first convening of its medical advisory board in 2016 to discuss its development programs in substance use, addictive and
eating disorders.
On April 26, 2016 (the “Amendment Date”), the Company and Aegis entered into the Amended
and Restated Material Transfer, Option and Research License Agreement (the “Restated License Agreement”) which amends
and restates in its entirety the Initial Aegis Agreement. Under the Restated License Agreement, the Company has been granted an
exclusive royalty-free research license to Aegis’ Technology, for a period of time (the “Compound Research Period”),
to enable the Company to conduct the Study and evaluate the Company’s interest in licensing the Technology through use of
the Compound in additional studies.
The Company agreed to pay Aegis (i)
an aggregate of $300,000, of which the Company may elect to pay up to 50% by issuing shares of the Company’s common
stock, par value $0.001 per share, to Aegis, with the number of shares to be issued equal to 75% of the average closing price
of the Company’s common stock over the 20 trading days preceding the date of payment as consideration for extending the
Compound Research Period pursuant to two separate extension payments of $150,000 each, and (ii) 50,000 shares of common stock
as partial consideration for entering into the Restated License Agreement. The Company exercised such extensions through
payment of the first and second extension fees prior to October 13, 2015 and prior to February 13, 2016, respectively. The
Restated License Agreement shall expire on the earlier of (i) the expiration of the “Opiant Negotiation Periods”
(as defined in the Restated License Agreement) and (ii) on 30 days prior written notice by the Company;
provided
,
however
,
that Aegis shall have the right to terminate the license granted in the event the Company does not pursue commercially
reasonable efforts to exploit a “Product”, defined as (i) pharmaceutical formulations containing the Compound as
an active ingredient and (ii) Aegis’s proprietary chemically synthesizable excipient(s), including without limitation
the Intravail® excipients pharmaceutical formulations containing certain ingredients of Aegis’
proprietary technology.
During the term of the Restated License
Agreement, the Company has a right of first refusal and option to add any, or all of the “Additional Compounds” (as
defined in the Restated License Agreement), which the Company may exercise at any time upon written notice to Aegis. The Company
has granted Aegis a co-exclusive license with the Company to use the data from the Company’s Studies under the Restated
License Agreement for certain purposes. Pursuant to the Restated License Agreement, Aegis granted the Company an exclusive option
(the “Opiant Option”) to obtain an exclusive, worldwide, royalty-bearing license (with the right to grant sublicenses
through multiple tiers) under Aegis’s interests in the Technology and any “Joint Invention” (as such term is
defined in the Restated License Agreement) to the Technology to research, develop, make, have made, use, sell, offer for sale,
and import products containing the “Compound” (as defined in the Restated License Agreement) or an Additional Compound.
The Company may exercise such Opiant Option with respect to the Compounds by written notice to Aegis within 90 days of the completion
of the Study for (i) the Compounds or (ii) the Additional Compounds. In the event the Company exercises the Opiant Option, the
parties have 120 days to negotiate and execute a definitive license agreement. The terms of such license agreement have been contemplated
and agreed upon by the parties under a letter agreement (the “Letter Agreement”). As partial consideration for exercising
the Option, the Company shall pay Aegis a nonrefundable and noncreditable license issuance fee of $300,000 as of the effective
date of the license agreement entered into by Company and Aegis, of which the Company may elect to pay up to 50% by issuing shares
of the Company’s common stock to Aegis, with the number of shares to be issued equal to 75% of the average closing price
of the Company’s stock over the prior 20 trading days. In the event the Company exercises the Opiant Option specific to
the “Opioid Field” (as defined in Exhibit 1 to the Letter Agreement), the Company shall pay Aegis an additional $100,000
fee and any such products in the Opioid Field shall be subject to the same milestones, royalties and other monetary obligations
set forth in the Letter Agreement and summarized below.
Under the Letter Agreement containing
the terms of such license, the Company will pay Aegis upon the achievement of each development milestone for a particular Compound
or Additional Compound, ranging from $250,000 to $4,000,000 per achievement. Additionally, the Company is required to make minimum
quarterly nonrefundable payments to Aegis in the amount of $25,000 (the “Quarterly Payments”), which Quarterly Payments
are fully creditable and treated as a prepayment against future milestones or royalties. During the “Royalty Term”
(as defined in Exhibit 1 to the Letter Agreement), the Company shall pay Aegis royalties (the “Royalties”) on annual
net sales of (i) pharmaceutical formulations containing the Compound as an active ingredient and (ii) Aegis’s proprietary
chemically synthesizable excipient(s), including without limitation the Intravail® excipients ((i) and (ii) together, the
“Products”), ranging from (A) low single digits for Products with an aggregate annual “Net Sales” (as
defined in Exhibit 1 to the Letter Agreement) during a calendar year of $50 million or less to (B) mid-single digits for Products
with Net Sales of greater than $1 billion. Such Royalties are subject to reduction as provided in Exhibit 1 to the Restated Agreement
but shall not be reduced by more than 50% of the regularly scheduled royalty payment.
The foregoing description of the Restated
License Agreement and the Letter Agreement is qualified in its entirety by reference to the complete text of the Restated License
Agreement and the Letter Agreement which were filed as exhibits to our Form 10-Q for the quarter ended April 30, 2016 which was
filed on June 8, 2016. The Company is seeking confidential treatment for certain terms and provisions of the Restated License
Agreement and the Letter Agreement.
Results of Operations
The following compares the Company’s
operations for the Year’s ended July 31, 2015 and 2014.
The Company had $1,550,000 of revenue
during the year ended July 31, 2015. The Company recognized $800,000 of revenue derived from the Adapt Agreement. The Company
also recognized $750,000 from investments in treatments that were classified as deferred revenue as of July 31, 2014. the Company
did not have any revenues during the year ended July 31, 2014 and had generated no revenue from inception through July 31, 2014
as the Company was devoting substantially all of its efforts on establishing the business and its planned principal operations
had not commenced.
General and Administrative Expenses
The Company’s general and administrative
expenses were incurred in the amounts of $6,034,520 and $10,838,760 for the years ended July 31, 2015 and 2014, respectively.
The difference in the year over year change of $4,804,240 was primarily due to a reduction in administrative compensation as the
Company recorded $1,729,216 of stock-based compensation during the year ended July 31, 2015 as compared to $9,003,582 during the
year ended July 31, 2014. This was partially offset by increases in professional fees, consulting costs, and non-stock based officer’s
compensation.
Research and Development
The Company spent $2,414,973 and $464,609
during the years ended July 31, 2015 and 2014, respectively. The year over year increase is primarily due to increased spending
on research and development of the Company’s opioid overdose reversal treatment.
Interest Expense
During the years ended July 31, 2015 and
2014, the Company’s interest expense decreased from $160,303 to $28,232. This decrease was due to a reduction in obligations
connected to outstanding debt.
Net Loss
The comparable net loss for the year ended
July 31, 2015, as compared to the net loss for the year ended July 31, 2014 was $7,037,873 and $11,482,818, respectively. This
reduction of net loss was due primarily to a reduction in operating expenses and stock-based compensation, partially offset by
an increase in research and development expenses.
The Company has not attained profitable
operations and is dependent upon generating sufficient revenues and/or obtaining financing to pursue its objectives and further
certain planned initiatives. In their report on the Company’s financial statements at July 31, 2015 and July 31, 2014, the
Company’s auditors raised substantial doubt about the Company’s ability to continue as a going concern.
The following compares Opiant’s
operations for the three months ended April 30, 2016 to the same period at April 30, 2015.
Revenues
Opiant had revenue of $2,605,097 and
$120,000 during the three months ended April 30, 2016 and 2015, respectively. The increase in revenue during the three month period
ended April 30, 2016 was the result of revenue derived from the Adapt Agreement during the period ended April 30, 2016, which
included $2,500,000 received as a result of the first commercial sale of NARCAN® (naloxone hydrochloride) Nasal Spray in the
U.S., one of the milestones set forth in the Adapt Agreement.
General and Administrative Expenses
General and administrative expenses
were incurred in the amount of $1,130,730 and $1,863,512 for the three months ended April 30, 2016 and 2015, respectively. The
decrease in expenses as compared to the same period in the prior year was primarily due to additional stock-based compensation
expense recorded during the three months ended April 30, 2015 related to the grant of options and warrants during the period.
Research and Development Expenses
Opiant spent $1,062,505 and $96,906
during the three months ended April 30, 2016 and 2015, respectively. The increase was primarily due to additional stock-based
compensation for research and development services during the 2016 period.
Interest Expense
During the three months ended April
30, 2016, interest expense decreased to $0 as compared to $4,102 at April 30, 2015. The decrease was due to a reduction in obligations
connected to outstanding debt.
Net Income
Opiant had net income for the three
months ended April 30, 2016 of $416,128 as compared to a net loss of $1,850,695 for the three months ended April 30, 2015. The
increase in net income was due primarily to the increase in revenues during the period ended April 30, 2016 compared to the period
ended April 30, 2015 and a decrease in general and administrative expenses during the period ended April 30, 2016 compared to
the period ended April 30, 2015. The increase in net income was offset by an increase in research and development expenses during
the period ended April 30, 2016 compared to the period ended April 30, 2015.
The following compares Opiant’s
operations for the nine months ended April 30, 2016 to the same period at April 30, 2015.
Revenues
Opiant had revenue of $9,585,097 and
$680,000 of revenue during the nine months ended April 30, 2016 and 2015 respectively. The increase in revenue during the nine
month period ended April 30, 2016 was partially the result of recognizing $4,800,000 of revenue from the sale of net profit interests
in the Company’s treatment to reverse opioid overdoses. The revenue from these sales was recognized during the nine months
ended April 30, 2016, because either the investment did not contain an option to exchange net profit interests for shares or the
product was approved by the FDA and marketed, which negated the investor’s option to exchange net profit interests for shares,
and the research and development work related to the product was completed as of April 30, 2016. The Company also recognized $4,785,097
of revenue derived from the Adapt Agreement during the period ended April 30, 2016, which included $2,000,000 received as a result
of the FDA’s approval of NARCAN® (naloxone hydrochloride) Nasal Spray for the emergency treatment of known or suspected
opioid overdose, and $2,500,000 received as a result of the first commercial sale of NARCAN® (naloxone hydrochloride) Nasal
Spray, two of the milestones set forth in the Adapt Agreement.
General and Administrative Expenses
General and administrative expenses
were incurred in the amount of $14,407,688 and $4,710,134 for the nine months ended April 30, 2016 and 2015, respectively. The
increase in expenses as compared to the same period in the prior year was primarily due to an increase in stock-based compensation
recorded during the nine months ended April 30, 2016 as compared to the nine months ended April 30, 2015.
Research and Development Expenses
Opiant incurred $1,865,014 and $1,340,754
of research and development expenses during the nine months ended April 30, 2016 and 2015, respectively. The increase was primarily
due to an increase in stock-based compensation recorded during the nine months ended April 30, 2016 as compared to the nine months
ended April 30, 2015.
Interest Expense
During the nine months ended April
30, 2016, interest expense decreased to $11,319 as compared to $23,480 at April 30, 2015. This decrease was due to a reduction
in obligations connected to outstanding debt.
Net Loss
The comparable net loss for the nine
months ended April 30, 2016 was $6,723,849 as compared to the net loss of $5,401,646 for the nine months ended April 30, 2015.
This increased net loss was due primarily to the increase in general and administrative and research and development expenses,
particularly stock-based compensation. This increase was offset by an increase in revenues during the nine months ended April
30, 2016.
Liquidity and Capital Resources
Opiant’s cash balance at April
30, 2016, was $2,363,465 together with $6,170,917 of outstanding liabilities. The Company’s management believes that the
Company’s current cash balance will not be sufficient to fund the Company’s operations for the next twelve months.
As a result, the Company will need to generate sufficient revenues and/or seek additional funding in the near future. The Company
currently does not have a specific plan of how it will obtain such funding, however, the Company anticipates that additional funding
will come in the form of debt financing and/or equity financing from the sale of the Company’s common stock. During the
nine months ended April 30, 2016, Opiant received $4,785,097 of revenue pursuant to the Adapt Agreement and $1,833,500 in funding
in exchange for interests in the Company’s treatments covered by commitment agreements. In addition to debt financing and/or
equity financing and similar to the funding received during the nine months ended April 30, 2016, funding of the Company may come
in the form of financing from the sale of interests in the Company’s current and/or prospective products and/or from revenue
received pursuant to the terms of the Adapt Agreement.
The financial position of Opiant at
April 30, 2016 showed an increase of $1,971,822 in assets from July 31, 2015 of $487,795 to $2,459,617. This was due to an increase
in the Company’s cash position of $1,929,248, which was due to the Company receiving funding of its operations in exchange
for interests in the Company’s treatments covered by commitment agreements and the Company receiving payments pursuant to
the Adapt Agreement. The liabilities decreased from $8,874,520 at July 31, 2015 to $6,170,917 at April 30, 2016. This decrease
was a result of a decrease in accounts payable and accrued liabilities of $108,639, a decrease in amounts due to related parties
and a decrease in deferred revenue of $2,966,500. This decrease was offset by an increase in the accrual of officer salaries of
$501,536.
Going Concern
The Company has not attained profitable
operations and is dependent upon obtaining financing and revenues to develop the Company’s pipeline. In their report
on the Company’s financial statements at April 30, 2016 and July 31, 2015, the Company’s auditors raised substantial
doubt about the Company’s ability to continue as a going concern.
The Company has incurred significant
losses, a working capital deficit as of April 30, 2016 of $1,653,576 and is dependent on generating sufficient revenues and/or
obtaining adequate capital to fund operating losses until it becomes profitable. If the Company is unable to generate sufficient
revenues and/or obtain the necessary funding it could cease operations as a new enterprise. This raises substantial doubt about
the Company’s ability to continue as a going concern. Management’s plans include seeking additional financing in the
form of debt financing and/or equity financing from the sale of the Company’s common stock and/or in the form of financing
from the sale of interests in the Company’s current and/or prospective products. Such funds may also be derived pursuant
to licensing agreements. There is no guarantee that additional capital or debt financing will be available when and to the extent
required, or that if available, it will be on terms acceptable to us. These financial statements do not include any adjustments
that might result from this uncertainty.
Plan of Operation
During the next year, the Company aims
to broaden the Company’s product pipeline, and anticipates commencing further trials based on the Company’s existing
as well as potential patents.
At this time, the Company cannot provide
investors with any assurance that the Company will be able to generate sufficient revenues and/or obtain sufficient funding to
meet the Company’s obligations over the next twelve months. The Company anticipates that if revenues are not sufficient
then additional funding will be required in the form of debt financing and/or equity financing from the sale of the Company’s
common stock and/or in the form of financing from the sale of interests in the Company’s current and/or prospective products. The
Company does not have any arrangements in place for any future funding. The Company may also seek to obtain short-term loans from
the Company’s officers and directors to meet the Company’s short-term funding needs.
Notwithstanding the foregoing, NARCAN®
(naloxone hydrochloride) Nasal Spray for the emergency treatment of known or suspected opioid overdose is currently being marketed
by Adapt and the Company expects to continue to receive funds pursuant to the terms of the Adapt Agreement.
Critical Accounting Policies and
Estimates
The Company believes that the following
critical policies affect the Company’s more significant judgments and estimates used in preparation of the Company’s
financial statements.
The Company prepares its financial
statements in conformity with generally accepted accounting principles in the United States of America. These principals require
management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent
assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting
period. Management believes that these estimates are reasonable and have been discussed with the Company’s board of directors;
however, actual results could differ from those estimates.
The Company issues restricted stock
to consultants for various services and employees for compensation. Cost for these transactions are measured at the fair value
of the consideration received or the fair value of the equity instruments issued, whichever is measurable more reliably measurable.
The value of the common stock is measured at the earlier of: (i) the date at which a firm commitment for performance by the counterparty
to earn the equity instruments is reached or (ii) the date at which the counterparty’s performance is complete.
The Company issues options and warrants
to consultants, directors, and officers as compensation for services. These options and warrants are valued using the Black-Scholes
model, which focuses on the current stock price and the volatility of moves to predict the likelihood of future stock moves. This
method of valuation is typically used to accurately price stock options and warrants based on the price of the underlying stock.
Long-lived assets such as property,
equipment and identifiable intangibles are reviewed for impairment whenever facts and circumstances indicate that the carrying
value may not be recoverable. When required impairment losses on assets to be held and used are recognized based on the fair value
of the asset. The fair value is determined based on estimates of future cash flows, market value of similar assets, if available,
or independent appraisals, if required. If the carrying amount of the long-lived asset is not recoverable from its undiscounted
cash flows, an impairment loss is recognized for the difference between the carrying amount and fair value of the asset. When
fair values are not available, the Company estimates fair value using the expected future cash flows discounted at a rate commensurate
with the risk associated with the recovery of the assets. The Company did not recognize any impairment losses for any periods
presented.
Fair value estimates used in preparation
of the financial statements are based upon certain market assumptions and pertinent information available to management. The respective
carrying value of certain on-balance-sheet financial instruments approximated their fair values. These financial instruments include
cash, accounts payable and due to related parties. Fair values were assumed to approximate carrying values for these financial
instruments since they are short-term in nature and their carrying amounts approximate fair values or they are receivable or payable
on demand.
Revenue Recognition
The Company recognizes revenues from
nonrefundable, up-front license fees related to collaboration agreements, on a straight-line basis over the contracted or estimated
period of performance. The period of performance over which the revenues are recognized is typically the period over which the
research and/or development is expected to occur or manufacturing services are expected to be provided. When the period of performance
is based on the period over which research and/or development is expected to occur, the Company is required to make estimates
regarding drug development and commercialization timelines. Because of the many risks and uncertainties associated with the development
of drug candidates, these estimates regarding the period of performance may change.
In addition, the Company evaluates
each arrangement to determine whether or not it qualifies as a multiple-deliverable revenue arrangement under ASC 605-25. If one
or more of the deliverables have a standalone value, then the arrangement would be separated into multiple units of accounting.
This normally occurs when the research and development services could contractually and feasibly be provided by other vendors
or if the customer could perform the remaining research and development itself, and when the Company has no further obligations
and the right has been conveyed. When the deliverables cannot be separated, any initial payment received is treated like an advance
payment for the services and recognized over the performance period, as determined based on all of the items in the arrangement.
This period is usually the expected research and development period.
Licensing Agreements
The Company has received payments upon
Adapt reaching various regulatory and sales milestones as well as royalty payments and the Company could receive additional sales
and regulatory milestone payments, and royalties, in the future. In addition, pursuant to the Adapt Agreement, the Company was
required to contribute $2,500,000 of development, regulatory, and commercialization costs, some of which was credited for costs
incurred by the Company prior to the execution of the Adapt Agreement. The Company fulfilled its requirement to contribute $2,500,000
during the three months ended October 31, 2015.
The Company recognized revenue for
fees related to participation in the initial development plan and joint development committee calls as revenue once the fee is
received and the Company has performed the required services for the period.
Treatment Investments
With respect to investments in interests
in the Company’s treatments, if an agreement provides an option that allows the investor in the treatment to convert an
interest in a treatment into shares of common stock of the Company, then revenue is deferred until such time that the option expires
or milestones are achieved that eliminate the investor’s right to exercise the option. Upon expiration of the exercise option,
the deliverables of the arrangement are reviewed and evaluated under ASC 605. In the event the investor chooses to convert interests
into shares of common stock, that transaction will be accounted for similar to a sale of shares of common stock for cash.
Off-Balance Sheet Arrangements
The Company has no off-balance sheet
arrangements as of April 30, 2016 and July 31, 2015.
Recent
Accounting Pronouncements
From time
to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that are adopted by the Company
as of the specified effective date. The Company believes that the impact of recently issued standards that are not yet effective
will not have a material impact on the Company’s financial position or results of operations upon adoption.
CHANGES IN AND DISAGREEMENTS
WITH ACCOUNTANTS
ON ACCOUNTING AND FINANCIAL DISCLOSURE
There have been no changes in or disagreements
with accountants on accounting or financial disclosure matters.
DIRECTORS AND EXECUTIVE
OFFICERS AND CORPORATE GOVERNANCE
The Company’s directors, executive
officers, and key employees are listed below. The number of directors is determined by the Company’s board of directors.
All of the Company’s directors hold office until the next annual meeting of the board or until their successors have been
duly elected and qualified. Dr. Roger Crystal and Kevin Pollack shall serve until the 2017 annual meeting. The Company’s
officers are elected by the Company’s board of directors and their terms of office are, except to the extent governed by
employment contract, at the discretion of the Company’s board of directors.
|
NAME
|
|
AGE
|
|
POSITION
|
|
|
|
|
|
|
|
Dr. Michael Sinclair
|
|
73
|
|
Executive Chairman, Chairman of the Board
|
|
Dr. Roger Crystal
|
|
39
|
|
Chief Executive Officer, President, Director
|
|
Kevin Pollack
|
|
45
|
|
Chief Financial Officer, Treasurer, Secretary, Director
|
|
Geoffrey Wolf
|
|
62
|
|
Director
|
|
Ann L. MacDougall
|
|
62
|
|
Director
|
|
Dr. Gabrielle Silver
|
|
42
|
|
Director
|
Set forth below is a brief description
of the background and business experience of the Company’s executive officers and directors for the past five years.
Dr. Michael Sinclair
has developed
and managed healthcare companies for over forty years. As a physician specializing in psychiatry, he began is medical career at
Middlesex Hospital in London. His transition to business came when he founded and acted as Chief Executive of Nestor PLC. His
tenure as CEO of Nestor resulted in a compound IRR of 38% over an 8 year period for its shareholders. He acted as President (International)
of INA Healthcare Group (subsequently CIGNA) and its Hospital Affiliates Inc. subsidiary. As executive Chairman of Kimberly
Quality Care (KQC), he was instrumental in growing KQC from one office in Nashville to a business with a turnover of $1 billion.
He was also the chairman and founder of U.S. based Atlantic Medical Management LLP, which managed the New York based healthcare
venture fund, Atlantic Medical Capital LP. Dr. Sinclair is Chief Executive Officer and Executive Chairman of Advanced Oncotherapy,
PLC and also serves on the Board of Overseers (emeritus) of the Tufts University School of Medicine.
Dr. Sinclair’s qualifications to
serve on the Company’s board of directors include his medical and management experience.
