UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
For
the quarterly period ended
Commission
file number:
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of | (I.R.S. Employer | |
incorporation or organization) | Identification Number) |
(Address of principal executive offices)
(Registrant’s telephone number, including area code)
(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.
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).
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 ☐ |
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
☐
As of August 18, 2023, the Company had shares of common stock, $0.001 par value, issued and outstanding.
RESPIRERX PHARMACEUTICALS INC.
AND SUBSIDIARY
TABLE OF CONTENTS
2 |
In this Quarterly Report on Form 10-Q, the terms the “Company,” “we,” “us” and “our” refer to RespireRx Pharmaceuticals Inc. a Delaware corporation (“RespireRx”), and, unless the context indicates otherwise, its consolidated subsidiaries, ResolutionRx Ltd (“ResolutionRx”) and Pier Pharmaceuticals, Inc. (“Pier”).
INTRODUCTORY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q of RespireRx Pharmaceuticals Inc., referred to herein as our “Q2 2023 Quarterly Report” (“RespireRx” and together with RespireRx’s wholly-owned subsidiaries, ResolutionRx Ltd (“ResolutionRx”) and 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 Q2 2023 Quarterly 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 our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 as filed with the SEC on April 17, 2023 (the “2022 Form 10-K”) and as may be included in this Q2 2023 Quarterly Report.
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 Q2 2023 Quarterly Report. We cannot assure you that the forward-looking statements in this Q2 2023 Quarterly Report or in our 2022 Form 10-K will prove to be accurate and therefore prospective investors are encouraged not to place undue reliance on forward-looking statements. You should read this Q2 2023 Quarterly 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 this Q2 2023 Quarterly Report and our 2022 Form 10-K, 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 this Q2 2023 Quarterly Report and 2022 Form 10-K. 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.
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.
3 |
PART I - FINANCIAL INFORMATION
ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
RESPIRERX PHARMACEUTICALS INC.
AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
June 30, 2023 | December 31, 2022 | |||||||
(unaudited) | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | $ | ||||||
Deferred financing costs | ||||||||
Prepaid research and development | ||||||||
Prepaid expenses | ||||||||
Total current assets | ||||||||
Total assets | $ | $ | ||||||
LIABILITIES AND STOCKHOLDERS’ DEFICIENCY | ||||||||
Current liabilities: | ||||||||
Accounts payable and accrued expenses, including amounts owed to related parties (Note 5) | $ | $ | ||||||
Accrued compensation and related expenses | ||||||||
Convertible notes payable, currently due and payable on demand, including accrued interest of $ | ||||||||
Note payable to SY Corporation, including accrued interest of $ | ||||||||
Notes and advances payable to officers and affiliates, including accrued interest (Note 4) | ||||||||
Notes payable to former officer, including accrued interest (Note 4) | ||||||||
Other short-term notes payable | ||||||||
Total current liabilities | ||||||||
Long-term liabilities | ||||||||
Long-term accounts payable associated with payment settlement agreements, net of current portion included in accounts payable at June 30, 2023 and December 31, 2022 (Note 5) | ||||||||
Total long-term liabilities | ||||||||
Total liabilities | ||||||||
Commitments and contingencies (Note 8) | ||||||||
Stockholders’ deficiency: (Note 6) | ||||||||
Series B convertible preferred stock, $ | par value; $||||||||
Series I 8% Redeemable Preferred Stock, par value $ | ,
stated value $||||||||
Series J 8% Voting, Participating, Redeemable Preferred Stock, par value $ | ,
stated value $||||||||
Common stock, $ | par value; shares authorized: ; shares issued and outstanding: outstanding at June 30, 2023 and at December 31, 2022, respectively||||||||
Additional paid-in capital | ||||||||
Accumulated deficit | ( | ) | ( | ) | ||||
Total stockholders’ deficiency | ( | ) | ( | ) | ||||
Total liabilities and stockholders’ deficiency | $ | $ |
See accompanying notes to condensed consolidated financial statements (unaudited).
4 |
RESPIRERX PHARMACEUTICALS INC.
AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three-Months Ended | Six-Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
Operating expenses: | ||||||||||||||||
General and administrative, including related parties | $ | $ | $ | $ | ||||||||||||
Research and development, including related parties | ||||||||||||||||
Total operating expenses | ||||||||||||||||
Loss from operations | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
Interest expense, including related parties | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
Foreign currency transaction gain | ||||||||||||||||
Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
Dividends on preferred stock and deemed dividends associated with most-favored nation provisions of convertible notes | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
Net loss attributable to common stockholders | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
Net loss per common share - basic and diluted | $ | ) | $ | ) | $ | ) | $ | ) | ||||||||
Weighted average common shares outstanding - basic and diluted |
See accompanying notes to condensed consolidated financial statements (unaudited).
5 |
RESPIRERX PHARMACEUTICALS INC.
AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIENCY
(Unaudited)
Three-months and Six-months Ended June 30, 2023
Series B | Series I | Series J | ||||||||||||||||||||||||||||||||||||||||||
Convertible | 8% | 8% | Additional | Total | ||||||||||||||||||||||||||||||||||||||||
Preferred Stock | Preferred Stock | Preferred Stock | Common Stock | Paid-in | Accumulated | Stockholders’ | ||||||||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Shares | Amount | Shares | Par Value | Capital | Deficit | Deficiency | ||||||||||||||||||||||||||||||||||
Balance, December 31, 2022 | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||||||||
Common Stock issued upon cashless warrant exercises | - | - | - | | ( | ) | ||||||||||||||||||||||||||||||||||||||
Net loss | - | - | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||
Balance, March 31, 2023 | $ | $ | $ | $ | $ | $ | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||
Issuance of Series I Preferred Stock | - | - | - | |||||||||||||||||||||||||||||||||||||||||
Accrued dividends on Series I Preferred Stock | - | - | - | ( | ) | |||||||||||||||||||||||||||||||||||||||
Issuance of Series J Preferred Stock | - | - | - | |||||||||||||||||||||||||||||||||||||||||
Accrued dividends on Series J Preferred Stock | - | - | - | ( | ) | |||||||||||||||||||||||||||||||||||||||
Issuance of common stock upon convertible notes conversions | - | - | - | |||||||||||||||||||||||||||||||||||||||||
Issuance of common stock upon cashless exercise of warrants | - | - | - | ( | ) | |||||||||||||||||||||||||||||||||||||||
Warrant issuances with respect to Demand Promissory Notes | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||
Net loss | - | - | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||
Balance, June 30, 2023 | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) |
Three-months and Six-months Ended June 30, 2022
Series B | Series I | Series J | ||||||||||||||||||||||||||||||||||||||||||
Convertible | 8% | 8% | Additional | Total | ||||||||||||||||||||||||||||||||||||||||
Preferred Stock | Preferred Stock | Preferred Stock | Common Stock | Paid-in | Accumulated | Stockholders’ | ||||||||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Shares | Amount | Shares | Par Value | Capital | Deficit | Deficiency | ||||||||||||||||||||||||||||||||||
Balance, December 31, 2021 | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||||||||
Net loss | - | - | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||
Balance, March 31, 2022 | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||||||
Warrant value for issuance of convertible note | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||
Issuance of common stock upon convertible notes conversions | - | - | - | |||||||||||||||||||||||||||||||||||||||||
Net loss | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||
Balance, June 30, 2022 | $ | $ | $ | $ | ( | ) | $ | ( | ) |
See accompanying notes to condensed consolidated financial statements (unaudited).
6 |
RESPIRERX PHARMACEUTICALS INC.
AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Six-months Ended June 30, | ||||||||
2023 | 2022 | |||||||
Cash flows from operating activities: | ||||||||
Net loss | $ | ( | ) | $ | ( | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Amortization of original issue discount, capitalized note costs and debt discounts to interest expense | ||||||||
Foreign currency transaction (gain) loss | ( | ) | ( | ) | ||||
Changes in operating assets and liabilities: | ||||||||
Increase (decrease) in cash from | ||||||||
Deferred financing costs | ( | ) | ||||||
Prepaid expenses | ( | ) | ||||||
Accounts payable and accrued expenses | ||||||||
Accrued compensation and related expenses | ||||||||
Officer and affiliate liabilities, including accrued interest | ||||||||
Accrued interest payable and notes payable | ||||||||
Net cash used in operating activities | ( | ) | ( | ) | ||||
Cash flows from financing activities: | ||||||||
Proceeds from preferred stock financings | ||||||||
Proceeds from convertible note financing | ||||||||
Proceeds from demand promissory notes | ||||||||
Payment of fees associated with conversions of convertible notes by issuance of stock | ||||||||
Borrowings on or repayments of short-term notes payable | ( | ) | ||||||
Proceeds from or repayment of officer advance | ||||||||
Net cash provided by financing activities | ||||||||
Cash and cash equivalents: | ||||||||
Net increase (decrease) | ( | ) | ||||||
Balance at beginning of period | ||||||||
Balance at end of period | $ | $ |
(Continued)
7 |
RESPIRERX PHARMACEUTICALS INC.
AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(Continued)
Six-months Ended June 30, | ||||||||
2023 | 2022 | |||||||
Supplemental disclosures of cash flow information: | ||||||||
Cash paid for - | ||||||||
Interest | $ | $ | ||||||
Income taxes | $ | $ | ||||||
Non-cash financing activities: | ||||||||
Amortization of deferred financing costs | $ | $ | ||||||
Insurance policies | $ | |||||||
Reclassification of long-term liabilities to short-term liabilities | $ | $ | ||||||
Debt discounts established for convertible debt | $ | $ | ||||||
Accrued compensation, accounts payable and other liabilities exchanged or settled for equity | $ | $ | ||||||
Debt and accrued interest and related fees converted to common stock | $ | $ | ||||||
Cashless warrant exercises | $ | $ |
See accompanying notes to condensed consolidated financial statements (unaudited).
8 |
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’s wholly-owned subsidiary ResolutionRx Ltd (“ResolutionRx”). On January 11, 2023, RespireRx formed as a wholly-owned subsidiary, ResolutionRx, an unlisted public company in Australia, into which RespireRx, as of August 3, 2023, has contributed its cannabinoid platform described below.
Basis of Presentation
The condensed consolidated financial statements are of RespireRx and its wholly-owned subsidiaries, Pier and ResolutionRx (collectively referred to herein as the “Company,” “we” or “our,” unless the context indicates otherwise).
The condensed consolidated financial statements and related notes are unaudited and 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 in our Form 10-K for the fiscal year ended December 31, 2022 as filed with the SEC on April 17, 2023 (“2022 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 affecting millions of people, but for which there are limited or poor treatment options, including OSA, attention deficit hyperactivity disorder (“ADHD”), epilepsy, acute and chronic pain, including inflammatory and neuropathic pain, recovery from spinal cord injury (“SCI”) and certain orphan disorders. We are also considering developing treatment options for other conditions based on results of preclinical and clinical studies to date. To achieve these goals, the Company has determined that some or all of these opportunities should be contributed to what could be, wholly-owned subsidiaries, joint ventures, licenses or sub-licenses, or even sold and has initiated efforts to do so.
In order to facilitate our business activities and product development and to set up our programs for development by subsidiaries, partnering or sale, we have implemented an internal restructuring plan based upon our two research platforms: pharmaceutical cannabinoids and neuromodulators. As of January 11, 2023, RespireRx had formed ResolutionRx, initially a wholly-owned subsidiary focused on pharmaceutical cannabinoids and previously, EndeavourRx, as a business unit focused on our neuromodulators. The Company will use, at least initially, its management personnel to provide management, research and development, operational and oversight services to these two lines of business.
