Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 15, 2024 | Jun. 30, 2023 | |
Document and Entity Information | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2023 | ||
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, $0.001 par value per share | ||
Trading Symbol | ACXP | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
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 | ||
ICFR Auditor Attestation Flag | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 27.9 | ||
Entity Common Stock, Shares Outstanding | 15,757,102 | ||
Entity Central Index Key | 0001736243 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Auditor Name | CohnReznick LLP | ||
Auditor Firm ID | 596 | ||
Auditor Location | Parsippany, NJ |
BALANCE SHEETS
BALANCE SHEETS - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
CURRENT ASSETS | ||
Cash | $ 7,474,188 | $ 9,111,751 |
Other Receivable | 129,159 | |
Prepaid Expenses | 105,776 | 264,955 |
TOTAL ASSETS | 7,709,123 | 9,376,706 |
CURRENT LIABILITIES | ||
Accounts Payable and Accrued Expenses | 3,042,438 | 2,061,685 |
TOTAL CURRENT LIABILITIES | 3,042,438 | 2,061,685 |
TOTAL LIABILITIES | 3,042,438 | 2,061,685 |
COMMITMENTS AND CONTINGENCIES | ||
SHAREHOLDERS' EQUITY | ||
Common Stock; $.001 par value, 200,000,000 shares authorized, 14,468,229 and 11,627,609 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively | 14,468 | 11,628 |
Additional Paid-In Capital | 57,871,070 | 45,944,478 |
Accumulated Deficit | (53,218,853) | (38,641,085) |
TOTAL SHAREHOLDERS' EQUITY | 4,666,685 | 7,315,021 |
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ 7,709,123 | $ 9,376,706 |
BALANCE SHEETS (Parenthetical)
BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 | Jul. 27, 2022 |
BALANCE SHEETS | |||
Common stock, Par value | $ 0.001 | $ 0.001 | $ 0.001 |
Common stock, Authorized (in shares) | 200,000,000 | 200,000,000 | |
Common stock, Issued (in shares) | 14,468,229 | 11,627,609 | |
Common stock, Outstanding (in shares) | 14,468,229 | 11,627,609 |
STATEMENTS OF OPERATIONS
STATEMENTS OF OPERATIONS - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
OPERATING EXPENSES | ||
Research and Development | $ 6,043,597 | $ 4,754,271 |
General and Administrative | 8,534,171 | 7,338,505 |
TOTAL OPERATING EXPENSES | 14,577,768 | 12,092,776 |
NET LOSS | $ (14,577,768) | $ (12,092,776) |
LOSS PER SHARE | ||
Basic net loss per common share | $ (1.15) | $ (1.12) |
Diluted net loss per common share | $ (1.15) | $ (1.12) |
Weighted average common shares outstanding basic | 12,671,572 | 10,816,412 |
Weighted average common shares outstanding diluted | 12,671,572 | 10,816,412 |
STATEMENTS OF CHANGES IN SHAREH
STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY - USD ($) | Common Stock Registered Direct Offering | Common Stock At the Market Offering | Common Stock | Additional Paid-In Capital Registered Direct Offering | Additional Paid-In Capital At the Market Offering | Additional Paid-In Capital | Accumulated Deficit | Registered Direct Offering | At the Market Offering | Total |
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 | |||||||||
Share-Based Compensation | 2,871,681 | 2,871,681 | ||||||||
Share-Based Payments to Vendors | $ 115 | 430,565 | 430,680 | |||||||
Share-Based Payments to Vendors (in shares) | (114,889) | |||||||||
Issuance of shares of common stock and pre-funded warrants, net of cash issuance costs | $ 1,159 | 3,694,023 | 3,695,182 | |||||||
Issuance of shares of common stock and pre-funded warrants, net of cash issuance costs (in shares) | 1,159,211 | |||||||||
Cashless Warrant Exercise | $ 7 | (7) | ||||||||
Cashless Warrant Exercise (in shares) | 6,948 | |||||||||
Pre-funded Warrant Exercise | $ 131 | (118) | 13 | |||||||
Pre-funded Warrant Exercise (in shares) | (130,769) | |||||||||
Net Income (Loss) | (12,092,776) | (12,092,776) | ||||||||
Balance at ending at Dec. 31, 2022 | $ 11,628 | 45,944,478 | (38,641,085) | $ 7,315,021 | ||||||
Balance at ending, Common shares (in shares) at Dec. 31, 2022 | 11,627,609 | 11,627,609 | ||||||||
Share-Based Compensation | 3,206,527 | $ 3,206,527 | ||||||||
Share-Based Payments to Vendors | $ 140 | 559,443 | 559,583 | |||||||
Share-Based Payments to Vendors (in shares) | 140,186 | |||||||||
Issuance of shares of common stock and pre-funded warrants, net of cash issuance costs | $ 602 | $ 680 | $ 3,543,010 | $ 2,399,958 | $ 3,543,612 | $ 2,400,638 | ||||
Issuance of shares of common stock and pre-funded warrants, net of cash issuance costs (in shares) | 601,851 | 680,252 | 698,121 | |||||||
Cashless Warrant Exercise | $ 4 | (4) | ||||||||
Cashless Warrant Exercise (in shares) | 4,080 | |||||||||
Warrant Exercise | $ 683 | 2,218,316 | 2,218,999 | |||||||
Warrant Exercise (in shares) | 682,769 | |||||||||
Pre-funded Warrant Exercise | $ 731 | (658) | 73 | |||||||
Pre-funded Warrant Exercise (in shares) | 731,482 | |||||||||
Net Income (Loss) | (14,577,768) | (14,577,768) | ||||||||
Balance at ending at Dec. 31, 2023 | $ 14,468 | $ 57,871,070 | $ (53,218,853) | $ 4,666,685 | ||||||
Balance at ending, Common shares (in shares) at Dec. 31, 2023 | 14,468,229 | 14,468,229 |
STATEMENTS OF CHANGES IN SHAR_2
STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (Parenthetical) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Registered Direct Offering | ||
Cash issuance cost | $ 456,314 | $ 529,805 |
At the Market Offering | ||
Cash issuance cost | $ 222,161 |
STATEMENTS OF CASH FLOWS
STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Cash Flow from Operating Activities: | ||
Net Loss | $ (14,577,768) | $ (12,092,776) |
Adjustments to Reconcile Net Loss to Net Cash Used in Operating Activities: | ||
Share-Based Compensation | 3,206,527 | 2,871,681 |
Share-Based Payments to Vendor | 559,583 | 430,680 |
(Increase)/Decrease in: | ||
Other Receivable | (129,159) | |
Prepaid Expenses | 159,179 | 30,349 |
Accounts Payable and Accrued Expenses | 980,753 | 1,217,776 |
Net Cash Used in Operating Activities | (9,800,885) | (7,542,290) |
Cash Flow from Financing Activities: | ||
Pre-funded Warrant Exercise | 73 | 13 |
Warrant Exercise | 2,218,999 | |
Net Cash Provided by Financing Activities | 8,163,322 | 3,695,195 |
Net Decrease in Cash | (1,637,563) | (3,847,095) |
