The following discussion and analysis should be read in conjunction with the condensed consolidated financial statements (unaudited) and notes related thereto appearing elsewhere in this document, as well as the audited consolidated financial statements, notes related thereto, and Management's Discussion and Analysis of Financial Condition and Results of Operations in
our 2020 Form 10-K. Overview 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 recently established pursuant to our entry with
the
affiliate of the
license agreement (the "UWMRF Patent License Agreement"). 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 OTCQB listing, and low market capitalization as a result of our low stock price. 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 theSEC qualifies the offering, a securities offering pursuant to Regulation A under the Securities Act. See Note 9. Subsequent Events - Filing of Form 1-A to the Company's condensed consolidated financial statements atJune 30, 2021 . The Company is also involved in business development efforts (licensing/sub-licensing, 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. These efforts have focused on, but have not been limited to, engaging with brand and generic pharmaceutical and biopharmaceutical companies as well as companies with potentially useful formulation or manufacturing capabilities, significant subject matter expertise and financial resources. No assurance can be given that any transaction will come to fruition or that if it does, that the terms will be favorable to the Company.
Below is a chart that represents our current development status for each of our product candidates for the disorders for which they are being developed. Preclinical testing is pre-human testing and includes in vitro and animal studies. Phase 1 clinical trials are primarily safety, generally conducted in healthy adults. Phase 2 clinical trials are generally somewhat larger than Phase 1 and often include dose finding, additional safety and preliminary efficacy. Phase 3 clinical trials are larger studies designed to test efficacy and safety in a broader population. See "Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations" in our 2020 Form 10-K for more information on our proposed regulatory approach and development plans for our product candidates. 25 [[Image Removed]] Below is our current business organization with ResolutionRx and EndeavourRx currently operating as divisions and which are planned to become, initially, wholly-owned subsidiaries. [[Image Removed]] Technology Rights
See Note 8. Commitments and Contingencies - Significant Agreements and Contracts
-
UWMRF Patent License Agreement
See Notes 1, 2 and 8 to our condensed consolidated financial statements at
Going Concern
See Note 2. Business - Going Concern to our condensed consolidated financial
statements at
The Company's regular efforts to raise capital and to evaluate measures to permit sustainability are time-consuming and intensive. Such efforts may not prove successful and may cause distraction, disruption or other adversity that limits the Company's development program efforts.
Recent Accounting Pronouncements
See Note 2 to the Company's condensed consolidated financial statements at
Management does not believe that any recently issued, but not yet effective, authoritative guidance, if currently adopted, would have a material impact on the Company's financial statement presentation or disclosures. Concentration of Risk
See Note 2. Significant Accounting Policies - Concentration of Credit Risk to
the Company's condensed consolidated financial statements at
See Note 8. Commitments and Contingencies -
See Note 8. Commitments and Contingencies - UWMRF Patent License Agreement to
the Company's condensed consolidated financial statements at
See Note 9. Subsequent Events -
26
Critical Accounting Policies and Estimates
The Company prepared its condensed consolidated financial statements in accordance with GAAP. The preparation of these condensed consolidated financial statements requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amount of revenues and expenses during the reporting period. Management periodically evaluates the estimates and judgments made. Management bases its estimates and judgments on historical experience and on various factors that are believed to be reasonable under the circumstances. Actual results may differ from these estimates as a result of different assumptions or conditions.
Critical accounting policies and estimates are described in the notes to the Company's condensed consolidated financial statements and include:
- Stock-based awards - Research and Development Costs - License Agreements - Patent Costs - Convertible Notes
See Critical Accounting Policies and Estimates in our 2020 Form 10-K for a complete description.
