Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 10, 2022 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2022 | |
Entity File Number | 001-40536 | |
Entity Registrant Name | Acurx Pharmaceuticals, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 82-3733567 | |
Entity Address State Or Province | NY | |
Entity Address, Address Line One | 259 Liberty Ave | |
Entity Address, City or Town | Staten Island | |
Entity Address, Postal Zip Code | 10305 | |
City Area Code | 917 | |
Local Phone Number | 533-1469 | |
Title of 12(b) Security | Common Stock | |
Trading Symbol | ACXP | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 11,592,609 | |
Entity Central Index Key | 0001736243 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
CONDENSED INTERIM BALANCE SHEET
CONDENSED INTERIM BALANCE SHEETS - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
CURRENT ASSETS | ||
Cash | $ 10,607,341 | $ 12,958,846 |
Prepaid Expenses | 337,807 | 295,304 |
TOTAL ASSETS | 10,945,148 | 13,254,150 |
CURRENT LIABILITIES | ||
Accounts Payable and Accrued Expenses | 1,182,080 | 843,909 |
TOTAL CURRENT LIABILITIES | 1,182,080 | 843,909 |
TOTAL LIABILITIES | 1,182,080 | 843,909 |
COMMITMENTS AND CONTINGENCIES | ||
SHAREHOLDERS' EQUITY | ||
Common Stock; $.001 par value, 200,000,000 shares authorized, 11,592,609 and 10,215,792 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively | 11,593 | 10,216 |
Additional Paid-In Capital | 45,132,049 | 38,948,334 |
Accumulated Deficit | (35,380,574) | (26,548,309) |
TOTAL SHAREHOLDERS' EQUITY | 9,763,068 | 12,410,241 |
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ 10,945,148 | $ 13,254,150 |
CONDENSED INTERIM BALANCE SHE_2
CONDENSED INTERIM BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
CONDENSED INTERIM BALANCE SHEETS | ||
Common stock, Par value | $ 0.001 | $ 0.001 |
Common stock, Authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock, Issued (in shares) | 11,592,609 | 10,215,792 |
Common stock, Outstanding (in shares) | 11,592,609 | 10,215,792 |
CONDENSED INTERIM STATEMENTS OF
CONDENSED INTERIM STATEMENTS OF OPERATIONS - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
OPERATING EXPENSES | ||||
Research and Development | $ 1,591,043 | $ 1,126,972 | $ 3,321,623 | $ 1,313,954 |
General and Administrative | 1,950,551 | 3,515,250 | 5,510,642 | 8,873,160 |
TOTAL OPERATING EXPENSES | 3,541,594 | 4,642,222 | 8,832,265 | 10,187,114 |
Gain on Forgiveness of Paycheck Protection Program Loan | 66,503 | |||
NET LOSS | $ (3,541,594) | $ (4,642,222) | $ (8,832,265) | $ (10,120,611) |
LOSS PER SHARE | ||||
Basic net loss per common share/units | $ (0.32) | $ (0.46) | $ (0.84) | $ (1.27) |
Diluted net loss per common share/units | $ (0.32) | $ (0.46) | $ (0.84) | $ (1.27) |
Weighted average common shares/units outstanding basic | 11,148,402 | 10,116,403 | 10,551,503 | 7,988,563 |
Weighted average common shares/units outstanding diluted | 11,148,402 | 10,116,403 | 10,551,503 | 7,988,563 |
CONDENSED INTERIM STATEMENTS _2
CONDENSED INTERIM STATEMENTS OF CHANGES IN MEMBERS' AND SHAREHOLDERS' EQUITY - USD ($) | Membership Interest Members' Equity, Class A | Membership Interest Members' Equity, Class B | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total |
Balance at beginning at Dec. 31, 2020 | $ 16,402,198 | $ 100,000 | $ (13,800,612) | $ 2,701,586 | ||
Balance at beginning, Member Units (in shares) at Dec. 31, 2020 | 13,493,807 | 100,000 | ||||
Executive Compensation Settled with Membership Interests | $ 186,650 | $ 730,115 | 916,765 | |||
Executive Compensation Settled with Membership Interests (in shares) | 57,430 | 471,042 | ||||
Cancellation of Class B Issuance (in shares) | (471,042) | |||||
Share-Based Compensation | $ 191,667 | 191,667 | ||||
Share-Based Compensation, (in shares) | 143,814 | |||||
Share-Based Payments to Vendors | $ 135,471 | 135,471 | ||||
Share-Based Payments to Vendors (in shares) | 30,145 | |||||
Net Loss | (1,474,330) | (1,474,330) | ||||
Balance at ending at Mar. 31, 2021 | $ 16,915,986 | $ 830,115 | (15,274,942) | 2,471,159 | ||
Balance at ending, Member Units (in shares) at Mar. 31, 2021 | 13,725,196 | 100,000 | ||||
Balance at beginning at Dec. 31, 2020 | $ 16,402,198 | $ 100,000 | (13,800,612) | 2,701,586 | ||
Balance at beginning, Member Units (in shares) at Dec. 31, 2020 | 13,493,807 | 100,000 | ||||
Net Loss | (10,120,611) | |||||
Balance at ending at Sep. 30, 2021 | $ 10,127 | $ 38,188,287 | (23,921,223) | 14,277,191 | ||
Balance at ending, Common shares (in shares) at Sep. 30, 2021 | 10,126,903 | |||||
Balance at beginning at Mar. 31, 2021 | $ 16,915,986 | $ 830,115 | (15,274,942) | 2,471,159 | ||
Balance at beginning, Member Units (in shares) at Mar. 31, 2021 | 13,725,196 | 100,000 | ||||
Share-Based Compensation | $ 563,889 | 1,655,885 | 2,219,774 | |||
Share-Based Compensation, (in shares) | 257,122 | |||||
Share-Based Payments to Vendors | $ 37,500 | 37,500 | ||||
Corporate Conversion | $ (17,517,375) | $ (830,115) | $ 7,041 | 18,340,449 | ||
Corporate Conversion (in shares) | (13,982,318) | (100,000) | 7,041,208 | |||
Issuance of shares of common stock and pre-funded warrants in registered direct offering, net of cash issuance costs | $ 2,875 | 14,794,257 | 14,797,132 | |||
Initial Public Offering and underwriter warrants, net of cash issuance costs (in shares) | 2,875,000 | |||||
Net Loss | (4,004,059) | (4,004,059) | ||||
Balance at ending at Jun. 30, 2021 | $ 9,916 | 34,790,591 | (19,279,001) | 15,521,506 | ||
Balance at ending, Common shares (in shares) at Jun. 30, 2021 | 9,916,208 | |||||
Share-Based Compensation | 2,070,637 | 2,070,637 | ||||
Share-Based Payments to Vendors | $ 211 | 1,327,059 | 1,327,270 | |||
Share-Based Payments to Vendors (in shares) | 210,695 | |||||
Net Loss | (4,642,222) | (4,642,222) | ||||
Balance at ending at Sep. 30, 2021 | $ 10,127 | 38,188,287 | (23,921,223) | 14,277,191 | ||
Balance at ending, Common shares (in shares) at Sep. 30, 2021 | 10,126,903 | |||||
Balance at beginning at Dec. 31, 2021 | $ 10,216 | 38,948,334 | (26,548,309) | $ 12,410,241 | ||
Balance at beginning, Common shares (in shares) at Dec. 31, 2021 | 10,215,792 | 10,215,792 | ||||
Share-Based Compensation | 761,069 | $ 761,069 | ||||
Share-Based Payments to Vendors | $ 44 | 188,056 | 188,100 | |||
Share-Based Payments to Vendors (in shares) | 43,889 | |||||
Cashless Warrant Exercise | $ 3 | (3) | ||||
Cashless Warrant Exercise (in shares) | 3,521 | |||||
Net Loss | (2,670,138) | (2,670,138) | ||||
Balance at ending at Mar. 31, 2022 | $ 10,263 | 39,897,456 | (29,218,447) | 10,689,272 | ||
Balance at ending, Common shares (in shares) at Mar. 31, 2022 | 10,263,202 | |||||
Balance at beginning at Dec. 31, 2021 | $ 10,216 | 38,948,334 | (26,548,309) | $ 12,410,241 | ||
Balance at beginning, Common shares (in shares) at Dec. 31, 2021 | 10,215,792 | 10,215,792 | ||||
Net Loss | $ (8,832,265) | |||||
Balance at ending at Sep. 30, 2022 | $ 11,593 | 45,132,049 | (35,380,574) | $ 9,763,068 | ||
Balance at ending, Common shares (in shares) at Sep. 30, 2022 | 11,592,609 | 11,592,609 | ||||
Balance at beginning at Mar. 31, 2022 | $ 10,263 | 39,897,456 | (29,218,447) | $ 10,689,272 | ||
Balance at beginning, Common shares (in shares) at Mar. 31, 2022 | 10,263,202 | |||||
Share-Based Compensation | 716,682 | 716,682 | ||||
Net Loss | (2,620,533) | (2,620,533) | ||||
Balance at ending at Jun. 30, 2022 | $ 10,263 | 40,614,138 | (31,838,980) | 8,785,421 | ||
Balance at ending, Common shares (in shares) at Jun. 30, 2022 | 10,263,202 | |||||
Share-Based Compensation | 696,965 | 696,965 | ||||
Share-Based Payments to Vendors | $ 36 | 127,044 | 127,080 | |||
Share-Based Payments to Vendors (in shares) | 36,000 | |||||
Cashless Warrant Exercise | $ 4 | (4) | ||||
Cashless Warrant Exercise (in shares) | 3,427 | |||||