Cash at Beginning of Year | 9,111,751 | 12,958,846 |
Cash at End of Year | 7,474,188 | 9,111,751 |
SUPPLEMENTAL DISCLOSURE OF NON-CASH FINANCING ACTIVITIES | ||
2023 Registered Direct offering costs (Note 4) | 1,990,153 | |
Warrants issued in connection with 2022 offerings (Note 4) | 171,409 | |
Registered Direct Offering | ||
Cash Flow from Financing Activities: | ||
Proceeds from Offering, net of issuance costs | 3,543,612 | $ 3,695,182 |
At the Market Offering | ||
Cash Flow from Financing Activities: | ||
Proceeds from Offering, net of issuance costs | $ 2,400,638 |
NATURE OF OPERATIONS
NATURE OF OPERATIONS | 12 Months Ended |
Dec. 31, 2023 | |
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 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 1,159,211 shares of common stock and 130,769 pre-funded warrants and series A warrants to purchase 1,289,980 shares of common stock and series B warrants to purchase 1,289,980 shares of common stock for gross proceeds of approximately $4.2 million. On May 18, 2023, the Company completed a registered direct offering and a concurrent private placement, issuing million. On November 15, 2023, the Company entered into a Sales Agreement and established an “At-the-Market” offering (the “ATM Program”), pursuant to which the Company may offer and sell, from time to time through A.G.P/Alliance Global Partners, as sales agent, shares of its common stock having an aggregate offering price of up to million. Under the ATM Program, the Company sold million. As of December 31, 2023, the Company had a cash balance of approximately financial statements for the year ended December 31, 2023. Management believes that the Company will continue to incur losses for the foreseeable future and will need additional resources to sustain its operations until it can achieve profitability and positive cash flows, if ever. Management plans to seek additional equity financing and grant funding, but cannot assure that such financing and funding will be available at acceptable terms, or at all. These matters raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying financial statements do not include any adjustments that might result from the outcome of this uncertainty. There can be no assurance that the Company’s research and development will be successfully completed or that any Company product candidate will be approved by the Food and Drug Administration (“FDA”) or any other worldwide regulatory authority or become commercially viable. The Company is subject to risks common to companies in the biopharmaceutical industry including, but not limited to, dependence on collaborative arrangements, development by the Company or its competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, and compliance with FDA and other governmental regulations and approval requirements |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2023 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES 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 years ended December 31, 2023 and 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. Concentration of Credit Risk The Company maintains the majority of 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 December 31, 2023, the Company had cash of approximately $7.5 million in U.S. bank accounts which was not fully insured by the FDIC. Research and Development The Company expenses research and development costs as 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 services are provided. The Company incurred research and development expenses in the amount of $6,043,597 and $4,754,271, for the years ended December 31, 2023 and 2022, respectively. Costs for certain research and development activities, such as the provision of services for clinical trial activity, are estimated based on an evaluation of the progress to completion of specific tasks which may use data such as subject enrollment, clinical site activations or information provided to the Company by its vendors with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid or accrued research and development expense, as the case may be. The estimates are adjusted to reflect the best information available at the time of the financial statement issuance. Although the Company does not expect its estimates to be materially different from amounts actually incurred, the Company’s estimate of the status and timing of services performed relative to the actual status and timing of services performed may vary. 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. 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 63% and 55% of the research and development expenditures for the years ended December 31, 2023 and 2022, respectively. The same vendor also accounted for approximately 53% and 56% of the total accounts payable and accrued expenses as of December 31, 2023 and 2022, respectively. |
ACCOUNTS PAYABLE AND ACCRUED EX
ACCOUNTS PAYABLE AND ACCRUED EXPENSES | 12 Months Ended |
Dec. 31, 2023 | |
ACCOUNTS PAYABLE AND ACCRUED EXPENSES | |
ACCOUNTS PAYABLE AND ACCRUED EXPENSES | NOTE 3 – ACCOUNTS PAYABLE AND ACCRUED EXPENSES Accounts payable and accrued expenses as of December 31, 2023 and 2022 were as follows: December 31, 2023 December 31, 2022 Accrued compensation expenses $ 716,307 $ 542,895 Accrued research and development 2,263,934 1,405,536 Accrued professional fees 58,388 83,715 Other accounts payable and accrued expenses 3,809 29,539 Total $ 3,042,438 $ 2,061,685 |
ISSUANCE OF EQUITY INTERESTS
ISSUANCE OF EQUITY INTERESTS | 12 Months Ended |
Dec. 31, 2023 | |
ISSUANCE OF EQUITY INTERESTS | |