Dr. Roger Crystal
has been Chief
Executive Officer and Director of the Company since September 23, 2009. Dr. Crystal is a pioneer in the development of intranasal
naloxone treatments for opioid overdose. He led the Company’s development of nasal naloxone for opioid overdose, which
led to FDA approval, is the lead inventor on the product’s patents. He has several years’ experience as a clinician,
and began his career as an ENT surgeon at Imperial College Healthcare, London. He holds degrees in Medicine and Physiology from
the University of Birmingham. He was also awarded Membership of The Royal College of Surgeons of England. He was an Honorary Research
Fellow at University College London and has authored of a number of peer-reviewed scientific articles. After completing an MBA
at London Business School, he worked for Goldman Sachs in Mergers and Acquisitions and then consulted for A.T. Kearney specializing
in healthcare strategy management. He served on the Global Business Development Product Acquisition and Licensing team at GE Healthcare
where he was responsible for evaluating acquisitions, licensing and partnering deals. Most recently he served as Chief Business
Officer for ImaginAb, a Los Angeles based venture capital backed biotechnology company, developing immuno-oncology imaging agents.
In this capacity he led the company’s turnaround, to establish the strategy for the development of its immune-imaging platform
and managed its partnerships, pharmaceutical company engagements and licensing deals.
Dr. Crystal’s qualifications to serve on the Company’s
board of directors include his knowledge of the healthcare industry combined with his operational, managerial and strategic expertise.
Kevin Pollack
has been Chief Financial
Officer and Director of the Company since November 26, 2012 and April 17, 2012, respectively. Mr. Pollack has been an investment
banker and securities attorney at Banc of America Securities LLC and Sidley Austin LLP (formerly Brown & Wood LLP), respectively,
and has previous asset management experience at Paragon Capital LP. He is a
magna cum laude
graduate of the Wharton School
of the University of Pennsylvania and holds JD and MBA degrees from Vanderbilt University, where he graduated with
Beta Gamma
Sigma
honors. Currently, Mr. Pollack sits on the Boards of Directors of MagneGas Corporation and Pressure BioSciences, Inc.
He also is President of Short Hills Capital LLC.
Mr. Pollack’s qualifications to
serve on the Company’s board of directors include his financial and management experience, including his experience with
other public companies.
Geoffrey Wolf
has been a Director
of the Company since December 31, 2012. Mr. Wolf resides in Switzerland. During 2008 to 2012, Mr. Wolf managed Vector Assets S.A.,
an asset management company, which controlled companies in the mining, oil and gas, pharmaceuticals, hospitality and real estate
industries. Since 2013, Mr. Wolf has been managing GTL Investments Limited, an asset management company, which controls companies
in the mining, oil and gas, pharmaceuticals, hospitality and real estate industries. He received a business degree from Middlesex
University in 1976.
Mr. Wolf’s qualifications to serve
on the Company’s board of directors include his financial and management experience.
Ms. MacDougall
has
extensive global experience spanning both operating and legal roles for both private and non-profit organizations. Since
January 2014, she has served as President of Encore.org, a national organization building a movement for individuals
developing second careers in public or non-profit service. From 2007 to December 2013, Ms. MacDougall was Chief Operating
Officer of Acumen, an investment fund focused on goods and services for low-income customers. Prior to Acumen, she had a long
career managing legal matters at PriceWaterhouseCoopers, including as General Counsel in the U.S. and Deputy General Counsel
based in Paris. Ms. MacDougall earned her B.A. at Tufts University and her J.D. at Brooklyn Law School.
Ms. MacDougall’s qualifications
to serve on the Company’s board of directors include her financial and management experience.
Dr. Silver
has extensive experience managing the growth and profitability of pharmaceuticals and diagnostics businesses with a key focus
on neurology. Since October 2015, she has served as a partner at Brunswick Group, an advisory firm specializing in critical issues
and corporate relations, where she is co-leading the firm’s global pharmaceutical and healthcare offering. From October
2013 to October 2015, she was an executive at GE Healthcare’s Operating Room Solutions business, a new division at GE Healthcare.
From September 2010 to October 2013, she was Global Head of Neuroscience/General Medicine Strategic Marketing at GE. In this role,
she developed the disease-focused growth strategy across the diagnostics and imaging portfolio. Earlier in her career, Dr. Silver
was the director of the CNS Franchise of Eisai Ltd., UK for which she was responsible for growth and profitability of key brands
in the UK including Aricept® and Zonegran®. Prior to her tenure at Eisai, she was Therapeutic Area Director of Neuroscience
at Bristol-Myers Squibb UK. Dr. Silver received her Bachelor of Science from the University of Bristol and her Bachelor of Medicine
and Bachelor of Surgery from the University of London. She is also a Fellow of the Faculty of Pharmaceutical Medicine in the UK.
Dr. Silver’s qualifications to
serve on the Company’s board of directors include her healthcare, financial and management experience.
EXECUTIVE COMPENSATION
Summary Compensation
Table
The following summary compensation table
sets forth all compensation awarded to, earned by, or paid to the named executive officers paid by the Company during the years
ended July 31, 2015, and 2014 in all capacities for the accounts of the Company’s executives, including the Chairman, Chief
Executive Officer, and Chief Financial Officer.
Name and
principal
position
|
|
Year
|
|
Salary($)(1)
|
|
|
Bonus($)
|
|
|
Stock
Award(s)($)
|
|
|
Option
awards
($)(2)
|
|
|
All Other
Compensation($)
|
|
|
Total
($)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr. Roger Crystal
|
|
2015
|
|
|
567,892
|
|
|
|
820,000
|
|
|
|
-0-
|
|
|
|
-0-
|
|
|
|
-0-
|
|
|
|
1,387,892
|
|
|
CEO
|
|
2014
|
|
|
402,083
|
|
|
|
50,000
|
|
|
|
-0-
|
|
|
|
4,961,650
|
|
|
|
-0-
|
|
|
|
5,413,733
|
|
|
Kevin Pollack,
|
|
2015
|
|
|
541,598
|
|
|
|
767,500
|
|
|
|
-0-
|
|
|
|
-0-
|
|
|
|
-0-
|
|
|
|
1,309,098
|
|
|
CFO
|
|
2014
|
|
|
366,667
|
|
|
|
40,000
|
|
|
|
-0-
|
|
|
|
4,311,650
|
|
|
|
-0-
|
|
|
|
4,718,317
|
|
|
Dr. Michael Sinclair
|
|
2015
|
|
|
355,918
|
|
|
|
193,000
|
|
|
|
-0-
|
|
|
|
-0-
|
|
|
|
-0-
|
|
|
|
548,918
|
|
|
Executive Chairman
|
|
2014
|
|
|
314,583
|
|
|
|
10,000
|
|
|
|
-0-
|
|
|
|
3,030,050
|
|
|
|
-0-
|
|
|
|
3,354,633
|
|
|
|
(1)
|
During
the fiscal year ended July 31, 2015, less than 50% of salaries were paid to each of Dr. Roger Crystal, Kevin Pollack, and
Dr. Michael Sinclair and less than 12% of bonus compensation was paid to each of Dr. Roger Crystal, Kevin Pollack, and Dr.
Michael Sinclair. The remaining amounts have been accrued and are owed.
|
|
|
|
|
|
|
|
Per the description
below, stock options are owed to Dr. Roger Crystal, Kevin Pollack, and Dr. Michael Sinclair, but they have not been disclosed
in the Summary Compensation Table because they were not actually issued as of July 31, 2015.
On
October 23, 2015, stock options were granted pursuant to stock option grant agreements signed by the Company and each executive
or director and the date of grant for each stock option grant was October 27, 2015. Each stock option grant, once exercisable,
entitles a recipient to purchase a share of Company common stock at the stock option’s exercise price. The exercise
price for each stock option is $7.25, which is equal to or greater than the fair market value of shares of Company common
stock on October 27, 2015. Each stock option has a ten-year term and expires on October 26, 2025. Each stock option is fully
vested on the date of grant, but may only be exercised between the following dates: (i) the first to occur of: (A) the commencement
of three trials on or subsequent to October 23, 2015; or (B) (1) the approval by the U.S. Food and Drug Administration of
the New Drug Application with respect to the opioid overdose reversal treatment, and (2) the commencement of two trials on
or subsequent to October 23, 2015; and (ii) the expiration date.
|
|
|
|
|
|
|
|
The stock options
granted to the Company’s executive officers and directors on October 27, 2015 are as follows:
|
|
Name
|
|
Number
of Shares
|
|
|
Michael Sinclair
|
|
|
250,000
|
|
|
Roger Crystal
|
|
|
500,000
|
|
|
Kevin Pollack
|
|
|
500,000
|
|
|
Geoffrey Wolf
|
|
|
62,500
|
|
|
|
|
With
the exception of the stock options grant made to Mr. Wolf, the stock options were granted in lieu of certain stock options
that were to be granted to Messrs. Sinclair, Crystal and Pollack pursuant to the following agreements: (i) for Dr. Sinclair,
that certain Employment Agreement with the Company dated August 6, 2010, and amended on December 31, 2012 and December 31,
2013, (ii) for Dr. Crystal, that certain Executive Letter of Reappointment with the Company dated November 26, 2012, and amended
on December 31, 2012 and December 31, 2013, and (iii) for Mr. Pollack, that certain Executive Letter of Appointment with the
Company dated November 26, 2012, and amended on December 31, 2012 and December 31, 2013 (collectively, the “Prior Options”).
By accepting the stock option grants, Messrs. Sinclair, Crystal and Pollack waived, released, forfeited and relinquished their
rights, claims, titles and interests to the Prior Options.
|
Director Compensation
The following
table provides information for 2015 regarding all compensation awarded to, earned by or paid to each person who served as a non-employee
director during the fiscal year ended July 31, 2015. With respect to the fiscal year ended July 31, 2015, other than as set forth
in the table, the Company has not paid any fees to or, except for reasonable expenses for attending board and committee meetings,
reimbursed any expenses of directors, made any equity or non-equity awards to directors, or paid any other compensation to directors.
|
Name
|
|
Fees
Earned
or Paid
in
Cash
($)
|
|
|
Stock
Awards
($)
|
|
|
Option
Awards
($)
|
|
|
Non-Equity
Incentive Plan
Compensation
($)
|
|
|
Nonqualified
Deferred
Compensation
Earnings
($)
|
|
|
All Other
Compensation
($)
|
|
|
Total
($)
|
|
|
Geoffrey Wolf
|
|
|
-0-
|
|
|
|
-0-
|
|
|
|
-0-
|
|
|
|
-0-
|
|
|
|
-0-
|
|
|
|
-0-
|
|
|
|
-0-
|
|
Employment Agreements
As previously disclosed in the Company’s
Current Report on Form 8-K filed on April 15, 2016 with the Securities and Exchange Commission (the “Employment Agreements
8-K”), on April 12, 2016, Opiant Pharmaceuticals, Inc. (the “Company”) amended its employment agreements with
Dr. Michael Sinclair, our Executive Chairman (the “Sinclair Amendment”), Dr. Roger Crystal, our Chief Executive Officer
(the “Crystal Amendment”), and Mr. Kevin Pollack, our Chief Financial Officer (the “Pollack Amendment”)
effective as of January 1, 2016.
The Sinclair Amendment
The Sinclair Amendment to the employment
agreement by and between the Company and Dr, Michael Sinclair dated August 6, 2010 amends the original agreement and the subsequent
amendments to the agreement effective as of December 31, 2012 and December 31, 2013, respectively. The Sinclair Amendment extends
the term of Dr. Sinclair’s employment until December 31, 2016.
From January 1, 2016 until December
31, 2016, Dr. Sinclair will receive a base salary of $350,000. The Company shall pay Dr. Sinclair no less than $265,000 of the
base salary earned between January 1, 2016 and December 31, 2016, and all amounts in excess of the amounts actually paid shall
accrue, with a minimum of 50% of the balance due being paid by September 30, 2017, and remaining balance paid by March 31, 2018.
Dr. Sinclair shall be eligible to earn an incentive bonus
in an amount and structure agreed upon by Dr. Sinclair and the Board of Directors of the Company (the “Board”). The
amount of the incentive bonus payment shall be determined based the achievement of specific milestones, representing a combination
of both individual management objectives and corporate objectives. The Board shall, in its sole discretion, determine whether
such objectives have been achieved, and the amount of Dr. Sinclair’s incentive bonus, if any. Any bonus awarded hereunder
shall be paid no later than February 15, 2017 and shall be subject to applicable payroll tax withholdings and deductions.
Subject to the approval by the Board,
Dr. Sinclair shall be granted options to purchase shares of the Company’s common stock (the “Options”) with
an exercise price per share equal to no less than the fair market value of one share of the Company’s common stock on the
date of grant of the Options, as determined by the Board. The Options shall also be subject to the terms and conditions of the
Company’s forthcoming stock plan.
The Crystal
Amendment
The Crystal Amendment to the employment
agreement by and between the Company and Dr. Roger Crystal dated November 26, 2012 amends the original agreement and the subsequent
amendments to the agreement effective as of December 31, 2012 and December 31, 2013, respectively. The Crystal Amendment extends
the term of Dr. Crystal’s employment until December 31, 2016.
From January 1, 2016 until December
31, 2016, Dr. Crystal will receive a base salary of $593,750. The Company shall pay Dr. Crystal no less than $450,000 of the base
salary earned between January 1, 2016 and December 31, 2016, and all amounts in excess of the amounts actually paid shall accrue,
with a minimum of 50% of the balance due being paid by September 30, 2017, and remaining balance paid by March 31, 2018.
Dr. Crystal shall be eligible to earn
an incentive bonus in an amount and structure agreed upon by Dr. Crystal and the Board. The amount of the incentive bonus payment
shall be determined based the achievement of specific milestones, representing a combination of both individual management objectives
and corporate objectives. The Board shall, in its sole discretion, determine whether such objectives have been achieved, and the
amount of Dr. Crystal’s incentive bonus, if any. Any bonus awarded hereunder shall be paid no later than February 15, 2017
and shall be subject to applicable payroll tax withholdings and deductions.
Subject to the approval by the Board, Dr. Crystal shall
be granted options to purchase shares of the Company’s common stock (the “Options”) with an exercise price per
share equal to no less than the fair market value of one share of the Company’s common stock on the date of grant of the
Options, as determined by the Board. The Options shall also be subject to the terms and conditions of the Company’s
forthcoming stock plan.
The Pollack
Amendment
The Pollack
Amendment to the employment agreement by and between the Company and Mr. Pollack dated November 26, 2012 amends the original agreement
and the subsequent amendments to the agreement dated December 31, 2012 and December 31, 2013, respectively. The Pollack Amendment
extends the term of Mr. Pollack’s employment until December 31, 2016.
From January 1, 2016 until December
31, 2016, Mr. Pollack will receive a base salary of $562,500. The Company shall pay Mr. Pollack no less than $425,000 of the base
salary earned between January 1, 2016 and December 31, 2016, and all amounts in excess of the amounts actually paid shall accrue,
with a minimum of 50% of the balance due being paid by September 30, 2017, and remaining balance paid by March 31, 2018.
Mr. Pollack shall be eligible to earn an incentive bonus
in an amount and structure agreed upon by Mr. Pollack and the Board. The amount of the incentive bonus payment shall be determined
based the achievement of specific milestones, representing a combination of both individual management objectives and corporate
objectives. The Board shall, in its sole discretion, determine whether such objectives have been achieved, and the amount of Mr.
Pollack’s incentive bonus, if any. Any bonus awarded hereunder shall be paid no later than February 15, 2017 and shall be
subject to applicable payroll tax withholdings and deductions.
Subject to the approval by the Board,
Mr. Pollack shall be granted options to purchase shares of the Company’s common stock (the “Options”) with an
exercise price per share equal to no less than the fair market value of one share of the Company’s common stock on the date
of grant of the Options, as determined by the Board.
The Company
has an agreement with Geoffrey Wolf, a director of the Company, which provides for the grant of 35,000 stock options exercisable
at $15.00 per share which terminate five (5) years from their grant date. The director agreement also provides warrants to purchase
345,000 shares of common stock exercisable at $15.00 per share with a five (5) year termination date. All of the above options
and warrants may only be exercised between the following dates: (i) the date on which the Company’s price per share has
traded at or above US $30.00 for at least three (3) trading days out of any ten (10) consecutive trading days; and (ii) five years
(5) from the grant date. The director agreement has a one-year term limit and can be renewed by mutual agreement.
SECURITY OWNERSHIP
OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
The following table sets forth certain
information regarding the Company’s shares of common stock beneficially owned as of August 18, 2016 for (i) each stockholder
known to be the beneficial owner of 5% or more of the Company’s outstanding shares of common stock, (ii) each named executive
officer and director, and (iii) all executive officers and directors as a group. A person is considered to beneficially own any
shares: (i) over which such person, directly or indirectly, exercises sole or shared voting or investment power, or (ii) of which
such person has the right to acquire beneficial ownership at any time within 60 days through an exercise of stock options or warrants.
Unless otherwise indicated, voting and investment power relating to the shares shown in the table for the Company’s directors
and executive officers is exercised solely by the beneficial owner or shared by the owner and the owner’s spouse or children.
For purposes of this table, a person
or group of persons is deemed to have “beneficial ownership” of any shares of common stock that such person has the
right to acquire within 60 days of August 18, 2016. For purposes of computing the percentage of outstanding shares of the Company’s
common stock held by each person or group of persons named above, any shares that such person or persons has the right to acquire
within 60 days of August 18, 2016, is deemed to be outstanding, but is not deemed to be outstanding for the purpose of computing
the percentage ownership of any other person. The inclusion herein of any shares listed as beneficially owned does not constitute
an admission of beneficial ownership. Unless otherwise specified, the address of each of the persons set forth below is care of
the company at the address of
:
401 Wilshire Blvd., 12
th
Floor, Santa Monica, CA 90401.
The following table sets forth information
on the ownership of the Company’s voting securities by officers, directors, and major shareholders as well as those who
own beneficially more than five percent of the Company’s common stock as of the date of this report:
|
Name of Beneficial Owner and Address
|
|
Amount and
Nature of
Beneficial
Ownership of
Common
Stock
|
|
|
Percent
of
Common
Stock (1)
|
|
|
5% Shareholders
|
|
|
|
|
|
|
|
None.
|
|
|
-
|
|
|
|
%
|
|
Directors and
Executive Officers
|
|
|
|
|
|
|
|
|
|
Kevin Pollack
|
|
|
1,460,000
|
(2)
|
|
|
41.94
|
%
|
|
Dr. Roger Crystal
|
|
|
1,430,000
|
(3)
|
|
|
41.49
|
%
|
|
Dr. Michael Sinclair
|
|
|
1,066,670
|
(4)
|
|
|
36.39
|
%
|
|
Geoffrey Wolf
|
|
|
381,000
|
(5)
|
|
|
16.24
|
%
|
|
All directors and officers as a group (4 people)
|
|
|
4,337,670
|
(6)
|
|
|
70.63
|
%
|
|
|
(1)
|
As of August 18, 2016, there were 2,021,577 shares issued and outstanding. Shares of common stock subject to options or warrants currently
exercisable or expected to be exercisable with the passage of time, are deemed outstanding for purposes of computing the percentage
of the person holding such options or warrants, but are not deemed outstanding for purposes of computing the percentage of
any other person.
|
|
|
(2)
|
This amount includes:
(1) 0 shares of common stock issuable upon the exercise of warrants and (2) 1,460,000 shares of common stock issuable upon
the exercise of stock options.
|
|
|
(3)
|
This amount includes:
(1) 0 shares of common stock issuable upon the exercise of warrants and (2) 1,425,000 shares of common stock issuable upon
the exercise of stock options, and (3) 5,000 shares of common stock.
|
|
|
(4)
|
This amount
includes: (1) 0 shares of common stock issuable upon the exercise of warrants; (2) 910,000 shares of common stock
issuable upon exercise of stock options; (3) 40,720 shares held in certificate form directly by Dr. Sinclair; (4) 27,450
shares held in certificate form indirectly by (i) Proton Therapy USA, a entity owned jointly by Dr. Sinclair and his son
(5,000 shares); (ii) one pension fund (10,000 shares); (iii) a second pension fund (2,000 shares); (iv) Clearsearch Ltd.,
an entity who holds the shares for the benefit of Dr. Sinclair (2,650 shares); and (v) Eastkings Pension Fund, an
entity which holds the shares for the benefit of Dr. Sinclair’s wife (7,800 shares); and (5) 88,500 shares held in
electronic form for the benefit of Dr. Sinclair.
|
|
|
(5)
|
This amount includes:
(a) 56,500 shares of common stock, 7,700 shares of which are held by GTL Investments Limited, of which Mr. Wolf is an asset
manager; (b) 0 shares of common stock issuable upon the exercise of warrants held directly by Mr. Wolf; (c) 137,000 of common
stock issuable upon the exercise of warrants held by GTL Investments Limited, of which Mr. Wolf is an asset manager; and (d)
187,500 shares of common stock issuable upon exercise of stock options.
|
|
|
(6)
|
This amount includes
an aggregate of 218,170 shares of common stock, 137,000 shares of common stock issuable upon exercise of warrants and 3,982,500
shares of common stock issuable upon exercise of stock options.
|
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The
following are the related party transactions in which the Company has engaged since August 1, 2014:
The
Company uses office space provided by an officer of the Company free of charge.
At
July 31, 2015, the Company had loans outstanding with each of its three executive officers, all of who are directors, in the total
amount of $130,000 (July 31, 2014 - $350,000). In December, 2012, the Company borrowed $350,000. These notes accrued interest
at 6.0% per year and were due December, 2013. These notes were amended on December 16, 2013 to extend the final maturity date
to January 6, 2015 and increase the interest rate to 8.5% per annum. During the year ended July 31, 2015, $220,000 of the
principal amount was repaid. In December 2014, the agreements were amended to extend the maturity date to April 30, 2016 and increase
the annual interest rate to 14.5%, which includes a penalty rate of 8.5% due to non-payment of the required repayment amounts.
The loans are unsecured.
During the six months ended January 31,
2016, the Company fully repaid the loans and interest payable.
During September 2015 and October 2015,
the Company received loans from each of its three executive officers, all of who are directors, totaling $151,191. The loans bear
interest at 6% per annum until January 31, 2016. After January 31, 2016, a penalty of 4% shall be added such that the loans bear
interest at 10% per annum. The loans are unsecured and are due on January 31, 2016 unless the Company receives specified funding.
If the Company receives the specified funding the loans become due 10 business days after the funding. If the loans are not repaid
by January 31, 2016, the maturity date of the loans shall be changed to May 31, 2016.
During the six months ended January 31,
2016, the Company fully repaid the loans and interest payable.