Pre-funded Warrant Exercise | $ 131 | (118) | 13 | |||
Pre-funded Warrant Exercise (in shares) | 130,769 | |||||
Issuance of shares of common stock and pre-funded warrants in registered direct offering, net of cash issuance costs | $ 1,159 | 3,694,024 | 3,695,183 | |||
Initial Public Offering and underwriter warrants, net of cash issuance costs (in shares) | 1,159,211 | |||||
Net Loss | (3,541,594) | (3,541,594) | ||||
Balance at ending at Sep. 30, 2022 | $ 11,593 | $ 45,132,049 | $ (35,380,574) | $ 9,763,068 | ||
Balance at ending, Common shares (in shares) at Sep. 30, 2022 | 11,592,609 | 11,592,609 |
CONDENSED INTERIM STATEMENTS _3
CONDENSED INTERIM STATEMENTS OF CHANGES IN MEMBERS' AND SHAREHOLDERS' EQUITY (Parenthetical) - USD ($) | 3 Months Ended | |
Jun. 29, 2021 | Sep. 30, 2022 | |
CONDENSED INTERIM STATEMENTS OF CHANGES IN MEMBERS' AND SHAREHOLDERS' EQUITY | ||
Cash issuance cost | $ 2,400,000 | $ 529,805 |
CONDENSED INTERIM STATEMENTS _4
CONDENSED INTERIM STATEMENTS OF CASH FLOWS - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash Flow from Operating Activities: | ||
Net Loss | $ (8,832,265) | $ (10,120,611) |
Adjustments to Reconcile Net Loss to Net Cash Used in Operating Activities: | ||
Share-Based Compensation | 2,174,716 | 4,482,078 |
Share-Based Payments to Vendors | 315,180 | 1,500,241 |
Executive Compensation Settled with Membership Interests | 916,765 | |
Gain on Forgiveness of Paycheck Protection Program Loan | (66,503) | |
(Increase) / Decrease in: | ||
Prepaid Expenses | (42,503) | (481,973) |
Accounts Payable and Accrued Expenses | 338,171 | 256,506 |
Net Cash Used in Operating Activities | (6,046,701) | (3,513,497) |
Cash Flow from Financing Activities: | ||
Proceeds from Initial Public Offering, net of issuance costs | 14,797,132 | |
Proceeds from Registered Direct Offering, net of issuance costs | 3,695,183 | |
Pre-funded warrant exercise | 13 | |
Net Cash Provided by Financing Activities | 3,695,196 | 14,797,132 |
Net (Decrease) / Increase in Cash | (2,351,505) | 11,283,635 |
Cash at Beginning of Period | 12,958,846 | 3,175,411 |
Cash at End of Period | 10,607,341 | $ 14,459,046 |
SUPPLEMENTAL DISCLOSURE OF NON-CASH FINANCING ACTIVITIES | ||
Warrants issued in connection with offerings | 171,409 | |
Accrued Registered Direct Offering costs | $ 16,847 |
NATURE OF OPERATIONS
NATURE OF OPERATIONS | 9 Months Ended |
Sep. 30, 2022 | |
NATURE OF OPERATIONS | |
NATURE OF OPERATIONS | NOTE 1 – NATURE OF OPERATIONS Business Acurx Pharmaceuticals, Inc., a Delaware corporation, formerly Acurx Pharmaceuticals, LLC (the “Company”) is a clinical stage biopharmaceutical company formed in July 2017, with operations commencing in February 2018. The Company is focused on developing a novel class of antibiotics that address serious or life threatening bacterial infections. In March 2020, the World Health Organization declared the outbreak of COVID-19, a novel strain of coronavirus, a global pandemic. This outbreak caused major disruptions to businesses and markets worldwide as the virus continued to spread. The COVID-19 pandemic has disrupted, and the Company expects it will continue to disrupt, its operations. The extent of the effect on the Company’s operational and financial performance will depend on future developments, including the duration, spread and intensity of the pandemic, and governmental, regulatory and private sector responses, direct and indirect economic effects as a result of inflation, supply chain disruptions and labor shortages all of which are uncertain and difficult to predict. Although the Company is unable to estimate the financial effect of the pandemic, at this time, if the pandemic continues over a long period of time, it could have a material adverse effect on the Company’s business, results of operations, financial condition, and cash flows. The financial statements do not reflect any adjustments as a result of the pandemic. In February 2018, the Company purchased the active pharmaceutical ingredient, the intellectual property and other rights to an antibiotic product candidate known as GLS362E (renamed ACX-362E and now approved for non-proprietary name, ibezapolstat) (the “Asset”) from GLSynthesis, Inc. The Company paid $110,174 in cash, along with granting 100,000 Class B Membership Interests, profits interests as defined in the operating agreement, with an exercise price of $0.10 per share. The Company was also required to make certain milestone payments totaling $700,000 in aggregate if certain milestones are achieved, $50,000 of which has already been paid by the Company and royalty payments equal to 4% of net sales for a period of time equal to the last to expire of any applicable patents, as defined in the asset purchase agreement. The purchase of the Asset has resulted in our lead antibiotic product candidate, ibezapolstat, which targets the treatment of C. difficile infections (“CDI”). The Company’s primary activities since inception aside from organizational activities have included performing research and development activities relating to the development of its two antibiotic candidates and raising funds through equity offerings including its initial public offering (“IPO”) consummated in June 2021. The Company has not generated any revenues since inception. The Company has experienced net losses and negative cash flows from operations since inception and expects these conditions to continue for the foreseeable future. The Company has needed to raise capital from sales of its securities to sustain operations. On June 29, 2021, the Company completed the IPO, issuing 2,875,000 shares of common stock at a price of $6.00 per share, with gross proceeds of approximately $17.3 million. On July 27, 2022, the Company completed a registered direct offering and a concurrent private placement, issuing million. As of September 30, 2022, the Company had a cash balance of approximately |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 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 interim financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and in accordance with the rules and regulations of the United States Securities Exchange Commission for interim reporting. In the opinion of management, these unaudited interim financial statements include all adjustments, consisting only of normal, recurring adjustments, necessary for a fair statement of the Company’s financial position, results of operations, and cash flows. The unaudited interim results of operations are not necessarily indicative of the results that may occur for the full fiscal year. The year-end condensed balance sheet data was derived from audited financial statements, but does not include all disclosures required by GAAP. Management believes that the disclosures provided herein are adequate when these unaudited condensed interim financial statements are read in conjunction with the audited financial statements and notes thereto as of December 31, 2021 filed in Form 10-K. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Income Taxes The Company estimates an annual effective tax rate of 0% as the Company incurred net losses for the nine months ended September 30, 2022 resulting in an estimated net loss for both financial statement and tax purposes. Therefore, no current federal or state income tax expense has been recorded in the financial statements. Based on the Company’s history of generating operating losses and its anticipation of operating losses for the foreseeable future, the Company has determined that it is more likely than not that the tax benefits from those net operating losses would not be realized and a full valuation allowance against all deferred tax assets has been recorded. Should the Company’s assessment change, tax benefits associated with the historic net operating loss carryforwards could be limited due to future ownership changes. Prior to the Company’s corporate conversion in June 2021, the Company was organized as a limited liability company. As such, the Company was not a tax paying entity for federal income tax purposes and, therefore, no income tax expense had been recorded in the financial statements. Income or losses of the Company was passed through to the members for inclusion in their respective income tax returns. Concentration of Credit Risk The Company maintains its cash balance in one financial institution. The balance is insured up to the maximum allowable by the Federal Deposit Insurance Corporation (“FDIC”). The Company has not experienced any losses in such accounts and does not believe it is exposed to any significant risk of loss on cash. At times, the cash balance may exceed the maximum insured limit of the FDIC. As of September 30, 2022, the Company had cash of approximately $10.6 million in U.S. bank accounts which was not fully insured by the FDIC. Research and Development The Company expenses research and development costs when incurred. At times, the Company may make cash advances for future research and development services. These amounts are deferred and expensed in the period the service is provided. The Company incurred research and development expenses in the amount of $1,591,043 and $1,126,972 for the three months ended September 30, 2022 and 2021, respectively, and $3,321,623 and $1,313,954 for the nine months ended September 30, 2022 and 2021, respectively. Share-Based Compensation The Company accounts for the cost of services performed by officers and directors received in exchange for an award of Company membership interests, common stock or stock options, based on the grant-date fair value of the award. The Company recognizes compensation expense based on the requisite service period. Compensation expense associated with stock option awards is recognized over the requisite service period based on the fair value of the option at the grant date determined based on the Black-Scholes option pricing model. Option valuation models require the input of highly subjective assumptions including the expected price volatility. The Company’s employee stock options have characteristics significantly different from those of traded options, and changes in the subjective input assumptions can materially affect the fair value computation using the Black-Scholes option pricing model. Because there is no public market for the Company’s stock options and very little historical experience with the Company’s stock, similar public companies were used for the comparison of volatility and the dividend yield. The risk-free rate of return was derived from U.S. Treasury notes with comparable maturities. Share-Based Payments to Vendors The Company accounts for the cost of services performed by vendors in exchange for an award of Company membership interests, common stock, or stock options, based on the grant-date fair value of the award or the fair value of the services rendered; whichever is more readily determinable. Such fair value is measured as of the date the services or the date performance by the other party is complete. The Company recognizes the expense in the same period and in the same manner as if the Company had paid cash for the services. Major Vendor The Company had a major vendor that accounted for approximately 66% and 52% of the research and development expenditures for the three months ended September 30, 2022 and 2021, respectively, and 50% and 45% for the nine months ended September 30, 2022 and 2021, respectively. The same vendor also accounted for approximately 55% and 5% of the total accounts payable and accrued expenses as of September 30, 2022 and December 31, 2021, respectively. The Company continues to maintain this vendor relationship and anticipates incurring significant expenses with this vendor over the next 12 months. |
ACCOUNTS PAYABLE AND ACCRUED EX
ACCOUNTS PAYABLE AND ACCRUED EXPENSES | 9 Months Ended |
Sep. 30, 2022 | |
ACCOUNTS PAYABLE AND ACCRUED EXPENSES | |
ACCOUNTS PAYABLE AND ACCRUED EXPENSES | NOTE 3 - ACCOUNTS PAYABLE AND ACCRUED EXPENSES Accounts payable and accrued expenses as of September 30, 2022 and December 31, 2021 were as follows: September 30, 2022 December 31, 2021 Accrued compensation expenses $ 296,655 $ 508,343 Accrued research and development 764,296 229,090 Accrued professional fees 115,189 43,102 Other accounts payable and accrued expenses 5,940 63,374 Total $ 1,182,080 $ 843,909 |
EXECUTIVE COMPENSATION
EXECUTIVE COMPENSATION | 9 Months Ended |
Sep. 30, 2022 | |
EXECUTIVE COMPENSATION | |
EXECUTIVE COMPENSATION | NOTE 4 – EXECUTIVE COMPENSATION In January 2021, the Company issued 57,430 Class A Membership Interests at $3.25 per unit, equal to the value of the most recent private placement, to two of its executives to settle unpaid year-end bonus award and deferred compensation, which was approved by the board of directors. The year-end bonus component was equal to 38,353 Class A Membership Interests, which was included as accrued compensation. In January 2021, the Company also amended the employment agreements for the three executives. The board of directors also approved certain grants to members of management as a component of their 2020 year-end compensation, authorizing the issuance of 1,540,000 Class B Membership Interests to its three executives, as well as 75,000 Class B Membership Interests which were granted to non-employee management team members. The Class B Membership Interests are profits interests with a defined exercise price of $3.25 per interest, the Company’s most recent financing offering price. In March 2021, the Company along with its three executives and non-employee management team agreed voluntarily to cancel the aforementioned equity grants. The Company granted options to purchase 770,000 shares of the Company’s common stock in June 2021 to the three-member management team in replacement of the cancelled year-end grants described above. The Company is currently managed by three executives, in each case pursuant to new employment agreements effective June 29, 2021. |
ISSUANCE OF EQUITY INTERESTS
ISSUANCE OF EQUITY INTERESTS | 9 Months Ended |
Sep. 30, 2022 | |
ISSUANCE OF EQUITY INTERESTS | |
ISSUANCE OF EQUITY INTERESTS | NOTE 5 – ISSUANCE OF EQUITY INTERESTS On June 23, 2021, Acurx Pharmaceuticals, LLC was converted into a corporation and renamed Acurx Pharmaceuticals, Inc. The Company’s certificate of incorporation authorizes 200,000,000 shares of common stock of which 11,592,609 were outstanding as of September 30, 2022. On June 29, 2021, the Company completed an IPO issuing 2,875,000 shares of common stock at a price of $6.00 per share, resulting in net cash proceeds of approximately $14.8 million, with cash issuance costs of approximately $2.4 million. The outstanding Class A and Class B Membership Interests were converted to shares of common stock pursuant to a conversion ratio of one-for-two of the Membership Interests outstanding, resulting in the conversion of 14,082,318 Class A and Class B Membership Interests into 7,041,208 shares of common stock. Warrants to purchase Class A Membership Interests were converted to warrants to purchase common stock at the same one-for two conversion ratio, resulting in 1,437,577 warrants to purchase common stock with a weighted average exercise price of $2.88. In connection with the IPO, the Company issued 150,000 warrants to the underwriter. Each warrant is exercisable for 4.5 years from December 21, 2021 at an exercise price of $7.50 per share. The Company used the Black-Scholes model to calculate the value of the warrants with an estimated fair value of $618,000. The inputs utilized in the