Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2024 | May 10, 2024 | |
Cover [Abstract] | ||
Entity Registrant Name | TENAX THERAPEUTICS, INC. | |
Entity Central Index Key | 0000034956 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Small Business | true | |
Entity Shell Company | false | |
Entity Emerging Growth Company | false | |
Entity Current Reporting Status | Yes | |
Document Period End Date | Mar. 31, 2024 | |
Entity Filer Category | Non-accelerated Filer | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2024 | |
Entity Common Stock Shares Outstanding | 1,958,245 | |
Entity File Number | 001-34600 | |
Entity Incorporation State Country Code | DE | |
Entity Tax Identification Number | 26-2593535 | |
Entity Address Address Line 1 | 101 Glen Lennox Drive | |
Entity Address Address Line 2 | Suite 300 | |
Entity Address City Or Town | Chapel Hill | |
Entity Address State Or Province | NC | |
Entity Address Postal Zip Code | 27517 | |
City Area Code | 919 | |
Local Phone Number | 855-2100 | |
Security 12b Title | Common Stock, $0.0001 par value per share | |
Trading Symbol | TENX | |
Security Exchange Name | NASDAQ | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Interactive Data Current | Yes |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 |
Cash and cash equivalents | $ 12,549,475 | $ 9,792,130 |
Prepaid expenses | 1,843,047 | 1,639,797 |
Other current assets | 66,625 | 251,583 |
Total current assets | 14,459,147 | 11,683,510 |
Other assets | 1,117 | 1,117 |
Total assets | 14,460,264 | 11,684,627 |
Accounts payable | 1,080,962 | 2,073,149 |
Accrued liabilities | 536,443 | 1,012,468 |
Note Payable | 413,174 | 500,903 |
Total current liabilities | 2,030,579 | 3,586,520 |
Total liabilities | 2,030,579 | 3,586,520 |
Common stock, par value $.0001 per share; authorized 400,000,000 shares; issued and outstanding 1,958,245 as of March 31, 2024 and 298,281 as of December 31, 2023, respectively | 0 | 0 |
Additional paid-in capital | 313,481,082 | 305,350,830 |
Accumulated deficit | (301,051,593) | (297,252,753) |
Total stockholders' equity | 12,429,685 | 8,098,107 |
Total liabilities and stockholders' equity | 14,460,264 | 11,684,627 |
Series A Preferred Stock [Member] | ||
Series A Preferred stock, par value $.0001, authorized 5,181,346 shares; issued and outstanding 210, as of March 31, 2024 and December 31, 2023, respectively | $ 196 | $ 30 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
Common Stock, Par Value | $ 0.0001 | $ 0.0001 |
Common Stock, Shares Authorized | 400,000,000 | 400,000,000 |
Common Stock, Shares Issued | 1,958,245 | 298,281 |
Common Stock, Shares Outstanding | 1,958,245 | 298,281 |
Preferred Stock, Undesignated Shares Authorized | 4,818,654 | 4,818,654 |
Series A Preferred Stock [Member] | ||
Preferred Stock, Par Value | $ 1 | $ 0.0001 |
Prefered Stock, Shares Issued | 5,181,346 | 5,181,346 |
Prefered Stock ,Shares Outstanding | 210 | 210 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Operating expenses | ||
General and administrative | $ 1,232,674 | $ 1,273,730 |
Research and development | 2,675,652 | 265,735 |
Total operating expenses | 3,908,326 | 1,539,465 |
Net operating loss | 3,908,326 | 1,539,465 |
Interest expense | 7,963 | 7,350 |
Other expense (income), net | (117,449) | (140,055) |
Net loss | $ 3,798,840 | $ 1,406,760 |
Net loss per share, basic and diluted | $ (3.12) | $ (12.10) |
Weighted average number of common shares outstanding, basic and diluted | 1,219,139 | 116,259 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY (Unaudited) - USD ($) | Total | Preferred Stock | Common Stock | Additional Paid-In Capital | Accumulated Deficit |
Balance, shares at Dec. 31, 2022 | 210 | 28,647 | |||
Balance, amount at Dec. 31, 2022 | $ 1,492,741 | $ 0 | $ 3 | $ 291,034,818 | $ (289,542,080) |
Public offering sale of common stock and prefunded warrants, net, shares | 86,994 | ||||
Public offering sale of common stock and prefunded warrants, net, amount | 13,896,525 | 0 | $ 9 | 13,896,516 | 0 |
Offering costs | (282,647) | 0 | $ 0 | (282,647) | 0 |
Exercise of pre-funded warrants for cash, shares | 18,076 | ||||
Exercise of pre-funded warrants for cash, amount | 511,311 | 0 | $ 2 | 511,309 | 0 |
Exercise of pre-funded warrants, cashless, shares | 3,259 | ||||
Exercise of pre-funded warrants, cashless, amount | 0 | 0 | $ 0 | 0 | 0 |
Exercise of warrants, cashless, shares | 135,069 | ||||
Exercise of warrants, cashless, amount | 0 | 0 | $ 13 | (13) | 0 |
Stock split and fractional shares issued, shares | 174 | ||||
Stock split and fractional shares issued, amount | 0 | 0 | $ 0 | 0 | 0 |
Compensation on options issued | 66,543 | 0 | 0 | 66,543 | 0 |
Net loss | (1,406,760) | $ 0 | $ 0 | 0 | (1,406,760) |
Balance, shares at Mar. 31, 2023 | 210 | 272,219 | |||
Balance, amount at Mar. 31, 2023 | 14,277,713 | $ 0 | $ 27 | 305,226,526 | (290,948,840) |
Balance, shares at Dec. 31, 2023 | 210 | 298,281 | |||
Balance, amount at Dec. 31, 2023 | 8,098,107 | $ 0 | $ 30 | 305,350,830 | (297,252,753) |
Public offering sale of common stock and prefunded warrants, net, shares | 421,260 | ||||
Public offering sale of common stock and prefunded warrants, net, amount | 6,183,661 | 0 | $ 42 | 6,183,619 | 0 |
Exercise of pre-funded warrants for cash, shares | 973,240 | ||||
Exercise of pre-funded warrants for cash, amount | 1,827,133 | 0 | $ 97 | 1,827,036 | 0 |
Exercise of pre-funded warrants, cashless, shares | 205,467 | ||||
Exercise of pre-funded warrants, cashless, amount | 0 | 0 | $ 21 | (21) | 0 |
Stock split and fractional shares issued, shares | 59,997 | ||||
Stock split and fractional shares issued, amount | 834 | 0 | $ 6 | 828 | 0 |
Compensation on options issued | 118,790 | 0 | 0 | 118,790 | 0 |
Net loss | (3,798,840) | $ 0 | $ 0 | 0 | (3,798,840) |
Balance, shares at Mar. 31, 2024 | 210 | 1,958,245 | |||
Balance, amount at Mar. 31, 2024 | $ 12,429,685 | $ 0 | $ 196 | $ 313,481,082 | $ (301,051,593) |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net Loss | $ (3,798,840) | $ (1,406,760) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Depreciation and amortization | 0 | 895 |
