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UNITED
STATES
SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C.
20549
FORM
10-Q
☒
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
For the
quarterly period ended
☐
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
Commission file
number:
1-16467
RESPIRERX
PHARMACEUTICALS INC.
(Exact name
of registrant as specified in its charter)
Delaware |
|
33-0303583 |
(State or
other jurisdiction of |
|
(I.R.S.
Employer |
incorporation or
organization) |
|
Identification
Number) |
126 Valley
Road,
Suite C
Glen
Rock,
New Jersey 07452
(Address of
principal executive offices)
(201)
444-4947
(Registrant’s telephone
number, including area code)
Not
applicable
(Former
name, former address and former fiscal year, if changed since last
report)
Securities
registered pursuant to Section 12(b) of the Act:
Title of
each class |
|
Trading
Symbol(s) |
|
Name of each
exchange on which registered |
N/A |
|
N/A |
|
N/A |
Indicate by
check mark whether the registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities
Exchange Act of 1934 during the preceding 12 months (or for such
shorter period that the registrant was required to file such
reports), and (2) has been subject to such filing requirements for
the past 90 days.
Yes
☒ No
☐
Indicate by
check mark whether the registrant has submitted electronically
every Interactive Data File required to be submitted pursuant to
Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the
preceding 12 months (or for such shorter period that the registrant
was required to submit such files).
Yes
☒ No
☐
Indicate by
check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, a smaller reporting
company or an emerging growth company. See the definitions of
“large accelerated filer,” “accelerated filer,” “smaller reporting
company,” and “emerging growth company” in Rule 12b-2 of the
Exchange Act.
Large
accelerated filer ☐ |
Accelerated
filer ☐ |
|
|
Non-accelerated
filer ☒ |
Smaller
reporting company
☒ |
|
|
|
Emerging
growth company
☐ |
If an
emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by
check mark whether the registrant is a shell company (as defined in
Rule 12b-2 of the Exchange Act).
Yes ☐
No ☒
As of
November 10, 2021, the Company had
94,907,943, shares of common stock,
$0.001 par value, issued and outstanding.
RESPIRERX
PHARMACEUTICALS INC.
AND
SUBSIDIARY
TABLE OF
CONTENTS
In this
Quarterly Report on Form 10-Q, the terms “RespireRx,” the
“Company,” “we,” “us” and “our” refer to RespireRx Pharmaceuticals
Inc. a Delaware corporation, and, unless the context indicates
otherwise, its consolidated subsidiaries.
INTRODUCTORY NOTE
REGARDING FORWARD-LOOKING STATEMENTS
This
Quarterly Report on Form 10-Q of RespireRx Pharmaceuticals Inc.
(“RespireRx” and together with RespireRx’s wholly owned subsidiary,
Pier Pharmaceuticals, Inc. (“Pier”), the “Company, “we,” or “our,”
unless the context indicates otherwise) contains certain
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended (the “Securities Act”) and
Section 21E of the Securities Exchange Act of 1934, as amended (the
“Exchange Act”), and the Company intends that such forward-looking
statements be subject to the safe harbor created thereby. These
might include statements regarding the Company’s future plans,
targets, estimates, assumptions, financial position, business
strategy and other plans and objectives for future operations, and
assumptions and predictions about research and development efforts,
including, but not limited to, preclinical and clinical research
design, execution, timing, costs and results, future product
demand, supply, manufacturing, costs, marketing and pricing
factors.
In some
cases, forward-looking statements may be identified by words
including “assumes,” “could,” “ongoing,” “potential,” “predicts,”
“projects,” “should,” “will,” “would,” “anticipates,” “believes,”
“intends,” “estimates,” “expects,” “plans,” “contemplates,”
“targets,” “continues,” “budgets,” “may,” or the negative of these
terms or other comparable terminology, although not all
forward-looking statements contain these words, and such statements
may include, but are not limited to, statements regarding (i)
future research plans, expenditures and results, (ii) potential
collaborative arrangements, (iii) the potential utility of the
Company’s products candidates, (iv) reorganization plans, and (v)
the need for, and availability of, additional financing.
Forward-looking statements are based on information available at
the time the statements are made and involve known and unknown
risks, uncertainties and other factors that may cause our results,
levels of activity, performance or achievements to be materially
different from the information expressed or implied by the
forward-looking statements in this report.
These
factors include but are not limited to, regulatory policies or
changes thereto, available cash, research and development results,
issuance of patents, competition from other similar businesses,
interest of third parties in collaborations with us, and market and
general economic factors, and other risk factors disclosed in “Item
1A. Risk Factors” in the Company’s Annual Report on Form 10-K for
the fiscal year ended December 31, 2020, as filed with the SEC on
April 15, 2020 (the “2020 Form 10-K”) as well as any subsequent
reports filed from time to time with the SEC.
You should
read these risk factors and the other cautionary statements made in
the Company’s filings as being applicable to all related
forward-looking statements wherever they appear in this report. We
cannot assure you that the forward-looking statements in this
report will prove to be accurate and therefore prospective
investors are encouraged not to place undue reliance on
forward-looking statements. You should read this report completely.
Other than as required by law, we undertake no obligation to update
or revise these forward-looking statements, even though our
situation may change in the future.
We caution
investors not to place undue reliance on any forward-looking
statement that speaks only as of the date made and to recognize
that forward-looking statements are predictions of future results,
which may not occur as anticipated. Actual results could differ
materially from those anticipated in the forward-looking statements
and from historical results, due to the risks and uncertainties
described in the 2020 Form 10-K and in this report, as well as
others that we may consider immaterial or do not anticipate at this
time. These forward-looking statements are based on assumptions
regarding the Company’s business and technology, which involve
judgments with respect to, among other things, future scientific,
economic, regulatory and competitive conditions, collaborations
with third parties, and future business decisions, all of which are
difficult or impossible to predict accurately and many of which are
beyond the Company’s control. Although we believe that the
expectations reflected in our forward-looking statements are
reasonable, we do not know whether our expectations will prove
correct. Our expectations reflected in our forward-looking
statements can be affected by inaccurate assumptions that we might
make or by known or unknown risks and uncertainties, including
those described in the 2020 Form 10-K and in this report. These
risks and uncertainties are not exclusive and further information
concerning us and our business, including factors that potentially
could materially affect our financial results or condition, may
emerge from time to time.
For more
information about the risks and uncertainties the Company faces,
see “Item 1A. Risk Factors” in our 2020 Form 10-K, and subsequent
reports and registration statements filed from time to time with
the SEC. Forward-looking statements speak only as of the date they
are made. The Company does not undertake and specifically declines
any obligation to update any forward-looking statements or to
publicly announce the results of any revisions to any statements to
reflect new information or future events or developments. We advise
investors to consult any further disclosures we may make on related
subjects in our annual reports on Form 10-K, as well as subsequent
reports file from time to time with the SEC.
PART I - FINANCIAL
INFORMATION
ITEM 1. CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS
RESPIRERX
PHARMACEUTICALS INC.
AND
SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE
SHEETS
See
accompanying notes to condensed consolidated financial statements
(unaudited).
RESPIRERX
PHARMACEUTICALS INC.
AND
SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
(Unaudited)
See
accompanying notes to condensed consolidated financial statements
(unaudited).
RESPIRERX
PHARMACEUTICALS INC.