calculation were as follows: four On July 25, 2022, the Company entered into securities purchase agreements (the “Purchase Agreements”) with two of the Company’s executives and a member of the Company’s board of directors (collectively, the “Affiliate Investors”), and a single U.S. institutional investor (the “Investor”) pursuant to which the Company issued and sold in a registered direct offering an aggregate of 1,159,211 shares of common stock, par value $0.001 per share and pre-funded warrants to purchase an aggregate of 130,769 shares of common stock. The Affiliate Investors purchased an aggregate of 59,211 shares of common stock at a purchase price of $3.80 per share. The Investor purchased an aggregate of 1,100,000 shares of common stock at a purchase price of $3.25 per share and an aggregate of 130,769 prefunded warrants at a purchase price of $3.2499 per pre-funded warrant. The pre-funded warrants sold to the Investor have an exercise price of $0.0001 , were immediately exercisable. As of September 30, 2022, all of the pre-funded warrants were exercised. The Company also issued to the Affiliate Investors and the Investor, series A warrants to purchase The gross proceeds to the Company from the registered direct offering were $4.2 million and net proceeds after deducting the placement agents’ fees and other offering expenses payable by the Company were approximately $3.7 million. On July 25, 2022, the Company entered into a co-placement agent agreement (the “Placement Agent Agreement”), with two placement agents in connection with the registered direct offering pursuant to which the Company paid the Placement Agents a cash fee of $287,874 and issued to the Placement Agents an aggregate of 63,018 warrants to purchase shares of common stock. The warrants have an exercise price of of the weighted average public offering price of the aggregate number of shares of common stock sold in the registered direct offering to the Investor and Affiliate Investors) and expire on July 27, 2027. The Company used the Black-Scholes model to calculate the value of the warrants with an estimated fair value of . The inputs utilized in the calculation were as follows: five year volatility utilizing comparable companies. This amount was recorded as both an increase to additional paid-in capital and as a non-cash issuance cost of the offering. The following table summarizes information with respect to outstanding warrants to purchase common stock of the Company at September 30, 2022: Weighted Average Number of Warrants Exercise Price Balance, December 31, 2021 1,588,477 $ 3.32 Issued 2,773,747 $ 3.12 Exercised (147,144) $ 0.27 Balance, September 30, 2022 4,215,080 $ 3.29 The weighted average contractual life of the outstanding warrants is 4.30 years. |
SHARE-BASED COMPENSATION
SHARE-BASED COMPENSATION | 9 Months Ended |
Sep. 30, 2022 | |
SHARE-BASED COMPENSATION | |
SHARE-BASED COMPENSATION | NOTE 6 – SHARE-BASED COMPENSATION While the Company was a limited liability company in its pre-IPO phase of corporate development, the Company granted performance-based awards of restricted Class A Membership Interests to board members and corporate advisory council members in exchange for services. All of these awards of membership interests became fully vested upon consummation of the Company’s corporate conversion from a Delaware limited liability company to a Delaware corporation immediately prior to the Company’s IPO in June 2021, with the Company recognizing all previously unrecognized compensation expense. The fair value of the membership interests granted during 2020 and 2019 was equal to the per-membership interest value of the most recent private placement. Total share-based compensation associated with these awards had been recorded as general and administrative expenses in the amount of $0 and $755,556 for the three and nine months ended September 30, 2021, respectively. In April 2021, the board of directors approved the creation of the 2021 Equity Incentive Plan (the “Plan”). The Plan became effective as of the completion of the corporate conversion, with an annual evergreen provision pursuant to the Plan. The Plan currently reserves an aggregate of 2,408,631 shares of common stock, subject to adjustments as provided in the Plan, of which 537,936 are currently still available for issuance. The purpose of the Plan is to attract, retain and incentivize directors, officers, employees, and consultants. In June 2021, the Company granted stock options to purchase a total of 807,500 shares of common stock to its three executives and three non-employee management team members to replace the Class B Membership Interests that were cancelled in March 2021. The options were issued at an exercise price of $6.26, with the employee options vesting 40% upon issuance and the balance over 36 months, and the non-employee options vesting at grant date. The Company recorded general and administrative expense of $181,720 and $545,160 for the three and nine months ended September 30, 2022, respectively, and $181,720 and $1,837,605 for the three and nine months ended September 30, 2021, respectively, related to compensation expense for these options. In the second quarter of 2021, the Company entered into a number of agreements with vendors pursuant to which the Company granted a total of 175,000 shares of common stock, cash payments in the amount of $343,500 and 100,000 options which were included as a part of the July 2021 grant. These contracts have terms which range from six months to three years. The common stock was valued based on the grant date fair value and the options valued utilizing Black-Scholes option pricing model. The cash payments were expensed over the service period and the equity component expensed consistent with the contractual vesting. The Company recorded general and administrative expense of $0 for the three and nine months ended September 30, 2022, respectively, and $0 and $1,095,500 for the three and nine months ended September 30, 2021, respectively, related to compensation expense for these shares. In July 2021, the Company granted stock options to purchase a total of 1,550,000 shares of common stock to its three executives pursuant to their respective employment agreements, the independent directors, and one consultant, pursuant to the Plan. The options were issued at an exercise price of $6.18, the grant date fair value, with one In January 2022, the Company granted stock options to purchase a total of 80,000 shares of common stock to seven consultants pursuant to the Plan. The options were issued at an exercise price of $4.44, the grant date fair value, with one In April 2022, the Company granted stock options to purchase a total of 30,000 shares of common stock to a new employee pursuant to the Plan. The options were issued at an exercise price of $3.79, the grant date fair value, with one Compensation expense associated with these awards is recognized over the vesting period based on the fair value of the option at the grant date determined based on the Black-Scholes model. Option valuation models require the input of highly subjective assumptions including the expected price volatility. The Company’s employee stock options have characteristics significantly different from those of traded options, and changes in the subjective input assumptions can materially affect the fair value computation using the Black-Scholes option pricing model. Because there is no public market for the Company’s stock options and very little historical experience with the Company’s stock, similar public companies were used for the comparison of volatility and the dividend yield. The risk-free rate of return was derived from U.S. Treasury notes with comparable maturities. The Company determined the fair value of the option awards using the Black-Scholes option pricing model using the following weighted average assumptions: Nine Months Ended September 30, 2022 Expected term 9 years Volatility 90 % Dividend yield — % Risk-free interest rate 2.01 % Weighted average grant date fair value $ 3.54 A summary of the Company’s stock option activity is as follows: Nine Months Ended Weighted Average September 30, 2022 Exercise Price Outstanding at the beginning of the period 2,357,500 $ 6.21 Granted 110,000 $ 4.26 Vested (1,402,792) $ 6.15 Outstanding and expected to vest 1,064,708 $ 6.08 The total compensation expense not yet recognized as of September 30, 2022 was $4,940,891. The weighted average vesting period for the unvested options is 1.79 years. The intrinsic value of the stock options as of September 30, 2022 was $0, with a remaining weighted average contractual life of 8.78 years. The weighted average grant date fair value for all options is $4.67 as of September 30, 2022. The Company records the impact of any forfeitures of options as they occur. |
