Cover
Cover | 9 Months Ended |
Sep. 30, 2023 | |
Cover [Abstract] | |
Entity Registrant Name | Tenax Therapeutics, Inc. |
Entity Central Index Key | 0000034956 |
Document Type | S-1/A |
Amendment Flag | true |
Entity Small Business | true |
Entity Emerging Growth Company | false |
Entity Filer Category | Non-accelerated Filer |
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 |
Amendment Description | This Amendment No. 2 (this “Amendment”) to the Registration Statement on Form S-1 of Tenax Therapeutics, Inc. (Registration No. 333-275856) (the “Registration Statement”) is being filed solely for the purpose of filing the Inline eXtensible Business Reporting Language (XBRL) exhibits as indicated in Part II, Item 16 of this Amendment. Accordingly, Part I, consisting of the preliminary prospectus, and the balance of Part II of the Registration Statement are unchanged. |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets | |||
Cash and cash equivalents | $ 11,141,136 | $ 2,123,682 | $ 5,583,922 |
Prepaid expenses | 474,866 | 738,927 | 105,078 |
Other current assets | 267,084 | 345,856 | 0 |
Total current assets | 11,883,086 | 3,208,465 | 5,689,000 |
Right of use asset | 0 | 179,503 | 287,692 |
Property and equipment, net | 4,706 | 7,189 | 7,108 |
Other assets | 1,117 | 9,552 | 8,435 |
Total assets | 11,888,909 | 3,404,709 | 5,992,235 |
Current liabilities | |||
Accounts payable | 134,787 | 448,425 | 859,638 |
Accrued liabilities | 292,961 | 775,045 | 704,340 |
Note Payable | 174,466 | 624,302 | 0 |
Total current liabilities | 602,214 | 1,847,772 | 1,563,978 |
Lease liability | 0 | 64,196 | 183,589 |
Total long term liabilities | 0 | 64,196 | 183,589 |
Total liabilities | 602,214 | 1,911,968 | 1,747,567 |
Stockholders' equity | |||
Preferred stock, undesignated, authorized 4,818,654 shares; See Note 8 Series A Preferred stock, par value $.0001, issued 5,181,346 shares; outstanding 210, as of December 31, 2022 and December 31, 2021 | 0 | 0 | |
Common stock, par value $.0001 per share; authorized 400,000,000 shares; issued and outstanding 23,862,434 as of September 30, 2023 and 2,291,809 as of December 31, 2022, respectively | 2,386 | 229 | 2,521 |
Additional paid-in capital | 305,311,462 | 291,034,592 | 282,736,332 |
Accumulated deficit | (294,027,153) | (289,542,080) | (278,494,185) |
Total stockholders' equity | 11,286,695 | 1,492,741 | 4,244,668 |
Total liabilities and stockholders' equity | 11,888,909 | 3,404,709 | $ 5,992,235 |
Series A Preferred Stock | |||
Stockholders' equity | |||
Preferred stock, undesignated, authorized 4,818,654 shares; See Note 8 Series A Preferred stock, par value $.0001, issued 5,181,346 shares; outstanding 210, as of December 31, 2022 and December 31, 2021 | $ 0 | $ 0 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Common Stock, Par Value | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Preferred Stock, Shares Authorized | 4,818,654 | 4,818,654 | |
Common Stock, Shares Authorized | 400,000,000 | 400,000,000 | 400,000,000 |
Common Stock, Shares Issued | 23,862,434 | 2,291,809 | 1,260,346 |
Common Stock, Shares Outstanding | 23,862,434 | 2,291,809 | 1,260,346 |
Preferred Stock, Undesignated Shares Authorized | 4,818,654 | 4,818,654 | |
Series A Preferred Stock | |||
Preferred Stock, Shares Authorized | 259,068 | 259,068 | |
Preferred Stock, Par Value | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Preferred Stock, Shares Issued | 210 | 5,181,346 | 5,181,346 |
Preferred Stock, Shares Outstanding | 210 | 210 | 210 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Operating expenses | ||||||
General and administrative | $ 1,051,524 | $ 1,377,283 | $ 3,363,511 | $ 4,255,454 | $ 5,675,231 | $ 7,580,847 |
Research and development | 1,065,855 | 1,540,205 | 1,529,493 | 4,242,565 | 5,377,412 | 25,147,394 |
Total operating expenses | 2,117,379 | 2,917,488 | 4,893,004 | 8,498,019 | 11,052,643 | 32,728,241 |
Net operating loss | 2,117,379 | 2,917,488 | 4,893,004 | 8,498,019 | 11,052,643 | 32,728,241 |
Interest expense | 5,337 | 372 | 21,813 | 4,443 | 4,443 | 949 |
Interest income | (150,741) | 0 | (366,877) | 0 | ||
Other expense (income), net | 0 | (1,323) | (62,866) | (3,368) | (9,191) | (254,832) |
Net loss | $ 1,971,975 | $ 2,916,537 | $ 4,485,074 | $ 8,499,094 | 11,047,895 | 32,474,358 |
Unrealized gain on marketable securities | 0 | (70) | ||||
Total comprehensive loss | $ 11,047,895 | $ 32,474,288 | ||||
Net loss per share, basic and diluted | $ (0.08) | $ (2.22) | $ (0.24) | $ (6.64) | $ (7.51) | $ (31.56) |
Weighted average number of common shares outstanding, basic and diluted | 23,862,434 | 1,316,504 | 18,532,270 | 1,279,271 | 1,471,303 | 1,028,862 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY (Unaudited) - USD ($) | Total | Preferred Stock | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Gain (Loss) | Accumulated Deficit |
Balance, shares at Dec. 31, 2020 | 210 | 630,968 | ||||
Balance, amount at Dec. 31, 2020 | $ 4,625,562 | $ 0 | $ 1,262 | $ 250,644,197 | $ (70) | $ (246,019,827) |
Common stock and preferred stock issued for asset acquisition, shares | 10,232 | 94,645 | ||||
Common stock and preferred stock issued for asset acquisition, amount | 21,582,331 | $ 1 | $ 189 | 21,582,141 | ||
Common stock issued for convertible preferred stock, shares | (10,232) | 511,600 | ||||
Common stock issued for convertible preferred stock, amount | 0 | $ (1) | $ 1,023 | (1,022) | ||
Pre-funded warrants sold, net of offering costs | 9,192,624 | 9,192,624 | ||||
Compensation on options issued | 773,787 | 773,787 | ||||
Exercise of warrants, shares | 22,852 | |||||
Exercise of warrants, amount | 544,651 | $ 46 | 544,605 | |||
Exercise of stock options, shares | 280 | |||||
Exercise of stock options, amount | 1 | $ 1 | ||||
Unrealized loss on marketable securities | 70 | 70 | ||||
Net loss | (32,474,358) | (32,474,358) | ||||
Net loss | 32,474,358 | |||||
Balance, shares at Dec. 31, 2021 | 210 | 1,260,346 | ||||
Balance, amount at Dec. 31, 2021 | 4,244,668 | $ 0 | $ 126 | 282,738,727 | 0 | (278,494,185) |
Compensation on options issued | 83,069 | 0 | 0 | 83,069 | ||
Net loss | (2,721,536) | $ 0 | $ 0 | 0 | (2,721,536) | |
Balance, shares at Mar. 31, 2022 | 210 | 1,260,346 | ||||
Balance, amount at Mar. 31, 2022 | 1,606,201 | $ 0 | $ 126 | 282,821,796 | (281,215,721) | |
Balance, shares at Dec. 31, 2021 | 210 | 1,260,346 | ||||
Balance, amount at Dec. 31, 2021 | 4,244,668 | $ 0 | $ 126 | 282,738,727 | 0 | (278,494,185) |
Net loss | 8,499,094 | |||||
Balance, shares at Sep. 30, 2022 | 210 | 6,033,615 | ||||
Balance, amount at Sep. 30, 2022 | 3,953,851 | $ 0 | $ 603 | 290,946,527 | (286,993,279) | |
Balance, shares at Dec. 31, 2021 | 210 | 1,260,346 | ||||
Balance, amount at Dec. 31, 2021 | 4,244,668 | $ 0 | $ 126 | 282,738,727 | 0 | (278,494,185) |
Compensation on options issued | 365,314 | 365,314 | ||||
Net loss | (11,047,895) | (11,047,895) | ||||
Net loss | 11,047,895 | |||||
Pre-funded warrants and warrants sold, net of offering costs | 7,928,591 | 7,928,591 | ||||
Exercise of pre-funded warrants, shares | 1,031,463 | |||||
Exercise of pre-funded warrants, amount | 2,063 | $ 2,063 | ||||
Balance, shares at Dec. 31, 2022 | 210 | 2,291,809 | ||||
Balance, amount at Dec. 31, 2022 | 1,492,741 | $ 0 | $ 230 | 291,034,591 | 0 | (289,542,080) |
Balance, shares at Mar. 31, 2022 | 210 | 1,260,346 | ||||
Balance, amount at Mar. 31, 2022 | 1,606,201 | $ 0 | $ 126 | 282,821,796 | (281,215,721) | |
Compensation on options issued | 110,031 | 0 | 0 | 110,031 | 0 | |
Net loss | (2,861,021) | 0 | 0 | 0 | (2,861,021) | |
Pre-funded warrants and warrants sold, net of offering costs | 7,928,591 | $ 0 | $ 0 | 7,928,591 | 0 | |
Balance, shares at Jun. 30, 2022 | 210 | 1,260,346 | ||||
Balance, amount at Jun. 30, 2022 | 6,783,802 | $ 0 | $ 126 | 290,860,418 | (284,076,742) | |
Compensation on options issued | 86,109 | 0 | 0 | 86,109 | 0 | |
Net loss | 2,916,537 | 0 | $ 0 | 0 | (2,916,537) | |
Exercise of pre-funded warrants, shares | 4,773,269 | |||||
Exercise of pre-funded warrants, amount | 477 | $ 0 | $ 477 | 0 | ||
Balance, shares at Sep. 30, 2022 | 210 | 6,033,615 | ||||
Balance, amount at Sep. 30, 2022 | 3,953,851 | $ 0 | $ 603 | 290,946,527 | (286,993,279) | |
Balance, shares at Dec. 31, 2022 | 210 | 2,291,809 | ||||
Balance, amount at Dec. 31, 2022 | 1,492,741 | $ 0 | $ 230 | 291,034,591 | 0 | (289,542,080) |
Compensation on options issued | 66,543 | 0 | 0 | 66,543 | 0 | |
Net loss | (1,406,760) | 0 | 0 | 0 | (1,406,760) | |
Pre-funded warrants and warrants sold, net of offering costs | (282,647) | 0 | $ 0 | (282,647) | 0 | |
Public offering sale of common stock and warrants, net of offering costs, shares | 6,959,444 | |||||
Public offering sale of common stock and warrants, net of offering costs, amount | 13,896,525 | 0 | $ 696 | 13,895,829 | 0 | |
Exercise of pre-funded warrants for cash, shares | 1,446,110 | |||||
Exercise of pre-funded warrants for cash, amount | 511,311 | 0 | $ 145 | 511,166 | 0 | |
Exercise of pre-funded warrants, cashless, shares | 260,722 | |||||
Exercise of pre-funded warrants, cashless, amount | 0 | 0 | $ 26 | (26) | 0 | |
Exercise of warrants, cashless, shares | 10,805,503 | |||||
Exercise of warrants, cashless, amount | 0 | 0 | $ 1,081 | (1,081) | 0 | |
Stock split and fractional shares issued, shares | 13,846 | |||||
Stock split and fractional shares issued, amount | 0 | $ 0 | $ 0 | 0 | 0 | |
Balance, shares at Mar. 31, 2023 | 210 | 21,777,434 | ||||
Balance, amount at Mar. 31, 2023 | 14,277,713 | $ 0 | $ 2,178 | 305,224,375 | (290,948,840) | |
Balance, shares at Dec. 31, 2022 | 210 | 2,291,809 | ||||
Balance, amount at Dec. 31, 2022 | 1,492,741 | $ 0 | $ 230 | 291,034,591 | $ 0 | (289,542,080) |
Net loss | 4,485,074 | |||||
Balance, shares at Sep. 30, 2023 | 210 | 23,862,434 | ||||
Balance, amount at Sep. 30, 2023 | 11,286,695 | $ 0 | $ 2,386 | 305,311,462 | (294,027,153) | |
Balance, shares at Mar. 31, 2023 | 210 | 21,777,434 | ||||
Balance, amount at Mar. 31, 2023 | 14,277,713 | $ 0 | $ 2,178 | 305,224,375 | (290,948,840) | |
Compensation on options issued | 50,283 | 0 | 0 | 50,283 | 0 | |
Net loss | (1,106,338) | 0 | $ 0 | 0 | (1,106,338) | |
Exercise of warrants, cashless, shares | 2,085,000 | |||||
Exercise of warrants, cashless, amount | 0 | $ 0 | $ 208 | (208) | ||
Balance, shares at Jun. 30, 2023 | 210 | 23,862,434 | ||||
Balance, amount at Jun. 30, 2023 | 13,221,658 | $ 0 | $ 2,386 | 305,274,450 | (292,055,178) | |
Compensation on options issued | 37,012 | 0 | 0 | 37,012 | 0 | |
Net loss | 1,971,975 | $ 0 | $ 0 | 0 | (1,971,975) | |
Balance, shares at Sep. 30, 2023 | 210 | 23,862,434 | ||||
Balance, amount at Sep. 30, 2023 | $ 11,286,695 | $ 0 | $ 2,386 | $ 305,311,462 | $ (294,027,153) |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||||
Net Loss | $ (4,485,074) | $ (8,499,094) | $ (11,047,895) | $ (32,474,358) |
Adjustments to reconcile net loss to net cash used in operating activities | ||||
Depreciation and amortization | 2,864 | 3,798 | 5,143 | 4,116 |
Interest on debt instrument | 21,151 | 4,443 | 4,443 | 949 |
Amortization of right of use asset | 0 | 80,332 | 108,189 | 104,866 |
Gain on sale of equipment | 1,125 | 0 | (2,901) | |
Gain on debt settlement and extinguishment | 0 | (247,233) | ||
Issuance and vesting of compensatory stock options and warrants | 153,838 | 279,686 | 365,314 | 773,787 |
Issuance of common stock and preferred stock for asset acquisition | 0 | 21,582,331 | ||
Amortization of premium on marketable securities | 0 | 9,427 | ||
Changes in operating assets and liabilities | ||||
Accounts receivable, prepaid expenses and other assets | 342,834 | (606,559) | (980,822) | (22,500) |
Accounts payable and accrued liabilities | (765,730) | (874,156) | (344,951) | (544,589) |
Long term portion of lease liability | 0 | (88,241) | (119,393) | (42,999) |
Net cash used in operating activities | (4,728,992) | (9,699,791) | (12,012,873) | (10,856,203) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||||
Purchase (proceeds) from sale of property and equipment | 2,843 | (6,323) | ||
Sale of marketable securities | 0 | 803,401 | ||
Purchase of marketable securities | 0 | (345,540) | ||
Purchase of property and equipment | (2,323) | (5,252) | ||
Net cash provided by (used in) investing activities | 2,843 | (6,323) | (2,323) | 452,609 |
CASH FLOWS FROM FINANCING ACTIVITIES | ||||
Proceeds from issuance of common stock, warrants and pre-funded warrants, net of issuance costs | 14,193,439 | 7,928,591 | 7,928,591 | 9,192,624 |
Proceeds from the issuance of note payable | 0 | 364,546 | 624,302 | 0 |
Payments on short-term note | (449,836) | (364,546) | ||
Proceeds from the exercise of warrants | 2,063 | 544,651 | ||
Net cash provided by financing activities | 13,743,603 | 7,928,591 | 8,554,956 | 9,737,275 |
Net change in cash and cash equivalents | 9,017,454 | (1,777,523) | (3,460,240) | (666,319) |
Cash and cash equivalents, beginning of period | 2,123,682 | 5,583,922 | 5,583,922 | 6,250,241 |
Cash and cash equivalents, end of period | $ 11,141,136 | $ 3,806,399 | 2,123,682 | 5,583,922 |
Non-cash investing activity | ||||
Addition to right of use asset obtained from new operating lease liability | $ 0 | $ 333,779 |
DESCRIPTION OF BUSINESS
DESCRIPTION OF BUSINESS | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
DESCRIPTION OF BUSINESS | ||
DESCRIPTION OF BUSINESS | 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. 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, sublicenseable 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 new oral product dose forms containing levosimendan in capsule and solid dosage form, and a subcutaneously administered product containing levosimendan, subject to certain limitations (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 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 $294.0 million at September 30, 2023, and used cash in operations of approximately $4.7 million during the nine months ended September 30, 2023. 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 as part of its ongoing strategic process; 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 September 30, 2023 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. | NOTE A—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. On November 13, 2013, the Company, through its wholly-owned subsidiary, Life Newco, Inc., a Delaware corporation, 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, sublicenseable 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 new oral product dose forms containing levosimendan, in capsule and solid dosage form, and a subcutaneously administered product containing levosimendan, subject to certain limitations (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 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 one or two upcoming Phase 3 studies in pulmonary hypertension patients utilizing one of these oral formulations. See “Note –G - 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 PAH (“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 –E - Merger” below for a further discussion of the Merger. Going Concern Management believes the accompanying 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 $289,542,080 and $278,494,185 on December 31, 2022 and 2021, respectively, and used cash in operations of $12,012,873 and $10,856,203 during the years ended December 31, 2022 and 2021, respectively. 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 December 31, 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 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 | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
