NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Three
Months Ended March 31, 2018 and 2017
1.
Organization and Basis of Presentation
Organization
RespireRx
Pharmaceuticals Inc. (“RespireRx”) was formed in 1987 under the name Cortex Pharmaceuticals, Inc. to engage in the
discovery, development and commercialization of innovative pharmaceuticals for the treatment of neurological and psychiatric disorders.
On December 16, 2015, RespireRx filed a Certificate of Amendment to its Second Restated Certificate of Incorporation with the
Secretary of State of the State of Delaware to amend its Second Restated Certificate of Incorporation to change its name from
Cortex Pharmaceuticals, Inc. to RespireRx Pharmaceuticals Inc. While developing potential applications for respiratory disorders,
RespireRx has retained and expanded its ampakine intellectual property and data with respect to neurological and psychiatric disorders
and is considering developing certain potential products in this platform, pending additional financing and/or strategic
relationships.
In
August 2012, RespireRx acquired Pier Pharmaceuticals, Inc. (“Pier”), which is now its wholly-owned subsidiary.
Basis
of Presentation
The
condensed consolidated financial statements are of RespireRx and its wholly-owned subsidiary, Pier (collectively referred
to herein as the “Company,” unless the context indicates otherwise). The condensed consolidated financial statements
of the Company at March 31, 2018 and for the three months ended March 31, 2018 and 2017, are unaudited. In the opinion of management,
all adjustments (including normal recurring adjustments) have been made that are necessary to present fairly the condensed
consolidated financial position of the Company as of March 31, 2018, the results of its condensed consolidated operations
for the three months ended March 31, 2018 and 2017, and its condensed consolidated cash flows for the three months ended
March 31, 2018 and 2017. Condensed consolidated operating results for the interim periods presented are not necessarily
indicative of the results to be expected for a full fiscal year. The consolidated balance sheet at December 31, 2017 has been
derived from the Company’s audited consolidated financial statements at such date.
The
condensed consolidated financial statements and related notes have been prepared pursuant to the rules and regulations of the
Securities and Exchange Commission (the “SEC”). Accordingly, certain information and footnote disclosures normally
included in financial statements prepared in accordance with generally accepted accounting principles have been omitted pursuant
to such rules and regulations. These condensed consolidated financial statements should be read in conjunction with the consolidated
financial statements and other information included in the Company’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2017, as filed with the SEC.
2.
Business
RespireRx
is developing dronabinol, a synthetic derivative of a naturally occurring substance in the cannabis plant, otherwise known as
Δ9-THC or Δ9-tetrahydrocannabinol, for the treatment of Obstructive Sleep Apnea (“OSA”), a serious respiratory
disorder that impacts an estimated 29.4 million people in the United States according to the American Academy of Sleep Medicine
(“AASM”), published in August 2016. OSA has been linked to increased risk for hypertension, heart failure,
depression, and diabetes, and has an annual economic cost of $162 billion according to the AASM. There are no approved
drug treatments for OSA.
RespireRx
holds the exclusive world-wide license to a family of patents for the use of cannabinoids, including dronabinol, in the treatment
of sleep disordered breathing from the University of Illinois at Chicago (“UIC”). In addition, RespireRx has several
extensions and pending applications that, if issued, will extend patent protection for over a decade. UIC recently completed a
Phase 2B multi-center, double-blind, placebo-controlled clinical trial of dronabinol in patients with OSA. Entitled Pharmacotherapy
of Apnea with Cannabimimetic Enhancement (“PACE”), this study replicated an earlier Phase 2A RespireRx sponsored clinical
trial and demonstrated statistically significant improvements in respiration, daytime sleepiness, and patient satisfaction after
administration of dronabinol. The results from PACE were published in the journal Sleep Vol. 41. No. 1, 2018.
RespireRx
believes that the most direct route to commercialization is to proceed directly to a Phase 3 pivotal trial using the currently
available dronabinol formulation (2.5, 5 and 10 mg gel caps) and to then commercialize a RespireRx branded dronabinol capsule
(“RBDC”).
RespireRx
also believes that there are
numerous opportunities for reformulation of dronabinol to produce a second generation proprietary, branded product for the treatment
of OSA with an improved profile. Therefore, simultaneous with the development of the RBDC, RespireRx plans to develop a proprietary
dronabinol formulation to optimize the dose and duration of action for treating OSA.
RespireRx
initiated its dronabinol program when it acquired 100% of the issued and outstanding equity securities of Pier effective August
10, 2012 pursuant to an Agreement and Plan of Merger. Pier was formed in June 2007 (under the name SteadySleep Rx Co.) as a clinical
stage pharmaceutical company to develop a pharmacologic treatment for OSA and had been engaged in research and clinical development
activities.
Prior
to the merger, Pier conducted a 21 day, randomized, double-blind, placebo-controlled, dose escalation Phase 2 clinical study in
22 patients with OSA, in which dronabinol produced a statistically significant reduction in the Apnea-Hypopnea Index, the primary
therapeutic end-point, and was observed to be safe and well tolerated.
Through
the merger, RespireRx gained access to a 2007 Exclusive License Agreement (as amended, the “Old License”) that Pier
had entered into with the University of Illinois on October 10, 2007. The Old License covered certain patents and patent applications
in the United States and other countries claiming the use of certain compounds referred to as cannabinoids, including dronabinol,
for the treatment of sleep-related breathing disorders (including sleep apnea).
Dronabinol
is a Schedule III, controlled generic drug with a relatively low abuse potential that is approved by the U.S. Food and Drug Administration
(the “FDA”) for the treatment of AIDS-related anorexia and chemotherapy-induced emesis. The use of dronabinol for
the treatment of OSA is a novel indication for an already approved drug and, as such, the Company believes that it would only
require approval by the FDA of a 505(b)(2) new drug application, an efficient regulatory pathway.
The
Old License was terminated effective March 21, 2013, due to the Company’s failure to make a required payment. Subsequently,
current management opened negotiations with the University of Illinois, and as a result, the Company entered into a new license
agreement (the “2014 License Agreement”) with the University of Illinois on June 27, 2014, the material terms of which
were similar to the Old License.
Similar
to the Old License, the 2014 License Agreement grants the Company, among other provisions, exclusive rights: (i) to practice certain
patents and patent applications, as defined in the 2014 License Agreement, that are held by the University of Illinois; (ii) to
identify, develop, make, have made, import, export, lease, sell, have sold or offer for sale any related licensed products; and
(iii) to grant sub-licenses of the rights granted in the 2014 License Agreement, subject to the provisions of the 2014 License
Agreement. The Company is required under the 2014 License Agreement, among other terms and conditions, to pay the University of
Illinois a license fee, royalties, patent costs and certain milestone payments.
Since
its formation in 1987, RespireRx has been engaged in the research and clinical development of a class of proprietary compounds
known as ampakines, which act to enhance the actions of the excitatory neurotransmitter glutamate at AMPA glutamate receptors.
Several ampakines, in both oral and injectable form, are being developed by the Company for the treatment of a variety of breathing
and other disorders. In clinical studies, select ampakines have shown preliminary efficacy in central sleep apnea and in the control
of respiratory depression produced by opioids, without altering their analgesic effects. In animal models of certain orphan
disorders, such as Pompe Disease, Rett’s Syndrome and perinatal respiratory distress, certain ampakines have been
shown to improve breathing function.
Ampakines
also have shown potential as possible therapeutic agents for the treatment of certain neuropsychiatric and neurological disorders.
Ampakines have demonstrated positive activity in animal models of Attention Deficit Hyperactivity Disorder (“ADHD”),
results that have been extended translationally into statistically significant improvement of symptoms observed
in a Phase 2 clinical trial of CX717 in adults with ADHD. At present, the major pharmacotherapies available for ADHD are
made up of two types of drugs. Stimulants, such as amphetamine, rapidly produce robust effects, but suffer from side effects
typical of stimulants, including tolerance, dependence, withdrawal and abuse. For these reasons, stimulants are scheduled
by the FDA. Non-stimulants, such as Straterra® (atomoxetine) tend to be less effective than stimulants with a
much longer (approximately 4 – 8 week) latency to onset of action. In a number of animal and human studies, CX717
and other ampakines did not display any stimulant properties typically associated with drugs like amphetamine. In
the Phase 2 ADHD clinical trial, statistically significant therapeutic effects were observed within one week. Therefore, we
believe ampakines may represent a novel, non-stimulant treatment for ADHD with a more rapid onset of action than alternative
non-stimulant treatment options.
The
Company owns patents and patent applications, or the rights thereto (see Note 9. Subsequent Events), for certain families
of chemical compounds, including ampakines, which claim the chemical structures, their actions as ampakines and their use in the
treatment of various disorders. Patents claiming a family of chemical structures, including CX1739 and CX1942, as well as their
use in the treatment of various disorders extend through at least 2028. Additional patents claiming a family of chemical structures,
including CX717, as well as their use in the treatment of various disorders expired in 2017 in the U.S. and will expire in 2018
internationally.
In
2011, RespireRx conducted a re-evaluation of its strategic focus and determined that clinical development in the area of respiratory
disorders, particularly sleep apnea and drug-induced respiratory depression, provided the most cost-effective opportunities for
potential rapid development and commercialization of RespireRx’s compounds. Accordingly, RespireRx narrowed its clinical
focus at that time and sidelined other avenues of scientific inquiry. This re-evaluation provided the impetus for RespireRx’s
acquisition of Pier in August 2012, as described above. The Company is re-evaluating the potential of ampakines as drug candidates
for non-respiratory central nervous system (“CNS”) therapeutic applications, especially considering the data the
Company has in respect to its ampakines for certain neuropsychiatric and neurological conditions. Part of the stimulus
for the re-evaluation is the March 12, 2018 announcement of the acquisition by Biogen Inc. from Pfizer Inc. of an AMPA receptor
modulator which has been in development for schizophrenia, for $75 million upfront and possible $515 million potential milestones
and tiered royalties. Additionally, in March 2017, Otsuka Pharmaceutical Co., Ltd. announced that it had agreed to buy Neurovance,
Inc. for $100 million plus up to an additional $150 million of contingent payments for a drug in advanced clinical trials for
ADHD, a therapeutic area for which one of the Company’s ampakines, CX717, has already demonstrated efficacy in a Phase 2
clinical trial, as discussed above.
The
Company has continued to implement its respiratory strategic focus, notwithstanding a change in management in March 2013,
and has continued its efforts to obtain the capital necessary to fund the clinical activities. As a result of the Company’s
scientific discoveries and the acquisition of strategic, exclusive license agreements (see Note 8. Commitments and Contingencies-Significant
Agreements and Contracts-University of Alberta License Agreement, Note 8. Commitments and Contingencies-Significant Agreements
and Contracts-University of Illinois 2014 Exclusive License Agreement and Note 9. Subsequent Events), management believes
that the Company is a leader in developing drugs for respiratory disorders, particularly sleep apneas and drug-induced respiratory
depression, which is a form of apnea. In addition, the Company recently added to its focus CNS applications other than
respiratory, particularly ADHD and spinal cord injury.
On
May 9, 2007, RespireRx entered into a license agreement, as subsequently amended, with the University of Alberta granting RespireRx
exclusive rights to method of treatment patents held by the University of Alberta claiming the use of ampakines for the treatment
of various respiratory disorders. These patents, along with RespireRx’s own patents claiming chemical structures, comprise
RespireRx’s principal intellectual property supporting RespireRx’s research and clinical development program in the
use of ampakines for the treatment of respiratory disorders. RespireRx has completed pre-clinical studies indicating that several
of its ampakines, including CX717, CX1739 and CX1942, were efficacious in treating drug induced respiratory depression caused
by opioids or certain anesthetics without offsetting the analgesic effects of the opioids or the anesthetic effects of the anesthetics.
In two clinical Phase 2 studies, one of which was published in a peer-reviewed journal, CX717, a predecessor compound to CX1739
and CX1942, antagonized the respiratory depression produced by fentanyl, a potent narcotic, without affecting the analgesia produced
by this drug. In addition, RespireRx has conducted a Phase 2A clinical study in which patients with sleep apnea were administered
CX1739, RespireRx’s lead clinical compound. The results suggested that CX1739 might have use as a treatment for central
sleep apnea (“CSA”) and mixed sleep apnea, but not OSA. For more information about recent developments regarding
the license agreement with the University of Alberta, see Note 9. Subsequent Events.
Going
Concern
The
Company’s condensed consolidated financial statements have been presented on the basis that it is a going concern, which
contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company has incurred
net losses of $746,678 for the three months ended March 31, 2018 and $4,291,483 for the fiscal year ended December 31, 2017, and
negative operating cash flows of $140,022 for the three months ended March 31, 2018 and $697,009 for the fiscal year ended December
31, 2017. The Company also had a stockholders’ deficiency of $4,977,253 at March 31, 2018 and expects to continue to incur
net losses and negative operating cash flows for at least the next few years. As a result, management has concluded that there
is substantial doubt about the Company’s ability to continue as a going concern, and the Company’s independent registered
public accounting firm, in its report on the Company’s consolidated financial statements for the year ended December 31,
2017, expressed substantial doubt about the Company’s ability to continue as a going concern.
The
Company is currently, and has for some time, been in significant financial distress. It has extremely limited cash resources and
current assets and has no ongoing source of sustainable revenue. Management is continuing to address various aspects of the Company’s
operations and obligations, including, without limitation, debt obligations, financing requirements, intellectual property, licensing
agreements, legal and patent matters and regulatory compliance, and has taken steps to continue to raise new debt and equity capital
to fund the Company’s business activities from both related and unrelated parties.