AND
SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF
STOCKHOLDERS’ DEFICIENCY
(Unaudited)
Nine-months and
Three-months Ended September 30, 2021
Nine-months and
Three-months Ended September 30, 2020
|
|
Series B
Convertible
Preferred Stock |
|
|
Common
Stock |
|
|
Additional |
|
|
|
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
Par |
|
|
Paid-in |
|
|
Accumulated |
|
|
Stockholders’ |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Value |
|
|
Capital |
|
|
Deficit |
|
|
Deficiency |
|
Balance,
December 31, 2019 |
|
|
37,500 |
|
|
$ |
21,703 |
|
|
|
417,507 |
|
|
$ |
418 |
|
|
$ |
159,042,145 |
|
|
$ |
(166,509,085 |
) |
|
$ |
(7,444,819 |
) |
Issuances of
common stock |
|
|
- |
|
|
|
- |
|
|
|
2,951,878 |
|
|
|
2,952 |
|
|
|
937,166 |
|
|
|
- |
|
|
|
940,118 |
|
Net loss for the three
months ended March 31, 2020 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(946,718 |
) |
|
|
(946,718 |
) |
Balance at March 31,
2020 |
|
|
37,500 |
|
|
$ |
21,703 |
|
|
|
3,369,385 |
|
|
$ |
3,370 |
|
|
$ |
159,979,311 |
|
|
$ |
(167,455,803 |
|
|
$ |
(7,451,419 |
) |
Issuances of
common stock |
|
|
- |
|
|
|
- |
|
|
|
18,861,353 |
|
|
|
18,861 |
|
|
|
311,947 |
|
|
|
- |
|
|
|
330,808 |
|
Note
discounts |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
90,000 |
|
|
|
- |
|
|
|
90,000 |
|
Net
loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(816,137 |
) |
|
|
(816,137 |
) |
Balance, June 30,
2020 |
|
|
37,500 |
|
|
$ |
21,703 |
|
|
|
22,230,738 |
|
|
$ |
22,231 |
|
|
$ |
160,381,258 |
|
|
$ |
(168,271,940 |
) |
|
$ |
(7,846,748 |
) |
Issuances of
common stock (after issuance and full conversion of Series H
Preferred Stock) |
|
|
- |
|
|
|
- |
|
|
|
25,377,426 |
|
|
|
25,377 |
|
|
|
1,664,307 |
|
|
|
- |
|
|
|
1,689,684 |
|
Note payable
conversions |
|
|
- |
|
|
|
- |
|
|
|
1,355,080 |
|
|
|
1,355 |
|
|
|
9,379 |
|
|
|
- |
|
|
|
10,734 |
|
Option
grants |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
337,500 |
|
|
|
- |
|
|
|
337,500 |
|
Warrant
exercises |
|
|
- |
|
|
|
- |
|
|
|
8,820,956 |
|
|
|
8,821 |
|
|
|
(8,821 |
) |
|
|
- |
|
|
|
- |
|
Net
loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,479,355 |
) |
|
|
(1,479,355 |
) |
Balance, September 30,
2020 |
|
|
37,500 |
|
|
$ |
21,703 |
|
|
|
57,784,200 |
|
|
$ |
57,784 |
|
|
$ |
162,383,623 |
|
|
$ |
(169,751,295 |
) |
|
$ |
(7,288,185 |
) |
See
accompanying notes to condensed consolidated financial statements
(unaudited).
RESPIRERX
PHARMACEUTICALS INC.
AND
SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF
CASH FLOWS
(Unaudited)
(Continued)
RESPIRERX
PHARMACEUTICALS INC.
AND
SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF
CASH FLOWS
(Unaudited)
(Continued)
|
|
Nine-months Ended
June 30,
|
|
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
Supplemental
disclosures of cash flow information: |
|
|
|
|
|
|
|
|
Cash paid
for - |
|
|
|
|
|
|
|
|
Interest |
|
$ |
6,653 |
|
|
$ |
1,498 |
|
Income
taxes |
|
$ |
- |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
Non-cash
financing activities: |
|
|
|
|
|
|
|
|
Deferred
offering costs applied against equity proceeds
|
|
$ |
52,609
|
|
|
$ |
- |
|
Conversion
of accounts payable to long-term liabilities |
|
$ |
332,000
|
|
|
$ |
- |
|
Commitment
shares issued with debt financing |
|
$ |
58,500
|
|
|
$ |
- |
|
Shares
issued with conversion of debt |
|
$ |
235,885
|
|
|
$ |
- |
|
Debt
discounts established for convertible debt |
|
$ |
580,725 |
|
|
$ |
90,000 |
|
Issuance of
common stock for accrued compensation and benefits |
|
$ |
- |
|
|
$ |
306,000 |
|
Increase in
principal amount of convertible note |
|
$ |
5,000 |
|
|
$ |
- |
|
Issuance of
warrants as deemed dividend associated with most-favored nation
provisions of convertible notes |
|
$ |
378,042 |
|
|
$ |
- |
|
Debt and
accrued interest converted to common stock |
|
$ |
4,000 |
|
|
$ |
950,241 |
|
Cashless
warrant exercises |
|
$ |
900 |
|
|
$ |
15,638 |
|
See
accompanying notes to condensed consolidated financial statements
(unaudited).
RESPIRERX
PHARMACEUTICALS INC.
AND
SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS
(Unaudited)
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 (as amended, the
“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. In August 2012, RespireRx
acquired Pier Pharmaceuticals, Inc. (“Pier”), which is now a wholly
owned subsidiary. Pier was a clinical stage biopharmaceutical
company developing a pharmacologic treatment for obstructive sleep
apnea (“OSA”) and had been engaged in research and clinical
development activities which activities are now in
RespireRx.
Basis of
Presentation
The
condensed consolidated financial statements are of RespireRx and
its wholly-owned subsidiary, Pier (collectively referred to herein
as the “Company,” “we” or “our,” unless the context indicates
otherwise). The condensed consolidated financial statements of the
Company at September 30, 2021 and for the three-months and
nine-months ended September 30, 2021 and 2020, 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, the condensed results of operations, condensed changes in
stockholders’ deficiency and condensed changes in cash flows as of
and for the periods ended September 30, 2021and 2020. 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,
2020 has been derived from the Company’s audited consolidated
financial statements at such date. For comparative purposes,
certain 2021 and 2020 amounts, including, but not limited to, share
and per share amounts, par value and additional paid-in capital
have been adjusted to a post-reverse stock split basis which
occurred on January 5, 2021.
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 note disclosures normally included in
financial statements prepared in accordance with United States
generally accepted accounting principles (“GAAP”) 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, 2020 as filed with the SEC on April 15,
2021 (“2020 Form 10-K”).
2.
Business
The mission
of the Company is to develop innovative and revolutionary
treatments to combat disorders caused by disruption of neuronal
signaling. We are developing treatment options that address
conditions that affect millions of people, but for which there are
limited or poor treatment options, including obstructive sleep
apnea (“OSA”), attention deficit hyperactivity disorder (“ADHD”),
epilepsy, chronic pain, including inflammatory and neuropathic
pain, recovery from spinal cord injury (“SCI”), as well as other
areas of interest based on results of preclinical and clinical
studies to date.
RespireRx is
developing a pipeline of new drug products based on our broad
patent portfolios across two distinct drug platforms:
|
(i) |
our
pharmaceutical cannabinoids platform (which we refer to as
ResolutionRx) is developing compounds that target the body’s
endocannabinoid system, and in particular, the re-purposing of
dronabinol, an endocannabinoid CB1 and CB2 receptor agonist, for
the treatment of OSA. Dronabinol is already approved by the FDA for
other indications. |
|
|
|
|
(ii) |
our
neuromodulators platform (which we refer to as EndeavourRx) is made
up of two programs: (a) our AMPAkines program, which is developing
proprietary compounds that are positive allosteric modulators
(“PAMs”) of AMPA-type glutamate receptors to promote neuronal
function and (b) our GABAkines program, which is developing
proprietary compounds that are PAMs of GABAA receptors,
and which was established pursuant to our entry into a patent
license agreement (the “UWMRF Patent License Agreement”) with the
University of Wisconsin-Milwaukee Research Foundation, Inc., an
affiliate of the University of Wisconsin-Milwaukee
(“UWMRF”). |
Financing our
Platforms
Our major
challenge has been to raise substantial equity or equity-linked
financing to support research and development plans for our
pharmaceutical cannabinoid and neuromodulator platforms, while
minimizing the dilutive effect to pre-existing stockholders. At
present, we believe that we are hindered primarily by our public
corporate structure, our common stock not being listed on a
national exchange, and low market capitalization as a result of our
low stock price. Our shares are quoted on the OTCQB, the OTC
Market’s venture market.
For this
reason, the Company has implemented an internal restructuring plan
through which our two drug platforms have been reorganized into
separate business units and may in the future be organized into
subsidiaries of RespireRx. We believe that by creating one or more
subsidiaries to further the aims of ResolutionRx and EndeavourRx,
it may be possible, through separate finance channels, to optimize
the asset values of each. We are also planning to commence,
assuming the SEC qualifies the offering, a securities offering
pursuant to Regulation A under the Securities Act. See Note 9.
Subsequent Events – Filing of Form 1-A for further
information.