Director Independence
Because the Company’s common stock
is not currently listed on a national securities exchange, the Company has used the definition of “independence” of
The NASDAQ Stock Market to make this determination. NASDAQ Listing Rule 5605(a)(2) provides that an “independent director”
is a person other than an officer or employee of the company or any other individual having a relationship which, in the opinion
of the Company’s board of directors, would interfere with the exercise of independent judgment in carrying out the responsibilities
of a director. The NASDAQ listing rules provide that a director cannot be considered independent if:
|
|
●
|
the
director is, or at any time during the past three years was, an employee of the company;
|
|
|
●
|
the
director or a family member of the director accepted any compensation from the company in excess of $120,000 during any period
of 12 consecutive months within the three years preceding the independence determination (subject to certain exclusions, including,
among other things, compensation for board or board committee service);
|
|
|
●
|
a
family member of the director is, or at any time during the past three years was, an executive officer of the company;
|
|
|
●
|
the
director or a family member of the director is a partner in, controlling stockholder of, or an executive officer of an entity
to which the company made, or from which the company received, payments in the current or any of the past three fiscal years
that exceed 5% of the recipient’s consolidated gross revenue for that year or $200,000, whichever is greater (subject
to certain exclusions);
|
|
|
●
|
the
director or a family member of the director is employed as an executive officer of an entity where, at any time during the
past three years, any of the executive officers of the company served on the compensation committee of such other entity;
or
|
|
|
●
|
the
director or a family member of the director is a current partner of the company’s outside auditor, or at any time during
the past three years was a partner or employee of the company’s outside auditor, and who worked on the company’s
audit.
|
Based on the rule listed above, the Company’s board of
directors determined that the Company’s only independent director is Mr. Geoffrey Wolf.
The Company does not currently have a separately designated
audit, nominating, or compensation committee.
WHERE YOU CAN FIND
MORE INFORMATION
The Company has filed a registration statement,
of which this Prospectus is a part, with the SEC under the Securities Act with respect to the Company’s common stock. This
Prospectus, which constitutes a part of the registration statement, does not contain all of the information set forth in the registration
statement, parts of which are omitted as permitted by the rules and regulations of the SEC. Statements contained in this Prospectus
as to the contents of any contract or other document are not necessarily complete. For further information pertaining to the Company
and its common stock, we refer you to the Company’s registration statement and the exhibits thereto, copies of which may
be inspected without charge at the SEC’s Public Reference Room, 100 F Street, N.E., Washington, D.C. 20549. Information
concerning the operation of the SEC’s Public Reference Room is available by calling the SEC at 1-800-SEC-0330. Copies of
all or any part of the registration statement may be obtained at prescribed rates from the SEC. The SEC also makes the Company’s
filings available to the public on its Internet site (http://www.sec.gov). Quotations relating to the Company’s common stock
appear on the OTC Markets, and such reports, proxy statements and other information concerning the Company can also be inspected
at the offices of the National Association of Securities Dealers, Inc., 1735 K Street N.W., Washington, D.C. 20006.
The Company files annual, quarterly and special reports, proxy
statements and other information with the SEC. Such periodic reports, proxy, and information statements and other information
are available for inspection and copying at the public reference facilities and Internet site of the SEC referred to above.
Website Access to Information and Disclosure
of Web Access to Company Reports
The Company’s website address is: http://www.opiant.com.
The Company makes available free of charge through the Company’s website the Company’s Annual Report on Form 10-K,
Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, Forms 3, 4, and 5, and all amendments to those reports as soon as
reasonably practicable after such material is electronically filed with the SEC.
Opiant Pharmaceuticals, Inc.
(formerly Lightlake Therapeutics Inc.)
Index to Financial Statements
July 31, 2015 and 2014
REPORT OF INDEPENDENT REGISTERED PUBLIC
ACCOUNTING FIRM
To the Board of Directors of
Opiant Pharmaceuticals, Inc.
(formerly Lightlake Therapeutics Inc.)
We have audited the accompanying balance
sheets of Opiant Pharmaceuticals, Inc. (formerly Lightlake Therapeutics Inc.) as of July 31, 2015 and 2014 and the related statements
of operations, stockholders’ deficit, and cash flows for each of the years then ended. These financial statements are the
responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on
our audits.
We conducted our audits in accordance
with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and
perform an audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. The
Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our
audit included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate
in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control
over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence
supporting the amounts and disclosures in the financial statements and assessing the accounting principles used and significant
estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide
a reasonable basis for our opinion.
In our opinion, the financial statements
referred to above present fairly, in all material respects, the financial position of Opiant Pharmaceuticals, Inc. (formerly Lightlake
Therapeutics Inc.) as of July 31, 2015 and 2014 and the results of its operations and its cash flows for each of the years then
ended, in conformity with accounting principles generally accepted in the United States of America.
The accompanying financial statements
have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the financial statements,
the Company has suffered losses from operations and has a working capital deficit, which raises substantial doubt about its ability
to continue as a going concern. Management's plans regarding these matters also are described in Note 2. The financial statements
do not include any adjustments that might result from the outcome of this uncertainty.
|
/s/ MaloneBailey, LLP
|
|
|
www.malone-bailey.com
|
|
|
Houston, Texas
|
|
|
October 26, 2015
|
|
Opiant Pharmaceuticals, Inc.
(formerly Lightlake Therapeutics Inc.)
Balance Sheets
As of July 31, 2015 and 2014
|
|
|
July 31,
|
|
|
July 31,
|
|
|
|
|
2015
|
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
Current assets
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
434,217
|
|
|
$
|
254,770
|
|
|
Prepaid insurance
|
|
|
33,143
|
|
|
|
24,079
|
|
|
Total current assets
|
|
|
467,360
|
|
|
|
278,849
|
|
|
|
|
|
|
|
|
|
|
|
|
Other assets
|
|
|
|
|
|
|
|
|
|
Patents and patent applications
(net of accumulated amortization of $7,015 at July 31, 2015 and $5,642 at July 31, 2014)
|
|
|
20,435
|
|
|
|
21,808
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
487,795
|
|
|
$
|
300,657
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders' Deficit
|
|
|
|
|
|
|
|
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
Current liabilities
|
|
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities
|
|
$
|
315,460
|
|
|
$
|
200,604
|
|
|
Accrued salaries and wages
|
|
|
3,129,060
|
|
|
|
1,416,651
|
|
|
Due to related parties
|
|
|
130,000
|
|
|
|
350,000
|
|
|
Total current liabilities
|
|
|
3,574,520
|
|
|
|
1,967,255
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred revenue
|
|
|
5,300,000
|
|
|
|
1,411,470
|
|
|
Total liabilities
|
|
|
8,874,520
|
|
|
|
3,378,725
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' deficit
|
|
|
|
|
|
|
|
|
|
Common stock; par value $0.001; 1,000,000,000 shares authorized;
|
|
|
|
|
|
|
|
|
|
1,841,866 shares issued and outstanding at July 31,
2015 and 1,782,073 shares issued and outstanding at July 31, 2014
|
|
|
1,842
|
|
|
|
1,782
|
|
|
Additional paid-in capital
|
|
|
44,982,519
|
|
|
|
43,253,363
|
|
|
Accumulated deficit
|
|
|
(53,371,086
|
)
|
|
|
(46,333,213
|
)
|
|
Total stockholders' deficit
|
|
|
(8,386,725
|
)
|
|
|
(3,078,068
|
)
|
|
Total liabilities and stockholders' deficit
|
|
$
|
487,795
|
|
|
$
|
300,657
|
|
The accompanying notes are an integral
part of these financial statements.
Opiant Pharmaceuticals, Inc.
(formerly Lightlake Therapeutics Inc.)
Statements of Operations
For the years ended July 31, 2015 and 2014
|
|
|
For the
|
|
|
|
|
Year Ended
|
|
|
|
|
July 31,
|
|
|
|
|
2015
|
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
|
1,550,000
|
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses
|
|
|
|
|
|
|
|
|
|
General and administrative
|
|
|
6,034,520
|
|
|
|
10,838,760
|
|
|
Research and development
|
|
|
2,414,973
|
|
|
|
464,609
|
|
|
Total operating
expenses
|
|
|
8,449,493
|
|
|
|
11,303,369
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(6,899,493
|
)
|
|
|
(11,303,369
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense)
|
|
|
|
|
|
|
|
|
|
Interest expense
|
|
|
(28,232
|
)
|
|
|
(160,303
|
)
|
|
Change in derivative
|
|
|
-
|
|
|
|
(27,067
|
)
|
|
Loss on foreign exchange
|
|
|
(110,148
|
)
|
|
|
(12,730
|
)
|
|
Gain on debt settlement/forgiveness
|
|
|
-
|
|
|
|
20,651
|
|
|
Total other income
(expense)
|
|
|
(138,380
|
)
|
|
|
(179,449
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Loss before provision for income taxes
|
|
|
(7,037,873
|
)
|
|
|
(11,482,818
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Provision for income taxes
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(7,037,873
|
)
|
|
$
|
(11,482,818
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Loss per common share:
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
$
|
(3.88
|
)
|
|
$
|
(6.57
|
)
|
|
Weighted average common shares outstanding
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
|
1,813,069
|
|
|
|
1,747,881
|
|
The accompanying notes are an integral
part of these financial statements.
Opiant Pharmaceuticals, Inc.
(formerly Lightlake Therapeutics Inc.)
Statements of Stockholders' Deficit
For the years ended July 31, 2015 and 2014
|
|
|
|
|
|
|
|
|
Additional
|
|
|
|
|
|
|
|
|
|
|
Common Stock
|
|
|
Paid In
|
|
|
Accumulated
|
|
|
|
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Deficit
|
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at July 31, 2013
|
|
|
1,647,001
|
|
|
$
|
1,647
|
|
|
$
|
33,858,732
|
|
|
$
|
(34,850,395
|
)
|
|
|
(990,016
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivative liability
|
|
|
-
|
|
|
|
-
|
|
|
|
(337,413
|
)
|
|
|
-
|
|
|
|
(337,413
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Settlement of derivative liability
|
|
|
-
|
|
|
|
-
|
|
|
|
506,574
|
|
|
|
-
|
|
|
|
506,574
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of convertible note to common stock
|
|
|
3,333
|
|
|
|
3
|
|
|
|
8,053
|
|
|
|
-
|
|
|
|
8,056
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued for services
|
|
|
41,867
|
|
|
|
42
|
|
|
|
213,925
|
|
|
|
-
|
|
|
|
213,967
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued due to exercise of warrants
|
|
|
89,872
|
|
|
|
90
|
|
|
|
(90
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation from issuance of stock options
|
|
|
-
|
|
|
|
-
|
|
|
|
8,283,582
|
|
|
|
-
|
|
|
|
8,283,582
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation from issuance of warrants
|
|
|
-
|
|
|
|
-
|
|
|
|
720,000
|
|
|
|
-
|
|
|
|
720,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(11,482,818
|
)
|
|
|
(11,482,818
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at July 31, 2014
|
|
|
1,782,073
|
|
|
$
|
1,782
|
|
|
$
|
43,253,363
|
|
|
$
|
(46,333,213
|
)
|
|
$
|
(3,078,068
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued for services
|
|
|
59,793
|
|
|
|
60
|
|
|
|
311,605
|
|
|
|
-
|
|
|
|
311,665
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation from issuance of stock options
|
|
|
-
|
|
|
|
-
|
|
|
|
1,008,239
|
|
|
|
-
|
|
|
|
1,008,239
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation from issuance of warrants
|
|
|
-
|
|
|
|
-
|
|
|
|
409,312
|
|
|
|
-
|
|
|
|
409,312
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(7,037,873
|
)
|
|
|
(7,037,873
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at July 31, 2015
|
|
|
1,841,866
|
|
|
$
|
1,842
|
|
|
$
|
44,982,519
|
|
|
$
|
(53,371,086
|
)
|
|
$
|
(8,386,725
|
)
|
The accompanying notes are an integral
part of these financial statements.
Opiant Pharmaceuticals, Inc.
(formerly Lightlake Therapeutics Inc.)
Statements of Cash Flows
For the years ended July 31, 2015 and 2014
|
|
|
For the
|
|
|
|
|
Year Ended
|
|
|
|
|
July 31,
|
|
|
July 31,
|
|
|
|
|
2015
|
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
Cash flows provided by (used in) operating activities
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(7,037,873
|
)
|
|
$
|
(11,482,818
|
)
|
|
Adjustments to reconcile net loss to net cash used by operating activities:
|
|
|
|
|
|
|
|
|
|
Amortization
|
|
|
1,373
|
|
|
|
1,372
|
|
|
Issuance of common stock for services
|
|
|
311,665
|
|
|
|
213,967
|
|
|
Stock based compensation from issuance of options
|
|
|
1,008,239
|
|
|
|
8,283,582
|
|
|
Stock based compensation from issuance of warrants
|
|
|
409,312
|
|
|
|
720,000
|
|
|
Accreted interest on debt discounts
|
|
|
-
|
|
|
|
132,428
|
|
|
Gain on debt settlement/forgiveness
|
|
|
-
|
|
|
|
(20,651
|
)
|
|
Change in derivative
|
|
|
-
|
|
|
|
27,067
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes in assets and liabilities:
|
|
|
|
|
|
|
|
|
|
Increase in prepaid insurance
|
|
|
(9,064
|
)
|
|
|
(2,829
|
)
|
|
Decrease in deferred revenue
|
|
|
(750,000
|
)
|
|
|
-
|
|
|
Increase in accounts payable
|
|
|
114,856
|
|
|
|
159,837
|
|
|
Increase in accrued salaries and wages
|
|
|
1,712,409
|
|
|
|
962,722
|
|
|
Net cash used in operating activities
|
|
|
(4,239,083
|
)
|
|
|
(1,005,323
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows provided by (used in) financing activities
|
|
|
|
|
|
|
|
|
|
Payments to related parties on notes payable
|
|
|
(220,000
|
)
|
|
|
-
|
|
|
Investment received in exchange for royalty agreement
|
|
|
4,638,530
|
|
|
|
661,470
|
|
|
Net cash provided by financing activities
|
|
|
4,418,530
|
|
|
|
661,470
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents
|
|
|
179,447
|
|
|
|
(343,853
|
)
|
|
Cash and cash equivalents, beginning of period
|
|
|
254,770
|
|
|
|
598,623
|
|
|
Cash and cash equivalents, end of period
|
|
$
|
434,217
|
|
|
$
|
254,770
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure
|
|
|
|
|
|
|
|
|
|
Interest paid during the period
|
|
$
|
-
|
|
|
$
|
-
|
|
|
Taxes paid during the period
|
|
$
|
-
|
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-Cash Transactions
|
|
|
|
|
|
|
|
|
|
Conversion of debt to equity
|
|
$
|
-
|
|
|
$
|
8,056
|
|
|
Debt discounts attributable to derivative valuation
|
|
$
|
-
|
|
|
$
|
132,428
|
|
|
Settlement of derivative liability
|
|
$
|
-
|
|
|
$
|
506,574
|
|
|
Cashless exercise of warrants
|
|
$
|
-
|
|
|
$
|
8,987
|
|
|
Derivative liability
|
|
$
|
-
|
|
|
$
|
337,413
|
|
The accompanying notes are an integral part of these financial
statements.
Opiant Pharmaceuticals, Inc.
(formerly Lightlake Therapeutics Inc.)
Notes to Financial Statements
For the years ended July 31, 2015 and 2014
|
|
1.
|
Organization
and Basis of Presentation
|
Opiant
Pharmaceuticals, Inc. (formerly Lightlake Therapeutics Inc.) (“Opiant
”,
“we”, “our”, the “Company”) was originally incorporated in the State of Nevada on June 21,
2005. On September 16, 2009, the Company changed its name to Lightlake Therapeutics Inc. The Company is a specialty pharmaceutical
company developing opioid antagonist treatments for substance use, addictive and eating disorders, including a treatment to reverse
opioid overdoses. The Company’s fiscal year end is July 31.
Reverse Stock Split
In December 2014, Opiant effected
a one-for-one hundred reverse stock split of its common stock (the “1:100 Reverse Stock Split”) which decreased the
number of common shares issued and outstanding from approximately 182.7 million shares to approximately 1.827 million shares as
of March 12, 2015. Unless otherwise noted, impacted amounts included in the financial statements and notes thereto have been retroactively
adjusted for the stock splits as if such stock splits occurred on the first day of the first period presented. Impacted amounts
include but are not limited to shares of common stock issued and outstanding, stock options, shares reserved, exercise prices
of warrants or options, and loss per share. There was no impact on preferred or common stock authorized resulting from the 1:100
Reverse Stock Split.
The accompanying financial statements
have been prepared assuming Opiant will continue as a going concern, which contemplates the realization of assets and the liquidation
of liabilities in the normal course of business. However, the Company has incurred significant losses, a working capital deficit
as of July 31, 2015 of $3,107,160 and is dependent on generating sufficient revenues and/or obtaining adequate capital to fund
operating losses until it becomes profitable. If the Company is unable to generate sufficient revenues and/or obtain the necessary
funding it could cease operations as a new enterprise. This raises substantial doubt about the Company’s ability to continue
as a going concern. These financial statements do not include any adjustments that might result from this uncertainty.
|
|
3.
|
Summary
of Significant Accounting Policies
|
Basis of Presentation and
Use of Estimates
Opiant prepares its financial
statements in conformity with accounting principles generally accepted in the United States of America (“GAAP”), which
require management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the date of the financial statements, and reported amounts of revenues and expenses during
the reporting period. Actual results could differ from those estimates.
Cash and Cash Equivalents
Opiant considers all highly
liquid investments purchased with an original maturity of three months or less to be cash equivalents. Cash and cash equivalents
were $434,217 and $254,770 at July 31, 2015 and 2014, respectively. The Company maintains cash balances at financial institutions
insured up to $250,000 by the Federal Deposit Insurance Corporation. Balances in the UK are insured up to £85,000 by the
Financial Services Compensation Scheme (UK Equivalent). The cash balances exceeded these insured amounts during the year.
Long-Lived Assets
Opiant follows ASC 360,
Property,
Plant, and Equipment,
for its fixed assets. Property and equipment is stated at cost less accumulated depreciation. Depreciation
is computed by the straight-line method over estimated useful lives (3 to 7 years). The Company’s capitalizes all asset
purchases greater than $500 having a useful life greater than one year.
Opiant Pharmaceuticals, Inc.
(formerly Lightlake Therapeutics Inc.)
Notes to Financial Statements
For the years ended July 31, 2015 and 2014
Opiant follows ASC 350,
Intangibles
– Goodwill and Other
for its intellectual property asset. Intellectual property consists of patents which are stated
at their fair value acquisition cost. Amortization is calculated by the straight line method over their estimated useful lives
(20 years).
Long-lived assets such as property
and equipment and identifiable intangibles are reviewed for impairment whenever facts and circumstances indicate that the carrying
value may not be recoverable. When required, impairment losses on assets to be held and used are recognized based on the
fair value of the asset. The fair value is determined based on estimates of future cash flows, market value of similar assets,
if available, or independent appraisals, if required. If the carrying amount of the long-lived asset is not recoverable from
its undiscounted cash flows, an impairment loss is recognized for the difference between the carrying amount and fair value of
the asset. When fair values are not available, Opiant estimates fair value using the expected future cash flows discounted
at a rate commensurate with the risk associated with the recovery of the assets. The Company did not recognize any impairment
losses for any years presented.
Earnings (Loss) per Share
Opiant follows ASC 260,
Earnings
per Share
. Basic earnings (loss) per share is computed by dividing the net income (loss) available to common shareholders
by the weighted-average number of common shares outstanding during the respective period presented in the Company’s accompanying
financial statements.
Fully diluted earnings (loss)
per share is computed similar to basic income (loss) per share except that the denominator is increased to include the number
of common stock equivalents (primarily outstanding options and warrants).
Common stock equivalents represent
the dilutive effect of the assumed exercise of outstanding stock options and warrants, using the treasury stock method, at either
the beginning of the respective period presented or the date of issuance, whichever is later, and only if the common stock equivalents
are considered dilutive based upon Opiant’ s net loss position at the calculation date.
Common stock equivalents have
not been included in the calculation of dilutive earnings (loss) per share as the result would be anti-dilutive. At July 31 2015,
potentially dilutive common stock equivalents are approximately 4,496,052 (2014 – 3,184,523) which consist of options and
warrants.
Research and Development
Costs
Opiant follows ASC 730,
Research
and Development
, and expenses all research and development costs as incurred for which there is no alternative future use.
These costs also include the expensing of employee compensation and employee stock based compensation.
Foreign Currency Translation
Opiant functional and reporting
currency is the United States dollar. Occasional transactions may occur in British Pounds and management has adopted ASC 830,
Foreign Currency Translation Matters
. Monetary assets and liabilities denominated in foreign currencies are translated
using the exchange rate prevailing at the balance sheet date. Gains and losses arising on translation or settlement of foreign
currency denominated transactions or balances are included in the determination of income.
Stock-Based Compensation
ASC 718
Compensation –
Stock Compensation
prescribes accounting and reporting standards for all share-based payment transactions in which employee
services are acquired. Transactions include incurring liabilities, or issuing or offering to issue shares, options, and other
equity instruments such as employee stock ownership plans and stock appreciation rights. Share-based payments to employees, including
grants of employee stock options, are recognized as compensation expense in the financial statements based on their fair values.
That expense is recognized over the period during which an employee is required to provide services in exchange for the award,
known as the requisite service period (usually the vesting period).
Opiant Pharmaceuticals, Inc.
(formerly Lightlake Therapeutics Inc.)
Notes to Financial Statements
For the years ended July 31, 2015 and 2014
Opiant accounts for stock-based
compensation issued to non-employees and consultants in accordance with the provisions of ASC 505-50,
Equity – Based
Payments to Non-Employees.
Measurement of share-based payment transactions with non-employees is based on the fair value of
whichever is more reliably measurable: (a) the goods or services received; or (b) the equity instruments issued. The fair value
of the share-based payment transaction is determined at the earlier of performance commitment date or performance completion date.
Opiant had stock-based compensation
of $1,729,216 and $9,217,549 for the years ended July 31, 2015 and 2014, respectively.
Fair Value of Financial Instruments
ASC 820
Fair Value Measurements
and Disclosures
defines fair value as the exchange price that would be received for an asset or paid to transfer a liability
(an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market
participants on the measurement date. ASC 820 also establishes a fair value hierarchy that distinguishes between (1) market
participant assumptions developed based on market data obtained from independent sources (observable inputs) and (2) an entity’s
own assumptions about market participant assumptions developed based on the best information available in the circumstances (unobservable
inputs). The fair value hierarchy consists of three broad levels, which gives the highest priority to unadjusted quoted prices
in active markets for identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3).
The three levels of the fair
value hierarchy are described below:
Level 1 - Unadjusted quoted prices
in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities.