On
March 10, 2017 and March 28, 2017, the Company sold units to investors in the 1
st
2017 Unit Offering (“1
st
2017 Unit Offering”) for aggregate gross proceeds of $350,000, with each unit consisting of one share of the Company’s
common stock and one common stock purchase warrant to purchase one share of the Company’s common stock. Units were sold
for $2.50 per unit and the warrants issued in connection with the units were exercisable through December 31, 2021 at a fixed
price $2.75 per share of the Company’s common stock. The warrants contained a cashless exercise provision and certain blocker
provisions preventing exercise if the investor would beneficially own more than 4.99% of the Company’s outstanding shares
of common stock as a result of such exercise. The warrants were also subject to redemption by the Company at $0.001 per share
upon ten (10) days written notice if the Company’s common stock closed at 200% or more of the unit purchase price for any
five (5) consecutive trading days. The investors were not affiliates of the Company. Investors received an unlimited number of
piggy-back registration rights. Investors also received an unlimited number of exchange rights, which were options and not obligations,
to exchange such investor’s entire investment (and not less than the entire investment) into one or more subsequent equity
financings (consisting solely of convertible preferred stock or common stock or units containing preferred stock or common stock
and warrants exercisable only into preferred stock or common stock) that would be considered as “permanent equity”
under United States Generally Accepted Accounting Principles and the rules and regulations of the United States Securities and
Exchange Commission, and therefore classified as stockholders’ equity, and excluding any form of debt or convertible debt
(each such financing a “Subsequent Equity Financing”). These exchange rights were effective until the earlier of:
(i) the completion of any number of subsequent financings aggregating at least $15 million gross proceeds to the Company, or (ii)
December 30, 2017. The dollar amount used to determine the amount invested or exchanged into the subsequent financing would have
been 1.2 times the amount of the original investment. Under certain circumstances, the ratio might have been 1.4 instead of 1.2.
The exchange right did not permit the investors to exchange into a debt offering or into redeemable preferred stock. In connection
with this transaction, Aurora Capital LLC (“Aurora”) served as a placement agent and earned $20,000 of cash fees and
8,000 placement agent common stock warrants associated with the closing of 1
st
2017 Unit Offering. The cash fees were
unpaid as of March 31, 2018.
On
July 26, 2017, the Company’s Board approved the 2
nd
2017 Unit Offering (“2
nd
2017 Unit Offering”).
The terms of the 2
nd
2017 Unit Offering as compared to the terms of the 1
st
2017 Unit Offering were such,
that it resulted in an exchange of units from the 1
st
2017 Unit Offering for new equity securities and warrants of
the Company in the 2
nd
2017 Unit Offering by the Company by all of the investors in the 1
st
2017 Unit Offering.
On
August 29, 2017, September 27, 2017, September 28, 2017, October 5, 2017, October 25, 2017, November 29, 2017, December 13, 2017,
December 21, 2017, December 22, 2017 and December 29, 2017 the Company sold units to investors in the 2
nd
2017 Unit
Offering for aggregate gross proceeds of $404,500, with each unit consisting of one share of the Company’s common stock
and one common stock purchase warrant to purchase one share of the Company’s common stock. Units were sold for $1.00 per
unit and the warrants issued in connection with the units are exercisable through September 29, 2022 at a fixed price $1.10 per
share of the Company’s common stock. The warrants contain a cashless exercise provision and certain blocker provisions preventing
exercise if the investor would beneficially own more than 4.99% of the Company’s outstanding shares of common stock as a
result of such exercise. The warrants are also subject to redemption by the Company at $0.001 per share upon ten (10) days written
notice if the Company’s common stock closes at 250% or more of the unit purchase price for any five (5) consecutive trading
days. Investors were not affiliates of the Company. Investors also received an unlimited number of piggy-back registration rights.
Investors received an unlimited number of exchange rights, which were options and not obligations, to exchange such investor’s
entire investment (and not less than the entire investment) into one or more subsequent equity financings (consisting solely of
convertible preferred stock or common stock or units containing preferred stock or common stock and warrants exercisable only
into preferred stock or common stock) that would be considered as “permanent equity” under United States Generally
Accepted Accounting Principles and the rules and regulations of the United States Securities and Exchange Commission, and therefore
classified as stockholders’ equity, and excluding any form of debt or convertible debt (each such financing a “Subsequent
Equity Financing”). These exchange rights were effective until the earlier of: (i) the completion of any number of subsequent
financings aggregating at least $15 million gross proceeds to the Company, or (ii) December 30, 2017, and have therefore expired.
The dollar amount used to determine the amount invested or exchanged into the subsequent financing would have been 1.2 times the
amount of the original investment. Under certain circumstances, the ratio might have been 1.4 instead of 1.2. The exchange right
did not permit the investors to exchange into a debt offering or into redeemable preferred stock. There was no placement agent
and therefore no fees associated with the 2
nd
2017 Unit Offering.
The
terms of the 2
nd
2017 Unit Offering as compared to the terms of the offering by the Company with closings on December
29, 2016 and December 30, 2016 (the “2
nd
2016 Unit Offering”), as discussed in more detail below, and the
1
st
2017 Unit Offering, has resulted in an exchange of all of the units from each of the 2
nd
2016 Unit Offering
and the 1
st
2017 Unit Offering into equity securities and warrants of the 2
nd
2017 Unit Offering.
The
Company is continuing its efforts to raise additional capital in order to be able to pay its liabilities and fund its business
activities on a going forward basis, including the pursuit of the Company’s planned research and development activities.
The Company regularly evaluates various measures to satisfy the Company’s liquidity needs, including development and other
agreements with collaborative partners and, when necessary, seeking to exchange or restructure the Company’s outstanding
securities. The Company is evaluating certain changes to its operations and structure to facilitate raising capital from sources
that may be interested in financing only discrete aspects of the Company’s development programs. Such changes could include
a significant reorganization, which may include the formation of one or more subsidiaries into which one or more programs may
be contributed. As a result of the Company’s current financial situation, the Company has limited access to external sources
of debt and equity financing. Accordingly, there can be no assurances that the Company will be able to secure additional financing
in the amounts necessary to fully fund its operating and debt service requirements. If the Company is unable to access sufficient
cash resources, the Company may be forced to discontinue its operations entirely and liquidate.
3.
Summary of Significant Accounting Policies
Principles
of Consolidation
The
accompanying condensed consolidated financial statements are prepared in accordance with United States generally accepted accounting
principles (“GAAP”) and include the financial statements of RespireRx and its wholly-owned subsidiary, Pier. Intercompany
balances and transactions have been eliminated in consolidation.
Use
of Estimates
The
preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions. These estimates
and assumptions affect the reported amounts of assets and liabilities, 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. Significant estimates
include, among other things, accounting for potential liabilities, and the assumptions used in valuing stock-based compensation
issued for services. Actual amounts may differ from those estimates.
Concentrations
of Credit Risk
Financial
instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents.
The Company limits its exposure to credit risk by investing its cash with high quality financial institutions. The Company’s
cash balances may periodically exceed federally insured limits. The Company has not experienced a loss in such accounts to date.
Cash
Equivalents
The
Company considers all highly liquid short-term investments with maturities of less than three months when acquired to be cash
equivalents.
Fair
Value of Financial Instruments
The
authoritative guidance with respect to fair value of financial instruments established a fair value hierarchy that prioritizes
the inputs to valuation techniques used to measure fair value into three levels and requires that assets and liabilities carried
at fair value be classified and disclosed in one of three categories, as presented below. Disclosure as to transfers into and
out of Levels 1 and 2, and activity in Level 3 fair value measurements, is also required.
Level
1. Observable inputs such as quoted prices in active markets for an identical asset or liability that the Company has the ability
to access as of the measurement date. Financial assets and liabilities utilizing Level 1 inputs include active-exchange traded
securities and exchange-based derivatives.
Level
2. Inputs, other than quoted prices included within Level 1, which are directly observable for the asset or liability or indirectly
observable through corroboration with observable market data. Financial assets and liabilities utilizing Level 2 inputs include
fixed income securities, non-exchange based derivatives, mutual funds, and fair-value hedges.
Level
3. Unobservable inputs in which there is little or no market data for the asset or liability which requires the reporting entity
to develop its own assumptions. Financial assets and liabilities utilizing Level 3 inputs include infrequently-traded, non-exchange-based
derivatives and commingled investment funds, and are measured using present value pricing models.
The
Company determines the level in the fair value hierarchy within which each fair value measurement falls in its entirety, based
on the lowest level input that is significant to the fair value measurement in its entirety. In determining the appropriate levels,
the Company performs an analysis of the assets and liabilities at each reporting period end.
The
carrying amounts of financial instruments (consisting of cash, cash equivalents, advances on research grants and accounts payable
and accrued expenses) are considered by the Company to be representative of the respective fair values of these instruments
due to the short-term nature of those instruments. With respect to the note payable to SY Corporation and the convertible notes
payable, management does not believe that the credit markets have materially changed for these types of borrowings since the original
borrowing date. The Company considers the carrying amounts of the notes payable to officers, inclusive of accrued interest, to
be representative of the respective fair values of such instruments due to the short-term nature of those instruments and their
terms.
Deferred
Financing Costs
Costs
incurred in connection with ongoing debt and equity financings, including legal fees, are deferred until the related financing
is either completed or abandoned.
Costs
related to abandoned debt or equity financings are charged to operations in the period of abandonment. Costs related to completed
debt financings are presented as a direct deduction from the carrying amount of the related debt liability (see “Capitalized
Financing Costs” below). Costs related to completed equity financings are charged directly to additional paid-in capital.
Capitalized
Financing Costs
The
Company presents debt issuance costs related to a debt liability in its condensed consolidated balance sheet as a direct deduction
from the carrying amount of that debt liability, consistent with the presentation for debt discounts.
Convertible
Notes Payable
Original
Issuance of Notes and Warrants
The
convertible notes sold to investors in 2014 and 2015, which aggregated a total of $579,500, had a fixed interest rate of 10% per
annum and are convertible into common stock at a fixed price of $11.3750 per share. The convertible notes have no reset rights
or other protections based on subsequent equity transactions, equity-linked transactions or other events. The warrants to purchase
50,945 shares of common stock issued in connection with the sale of the convertible notes were exercisable at a fixed price of
$11.3750 per share, provided no right to receive a cash payment, and included no reset rights or other protections based on subsequent
equity transactions, equity-linked transactions or other events. The Company determined that there were no embedded derivatives
to be identified, bifurcated and valued in connection with this financing.
The
maturity date of the notes was extended to September 15, 2016 and included the issuance of 27,936 additional warrants to purchase
common stock, exercisable at $11.375 per share of common stock.
2018
Notes Exchange
On
February 28, 2018, the Company entered into an exchange agreement with a single holder of two convertible notes. The note holder
agreed to exchange an aggregate of $43,552 of principal and accrued interest for 58,071 shares of the Company’s common stock.
The closing price of the Company’s common stock on February 28, 2018 was $1.90 per share. As a result of the exchange, $43,552
of convertible notes, inclusive of accrued interest, were cancelled and $110,334 market value of common stock was issued,
resulting in a loss on extinguishment of debt of $66,782.
2
nd
2016 Unit Offering
On
December 29, 2016 and December 30, 2016, the Company sold units to investors for aggregate gross proceeds of $185,000, comprised
of one share of the Company’s common stock and one common stock purchase warrant to purchase one share of the Company’s
common stock (this 2
nd
2016 Unit Offering followed an earlier unit offering in 2016). Units were sold for $1.42
per unit and the warrants issued in connection with the units were exercisable through December 31, 2021 at a fixed price $1.562
per share of the Company’s common stock. The warrants contained a cashless exercise provision and certain blocker provisions
preventing exercise if the investor would beneficially own more than 4.99% of the Company’s outstanding shares of common
stock as a result of such exercise. The warrants were also subject to redemption by the Company at $0.001 per share upon ten (10)
days written notice if the Company’s common stock closed at 200% or more of the unit purchase price for any five
(5) consecutive trading days. The investors were not affiliates of the Company. Investors received an unlimited number of piggy-back
registration rights. The investors also received an unlimited number of exchange rights to exchange such investor’s entire
investment (and not less than the entire investment) into subsequent offerings of the Company until the earlier of: (i) the completion
of any number of subsequent financings aggregating at least $15 million gross proceeds to the Company, or (ii) December 30, 2017.
The dollar amount used to determine the amount invested or exchanged into the subsequent financing was 1.2 times the amount of
the original investment. Under certain circumstances, the ratio might have been 1.4 instead of 1.2. The Company evaluated whether
the warrants or the exchange rights met criteria to be accounted for as a derivative in accordance with Accounting Standard Codification
(ASC) 815 and determined that the derivative criteria were not met. Therefore, the Company determined no bifurcation and separate
valuation was necessary and that the warrants and exchange right should be accounted for with the host instrument. The Company
then looked to how the host instrument should be classified and determined that it could not, at that time, be classified as permanent
equity as there was a potential that the Unit investment amount could be exchanged for debt (convertible or otherwise) or for
redeemable preferred stock. Since the exchange right expired within one year, the Company concluded at that time that the
Unit investment would be appropriately classified as a current liability. The Unit investment has since been reclassified to
“permanent equity.” The closing market prices of the Company’s common stock on December 29, 2016 and December
30, 2016 were $2.85 and $2.80 respectively.
1
st
2017 Unit Offering
On
March 10, 2017 and March 28, 2017, the Company sold units to investors for aggregate gross proceeds of $350,000, with each unit
consisting of one share of the Company’s common stock and one common stock purchase warrant to purchase one share of the
Company’s common stock (the “1
st
2017 Unit Offering”). Units were sold for $2.50 per unit and the
warrants issued in connection with the units were exercisable through December 31, 2021 at a fixed price $2.75 per share
of the Company’s common stock. The warrants contained a cashless exercise provision and certain blocker provisions preventing
exercise if the investor would beneficially own more than 4.99% of the Company’s outstanding shares of common stock as a
result of such exercise. The warrants were also subject to redemption by the Company at $0.001 per share upon ten (10) days written
notice if the Company’s common stock closed at 200% or more of the unit purchase price for any five (5) consecutive
trading days. The investors were not affiliates of the Company. Investors received an unlimited number of piggy-back registration
rights. Investors also received an unlimited number of exchange rights, which were options and not obligations, to exchange such
investor’s entire investment (and not less than the entire investment) into one or more subsequent equity financings (consisting
solely of convertible preferred stock or common stock or units containing preferred stock or common stock and warrants exercisable
only into preferred stock or common stock) that would be considered as “permanent equity” under United States Generally
Accepted Accounting Principles and the rules and regulations of the United States Securities and Exchange Commission, and therefore
classified as stockholders’ equity, and excluding any form of debt or convertible debt (each such financing a “Subsequent
Equity Financing”). These exchange rights were effective until the earlier of: (i) the completion of any number of subsequent
financings aggregating at least $15 million gross proceeds to the Company, or (ii) December 30, 2017. The dollar amount used to
determine the amount invested or exchanged into the subsequent financing was 1.2 times the amount of the original investment.
