Acurx Pharmaceuticals (ACXP) 10-Q 12 Nov 24 2024 Q3 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	9 Months Ended
	Sep. 30, 2024	Nov. 12, 2024
Document and Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Sep. 30, 2024
Securities Act 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 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		16,892,548
Entity Central Index Key	0001736243
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q3
Amendment Flag	false

BALANCE SHEETS

BALANCE SHEETS - USD ($)	Sep. 30, 2024	Dec. 31, 2023
CURRENT ASSETS
Cash	$ 5,762,564	$ 7,474,188
Other Receivable	97,373	129,159
Prepaid Expenses	122,822	105,776
TOTAL ASSETS	5,982,759	7,709,123
CURRENT LIABILITIES
Accounts Payable and Accrued Expenses	3,318,765	3,042,438
TOTAL CURRENT LIABILITIES	3,318,765	3,042,438
TOTAL LIABILITIES	3,318,765	3,042,438
SHAREHOLDERS' EQUITY
Common Stock; $.001 par value, 200,000,000 shares authorized, 16,770,378 and 14,468,229 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively	16,770	14,468
Additional Paid-In Capital	67,187,389	57,871,070
Accumulated Deficit	(64,540,165)	(53,218,853)
TOTAL SHAREHOLDERS' EQUITY	2,663,994	4,666,685
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY	$ 5,982,759	$ 7,709,123

BALANCE SHEETS (Parenthetical)

BALANCE SHEETS (Parenthetical) - $ / shares	Sep. 30, 2024	Dec. 31, 2023
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)	16,770,378	14,468,229
Common stock, Outstanding (in shares)	16,770,378	14,468,229

STATEMENTS OF OPERATIONS

STATEMENTS OF OPERATIONS - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
OPERATING EXPENSES
Research and Development	$ 1,198,184	$ 1,348,985	$ 4,578,777	$ 4,100,954
General and Administrative	1,623,413	1,765,996	6,742,535	5,362,224
TOTAL OPERATING EXPENSES	2,821,597	3,114,981	11,321,312	9,463,178
NET LOSS	$ (2,821,597)	$ (3,114,981)	$ (11,321,312)	$ (9,463,178)
LOSS PER SHARE
Basic net loss per common share	$ (0.17)	$ (0.24)	$ (0.71)	$ (0.77)
Diluted net loss per common share	$ (0.17)	$ (0.24)	$ (0.71)	$ (0.77)
Weighted average common shares outstanding basic	16,363,473	13,005,128	15,907,778	12,282,004
Weighted average common shares outstanding diluted	16,363,473	13,005,128	15,907,778	12,282,004