Results of Operations The Company's consolidated statements of operations as discussed herein are presented below. Three-Months Ended Six-Months Ended June 30, June 30, 2021 2020 2021 2020 Operating expenses: General and administrative, including related parties$ 426,169 $ 463,739 $ 1,071,545 $ 829,019 Research and development, including related parties 237,828 153,176 392,592 308,466 Total operating expenses 663,997 616,915 1,464,137 1,137,485 Loss from operations (663,997 ) (616,915 ) (1,464,137 ) (1,137,485 ) Gain on warrant exchange, 1,099 -
1,099
Loss on extinguishment of debt and other liabilities in exchange for equity - - - (323,996 ) Interest expense, including related parties (151,842 ) (190,606 ) (231,312 ) (331,316 ) Foreign currency transaction gain (loss) 2,526 ) (8,616 ) 31,887 29,942 Net loss attributable to common stockholders$ (812,214 ) $ (816,137 ) $
(1,662,463 )
Net loss per common share - basic and diluted$ (0.01 ) $ (0.01 ) $
(0.02 )
Weighted average common shares outstanding - basic and diluted 89,832,860 86,606,705 82,212,945 49,320,761
Three-months Ended
Revenues. The Company had no revenues during the three-months ended
General and Administrative. For the three-months endedJune 30, 2021 general and administrative expenses were$426,169 , a decrease of$37,570 , as compared to$463,739 for the three-months endedJune 30, 2020 . The decrease is primarily the result of decreases in general legal expenses of$77,654 due to reduced usage of professional services and a decrease of$10,769 in expenses for directors and officers liability insurance ("D&O") premiums as a result of the expiration afterJune 30, 2020 of the tail component of such D&O coverage, offset by increases in salaries of$39,300 as a result of our President and CEO accruing salary for the full quarter in 2021 in contrast to only a partial quarter in 2020, as well as an increase in accounting services of$37,783 and smaller increases in other categories of general and administrative expenses. 27 Research and Development. For the three-months endedJune 30, 2021 , research and development expenses were$237,828 , an increase of$84,652 , as compared to$153,176 for the three-months endedJune 30, 2020 . The increase in research and development expenses for the three-months endedJune 30, 2021 , as compared to the three-months endedJune 30, 2020 , is primarily due to the increase in expenses with respect to new product formulation development and for quality testing of active pharmaceutical ingredients for anticipated research and development activities. Research and development expenses included$7,500 of stock-based compensation for the three-months endedJune 30, 2021 and$0 for the three-months ended
June 30, 2020 . Interest Expense. During the three-months endedJune 30, 2021 , interest expense was$151,842 as compared to$190,606 for the three-months endedJune 30, 2020 . The decrease of$38,764 is primarily the result of interest no longer being incurred on convertible notes repaid in full or in part as a result of conversion. Foreign Currency Transaction (Loss) Gain. Foreign currency transaction gain was$2,526 for the three-months endedJune 30, 2021 , as compared to a foreign currency transaction loss of$8,616 for the three-months endedJune 30, 2020 . The foreign currency transaction (loss) gain relates to the$399,774 loan from SY Corporation, made inJune 2012 , which is denominated in the South Korean Won. Net Loss Attributable to Common Stockholders. For the three-months endedJune 30, 2021 , the Company incurred a net loss of$812,214 as compared to a net loss of$816,137 for the three-months endedJune 30, 2020 .
Six-months Ended
Revenues. The Company had no revenues during the six-months ended
General and Administrative. For the six-months endedJune 30, 2021 , general and administrative expenses were$1,071,545 , an increase of$242,526 , as compared to$829,019 for the six-months endedJune 30, 2020 . The increase in general and administrative expenses is primarily due to an increase of$314,300 in salaries, primarily due to a$200,000 guaranteed bonus to our President and CEO as well as a full six months of salary and benefits in 2021 compared to a salary for a partial period in the prior year given that our President and CEO had joined the Company inMay 2020 and had not accrued a full six months salary. In addition, there was an increase of$54,433 in accounting expenses and$20,437 in transfer agent expenses. These increases were offset by decreases of$120,651 in corporate legal expenses and$10,398 in directors and officers liability insurance ("D&O") premiums as a result of the expiration afterJune 30, 2020 of the tail component of such D&O coverage. Research and Development. For the six-months endedJune 30, 2021 , research and development expenses were$392,592 , an increase of$84,126 , as compared to$308,466 for the six-months endedJune 30, 2020 . The increase in research and development expenses for the six-months endedJune 30, 2021 , as compared to the three-months endedJune 30, 2020 , is primarily due to the increase in expenses with respect to new product formulation development and for quality testing of active pharmaceutical ingredients for anticipated research and development activities. Research and development expenses included$15,000 of stock-based compensation for the six-months endedJune 30, 2021 and$0 for the six-months ended June
30, 2020.
Loss on Extinguishment of Convertible Debt. There was no loss on extinguishment
of debt during the six-months ended
Interest Expense. During the six-months endedJune 30, 2021 , interest expense was$231,312 as compared to$331,316 for the six-months endedJune 30, 2020 . The decrease of$100,004 is primarily the result of interest no longer being incurred on convertible notes repaid in full or in part as a result of conversion. Foreign Currency Transaction (Loss) Gain. Foreign currency transaction gain was$31,887 for the six-months endedJune 30, 2021 , as compared to a foreign currency transaction gain of$29,942 for the six-months endedJune 30, 2020 . The foreign currency transaction (loss) gain relates to the$399,774 loan from SY Corporation, made inJune 2012 , which is denominated in the South Korean Won. Net Loss Attributable to Common Stockholders. For the six-months endedJune 30, 2021 , the Company incurred a net loss of$1,662,463 as compared to a net loss of$1,762,855 for the six-months endedJune 30, 2020 .