Under certain circumstances, the ratio might have been 1.4 instead of 1.2. The exchange right did not permit the investors to
exchange into a debt offering or into redeemable preferred stock, therefore, the 1
st
2017 Unit Offering resulted
in the issuance of permanent equity. The Company evaluated whether the warrants or the exchange rights met criteria to be accounted
for as a derivative in accordance with Accounting Standard Codification Topic (ASC) 815 and determined that the derivative criteria
were not met. Therefore, the Company determined no bifurcation and separate valuation was necessary and that the warrants and
exchange right should be accounted for with the host instrument. The closing market prices of the Company’s common stock
on March 10, 2017 and March 28, 2017 were $4.05 and $3.80 respectively. In connection with this transaction, Aurora Capital LLC
(“Aurora”) served as a placement agent and earned $20,000 fees and 8,000 placement agent common stock warrants associated
with the closing of 1
st
2017 Unit Offering. The fees were unpaid as of March 31, 2018 and have been accrued
in accounts payable and accrued expenses and charged against Additional paid-in capital as of March 31, 2017, June 30, 2017, September
30, 2017, December 31, 2017 and March 31, 2018. The placement agent common stock warrants were valued at $27,648
and were accounted for in Additional paid-in capital as of March 31, 2017 and remain valued at that amount as of March 31, 2018.
For additional information see Note 6.
On
July 26, 2017, the Company’s Board approved an offering of securities conducted via private placement (the “2
nd
2017 Unit Offering” discussed below) that, because of the terms of the 2
nd
2017 Unit Offering as compared
to the terms of the 2
nd
2016 Unit offering and the 1
st
2017 Unit Offering, resulted in an exchange of all
of the units from the 2
nd
2016 Unit Offering and the 1
st
2017 Unit Offering into equity securities of the
Company in the 2
nd
2017 Unit Offering by all of the investors in the 2
nd
2016 Unit Offering and all of the
investors in the 1
st
2017 Unit Offering. Because all of the investors in the 2
nd
2016 Unit Offering exchanged
their units into the 2
nd
2017 Unit Offering the current non-permanent equity liability as of December 31, 2016 had
been reclassified in 2017 as permanent equity capital. Because the 1
st
2017 Unit Offering and the 2
nd
2017
Unit Offering were both originally accounted for as equity, a reclassification similar to the one effected with respect to the
2
nd
2016 Unit Offering was not required.
Extinguishment
of Debt
The
Company accounts for the extinguishment of debt in accordance with GAAP by comparing the carrying value of the debt to the fair
value of consideration paid or assets given up and recognizing a loss or gain in the condensed consolidated statement of operations
in the amount of the difference in the period in which such transaction occurs.
Equipment
Equipment
is recorded at cost and depreciated on a straight-line basis over their estimated useful lives, which range from three to five
years. All equipment was fully depreciated as of March 31, 2018.
Long-Term
Prepaid Insurance
Long-term
prepaid insurance represents the premium paid in March 2017 for directors’ and officers’ insurance tail coverage,
which is being amortized on a straight-line basis over the policy period of six years. The amount amortizable in the ensuing twelve-month
period is recorded as a current asset in the Company’s condensed consolidated balance sheet at each reporting date.
Impairment
of Long-Lived Assets
The
Company reviews its long-lived assets, including long-term prepaid insurance, for impairment whenever events or changes in circumstances
indicate that the total amount of an asset may not be recoverable, but at least annually. An impairment loss is recognized when
estimated future cash flows expected to result from the use of the asset and its eventual disposition is less than the asset’s
carrying amount. The Company has not deemed any long-lived assets as impaired at March 31, 2018.
Stock-Based
Compensation
The
Company periodically issues common stock and stock options to officers, directors, Scientific Advisory Board members and consultants
for services rendered. Such issuances vest and expire according to terms established at the issuance date of each grant.
The
Company accounts for stock-based payments to officers and directors by measuring the cost of services received in exchange for
equity awards based on the grant date fair value of the awards, with the cost recognized as compensation expense on the straight-line
basis in the Company’s financial statements over the vesting period of the awards. The Company accounts for stock-based
payments to Scientific Advisory Board members and consultants by determining the value of the stock compensation based upon the
measurement date at either (a) the date at which a performance commitment is reached, or (b) at the date at which the necessary
performance to earn the equity instruments is complete.
Stock
grants, which are generally subject to time-based vesting, are measured at the grant date fair value and charged to operations
ratably over the vesting period.
Stock
options granted to members of the Company’s Scientific Advisory Board and to outside consultants are revalued each reporting
period until vested to determine the amount to be recorded as an expense in the respective period. As the stock options vest,
they are valued on each vesting date and an adjustment is recorded for the difference between the value already recorded and the
value on the date of vesting.
The
fair value of stock options granted as stock-based compensation is determined utilizing the Black-Scholes option-pricing model,
and is affected by several variables, the most significant of which are the life of the equity award, the exercise price of the
stock option as compared to the fair market value of the common stock on the grant date, and the estimated volatility of the common
stock over the term of the equity award. Estimated volatility is based on the historical volatility of the Company’s common
stock. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant. The fair market value
of common stock is determined by reference to the quoted market price of the Company’s common stock.
Stock
options and warrants issued to non-employees as compensation for services to be provided to the Company or in settlement of debt
are accounted for based upon the fair value of the services provided or the estimated fair value of the stock option or warrant,
whichever can be more clearly determined. Management uses the Black-Scholes option-pricing model to determine the fair value of
the stock options and warrants issued by the Company. The Company recognizes this expense over the period in which the services
are provided.
For
stock options requiring an assessment of value during the three months ended March 31, 2018, the fair value of each stock option
award was estimated using the Black-Scholes option-pricing model using the following assumptions:
Risk-free
interest rate
|
|
|
2.56
|
%
|
Expected
dividend yield
|
|
|
0
|
%
|
Expected
volatility
|
|
|
185.41
|
%
|
Expected
life
|
|
|
4.7
|
|
For
stock options requiring an assessment of value during the three months ended March 31, 2017, the fair value of each stock
option award was estimated using the Black-Scholes option-pricing model using the following assumptions:
Risk-free
interest rate
|
|
|
1.75
|
%
|
Expected
dividend yield
|
|
|
0
|
%
|
Expected
volatility
|
|
|
145.00
|
%
|
Expected
life
|
|
|
3.6
to 5 years
|
|
The
Company recognizes the fair value of stock-based compensation in general and administrative costs and in research and development
costs, as appropriate, in the Company’s condensed consolidated statements of operations. The Company issues new shares of
common stock to satisfy stock option and warrant exercises. There were no stock options exercised during the three months ended
March 31, 2018 and 2017.
Income
Taxes
The
Company accounts for income taxes under an asset and liability approach for financial accounting and reporting for income taxes.
Accordingly, the Company recognizes deferred tax assets and liabilities for the expected impact of differences between the financial
statements and the tax basis of assets and liabilities.
The
Company records a valuation allowance to reduce its deferred tax assets to the amount that is more likely than not to be realized.
In the event the Company was to determine that it would be able to realize its deferred tax assets in the future in excess of
its recorded amount, an adjustment to the deferred tax assets would be credited to operations in the period such determination
was made. Likewise, should the Company determine that it would not be able to realize all or part of its deferred tax assets in
the future, an adjustment to the deferred tax assets would be charged to operations in the period such determination was made.
Pursuant
to Internal Revenue Code Sections 382 and 383, use of the Company’s net operating loss and credit carryforwards may be limited
if a cumulative change in ownership of more than 50% occurs within any three-year period since the last ownership change. The
Company may have had a change in control under these Sections. However, the Company does not anticipate performing a complete
analysis of the limitation on the annual use of the net operating loss and tax credit carryforwards until the time that it anticipates
it will be able to utilize these tax attributes.
As
of March 31, 2018, the Company did not have any unrecognized tax benefits related to various federal and state income tax matters
and does not anticipate any material amount of unrecognized tax benefits within the next 12 months.
The
Company is subject to U.S. federal income taxes and income taxes of various state tax jurisdictions. As the Company’s net
operating losses have yet to be utilized, all previous tax years remain open to examination by Federal authorities and other jurisdictions
in which the Company currently operates or has operated in the past.
The
Company accounts for uncertainties in income tax law under a comprehensive model for the financial statement recognition, measurement,
presentation and disclosure of uncertain tax positions taken or expected to be taken in income tax returns as prescribed by GAAP.
The tax effects of a position are recognized only if it is “more-likely-than-not” to be sustained by the taxing authority
as of the reporting date. If the tax position is not considered “more-likely-than-not” to be sustained, then no benefits
of the position are recognized. As of March 31, 2018, the Company had not recorded any liability for uncertain tax positions.
In subsequent periods, any interest and penalties related to uncertain tax positions will be recognized as a component of income
tax expense.
Foreign
Currency Transactions
The
note payable to SY Corporation, which is denominated in a foreign currency (the South Korean Won), is translated into the Company’s
functional currency (the United States Dollar) at the exchange rate on the balance sheet date. The foreign currency exchange gain
or loss resulting from translation is recognized in the related condensed consolidated statements of operations.
Research
and Development
Research
and development costs include compensation paid to management directing the Company’s research and development activities,
and fees paid to consultants and outside service providers and organizations (including research institutes at universities),
and other expenses relating to the acquisition, design, development and clinical testing of the Company’s treatments and
product candidates.
Research
and development costs incurred by the Company under research grants are expensed as incurred over the life of the underlying contracts,
unless the terms of the contract indicate that a different expensing schedule is more appropriate.
The
Company reviews the status of its research and development contracts on a quarterly basis.
On
May 6, 2016, the Company made an advance payment to Duke University with respect to the Phase 2A clinical trial of CX1739. At
March 31, 2018, an asset balance of $48,912 remained from the advance payment.
License
Agreements
Obligations
incurred with respect to mandatory payments provided for in license agreements are recognized ratably over the appropriate period,
as specified in the underlying license agreement, and are recorded as liabilities in the Company’s condensed consolidated
balance sheet, with a corresponding charge to research and development costs in the Company’s condensed consolidated statement
of operations. Obligations incurred with respect to milestone payments provided for in license agreements are recognized when
it is probable that such milestone will be reached and are recorded as liabilities in the Company’s condensed consolidated
balance sheet, with a corresponding charge to research and development costs in the Company’s condensed consolidated statement
of operations. Payments of such liabilities are made in the ordinary course of business.
Patent
Costs
Due
to the significant uncertainty associated with the successful development of one or more commercially viable products based on
the Company’s research efforts and any related patent applications, all patent costs, including patent-related legal and
filing fees, are expensed as incurred.
Earnings
per Share
The
Company’s computation of earnings per share (“EPS”) includes basic and diluted EPS. Basic EPS is measured as
the income (loss) attributable to common stockholders divided by the weighted average common shares outstanding for the period.
Diluted EPS is similar to basic EPS but presents the dilutive effect on a per share basis of potential common shares (e.g., warrants
and options) as if they had been converted at the beginning of the periods presented, or issuance date, if later. Potential common
shares that have an anti-dilutive effect (i.e., those that increase income per share or decrease loss per share) are excluded
from the calculation of diluted EPS.
Net
income (loss) attributable to common stockholders consists of net income or loss, as adjusted for actual and deemed preferred
stock dividends declared, amortized or accumulated.
Loss
per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during
the respective periods. Basic and diluted loss per common share is the same for all periods presented because all warrants and
stock options outstanding are anti-dilutive.
At
March 31, 2018 and 2017, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to
acquire shares of common stock, from its calculation of earnings per share, as their effect would have been anti-dilutive.
|
|
March
31,
|
|
|
|
2018
|
|
|
2017
|
|
Series
B convertible preferred stock
|
|
|
11
|
|
|
|
11
|
|
Convertible
notes payable
|
|
|
29,957
|
|
|
|
30,596
|
|
Common
stock warrants
|
|
|
1,464,415
|
|
|
|
688,198
|
|
Common
stock options
|
|
|
4,012,929
|
|
|
|
1,702,749
|
|
Total
|
|
|
5,507,312
|
|
|
|
2,421,554
|
|
Reclassifications
Certain
comparative figures in 2017 have been reclassified to conform to the current quarter’s presentation. These reclassifications
were immaterial, both individually and in the aggregate.
Recent
Accounting Pronouncements
Management
does not believe that any recently issued, but not yet effective, authoritative guidance, if currently adopted, would have a material
impact on the Company’s financial statement presentation or disclosures.
4.
Notes Payable
Convertible
Notes Payable
The
convertible notes sold to investors in 2014 and 2015, which aggregated a total of $579,500, had a fixed interest rate of 10% per
annum and those that remain outstanding are convertible into common stock at a fixed price of $11.3750 per share. The convertible
notes have no reset rights or other protections based on subsequent equity transactions, equity-linked transactions or other events.
The warrants to purchase 50,945 shares of common stock issued in connection with the sale of the convertible notes were exercisable
at a fixed price of $11.3750 per share, provided no right to receive a cash payment, and included no reset rights or other protections
based on subsequent equity transactions, equity-linked transactions or other events. All such warrants have either been exchanged
as part of April and May 2016 note and warrant exchange agreements or expired on September 15, 2016. The Company determined that
there were no embedded derivatives to be identified, bifurcated and valued in connection with this financing.
The
maturity date of the notes was extended to September 15, 2016 and included the issuance of 27,936 additional warrants to purchase
common stock, exercisable at $11.375 per share of common stock expiring on September 15, 2016.