ISSUANCE OF EQUITY INTERESTS | NOTE 4 – 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 14,468,229 were issued 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 one 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 pre-funded 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 December 31, 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 series A warrants were exercisable commencing on January 27, 2023 and will expire on May 18, 2029 for the Investor and January 27, 2028 for the Affiliates. The series B warrants were exercisable commencing on January 27, 2023 and will expire on May 18, 2029 for the Investor and January 27, 2024 for the Affiliates. The registered direct offering closed on July 27, 2022. As of December 31, 2023, million in proceeds from these warrant exercises. 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: 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. On May 16, 2023, the Company entered into a securities purchase agreement with a single healthcare-focused U.S. institutional investor named therein (the “2023 Investor”), pursuant to which the Company issued and sold, in a registered direct offering by the Company directly to the 2023 Investor (the “2023 Registered Offering”), an aggregate of 601,851 shares of common stock at an offering price of $3.00 per share and an aggregate of 731,482 pre-funded warrants exercisable for shares of common stock at an offering price of $2.9999 per pre-funded warrant. The pre-funded warrants sold to the Investor have an exercise price of and were immediately exercisable. As of December 31, 2023, all of the pre-funded warrants were exercised. The gross proceeds to the Company from the registered direct offering were approximately $4.0 million and net proceeds after deducting the placements agent’s fees and other offering expenses payable by the Company were approximately $3.5 million. In a concurrent private placement (the “2023 Private Placement” and together with the 2023 Registered Offering, the “2023 Offerings”), the Company issued to the Investor series C warrants exercisable for an aggregate of 1,333,333 shares of common stock at an exercise price of $3.26 per share and series D warrants exercisable for an aggregate of 1,333,333 shares of common stock at an exercise price of $3.26 per share. The Series C Warrants were exercisable commencing on November 18, 2023 and will expire on November 18, 2025. The Series D Warrants were exercisable commencing on November 18, 2023 and will expire on November 19, 2029. In connection with the 2023 Offerings, the Company also entered into a Warrant Amendment Agreement with the 2023 Investor. Under the Warrant Amendment Agreement, the Company amended its existing series A warrants to purchase up to an aggregate of 1,230,769 shares of the Company's common stock and series B warrants to purchase up to an aggregate of 1,230,769 shares of the Company's common stock (collectively, the “Existing Warrants”) that were previously issued in July 2022, such that effective upon the closing of the offering, the amended Existing Warrants have a termination date of May 18, 2029. The Company used the Black-Scholes model to calculate the change in the value of the aforementioned series A and series B warrants attributable to the change in the termination date, with an estimated increase in fair value of approximately On November 15, 2023, the Company entered into a Sales Agreement and established the ATM Program, pursuant to which the Company may offer and sell, from time to time through A.G.P./Alliance Global Partners, as sales agent, shares of its common stock having an aggregate offering price of up to $17.0 million. Under the sales agreement, the sales agent is entitled to compensation of During the year ended December 31, 2023, the Company sold 698,121 shares of its common stock under the ATM Program at a weighted-average price of $3.76 per share, raising $2.6 million of gross proceeds and net proceeds of $2.4 million, after deducting commissions to the sales agent and other ATM Program related expenses. The Company recorded a receivable of shares had yet to be issued by the transfer agent as of year-end. The receivable for the unsettled shares as of December 31, 2023 is included within the “Other Receivable” balance in the accompanying balance sheets. The receivables were collected on January 3, 2024 and As of December 31, 2023, the Company has $14.4 million available under the ATM Program. The following table summarizes information with respect to outstanding warrants to purchase common stock of the Company at December 31, 2023: Weighted Average Number of Warrants Exercise Price Balance at December 31, 2022 4,217,809 $ 3.29 Issued 3,398,148 2.56 Exercised (1,420,501) 1.57 Balance at December 31, 2023 6,195,456 $ 3.28 The weighted average contractual life of the outstanding warrants is 4.46 years. |
SHARE-BASED COMPENSATION
SHARE-BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2023 | |
SHARE-BASED COMPENSATION | |
SHARE-BASED COMPENSATION | NOTE 5 – SHARE-BASED COMPENSATION 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. The Plan originally reserved an aggregate of 2,000,000 shares of common stock, subject to annual adjustments as provided in the Plan, which was 465,432 shares for the year ended December 31, 2023. The Plan currently has 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 expenses of $726,880 for each of the years ended December 31, 2023 and 2022, related to compensation expenses for these options. 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 In February 2023, the Company granted stock options to purchase a total of 467,500 shares of common stock to its four employees and seven consultants pursuant to the Plan. The options were issued at an exercise price of date fair value, with the options vesting monthly over 36 months . The Company recorded general and administrative expenses of In June 2023, the Company granted stock options to purchase a total of 50,000 shares of common stock to its five independent board of directors pursuant to the Plan. The options were issued at an exercise price of one -year anniversary of the grant date. The Company recorded general and administrative expenses of 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 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. The Company determined the fair value of the option awards during the years ended December 31, 2023 and 2022, using the Black-Scholes option pricing model using the following weighted average assumptions: Years Ended December 31, 2023 2022 Expected term 6.9 years 9.0 years Volatility 98 % 90 % Dividend yield — % — % Risk-free interest rate 3.85 % 2.01 % Weighted average grant date fair value $ 2.75 $ 3.54 A summary of the Company’s stock option activity is as follows: Weighted Average Weighted Remaining Aggregate Number of Average Contractual Term Intrinsic Options Exercise Price (in years) Value Outstanding, vested and expected to vest at December 31, 2022 2,467,500 $ 6.12 8.53 $ 5,700 Granted 517,500 3.35 9.16 Exercised — — — Forfeited — — — Outstanding, vested and expected to vest at December 31, 2023 2,985,000 $ 5.64 7.81 $ 251,550 Exercisable 2,280,361 $ 5.98 7.61 $ 55,342 The total compensation expense not yet recognized as of December 31, 2023 was $2,458,851. The weighted average vesting period for the unvested options is 1.30 years. The weighted average grant date fair value of all options granted is |