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 $708,682
and
$2,371,145
for the
three-months and nine-months ended September 30, 2021,
respectively, and $4,301,211
for the
fiscal year ended December 31, 2020, as well as negative operating
cash flows of $800,622
for the
nine-months ended September 30, 2021 and $513,001
for the
fiscal year ended December 31, 2020. The Company also had a
stockholders’ deficiency of $9,424,888
at September
30, 2021 and expects to continue to incur net losses and negative
operating cash flows for the foreseeable future. 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, 2020, 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.
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 assurance 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 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.
Reverse Stock
Split on January 5, 2021
On January
5, 2021,
the Company effected a ten to one reverse-stock split of its common
stock. Every ten shares of
the “old” common stock was exchanged for one “new” share of common
stock rounded down to the nearest whole share with any fractional
shares of common stock paid to the stockholder in cash. Option and
warrant issuances prior to January 5, 2021 have also been
proportionately adjusted by dividing the number of shares into
which such options and warrants may exercise by ten and multiplying
the exercise price by ten. The effect of the reverse-stock split
has been reflected retroactively in the Company’s consolidated
financial statements as of December 31, 2020 and any interim
periods in 2020. Certain amount with respect to 2019 that appear in
these condensed consolidated financial statements have also been
reflected on a post reverse-stock split basis.
Concentration 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.
Value of Financial
Instruments
The
authoritative guidance with respect to value of financial
instruments established a value hierarchy that prioritizes the
inputs to valuation techniques used to measure value into three
levels and requires that assets and liabilities carried at 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 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 value hierarchy within which each value
measurement falls in its entirety, based on the lowest level input
that is significant to the 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, and accounts payable and accrued expenses) are
considered by the Company to be representative of the respective
values of these instruments due to the short-term nature of those
instruments. With respect to the note payable to SY Corporation
Co., Ltd. (“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 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 and accounting 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
equity financings are netted against the proceeds.
Debt Issuance
Costs
The Company
presents debt issuance costs related to debt obligations in its
consolidated balance sheet as a direct deduction from the carrying
amount of that debt obligation, consistent with the presentation
for debt discounts.
Convertible Notes
Payable
Convertible
notes are evaluated to determine if they should be recorded at
amortized cost. To the extent that there are associated warrants,
commitment shares of common stock or a beneficial conversion
feature, the convertible notes and equity or equity-linked
securities are evaluated to determine if there are embedded
derivatives to be identified, bifurcated and valued in connection
with and at the time of such financing.
Extinguishment of
Debt and Settlement of Liabilities
The Company
accounts for the extinguishment of debt and settlement of
liabilities by comparing the carrying value of the debt or
liability to the 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. See Note 4 for additional
information.
Prepaid
Insurance
Prepaid
insurance represents the premiums paid in March 2021 for directors
and officers insurance and other insurance in April 2021. The
amounts of prepaid insurance amortizable in the ensuing
twelve-month period are recorded as prepaid insurance in the
Company’s consolidated balance sheet at each reporting date and
then amortized to the Company’s consolidated statement of
operations for each reporting period.
Stock-Based
Awards
The Company
periodically issues common stock and stock options to officers,
directors, Scientific Advisory Board members, consultants and
vendors 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, directors, outside
consultants and vendors by measuring the cost of services
provided 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
consolidated financial statements over the vesting period of the
awards.
Stock grants
and stock options, which are sometimes subject to time-based
vesting, are measured at the grant date fair value and charged to
operations ratably over the vesting period.
The value of
stock options granted as stock-based payments 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 and
stock option grants and warrants issued to non-employees as
compensation for services to be provided to the Company is
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.
Stock and
stock option grants and warrants issued to non-employees for
services already rendered represent settlement of debt or
liabilities and are accounted for by valuing both the amount of the
amount of debt or liabilities settled and the value of the stock,
stock option or warrant grants and recording a gain or loss as
appropriate.
Stock and
stock option grants and warrants issued to officers, directors,
employees and affiliates in settlement of accrued compensation or
other amounts payable are recorded at the amount of the liability
settled. Therefore, there are no gains or losses recorded with
respect to such settlements.
There were
no stock or stock option
grants during the nine-months ended September 30, 2021.
The Company
recognizes the amortized value of stock-based payments 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 nine-months ended September 30, 2021 and 2020,
respectively.
There were
warrants to purchase
380,568 shares of common stock
issued as compensation or for services during the nine-months ended
September 30, 2021 and
none during the nine-months
ended September 30, 2020. Warrants, if issued for services, are
typically issued to placement agents or brokers for fund raising
services. In addition warrants to purchase
31,766,883 shares of common stock
were issued to lenders during the nine-months ended September 30,
2021 with respect to or in association with the issuance of
convertible notes to such lenders. Warrant are not issued from any
of the Company’s stock and option plans, from which options issued
to non-employees for services are typically issued.
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
September 30, 2021, 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 September 30, 2021, 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, including but
not limited to compensation paid to our Chief Scientific Officer
who is also our Executive Chairman, 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.
License
Agreements
Obligations
incurred with respect to mandatory payments provided for in license
agreements are recognized ratably over the appropriate term, 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 expenses in the
Company’s condensed consolidated statement of
operations.
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 and recorded as general and administrative
expenses.
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 loss
attributable to common stockholders consists of net 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 September
30, 2021 and 2020 the Company excluded the outstanding shares of
common stock in the table below, into which the securities
described below may convert, thereby entitling the holders thereof
to acquire shares of common stock, from the Company’s calculation
of earnings per share, as the effect would have been
anti-dilutive.
Schedule
of Anti-dilutive Securities Excluded from Computation of Earnings
Per Share
|
|
|
|
|
|
|
|
|
|
|
September
30, |
|
|
|
2021 |
|
|
2020 |
|
Series B
convertible preferred stock |
|
|
1 |
|
|
|
1 |
|
Convertible
notes payable |
|
|
40,542,856 |
|
|
|
4,723,986 |
|
Common stock
warrants |
|
|
59,505,140 |
|
|
|
28,809,358 |
|
Common stock
options |
|
|
7,111,924 |
|
|
|
7,166,094 |
|
Total |
|
|
107,159,921 |
|
|
|
40,699,439 |
|
Reclassifications
Certain
comparative figures in 2020 have been reclassified to conform to
the current quarter’s presentation. These reclassifications were
immaterial, both individually and in the aggregate.
Recent Accounting
Pronouncements
In August
2020, the FASB issued Accounting Standards Update No. 2020-06, Debt
– Debt with Conversion and Other Options (Subtopic 470-20) and
Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic
815-40). The subtitle is Accounting for Convertible Instruments and
Contracts in an Entity’s Own Equity. This Accounting Standard
Update (“ASU”) addresses complex financial instruments that have
characteristics of both debt and equity. The application of this
ASU would reduce the number of accounting models for convertible
debt instruments and convertible preferred stock. Limiting the
accounting models would result in fewer embedded conversion
features being separately recognized from the host contract as
compared with current GAAP. Convertible instruments that continue
to be subject to separation models are (1) those with embedded
conversion features that are not clearly and closely related to the
host contract, that meet the definition of a derivative, and that
do not qualify for a scope exception from derivative accounting and
(2) convertible debt instruments issued with substantial premiums
for which the premiums are recorded as paid-in capital. The Company
has historically issued complex financial instruments and has
considered whether embedded conversion features have existed within
those contracts or whether derivatives would appropriately be
bifurcated. To date, no such bifurcation has been necessary.
However, it is possible that this ASU may have a substantial impact
on the Company’s financial statements. Management is evaluating the
potential impact. This ASU becomes effective for fiscal years
beginning after December 15, 2023.
In January
2020, the FASB issued ASU 2020-01, Clarifying the Interactions
between Topic 321, Topic 323, Equity Method and Joint Ventures, and
Topic 815, Derivatives and Hedging which represents an amendment
clarifying the interaction between accounting standards related to
equity securities, equity method investments and certain
derivatives. The guidance is effective for fiscal years beginning
after December 15, 2020 and interim periods within those years.
Management has evaluated the guidance and determined that the
implementation of such guidance does not have a material impact on
our condensed consolidated financial statements.
4.