Liquidity and Capital Resources -
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$1,662,463 for the six-months endedJune 30, 2021 and$4,301,210 for the fiscal year endedDecember 31, 2020 , has incurred negative operating cash flows of$688,571 for the six-months endedJune 30, 2021 and$513,001 for the fiscal year endedDecember 31, 2020 , had a stockholders' deficiency of$8,816,881 atJune 30, 2021 , and expects to continue to incur net losses and negative operating cash flows for at least the next few years. As a result, management has concluded that there is substantial doubt about the Company's ability to continue as a going concern, and the Company's independent registered public accounting firm, in its report on the Company's consolidated financial statements for the year endedDecember 31, 2020 , expressed substantial doubt about the Company's ability to continue as a going concern. AtJune 30, 2021 , the Company had a working capital deficit of$8,816,881 , as compared to a working capital deficit of$8,063,320 atDecember 31, 2020 , reflecting an increase in the working capital deficit of$753,561 for the six-months endedJune 30, 2021 . This is primarily the result of increases in accounts payable and accrued expenses and accrued compensation reflected in our loss from operations during the six-months endedJune 30, 2021 . During the fiscal year endedDecember 31, 2020 , there was forgiveness of certain compensation and related benefits by certain executive officers aggregating$1,684,218 in exchange for equity, having the effect of reducing accrued compensation and related benefits by that amount, which did not occur during the six-month period endedJune 30, 2021 . For more information, see "Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations-Forgiveness of Accrued Compensation and Related Costs" in our 2020 Form 10-K. In addition, a portion of accounts payable to two vendors totaling$241,109 was exchanged for equity during the fiscal year endedDecember 31, 2020 . No similar exchanges occurred during the six-months endedJune 30, 2021 .
At
In general, substantially all of the cash raised in financings during the six-months endedJune 30, 2021 and during fiscal year endedDecember 31, 2020 was utilized to pay general and administrative expenses or the related accounts payable, including, but not limited to, payments to our licensors, our independent registered public accounting firm, our corporate law firm, our patent and intellectual property law firm and for other patent and intellectual property services, our transfer agent, our financial printer and limited cash payments of compensation. Cash was also utilized to pay research and development expenses or the related accounts payable for new product formulation work performed by a contractor with respect to the development of a new proprietary formulation of dronabinol. Cash was also utilized, among other purposes, to make payments pursuant to directors and officers insurance and other insurance financings and to repay, in part, certain advances made by officers and one vendor and payments of certain outstanding accounts payable. 28 The Company is currently, and has for some time, been in significant financial distress. It has 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 continued to raise new debt and equity capital to fund the Company's general and administrative and research and development 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. We are planning to commence, assuming theSEC qualifies the offering, a securities offering pursuant to Regulation A under the Securities Act. See Note 9. Subsequent Events - Filing of Form 1-A to the Company's condensed consolidated financial statement atJune 30, 2021 . We provide no assurance that this offering will be qualified, or if qualified, would result in a financing on terms or for net proceeds acceptable to the Company. The Company regularly evaluates various other measures to satisfy the Company's liquidity needs, including development and other agreements with collaborative partners and, when necessary, seeks to exchange or restructure the Company's outstanding securities. The Company is evaluating certain changes to its operations and structure to facilitating raising capital from sources that may be interested in financing only discrete aspects of the Company's development programs. Such changes could include a significant reorganization, which may include the formation of one or more subsidiaries into which one or more programs may be contributed. As a result of the Company's current financial situation, the Company has limited access to external sources of debt and equity financing. Accordingly, there can be no assurances that the Company will be able to secure additional financing in the amounts necessary to fully fund its operating and debt service requirements. If the Company is unable to access sufficient cash resources, the Company may be forced to discontinue its operations entirely and liquidate. Operating Activities. For the six-months endedJune 30, 2021 , operating activities utilized cash of$688,571 , as compared to utilizing cash of$106,448 for the six-months endedJune 30, 2020 , to support the Company's ongoing general and administrative expenses as well as its research and development activities. Financing Activities. For the six-months endedJune 30, 2021 , financing activities consisted of net proceeds from convertible note financings of$541,050 net of original issue discounts and note costs, sales of common stock pursuant to an equity line of$117,299 and$66,453 with respect to financing of a new directors and officers insurance policy, offset by a$5,000 partial repayment of an officer advance. Principal Commitments Employment Agreements See Note 8. Commitments and Contingencies - Significant Agreements and Contracts - Employment Agreements to our condensed consolidated financial statements
atJune 30, 2021 .
See Note 8. Commitments and Contingencies - Significant Agreements and Contracts
-
UWM Research Foundation Patent License Agreement
See Note 8. Commitments and Contingencies - Significant Agreements and
Contracts, UWM Research Foundation Patent License Agreement to our condensed
consolidated financial statements at
See Note 9. Subsequent Events -
A table setting forth the Company's principal cash obligations and commitments for the next five fiscal years as ofJune 30, 2021 , aggregating$2,179,870 , is set forth in Note 8. Commitments and Contingencies - Summary of Principal Cash Obligations and Commitments.
Off-Balance Sheet Arrangements
At
29
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