SHARE-BASED PAYMENTS TO VENDORS
SHARE-BASED PAYMENTS TO VENDORS | 9 Months Ended |
Sep. 30, 2022 | |
SHARE-BASED PAYMENTS TO VENDORS | |
SHARE-BASED PAYMENTS TO VENDORS | NOTE 7 – SHARE-BASED PAYMENTS TO VENDORS While the Company was a limited liability company in its pre-IPO phase of corporate development, the Company granted Class A Membership Interests to certain vendors in the ordinary course of business in exchange for consulting services relating to research and development activities and investor relations. The Company granted 0 and 30,145 Class A Membership Interests for the three and nine months ended September 30, 2021. The fair value of the Class A Membership Interests granted was equal to the value of the most recent private placement. The Company recognized the expense in the same period and in the same manner as if the Company had paid cash for the services. The Company recorded general and administrative expenses and research and development expenses for vendor equity grants in the amounts of $37,500 and $0 for the three months ended September 30, 2021, respectively, and $188,875 and $21,596 for the nine months ended September 30, 2021, respectively. In October 2019, the Company granted a total of 150,000 restricted Class A Membership Interests to three consultants for investor relations consulting services performed in 2019 through October 2021. These Class A Membership Interests vested on the second anniversary of the grant date, and were subject to accelerated vesting provisions upon a change of control of the Company. The fair value of the Class A Membership Interests granted was equal to the value of the most recent private placement, $2.00 per Class A Membership Interest. The Company recognized the expense on a straight-line basis over the vesting period. The Company recorded general and administrative expenses of $37,500 for the three months ended September 30, 2021 and $112,500 for the nine months ended September 30, 2021 with an unrecognized expense of $12,500 at September 30, 2021. The conversion adjusted shares of common stock were issued in October 2021. In October 2021, the Company entered into an agreement with a consultant to provide financial advisory services for a six-month term. Pursuant to the agreement, the Company will grant $150,000 of common stock over the term of service. In January 2022, The Company granted 13,889 shares of common stock at grant date fair value, pursuant to the agreement, and recorded general and administrative expenses of $0 for the three months ended September 30, 2022 and $75,000 for the nine months ended September 30, 2022. In March 2022, the Company entered into an agreement with a consultant to provide investor relation services for a six-month term. Pursuant to the agreement, the Company granted 30,000 shares of common stock with a grant date fair value of $3.77 and paid $25,000 of cash compensation The cash component will be expensed over the service period and the equity component expensed consistent with the contractual vesting. The Company recorded general and administrative expenses of $0 for the three months ended September 30, 2022 and $113,100 for the nine months ended September 30, 2022. In September 2022, the Company entered into an agreement with a company to provide consulting services for a six-month term. Pursuant to the agreement, the Company granted , which was expensed consistent with the contractual vesting. The Company recorded general and administrative expenses of for the three and nine months ended September 30, 2022. |
NET LOSS PER SHARE
NET LOSS PER SHARE | 9 Months Ended |
Sep. 30, 2022 | |
LOSS PER SHARE | |
NET LOSS PER SHARE | NOTE 8 – NET LOSS PER SHARE On June 23, 2021, the Company completed a corporate conversion from a limited liability company to a corporation. Accordingly, the outstanding Class A and Class B Membership Interests were converted to shares of common stock using a conversion ratio of one-half of one share of common stock for each Class A membership interest or Class B membership interest. Basic and diluted net loss per share of common stock for the three and nine months ended September 30, 2022 and 2021 was determined by dividing net loss by the weighted average shares of common stock outstanding during the period. The Company’s potentially dilutive shares, consisting of 4,215,080 warrants and 2,467,500 stock options, have not been included in the computation of diluted net loss per share for all periods as the result would be antidilutive. The effects of the corporate conversion on the Company’s weighted average shares of common stock outstanding and net loss per share have been reflected for all periods presented retroactively. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended |
Sep. 30, 2022 | |
COMMITMENTS AND CONTINGENCIES. | |
COMMITMENTS AND CONTINGENCIES | NOTE 9 – COMMITMENTS AND CONTINGENCIES In conjunction with the Asset purchase in February 2018, the Company is required to make certain milestone payments related to the ongoing development of ACX-362E totaling $700,000 in the aggregate if certain milestones are achieved (which includes $50,000 already paid after the acquisition in February 2018). The Company is also obligated to make royalty payments equal to 4% of net sales of ACX-362E for a period of time equal to the last to expire of any applicable patents, as defined in the purchase agreement. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed interim financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and in accordance with the rules and regulations of the United States Securities Exchange Commission for interim reporting. In the opinion of management, these unaudited interim financial statements include all adjustments, consisting only of normal, recurring adjustments, necessary for a fair statement of the Company’s financial position, results of operations, and cash flows. The unaudited interim results of operations are not necessarily indicative of the results that may occur for the full fiscal year. The year-end condensed balance sheet data was derived from audited financial statements, but does not include all disclosures required by GAAP. Management believes that the disclosures provided herein are adequate when these unaudited condensed interim financial statements are read in conjunction with the audited financial statements and notes thereto as of December 31, 2021 filed in Form 10-K. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. |
Income Taxes | Income Taxes The Company estimates an annual effective tax rate of 0% as the Company incurred net losses for the nine months ended September 30, 2022 resulting in an estimated net loss for both financial statement and tax purposes. Therefore, no current federal or state income tax expense has been recorded in the financial statements. Based on the Company’s history of generating operating losses and its anticipation of operating losses for the foreseeable future, the Company has determined that it is more likely than not that the tax benefits from those net operating losses would not be realized and a full valuation allowance against all deferred tax assets has been recorded. Should the Company’s assessment change, tax benefits associated with the historic net operating loss carryforwards could be limited due to future ownership changes. Prior to the Company’s corporate conversion in June 2021, the Company was organized as a limited liability company. As such, the Company was not a tax paying entity for federal income tax purposes and, therefore, no income tax expense had been recorded in the financial statements. Income or losses of the Company was passed through to the members for inclusion in their respective income tax returns. |
Concentration of Credit Risk | Concentration of Credit Risk The Company maintains its cash balance in one financial institution. The balance is insured up to the maximum allowable by the Federal Deposit Insurance Corporation (“FDIC”). The Company has not experienced any losses in such accounts and does not believe it is exposed to any significant risk of loss on cash. At times, the cash balance may exceed the maximum insured limit of the FDIC. As of September 30, 2022, the Company had cash of approximately $10.6 million in U.S. bank accounts which was not fully insured by the FDIC. |
Research and Development | Research and Development The Company expenses research and development costs when incurred. At times, the Company may make cash advances for future research and development services. These amounts are deferred and expensed in the period the service is provided. The Company incurred research and development expenses in the amount of $1,591,043 and $1,126,972 for the three months ended September 30, 2022 and 2021, respectively, and $3,321,623 and $1,313,954 for the nine months ended September 30, 2022 and 2021, respectively. |
Share-Based Compensation | Share-Based Compensation The Company accounts for the cost of services performed by officers and directors received in exchange for an award of Company membership interests, common stock or stock options, based on the grant-date fair value of the award. The Company recognizes compensation expense based on the requisite service period. Compensation expense associated with stock option awards is recognized over the requisite service period based on the fair value of the option at the grant date determined based on the Black-Scholes option pricing model. Option valuation models require the input of highly subjective assumptions including the expected price volatility. The Company’s employee stock options have characteristics significantly different from those of traded options, and changes in the subjective input assumptions can materially affect the fair value computation using the Black-Scholes option pricing model. Because there is no public market for the Company’s stock options and very little historical experience with the Company’s stock, similar public companies were used for the comparison of volatility and the dividend yield. The risk-free rate of return was derived from U.S. Treasury notes with comparable maturities. |
Share-Based Payments to Vendors | Share-Based Payments to Vendors The Company accounts for the cost of services performed by vendors in exchange for an award of Company membership interests, common stock, or stock options, based on the grant-date fair value of the award or the fair value of the services rendered; whichever is more readily determinable. Such fair value is measured as of the date the services or the date performance by the other party is complete. The Company recognizes the expense in the same period and in the same manner as if the Company had paid cash for the services. |
Major Vendor | Major Vendor The Company had a major vendor that accounted for approximately 66% and 52% of the research and development expenditures for the three months ended September 30, 2022 and 2021, respectively, and 50% and 45% for the nine months ended September 30, 2022 and 2021, respectively. The same vendor also accounted for approximately 55% and 5% of the total accounts payable and accrued expenses as of September 30, 2022 and December 31, 2021, respectively. The Company continues to maintain this vendor relationship and anticipates incurring significant expenses with this vendor over the next 12 months. |
ACCOUNTS PAYABLE AND ACCRUED _2
ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
ACCOUNTS PAYABLE AND ACCRUED EXPENSES | |
Summary of accounts payable and accrued expenses | September 30, 2022 December 31, 2021 Accrued compensation expenses $ 296,655 $ 508,343 Accrued research and development 764,296 229,090 Accrued professional fees 115,189 43,102 Other accounts payable and accrued expenses 5,940 63,374 Total $ 1,182,080 $ 843,909 |
ISSUANCE OF EQUITY INTERESTS (T
ISSUANCE OF EQUITY INTERESTS (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
ISSUANCE OF EQUITY INTERESTS | |
Summary of outstanding warrants | Weighted Average Number of Warrants Exercise Price Balance, December 31, 2021 1,588,477 $ 3.32 Issued 2,773,747 $ 3.12 Exercised (147,144) $ 0.27 Balance, September 30, 2022 4,215,080 $ 3.29 |
SHARE-BASED COMPENSATION (Table
SHARE-BASED COMPENSATION (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
SHARE-BASED COMPENSATION | |
Schedule of fair value of options using Black-Scholes option pricing model | Nine Months Ended September 30, 2022 Expected term 9 years Volatility 90 % Dividend yield — % Risk-free interest rate 2.01 % Weighted average grant date fair value $ 3.54 |
Schedule of stock option activity | Nine Months Ended Weighted Average September 30, 2022 Exercise Price Outstanding at the beginning of the period 2,357,500 $ 6.21 Granted 110,000 $ 4.26 Vested (1,402,792) $ 6.15 Outstanding and expected to vest 1,064,708 $ 6.08 |
NATURE OF OPERATIONS (Details)
NATURE OF OPERATIONS (Details) - USD ($) | 1 Months Ended | ||||||
Jul. 27, 2022 | Jul. 25, 2022 | Jun. 29, 2021 | Feb. 28, 2018 | Sep. 30, 2022 | Dec. 31, 2021 | Jan. 31, 2021 | |
Shares issued during the period | 2,875,000 | ||||||
Stock issue gross proceeds | $ 17,300,000 | ||||||
Share price (in dollars per share) | $ 6 | ||||||
Cash | $ 10,607,341 | $ 12,958,846 | |||||
Registered direct offering | |||||||
Shares issued during the period | 1,159,211 | 1,159,211 | |||||
Stock issue gross proceeds | $ 4,200,000 | $ 4,200,000 | |||||
Pre-funded Warrant Exercise (in shares) | 130,769 | 130,769 | |||||
Registered direct offering | Series A warrants | |||||||
Number of warrants | 1,289,980 | ||||||
Registered direct offering | Series B warrants | |||||||
Number of warrants | 1,289,980 | ||||||
Private Placement | Series A warrants | |||||||
Number of warrants | 1,289,980 | ||||||
Private Placement | Series B warrants | |||||||
Number of warrants | 1,289,980 | ||||||
Members' Equity, Class B | |||||||
Share price (in dollars per share) | $ 3.25 | ||||||
ACX362E | |||||||
Cash paid | $ 110,174 | ||||||
Achieve Milestone payment | 700,000 | ||||||
Royalty payments | $ 50,000 | ||||||
Royalty payments on net sales (as a percent) | 4% | ||||||
ACX362E | Members' Equity, Class B | |||||||
Granting (in shares) | 100,000 | ||||||
Warrant exercise price (in dollars per share) | $ 0.10 |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |||||
Effective tax rate | 0% | ||||
Current federal or state income tax expense | $ 0 | ||||
Income tax expense | 0 | ||||
Cash | $ 10,607,341 | 10,607,341 | $ 12,958,846 | ||
Research and development expense | $ 1,591,043 | $ 1,126,972 | $ 3,321,623 | $ 1,313,954 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Concentration (Details) - Supplier Concentration Risk - Vendor One | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Research and development expenditures | |||||
Concentration | |||||
Concentration Risk (as a percent) | 66% | 52% | 50% | 45% | |
Accounts payable and accrued expense | |||||
Concentration | |||||
Concentration Risk (as a percent) | 55% | 5% |
ACCOUNTS PAYABLE AND ACCRUED _3
ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
ACCOUNTS PAYABLE AND ACCRUED EXPENSES | ||
Accrued compensation expenses | $ 296,655 | $ 508,343 |
Accrued research and development | 764,296 | 229,090 |
Accrued professional fees | 115,189 | 43,102 |
Other accounts payable and accrued expenses | 5,940 | 63,374 |
Total | $ 1,182,080 | $ 843,909 |
EXECUTIVE COMPENSATION (Details
EXECUTIVE COMPENSATION (Details) | 1 Months Ended | 9 Months Ended | ||
Jun. 29, 2021 item $ / shares | Jun. 30, 2021 item shares | Jan. 31, 2021 item $ / shares shares | Sep. 30, 2022 shares | |
Purchase price (in dollars per share) | $ / shares | $ 6 | |||
Number of executives pursuant to new employment | item | 3 | |||
Stock options granted (in shares) | 770,000 | 110,000 | ||
Members' Equity, Class A | ||||
Shares issued (in shares) | 57,430 | |||
Purchase price (in dollars per share) | $ / shares | $ 3.25 | |||
Number of executives not received compensation | item | 2 | |||
Number of executives amended agreement | item | 3 | |||
Shares issued for bonus (in shares) | 38,353 | |||
Members' Equity, Class B | ||||
Purchase price (in dollars per share) | $ / shares | $ 3.25 | |||
Number of executives pursuant to new employment | item | 3 | |||
Members' Equity, Class B | Directors | ||||
Shares issued (in shares) | 1,540,000 | |||
Members' Equity, Class B | Non-Employee | ||||
Shares issued (in shares) | 75,000 |
ISSUANCE OF EQUITY INTERESTS (D
ISSUANCE OF EQUITY INTERESTS (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||||||
Jul. 27, 2022 | Jul. 25, 2022 | Jun. 29, 2021 | Sep. 30, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | Jun. 23, 2021 | Jan. 31, 2021 | |
Equity | |||||||||
Common stock, Authorized (in shares) | 200,000,000 | 200,000,000 | 200,000,000 | 200,000,000 | |||||
Common stock, Outstanding (in shares) | 11,592,609 | 11,592,609 | 10,215,792 | ||||||
Shares issued during the period | 2,875,000 | ||||||||
Purchase price (in dollars per share) | $ 6 | ||||||||
Proceeds from Initial Public Offering, net of issuance costs | $ 14,800,000 | $ 14,797,132 | |||||||
Cash issuance cost | 2,400,000 | $ 529,805 | |||||||
Common stock, par value | $ 0.001 | $ 0.001 | $ 0.001 | ||||||
Stock issue gross proceeds | $ 17,300,000 | ||||||||
Proceeds from stock issue, net of costs | $ 3,695,183 | ||||||||
Members' Equity, Class A and Class B | |||||||||
Equity | |||||||||
Converted to shares of common stock | 14,082,318 | ||||||||
Converted shares of common stock | 7,041,208 | ||||||||
Members' Equity, Class A | |||||||||
Equity | |||||||||
Purchase price (in dollars per share) | $ 3.25 | ||||||||
Number of warrants | 1,437,577 | ||||||||
Warrant exercise price (in dollars per share) | $ 2.88 | ||||||||
Members' Equity, Class B | |||||||||
Equity | |||||||||
Purchase price (in dollars per share) | $ 3.25 | ||||||||
Underwriter | |||||||||
Equity | |||||||||
Number of warrants | 150,000 | ||||||||
Warrant exercise price (in dollars per share) | $ 7.50 | ||||||||
Warrant exercisable term | 4 years 6 months | ||||||||
Registered direct offering | |||||||||
Equity | |||||||||
Shares issued during the period | 1,159,211 | 1,159,211 | |||||||
Common stock, par value | $ 0.001 | ||||||||
Pre-funded Warrant Exercise (in shares) | 130,769 | 130,769 | |||||||
Stock issue gross proceeds | $ 4,200,000 | $ 4,200,000 | |||||||
Proceeds from stock issue, net of costs | $ 3,700,000 | ||||||||
Registered direct offering | Series A warrants | |||||||||
Equity | |||||||||
Number of warrants | 1,289,980 | ||||||||
Registered direct offering | Series B warrants | |||||||||
Equity | |||||||||
Number of warrants | 1,289,980 | ||||||||
Registered direct offering | Affiliate Investors | |||||||||
Equity | |||||||||
Shares issued during the period | 59,211 | ||||||||
Purchase price (in dollars per share) | $ 3.80 | ||||||||
Warrant exercise price (in dollars per share) | $ 3.55 | ||||||||
Registered direct offering | Affiliate Investors | Series A warrants | |||||||||
Equity | |||||||||
Number of warrants | 59,211 | ||||||||
Registered direct offering | Affiliate Investors | Series B warrants | |||||||||
Equity | |||||||||
Number of warrants | 59,211 | ||||||||
Registered direct offering | Investor | |||||||||
Equity | |||||||||
Shares issued during the period | 1,100,000 | ||||||||
Purchase price (in dollars per share) | $ 3.25 | ||||||||
Warrant exercise price (in dollars per share) | $ 0.0001 | ||||||||
Pre-funded Warrant Exercise (in shares) | 130,769 | ||||||||
Purchase price pre-funded warrant (in dollars per share) | $ 3.2499 | ||||||||
Registered direct offering | Investor | Series A warrants | |||||||||
Equity | |||||||||
Number of warrants | 1,230,769 | ||||||||
Registered direct offering | Investor | Series B warrants | |||||||||
Equity | |||||||||
Number of warrants | 1,230,769 | ||||||||
Warrant exercise price (in dollars per share) | $ 3.25 | ||||||||
Placement Agents | |||||||||
Equity | |||||||||
Cash issuance cost | $ 287,874 | ||||||||
Number of warrants | 63,018 | ||||||||
Warrant exercise price (in dollars per share) | $ 3.60 | ||||||||
Weighted average aggregate offering price (as a percent) | 110% |
ISSUANCE OF EQUITY INTERESTS -
ISSUANCE OF EQUITY INTERESTS - Fair Value (Details) | Jul. 25, 2022 USD ($) Y $ / shares | Jun. 29, 2021 USD ($) Y $ / shares |
Underwriter | ||
Warrants fair value | ||
Fair value of Warrants | $ 618,000 | |
Underwriter | Measurement Input, Expected Term | ||
Warrants fair value | ||
Measurement Input, Warrants | Y | 4.5 | |
Underwriter | Measurement Input, Risk Free Rate | ||
Warrants fair value | ||
Measurement Input, Warrants | 0.79 | |
Underwriter | Measurement Input, Share Price | ||
Warrants fair value | ||
Measurement Input, Warrants | $ / shares | 6.26 | |
Underwriter | Measurement Input, Volatility | ||
Warrants fair value | ||
Measurement Input, Warrants | 94 | |
Placement Agents | ||
Warrants fair value | ||
Fair value of Warrants | $ 171,409 | |
Placement Agents | Measurement Input, Expected Term | ||
Warrants fair value | ||
Measurement Input, Warrants | Y | 5 | |
Placement Agents | Measurement Input, Risk Free Rate | ||
Warrants fair value | ||
Measurement Input, Warrants | 2.82 | |
Placement Agents | Measurement Input, Share Price | ||
Warrants fair value | ||
Measurement Input, Warrants | $ / shares | 3.70 | |
Placement Agents | Measurement Input, Volatility | ||
Warrants fair value | ||
Measurement Input, Warrants | 95 |
ISSUANCE OF EQUITY INTERESTS _2
ISSUANCE OF EQUITY INTERESTS - Outstanding warrants (Details) - $ / shares | 9 Months Ended | |
Sep. 30, 2022 | Dec. 31, 2021 | |
Equity | ||
Warrants outstanding (in shares), beginning balance | 1,588,477 | |
Warrants issued (in shares) | 2,773,747 | |
Warrants exercised (in shares) | (147,144) | |
Warrants outstanding (in shares), ending balance | 4,215,080 | |
Weighted Average | ||
Equity | ||
Warrant exercise price, outstanding (in dollars per share) | $ 3.29 | $ 3.32 |
Warrant exercise price, issued (in dollars per share) | 3.12 | |
Warrant exercise price, exercised (in dollars per share) | $ 0.27 | |
Warrant exercisable term | 4 years 3 months 18 days |
SHARE-BASED COMPENSATION - (Det
SHARE-BASED COMPENSATION - (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||||