STATEMENTS OF CHANGES IN SHAREH

STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY - USD ($)	Common Stock	Additional Paid-In Capital	Accumulated Deficit	Total
Balance at beginning at Dec. 31, 2022	$ 11,628	$ 45,944,478	$ (38,641,085)	$ 7,315,021
Balance at beginning, Common shares (in shares) at Dec. 31, 2022	11,627,609
Share-Based Compensation		733,472		733,472
Share-Based Payments to Vendors	$ 44	165,859		165,903
Share-Based Payments to Vendors (in shares)	44,186
Net Income (Loss)			(2,902,957)	(2,902,957)
Balance at ending at Mar. 31, 2023	$ 11,672	46,843,809	(41,544,042)	5,311,439
Balance at ending, Common shares (in shares) at Mar. 31, 2023	11,671,795
Balance at beginning at Dec. 31, 2022	$ 11,628	45,944,478	(38,641,085)	7,315,021
Balance at beginning, Common shares (in shares) at Dec. 31, 2022	11,627,609
Net Income (Loss)				(9,463,178)
Balance at ending at Sep. 30, 2023	$ 13,005	52,025,931	(48,104,263)	3,934,673
Balance at ending, Common shares (in shares) at Sep. 30, 2023	13,005,128
Balance at beginning at Mar. 31, 2023	$ 11,672	46,843,809	(41,544,042)	5,311,439
Balance at beginning, Common shares (in shares) at Mar. 31, 2023	11,671,795
Share-Based Compensation		806,485		806,485
Issuance of shares of common stock	$ 602	3,543,010		3,543,612
Issuance of shares of common stock (in shares)	601,851
Pre-funded Warrant Exercise	$ 731	(658)		73
Pre-funded Warrant Exercise (in shares)	731,482
Net Income (Loss)			(3,445,240)	(3,445,240)
Balance at ending at Jun. 30, 2023	$ 13,005	51,192,646	(44,989,282)	6,216,369
Balance at ending, Common shares (in shares) at Jun. 30, 2023	13,005,128
Share-Based Compensation		833,285		833,285
Net Income (Loss)			(3,114,981)	(3,114,981)
Balance at ending at Sep. 30, 2023	$ 13,005	52,025,931	(48,104,263)	3,934,673
Balance at ending, Common shares (in shares) at Sep. 30, 2023	13,005,128
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
Share-Based Compensation		894,523		$ 894,523
Share-Based Payments to Vendors	$ 90	305,510		305,600
Share-Based Payments to Vendors (in shares)	90,000
Issuance of shares of common stock	$ 1,140	4,298,334		4,299,474
Issuance of shares of common stock (in shares)	1,139,662
Warrant Exercise	$ 59	210,140		210,199
Warrant Exercise (in shares)	59,211
Net Income (Loss)			(4,377,889)	(4,377,889)
Balance at ending at Mar. 31, 2024	$ 15,757	63,579,577	(57,596,742)	5,998,592
Balance at ending, Common shares (in shares) at Mar. 31, 2024	15,757,102
Balance at beginning at Dec. 31, 2023	$ 14,468	57,871,070	(53,218,853)	$ 4,666,685
Balance at beginning, Common shares (in shares) at Dec. 31, 2023	14,468,229			14,468,229
Net Income (Loss)				$ (11,321,312)
Balance at ending at Sep. 30, 2024	$ 16,770	67,187,389	(64,540,165)	$ 2,663,994
Balance at ending, Common shares (in shares) at Sep. 30, 2024	16,770,378			16,770,378
Balance at beginning at Mar. 31, 2024	$ 15,757	63,579,577	(57,596,742)	$ 5,998,592
Balance at beginning, Common shares (in shares) at Mar. 31, 2024	15,757,102
Share-Based Compensation		1,016,998		1,016,998
Share-Based Payments to Vendors	$ 106	213,394		213,500
Share-Based Payments to Vendors (in shares)	106,000
Issuance of shares of common stock	$ 133	320,078		320,211
Issuance of shares of common stock (in shares)	133,066
Net Income (Loss)			(4,121,826)	(4,121,826)
Balance at ending at Jun. 30, 2024	$ 15,996	65,130,047	(61,718,568)	3,427,475
Balance at ending, Common shares (in shares) at Jun. 30, 2024	15,996,168
Share-Based Compensation		345,191		345,191
Share-Based Payments to Vendors	$ 60	121,340		121,400
Share-Based Payments to Vendors (in shares)	60,000
Issuance of shares of common stock	$ 714	1,590,811		1,591,525
Issuance of shares of common stock (in shares)	714,210
Net Income (Loss)			(2,821,597)	(2,821,597)
Balance at ending at Sep. 30, 2024	$ 16,770	$ 67,187,389	$ (64,540,165)	$ 2,663,994
Balance at ending, Common shares (in shares) at Sep. 30, 2024	16,770,378			16,770,378

STATEMENTS OF CHANGES IN SHAR_2

STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (Parenthetical) - USD ($)	3 Months Ended				9 Months Ended
	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Jun. 30, 2023	Sep. 30, 2023
STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY
Cash issuance cost	$ 51,455	$ 10,601	$ 135,741	$ 456,314	$ 1,990,153

STATEMENTS OF CASH FLOWS

STATEMENTS OF CASH FLOWS - USD ($)	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Cash Flow from Operating Activities:
Net Loss	$ (11,321,312)	$ (9,463,178)
Adjustments to Reconcile Net Loss to Net Cash Used in Operating Activities:
Share-Based Compensation	2,256,712	2,373,242
Share-Based Payments to Vendors	640,500	165,903
Changes in Assets and Liabilities:
Other Receivable	31,786
Prepaid Expenses	(17,046)	159,233
Accounts Payable and Accrued Expenses	276,327	1,161,693
Net Cash Used in Operating Activities	(8,133,033)	(5,603,107)
Cash Flow from Financing Activities
Pre-funded Warrant Exercise		73
Warrant Exercise	210,199
Net Cash Provided by Financing Activities	6,421,409	3,543,685
Net Decrease in Cash	(1,711,624)	(2,059,422)
Cash at Beginning of Period	7,474,188	9,111,751
Cash at End of Period	5,762,564	7,052,329
SUPPLEMENTAL DISCLOSURE OF NON-CASH FINANCING ACTIVITIES
Offering costs		1,990,153
At the Market Offering
Cash Flow from Financing Activities
Proceeds from stock offering, net of issuance costs	$ 6,211,210
Registered Direct Offering
Cash Flow from Financing Activities
Proceeds from stock offering, net of issuance costs		$ 3,543,612

