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NOTE 1. DESCRIPTION OF BUSINESS Tenax Therapeutics, Inc. (the “Company”) was originally formed as a New Jersey corporation in 1967 under the name Rudmer, David & Associates, Inc., and subsequently changed its name to Synthetic Blood International, Inc. On June 17, 2008, the stockholders of Synthetic Blood International approved the Agreement and Plan of Merger dated April 28, 2008, between Synthetic Blood International and Oxygen Biotherapeutics, Inc., a Delaware corporation. Synthetic Blood International formed Oxygen Biotherapeutics on April 17, 2008 to participate in the merger for the purpose of changing the state of domicile of Synthetic Blood International from New Jersey to Delaware. Certificates of Merger were filed with the states of New Jersey and Delaware and the merger was effective June 30, 2008. Under the Plan of Merger, Oxygen Biotherapeutics was the surviving corporation and each share of Synthetic Blood International common stock outstanding on June 30, 2008 was converted into one share of Oxygen Biotherapeutics common stock. On September 19, 2014, the Company changed its name to Tenax Therapeutics, Inc. As announced in September 2022, the Company has turned its primary focus to the careful evaluation of alternative strategic paths focused on maximizing stockholder value. On November 13, 2013, the Company acquired, through its wholly-owned subsidiary, Life Newco, Inc., a Delaware corporation (“Life Newco”), certain assets of Phyxius Pharma, Inc., a Delaware corporation (“Phyxius”) pursuant to an Asset Purchase Agreement dated October 21, 2013 (the “Asset Purchase Agreement”), by and among the Company, Life Newco, Phyxius and the stockholders of Phyxius. Among these assets was a license between Phyxius and Orion Corporation, a global healthcare company incorporated under the laws of Finland (“Orion”), dated September 20, 2013, and that certain Side Letter, dated October 15, 2013, for the exclusive, sublicensable right to develop and commercialize pharmaceutical products containing levosimendan, 2.5 mg/ml concentrate for solution for infusion / 5ml vial in the United States and Canada (the “Territory”). On October 9, 2020 and January 25, 2022, the Company amended the license (as amended, the “License”), to include two product dose forms containing levosimendan, in capsule and solid dosage form, and a subcutaneously administered product containing levosimendan, subject to specified limitations in the License (together, the “Product”). Pursuant to the License, the Company and Orion will agree to a new trademark when commercializing levosimendan in either of these forms. The term of the License extends until 10 years after the launch of the Product in the Territory, provided that the License will continue after the end of the term in each country in the Territory until the expiration of Orion’s patent rights in the Product in such country. In the event that no regulatory approval for the Product has been granted in the United States on or before September 20, 2030, however, either party will have the right to terminate the License with immediate effect. The Company intends to conduct an upcoming Phase 3 study in pulmonary hypertension patients utilizing one of these formulations, pending the outcome of the strategic process announced in September 2022. See “Note 7 - Commitments and Contingencies” below for a further discussion of the License. On January 15, 2021, the Company, Life Newco II, Inc., a Delaware corporation and a wholly-owned subsidiary of the Company (“Life Newco II”), PHPrecisionMed Inc., a Delaware corporation (“PHPM”) and Dr. Stuart Rich, solely in his capacity as holders’ representative ( the “Representative”), entered into an Agreement and Plan of Merger (the “Merger Agreement”) pursuant to which the Company acquired all of the equity of PHPM, a company developing pharmaceutical products containing imatinib for the treatment of pulmonary arterial hypertension (“PAH”) in the United States and the rest of the world. Under the terms of the Merger Agreement, Life Newco II merged with and into PHPM, with PHPM surviving as a wholly-owned subsidiary of the Company (the “Merger”). See “Note 6 - Merger” below for a further discussion of the Merger. Going Concern Management believes the accompanying condensed consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States of America (“GAAP”), which contemplate continuation of the Company as a going concern. The Company has an accumulated deficit of $287.0 million on September 30, 2022 and $278.5 million on December 31, 2021 and used cash in operations of $9.7 million and $8.1 million during the nine months ended September 30, 2022 and 2021, respectively. The Company, pending the outcome of the strategic process announced in September 2022, requires substantial additional funds to complete clinical trials and pursue regulatory approvals. Management has implemented certain cost-cutting measures, including administrative expense reductions, delaying clinical trials and relocating its corporate headquarters to a shared office space with the majority of its employees now working remotely. The Company is actively exploring a diverse range of strategic options to help drive stockholder value including, among other things, a sale, merger, or other strategic transaction, and continues to seek additional sources of equity and/or debt financing; however, there is no assurance that these efforts will result in a transaction or other alternative or that any additional funding will be available.In view of the matters described above, recoverability of a major portion of the recorded asset amounts shown in the accompanying September 30, 2022 balance sheet is dependent upon continued operations of the Company, which in turn is dependent upon the Company’s ability to meet its financing requirements on a continuing basis, to maintain present financing, and to generate cash from future operations. These factors, among others, raise substantial doubt about the Company’s ability to continue as a going concern. The condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or amounts and classification of liabilities that might be necessary should the Company be unable to continue in existence.

NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with GAAP for interim financial information and the instructions to Form 10‑Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the unaudited condensed consolidated financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results for the periods presented. Certain information and footnote disclosures normally included in the Company’s annual financial statements prepared in accordance with GAAP have been condensed or omitted. These condensed consolidated financial statement results are not necessarily indicative of results to be expected for the full fiscal year or any future period. The accompanying unaudited condensed consolidated financial statements and related disclosures have been prepared with the presumption that users of the unaudited condensed consolidated financial statements have read or have access to the audited financial statements for the preceding fiscal year. Accordingly, these unaudited condensed consolidated financial statements should be read in conjunction with the Company’s Form 10-K, which was filed with the United States Securities and Exchange Commission (“SEC”) on March 29, 2022, from which the Company derived the balance sheet data at December 31, 2021. Use of Estimates The preparation of the accompanying unaudited condensed consolidated financial statements in conformity with GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements and reported amounts of expenses during the reporting period. Actual results could differ from those estimates. On an ongoing basis, management reviews its estimates to ensure that these estimates appropriately reflect changes in the Company’s business and new information as it becomes available. If historical experience and other factors used by management to make these estimates do not reasonably reflect future activity, the Company’s results of operations and financial position could be materially impacted. Principles of Consolidation The accompanying unaudited condensed consolidated financial statements include the accounts and transactions of Tenax Therapeutics, Inc., Life Newco, Inc. and PHPrecisionMed Inc. All material intercompany transactions and balances have been eliminated in consolidation. Cash and Cash Equivalents The Company considers all highly liquid instruments with a maturity date of three months or less, when acquired, to be cash equivalents. Liquidity and Capital Resources On September 30, 2022, the Company had cash and cash equivalents of approximately $3.8 million. The Company used $9.7 million of cash for operating activities during the nine months ended September 30, 2022 and had stockholders’ equity of $4.0 million, versus $4.2 million on December 31, 2021.Pending the outcome of the strategic process announced in September 2022, the Company expects to continue to incur certain expenses related to the development of imatinib for PAH and levosimendan for pulmonary hypertension. Based on its resources on September 30, 2022, the Company believes that it has sufficient capital to fund its planned operations through the first quarter of calendar year 2023. The Company is evaluating alternative strategic paths focused on maximizing stockholder value including, among other things, a sale, merger, or other strategic transaction. There can be no assurance, however, that this process will result in a transaction or other alternative. Pending the outcome of the strategic process announced in September 2022, the Company will need substantial additional financing in order to fund its operations beyond such period and thereafter until it can achieve profitability, if ever. The Company depends on its ability to raise additional funds through various potential sources, such as equity and debt financing, or licensing its product candidates to another pharmaceutical company. The Company intends to continue to fund operations from cash on hand and through sources of capital similar to those previously described. The Company cannot provide assurance that it will be able to secure such additional financing on reasonable terms, or if available, that it will be sufficient to meet its needs. To the extent that the Company raises additional funds by issuing shares of its common stock or other securities convertible or exchangeable for shares of common stock, stockholders will experience dilution, which may be significant. In the event the Company raises additional capital through debt financings, the Company may incur significant interest expense and become subject to restrictive covenants in the related transaction documentation that may affect the manner in which the Company conducts its business. To the extent that the Company raises additional funds through collaboration and licensing arrangements, it may be necessary to relinquish some rights to its technologies or product candidates or grant licenses on terms that may not be favorable to the Company. Any or all of the foregoing may have a material adverse effect on the Company’s business and financial performance. Loss Per Share Basic loss per share, which excludes antidilutive securities, is computed by dividing net loss by the weighted-average number of common shares outstanding for that particular period. In contrast, diluted loss per share considers the potential dilution that could occur from other equity instruments that would increase the total number of outstanding shares of common stock. Such amounts include shares potentially issuable under outstanding options, restricted stock and warrants. The following outstanding options, restricted stock grants, convertible preferred shares and warrants were excluded from the computation of basic and diluted net loss per share for the periods presented because including them would have had an anti-dilutive effect. <table cellpadding="0" style="border-spacing:0;text-align:left;font:10pt times new roman;margin-left:auto;margin-right:auto;width:85%"><tbody><tr style="height:15px"><td> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="6" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">Nine months ended September 30,</td><td style="white-space: nowrap;"> </td></tr><tr style="height:15px"><td> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">2022</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">2021</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td></tr><tr style="height:15px"><td> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" colspan="2" style="width:9%;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" colspan="2" style="width:9%;"> </td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Warrants to purchase common stock</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">31,524,794</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">20,928,767</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">Pre-funded warrants to purchase common stock</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">15,856,032</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">10,033,274</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Options to purchase common stock</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">1,558,220</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">1,330,366</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">Convertible preferred shares outstanding</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">210</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">210</td><td style="width:1%;white-space: nowrap;"> </td></tr></tbody></table> Operating Leases The Company determines if an arrangement includes a lease at inception. Operating leases are included in operating lease right-of-use assets, other current liabilities, and long-term lease liabilities in the Company’s condensed consolidated balance sheet as of September 30, 2022. Right-of-use assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the net present value of lease payments, the Company uses the incremental borrowing rate based on the information available at the lease commencement date. The operating lease right-of-use assets also include any lease payments made and exclude lease incentives. The Company’s leases may include options to extend or terminate the lease which are included in the lease term when it is reasonably certain that the Company will exercise any such option. Lease expense is recognized on a straight-line basis over the expected lease term. The Company has elected to account for leases with an initial term of 12 months or less similar to previous guidance for operating leases, under which the Company will recognize those lease payments in the consolidated statements of operations and comprehensive loss on a straight-line basis over the lease term.Recent Accounting Pronouncements In August 2020, the Financial Accounting Standards Board (“FASB”) issued accounting standards update (“ASU”) 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): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which simplifies accounting for convertible instruments by removing major separation models required under current GAAP. The ASU removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception and it also simplifies the diluted earnings per share calculation in certain areas. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2023. Early adoption will be permitted. The Company is currently evaluating the impact of this standard on its condensed consolidated financial statements. In June 2016, the FASB issued ASU-2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which amends how credit losses are measured and reported for certain financial instruments that are not accounted for at fair value through net income. This standard requires that credit losses be presented as an allowance rather than as a write-down for available-for-sale debt securities and will be effective for interim and annual reporting periods beginning January 1, 2023, with early adoption permitted. A modified retrospective approach is to be used for certain parts of this guidance, while other parts of the guidance are to be applied using a prospective approach. The Company does not believe the adoption of this standard will have a material impact on its condensed consolidated financial statements and related disclosures.