Interest on debt instrument | 7,963 | 4,443 |
Gain on sale of equipment | 0 | 3,771 |
Issuance and vesting of compensatory stock options and warrants | 118,790 | 66,543 |
Changes in operating assets and liabilities | ||
Accounts receivable, prepaid expenses and other assets | (18,292) | 234,802 |
Accounts payable and accrued liabilities | (1,475,201) | (628,566) |
Net cash used in operating activities | (5,165,580) | (1,724,872) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Proceeds from sale of property and equipment | 0 | 1,241 |
Net cash provided by investing activities | 0 | 1,241 |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Proceeds from issuance of common stock, warrants and pre-funded warrants | 6,524,262 | 13,896,525 |
Offering cost | (340,643) | (282,647) |
Proceeds from the exercise of warrants | 1,827,036 | 511,311 |
Payments on short-term note | (87,730) | (110,396) |
Net cash provided by financing activities | 7,922,925 | 14,014,793 |
Net change in cash and cash equivalents | 2,757,345 | 12,291,162 |
Cash and cash equivalents, beginning of period | 9,792,130 | 2,123,682 |
Cash and cash equivalents, end of period | $ 12,549,475 | $ 14,414,844 |
DESCRIPTION OF BUSINESS
DESCRIPTION OF BUSINESS | 3 Months Ended |
Mar. 31, 2024 | |
DESCRIPTION OF BUSINESS | |
DESCRIPTION OF BUSINESS | NOTE 1. DESCRIPTION OF BUSINESS Tenax Therapeutics, Inc. (the “Company” or “Tenax”) 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. On November 13, 2013, the Company, through its wholly-owned subsidiary, Life Newco, Inc., a Delaware corporation (“Life NewCo”), acquired 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 with Orion Corporation, a global healthcare company incorporated under the laws of Finland (“Orion”) 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. On October 9, 2020 and January 25, 2022, the Company entered into an amendment to the license to include in the scope of the license two new oral product formulations containing levosimendan, in capsule and solid dosage form (TNX-103) and a subcutaneously administered dosage form (TNX-102), subject to specified limitations (together, the “Product”). In February 2024, the Company entered into an additional amendment to the license (as amended, the “License”), providing global rights to oral and subcutaneous formulations of levosimendan used in the treatment of pulmonary hypertension in heart failure with preserved ejection fraction (“PH-HFpEF”), revising the royalty structure, lowering the royalty rates, modifying milestones associated with certain regulatory and commercial achievements, and excluding from the Company’s right of first refusal the right to commercialize new applications of levosimendan for neurological diseases and disorders developed by Orion. 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 has been extended 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 two upcoming Phase 3 studies in pulmonary hypertension patients utilizing one of these oral formulations. See “Note 6 - 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, 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. Going Concern Management believes the accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”), which contemplate continuation of the Company as a going concern. The Company has an accumulated deficit of approximately $301.1 million and $297.2 million on March 31, 2024, and December 31, 2023, respectively, and expects to incur substantial operating losses for the foreseeable future. As such, the Company requires substantial additional funds to complete clinical trials and pursue regulatory approvals. Management is actively seeking additional sources of equity and/or debt financing; however, there is no assurance 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 March 31, 2024, 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 unaudited 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. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Mar. 31, 2024 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 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 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 28, 2024, from which the Company derived the balance sheet data at December 31, 2023. 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, Life Newco, Inc. and PHPM. All material intercompany transactions and balances have been eliminated in consolidation. Reverse Stock Splits The Company has adjusted the financial statements to reflect that on January 2, 2024, we effected a 1-for-80 reverse stock split (the “Reverse Stock Split”). The Company has also adjusted the financial statements to reflect that on January 4, 2023, we effected a 1-for-20 reverse stock split (the “Prior Reverse Stock Split”, together with the Reverse Stock Split, the “Reverse Stock Splits”). The Reverse Stock Splits did not change the number of authorized shares of capital stock or cause an adjustment to the par value of our capital stock. Pursuant to their terms, a proportionate adjustment was made to the per share exercise price and number of shares issuable under our outstanding stock options and warrants. The number of shares authorized for issuance pursuant to our equity incentive plans have also been adjusted proportionately to reflect the Reverse Stock Splits. 