(i) | ResolutionRx, our pharmaceutical cannabinoids subsidiary 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. |
9 |
(ii) | EndeavourRx, our neuromodulators platform is made up of two programs: (a) our AMPAkines program, which is developing proprietary compounds that act as positive allosteric modulators (“PAMs”) of AMPA-type glutamate receptors to promote neuronal function and (b) our GABAkines program, which is developing proprietary compounds that act as 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”). |
Like ResolutionRx, which as of January 11, 2023, was organized as a wholly-owned subsidiary, of RespireRx, management also intends to organize our EndeavourRx business unit, in part or in whole, into one or more subsidiaries that would conduct research and development of our neuromodulator platform, including either or both of the AMPAkine and GABAkine programs and their related tangible and intangible assets and certain of their liabilities.
The Company’s business development efforts (licensing, sub-licensing, joint venture and other commercial structures), if successful, would represent strategic and operational infrastructure additions, as well as cash and in-kind funding opportunities. These efforts have focused on, but have not been limited to, seeking transactions with brand and generic pharmaceutical and biopharmaceutical companies as well as companies with potentially useful clinical development, formulation or manufacturing capabilities, significant subject matter expertise and financial resources. No assurance can be given that any transaction will come to fruition and that, if it does, the terms will be favorable to the Company.
Financing our Platforms
Our major challenge has been to raise substantial equity or equity-linked financing to support research and development plans for our 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 OTC Pink Market listing and our low market capitalization as a result of our low stock price as well as the weakness of our balance sheet.
For this reason, the Company has affected an internal restructuring plan described above that we believe will further the aims of RespireRx, ResolutionRx and EndeavourRx, and may make it possible, through separate finance channels, to unlock the unrealized asset values of each and set up its programs for partnering or sale.
The Company is also engaged in business development efforts (licensing/sublicensing, joint venture and other commercial structures) with a view to securing strategic partnerships that represent strategic and operational infrastructure additions, as well as cash and in-kind funding opportunities. We believe that some or all of our assets should be licensed, sublicensed, joint ventured or even sold and have initiated efforts to do so. No assurance can be given that any transaction will come to fruition and that if it does, that the terms will be favorable to the Company.
On
May 18, 2023, ResolutionRx entered into a Letter of Intent with Cantheon Capital (“Cantheon” and “Cantheon LOI”)
that describes an intended investment of US$
On May 11, 2023, RespireRx entered into a Letter Agreement (“Letter Agreement”) with Viridian Capital Advisors (“VCA”) pursuant to which, VCA would perform the following services (“Valuation Services”): (i) review the Company’s intellectual property assets and licensing agreements as they relate to Company’s cannabinoid program, net of any associated liabilities, (ii) review the Company’s financial models and forecasts as they relate to the Company’s cannabinoid program and (iii) prepare the data, analytics and Company valuation analysis (“Valuation Analysis”) specifically with respect to the Company’s cannabinoid program. The Letter Agreement became effective on May 22, 2023. The Company entered this Letter Agreement as part of the process that began with the establishment of ResolutionRx, into which the net assets of the Company’s cannabinoid program have been contributed via license and sublicense in exchange for Ordinary Shares of ResolutionRx, all as of August 3, 2023. RespireRx received the final Valuation Analysis on August 7, 2023. See Note 9. Subsequent Events.
10 |
On August 3, 2023, Respirerx entered into a License Agreement with ResolutionRx See Note 9. Subsequent Events - Entry into License Agreement with ResolutionRx Ltd
On August 3, 2023, RespireRx entered into a Sublicense Agreement with ResolutionRx - See Note 9. Subsequent Events - Entry into Sublicense Agreement with ResolutionRx Ltd
On August 3, 2023, RespireRx entered into a Stock Transfer Agreement with ResolutionRx - See Note 9. Subsequent Events – Entry into Stock Transfer Agreement with ResolutionRx Ltd
On August 3, 2023, RespireRx entered into a Master Intercompany Services Agreement with ResolutionRx - See Note 9. Subsequent Events – Entry into Master Intercompany Services Agreement with ResolutionRx Ltd
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 and net losses attributable to common stockholders of $
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 and liabilities. 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 and, in that regard, has formed an Australian subsidiary, ResolutionRx. In addition to the formation of ResolutionRx, such changes could include additional significant reorganizations, which may include the formation of one or more additional 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.