The
Notes (including those for which default notices have been received) consist of the following at March 31, 2018
and December 31, 2017:
|
|
March
31, 2018
|
|
|
December
31, 2017
|
|
Principal
amount of notes payable
|
|
$
|
245,000
|
|
|
$
|
276,000
|
|
Add
accrued interest payable
|
|
|
95,737
|
|
|
|
98,646
|
|
|
|
$
|
340,737
|
|
|
$
|
374,646
|
|
Between
October 3, 2016 and October 25, 2016, the Company received several notices of default from holders of convertible notes. The effect
of such notices of default was to increase the annual interest rate from 10% to 12% with respect to the convertible notes to which
such notices applied. On February 28, 2018, two of such convertible notes were exchanged for common stock of the Company and were
extinguished. The Company measured the fair value of the shares of common stock issued to the holder in respect to the extinguishment
of the two convertible notes as compared to the aggregate of principal and interest on such notes and recorded a loss of 66,782
which is the amount of the excess fair value paid as compared to the aggregate principal and interest extinguished. The total
amount of principal and accrued interest that was due and payable was $43,552. The notes were exchanged for 58,071 shares of the
Company’s common stock. The effective exchange rate was $0.75 per share of the Company’s common stock. The closing
price of the Company’s common stock on February 28, 2018, was $1.90 as reported by the OTC Markets.
On
February 28, 2018, the Board of Directors authorized the offering of a similar exchange arrangement at the same effective exchange
rate of $0.75 per share of the Company’s common stock to all remaining holders of 10% Convertible Notes (some of which notes
are the subject of notices of default and therefore accruing annual interest at 12%); however, as of March 31, 2018, no other
holders of notes have elected to exchange their notes on such terms.
As
of March 31, 2018, principal and accrued interest on convertible notes subject to default notices totaled $49,807, of which
$14,807 was accrued interest. As of December 31, 2017, principal and accrued interest on convertible notes subject to default
notices totaled $91,028 of which $25,028 was accrued interest.
As
of March 31, 2018, the remaining outstanding convertible notes were convertible into 29,957 shares of the Company’s common
stock, including 6,700 shares attributable to accrued interest of $95,737 payable as of such date. As of December 31, 2017, the
Notes were convertible into 32,941 shares of the Company’s common stock, including 8,677 shares attributable to accrued
interest of $98,646 payable as of such date. Such notes will continue to accrue interest until exchanged, if exchanged. If such
notes are not exchanged, they will continue to accrue interest until either paid or otherwise discharged. There can be
no assurance that any of the additional holders of the remaining 10% Convertible Notes will exchange their notes.
Note
Payable to SY Corporation Co., Ltd.
On
June 25, 2012, the Company borrowed 465,000,000 Won (the currency of South Korea, equivalent to approximately $400,000 United
States Dollars) from and executed a secured note payable to SY Corporation Co., Ltd., formerly known as Samyang Optics Co. Ltd.
(“SY Corporation”), an approximately 20% common stockholder of the Company at that time. SY Corporation was a significant
stockholder and a related party at the time of the transaction but has not been a significant stockholder or related party of
the Company subsequent to December 31, 2014. The note accrues simple interest at the rate of 12% per annum and had a maturity
date of June 25, 2013. The Company has not made any payments on the promissory note. At June 30, 2013 and subsequently, the promissory
note was outstanding and in default, although SY Corporation has not issued a notice of default or a demand for repayment. Management
believes that SY Corporation is in default of its obligations under its January 2012 license agreement, as amended, with the
Company, but the Company has not yet issued a notice of default. The Company has in the past made several efforts towards
a comprehensive resolution of the aforementioned matters involving SY Corporation. During the three months ended March 31,
2018, there were no further communications between the Company and SY Corporation.
The
promissory note is secured by collateral that represents a lien on certain patents owned by the Company, including composition
of matter patents for certain of the Company’s high impact ampakine compounds and the low impact ampakine compounds CX2007
and CX2076, and other related compounds. The security interest does not extend to the Company’s patents for its ampakine
compounds CX1739 and CX1942, or to the patent for the use of ampakine compounds for the treatment of respiratory depression.
Note
payable to SY Corporation consists of the following at March 31, 2018 and December 31, 2017:
|
|
March
31, 2018
|
|
|
December
31, 2017
|
|
Principal
amount of note payable
|
|
$
|
399,774
|
|
|
$
|
399,774
|
|
Accrued
interest payable
|
|
|
279,164
|
|
|
|
267,335
|
|
Foreign
currency transaction adjustment
|
|
|
63,164
|
|
|
|
(83,282
|
)
|
|
|
$
|
742,102
|
|
|
$
|
583,827
|
|
Interest
expense with respect to this promissory note was $11,829 and $11,829 for three months ended March 31, 2018 and 2017, respectively.
Advances
and Notes Payable to Officers
On
January 29, 2016, Dr. Arnold S. Lippa, the Company’s Chief Scientific Officer and Chairman of the Board of Directors, advanced
$52,600 to the Company for working capital purposes under a demand promissory note with interest at 10% per annum. On September
23, 2016, Dr. Lippa advanced $25,000 to the Company for working capital purposes under a second demand promissory note with interest
at 10% per annum. The notes are secured by the assets of the Company. During the three months ended March 31, 2018 and 2017,
$2,808 and $1,913 was charged to interest expense with respect to the notes, respectively. In connection with
the loan, Dr. Lippa was issued fully vested warrants to purchase 15,464 shares of the Company’s common stock, 10,309 of
which have an exercise price of $5.1025 per share and 5,155 of which have an exercise price of $4.85 which were the closing prices
of the Company’s common stock on the respective dates of grant. The warrants expire on January 29, 2019 and September 23,
2019 respectively and may be exercised on a cashless basis.
On
February 2, 2016, Dr. James S. Manuso, the Company’s Chief Executive Officer and Vice Chairman of the Board of Directors,
advanced $52,600 to the Company for working capital purposes under a demand promissory note with interest at 10% per annum. On
September 22, 2016, Dr. Manuso, advanced $25,000 to the Company for working capital purposes under a demand promissory note with
interest at 10% per annum. The notes are secured by the assets of the Company. During the three months ended March 31, 2018
and 2017, $2,802 and $1,913 was charged to interest expense with respect to the notes, respectively. In connection
with the loan, Dr. Manuso was issued fully vested warrants to purchase 13,092 shares of the Company’s common stock, 8,092
of which have an exercise price of $6.5000 per share and 5,000 of which have an exercise price of $5.00, which were the closing
market prices of the Company’s common stock on the respective dates of grant. The warrants expire on February 2, 2019 and
September 22, 2019, respectively, and may be exercised on a cashless basis.
Other
Short-Term Notes Payable
Other
short-term notes payable at March 31, 2018 and December 31, 2017 consisted of premium financing agreements with respect to various
insurance policies. At March 31, 2018, a premium financing agreement was payable in the amount of $63,750, with interest at 8.930%
per annum, in ten monthly installments of $6,639. In addition, there was a remaining amount $356 of a short term note payable
with respect to an expiring policy. At March 31, 2018, the aggregate amount of the short-term notes payable
was $64,016.
5.
Settlement and Payment Agreements
On
December 9, 2017, the Company accepted offers from certain executive officers, a former executive officer, the independent members
of the Board of Directors and two consultants (“Offerees”) pursuant to which such Offerees offered to forgive all,
or in one case, a portion of their accrued compensation and compensation related amounts owed to them and vendor accounts payable
as of September 30, 2017. Also, on December 9, 2017, the Company granted non-qualified stock options (“NQSOs”) to
the Offerees. The NQSOs immediately vested, have a term of 10 years and have an exercise price of $1.45 per share, which was the
closing price on the last trading day before the grant date (Friday, December 8, 2017). The NQSOs were valued using the Black-Scholes
option pricing model utilizing the following assumptions: (i) stock price $1.45, (ii) exercise price $1.45, (iii) estimated term
5 years (utilizing the simple method to determine estimated option life when option terms exceed 5 years, which method
is to sum the vesting period (in this case 0) and the term (in this case 10 years) and divide by 2), (iv) estimated volatility
of 184.92%, (v) risk free rate 1.62% and (vi) dividend yield 0%. The resulting value was $1.396 per NQSO.
The
table below summarizes the result of the forgiveness and NQSO grant transactions:
|
|
Dollar
amount
forgiven
|
|
|
Number
of
NQSOs granted
|
|
|
Value
of
NQSOs granted
|
|
|
Gain
|
|
Executive
Officers, former executive officer, independent members of the Board of Directors
|
|
$
|
2,557,083
|
|
|
|
1,772,056
|
|
|
$
|
2,475,561
|
|
|
$
|
81,522
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consultants
|
|
$
|
111,635
|
|
|
|
77,362
|
|
|
$
|
108,076
|
|
|
$
|
3,559
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
2,668,718
|
|
|
|
1,849,418
|
|
|
$
|
2,583,637
|
|
|
$
|
85,081
|
|
6.
Stockholders’ Deficiency
Preferred
Stock
The
Company has authorized a total of 5,000,000 shares of preferred stock, par value $0.001 per share. As of March 31, 2018 and December
31, 2017, 1,250,000 shares were designated as 9% Cumulative Convertible Preferred Stock (non-voting, “9% Preferred Stock”);
37,500 shares were designated as Series B Convertible Preferred Stock (non-voting, “Series B Preferred Stock”); 205,000
shares were designated as Series A Junior Participating Preferred Stock (non-voting, “Series A Junior Participating Preferred
Stock”); and 1,700 shares were designated as Series G 1.5% Convertible Preferred Stock. Accordingly, as of March 31, 2018
and December 31, 2017, 3,505,800 shares of preferred stock were undesignated and may be issued with such rights and powers as
the Board of Directors may designate.
There
were no shares of 9% Preferred Stock, Series A Junior Participating Preferred Stock, or Series G 1.5% Convertible Preferred Stock
outstanding as of March 31, 2018 and December 31, 2017.
Series
B Preferred Stock outstanding as of March 31, 2018 and December 31, 2017 consisted of 37,500 shares issued in a May 1991 private
placement. Each share of Series B Preferred Stock is convertible into approximately 0.00030 shares of common stock at an effective
conversion price of $2,208.375 per share of common stock, which is subject to adjustment under certain circumstances.
As of March 31, 2018 and December 31, 2017, the shares of Series B Preferred Stock outstanding are convertible into 11 shares
of common stock. The Company may redeem the Series B Preferred Stock for $25,001, equivalent to $0.6667 per share of Series B
Preferred Stock, an amount equal to its liquidation preference, at any time upon 30 days prior notice.
Common
Stock
Company
has 70,000,000 authorized shares of stock, consisting of 65,000,000 shares designated as common stock, par value $0.001 per share,
and 5,000,000 shares designated as preferred stock, par value $0.001 per share.
1
st
2017 Unit Offering
On
March 10, 2017 and March 28, 2017, the Company sold units to investors for aggregate gross proceeds of $350,000, with each unit
consisting of one share of the Company’s common stock and one common stock purchase warrant to purchase one share of the
Company’s common stock (the “1
st
2017 Unit Offering”). Units were sold for $2.50 per unit and the
warrants issued in connection with the units were exercisable through December 31, 2021 at a fixed price $2.75 per share
of the Company’s common stock. The warrants contained a cashless exercise provision and certain blocker provisions preventing
exercise if the investor would beneficially own more than 4.99% of the Company’s outstanding shares of common stock as a
result of such exercise. The warrants were also subject to redemption by the Company at $0.001 per share upon ten (10) days written
notice if the Company’s common stock closed at 200% or more of the unit purchase price for any five (5) consecutive trading
days. Investors were not affiliates of the Company. The investors received an unlimited number of piggy-back registration rights.
Investors also received an unlimited number of exchange rights, which were options and not obligations, to exchange such investor’s
entire investment (and not less than the entire investment) into one or more subsequent equity financings (consisting solely of
convertible preferred stock or common stock or units containing preferred stock or common stock and warrants exercisable only
into preferred stock or common stock) that would be considered as “permanent equity” under United States Generally
Accepted Accounting Principles and the rules and regulations of the United States Securities and Exchange Commission, and therefore
classified as stockholders’ equity, and excluding any form of debt or convertible debt (each such financing a “Subsequent
Equity Financing”). These exchange rights were effective until the earlier of: (i) the completion of any number of subsequent
financings aggregating at least $15 million gross proceeds to the Company, or (ii) December 30, 2017. The dollar amount used to
determine the amount invested or exchanged into the subsequent financing would be 1.2 times the amount of the original investment.
Under certain circumstances, the ratio might have been 1.4 instead of 1.2. The exchange right did not permit the investors to
exchange into a debt offering or into redeemable preferred stock, therefore, unlike the 2
nd
2016 Unit Offering, the
2017 Unit Offering resulted in the issuance of permanent equity. The Company evaluated whether the warrants or the exchange rights
met criteria to be accounted for as a derivative in accordance with Accounting Standard Codification Topic (ASC) 815 and determined
that the derivative criteria were not met. Therefore, the Company determined no bifurcation and separate valuation was necessary
and that the warrants and exchange right should be accounted for with the host instrument. The closing market prices of the Company’s
common stock on March 10, 2017 and March 28, 2017 were $4.05 and $3.80 respectively. In connection with this transaction, Aurora
Capital LLC (“Aurora”) served as a placement agent and earned $20,000 fees and 8,000 placement agent common stock
warrants associated with the closing of 1
st
2017 Unit Offering. The fees were unpaid as of March 31, 2018 and
have been accrued in accounts payable and accrued expenses and charged against Additional paid-in capital as of March 31, 2017,
June 30, 2017, September 30, 2017, December 31, 2017 and March 31, 2018. The placement agent common stock warrants
were valued at $27,648 and were accounted for in Additional paid-in capital as of March 31, 2017 and remain valued at that amount
as of March 31, 2018.
On
July 26, 2017, the Company’s Board approved an offering of securities conducted via private placement (the “2
nd
2017 Unit Offering” described below) that, because of the terms of the 2
nd
2017 Unit Offering as compared
to the terms of the 2
nd
2016 Unit offering and the 1
st
2017 Unit Offering, resulted in an exchange of all
of the units from the 2
nd
2016 Unit Offering and the 1
st
2017 Unit Offering into equity securities of the
Company in the 2
nd
2017 Unit Offering by all of the investors in the 2
nd
2016 Unit Offering and all of the
investors in the 1
st
2017 Unit Offering. Because all of the investors in the 2
nd
2016 Unit Offering exchanged
their units into the 2
nd
2017 Unit Offering the current non-permanent equity liability as of December 31, 2016 has
been reclassified in 2017 as permanent equity capital. Because the 1
st
2017 Unit Offering and the 2
nd
2017
Unit Offering were both originally accounted for as equity, no reclassification was required.