NATURE OF OPERATIONS

NATURE OF OPERATIONS	9 Months Ended
	Sep. 30, 2024
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. Previously, the Company’s clinical trial operations were directly and indirectly adversely impacted, and could continue to be directly and indirectly adversely impacted, by the COVID-19 pandemic. 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 million. On May 18, 2023, the Company completed a registered direct offering and a concurrent private placement, issuing million. million. Under the ATM Program, the Company sold a total of million. financial statements for the period ended September 30, 2024. 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 condensed 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	9 Months Ended
	Sep. 30, 2024
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying unaudited condensed 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 and 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 interim 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, 2023 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 three and nine months ended September 30, 2024, 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. During the second quarter of 2024, the Company applied for a qualified small business payroll tax credit for increasing research activities in the amount of $51,127 and is included within the “Other Receivable” on the accompanying condensed interim balance sheet as of September 30, 2024. 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 September 30, 2024, the Company had cash of approximately $5.8 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 $1,198,184 and $1,348,985 for the three months ended September 30, 2024 and 2023, respectively, and $4,578,777 and $4,100,954 for the nine months ended September 30, 2024 and 2023, 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 applicable. The estimates are adjusted to reflect the best information available at the time of the financial statement issuance. The Company’s estimate of the status and timing of services performed could differ from the actual status and timing of services performed. Share-Based Compensation The Company accounts for the cost of services performed by employees, directors and consultants received in exchange for an award of the Company’s 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 common stock, stock options, or warrants 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 three major vendors that accounted for approximately 44% of the research and development expenditures for the each of the three and nine months ended September 30, 2024, and a major vendor that accounted for approximately 59% and 66% of the research and development expenditures for the three and nine months ended September 30, 2023, respectively. As of September 30, 2024, there were three vendors who accounted for approximately 65% of the total accounts payable and accrued expenses and as of December 31, 2023, these vendors accounted for 54% of the total accounts payable and accrued expenses.

ACCOUNTS PAYABLE AND ACCRUED EX

ACCOUNTS PAYABLE AND ACCRUED EXPENSES	9 Months Ended
	Sep. 30, 2024
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, 2024 and December 31, 2023 were as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, 2024 December 31, 2023 Accrued research and development ​ $ 2,968,508 ​ $ 2,263,934 Accrued compensation expenses ​ 247,210 ​ 716,307 Accrued professional fees ​ 83,950 ​ 58,388 Other accounts payable and accrued expenses ​ 19,097 ​ 3,809 Total ​ $ 3,318,765 ​ $ 3,042,438 ​

ISSUANCE OF EQUITY INTERESTS

ISSUANCE OF EQUITY INTERESTS	9 Months Ended
	Sep. 30, 2024
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 16,770,378 were outstanding as of September 30, 2024. 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 2023 Investor have an exercise price of and were immediately exercisable. All of the pre-funded warrants were exercised in June 2023. The gross proceeds to the Company from the 2023 Registered Offering were approximately $4.0 million and net proceeds after deducting the placement 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 shares of the common stock (collectively, the “Existing Warrants”) that were previously issued in July 2022, such that 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 million. This amount was recorded as both an increase to additional paid-in capital and as a non-cash issuance cost of the 2023 offerings. In January 2024, the Affiliate Investors exercised 59,211 of Series B Warrants which generated approximately $0.2 million in proceeds for the Company. The following table summarizes information with respect to outstanding warrants to purchase common stock of the Company as of September 30, 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted Average ​ ​ Number of Warrants Exercise Price Balance at December 31, 2023 ​ ​ 6,195,456 ​ $ 3.28 Issued ​ — ​ ​ — Exercised ​ (59,211) ​ ​ 3.55 Balance at September 30, 2024 ​ 6,136,245 ​ $ 3.28 ​ The weighted average contractual life of the outstanding warrants is 3.76 years. 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 The Company sold 1,994,069 shares of its common stock under the ATM Program at a weighted-average price of $3.21 per share, raising $6.4 million of gross proceeds and net proceeds of $6.2 million, after deducting commissions to the sales agent for the nine months ended September 30, 2024. As of September 30, 2024, the Company sold a total of 2,692,190 shares of its common stock under the ATM Program, at a weighted-average price of $3.35 per share, raising $9.0 million of gross proceeds and net proceeds of $8.6 million, after deducting commissions to the sales agent and other ATM Program related expenses. The Company recorded a receivable of $46,246 for 25,000 shares sold under the ATM Program as they were yet to be settled by the transfer agent as of September 30, 2024. The receivables for the unsettled shares as of September 30, 2024 is included within the “Other Receivable” balance in the accompanying condensed interim balance sheets. The receivables for unsettled shares were collected on October 1, 2024 and shares were issued on October 1, 2024. As of September 30, 2024, the Company has $8.0 million available under the ATM Program.