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. Cash Concentration Risk The Federal Deposit Insurance Corporation (the “FDIC”) insurance limits are $250,000 per depositor per insured bank. The Company had cash balances of $683,170 and $2,383,498 uninsured by the FDIC as of March 31, 2024 and December 31, 2023, respectively. In August 2023, the Company, through its commercial bank began to utilize the IntraFi network of commercial banks. IntraFi deposits $250,000 in each of its member banks to maintain the FDIC insurance limit. On March 31, 2024, the Company had $11.6 million deposited in the network which is fully FDIC insured. Liquidity and Capital Resources The Company has financed its operations since September 1990 through the issuance of debt and equity securities and loans from stockholders. The Company had total current assets of approximately $14.5 million and $11.7 million and working capital of $12.4 million and $8.1 million as of March 31, 2024, and December 31, 2023, respectively. The Company’s cash resources were approximately $12.5 million as of March 31, 2024, compared to cash resources of approximately $9.8 million as of December 31, 2023. The Company expects to continue to incur expenses related to the development of levosimendan for PH-HFpEF and other potential indications and, over the long term, imatinib for PAH, as well as identifying and developing other potential product candidates. Based on its resources on March 31, 2024, the Company believes that it has sufficient capital to fund its planned operations through calendar year 2024. However, 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 to license 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. Stock-Based Compensation The Company accounts for stock-based awards to employees in accordance with Accounting Standards Codification (“ASC”) 718, Compensation — Stock Compensation, which provides for the use of the fair value-based method to determine compensation for all arrangements where shares of stock or equity instruments are issued for compensation. Fair values of equity securities are determined by management based predominantly on the trading price of the Company’s common stock. The values of these awards are based upon their grant-date fair value. That cost is recognized over the period during which the employee is required to provide service in exchange for the reward. Equity-Based Payments to Non-Employees The Company accounts for equity instruments issued to non-employees in accordance with ASC 505-50, Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services. Equity instruments issued to non-employees are recorded at their fair value on the measurement date and are subject to periodic adjustment as the underlying equity instruments vest. Warrants for Common Shares and Derivative Financial Instruments Warrants for our shares of common stock and other derivative financial instruments are classified as equity if the contracts: (i) require physical settlement or net-share settlement or (ii) give the Company a choice of net-cash settlement or settlement in its own shares (physical settlement or net-share settlement). Contracts are classified as equity or liabilities if the contracts: (i) require net-cash settlement (including a requirement to net cash settle the contract if an event occurs and if that event is outside the control of the Company), (ii) give the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement), or (iii) contain reset provisions that do not qualify for the scope exception. The Company assesses classification of its warrants for shares of common stock and other derivatives at each reporting date to determine whether a change in classification between equity and liabilities is required. 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. Three months ended March 31, 2024 2023 Warrants to purchase common stock 3,219,694 56,278 Pre-funded warrants to purchase common stock - - Options to purchase common stock 936 946 Convertible preferred shares outstanding 210 210 |
BALANCE SHEET COMPONENTS
BALANCE SHEET COMPONENTS | 3 Months Ended |
Mar. 31, 2024 | |
BALANCE SHEET COMPONENTS | |
BALANCE SHEET COMPONENTS | NOTE 3. BALANCE SHEET COMPONENTS Property and equipment, net Property and equipment primarily consist of office furniture and fixtures. The Company had no depreciation expense and depreciation expense of $895 for the three months ended March 31, 2024, and 2023, respectively. Accrued liabilities Accrued liabilities consist of the following: March 31, 2024 December 31, 2023 Operating costs $ 253,517 $ 236,878 Employee related 282,926 775,590 $ 536,443 $ 1,012,468 |
NOTE PAYABLE
NOTE PAYABLE | 3 Months Ended |
Mar. 31, 2024 | |
NOTE PAYABLE | |
NOTE PAYABLE | NOTE 4. NOTE PAYABLE Premium Finance Agreement On December 31, 2023, the Company executed a premium finance note agreement (the “Note”) with Premium Funding Associates, Inc. The Note financed the Company’s Directors and Officers Insurance Policy as well as the Errors and Omissions policy. The total amount financed was $548,750. The Company paid a down payment of $47,847 at execution leaving a balance of $500,903 payable in monthly installments of $47,847 through December 1, 2024. The Note has an interest rate of 9.95%. The Company recorded interest expense on the Note in the amount of $7,963 for the three months ended March 31, 2024. The balance on the Note as of March 31, 2024, and December 31, 2023, was $413,174 and $500,903, respectively. |
LEASE
LEASE | 3 Months Ended |
Mar. 31, 2024 | |
LEASE | |
LEASE | NOTE 5. LEASE In January 2011, the Company entered into a lease (the “Lease”) with Concourse Associates, LLC (the “Landlord”) for its headquarters located at ONE Copley Parkway, Suite 490, Morrisville, North Carolina (the “Premises”). The Lease was amended in August 2015, March 2016 and April 2021 to extend the term for the 5,954 square foot rental. Pursuant to the Amendment dated April 2021, the existing lease term was extended through June 30, 2024, and the annual base rent of $125,034 would increase 2.5% annually for lease years two and three. On February 7, 2023, the Company entered into a Lease Termination Agreement with the Landlord, with respect to the Premises. As consideration for the Landlord’s entry into the Lease Termination Agreement, including a release of any claims the Landlord may have had against the Company under the Lease, the Company paid the Landlord $169,867. Pursuant to the Lease Termination Agreement, effective February 8, 2023, the Company has no remaining rent or further obligations to the Landlord pursuant to the Lease. The Company performed an evaluation of its other contracts with customers and suppliers in accordance with ASC 842, Leases, and determined that, except for the Lease described above, none of the Company’s contracts contain a lease. The Company owns no real property. Beginning November 1, 2022, we maintain a membership providing dedicated office space, as well as shared services and shared space for meetings, catering, and other business activities, at our principal executive office relocated to 101 Glen Lennox Drive, Suite 300, Chapel Hill, North Carolina 27517. The current rent is approximately $800 per month. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 3 Months Ended |