2
nd
2017 Unit Offering
On
August 29, 2017, September 27, 2017, September 28, 2017, October 5, 2017, October 25, 2017, November 29, 2017, December 13, 2017,
December 21, 2017, December 22, 2017 and December 29, 2017 the Company sold units in the 2
nd
2017 Unit Offering to
investors for aggregate gross proceeds of $404,500, with each unit consisting of one share of the Company’s common stock
and one common stock purchase warrant to purchase one share of the Company’s common stock. Units were sold for $1.00 per
unit and the warrants issued in connection with the units are exercisable through September 29, 2022 at a fixed price $1.10 per
share of the Company’s common stock. The warrants contain a cashless exercise provision and certain blocker provisions preventing
exercise if the investor would beneficially own more than 4.99% of the Company’s outstanding shares of common stock as a
result of such exercise. The warrants are also subject to redemption by the Company at $0.001 per share upon ten (10) days written
notice if the Company’s common stock closes at 250% or more of the unit purchase price for any five (5) consecutive trading
days. The investors were not affiliates of the Company. Investors received an unlimited number of piggy-back registration rights.
Investors also received an unlimited number of exchange rights, which were options and not obligations, to exchange such
investor’s entire investment (and not less than the entire investment) into one or more subsequent equity financings (consisting
solely of convertible preferred stock or common stock or units containing preferred stock or common stock and warrants exercisable
only into preferred stock or common stock) that would be considered as “permanent equity” under United States Generally
Accepted Accounting Principles and the rules and regulations of the United States Securities and Exchange Commission, and therefore
classified as stockholders’ equity, and excluding any form of debt or convertible debt (each such financing a “Subsequent
Equity Financing” as in the 1
st
2017 Unit Offering). These exchange rights were effective until the earlier
of: (i) the completion of any number of subsequent financings aggregating at least $15 million gross proceeds to the Company,
or (ii) December 30, 2017 and have therefore expired. The dollar amount used to determine the amount invested or exchanged into
the subsequent financing would have been 1.2 times the amount of the original investment. Under certain circumstances, the ratio
might have been 1.4 instead of 1.2. The exchange right did not permit the investors to exchange into a debt offering or into redeemable
preferred stock, therefore, unlike the 2
nd
2016 Unit Offering, the 2
nd
2017 Unit Offering resulted in the
issuance of permanent equity. All exchange rights have expired as of December 30, 2017. The Company evaluated whether the warrants
or the exchange rights met criteria to be accounted for as a derivative in accordance with Accounting Standard Codification Topic
(ASC) 815 and determined that the derivative criteria were not met. Therefore, the Company determined no bifurcation and separate
valuation was necessary and that the warrants and exchange right should be accounted for with the host instrument. The closing
market prices of the Company’s common stock on August 29, 2017, September 27, 2017, September 28, 2017, October 5, 2017,
October 25, 2017, November 29, 2017, December 13, 2017, December 21, 2017, December 22, 2017 and December 29, 2017 were $1.00,
$1.40, $1.40, $1.50, $0.80, $1.05, $1.45, $1.51, $1.45 and $1.14, respectively. There was no placement agent and therefore no
fees associated with the 2
nd
2017 Unit Offering.
The
terms of the 2
nd
2017 Unit Offering, as compared to the terms of the 2
nd
2016 Unit Offering and the 1
st
2017 Unit Offering, resulted in an exchange of all of the units from each of the 2
nd
2016 Unit Offering and the
1
st
2017 Unit Offering into equity securities of the 2
nd
2017 Unit Offering. The 1
st
2017
Unit Offering and the 2
nd
2017 Unit Offering were both originally accounted for as equity.
Common
Stock Warrants
Information
with respect to the issuance and exercise of common stock purchase warrants in connection with the Convertible Note Payable and
Warrant Purchase Agreement, and Notes Payable to Officers, is provided at Note 4.
A
summary of warrant activity for the three months ended March 31, 2018 is presented below.
|
|
Number
of
Shares
|
|
|
Weighted
Average
Exercise Price
|
|
|
Weighted
Average
Remaining
Contractual
Life (in Years)
|
|
Warrants
outstanding at December 31, 2017
|
|
|
1,464,415
|
|
|
$
|
2.68146
|
|
|
|
|
|
Issued
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
Warrants
outstanding at March 31, 2018
|
|
|
1,464,415
|
|
|
$
|
2.68146
|
|
|
|
4.59
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants
exercisable at December 31, 2017
|
|
|
1,464,415
|
|
|
$
|
2,68146
|
|
|
|
4.88
|
|
Warrants
exercisable at March 31, 2018
|
|
|
1,464,415
|
|
|
$
|
2.68146
|
|
|
|
4.59
|
|
The
exercise prices of common stock warrants outstanding and exercisable are as follows at March 31, 2018:
Exercise
Price
|
|
|
Warrants
Outstanding
(Shares)
|
|
|
Warrants
Exercisable
(Shares)
|
|
|
Expiration
Date
|
$
|
1.0000
|
|
|
|
916,217
|
|
|
|
916,217
|
|
|
September
20, 2022
|
$
|
1.2870
|
|
|
|
41,002
|
|
|
|
41,002
|
|
|
April
17, 2019
|
$
|
1.5620
|
|
|
|
130,284
|
|
|
|
130,284
|
|
|
December
31, 2021
|
$
|
2.7500
|
|
|
|
8,000
|
|
|
|
8000
|
|
|
September
20, 2022
|
$
|
4.8500
|
|
|
|
5,155
|
|
|
|
5,155
|
|
|
September
23, 2019
|
$
|
4.8750
|
|
|
|
108,594
|
|
|
|
108,594
|
|
|
September
30, 2020
|
$
|
5.0000
|
|
|
|
5,000
|
|
|
|
5,000
|
|
|
September
22, 2019
|
$
|
5.1025
|
|
|
|
10,309
|
|
|
|
10,309
|
|
|
January
29, 2019
|
$
|
6.5000
|
|
|
|
8,092
|
|
|
|
8,092
|
|
|
February
4, 2019
|
$
|
6.8348
|
|
|
|
145,758
|
|
|
|
145,758
|
|
|
September
30, 2020
|
$
|
7.9300
|
|
|
|
86,004
|
|
|
|
86,004
|
|
|
February
28, 2021
|
|
|
|
|
|
1,464,415
|
|
|
|
1,464,415
|
|
|
|
Based
on a fair market value of $1.3100 per share on March 31, 2018, the intrinsic value of exercisable in-the-money common stock warrants
was $284,970 as of March 31, 2018.
A
summary of warrant activity for the three months ended March 31, 2017 is presented below.
|
|
Number
of
Shares
|
|
|
Weighted
Average Exercise Price
|
|
|
Weighted
Average Remaining
Contractual Life
(in Years)
|
|
Warrants
outstanding at December 31, 2016
|
|
|
540,198
|
|
|
$
|
4.84842
|
|
|
|
|
|
Issued
|
|
|
148,000
|
|
|
|
2.75000
|
|
|
|
|
|
Warrants
outstanding at March 31, 2017
|
|
|
688,198
|
|
|
$
|
4.39715
|
|
|
|
4.11
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants
exercisable at December 31, 2016
|
|
|
540,198
|
|
|
$
|
4.84842
|
|
|
|
3.93
|
|
Warrants
exercisable at March 31, 2017
|
|
|
688,198
|
|
|
$
|
4.39715
|
|
|
|
4.11
|
|
Based
on a fair market value of $3.8000 per share on March 31, 2017, the intrinsic value of exercisable in-the-money common stock warrants
was $550,014 as of March 31, 2017.
Stock
Options
On
March 18, 2014, the stockholders of the Company holding a majority of the votes to be cast on the issue approved the adoption
of the Company’s 2014 Equity, Equity-Linked and Equity Derivative Incentive Plan (the “2014 Plan”), which had
been previously adopted by the Board of Directors of the Company, subject to stockholder approval. The Plan permits the grant
of options and restricted stock with respect to up to 325,025 shares of common stock, in addition to stock appreciation rights
and phantom stock, to directors, officers, employees, consultants and other service providers of the Company.
On
June 30, 2015, the Board of Directors adopted the 2015 Stock and Stock Option Plan (the “2015 Plan”). The 2015 Plan
initially provided for, among other things, the issuance of either or any combination of restricted shares of common stock and
non-qualified stock options to purchase up to 461,538 shares of the Company’s common stock for periods up to ten years to
management, members of the Board of Directors, consultants and advisors. The Company has not and does not intend to present the
2015 Plan to stockholders for approval. On August 18, 2015, the Board of Directors increased the number of shares that may be
issued under the 2015 Plan to 769,231 shares of the Company’s common stock. On March 31, 2016, the Board of Directors further
increased the number of shares that may be issued under the 2015 Plan to 1,538,461 shares of the Company’s common stock.
On January 17, 2017, the Board of Directors further increased the number of shares that may be issued under the 2015 Plan to 3,038,461
shares of the Company’s common stock. On December 9, 2017, the Board of Directors further increased the number of shares
that may be issued under the 2015 Plan to 6,985,260 shares of the Company’s common stock.
Information
with respect to the Black-Scholes variables used in connection with the evaluation of the fair value of stock-based compensation
is provided at Note 3.
A
summary of stock option activity for the three months ended March 31, 2018 is presented below.
|
|
Number
of
Shares
|
|
|
Weighted
Average
Exercise
Price
|
|
|
Weighted
Average
Remaining
Contractual
Life (in Years)
|
|
Options
outstanding at December 31, 2017
|
|
|
3,996,167
|
|
|
$
|
3.7868
|
|
|
|
|
|
Granted
|
|
|
16,762
|
|
|
|
1.2500
|
|
|
|
|
|
Expired
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
Forfeited
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
Options
outstanding at March 31, 2018
|
|
|
4,012,929
|
|
|
$
|
3.7762
|
|
|
|
6.79
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
exercisable at December 31, 2017
|
|
|
3,996,167
|
|
|
$
|
3.7868
|
|
|
|
|
|
Options
exercisable at March 31, 2018
|
|
|
4,007,691
|
|
|
$
|
3.7795
|
|
|
|
6.80
|
|
There
was no deferred compensation expense for the outstanding and unvested stock options at March 31, 2018.
The
exercise prices of common stock options outstanding and exercisable were as follows at March 31, 2018:
Exercise
Price
|
|
|
Options
Outstanding
(Shares)
|
|
|
Options
Exercisable
(Shares)
|
|
|
Expiration
Date
|
$
|
1.2500
|
|
|
|
16,762
|
|
|
|
11,524
|
|
|
December
7, 2022
|
$
|
1.3500
|
|
|
|
34,000
|
|
|
|
34,000
|
|
|
July
28, 2022
|
$
|
1.4500
|
|
|
|
1,849,418
|
|
|
|
1,849,418
|
|
|
December
9, 2027
|
$
|
1.4500
|
|
|
|
100,000
|
|
|
|
100,000
|
|
|
December
9, 2027
|
$
|
2.0000
|
|
|
|
285,000
|
|
|
|
285,000
|
|
|
June
30, 2022
|
$
|
2.0000
|
|
|
|
25,000
|
|
|
|
25,000
|
|
|
July
26, 2022
|
$
|
3.9000
|
|
|
|
395,000
|
|
|
|
395,000
|
|
|
January
17, 2022
|
$
|
4.5000
|
|
|
|
7,222
|
|
|
|
7,222
|
|
|
September
2, 2021
|
$
|
5.6875
|
|
|
|
89,686
|
|
|
|
89,686
|
|
|
June
30, 2020
|
$
|
5.7500
|
|
|
|
2,608
|
|
|
|
2,608
|
|
|
September
12, 2021
|
$
|
6.4025
|
|
|
|
27,692
|
|
|
|
27,692
|
|
|
August
18, 2020
|
$
|
6.4025
|
|
|
|
129,231
|
|
|
|
129,231
|
|
|
August
18, 2022
|
$
|
6.4025
|
|
|
|
261,789
|
|
|
|
261,789
|
|
|
August
18, 2025
|
$
|
6.8250
|
|
|
|
8,791
|
|
|
|
8,791
|
|
|
December
11, 2020
|
$
|
7.3775
|
|
|
|
523,077
|
|
|
|
523,077
|
|
|
March
31, 2021
|
$
|
8.1250
|
|
|
|
169,231
|
|
|
|
169,231
|
|
|
June
30, 2022
|
$
|
13.0000
|
|
|
|
7,385
|
|
|
|
7,385
|
|
|
March
13, 2019
|
$
|
13.0000
|
|
|
|
3,846
|
|
|
|
3,846
|
|
|
April
14, 2019
|
$
|
13.9750
|
|
|
|
3,385
|
|
|
|
3,385
|
|
|
March
14, 2024
|
$
|
15.4700
|
|
|
|
7,755
|
|
|
|
7,755
|
|
|
April
8, 2020
|
$
|
15.9250
|
|
|
|
2,462
|
|
|
|
2,462
|
|
|
February
28, 2024
|
$
|
16.0500
|
|
|
|
46,154
|
|
|
|
46,154
|
|
|
July
17, 2019
|
$
|
16.6400
|
|
|
|
1,538
|
|
|
|
1,538
|
|
|
January
29, 2020
|
$
|
19.5000
|
|
|
|
9,487
|
|
|
|
9,487
|
|
|
July
17, 2022
|
$
|
19.5000
|
|
|
|
6,410
|
|
|
|
6,410
|
|
|
August
10, 2022
|
|
|
|
|
|
4,012,929
|
|
|
|
4,007,691
|
|
|
|
Based
on a fair market value of $1.3100 per share on March 31, 2018, the intrinsic value of exercisable in-the-money options was $691
as of March 31, 2018.