11 |
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 subsidiaries, Pier and ResolutionRx. Intercompany balances and transactions have been eliminated in consolidation.
Use of Estimates
The preparation of condensed consolidated 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.
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 for companies like the Company. 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.
12 |
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 or is unlikely to be completed.
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.
Capitalized Financing Costs
The Company presents debt issuance costs related to debt obligations in its condensed 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 or commitment shares of Common Stock, 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.
Debt and Other Liability Exchanges
In cases where debt or other liabilities are exchanged for equity, the Company compares the carrying value of debt, inclusive of accrued interest, if applicable, being exchanged, to the fair value of the equity issued and records any loss or gain as a result of such exchange. See Note 4. Notes Payable.
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.
Prepaid Insurance
Prepaid insurance represents the premium that was due in March 2023 for directors and officers insurance. The amounts of prepaid insurance amortizable in the ensuing twelve-month period are recorded as prepaid insurance in the Company’s condensed consolidated balance sheet at each reporting date and amortized to the Company’s condensed consolidated statement of operations for each reporting period.
The Company periodically issues common stock and stock options and phantom stock (collectively, “Stock-Based Awards”) to officers, directors, Scientific Advisory Board members, consultants and other 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 and directors, outside consultants and vendors 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 consolidated or condensed consolidated financial statements, as appropriate, over the vesting period of the awards.
13 |
Stock grants, which are sometimes subject to time-based vesting, are measured at the grant date fair value of the common stock and charged to operations ratably over the vesting period.
Stock options granted to members of the Company’s outside consultants and other vendors are valued on the grant date. As the stock options vest, the Company recognizes this expense over the period in which the services are provided.
The 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 value of the common stock on the grant date, and the estimated volatility of the common stock over the estimated life 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 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.
Phantom stock awards, which are sometimes subject to time-based vesting, are measured at the award date fair value, if measurable. As the phantom stock awards vest, the Company recognizes the expense, if measurable, upon vesting. To the extent that the value of phantom stock awards is not measurable on the award date, measurement only being possible on the satisfaction of certain contingent events that may not be predictable and measurable at the time of the award, the Company recognizes the expense as a change in an estimate as of the date on which the contingent event becomes predictable and measurable.
The Company recognizes the value of stock-based payments in general and administrative costs and in research and development costs, as appropriate, in the Company’s consolidated or condensed consolidated statements of operations, as appropriate. The Company issues new shares of Common Stock to satisfy stock option and warrant exercises.
There were stock or stock option grants during the three-months or six-months ended June 30, 2023.
There were stock options exercised during the three-months or six months ended June 30, 2023 and 2022.
There
were
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.
14 |
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 June 30, 2023, 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 June 30, 2023, 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 accounts for ResolutionRx are maintained in Australian dollars and are converted to U.S. dollars at the exchange rate on the balance sheet. In both cases, 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 RespireRx’s research and development activities, including but not limited to compensation paid to our Chief Scientific Officer who is also our Executive Chairman, our Interim President and our Interim Chief Executive Officer and who has similar roles at ResolutionRx, 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.
15 |
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.
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.
Net 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.
June 30, | ||||||||
2023 | 2022 | |||||||
Series B convertible preferred stock | ||||||||
Convertible notes payable | ||||||||
Common stock warrants | ||||||||
Common stock options | ||||||||
Total |
Reclassifications
Certain comparative figures in 2022 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. Management has evaluated the potential impact and has early adopted this ASU as of January 1, 2022. Management believes the adoption has simplified the accounting for convertible debt instruments and does not believe adoption has had a substantial impact on the financial statements, however, it is possible that this ASU may have a substantial impact on the Company’s financial statements from future convertible debt or preferred stock financings.