SHARE-BASED COMPENSATION

SHARE-BASED COMPENSATION	9 Months Ended
	Sep. 30, 2024
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, with an annual evergreen provision pursuant to the Plan. The Plan currently reserves an aggregate of 3,454,915 shares of common stock, subject to adjustments as provided in the Plan, of which 171,720, are currently still available for issuance as of September 30, 2024. 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 expenses of $0 and $181,720 for the three months ended September 30, 2024 and 2023, respectively, and $363,440 and $545,160 for the nine months ended September 30, 2024 and 2023, respectively, related to compensation expense 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 . 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 for the three months ended September 30, 2024 and 2023, respectively, and In February 2024, the Company granted stock options to purchase a total of 835,000 shares of common stock to its four employees and a number of consultants pursuant to the Plan. The options were issued at an exercise price of the options vesting monthly over 36 months . The Company recorded general and administrative expenses of In June 2024, the Company granted stock options to purchase a total of 60,000 shares of common stock to its five independent board of directors pursuant to the Plan. The options were issued at an exercise price of anniversary of the grant date. The Company recorded 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 ​ Sep 30, ​ 2024 ​ 2023 Expected term ​ 6.72 years ​ ​ 6.90 years Volatility ​ 103 % ​ ​ 98 % Dividend yield ​ — % ​ ​ — % Risk-free interest rate ​ 4.28 % ​ ​ 3.85 % Weighted average grant date fair value $ 2.59 ​ ​ $ 2.75 ​ ​ 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, 2023 2,985,000 ​ $ 5.64 ​ 7.81 ​ $ 251,550 Granted 895,000 ​ ​ 3.10 ​ 9.44 ​ ​ — Exercised — ​ ​ — ​ — ​ ​ — Forfeited — ​ ​ — ​ — ​ ​ — Outstanding, vested and expected to vest at September 30, 2024 3,880,000 ​ $ 5.05 ​ 7.61 ​ $ — Exercisable 2,915,556 ​ $ 5.68 ​ 7.09 ​ $ — ​ The total non-cash compensation expense for these options not yet recognized as of September 30, 2024 was $2,517,214. The weighted average vesting period for the unvested options is 2.05 years. The weighted average grant date fair value of all options granted is $3.93 as of September 30, 2024. 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, 2024
SHARE-BASED PAYMENTS TO VENDORS
SHARE-BASED PAYMENTS TO VENDORS	NOTE 6 – SHARE-BASED PAYMENTS TO VENDORS 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 shares of common stock with grant date fair values ranging from $3.30 to $3.67, up to 10,096 of warrants, and cash payments. These contracts have terms with various contractual vesting periods. The cash payments were expensed over the service period and the equity components were 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 $0 for each of the three months ended September 30, 2024 and 2023, respectively, and $0 and $119,160 for the nine months ended September 30, 2024 and 2023, respectively. In the fourth quarter of 2023, the Company entered into a number of agreements with vendors pursuant to which the Company made grants of a total of 116,000 shares of common stock with grant date fair values ranging from $1.50 to $5.18 and cash payments. These contracts had four terms with various contractual vesting periods. The cash payments were expensed over the service period and the equity components were expensed consistent with the various contractual vesting periods. The Company recorded general and administrative expenses of In the first quarter of 2024, the Company entered into two respective agreements with consultants to provide investor relation services for four-month terms. The cash payments were expensed over the service period and the equity components were expensed consistent with the various contractual vesting periods. Per the agreements, the Company issued a total of four-month In the second quarter of 2024, the Company entered into two separate agreements with consultants to provide investor relation services for six-month terms . The equity components are expensed consistent with the various contractual vesting periods. Per the agreements, the