A
summary of stock option activity for the three months ended March 31, 2017 is presented below.
|
|
Number
of
Shares
|
|
|
Weighted
Average
Exercise
Price
|
|
|
Weighted
Average Remaining Contractual Life
(in Years)
|
|
Options
outstanding at December 31, 2016
|
|
|
1,307,749
|
|
|
$
|
7.6515
|
|
|
|
|
|
Granted
|
|
|
395,000
|
|
|
|
3.9000
|
|
|
|
|
|
Expired
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
Forfeited
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
Options
outstanding at March 31, 2017
|
|
|
1,702,749
|
|
|
$
|
6.7812
|
|
|
|
5.23
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
exercisable at March 31, 2017
|
|
|
1,505,249
|
|
|
$
|
7.1593
|
|
|
|
5.27
|
|
Options
exercisable at December 31, 2016
|
|
|
1,307,749
|
|
|
$
|
7.6515
|
|
|
|
|
|
The
exercise prices of common stock options outstanding and exercisable were as follows at March 31, 2017:
Exercise
Price
|
|
|
Options
Outstanding (Shares)
|
|
|
Options
Exercisable (Shares)
|
|
|
Expiration
Date
|
$
|
3.9000
|
|
|
|
395,000
|
|
|
|
197,500
|
|
|
January
17, 2022
|
$
|
4.5000
|
|
|
|
7,222
|
|
|
|
7,222
|
|
|
September
2, 2021
|
$
|
5.6875
|
|
|
|
89,686
|
|
|
|
89,686
|
|
|
June
30, 2020
|
$
|
5.7500
|
|
|
|
2,608
|
|
|
|
2,608
|
|
|
September
12, 2021
|
$
|
6.4025
|
|
|
|
27,692
|
|
|
|
27,692
|
|
|
August
18, 2020
|
$
|
6.4025
|
|
|
|
129,231
|
|
|
|
129,231
|
|
|
August
18, 2022
|
$
|
6.4025
|
|
|
|
261,789
|
|
|
|
261,789
|
|
|
August
18, 2025
|
$
|
6.8250
|
|
|
|
8,791
|
|
|
|
8,791
|
|
|
December
11, 2020
|
$
|
7.3775
|
|
|
|
523,077
|
|
|
|
523,077
|
|
|
March
31, 2021
|
$
|
8.1250
|
|
|
|
169,231
|
|
|
|
169,231
|
|
|
June
30, 2022
|
$
|
13.0000
|
|
|
|
7,385
|
|
|
|
7,385
|
|
|
March
13, 2019
|
$
|
13.0000
|
|
|
|
3,846
|
|
|
|
3,846
|
|
|
April
14, 2019
|
$
|
13.9750
|
|
|
|
3,385
|
|
|
|
3,385
|
|
|
March
14, 2024
|
$
|
15.4700
|
|
|
|
7,755
|
|
|
|
7,755
|
|
|
April
8, 2020
|
$
|
15.9250
|
|
|
|
2,462
|
|
|
|
2,462
|
|
|
February
28, 2024
|
$
|
16.2500
|
|
|
|
46,154
|
|
|
|
46,154
|
|
|
July
17, 2019
|
$
|
16.6400
|
|
|
|
1,538
|
|
|
|
1,538
|
|
|
January
29, 2020
|
$
|
19.5000
|
|
|
|
9,487
|
|
|
|
9,487
|
|
|
July
17, 2022
|
$
|
19.500
|
|
|
|
6,410
|
|
|
|
6,410
|
|
|
August
10, 2022
|
|
|
|
|
|
1,702,749
|
|
|
|
1,505,249
|
|
|
|
Based
on a fair market value of $3.8000 per share on March 31, 2017, the intrinsic value of exercisable in-the-money common stock options
was $0 as of March 31, 2017.
For
the three months ended March 31, 2018 and 2017, stock-based compensation costs included in the condensed consolidated statements
of operations consisted of general and administrative expenses of $0 and $494,904, respectively, and research and development
expenses of $0 and $226,138, respectively.
Pier
Contingent Stock Consideration
In
connection with the merger transaction with Pier effective August 10, 2012, RespireRx issued 179,747 newly issued shares of its
common stock with an aggregate fair value of $3,271,402 ($18.2000 per share), based upon the closing price of RespireRx’s
common stock on August 10, 2012. The shares of common stock were distributed to stockholders, convertible note holders, warrant
holders, option holders, and certain employees and vendors of Pier in satisfaction of their interests and claims. The common stock
issued by RespireRx represented approximately 41% of the 443,205 common shares outstanding immediately following the closing of
the transaction.
Pursuant
to the terms of the transaction, RespireRx agreed to issue additional contingent consideration, consisting of up to 56,351 shares
of common stock, to Pier’s former security holders and certain other creditors and service providers (the “Pier Stock
Recipients”) that received RespireRx’s common stock as part of the Pier transaction if certain of RespireRx’s
stock options and warrants outstanding immediately prior to the closing of the merger were subsequently exercised. In the event
that such contingent shares were issued, the ownership percentage of the Pier Stock Recipients, following their receipt of such
additional shares, could not exceed their ownership percentage as of the initial transaction date.
The
stock options and warrants outstanding at June 30, 2012 were all out-of-the-money on August 10, 2012. During late July and early
August 2012, shortly before completion of the merger, the Company issued options to officers and directors at that time to purchase
a total of 22,651 shares of common stock exercisable for ten years at $19.5000 per share. By October 1, 2012, these options, as
well as the options and warrants outstanding at June 30, 2012, were also out-of-the-money and continued to be out-of-the-money
through March 31, 2018.
There
were no stock options or warrants exercised subsequent to August 10, 2012 that triggered additional contingent consideration,
and the only remaining stock options outstanding that could still trigger the additional contingent consideration remained out-of-the-money
through March 31, 2018. As of March 31, 2018, due to the expirations and forfeitures of RespireRx stock options and warrants occurring
since August 10, 2012, 6,497 contingent shares of common stock remained issuable under the Pier merger agreement.
The
Company concluded that the issuance of any of the contingent shares to the Pier Stock Recipients was remote, as a result of the
large spread between the exercise prices of these stock options and warrants as compared to the common stock trading range, the
subsequent expiration or forfeiture of most of the options and warrants, the Company’s distressed financial condition and
capital requirements, and that these stock options and warrants have remained significantly out-of-the-money through March 31,
2018. Accordingly, the Company considered the fair value of the contingent consideration to be immaterial and therefore did not
ascribe any value to such contingent consideration. If any such shares are ultimately issued to the former Pier stockholders,
the Company will recognize the fair value of such shares as a charge to operations at that time.
Reserved
and Unreserved Shares of Common Stock
On
January 17, 2017, the Board of Directors of the Company approved the adoption of the Amendment of the Amended and Restated RespireRx
Pharmaceuticals, Inc. 2015 Stock and Stock Option Plan (the “2015 Plan”). The Amendment increases the shares issuable
under the plan by 1,500,000, from 1,538,461 to 3,038,461. On December 9, 2017, the Board of Directors further increased the number
of shares that may be issued under the 2015 Plan to 6,985,260 shares of the Company’s common stock.
Other
than the change in the number of shares available under the 2015 Plan, no other changes were made to the 2015 Plan by the Amendment.
At
March 31, 2018, the Company had 65,000,000 shares of common stock authorized and 3,123,332 shares of common stock issued and outstanding.
Furthermore, as of March 31, 2018, the Company had reserved an aggregate of 11 shares for issuance upon conversion of the Series
B Preferred Stock; 1,464,415 shares for issuance upon exercise of warrants; 4,012,929 shares for issuance upon exercise of outstanding
stock options; 63,236 shares to cover equity grants available for future issuance pursuant to the 2014 Plan; 3,043,050 shares
to cover equity grants available for future issuance pursuant to the 2015 Plan; 29,823 shares for issuance upon conversion of
the Convertible Notes; and 6,497 shares issuable as contingent shares pursuant to the Pier merger. Accordingly, as of March 31,
2018, the Company had an aggregate of 8,620,000 shares of common stock reserved for issuance and 53,256,668 shares of common stock
unreserved and available for future issuance. The Company expects to satisfy its future common stock commitments through the issuance
of authorized but unissued shares of common stock.
7.
Related Party Transactions
Dr.
Arnold S. Lippa and Jeff E. Margolis, officers and directors of the Company since March 22, 2013, have indirect ownership interests
and managing memberships in Aurora Capital LLC (“Aurora”) through interests held in its members, and Jeff. E. Margolis
is also an officer of Aurora. Aurora is a boutique investment banking firm specializing in the life sciences sector that is also
a full service brokerage firm.
On
March 31, 2013, the Company accrued $85,000 as reimbursement for legal fees incurred by Aurora in conjunction with the removal
of the Company’s prior Board of Directors on March 22, 2013, which amount has been included in accounts payable and accrued
expenses at March 31, 2018 and December 31, 2017.
On
June 30, 2015, the Board of Directors of the Company awarded, but did not pay, cash bonuses totaling $215,000, including an aggregate
of $195,000 to certain of the Company’s executive officers and an aggregate of $20,000 to the independent members of the
Company’s Board of Directors. The cash bonuses awarded to executive officers were as follows: Dr. Arnold S. Lippa - $75,000;
Jeff E. Margolis - $60,000; and Robert N. Weingarten (resigned as an officer and director of the Company in February 2017, but
remains a consultant to the Company) - $60,000. The cash bonuses awarded to the two independent members of the Company’s
Board of Directors were as follows: James E. Sapirstein - $10,000; and Kathryn MacFarlane - $10,000. The cash bonuses were awarded
as partial compensation for services rendered by such persons from January 1, 2015 through June 30, 2015. Such amounts of accrued
compensation through September 30, 2017 were forgiven on December 9, 2017 when, on the same date certain amounts were granted
as options (See Note 7. Related Party Transactions), and therefore such amounts are no longer included in accrued compensation
and related expenses as of March 31, 2018 or December 31, 2017.
On
June 30, 2015, the Board of Directors also established cash compensation arrangements for certain of the Company’s executive
officers at the following monthly rates: Dr. Arnold S. Lippa - $12,500; Jeff E. Margolis - $10,000; and Robert N. Weingarten (resigned
as an officer and director of the Company in February 2017, but remains a consultant to the Company) - $10,000. In addition, the
Company established quarterly cash board fees for the two independent members of the Company’s Board of Directors as follows:
James E. Sapirstein - $5,000; and Kathryn MacFarlane - $5,000. This compensation was payable in arrears and commenced on July
1, 2015. On August 18, 2015, the cash compensation arrangements for these executive officers were further revised as described
below in Note 8.
These compensation arrangements have
been extended through September 30, 2018.
Both
the cash bonuses and the cash monthly compensation were accrued and will not paid until such time as the Board of Directors of
the Company determines that sufficient capital has been raised by the Company or is otherwise available to fund the Company’s
operations on an ongoing basis.
Effective
August 18, 2015, Company entered into employment agreements with Dr. Arnold S. Lippa, Robert N. Weingarten and Jeff E. Margolis,
which superseded the compensation arrangements previously established for those officers on June 30, 2015, excluding the cash
bonuses referred to above.
On
February 17, 2017, Robert N. Weingarten resigned as a director and as the Company’s Vice President and Chief Financial
Officer, but remains a consultant to the Company.
Jeff
E. Margolis’ employment agreement was amended effective July 1, 2017. The employment agreement amendment called for payment
in three installments in cash of the $60,000 bonus granted on June 30, 2015. A minimum of $15,000 was to be payable in cash as
follows: (a) $15,000 payable in cash upon the next closing (after July 1, 2017) of any financing in excess of $100,000 (b) $15,000
payable by the end of the following month assuming cumulative closings (beginning with the closing that triggered (a)) in excess
of $200,000 and (c) $30,000 payable in cash upon the next closing of any financing in excess of an additional $250,000. The conditions
of (a), (b) and (c) above were met as of December 31, 2017, however Mr. Margolis has waived the Company’s obligation to
make any payments of the cash bonus until the Board of Directors of the Company determines that sufficient capital has been raised
by the Company or is otherwise available to fund the Company’s operations on an ongoing basis. Obligations through September
30, 2017 were forgiven by Mr. Margolis as described below.
On
March 28, 2017, Aurora earned $20,000 of cash fees and 8,000 placement agent common stock warrants associated with the closing
of 1
st
2017 Unit Offering. The cash fees were unpaid as of March 31, 2018 and have been included in accounts
payable and accrued expenses and charged against Additional paid-in capital as of March 31, 2018 and December 31, 2017.
The placement agent common stock warrants were valued at $27,648 and were accounted for in Additional paid-in capital as of March
31, 2018 and December 31, 2017.
On
December 9, 2017, the Company accepted offers from Dr. Arnold S. Lippa, Dr. James S. Manuso, Jeff E. Margolis, James E. Sapirstein,
Kathryn MacFarlane and Robert N. Weingarten (former Chief Financial Officer) pursuant to which such individuals would forgive
accrued compensation and related accrued expenses as of September 30, 2017 in the following amounts: $807,497; $878,360; $560,876;
$55,000; $55,000 and $200,350 respectively for a total of $2,557,083. On the same date, the Company granted to the same individuals,
or designees of such individuals from the 2015 Plan, non-qualified stock options, exercisable for 10 years with an exercise price
of $1.45 per share of common stock, among other terms and features as follows: 559,595; 608,704; 388,687; 38114; 38,114 and 138,842
respectively, for options exercisable into a total of 1,772,055 shares of common stock with a total value of $2,475,561.
As
a result of his resignation in February 2017, Mr. Weingarten is no longer considered a related party as of March 31, 2018.
A
description of advances and notes payable to officers is provided at Note 4.
8.
Commitments and Contingencies
Pending
or Threatened Legal Actions and Claims
By
letter dated May 18, 2018, the Company received notice from counsel claiming to represent TEC Edmonton and The Governors of the
University of Alberta, which purports to terminate, effective December 12, 2017, the license agreement dated May 9, 2007
between the Company and The Governors of the University of Alberta. The Company, through its counsel, disputed any grounds
for termination and has notified the representative of its intention to invoke Section 13 of that license agreement, which mandates a
meeting to be attended by individuals with decision-making authority to attempt in good faith to negotiate a resolution to the
dispute. No assurance can be provided that the parties will reach an acceptable resolution and, in light of the early stages of
the disagreement, we cannot estimate the possible impact of this disagreement on the Company’s operations or business prospects.
By
letter dated November 11, 2014, a former director of the Company, who joined the Company’s Board of Directors on August
10, 2012 in conjunction with the Pier transaction and who resigned from the Company’s Board of Directors on September 28,
2012, asserted a claim for unpaid consulting compensation of $24,000. The Company has not received any further communications
from the former director with respect to this matter.