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 31, 2023, from which the Company derived the balance sheet data at December 31, 2022. 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 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 4, 2023, the Company effected a 1-for-20 reverse stock split of its outstanding common stock (the “Reverse Stock Split”). The Reverse Stock Split did not change the number of authorized shares of capital stock or cause an adjustment to the par value of its capital stock. Pursuant to their terms, a proportionate adjustment was made to the per share exercise price and number of shares issuable under the Company’s outstanding stock options and warrants. The number of shares authorized for issuance pursuant to the Company’s equity incentive plans have also been adjusted proportionately to reflect the Reverse Stock Split. 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 $345,000 and $1.9 million uninsured by the FDIC as of September 30, 2023 and December 31, 2022, 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 September 30, 2023, the Company had $10.5 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 $11.9 million and $3.2 million and working capital of $11.3 million and $1.4 million as of September 30, 2023 and December 31, 2022, respectively. The Company’s cash resources were approximately $11.1 million as of September 30, 2023, compared to cash resources of approximately $2.1 million as of December 31, 2022. The Company expects to continue to incur expenses related to the development of oral levosimendan to treat pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF) in the Phase 3 LEVEL trial, and, potentially for other indications of levosimendan and imatinib for PAH, as well as identifying and developing other potential product candidates. Based on its resources on September 30, 2023, the Company believes that it has sufficient capital to fund its planned operations through to the first quarter of 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. The COVID-19 pandemic or a similar societal healthcare disruption could in the future, directly or indirectly, adversely affect the Company’s clinical trial operations, including its ability to recruit and retain patients, principal investigators and site staff who, as healthcare providers, may have heightened exposure to or impact from infectious diseases if an outbreak occurs in their geography. Further, some patients may be unable to comply with clinical trial protocols if quarantines or travel restrictions impede patient movement or interrupt healthcare services, or if the patients become infected with coronavirus or a similar virus themselves, which would delay the Company’s ability to initiate and/or complete planned clinical and preclinical studies in the future. In May 2023, the World Health Organization declared that COVID-19 was no longer a global health emergency, however, any lingering impact or resurgence of COVID-19 cannot be estimated. 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. 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 (1) require physical settlement or net-share settlement or (2) give the Company a choice of net-cash settlement or settlement in its own shares (physical settlement or net-share settlement). Contracts which (1) 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), (2) give the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement), or (3) that contain reset provisions that do not qualify for the scope exception are classified as equity or liabilities. 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. Nine months ended September 30, 2023 2022 Warrants to purchase common stock 1,722,240 1,576,240 Pre-funded warrants to purchase common stock - 792,802 Options to purchase common stock 74,873 77,911 Convertible preferred shares outstanding 210 210 Recent Accounting Pronouncements 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 is 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 adoption of this standard has not had a material impact on its condensed consolidated financial statements and related disclosures. | NOTE B—SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Use of Estimates The preparation of the accompanying 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 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 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. Reverse Stock Split The Company has adjusted the financial statements to reflect that on January 4, 2023, we effected a 1-for-20 reverse stock split (the “Reverse Stock Split”). The Reverse Stock Split 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 Split. 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 $1,877,589 and $5,127,956 uninsured by the FDIC as of December 31, 2022 and 2021, respectively. 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 $3.2 million and $5.7 million and working capital of $1.4 million and $4.1 million as of December 31, 2022 and 2021, respectively. The Company’s cash resources were approximately $2.1 million as of December 31, 2022, compared to cash resources of approximately $5.6 million as of December 31, 2021. The Company expects to continue to incur expenses related to development of levosimendan for pulmonary hypertension and other potential indications and imatinib for PAH, as well as identifying and developing other potential product candidates. Based on its resources on December 31, 2022, the Company believes that it has sufficient capital to fund its planned operations through to the first quarter of 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 will 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, 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 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. The COVID-19 pandemic or a similar societal disruption could in the future, directly or indirectly, adversely affect the Company’s clinical trial operations, including its ability to recruit and retain patients, principal investigators and site staff who, as healthcare providers, may have heightened exposure to infectious diseases if an outbreak occurs in their geography. Further, some patients may be unable to comply with clinical trial protocols if quarantines or travel restrictions impede patient movement or interrupt healthcare services, or if the patients become infected with COVID-19 themselves, which would delay the Company’s ability to initiate and/or complete planned clinical and preclinical studies in the future. Any or all of the foregoing may have a material adverse effect on the Company’s business and financial performance. Deferred financing costs Deferred financing costs represent legal, due diligence and other direct costs incurred to raise capital or obtain debt. Direct costs include only “out-of-pocket” or incremental costs directly related to the effort, such as a finder’s fee and accounting and legal fees. These costs will be capitalized if the efforts are successful or expensed when unsuccessful. Indirect costs are expensed as incurred. Deferred financing costs related to debt are amortized over the life of the debt. Deferred financing costs related to issuing equity are charged to Additional Paid-in Capital. Derivative financial instruments The Company does not use derivative instruments to hedge exposures to cash flow, market or foreign currency risk. Terms of convertible promissory note instruments and other convertible equity instruments are reviewed to determine whether or not they contain embedded derivative instruments that are required under Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 815, Derivatives and Hedging (“ASC 815”) to be accounted for separately from the host contract and recorded on the balance sheet at fair value. The fair value of derivative liabilities, if any, is required to be revalued at each reporting date, with corresponding changes in fair value recorded in current period operating results. Freestanding warrants issued by the Company in connection with the issuance or sale of debt and equity instruments are considered to be derivative instruments and are evaluated and accounted for in accordance with the provisions of ASC 815. Preclinical Study and Clinical Accruals The Company estimates its preclinical study and clinical trial expenses based on the services received pursuant to contracts with several research institutions and contract research organizations (“CROs”) that do or may conduct and manage preclinical and clinical trials on its behalf. The financial terms of the agreements vary from contract to contract, may be estimated by Tenax Therapeutics and outside advisors prior to contracting with a CRO, and may result in uneven expenses and payment flows. Preclinical study and clinical trial expenses include the following: - fees paid to CROs in connection with clinical trials, - fees paid to research institutions in conjunction with preclinical and clinical research studies, and - fees paid to contract manufacturers and service providers in connection with the production and testing of active pharmaceutical ingredients and drug materials for use in preclinical studies and clinical trials. Property and Equipment, Net Property and equipment are stated at cost, subject to adjustments for impairment, less accumulated depreciation and amortization. Depreciation and amortization are computed using the straight-line method with estimated useful lives of three to seven years. Maintenance and repairs are charged to expense as incurred, and improvements to leased facilities and equipment are capitalized. Research and Development Costs Research and development costs include, but are not limited to, (i) expenses incurred under agreements with CROs and investigative sites, which conduct our clinical trials; (ii) the cost of supplying clinical trial materials; (iii) payments to contract service organizations, as well as consultants; (iv) employee-related expenses, which include salaries and benefits; and (v) depreciation and other allocated expenses, which include direct and allocated expenses for equipment, laboratory and other supplies. All research and development expenses are expensed as incurred. Income Taxes Deferred tax assets and liabilities are recorded for differences between the financial statement and tax bases of the assets and liabilities that will result in taxable or deductible amounts in the future based on enacted tax laws and rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. Income tax expense is recorded for the amount of income tax payable or refundable for the period increased or decreased by the change in deferred tax assets and liabilities during the period. Stock-Based Compensation The Company accounts for stock-based awards to employees in accordance with 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. 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. 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. Year ended December 31, 2022 2021 Warrants to purchase common stock 1,576,240 1,046,438 Pre-funded warrants to purchase common stock - 501,664 Options to purchase common stock 77,472 64,978 Convertible preferred shares outstanding 210 210 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 consolidated balance sheet as of December 31, 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 December 2019, the FASB issued accounting standards update (“ASU”), ASU-2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes In June 2016, the FASB issued an accounting standard, ASU-2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments Fair Value The Company determines the fair value of its financial assets and liabilities in accordance with the ASC 820, Fair Value Measurements. The Company’s balance sheet includes the following financial instruments: cash and cash equivalents, investments in marketable securities and short-term notes payable. The Company considers the carrying amount of its cash and cash equivalents and short-term notes payable to approximate fair value due to the short-term nature of these instruments. Accounting for fair value measurements involves a single definition of fair value, along with a conceptual framework to measure fair value, with a fair value defined as “the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date”. The fair value measurement hierarchy consists of three levels: Level one Quoted market prices in active markets for identical assets or liabilities; Level two Inputs other than level one inputs that are either directly or indirectly observable; and Level three Unobservable inputs developed using estimates and assumptions; which are developed by the reporting entity and reflect those assumptions that a market participant would use. The Company applies valuation techniques that (1) place greater reliance on observable inputs and less reliance on unobservable inputs and (2) are consistent with the market approach, the income approach and/or the cost approach, and include enhanced disclosures of fair value measurements in the Company’s consolidated financial statements. |
BALANCE SHEET COMPONENTS
BALANCE SHEET COMPONENTS | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
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. Depreciation expense was $1,000 and $1,200 for the three months ended September 30, 2023 and 2022, respectively. For the nine months ended September 30, 2023 and 2022, depreciation expense was $2,900 and $3,800, respectively. Accrued liabilities Accrued liabilities consist of the following: September 30, 2023 December 31, 2022 Operating costs $ 245,545 $ 245,391 Lease liability - 119,393 Employee related 47,416 410,261 $ 292,961 $ 775,045 | NOTE C—BALANCE SHEET COMPONENTS Property and equipment, net Property and equipment primarily consist of office furniture and fixtures. Depreciation and amortization expense were $5,143 and $4,116 for the years ended December 31, 2022 and 2021, respectively. Accrued liabilities Accrued liabilities consist of the following: December 31, 2022 December 31, 2021 Operating costs $ 245,391 $ - Lease liability 119,393 107,192 Employee related 410,261 597,148 $ 775,045 $ 704,340 |
NOTE PAYABLE
NOTE PAYABLE | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
NOTE PAYABLE | ||
NOTE PAYABLE | NOTE 4. NOTE PAYABLE Premium Finance Agreement On December 31, 2022, the Company executed a premium finance note agreement (the “Note”) with AFCO Credit Corporation. The Note financed the Company’s Directors and Officers Insurance Policy as well as the Errors and Omissions policy. The total amount financed was $693,669. The Company paid a down payment of $69,367 at execution leaving a balance of $624,302 payable in monthly installments of $58,873 through December 1, 2023. The Note has an interest rate of 7.39%. The Company recorded interest expense on the Note in the amount of $5,337 and $21,151 for the three and nine months ended September 30, 2023. The balance on the Note as of September 30, 2023 and December 31, 2022 was $174,466 and $624,302, respectively. | NOTE D—NOTE PAYABLE Premium Finance Agreement On December 31, 2022, the Company executed a premium finance agreement with Premium Funding Associates, Inc. The agreement financed the Company’s Directors and Officers Insurance Policy as well as the Errors and Omissions policy. The total amount financed was $693,669. The Company paid a down payment of $69,367 at execution leaving a balance of $624,302 payable in monthly installments of $58,873 through December 1, 2023. The agreement has an interest rate of 7.39%. Payroll Protection Program Loan On April 30, 2020, the Company received a loan pursuant to the Paycheck Protection Program (the “PPP Loan”) under the Coronavirus Aid, Relief, and Economic Security Act, as administered by the U.S. Small Business Administration (“SBA”). The PPP Loan in the principal amount of $244,657 was disbursed by First Horizon Bank (the “Lender”) pursuant to a promissory note issued by the Company. On May 28, 2021, the Company received notice from the SBA that the SBA had remitted $244,657 in principal and $2,576 in interest to the Lender in full forgiveness of the Company’s PPP Loan pursuant to the Company’s application to the SBA for forgiveness of the PPP Loan. The total amount was recorded as other income in our consolidated statement of comprehensive loss. |
LEASE
LEASE | 9 Months Ended |
Sep. 30, 2023 | |
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 $750 per month. |
MERGER
MERGER | 12 Months Ended |
Dec. 31, 2022 | |
MERGER | |
MERGER | NOTE E—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, were 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, which were 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 planning to use the acquired asset to further its clinical development in a potential future 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: Fair value of shares of Common Stock issued $ 3,369,371 Fair Value of Series B Convertible Preferred Stock issued at closing 18,212,960 Total fair value of consideration transferred $ 21,582,331 Tangible assets acquired $ - Accounts payable assumed (150,000 ) Total identifiable net assets (150,000 ) IPR&D expense recognized 21,732,331 Total fair value of consideration $ 21,582,331 |
STOCKHOLDERS EQUITY