SHARE-BASED PAYMENTS TO VENDORS
SHARE-BASED PAYMENTS TO VENDORS | 12 Months Ended |
Dec. 31, 2023 | |
SHARE-BASED PAYMENTS TO VENDORS | |
SHARE-BASED PAYMENTS TO VENDORS | NOTE 6 – SHARE-BASED PAYMENTS TO VENDORS In the fourth quarter of 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 granted $150,000 of common stock over the term of service. The Company granted total of 27,778 shares of common stock at grant date fair value and recorded general and administrative expenses of $0 and $75,000 for the years ended December 31, 2023 and 2022, respectively. In the first quarter of 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 was expensed over the service period and the equity component was expensed consistent with the contractual vesting. The Company recorded general and administrative expenses of $0 and $113,100 for the years ended December 31, 2023 and 2022, respectively. In the third quarter of 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 years ended December 31, 2023 and 2022, respectively. In the fourth quarter of 2022, the Company entered into a number of agreements with vendors pursuant to which the Company made grants of a total of 43,186 share of common stock with a grant date fair values ranging from $3.30 to $3.67, up to 10,096 of warrants, and cash payments. These contracts have six-months terms with various contractual vesting periods. The cash payments were expensed over the service period and the equity component was expensed consistent with the various contractual vesting periods. The Company recorded general and administrative expenses of In the first quarter of 2023, the Company entered into an agreement with a consultant to provide investor relation services for a six-month term. The Company granted 36,000 shares of common stock at a grant date fair value of $3.31, pursuant to the agreement and recorded general and administrative expenses of $119,160 for the year ended December 31, 2023. In the fourth quarter of 2023, the Company entered into a number of agreements with vendors pursuant to which the Company will make grants of a total of 116,000 share of common stock and cash payments, of which 96,000 shares of common stock were issued as of December 31, 2023 with grant date fair values ranging from $1.50 to $5.07 . These contracts have four terms with various contractual vesting periods. The cash payments are expensed over the service period and the equity components are expensed consistent with the various contractual vesting periods. The Company recorded general and administrative expenses of |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2023 | |
INCOME TAXES | |
INCOME TAXES | NOTE 7 – INCOME TAXES The Company has $17.6 million of net operating loss carryforwards and $0.3 million of research tax credit carryforwards as of December 31, 2023. The net operating loss carryforwards are indefinite lived and research tax credit carryforwards will expire in 2043. Net operating loss and tax credit carryforwards may become subject to annual limitations in the event of certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50%, as defined by Sections 382 and 383 of the Internal Revenue Code as well as similar state provisions. This could limit the amount of tax attributes that can be utilized annually to offset future taxable income or tax liabilities. The components of the net deferred income tax asset at December 31, 2023 and 2022 are as follows: December 31, 2023 December 31, 2022 Deferred tax assets Net operating loss carry forwards $ 5,517,038 $ 3,359,183 Share-based compensation 3,255,964 2,262,381 Research and development credit carryforwards 331,671 141,671 Capitalized research and development 2,807,846 1,347,028 Other 10,945 — Gross deferred tax assets 11,923,464 7,110,263 Less valuation allowance (11,923,464) (7,110,263) Net deferred tax asset $ — $ — The Tax Cuts and Jobs Act of 2017 (TCJA) amended IRC Section 174 to require capitalization of all research and developmental (R&D) costs incurred in tax years beginning after December 31, 2021. These costs are required to be amortized over five years if the R&D activities are performed in the U.S., or over 15 years if the activities were performed outside the U.S. The Company capitalized approximately $6.1 million and $4.8 million of R&D expenses for the years ended December 31, 2023 and 2022, respectively. In assessing the realizability of deferred tax assets, the Company considers whether it is more-likely-than-not that some portion or all the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which the temporary differences representing net future deductible amounts become deductible. After consideration of all the evidence, both positive and negative, the Company has recorded a full valuation allowance against their net deferred tax assets at December 31, 2023 because the Company has concluded that it is more-likely-than-not that these assets will not be realized. A reconciliation of income tax expense (benefit) at the statutory Federal income tax rate and income taxes as reflected in the financial statements for both years ended December 31, 2023 and 2022 is as follows: December 31, 2023 December 31, 2022 Federal income tax expense at statutory rate 21.0 % 21.0 % State income tax, net of federal benefit 10.4 14.4 Permanent differences 1.6 (0.5) Research and development tax credit - 0.3 Change in valuation allowance (33.0) (35.2) Effective income tax rate — % — % The Company files income tax returns in the U.S. and the State of New York. The tax years 2021 and thereafter are open and potentially subject to examination by the federal and state taxing authorities. The Company is currently not under examination by the Internal Revenue Service (“IRS”) or any other jurisdictions for any tax years and has no knowledge of any pending examinations by the IRS or any other jurisdictions. To the extent the Company utilizes any tax attributes from a tax period that may otherwise be closed due to statute expiration, the IRS, state tax authorities, or other governing parties may still adjust the tax attributes upon their examination of the future period in which the attribute was utilized. There are no uncertain tax positions recorded for any federal or state positions at December 31, 2023 and 2022. The Company’s policy is to record interest and penalties related to tax matters in income tax expense. |