Level 2 - Inputs other than quoted
prices included within Level 1 that are observable for the asset or liability, either directly or indirectly, including quoted
prices for similar assets or liabilities in active markets; quoted prices for identical or similar assets or liabilities in markets
that are not active; inputs other than quoted prices that are observable for the asset or liability (e.g., interest rates); and
inputs that are derived principally from or corroborated by observable market data by correlation or other means.
Level 3 - Inputs that are both
significant to the fair value measurement and unobservable.
The carrying value of certain
on-balance-sheet financial instruments approximated their fair values due to the short-term nature of these instruments. These
financial instruments include cash, accounts payable, and due to related parties. The fair value of Opiant’s convertible
note payable is estimated based on current rates that would be available for debt of similar terms which is not significantly
different from its stated value.
As of July 31, 2014, the convertible
note was converted into equity and the derivative warrants were either exchanged for common stock or no longer required derivative
treatment as a result of note conversion into equity. Consequently, at July 31, 2014, derivative liabilities have a balance of
zero. The derivative instruments were marked to market at settlement dates and the corresponding value of the derivative liabilities
of $506,574 was credited to additional paid in capital.
As of July 31, 2015 and 2014
Opiant did not have any financial liabilities measured and recorded at fair value on the Company’s balance sheets on a recurring
basis.
The following table provides
a summary of the changes in fair value, including net transfers in and/or out, of the derivative financial instruments, measured
at fair value on a recurring basis using significant unobservable inputs:
Opiant Pharmaceuticals, Inc.
(formerly Lightlake Therapeutics Inc.)
Notes to Financial Statements
For the years ended July 31, 2015 and 2014
|
Balance at July 31, 2013
|
|
$
|
9,666
|
|
|
Fair value of warrant derivative liabilities at issuance
|
|
|
469,841
|
|
|
Settlement of derivative liability
|
|
|
(506,574
|
)
|
|
Unrealized derivative loss included in other expense
|
|
|
27,067
|
|
|
Balance at July 31, 2015 and 2014
|
|
$
|
-
|
|
The fair value of the derivative
liabilities are calculated at inception and Opiant records a derivative liability for the calculated value. Changes in the fair
value of the derivative liabilities are recorded in other income (expense) in the statements of operations.
The derivative warrants were
valued using the Black-Scholes option pricing model using the following assumptions:
|
|
|
At settlement
dates
|
|
|
Market
value of stock on measurement date
|
|
|
$
0.043-$0.05
|
|
|
Risk-free interest
rate
|
|
|
0.77-0.96
|
%
|
|
Dividend yield
|
|
|
0
|
%
|
|
Volatility factor
|
|
|
169-217
|
%
|
|
Term
|
|
|
2.8-3.9
years
|
|
Related Parties
Opiant follows ASC 850,
Related
Party Disclosures
,
for the identification of related parties and disclosure of related party transactions. Related
party balance as of July 31, 2015 amount to $130,000 (2014 - $350,000), and was comprised of loans to the Company. (See Note 4)
Revenue Recognition
We recognize revenues from nonrefundable,
up-front license fees related to collaboration agreements, on a straight-line basis over the contracted or estimated period of
performance. The period of performance over which the revenues are recognized is typically the period over which the research
and/or development is expected to occur or manufacturing services are expected to be provided. When the period of performance
is based on the period over which research and/or development is expected to occur, we are required to make estimates regarding
drug development and commercialization timelines. Because of the many risks and uncertainties associated with the development
of drug candidates, these estimates regarding the period of performance may change.
In addition, we evaluate each
arrangement to determine whether or not it qualifies as a multiple-deliverable revenue arrangement under ASC 605-25. If one or
more of the deliverables have a standalone value, then the arrangement would be separated into multiple units of accounting. This
normally occurs when the R&D services could contractually and feasibly be provided by other vendors or if the customer could
perform the remaining R&D itself, and when the Company has no further obligations and the right has been conveyed. When the
deliverables cannot be separated, any initial payment received is treated like an advance payment for the services and recognized
over the performance period, as determined based on all of the items in the arrangement. This period is usually the expected research
and development period.
Licensing Agreement
On December 15, 2014, Opiant
entered into a licensing agreement with Adapt Pharma Operations Limited. Pursuant to the license agreement the Company provided
a global license to develop and commercialize the Company’s intranasal naloxone opioid overdose reversal treatment. In exchange
for licensing its treatment, the Company received a nonrefundable, upfront license fee of $500,000 in December 2014. The Company
is also to receive a monthly fee for up to one year, for participation in joint development committee calls and the production
and submission of an initial development plan. The initial development plan was completed and submitted in May 2015. Management
evaluated the deliverables of this arrangement and determined that the licensing deliverable has a standalone value and therefore,
the payment was recognized as revenue.
Opiant could also receive additional
payments upon reaching various sales and regulatory milestones. In addition, pursuant to the licensing agreement, the Company
is required to contribute $2,500,000 of development, regulatory, and commercialization costs, some of which was credited for costs
incurred by the Company prior to the execution of the agreement with Adapt Pharma Operations Limited. At July 31, 2015, the Company
had contributed $2,341,419 of which $204,908 is unpaid and reported in accounts payable and accrued liabilities in the balance
sheets.
Opiant Pharmaceuticals, Inc.
(formerly Lightlake Therapeutics Inc.)
Notes to Financial Statements
For the years ended July 31, 2015 and 2014
Opiant recognizes revenue for
fees related to participation in the initial development plan and joint development calls as revenue once the fee is received
and the Company has performed the required services for the period.
Treatment Investments
With respect to investments
in interests in treatments, if an agreement provides an option that allows the investor in the treatment to convert an interest
in a treatment into shares of common stock of Opiant, then revenue is deferred until such time that the option expires or milestones
are achieved that eliminate the investor’s right to exercise the option. Upon expiration of the exercise option, the deliverables
of the arrangement are reviewed and evaluated under ASC 605. In the event the investor chooses to convert interests into shares
of common stock, that transaction will be accounted for similar to a sale of shares of common stock for cash.
Recently Issued Accounting
Pronouncements
In August 2014, Opiant elected
to early adopt Accounting Standards Update No. 2014-10,
Development Stage Entities (Topic 915): Elimination of Certain Financial
Reporting Requirements
. The adoption of this ASU allows the Company to remove the inception to date information and all references
to development stage.
Opiant has implemented all new
accounting pronouncements that are in effect and that may impact its financial statements and does not believe that there are
any other new pronouncements that have been issued that might have a material impact on its financial position or results of operations.
|
|
4.
|
Related
Party Transactions
|
At July 31, 2015, Opiant had
loans outstanding with its three directors (two of which are officers), in the total amount of $130,000 (July 31, 2014 - $350,000).
During the year ended July 31, 2015, $220,000 of the principal amount was repaid. In December 2014, the agreements were amended
to extend the maturity date to April 30, 2016 and increase the annual interest rate to 14.5%, which includes a penalty rate of
8.5% due to non-payment of the required repayment amounts. The loans are unsecured.
On April 16, 2013, Opiant entered
into an agreement and subsequently received funding in the amount of $600,000 for the research, development, marketing and commercialization
of a product relating to a treatment for opioid addiction. In exchange for this funding, the Company agreed to pay the investor
6.0% of the net profit generated from the product in perpetuity. Net profit is defined as the pre-tax profit generated from the
product after the deduction of all expenses incurred by and payments made by the Company in connection with the product, including
but not limited to an allocation of Company overhead. If the product is not introduced to the market and not approved for marketing
within 24 months, the investor will have a sixty day option to receive 75,000 shares of common stock in lieu of the 6.0% interest
in the product. During the year ended July 31, 2015, the Company recognized $600,000 as revenue because the option to receive
the shares of common stock expired unexercised, and the research and development work related to the product was completed as
of July 31, 2015.
On May 30, 2013, Opiant entered
into an agreement and subsequently received additional funding totaling $150,000 for the research, development, marketing and
commercialization of a product relating to a treatment for opioid addiction. In exchange for this funding, the Company agreed
to pay the investor 1.50% of the net profit generated from the product in perpetuity. Net profit is defined as the pre-tax profit
generated from the product after the deduction of all expenses incurred by and payments made by the Company in connection with
the product, including but not limited to an allocation of Company overhead. If the product is not introduced to the market and
not approved for marketing within 24 months, the investor will have a sixty day option to receive 18,750 shares of common stock
in lieu of the 1.50% interest in the product. During the year ended July 31, 2015, the Company recognized $150,000 as revenue
because the option to receive shares of common stock expired unexercised, and the research and development work related to the
product was completed as of July 31, 2015.
Opiant Pharmaceuticals, Inc.
(formerly Lightlake Therapeutics Inc.)
Notes to Financial Statements
For the years ended July 31, 2015 and 2014
On December 17, 2013, Opiant
entered into an agreement and subsequently received additional funding totaling $250,000 for use by the Company for any purpose.
In exchange for this funding, the Company agreed to provide the investor with a 0.5% interest in the Company’s Binge Eating
Disorder treatment product and pay the investor 0.5% of the net profit generated from this treatment in perpetuity. Net profit
is defined as the pre-tax profit generated from the product after the deduction of all expenses incurred by and payments made
by the Company in connection with the product, including but not limited to an allocation of Company overhead. If the product
is not approved by the U.S. Food and Drug Administration within 36 months the investor will have a sixty day option to receive
31,250 shares of common stock in lieu of the 0.5% interest in the product.
On May 15, 2014, Opiant entered
into an agreement and subsequently received funding from an individual investor in the amount of $300,000 for use by the Company
for any purpose. In exchange for this funding, the Company agreed to provide the investor with a 1.5% interest in the Net Profit
as related to the Company’s treatment to reverse opioid overdoses. Net profit is defined as the pre-tax profit generated
from the product after the deduction of all expenses incurred by and payments made by the Company in connection with the product,
including but not limited to an allocation of Company overhead. The investor also has rights with respect to its 1.5% interest
if the treatment is sold or the Company is sold. If the product is not approved by the U.S. Food and Drug Administration within
24 months the investor will have a 60 day option to receive 37,500 shares of common stock in lieu of the 1.5% interest in the
product.
On July 22, 2014, Opiant received
a $3,000,000 commitment, from which the Company has the right to make capital calls, from a foundation for the research, development,
marketing, commercialization, and any other activities connected to the Company’s treatment to reverse opioid overdoses,
certain operating expenses, and any other purpose consistent with the goals of the foundation. In exchange for funds invested by
the foundation the Company agreed to provide the foundation with pro-rata share up to a 6.0% interest in the Net Profit as related
to the Company’s treatment to reverse opioid overdoses. Net profit is defined as the pre-tax profit generated from the product
after the deduction of all expenses incurred by and payments made by the Company in connection with the product, including but
not limited to an allocation of Company overhead. The foundation also has rights with respect to its 6.0 % interest if the
treatment is sold or the Company is sold. Additionally, the Company may buyback interests from the foundation within two and one
half years or after two and a half years of the initial investment at a price of two times or three and a half times, respectively,
the relevant investment amount represented by the interests to be bought back. If the product is not approved by the U.S. Food
and Drug Administration or an equivalent body in Europe for marketing and is not actually marketed within 24 months the foundation
will have a 60 day option to receive shares of the Company’s common stock in lieu of the interest in the treatment at a rate
of 10 shares for every dollar of its investment. On July 28, 2014 the Company received an initial investment of $111,470 from the
foundation in exchange for a 0.22294% interest. On August 13, 2014, September 8, 2014, November 13, 2014, and February 17, 2015,
the Company made capital calls of $422,344, $444,530, $1,033,614, and $988,043, respectively, from the foundation in exchange for
0.844687%, 0.888906%, 2.067228%, and 1.976085% interests, respectively, in the Net Profit as related to the Company’s treatment
to reverse opioid overdoses.
Opiant Pharmaceuticals, Inc.
(formerly Lightlake Therapeutics Inc.)
Notes to Financial Statements
For the years ended July 31, 2015 and 2014
On September 9, 2014, Opiant
entered into an agreement and subsequently received funding from an individual investor in the amount of $500,000 for use by the
Company for any purpose. In exchange for this funding, the Company agreed to provide the investor with a 0.98% interest in the
Net Profit as related to the Company’s treatment to reverse opioid overdoses. Net Profit includes the pre-tax profit received
by the Company derived from the sale of the product after the deduction of all expenses incurred by and payments made by the Company
in connection with the product, including but not limited to an allocation of Company overhead. The investor also has rights with
respect to its 0.98% interest if the treatment is sold or the Company is sold. Additionally, the Company may buyback interests
from the investor within two and one half years or after two and a half years of the investment at a price of two times or three
and a half times, respectively, the relevant investment amount represented by the interests to be bought back. If the product
is not introduced to the market and not approved by the U.S. Food and Drug Administration or an equivalent body in Europe and
not marketed within 24 months, the investor will have a 60 day option to receive 50,000 shares of common stock in lieu of the
interest in the product.
On September 17, 2014, Opiant
entered into an agreement and subsequently received funding totaling $500,000 for use by the Company for any purpose. In exchange
for this funding, the Company agreed to provide the investor with a 1.0% interest in the Company’s Binge Eating Disorder
treatment product and pay the investor 1.0% of the Net Profit generated from this treatment in perpetuity. Net Profit includes
the pre-tax profit generated from the product after the deduction of all expenses incurred by and payments made by the Company
in connection with the product, including but not limited to an allocation of Company overhead. If the product is not approved
by the U.S. Food and Drug Administration within 36 months, the investor will have a sixty day option to receive 62,500 shares
of common stock in lieu of the 1.0% interest in the product.
On October 31, 2014, Opiant
entered into an agreement and subsequently received funding from an individual investor in the amount of $500,000 for use by the
Company for any purpose. In exchange for this funding, the Company agreed to provide the investor with a 0.98% interest in the
Net Profit as related to the Company’s treatment to reverse opioid overdoses. Net Profit includes the pre-tax profit received
by the Company derived from the sale of the product after the deduction of all expenses incurred by and payments made by the Company
in connection with the product, including but not limited to an allocation of Company overhead. The investor also has rights with
respect to its 0.98% interest if the treatment is sold or the Company is sold. Additionally, the Company may buyback the interest
from the investor within two and one half years or after two and a half years but no later than four years of the investment at
a price of two times or three and a half times, respectively, of the investment amount. If the product is not introduced to the
market and not approved by the FDA or an equivalent body in Europe and not marketed within 24 months, the investor will have a
60 day option to receive 50,000 shares of common stock in lieu of the interest in the product.
On July 20, 2015, Opiant entered
into an agreement and subsequently received funding from an individual investor in the amount of $250,000 for use by the Company
for any purpose. In exchange for this funding, the Company agreed to provide the investor with a 0.50% interest in the Net Profit
as related to the Company’s treatment of binge eating disorder. Net Profit includes the pre-tax profit received by the Company
derived from the sale of the product after the deduction of all expenses incurred by and payments made by the Company in connection
with the product, including but not limited to an allocation of Company overhead. The investor also has rights with respect to
its 0.50% interest if the treatment is sold or the Company is sold. If the product is not introduced to the market and not approved
by the FDA or an equivalent body in Europe and not marketed within 36 months, the investor will have a 60 day option to receive
25,000 shares of common stock in lieu of the interest in the product.
Common Stock
On November 26, 2014, Opiant
amended its articles of incorporation to increase its authorized capital stock from 200,000,000 common shares to 1,000,000,000
common shares.
During the year ended July
31, 2015
In August 2014, Opiant issued
7,846 shares to consultants for services rendered. The shares have a fair value of $44,723 based on stock prices at issuance dates.
Opiant Pharmaceuticals, Inc.
(formerly Lightlake Therapeutics Inc.)
Notes to Financial Statements
For the years ended July 31, 2015 and 2014
In December 2014, Opiant issued
24,015 shares to a company for services rendered. The shares have a fair value of $91,258 based on the stock prices at issuance
dates.
In January 2015, Opiant issued
a total of 5,000 shares to two consultants for services rendered. The shares have a fair value of $19,720 based on the stock prices
at issuance dates.
In March 2015, Opiant issued
a total of 20,900 shares to two companies and a consultant for services rendered. The shares have a fair value of $141,130 based
on the stock prices at issuance dates.
In April 2015, Opiant issued
1,232 shares to a consultant for services rendered. The shares have a fair value of $8,994 based on the stock prices at issuance
dates.
In July, 2015, Opiant issued
800 shares to a consultant for services rendered. The shares have a fair value of $5,840 based on the stock prices at the date
performance by the consultant was complete.
During the year ended July
31, 2014
On August 12, 2013, Opiant issued
3,750 shares in exchange for services rendered. The shares issued in this transaction were valued at market and amounted to $15,000.
On August 28, 2013, Opiant issued
5,000 shares in exchange for services rendered. The shares issued in this transaction were valued at market and amounted to $35,000.
On September 18, 2013, Opiant
issued 3,750 shares in exchange for services rendered. The shares issued in this transaction were valued at market and amounted
to $22,500.
On October 21, 2013, Opiant
issued 2,259 shares in exchange for services rendered. The shares issued in this transaction were valued at market and amounted
to $9,036.
On October 25, 2013, Opiant
issued 3,346 shares in exchange for services rendered. The shares issued in this transaction were valued at market and amounted
to $13,382.
On October 31, 2013, Opiant
issued 3,750 shares in exchange for services rendered. The shares issued in this transaction were valued at market and amounted
to $15,750.
In November 2013, Opiant issued
12,500 shares in exchange for services rendered. The shares issued were valued at market and amounted to $66,500.
On December 23, 2013, Opiant
issued 3,750 shares in exchange for services rendered. The shares issued in this transaction were valued at market and amounted
to $21,750.
On January 23, 2014, Opiant
issued 3,333 shares in settlement of a convertible note payable in the amount of $25,000 and accrued interest of $3,707. This
transaction resulted in a gain on the extinguishment of the debt in the amount of $20,651.
On April 7, 2014, Opiant issued
3,762 shares in exchange for services rendered. The shares issued in this transaction were valued at market and amounted to $15,049.
During the year ended July 31,
2014, Opiant issued 89,872 shares as a result of the cashless exercise of 888,452 warrants.
Opiant Pharmaceuticals, Inc.
(formerly Lightlake Therapeutics Inc.)
Notes to Financial Statements
For the years ended July 31, 2015 and 2014
Stock Options
As required by the Stock Compensation
Topic, ASC 718, Opiant measures and recognizes compensation expense for all share based payment awards made to the officers and
directors based on estimated fair values at the grant date and over the requisite service period. Stock option expense recognized
for the years ended July 31, 2015 and 2014 was $1,008,239 and $8,283,582, respectively.
On August 1, 2013, Opiant granted
its executive officers cashless stock options to purchase a total of 375,000 shares of its common stock at exercise prices ranging
from $10.00 to $20.00 per share. These options vested immediately and expire in ten years on July 31, 2023. The Company has valued
these options using the Black-Scholes option pricing model which resulted in a fair market value of $1,068,750 which has been
fully recognized as expense for the year ended July 31, 2014.
On November 1, 2013, Opiant granted its executive
officers cashless stock options to purchase a total of 225,000 shares of its common stock at exercise prices ranging from $6.00
to $10.00 per share.
These options vested immediately
and expire in ten years on October 31, 2023. Opiant has valued these options using the Black-Scholes option pricing model which
resulted in a fair market value of $985,500 which has been fully recognized as expense for the year ended July 31, 2014.
On December 31, 2013, Opiant
granted its executive officers cashless stock options to purchase a total of 665,000 shares of its common stock at exercise prices
ranging from $6.00 to $10.00 per share. These options vested immediately and expire in ten years on December 30, 2023. The Company
has valued these options using the Black-Scholes option pricing model which resulted in a fair market value of $3,591,000 which
has been fully recognized as expense for the year ended July 31, 2014.
On June 15, 2014, Opiant granted
its executive officers and a director cashless stock options to purchase a total of 1,075,000 shares of its common stock at exercise
prices ranging from $5.00 to $8.00 per share. These options vest immediately and expire in ten years on June 14, 2024. These options
may only be exercised between the following dates: (i) the first to occur of: (A) the commencement of the next trial with respect
to the opioid overdose reversal treatment; (B) the entrance into a distribution, licensing, royalty, partnership, collaboration,
or other significant transaction with respect to the opioid overdose reversal treatment; or (C) the filing of a New Drug Application
with the U.S. Food and Drug Administration with respect to the opioid overdose reversal treatment; and (ii) the Expiration Date.
The Company has valued these options using the Black-Scholes option pricing model which resulted in a fair market value of $2,580,000
which has been fully recognized as expense for the year ended July 31, 2014.
On June 24, 2014, Opiant granted
30,000 cashless stock options to an outside consultant to purchase its common stock at an exercise price of $5.00 per share. These
options vest immediately and expire in seven years on June 23, 2021. The Company has valued these options using the Black-Scholes
option pricing model which resulted in a fair market value of $69,000 of which $34,500 has been recognized as expense for the
year ended July 31, 2014, and $34,500 has been recognized as expense for the year ended July 31, 2015.
On June 11, 2014, Opiant issued
a total of 240,000 warrants with a strike price of $10.00 per share to a consultant in exchange for consulting and other strategic
advisory services, including clinical strategy and intellectual property strategy. These warrants expire in ten years on June
10, 2024. Additionally, upon the achievement of certain milestones the consultant will be granted up to an additional 225,400
warrants with strike prices from $12.50 to $25.00 per share.
On August 2, 2014, Opiant granted
30,000 cashless stock options with an exercise price of $10.00 per share to a consultant for services rendered. These options
have a term of 5 years and vested immediately. The Company has valued these options using the Black-Scholes option pricing model
which resulted in a fair market value of $173,999 which have been fully recognized as expense for the year ended July 31, 2015.
Opiant Pharmaceuticals, Inc.
(formerly Lightlake Therapeutics Inc.)
Notes to Financial Statements
For the years ended July 31, 2015 and 2014
On November 12, 2014, Opiant
granted 30,000 cashless stock options with an exercise price of $10.00 per share to a consultant for services rendered. These
options have a term of 5 years and vest over 3 years. The Company has valued these options using the Black-Scholes option pricing
model which resulted in a fair market value of $188,825, of which $103,951 has been fully recognized as expense for the year ended
July 31, 2015.
On November 12, 2014, Opiant
granted 20,000 cashless stock options with an exercise price of $15.00 per share to a consultant for services rendered. These
options have a term of 5 years and vest over three years. The Company has valued these options using the Black-Scholes option
pricing model which resulted in a fair market value of $127,150, of which $67,984 has been fully recognized as expense for the
year ended July 31, 2015.