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with GAAP for interim financial information and the instructions to Form 10‑Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the unaudited condensed consolidated financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results for the periods presented. Certain information and footnote disclosures normally included in the Company’s annual financial statements prepared in accordance with GAAP have been condensed or omitted. These condensed consolidated financial statement results are not necessarily indicative of results to be expected for the full fiscal year or any future period. The accompanying unaudited condensed consolidated financial statements and related disclosures have been prepared with the presumption that users of the unaudited condensed consolidated financial statements have read or have access to the audited financial statements for the preceding fiscal year. Accordingly, these unaudited condensed consolidated financial statements should be read in conjunction with the Company’s Form 10-K, which was filed with the United States Securities and Exchange Commission (“SEC”) on March 29, 2022, from which the Company derived the balance sheet data at December 31, 2021.

The preparation of the accompanying unaudited condensed consolidated financial statements in conformity with GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements and reported amounts of expenses during the reporting period. Actual results could differ from those estimates. On an ongoing basis, management reviews its estimates to ensure that these estimates appropriately reflect changes in the Company’s business and new information as it becomes available. If historical experience and other factors used by management to make these estimates do not reasonably reflect future activity, the Company’s results of operations and financial position could be materially impacted.

The accompanying unaudited condensed consolidated financial statements include the accounts and transactions of Tenax Therapeutics, Inc., Life Newco, Inc. and PHPrecisionMed Inc. All material intercompany transactions and balances have been eliminated in consolidation.

The Company considers all highly liquid instruments with a maturity date of three months or less, when acquired, to be cash equivalents.

On September 30, 2022, the Company had cash and cash equivalents of approximately $3.8 million. The Company used $9.7 million of cash for operating activities during the nine months ended September 30, 2022 and had stockholders’ equity of $4.0 million, versus $4.2 million on December 31, 2021.Pending the outcome of the strategic process announced in September 2022, the Company expects to continue to incur certain expenses related to the development of imatinib for PAH and levosimendan for pulmonary hypertension. Based on its resources on September 30, 2022, the Company believes that it has sufficient capital to fund its planned operations through the first quarter of calendar year 2023. The Company is evaluating alternative strategic paths focused on maximizing stockholder value including, among other things, a sale, merger, or other strategic transaction. There can be no assurance, however, that this process will result in a transaction or other alternative. Pending the outcome of the strategic process announced in September 2022, the Company will need substantial additional financing in order to fund its operations beyond such period and thereafter until it can achieve profitability, if ever. The Company depends on its ability to raise additional funds through various potential sources, such as equity and debt financing, or licensing its product candidates to another pharmaceutical company. The Company intends to continue to fund operations from cash on hand and through sources of capital similar to those previously described. The Company cannot provide assurance that it will be able to secure such additional financing on reasonable terms, or if available, that it will be sufficient to meet its needs. To the extent that the Company raises additional funds by issuing shares of its common stock or other securities convertible or exchangeable for shares of common stock, stockholders will experience dilution, which may be significant. In the event the Company raises additional capital through debt financings, the Company may incur significant interest expense and become subject to restrictive covenants in the related transaction documentation that may affect the manner in which the Company conducts its business. To the extent that the Company raises additional funds through collaboration and licensing arrangements, it may be necessary to relinquish some rights to its technologies or product candidates or grant licenses on terms that may not be favorable to the Company. Any or all of the foregoing may have a material adverse effect on the Company’s business and financial performance. 3800000 4000000 420000

Basic loss per share, which excludes antidilutive securities, is computed by dividing net loss by the weighted-average number of common shares outstanding for that particular period. In contrast, diluted loss per share considers the potential dilution that could occur from other equity instruments that would increase the total number of outstanding shares of common stock. Such amounts include shares potentially issuable under outstanding options, restricted stock and warrants. The following outstanding options, restricted stock grants, convertible preferred shares and warrants were excluded from the computation of basic and diluted net loss per share for the periods presented because including them would have had an anti-dilutive effect. <table cellpadding="0" style="border-spacing:0;text-align:left;font:10pt times new roman;margin-left:auto;margin-right:auto;width:85%"><tbody><tr style="height:15px"><td> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="6" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">Nine months ended September 30,</td><td style="white-space: nowrap;"> </td></tr><tr style="height:15px"><td> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">2022</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">2021</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td></tr><tr style="height:15px"><td> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" colspan="2" style="width:9%;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" colspan="2" style="width:9%;"> </td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Warrants to purchase common stock</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">31,524,794</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">20,928,767</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">Pre-funded warrants to purchase common stock</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">15,856,032</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">10,033,274</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Options to purchase common stock</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">1,558,220</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">1,330,366</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">Convertible preferred shares outstanding</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">210</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">210</td><td style="width:1%;white-space: nowrap;"> </td></tr></tbody></table>

<table cellpadding="0" style="border-spacing:0;text-align:left;font:10pt times new roman;margin-left:auto;margin-right:auto;width:85%"><tbody><tr style="height:15px"><td> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="6" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">Nine months ended September 30,</td><td style="white-space: nowrap;"> </td></tr><tr style="height:15px"><td> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">2022</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">2021</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td></tr><tr style="height:15px"><td> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" colspan="2" style="width:9%;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" colspan="2" style="width:9%;"> </td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Warrants to purchase common stock</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">31,524,794</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">20,928,767</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">Pre-funded warrants to purchase common stock</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">15,856,032</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">10,033,274</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Options to purchase common stock</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">1,558,220</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">1,330,366</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">Convertible preferred shares outstanding</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">210</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">210</td><td style="width:1%;white-space: nowrap;"> </td></tr></tbody></table>

31524794

20928767

15856032

10033274

1558220

210

The Company determines if an arrangement includes a lease at inception. Operating leases are included in operating lease right-of-use assets, other current liabilities, and long-term lease liabilities in the Company’s condensed consolidated balance sheet as of September 30, 2022. Right-of-use assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the net present value of lease payments, the Company uses the incremental borrowing rate based on the information available at the lease commencement date. The operating lease right-of-use assets also include any lease payments made and exclude lease incentives. The Company’s leases may include options to extend or terminate the lease which are included in the lease term when it is reasonably certain that the Company will exercise any such option. Lease expense is recognized on a straight-line basis over the expected lease term. The Company has elected to account for leases with an initial term of 12 months or less similar to previous guidance for operating leases, under which the Company will recognize those lease payments in the consolidated statements of operations and comprehensive loss on a straight-line basis over the lease term.