NET LOSS PER SHARE
NET LOSS PER SHARE | 12 Months Ended |
Dec. 31, 2023 | |
NET LOSS PER SHARE | |
NET LOSS PER SHARE | NOTE 8 – NET LOSS PER SHARE Basic and diluted net loss per share of common stock for the year ended December 31, 2023 and 2022 was determined by dividing net loss by the weighted average shares of common stock outstanding during the period. The Company’s potentially dilutive securities, consisting of 6,195,456 warrants, and 2,985,000 stock options, have not been included in the computation of diluted net loss per share for all periods as the result would be antidilutive. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2023 | |
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). During the fourth quarter of 2023, the Company achieved the Phase 2 clinical trial milestone and included $150,000 as a part of accounts payable and accrued expenses as of December 31, 2023. The Company is also obligated to make royalty payments equal to |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2023 | |
SUBSEQUENT EVENTS | |
SUBSEQUENT EVENTS | NOTE 10 – SUBSEQUENT EVENTS As a part of the ATM Program, the Company sold a total of 1,819,914 shares of its common stock pursuant to the Sales Agreement at an average price of $3.88 for aggregate net proceeds of approximately $6.7 million as of March 15, 2024. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
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 years ended December 31, 2023 and 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. |
Concentration of Credit Risk | Concentration of Credit Risk The Company maintains the majority of 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 December 31, 2023, the Company had cash of approximately $7.5 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 as 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 services are provided. The Company incurred research and development expenses in the amount of $6,043,597 and $4,754,271, for the years ended December 31, 2023 and 2022, respectively. Costs for certain research and development activities, such as the provision of services for clinical trial activity, are estimated based on an evaluation of the progress to completion of specific tasks which may use data such as subject enrollment, clinical site activations or information provided to the Company by its vendors with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid or accrued research and development expense, as the case may be. The estimates are adjusted to reflect the best information available at the time of the financial statement issuance. Although the Company does not expect its estimates to be materially different from amounts actually incurred, the Company’s estimate of the status and timing of services performed relative to the actual status and timing of services performed may vary. |
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. 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 63% and 55% of the research and development expenditures for the years ended December 31, 2023 and 2022, respectively. The same vendor also accounted for approximately 53% and 56% of the total accounts payable and accrued expenses as of December 31, 2023 and 2022, respectively. |
ACCOUNTS PAYABLE AND ACCRUED _2
ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
ACCOUNTS PAYABLE AND ACCRUED EXPENSES | |
Summary of accounts payable and accrued expenses | December 31, 2023 December 31, 2022 Accrued compensation expenses $ 716,307 $ 542,895 Accrued research and development 2,263,934 1,405,536 Accrued professional fees 58,388 83,715 Other accounts payable and accrued expenses 3,809 29,539 Total $ 3,042,438 $ 2,061,685 |
ISSUANCE OF EQUITY INTERESTS (T
ISSUANCE OF EQUITY INTERESTS (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
ISSUANCE OF EQUITY INTERESTS | |
Summary of outstanding warrants | Weighted Average Number of Warrants Exercise Price Balance at December 31, 2022 4,217,809 $ 3.29 Issued 3,398,148 2.56 Exercised (1,420,501) 1.57 Balance at December 31, 2023 6,195,456 $ 3.28 |
SHARE-BASED COMPENSATION (Table
SHARE-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
SHARE-BASED COMPENSATION | |
Schedule of fair value of options assumptions | Years Ended December 31, 2023 2022 Expected term 6.9 years 9.0 years Volatility 98 % 90 % Dividend yield — % — % Risk-free interest rate 3.85 % 2.01 % Weighted average grant date fair value $ 2.75 $ 3.54 |
Schedule of stock option activity | Weighted Average Weighted Remaining Aggregate Number of Average Contractual Term Intrinsic Options Exercise Price (in years) Value Outstanding, vested and expected to vest at December 31, 2022 2,467,500 $ 6.12 8.53 $ 5,700 Granted 517,500 3.35 9.16 Exercised — — — Forfeited — — — Outstanding, vested and expected to vest at December 31, 2023 2,985,000 $ 5.64 7.81 $ 251,550 Exercisable 2,280,361 $ 5.98 7.61 $ 55,342 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
INCOME TAXES | |
Schedule of components of net deferred income tax asset | December 31, 2023 December 31, 2022 Deferred tax assets Net operating loss carry forwards $ 5,517,038 $ 3,359,183 Share-based compensation 3,255,964 2,262,381 Research and development credit carryforwards 331,671 141,671 Capitalized research and development 2,807,846 1,347,028 Other 10,945 — Gross deferred tax assets 11,923,464 7,110,263 Less valuation allowance (11,923,464) (7,110,263) Net deferred tax asset $ — $ — |