On January 9, 2015, Opiant granted
15,000 cashless stock options with an exercise price of $10.00 per share to a consultant for services rendered. These options
have a term of 5 years and vested immediately. The Company has valued these options using the Black-Scholes option pricing model
which resulted in a fair market value of $65,163 which have been fully recognized as expense for the year ended July 31, 2015.
On January 25, 2015, Opiant
granted 10,000 cashless stock options with an exercise price of $10.00 per share to a consultant for services rendered. These
options have a term of 5 years and vested immediately. The Company has valued these options using the Black-Scholes option pricing
model which resulted in a fair market value of $36,169 which have been fully recognized as expense for the year ended July 31,
2015.
On March 19, 2015, Opiant granted
48,000 cashless stock options with an exercise price of $10.00 per share to a consultant for services rendered. These options
have a term of 5 years and vested immediately. The Company has valued these options using the Black-Scholes option pricing model
which resulted in a fair market value of $282,227 which have been fully recognized as expense for the year ended July 31, 2015.
On March 19, 2015, Opiant granted
32,000 cashless stock options with an exercise price of $15.00 per share to a consultant for services rendered. These options
have a term of 5 years and vested immediately. The Company has valued these options using the Black-Scholes option pricing model
which resulted in a fair market value of $186,655 which have been fully recognized as expense for the year ended July 31, 2015.
On July, 2015, Opiant granted
10,000 cashless stock options with an exercise price of $10.00 per share to a consultant for services rendered. These options
have a term of 3 years and vested immediately. The Company has valued these options using the Black-Scholes option pricing model
which resulted in a fair market value of $55,043 which have been fully recognized as expense for the year ended July 31, 2015.
Opiant also recognized stock
based compensation expense of $37,048 in connection with vested options granted in prior periods.
The assumptions used in the
valuation for all of the options granted for the year ended July 31, 2015 were as follows:
|
Market value of stock on
measurement date
|
|
|
$
3.75 to 7.30
|
|
|
|
$ 2.40
to 5.40
|
|
|
Risk-free interest rate
|
|
|
1.00 to 1.73
|
%
|
|
|
2.19-2.99
|
%
|
|
Dividend yield
|
|
|
0
|
%
|
|
|
0
|
%
|
|
Volatility factor
|
|
|
147 to 407
|
%
|
|
|
418-459
|
%
|
|
Term
|
|
|
3 to 5 years
|
|
|
|
7-10 years
|
|
Opiant Pharmaceuticals, Inc.
(formerly Lightlake Therapeutics Inc.)
Notes to Financial Statements
For the years ended July 31, 2015 and 2014
Stock option activity for year ended July 31, 2015
is presented in the table below:
|
|
|
Number of
Shares
|
|
|
Weighted-
average
Exercise
Price
|
|
|
Weighted-
average
Remaining
Contractual
Term
(years)
|
|
|
Aggregate
Intrinsic
Value
|
|
|
Outstanding at July 31, 2014
|
|
|
3,047,500
|
|
|
|
9.00
|
|
|
|
8.56
|
|
|
|
|
|
|
Granted
|
|
|
195,000
|
|
|
|
11.33
|
|
|
|
|
|
|
|
|
|
|
Forfeited/expired/cancelled
|
|
|
(85,000
|
)
|
|
|
11.21
|
|
|
|
|
|
|
|
|
|
|
Outstanding at July 31, 2015
|
|
|
3,157,500
|
|
|
|
9.42
|
|
|
|
7.58
|
|
|
$
|
1,569,000
|
|
|
Exercisable at July 31, 2015
|
|
|
2,743,750
|
|
|
|
8.88
|
|
|
|
8.11
|
|
|
$
|
1,569,000
|
|
A summary of the status of Opiant’s non-vested
options as of July 31, 2015 and changes during the year ended July 31, 2015 are presented below:
|
Non-vested options
|
|
Number of
Options
|
|
|
Weighted Average
Grant Date
Fair Value
|
|
|
|
|
|
|
|
|
|
|
Non-vested at July 31, 2014
|
|
|
17,500
|
|
|
$
|
3.11
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
195,000
|
|
|
|
5.09
|
|
|
Vested
|
|
|
(175,000
|
)
|
|
|
5.06
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-vested at July 31, 2015
|
|
|
37,500
|
|
|
$
|
3.85
|
|
At July 31, 2015, there was
$135,640 of unrecognized compensation costs related to non-vested stock options.
Warrants
On December 16, 2014, Opiant
issued 38,800 stock warrants with an exercise price of $8.00 per share to a consultant for services rendered. These warrants have
a term of 10 years and vested immediately. The Company has valued these warrants using the Black-Scholes option pricing model
which resulted in a fair market value of $144,724 which have been fully recognized as expense for the year ended July 31, 2015.
On March 19, 2015, Opiant issued
45,000 stock warrants with an exercise price of $10.00 per share to a consultant for services rendered. These warrants have a
term of 5 years and vested immediately. The Company has valued these warrants using the Black-Scholes option pricing model
which resulted in a fair market value of $264,588 which have been fully recognized as expense for the year ended July 31, 2015.
Warrant activity for the year ended July 31, 2015
is presented in the table below:
|
|
|
Number of
Shares
|
|
|
Weighted-
average
Exercise
Price
|
|
|
Weighted-
average
Remaining
Contractual
Term (years)
|
|
|
Aggregate
Intrinsic
Value
|
|
|
Outstanding at July 31, 2014
|
|
|
1,254,752
|
|
|
$
|
20.00
|
|
|
|
4.33
|
|
|
$
|
-
|
|
|
Issued
|
|
|
83,800
|
|
|
|
9.07
|
|
|
|
-
|
|
|
|
-
|
|
|
Exercised
|
|
|
-
|
|
|
|
|
|
|
|
-
|
|
|
|
-
|
|
|
Outstanding at July 31, 2015
|
|
|
1,338,552
|
|
|
$
|
19.53
|
|
|
|
3.55
|
|
|
$
|
-
|
|
|
Exercisable at July 31, 2015
|
|
|
613,552
|
|
|
$
|
24.88
|
|
|
|
4.89
|
|
|
$
|
-
|
|
Opiant Pharmaceuticals, Inc.
(formerly Lightlake Therapeutics Inc.)
Notes to Financial Statements
For the years ended July 31, 2015 and 2014
|
|
7.
|
Settlement
of Convertible Note Payable
|
On January 23, 2014, Opiant
entered into a settlement of a convertible note payable in the amount of $25,000 and accrued interest of $3,707 through the issuance
of 3,333 shares of common stock. This transaction resulted in a gain on the extinguishment of the debt in the amount of $20,651.
Opiant provides for income taxes
asset and liability approach in accounting for income taxes. Deferred tax assets and liabilities are recorded based on the differences
between the financial statement and tax bases of assets and liabilities and the tax rates in effect when these differences are
expected to reverse. This method requires the reduction of deferred tax assets by a valuation allowance if, based on the weight
of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.
Opiant has net operating loss
(NOL) carry forwards that were derived solely from operating losses from prior years. These amounts can be carried forward to
offset future taxable income for a period of 20 years for each tax year’s loss. These NOL carry forwards begin to expire
in 2026. No provision was made for federal income taxes as the Company has significant net operating losses. The income tax period
for 2015 is open for examination by taxing authorities.
The provision for income taxes
differs from the amounts which would be provided by applying the statutory federal income tax rate to the net loss before provision
for income taxes for the following reasons:
|
|
|
July 31, 2015
|
|
|
July 31, 2014
|
|
|
|
|
|
|
|
|
|
|
Income tax expense at statutory rate
|
|
$
|
(2,070,422
|
)
|
|
$
|
(5,527,011
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Valuation allowance
|
|
|
2,070,422
|
|
|
|
5,527,011
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense per books
|
|
$
|
-
|
|
|
$
|
-
|
|
Net deferred tax assets consist
of the following components as of:
|
|
|
July 31, 2015
|
|
|
July 31, 2014
|
|
|
|
|
|
|
|
|
|
|
Net operating loss carryover
at statutory rate
|
|
$
|
(16,040,239
|
)
|
|
$
|
(13,969,817
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Valuation allowance
|
|
|
16,040,239
|
|
|
|
13,969,817
|
|
|
|
|
|
|
|
|
|
|
|
|
Net deferred tax asset
|
|
$
|
-
|
|
|
$
|
.-
|
|
Opiant had no uncertain tax
positions at July 31, 2015 or July 31, 2014.
Opiant Pharmaceuticals, Inc.
(formerly Lightlake Therapeutics Inc.)
Notes to Financial Statements
For the years ended July 31, 2015 and 2014
|
|
a)
|
On September 22, 2015, Opiant received
a $1,600,000 commitment from a foundation, from which the Company has the right to make
capital calls, for the research, development, any other activities connected to the Company’s
opioid antagonist treatments for addictions and related disorders that materially rely
on certain studies funded by the foundation’s investment, certain operating expenses,
and any other purpose consistent with the goals of the foundation. In exchange for funds
invested by the foundation the Company agreed to provide the foundation with pro-rata
share up to a 2.1333% interest in the Net Profit as related to the Company’s opioid
antagonist treatments for addictions and related disorders that materially rely on certain
studies funded by the foundation’s investment. Net profit is defined as any pre-tax
revenue received by the Company that was derived from the sale of the products less any
and all expenses incurred by and payments made by the Company in connection with the
products, including but not limited to an allocation of Company overhead. The foundation
also has rights with respect to its up to 2.1333% interest if the products are sold or
the Company is sold. Additionally, the Company may buyback interests from the foundation
within two and one half years or after two and a half years of the initial investment
at a price of two times or three and a half times, respectively, the relevant investment
amount represented by the interests to be bought back. If a product is not introduced
to the market within 36 months the foundation will have a 60 day option to receive shares
of the Company’s common stock in lieu of the interest in the product at a rate
of one-tenth of a share for every dollar of its investment. On October 6, 2015, the Company
received $618,000 from the foundation in exchange for a 0.824% interest in the Company’s
products covered by the commitment agreement. The Company will defer recording
revenue until such time as the option expires or milestones are achieved that eliminate
the investor’s right to exercise the option. Upon expiration of the exercise option,
the deliverables of the arrangement will be reviewed and evaluated under ASC 605. In
the event the investor chooses to convert interests into shares of common stock, that
transaction will be accounted for similar to a sale of shares of common stock for cash.
|
|
|
b)
|
During September 2015 and October
2015, the Company received loans from each of its three executive officers, all of who
are directors, totaling $151,191. The loans bear interest at 6% per annum until January
31, 2016. After January 31, 2016, a penalty of 4% shall be added such that the loans
bear interest at 10% per annum. The loans are unsecured and are due on January 31, 2016
unless the Company receives specified funding. If the Company receives the specified
funding the loans become due 10 business days after the funding. If the loans are not
repaid by January 31, 2016, the maturity date of the loans shall be changed to May 31,
2016.
|
|
|
c)
|
On September 1, 2015, Opiant entered
into an agreement with a consultant with significant regulatory experience that contributed
to the progression of the Company’s opioid overdose reversal treatment through
the providing of significant strategic advice and other value-add. The agreement provides
for payment of $50,000 and 10,000 shares of common stock to the consultant. In addition,
the consultant may receive other cash amounts including payments of up to $535,000 upon
the Company’s receipt of certain milestone payments pursuant to the agreement with
Adapt Pharma Operations Limited. The agreement also provides that the consultant is entitled
to 1.0% of the net profit, as defined in the agreement that the Company receives from
Adapt Pharma Operations Limited with respect to the treatment, excluding certain amounts
received by the Company from Adapt Pharma Operations Limited. So long as the consultant
continues to provide services to the Company pursuant to the agreement, the consultant
is entitled to 0.5% of the net profit, as defined in the agreement, that the Company
receives from Adapt Pharma Operations Limited with respect to the treatment, excluding
certain amounts received by the Company from Adapt Pharma Operations Limited, and other
cash compensation. Subsequent to July 31, 2015, the Company issued 10,000 shares to the
consultant.
|
|
|
d)
|
On October 6, 2015, the Company
entered into an amendment to an agreement to use certain technology owned by Aegis Therapeutics,
LLC. This amendment had an effective date of May 19, 2015 and allowed the Company to
evaluate Aegis’ Technology until August 17, 2015. The amendment also provided an
opportunity for the Company to elect to further extend the period of time during which
the Company could evaluate Aegis’ Technology until February 13, 2016. In exchange
for electing to further extend this period of time, the Company paid Aegis $75,000 and
issued 13,697 shares of the Company’s common stock.
|
Opiant Pharmaceuticals, Inc.
(formerly
Lightlake Therapeutics Inc.)
Index
to Financial Statements
April
30, 2016 and 2015
Opiant Pharmaceuticals, Inc.
(formerly Lightlake Therapeutics Inc.)
Balance Sheets (Unaudited)
As of April 30, 2016 and July 31, 2015
|
|
|
April 30,
|
|
|
July 31,
|
|
|
|
|
2016
|
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
Current assets
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
2,363,465
|
|
|
$
|
434,217
|
|
|
Prepaid insurance
|
|
|
70,376
|
|
|
|
33,143
|
|
|
Total current assets
|
|
|
2,433,841
|
|
|
|
467,360
|
|
|
|
|
|
|
|
|
|
|
|
|
Other assets
|
|
|
|
|
|
|
|
|
|
Computer equipment (net of accumulated amortization
of $158 at April 30, 2016 and $0 at July 31, 2015)
|
|
|
6,370
|
|
|
|
-
|
|
|
Patents and patent applications
(net of accumulated amortization of $8,044 at April 30, 2016 and $7,015 at July 31, 2015)
|
|
|
19,406
|
|
|
|
20,435
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
2,459,617
|
|
|
$
|
487,795
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders' Deficit
|
|
|
|
|
|
|
|
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
Current liabilities
|
|
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities
|
|
$
|
206,821
|
|
|
$
|
315,460
|
|
|
Accrued salaries and wages
|
|
|
3,630,596
|
|
|
|
3,129,060
|
|
|
Deferred revenue
|
|
|
250,000
|
|
|
|
-
|
|
|
Due to related parties
|
|
|
-
|
|
|
|
130,000
|
|
|
Total current liabilities
|
|
|
4,087,417
|
|
|
|
3,574,520
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred revenue
|
|
|
2,083,500
|
|
|
|
5,300,000
|
|
|
Total liabilities
|
|
|
6,170,917
|
|
|
|
8,874,520
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' deficit
|
|
|
|
|
|
|
|
|
|
Common stock; par value $0.001; 1,000,000,000 shares authorized;
|
|
|
|
|
|
|
|
|
|
1,981,433 shares issued and outstanding at April
30, 2016 and 1,841,866 shares issued and outstanding at July 31, 2015
|
|
|
1,981
|
|
|
|
1,842
|
|
|
Additional paid-in capital
|
|
|
56,381,654
|
|
|
|
44,982,519
|
|
|
Accumulated deficit
|
|
|
(60,094,935
|
)
|
|
|
(53,371,086
|
)
|
|
Total stockholders' deficit
|
|
|
(3,711,300
|
)
|
|
|
(8,386,725
|
)
|
|
Total liabilities and stockholders' deficit
|
|
$
|
2,459,617
|
|
|
$
|
487,795
|
|
The accompanying notes are an integral
part of these unaudited financial statements.
Opiant Pharmaceuticals, Inc.
(formerly Lightlake Therapeutics Inc.)
Statements of Operations (Unaudited)
For the three and nine months ended April 30, 2016 and
2015
|
|
|
For the
|
|
|
For the
|
|
|
|
|
Three Months Ended
|
|
|
Nine Months Ended
|
|
|
|
|
April 30,
|
|
|
April 30,
|
|
|
|
|
2016
|
|
|
2015
|
|
|
2016
|
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
|
2,605,097
|
|
|
$
|
120,000
|
|
|
$
|
9,585,097
|
|
|
$
|
680,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative
|
|
|
1,130,730
|
|
|
|
1,863,512
|
|
|
|
14,407,688
|
|
|
|
4,710,134
|
|
|
Research and development
|
|
|
1,062,505
|
|
|
|
96,906
|
|
|
|
1,865,014
|
|
|
|
1,340,754
|
|
|
Total operating expenses
|
|
|
2,193,235
|
|
|
|
1,960,418
|
|
|
|
16,272,702
|
|
|
|
6,050,888
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations
|
|
|
411,862
|
|
|
|
(1,840,418
|
)
|
|
|
(6,687,605
|
)
|
|
|
(5,370,888
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income (expense)
|
|
|
-
|
|
|
|
4,102
|
|
|
|
(11,319
|
)
|
|
|
(23,480
|
)
|
|
Income (loss) on foreign exchange
|
|
|
4,266
|
|
|
|
(14,379
|
)
|
|
|
(24,925
|
)
|
|
|
(7,278
|
)
|
|
Total other income (expense)
|
|
|
4,266
|
|
|
|
(10,277
|
)
|
|
|
(36,244
|
)
|
|
|
(30,758
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before provision for income taxes
|
|
|
416,128
|
|
|
|
(1,850,695
|
)
|
|
|
(6,723,849
|
)
|
|
|
(5,401,646
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for income taxes
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
$
|
416,128
|
|
|
$
|
(1,850,695
|
)
|
|
$
|
(6,723,849
|
)
|
|
$
|
(5,401,646
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic income (loss) per common share
|
|
$
|
0.22
|
|
|
$
|
(1.01
|
)
|
|
$
|
(3.57
|
)
|
|
$
|
(2.99
|
)
|
|
Diluted income (loss) per common share
|
|
$
|
0.15
|
|
|
$
|
(1.01
|
)
|
|
$
|
(3.57
|
)
|
|
$
|
(2.99
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic weighted average common shares outstanding
|
|
|
1,916,554
|
|
|
|
1,830,134
|
|
|
|
1,882,088
|
|
|
|
1,803,634
|
|
|
Diluted weighted average common shares outstanding
|
|
|
2,734,760
|
|
|
|
1,830,134
|
|
|
|
1,882,088
|
|
|
|
1,803,634
|
|
The accompanying notes are an integral
part of these unaudited financial statements.
Opiant Pharmaceuticals, Inc.
(formerly Lightlake Therapeutics Inc.)
Statements of Stockholders' Deficit
(Unaudited)
For the nine months ended April 30, 2016
|
|
|
|
|
|
|
|
|
Additional
|
|
|
|
|
|
|
|
|
|
|
Common Stock
|
|
|
Paid In
|
|
|
Accumulated
|
|
|
|
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Deficit
|
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at July 31, 2015
|
|
|
1,841,866
|
|
|
$
|
1,842
|
|
|
$
|
44,982,519
|
|
|
$
|
(53,371,086
|
)
|
|
$
|
(8,386,725
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued for services
|
|
|
123,852
|
|
|
|
124
|
|
|
|
1,215,595
|
|
|
|
-
|
|
|
|
1,215,719
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued upon the exercise of options
|
|
|
15,715
|
|
|
|
15
|
|
|
|
(15
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation from issuance of stock options
|
|
|
-
|
|
|
|
-
|
|
|
|
10,183,555
|
|
|
|
-
|
|
|
|
10,183,555
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(6,723,849
|
)
|
|
|
(6,723,849
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at April 30, 2016
|
|
|
1,981,433
|
|
|
$
|
1,981
|
|
|
$
|
56,381,654
|
|
|
$
|
(60,094,935
|
)
|
|
$
|
(3,711,300
|
)
|
The accompanying notes are an integral
part of these unaudited financial statements.
Opiant Pharmaceuticals, Inc.
(formerly Lightlake Therapeutics Inc.)
Statements of Cash Flows (Unaudited)
For the nine months ended April 30, 2016 and 2015
|
|
|
For the
|
|
|
|
|
Nine Months Ended
|
|
|
|
|
April 30,
|
|
|
April 30,
|
|
|
|
|
2016
|
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
Cash flows used in operating activities
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(6,723,849
|
)
|
|
$
|
(5,401,646
|
)
|
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
|
Amortization
|
|
|
1,187
|
|
|
|
1,030
|
|
|
Issuance of common stock for services
|
|
|
1,215,719
|
|
|
|
305,825
|
|
|
Stock based compensation from issuance of options
|
|
|
10,183,555
|
|
|
|
911,256
|
|
|
Stock based compensation from issuance of warrants
|
|
|
-
|
|
|
|
409,312
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes in assets and liabilities:
|
|
|
|
|
|
|
|
|
|
Increase in prepaid insurance
|
|
|
(37,233
|
)
|
|
|
(26,903
|
)
|
|
Decrease in deferred revenue
|
|
|
(4,300,000
|
)
|
|
|
-
|
|
|
Decrease in accounts payable
|
|
|
(108,639
|
)
|
|
|
(124,558
|
)
|
|
Increase (decrease) in accrued salaries and wages
|
|
|
501,536
|
|
|
|
841,613
|
|
|
Net cash provided by (used in) operating activities
|
|
|
732,276
|
|
|
|
(3,084,071
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows used in investing activities
|
|
|
|
|
|
|
|
|
|
Purchase of equipment
|
|
|
(6,528
|
)
|
|
|
-
|
|
|
Net cash used in investing activities
|
|
|
(6,528
|
)
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows provided by financing activities
|
|
|
|
|
|
|
|
|
|
Proceeds from related parties notes payable
|
|
|
151,191
|
|
|
|
-
|
|
|
Payments of related parties notes payable
|
|
|
(281,191
|
)
|
|
|
(220,000
|
)
|
|
Investment received in exchange for royalty agreement
|
|
|
1,333,500
|
|
|
|
4,388,530
|
|
|
Net cash provided by financing activities
|
|
|
1,203,500
|
|
|
|
4,168,530
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents
|
|
|
1,929,248
|
|
|
|
1,084,459
|
|
|
Cash and cash equivalents, beginning of period
|
|
|
434,217
|
|
|
|
254,770
|
|
|
Cash and cash equivalents, end of period
|
|
$
|
2,363,465
|
|
|
$
|
1,339,229
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure
|
|
|
|
|
|
|
|
|
|
Interest paid during the period
|
|
$
|
78,865
|
|
|
$
|
-
|
|
|
Taxes paid during the period
|
|
$
|
-
|
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-Cash Transactions
|
|
|
|
|
|
|
|
|
|
Cashless exercise of options
|
|
$
|
15
|
|
|
$
|
-
|
|
The accompanying notes are an integral
part of these unaudited financial statements.
Opiant Pharmaceuticals, Inc.
(formerly Lightlake Therapeutics Inc.)
Notes to Unaudited Financial Statements
For the nine months ended April 30, 2016 and 2015
1. Organization
and Basis of Presentation
Opiant Pharmaceuticals, Inc.