By
letter dated February 5, 2016, the Company received a demand from a law firm representing a professional services vendor of the
Company alleging an amount due and owing for unpaid services rendered. On January 18, 2017, following an arbitration proceeding,
an arbitrator awarded the vendor the full amount sought in arbitration of $146,082. Additionally, the arbitrator granted the vendor
attorneys’ fees and costs of $47,937. All such amounts have been accrued at March 31, 2018 and December 31, 2017.
By
e-mail dated July 21, 2016, the Company received a demand from an investment banking consulting firm that represented the Company
in 2012 in conjunction with the Pier transaction alleging that $225,000 is due and owing for unpaid investment banking services
rendered. Such amount has been accrued at March 31, 2018 and December 31, 2017.
The
Company is periodically the subject of various pending and threatened legal actions and claims. In the opinion of management of
the Company, adequate provision has been made in the Company’s consolidated financial statements at March 31, 2018, December
31, 2017 and March 31, 2017 with respect to such matters, including, specifically, the matters noted above. The Company intends
to vigorously defend itself if any of the matters described above results in the filing of a lawsuit or formal claim.
Significant
Agreements and Contracts
Consulting
Agreement
Richard
Purcell was appointed as the Company’s Senior Vice President of Research and Development effective October 15, 2014. Mr.
Purcell provides his services to the Company on a month-to-month basis through his consulting firm, DNA Healthlink, Inc., through
which the Company has contracted for his services, for a monthly cash fee of $12,500. Additional information with respect to shares
of common stock issued to Mr. Purcell is provided at Note 6. Cash compensation expense pursuant to this agreement totaled $37,608
for the three months ended March 31, 2018 and 2017, which is included in research and development expenses in the Company’s
condensed consolidated statements of operations for such periods.
Employment
Agreements
On
August 18, 2015, the Company entered into an employment agreement with Dr. James S. Manuso, Ph.D., to be its new President and
Chief Executive Officer. Pursuant to the agreement, which is for an initial term through September 30, 2018 (and which will be
deemed to be automatically extended, upon the same terms and conditions, for successive periods of one year, unless either party
provides written notice of its intention not to extend the term of the agreement at least 90 days prior to the applicable renewal
date), Dr. Manuso received an annual base salary of $375,000. Dr. Manuso is also eligible to earn a performance-based annual bonus
award of up to 50% of his base salary, based upon the achievement of annual performance goals established by the Board of Directors
in consultation with the executive prior to the start of such fiscal year, or any amount at the discretion of the Board of Directors.
Additionally, Dr. Manuso was granted stock options to acquire 261,789 shares of common stock of the Company and is eligible to
receive additional awards under the Company’s Plans in the discretion of the Board of Directors. Dr. Manuso is also entitled
to receive, until such time as the Company establishes a group health plan for its employees, $1,200 per month, on a tax-equalized
basis, as additional compensation to cover the cost of health coverage and up to $1,000 per month, on a tax-equalized basis, as
additional compensation for a term life insurance policy and disability insurance policy. Dr. Manuso is also entitled to be reimbursed
for business expenses. Additional information with respect to the stock options granted to Dr. Manuso is provided at Note 6. Cash
compensation accrued pursuant to this agreement totaled $103,650 for each of the three months ended March
31, 2018, and 2017, respectively. Such amounts were included in accrued compensation and related expenses in
the Company’s condensed consolidated balance sheet at March 31, 2018 and 2017, respectively, and in
general and administrative expenses in the Company’s consolidated statement of operations for the three months ended
March 31, 2018 and 2017. On December 9, 2017, Dr. Manuso forgave $878,360 of accrued compensation and related
expenses which was the amount owed by the Company as of September 30, 2017, as described in more detail below. On the same
date, Dr. Manuso received options to purchase 608,704 shares of common stock, as described in more detail below. Dr. Manuso
does not receive any additional compensation for serving as Vice Chairman or a member of on the Board of Directors. Such amounts
have not been paid to Dr. Manuso.
On
August 18, 2015, concurrently with the hiring of Dr. James S. Manuso as the Company’s new President and Chief Executive
Officer, Dr. Arnold S. Lippa resigned as the Company’s President and Chief Executive Officer. Dr. Lippa continues to serve
as the Company’s Executive Chairman and as a member of the Board of Directors. Also on August 18, 2015, Dr. Lippa was named
Chief Scientific Officer of the Company, and the Company entered into an employment agreement with Dr. Lippa in that capacity.
Pursuant to the agreement, which is for an initial term through September 30, 2018 (and which will be deemed to be automatically
extended, upon the same terms and conditions, for successive periods of one year, unless either party provides written notice
of its intention not to extend the term of the agreement at least 90 days prior to the applicable renewal date), Dr. Lippa received
an annual base salary of $300,000. Dr. Lippa is also eligible to earn a performance-based annual bonus award of up to 50% of his
base salary, based upon the achievement of annual performance goals established by the Board of Directors in consultation with
the executive prior to the start of such fiscal year, or any amount at the discretion of the Board of Directors. Additionally,
Dr. Lippa was granted stock options to acquire 30,769 shares of common stock of the Company and is eligible to receive additional
awards under the Company’s Plans at the discretion of the Board of Directors. Dr. Lippa is also entitled to receive, until
such time as the Company establishes a group health plan for its employees, $1,200 per month, on a tax-equalized basis, as additional
compensation to cover the cost of health coverage and up to $1,000 per month, on a tax-equalized basis, as reimbursement for a
term life insurance policy and disability insurance policy. Dr. Lippa is also entitled to be reimbursed for business expenses.
Additional information with respect to the stock options granted to Dr. Lippa is provided at Note 6. Cash compensation accrued
pursuant to this agreement totaled $84,900 for each of the three months ended March 31, 2018 and 2017, respectively, which is
included in accrued compensation and related expenses in the Company’s consolidated balance sheet at March 31, 2018 and
2017, and in research and development expenses in the Company’s consolidated statement of operations. Cash compensation
accrued to Dr. Lippa for bonuses and under a prior superseded arrangement, while still serving as the Company’s President
and Chief Executive Officer, totaled $94,758 and was part of the amount forgiven on December 9, 2017 and therefore is no longer
included in accrued compensation and related expenses as of March 31, 2018. Dr. Lippa does not receive any additional compensation
for serving as Executive Chairman and on the Board of Directors. On December 9, 2017, Dr. Lippa forgave $807,497 of accrued compensation
and related expenses which was the amount owed by the Company as of September 30, 2017. On the same date, Dr. Lippa received options
to purchase 559,595 shares of common stock, as described in more detail below.
On
August 18, 2015, the Company also entered into an employment agreement with Jeff E. Margolis, in his continuing role as Vice President,
Secretary and Treasurer. Pursuant to the agreement, which was for an initial term through September 30, 2016 (and which will be
deemed to be automatically extended upon the same terms and conditions, for successive periods of one year, unless either party
provides written notice of its intention not to extend the term of the agreement at least 90 days prior to the applicable renewal
date), Mr. Margolis received an annual base salary of $195,000, and is also eligible to receive performance-based annual bonus
awards ranging from $65,000 to $125,000, based upon the achievement of annual performance goals established by the Board of Directors
in consultation with the executive prior to the start of such fiscal year, or any amount at the discretion of the Board of Directors.
Additionally, Mr. Margolis was granted stock options to acquire 30,769 shares of common stock of the Company and is eligible to
receive additional awards under the Company’s Plans at the discretion of the Board of Directors. Mr. Margolis is also entitled
to receive, until such time as the Company establishes a group health plan for its employees, $1,200 per month, on a tax-equalized
basis, as additional compensation to cover the cost of health coverage and up to $1,000 per month, on a tax-equalized basis, as
reimbursement for a term life insurance policy and disability insurance policy. Mr. Margolis is also each entitled to be reimbursed
for business expenses. Additional information with respect to the stock options granted to Mr. Margolis is provided at Note 6.
Cash compensation accrued pursuant to this agreement totaled $80,400 for Mr. Margolis for the three months ended March 31, 2018
and $54,150 for the three months ended March 31, 2017, which is included in accrued compensation and related expenses in the Company’s
consolidated balance sheet at March 31, 2018 and 2017, and in general and administrative expenses in the Company’s consolidated
statement of operations. On December 9, 2017, Mr. Margolis forgave $560,876 of accrued compensation and related expenses which
was the amount owed by the Company as of September 30, 2017. On the same date, Mr. Margolis received options to purchase 388,687
shares of common stock, as described in more detail below. Cash compensation accrued to Mr. Margolis for bonuses and under prior
superseded arrangements totaled $75,806 and was part of the amount forgiven on December 9, 2017 and therefore is no longer
included in accrued compensation and related expenses as of March 31, 2018. Mr. Margolis serves as a Director of the Company
but does not receive any additional compensation for serving on the Board of Directors.
The
employment agreements between the Company and each of Dr. Manuso, Dr. Lippa, and Mr. Margolis, respectively, provided that
the payment obligations associated with the first year base salary were to accrue, but no payments were to be made, until at least
$2,000,000 of net proceeds from any offering or financing of debt or equity, or a combination thereof, was received by the Company,
at which time scheduled payments were to commence. As this financing milestone has not been achieved, Dr. Manuso, Dr. Lippa, and
Mr. Margolis (who are each also directors of the Company) have each agreed, effective as of August 11, 2016, to continue to
defer the payment of such amounts indefinitely, until such time as the Board of Directors of the Company determines that sufficient
capital has been raised by the Company or is otherwise available to fund the Company’s operations on an ongoing basis.
Jeff
E. Margolis’ employment agreement was amended effective July 1, 2017. The employment agreement amendment called for payment
in three installments in cash of the $60,000 bonus granted on June 30, 2015. A minimum of $15,000 was to be payable in cash as
follows: (a) $15,000 payable in cash upon the next closing (after July 1, 2017) of any financing in excess of $100,000 (b) $15,000
payable by the end of the following month assuming cumulative closings (beginning with the closing that triggered (a)) in excess
of $200,000 and (c) $30,000 payable in cash upon the next closing of any financing in excess of an additional $250,000. The conditions
of (a), (b) and (c) above were met as of December 31, 2017, however Mr. Margolis has waived the Company’s obligation to
make any payments of the cash bonus until the Board of Directors of the Company determines that sufficient capital has been raised
by the Company or is otherwise available to fund the Company’s operations on an ongoing basis. Obligations through September
30, 2017 were forgiven by Mr. Margolis as described in the next paragraph below.
On
December 9, 2017, the Company accepted offers from Dr. Arnold S. Lippa, Dr. James S. Manuso, Jeff E. Margolis, James E. Sapirstein,
Kathryn MacFarlane and Robert N. Weingarten (former Chief Financial Officer) pursuant to which such individuals would forgive
accrued compensation and related accrued expenses as of September 30, 2017 in the following amounts: $807,497, $878,360,
$560,876, $55,000, $55,000, and $200,350 respectively for a total of $2,557,083. On the same date, the
Company granted to the same individuals, or designees of such individuals from the 2015 Plan, non-qualified stock options, exercisable
for 10 years with an exercise price of $1.45 per share of common stock, among other terms and features as follows: 559,595,
608,704, 388,687, 38114, 38,114, and 138,842 respectively, for options exercisable into a total
of 1,772,055 shares of common stock with a total value of $2,475,561.
University
of California, Irvine License Agreements
The
Company entered into a series of license agreements in 1993 and 1998 with the University of California, Irvine (“UCI”)
that granted the Company proprietary rights to certain chemical compounds that acted as ampakines and to their therapeutic uses.
These agreements granted the Company, among other provisions, exclusive rights: (i) to practice certain patents and patent applications,
as defined in the license agreement, that were then held by UCI; (ii) to identify, develop, make, have made, import, export, lease,
sell, have sold or offer for sale any related licensed products; and (iii) to grant sub-licenses of the rights granted in the
license agreements, subject to the provisions of the license agreements. The Company was required, among other terms and conditions,
to pay UCI a license fee, royalties, patent costs and certain additional payments.
Under
such license agreements, the Company was required to make minimum annual royalty payments of approximately $70,000. The Company
was also required to spend a minimum of $250,000 per year to advance the ampakine compounds until the Company began to market
an ampakine compound. The commercialization provisions in the agreements with UCI required the Company to file for regulatory
approval of an ampakine compound before October 2012. In March 2011, UCI agreed to extend the required date for filing regulatory
approval of an ampakine compound to October 2015. During December 2012, the Company informed UCI that it would be unable to make
the annual payment due to a lack of funds. The Company believes that this notice, along with its subsequent failure to make its
minimum annual payment obligation, constituted a default and termination of the license agreements.
On
April 15, 2013, the Company received a letter from UCI indicating that the license agreements between UCI and the Company had
been terminated due to the Company’s failure to make certain payments required to maintain the agreements. Since the patents
covered in these license agreements had begun to expire and the therapeutic uses described in these patents were no longer germane
to the Company’s new focus on respiratory disorders, the loss of these license agreements is not expected to have a material
impact on the Company’s current drug development programs. In the opinion of management, the Company has made adequate provision
for any liability relating to this matter in its consolidated financial statements at March 31, 2018 and December 31, 2017.
University
of Alberta License Agreement
On
May 9, 2007, the Company entered into a license agreement, as amended, with the University of Alberta granting the Company
exclusive rights to practice patents held by the University of Alberta claiming the use of ampakines for the treatment of various
respiratory disorders. The Company agreed to pay the University of Alberta a licensing fee and a patent issuance fee, which were
paid, and prospective payments consisting of a royalty on net sales, sublicense fee payments, maintenance payments and milestone
payments. The prospective maintenance payments commence on the enrollment of the first patient into the first Phase 2B clinical
trial and increase upon the successful completion of the Phase 2B clinical trial. As the Company does not at this time anticipate
scheduling a Phase 2B clinical trial in the near term, no maintenance payments to the University of Alberta are currently due
and payable, nor are any maintenance payments expected to be due in the near future in connection with the license agreement.
See Note 9. Subsequent Events.
Transactions
with Biovail Laboratories International SRL
In
March 2010, the Company entered into an asset purchase agreement with Biovail Laboratories International SRL (“Biovail”).