P12Y

In August 2020, the Financial Accounting Standards Board (“FASB”) issued accounting standards update (“ASU”) 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): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which simplifies accounting for convertible instruments by removing major separation models required under current GAAP. The ASU removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception and it also simplifies the diluted earnings per share calculation in certain areas. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2023. Early adoption will be permitted. The Company is currently evaluating the impact of this standard on its condensed consolidated financial statements. In June 2016, the FASB issued ASU-2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which amends how credit losses are measured and reported for certain financial instruments that are not accounted for at fair value through net income. This standard requires that credit losses be presented as an allowance rather than as a write-down for available-for-sale debt securities and will be effective for interim and annual reporting periods beginning January 1, 2023, with early adoption permitted. A modified retrospective approach is to be used for certain parts of this guidance, while other parts of the guidance are to be applied using a prospective approach. The Company does not believe the adoption of this standard will have a material impact on its condensed consolidated financial statements and related disclosures.

NOTE 3. BALANCE SHEET COMPONENTS Prepaid expenses Prepaid expenses primarily consist of clinical trial costs, rent and insurance. Property and equipment, net Property and equipment primarily consist of office furniture and fixtures. Depreciation expense was approximately $1,200 and $1,000 for the three months ended September 30, 2022 and 2021, respectively. Depreciation expense was approximately $3,800 and $3,000 for the nine months ended September 30, 2022 and 2021, respectively. Accrued liabilities Accrued liabilities consist of the following: <table cellpadding="0" style="border-spacing:0;text-align:left;font:10pt times new roman;margin-left:auto;margin-right:auto;width:85%"><tbody><tr style="height:15px"><td> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">September 30, 2022</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">December 31, 2021</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Operating costs</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">230,480</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">-</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">Lease liability</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">116,243</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">107,192</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Employee related</td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;white-space: nowrap;"> </td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">77,692</td><td style="PADDING-BOTTOM: 1px;width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;white-space: nowrap;"> </td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">597,148</td><td style="PADDING-BOTTOM: 1px;width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td> </td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 3px double;width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="BORDER-BOTTOM: 3px double;width:9%;vertical-align:bottom;text-align:right;">424,415</td><td style="PADDING-BOTTOM: 3px;width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 3px double;width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="BORDER-BOTTOM: 3px double;width:9%;vertical-align:bottom;text-align:right;">704,340</td><td style="PADDING-BOTTOM: 3px;width:1%;white-space: nowrap;"> </td></tr></tbody></table>

1200

1000

3800

3000

<table cellpadding="0" style="border-spacing:0;text-align:left;font:10pt times new roman;margin-left:auto;margin-right:auto;width:85%"><tbody><tr style="height:15px"><td> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">September 30, 2022</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">December 31, 2021</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Operating costs</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">230,480</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">-</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">Lease liability</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">116,243</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">107,192</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Employee related</td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;white-space: nowrap;"> </td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">77,692</td><td style="PADDING-BOTTOM: 1px;width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;white-space: nowrap;"> </td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">597,148</td><td style="PADDING-BOTTOM: 1px;width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td> </td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 3px double;width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="BORDER-BOTTOM: 3px double;width:9%;vertical-align:bottom;text-align:right;">424,415</td><td style="PADDING-BOTTOM: 3px;width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 3px double;width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="BORDER-BOTTOM: 3px double;width:9%;vertical-align:bottom;text-align:right;">704,340</td><td style="PADDING-BOTTOM: 3px;width:1%;white-space: nowrap;"> </td></tr></tbody></table>

230480

116243

107192

77692

597148

424415

704340

NOTE 4. NOTE PAYABLE Financed Insurance Premium The Company entered into a Premium Finance Agreement with Premium Funding Associates, Inc. in connection with certain of the Company’s insurance policies and, pursuant thereto, issued a note payable to Premium Funding, Inc. for $364,546 (the “Note”). The Note has an eight-month term, bears interest at a rate of 3.24% per annum, and is secured by the policies. Under the terms of the Note, the Company is required to make monthly installments of principal and interest totaling $46,124 through August 31, 2022. The Company recorded interest expense of $372 and $4,443 for the three and nine months ended September 30, 2022, respectively. As of September 30, 2022 the Note was paid in full.

364546

0.0324

46124

372

4443 NOTE 5. LEASE In January 2011, the Company entered into a lease with Concourse Associates, LLC for its headquarters in Morrisville, North Carolina (the “Lease”). The Lease was amended in August 2015 to extend the term for the 5,954 square foot rental. The subsequent term began on March 1, 2016 and continued for 64 months to June 30, 2021. Rent payments began on July 1, 2016, following the conclusion of a four-month rent abatement period. The Company has two five-year options to extend the Lease and a one-time option to terminate the Lease 36 months after the commencement of the initial term if no additional space became available. On April 2, 2021, the Company negotiated a three-year extension to the existing lease term, commencing July 1, 2021 (the “Commencement Date”). Beginning on the Commencement Date, the annual base rent was increased to $125,034 and will increase 2.5% annually for lease years two and three.The Company performed an evaluation of its other contracts with customers and suppliers in accordance with Accounting Standards Codification (“ASC”) 842, Leases, and determined that, except for the Lease described above, none of the Company’s contracts contain a lease. The balance sheet classification of our lease liabilities was as follows: <table cellpadding="0" style="border-spacing:0;text-align:left;font:10pt times new roman;margin-left:auto;margin-right:auto;width:85%"><tbody><tr style="height:15px"><td> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">September 30, 2022</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">December 31, 2021</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Current portion included in accrued liabilities</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">116,243</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">107,192</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">Long term lease liability</td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;white-space: nowrap;"> </td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">95,347</td><td style="PADDING-BOTTOM: 1px;width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;white-space: nowrap;"> </td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">183,589</td><td style="PADDING-BOTTOM: 1px;width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td> </td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 3px double;width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="BORDER-BOTTOM: 3px double;width:9%;vertical-align:bottom;text-align:right;">211,590</td><td style="PADDING-BOTTOM: 3px;width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 3px double;width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="BORDER-BOTTOM: 3px double;width:9%;vertical-align:bottom;text-align:right;">290,781</td><td style="PADDING-BOTTOM: 3px;width:1%;white-space: nowrap;"> </td></tr></tbody></table> As of September 30, 2022, the maturities of our operating lease liabilities were as follows: <table cellpadding="0" style="border-spacing:0;text-align:left;font:10pt times new roman;margin-left:auto;margin-right:auto;width:85%"><tbody><tr style="height:15px"><td style="vertical-align:top;">Year ending December 31, </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" colspan="2" style="width:9%;"> </td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">2022</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">32,047</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">2023</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">129,797</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">2024</td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;white-space: nowrap;"> </td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">65,702</td><td style="PADDING-BOTTOM: 1px;width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;"> </td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Total lease payments</td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">227,546</td><td style="PADDING-BOTTOM: 1px;width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">Less: Imputed interest</td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;white-space: nowrap;"> </td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">(15,956</td><td style="PADDING-BOTTOM: 1px;width:1%;vertical-align:bottom;white-space: nowrap;">)</td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Operating lease liability</td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 3px double;width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="BORDER-BOTTOM: 3px double;width:9%;vertical-align:bottom;text-align:right;">211,590</td><td style="PADDING-BOTTOM: 3px;width:1%;white-space: nowrap;"> </td></tr></tbody></table> Operating lease liabilities are based on the net present value of the remaining lease payments over the remaining lease term. In determining the present value of lease payments, the Company used the incremental borrowing rate based on the information available at its Lease’s Commencement Date. As of September 30, 2022, the remaining Lease term is 18 months and the discount rate used to determine the operating lease liability was 8.0%. For the nine months ending September 30, 2022, the Company paid $95,719 in total lease expenses, including $1,155 for common area maintenance charges. P64Y The Company has two five-year options to extend the Lease and a one-time option to terminate the Lease 36 months after the commencement of the initial term if no additional space became available. On April 2, 2021, the Company negotiated a three-year extension to the existing lease term 125034 0.025 <table cellpadding="0" style="border-spacing:0;text-align:left;font:10pt times new roman;margin-left:auto;margin-right:auto;width:85%"><tbody><tr style="height:15px"><td> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">September 30, 2022</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">December 31, 2021</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Current portion included in accrued liabilities</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">116,243</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">107,192</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">Long term lease liability</td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;white-space: nowrap;"> </td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">95,347</td><td style="PADDING-BOTTOM: 1px;width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;white-space: nowrap;"> </td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">183,589</td><td style="PADDING-BOTTOM: 1px;width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td> </td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 3px double;width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="BORDER-BOTTOM: 3px double;width:9%;vertical-align:bottom;text-align:right;">211,590</td><td style="PADDING-BOTTOM: 3px;width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 3px double;width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="BORDER-BOTTOM: 3px double;width:9%;vertical-align:bottom;text-align:right;">290,781</td><td style="PADDING-BOTTOM: 3px;width:1%;white-space: nowrap;"> </td></tr></tbody></table>