(formerly Lightlake Therapeutics Inc.) (“Opiant”, “we”, “our”, the “Company”)
is a specialty pharmaceutical company developing pharmacological treatments for substance use, addictive and eating disorders.
The Company changed its name to Opiant on January 28, 2016. The Company also has worked on developing a treatment to reverse opioid
overdoses, now known as NARCAN® (naloxone hydrochloride) Nasal Spray, which was approved by the U.S. Food and Drug Administration
(“FDA”) in November 2015.
The accompanying unaudited
financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America
for interim financial information and with the instructions to Form 10-Q and Regulation S-X. Accordingly, these condensed financial
statements do not include all of the information and footnotes required by generally accepted accounting principles for complete
financial statements. In the opinion of management, all adjustments considered necessary for a fair presentation have been included
and such adjustments are of a normal recurring nature. These financial statements should be read in conjunction with the financial
statements for the year ended July 31, 2015 and notes thereto and other pertinent information contained in the Form 10-K the Company
has filed with the Securities and Exchange Commission (the “SEC”).
The results of operations
for the nine months ended April 30, 2016 are not necessarily indicative of the results for the full fiscal year ending July 31,
2016.
Reverse Stock Split
In December 2014, the Company
effected a one-for-one hundred reverse stock split of its common stock (the “1:100 Reverse Stock Split”). The number
of authorized shares of common stock and preferred stock remained the same following the 1:100 Reverse Stock Split. Unless otherwise
noted, impacted amounts included in the financial statements and notes thereto have been retroactively adjusted for the stock
splits as if such stock splits occurred on the first day of the first period presented. Impacted amounts include but are not limited
to shares of common stock issued and outstanding, stock options, shares reserved, exercise prices of warrants or options, and
loss per share. There was no impact on preferred or common stock authorized resulting from the 1:100 Reverse Stock Split.
2. Going
Concern
The accompanying financial
statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets
and the liquidation of liabilities in the normal course of business. However, the Company has incurred significant losses, has
a working capital deficit as of April 30, 2016 of $1,653,576 and is dependent on generating sufficient revenues and/or obtaining
adequate capital to fund operating losses until it becomes profitable. If the Company is unable to generate sufficient revenues
and/or obtain the necessary funding it could cease operations as a new enterprise. This raises substantial doubt about the Company’s
ability to continue as a going concern. Management’s plans include seeking additional financing in the form of debt financing
and/or equity financing from the sale of the Company’s common stock and/or in the form of financing from the sale of interests
in the Company’s current and/or prospective products. Such funds may also be derived pursuant to licensing agreements. There
is no guarantee that additional capital or debt financing will be available when and to the extent required, or that if available,
it will be on terms acceptable to the Company. These financial statements do not include any adjustments that might result from
this uncertainty.
3. Summary
of Significant Accounting Policies
Basis of Presentation
and Use of Estimates
The Company prepares its
financial statements in conformity with accounting principles generally accepted in the United States of America (“GAAP”),
which require management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the date of the financial statements, and reported amounts of revenues and expenses during
the reporting period. Actual results could differ from those estimates.
Basic and Diluted Net
Income (Loss) Per Share
Earnings (loss) per share
is calculated by dividing the net income (loss) available to common stockholders by the weighted average number of shares outstanding
during the year. Diluted earnings per share reflect the potential dilution of securities that could share in earnings of an entity.
Diluted income per share reflects the potential dilution that would occur if outstanding stock options and warrants were exercised
utilizing the treasury stock method. In a loss year, dilutive common equivalent shares are excluded from the loss per share calculation
as the effect would be anti-dilutive.
A reconciliation of the components
of basic and diluted net income (loss) per common share is presented in the tables below:
|
|
|
For the Three Months Ended April 30,
|
|
|
|
|
2016
|
|
|
2015
|
|
|
|
|
Income
(Loss)
$
|
|
|
Weighted
Average
Common
Shares
Outstanding
|
|
|
Per Share
$
|
|
|
Income
(Loss)
$
|
|
|
Weighted
Average
Common
Shares
Outstanding
|
|
|
Per Share
$
|
|
|
Basic:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) attributable to common stock
|
|
|
416,128
|
|
|
|
1,916,554
|
|
|
|
0.22
|
|
|
|
(1,850,695
|
)
|
|
|
1,830,134
|
|
|
|
(1.01
|
)
|
|
Effective of Dilutive Securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options and warrants
|
|
|
–
|
|
|
|
818,206
|
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) attributable to common stock, including assumed conversions
|
|
|
416,128
|
|
|
|
2,734,760
|
|
|
|
0.15
|
|
|
|
(1,850,695
|
)
|
|
|
1,830,134
|
|
|
|
(1.01
|
)
|
|
|
|
For the Nine Months Ended April 30,
|
|
|
|
|
2016
|
|
|
2015
|
|
|
|
|
Income
(Loss)
$
|
|
|
Weighted
Average
Common
Shares
Outstanding
|
|
|
Per Share
$
|
|
|
Income
(Loss)
$
|
|
|
Weighted
Average
Common
Shares
Outstanding
|
|
|
Per Share
$
|
|
|
Basic:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) attributable to common stock
|
|
|
(6,723,849
|
)
|
|
|
1,882,088
|
|
|
|
(3.57
|
)
|
|
|
(5,401,646
|
)
|
|
|
1,803,634
|
|
|
|
(2.99
|
)
|
|
Effective of Dilutive Securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options and warrants
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) attributable to common stock, including assumed conversions
|
|
|
(6,723,849
|
)
|
|
|
1,882,088
|
|
|
|
(3.57
|
)
|
|
|
(5,401,646
|
)
|
|
|
1,803,634
|
|
|
|
(2.99
|
)
|
Recently Issued Accounting Pronouncements
The Company has implemented
all new accounting pronouncements that are in effect and that may impact its financial statements and does not believe that there
are any other new pronouncements that have been issued that might have a material impact on its financial position or results
of operations.
4. Related
Party Transactions
At July 31, 2015, the Company
had loans outstanding with each of its three executive officers, all of whom are directors, in the total amount of $130,000. In
December 2014, the agreements were amended to extend the maturity date to April 30, 2016 and increase the annual interest rate
to 14.5%, which includes a penalty rate of 8.5% due to non-payment of the required repayment amounts. The loans were unsecured.
During the nine months ended April 30, 2016, the Company fully repaid the loans and interest payable.
During the nine months ended
April 30, 2016, the Company received loans from each of its three executive officers, all of whom are directors, totaling $151,191.
The loans bore interest at 6% per annum until January 31, 2016. During the nine months ended April 30, 2016, the Company fully
repaid the loans and interest payable.
5. Deferred
Revenue
On May 15, 2014, the Company
entered into an agreement and subsequently received funding from an individual investor in the amount of $300,000 for use by the
Company for any purpose. In exchange for this funding, the Company agreed to provide the investor with a 1.5% interest in the
Net Profit as related to the Company’s treatment to reverse opioid overdoses. Net profit is defined as the pre-tax profit
generated from the product after the deduction of all expenses incurred by and payments made by the Company in connection with
the product, including but not limited to an allocation of Company overhead. The investor also has rights with respect to its
1.5% interest if the treatment is sold or the Company is sold. If the product is not approved by the FDA within 24 months the
investor will have a 60 day option to receive 37,500 shares of common stock in lieu of the 1.5% interest in the product. The product
was approved by the FDA during the nine month period ended April 30, 2016 and as result the investor will not receive the option
to receive shares. During the nine months ended April 30, 2016, the Company recognized $300,000 as revenue because the option
to receive the shares of common stock was removed, and the research and development work related to the product was completed
as of April 30, 2016.
On July 22, 2014, the Company
received a $3,000,000 commitment, from which the Company has the right to make capital calls, from a foundation for the research,
development, marketing, commercialization, and any other activities connected to the Company’s treatment to reverse opioid
overdoses, certain operating expenses, and any other purpose consistent with the goals of the foundation. In exchange for funds
invested by the foundation the Company agreed to provide the foundation with pro-rata share up to a 6.0% interest in the Net Profit
as related to the Company’s treatment to reverse opioid overdoses. Net profit is defined as the pre-tax profit generated
from the product after the deduction of all expenses incurred by and payments made by the Company in connection with the product,
including but not limited to an allocation of Company overhead. The foundation also has rights with respect to its 6.0% interest
if the treatment is sold or the Company is sold. Additionally, the Company may buyback interests from the foundation within two
and one half years or after two and a half years of the initial investment at a price of two times or three and a half times,
respectively, the relevant investment amount represented by the interests to be bought back. Such buyback can be for a portion
of the interest rather than for the entire interest. If the product is not approved by the FDA or an equivalent body in Europe
for marketing and is not actually marketed within 24 months the foundation will have a 60 day option to receive shares of the
Company’s common stock in lieu of the interest in the treatment at a rate of 10 shares for every dollar of its investment.
On July 28, 2014 the Company received an initial investment of $111,470 from the foundation in exchange for a 0.22294% interest.
On August 13, 2014, September 8, 2014, November 13, 2014, and February 17, 2015, the Company made capital calls of $422,344, $444,530,
$1,033,614, and $988,043, respectively, from the foundation in exchange for 0.844687%, 0.888906%, 2.067228%, and 1.976085% interests,
respectively, in the Net Profit as related to the Company’s treatment to reverse opioid overdoses. The product was approved
by the FDA during the nine month period ended April 30, 2016 and as result the investor will not receive the option to receive
shares. During the nine months ended April 30, 2016, the Company recognized $3,000,000 as revenue because the option to receive
the shares of common stock was removed, and the research and development work related to the product was completed as of April
30, 2016.
On September 9, 2014, the
Company entered into an agreement and subsequently received funding from an individual investor in the amount of $500,000 for
use by the Company for any purpose. In exchange for this funding, the Company agreed to provide the investor with a 0.98% interest
in the Net Profit as related to the Company’s treatment to reverse opioid overdoses. Net Profit includes the pre-tax profit
received by the Company derived from the sale of the product after the deduction of all expenses incurred by and payments made
by the Company in connection with the product, including but not limited to an allocation of Company overhead. The investor also
has rights with respect to its 0.98% interest if the treatment is sold or the Company is sold. Additionally, the Company may buyback
interests from the investor within two and one half years or after two and a half years but no later than four years of the investment
at a price of two times or three and a half times, respectively, the relevant investment amount represented by the interests to
be bought back. Such buyback can be for a portion of the interest rather than for the entire interest. If the product is not introduced
to the market and not approved by the FDA or an equivalent body in Europe and not marketed within 24 months, the investor will
have a 60 day option to receive 50,000 shares of common stock in lieu of the interest in the product. The product was approved
by the FDA during the nine month period ended April 30, 2016 and as result the investor will not receive the option to receive
shares. During the nine months ended April 30, 2016, the Company recognized $500,000 as revenue because the option to receive
the shares of common stock was removed, and the research and development work related to the product was completed as of April
30, 2016.
On October 31, 2014, the
Company entered into an agreement and subsequently received funding from an individual investor in the amount of $500,000 for
use by the Company for any purpose. In exchange for this funding, the Company agreed to provide the investor with a 0.98% interest
in the Net Profit as related to the Company’s treatment to reverse opioid overdoses. Net Profit includes the pre-tax profit
received by the Company derived from the sale of the product after the deduction of all expenses incurred by and payments made
by the Company in connection with the product, including but not limited to an allocation of Company overhead. The investor also
has rights with respect to its 0.98% interest if the treatment is sold or the Company is sold. Additionally, the Company may buyback
interests from the investor within two and one half years or after two and a half years but no later than four years of the investment
at a price of two times or three and a half times, respectively, the relevant investment amount represented by the interests to
be bought back. Such buyback can be for a portion of the interest rather than for the entire interest. If the product is not introduced
to the market and not approved by the FDA or an equivalent body in Europe and not marketed within 24 months, the investor will
have a 60 day option to receive 50,000 shares of common stock in lieu of the interest in the product. The product was approved
by the FDA during the nine month period ended April 30, 2016 and as result the investor will not receive the option to receive
shares. During the nine months ended April 30, 2016, the Company recognized $500,000 as revenue because the option to receive
the shares of common stock was removed, and the research and development work related to the product was completed as of April
30, 2016.
On September 22, 2015, the
Company received a $1,600,000 commitment from a foundation, from which the Company has the right to make capital calls, for the
research, development, any other activities connected to the Company’s opioid antagonist treatments for addictions and related
disorders that materially rely on certain studies funded by the foundation’s investment, certain operating expenses, and
any other purpose consistent with the goals of the foundation. In exchange for funds invested by the foundation the Company agreed
to provide the foundation with pro-rata share up to a 2.1333% interest in the Net Profit as related to the Company’s opioid
antagonist treatments for addictions and related disorders that materially rely on certain studies funded by the foundation’s
investment. Net profit is defined as any pre-tax revenue received by the Company that was derived from the sale of the products
less any and all expenses incurred by and payments made by the Company in connection with the products, including but not limited
to an allocation of Company overhead. The foundation also has rights with respect to its 2.1333% interest if the products are
sold or the Company is sold. Additionally, the Company may buyback interests from the foundation within two and one half years
or after two and a half years of the initial investment at a price of two times or three and a half times, respectively, the relevant
investment amount represented by the interests to be bought back. Such buyback can be for a portion of the interest rather than
for the entire interest. If a product is not introduced to the market within 36 months the foundation will have a 60 day option
to receive shares of the Company’s common stock in lieu of the interest in the product at a rate of one-tenth of a share
for every dollar of its investment. On October 6, 2015, the Company received an initial investment of $618,000 from the foundation
in exchange for a 0.824% interest in the Company’s treatments covered by the commitment agreement. On December 23,
2015, the Company made a capital call of $715,500 from the foundation in exchange for a 0.954% interest in the Company’s
treatments covered by the commitment agreement.
On December 8, 2015, the
Company entered into an agreement with an individual investor to receive $500,000 for use by the Company for any purpose, which
$500,000 was to be invested by December 18, 2015. In exchange for this funding, the Company has agreed to provide the investor
with a 0.75% interest in the Net Profit as related to the Company’s treatment to reverse opioid overdoses. Net Profit includes
the pre-tax profit received by the Company derived from the sale of the product after the deduction of all expenses incurred by
and payments made by the Company in connection with the product, including but not limited to an allocation of Company overhead.
The investor also has rights with respect to its 0.75% interest if the treatment is sold or the Company is sold. Additionally,
the Company may buyback interests from the investor within two and one half years or after two and a half years but no later than
four years of the initial investment at a price of two times or three and a half times, respectively, the relevant investment
amount represented by the interests to be bought back. Such buyback can be for a portion of the interest rather than for the entire
interest. The investor also had an option to invest an additional $1,000,000 by February 29, 2016 for use by the Company for any
purpose in exchange for a 1.50% interest in the Net Profit as related to the Company’s treatment to reverse opioid overdoses.
If such investment were made, then the investor also would have rights with respect to its 1.50% interest if the treatment were
sold or the Company were sold. Additionally, the Company would be able to buyback interests from the investor within two and one
half years or after two and a half years but no later than four years of the initial investment at a price of two times or three
and a half times, respectively, the relevant investment amount represented by the interests to be bought back. Such buyback could
be for a portion of the interest rather than for the entire interest. This option expired unexercised. During the nine months
ended April 30, 2016, the Company recognized $500,000 as revenue because the investment did not contain an option to receive shares,
and the research and development work related to the product was completed as of April 30, 2016.
6. Stockholders’
Equity
Common Stock
Pursuant to an agreement
dated September 1, 2015, the Company issued 10,000 shares in exchange for services rendered by a consultant. The shares issued
in this transaction were valued using the stock price at issuance date and amounted to $80,500.
On October 6, 2015, the Company
issued 13,697 shares of the Company’s common stock pursuant to the agreement described in Note 7. The shares issued in this
transaction were using the stock price at issuance date and amounted to $106,152.
On November 19, 2015, the
Company issued 14,327 shares of common stock upon the execution of a binding letter of intent to agree to negotiate and enter
into an exclusive license agreement and collaboration agreement with a pharmaceutical company with certain desirable proprietary
information. The shares issued in this transaction were valued using the stock price at issuance date and amounted to $120,347.
Pursuant to the letter of intent, the Company is obligated to issue up to an additional 92,634 common shares upon the occurrence
of various milestones.
On December 16, 2015, the
Company entered into a services agreement with a term of one year. Pursuant to the agreement, the Company issued 7,000 shares
of common stock on December 18, 2015 and 9,000 shares of common stock on March 21, 2016 in exchange for services rendered by a
consultant. The shares issued in this transaction were valued using the stock price at issuance date and amounted to $64,050 and
$94,500 respectively. In addition, the Company agreed to issue 11,000 shares of common stock by June 30, 2016 and 13,000 shares
of common stock by September 30, 2016. At April 30, 2016, the Company had recorded $121,760 of stock-based compensation for the
additional 24,000 shares to be issued by September 30, 2016.
On February 1, 2016, the
Company issued 5,500 shares of the Company’s common stock to a consultant for consulting services. The shares issued in
this transaction were valued using the stock price at issuance date and amounted to $57,750.
On February 8, 2016, the
Company issued 10,746 shares of the Company’s common stock pursuant to the agreement described in Note 7. The shares issued
in this transaction were valued using the stock price at issuance date and amounted to $106,385.
On March 8, 2016, the Company
issued 3,582 shares of common stock to a consultant as a result of the first commercial sale of NARCAN® Nasal Spray by Adapt
Pharma Operations Limited in the U.S. The shares issued in this transaction were valued using the stock price at issuance date
and amounted to $32,775.
On March 25, 2016, the Company
issued 15,715 shares of common stock as a result of the cashless exercise of 30,000 options.
On April 26, 2016, the Company
issued 50,000 shares of common stock pursuant to the agreement described in Note 7. The shares issued in this transaction were
valued using the stock price at issuance date and amounted to $431,500.
Stock Options
As required by the Stock
Compensation Topic, ASC 718, the Company measures and recognizes compensation expense for all share based payment awards made
to the officers and directors based on estimated fair values at the grant date and over the requisite service period.
On October 27, 2015, the
Company granted 1,437,500 cashless stock options to the board of directors and a senior executive of the Company. These options
have an exercise price of $7.25, a term of 10 years and vested immediately. Each stock option is fully vested on the date of grant,
but may only be exercised between the following dates: (i) the first to occur of: (A) the commencement of three trials on or subsequent
to October 23, 2015; or (B) (1) the approval by the FDA of the New Drug Application with respect to the opioid overdose reversal
treatment, and (2) the commencement of two trials on or subsequent to October 23, 2015; and (ii) the expiration date. As
of April 30, 2016, the conditions for exercisability were met and the options were fully exercisable. The Company has valued these
options using the Black-Scholes option pricing model which resulted in a fair market value of $10,062,500 which have been fully
recognized as expense for the nine months ended April 30, 2016.
The Company also recognized
stock based compensation expense of $121,055 in connection with vested options granted in prior periods.
The assumptions used in the
valuation for all of the options granted for the nine months ended April 30, 2016 were as follows:
|
Market value of stock on measurement date
|
|
$
|
7.00
|
|
|
Risk-free interest rate
|
|
|
2.05
|
%
|
|
Dividend yield
|
|
|
0
|
%
|
|
Volatility factor
|
|
|
373
|
%
|
|
Term
|
|
|
10
years
|
|
Stock option activity for nine months
ended April 30, 2016 is presented in the table below:
|
|
|
Number of
Shares
|
|
|
Weighted-
average
Exercise
Price
|
|
|
Weighted-
average
Remaining
Contractual
Term
(years)
|
|
|
Aggregate
Intrinsic
Value
|
|
|
Outstanding at July 31, 2015
|
|
|
3,157,500
|
|
|
$
|
9.42
|
|
|
$
|
7.58
|
|
|
|
|
|
|
Granted
|
|
|
1,437,500
|
|
|
|
7.25
|
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
(30,000
|
)
|
|
|
5.00
|
|
|
|
|
|
|
|
|
|
|
Outstanding at April 30, 2016
|
|
|
4,565,000
|
|
|
$
|
8.77
|
|
|
$
|
7.68
|
|
|
$
|
5,969,725
|
|
|
Exercisable at April 30, 2016
|
|
|
4,277,500
|
|
|
$
|
8.37
|
|
|
$
|
8.07
|
|
|
$
|
5,969,725
|
|
A summary of the status of the Company’s
non-vested options as of April 30, 2016 and changes during the nine months ended April 30, 2016 are presented below:
|
Non-vested options
|
|
Number of
Options
|
|
|
Weighted Average
Grant Date
Fair Value
|
|
|
|
|
|
|
|
|
|
|
Non-vested at July 31, 2015
|
|
|
37,500
|
|
|
$
|
3.85
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
1,437,500
|
|
|
|
7.00
|
|
|
Vested
|
|
|
(1,450,000
|
)
|
|
|
7.01
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-vested at April 30, 2016
|
|
|
25,000
|
|
|
$
|
3.85
|
|
At April 30, 2016, there
was $44,352 of unrecognized compensation costs related to non-vested stock options.
Warrants
Warrant activity for the nine months ended April
30, 2016 is presented in the table below:
|
|
|
Number of
Shares
|
|
|
Weighted-
average
Exercise
Price
|
|
|
Weighted-
average
Remaining
Contractual
Term (years)
|
|
|
Aggregate
Intrinsic
Value
|
|
|
Outstanding at July 31, 2015
|
|
|
1,338,552
|
|
|
$
|
19.53
|
|
|
|
3.55
|
|
|
$
|
–
|
|
|
Issued
|
|
|
–
|
|
|
|
|
|
|
|
–
|
|
|
|
–
|
|
|
Expired
|
|
|
(119,767
|
)
|
|
|
35.14
|
|
|
|
–
|
|
|
|
–
|
|
|
Outstanding at April 30, 2016
|
|
|
1,218,785
|
|
|
$
|
17.99
|
|
|
|
3.11
|
|
|
$
|
34,144
|
|
|
Exercisable at April 30, 2016
|
|
|
493,785
|
|
|
$
|
22.39
|
|
|
|
5.22
|
|
|
$
|
34,144
|
|
7. Licensing
Agreement
On October 6, 2015, the Company
entered into an amendment to an agreement to use certain technology owned by Aegis Therapeutics, LLC (“Aegis’ Technology”).
This amendment had an effective date of May 19, 2015 and allowed the Company to evaluate Aegis’ Technology until August
17, 2015. The amendment also provided an opportunity for the Company to elect to further extend the period of time during which
the Company could evaluate Aegis’ Technology until February 13, 2016. In exchange for electing to further extend this period
of time, the Company paid Aegis $75,000 and issued 13,697 shares of the Company’s common stock. The shares issued in this
transaction were using the stock price at issuance date and amounted to $106,152.