Notes
Payable
Convertible Notes
Payable
On April 1,
2021, May 3, 2021, May 10, 2021, June 30, 2021 and August 31, 2021,
the Company closed on financings, pursuant to which, five
convertible notes were issued to four separate investors, due in
each case, one year from the effective date (which for the each
closing was March 31, 2021, April 30, 2021, May 10, 2021, June 29,
2021 and August 31, 2021, respectively), with maturity amounts of
$112,500,
$150,000,
$150,000,
$115,000
and
$115,000,
respectively. In addition, the noteholders received as
consideration, warrants to purchase
2,400,000,
3,200,000,
3,200,000,
2,453,333 and
5,750,000 shares of common stock,
respectively, each exercisable for a period of five years at an
exercise price of $0.02
per share.
The August 31, 2021 issuance triggered the most-favored nation
provisions of four notes already outstanding, resulting in the
issuance of
15,121,667 additional warrants on
September 7, 2021. As a result of the note issuances, the Company
received net proceeds of $96,750,
$123,400,
$123,400,
$100,000
and
$103,500
respectively, for an
aggregate of $547,050.
The
difference between the maturity amounts and the net proceeds were
due to original issue discounts, in four cases, investor legal fees
and in two cases, broker fees. The five notes are convertible at a
fixed price of $0.02
per share
and bear interest at
10% per year which interest
is guaranteed regardless of prepayment. The Company has the right
to prepay the notes during the first six months subject to
prepayment premiums that range from
0% to
15% (100%
to
115% of the maturity amount
plus accrued interest and any default interest and similar
costs).
The Company
periodically issues convertible notes with similar characteristics.
As described in the table below, as of September 30, 2021, there
were nine such notes outstanding (including the convertible notes
described in the paragraph above), two of which were satisfied in
full by conversion of both principal and interest and one of which
was satisfied in part, principal only, during that period. These
notes all have or had a fixed conversion price of $0.02
per share of
common stock, subject to adjustment in certain circumstances. All
notes but one had an annual interest rate of
10% which was guaranteed in
full. One note had an annual interest rate of
8%. The convertible notes
had an original issue discount (“OID”), debt issuance costs (“DIC”)
that were capitalized by the Company, a warrant (“WT”) or
commitment shares (“CS”) and in three cases a beneficial conversion
feature (“BCF”). The OID, CN, WTs, CSs and BCF allocated values are
amortized over the life of the notes to interest expense. All notes
mature or matured nine to fifteen months from their issuance date.
All notes were prepayable by the Company during the first six
months, subject to prepayment premiums that range from
100% to
115% of the maturity amount
plus accrued interest. If not earlier paid, the notes were
convertible by the holder into the Company’s common stock. Two of
the notes were paid before maturity.
The table
below summarizes the convertible notes with similar characteristics
outstanding as of September 30, 2021 and the repayments by
conversion during the nine-months ended September 30,
2021:
Schedule
of Convertible Notes Outstanding
Inception
Date |
|
Maturity
date |
|
Original
Principal Amount |
|
|
Interest
rate |
|
|
Original
aggregate DIC, OID, Wts, CS and BCF |
|
|
Cumulative
amortization of DIC, OID, Wts, CS and BCF |
|
|
Accrued
coupon interest |
|
|
Repayment
by
conversion |
|
|
Balance
sheet
carrying amount
at September 30,
2021 inclusive
of accrued interest |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
July 2,
2020 |
|
April 2,
2021 |
|
$ |
137,500 |
|
|
|
10.00 |
% |
|
$ |
(44,423 |
) |
|
$ |
44,423 |
|
|
$ |
6,875 |
|
|
$ |
(144,375 |
) |
|
$ |
- |
|
July 28,
2020 |
|
July 28,
2021 |
|
|
45,000 |
|
|
|
8.00 |
% |
|
|
(5,000 |
) |
|
|
— |
|
|
|
2,743 |
|
|
|
(25,000 |
) |
|
|
17,743 |
|
July 30,
2020 |
|
October 30,
2021 |
|
|
75,000 |
|
|
|
10.00 |
% |
|
|
(27,778 |
) |
|
|
27,778 |
|
|
|
4,136 |
|
|
|
(79,136 |
) |
|
|
- |
|
February 17,
2021 |
|
November 17,
2021 |
|
|
112,000 |
|
|
|
10.00 |
% |
|
|
(112,000 |
) |
|
|
91,608 |
|
|
|
9,161 |
|
|
|
- |
|
|
|
100,769 |
|
April 1,
2021 |
|
March 31,
2022 |
|
|
112,500 |
|
|
|
10.00 |
% |
|
|
(112,500 |
) |
|
|
56,404 |
|
|
|
5,640 |
|
|
|
- |
|
|
|
62,044 |
|
May 3,
2021 |
|
April 30,
2022 |
|
|
150,000 |
|
|
|
10.00 |
% |
|
|
(150,000 |
) |
|
|
62,877 |
|
|
|
6,288 |
|
|
|
- |
|
|
|
69,165 |
|
May 10,
2021 |
|
May 10,
2022 |
|
|
150,000 |
|
|
|
10.00 |
% |
|
|
(150,000 |
) |
|
|
58,767 |
|
|
|
5,877 |
|
|
|
- |
|
|
|
64,644 |
|
June 30,
2021 |
|
June 29,
2022 |
|
|
115,000 |
|
|
|
10.00 |
% |
|
|
(115,000 |
) |
|
|
29,301 |
|
|
|
2,930 |
|
|
|
- |
|
|
|
32,231 |
|
August 31,
2021 |
|
August 31,
2022 |
|
|
115,000 |
|
|
|
10.00 |
% |
|
|
(109,675 |
) |
|
|
9,015 |
|
|
|
945 |
|
|
|
- |
|
|
|
15,285 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
$ |
1,012,000 |
|
|
|
|
|
|
$ |
(826,376 |
) |
|
$ |
380,173 |
|
|
$ |
44,595 |
|
|
$ |
(248,511 |
) |
|
$ |
361,881 |
|
In addition
to what appears in the table above, there is outstanding accrued
interest of $2,747
from a prior
floating rate convertible note that has not been paid in cash or by
conversion as of September 30, 2021.
On July 27,
2021, the maturity date of the note scheduled to mature on
July 28, 2021,was extended to
December 1, 2021 and the original and
remaining principal amount of the note was increased by $5,000
from
$40,000
to
$45,000
and from
$15,000
to
$20,000
respectively, with
interest on the incremental increase in principal amount accruing
from the note inception date. Since the Company did not receive any
cash proceeds from the increase in the principal amount of the
note, the increase was recorded as a debt discount to be amortized
to interest expense through the maturity date.
In addition
to the convertible notes with similar characteristics described
above, on December 31, 2018 and January 2, 2019, the Company issued
convertible notes to a single investor totaling $35,000
of maturity
amount with accrued interest of $10,399
as of
September 30, 2021. The number of shares of common stock (or
preferred stock) into which these notes may convert is not
determinable. The warrants to purchase
19,000 shares of common stock
issued in connection with the sale of these notes and other
convertible notes issued December 2018 and March 2019 are
exercisable at a fixed price of $15.00
per share of
common stock, provide 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 and
expire on
December 30, 2023.
Other
convertible notes were also sold to investors in 2014 and 2015
(“Original Convertible Notes”), which aggregated a total of
$579,500,
and had a fixed interest rate of
10% per annum. The Original
Convertible Notes have no reset rights or other protections based
on subsequent equity transactions, equity-linked transactions or
other events. The warrants to purchase shares of common stock
issued in connection with the sale of the Original Convertible
Notes have either been exchanged as part of note and warrant
exchange agreements executed in April and May of 2016 or expired on
September 15, 2016.
The
remaining outstanding Original Convertible Notes (including those
for which default notices have been received) consist of the
following at September 30, 2021 and December 31, 2020:
Schedule
of Convertible Notes Payable
|
|
September
30, 2021 |
|
|
December 31,
2020 |
|
Principal
amount of notes payable |
|
$ |
75,000 |
|
|
$ |
75,000 |
|
Accrued
interest payable |
|
|
74,763 |
|
|
|
64,357 |
|
Foreign
currency transaction adjustment |
|
|
(16,838 |
) |
|
|
53,393 |
|
Total
note payable |
|
$ |
149,256 |
|
|
$ |
139,357 |
|
As of
September 30, 2021, principal and accrued interest on the Original
Convertible Note that is subject to a default notice accrues annual
interest at
12% instead of
10%, totaled $52,337,
of which $27,337
was accrued
interest. As of December 31, 2020, principal and accrued interest
on Original Convertible Notes subject to default notices totaled
$48,700
of which
$23,700
was accrued
interest.