116243

107192

95347

183589

211590

290781

<table cellpadding="0" style="border-spacing:0;text-align:left;font:10pt times new roman;margin-left:auto;margin-right:auto;width:85%"><tbody><tr style="height:15px"><td style="vertical-align:top;">Year ending December 31, </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" colspan="2" style="width:9%;"> </td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">2022</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">32,047</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">2023</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">129,797</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">2024</td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;white-space: nowrap;"> </td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">65,702</td><td style="PADDING-BOTTOM: 1px;width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;"> </td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Total lease payments</td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">227,546</td><td style="PADDING-BOTTOM: 1px;width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">Less: Imputed interest</td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;white-space: nowrap;"> </td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">(15,956</td><td style="PADDING-BOTTOM: 1px;width:1%;vertical-align:bottom;white-space: nowrap;">)</td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Operating lease liability</td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 3px double;width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="BORDER-BOTTOM: 3px double;width:9%;vertical-align:bottom;text-align:right;">211,590</td><td style="PADDING-BOTTOM: 3px;width:1%;white-space: nowrap;"> </td></tr></tbody></table>

32047

129797

65702

227546

-15956

211590

P18Y

0.080

95719

1155

NOTE 6. MERGER On January 15, 2021, the Company, Life Newco II, PHPM, and Dr. Rich, as Representative, entered into the Merger Agreement, pursuant to which, the Company acquired all of the equity of PHPM. Under the terms of the Merger Agreement, Life Newco II merged with and into PHPM, with PHPM surviving as a wholly-owned subsidiary of the Company. As consideration for the Merger, the stockholders of PHPM received (i) 1,892,905 shares of Company common stock, and (ii) 10,232 shares of the Company’s Series B convertible preferred stock (“Series B Stock”), which were convertible into up to an aggregate of 10,232,000 shares of common stock (collectively, the “Merger Consideration”). To satisfy the Company’s post-closing rights to closing adjustments and indemnification by PHPM and the former stockholders of PHPM pursuant to the Merger Agreement, 1,212,492 shares of common stock issuable upon conversion of the Series B Stock, which represented approximately 10% of the Merger Consideration, are subject to holdback restrictions for 24 months following closing of the transaction (the “Holdback Shares”). Pursuant to the Merger Agreement, the Company’s Board of Directors, at its annual meeting of stockholders held on June 10, 2021, recommended to the Company’s stockholders, and the stockholders approved, the conversion of the Series B Stock pursuant to the Certificate of Designation. As a result, each share of Series B Stock automatically converted into (i) 881.5 shares of common stock, and (ii) the right to receive up to 118.5 Holdback Shares, to be delivered 24 months after the date of issuance of the Series B Stock, subject to reduction for indemnification claims. Pursuant to the terms of the Merger Agreement, on February 25, 2021, the Board appointed three directors designated by the PHPM representative to serve on the Board: Dr. Rich, the co-founder and Chief Executive Officer and a stockholder of PHPM, and Drs. Michael Davidson and Declan Doogan. In connection with the closing of the Merger, Dr. Rich also was appointed Chief Medical Officer of the Company. The Company evaluated this acquisition in accordance with ASC 805, Business Combinations, to determine whether the assets and operations of PHPM met the definition of a business. Included in the in-process research and development project is the historical know-how, formula protocols, designs, and procedures expected to be needed to complete the related phase of testing. The Company concluded that the in-process research and development project is an identifiable intangible asset that would be accounted for as a single asset in a business combination. The Company also qualitatively concluded that there is no fair value associated with the clinical research organization contract and the clinical manufacturing organization contract because the services are being provided at market rates and could be provided by multiple vendors in the marketplace. Therefore, all of the consideration in the transaction was allocated to the in-process research and development project. As such, the Company concluded that substantially all of the fair value of the gross assets acquired was concentrated in the single in-process research and development asset and the set was not a business. The Company is furthering the clinical development of the acquired asset in an upcoming Phase 3 clinical trial for the treatment of patients with PAH. Although the acquired asset may have utility in other patient populations, future development decisions for the acquired asset will be contingent upon the results of the contemplated Phase 3 program for PAH. As such, the acquired asset does not have an alternative future use at the acquisition date. In accordance with ASC 730, Research and Development, the Company concluded the entire Purchase Price for the asset acquisition was an expense on the acquisition date. The consideration transferred, assets acquired and liabilities assumed were recognized as follows: <table cellpadding="0" style="border-spacing:0;text-align:left;font:10pt times new roman;margin-left:auto;margin-right:auto;width:85%"><tbody><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Fair value of shares of Common Stock issued</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">3,369,371</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">Fair Value of Series B Convertible Preferred Stock issued at closing</td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;white-space: nowrap;"> </td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">18,212,960</td><td style="PADDING-BOTTOM: 1px;width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;"> Total fair value of consideration transferred</td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 3px double;width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="BORDER-BOTTOM: 3px double;width:9%;vertical-align:bottom;text-align:right;">21,582,331</td><td style="PADDING-BOTTOM: 3px;width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;"> </td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Tangible assets acquired</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">-</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">Accounts payable assumed</td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;white-space: nowrap;"> </td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">(150,000</td><td style="PADDING-BOTTOM: 1px;width:1%;vertical-align:bottom;white-space: nowrap;">)</td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Total identifiable net assets</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">(150,000</td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">)</td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">IPR&D expense recognized</td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;white-space: nowrap;"> </td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">21,732,331</td><td style="PADDING-BOTTOM: 1px;width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Total fair value of consideration</td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 3px double;width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="BORDER-BOTTOM: 3px double;width:9%;vertical-align:bottom;text-align:right;">21,582,331</td><td style="PADDING-BOTTOM: 3px;width:1%;white-space: nowrap;"> </td></tr></tbody></table>

1892905 10232 10232000

1212492

0.10 881.5 shares of common stock, and (ii) the right to receive up to 118.5 Holdback Shares, to be delivered 24 months after the date of issuance of the Series B Stock, subject to reduction for indemnification claims

<table cellpadding="0" style="border-spacing:0;text-align:left;font:10pt times new roman;margin-left:auto;margin-right:auto;width:85%"><tbody><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Fair value of shares of Common Stock issued</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">3,369,371</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">Fair Value of Series B Convertible Preferred Stock issued at closing</td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;white-space: nowrap;"> </td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">18,212,960</td><td style="PADDING-BOTTOM: 1px;width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;"> Total fair value of consideration transferred</td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 3px double;width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="BORDER-BOTTOM: 3px double;width:9%;vertical-align:bottom;text-align:right;">21,582,331</td><td style="PADDING-BOTTOM: 3px;width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;"> </td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Tangible assets acquired</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">-</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">Accounts payable assumed</td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;white-space: nowrap;"> </td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">(150,000</td><td style="PADDING-BOTTOM: 1px;width:1%;vertical-align:bottom;white-space: nowrap;">)</td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Total identifiable net assets</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">(150,000</td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">)</td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">IPR&D expense recognized</td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;white-space: nowrap;"> </td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">21,732,331</td><td style="PADDING-BOTTOM: 1px;width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Total fair value of consideration</td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 3px double;width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="BORDER-BOTTOM: 3px double;width:9%;vertical-align:bottom;text-align:right;">21,582,331</td><td style="PADDING-BOTTOM: 3px;width:1%;white-space: nowrap;"> </td></tr></tbody></table>

3369371

18212960

21582331

-150000

21732331

21582331

NOTE 7. COMMITMENTS AND CONTINGENCIES Simdax license agreement On November 13, 2013, the Company acquired, through its wholly-owned subsidiary, Life Newco, that certain License, dated September 20, 2013, as amended on October 9, 2020 and January 25, 2022, by and between Phyxius and Orion, and that certain Side Letter, dated October 15, 2013 by and between Phyxius and Orion. The License grants the Company an exclusive, sublicensable right to develop and commercialize pharmaceutical products containing levosimendan in the Territory and, pursuant to the October 9, 2020 and January 25, 2022 amendments, also includes two product dose forms containing levosimendan, in capsule and solid dosage form, and a subcutaneously administered product containing levosimendan, subject to specified limitations in the License. Pursuant to the License, the Company and Orion will agree to a new trademark when commercializing levosimendan in either of these forms. The License also grants the Company a right of first refusal to commercialize new developments of the Product, including developments as to the formulation, presentation, means of delivery, route of administration, dosage or indication (i.e., line extension products). As of September 30, 2022 and September 30, 2021, the Company has not met any of the developmental milestones under the License and, accordingly, has not recorded any liability for the contingent payments due to Orion.

NOTE 8. STOCKHOLDERS’ EQUITY Under the Company’s Certificate of Incorporation, the Board is authorized, without further stockholder action, to provide for the issuance of up to 10,000,000 shares of preferred stock, par value $0.0001 per share, in one or more series, to establish from time to time the number of shares to be included in each such series, and to fix the designation, powers, preferences and rights of the shares of each such series and the qualifications, limitations and restrictions thereof. Series B Stock As further discussed in “Note 6—Merger” above, on January 15, 2021, the Company issued 10,232 shares of its Series B Stock, which were convertible into an aggregate of 10,232,000 shares of common stock, to the stockholders of PHPM as partial consideration for the Merger with PHPM pursuant to the Merger Agreement. The rights, preferences and privileges of the Series B Stock are set forth in the Certificate of Designation. Following receipt of the approval of the stockholders of the Company on June 10, 2021 for the Conversion, each share of Series B Stock automatically converted into (i) 881.5 shares of common stock and (ii) the right to receive up to 118.5 Holdback Shares, to be delivered 24 months after the date of issuance of the Series B Stock, subject to reduction for indemnification claims. As of September 30, 2022, there were no shares of Series B Stock outstanding. Series A Stock On December 11, 2018, the Company closed its underwritten offering of 5,181,346 units for net proceeds of approximately $9.0 million (the “2018 Offering”). Each unit consisted of (i) one share of the Company’s Series A convertible preferred stock, par value $0.0001 per share (the “Series A Stock”), (ii) a two-year warrant to purchase one share of common stock at an exercise price of $1.93, and (iii) a five-year warrant to purchase one share of common stock at an exercise price of $1.93. In accordance with ASC 480, Distinguishing Liabilities from Equity, the estimated fair value of $1,800,016 for the beneficial conversion feature was recognized as a deemed dividend on the Series A Stock during the year ended December 31, 2020. The table below sets forth a summary of the designation, powers, preferences and rights of the Series A Stock. <table cellpadding="0" style="border-spacing:0;font-size:10pt;width:100%"><tbody><tr style="height:15px"><td style="width:4%;"> </td><td style="width:8%;vertical-align:top;"> Conversion </td><td style="vertical-align:bottom;">Subject to the ownership limitations described below, the Series A Stock is convertible at any time at the option of the holder into shares of the Company’s common stock at a conversion ratio determined by dividing the stated value of the Series A Stock by a conversion price of $1.93 per share. The conversion price is subject to adjustment in the case of stock splits, stock dividends, combinations of shares and similar recapitalization transactions. The Company will not affect any conversion of the Series A Stock, nor shall a holder convert its shares of Series A Stock, to the extent that such conversion would cause the holder to have acquired, through conversion of the Series A Stock or otherwise, beneficial ownership of a number shares of common stock in excess of 4.99% (or, at the election of the holder prior to the issuance of any shares of Series A Stock, 9.99%) of the common stock outstanding after giving effect to such exercise. </td></tr><tr style="height:15px"><td> </td><td style="vertical-align:top;">Dividends </td><td style="vertical-align:top;">In the event the Company pays dividends on its shares of common stock, the holders of the Series A Stock will be entitled to receive dividends on shares of Series A Stock equal, on an as-if-converted basis, to and in the same form as paid on the common stock. No other dividends will be paid on the shares of Series A Stock.</td></tr><tr style="height:15px"><td> </td><td style="vertical-align:top;">Liquidation </td><td style="vertical-align:bottom;">Upon any liquidation, dissolution or winding up of the Company after payment or provision for payment of debts and other liabilities of the Company, the holders of Series A Stock shall be entitled to be paid out of the assets of the Company available for distribution to its stockholders an amount equal to the amount that a holder of common stock would receive if the Series A Stock were fully converted to common stock, which amounts will be paid pari passu with all holders of common stock. </td></tr><tr style="height:15px"><td> </td><td style="vertical-align:top;">Voting rights </td><td style="vertical-align:bottom;">Shares of Series A Stock will generally have no voting rights, except as required by law and except that the consent of holders of a majority of the then outstanding Series A Stock will be required to amend the terms of the Series A Stock or to take other action that adversely affects the rights of the holders of Series A Stock. </td></tr></tbody></table>As of September 30, 2022, there were 210 shares of Series A Stock outstanding. Common Stock and Pre-Funded Warrants The Company’s Certificate of Incorporation authorizes it to issue 400,000,000 shares of $0.0001 par value common stock. As of September 30, 2022, and December 31, 2021, there were 29,980,183 and 25,206,914 shares of common stock issued and outstanding, respectively. As of September 30, 2022 and December 31, 2021, there were 15,856,032 and 10,033,274 pre-funded warrants outstanding, respectively. May 2022 Private Placement (the “May 2022 Offering”) On May 17, 2022, the Company entered into a securities purchase agreement with an institutional investor, a related party, pursuant to which the Company agreed to sell and issue to the investor 10,596,027 units in a private placement at a purchase price of $0.775 per unit. Each unit consisted of (i) one unregistered pre-funded warrant to purchase one share of common stock and (ii) one unregistered warrant to purchase one share of common stock (together with the pre-funded warrants, the “2022 Warrants”). In the aggregate, 21,192,054 shares of the Company’s common stock are underlying the 2022 Warrants. The net proceeds from the private placement, after direct offering expenses, were approximately $7.9 million. The fair value allocated to the pre-funded warrants and warrants was $4.2 million and $3.8 million, respectively. Also, on May 17, 2022 and in connection with the May 2022 Offering, the Company entered into a registration rights agreement (the “May 2022 Registration Rights Agreement”) with the investor, pursuant to which the Company agreed to register for resale the shares of common stock issuable upon exercise of the 2022 Warrants within 120 days following the effective date of the May 2022 Registration Rights Agreement. Pursuant to the May 2022 Registration Rights Agreement, on May 25, 2022, the Company filed a resale registration statement on Form S-3 with the SEC, which went effective on June 3, 2022. Additionally, in connection with the May 2022 Offering, the Company entered into a warrant amendment agreement (the “Warrant Amendment Agreement”) with the investor, in consideration for the investor’s purchase of units in the May 2022 Offering, pursuant to which the Company agreed to amend certain previously issued warrants held by the investor. The terms of the amended and restated warrants are described further below under “Note 8—Stockholders Equity—Warrants”. July 2021 Private Placement (the “July 2021 Offering”) On July 6, 2021, the Company entered into a securities purchase agreement with an institutional investor, a related party, pursuant to which the Company agreed to sell and issue to the investor 4,773,269 units in a private placement at a purchase price of $2.095 per unit. Each unit consisted of (i) one unregistered pre-funded warrant to purchase one share of common stock and (ii) one unregistered warrant to purchase one share of common stock (together with the pre-funded warrants, the “2021 Warrants”). In the aggregate, 9,546,538 shares of the Company’s common stock are underlying the 2021 Warrants. The net proceeds from the private placement, after deducting placement agent fees and other direct offering expenses, were approximately $9.2 million. The fair value allocated to the pre-funded warrants and warrants was $5.5 million and $4.5 million, respectively. Also, on July 6, 2021 and in connection with the July 2021 Offering, the Company entered into a registration rights agreement (the “July 2021 Registration Rights Agreement”) with the investor, pursuant to which the Company agreed to register for resale the shares of common stock issuable upon exercise of the 2021 Warrants within 120 days following the effective date of the July 2021 Registration Rights Agreement. Pursuant to the July 2021 Registration Rights Agreement, on August 20, 2021, the Company filed a resale registration statement on Form S-3 with the SEC, which went effective on September 1, 2021. Warrants As of September 30, 2022, the Company has 31,524,794 warrants outstanding. The following table summarizes the Company’s warrant activity for the nine months ended September 30, 2022: <table cellpadding="0" style="border-spacing:0;text-align:left;font:10pt times new roman;margin-left:auto;margin-right:auto;width:85%"><tbody><tr style="height:15px"><td> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">Warrants</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">Weighted Average Exercise Price</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Outstanding at December 31, 2021</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">20,928,767</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">1.45</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">Issued</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">10,596,027</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">0.63</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Amended and restated</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">(9,206,120</td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">)</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">1.72</td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">(1)</td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">Amended and restated</td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;white-space: nowrap;"> </td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">9,206,120</td><td style="PADDING-BOTTOM: 1px;width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;white-space: nowrap;"> </td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">0.63</td><td style="PADDING-BOTTOM: 1px;width:1%;vertical-align:bottom;white-space: nowrap;">(1)</td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Outstanding at September 30, 2022</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">31,524,794</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">0.86</td><td style="width:1%;white-space: nowrap;"> </td></tr></tbody></table> (1) This reflects the portion of the warrants that were amended and restated to lower the exercise price to $0.63 in connection with the May 2022 Warrant Amendment Agreement, which is described further below.May 2022 Warrants As described above, as a part of the May 2022 Offering, the Company issued unregistered warrants to purchase 10,596,027 shares of its common stock at an exercise price of $0.63 per share and contractual term of five and one-half years. The unregistered warrants were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”) and Regulation D promulgated thereunder. In accordance with ASC 815, Derivatives and Hedging, these warrants are classified as equity and their relative fair value of approximately $3.8 million was recognized as additional paid in capital. The estimated fair value is determined using the Black-Scholes Option Pricing Model which is based on the value of the underlying common stock at the valuation measurement date, the remaining contractual term of the warrants, risk-free interest rates, expected dividends and expected volatility of the price of the underlying common stock. July 2021 Warrants As described above, as a part of the July 2021 Offering, the Company issued unregistered warrants to purchase 4,773,269 shares of its common stock at an exercise price of $1.97 per share and contractual term of five and one-half years. In connection with the May 2022 Offering, the unregistered warrants were subsequently amended by reducing the exercise price to $0.63 and extending the termination date of the warrants to January 8, 2029. The unregistered warrants were offered in a private placement under Section 4(a)(2) of the Securities Act and Regulation D promulgated thereunder. In accordance with ASC 815, these warrants are classified as equity and their relative fair value of approximately $4.5 million was recognized as additional paid in capital. The estimated fair value is determined using the Black-Scholes Option Pricing Model which is based on the value of the underlying common stock at the valuation measurement date, the remaining contractual term of the warrants, risk-free interest rates, expected dividends and expected volatility of the price of the underlying common stock Warrants Issued for Services In connection with the July 2021 Offering described above, the Company issued designees of the placement agent warrants to purchase 357,995 shares of common stock at an exercise price of $2.46 and a contractual term of five years. In accordance with ASC 815, these warrants are classified as equity and its estimated fair value of $558,472 was recognized as additional paid in capital. The estimated fair value is determined using the Black-Scholes Option Pricing Model which is based on the value of the underlying common stock at the valuation measurement date, the remaining contractual term of the warrant, risk-free interest rates, expected dividends and expected volatility of the price of the underlying common stock. July 2020 Warrants On July 6, 2020, the Company issued unregistered warrants to purchase 7,783,616 shares of its common stock at an exercise price of $0.903 per share and contractual term of five and one-half years. In connection with the May 2022 Offering, the unregistered warrants were subsequently amended by extending the termination date of the warrants to January 8, 2028. March 2020 Warrants On March 13, 2020, the Company issued unregistered warrants to purchase 2,360,313 shares of its common stock at an exercise price of $1.04 per share and contractual term of five and one-half years. In connection with the May 2022 Offering, the unregistered warrants were subsequently amended by reducing the exercise price to $0.63 and extending the termination date of the warrants to September 15, 2027. December 2018 Warrants On December 11, 2018, the Company issued warrants to purchase 5,181,346 shares of its common stock at an exercise price of $1.93 per share and contractual term of five years. In connection with the May 2022 Offering, 2,072,538 of these warrants were subsequently amended by reducing the exercise price to $0.63 and extending the termination date of the warrants to December 11, 2025. Stock Options 2022 Stock Incentive Plan In June 2022, the Company adopted the 2022 Stock Incentive Plan (the “2022 Plan”). Under the 2022 Plan, with the approval of the Board’s Compensation Committee, the Company may grant stock options, stock appreciation rights, restricted stock, restricted stock units, performance shares, performance units, cash-based awards or other stock-based awards. On June 9, 2022, the Company’s stockholders approved the 2022 Plan, which authorizes for issuance under the 2022 Plan a total of 1,100,000 shares of common stock. Upon approval by the stockholders, the 2022 Plan superseded and replaced the Tenax Therapeutics, Inc. 2016 Stock Incentive Plan, as amended (the “2016 Plan”) and all shares of common stock remaining authorized and available for issuance under the 2016 Plan and any shares subject to outstanding awards under the 2016 Plan that subsequently expire, terminate, or are surrendered or forfeited for any reason without issuance of shares automatically become available for issuance under our 2022 Plan. The following table summarizes the shares available for grant under the 2022 Plan for the nine months ended September 30, 2022: <table cellpadding="0" style="border-spacing:0;text-align:left;font:10pt times new roman;margin-left:auto;margin-right:auto;width:85%"><tbody><tr style="height:15px"><td> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">Shares Available for Grant</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Balances, at December 31, 2021</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">-</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">Shares reserved under 2022 Plan</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">1,100,000</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Shares rolled over from 2016 Plan</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">819,750</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">Options granted</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">(571,250</td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">)</td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Options cancelled/forfeited </td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;white-space: nowrap;"> </td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">195,000</td><td style="PADDING-BOTTOM: 1px;width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">Balances, at September 30, 2022</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">1,543,500</td><td style="width:1%;white-space: nowrap;"> </td></tr></tbody></table> 2022 Plan Stock Options Stock options granted under the 2022 Plan may be either incentive stock options (“ISOs”) or nonqualified stock options (“NSOs”). ISOs may be granted only to employees. NSOs may be granted to employees, consultants and directors. Stock options under the 2022 Plan may be granted with a term of up to ten years and at prices no less than fair market value at the time of grant. Stock options granted generally vest over one to four years. The following table summarizes the outstanding stock options under the 2022 Plan for the nine months ended September 30, 2022. <table cellpadding="0" style="border-spacing:0;text-align:left;font:10pt times new roman;margin-left:auto;margin-right:auto;width:85%"><tbody><tr style="height:15px"><td> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="6" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">Outstanding Options</td><td style="white-space: nowrap;"> </td></tr><tr style="height:15px"><td> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">Number of Shares</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">Weighted Average Exercise Price</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Balances at December 31, 2021</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">-</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">-</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">Options granted</td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;white-space: nowrap;"> </td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">571,250</td><td style="PADDING-BOTTOM: 1px;width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">0.62</td><td style="PADDING-BOTTOM: 1px;width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Balances at September 30, 2022</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">571,250</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">0.62</td><td style="width:1%;white-space: nowrap;"> </td></tr></tbody></table> The Company chose the “straight-line” attribution method for allocating compensation costs of each stock option over the requisite service period using the Black-Scholes Option Pricing Model to calculate the grant date fair value. The Company recorded compensation expense for stock option grants of $35,982 for the three months ended September 30, 2022, and $69,932 for the nine months ended September 30, 2022. As of September 30, 2022, there were unrecognized compensation costs of approximately $219,314 related to non-vested stock option awards under the 2022 Plan that will be recognized on a straight-line basis over the weighted average remaining vesting period of 2.12 years.The Company used the following assumptions to estimate the fair value of options granted under the 2022 Plan for the nine months ended September 30, 2022: <table cellpadding="0" style="border-spacing:0;text-align:left;font:10pt times new roman;margin-left:auto;margin-right:auto;width:85%"><tbody><tr style="height:15px"><td> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">For the nine months ended September 30, 2022</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td></tr><tr style="height:15px"><td> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" colspan="2" style="width:9%;"> </td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Risk-free interest rate (weighted average)</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">3.08</td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">%</td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">Expected volatility (weighted average)</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">102.01</td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">%</td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Expected term (in years)</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">7</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">Expected dividend yield</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">0.00</td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">%</td></tr></tbody></table> <table cellpadding="0" style="border-spacing:0;font-size:10pt;width:100%"><tbody><tr style="height:15px"><td style="width:15%;vertical-align:top;">Risk-Free Interest Rate </td><td style="vertical-align:top;">The risk-free interest rate assumption was based on U.S. Treasury instruments with a term that is consistent with the expected term of the Company’s stock options. </td></tr><tr style="height:15px"><td style="vertical-align:top;">Expected Volatility </td><td style="vertical-align:top;">The expected stock price volatility for the Company’s common stock was determined by examining the historical volatility and trading history for its common stock over a term consistent with the expected term of its options. </td></tr><tr style="height:15px"><td style="vertical-align:top;">Expected Term </td><td style="vertical-align:top;">The expected term of stock options represents the weighted average period the stock options are expected to remain outstanding. It was calculated based on the Company’s historical experience with its stock option grants. </td></tr><tr style="height:15px"><td style="vertical-align:top;">Expected Dividend Yield </td><td style="vertical-align:top;">The expected dividend yield of 0% is based on the Company’s history and expectation of dividend payouts. The Company has not paid and does not anticipate paying any dividends in the near future. </td></tr><tr style="height:15px"><td style="vertical-align:top;">Forfeitures </td><td style="vertical-align:top;">Stock compensation expense recognized in the statements of operations for the nine months ended September 30, 2022 is based on awards ultimately expected to vest, and it has been reduced for estimated forfeitures. ASC 718 requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Forfeitures were estimated based on the Company’s historical