During February 2016, the
Company elected to further extend the period of time during which the Company could evaluate Aegis’ Technology until August
11, 2016. The Company paid Aegis $75,000 and issued 10,746 shares of the Company’s common stock. The shares issued in this
transaction were using the stock price at issuance date and amounted to $106,385.
On April 26, 2016 (the “Amendment
Date”), the Company and Aegis entered into the Amended and Restated Material Transfer, Option and Research License Agreement
(the “Restated License Agreement”) which amends and restates in its entirety the Material Transfer, Option and Research
License Agreement, dated as of December 1, 2014, by and between the Company and Aegis. Under the Restated License Agreement, the
Company has been granted an exclusive royalty-free research license, for a period of time (the “Compound Research Period”)
to Aegis’ proprietary delivery enhancement and stabilization agents, including, but not limited to, Aegis’ ProTek®
and Intravail® technologies (collectively, the “Technology”) to enable the Company to conduct a feasibility study
of opioid antagonists when used with the Technology (the “Study”) and evaluate the Company’s interest in licensing
the Technology through use of the Compound in additional studies.
The Company agreed to
pay Aegis (i) an aggregate of $300,000, of which the Company may elect to pay up to 50% by issuing shares of the
Company’s common stock, par value $0.001 per share, to Aegis, with the number of shares to be issued equal to 75% of
the average closing price of the Company’s common stock over the 20 trading days preceding the date of payment as
consideration for extending the Compound Research Period pursuant to two separate extension payments of $150,000 each, and
(ii) 50,000 shares of common stock as partial consideration for entering into the Restated License Agreement. The shares
issued in this transaction were valued using the stock price at issuance date and amounted to $431,500. The Company exercised
such extensions through payment of the first and second extension fees prior to October 13, 2015 and prior to February 13,
2016, respectively. The Restated License Agreement shall expire on the earlier of (i) the expiration of the “Opiant
Negotiation Periods” (as defined in the Restated License Agreement) and (ii) on 30 days prior written notice by the
Company; provided, however, that Aegis shall have the right to terminate the license granted in the event the Company does
not pursue commercially reasonable efforts to exploit a “Product”, defined as (i) pharmaceutical formulations
containing the Compound as an active ingredient and (ii) Aegis’s proprietary chemically synthesizable excipient(s),
including without limitation the Intravail® excipients.
During the term of the Restated
License Agreement, the Company has a right of first refusal and option to add any, or all of the “Additional Compounds”
(as defined in the Restated License Agreement), which the Company may exercise at any time upon written notice to Aegis. The Company
has granted Aegis a co-exclusive license with the Company to use the data from the Company’s Studies under the Restated
License Agreement for certain purposes. Pursuant to the Restated License Agreement, Aegis granted the Company an exclusive option
(the “Opiant Option”) to obtain an exclusive, worldwide, royalty-bearing license (with the right to grant sublicenses
through multiple tiers) under Aegis’s interests in the Technology and any “Joint Invention” (as such term is
defined in the Restated License Agreement) to the Technology to research, develop, make, have made, use, sell, offer for sale,
and import products containing the “Compound” (as defined in the Restated License Agreement) or an Additional Compound.
The Company may exercise such Opiant Option with respect to the Compounds by written notice to Aegis within 90 days of the completion
of the Study for (i) the Compounds or (ii) the Additional Compounds. In the event the Company exercises the Opiant Option, the
parties have 120 days to negotiate and execute a definitive license agreement.
8.
Subsequent
Events
On May 17, 2016, the Company
granted 70,000 cashless stock options to two new members of the board of directors of the Company. These options have an exercise
price of $10.00, and a term of 5 years. The options vest as follows: 23,334 vest upon the uplisting of the Company to the NASDAQ
Stock Market; 23,334 vest upon the cumulative funding of the Company of or in excess of $5,000,000 by institutional investors;
and 23,332 vest upon the first submission of a new drug application to the FDA.
On May 18, 2016, the Company
made a capital call of $266,500 from the foundation in exchange for a 0.355% interest in the Company’s treatments covered
by the September 22, 2015 commitment described in Note 5.
On June 24, 2016, the Company
issued 11,000 shares of common stock to a consultant as required by the services agreement entered into with the latter on December
16, 2015. See also Note 6.
On June 21, 2016, the Company
entered into a settlement and release agreement with a former advisor pursuant to which, in exchange for prior advisory services
rendered to the Company in full pursuant to an advisory services agreement dated on or about September 17, 2012, the Company has
agreed to pay the $165,000 amount owed to the advisor for the past services rendered (such amount, the “Outstanding Advisor
Balance”). As evidence of the Company’s obligation to pay the Outstanding Advisor Balance, the Company issued a secured
promissory note (the “Advisor Note”) to the advisor on June 21, 2016, earning interest at the rate of six percent
per annum, with the unpaid principal amount and accrued and unpaid interest due and payable in full on the earlier of (i) the
closing by the Company of one or more equity or debt financings with aggregate gross proceeds to the Company of at least $2,200,000,
and (ii) December 15, 2016. In addition, as security for the prompt payment of the Outstanding Advisor Balance, the Company has
pledged 22,916 shares of common stock as collateral pursuant to a pledge agreement, dated as of June 21, 2016, by and between
the Company and the advisor. Such 22,916 shares of common stock are being held by an escrow agent pursuant to a securities escrow
agreement, dated as of June 21, 2016, by and between the Company and the advisor, and shall be released to the advisor upon an
“Event of Default” (as defined in the Advisor Note).
PART
II — INFORMATION NOT REQUIRED IN THE PROSPECTUS
Item. 13 Other Expenses Of Issuance And Distribution.
|
Securities and Exchange
Commission registration fee
|
|
$
|
2,091.75
|
|
|
Transfer Agent Fees
|
|
$
|
3,000
|
|
|
Accounting fees and expenses
|
|
$
|
26,500
|
|
|
Legal fees and expense
|
|
$
|
15,000
|
|
|
Miscellaneous
|
|
$
|
n/a
|
|
|
Total
|
|
$
|
46,591.75
|
|
All amounts are estimates other than the
SEC’s registration fee. The Company is paying all of the registration expenses incurred in connection with the registration
of the shares. No portion of these expenses will be borne by the selling security holders. The selling security holders, however,
will pay any other expenses incurred in selling their common stock, including any brokerage commissions or costs of sale.
Item 14. Indemnification of Directors and Officers.
Our directors and officers are indemnified as provided by the
Nevada corporate law and our Bylaws. We have agreed to indemnify each of our directors and certain officers against certain liabilities,
including liabilities under the Securities Act of 1933. Insofar as indemnification for liabilities arising under the Securities
Act of 1933 may be permitted to our directors, officers and controlling persons pursuant to the provisions described above, or
otherwise, we have been informed that in the opinion of the Securities and Exchange Commission such indemnification is against
public policy as expressed in the Securities Act of 1933 and is, therefore, unenforceable. In the event that a claim for indemnification
against such liabilities (other than our payment of expenses incurred or paid by our director, officer or controlling person in
the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection
with the securities being registered, we will, unless in the opinion of our counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy
as expressed in the Securities Act and will be governed by the final adjudication of such issue.
Item 15. Recent Sales of Unregistered Securities.
On January 14, 2013, the Company
issued 100,628 shares in exchange for services rendered. The shares issued in this transaction were valued at market and amounted
to $7,044.
On February 21, 2013, the Company
issued 2,000,000 shares in exchange for services rendered. The shares issued in this transaction were valued at market and amounted
to $120,000.
On March 14, 2013, the Company
issued 750,000 shares in exchange for services rendered. The shares issued in this transaction were valued at market and amounted
to $37,500.
On March 25, 2013, the Company
sold 666,667 shares of its common stock at $0.06 per share through a private placement the amount of this transaction was $40,000.
On March 29, 2013, the Company
sold 250,000 shares of its common stock at $0.06 per share through a private placement the amount of this transaction was $15,000.
On June 7, 2013, the Company
issued 2,000,000 shares in exchange for services rendered. The shares issued in this transaction were valued at market and amounted
to $82,000.
On July 15, 2013, the Company
issued 856,708 shares in exchange for services rendered. The shares issued in this transaction were valued at market and amounted
to $20,561.
On July 16, 2013, the Company
issued 675,000 shares in exchange for services rendered. The shares issued in this transaction were valued at market and amounted
to $18,900.
On July 26, 2013, the Company
issued 438,596 shares in exchange for services rendered. The shares issued in this transaction were valued at market and amounted
to $13,816.
On August 1, 2013, the Company
granted its executive officers cashless stock options to purchase a total of 37,500,000 shares of its common stock at exercise
prices ranging from $0.10 to $0.20 per share. These options vested immediately and expire in ten years on July 31, 2023. The Company
has valued these options using the Black-Scholes option pricing model which resulted in a fair market value of $1,068,750 which
has been fully recognized as expense for the year ended July 31, 2014.
On August 12, 2013, the Company
issued 375,000 shares in exchange for services rendered. The shares issued in this transaction were valued at market and amounted
to $15,000.
On August 28, 2013, the Company
issued 500,000 shares in exchange for services rendered. The shares issued in this transaction were valued at market and amounted
to $35,000.
On September 18, 2013, the
Company issued 375,000 shares in exchange for services rendered. The shares issued in this transaction were valued at market and
amounted to $22,500.
On October 21, 2013, the Company
issued 225,895 shares in exchange for services rendered. The shares issued in this transaction were valued at market and amounted
to $9,036.
On October 25, 2013, the Company
issued 334,572 shares in exchange for services rendered. The shares issued in this transaction were valued at market and amounted
to $13,382.
On October 31, 2013, the Company
issued 375,000 shares in exchange for services rendered. The shares issued in this transaction were valued at market and amounted
to $15,750.
On November 1, 2013, the
Company granted its executive officers cashless stock options to purchase a total of 22,500,000 shares of its common stock at
exercise prices ranging from $0.06 to $0.10 per share. These options vested immediately and expire in ten years on October 31,
2023. The Company has valued these options using the Black-Scholes option pricing model which resulted in a fair market value
of $985,500 which has been fully recognized as expense for the year ended July 31, 2014.
In November 2013, the Company
issued 1,250,000 shares in exchange for services rendered. The shares issued were valued at market and amounted to $66,500.
On December 23, 2013, the Company
issued 375,000 shares in exchange for services rendered. The shares issued in this transaction were valued at market and amounted
to $21,750.
On December
17, 2013, the Company entered into an agreement and subsequently received additional funding totaling $250,000 for use by the
Company for any purpose. In exchange for this funding, the Company agreed to provide the investor with a 0.5% interest in the
net profit as related to the Company’s BED treatment. Net profit is defined as the pre-tax profit generated from the product
after the deduction of all expenses incurred by and payments made by the Company in connection with the product, including but
not limited to an allocation of Company overhead. The investor also has rights with respect to its 0.5% interest if the treatment
is sold or the Company is sold. If the product is not approved by the U.S. Food and Drug Administration within 36 months the investor
will have a 60 day option to receive 31,250 shares of common stock in lieu of the 0.5% interest in the product.
On December 31, 2013, the
Company granted its executive officers cashless stock options to purchase a total of 66,500,000 shares of its common stock at
exercise prices ranging from $0.06 to $0.10 per share. These options vested immediately and expire in ten years on December 30,
2023. The Company has valued these options using the Black-Scholes option pricing model which resulted in a fair market value
of $3,591,000 which has been fully recognized as expense for the year ended July 31, 2014.
On April 7, 2014, the Company
issued 376,225 shares in exchange for services rendered. The shares issued in this transaction were valued at market and amounted
to $15,049.
On May 15,
2014, the Company entered into an agreement and subsequently received funding from an individual investor in the amount of $300,000
for use by the Company for any purpose. In exchange for this funding, the Company agreed to provide the investor with a 1.5% interest
in the net profit as related to the Company’s treatment to reverse opioid overdoses. Net profit is defined as the pre-tax
profit generated from the product after the deduction of all expenses incurred by and payments made by the Company in connection
with the product, including but not limited to an allocation of Company overhead. The investor also has rights with respect to
its 1.5% interest if the treatment is sold or the Company is sold. If the product is not introduced to the market and not approved
for marketing within 24 months, the investor will have a 60 day option to receive 37,500 shares of common stock in lieu of
the 1.5% interest in the product. The product was approved by the FDA during the six month period ended January 31, 2016 and as
result the investor will not receive the option to receive shares. During the six months ended January 31, 2016, the Company recognized
$300,000 as revenue because the option to receive the shares of common stock was removed, and the research and development work
related to the product was completed as of January 31, 2016.
On June 11, 2014, the Company
issued a total of 24,000,000 warrants with a strike price of $0.10 per share to a consultant in exchange for consulting and other
strategic advisory services, including clinical strategy and intellectual property strategy. These warrants expire in ten years
on June 10, 2024. Additionally, upon the achievement of certain milestones the consultant will be granted up to an additional
22,540,000 warrants with strike prices from $0.125 to $0.25 per share.
On June 15, 2014, the Company
granted its executive officers and a director cashless stock options to purchase a total of 107,500,000 shares of its common stock
at exercise prices ranging from $0.05 to $0.08 per share. These options vest immediately and expire in ten years on June 14, 2024.
These options may only be exercised between the following dates: (i) the first to occur of: (A) the commencement of the next trial
with respect to the opioid overdose reversal treatment; (B) the entrance into a distribution, licensing, royalty, partnership,
collaboration, or other significant transaction with respect to the opioid overdose reversal treatment; or (C) the filing of a
New Drug Application with the U.S. Food and Drug Administration with respect to the opioid overdose reversal treatment; and (ii)
the Expiration Date. The Company has valued these options using the Black-Scholes option pricing model which resulted in a fair
market value of $2,580,000 which has been fully recognized as expense for the year ended July 31, 2014.
On June 24, 2014, the Company
granted 3,000,000 cashless stock options to an outside consultant to purchase its common stock at an exercise price of $0.05 per
share. These options vest immediately and expire in seven years on June 23, 2021. The Company has valued these options using the
Black-Scholes option pricing model which resulted in a fair market value of $69,000 of which 34,500 has been recognized as expense
for the year ended July 31, 2014.
On July 22, 2014, the Company
received a $3,000,000 commitment, from which the Company has the right to make capital calls, from a foundation for the research,
development, marketing, commercialization, and any other activities connected to the Company’s treatment to reverse opioid
overdoses, certain operating expenses, and any other purpose consistent with the goals of the foundation. In exchange for funds
invested by the foundation the Company agreed to provide the foundation with pro-rata share up to a 6.0% interest in the net profit
as related to the Company’s treatment to reverse opioid overdoses. Net profit is defined as the pre-tax profit generated
from the product after the deduction of all expenses incurred by and payments made by the Company in connection with the product,
including but not limited to an allocation of Company overhead. The foundation also has rights with respect to its up to 6.0%
interest if the treatment is sold or the Company is sold. Additionally, the Company may buyback interests from the foundation
within two and one half years or after two and a half years of the initial investment at a price of two times or three and a half
times, respectively, the relevant investment amount represented by the interests to be bought back. Such buyback can be for a
portion of the interest rather than for the entire interest. If the product is not approved by the U.S. Food and Drug Administration
or an equivalent body in Europe for marketing and is not actually marketed within 24 months the foundation will have a 60 day
option to receive shares of the Company’s common stock in lieu of the interest in the treatment at a rate of 10 shares for
every dollar of its investment. On July 28, 2014 the Company received an initial investment of $111,470 from the foundation in
exchange for a 0.22294% interest. On August 13, 2014, September 8, 2014, November 13, 2014, and February 17, 2015, the Company
made capital calls of $422,344, $444,530, $1,033,614, and $988,043, respectively, from the foundation in exchange for 0.844687%,
0.888906%, 2.067228%, and 1.976085% interests, respectively, in the net profit as related to the Company’s treatment to
reverse opioid overdoses. The product was approved by the FDA during the three month period ended January 31, 2016 and as result
the investor will not receive the option to receive shares. During the three months ended January 31, 2016, the Company recognized
$3,000,000 as revenue because the option to receive the shares of common stock was removed, and the research and development work
related to the product was completed as of January 31, 2016.
In August 2014, Opiant issued
7,846 shares to consultants for services rendered. The shares have a fair value of $44,723 based on stock prices at issuance dates.
On August 2, 2014, the Company
granted 3,000,000 cashless stock options with an exercise price of $0.10 per share to a consultant for services rendered. These
options have a term of 5 years and vested immediately. The Company has valued these options using the Black-Scholes option pricing
model which resulted in a fair market value of $173,999 which have been fully recognized as expense for the year ended July 31,
2015.
On September 9, 2014, Opiant
entered into an agreement and subsequently received funding from an individual investor in the amount of $500,000 for use by the
Company for any purpose. In exchange for this funding, the Company agreed to provide the investor with a 0.98% interest in the
Net Profit as related to the Company’s treatment to reverse opioid overdoses. Net Profit includes the pre-tax profit received
by the Company derived from the sale of the product after the deduction of all expenses incurred by and payments made by the Company
in connection with the product, including but not limited to an allocation of Company overhead. The investor also has rights with
respect to its 0.98% interest if the treatment is sold or the Company is sold. Additionally, the Company may buyback interests
from the investor within two and one half years or after two and a half years of the investment at a price of two times or three
and a half times, respectively, the relevant investment amount represented by the interests to be bought back. If the product
is not introduced to the market and not approved by the U.S. Food and Drug Administration or an equivalent body in Europe and
not marketed within 24 months, the investor will have a 60 day option to receive 50,000 shares of common stock in lieu of the
interest in the product.
On September 17, 2014, Opiant
entered into an agreement and subsequently received funding totaling $500,000 for use by the Company for any purpose. In exchange
for this funding, the Company agreed to provide the investor with a 1.0% interest in the Company’s Binge Eating Disorder
treatment product and pay the investor 1.0% of the Net Profit generated from this treatment in perpetuity. Net Profit includes
the pre-tax profit generated from the product after the deduction of all expenses incurred by and payments made by the Company
in connection with the product, including but not limited to an allocation of Company overhead. If the product is not approved
by the U.S. Food and Drug Administration within 36 months, the investor will have a sixty day option to receive 62,500 shares
of common stock in lieu of the 1.0% interest in the product.
On October 31, 2014, Opiant
entered into an agreement and subsequently received funding from an individual investor in the amount of $500,000 for use by the
Company for any purpose. In exchange for this funding, the Company agreed to provide the investor with a 0.98% interest in the
Net Profit as related to the Company’s treatment to reverse opioid overdoses. Net Profit includes the pre-tax profit received
by the Company derived from the sale of the product after the deduction of all expenses incurred by and payments made by the Company
in connection with the product, including but not limited to an allocation of Company overhead. The investor also has rights with
respect to its 0.98% interest if the treatment is sold or the Company is sold. Additionally, the Company may buyback the interest
from the investor within two and one half years or after two and a half years but no later than four years of the investment at
a price of two times or three and a half times, respectively, of the investment amount. If the product is not introduced to the
market and not approved by the FDA or an equivalent body in Europe and not marketed within 24 months, the investor will have a
60 day option to receive 50,000 shares of common stock in lieu of the interest in the product.
On November 12, 2014, the
Company granted 3,000,000 cashless stock options with an exercise price of $0.10 per share to a consultant for services rendered.
These options have a term of 5 years and vest over 3 years. The Company has valued these options using the Black-Scholes option
pricing model which resulted in a fair market value of $188,825, of which $103,951 has been fully recognized as expense for the
year ended July 31, 2015.
On November 12, 2014, the
Company granted 2,000,000 cashless stock options with an exercise price of $0.15 per share to a consultant for services rendered.
These options have a term of 5 years and vest over three years. The Company has valued these options using the Black-Scholes option
pricing model which resulted in a fair market value of $127,150, of which $67,984 has been fully recognized as expense for the
year ended July 31, 2015.
On September
9, 2014, the Company entered into an agreement and subsequently received funding from an individual investor in the amount of
$500,000 for use by the Company for any purpose. In exchange for this funding, the Company agreed to provide the investor with
a 0.98% interest in the net profit as related to the Company’s treatment to reverse opioid overdoses. Net profit includes
the pre-tax profit received by the Company derived from the sale of the product after the deduction of all expenses incurred by
and payments made by the Company in connection with the product, including but not limited to an allocation of Company overhead.
The investor also has rights with respect to its 0.98% interest if the treatment is sold or the Company is sold. Additionally,
the Company may buyback interests from the investor within two and one half years or after two and a half years but no later than
four years of the initial investment at a price of two times or three and a half times, respectively, the relevant investment
amount represented by the interests to be bought back. Such buyback can be for a portion of the interest rather than for the entire
interest. If the product is not introduced to the market and not approved by the FDA or an equivalent body in Europe and not marketed
within 24 months the investor will have a 60 day option to receive 50,000 shares of common stock in lieu of the interest in the
product. The product was approved by the FDA during the three month period ended January 31, 2016 and as result the investor will
not receive the option to receive shares. During the three months ended January 31, 2016, the Company recognized $500,000 as revenue
because the option to receive the shares of common stock was removed, and the research and development work related to the product
was completed as of January 31, 2016.
On September 17, 2014, the
Company entered into an agreement and subsequently received funding totaling $500,000 for use by the Company for any purpose.
In exchange for this funding, the Company agreed to provide the investor with a 1.0% interest in the Company’s BED treatment
product and pay the investor 1.0% of the net profit generated from this treatment in perpetuity. Net profit is defined as the
pre-tax profit generated from the product after the deduction of all expenses incurred by and payments made by the Company in
connection with the product, including but not limited to an allocation of Company overhead. If the product is not approved by
the FDA within 36 months the investor will have a sixty day option to receive 62,500 shares of common stock in lieu of the 1.0%
interest in the product.
On October
31, 2014, the Company entered into an agreement and subsequently received funding from an individual investor in the amount of
$500,000 for use by the Company for any purpose. In exchange for this funding, the Company agreed to provide the investor with
a 0.98% interest in the net profit as related to the Company’s treatment to reverse opioid overdoses. Net profit includes
the pre-tax profit received by the Company derived from the sale of the product after the deduction of all expenses incurred by
and payments made by the Company in connection with the product, including but not limited to an allocation of Company overhead.
The investor also has rights with respect to its 0.98% interest if the treatment is sold or the Company is sold. Additionally,
the Company may buyback interests from the investor within two and one half years or after two and a half years but no later than
four years of the initial investment at a price of two times or three and a half times, respectively, the relevant investment
amount represented by the interests to be bought back. Such buyback can be for a portion of the interest rather than for the entire
interest. If the product is not introduced to the market and not approved by the FDA or an equivalent body in Europe and not marketed
within 24 months the investor will have a 60 day option to receive 50,000 shares of common stock in lieu of the interest in the
product. The product was approved by the FDA during the three month period ended January 31, 2016 and as result the investor will
not receive the option to receive shares. During the three months ended January 31, 2016, the Company recognized $500,000 as revenue
because the option to receive the shares of common stock was removed, and the research and development work related to the product
was completed as of January 31, 2016.
In December 2014, the
Company effected a one-for-one hundred reverse stock split of its common stock (the "1:100 Reverse Stock Split") which
decreased the number of common shares issued and outstanding from approximately 182.0 million shares to approximately 1.82 million
shares,. All share amounts listed above in this Report have not been adjusted for the 1:100 Reverse Stock
On December 16, 2014, the Company
issued 38,800 stock warrants with an exercise price of $8.00 per share to a consultant for services rendered. These warrants have
a term of 10 years and vested immediately. The Company has valued these warrants using the Black-Scholes option pricing model
which resulted in a fair market value of $144,724 which have been fully recognized as expense for the year ended July 31, 2015.
In December 2014, the Company
issued 24,015 shares to a company for services rendered. The shares have a fair value of $91,258 based on the stock prices at issuance
dates.
In January 2015, Lightlake issued
a total of 5,000 shares to two consultants for services rendered. The shares have a fair value of $19,720 based on the stock prices
at issuance dates.
On January 9, 2015, the
Company granted 15,000 cashless stock options with an exercise price of $10.00 per share to a consultant for services rendered.
These options have a term of 5 years and vested immediately. The Company has valued these options using the Black-Scholes option
pricing model which resulted in a fair market value of $65,163 which have been fully recognized as expense for the year ended
July 31, 2015.
On January 25, 2015,
the Company granted 10,000 cashless stock options with an exercise price of $10.00 per share to a consultant for services rendered.
These options have a term of 5 years and vested immediately. The Company has valued these options using the Black-Scholes option
pricing model which resulted in a fair market value of $36,169 which have been fully recognized as expense for the year ended
July 31, 2015.
In January 2015, the Company
issued a total of 5,000 shares to two consultants for services rendered. The shares have a fair value of $19,720 based on the stock
prices at issuance dates.
In March 2015, Lightlake
issued a total of 20,900 shares to two companies and a consultant for services rendered. The shares have a fair value of $141,130
based on the stock prices at issuance dates
On March 19, 2015, the Company
granted 48,000 cashless stock options with an exercise price of $10.00 per share to a consultant for services rendered. These
options have a term of 5 years and vested immediately. The Company has valued these options using the Black-Scholes option pricing
model which resulted in a fair market value of $282,227 which have been fully recognized as expense for the year ended July 31,
2015.
On March 19, 2015, the Company
granted 32,000 cashless stock options with an exercise price of $15.00 per share to a consultant for services rendered. These
options have a term of 5 years and vested immediately. The Company has valued these options using the Black-Scholes option pricing
model which resulted in a fair market value of $186,655 which have been fully recognized as expense for the year ended July 31,
2015.
On March 19, 2015, the Company
issued 45,000 stock warrants with an exercise price of $10.00 per share to a consultant for services rendered. These warrants
have a term of 5 years and vested immediately. The Company has valued these warrants using the Black-Scholes option pricing
model which resulted in a fair market value of $264,588 which have been fully recognized as expense for the year ended July 31,
2015.
On March 21, 2015, the Company
issued 9,000 shares of common stock in exchange for services rendered.
On March 25, 2015, the Company
issued 15,715 shares of common stock as a result of the exercise of cashless options
In March 2015, the Company issued
a total of 20,900 shares to two companies and a consultant for services rendered. The shares have a fair value of $141,130 based
on the stock prices at issuance dates.
In April 2015, the Company issued
1,232 shares to a consultant for services rendered. The shares have a fair value of $8,994 based on the stock prices at issuance
dates.
In July, 2015, the Company
granted 10,000 cashless stock options with an exercise price of $10.00 per share to a consultant for services rendered. These
options have a term of 3 years and vested immediately. The Company has valued these options using the Black-Scholes option pricing
model which resulted in a fair market value of $55,043 which have been fully recognized as expense for the year ended July 31,
2015.
On July 20, 2015, Lightlake
entered into an agreement and subsequently received funding from an individual investor in the amount of $250,000 for use by the
Company for any purpose. In exchange for this funding, the Company agreed to provide the investor with a 0.50% interest in the
Net Profit as related to the Company’s treatment of binge eating disorder. Net Profit includes the pre-tax profit received
by the Company derived from the sale of the product after the deduction of all expenses incurred by and payments made by the Company
in connection with the product, including but not limited to an allocation of Company overhead. The investor also has rights with
respect to its 0.50% interest if the treatment is sold or the Company is sold. If the product is not introduced to the market
and not approved by the FDA or an equivalent body in Europe and not marketed within 36 months, the investor will have a 60 day
option to receive 25,000 shares of common stock in lieu of the interest in the product.
In July, 2015, the Company issued
800 shares to a consultant for services rendered. The shares have a fair value of $5,840 based on the stock prices at the date
performance by the consultant was complete.
On September 16, 2015, the
Company issued 10,000 shares in exchange for services rendered. The shares issued in this transaction were valued at market and
amounted to $80,500.
On
September 22, 2015, the Company received a $1,600,000 commitment from a foundation, from which the Company has the right to make
capital calls, for the research, development, any other activities connected to the Company’s opioid antagonist treatments
for addictions and related disorders that materially rely on certain studies funded by the foundation’s investment, certain
operating expenses, and any other purpose consistent with the goals of the foundation. In exchange for funds invested by the foundation
the Company agreed to provide the foundation with pro-rata share up to a 2.1333% interest in the Net Profit as related to the
Company’s opioid antagonist treatments for addictions and related disorders that materially rely on certain studies funded
by the foundation’s investment. Net profit is defined as any pre-tax revenue received by the Company that was derived from
the sale of the products less any and all expenses incurred by and payments made by the Company in connection with the products,
including but not limited to an allocation of Company overhead. The foundation also has rights with respect to its up to 2.1333%
interest if the products are sold or the Company is sold. Additionally, the Company may buyback interests from the foundation
within two and one half years or after two and a half years of the initial investment at a price of two times or three and a half
times, respectively, the relevant investment amount represented by the interests to be bought back. Such buyback can be for a
portion of the interest rather than for the entire interest. If a product is not introduced to the market within 36 months the
foundation will have a 60 day option to receive shares of the Company’s common stock in lieu of the interest in the product
at a rate of one-tenth of a share for every dollar of its investment. On October 6, 2015, and December 23, 2015, the Company received
$618,000 and $715,500 from the foundation in exchange for a 0.824% and 0.954% interests, respectively, in the Company’s
treatments covered by the commitment agreement. The Company will defer recording revenue until such time as the option expires
or milestones are achieved that eliminates the investor’s right to exercise the option. Upon expiration of the exercise
option, the deliverables of the arrangement will be reviewed and evaluated under ASC 605. In the event the investor chooses to
convert interests into shares of common stock, that transaction will be accounted for similar to a sale of shares of common stock
for cash.
On October 6, 2015, the Company
issued 13,697 shares of the Company’s common stock pursuant to an amendment to an agreement to use certain technology owned
by Aegis Therapeutics, LLC that extended the period of time during which the Company could evaluate Aegis’ Technology until
February 13, 2016.
On October 27, 2015, the
Company granted 1,437,500 cashless stock options to the board of directors and a senior executive of the Company. These options
have an exercise price of $7.25, a term of 10 years and vested immediately. Each stock option is fully vested on the date of grant,
but may only be exercised between the following dates: (i) the first to occur of: (A) the commencement of three trials on or subsequent
to October 23, 2015; or (B) (1) the approval by the FDA of the New Drug Application with respect to the opioid overdose reversal
treatment, and (2) the commencement of two trials on or subsequent to October 23, 2015; and (ii) the expiration date. As
of April 30, 2016, the conditions for exercisability were met and the options were fully exercisable. The Company has valued these
options using the Black-Scholes option pricing model which resulted in a fair market value of $10,062,500 which have been fully
recognized as expense for the nine months ended April 30, 2016.
On November 19, 2015, the Company
issued 14,327 shares of common stock upon the execution of a binding letter of intent to agree to negotiate and enter into an
exclusive license agreement and collaboration agreement with a pharmaceutical company with certain desirable proprietary information.
The shares issued in this transaction were valued at market and amounted to $120,347.
On December
8, 2015, the Company entered into an agreement with an individual investor to receive $500,000 for use by the Company for any
purpose, which $500,000 shall be invested by December 18, 2015. In exchange for this funding, the Company has agreed to provide
the investor with a 0.75% interest in the Net Profit as related to the Company’s treatment to reverse opioid overdoses.
Net Profit includes the pre-tax profit received by the Company derived from the sale of the product after the deduction of all
expenses incurred by and payments made by the Company in connection with the product, including but not limited to an allocation
of Company overhead. The investor also has rights with respect to its 0.75% interest if the treatment is sold or the Company is
sold. Additionally, the Company may buyback interests from the investor within two and one half years or after two and a half
years but no later than four years of the initial investment at a price of two times or three and a half times, respectively,
the relevant investment amount represented by the interests to be bought back. Such buyback can be for a portion of the interest
rather than for the entire interest. The investor also had an option to invest an additional $1,000,000 by February 29, 2016 for
use by the Company for any purpose in exchange for a 1.50% interest in the Net Profit as related to the Company’s treatment
to reverse opioid overdoses. If such investment were made, then the investor also would have rights with respect to its 1.50%
interest if the treatment were sold or the Company were sold. Additionally, the Company would be able to buyback interests from
the investor within two and one half years or after two and a half years but no later than four years of the initial investment
at a price of two times or three and a half times, respectively, the relevant investment amount represented by the interests to
be bought back. Such buyback could be for a portion of the interest rather than for the entire interest. This option expired unexercised.
During the three months ended January 31, 2016, the Company recognized $500,000 as revenue because the investment did not contain
an option to receive shares, and the research and development work related to the product was completed as of January 31, 2016.
On December 16, 2015, the
Company entered into a services agreement with a term of one year. Pursuant to the agreement, the Company issued 7,000 shares
of common stock on December 18, 2015 and 9,000 shares of common stock on March 21, 2016 in exchange for services rendered by a
consultant. The shares issued in this transaction were valued using the stock price at issuance date and amounted to $64,050 and
$94,500 respectively.
On February 1, 2016, the
Company issued 5,500 shares of the Company’s common stock to a consultant for consulting services. The shares issued in
this transaction were valued using the stock price at issuance date and amounted to $57,750.
On February 8, 2016, the
Company issued 10,746 shares of the Company’s common stock pursuant to a licensing agreement. The shares issued in this
transaction were valued using the stock price at issuance date and amounted to $106,385.
On March 8, 2016, the Company
issued 3,582 shares of common stock to a consultant as a result of the first commercial sale of NARCAN® Nasal Spray by Adapt
Pharma Operations Limited in the U.S. The shares issued in this transaction were valued using the stock price at issuance date
and amounted to $32,775.
On March 21, 2016, the Company
issued 9,000 shares of common stock in exchange for services rendered. The shares issued in this transaction were valued at market
and amounted to $94,500.
On March 25, 2016, the Company
issued 15,715 shares of common stock as a result of the exercise of cashless options of 30,000 options.
On April 26, 2016, the Company
issued 50,000 shares of common stock in exchange for services rendered. The shares issued in this transaction were valued at market
and amounted to $431,500.
On May 17, 2016, the Company granted 70,000 cashless stock options to two new members of the board
of directors of the Company. These options have an exercise price of $10.00, and a term of 5 years. The options vest as follows:
23,334 vest upon the uplisting of the Company to the NASDAQ Stock Market; 23,334 vest upon the cumulative funding of the Company
of or in excess of $5,000,000 by institutional investors; and 23,332 vest upon the first submission of a new drug application
to the FDA.
These shares, warrants and options were issued in reliance on the exemption under Section 4(2) of
the Securities Act. These shares of the Company’s common stock qualified for exemption under Section 4(2) since the issuance
shares by the Company did not involve a public offering. The offering was not a “public offering” as defined in Section
4(2) due to the insubstantial number of persons involved in the deal, size of the offering, manner of the offering and number
of shares offered. The Company did not undertake an offering in which the Company sold a high number of shares to a high number
of investors. In addition, the investors had the necessary investment intent as required by Section 4(2) since they agreed to
and received share certificates bearing a legend stating that such shares are restricted pursuant to Rule 144 of the Act. This
restriction ensures that these shares would not be immediately redistributed into the market and therefore not be part of a “public
offering.” Based on an analysis of the above factors, the Company has met the requirements to qualify for exemption under
Section 4(2) of the Securities Act for this transaction.
Item 16. Exhibits and Financial Statement Schedules.
|
EXHIBIT
NUMBER
|
|
DESCRIPTION
|
|
3.1
|
|
Articles of Incorporation.
(1)
|
|
3.1(i)
|
|
Certificate
of Amendment, dated August 10, 2009. (4)
|
|
|
|
Certificate of Amendment, dated September 16, 2009 (4)
|
|
3.1(iii)
|
|
Certificate
of Amendment. dated November 26, 2014. (5)
|
|
3.1(iv)
|
|
Certificate
of Amendment, dated January 28, 2016. (8)
|
|
3.2
|
|
By-Laws. (1)
|
|
5.1
|
|
Opinion of DLA
Piper LLP (US)*
|
|
10.1
|
|
Michael Sinclair
Employment Agreement, dated December 31, 2012. (9)
|
|
10.2
|
|
Roger Crystal Employment
Agreement, dated December 31, 2012. (9)
|
|
10.3
|
|
Kevin Pollack Employment
Agreement, dated December 31, 2012. (9)
|
|
10.4
|
|
Geoffrey Wolf Director
Agreement, dated December 31, 2012. (9)
|
|
10.5
|
|
First Amendment
to Employment Agreement with Michael Sinclair, dated December 31, 2012. (2)
|
|
10.6
|
|
First Amendment
to Executive Letter of Reappointment with Roger Crystal, dated December 31, 2012. (2)
|
|
10.7
|
|
First Amendment
to Executive Letter of Appointment with Kevin Pollack, dated December 31, 2012. (2)
|
|
10.8
|
|
Second Amendment
to Employment Agreement with Michael Sinclair dated December 31, 2013. (3)
|
|
10.9
|
|
Second Amendment
to Executive Letter of Reappointment with Roger Crystal dated December 31, 2013. (3)
|
|
10.10
|
|
Second Amendment
to Executive Letter of Appointment with Kevin Pollack dated December 31, 2013. (3)
|
|
10.11
|
|
Third Amendment
to Employment Agreement with Michael Sinclair, effective as of January 1, 2016. (12)
|
|
10.12
|
|
Third Amendment
to Executive Letter of Reappointment with Roger Crystal, effective as of January 1, 2016. (12)
|
|
10.13
|
|
Third Amendment to Executive Letter of Appointment with Kevin Pollack, effective as of January
1, 2016. (12)
|
|
10.14
|
|
License Agreement with Adapt Pharma Operation Limited,
dated December 1, 2015. (6)
|
|
10.15
|
|
Material Transfer. Option and Research License Agreement with
Adapt Pharma Operation Limited, dated December 1, 2015. (6)
|
|
10.16
|
|
Stock Option Grant Agreement with Michael Sinclair, dated October
23, 2015. (7)
|
|
10.17
|
|
Stock Option Grant Agreement with Roger Crystal, dated October
23, 2015. (7)
|
|
10.18
|
|
Stock Option Grant Agreement with Kevin Pollack, dated October
23, 2015. (7)
|
|
10.19
|
|
Stock Option Grant Agreement with Geoffrey Wolf, dated October
23, 2015. (7)
|
|
10.20
|
|
Material Transfer, Option and Research License Agreement with
Aegis Therapeutics, LLC, dated as of December 1, 2014, as amended December 16, 2014. (10)
|
|
10.21
|
|
Amendment No. 2 to the Material Transfer, Option and Research
License Agreement with Aegis Therapeutics, LLC, effective May 19, 2015 (11)
|
|
10.22
|
|
Director Agreement with Ann L. MacDougall, dated May 5, 2016.
(13)
|
|
10.23
|
|
Director Agreement with Dr. Gabrielle Silver, dated
May 5, 2016. (13)
|
|
23.1
|
|
Consent of MaloneBailey, LLP. *
|
|
23.2
|
|
Consent of DLA Piper LLP (US) (included in Exhibit 5.1).
*
|
|
101.INS
|
|
XBRL Instance Document*
|
|
101.SCH
|
|
XBRL Taxonomy Extension Schema*
|
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase*
|
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase*
|
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase*
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase*
|
|
|
(1)
|
Filed with the Securities and Exchange Commission on
January 11, 2007 on Form SB-2, which exhibit is incorporated herein by reference.
|
|
|
(2)
|
Filed with the Securities and Exchange Commission on
November 1, 2013 on Form 10-K, which exhibit is incorporated herein by reference.
|
|
|
(3)
|
Filed with the Securities and Exchange Commission on
February 25, 2014 on Form 8-K, which exhibit is incorporated herein by reference.
|
|
|
(4)
|
Filed with the Securities and Exchange Commission on
September 4, 2014 on Form 8-K, which exhibit is incorporated herein by reference.
|
|
|
(5)
|
Filed with the Securities and Exchange Commission on
December 1, 2014 on Form 8-K, which exhibit is incorporated herein by reference.
|
|
|
(6)
|
Filed
with the Securities and Exchange Commission on October 26, 2015 on Form 10-K, which exhibit is incorporated herein by reference.
|
|
|
(7)
|
Filed with the Securities and Exchange Commission on
October 29, 2015 on Form 8-K, which exhibit is incorporated herein by reference.
|
|
|
(8)
|
Filed
with the Securities and Exchange Commission on February 3, 2016 on Form 8-K, which exhibit is incorporated herein by reference.
|
|
|
(9)
|
Filed
with the Securities and Exchange Commission on October 29, 2013 on Form 10-K, which exhibit is incorporated herein by reference.
|
|
|
(10)
|
Filed
with the Securities and Exchange Commission on November 19, 2015 on Form 10-Q, which exhibit is incorporated herein by reference.
|
|
|
(11)
|
Filed
with the Securities and Exchange Commission on October 26, 2015 on Form 10-K, which exhibit is incorporated herein by reference.
|
|
|
(12)
|
Filed
with the Securities and Exchange Commission on April 15, 2016 on Form 8-K, which exhibit
is incorporated herein by reference.
|
|
|
(13)
|
Filed with the Securities and
Exchange Commission on May 11, 2016 on Form 8-K, which exhibit is incorporated herein by reference.
|
Item 17. Undertakings.
The undersigned registrant hereby undertakes:
(1) To file, during any
period in which offers or sales are being made, a post-effective amendment to this registration statement:
i. To include any
prospectus required by section 10(a)(3) of the Securities Act of 1933;
ii. To reflect in
the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective
amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the
registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total
dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the
estimated maximum offering range may be reflected in the form of prospectus filed with the SEC pursuant to Rule 424(b) if, in
the aggregate, the changes in volume and price represent no more than 20% change in the maximum aggregate offering price set forth
in the “Calculation of Registration Fee” table in the effective registration statement.
iii. To include
any material information with respect to the plan of distribution not previously disclosed in the registration statement or any
material change to such information in the registration statement;
(2) That, for the purpose
of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new
registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed
to be the initial bona fide offering thereof.
(3) To remove from registration
by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.
(4) Insofar as indemnification
for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the
registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities
and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable.
In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred
or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding)
is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant
will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is against public policy as expressed in the Act and will be governed
by the final adjudication of such issue.
(5) Each prospectus filed pursuant to
Rule 424(b) as part of a registration statement relating to an offering, other than registration statements relying on Rule 430B
or other than prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included in the registration statement
as of the date it is first used after effectiveness.
Provided, however
, that no statement made in a registration statement
or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference
into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of
contract of sale prior to such first use, supersede or modify any statement that was made in the registration statement or prospectus
that was part of the registration statement or made in any such document immediately prior to such date of first use.
(6) The undersigned registrant undertakes
that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of
the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser
by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered
to offer or sell such securities to such purchaser:
(i) Any preliminary
prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424 (§
230.424 of this chapter);
(ii) Any free writing
prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned
registrant;
(iii) The portion of any other
free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities
provided by or on behalf of the undersigned registrant; and
(iv) Any other communication
that is an offer in the offering made by the undersigned registrant to the purchaser.
SIGNATURES
Pursuant to the requirements of the
Securities Act of 1933, the registrant has duly caused this registration statement to be signed on its behalf by the undersigned,
thereunto duly authorized in the City of Santa Monica, State of California, on August 24, 2016.
|
|
OPIANT PHARMACEUTICALS, INC.
|
|
|
|
|
|
|
By:
|
/s/
Kevin A. Pollack
|
|
|
|
Kevin A. Pollack
|
|
|
|
Chief Financial Officer
|
Pursuant to the requirements of the Securities
Act of 1933, this registration statement has been signed by the following persons in the capacities and on the dates indicated.
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
|
|
/s/
Dr. Roger Crystal
|
|
Chief Executive
Officer and Director
|
|
August
24, 2016
|
|
Dr. Roger Crystal
|
|
(Principal
Executive Officer)
|
|
|
|
|
|
|
|
|
|
/s/
Kevin A. Pollack
|
|
Chief Financial
Officer and Director
|
|
August
24, 2016
|
|
Kevin A. Pollack
|
|
(Principal
Financial and Accounting Officer)
|
|
|
|
|
|
|
|
|
|
/s/
Dr. Michael Sinclair
|
|
Executive
Chairman and Director
|
|
August
24, 2016
|
|
Dr. Michael Sinclair
|
|
|
|
|
|
|
|
|
|
|
|
/s/
Geoffrey Wolf
|
|
Director
|
|
August
24, 2016
|
|
Geoffrey Wolf
|
|
|
|
|
|
|
|
|
|
|
|
/s/ Ann L. MacDougall
|
|
Director
|
|
August
24, 2016
|
|
Ann L. MacDougall
|
|
|
|
|
|
|
|
|
|
|
|
/s/
Dr. Gabrielle Silver
|
|
Director
|
|
August
24, 2016
|
|
Dr. Gabrielle Silver
|
|
|
|
|
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