Summary of reconciliation of income tax expense (benefit) | December 31, 2023 December 31, 2022 Federal income tax expense at statutory rate 21.0 % 21.0 % State income tax, net of federal benefit 10.4 14.4 Permanent differences 1.6 (0.5) Research and development tax credit - 0.3 Change in valuation allowance (33.0) (35.2) Effective income tax rate — % — % |
NATURE OF OPERATIONS (Details)
NATURE OF OPERATIONS (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||||||
Jan. 02, 2024 | Nov. 15, 2023 | May 18, 2023 | Jul. 27, 2022 | Jun. 29, 2021 | Feb. 28, 2018 | Dec. 31, 2023 | Dec. 31, 2022 | |
Warrant exercise price (in dollars per share) | $ 2.9999 | $ 3.60 | ||||||
Shares issued (in shares) | 17,869 | 698,121 | 601,851 | 1,159,211 | 2,875,000 | |||
Gross proceeds from stock issue | $ 2,600,000 | $ 4,000,000 | $ 4,200,000 | $ 17,300,000 | ||||
Share price (in dollars per share) | $ 3 | $ 6 | ||||||
Pre-funded Warrant Exercise (in shares) | 731,482 | 130,769 | ||||||
Cash | $ 7,474,188 | $ 9,111,751 | ||||||
Number of warrants | 731,482 | 63,018 | ||||||
Series A warrants | ||||||||
Number of warrants | 1,289,980 | |||||||
Series B warrants | ||||||||
Number of warrants | 1,289,980 | |||||||
Series C warrants | ||||||||
Warrant exercise price (in dollars per share) | $ 3.26 | |||||||
Number of warrants | 1,333,333 | |||||||
Series D warrants | ||||||||
Warrant exercise price (in dollars per share) | $ 3.26 | |||||||
Number of warrants | 1,333,333 | |||||||
At the Market Offering | ||||||||
Shares issued (in shares) | 698,121 | |||||||
Gross proceeds from stock issue | $ 2,600,000 | |||||||
Aggregate offering price | $ 17,000,000 | $ 14,400,000 | ||||||
ACX362E | ||||||||
Cash paid | $ 110,174 | |||||||
Future commitment | 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 ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||
Effective tax rate | 0% | 0% |
Current federal or state income tax expense | $ 0 | |
Cash | 7,474,188 | $ 9,111,751 |
Research and development expense | $ 6,043,597 | $ 4,754,271 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Major Vendor (Details) - Supplier Concentration Risk - Vendor One | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Research and development expenditures | ||
Concentration | ||
Concentration Risk (as a percent) | 63% | 55% |
Accounts payable and accrued expense | ||
Concentration | ||
Concentration Risk (as a percent) | 53% | 56% |
ACCOUNTS PAYABLE AND ACCRUED _3
ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
ACCOUNTS PAYABLE AND ACCRUED EXPENSES | ||
Accrued compensation expenses | $ 716,307 | $ 542,895 |
Accrued research and development | 2,263,934 | 1,405,536 |
Accrued professional fees | 58,388 | 83,715 |
Other accounts payable and accrued expenses | 3,809 | 29,539 |
Total | $ 3,042,438 | $ 2,061,685 |
ISSUANCE OF EQUITY INTERESTS (D
ISSUANCE OF EQUITY INTERESTS (Details) | 12 Months Ended | |||||||
Mar. 15, 2024 USD ($) $ / shares shares | Jan. 02, 2024 shares | Nov. 15, 2023 USD ($) shares | May 18, 2023 USD ($) $ / shares shares | Jul. 27, 2022 USD ($) $ / shares shares | Jun. 29, 2021 USD ($) $ / shares shares | Dec. 31, 2023 USD ($) $ / shares shares | Dec. 31, 2022 shares | |
Equity | ||||||||
Common stock, Authorized (in shares) | 200,000,000 | 200,000,000 | ||||||
Common stock, Outstanding (in shares) | 14,468,229 | 11,627,609 | ||||||
Common stock, Issued (in shares) | 14,468,229 | 11,627,609 | ||||||
Shares issued (in shares) | 17,869 | 698,121 | 601,851 | 1,159,211 | 2,875,000 | |||
Purchase price (in dollars per share) | $ / shares | $ 3 | $ 6 | ||||||
Cash issuance cost | $ | $ 287,874 | |||||||
Number of warrants | 731,482 | 63,018 | ||||||
Warrant exercise price (in dollars per share) | $ / shares | $ 2.9999 | $ 3.60 | ||||||
Proceeds from warrant exercises | $ | $ 2,218,999 | |||||||
Pre-funded Warrant Exercise (in shares) | 731,482 | 130,769 | ||||||
Gross proceeds from stock issue | $ | $ 2,600,000 | $ 4,000,000 | $ 4,200,000 | $ 17,300,000 | ||||
Net proceeds stock issuance | $ | 3,500,000 | $ 3,700,000 | ||||||
Weighted average aggregate offering price (as a percent) | 110% | |||||||
Warrants fair value increase adjustment | $ | $ 2,000,000 | |||||||
Subsequent Event | ||||||||
Equity | ||||||||
Shares issued (in shares) | 1,819,914 | |||||||
Purchase price (in dollars per share) | $ / shares | $ 3.88 | |||||||
Gross proceeds from stock issue | $ | $ 6,700,000 | |||||||
Series A warrants | ||||||||
Equity | ||||||||
Number of warrants | 1,289,980 | |||||||
Series B warrants | ||||||||
Equity | ||||||||
Number of warrants | 1,289,980 | |||||||
Number of warrants exercised | 682,769 | |||||||
Proceeds from warrant exercises | $ | $ 2,200,000 | |||||||
Series C warrants | ||||||||
Equity | ||||||||
Number of warrants | 1,333,333 | |||||||
Warrant exercise price (in dollars per share) | $ / shares | $ 3.26 | |||||||
Series D warrants | ||||||||
Equity | ||||||||
Number of warrants | 1,333,333 | |||||||
Warrant exercise price (in dollars per share) | $ / shares | $ 3.26 | |||||||
Affiliate Investors | ||||||||
Equity | ||||||||
Shares issued (in shares) | 59,211 | |||||||
Purchase price (in dollars per share) | $ / shares | $ 3.80 | |||||||
Affiliate Investors | Series A warrants | ||||||||
Equity | ||||||||
Number of warrants | 59,211 | |||||||
Warrant exercise price (in dollars per share) | $ / shares | $ 3.25 | |||||||
Affiliate Investors | Series B warrants | ||||||||
Equity | ||||||||
Number of warrants | 59,211 | |||||||
Warrant exercise price (in dollars per share) | $ / shares | $ 3.55 | |||||||
Investor | ||||||||
Equity | ||||||||
Shares issued (in shares) | 1,100,000 | |||||||
Purchase price (in dollars per share) | $ / shares | $ 3.25 | |||||||
Warrant exercise price (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||||||
Pre-funded Warrant Exercise (in shares) | 130,769 | |||||||
Warrant exercise price, exercised (in dollars per share) | $ / shares | $ 3.2499 | |||||||
Investor | Series A warrants | ||||||||
Equity | ||||||||
Number of warrants | 1,230,769 | |||||||
Investor | Series B warrants | ||||||||
Equity | ||||||||
Number of warrants | 1,230,769 | |||||||
IPO | ||||||||
Equity | ||||||||
Shares issued (in shares) | 2,875,000 | |||||||
Purchase price (in dollars per share) | $ / shares | $ 6 | |||||||
Proceeds from IPO, net of issuance costs | $ | $ 14,800,000 | |||||||