16 |
4. Notes Payable
Convertible Notes Payable
The table below summarizes all convertible notes outstanding as of June 30, 2023. Those with similar characteristics outstanding as of June 30, 2023 are grouped separately. The following abbreviations are used in the column headings: DIC is Debt Issuance Cost, OID is Original Issue Discount, Wts are warrants, CNC is Capitalized Note Cost and BCF is Beneficial Conversion Feature. Also included are repayments by conversion, exchange or otherwise during or prior to the three-month period ended June 30, 2023:
Inception Date | Maturity date | Original Principal Amount | Interest rate | Original aggregate DIC, OID, Wts, CNC and BCF | Cumulative amortization of DIC, OID, Wts, CNC and BCF | Accrued coupon interest | Repayment
by conversion, increase in principal amount, net where appropriate | Balance
sheet carrying amount at June 30, 2023 inclusive | ||||||||||||||||||||||
November 5, 2014 | $ | % | $ | $ | $ | $ | $ | |||||||||||||||||||||||
November 5, 2014 | % | |||||||||||||||||||||||||||||
November 5, 2014 | % | |||||||||||||||||||||||||||||
Sub-total | ||||||||||||||||||||||||||||||
December 31, 2018 | % | |||||||||||||||||||||||||||||
January 2, 2019 | % | |||||||||||||||||||||||||||||
Sub-total | ||||||||||||||||||||||||||||||
May 17, 2019 | % | ( | ) | ( | ) | |||||||||||||||||||||||||
July 28, 2020 | % | ( | ) | ( | ) | |||||||||||||||||||||||||
February 17, 2021 | % | ( | ) | ( | ) | |||||||||||||||||||||||||
April 1, 2021 | % | ( | ) | ( | ) | |||||||||||||||||||||||||
May 3, 2021 | % | ( | ) | ( | ) | |||||||||||||||||||||||||
May 10, 2021 | % | ( | ) | ( | ) | |||||||||||||||||||||||||
June 30, 2021 | % | ( | ) | |||||||||||||||||||||||||||
August 31, 2021 | % | ( | ) | |||||||||||||||||||||||||||
October 7, 2021 | % | ( | ) | |||||||||||||||||||||||||||
December 23, 2021 | % | ( | ) | ( | ) | |||||||||||||||||||||||||
April 14, 2022 | % | ( | ) | |||||||||||||||||||||||||||
August 22, 2022 | % | ( | ) | |||||||||||||||||||||||||||
August 22, 2022 | % | ( | ) | |||||||||||||||||||||||||||
August 22, 2022 | % | ( | ) | |||||||||||||||||||||||||||
Sub-total | ( | ) | ( | ) | ||||||||||||||||||||||||||
Total | $ | $ | ( | ) | $ | $ | $ | ( | ) | $ |
1 | ||
2 | ||
3 |
17 |
Note Payable to SY Corporation Co., Ltd.
On
June 25, 2012, the Company borrowed
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 AMPAkine compounds CX1739 and CX1942 or certain related method of use patents.
The note payable to SY Corporation consists of the following at June 30, 2023 and December 31, 2022:
June 30, 2023 | December 31, 2022 | |||||||
Principal amount of note payable | $ | $ | ||||||
Accrued interest payable | ||||||||
Foreign currency transaction adjustment | ( | ) | ( | ) | ||||
$ | $ |
Interest
expense with respect to this promissory note was $
Notes Payable to Officers and Affiliates
For
the three-months ended June 30, 2023 and 2022, $
In addition, Dr. Lippa periodically makes advances to the Company which are re-payable upon demand, do not accrue interest and are included in the total of notes payable to Officers.