NET LOSS PER SHARE

NET LOSS PER SHARE	9 Months Ended
	Sep. 30, 2024
NET LOSS PER SHARE
NET LOSS PER SHARE	NOTE 7 – NET LOSS PER SHARE Basic and diluted net loss per shares of common stock for the nine months ended September 30, 2024 and 2023 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 6,136,245 warrants and 3,880,000 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	9 Months Ended
	Sep. 30, 2024
COMMITMENTS AND CONTINGENCIES.
COMMITMENTS AND CONTINGENCIES	NOTE 8 – 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 September 30, 2024 and December 31, 2023. 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.

Pay vs Performance Disclosure

Pay vs Performance Disclosure - USD ($)	3 Months Ended						9 Months Ended
	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2024	Sep. 30, 2023
Pay vs Performance Disclosure
Net Income (Loss)	$ (2,821,597)	$ (4,121,826)	$ (4,377,889)	$ (3,114,981)	$ (3,445,240)	$ (2,902,957)	$ (11,321,312)	$ (9,463,178)

Insider Trading Arrangements

Insider Trading Arrangements	3 Months Ended
	Sep. 30, 2024
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

SUMMARY OF SIGNIFICANT ACCOUN_2

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)	9 Months Ended
	Sep. 30, 2024
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 and 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 interim 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, 2023 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 three and nine months ended September 30, 2024, 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. During the second quarter of 2024, the Company applied for a qualified small business payroll tax credit for increasing research activities in the amount of $51,127 and is included within the “Other Receivable” on the accompanying condensed interim balance sheet as of September 30, 2024.
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 September 30, 2024, the Company had cash of approximately $5.8 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 $1,198,184 and $1,348,985 for the three months ended September 30, 2024 and 2023, respectively, and $4,578,777 and $4,100,954 for the nine months ended September 30, 2024 and 2023, 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 applicable. The estimates are adjusted to reflect the best information available at the time of the financial statement issuance. The Company’s estimate of the status and timing of services performed could differ from the actual status and timing of services performed.
Share-Based Compensation	Share-Based Compensation The Company accounts for the cost of services performed by employees, directors and consultants received in exchange for an award of the Company’s 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 common stock, stock options, or warrants 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 three major vendors that accounted for approximately 44% of the research and development expenditures for the each of the three and nine months ended September 30, 2024, and a major vendor that accounted for approximately 59% and 66% of the research and development expenditures for the three and nine months ended September 30, 2023, respectively. As of September 30, 2024, there were three vendors who accounted for approximately 65% of the total accounts payable and accrued expenses and as of December 31, 2023, these vendors accounted for 54% of the total accounts payable and accrued expenses.

ACCOUNTS PAYABLE AND ACCRUED _2

ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Tables)	9 Months Ended
	Sep. 30, 2024
ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Summary of accounts payable and accrued expenses	​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, 2024 December 31, 2023 Accrued research and development ​ $ 2,968,508 ​ $ 2,263,934 Accrued compensation expenses ​ 247,210 ​ 716,307 Accrued professional fees ​ 83,950 ​ 58,388 Other accounts payable and accrued expenses ​ 19,097 ​ 3,809 Total ​ $ 3,318,765 ​ $ 3,042,438 ​

ISSUANCE OF EQUITY INTERESTS (T

ISSUANCE OF EQUITY INTERESTS (Tables)	9 Months Ended
	Sep. 30, 2024
ISSUANCE OF EQUITY INTERESTS
Summary of outstanding warrants	​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted Average ​ ​ Number of Warrants Exercise Price Balance at December 31, 2023 ​ ​ 6,195,456 ​ $ 3.28 Issued ​ — ​ ​ — Exercised ​ (59,211) ​ ​ 3.55 Balance at September 30, 2024 ​ 6,136,245 ​ $ 3.28

SHARE-BASED COMPENSATION (Table

SHARE-BASED COMPENSATION (Tables)	9 Months Ended
	Sep. 30, 2024
SHARE-BASED COMPENSATION
Schedule of fair value of options assumptions	​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Nine Months Ended ​ Sep 30, ​ 2024 ​ 2023 Expected term ​ 6.72 years ​ ​ 6.90 years Volatility ​ 103 % ​ ​ 98 % Dividend yield ​ — % ​ ​ — % Risk-free interest rate ​ 4.28 % ​ ​ 3.85 % Weighted average grant date fair value $ 2.59 ​ ​ $ 2.75 ​
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, 2023 2,985,000 ​ $ 5.64 ​ 7.81 ​ $ 251,550 Granted 895,000 ​ ​ 3.10 ​ 9.44 ​ ​ — Exercised — ​ ​ — ​ — ​ ​ — Forfeited — ​ ​ — ​ — ​ ​ — Outstanding, vested and expected to vest at September 30, 2024 3,880,000 ​ $ 5.05 ​ 7.61 ​ $ — Exercisable 2,915,556 ​ $ 5.68 ​ 7.09 ​ $ —

NATURE OF OPERATIONS (Details)

NATURE OF OPERATIONS (Details) - USD ($)						1 Months Ended	9 Months Ended
	Oct. 01, 2024	Nov. 15, 2023	May 16, 2023	Jul. 25, 2022	Jun. 29, 2021	Feb. 28, 2018	Sep. 30, 2024	Dec. 31, 2023
Warrant exercise price (in dollars per share)			$ 2.9999
Shares issued (in shares)			601,851	1,159,211	2,875,000
Gross proceeds from stock issue			$ 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							$ 5,762,564	$ 7,474,188
Number of warrants			731,482
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)	25,000						1,994,069
Gross proceeds from stock issue							$ 6,400,000
Aggregate offering price		$ 17,000,000					$ 8,000,000
At the Market Offering | Aggregate
Shares issued (in shares)							2,692,190
Gross proceeds from stock issue							$ 9,000,000
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 ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Effective tax rate	0%		0%
Current federal or state income tax expense	$ 0		$ 0
Tax credit receivable	51,127		51,127
Cash	5,762,564		5,762,564		$ 7,474,188
Research and development expense	$ 1,198,184	$ 1,348,985	$ 4,578,777	$ 4,100,954

SUMMARY OF SIGNIFICANT ACCOUN_4

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Major Vendor (Details) - Supplier Concentration Risk - Major vendors, combined	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Research and development expenditures
Concentration
Concentration Risk (as a percent)	44%	59%	44%	66%
Accounts payable and accrued expense
Concentration
Concentration Risk (as a percent)			65%		54%

ACCOUNTS PAYABLE AND ACCRUED _3

ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Details) - USD ($)	Sep. 30, 2024	Dec. 31, 2023
ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accrued research and development	$ 2,968,508	$ 2,263,934
Accrued compensation expenses	247,210	716,307
Accrued professional fees	83,950	58,388
Other accounts payable and accrued expenses	19,097	3,809
Total	$ 3,318,765	$ 3,042,438

ISSUANCE OF EQUITY INTERESTS (D

ISSUANCE OF EQUITY INTERESTS (Details) - USD ($)						1 Months Ended	3 Months Ended				9 Months Ended
	Oct. 01, 2024	Nov. 15, 2023	May 16, 2023	Jul. 25, 2022	Jun. 29, 2021	Jan. 31, 2024	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Jun. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023	Jun. 23, 2021
Equity
Common stock, Authorized (in shares)							200,000,000				200,000,000		200,000,000	200,000,000
Common stock, Outstanding (in shares)							16,770,378				16,770,378		14,468,229
Shares issued (in shares)			601,851	1,159,211	2,875,000
Purchase price (in dollars per share)			$ 3		$ 6
Cash issuance cost							$ 51,455	$ 10,601	$ 135,741	$ 456,314		$ 1,990,153
Number of warrants			731,482
Warrant exercise price (in dollars per share)			$ 2.9999
Proceeds from warrant exercises											$ 210,199
Pre-funded Warrant Exercise (in shares)			731,482	130,769
Gross proceeds from stock issue			$ 4,000,000	$ 4,200,000	$ 17,300,000
Net proceeds stock issuance			3,500,000
Warrants fair value increase adjustment			$ 2,000,000
Series A warrants
Equity
Number of warrants				1,289,980
Series B warrants
Equity
Number of warrants				1,289,980
Series C warrants
Equity
Number of warrants			1,333,333
Warrant exercise price (in dollars per share)			$ 3.26
Series D warrants
Equity
Number of warrants			1,333,333
Warrant exercise price (in dollars per share)			$ 3.26
Affiliate Investors | Series B warrants
Equity
Number of warrants exercised						59,211
Proceeds from warrant exercises						$ 200,000
Investor
Equity
Warrant exercise price (in dollars per share)			$ 0.0001
Investor | Series A warrants
Equity
Number of warrants			1,230,769
Investor | Series B warrants
Equity
Number of warrants			1,230,769
At the Market Offering
Equity
Shares issued (in shares)	25,000										1,994,069
Gross proceeds from stock issue											$ 6,400,000
Net proceeds stock issuance											6,211,210
Aggregate offering price		$ 17,000,000									$ 8,000,000
Percentage on gross offering proceeds		3%
Sale of stock price per share							$ 3.21				$ 3.21
Subscriptions receivable							$ 46,246				$ 46,246
Shares subscribed and unissued (in shares)							25,000				25,000
At the Market Offering | Aggregate
Equity
Shares issued (in shares)											2,692,190
Gross proceeds from stock issue											$ 9,000,000
Net proceeds stock issuance											$ 8,600,000
Sale of stock price per share							$ 3.35				$ 3.35