STOCKHOLDERS EQUITY | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
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 259,068 units for net proceeds of approximately $9.0 million (the “2018 Offering”). Each unit consisted of (i) 20 shares 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 $38.60, and (iii) a five-year warrant to purchase one share of common stock at an exercise price of $38.60. 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. As of September 30, 2023, 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, 2023, and December 31, 2022, there were 23,862,434 and 2,291,809 shares of common stock issued and outstanding, respectively. As of September 30, 2023 and December 31, 2022, there were no pre-funded warrants outstanding. The Company has adjusted the financial statements to reflect the January 4, 2023, 1-for-20 Reverse Stock Split. The Reverse Stock Split 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 Split. 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 6,959,444 shares of its common stock, and pre-funded warrants to purchase an aggregate of 1,707,222 shares of common stock and (ii) accompanying warrants to purchase up to an aggregate of 17,333,332 shares of its common stock at a combined offering price of $1.80 per share of common stock and associated common warrant, or $1.799 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 $13.7 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 529,802 units in a private placement at a purchase price of $15.50 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, 1,059,603 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 September 30, 2023, the Company has 1,722,240 warrants outstanding. The following table summarizes the Company’s warrant activity for the nine months ended September 30, 2023: Warrants Weighted Average Exercise Price Outstanding at December 31, 2022 1,576,240 $ 17.13 Issued 17,333,332 2.25 Exercised (17,187,332 ) 2.25 Outstanding at September 30, 2023 1,722,240 $ 15.87 February 2023 Warrants As described above, as a part of the February 2023 Offering, the Company issued unregistered warrants to purchase 17,333,332 shares of its common stock at an exercise price of $2.25 per share and contractual term of five 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 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 529,802 shares of its common stock at an exercise price of $12.60 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 and Regulation D promulgated thereunder. In accordance with ASC 815, Derivatives and Hedging Stock Options 2022 Stock Incentive Plan On June 9, 2022, the Company’s stockholders approved the Tenax Therapeutics. Inc. 2022 Stock Incentive Plan (the “2022 Plan”), which authorizes for issuance a total of 55,000 shares of common stock. 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. 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 the 2022 Plan. At September 30, 2023 there were 51,487 shares that rolled over from the 2016 Plan and 28,488 shares remaining under the 2022 Plan resulting in an aggregate of 79,975 shares available for issuance under the 2022 Plan. The following table summarizes the shares available for grant under the 2022 Plan for the nine months ended September 30, 2023. Shares Available for Grant Balances, at December 31, 2022 77,616 Options cancelled/forfeited 2,359 Balances, at September 30, 2023 79,975 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, 2023. Outstanding Options Number of Shares Weighted Average Exercise Price Balances at December 31, 2022 28,163 $ 12.40 Options cancelled/forfeited (1,650 ) $ 12.40 Balances at September 30, 2023 26,513 $ 12.40 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 $16,089 and $68,586 for the three and nine months ended September 30, 2023, respectively. No compensation expense was recorded for the nine months ended September 30, 2022. As of September 30, 2023, there were unrecognized compensation costs of approximately $91,779 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 1.69 years. 2016 Stock Incentive Plan On June 16, 2016, the Company’s stockholders approved the 2016 Plan and authorized for issuance under the 2016 Plan a total of 7,500 shares of common stock. 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 37,500 shares, up from 7,500 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 75,000 shares, up from 37,500 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 nine months ended September 30, 2023. Outstanding Options Number of Shares Weighted Average Exercise Price Balances at December 31, 2022 23,373 $ 40.13 Options cancelled/forfeited (709 ) $ 23.60 Balances at September 30, 2023 22,664 $ 40.64 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 these stock options grants of $7,840 and $23,574 for the three and nine months ended September 30, 2023, respectively. As of September 30, 2023, there were unrecognized compensation costs of approximately $8,805 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 0.27 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 10,000 shares, up from 750 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 12,500 shares, up from 10,000 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, 2023: Outstanding Options Number of Shares Weighted Average Exercise Price Balances at December 31, 2022 936 $ 1,122.75 Options cancelled/forfeited (240 ) $ 1,253.83 Balances at September 30, 2023 696 $ 1,076.36 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 and nine months ended September 30, 2023 and 2022, respectively. As of September 30, 2023, 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 5,000 shares of common stock and the other for 12,500 shares of common stock, to its new CEO on July 6, 2021. The employment inducement stock option for 5,000 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 $39.40 per share, the July 6, 2021 closing price of our common stock. None of the vesting milestones were 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 12,500 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 $39.40 per share, the July 6, 2021 closing price of our common stock. 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 12,500 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 $35.60 per share, the January 15, 2021 closing price of our common stock. 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 $13,083 and $61,678 for the three and nine months ended September 30, 2023, respectively. As of September 30, 2023, there was $371,384 of remaining unrecognized compensation expense related to these inducement stock options. | NOTE F—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 E—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, where were delivered 24 months after the date of issuance of the Series B Stock and were subject to reduction for indemnification claims. As of December 31, 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 table below sets forth a summary of the designation, powers, preferences and rights of the Series A Stock. Conversion 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. Dividends 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. Liquidation 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. Voting rights 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. As of December 31, 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 December 31, 2022, and December 31, 2021, there were 2,291,809 and 1,260,346 shares of common stock issued and outstanding, respectively. As of December 31, 2022 and 2021, there were 0 and 501,664 respectively of pre-funded warrants outstanding. 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 529,802 units in a private placement at a purchase price of $0.155 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, 1,059,603 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 pursuant to which the Company agreed to sell and issue to the investor 238,664 units in a private placement at a purchase price of $41.90 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, 477,327 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, which went effective on September 1, 2021. Warrants During the year ended December 31, 2022, the Company received approximately $526 and issued 263,000 shares of common stock upon the exercise of previously outstanding pre-funded warrants issued in connection with the Company’s July 2020 offering. During the year ended December 31, 2022, the Company received approximately $477 and issued 238,664 shares of common stock upon the exercise of previously outstanding pre-funded warrants issued in connection with the Company’s July 2021 Offering. During the year ended December 31, 2022, the Company received approximately $1,060 and issued 529,802 shares of common stock upon the exercise of previously outstanding pre-funded warrants issued in connection with the Company’s May 2022 Offering. During the year ended December 31, 2021, the Company received approximately $545,000 and issued 14,110 shares of common stock upon the exercise of previously outstanding warrants issued in connection with the Company’s December 2018 offering. During the year ended December 31, 2021, the Company issued 25,969 shares of common stock upon the cashless exercise of previously outstanding placement agent warrants issued in connection with the Company’s July 2020 and March 2020 offerings. As of December 31, 2022, the Company has 1,576,240 warrants outstanding. The following table summarizes the Company’s warrant activity for the year ended December 31, 2021 and 2022: Warrants Weighted Average Exercise Price Outstanding at December 31, 2021 1,046,438 $ 29.04 Issued 529,801 12.60 Amended and restated (460,306 ) 34.46 Amended and restated 460,306 12.60 Outstanding at December 31, 2022 1,576,240 $ 17.13 May 2022 Warrants As described above, as a part of the May 2022 Offering, the Company issued unregistered warrants to purchase 529,802 shares of its common stock at an exercise price of $12.60 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 July 2021 Warrants As described above, as a part of the July 2021 Offering, the Company issued unregistered warrants to purchase 238,664 shares of its common stock at an exercise price of $39.40 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 480, 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. July 2020 Warrants As described above, as a part of the July 2020 offering, the Company issued unregistered warrants to purchase 389,181 shares of its common stock at an exercise price of $18.06 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, and Regulation D promulgated thereunder. In accordance with ASC 815, Derivatives and Hedging March 2020 Warrants As described above, as part of the March 2020 Offering, the Company issued unregistered warrants to purchase 118,016 shares of its common stock at an exercise price of $20.80 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, 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 $1.1 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 17,890 shares of common stock at an exercise price of $49.20 and a contractual term of five years. In accordance with ASC 815, Derivatives and Hedging, 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. Stock Options The following table summarizes all options outstanding as of December 31, 2022: Options Outstanding at December 31, 2022 Options Exercisable and Vested at December 31, 2022 Exercise Price Number of Options Weighted Average Remaining Contractual Life (Years) Number of Options Weighted Average Exercise Price $ 12.40 to $ 37.00 47,847 8.7 11,549 $ 25.89 $ 39.40 to $ 224.00 3,789 6.4 3,789 $ 97.49 $ 828.00 to $ 1,264.00 603 3.5 603 $ 994.17 $ 1,368.00 $ 2,260.00 238 1.4 238 $ 1,825.97 52,477 8.4 16,179 $ 105.22 The following table summarizes options outstanding that have vested and are expected to vest based on options outstanding as of December 31, 2022: Number of Options WA Exercise Price Aggregate Intrinsic Value Weighted Average Remaining Contractual Life (Years) Vested 16,179 $ 105.22 $ - 7.1 Vested & expected to vest 48,486 $ 46.78 $ - 9.0 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 55,000 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. Shares Available for Grant Balances, at December 31, 2021 - Shares reserved under 2022 Plan 55,000 Shares rolled over from 2016 Plan 40,988 Options granted (28,563 ) Options cancelled/forfeited 10,191 Balances, at December 31, 2022 77,616 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 year ended December 31, 2022. Outstanding Options Number of Shares Weighted Average Exercise Price Aggregate Intrinsic Value Balances at December 31, 2021 - $ - Options granted 28,563 $ 12.40 Options cancelled/forfeited (400 ) $ 12.40 Balances at December 31, 2022 28,163 $ 12.40 $ - (1) (1) Amount represents the difference between the exercise price and $2.22, the closing price of Tenax Therapeutics’ stock on December 31, 2022, as reported on the Nasdaq Capital Market, for all in-the-money options outstanding. 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 7,500 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 37,500 shares, up from 7,500 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 75,000 shares, up from 37,500 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 year ended December 31, 2022. Outstanding Options Number of Shares Weighted Average Exercise Price Aggregate Intrinsic Value Balances at December 31, 2020 19,675 $ 23.60 Options granted 18,939 $ 37.60 Options exercised (850 ) $ 23.60 Options cancelled/forfeited (4,600 ) $ 31.80 Balances at December 31, 2021 33,164 $ 38.00 Options cancelled/forfeited (9,791 ) $ 32.42 Balances at December 31, 2022 23,373 $ 40.13 $ - (1) (1) Amount represents the difference between the exercise price and $2.22, the closing price of Tenax Therapeutics’ stock on December 31, 2022, as reported on the Nasdaq Capital Market, for all in-the-money options outstanding. 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 used the following assumptions to estimate the fair value of options granted under the 2016 Plan for the years ended December 31, 2022 and 2021: For the year ended December 31, 2022 2021 Risk-free interest rate (weighted average) 3.08 % 0.72 % Expected volatility (weighted average) 102.01 % 101.60 % Expected term (in years) 7.0 6.7 Expected dividend yield 0.00 % 0.00 % Risk-Free Interest Rate 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. Expected Volatility 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. Expected Term 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. Expected Dividend Yield 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. Forfeitures As stock-based compensation expense recognized in the statement of operations for the years ended December 31, 2022 and 2021 is based on awards ultimately expected to vest, 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. The weighted-average grant-date fair value of options granted during the years ended December 31, 2022 and 2021 was $12.40 and $30.60, respectively. The Company recorded compensation expense for these stock options grants of $223,277 and $391,801 for the years ended December 31, 2022 and 2021, respectively. As of December 31, 2022, there were unrecognized compensation costs of approximately $214,175 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 0.82 years. 1999 Stock Plan 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 10,000 shares, up from 750 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 12,500 shares, up from 10,000 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 years ended December 31, 2022 and 2021: Outstanding Options Number of Shares Weighted Average Exercise Price Aggregate Intrinsic Value Balances at December 31, 2020 2,883 $ 926.80 Options cancelled (1,067 ) $ 1,065.60 Balances at December 31, 2021 1,816 $ 845.20 Options cancelled (880 ) $ 558.34 Balances at December 31, 2022 936 $ 1,122.75 $ - (1) (1) Amount represents the difference between the exercise price and $2.22, the closing price of Tenax Therapeutics’ stock on December 31, 2022, as reported on the Nasdaq Capital Market, for all in-the-money options outstanding. 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 these stock options grants of $0 and $1,290 for the years ended December 31, 2022 and 2021, respectively. As of December 31, 2022, there were no unrecognized compensation costs related to non-vested stock option awards under the 1999 Plan. In connection with the retirement of the Company’s former Chief Executive Officer (“CEO”), effective July 13, 2021 (the “Modification Date”), the Company modified the terms of the former CEO’s outstanding stock awards to: (1) accelerate the 152,500 unvested shares underlying his outstanding stock awards immediately as of the Modification Date and (2) extend the period during which his outstanding stock awards for an aggregate of 218,706 shares may be exercised through the earlier of the stock award’s original termination date or the five-year anniversary of the Modification Date. The Company determined that the extension of the period during which the vested shares may be exercised was a Type 1 modification pursuant to ASC 718, Compensation-Stock Compensation. However, acceleration of vesting and extension of the exercise period for the remaining Stock Awards was a Type 3 modification pursuant to ASC 718 because absent the modification terms, those Stock Awards would have been forfeited as of the former CEO’s retirement date. On the Modification Date, the Company recognized approximately $187,000 of compensation expense, which is included in General and administrative expense for the year ended December 31, 2022, with respect to these modifications. Inducement Stock Options The Company granted two employment inducement stock option awards, one for 5,000 shares of common stock and the other for 12,500 shares of common stock, to its new CEO on July 6, 2021. The employment inducement stock option for 5,000 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 $39.40 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 12,500 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 $39.40 per share, the July 6, 2021 closing price of our common stock. As of December 31, 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 12,500 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 $35.60 per share, the January 15, 2021 closing price of our common stock. As of December 31, 2022, none 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 $142,037 for the year ended December 31, 2022. As of December 31, 2022, there was $440,682 of remaining unrecognized compensation expense related to these inducement stock options. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