Pursuant to the asset purchase agreement, Biovail acquired the Company’s interests in CX717, CX1763, CX1942 and the injectable
dosage form of CX1739, as well as certain of its other ampakine compounds and related intellectual property for use in the field
of respiratory depression or vaso-occlusive crises associated with sickle cell disease. The agreement provided the Company with
the right to receive milestone payments in an aggregate amount of up to $15,000,000 plus the reimbursement of certain related
expenses, conditioned upon the occurrence of particular events relating to the clinical development of certain assets that Biovail
acquired. None of these events occurred.
As
part of the transaction, Biovail licensed back to the Company certain exclusive and irrevocable rights to some acquired ampakine
compounds, other than CX717, an injectable dosage form of CX1739, CX1763 and CX1942, for use outside of the field of respiratory
depression or vaso-occlusive crises associated with sickle cell disease. Accordingly, following the transaction with Biovail,
the Company retained its rights to develop and commercialize the non-acquired ampakine compounds as a potential treatment for
neurological diseases and psychiatric disorders. Additionally, the Company retained its rights to develop and commercialize the
ampakine compounds as a potential treatment for sleep apnea disorders, including an oral dosage form of ampakine CX1739.
In
September 2010, Biovail’s parent corporation, Biovail Corporation, combined with Valeant Pharmaceuticals International in
a merger transaction and the combined company was renamed “Valeant Pharmaceuticals International, Inc.” (“Valeant”).
Following the merger, Valeant and Biovail conducted a strategic and financial review of their product pipeline and, as a result,
in November 2010, Biovail announced its intent to exit from the respiratory depression project acquired from the Company in March
2010.
Following
that announcement, the Company entered into discussions with Biovail regarding the future of the respiratory depression project.
In March 2011, the Company entered into a new agreement with Biovail to reacquire the ampakine compounds, patents and rights that
Biovail had acquired from the Company in March 2010. The new agreement provided for potential future payments of up to $15,150,000
by the Company based upon the achievement of certain developments, including new drug application submissions and approval milestones.
Biovail is also eligible to receive additional payments of up to $15,000,000 from the Company based upon the Company’s net
sales of an intravenous dosage form of the compounds for respiratory depression.
At
any time following the completion of Phase 1 clinical studies and prior to the end of Phase 2A clinical studies, Biovail retains
an option to co-develop and co-market intravenous dosage forms of an ampakine compound as a treatment for respiratory depression
and vaso-occlusive crises associated with sickle cell disease. In such an event, the Company would be reimbursed for certain development
expenses to date and Biovail would share in all such future development costs with the Company. If Biovail makes the co-marketing
election, the Company would owe no further milestone payments to Biovail and the Company would be eligible to receive a royalty
on net sales of the compound by Biovail or its affiliates and licensees.
University
of Illinois 2014 Exclusive License Agreement
On
June 27, 2014, the Company entered into an Exclusive License Agreement (the “2014 License Agreement”) with the University
of Illinois, the material terms of which were similar to a License Agreement between the parties that had been previously terminated
on March 21, 2013. The 2014 License Agreement became effective on September 18, 2014, upon the completion of certain conditions
set forth in the 2014 License Agreement, including: (i) the payment by the Company of a $25,000 licensing fee, (ii) the payment
by the Company of outstanding patent costs aggregating $15,840, and (iii) the assignment to the University of Illinois of rights
the Company held in certain patent applications, all of which conditions were fulfilled.
The
2014 License Agreement granted the Company (i) exclusive rights to several issued and pending patents in numerous jurisdictions
and (ii) the non-exclusive right to certain technical information that is generated by the University of Illinois in connection
with certain clinical trials as specified in the 2014 License Agreement, all of which relate to the use of cannabinoids for the
treatment of sleep related breathing disorders. The Company is developing dronabinol (Δ9-tetrahydrocannabinol), a cannabinoid,
for the treatment of OSA, the most common form of sleep apnea.
The
2014 License Agreement provides for various commercialization and reporting requirements commencing on June 30, 2015 and also
requires the Company to pay the University of Illinois a license fee, royalties, patent costs and certain milestone payments.
The 2014 License Agreement provides for various royalty payments by the Company, including a royalty on net sales of 4%, payment
on sub-licensee revenues of 12.5%, and a minimum annual royalty of $100,000 beginning in 2015, which is due and payable on December
31 of each year. The 2017 minimum annual royalty of $100,000 was paid as scheduled in December 2017. In the year after the first
application for market approval is submitted to the FDA and until approval is obtained, the minimum annual royalty will increase
to $150,000. In the year after the first market approval is obtained from the FDA and until the first sale of a product, the minimum
annual royalty payable by the Company will increase to $200,000. In the year after the first commercial sale of a product, the
minimum annual royalty will increase to $250,000.
The
2014 License Agreement also provides for certain one-time milestone payments by the Company. A payment of $75,000 is due within
five days after any one of the following: (a) dosing of the first patient with a product in a Phase 2 human clinical study anywhere
in the world that is not sponsored by the University of Illinois, (b) dosing of the first patient in a Phase 2 human clinical
study anywhere in the world with a low dose of dronabinol, or (c) dosing of the first patient in a Phase 1 human clinical study
anywhere in the world with a proprietary reformulation of dronabinol. A payment of $350,000 is due within five days after dosing
of the first patient with a product in a Phase 3 human clinical trial anywhere in the world. A payment of $500,000 is due within
five days after the first new drug application filing with the FDA or a foreign equivalent for a product. A payment of $1,000,000
is due within 12 months after the first commercial sale of a product.
During
the three months ended March 31, 2018 and 2017, the Company recorded a charge to operations of $25,000 and $25,000, respectively,
with respect to its 2018 and 2017 minimum annual royalty obligation, which is included in research and development expenses in
the Company’s condensed consolidated statement of operations for the three months ended March 31, 2018 and 2017.
Research
Contract with the University of Alberta
On
January 12, 2016, the Company entered into a Research Contract with the University of Alberta in order to test the efficacy of
ampakines at a variety of dosage and formulation levels in the potential treatment of Pompe Disease, apnea of prematurity and
spinal cord injury, as well as to conduct certain electrophysiological studies to explore the ampakine mechanism of action for
central respiratory depression. The Company agreed to pay the University of Alberta total consideration of approximately CAD$146,000
(approximately US$111,000), consisting of approximately CAD$85,000 (approximately US$65,000) of personnel funding in cash in four
installments during 2016, to provide approximately CAD$21,000 (approximately US$16,000) in equipment, to pay patent costs of CAD$20,000
(approximately US$15,000), and to underwrite additional budgeted costs of CAD$20,000 (approximately US$15,000). As of December
31, 2017, the Company had recorded final amounts payable in respect to this Research Contract of US$16,207 (CAD$21,222)
which amount was paid in US dollars in January 2018 and completed the payments under the contract. The conversion to US
dollars above utilizes an exchange rate of approximately US$0.76 for every CAD$1.00.
The
University of Alberta received matching funds through a grant from the Canadian Institutes of Health Research in support of this
research. The Company retained the rights to research results and any patentable intellectual property generated by the research.
Dr. John Greer, faculty member of the Department of Physiology, Perinatal Research Centre and Women & Children’s Health
Research Institute at the University of Alberta collaborated on this research. The studies were completed in 2016.
National
Institute of Drug Abuse Agreement
As
a result of agreements entered into on October 19, 2015 and January 19, 2016, the Medications Development Program of the National
Institute of Drug Abuse (“NIDA”) funded and conducted research on the Company’s ampakine compounds CX717 and
CX1739 to determine their potential usefulness for the treatment of cocaine and methamphetamine addiction and abuse. The Company
retains all intellectual property resulting from this research, as well as proprietary and commercialization rights to these compounds.
In
general, the ampakines did not produce in rats and mice behavioral effects that are commonly associated with administration
of stimulants such as cocaine or amphetamines. Instead, the ampakines reduced the stimulation produced by both of these
drugs. The absence of stimulation on the part of the ampakines may confirm their value as potential non-stimulant treatments
for ADHD. In addition, the ampakines did not affect the behavior of rats that had been trained to recognize whether they
had been administered cocaine or methamphetamine.
Duke
University Clinical Trial Agreement
On
January 27, 2015, the Company entered into a Clinical Study and Research Agreement (the “Agreement”) with Duke University
to develop and conduct a protocol for a program of clinical study and research which was amended on October 30, 2015 and further
amended on July 28, 2016, which agreement, as amended, resulted in a total amount payable under the Agreement to $678,327. During
the three months ended March 31, 2018 and 2017, the Company charged $0 to research and development expenses with respect to work
conducted pursuant to the amended Agreement. The clinical trial completed in October 2016 and the Company announced the
study results on December 15, 2016.
Sharp
Clinical Services, Inc. Agreement
The
Company has various agreements with Sharp Clinical Services, Inc. to provide packaging, labeling, distribution and analytical
services.
Covance
Laboratories Inc. Agreement
On
October 26, 2016, the Company entered into a twelve month agreement with Covance Laboratories Inc. to provide compound testing
and storage services with respect to CX1739, CX1866 and CX1929 at a total budgeted cost of $35,958.
This
agreement was renewed in October 2017.
Summary
of Principal Cash Obligations and Commitments
The
following table sets forth the Company’s principal cash obligations and commitments for the next five fiscal years as of
March 31, 2018, aggregating $1,034,400. Amounts included in the 2018 column represent amounts contractually due at March 31, 2018
during the remainder of the 2018 fiscal year ending December 31, 2018.
|
|
|
|
|
Payments
Due By Year
|
|
|
|
Total
|
|
|
2018
|
|
|
2019
|
|
|
2020
|
|
|
2021
|
|
|
2022
|
|
Research
and development contracts
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
-
|
|
Clinical
trial agreements
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
License
agreements
|
|
|
475,000
|
|
|
|
75,000
|
|
|
|
100,000
|
|
|
|
100,000
|
|
|
|
100,000
|
|
|
|
100,000
|
|
Digital
media consulting agreement
|
|
|
12,500
|
|
|
|
12,500
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employment
and consulting agreements (1)
|
|
|
546,900
|
|
|
|
546,900
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Total
|
|
$
|
1,034,400
|
|
|
$
|
634,400
|
|
|
$
|
100,000
|
|
|
$
|
100,000
|
|
|
$
|
100,000
|
|
|
$
|
100,000
|
|
(1)
The payment of such amounts has been deferred indefinitely, as described above at “Employment Agreements”.
9.
Subsequent Events
On
May 18, 2018, the Company received a letter from counsel claiming to represent TEC Edmonton and The Governors of the University
of Alberta, which purports to terminate, effective December 12, 2017, the license agreement dated May 9, 2007 (as subsequently
amended) between the Company and The Governors of the University of Alberta. The Company, through its counsel, has disputed
any grounds for termination and has notified the representative of its intention to invoke Section 13 of that license agreement,
which mandates a meeting to be attended by individuals with decision-making authority to attempt in good faith to negotiate
a resolution to the dispute. No assurance can be provided that the parties will reach an acceptable resolution and, in light of
the early stages of the disagreement, we cannot estimate the possible impact of this disagreement on the Company’s operations
or business prospects.
On
April 5, 2018, the Board of Directors approved and the Company granted a non-qualified stock option from the 2015 Plan to a vendor,
in satisfaction of $124,025 of amounts owed to that vendor (“Vendor Option”). The Vendor Option, which is exercisable
into 125,000 shares of common stock at $1.12 per share, which was the closing price of the Company’s common stock on April
5, 2018 as reported by OTC Markets, vested upon grant and is exercisable for five years. The Vendor Option had an estimated value
on April 5, 2018, based upon the Black-Scholes option valuation method of $1.081 per share of common stock, or $135,125. The assumptions
used for the valuation of the Vendor Options included a stock price and exercise price of $1.12, an annual volatility of 186.07%,
a risk-free rate equal to the yield on the five-year Treasury Note of 2.64% and a zero expected dividend yield.
On
April 5, 2018, the Board of Directors approved and the Company granted a non-qualified stock option from the 2015 Plan to Robert
N. Weingarten (the “Weingarten Option”), the Company’s most recent former Chief Financial Officer who is also
a former member of the Company’s Board of Directors, which grant was in connection with Mr. Weingarten’s agreement
to forgive $200,350 of accrued compensation and related costs owed to him. The Weingarten Option, which is exercisable
into 185,388 shares of common stock at $1.12 per share, which was the closing price of the Company’s common stock on April
5, 2018 as reported by OTC Markets, vested upon grant and is exercisable for five years. The Weingarten Option had an estimated
value on April 5, 2018, based upon the Black-Scholes option valuation method of $1.081 per share of common stock, or $200,404.
The assumptions used for the valuation of the Weingarten Option included a stock price and exercise price of $1.12, an annual
volatility of 186.07%, a risk-free rate equal to the yield on the five-year Treasury Note of 2.64% and a zero expected dividend
yield.
On
April 5, 2018, the Company agreed to issue one or more demand promissory notes, in exchange for borrowings up to a maximum principal
amount of $100,000 in the aggregate to Arnold S. Lippa and James S. Manuso, the Company’s Executive Chairman and Chief Scientific
Officer and the Company’s Vice Chairman and Chief Executive Officer respectively (“New Officer Notes”). The
New Officer Notes bear simple interest at 10% per year. Demand for payment is available only after June 30, 2018. Until
then, the principal amount of the New Officer Notes will mandatorily exchange into the first financing by the Company that results
in accounting for the financing as an equity financing (consisting solely of convertible preferred stock or common stock or units
containing preferred stock or common stock and warrants exercisable only into preferred stock or common stock) that would be considered
as “permanent equity” under United States Generally Accepted Accounting Principles and the rules and regulations of
the United States Securities and Exchange Commission, and therefore classified within stockholders’ equity, but excluding
any form of debt or convertible debt or preferred stock redeemable at the discretion of the holder. The principal amount of the
New Officer Notes exchanged will be included in determining if the offering’s minimum amount, if any, is met.
Accrued and unpaid interest may be exchanged into the offering, but is not mandatorily exchangeable and will not
be considered in determining if the minimum amount has been met. If no such offering has a first closing prior to June 30, 2018,
a demand for payment of the New Officer Notes may be made individually by the holders of the notes.