ISSUANCE OF EQUITY INTERESTS -

ISSUANCE OF EQUITY INTERESTS - Warrants outstanding (Details) - $ / shares	9 Months Ended
	Sep. 30, 2024	Dec. 31, 2023	May 16, 2023
Equity
Warrants outstanding (in shares), beginning balance	6,195,456
Warrants exercised (in shares)	(59,211)
Warrants outstanding (in shares), ending balance	6,136,245
Warrant exercise price, outstanding (in dollars per share)			$ 2.9999
Weighted Average
Equity
Warrant exercise price, outstanding (in dollars per share)	$ 3.28	$ 3.28
Warrant exercise price, exercised (in dollars per share)	$ 3.55
Warrants term	3 years 9 months 3 days

SHARE-BASED COMPENSATION - (Det

SHARE-BASED COMPENSATION - (Details) - USD ($)

1 Months Ended

3 Months Ended

9 Months Ended

Jun. 30, 2024

Feb. 29, 2024

Jun. 30, 2023

Feb. 28, 2023

Apr. 30, 2022

Jan. 31, 2022

Jul. 31, 2021

Jun. 30, 2021

Sep. 30, 2024

Sep. 30, 2023

Sep. 30, 2024

Sep. 30, 2023

Dec. 31, 2023

Apr. 30, 2021

Share-based compensation

Stock options granted (in shares)

895,000

Grant exercise price (in dollars per share)

$ 3.10

Total compensation expense not yet recognized

$ 2,517,214

$ 2,517,214

Weighted average vesting period

2 years 18 days

Intrinsic value of stock option

$ 251,550

Weighted average grant date fair value

$ 3.93

June 2021

Share-based compensation

Share based compensation expense

0

$ 181,720

$ 363,440

$ 545,160

Common stock shares available (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

0

490,917

981,833

1,472,750

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/consultants

Share-based compensation

Vesting term of options

36 months

January 2022

Share-based compensation

Share based compensation expense

18,950

18,950

56,850

56,850

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

5,377

5,377

16,133

16,133

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

109,521

109,521

328,563

255,549

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

0

$ 26,800

53,600

$ 26,800

Stock options granted (in shares)

50,000

Grant exercise price (in dollars per share)

$ 2.75

Vesting term of options

1 year

February 2024

Share-based compensation

Share based compensation expense

183,713

428,663

Stock options granted (in shares)

835,000

Grant exercise price (in dollars per share)

$ 3.15

Vesting term of options

36 months

June 2024

Share-based compensation

Share based compensation expense

$ 27,630

$ 27,630

Stock options granted (in shares)

60,000

Grant exercise price (in dollars per share)

$ 2.38

Vesting term of options

1 year

2021 Equity Incentive Plan

Share-based compensation

Common stock shares reserved

3,454,915

Common stock shares available (in shares)

171,720

171,720

SHARE-BASED COMPENSATION - Opti

SHARE-BASED COMPENSATION - Option pricing (Details) - $ / shares	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
SHARE-BASED COMPENSATION
Expected term	6 years 8 months 19 days	6 years 10 months 24 days
Volatility	103%	98%
Risk-free interest rate	4.28%	3.85%
Weighted average grant date fair value	$ 2.59	$ 2.75