COMMITMENTS AND CONTINGENCIES | ||
COMMITMENTS AND CONTINGENCIES | NOTE 6. 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, 2023, 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. | NOTE G—COMMITMENTS AND CONTINGENCIES Operating Leases As described above in “NOTE B”, the Company adopted ASC 842 as of January 1, 2019. Prior period amounts have not been adjusted and continue to be reported in accordance with the Company’s historic accounting under ASC 840. In January 2011, the Company entered into a lease with Concourse Associates, LLC for its headquarters in Morrisville, North Carolina (the “Prior Lease”). On April 2, 2021, the Company negotiated a 3-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 increased 2.5% annually for lease years 2 and 3. 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 Prior Lease described above, none of the Company’s contracts contain a lease. The balance sheet classification of our lease liabilities was as follows: December 31, 2022 December 31, 2021 Current portion included in accrued liabilities $ 119,393 $ 107,192 Long term lease liability 64,196 183,589 $ 183,589 $ 290,781 As of December 31, 2022, the maturities of our operating lease liabilities were as follows: Year ending December 31, 2023 129,797 2024 65,702 Total lease payments $ 195,499 Less: Imputed interest (11,910 ) Operating lease liability $ 183,589 Simdax License Agreement On November 13, 2013, the Company acquired, through its wholly-owned subsidiary, Life Newco, that certain License Agreement, dated September 20, 2013, as amended on October 9, 2020 and January 25, 2022, by and between Phyxius and Orion (as amended, the “License”), and that certain Side Letter, dated October 15, 2013 by and between Phyxius and Orion. The License grants the Company an exclusive, sublicenseable right to develop and commercialize pharmaceutical products containing levosimendan in the Territory and, pursuant to the October 9, 2020 amendment, 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). Orion’s ongoing role under the License includes sublicense approval, serving as the sole source of manufacture, holding a first right to enforce intellectual property rights in the Territory, and certain regulatory participation rights. Orion must notify the Company before the end of 2024 if it chooses not to exercise its right to supply oral formulations of levosimendan to the Company for commercialization in the Territory. Additionally, the Company must grant back to Orion a broad non-exclusive license to any patents or clinical trial data related to the Product developed by the Company under the License. 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. Pursuant to the terms of the License, on November 13, 2013, the Company paid to Orion a non-refundable up-front payment in the amount of $1.0 million. The License also includes the following development milestones for which the Company must make non-refundable payments to Orion no later than 28 days after the occurrence of the applicable milestone event: (1) $2.0 million upon the grant of United States Food and Drug Administration approval, including all registrations, licenses, authorizations and necessary approvals, to develop and/or commercialize the Product in the United States; and (2) $1.0 million upon the grant of regulatory approval for the Product in Canada. Once commercialized, the Company is obligated to make certain non-refundable commercialization milestone payments to Orion, aggregating to up to $13.0 million, contingent upon achievement of certain cumulative net sales amounts in the Territory. The Company also must pay Orion tiered royalties based on net sales of the Product in the Territory made by the Company and its sublicensees. After the end of the License term, the Company must pay Orion a royalty based on net sales of the Product in the Territory for as long as the Company sells the Product in the Territory. As of December 31, 2022, 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. |
401(k) BENEFIT PLAN
401(k) BENEFIT PLAN | 12 Months Ended |
Dec. 31, 2022 | |
401(k) BENEFIT PLAN | |
401(k) BENEFIT PLAN | NOTE G—401(k) BENEFIT PLAN The Company sponsors a 401(k) Retirement Savings Plan (the “401(k) Plan”) for all eligible employees. Full-time employees over the age of eighteen are eligible to participate in the 401(k) Plan after 90 days of continuous employment. Participants may elect to defer earnings into the 401(k) Plan up to the annual IRS limits and the Company provides a matching contribution up to 5% of the participants’ annual salary in accordance with the 401(k) Plan documents. A third-party trustee manages the 401(k) Plan. For the years ended December 31, 2022 and 2021, the Company recorded $90,873 and $73,855 for matching contributions expense, respectively. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2022 | |
INCOME TAXES | |
INCOME TAXES | NOTE H—INCOME TAXES The Company has not recorded any income tax expense (benefit) for the period ended December 31, 2022 due to its history of net operating losses. The reconciliation of income tax expenses (benefit) at the statutory federal income tax rate of 21% for the periods ended December 31, 2022 and December 31, 2021 is as follows: December 31, 2022 2021 U.S. federal tax benefit at statutory rate $ (2,320,057 ) $ (6,819,615 ) State income tax benefit, net of federal benefit (218,196 ) (641,368 ) Stock compensation 79,090 171,269 Other nondeductible, including IPR&D expense - 5,032,981 Change in state tax rate 116,392 1,768,013 Federal and state net operating loss adjustments 423,066 745,439 Other, including effect of tax rate brackets 8,850 (73 ) Change in realizability of IPR&D - 229,750 Change in valuation allowance 1,910,855 (486,396 ) $ - $ - The tax effects of temporary differences and carry forwards that give rise to significant portions of the deferred tax assets are as follows: December 31, Deferred Tax Assets 2022 2021 Net operating loss carryforwards $ 36,106,727 $ 35,291,097 Accruals and other 1,412,267 308,296 Capital loss carryforwards 2,258 11,003 Valuation allowance (37,521,252 ) (35,610,396 ) Net deferred tax assets - - Deferred Tax Liabilities Other liabilities - - Net Deferred Tax Liabilities $ - $ - The Company has established a valuation allowance against net deferred tax assets due to the uncertainty that such assets will be realized. The Company periodically evaluates the recoverability of the deferred tax assets. At such time that it is determined that it is more likely than not that deferred tax assets will be realizable, the valuation allowance will be reduced. The net increase in the valuation allowance during 2022 was approximately $1.9 million. As of December 31, 2022, the Company had Federal and State net operating loss carryforwards of approximately $163.2 million and $125.1 million available to offset future federal and state taxable income, respectively. Federal net operating losses of $122.9 million begin to expire in 2023, while the remaining $40.3 million carryforward indefinitely. State net operating losses begin to expire in 2023. Utilization of the net operating loss carryforwards may be subject to an annual limitation due to the ownership percentage change limitations provided by the Internal Revenue Code of 1986 and similar state provisions. The annual limitations may result in the expiration of the net operating losses before utilization. We have U.S. federal net operating loss carryforwards, or NOLs, which expire in various years if not utilized. Under Sections 382 and 383 of Internal Revenue Code of 1986, as amended, or the Code, if a corporation undergoes an “ownership change,” the corporation’s ability to use its pre-change NOLs and other pre-change tax attributes, such as research tax credits, to offset its future post-change income and taxes may be limited. In general, an “ownership change” occurs if there is a cumulative change in our ownership by “5% shareholders” that exceeds 50 percentage points over a rolling three-year period. Similar rules may apply under state tax laws. We have not performed a formal study to determine whether any of our NOLs are subject to these limitations. We have recorded deferred tax assets for our NOLs and research and development credits and have recorded a full valuation allowance against these deferred tax assets. In the event that it is determined that we have in the past experienced additional ownership changes, or if we experience one or more ownership changes as a result of future transactions in our stock, then we may be further limited in our ability to use our NOLs and other tax assets to reduce taxes owed on the net taxable income that we earn in the event that we attain profitability. Any such limitations on the ability to use our NOLs and other tax assets could adversely impact our business, financial condition, and operating results in the event that we attain profitability. Management has evaluated all other tax positions that could have a significant effect on the financial statements and determined the Company had no uncertain income tax positions at December 31, 2022. The Company files U.S. and state income tax returns with varying statutes of limitations. The tax years 2002 and forward remain open to examination due to the carryover of unused net operating losses or tax credits. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
SUBSEQUENT EVENTS | ||
SUBSEQUENT EVENTS | NOTE 8. SUBSEQUENT EVENTS None. | NOTE I—SUBSEQUENT EVENTS i. The Company filed a Certificate of Amendment to the Company’s Certificate of Incorporation, as amended (the “Certificate of Amendment”) with the Secretary of State of Delaware for the purpose of effecting the Reverse Stock Split. The Reverse Stock Split was approved by our stockholders at the annual meeting of stockholders held on June 9, 2022 and the Company’s Board of Directors approved the Certificate of Amendment with a 1-for-20 ratio on December 15, 2022. The Reverse Stock Split was effective at 5:00 p.m. on January 4, 2023. The Reverse Stock Split was effected primarily to enable the Company to regain compliance with Nasdaq Listing Rule 5550(a)(2) regarding the minimum $1.00 per share closing bid price requirement (the “Bid Price Rule”). The Company regained compliance with the Bid Price Rule on January 20, 2023. ii. On March 29, 2023, Nasdaq notified the Company that it was no longer in compliance with the Bid Price Rule given that for the prior 30 consecutive business days, the bid price for the Company’s common stock had closed below the minimum $1.00 per share requirement. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has a compliance period of 180 calendar days, or until September 25, 2023, to regain compliance with the Bid Price Rule. If at any time before September 25, 2023, the bid price of the Company’s common stock closes at $1.00 per share or more for a minimum of ten consecutive business days, Nasdaq will provide the Company with a written confirmation of compliance with the Bid Price Rule. iii. On February 3, 2023, the Company entered into a placement agency agreement (the “Placement Agency Agreement”) with Roth Capital Partners, LLC (the “Placement Agent”) and a securities purchase agreement (the “Purchase Agreement”) with certain purchasers for the purchase and sale, in a registered public offering by the Company (the “February 2023 Public Offering”), of (i) an aggregate of 6,959,444 shares of its common stock, par value $0.0001 per share and pre-funded warrants to purchase an aggregate of 1,707,222 shares of Common Stock and (ii) accompanying warrants to purchase up to an aggregate of 17,333,332 shares of its Common Stock at a combined offering price of $1.80 per share of common stock and associated common warrant, or $1.799 per pre-funded warrant and associated common warrant, resulting in gross proceeds of approximately $15.6 million. Estimated net proceeds of the February 2023 Public Offering were approximately $14.1 million, after deducting the Placement Agent fees and estimated offering expenses payable by the Company. The February 2023 Public Offering closed on February 7, 2023. The Company’s stockholders’ equity at December 31, 2022 was $1.5 million which is lower than the minimum requirement for continued listing on the Nasdaq Capital Market of $2.5 million. The Company believes that, after taking into account the February 2023 Public Offering for net proceeds of $14.1 million, and based on interim financial data available to the Company, the Company’s stockholders’ equity at March 28, 2023 exceeds $2.5 million, which is the minimum stockholders’ equity requirement under the Nasdaq Listing Rules. In addition, the Company’s cash balance at March 28, 2023 is approximately $14.6 million. iv. On February 7, 2023, the Company entered into a Lease Termination Agreement with CCP Concourse, LLC, a Virginia limited liability company (the “Landlord”) with respect to the prior lease of its headquarters formerly located at ONE Copley Parkway, Suite 490, Morrisville, North Carolina (the “Premises”). The prior lease, as amended, was originally entered into on January 27, 2011 and would have terminated on June 30, 2024. 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 prior lease, the Company has paid the Landlord $169,867.41. 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 prior lease. v. On March 21, 2023, the U.S. Patent and Trademark Office (USPTO) issued to Tenax Therapeutics a patent covering the use of IV levosimendan in patients with PH-HFpEF. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||
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. | The preparation of the accompanying 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 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. |