Cash issuance cost | $ | $ 2,400,000 | |||||||
Shares of common stock issued in conversion (in shares) | 7,041,208 | |||||||
IPO | Members' Equity, Class A and Class B | ||||||||
Equity | ||||||||
Convertible conversion ratio | 0.5 | |||||||
Converted to common stock (in shares) | 14,082,318 | |||||||
IPO | Series A warrants | ||||||||
Equity | ||||||||
Number of shares called by Warrant | 0.5 | |||||||
Number of warrants | 1,437,577 | |||||||
Warrant exercise price (in dollars per share) | $ / shares | $ 2.88 | |||||||
Underwriter option | ||||||||
Equity | ||||||||
Number of warrants | 150,000 | |||||||
Warrant exercise price (in dollars per share) | $ / shares | $ 7.50 | |||||||
Warrants term | 4 years 6 months | |||||||
At the Market Offering | ||||||||
Equity | ||||||||
Shares issued (in shares) | 698,121 | |||||||
Cash issuance cost | $ | $ 222,161 | |||||||
Gross proceeds from stock issue | $ | 2,600,000 | |||||||
Net proceeds stock issuance | $ | 2,400,638 | |||||||
Aggregate offering price | $ | $ 17,000,000 | $ 14,400,000 | ||||||
Percentage on gross offering proceeds | 3% | |||||||
Sale of stock price per share | $ / shares | $ 3.76 | |||||||
Subscriptions receivable | $ | $ 129,159 | |||||||
Shares sold as receivable (in shares) | 34,116 | |||||||
Shares subscribed and unissued (in shares) | 17,869 |
ISSUANCE OF EQUITY INTERESTS -
ISSUANCE OF EQUITY INTERESTS - Warrant fair value (Details) | Jul. 27, 2022 USD ($) Y $ / shares | Jun. 29, 2021 USD ($) $ / shares Y |
Warrants fair value | ||
Fair value of Warrants | $ | $ 171,409 | |
Measurement Input, Expected Term | ||
Warrants fair value | ||
Measurement Input, Warrants | Y | 5 | |
Measurement Input, Risk Free Rate | ||
Warrants fair value | ||
Measurement Input, Warrants | 0.0282 | |
Measurement Input, Share Price | ||
Warrants fair value | ||
Measurement Input, Warrants | $ / shares | 3.70 | |
Measurement Input, Volatility | ||
Warrants fair value | ||
Measurement Input, Warrants | 0.95 | |
Underwriter option | ||
Warrants fair value | ||
Fair value of Warrants | $ | $ 618,000 | |
Underwriter option | Measurement Input, Expected Term | ||
Warrants fair value | ||
Measurement Input, Warrants | Y | 4.5 | |
Underwriter option | Measurement Input, Risk Free Rate | ||
Warrants fair value | ||
Measurement Input, Warrants | 0.0079 | |
Underwriter option | Measurement Input, Share Price | ||
Warrants fair value | ||
Measurement Input, Warrants | $ / shares | 6.26 | |
Underwriter option | Measurement Input, Volatility | ||
Warrants fair value | ||
Measurement Input, Warrants | 0.94 |
ISSUANCE OF EQUITY INTERESTS _2
ISSUANCE OF EQUITY INTERESTS - Warrants outstanding (Details) - $ / shares | 12 Months Ended | |||
Dec. 31, 2023 | May 18, 2023 | Dec. 31, 2022 | Jul. 27, 2022 | |
Equity | ||||
Warrants outstanding (in shares), beginning balance | 4,217,809 | |||
Warrants issued (in shares) | 3,398,148 | |||
Warrants exercised (in shares) | (1,420,501) | |||
Warrants outstanding (in shares), ending balance | 6,195,456 | |||
Warrant exercise price, outstanding (in dollars per share) | $ 2.9999 | $ 3.60 | ||
Weighted Average | ||||
Equity | ||||
Warrant exercise price, outstanding (in dollars per share) | $ 3.28 | $ 3.29 | ||
Warrant exercise price, issued (in dollars per share) | 2.56 | |||
Warrant exercise price, exercised (in dollars per share) | $ 1.57 | |||
Warrants term | 4 years 5 months 15 days |
SHARE-BASED COMPENSATION - (Det
SHARE-BASED COMPENSATION - (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||||||
Jun. 30, 2023 | Feb. 28, 2023 | Apr. 30, 2022 | Jan. 31, 2022 | Jul. 31, 2021 | Jun. 30, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | Apr. 30, 2021 | |
Share-based compensation | |||||||||
Stock options granted (in shares) | 517,500 | ||||||||
Grant exercise price (in dollars per share) | $ 3.35 | ||||||||
Total compensation expense not yet recognized | $ 2,458,851 | ||||||||
Weighted average vesting period | 1 year 3 months 18 days | ||||||||
Intrinsic value of stock option | $ 251,550,000 | $ 5,700,000 | |||||||
Weighted average grant date fair value | $ 4.33 | ||||||||
June 2021 | |||||||||
Share-based compensation | |||||||||
Share based compensation expense | $ 726,880 | 726,880 | |||||||
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 | |||||||||
Share-based compensation | |||||||||
Share based compensation expense | 1,963,667 | 1,963,667 | |||||||
Stock options granted (in shares) | 1,550,000 | ||||||||
Grant 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 | 75,800 | 145,283 | |||||||
Stock options granted (in shares) | 80,000 | ||||||||
Grant exercise price (in dollars per share) | $ 4.44 | ||||||||
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 | 21,510 | $ 35,850 | |||||||
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 | ||||||||
February 2023 | |||||||||
Share-based compensation | |||||||||
Share based compensation expense | 365,070 | ||||||||
Stock options granted (in shares) | 467,500 | ||||||||
Grant exercise price (in dollars per share) | $ 3.41 | ||||||||
Vesting term of options | 36 months | ||||||||
June 2023 | |||||||||
Share-based compensation | |||||||||
Share based compensation expense | $ 53,600 | ||||||||
Stock options granted (in shares) | 50,000 | ||||||||
Grant exercise price (in dollars per share) | $ 2.75 | ||||||||
Vesting term of options | 1 year | ||||||||
2021 Equity Incentive Plan | |||||||||
Share-based compensation | |||||||||
Common stock shares reserved | 2,000,000 | ||||||||
Additional common stock shares reserved | 465,432 | ||||||||
Common stock shares available (in shares) | 485,868 |
SHARE-BASED COMPENSATION - Opti
SHARE-BASED COMPENSATION - Option pricing (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
SHARE-BASED COMPENSATION | ||
Expected term | 6 years 10 months 24 days | 9 years |
Volatility | 98% | 90% |
Risk-free interest rate | 3.85% | 2.01% |
Weighted average grant date fair value | $ 2.75 | $ 3.54 |
SHARE-BASED COMPENSATION - Op_2
SHARE-BASED COMPENSATION - Option activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Options outstanding | ||
Outstanding at the beginning of the period | 2,467,500 | |
Granted | 517,500 | |
Outstanding at the end of the period | 2,985,000 | 2,467,500 |