SHARE-BASED COMPENSATION - Op_2

SHARE-BASED COMPENSATION - Option activity (Details) - USD ($)	9 Months Ended	12 Months Ended
	Sep. 30, 2024	Dec. 31, 2023
Options outstanding
Outstanding at the beginning of the period	2,985,000
Granted	895,000
Outstanding at the end of the period	3,880,000	2,985,000
Exercisable	2,915,556
Weighted Average Exercise Price
Weighted Average Exercise price, Beginning of the period	$ 5.64
Weighted Average Exercise price, granted	3.10
Weighted Average Exercise price, End of the period	5.05	$ 5.64
Exercisable	$ 5.68
Weighted Average Remaining Contractual Term (in years)
Weighted average contractual life	7 years 7 months 9 days	7 years 9 months 21 days
Weighted average remaining contractual term, Granted	9 years 5 months 8 days
Weighted Average Remaining Contractual Term, Exercisable	7 years 1 month 2 days
Aggregate Intrinsic Value
Aggregate Intrinsic Value, Beginning of the period	$ 251,550
Aggregate Intrinsic Value, End of the period		$ 251,550

SHARE-BASED PAYMENTS TO VENDO_2

SHARE-BASED PAYMENTS TO VENDORS (Details) - USD ($)	3 Months Ended							9 Months Ended
	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Dec. 31, 2023	Sep. 30, 2023	Mar. 31, 2023	Dec. 31, 2022	Sep. 30, 2024	Sep. 30, 2023
Share-based compensation
Share-based vendor payments								$ 640,500	$ 165,903
Warrants outstanding (in shares)	6,136,245			6,195,456				6,136,245
Fourth Quarter 2022
Share-based compensation
Share-based vendor payments (in shares)							43,186
Share-based vendor payments	$ 0				$ 0			$ 0	46,743
Contract term							6 months
Warrants outstanding (in shares)							10,096
Fourth Quarter 2022 | Minimum
Share-based compensation
Grant date fair value ($ per share)							$ 3.30
Fourth Quarter 2022 | Maximum
Share-based compensation
Grant date fair value ($ per share)							$ 3.67
First Quarter 2023
Share-based compensation
Share-based vendor payments (in shares)						36,000
Share-based vendor payments	0				0			0	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)				116,000
Share-based vendor payments	0				$ 0			76,600	$ 0
Fourth Quarter 2023 | Minimum
Share-based compensation
Grant date fair value ($ per share)				$ 1.50
Contract term				4 months
Fourth Quarter 2023 | Maximum
Share-based compensation
Grant date fair value ($ per share)				$ 5.18
Contract term				6 months
First Quarter 2024
Share-based compensation
Share-based vendor payments	0							$ 329,700
Shares to be granted pursuant to vendor agreements			120,000
Contract term			4 months
First Quarter 2024 | Minimum
Share-based compensation
Grant date fair value ($ per share)			$ 1.87
First Quarter 2024 | Maximum
Share-based compensation
Grant date fair value ($ per share)			$ 4.81
Second Quarter 2024
Share-based compensation
Share-based vendor payments (in shares)								116,000
Share-based vendor payments	$ 121,400							$ 234,200
Shares to be granted pursuant to vendor agreements		156,000
Contract term		6 months
Second Quarter 2024 | Minimum
Share-based compensation
Grant date fair value ($ per share)	$ 1.80							$ 1.80
Second Quarter 2024 | Maximum
Share-based compensation
Grant date fair value ($ per share)	$ 2.40							$ 2.40

NET LOSS PER SHARE (Details)

NET LOSS PER SHARE (Details) - shares	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Warrant
Antidilutive security
Potentially dilutive shares	6,136,245	6,136,245	6,136,245	6,136,245
Employee Stock Option
Antidilutive security
Potentially dilutive shares			3,880,000

COMMITMENTS AND CONTINGENCIES (

COMMITMENTS AND CONTINGENCIES (Details) - USD ($)	1 Months Ended
	Feb. 28, 2018	Sep. 30, 2024	Dec. 31, 2023
Contingency
Accrued research and development		$ 2,968,508	$ 2,263,934
ACX362E
Contingency
Future commitment	$ 700,000
Royalty payments	$ 50,000
Accrued research and development		$ 150,000	$ 150,000
Royalty payments on net sales (as a percent)	4%