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 31, 2023, from which the Company derived the balance sheet data at December 31, 2022. 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 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 4, 2023, the Company effected a 1-for-20 reverse stock split of its outstanding common stock (the “Reverse Stock Split”). The Reverse Stock Split did not change the number of authorized shares of capital stock or cause an adjustment to the par value of its capital stock. Pursuant to their terms, a proportionate adjustment was made to the per share exercise price and number of shares issuable under the Company’s outstanding stock options and warrants. The number of shares authorized for issuance pursuant to the Company’s equity incentive plans have also been adjusted proportionately to reflect the Reverse Stock Split. 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 $345,000 and $1.9 million uninsured by the FDIC as of September 30, 2023 and December 31, 2022, 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 September 30, 2023, the Company had $10.5 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 $11.9 million and $3.2 million and working capital of $11.3 million and $1.4 million as of September 30, 2023 and December 31, 2022, respectively. The Company’s cash resources were approximately $11.1 million as of September 30, 2023, compared to cash resources of approximately $2.1 million as of December 31, 2022. The Company expects to continue to incur expenses related to the development of oral levosimendan to treat pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF) in the Phase 3 LEVEL trial, and, potentially for other indications of levosimendan and imatinib for PAH, as well as identifying and developing other potential product candidates. Based on its resources on September 30, 2023, the Company believes that it has sufficient capital to fund its planned operations through to the first quarter of 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. | |
Principles Of Consolidation | The accompanying unaudited condensed consolidated financial statements include the accounts and transactions of Tenax Therapeutics, Inc., 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 4, 2023, the Company effected a 1-for-20 reverse stock split of its outstanding common stock (the “Reverse Stock Split”). The Reverse Stock Split did not change the number of authorized shares of capital stock or cause an adjustment to the par value of its capital stock. Pursuant to their terms, a proportionate adjustment was made to the per share exercise price and number of shares issuable under the Company’s outstanding stock options and warrants. The number of shares authorized for issuance pursuant to the Company’s equity incentive plans have also been adjusted proportionately to reflect the Reverse Stock Split. 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 $345,000 and $1.9 million uninsured by the FDIC as of September 30, 2023 and December 31, 2022, 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 September 30, 2023, the Company had $10.5 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 $11.9 million and $3.2 million and working capital of $11.3 million and $1.4 million as of September 30, 2023 and December 31, 2022, respectively. The Company’s cash resources were approximately $11.1 million as of September 30, 2023, compared to cash resources of approximately $2.1 million as of December 31, 2022. The Company expects to continue to incur expenses related to the development of oral levosimendan to treat pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF) in the Phase 3 LEVEL trial, and, potentially for other indications of levosimendan and imatinib for PAH, as well as identifying and developing other potential product candidates. Based on its resources on September 30, 2023, the Company believes that it has sufficient capital to fund its planned operations through to the first quarter of 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. | The accompanying 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. |
Reverse Stock Split | The Company has adjusted the financial statements to reflect that on January 4, 2023, the Company effected a 1-for-20 reverse stock split of its outstanding common stock (the “Reverse Stock Split”). The Reverse Stock Split did not change the number of authorized shares of capital stock or cause an adjustment to the par value of its capital stock. Pursuant to their terms, a proportionate adjustment was made to the per share exercise price and number of shares issuable under the Company’s outstanding stock options and warrants. The number of shares authorized for issuance pursuant to the Company’s equity incentive plans have also been adjusted proportionately to reflect the Reverse Stock Split. 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 $345,000 and $1.9 million uninsured by the FDIC as of September 30, 2023 and December 31, 2022, 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 September 30, 2023, the Company had $10.5 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 $11.9 million and $3.2 million and working capital of $11.3 million and $1.4 million as of September 30, 2023 and December 31, 2022, respectively. The Company’s cash resources were approximately $11.1 million as of September 30, 2023, compared to cash resources of approximately $2.1 million as of December 31, 2022. The Company expects to continue to incur expenses related to the development of oral levosimendan to treat pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF) in the Phase 3 LEVEL trial, and, potentially for other indications of levosimendan and imatinib for PAH, as well as identifying and developing other potential product candidates. Based on its resources on September 30, 2023, the Company believes that it has sufficient capital to fund its planned operations through to the first quarter of 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. | The Company has adjusted the financial statements to reflect that on January 4, 2023, we effected a 1-for-20 reverse stock split (the “Reverse Stock Split”). The Reverse Stock Split 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 Split. 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 $1,877,589 and $5,127,956 uninsured by the FDIC as of December 31, 2022 and 2021, respectively. 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 $3.2 million and $5.7 million and working capital of $1.4 million and $4.1 million as of December 31, 2022 and 2021, respectively. The Company’s cash resources were approximately $2.1 million as of December 31, 2022, compared to cash resources of approximately $5.6 million as of December 31, 2021. The Company expects to continue to incur expenses related to development of levosimendan for pulmonary hypertension and other potential indications and imatinib for PAH, as well as identifying and developing other potential product candidates. Based on its resources on December 31, 2022, the Company believes that it has sufficient capital to fund its planned operations through to the first quarter of 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 will 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, 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 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. |
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 $345,000 and $1.9 million uninsured by the FDIC as of September 30, 2023 and December 31, 2022, 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 September 30, 2023, the Company had $10.5 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 $11.9 million and $3.2 million and working capital of $11.3 million and $1.4 million as of September 30, 2023 and December 31, 2022, respectively. The Company’s cash resources were approximately $11.1 million as of September 30, 2023, compared to cash resources of approximately $2.1 million as of December 31, 2022. The Company expects to continue to incur expenses related to the development of oral levosimendan to treat pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF) in the Phase 3 LEVEL trial, and, potentially for other indications of levosimendan and imatinib for PAH, as well as identifying and developing other potential product candidates. Based on its resources on September 30, 2023, the Company believes that it has sufficient capital to fund its planned operations through to the first quarter of 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. | 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 $1,877,589 and $5,127,956 uninsured by the FDIC as of December 31, 2022 and 2021, respectively. 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 $3.2 million and $5.7 million and working capital of $1.4 million and $4.1 million as of December 31, 2022 and 2021, respectively. The Company’s cash resources were approximately $2.1 million as of December 31, 2022, compared to cash resources of approximately $5.6 million as of December 31, 2021. The Company expects to continue to incur expenses related to development of levosimendan for pulmonary hypertension and other potential indications and imatinib for PAH, as well as identifying and developing other potential product candidates. Based on its resources on December 31, 2022, the Company believes that it has sufficient capital to fund its planned operations through to the first quarter of 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 will 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, 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 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. |
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 $345,000 and $1.9 million uninsured by the FDIC as of September 30, 2023 and December 31, 2022, 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 September 30, 2023, the Company had $10.5 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 $11.9 million and $3.2 million and working capital of $11.3 million and $1.4 million as of September 30, 2023 and December 31, 2022, respectively. The Company’s cash resources were approximately $11.1 million as of September 30, 2023, compared to cash resources of approximately $2.1 million as of December 31, 2022. The Company expects to continue to incur expenses related to the development of oral levosimendan to treat pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF) in the Phase 3 LEVEL trial, and, potentially for other indications of levosimendan and imatinib for PAH, as well as identifying and developing other potential product candidates. Based on its resources on September 30, 2023, the Company believes that it has sufficient capital to fund its planned operations through to the first quarter of 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. | The Federal Deposit Insurance Corporation (the “FDIC”) insurance limits are $250,000 per depositor per insured bank. The Company had cash balances of $1,877,589 and $5,127,956 uninsured by the FDIC as of December 31, 2022 and 2021, respectively. 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 $3.2 million and $5.7 million and working capital of $1.4 million and $4.1 million as of December 31, 2022 and 2021, respectively. The Company’s cash resources were approximately $2.1 million as of December 31, 2022, compared to cash resources of approximately $5.6 million as of December 31, 2021. The Company expects to continue to incur expenses related to development of levosimendan for pulmonary hypertension and other potential indications and imatinib for PAH, as well as identifying and developing other potential product candidates. Based on its resources on December 31, 2022, the Company believes that it has sufficient capital to fund its planned operations through to the first quarter of 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 will 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, 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 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. |
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 $11.9 million and $3.2 million and working capital of $11.3 million and $1.4 million as of September 30, 2023 and December 31, 2022, respectively. The Company’s cash resources were approximately $11.1 million as of September 30, 2023, compared to cash resources of approximately $2.1 million as of December 31, 2022. The Company expects to continue to incur expenses related to the development of oral levosimendan to treat pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF) in the Phase 3 LEVEL trial, and, potentially for other indications of levosimendan and imatinib for PAH, as well as identifying and developing other potential product candidates. Based on its resources on September 30, 2023, the Company believes that it has sufficient capital to fund its planned operations through to the first quarter of 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. The COVID-19 pandemic or a similar societal healthcare disruption could in the future, directly or indirectly, adversely affect the Company’s clinical trial operations, including its ability to recruit and retain patients, principal investigators and site staff who, as healthcare providers, may have heightened exposure to or impact from infectious diseases if an outbreak occurs in their geography. Further, some patients may be unable to comply with clinical trial protocols if quarantines or travel restrictions impede patient movement or interrupt healthcare services, or if the patients become infected with coronavirus or a similar virus themselves, which would delay the Company’s ability to initiate and/or complete planned clinical and preclinical studies in the future. In May 2023, the World Health Organization declared that COVID-19 was no longer a global health emergency, however, any lingering impact or resurgence of COVID-19 cannot be estimated. Any or all of the foregoing may have a material adverse effect on the Company’s business and financial performance. | 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 $3.2 million and $5.7 million and working capital of $1.4 million and $4.1 million as of December 31, 2022 and 2021, respectively. The Company’s cash resources were approximately $2.1 million as of December 31, 2022, compared to cash resources of approximately $5.6 million as of December 31, 2021. The Company expects to continue to incur expenses related to development of levosimendan for pulmonary hypertension and other potential indications and imatinib for PAH, as well as identifying and developing other potential product candidates. Based on its resources on December 31, 2022, the Company believes that it has sufficient capital to fund its planned operations through to the first quarter of 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 will 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, 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 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. The COVID-19 pandemic or a similar societal disruption could in the future, directly or indirectly, adversely affect the Company’s clinical trial operations, including its ability to recruit and retain patients, principal investigators and site staff who, as healthcare providers, may have heightened exposure to infectious diseases if an outbreak occurs in their geography. Further, some patients may be unable to comply with clinical trial protocols if quarantines or travel restrictions impede patient movement or interrupt healthcare services, or if the patients become infected with COVID-19 themselves, which would delay the Company’s ability to initiate and/or complete planned clinical and preclinical studies in the future. Any or all of the foregoing may have a material adverse effect on the Company’s business and financial performance. |
Deferred financing costs | Deferred financing costs represent legal, due diligence and other direct costs incurred to raise capital or obtain debt. Direct costs include only “out-of-pocket” or incremental costs directly related to the effort, such as a finder’s fee and accounting and legal fees. These costs will be capitalized if the efforts are successful or expensed when unsuccessful. Indirect costs are expensed as incurred. Deferred financing costs related to debt are amortized over the life of the debt. Deferred financing costs related to issuing equity are charged to Additional Paid-in Capital. Derivative financial instruments The Company does not use derivative instruments to hedge exposures to cash flow, market or foreign currency risk. Terms of convertible promissory note instruments and other convertible equity instruments are reviewed to determine whether or not they contain embedded derivative instruments that are required under Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 815, Derivatives and Hedging (“ASC 815”) to be accounted for separately from the host contract and recorded on the balance sheet at fair value. The fair value of derivative liabilities, if any, is required to be revalued at each reporting date, with corresponding changes in fair value recorded in current period operating results. Freestanding warrants issued by the Company in connection with the issuance or sale of debt and equity instruments are considered to be derivative instruments and are evaluated and accounted for in accordance with the provisions of ASC 815. Preclinical Study and Clinical Accruals The Company estimates its preclinical study and clinical trial expenses based on the services received pursuant to contracts with several research institutions and contract research organizations (“CROs”) that do or may conduct and manage preclinical and clinical trials on its behalf. The financial terms of the agreements vary from contract to contract, may be estimated by Tenax Therapeutics and outside advisors prior to contracting with a CRO, and may result in uneven expenses and payment flows. Preclinical study and clinical trial expenses include the following: - fees paid to CROs in connection with clinical trials, - fees paid to research institutions in conjunction with preclinical and clinical research studies, and - fees paid to contract manufacturers and service providers in connection with the production and testing of active pharmaceutical ingredients and drug materials for use in preclinical studies and clinical trials. Property and Equipment, Net Property and equipment are stated at cost, subject to adjustments for impairment, less accumulated depreciation and amortization. Depreciation and amortization are computed using the straight-line method with estimated useful lives of three to seven years. Maintenance and repairs are charged to expense as incurred, and improvements to leased facilities and equipment are capitalized. | |
Derivative financial instruments | The Company does not use derivative instruments to hedge exposures to cash flow, market or foreign currency risk. Terms of convertible promissory note instruments and other convertible equity instruments are reviewed to determine whether or not they contain embedded derivative instruments that are required under Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 815, Derivatives and Hedging (“ASC 815”) to be accounted for separately from the host contract and recorded on the balance sheet at fair value. The fair value of derivative liabilities, if any, is required to be revalued at each reporting date, with corresponding changes in fair value recorded in current period operating results. Freestanding warrants issued by the Company in connection with the issuance or sale of debt and equity instruments are considered to be derivative instruments and are evaluated and accounted for in accordance with the provisions of ASC 815. | |
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. 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. | The Company accounts for stock-based awards to employees in accordance with 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. 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. |
Preclinical Study and Clinical Accruals | The Company estimates its preclinical study and clinical trial expenses based on the services received pursuant to contracts with several research institutions and contract research organizations (“CROs”) that do or may conduct and manage preclinical and clinical trials on its behalf. The financial terms of the agreements vary from contract to contract, may be estimated by Tenax Therapeutics and outside advisors prior to contracting with a CRO, and may result in uneven expenses and payment flows. Preclinical study and clinical trial expenses include the following: - fees paid to CROs in connection with clinical trials, - fees paid to research institutions in conjunction with preclinical and clinical research studies, and - fees paid to contract manufacturers and service providers in connection with the production and testing of active pharmaceutical ingredients and drug materials for use in preclinical studies and clinical trials. | |
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 (1) require physical settlement or net-share settlement or (2) give the Company a choice of net-cash settlement or settlement in its own shares (physical settlement or net-share settlement). Contracts which (1) 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), (2) give the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement), or (3) that contain reset provisions that do not qualify for the scope exception are classified as equity or liabilities. 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. Nine months ended September 30, 2023 2022 Warrants to purchase common stock 1,722,240 1,576,240 Pre-funded warrants to purchase common stock - 792,802 Options to purchase common stock 74,873 77,911 Convertible preferred shares outstanding 210 210 Recent Accounting Pronouncements 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 is 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 adoption of this standard has not had a material impact on its condensed consolidated financial statements and related disclosures. | |
Property and Equipment, Net | Property and equipment are stated at cost, subject to adjustments for impairment, less accumulated depreciation and amortization. Depreciation and amortization are computed using the straight-line method with estimated useful lives of three to seven years. Maintenance and repairs are charged to expense as incurred, and improvements to leased facilities and equipment are capitalized. | |
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. Nine months ended September 30, 2023 2022 Warrants to purchase common stock 1,722,240 1,576,240 Pre-funded warrants to purchase common stock - 792,802 Options to purchase common stock 74,873 77,911 Convertible preferred shares outstanding 210 210 | 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. Year ended December 31, 2022 2021 Warrants to purchase common stock 1,576,240 1,046,438 Pre-funded warrants to purchase common stock - 501,664 Options to purchase common stock 77,472 64,978 Convertible preferred shares outstanding 210 210 |
Research and Development Costs | Research and development costs include, but are not limited to, (i) expenses incurred under agreements with CROs and investigative sites, which conduct our clinical trials; (ii) the cost of supplying clinical trial materials; (iii) payments to contract service organizations, as well as consultants; (iv) employee-related expenses, which include salaries and benefits; and (v) depreciation and other allocated expenses, which include direct and allocated expenses for equipment, laboratory and other supplies. All research and development expenses are expensed as incurred. Income Taxes Deferred tax assets and liabilities are recorded for differences between the financial statement and tax bases of the assets and liabilities that will result in taxable or deductible amounts in the future based on enacted tax laws and rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. Income tax expense is recorded for the amount of income tax payable or refundable for the period increased or decreased by the change in deferred tax assets and liabilities during the period. Stock-Based Compensation The Company accounts for stock-based awards to employees in accordance with 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. 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. 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. Year ended December 31, 2022 2021 Warrants to purchase common stock 1,576,240 1,046,438 Pre-funded warrants to purchase common stock - 501,664 Options to purchase common stock 77,472 64,978 Convertible preferred shares outstanding 210 210 | |
Recent Accounting Pronouncements | 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 is 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 adoption of this standard has not had a material impact on its condensed consolidated financial statements and related disclosures. | In December 2019, the FASB issued accounting standards update (“ASU”), ASU-2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes In June 2016, the FASB issued an accounting standard, ASU-2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments |
Income Taxes | Deferred tax assets and liabilities are recorded for differences between the financial statement and tax bases of the assets and liabilities that will result in taxable or deductible amounts in the future based on enacted tax laws and rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. Income tax expense is recorded for the amount of income tax payable or refundable for the period increased or decreased by the change in deferred tax assets and liabilities during the period. Stock-Based Compensation The Company accounts for stock-based awards to employees in accordance with 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. 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. 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. Year ended December 31, 2022 2021 Warrants to purchase common stock 1,576,240 1,046,438 Pre-funded warrants to purchase common stock - 501,664 Options to purchase common stock 77,472 64,978 Convertible preferred shares outstanding 210 210 | |
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 consolidated balance sheet as of December 31, 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 December 2019, the FASB issued accounting standards update (“ASU”), ASU-2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes In June 2016, the FASB issued an accounting standard, ASU-2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments Fair Value The Company determines the fair value of its financial assets and liabilities in accordance with the ASC 820, Fair Value Measurements. The Company’s balance sheet includes the following financial instruments: cash and cash equivalents, investments in marketable securities and short-term notes payable. The Company considers the carrying amount of its cash and cash equivalents and short-term notes payable to approximate fair value due to the short-term nature of these instruments. Accounting for fair value measurements involves a single definition of fair value, along with a conceptual framework to measure fair value, with a fair value defined as “the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date”. The fair value measurement hierarchy consists of three levels: Level one Quoted market prices in active markets for identical assets or liabilities; Level two Inputs other than level one inputs that are either directly or indirectly observable; and Level three Unobservable inputs developed using estimates and assumptions; which are developed by the reporting entity and reflect those assumptions that a market participant would use. The Company applies valuation techniques that (1) place greater reliance on observable inputs and less reliance on unobservable inputs and (2) are consistent with the market approach, the income approach and/or the cost approach, and include enhanced disclosures of fair value measurements in the Company’s consolidated financial statements. | |
Fair Value | The Company determines the fair value of its financial assets and liabilities in accordance with the ASC 820, Fair Value Measurements. The Company’s balance sheet includes the following financial instruments: cash and cash equivalents, investments in marketable securities and short-term notes payable. The Company considers the carrying amount of its cash and cash equivalents and short-term notes payable to approximate fair value due to the short-term nature of these instruments. Accounting for fair value measurements involves a single definition of fair value, along with a conceptual framework to measure fair value, with a fair value defined as “the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date”. The fair value measurement hierarchy consists of three levels: Level one Quoted market prices in active markets for identical assets or liabilities; Level two Inputs other than level one inputs that are either directly or indirectly observable; and Level three Unobservable inputs developed using estimates and assumptions; which are developed by the reporting entity and reflect those assumptions that a market participant would use. The Company applies valuation techniques that (1) place greater reliance on observable inputs and less reliance on unobservable inputs and (2) are consistent with the market approach, the income approach and/or the cost approach, and include enhanced disclosures of fair value measurements in the Company’s consolidated financial statements. |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||
Anti-dilutive Securities | Nine months ended September 30, 2023 2022 Warrants to purchase common stock 1,722,240 1,576,240 Pre-funded warrants to purchase common stock - 792,802 Options to purchase common stock 74,873 77,911 Convertible preferred shares outstanding 210 210 | Year ended December 31, 2022 2021 Warrants to purchase common stock 1,576,240 1,046,438 Pre-funded warrants to purchase common stock - 501,664 Options to purchase common stock 77,472 64,978 Convertible preferred shares outstanding 210 210 |
BALANCE SHEET COMPONENTS (Table
BALANCE SHEET COMPONENTS (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
BALANCE SHEET COMPONENTS | ||
Accrued Liabilities | September 30, 2023 December 31, 2022 Operating costs $ 245,545 $ 245,391 Lease liability - 119,393 Employee related 47,416 410,261 $ 292,961 $ 775,045 | December 31, 2022 December 31, 2021 Operating costs $ 245,391 $ - Lease liability 119,393 107,192 Employee related 410,261 597,148 $ 775,045 $ 704,340 |
MERGER (Tables)
MERGER (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
MERGER | |
Consideration Transferred, Asset Acquired And Liabilities Assumed | Fair value of shares of Common Stock issued $ 3,369,371 Fair Value of Series B Convertible Preferred Stock issued at closing 18,212,960 Total fair value of consideration transferred $ 21,582,331 Tangible assets acquired $ - Accounts payable assumed (150,000 ) Total identifiable net assets (150,000 ) IPR&D expense recognized 21,732,331 Total fair value of consideration $ 21,582,331 |
STOCKHOLDERS EQUITY (Tables)
STOCKHOLDERS EQUITY (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Schedule of Warrants | Warrants Weighted Average Exercise Price Outstanding at December 31, 2022 1,576,240 $ 17.13 Issued 17,333,332 2.25 Exercised (17,187,332 ) 2.25 Outstanding at September 30, 2023 1,722,240 $ 15.87 | Warrants Weighted Average Exercise Price Outstanding at December 31, 2021 1,046,438 $ 29.04 Issued 529,801 12.60 Amended and restated (460,306 ) 34.46 Amended and restated 460,306 12.60 Outstanding at December 31, 2022 1,576,240 $ 17.13 |
Schedule of Black-Scholes Option Pricing model | Remaining contractual term 5 Years Risk free interest rate 2.23 % Expected dividends - Expected Volatility 105.69 % | |
Schedule of outstanding stock options | Outstanding Options Number of Shares Weighted Average Exercise Price Aggregate Intrinsic Value Balances at December 31, 2021 - $ - Options granted 28,563 $ 12.40 Options cancelled/forfeited (400 ) $ 12.40 Balances at December 31, 2022 28,163 $ 12.40 $ - (1) Outstanding Options Number of Shares Weighted Average Exercise Price Aggregate Intrinsic Value Balances at December 31, 2020 19,675 $ 23.60 Options granted 18,939 $ 37.60 Options exercised (850 ) $ 23.60 Options cancelled/forfeited (4,600 ) $ 31.80 Balances at December 31, 2021 33,164 $ 38.00 Options cancelled/forfeited (9,791 ) $ 32.42 Balances at December 31, 2022 23,373 $ 40.13 $ - (1) Outstanding Options Number of Shares Weighted Average Exercise Price Aggregate Intrinsic Value Balances at December 31, 2020 2,883 $ 926.80 Options cancelled (1,067 ) $ 1,065.60 Balances at December 31, 2021 1,816 $ 845.20 Options cancelled (880 ) $ 558.34 Balances at December 31, 2022 936 $ 1,122.75 $ - (1) | |
Options outstanding | Options Outstanding at December 31, 2022 Options Exercisable and Vested at December 31, 2022 Exercise Price Number of Options Weighted Average Remaining Contractual Life (Years) Number of Options Weighted Average Exercise Price $ 12.40 to $ 37.00 47,847 8.7 11,549 $ 25.89 $ 39.40 to $ 224.00 3,789 6.4 3,789 $ 97.49 $ 828.00 to $ 1,264.00 603 3.5 603 $ 994.17 $ 1,368.00 $ 2,260.00 238 1.4 238 $ 1,825.97 52,477 8.4 16,179 $ 105.22 | |
Options outstanding that have vested and are expected | Number of Options WA Exercise Price Aggregate Intrinsic Value Weighted Average Remaining Contractual Life (Years) Vested 16,179 $ 105.22 $ - 7.1 Vested & expected to vest 48,486 $ 46.78 $ - 9.0 | |
Shares available for grant | Shares Available for Grant Balances, at December 31, 2021 - Shares reserved under 2022 Plan 55,000 Shares rolled over from 2016 Plan 40,988 Options granted (28,563 ) Options cancelled/forfeited 10,191 Balances, at December 31, 2022 77,616 | |
Schedule of Estimated fair value of options granted | For the year ended December 31, 2022 2021 Risk-free interest rate (weighted average) 3.08 % 0.72 % Expected volatility (weighted average) 102.01 % 101.60 % Expected term (in years) 7.0 6.7 Expected dividend yield 0.00 % 0.00 % | |
2022 Stock Incentive Plan | ||
Summarizes shares available for grant | Shares Available for Grant Balances, at December 31, 2022 77,616 Options cancelled/forfeited 2,359 Balances, at September 30, 2023 79,975 | |
2022 Plan Stock Options | ||
Schedule of outstanding stock options | Outstanding Options Number of Shares Weighted Average Exercise Price Balances at December 31, 2022 28,163 $ 12.40 Options cancelled/forfeited (1,650 ) $ 12.40 Balances at September 30, 2023 26,513 $ 12.40 | |
2016 Plan Stock Options | ||
Schedule of outstanding stock options | Outstanding Options Number of Shares Weighted Average Exercise Price Balances at December 31, 2022 23,373 $ 40.13 Options cancelled/forfeited (709 ) $ 23.60 Balances at September 30, 2023 22,664 $ 40.64 | |
1999 Plan Stock Options | ||
Schedule of outstanding stock options | Outstanding Options Number of Shares Weighted Average Exercise Price Balances at December 31, 2022 936 $ 1,122.75 Options cancelled/forfeited (240 ) $ 1,253.83 Balances at September 30, 2023 696 $ 1,076.36 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
COMMITMENTS AND CONTINGENCIES | |
Schedule of classification of our lease liabilities | December 31, 2022 December 31, 2021 Current portion included in accrued liabilities $ 119,393 $ 107,192 Long term lease liability 64,196 183,589 $ 183,589 $ 290,781 |
Maturities of our operating lease liabilities | Year ending December 31, 2023 129,797 2024 65,702 Total lease payments $ 195,499 Less: Imputed interest (11,910 ) Operating lease liability $ 183,589 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
INCOME TAXES | |
Schedule of income tax expenses | December 31, 2022 2021 U.S. federal tax benefit at statutory rate $ (2,320,057 ) $ (6,819,615 ) State income tax benefit, net of federal benefit (218,196 ) (641,368 ) Stock compensation 79,090 171,269 Other nondeductible, including IPR&D expense - 5,032,981 Change in state tax rate 116,392 1,768,013 Federal and state net operating loss adjustments 423,066 745,439 Other, including effect of tax rate brackets 8,850 (73 ) Change in realizability of IPR&D - 229,750 Change in valuation allowance 1,910,855 (486,396 ) $ - $ - |
Schedule of tax effects of temporary differences and carry forwards | December 31, Deferred Tax Assets 2022 2021 Net operating loss carryforwards $ 36,106,727 $ 35,291,097 Accruals and other 1,412,267 308,296 Capital loss carryforwards 2,258 11,003 Valuation allowance (37,521,252 ) (35,610,396 ) Net deferred tax assets - - Deferred Tax Liabilities Other liabilities - - Net Deferred Tax Liabilities $ - $ - |
DESCRIPTION OF BUSINESS (Detail
DESCRIPTION OF BUSINESS (Details Narrative) - USD ($) | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
DESCRIPTION OF BUSINESS | |||
Accumulated Deficit | $ (294) | ||
Cash Used In Operating Activities | 4,700,000 | ||
Accumulated Deficit | $ (294,027,153) | $ (289,542,080) | $ (278,494,185) |
Cash Used In Operating Activities | $ (12,012,873) | $ (10,856,203) |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - shares | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Warrants To Purchase Common Stock[Member] | ||||
Anti- Securities Dilutive | 1,722,240 | 1,576,240 | 1,576,240 | 1,046,438 |
Pre-Funded Warrants To Purchase Common Stock [Member] | ||||
Anti- Securities Dilutive | 210 | 792,802 | 501,664 | |
Options To Purchase Common Stock[Member] | ||||
Anti- Securities Dilutive | 74,873 | 77,911 | 77,472 | 64,978 |
Covertible Preferred Shares Outstanding [Member] | ||||
Anti- Securities Dilutive | 210 | 210 | 210 |
SUMMARY OF SIGNIFICANT ACCOUN_5
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) | Sep. 30, 2023 | Aug. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Cash uninsured amount | $ 1,900,000 | $ 1,877,589 | $ 5,127,956 | |
Federal Deposit Insurance Corporation insurance limits | 250,000 | 250,000 | ||
Total current assets | 11,900,000 | 3,200,000 | ||
Working capital amount | 11,300,000 | 1,400,000 | 4,100,000 | |
Cash resources | 11,100,000 | 2,100,000 | ||
Fully fdic insured amount deposit | 10,500,000 | |||
Cash | $ 345,000 | 2,100,000 | 5,600,000 | |
Total current assets | $ 3,200,000 | $ 5,700,000 | ||
Intra Fi Network [Member] | ||||
Federal Deposit Insurance Corporation insurance limits | $ 250,000 |
BALANCE SHEET COMPONENTS (Detai
BALANCE SHEET COMPONENTS (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
BALANCE SHEET COMPONENTS | |||
Operating Costs | $ 245,545 | $ 245,391 | $ 0 |
Lease Liability | 0 | 119,393 | 107,192 |
Employee Related | 47,416 | 410,261 | 597,148 |
Total | 292,961 | 775,045 | |
Total | $ 292,961 | $ 775,045 | $ 704,340 |
BALANCE SHEET COMPONENTS (Det_2
BALANCE SHEET COMPONENTS (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
BALANCE SHEET COMPONENTS | ||||||
Depreciation expense | $ 1,000 | $ 1,200 | $ 2,900 | $ 3,800 | $ 5,143 | $ 4,116 |
NOTE PAYABLE (Details Narrative
NOTE PAYABLE (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
May 28, 2021 | Sep. 30, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Apr. 30, 2020 | |
NOTE PAYABLE | |||||||
Note Payable | $ 174,466 | $ 174,466 | $ 624,302 | $ 0 | |||
Notes payble Gross | 624,302 | 624,302 | |||||
Interest expense | 5,337 | 21,151 | $ 4,443 | 4,443 | $ 949 | ||
Proceeds from issuance of note payable | $ 693,669 | $ 693,669 | |||||
Interest rate on notes payable | 7.39% | ||||||
Note payable downpayment | $ 69,367 | $ 69,367 | |||||
Monthly installment | $ 58,873 | ||||||
PPP loan amount | $ 244,657 | $ 244,657 | |||||
Accrued interest | $ 2,576 | ||||||
Interest rate on notes payable | 7.39% | ||||||
Note payable downpayment | $ 69,367 | ||||||
Monthly installment | $ 58,873 |
LEASE (Details Narrative)
LEASE (Details Narrative) - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
LEASE | ||
Lease Expense | $ 169,867 | |
Annual Base Rent Increased | 125,034 | |
Monthly installment | $ 750 | |
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% | 2.50% |
MERGER (Details)
MERGER (Details) | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
MERGER | |
Fair Value of shares of Common Stock Issued | $ 3,369,371 |
Fair Value of Series B Convertible Preferred Stock issued at closing | 18,212,960 |
Total fair value of consideration transferred | 21,582,331 |
Tangible assets acquired | 0 |
Accounts payable assumed | (150,000) |
Total identifiable net assets | (150,000) |
IPR&D expense recognized | 21,732,331 |
Total fair value of consideration | $ 21,582,331 |
MERGER (Details Narrative)
MERGER (Details Narrative) | 12 Months Ended |
Dec. 31, 2022 shares | |
MERGER | |
Common stock acquired | 1,892,905 |
Stock issued for conversion | 1,212,492 |
Percentage of preferred stock carries voting rights | 10% |
Series B convertible preferred stock conversion | 10,232 |
Common stock for conversion | 10,232,000 |
Series B stock conversion description | 881.5 shares of common stock, and (ii) the right to receive up to 118.5 Holdback Shares, which were delivered 24 months after the date of issuance of the Series B Stock, subject to reduction for indemnification claims. |
STOCKHOLDERS EQUITY (Details)
STOCKHOLDERS EQUITY (Details) - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
STOCKHOLDERS EQUITY | ||
Warrants outstanding beginning | 1,576,240 | 1,046,438 |
Warrants issued | 17,333,332 | 529,801 |
Warrants amended and restated | (17,187,332) | (460,306) |
Warrants outstanding ending | 1,722,240 | 1,576,240 |
Warrants,Weighted average exercise price beginning | $ 17.13 | $ 29.04 |
Weighted average exercise price, issued | 2.25 | 12.60 |
Weighted average exercise price, excercised | 2.25 | 34.46 |
Warrants, weighted average exercise price, ending | $ 15.87 | $ 17.13 |
Warrants amended and restated | 460,306 | |
Weighted average exercise price, amended and restared | $ 12.60 |
STOCKHOLDERS EQUITY (Details 1)
STOCKHOLDERS EQUITY (Details 1) | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Remaining contractual term | 5 years | 8 years 4 months 24 days | |
Risk free interest rate | 2.23% | ||
Expected dividends | 0% | ||
Expected Volatility | 105.69% | ||
Grant under 2022 Plan [Member] | |||
Risk free interest rate | 3.08% | 0.72% | |
Expected dividends | 0% | 0% | |
Expected volatility (weighted average) | 102.01% | 101.60% | |
Expected term (in years) | 7 years | 6 years 8 months 12 days |
STOCKHOLDERS EQUITY (Details 2)
STOCKHOLDERS EQUITY (Details 2) - Grant under 2022 Plan [Member] - shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Shares reserved under 2022 Plan Ending Balance | 79,975 | |
Options cancelled/forfeited | 2,359 | 10,191 |
Shares reserved under 2022 Plan Beginning Balance | 77,616 | |
Shares reserved under 2022 Plan | 55,000 | |
Shares rolled over from 2016 Plan | 40,988 | |
Options Granted | (28,563) | |
Options granted, ending | 77,616 |
STOCKHOLDERS EQUITY (Details 3)
STOCKHOLDERS EQUITY (Details 3) - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Number of shares, Options Outstanding, Beginning | 52,477 | |
Warrants,Weighted average exercise price beginning | $ 17.13 | $ 29.04 |
Number of shares, Options Outstanding, Ending | 52,477 | |
Grant under 2022 Plan [Member] | ||
Number of shares, Options Outstanding, Beginning | 28,163 | |
Number of shares beggining | 28,163 | |
Number of shares options cancelled /forfeited | (1,650) | |
Number of shares, Options Outstanding, Options granted | 28,563 | |
Number of shares, Options Outstanding, cancelled/forfeited | (400) | |
Number of shares Ending Balance | 26,513 | |
Warrants,Weighted average exercise price beginning | $ 12.40 | |
Weighted average exercise price, option granted | 12.40 | |
Number of shares, Options Outstanding, Ending | 28,163 | |
Warrants,Weighted average exercise price Ending Balance | 12.40 | |
Weighted average exercise price, option outstanding, Ending Balance | $ 12.40 | |
Weighted average exercise price, Options Options granted | 12.40 | |
Weighted average exercise price, Options cancelled/forfeited | 12.40 | |
Weighted average exercise price, option outstanding, Beginning Balance | $ 12.40 | $ 0 |
STOCKHOLDERS EQUITY (Details 4)
STOCKHOLDERS EQUITY (Details 4) - $ / shares | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Number of shares, Options Outstanding, Beginning | 52,477 | ||
Number of shares, Options Outstanding, Ending | 52,477 | ||
Grant under 2016 Plan [Member] | |||
Number of shares, Options Outstanding, Beginning | 23,373 | 33,164 | 19,675 |
Number of shares, Options Outstanding, Options granted | 18,939 | ||
Number of shares, Options Outstanding, Options exercised | (850) | ||
Number of shares, Options Outstanding, cancelled/forfeited | (709) | (9,791) | (4,600) |
Number of shares, Options Outstanding, Ending | 22,664 | 23,373 | 33,164 |
Weighted average exercise price, option outstanding, Beginning Balance | $ 40.13 | $ 38 | $ 23.60 |
Warrants,Weighted average exercise price, Options Options granted | 37.60 | ||
Warrants,Weighted average exercise price, Options exercised | 23.60 | ||
Warrants,Weighted average exercise price, Options cancelled/forfeited | 23.60 | 32.42 | 31.80 |
Weighted average exercise price, option outstanding, Ending Balance | $ 40.64 | $ 40.13 | $ 38 |
STOCKHOLDERS EQUITY (Details 5)
STOCKHOLDERS EQUITY (Details 5) - $ / shares | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Number of shares, Options Outstanding, Beginning | 52,477 | ||
Number of shares, Options Outstanding, Ending | 52,477 | ||
Stock Options 1999 Plan [Member] | |||
Number of shares, Options Outstanding, Beginning | 936 | 1,816 | 2,883 |
Number of shares, Options Outstanding, cancelled | (240) | (880) | (1,067) |
Number of shares, Options Outstanding, Ending | 696 | 936 | 1,816 |
Weighted average exercise price, option outstanding, Beginning Balance | $ 1,122.75 | $ 845.20 | $ 926.80 |
Warrants,Weighted average exercise price, Options cancelled | 1,253.83 | 558.34 | 1,065.60 |
Weighted average exercise price, option outstanding, Ending Balance | $ 1,076.36 | $ 1,122.75 | $ 845.20 |
STOCKHOLDERS EQUITY (Details 6)
STOCKHOLDERS EQUITY (Details 6) - Stock Options [Member] | 12 Months Ended |
Dec. 31, 2022 USD ($) $ / shares shares | |
Number of option shares vested | shares | 16,179 |
Weighted average exercise price vested | $ / shares | $ 105.22 |
Aggregate intrinsic value vested | $ | $ 0 |
Weighted average remaining contractual life vested | 7 years 1 month 6 days |
Number of option shares vested and expected to vest | shares | 48,486 |
Weighted average exercise price vested and expected to vest | $ / shares | $ 46.78 |
Aggregate intrinsic value vested and expected to vest | $ | $ 0 |
Weighted average remaining contractual life vested and expected to vest | 9 years |
STOCKHOLDERS EQUITY (Details 7)
STOCKHOLDERS EQUITY (Details 7) - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Number of options outstanding | 52,477 | |
Weighted average remaining contractual life | 5 years | 8 years 4 months 24 days |
Number of options exercisable and vested | 16,179 | |
Options exercisable and vested weighted average exercise price | $ 105.22 | |
Exercise Price One [Member] | ||
Number of options outstanding | 47,847 | |
Weighted average remaining contractual life | 8 years 8 months 12 days | |
Number of options exercisable and vested | 11,549 | |
Options exercisable and vested weighted average exercise price | $ 25.89 | |
Exercise Price Two [Member] | ||
Number of options outstanding | 3,789 | |
Weighted average remaining contractual life | 6 years 4 months 24 days | |
Number of options exercisable and vested | 3,789 | |
Options exercisable and vested weighted average exercise price | $ 97.49 | |
Exercise Price Three [Member] | ||
Number of options outstanding | 603 | |
Weighted average remaining contractual life | 3 years 6 months | |
Number of options exercisable and vested | 603 | |
Options exercisable and vested weighted average exercise price | $ 994.17 | |
Exercise Price Four [Member] | ||
Number of options outstanding | 238 | |
Weighted average remaining contractual life | 1 year 4 months 24 days | |
Number of options exercisable and vested | 238 | |
Options exercisable and vested weighted average exercise price | $ 1,825.97 |
STOCKHOLDERS EQUITY (Details Na
STOCKHOLDERS EQUITY (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | 84 Months Ended | ||||||||||||||||
Jun. 09, 2022 | Jul. 06, 2021 | Jun. 10, 2021 | Jan. 15, 2021 | Dec. 11, 2018 | Mar. 13, 2014 | Jun. 10, 2021 | Jun. 13, 2019 | Jun. 16, 2016 | Sep. 15, 2015 | Sep. 15, 2015 | Sep. 30, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Mar. 13, 2021 | Jun. 30, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | May 22, 2022 | |
Common Stock, Shares Authorized | 400,000,000 | 400,000,000 | 400,000,000 | 400,000,000 | |||||||||||||||||
Common Stock, Par Value | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||||||||||||||||
Common Stock, Shares Outstanding | 23,862,434 | 23,862,434 | 2,291,809 | 1,260,346 | |||||||||||||||||
Warrants outstanding ending | 1,722,240 | 1,722,240 | 1,576,240 | 1,046,438 | 1,722,240 | 31,524,794 | 31,524,794 | ||||||||||||||
Common Stock, Shares Issued | 2,291,809 | 1,260,346 | |||||||||||||||||||
Conversion Of Preferred Stock Into Common Stock, Maximum Ownership Limit, Percentage | 4.99% | ||||||||||||||||||||
Risk-free interest rate | 2.23% | ||||||||||||||||||||
Volatility Factor Rate | 105.69% | ||||||||||||||||||||
Common Stock, Shares Issued | 23,862,434 | 23,862,434 | 2,291,809 | 1,260,346 | |||||||||||||||||
Warrants, Exercise Price | $ 15.87 | $ 15.87 | $ 17.13 | $ 29.04 | $ 0.0001 | $ 0.86 | |||||||||||||||
2022 Stock Incentive Plan | |||||||||||||||||||||
Number Of Shares Of Common Stock Authorized For Issuance | 55,000 | ||||||||||||||||||||
Number of shares rolled over | 51,487 | 51,487 | |||||||||||||||||||
Number of shares remaining | 28,488 | 28,488 | |||||||||||||||||||
Aggregate issuance shares | 79,975 | 79,975 | |||||||||||||||||||
2022 Plan Stock Options | |||||||||||||||||||||
Exercise price | 2.22 | ||||||||||||||||||||
Expenses | $ 16,089 | $ 68,586 | |||||||||||||||||||
Unrecognized Compensation Costs | 91,779 | $ 91,779 | |||||||||||||||||||
Weighted average remaining vesting period | 1 year 8 months 8 days | ||||||||||||||||||||
2016 Plan Stock Options | |||||||||||||||||||||
Exercise price | $ 2.22 | ||||||||||||||||||||
Unrecognized Compensation Costs | 8,805 | $ 8,805 | $ 214,175 | ||||||||||||||||||
Weighted average remaining vesting period | 3 months 7 days | 19 hours | |||||||||||||||||||
Stock Options Granted, Vesting Period | Stock options granted generally vest over three to four years. | Stock options granted generally vest over three to four years. | |||||||||||||||||||
Compensation Expense | 7,840 | $ 23,574 | $ 223,277 | $ 391,801 | |||||||||||||||||
Weighted average fair value | $ 12.40 | $ 30.60 | |||||||||||||||||||
First Inducement Stock Options | |||||||||||||||||||||
Stock Option Award Granted | 5,000 | 5,000 | 5,000 | ||||||||||||||||||
Stock Options Description | The options had a 10-year term and an exercise price of $39.40 per share, the July 6, 2021 closing price of our common stock. | 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 $39.40 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% | 1.37% | |||||||||||||||||||
Dividend Yield | 0% | 0% | |||||||||||||||||||
Volatility Factor Rate | 103.50% | 103.50% | |||||||||||||||||||
Expected Life | 10 years | 10 days | |||||||||||||||||||
Stock Options Exercise Term | 10 years | ||||||||||||||||||||
Stock Options Exercise Price | $ 39.40 | ||||||||||||||||||||
Second Inducement Stock Options | |||||||||||||||||||||
Stock Option Award Granted | 12,500 | 12,500 | 12,500 | ||||||||||||||||||
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 $39.40 per share, the July 6, 2021 closing price of our common stock. | 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 $39.40 per share, the July 6, 2021 closing price of our common stock. | |||||||||||||||||||
Estimated Fair Value Of The Inducement Stock Option Award Granted | $ 403,180 | ||||||||||||||||||||
Risk-free interest rate | 1.13% | 1.13% | |||||||||||||||||||
Dividend Yield | 0% | 0% | |||||||||||||||||||
Volatility Factor Rate | 99.36% | 99.36% | |||||||||||||||||||
Expected Life | 7 years | 7 days | |||||||||||||||||||
Stock Options Exercise Term | 10 years | ||||||||||||||||||||
Stock Options Exercise Price | $ 39.40 | ||||||||||||||||||||
Inducement Stock Options | |||||||||||||||||||||
Unrecognized Compensation Costs | 371,384 | $ 371,384 | $ 440,682 | ||||||||||||||||||
Compensation Expense | $ 13,083 | $ 61,678 | $ 142,037 | ||||||||||||||||||
Inducement Stock Options | Cheif Medical Officer | |||||||||||||||||||||
Stock Option Award Granted | 12,500 | 12,500 | |||||||||||||||||||
Stock Options Description | 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 $35.60 per share, the January 15, 2021 closing price of our common stock. | ||||||||||||||||||||
Estimated Fair Value Of The Inducement Stock Option Award Granted | $ 402,789 | ||||||||||||||||||||
Risk-free interest rate | 11% | ||||||||||||||||||||
Dividend Yield | 0% | ||||||||||||||||||||
Volatility Factor Rate | 103.94% | ||||||||||||||||||||
Expected Life | 10 days | ||||||||||||||||||||
Stock Options Exercise Term | 10 years | ||||||||||||||||||||
Stock Options Exercise Price | $ 35.60 | ||||||||||||||||||||
Inducement Stock Options | Chief Medical Officer [Member] | |||||||||||||||||||||
Stock Option Award Granted | 12,500 | ||||||||||||||||||||
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 $35.60 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 | ||||||||||||||||||||
1999 Amended Stock Plan | |||||||||||||||||||||
Number Of Shares Of Common Stock Authorized For Issuance | 10,000 | 12,500 | 12,500 | 10,000 | |||||||||||||||||
Number Of Shares Previously Authorized For Issuance | 750 | 10,000 | 10,000 | 750 | |||||||||||||||||
Compensation Expense | $ 0 | $ 1,290 | |||||||||||||||||||
Stock options granted fair market value percentage | 85% | ||||||||||||||||||||
Unvested shares underlying outstanding stock awards | 152,500 | ||||||||||||||||||||
Outstanding stock awards | 218,706 | ||||||||||||||||||||
General and administrative compensation expense | $ 187,000 | ||||||||||||||||||||
2016 Stock Incentive Plan | |||||||||||||||||||||
Number Of Shares Of Common Stock Authorized For Issuance | 37,500 | 75,000 | 37,500 | 7,500 | |||||||||||||||||
Number Of Shares Previously Authorized For Issuance | 37,500 | 7,500 | |||||||||||||||||||
Series A Stock Plan | |||||||||||||||||||||
Underwritten offering | 259,068 | ||||||||||||||||||||
Exercise price | $ 38.60 | ||||||||||||||||||||
Pre-funded Warrants, Fair Value | $ 9,000,000 | ||||||||||||||||||||
Estimated fair value | 1,800,016 | ||||||||||||||||||||
Prefered Stock ,Shares Outstanding | 210 | 210 | |||||||||||||||||||
Preferred Stock, Par Value | $ 0.0001 | $ 0.0001 | |||||||||||||||||||
July 2021 Warrants | |||||||||||||||||||||
Exercise price | $ 39.40 | ||||||||||||||||||||
Warrant To Purchase Of Unregistered Common Stock | 238,664 | ||||||||||||||||||||
Warrant To Purchase Of Unregistered Common Stock, Value | $ 4,500,000 | ||||||||||||||||||||
May 2022 Warrants | |||||||||||||||||||||
Exercise price | $ 12.60 | $ 12.60 | $ 12.60 | ||||||||||||||||||
Warrant To Purchase Of Unregistered Common Stock | 529,802 | 529,802 | |||||||||||||||||||
Warrant To Purchase Of Unregistered Common Stock, Value | $ 3,800,000 | $ 3,800,000 | |||||||||||||||||||
July 2020 Warrants | |||||||||||||||||||||
Exercise price | $ 18.06 | ||||||||||||||||||||
Warrant To Purchase Of Unregistered Common Stock | 389,181 | ||||||||||||||||||||
Warrant To Purchase Of Unregistered Common Stock, Value | $ 3,500,000 | ||||||||||||||||||||
Pre-Funded Warrants | |||||||||||||||||||||
Warrants outstanding ending | 0 | 501,664 | |||||||||||||||||||
Pre-Funded Warrants | December 2018 Offering | |||||||||||||||||||||
Stock issued during period, shares | 14,110 | ||||||||||||||||||||
Stock issued during period, value | $ 545,000 | ||||||||||||||||||||
March 2020 Warrants | |||||||||||||||||||||
Exercise price | $ 20.80 | ||||||||||||||||||||
Warrant To Purchase Of Unregistered Common Stock | 118,016 | ||||||||||||||||||||
Warrant To Purchase Of Unregistered Common Stock, Value | $ 1,100,000 | ||||||||||||||||||||
Warrants Issued for Services | |||||||||||||||||||||
Warrant to purchase of common stock | 17,890 | ||||||||||||||||||||
Warrant to purchase of common stock exercise price | $ 49.20 | ||||||||||||||||||||
Estimated fair value | $ 558,472 | ||||||||||||||||||||
May 2022 Offering | Pre-Funded Warrants | |||||||||||||||||||||
Pre-funded Warrants, Fair Value | $ 4,200,000 | $ 4,200,000 | |||||||||||||||||||
Stock issued during period, shares | 529,802 | 529,802 | |||||||||||||||||||
Purchase Price Per Unit | $ 15.50 | $ 15.50 | |||||||||||||||||||
Number Of Securities Called By Warrants | 1,059,603 | 1,059,603 | |||||||||||||||||||
Proceeds From Issuance Of Private Placement | $ 7,900,000 | ||||||||||||||||||||
Warrants, Fair Value | $ 3,800,000 | $ 3,800,000 | |||||||||||||||||||
Warrants outstanding ending | 1,722,240 | ||||||||||||||||||||
Stock issued during period, value | $ 1,060 | ||||||||||||||||||||
July 2021 Offering | |||||||||||||||||||||
Pre-funded Warrants, Fair Value | $ 550,000 | ||||||||||||||||||||
Purchase Price Per Unit | $ 41.90 | ||||||||||||||||||||
Number Of Securities Called By Warrants | 477,327 | ||||||||||||||||||||
Proceeds From Issuance Of Private Placement | $ 9,200,000 | ||||||||||||||||||||
Warrants, Fair Value | $ 450,000 | ||||||||||||||||||||
Stock Units Issued | 238,664 | ||||||||||||||||||||
July 2021 Offering | Pre-Funded Warrants | |||||||||||||||||||||
Stock issued during period, shares | 238,664 | ||||||||||||||||||||
Stock issued during period, value | $ 477 | ||||||||||||||||||||
July 2020 and March 2020 Offerings | Pre-Funded Warrants | |||||||||||||||||||||
Stock issued during period, shares | 25,969 | ||||||||||||||||||||
July 2020 Offering | Pre-Funded Warrants | |||||||||||||||||||||
Stock issued during period, shares | 263,000 | ||||||||||||||||||||
Stock issued during period, value | $ 526 | ||||||||||||||||||||
Febuary 2023 Offering | |||||||||||||||||||||
Warrant To Purchase Of Unregistered Common Stock | 6,959,444 | ||||||||||||||||||||
Common stock shares | 1,707,222 | ||||||||||||||||||||
Warrnat purchase | 17,333,332 | ||||||||||||||||||||
Offering Price | $ 1.80 | ||||||||||||||||||||
Common stock warrant | $ 1.799 | ||||||||||||||||||||
Gross proceeds form warrant | $ 15,600,000 | ||||||||||||||||||||
Agent fees and direct offering expenses | 13,700,000 | ||||||||||||||||||||
fair value allocated | 5,000,000 | ||||||||||||||||||||
Pre-funded warrants | 1,200,000 | ||||||||||||||||||||
Warrant | $ 9,400,000 | ||||||||||||||||||||
Febuary 2023 | |||||||||||||||||||||
Warrnat purchase | 17,333,332 | ||||||||||||||||||||
Offering Price | $ 2.25 | ||||||||||||||||||||
Warrant | $ 10,600,000 | ||||||||||||||||||||
Series A Preferred Stock | |||||||||||||||||||||
Prefered Stock ,Shares Outstanding | 210 | 210 | 210 | 210 | |||||||||||||||||
Preferred Stock, Par Value | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||||||||||||
Conversion Of Preferred Stock Into Common Stock, Maximum Ownership Limit, Percentage | 9.99% | ||||||||||||||||||||
Stock Units Issued | 5,181,346 | ||||||||||||||||||||
Proceeds From Issuance Of Common Stock And Pre-funded Warrants, Net Of Issuance Costs | $ 9,000,000 | ||||||||||||||||||||
Preferred Stock Dividend | $ 1,800,016 | ||||||||||||||||||||
Preferred Stock, Convertible, Conversion Price | $ 1.93 | ||||||||||||||||||||
Preferred Stock, Shares Issued | 210 | 210 | 5,181,346 | 5,181,346 | |||||||||||||||||
Series A Preferred Stock | Five-Year Warrant | |||||||||||||||||||||
Warrants, Exercise Price | $ 1.93 | ||||||||||||||||||||
Warrants One | May 2022 Offering | |||||||||||||||||||||
Pre-funded Warrants, Fair Value | $ 4,200,000 | ||||||||||||||||||||
Purchase Price Per Unit | $ 0.155 | ||||||||||||||||||||
Number Of Securities Called By Warrants | 1,059,603 | ||||||||||||||||||||
Proceeds From Issuance Of Private Placement | $ 7,900,000 | ||||||||||||||||||||
Warrants, Fair Value | $ 380,000 | ||||||||||||||||||||
Stock Units Issued | 529,802 | ||||||||||||||||||||
Series B Preferred Stock | |||||||||||||||||||||
Preferred Stock, Shares Issued | 10,232 | ||||||||||||||||||||
Preferred Stock, Convertible, Terms | (i) 881.5 shares of common stock and (ii) the right to receive up to 118.5 Holdback Shares, where were delivered 24 months after the date of issuance of the Series B Stock and were subject to reduction for indemnification claims | ||||||||||||||||||||
Stock Convertible Into An Aggregate Shares Of Common Stock | $ 10,232,000 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
COMMITMENTS AND CONTINGENCIES | |||
Current Portion Included In Accrued Liabilities | $ 119,393 | $ 107,192 | |
Long Term Lease Liability | $ 0 | 64,196 | 183,589 |
Total | $ 183,589 | $ 290,781 |
COMMITMENTS AND CONTINGENCIES_3
COMMITMENTS AND CONTINGENCIES (Details 1) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
COMMITMENTS AND CONTINGENCIES | ||
2023 | $ 129,797 | |
2024 | 65,702 | |
Total Lease Payments | 195,499 | |
Less: Imputed Interest | (11,910) | |
Operating Lease Liability | $ 183,589 | $ 290,781 |
COMMITMENTS AND CONTINGENCIES_4
COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Annual Lease Term minimum | 2 years | |
Annual Lease Term maximum | 3 years | |
Optioin to extend description | On April 2, 2021, the Company negotiated a 3-year extension to the existing lease term | |
Description Of Lease Contract | In January 2011, the Company entered into a lease with Concourse Associates, LLC for its headquarters in Morrisville, North Carolina (the “Prior Lease”). On April 2, 2021, the Company negotiated a 3-year extension to the existing lease term, commencing July 1, 2021 (the “Commencement Date”). | |
Annual Base Rent Increased | $ 125,034 | |
Percentage Of Annual Increase In Rent | 2.50% | 2.50% |
Simdax License Agreement [Member] | ||
Grant paid to canadian authority | $ 1,000,000 | |
Grant paid to authority | 2,000,000 | |
Non refundable up front payment | 1,000,000 | |
Non-refundable commercialization milestone payment | $ 13,000,000 | |
Lease Term Period | 10 years |
401(k) BENEFIT PLAN (Details Na
401(k) BENEFIT PLAN (Details Narrative) - 401(k) Retirement Savings Plan [Member] - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Contribution Term Period | 90 days | |
Contributions expense | $ 90,873 | $ 73,855 |
Contribution percentage rate | 5% |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
INCOME TAXES | ||
U.S. federal tax benefit at statutory rate | $ (2,320,057) | $ (6,819,615) |
State income tax benefit, net of federal benefit | (218,196) | (641,368) |
Stock compensation | 79,090 | 171,269 |
Other nondeductible, including IPR and D expense | 0 | 5,032,981 |
Change in state tax rate | 116,392 | 1,768,013 |
Federal and state net operating loss adjustments | 423,066 | 745,439 |
Other, including effect of tax rate brackets | 8,850 | (73) |
Change in realizability of IPR and D | 0 | 229,750 |
Change in valuation allowance | 1,910,855 | (486,396) |
Income-tax expense (benefit) | $ 0 | $ 0 |
INCOME TAXES (Details 1)
INCOME TAXES (Details 1) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred Tax Assets | ||
Net operating loss carryforwards | $ 36,106,727 | $ 35,291,097 |
Accruals and others | 1,412,267 | 308,296 |
Capital loss carryoforwards | 2,258 | 11,003 |
Valuation allowance | (37,521,252) | (35,610,396) |
Net deferred tax assets | 0 | 0 |
Deferred Tax Liabilities | ||
Other liabilities | 0 | 0 |
Net deferred tax liabilities | $ 0 | $ 0 |
INCOME TAXES (Details Narrative
INCOME TAXES (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income tax rate | 21% | 21% | ||||
Description of income taxes | there is a cumulative change in our ownership by “5% shareholders” that exceeds 50 percentage points over a rolling three-year period. | |||||
Valuation allowance, decrease | $ 1,900,000 | |||||
Operating Loss Carryforwards | $ 2,117,379 | $ 2,917,488 | $ 4,893,004 | $ 8,498,019 | 11,052,643 | $ 32,728,241 |
Federal [Member] | ||||||
Operating Loss Carryforwards | 163,200,000 | |||||
Net operating losses | 122,900,000 | |||||
State [Member] | ||||||
Operating Loss Carryforwards | 125,100,000 | |||||
Remaining operating losses carryforward | $ 40,300,000 |
SUBSEQUENT EVENTS (Details Narr
SUBSEQUENT EVENTS (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | |||||||
Feb. 07, 2023 | Mar. 28, 2023 | Feb. 28, 2023 | Dec. 31, 2022 | Sep. 30, 2023 | Feb. 03, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Dec. 31, 2021 | |
Stockholders' equity | $ 2,500,000 | $ 1,500,000 | |||||||
Minimum Requirement of Nasdaq Capital Market | $ 2,500,000 | ||||||||
Public Offering for net proceeds | $ 14,100,000 | ||||||||
Cash | $ 14,600,000 | ||||||||
Common stock, minimum closing price per share | $ 1 | ||||||||
Lease termination agreement amount paid | $ 169,867 | ||||||||
Lease termination date | Jun. 30, 2024 | ||||||||
Issuance of pre fund warrant shares, offering price per share | $ 17.13 | $ 15.87 | $ 0.0001 | $ 0.86 | $ 29.04 | ||||
Roth Capital Partners, LLC [Member] | |||||||||
Warrants to purchase shares of common stock | 17,333,332 | ||||||||
Sale of common stock shares | 6,959,444 | ||||||||
Sale of common stock, price per share | $ 0.0001 | ||||||||
Issuance of pre fund warrant shares | 1,707,222 | ||||||||
Issuance of pre fund warrant shares, offering price per share | $ 1.80 | ||||||||
Common warrant, pre-funded warrant per share price | $ 1.799 | ||||||||
Gross proceeds from common stock warrants | 15,600,000 | ||||||||
Estimated net proceeds from public offering after deduction of placement agent fees and estimated offering expenses payable | $ 14,100,000 |