As of
September 30, 2021 all of the outstanding Original Convertible
Notes, inclusive of accrued interest, were convertible into an
aggregate of
1,317 shares of the Company’s
common stock. Such Original Convertible Notes will continue to
accrue interest until exchanged, paid or otherwise discharged.
There can be no assurance that any of the additional holders of the
remaining Original Convertible Notes will exchange their Original
Convertible 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 as of that date) from and executed a secured note
payable to SY Corporation Co., Ltd., (“SY Corporation”). 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
nine-months ended September 30, 2021, 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, dating back to January,
August and September 2007, 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 that the Company is no longer developing and where patent
rights date back to January, August and September 2007. The
security interest does not extend to the Company’s patents for its
low impact ampakine compounds, such as CX717, CX1739 and CX1942 or
certain related method of use patents.
The note
payable to SY Corporation consists of the following at September
30, 2021 and December 31, 2020:
Schedule
of Convertible Notes Payable
|
|
September
30, 2021 |
|
|
December 31,
2020 |
|
Principal
amount of note payable |
|
$ |
399,774 |
|
|
$ |
399,774 |
|
Accrued
interest payable |
|
|
447,266 |
|
|
|
411,384 |
|
Foreign
currency transaction adjustment |
|
|
(16,838 |
) |
|
|
53,393 |
|
Total
note payable |
|
$ |
830,202 |
|
|
$ |
864,551 |
|
Interest
expense with respect to this promissory note was $35,881
and
$36,013
for the
nine-months ended September 30, 2021 and 2020, respectively, and
$12,092
for the
three-months ended September 30, 2021 and 2020.
Notes
Payable to Officers and Former Officers
The
following amounts were charged to interest expense with respect to
notes payable to Dr. Arnold S. Lippa: $3,096
and
$2,848
for the
three-months ended September 30, 2021 and 2020, respectively, and $
9,193 and $8,481
for the
nine-months ended September 30, 2021 and 2020,
respectively.
The
following amounts were charged to interest expense with respect to
notes payable to Dr. James S. Manuso: $4,702
and
$4,274
for the
three-months ended September 30, 2021 and 2020, respectively, and
$13,954
and
$12,714
for the
nine-months ended September 30, 2021 and 2020,
respectively.
Other
Short-Term Notes Payable
Other
short-term notes payable at September 30, 2021 and December 31,
2020 consisted of premium financing agreements with respect to
various insurance policies. At September 30, 2021, a premium
financing agreement was payable in the initial amount of $81,672
(after
payment of a deposit of $20,347),
with interest at
11% per annum, in eight
monthly installments of $10,635.
In addition, there is $9,238
of
short-term financing of office and clinical trials insurance
premiums. At September 30, 2021 and December 31, 2020, the
aggregate amount of the short-term notes payable was $35,982
and
$4,608
respectively.
5.
Settlement and Payment
Agreements
On February 21,
2020, Sharp Clinical Services, Inc. (“Sharp”), a vendor of the
Company, filed a complaint against the Company in the Superior
Court of New Jersey Law Division, Bergen County related to a
December 16, 2019 demand for payment of past due invoices inclusive
of late fees totaling $103,890
of which
$3,631 related to late fees, seeking $100,259 plus 1.5% interest
per month on outstanding unpaid invoices. On May 29, 2020, a
default was entered against the Company, and on September 4, 2020,
a final judgment by default was entered against the Company in the
amount of $104,217.
On March 3, 2021, we executed a settlement agreement with Sharp
(the “Sharp Settlement Agreement”), and on March 9, 2021, Sharp
requested of the Bergen (NJ) County Sheriff, the return of the Writ
of Execution which resulted in a release of the lien in favor of
Sharp. The Sharp Settlement Agreement calls for a payment schedule
of ten $10,000 payments due on April 1, 2021 and every other month
thereafter, and permitted early settlement at $75,000 if the
Company had paid Sharp that lower total by August 1, 2021, but the
Company did not pay Sharp that lower amount by that date. The
Company has recorded a liability to Sharp of $63,859
as of
September 30, 2021 after payments totaling $30,000
pursuant to
the Sharp Settlement Agreement.
By letter
dated February 5, 2016, the Company received a demand from a law
firm representing Salamandra, LLC (“Salamandra”) alleging an amount
due and owing for unpaid services rendered. On January 18, 2017,
following an arbitration proceeding, an arbitrator awarded
Salamandra the full amount sought in arbitration of $146,082.
Additionally, the arbitrator granted Salamandra attorneys’ fees and
costs of $47,937.
All such amounts have been accrued as of September 30, 2021 and
December 31, 2020, including accrued interest at
4.5% annually from February 26, 2018, the date of the
judgment, through September 30, 2021, totaling $29,897. The Company
had previously entered into a settlement agreement with Salamandra
that is no longer in effect. The Company has approached
Salamandra seeking to negotiate a new settlement agreement. A lien
with respect to the amounts owed is in effect.
On February
23, 2021, our bank received two New Jersey Superior Court Levies
totaling $320,911
related to
amounts owed to Sharp and Salamandra which amounts were not in
dispute. The bank debited our accounts and restricted access to
those accounts pursuant to the liens placed on the accounts. Our
accounts were debited for $1,559
on February
23, 2021, which represented all of the cash in our accounts on that
date.
On April 29,
2021, the Company entered into a payment and settlement agreement
with the University of California Innovation and Entrepreneurship,
pursuant to which it agreed to a payment schedule that is reflected
in accounts payable and accrued expenses in the Company’s condensed
consolidated financial statements. The total amount due is
$234,657.
The agreed payment schedule is for the Company to pay $10,000 on
each of July 1, 2021, September 1, 2021, November 1, 2021, January
1, 2022 and March 31, 2022. If the Company pays an aggregate of
$175,000 on or before March 31, 2022, the amounts will be
considered paid in full with no further amounts due. If an
aggregate of $175,000 has not been paid by March 31, 2022, the
remaining unpaid amount up to an aggregate of the original amount
of $234,657 would be due and payable. The payments due on
July 1, 2021 and
September 1, 2021 were timely paid.
On September
14, 2021, the Company and DNA Healthlink, Inc. (“DNA Healthlink”) entered into a
settlement agreement (the “ DNA Healthlink Settlement Agreement”)
regarding $410,000
in unpaid
accounts payable owed by the Company to DNA Healthlink (the “DNA
Healthlink Settlement
Amount”) for services provided by DNA Healthlink to the
Company pursuant to an agreement by and between the Company and DNA
Healthlink dated October 15, 2014.
Under the terms of the DNA Healthlink Settlement Agreement, the
Company is obligated to pay to DNA Healthlink the full DNA
Healthlink Settlement Amount as follows: twelve monthly payments of
$8,000each
commencing on November 15, 2021, followed by twelve monthly
payments of $10,000 each
commencing on November 15, 2022, followed by twelve monthly
payments of $15,000 each
commencing on November 15, 2023, followed by one final payment of
$14,000 on
November 15, 2024.
If, prior to March 14, 2023, the Company receives one or more
upfront license fee payments or any other similar fee or fees from
one or more strategic partners that aggregate at least fifteen
million dollars ($15,000,000.00)
(“Upfront
Fees”), then the full DNA Healthlink Settlement
Amount, less any amounts previously paid, will be accelerated and
become due and payable in full within ninety (90) days of receipt
of any Upfront Fees. As a result of the DNA Healthlink Settlement
Agreement, the Company recorded a gain with respect to vendor
settlements of $62,548.
An annual
obligation payable to the
University of Illinois of $100,000
that was originally due on December 31, 2020 pursuant to the 2014
License Agreement was extended to April 19, 2021 and was paid in
full on April 1, 2021.
By email
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
payable for investment banking services rendered. Such amount has
been included in accrued expenses at September 30, 2021 and
December 31, 2020. See Note 1 for additional information on the
Pier transaction.
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 as of September 30, 2021 and December 31, 2020
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.
6.
Stockholders’
Deficiency
Preferred
Stock
RespireRx
has authorized a total of
5,000,000 shares of preferred
stock, par value $0.001
per share.
As of September 30, 2021 and December 31, 2020,
37,500 shares were designated
as Series B Convertible Preferred Stock (non-voting, “Series B
Preferred Stock”).