experience. </td></tr></tbody></table> 2016 Stock Incentive Plan, as Amended In June 2016, the Company adopted the 2016 Plan. Under the 2016 Plan, with the approval of the Board’s Compensation Committee, the Company could grant stock options, stock appreciation rights, restricted stock, restricted stock units, performance shares, performance units, cash-based awards or other stock-based awards. On June 13, 2019, the Company’s stockholders approved an amendment to the 2016 Plan which increased the number of shares of common stock authorized for issuance under the 2016 Plan to a total of 750,000 shares, up from 150,000 previously authorized. On June 10, 2021, the Company’s stockholders approved an additional amendment to the 2016 Plan which increased the number of shares of common stock authorized for issuance under the 2016 Plan to a total of 1.5 million shares, up from 750,000 previously authorized. In June 2022, the 2016 Plan was superseded and replaced by the 2022 Plan and no new awards will be granted under the 2016 Plan going forward. Any awards outstanding under the 2016 Plan on the date of approval of the 2022 Plan remain subject to the 2016 Plan. Upon approval of the 2022 Plan, all shares of common stock remaining authorized and available for issuance under the 2016 Plan and any shares subject to outstanding awards under the 2016 Plan that subsequently expire, terminate, or are surrendered or forfeited for any reason without issuance of shares automatically become available for issuance under our 2022 Plan. The following table summarizes the outstanding stock options under the 2016 Plan for the nine months ended September 30, 2022. <table cellpadding="0" style="border-spacing:0;text-align:left;font:10pt times new roman;margin-left:auto;margin-right:auto;width:85%"><tbody><tr style="height:15px"><td> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="6" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">Outstanding Options</td><td style="white-space: nowrap;"> </td></tr><tr style="height:15px"><td> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">Number of Shares</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">Weighted Average Exercise Price</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Balances at December 31, 2021</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">663,250</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">1.90</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">Options cancelled/forfeited </td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;white-space: nowrap;"> </td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">(195,000</td><td style="PADDING-BOTTOM: 1px;width:1%;vertical-align:bottom;white-space: nowrap;">)</td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">1.62</td><td style="PADDING-BOTTOM: 1px;width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Balances at September 30, 2022</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">468,250</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">2.02</td><td style="width:1%;white-space: nowrap;"> </td></tr></tbody></table> 2016 Plan Stock Options Stock options granted under the 2016 Plan could be either incentive stock options (“ISOs”) or nonqualified stock options (“NSOs”). ISOs could be granted only to employees. NSOs could be granted to employees, consultants and directors. Stock options under the 2016 Plan could be granted with a term of up to ten years and at prices no less than fair market value at the time of grant. Stock options granted under the 2016 Plan generally vest over three to four years. The Company chose the “straight-line” attribution method for allocating compensation costs of each stock option granted under the 2016 Plan over the requisite service period using the Black-Scholes Option Pricing Model to calculate the grant date fair value. The Company recorded compensation expense for these stock option grants under the 2016 Plan of $25,831 and $139,983 for the three months ended September 30, 2022 and 2021, and $91,536 and $322,641 for the nine months ended September 30, 2022 and 2021, respectively. As of September 30, 2022, there were unrecognized compensation costs of approximately $64,309 related to non-vested stock option awards under the 2016 Plan that will be recognized on a straight-line basis over the weighted average remaining vesting period of 0.62 years. 1999 Stock Plan, as Amended and Restated In October 2000, the Company adopted the 1999 Stock Plan, as amended and restated on June 17, 2008 (the “1999 Plan”). Under the 1999 Plan, with the approval of the Compensation Committee of the Board of Directors, the Company could grant stock options, restricted stock, stock appreciation rights and new shares of common stock upon exercise of stock options. On March 13, 2014, the Company’s stockholders approved an amendment to the 1999 Plan which increased the number of shares of common stock authorized for issuance under the 1999 Plan to a total of 200,000 shares, up from 15,000 previously authorized. On September 15, 2015, the Company’s stockholders approved an additional amendment to the 1999 Plan which increased the number of shares of common stock authorized for issuance under the 1999 Plan to a total of 250,000 shares, up from 200,000 previously authorized. The 1999 Plan expired on June 17, 2018 and no new grants may be made under that plan after that date. However, unexpired awards granted under the 1999 Plan remain outstanding and subject to the terms of the 1999 Plan. 1999 Plan Stock Options Stock options granted under the 1999 Plan may be ISOs or NSOs. ISOs could be granted only to employees. NSOs could be granted to employees, consultants and directors. Stock options under the 1999 Plan could be granted with a term of up to ten years and at prices no less than fair market value for ISOs and no less than 85% of the fair market value for NSOs. Stock options granted generally vest over one to three years.The following table summarizes the outstanding stock options under the 1999 Plan for the nine months ended September 30, 2022: <table cellpadding="0" style="border-spacing:0;text-align:left;font:10pt times new roman;margin-left:auto;margin-right:auto;width:85%"><tbody><tr style="height:15px"><td> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="6" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">Outstanding Options</td><td style="white-space: nowrap;"> </td></tr><tr style="height:15px"><td> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">Number of Shares</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">Weighted Average Exercise Price</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Balances at December 31, 2021</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">36,317</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">42.26</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">Options cancelled/forfeited </td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;white-space: nowrap;"> </td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">(17,597</td><td style="PADDING-BOTTOM: 1px;width:1%;vertical-align:bottom;white-space: nowrap;">)</td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">28.00</td><td style="PADDING-BOTTOM: 1px;width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Balances at September 30, 2022</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">18,720</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">55.66</td><td style="width:1%;white-space: nowrap;"> </td></tr></tbody></table> The Company chose the “straight-line” attribution method for allocating compensation costs of each stock option over the requisite service period using the Black-Scholes Option Pricing Model to calculate the grant date fair value. The Company recorded compensation expense for stock option grants of $0 and $1,290 for the three and nine months ended September 30, 2022 and 2021, respectively. As of September 30, 2021, there were no unrecognized compensation costs related to non-vested stock option awards under the 1999 Plan. Inducement Stock Options The Company granted two employment inducement stock option awards, one for 100,000 shares of common stock and the other for 250,000 shares of common stock, to its new CEO on July 6, 2021. The employment inducement stock option for 100,000 shares of common stock was awarded in accordance with the employment inducement award exemption provided by Nasdaq listing rule 5635(c)(4) and was therefore not awarded under the Company’s stockholder approved equity plan. The option award was to vest as follows: 50% upon initiation of a Phase 3 trial for levosimendan by June 30, 2022; and 50% upon initiation of a Phase 3 trial for imatinib by June 30, 2022. The options had a 10-year term and an exercise price of $1.97 per share, the July 6, 2021 closing price of our common stock. As of June 30, 2022, none of the vesting milestones had been achieved and the options were subsequently cancelled. The estimated fair value of this inducement stock option award was $178,291 using a Black-Scholes option pricing model based on market prices and the following assumptions at the date of inducement option grant: risk-free interest rate of 1.37%, dividend yield of 0%, volatility factor for our common stock of 103.50% and an expected life of 10 years. The employment inducement stock option award for 250,000 shares of common stock also was awarded in accordance with the employment inducement award exemption provided by Nasdaq listing rule 5635(c)(4) and was therefore not awarded under the Company’s stockholder approved equity plan. The option award will vest as follows: 25% on the one-year anniversary of the CEO’s employment start date and an additional 25% on each of the following three anniversaries of the CEO’s employment start date, subject to continued employment. The options have a 10-year term and an exercise price of $1.97 per share, the July 6, 2021 closing price of our common stock. As of September 30, 2022, none of the vesting milestones have been achieved. The estimated fair value of this inducement stock option award was $403,180 using a Black-Scholes option pricing model based on market prices and the following assumptions at the date of inducement option grant: risk-free interest rate of 1.13%, dividend yield of 0%, volatility factor for our common stock of 99.36% and an expected life of 7 years. The Company granted an employment inducement stock option award for 250,000 shares of common stock to our chief medical officer on January 15, 2021. This employment inducement stock option was awarded in accordance with the employment inducement award exemption provided by Nasdaq listing rule 5635(c)(4) and was therefore not awarded under the Company’s stockholder approved equity plan. The option award will vest as follows: 25% upon initiation of a Phase 3 trial; 25% upon database lock; 25% upon acceptance for review of an investigational NDA; and 25% upon approval. The options have a 10-year term and an exercise price of $1.78 per share, the January 15, 2021 closing price of our common stock. As of September 30, 2022, none of the remaining vesting milestones have been achieved. The estimated fair value of the inducement stock option award granted was $402,789 using a Black-Scholes option pricing model based on market prices and the following assumptions at the date of inducement option grant: risk-free interest rate of 1.11%, dividend yield of 0%, volatility factor for our common stock of 103.94% and an expected life of 10 years. Inducement stock option compensation expense totaled $24,296 and $117,741 for the three and nine months ended September 30, 2022, respectively. As of September 30, 2022, there was approximately $468,000 of remaining unrecognized compensation expense related to these inducement stock options.

10232

10232000

(i) 881.5 shares of common stock and (ii) the right to receive up to 118.5 Holdback Shares, to be delivered 24 months after the date of issuance of the Series B Stock, subject to reduction for indemnification claims

5181346

9000000

0.0001

1.93

1800016

0.0499 0.0999

210

400000000

0.0001

29980183

25206914

15856032

10033274

0.775

21192054

790000

4200000 3800000 4773269 2.095

9546538

5500000 4500000

<table cellpadding="0" style="border-spacing:0;text-align:left;font:10pt times new roman;margin-left:auto;margin-right:auto;width:85%"><tbody><tr style="height:15px"><td> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">Warrants</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">Weighted Average Exercise Price</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Outstanding at December 31, 2021</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">20,928,767</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">1.45</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">Issued</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">10,596,027</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">0.63</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Amended and restated</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">(9,206,120</td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">)</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">1.72</td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">(1)</td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">Amended and restated</td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;white-space: nowrap;"> </td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">9,206,120</td><td style="PADDING-BOTTOM: 1px;width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;white-space: nowrap;"> </td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">0.63</td><td style="PADDING-BOTTOM: 1px;width:1%;vertical-align:bottom;white-space: nowrap;">(1)</td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Outstanding at September 30, 2022</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">31,524,794</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">0.86</td><td style="width:1%;white-space: nowrap;"> </td></tr></tbody></table>

20928767

1.45

10596027

0.63 -9206120 1.72 9206120 0.63

31524794

0.86

0.63 10596027 3800000 1.97 0.63

357995

2.46 558472 7783616 0.903 2360313 1.04 0.63

5181346

1.93 2072538 0.63 2025-12-11

1100000

<table cellpadding="0" style="border-spacing:0;text-align:left;font:10pt times new roman;margin-left:auto;margin-right:auto;width:85%"><tbody><tr style="height:15px"><td> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="6" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">Outstanding Options</td><td style="white-space: nowrap;"> </td></tr><tr style="height:15px"><td> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">Number of Shares</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">Weighted Average Exercise Price</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Balances at December 31, 2021</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">-</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">-</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">Options granted</td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;white-space: nowrap;"> </td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">571,250</td><td style="PADDING-BOTTOM: 1px;width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">0.62</td><td style="PADDING-BOTTOM: 1px;width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Balances at September 30, 2022</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">571,250</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">0.62</td><td style="width:1%;white-space: nowrap;"> </td></tr></tbody></table>

571250 0.62

571250

0.62

35982

69932

219314 P2Y1M13D

0.0308

1.0201

P7Y

0.0000

750000 150000 1500000

750000

<table cellpadding="0" style="border-spacing:0;text-align:left;font:10pt times new roman;margin-left:auto;margin-right:auto;width:85%"><tbody><tr style="height:15px"><td> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="6" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">Outstanding Options</td><td style="white-space: nowrap;"> </td></tr><tr style="height:15px"><td> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">Number of Shares</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">Weighted Average Exercise Price</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Balances at December 31, 2021</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">663,250</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">1.90</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">Options cancelled/forfeited </td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;white-space: nowrap;"> </td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">(195,000</td><td style="PADDING-BOTTOM: 1px;width:1%;vertical-align:bottom;white-space: nowrap;">)</td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">1.62</td><td style="PADDING-BOTTOM: 1px;width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Balances at September 30, 2022</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">468,250</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">2.02</td><td style="width:1%;white-space: nowrap;"> </td></tr></tbody></table> 663250

1.90

-195000 1.62

468250

2.02

Stock options granted under the 2016 Plan could be either incentive stock options (“ISOs”) or nonqualified stock options (“NSOs”)

25831

139983

91536

322641

64309 P0Y7M13D

200000

15000

200000

<table cellpadding="0" style="border-spacing:0;text-align:left;font:10pt times new roman;margin-left:auto;margin-right:auto;width:85%"><tbody><tr style="height:15px"><td> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="6" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">Outstanding Options</td><td style="white-space: nowrap;"> </td></tr><tr style="height:15px"><td> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">Number of Shares</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td><td style="white-space: nowrap;"> </td><td class="hdcell" colspan="2" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:center;">Weighted Average Exercise Price</td><td style="PADDING-BOTTOM: 1px;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Balances at December 31, 2021</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">36,317</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">42.26</td><td style="width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#ffffff"><td style="vertical-align:top;">Options cancelled/forfeited </td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;white-space: nowrap;"> </td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">(17,597</td><td style="PADDING-BOTTOM: 1px;width:1%;vertical-align:bottom;white-space: nowrap;">)</td><td style="width:1%;white-space: nowrap;"> </td><td style="BORDER-BOTTOM: 1px solid;width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="BORDER-BOTTOM: 1px solid;width:9%;vertical-align:bottom;text-align:right;">28.00</td><td style="PADDING-BOTTOM: 1px;width:1%;white-space: nowrap;"> </td></tr><tr style="height:15px;background-color:#cceeff"><td style="vertical-align:top;">Balances at September 30, 2022</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">18,720</td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;white-space: nowrap;"> </td><td style="width:1%;vertical-align:bottom;white-space: nowrap;">$</td><td class="ffcell" style="width:9%;vertical-align:bottom;text-align:right;">55.66</td><td style="width:1%;white-space: nowrap;"> </td></tr></tbody></table>

36317

42.26

-17597 28.00

18720

55.66

1290

100000

250000

100000

The option award was to vest as follows: 50% upon initiation of a Phase 3 trial for levosimendan by June 30, 2022; and 50% upon initiation of a Phase 3 trial for imatinib by June 30, 2022. The options had a 10-year term and an exercise price of $1.97 per share, the July 6, 2021 closing price of our common stock. As of June 30, 2022

P10Y

1.97

178291

0.0137

1.0350

P10Y

250000

The option award will vest as follows: 25% on the one-year anniversary of the CEO’s employment start date and an additional 25% on each of the following three anniversaries of the CEO’s employment start date, subject to continued employment

1.97

403180

0.0113

0.9936

P7Y

250000

The option award will vest as follows: 25% upon initiation of a Phase 3 trial; 25% upon database lock; 25% upon acceptance for review of an investigational NDA; and 25% upon approval

P10Y

1.78

402789

0.0111

1.0394

P10Y

24296

117741

468000

NOTE 9. SUBSEQUENT EVENTS Common Shares Issued Subsequent to September 30, 2022, the Company issued 14,716,032 shares of its common stock upon the exercise of pre-funded warrants at an exercise price of $0.0001. Cost Reduction Measures As a part of the Company’s cost-cutting measures, on November 1, 2022, the Company relocated its corporate headquarters to a shared office space for a monthly fee and the majority of its employees now work remotely.

14716032

0.0001