On
May 22, 2023, RespireRx issued a demand promissory note in the principal amount of $
On
May 22, 2023, RespireRx issued a demand promissory note in the principal amount of $
Notes Payable to Former Officer
For
the three-months ended June 30, 2023 and 2022, $
18 |
Other Short-Term Notes Payable
Other
short-term notes payable at June 30, 2023 and December 31, 2022 consisted primarily of premium financing agreements with respect to the
Company’s directors and officers liability insurance policies. At June 30, 2023, a premium financing agreement was payable in the
initial amount of $
5. Settlement and Payment Agreements
Effective
December 15, 2022, the Company and the Board of Trustees of the University of Illinois (“UIL”) entered into the Second
Amendment to RespireRx -University of Illinois Exclusive License Agreement. The parties entered into the Second Amendment in order
to eliminate accrued financial obligations to UIL and reduce future obligations. Annual $
Effective
August 1, 2022, the Company and the Company’s former legal counsel, entered into a payment settlement agreement and release pursuant
to which the Company and its former legal counsel agreed that the Company owed $
Effective
January 31, 2022, the Company’s former President and Chief Executive Officer and Member of the Board of Directors, Timothy Jones,
resigned his officer positions as well as from the Board of Directors pursuant to an Employment Agreement Termination and Separation
Agreement (“SA”) dated February 8, 2022. Pursuant to the terms of the SA, the Company has agreed to pay Mr. Jones up to a
maximum of $
On
April 29, 2021, RespireRx agreed to a payment and settlement agreement with the University of California Innovation and
Entrepreneurship (“UIC”) with respect to accounts payable in an amount that was not in dispute and is reflected in
accounts payable and accrued expenses in the Company’s condensed consolidated financial statements as of December 31, 2022 and
June 30, 2023. The total amount due was $
19 |
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 $
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 $
On
September 14, 2021, the Company and DNA Healthlink, Inc. (“DNA Healthlink”) entered into a settlement agreement (the
“DNA Healthlink Settlement Agreement”) regarding $
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 $
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 June 30, 2023 and consolidated financial statements as of December 31, 2022 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.
20 |
6. Stockholders’ Deficiency
Preferred Stock
RespireRx has authorized a total of shares of preferred stock, par value $ per share. As of June 30, 2023 and December 31, 2022, shares were designated as Series B Convertible Preferred Stock (non-voting, “Series B Preferred Stock”).
Series
B Preferred Stock outstanding as of June 30, 2023 and December 31, 2022 consisted of
As of June 30, 2023, there were shares of Series H Preferred Stock designated and available for issuance.
On
April 3, 2023, RespireRx authorized
On
April 12, 2023, RespireRx authorized
21 |
Although other series of preferred stock have been designated, no other shares of preferred stock are outstanding. As of June 30, 2023, shares of preferred stock were undesignated and may be issued with such rights and powers as the Board of Directors may designate. As of December 31, 2022, shares of preferred stock were undesignated.
Common Stock
RespireRx
has authorized shares
of Common Stock, par value (“Common
Stock”). There are shares
of RespireRx’s Common Stock outstanding as of June 30, 2023. The issued and outstanding shares of Common Stock as of June 30,
2023 included shares of Common Stock issued upon conversion of convertible notes and shares of Common Stock
issued upon cashless exercise of warrants during the six-month period ended June 30, 2023. 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 shares
of RespireRx’s Common Stock available for future issuances as of June 30, 2023. No options were exercised during the six-month
period ended June 30, 2023. Options exercisable into shares
of Common Stock expired during the six-month period ended June 30, 2023. During the three-month and six-month periods ended June 30,
2023, warrants exercisable into
Common Stock Warrants
A summary of warrant activity for the six-months ended June 30, 2023 is presented below.
Number of Shares |
Weighted Average Exercise Price |
Weighted Average Remaining Contractual Life (in Years) |
||||||||||
Warrants outstanding and exercisable at December 31, 2022 | $ | |||||||||||
Exercised | ( |
) | - | |||||||||
Issued | ||||||||||||
Expired | ( |
) | ||||||||||
Warrants outstanding and exercisable at June 30, 2023 | $ |
22 |
The exercise prices of common stock warrants outstanding and exercisable are as follows at June 30, 2023:
Exercise Price | Warrants Outstanding and Exercisable (Shares) | Expiration Dates | ||||||||
$ | - | |||||||||
$ | ||||||||||
$ | ||||||||||
$ | ||||||||||
$ | ||||||||||
Based
on a value of $
A summary of warrant activity for the six-months ended June 30, 2022 is presented below.
Number of Shares | Weighted Average Exercise Price |