Jun. 29, 2021 | Apr. 30, 2022 | Jan. 31, 2022 | Oct. 31, 2021 | Jul. 31, 2021 | Jun. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Apr. 30, 2021 | |
Share-based compensation | ||||||||||||
Stock options granted (in shares) | 770,000 | 110,000 | ||||||||||
Grant exercise price (in dollars per share) | $ 4.26 | |||||||||||
Shares issued during the period | 2,875,000 | |||||||||||
Total compensation expense not yet recognized | $ 4,940,891 | $ 4,940,891 | ||||||||||
Weighted average vesting period | 1 year 9 months 14 days | |||||||||||
Intrinsic value of stock option | 0 | $ 0 | ||||||||||
Weighted average contractual life | 8 years 9 months 10 days | |||||||||||
Weighted average grant date fair value | $ 4.67 | |||||||||||
Vendor | ||||||||||||
Share-based compensation | ||||||||||||
Shares issued during the period | 175,000 | |||||||||||
Vendor payment | $ 343,500 | |||||||||||
Pre IPO | ||||||||||||
Share-based compensation | ||||||||||||
Share based compensation expense | $ 0 | $ 755,556 | ||||||||||
June 2021 | ||||||||||||
Share-based compensation | ||||||||||||
Share based compensation expense | 181,720 | 181,720 | $ 545,160 | 1,837,605 | ||||||||
Stock options granted (in shares) | 807,500 | |||||||||||
Grant exercise price (in dollars per share) | $ 6.26 | |||||||||||
June 2021 | Employee | Tranche one | ||||||||||||
Share-based compensation | ||||||||||||
Vesting percentage | 40% | |||||||||||
June 2021 | Employee | Tranche two | ||||||||||||
Share-based compensation | ||||||||||||
Vesting term of options | 36 months | |||||||||||
July 2021 | Vendor | ||||||||||||
Share-based compensation | ||||||||||||
Share based compensation expense | 0 | 0 | 0 | 1,095,500 | ||||||||
Stock options granted (in shares) | 100,000 | |||||||||||
July 2021 | Vendor | Minimum | ||||||||||||
Share-based compensation | ||||||||||||
Vesting term of options | 6 months | |||||||||||
July 2021 | Vendor | Maximum | ||||||||||||
Share-based compensation | ||||||||||||
Vesting term of options | 3 years | |||||||||||
July 2021 | Executives, Independent Directors, Consultant | ||||||||||||
Share-based compensation | ||||||||||||
Share based compensation expense | 490,917 | $ 1,888,917 | 1,472,750 | $ 1,888,917 | ||||||||
Stock options granted (in shares) | 1,550,000 | |||||||||||
Weighted average exercise price (in dollars per share) | $ 6.18 | |||||||||||
July 2021 | Executive officers | Tranche one | ||||||||||||
Share-based compensation | ||||||||||||
Vesting percentage | 25% | |||||||||||
July 2021 | Executive officers | Tranche two | ||||||||||||
Share-based compensation | ||||||||||||
Vesting term of options | 36 months | |||||||||||
July 2021 | Independent Directors, Consultant | ||||||||||||
Share-based compensation | ||||||||||||
Vesting term of options | 36 months | |||||||||||
January 2022 | ||||||||||||
Share-based compensation | ||||||||||||
Share based compensation expense | 18,950 | 126,333 | ||||||||||
Stock options granted (in shares) | 80,000 | |||||||||||
Grant exercise price (in dollars per share) | $ 4.44 | |||||||||||
Contract term | 6 months | |||||||||||
January 2022 | Tranche one | ||||||||||||
Share-based compensation | ||||||||||||
Vesting percentage | 25% | |||||||||||
January 2022 | Tranche two | ||||||||||||
Share-based compensation | ||||||||||||
Vesting term of options | 36 months | |||||||||||
April 2022 | ||||||||||||
Share-based compensation | ||||||||||||
Share based compensation expense | $ 5,378 | $ 30,473 | ||||||||||
Stock options granted (in shares) | 30,000 | |||||||||||
Grant exercise price (in dollars per share) | $ 3.79 | |||||||||||
April 2022 | Tranche one | ||||||||||||
Share-based compensation | ||||||||||||
Vesting percentage | 25% | |||||||||||
April 2022 | Tranche two | ||||||||||||
Share-based compensation | ||||||||||||
Vesting term of options | 36 months | |||||||||||
2021 Equity Incentive Plan | ||||||||||||
Share-based compensation | ||||||||||||
Common stock shares reserved | 2,408,631 | |||||||||||
Common stock shares available (in shares) | 537,936 |
SHARE-BASED COMPENSATION - Opti
SHARE-BASED COMPENSATION - Option pricing (Details) | 9 Months Ended |
Sep. 30, 2022 $ / shares | |
SHARE-BASED COMPENSATION | |
Expected term | 9 years |
Volatility | 90% |
Risk-free interest rate | 2.01% |
Weighted average grant date fair value | $ 3.54 |
SHARE-BASED COMPENSATION - Stoc
SHARE-BASED COMPENSATION - Stock option activity (Details) - $ / shares | 1 Months Ended | 9 Months Ended |
Jun. 30, 2021 | Sep. 30, 2022 | |
Options outstanding | ||
Outstanding at the beginning of the period | 2,357,500 | |
Granted | 770,000 | 110,000 |
Vested | (1,402,792) | |
Outstanding at the end of the period | 1,064,708 | |
Options outstanding exercise price | ||
Weighted Average Exercise price, Beginning of the period | $ 6.21 | |
Weighted Average Exercise price, granted | 4.26 | |
Weighted Average Exercise price, Vested | 6.15 | |
Weighted Average Exercise price, End of the period | $ 6.08 |
SHARE-BASED PAYMENTS TO VENDO_2
SHARE-BASED PAYMENTS TO VENDORS (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2022 | Mar. 31, 2022 | Jan. 31, 2022 | Oct. 31, 2021 | Oct. 31, 2019 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based compensation | |||||||||
Share-based vendor payments | $ 315,180 | $ 1,500,241 | |||||||
Total compensation expense not yet recognized | $ 4,940,891 | $ 4,940,891 | $ 4,940,891 | ||||||
General and Administrative Expense | |||||||||
Share-based compensation | |||||||||
Total compensation expense not yet recognized | $ 12,500 | 12,500 | |||||||
Pre IPO | |||||||||
Share-based compensation | |||||||||
Share based compensation expense | $ 0 | $ 755,556 | |||||||
Pre IPO | Members' Equity, Class A | |||||||||
Share-based compensation | |||||||||
Share-based vendor payments (in shares) | 0 | 30,145 | |||||||
Pre IPO | General and Administrative Expense | |||||||||
Share-based compensation | |||||||||
Share-based vendor payments | $ 37,500 | $ 188,875 | |||||||
Pre IPO | Research and Development Expense | |||||||||
Share-based compensation | |||||||||
Share-based vendor payments | 0 | 21,596 | |||||||
October 2019 | |||||||||
Share-based compensation | |||||||||
Share-based vendor payments | $ 37,500 | $ 112,500 | |||||||
October 2019 | Members' Equity, Class A | |||||||||
Share-based compensation | |||||||||
Share-based vendor payments (in shares) | 150,000 | ||||||||
Share Price | $ 2 | ||||||||
January 2022 | |||||||||
Share-based compensation | |||||||||
Share-based vendor payments (in shares) | 13,889 | 75,000 | |||||||
Share-based vendor payments | 0 | ||||||||
Share based compensation expense | 18,950 | $ 126,333 | |||||||
Contract term | 6 months | ||||||||
Future commitment | $ 150,000 | ||||||||
March 2022 | |||||||||
Share-based compensation | |||||||||
Share-based vendor payments (in shares) | 30,000 | ||||||||
Share-based vendor payments | 0 | 113,100 | |||||||
Share Price | $ 3.77 | ||||||||
Contract term | 6 months | ||||||||
Vendor payment | $ 25,000 | ||||||||
September 2022 | |||||||||
Share-based compensation | |||||||||
Share-based vendor payments (in shares) | 36,000 | ||||||||
Share-based vendor payments | $ 127,080 | $ 127,080 | |||||||
Share Price | $ 3.53 | $ 3.53 | $ 3.53 | ||||||
Contract term | 6 months |
NET LOSS PER SHARE (Details)
NET LOSS PER SHARE (Details) | 9 Months Ended |
Sep. 30, 2022 shares | |
Warrant | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |
Potentially dilutive shares | 4,215,080 |
Stock Options | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |
Potentially dilutive shares | 2,467,500 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details) - ACX362E | 1 Months Ended |
Feb. 28, 2018 USD ($) | |
Product Liability Contingency [Line Items] | |
Achieve Milestone payment | $ 700,000 |
Royalty payments | $ 50,000 |
Royalty payments on net sales (as a percent) | 4% |