Series B
Preferred Stock outstanding as of September 30, 2021 and 2020
consisted of
37,500 shares issued in a May
1991 private placement. The shares of Series B Preferred Stock are
convertible into
1 share of common stock.
RespireRx may redeem the Series B Preferred Stock for $25,001
at any time
upon 30 days prior notice.
Although
other series of preferred stock have been designated, no other
shares of preferred stock are outstanding. As of September 30, 2021
and December 31, 2020,
3,504,424 shares of preferred
stock were undesignated and may be issued with such rights and
powers as the Board of Directors may designate.
Common
Stock
RespireRx
has authorized
2,000,000,000 (2 billion) shares of
common stock, par value $0.001
per share.
There are
90,396,596 shares of the Company’s
common stock outstanding as of September 30, 2021. After reserving
for conversions of convertible debt and convertible preferred
stock, as well as exercises of common stock purchase options
(granted and available for grant within the 2014 and 2015 stock and
stock option plans) and warrants and the issuance of Pier
contingent shares and before accounting for incremental contract
excess reserves, there were
1,786,678,967 shares of the Company’s
common stock available for future issuances as of September 30,
2021. After accounting for incremental excess reserves
contractually required by the various convertible notes and certain
warrants, there were
1,702,729,267 shares of common stock
available for future issuances as of September 30, 2021. On May 27,
2021, a holder of a warrant exercised the warrant in part,
exercising into
900,000 shares of common stock
on a cashless basis, what would have exercised into
1,665,958 shares of common stock
on a cash basis. The Company did not receive any cash proceeds from
the exercise. No other warrants were exercised during the
nine-months ended September 30, 2021. No options were exercised
during the nine-months ended September 30, 2021. No warrants or
options were exercised after September 30, 2021. See Note 9 for a
description of a partial warrant exercise and a conversion of a
portion of the principal amount of one convertible note, both
occurring on November 8, 2021.
Common
Stock Warrants
A summary of
warrant activity for the nine-months ended September 30, 2021 is
presented below.
Schedule
of Warrants Activity
|
|
Number
of
Shares |
|
|
Weighted
Average
Exercise Price |
|
|
Weighted
Average
Remaining
Contractual
Life (in Years) |
|
Warrants
outstanding at December 31, 2020 |
|
|
28,809,352 |
|
|
$ |
0.1528 |
|
|
|
2.64 |
|
Issued |
|
|
33,432,841 |
|
|
|
0.0200 |
|
|
|
|
|
Expired |
|
|
(8,595 |
) |
|
|
|
|
|
|
|
|
Cancelled
upon exchange |
|
|
(1,062,500 |
) |
|
|
0.0700 |
|
|
|
|
|
Exercised -
cashless |
|
|
(1,665,958 |
) |
|
|
0.0200 |
|
|
|
|
|
Warrants outstanding at
September 30, 2021 |
|
|
59,505,140 |
|
|
$ |
0.0721 |
|
|
|
2.12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants exercisable at
September 30, 2020 |
|
|
28,809,358 |
|
|
$ |
0.1474 |
|
|
|
2.89 |
|
Warrants exercisable at
September 30, 2021 |
|
|
59,505,140 |
|
|
$ |
0.0721 |
|
|
|
2.12 |
|
The exercise
prices of common stock warrants outstanding and exercisable are as
follows at September 30, 2021:
Schedule
of Exercise Prices of Common Stock Warrants Outstanding and
Exercisable
Exercise
Price |
|
|
Warrants
Outstanding and Exercisable (Shares) |
|
|
Expiration
Date |
$ |
0.016 |
|
|
|
2,212,500 |
|
|
May 17,
2022 |
$ |
0.020 |
|
|
|
31,386,315 |
|
|
March 31,
2026-September
7, 2021 |
$ |
0.039 |
|
|
|
208,227 |
|
|
May 10,
2026 |
$ |
0.047 |
|
|
|
172,341 |
|
|
May 3,
2026 |
$ |
0.070 |
|
|
|
25,377,426 |
|
|
September 30,
2023 |
$ |
11.00
-27.50 |
|
|
|
148,331 |
|
|
December 31,
2021-December
30, 2023 |
|
|
|
|
|
59,505,140 |
|
|
|
Based on a
value of $0.0230
per share on
September 30, 2021, there were
33,598,815 exercisable in-the-money
common stock warrants as of September 30, 2021.
The exercise
prices of common stock warrants outstanding and exercisable at
September 30, 2020 ranged from $0.0161
to
$79.30
and these
warrants were exercisable into an aggregate of
28,809,358 shares, which warrants
have expired or will expire as applicable, between
February 28, 2021 and October 22, 2024.
The exercise
prices of common stock warrants outstanding and exercisable at
September 30, 2020 ranged from $0.016 to $79.30
and these
warrants were exercisable into an aggregate of
28,809,358 shares, which warrants
have expired or will expire, as applicable, between
February 28, 2021 and October 22, 2024.
Based on a
value of $0.054
per share on
September 30, 2020, there were
28,652,426 exercisable in-the-money
common stock warrants as of that date.
Stock
Options
On March 18,
2014, the stockholders of RespireRx holding a majority of the votes
to be cast on the issue approved the adoption of RespireRx’s 2014
Equity, Equity-Linked and Equity Derivative Incentive Plan (the
“2014 Plan”), which had been previously adopted by the Board of
Directors, subject to stockholder approval. The Plan permits the
grant of options and restricted 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 (as amended, the “2015 Plan”). As of September 30,
2021, there are
15,757,542 shares available in the
2015 Plan. On July 29, 2021, the Company amended the 2015 Plan to
increase the number of shares by an additional
7,000,000 to
22,898,526 shares. The Company has
not and does not intend to present the 2015 Plan to stockholders
for approval.
Information
with respect to the Black-Scholes variables used in connection with
the evaluation of the fair value of stock-based compensation costs
and fees is provided at Note 3.
A summary of
stock option activity for the six-months ended September 30, 2021
is presented below.
Summary
of Stock Option Activity
|
|
Number
of
Shares
|
|
|
Weighted
Average
Exercise
Price
|
|
|
Weighted
Average
Remaining
Contractual
Life (in
Years)
|
|
Options outstanding at
December 31, 2020 |
|
|
7,165,215 |
|
|
$ |
1.96 |
|
|
|
4.98 |
|
Expired |
|
|
(53,291 |
) |
|
|
73.78 |
|
|
|
- |
|
Options outstanding at
September 30, 2021 |
|
|
7,111,924 |
|
|
$ |
1.43 |
|
|
|
3.88 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at
September 30, 2021 |
|
|
7,111,924 |
|
|
$ |
1.43 |
|
|
|
3.88 |
|
The exercise
prices of common stock options outstanding and exercisable were as
follows at September 30, 2021:
Schedule
of Exercise Prices of Common Stock Options Outstanding and
Exercisable
Exercise
Price |
|
|
Options
Outstanding (Shares) |
|
|
Options
Exercisable (Shares) |
|
|
Expiration
Date |
$ |
0.0540 |
|
|
|
1,700,000 |
|
|
|
1,700,000 |
|
|
September 30,
2025 |
$ |
0.072 |
|
|
|
5,050,000 |
|
|
|
5,050,000 |
|
|
July 31,
2025 |
$ |
7.00-$195.00 |
|
|
|
361,924 |
|
|
|
361,924 |
|
|
September 12,
2021 -
December 9, 2027 |
|
|
|
|
|
7,111,924 |
|
|
|
7,111,924 |
|
|
|
There was no
deferred compensation expense for the outstanding and unvested
stock options at September 30, 2021.
Based on a
fair value of $0.023
per share on
September 30, 2021, there were no exercisable in-the-money common
stock options as of that date.
Reserved and
Unreserved Shares of Common Stock
As of
September 30, 2021, there are
2,000,000,000 shares of common stock
authorized, of which
90,396,596 are issued and
outstanding. As of September 30, 2021, there are outstanding
options to purchase
7,111,924 shares of common stock
and
6,325 and
15,757,542 shares available for
issuance under the 2014 Plan and 2015 Plan, respectively. There are
649 Pier contingent shares of common stock that may be issued under
certain circumstances. As of September 30, 2021, there are
40,542,856 shares issuable upon
conversion of convertible notes. As of June 30, 2021, there are
59,505,150 shares that may be
issued upon exercise of outstanding warrants. As of September 30,
2021, the Series B Preferred Stock may convert into 1 share of
common stock. Therefore, the Company is reserving
146,542,854 shares of common stock
for future issuances with respect to conversions and exercises as
well as for the Pier contingent shares. In addition, certain
convertible notes and related warrants impose an additional
contractual reserve requirement, above the number of shares into
which such convertible notes and related warrants may convert or
exercise respectively. Although the Company does not anticipate
having to issue such shares, such incremental additional
contractual reserves total
83,949,701 shares of common
stock.
7.
Related Party
Transactions
Dr. Arnold
S. Lippa and Jeff E. Margolis, officers and directors of RespireRx
since March 22, 2013, have indirect ownership and managing
membership interests in Aurora Capital LLC (“Aurora”) through
interests held in its members, and Jeff E. Margolis is also an
officer of Aurora. Aurora was a boutique investment banking firm
specializing in the life sciences sector that ceased its securities
related activities in April 2021. On May 5, 2021, Aurora filed to
withdraw its membership with FINRA and its registration with the
SEC which withdrawal became effective in July 2021. Although Aurora
has not provided services to RespireRx during the nine-months ended
September 30, 2021 or the fiscal year ended December 31, 2020,
Aurora had previously provided services to the Company and there
remains $96,000
owed to
Aurora by RespireRx which amount is included in accounts payable
and accrued expenses as of September 30, 2021.
A
description of advances and notes payable to officers is provided
at Note 4.
8.
Commitments and
Contingencies
Pending or
Threatened Legal Action and Claims
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 condensed
consolidated financial statements as of September 30, 2021 and 2020
with respect to such matters. See Note 5 for additional items and
details.
Significant
Agreements and Contracts
The Company entered into a consulting contract with David Dickason
effective September 15, 2020 pursuant to which Mr. Dickason was
appointed and serves as the Company’s Senior Vice President of
Pre-Clinical Product Development on an at-will basis at the rate of
$250 per hour. The Company recorded but did not pay cash
compensation expense pursuant to this agreement of
$72,375
for the
nine-months ended September 30, 2021.
See Note 5
for details of other agreements and contracts.
Employment
Agreements
Timothy L.
Jones, Arnold S. Lippa and Jeff E. Margolis have similar employment
agreements. Mr. Jones was appointed as RespireRx’s President and
Chief Executive Officer on May 6, 2020. Dr. Lippa is RespireRx’s
Chief Scientific Officer and Executive Chairman and Mr. Margolis is
the Company’s Senior Vice President, Chief Financial Officer,
Treasurer and Secretary. Dr. Lippa’s and Mr. Margolis’ employment
agreements became effective on August 18, 2015. All three
agreements are subject to automatic annual extensions on September
30th of each year beginning with the initial termination
date if not earlier terminated, subject to notice in accordance
with the terms of the agreements. Mr. Jones’ initial termination
date is
September 30, 2023 and Dr. Lippa’s and Mr.
Margolis’ agreements are in their automatic extension
periods.
The table
below summarized the current cash commitments to each individual
through the next September 30th renewal date and in the
case of Mr. Jones, through September 30, 2023.
Summary
of Current Cash Commitments in Employment
Agreements
|
|
Contract year
ending |
|
|
Contract year
ending |
|
|
|
September 30,
2022 |
|
|
September 30,
2023 |
|
|
|
Twelve
months |
|
|
Twelve
months |
|
|
|
Base |
|
|
|
|
|
Guaranteed |
|
|
|
|
|
Base |
|
|
|
|
|
Guaranteed |
|
|
|
|
|
|
Salary |
|
|
Benefits |
|
|
Bonus |
|
|
Total |
|
|
Salary |
|
|
Benefits |
|
|
Bonus |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Timothy L.
Jones |
|
$ |
265,500 |
|
|
$ |
39,600 |
|
|
$ |
300,000 |
|
|
$ |
605,100 |
|
|
$ |
300,000 |
|
|
$ |
39,600 |
|
|
$ |
300,000 |
|
|
$ |
639,600 |
|
Arnold S.
Lippa |
|
|
300,000 |
|
|
|
39,600 |
|
|
|
— |
|
|
|
339,600 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Jeff E.
Margolis |
|
|
300,000 |
|
|
|
21,600 |
|
|
|
— |
|
|
|
321,600 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
865,500 |
|
|
$ |
100,800 |
|
|
$ |
300,000 |
|
|
$ |
1,266,300 |
|
|
$ |
300,000 |
|
|
$ |
39,600 |
|
|
$ |
300,000 |
|
|
$ |
639,600 |
|
Under
certain circumstances base salaries may be contractually increased
or the executives may become eligible for additional benefits and
base salaries may be increased at the discretion of the Board of
Directors. All executives are eligible for stock and stock option
and similar grants at the discretion of the Board or
Directors.
The payment
of certain amounts reflected in the table above have been
voluntarily deferred indefinitely and payments against accrued
compensation may be made based upon the Company’s ability to make
such payments.
The second
amendment to the employment agreement of Timothy Jones, the
Company’s President and Chief Executive Officer (the “Employment
Agreement”) became effective on September 27, 2021 (“Amendment No.
2”). Mr. Jones is also a director of the Company.
Amendment
No. 2 reduces Mr. Jones’ annual Base Salary from $300,000
to
$231,000
from October
1, 2021 through March 31, 2022 and restores the annual Base Salary
to $300,000
on April 1,
2022. Each month commencing on October 1, 2021 and ending on the
last day of the month and on a monthly accumulating basis
thereafter until March 31, 2022, during which the Company raises at
least $200,000
up to an
aggregate amount equal to or greater than $1,200,000,
the Base Salary must be paid in cash at the rate of $19,250
per month.
In addition, the $150,000
guaranteed
bonus that would have been due on September 30, 2021 was adjusted
to $0
in
accordance with the terms of Amendment No. 2.
After March
31, 2022, until such time as at least $2,500,000
has been
raised, Mr. Jones’ salary may be accrued and remain unpaid, at the
discretion of the Board. In the event that a payment due in
accordance with the Amendment No. 2 payment schedule, is not timely
paid, and is not cured by payment during the subsequent month
inclusive of such subsequent month’s payment due,
Mr. Jones’s Base Salary will revert back to $300,000 per year, the
payment schedule becomes null and void and the adjustment to a $0
Guaranteed Bonus will also be deemed null and void and a payment of
$150,000 will become due and payable as of the same date that the
Base Salary is adjusted to $300,000.
If
$10,000,000
is raised by
April 30, 2022, Mr. Jones’ annual Base Salary will be adjusted to
$375,000.
Furthermore, if the Board determines that a sufficient amount of
funds have been raised or is otherwise available to fund the
Company’s operations on an ongoing basis, some or all of the
accrued and unpaid Base Salary or Guaranteed Bonus as described in
Amendment No. 2 may be paid in cash.
UWMRF
Patent License Agreement
On August 1,
2020, the (“Effective Date”), the Company and UWMRF executed the
UWMRF Patent License Agreement pursuant to which, the Company has
an exclusive license to commercialize GABAkine products based on
UWMRF’s rights in certain patents and patent applications, and a
non-exclusive license to commercialize products based on UWMRF’s
rights in certain technology that is not the subject of the patents
or patent applications. UWMRF maintains the right to use, and, upon
the approval of the Company, to license, these patent and
technology rights for any non-commercial purpose, including
research and education. The UWMRF Patent License Agreement expires
upon the later of the expiration of the Company’s payment
obligations to UWMRF or the expiration of the last remaining
licensed patent granted thereunder, subject to early termination
upon the occurrence of certain events. The License Agreement also
contains a standard indemnification provision in favor of UWMRF and
confidentiality provisions obligating both parties.
Under the
UWMRF Patent License Agreement, in consideration for the licenses
granted, the Company will pay to UWMRF the following: (i) patent
filing and prosecution costs incurred by UWMRF prior to the
effective date, paid in yearly installments over three years from
the Effective Date; (ii) annual maintenance fees, beginning on the
second anniversary of the Effective Date, which annual maintenance
fees terminate upon the Company’s payment of royalties pursuant to
clause (iv) below; (iii) milestone payments, paid upon the
occurrence of certain dosing events of patients during clinical
trials and certain approvals by the FDA; and (iv) royalties on net
sales of products developed with the licenses, subject to minimum
annual payments and to royalty rate adjustments based on whether
separate royalty payments by the Company yield an aggregate rate
beyond a stated threshold. The Company has also granted UWMRF
certain stock appreciation rights with respect to the Company’s
neuromodulator programs, subject to certain limitations, and will
pay to UWMRF certain percentages of revenues generated from
sublicenses of the licenses provided under the UWMRF Patent License
Agreement by the Company to third parties.
University of
Wisconsin-Milwaukee Outreach Services Agreement
On July 12,
2021, the Company and the Board of Regents of the University of
Wisconsin System on behalf of the University of Wisconsin-Milwaukee
(“UWM”) entered into an Outreach Services Agreement pursuant to
which UWM agreed to provide, among other molecules, multiple
milligram to gram quantities of KRM-II-81 (GABAkine) and the
Company agreed to pay UWM an annual sum of $75,000
payable in
three installments of $25,000
each
beginning October 12, 2021, which amount was timely paid, and on a
quarterly basis thereafter. The agreement terminates on
June 30, 2022 unless extended upon
consent of both parties.
University of
Illinois 2014 Exclusive License Agreement
The Company
and the University of Illinois entered into the Exclusive License
Agreement (the “2014 License Agreement”) effective September 18,
2014, pursuant to which the Company obtained (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 that commenced on June 30, 2015. In
addition, the 2014 License Agreement provides for various royalty
payments, including a royalty on net sales of
4%, payment on
sub-licensee revenues of
12.5%, and a minimum annual
royalty beginning in 2015 of $100,000,
which is due and payable on December 31 of each year beginning on
December 31, 2015. The minimum annual royalty obligation of
$100,000
due on
December 31, 2020, was extended to
April 19, 2021 and was paid in full on
April 1, 2021. One-time milestone
payments may become due based upon the achievement of certain
development milestones. $75,000
will be due
within 5 days of any one of the following, (a) dosing of the first
patient with a dronabinol 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 dronabinol
(defined as less than or equal to 1 mg), or (c) dosing of the first
patient in a Phase 1 human clinical study anywhere in the world
with a proprietary reformulation of dronabinol. $350,000
will be due
within five days after the dosing of the first patient is a Phase
III human clinical trial anywhere in the world. $500,000
will be due
within five days after the first NDA filing with FDA or a foreign
equivalent. $1,000,000
will be due
within twelve months of the first commercial sale. One-time royalty
payments may also become due and payable. Annual royalty payments
may also become due. In the year after the first application for
market approval is submitted to the FDA or a foreign equivalent 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 or a foreign equivalent and until the first sale of a product,
the minimum annual royalty 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 Company
recorded charges to operations of $25,000
during the
three-months ended September 30, 2021 and 2020, respectively, and
$75,000
during the
nine-months ended September 30, 2021 and 2020, respectively, with
respect to its 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 and
nine-months ended September 30, 2021 and 2020. As discussed above,
the Company did not pay the amount due on December 31, 2020 for
which the Company was granted an extension until April 19, 2021 and
which was paid in full on April 1, 2021.
Noramco
Inc. - Dronabinol Development and Supply Agreement
On September
4, 2018, RespireRx entered into a dronabinol Development and Supply
Agreement with Noramco Inc., one of the world’s major dronabinol
manufacturers, which Noramco subsequently assigned to its
subsidiary, Purisys LLC (the “Purisys Agreement”). Under the terms
of the Purisys Agreement, Purisys has agreed to (i) provide all of
the active pharmaceutical ingredient (“API”) estimated to be needed
for the clinical development process for both the first- and
second-generation products (each a “Product” and collectively, the
“Products”), three validation batches for New Drug Application
(“NDA”) filing(s) and adequate supply for the initial inventory
stocking for the wholesale and retail channels, subject to certain
limitations, (ii) maintain or file valid drug master files (“DMFs”)
with the FDA or any other regulatory authority and provide the
Company with access or a right of reference letter entitling the
Company to make continuing reference to the DMFs during the term of
the agreement in connection with any regulatory filings made with
the FDA by the Company, (iii) participate on a development
committee, and (iv) make available its regulatory consultants,
collaborate with any regulatory consulting firms engaged by the
Company and participate in all FDA or Drug Enforcement Agency
(“DEA”) meetings as appropriate and as related to the API. We now
refer to the second-generation product as our proprietary
formulation or proprietary product and have de-emphasized the
first-generation product.
In
consideration for these supplies and services, the Company has
agreed to purchase exclusively from Purisys during the
commercialization phase all API for its Products (as defined in the
Development and Supply Agreement) at a pre-determined price subject
to certain producer price index adjustments and agreed to Purisys’
participation in the economic success of the commercialized Product
or Products up to the earlier of the achievement of a maximum
dollar amount or the expiration of a period of time.
There was no
activity during the three-months ended and nine-months ended
September 30, 2021 or 2020 with respect to the Purisys
Agreement.
Transactions with
Bausch Health Companies Inc. (formerly known as Biovail
Laboratories International SRL)
Beginning in
March 2010, the Company entered into a series of asset purchase and
license agreements with Biovail Laboratories International SRL
which later merged with Valeant Pharmaceuticals International, Inc.
which was later renamed Bausch Health Companies Inc.
(“Bausch”).
In March
2011, the Company entered into a new agreement with Bausch to
reacquire the ampakine compounds, patents and rights that Bausch
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
pertaining to an intravenous dosage form of the ampakine compounds
for respiratory depression, a therapeutic area not currently
pursued by the Company. Bausch 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, Bausch 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 Bausch would share in all such future
development costs with the Company. If Bausch makes the
co-marketing election, the Company would owe no further milestone
payments to Bausch and the Company would be eligible to receive a
royalty on net sales of the compound by Bausch or its affiliates
and licensees.
There was no
activity during the three-months ended and nine-months ended
September 30, 2021 or 2020 that affect the Bausch
agreement.
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 September 30,
2021, aggregating $2,166,177. License
agreement amounts included in the 2021 column represents amounts
contractually due from October 1, 2021 through December 31, 2021
(three months) and in each of the subsequent years, represents the
full year. Employment agreement amounts included in the 2021 column
represent amounts contractually due from October 1, 2021 through
September 30, 2022 (twelve months) and September 30, 2023 in the
case of the employment agreement of Timothy Jones, when such
contracts expire unless extended pursuant to the terms of the
contracts.
Summary
of Principal Cash Obligations and Commitments
|
|
|
|
|
Payments Due By
Year |
|
|
|
Total |
|
|
2021 |
|
|
2022 |
|
|
2023 |
|
|
2024 |
|
|
2025 |
|
License
agreements |
|
$ |
520,277 |
|
|
$ |
25,000 |
|
|
$ |
120,092 |
|
|
$ |
140,185 |
|
|
$ |
110,000 |
|
|
$ |
115,000 |
|
Research and
development contracts |
|
|
50,000 |
|
|
|
- |
|
|
|
50,000 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Employment agreements
(1) |
|
|
1,605,900 |
|
|
|
232,950 |
|
|
|
1,118,250 |
|
|
|
254,700 |
|
|
|
- |
|
|
|
- |
|
Total |
|
$ |
2,166,177 |
|
|
$ |
257,950 |
|
|
$ |
1,288,342 |
|
|
$ |
394,885 |
|
|
$ |
110,000 |
|
|
$ |
115,000 |
|
(1) |
The payment of certain
of such amounts has been deferred indefinitely, as described above
in “Employment Agreements”. |
9.
Subsequent
Events
Amendment to Mr.
Jones’ Employment Agreement
See Note 8.
Commitments and Contingencies – Significant Agreements and
Contracts – Employment Agreements for a description of
Amendment No. 2 of Mr. Jones’ employment agreement.
Filing
of Form 1-A
On October
12, 2021, the Company filed amendment number one to its Form 1-A
which had previously been filed on August 9, 2021 with the SEC with
respect to a contemplated Tier 2 offering under Regulation A. The
Form 1-A and preliminary offering circular contained therein is
subject to further amendment. No securities may be offered prior to
qualification of the offering by the Securities and Exchange
Commission or in any jurisdiction in which such offer, solicitation
or sale of securities would be unlawful before registration or
qualification under the laws of such jurisdiction.