Mar. 31, 2024 | |
COMMITMENTS AND CONTINGENCIES | |
COMMITMENTS AND CONTINGENCIES | NOTE 6. COMMITMENTS AND CONTINGENCIES Simdax license agreement On November 13, 2013, the Company, through its wholly-owned subsidiary, Life Newco, Inc., acquired certain assets of Phyxius pursuant to the Asset Purchase Agreement by and among the Company, Life Newco, Phyxius and the stockholders of Phyxius. Among these assets was a license with Orion 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. On October 9, 2020 and January 25, 2022, the Company entered into an amendment to the license to include in the scope of the license two new oral Product formulations containing levosimendan, in capsule and solid dosage form (TNX-103) and a subcutaneously administered dosage form (TNX-102), subject to specified limitations. On February 19, 2024, the Company entered into an additional amendment to the License providing global rights to oral and subcutaneous formulations of levosimendan used in the treatment of PH-HFpEF. The amendment also reduced the tiered royalties based on worldwide net sales of the product by the Company and its sublicensees, increased the License’s existing milestone payment due to Orion upon the grant of United States Food and Drug Administration approval of a levosimendan-based product to $10.0 million and added a milestone payment to Orion of $5.0 million due upon the grant of regulatory approval for a levosimendan-based product in Japan. The amendment also (i) increased the Company’s obligations to make certain non-refundable commercialization milestone payments to Orion, aggregating to up to $45.0 million, contingent upon achievement of certain cumulative worldwide sales of the product by the Company, and (ii) reduced the maximum price per capsule payable by the Company to Orion, under a yet-to-be-negotiated supply agreement, for the commercial supply of oral levosimendan-based product. Pursuant to the License, the Company and Orion will agree to a new trademark when commercializing levosimendan in either of the dosage 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 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 but, pursuant to the February 2024 amendment, excluding new applications of levosimendan for neurological diseases and disorders developed by Orion. As of March 31, 2024, 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. Litigation The Company is subject to litigation in the normal course of business, none of which management believes will have a material adverse effect on the Company’s consolidated financial statements. |
STOCKHOLDERS EQUITY
STOCKHOLDERS EQUITY | 3 Months Ended |
Mar. 31, 2024 | |
STOCKHOLDERS EQUITY | |
STOCKHOLDERS' EQUITY | NOTE 7. 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 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 1/1600 th th ASC 480, Distinguishing Liabilities from Equity As of March 31, 2024, there were 210 shares of Series A Stock outstanding convertible in the aggregate into one share of common stock. 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 March 31, 2024, and December 31, 2023, there were 1,958,245 and 298,281 shares of common stock issued and outstanding, respectively. As of March 31, 2024, and December 31, 2023, there were no pre-funded warrants outstanding. The Company has adjusted all share amounts and references to stock prices in this Quarterly Report on Form 10-Q, as well as our financial statements, to reflect the Reverse Stock Splits. The Reverse Stock Splits did not change the number of authorized shares of capital stock or cause an adjustment to the par value of our capital stock. Pursuant to their terms, a proportionate adjustment was made to the per share exercise price and number of shares issuable under our outstanding stock options and warrants. The number of shares authorized for issuance pursuant to our equity incentive plans have also been adjusted proportionately to reflect the Reverse Stock Splits. February 2024 Registered Public Offering (the “February 2024 Offering”) On February 8, 2024, the Company entered into a securities purchase agreement with certain purchasers for the purchase and sale, in a registered public offering by the Company of (i) an aggregate of 421,260 shares of its common stock, and pre-funded warrants to purchase an aggregate of 1,178,740 shares of common stock and (ii) accompanying warrants to purchase up to an aggregate of 3,200,000 shares of its common stock at a combined offering price of $5.65 per share of common stock and associated warrant, or $5.649 per pre-funded warrant and associated warrant, resulting in gross proceeds of approximately $9.0 million. The net proceeds of the February 2024 Offering after deducting placement agent fees and direct offering expenses were approximately $8.0 million. The fair value allocated to the common stock, pre-funded warrants and warrants was $0.9 million, $2.4 million, and $5.7 million, respectively. February 2023 Registered Public Offering (the “February 2023 Offering”) On February 3, 2023, the Company entered into a securities purchase agreement with certain purchasers for the purchase and sale, in a registered public offering by the Company of (i) an aggregate of 86,994 shares of its common stock, and pre-funded warrants to purchase an aggregate of 21,341 shares of common stock and (ii) accompanying warrants to purchase up to an aggregate of 216,667 shares of its common stock at a combined offering price of $144 per share of common stock and associated common warrant, or $143.92 per pre-funded warrant and associated common warrant, resulting in gross proceeds of approximately $15.6 million. The net proceeds of the February 2023 Offering after deducting placement agent fees and direct offering expenses were approximately $14.1 million. The fair value allocated to the common stock, pre-funded warrants and warrants was $5.0 million, $1.2 million and $9.4 million, 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, pursuant to which the Company agreed to sell and issue to the investor 6,623 units in a private placement at a purchase price of $1,240 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, 13,246 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”. Warrants As of March 31, 2024, the Company has 3,219,694 warrants outstanding. The following table summarizes the Company’s warrant activity for the three months ended March 31, 2024, not including pre-funded warrants: Warrants Weighted Average Exercise Price Outstanding at December 31, 2023 19,694 $ 1,095.27 Issued 3,200,000 5.65 Exercised - - Outstanding at March 31, 2024 3,219,694 $ 12.32 February 2024 Warrants As described above, as a part of the February 2024 Offering, the Company issued registered warrants to purchase 3,200,000 shares of its common stock at an exercise price of $5.65 per share and contractual term of five years. In accordance with ASC 815, Derivatives and Hedging Remaining contractual term 5 Years Risk free interest rate 4.12 % Expected dividends - Expected Volatility 131.87 % February 2023 Warrants As described above, as a part of the February 2023 Offering, the Company issued registered warrants to purchase 216,667 shares of its common stock at an exercise price of $180.00 per share and contractual term of five years. In accordance with ASC 815, Derivatives and Hedging Remaining contractual term 5 Years Risk free interest rate 2.23 % Expected dividends - Expected Volatility 105.69 % May 2022 Warrants As described above, as a part of the May 2022 Offering, the Company issued unregistered warrants to purchase 6,623 shares of its common stock at an exercise price of $1,008.00 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 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 688 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 three months ended March 31, 2024. Shares Available for Grant Balances, at December 31, 2023 1,000 Options cancelled/forfeited - Balances, at March 31, 2024 1,000 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 three months ended March 31, 2024. Outstanding Options Number of Shares Weighted Average Exercise Price Balances at December 31, 2023 331 $ 992.00 Options cancelled/forfeited - $ - Balances at March 31, 2024 331 $ 992.00 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 $16,087 and $34,380 for the three months ended March 31, 2024 and 2023, respectively. As of March 31, 2024, there were unrecognized compensation costs of approximately $55,626 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 1.17 years. 2016 Stock Incentive Plan In June 2016, the Company adopted the 2016 Stock Incentive Plan (the “2016 Plan”). Under the 2016 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 16, 2016, the Company’s stockholders approved the 2016 Plan and authorized for issuance under the 2016 Plan a total of 94 shares of common stock. 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 469 shares, up from 94 shares previously authorized. On June 10, 2021, 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 938 shares, up from 469 shares 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. 2016 Plan Stock Options Stock options granted under the 2016 Plan could be either ISOs or 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 generally vest over three to four years. The following table summarizes the outstanding stock options under the 2016 Plan for the three months ended March 31, 2024. Outstanding Options Number of Shares Weighted Average Exercise Price Balances at December 31, 2023 284 $ 3,251.77 Options cancelled/forfeited - $ - Balances at March 31, 2024 284 $ 3,251.77 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 no compensation expense for these stock option grants for the three months ended March 31, 2024 and $7,867 for the three months ended March 31 2023, respectively. The Company granted no stock options for the three months ended March 31,2024. As of March 31, 2024, there were no unrecognized compensation costs related to non-vested stock option awards under the 2016 Plan. 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 125 shares, up from 10 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 157 shares, up from 125 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 three months ended March 31, 2024: Outstanding Options Number of Shares Weighted Average Exercise Price Balances at December 31, 2023 9 $ 86,108.80 Options cancelled/forfeited - $ - Balances at March 31, 2024 9 $ 86,108.80 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 no compensation expense for these stock option grants for the three months ended March 31, 2024 and 2023, respectively. As of March 31, 2024, 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 63 shares of common stock and the other for 156 shares of common stock, to its new CEO on July 6, 2021. The employment inducement stock option for 63 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 $3,152.00 per share, the July 6, 2021 closing price of our common stock. As of December 31, 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 156 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 $3,152 per share, the July 6, 2021 closing price of our common stock. As of March 31, 2024, half 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 156 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 $2,848 per share, the January 15, 2021 closing price of our common stock. As of March 31, 2024, two of the 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 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 $102,703 for the three months ended March 31, 2024. As of March 31, 2024, there was $252,362 remaining unrecognized compensation expense related to these inducement stock options. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 3 Months Ended |
Mar. 31, 2024 | |
SUBSEQUENT EVENTS | |
SUBSEQUENT EVENTS | NOTE 8. SUBSEQUENT EVENTS None. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
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 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. |
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, Life Newco, Inc. and PHPM. All material intercompany transactions and balances have been eliminated in consolidation. |
Reverse Stock Split | The Company has adjusted the financial statements to reflect that on January 2, 2024, we effected a 1-for-80 reverse stock split (the “Reverse Stock Split”). The Company has also adjusted the financial statements to reflect that on January 4, 2023, we effected a 1-for-20 reverse stock split (the “Prior Reverse Stock Split”, together with the Reverse Stock Split, the “Reverse Stock Splits”). The Reverse Stock Splits did not change the number of authorized shares of capital stock or cause an adjustment to the par value of our capital stock. Pursuant to their terms, a proportionate adjustment was made to the per share exercise price and number of shares issuable under our outstanding stock options and warrants. The number of shares authorized for issuance pursuant to our equity incentive plans have also been adjusted proportionately to reflect the Reverse Stock Splits. |
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. |
Cash Concentration Risk | The Federal Deposit Insurance Corporation (the “FDIC”) insurance limits are $250,000 per depositor per insured bank. The Company had cash balances of $683,170 and $2,383,498 uninsured by the FDIC as of March 31, 2024 and December 31, 2023, respectively. In August 2023, the Company, through its commercial bank began to utilize the IntraFi network of commercial banks. IntraFi deposits $250,000 in each of its member banks to maintain the FDIC insurance limit. On March 31, 2024, the Company had $11.6 million deposited in the network which is fully FDIC insured. |
Liquidity And Capital Resources | The Company has financed its operations since September 1990 through the issuance of debt and equity securities and loans from stockholders. The Company had total current assets of approximately $14.5 million and $11.7 million and working capital of $12.4 million and $8.1 million as of March 31, 2024, and December 31, 2023, respectively. The Company’s cash resources were approximately $12.5 million as of March 31, 2024, compared to cash resources of approximately $9.8 million as of December 31, 2023. The Company expects to continue to incur expenses related to the development of levosimendan for PH-HFpEF and other potential indications and, over the long term, imatinib for PAH, as well as identifying and developing other potential product candidates. Based on its resources on March 31, 2024, the Company believes that it has sufficient capital to fund its planned operations through calendar year 2024. However, 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 to license 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. |
Stock-Based Compensation | The Company accounts for stock-based awards to employees in accordance with Accounting Standards Codification (“ASC”) 718, Compensation — Stock Compensation, which provides for the use of the fair value-based method to determine compensation for all arrangements where shares of stock or equity instruments are issued for compensation. Fair values of equity securities are determined by management based predominantly on the trading price of the Company’s common stock. The values of these awards are based upon their grant-date fair value. That cost is recognized over the period during which the employee is required to provide service in exchange for the reward. |
Equity-Based Payments to Non-Employees | The Company accounts for equity instruments issued to non-employees in accordance with ASC 505-50, Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services. Equity instruments issued to non-employees are recorded at their fair value on the measurement date and are subject to periodic adjustment as the underlying equity instruments vest. |
Warrants for Common Shares and Derivative Financial Instruments | Warrants for our shares of common stock and other derivative financial instruments are classified as equity if the contracts: (i) require physical settlement or net-share settlement or (ii) give the Company a choice of net-cash settlement or settlement in its own shares (physical settlement or net-share settlement). Contracts are classified as equity or liabilities if the contracts: (i) require net-cash settlement (including a requirement to net cash settle the contract if an event occurs and if that event is outside the control of the Company), (ii) give the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement), or (iii) contain reset provisions that do not qualify for the scope exception. The Company assesses classification of its warrants for shares of common stock and other derivatives at each reporting date to determine whether a change in classification between equity and liabilities is required. |
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. Three months ended March 31, 2024 2023 Warrants to purchase common stock 3,219,694 56,278 Pre-funded warrants to purchase common stock - - Options to purchase common stock 936 946 Convertible preferred shares outstanding 210 210 |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Anti-dilutive Securities | Three months ended March 31, 2024 2023 Warrants to purchase common stock 3,219,694 56,278 Pre-funded warrants to purchase common stock - - Options to purchase common stock 936 946 Convertible preferred shares outstanding 210 210 |
BALANCE SHEET COMPONENTS (Table
BALANCE SHEET COMPONENTS (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
BALANCE SHEET COMPONENTS | |
Accrued Liabilities | March 31, 2024 December 31, 2023 Operating costs $ 253,517 $ 236,878 Employee related 282,926 775,590 $ 536,443 $ 1,012,468 |
STOCKHOLDERS EQUITY (Tables)
STOCKHOLDERS EQUITY (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
STOCKHOLDERS EQUITY | |
Schedule of Warrants Activity | Warrants Weighted Average Exercise Price Outstanding at December 31, 2023 19,694 $ 1,095.27 Issued 3,200,000 5.65 Exercised - - Outstanding at March 31, 2024 3,219,694 $ 12.32 |
Summary of vest based option outstanding | Remaining contractual term 5 Years Risk free interest rate 4.12 % Expected dividends - Expected Volatility 131.87 % Remaining contractual term 5 Years Risk free interest rate 2.23 % Expected dividends - Expected Volatility 105.69 % |
Schedule of options outstanding | Shares Available for Grant Balances, at December 31, 2023 1,000 Options cancelled/forfeited - Balances, at March 31, 2024 1,000 Outstanding Options Number of Shares Weighted Average Exercise Price Balances at December 31, 2023 331 $ 992.00 Options cancelled/forfeited - $ - Balances at March 31, 2024 331 $ 992.00 |
Schedule of outstanding stock options | Outstanding Options Number of Shares Weighted Average Exercise Price Balances at December 31, 2023 284 $ 3,251.77 Options cancelled/forfeited - $ - Balances at March 31, 2024 284 $ 3,251.77 Outstanding Options Number of Shares Weighted Average Exercise Price Balances at December 31, 2023 9 $ 86,108.80 Options cancelled/forfeited - $ - Balances at March 31, 2024 9 $ 86,108.80 |
DESCRIPTION OF BUSINESS (Detail
DESCRIPTION OF BUSINESS (Details Narrative) - USD ($) $ in Millions | Mar. 31, 2024 | Dec. 31, 2023 |
DESCRIPTION OF BUSINESS | ||
Accumulated Deficit | $ 301.1 | $ 297.2 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Pre-Funded Warrants To Purchase Common Stock [Member] | ||
Anti- Securities Dilutive | 0 | 0 |
Warrants To Purchase Common Stock[Member] | ||
Anti- Securities Dilutive | 3,219,694 | 56,278 |
Options To Purchase Common Stock[Member] | ||
Anti- Securities Dilutive | 936 | 946 |
Covertible Preferred Shares Outstanding [Member] | ||
Anti- Securities Dilutive | 210 | 210 |
SUMMARY OF SIGNIFICANT ACCOUN_5
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 | Aug. 31, 2023 |
Cash uninsured amount | $ 683,170 | $ 2,383,498 | |
Total current assets | 14,500,000 | 11,700,000 | |
Working capital amount | 12,400,000 | 8,100,000 | |
Cash resources | 12,500,000 | $ 9,800,000 | |
Deposits | 11,600,000 | ||
Intra Fi Network [Member] | |||
Federal Deposit Insurance Corporation insurance limits | $ 250,000 | $ 250,000 |
BALANCE SHEET COMPONENTS (Detai
BALANCE SHEET COMPONENTS (Details) - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 |
BALANCE SHEET COMPONENTS | ||
Operating Costs | $ 253,517 | $ 236,878 |
Employee Related | 282,926 | 775,590 |
Total | $ 536,443 | $ 1,012,468 |
BALANCE SHEET COMPONENTS (Det_2
BALANCE SHEET COMPONENTS (Details Narrative) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
BALANCE SHEET COMPONENTS | ||
Depreciation expense | $ 895 | $ 895 |
NOTE PAYABLE (Details Narrative
NOTE PAYABLE (Details Narrative) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
NOTE PAYABLE | ||
Note Payable | $ 413,174 | $ 500,903 |
Related party | 500,903 | |
Interest expense | $ 7,963 | |
Proceeds from issuance of note payable | 548,750 | |
Interest rate on notes payable | 9.95% | |
Note payable downpayment | $ 47,847 | |
Monthly installment | $ 47,847 |
LEASE (Details Narrative)
LEASE (Details Narrative) | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
LEASE | |
Lease Expense | $ 169,867 |
Annual Base Rent Increased | 125,034 |
Monthly installment | $ 800 |
Description of lease term | The Lease was amended in August 2015, March 2016 and April 2021 to extend the term for the 5,954 square foot rental. Pursuant to the Amendment dated April 2021, the existing lease term was extended through June 30, 2024 |
Percentage Of Annual Increase In Rent | 2.50% |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details Narrative) - Simdax License Agreement [Member] $ in Millions | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Grant paid to canadian authority | $ 10 |
Grant paid to authority | 5 |
Non-refundable commercialization milestone payment | $ 45 |
STOCKHOLDERS EQUITY (Details)
STOCKHOLDERS EQUITY (Details) | 3 Months Ended |
Mar. 31, 2024 $ / shares shares | |
STOCKHOLDERS EQUITY | |
Warrants outstanding beginning | shares | 19,694 |
Warrants issued | shares | 3,200,000 |
Exercised | shares | 0 |
Warrants outstanding ending | shares | 3,219,694 |
Warrants,Weighted average exercise price beginning | $ / shares | $ 1,095.27 |
Weighted average exercise price, issued | $ / shares | 5.65 |
Weighted average exercise price, excercised | $ / shares | 0 |
Warrants, weighted average exercise price, ending | $ / shares | $ 12.32 |
STOCKHOLDERS EQUITY (Details 1)
STOCKHOLDERS EQUITY (Details 1) | 3 Months Ended |
Mar. 31, 2024 | |
STOCKHOLDERS EQUITY | |
Remaining contractual term | 5 years |
Risk free interest rate | 4.12% |
Expected dividends | 0% |
Expected Volatility | 131.87% |
STOCKHOLDERS EQUITY (Details 2)
STOCKHOLDERS EQUITY (Details 2) | 3 Months Ended |
Mar. 31, 2024 | |
Remaining contractual term | 5 years |
Risk free interest rate | 4.12% |
Expected dividends | 0% |
Expected Volatility | 131.87% |
Grant under 2022 Plan | |
Remaining contractual term | 5 years |
Risk free interest rate | 2.23% |
Expected dividends | 0% |
Expected Volatility | 105.69% |
STOCKHOLDERS EQUITY (Details 3)
STOCKHOLDERS EQUITY (Details 3) - 2022 Stock Incentive Plan | 3 Months Ended |
Mar. 31, 2024 shares | |
Options granted, beginning | 1,000 |
Options cancelled/forfeited | 0 |
Options granted, ending | 1,000 |
STOCKHOLDERS EQUITY (Details 4)
STOCKHOLDERS EQUITY (Details 4) - 2022 Plan Stock Options | 3 Months Ended |
Mar. 31, 2024 $ / shares shares | |
Number of shares, Options Outstanding, Beginning | shares | 331 |
Number of shares outstanding ending balance | shares | 331 |
Number of shares, Options Outstanding, cancelled/forfeited | shares | 0 |
Weighted average exercise price, option outstanding, Beginning Balance | $ / shares | $ 992 |
Weighted average exercise price, Options cancelled/forfeited | $ / shares | 0 |
Weighted average exercise price, option outstanding, Ending Balance | $ / shares | $ 992 |
STOCKHOLDERS EQUITY (Details 5)
STOCKHOLDERS EQUITY (Details 5) - Grant under 2016 Plan [Member] | 3 Months Ended |
Mar. 31, 2024 $ / shares shares | |
Number of shares, Options Outstanding, Beginning | shares | 284 |
Number of shares, Options Outstanding, cancelled/forfeited | shares | 0 |
Number of shares outstanding ending balance | shares | 284 |
Weighted average exercise price, option outstanding, Beginning Balance | $ / shares | $ 3,251.77 |
Warrants,Weighted average exercise price, Options cancelled/forfeited | $ / shares | 0 |
Weighted average exercise price, option outstanding, Ending Balance | $ / shares | $ 3,251.77 |
STOCKHOLDERS EQUITY (Details 6)
STOCKHOLDERS EQUITY (Details 6) - Stock Options 1999 Plan [Member] | 3 Months Ended |
Mar. 31, 2024 $ / shares shares | |
Number of shares, Options Outstanding, Beginning | shares | 9 |
Number of shares, Options Outstanding Options cancelled | shares | 0 |
Number of shares outstanding ending balance | shares | 9 |
Weighted average exercise price, option outstanding, Beginning Balance | $ / shares | $ 86,108.80 |
Warrants,Weighted average exercise price, Options cancelled | $ / shares | 0 |
Weighted average exercise price, option outstanding, Ending Balance | $ / shares | $ 86,108.80 |
STOCKHOLDERS EQUITY (Details Na
STOCKHOLDERS EQUITY (Details Narrative) - USD ($) | 3 Months Ended | 12 Months Ended | ||||
Jul. 06, 2021 | Dec. 11, 2018 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | |
Common Stock, Shares Authorized | 400,000,000 | 400,000,000 | ||||
Common Stock, Par Value | $ 0.0001 | $ 0.0001 | ||||
Common Stock, Shares Outstanding | 1,958,245 | 298,281 | ||||
Pre-funded warrants | $ 6,524,262 | $ 13,896,525 | ||||
Risk-free interest rate | 4.12% | |||||
Volatility Factor Rate | 131.87% | |||||
May 2022 Warrants | ||||||
Exercise price | $ 1,008 | |||||
Warrant To Purchase Of Unregistered Common Stock | 6,623 | |||||
Warrant To Purchase Of Unregistered Common Stock, Value | $ 3,800,000 | |||||
2022 Stock Incentive Plan | ||||||
Stock Option Award Granted | 15,600,000 | 16,087 | 34,380 | |||
Expected Life | 1 year 2 months 1 day | |||||
Series A Stock Plan | ||||||
Underwritten offering | 5,181,346 | |||||
Exercise price | $ 1.93 | |||||
Estimated fair value | 1,800,016 | |||||
2016 Stock Incentive Plan | ||||||
Compensation Expense | $ 7,867 | |||||
Inducement Stock Options [Member] | ||||||
Unrecognized Compensation Costs | 252,362 | |||||
Compensation Expense | $ 102,703 | |||||
Inducement Stock Options [Member] | Chief Medical Officer [Member] | ||||||
Stock Option Award Granted | 402,789 | |||||
Stock Options Description | 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 $2,848 per share, the January 15, 2021 closing price of our common stock | |||||
Risk-free interest rate | 11% | |||||
Dividend Yield | 0% | |||||
Volatility Factor Rate | 103.94% | |||||
Expected Life | 10 years | |||||
First Inducement Stock Options | ||||||
Stock Options Description | The options had a 10-year term and an exercise price of $3,152.00 per share, the July 6, 2021 closing price of our common stock | |||||
Estimated Fair Value Of The Inducement Stock Option Award Granted | $ 178,291 | |||||
Risk-free interest rate | 1.37% | |||||
Dividend Yield | 0% | |||||
Volatility Factor Rate | 0% | |||||
Expected Life | 10 years | |||||
Second Inducement Stock Options | ||||||
Stock Option Award Granted | 403,180 | |||||
Stock Options Description | 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 $3,152 per share, the July 6, 2021 closing price of our common stock | |||||
Risk-free interest rate | 1.13% | |||||
Dividend Yield | 0% | |||||
Volatility Factor Rate | 99.36% | |||||
Expected Life | 7 years | |||||
Febuary 2024 | ||||||
Warrnat purchase | 3,200,000 | |||||
Offering Price | $ 5.65 | |||||
Agent fees and direct offering expenses | $ 14,100,000 | |||||
fair value allocated | 5,700,000 | |||||
Pre-funded warrants | 1,200,000 | |||||
Warrant | $ 9,300,000 | |||||
Febuary 2023 Offering | ||||||
Warrant To Purchase Of Unregistered Common Stock | 421,260 | |||||
Common stock shares | 1,178,740 | |||||
Warrnat purchase | 3,200,000 | |||||
Offering Price | $ 5.65 | |||||
Common stock warrant | $ 0.9 | |||||
Gross proceeds form warrant | $ 5,649,000 | |||||
Agent fees and direct offering expenses | 9,000,000 | |||||
fair value allocated | 900,000 | |||||
Pre-funded warrants | 2,400,000 | |||||
Warrant | $ 5,700,000 | |||||
Febuary 2024 Offering | ||||||
Warrant To Purchase Of Unregistered Common Stock | 86,994 | |||||
Common stock shares | 21,341 | |||||
Warrnat purchase | 216,667 | |||||
Offering Price | $ 144 | |||||
Gross proceeds form warrant | $ 143,920,000 | |||||
Agent fees and direct offering expenses | 8,000,000 | |||||
fair value allocated | 5,000,000 | |||||
Pre-funded warrants | 1,200,000 | |||||
Warrant | $ 9,400,000 | |||||
Warrants To Purchase Common Stock[Member] | ||||||
Anti- Securities Dilutive | 3,219,694 | 56,278 | ||||
Pre-Funded Warrants [Member] | May 2022 Offering [Member] | ||||||
fair value allocated | $ 420,000 | |||||
Pre-funded warrants | $ 1,060 | |||||
Shares | 13,246 | |||||
Warrant | $ 3,800,000 | |||||
Stock issued during period, shares | 6,623 | |||||
Proceeds From Issuance Of Private Placement | $ 7,900,000 | |||||
Pre-Funded Warrants [Member] | July 2020 Offering [Member] | ||||||
Pre-funded warrants issued | 2,143 | |||||
Pre-Funded Warrants [Member] | February 2023 Offering [Member] | ||||||
Public offering sale of common stock and prefunded warrants, shares | 216,667 | |||||
Common stock warrant | $ 180 | |||||
fair value allocated | $ 1,060,000 |