Exercisable | 2,280,361 | |
Weighted Average Exercise Price | ||
Weighted Average Exercise price, Beginning of the period | $ 6.12 | |
Weighted Average Exercise price, granted | 3.35 | |
Weighted Average Exercise price, End of the period | 5.64 | $ 6.12 |
Exercisable | $ 5.98 | |
Weighted Average Remaining Contractual Term (in years) | ||
Weighted average contractual life | 7 years 9 months 21 days | 8 years 6 months 10 days |
Weighted average remaining contractual term, Granted | 9 years 1 month 28 days | |
Weighted Average Remaining Contractual Term, Exercisable | 7 years 7 months 9 days | |
Aggregate Intrinsic Value | ||
Aggregate Intrinsic Value, Beginning of the period | $ 5,700 | |
Aggregate Intrinsic Value, End of the period | 251,550 | $ 5,700 |
Aggregate Intrinsic Value, Exercisable | $ 55,342 |
SHARE-BASED PAYMENTS TO VENDO_2
SHARE-BASED PAYMENTS TO VENDORS (Details) - USD ($) | 3 Months Ended | 12 Months Ended | ||||||
Dec. 31, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Mar. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | |
Share-based compensation | ||||||||
Share-based vendor payments | $ 559,583 | $ 430,680 | ||||||
Warrants outstanding (in shares) | 6,195,456 | 4,217,809 | 6,195,456 | 4,217,809 | ||||
Fourth Quarter 2021 | ||||||||
Share-based compensation | ||||||||
Share-based vendor payments (in shares) | 27,778 | |||||||
Share-based vendor payments | $ 0 | $ 75,000 | ||||||
Contract term | 6 months | |||||||
Future commitment | $ 150,000 | |||||||
First Quarter 2022 | ||||||||
Share-based compensation | ||||||||
Share-based vendor payments (in shares) | 30,000 | |||||||
Share-based vendor payments | 0 | 113,100 | ||||||
Grant date fair value ($ per share) | $ 3.77 | |||||||
Vendor payment | $ 25,000 | |||||||
Contract term | 6 months | |||||||
Fourth Quarter 2022 | ||||||||
Share-based compensation | ||||||||
Share-based vendor payments (in shares) | 43,186 | |||||||
Share-based vendor payments | 46,742 | $ 115,500 | ||||||
Contract term | 6 months | |||||||
Warrants outstanding (in shares) | 10,096 | 10,096 | ||||||
Fourth Quarter 2022 | Minimum | ||||||||
Share-based compensation | ||||||||
Grant date fair value ($ per share) | $ 3.30 | $ 3.30 | ||||||
Fourth Quarter 2022 | Maximum | ||||||||
Share-based compensation | ||||||||
Grant date fair value ($ per share) | $ 3.67 | $ 3.67 | ||||||
First Quarter 2023 | ||||||||
Share-based compensation | ||||||||
Share-based vendor payments (in shares) | 36,000 | |||||||
Share-based vendor payments | 119,160 | |||||||
Grant date fair value ($ per share) | $ 3.31 | |||||||
Contract term | 6 months | |||||||
Fourth Quarter 2023 | ||||||||
Share-based compensation | ||||||||
Share-based vendor payments (in shares) | 96,000 | |||||||
Share-based vendor payments | $ 393,681 | |||||||
Shares to be granted pursuant to vendor agreements | 116,000 | |||||||
Fourth Quarter 2023 | Minimum | ||||||||
Share-based compensation | ||||||||
Grant date fair value ($ per share) | $ 1.50 | $ 1.50 | ||||||
Contract term | 4 months | |||||||
Fourth Quarter 2023 | Maximum | ||||||||
Share-based compensation | ||||||||
Grant date fair value ($ per share) | $ 5.07 | $ 5.07 | ||||||
Contract term | 6 months | |||||||
Third Quarter 2022 | ||||||||
Share-based compensation | ||||||||
Share-based vendor payments (in shares) | 36,000 | |||||||
Share-based vendor payments | $ 0 | $ 127,080 | ||||||
Grant date fair value ($ per share) | $ 3.53 | |||||||
Contract term | 6 months |
INCOME TAXES (Details)
INCOME TAXES (Details) $ in Millions | Dec. 31, 2023 USD ($) |
INCOME TAXES | |
Net operating loss carryforward | $ 17.6 |
Research tax credit carryforward | $ 0.3 |
INCOME TAXES - Deferred tax ass
INCOME TAXES - Deferred tax asset (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Deferred tax assets | ||
Net operating loss carryforwards | $ 5,517,038 | $ 3,359,183 |
Share-based compensation | 3,255,964 | 2,262,381 |
Research and development credit carryforwards | 331,671 | 141,671 |
Capitalized research and development | 2,807,846 | 1,347,028 |
Other | 10,945 | |
Gross deferred tax assets | 11,923,464 | 7,110,263 |
Less valuation allowance | (11,923,464) | (7,110,263) |
Capitalized research and development | $ 6,100,000 | $ 4,800,000 |
INCOME TAXES - Tax reconciliati
INCOME TAXES - Tax reconciliation (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
INCOME TAXES | ||
Federal income tax expense at statutory rate | 21% | 21% |
State income tax, net of federal benefit | 10.40% | 14.40% |
Permanent differences | 1.60% | (0.50%) |
Research and development tax credit | 0.30% | |
Change in valuation allowance | (33.00%) | (35.20%) |
Effective income tax rate | 0% | 0% |
Unrecognized tax benefits | $ 0 | $ 0 |
NET LOSS PER SHARE (Details)
NET LOSS PER SHARE (Details) | 12 Months Ended |
Dec. 31, 2023 shares | |
Warrant | |
Antidilutive security | |
Potentially dilutive shares | 6,195,456 |
Employee Stock Option | |
Antidilutive security | |
Potentially dilutive shares | 2,985,000 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details) - USD ($) | 1 Months Ended | ||
Feb. 28, 2018 | Dec. 31, 2023 | Dec. 31, 2022 | |
Contingency | |||
Accrued research and development | $ 2,263,934 | $ 1,405,536 | |
ACX362E | |||
Contingency | |||
Future commitment | $ 700,000 | ||
Royalty payments | $ 50,000 | ||
Accrued research and development | $ 150,000 | ||
Royalty payments on net sales (as a percent) | 4% |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) - USD ($) $ / shares in Units, $ in Millions | Mar. 15, 2024 | Jan. 02, 2024 | Nov. 15, 2023 | May 18, 2023 | Jul. 27, 2022 | Jun. 29, 2021 |
Subsequent event | ||||||
Shares issued (in shares) | 17,869 | 698,121 | 601,851 | 1,159,211 | 2,875,000 | |
Share price (in dollars per share) | $ 3 | $ 6 | ||||
Gross proceeds from stock issue | $ 2.6 | $ 4 | $ 4.2 | $ 17.3 | ||
Subsequent Event | ||||||
Subsequent event | ||||||
Shares issued (in shares) | 1,819,914 | |||||
Share price (in dollars per share) | $ 3.88 | |||||
Gross proceeds from stock issue | $ 6.7 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (14,577,768) | $ (12,092,776) |
Insider Trading Arrangements
Insider Trading Arrangements | 12 Months Ended |
Dec. 31, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |