Acurx Pharmaceuticals (ACXP) 10-Q 12 May 23 2023 Q1 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	3 Months Ended
	Mar. 31, 2023	May 12, 2023
Document and Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Mar. 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 Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Ex Transition Period	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		11,671,795
Entity Central Index Key	0001736243
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q1
Amendment Flag	false

CONDENSED INTERIM BALANCE SHEET

CONDENSED INTERIM BALANCE SHEETS - USD ($)	Mar. 31, 2023	Dec. 31, 2022
CURRENT ASSETS
Cash	$ 7,178,820	$ 9,111,751
Prepaid Expenses	206,601	264,955
TOTAL ASSETS	7,385,421	9,376,706
CURRENT LIABILITIES
Accounts Payable and Accrued Expenses	2,073,982	2,061,685
TOTAL CURRENT LIABILITIES	2,073,982	2,061,685
TOTAL LIABILITIES	2,073,982	2,061,685
COMMITMENTS AND CONTINGENCIES
SHAREHOLDERS' EQUITY
Common Stock; $.001 par value, 200,000,000 shares authorized, 11,671,795 and 11,627,609 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively	11,672	11,628
Additional Paid-In Capital	46,843,809	45,944,478
Accumulated Deficit	(41,544,042)	(38,641,085)
TOTAL SHAREHOLDERS' EQUITY	5,311,439	7,315,021
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY	$ 7,385,421	$ 9,376,706

CONDENSED INTERIM BALANCE SHE_2

CONDENSED INTERIM BALANCE SHEETS (Parenthetical) - $ / shares	Mar. 31, 2023	Dec. 31, 2022
CONDENSED INTERIM BALANCE SHEETS
Common stock, Par value	$ 0.001	$ 0.001
Common stock, Authorized (in shares)	200,000,000	200,000,000
Common stock, Issued (in shares)	11,671,795	11,627,609
Common stock, Outstanding (in shares)	11,671,795	11,627,609

CONDENSED INTERIM STATEMENTS OF

CONDENSED INTERIM STATEMENTS OF OPERATIONS - USD ($)	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
OPERATING EXPENSES
Research and Development	$ 1,015,583	$ 818,888
General and Administrative	1,887,374	1,851,250
TOTAL OPERATING EXPENSES	2,902,957	2,670,138
NET LOSS	$ (2,902,957)	$ (2,670,138)
LOSS PER SHARE
Basic net loss per common share	$ (0.25)	$ (0.26)
Diluted net loss per common share	$ (0.25)	$ (0.26)
Weighted average common shares outstanding basic	11,639,395	10,232,843
Weighted average common shares outstanding diluted	11,639,395	10,232,843

CONDENSED INTERIM STATEMENTS _2

CONDENSED INTERIM STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY - USD ($)	Common Stock	Additional Paid-In Capital	Accumulated Deficit	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		761,069		761,069
Share-Based Payments to Vendors	$ 44	188,056		188,100
Share-Based Payments to Vendors (in shares)	43,889
Cashless Warrant Exercise	$ 3	(3)
Cashless Warrant Exercise (in shares)	3,521
Net Loss			(2,670,138)	(2,670,138)
Balance at ending at Mar. 31, 2022	$ 10,263	39,897,456	(29,218,447)	10,689,272
Balance at ending, Common shares (in shares) at Mar. 31, 2022	10,263,202
Balance at beginning at Dec. 31, 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			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 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			11,671,795

CONDENSED INTERIM STATEMENTS _3

CONDENSED INTERIM STATEMENTS OF CASH FLOWS - USD ($)	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Cash Flow from Operating Activities:
Net Loss	$ (2,902,957)	$ (2,670,138)
Adjustments to Reconcile Net Loss to Net Cash Used in Operating Activities:
Share-Based Compensation	733,472	761,069
Share-Based Payments to Vendors	165,903	188,100
(Increase) / Decrease in:
Prepaid Expenses	58,354	55,850
Accounts Payable and Accrued Expenses	12,297	(210,881)
Net Cash Used in Operating Activities	(1,932,931)	(1,876,000)
Cash Flow from Financing Activities:
Net (Decrease) Increase in Cash	(1,932,931)	(1,876,000)
Cash at Beginning of Period	9,111,751	12,958,846
Cash at End of Period	$ 7,178,820	$ 11,082,846

NATURE OF OPERATIONS

NATURE OF OPERATIONS	3 Months Ended
	Mar. 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 infections (“CDI”). The Company’s primary activities since inception aside from organizational activities have included performing research and development activities relating to the development of its two antibiotic candidates and raising funds through equity offerings including its initial public offering (“IPO”) consummated in June 2021. The Company has not generated any revenues since inception. The Company has experienced net losses and negative cash flows from operations since inception and expects these conditions to continue for the foreseeable future. The Company has needed to raise capital from sales of its securities to sustain operations. On June 29, 2021, the Company completed the IPO, issuing 2,875,000 shares of common stock at a price of $6.00 per share, with gross proceeds of approximately $17.3 million. On July 27, 2022, the Company completed a registered direct offering and a concurrent private placement, issuing million. As of March 31, 2023, the Company had a cash balance of approximately

SUMMARY OF SIGNIFICANT ACCOUNTI

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	3 Months Ended
	Mar. 31, 2023
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying unaudited condensed interim financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and in accordance with the rules and regulations of the United States Securities Exchange Commission for interim reporting. In the opinion of management, these unaudited interim financial statements include all adjustments, consisting only of normal, recurring adjustments, necessary for a fair statement of the Company’s financial position, results of operations, and cash flows. The unaudited interim results of operations are not necessarily indicative of the results that may occur for the full fiscal year. The year-end condensed balance sheet data was derived from audited financial statements, but does not include all disclosures required by GAAP. Management believes that the disclosures provided herein are adequate when these unaudited condensed interim financial statements are read in conjunction with the audited financial statements and notes thereto as of December 31, 2022 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 months ended March 31, 2023, 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 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 March 31, 2023, the Company had cash of approximately $7.2 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 $1,015,583 and $818,888 for the three months ended March 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. 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 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 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 a major vendor that accounted for approximately 60% and 49% of the research and development expenditures for the three months ended March 31, 2023 and 2022, respectively. The same vendor also accounted for approximately 82% and 56% of the total accounts payable and accrued expenses as of March 31, 2023 and December 31, 2022, respectively. The Company continues to maintain this vendor relationship and anticipates incurring significant expenses with this vendor over the next 12 months.

ACCOUNTS PAYABLE AND ACCRUED EX

ACCOUNTS PAYABLE AND ACCRUED EXPENSES	3 Months Ended
	Mar. 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 March 31, 2023 and December 31, 2022 were as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ March 31, 2023 December 31, 2022 Accrued compensation expenses ​ $ 20,390 ​ $ 542,895 Accrued research and development ​ 1,910,749 ​ 1,405,536 Accrued professional fees ​ 124,430 ​ 83,715 Other accounts payable and accrued expenses ​ 18,413 ​ 29,539 Total ​ $ 2,073,982 ​ $ 2,061,685 ​

ISSUANCE OF EQUITY INTERESTS

ISSUANCE OF EQUITY INTERESTS	3 Months Ended
	Mar. 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 11,671,795 were outstanding as of March 31, 2023. On June 29, 2021, the Company completed an IPO issuing 2,875,000 shares of common stock at a price of $6.00 per share, resulting in net cash proceeds of approximately $14.8 million, with cash issuance costs of approximately $2.4 million. The outstanding Class A and Class B Membership Interests were converted to shares of common stock pursuant to a conversion ratio of one-for-two of the Membership Interests outstanding, resulting in the conversion of 14,082,318 Class A and Class B Membership Interests into 7,041,208 shares of common stock. Warrants to purchase Class A Membership Interests were converted to warrants to purchase common stock at the same one-for two conversion ratio, resulting in 1,437,577 warrants to purchase common stock with a weighted average exercise price of $2.88. ​ In connection with the IPO, the Company issued 150,000 warrants to the underwriter. Each warrant is exercisable for 4.5 years from December 21, 2021 at an exercise price of $7.50 per share. The Company used the Black-Scholes model to calculate the value of the warrants with an estimated fair value of $618,000. The inputs utilized in the calculation were as follows: four ​ On July 25, 2022, the Company entered into securities purchase agreements (the “Purchase Agreements”) with two of the Company’s executives and a member of the Company’s board of directors (collectively, the “Affiliate Investors”), and a single U.S. institutional investor (the “Investor”) pursuant to which the Company issued and sold in a registered direct offering an aggregate of 1,159,211 shares of common stock, par value $0.001 per share and pre-funded warrants to purchase an aggregate of 130,769 shares of common stock. The Affiliate Investors purchased an aggregate of 59,211 shares of common stock at a purchase price of $3.80 per share. The Investor purchased an aggregate of 1,100,000 shares of common stock at a purchase price of $3.25 per share and an aggregate of 130,769 prefunded warrants at a purchase price of $3.2499 per pre-funded warrant. The pre-funded warrants sold to the Investor have an exercise price of $0.0001 and were immediately exercisable. As of March 31, 2023, all of the pre-funded warrants were exercised. The Company also issued to the Affiliate Investors and the Investor, series A warrants to purchase The gross proceeds to the Company from the registered direct offering were $4.2 million and net proceeds after deducting the placement agents’ fees and other offering expenses payable by the Company were approximately $3.7 million. On July 25, 2022, the Company entered into a co-placement agent agreement (the “Placement Agent Agreement”), with two placement agents in connection with the registered direct offering pursuant to which the Company paid the Placement Agents a cash fee of $287,874 and issued to the Placement Agents an aggregate of 63,018 warrants to purchase shares of common stock. The warrants have an exercise price of of the weighted average public offering price of the aggregate number of shares of common stock sold in the registered direct offering to the Investor and Affiliate Investors) and expire on July 27, 2027. The Company used the Black-Scholes model to calculate the value of the warrants with an estimated fair value of . The inputs utilized in the calculation were as follows: volatility utilizing comparable companies. This amount was recorded as both an increase to additional paid-in capital and as a non-cash issuance cost of the offering. The following table summarizes information with respect to outstanding warrants to purchase common stock of the Company at March 31, 2023: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted Average ​ ​ Number of Warrants Exercise Price Balance, December 31, 2022 ​ ​ 4,217,809 ​ $ 3.29 Issued ​ — ​ ​ - Exercised ​ — ​ ​ - Balance, March 31, 2023 ​ 4,217,809 ​ $ 3.29 ​ The weighted average contractual life of the outstanding warrants is 3.8 years.

SHARE-BASED COMPENSATION

SHARE-BASED COMPENSATION	3 Months Ended
	Mar. 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, with an annual evergreen provision pursuant to the Plan. The Plan currently reserves an aggregate of 2,874,063 shares of common stock, subject to adjustments as provided in the Plan, of which 535,868 are currently still available for issuance as of March 31, 2023. 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 $181,720 for each of the three months ended March 31, 2023 and 2022, 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 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: ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended ​ March 31, 2023 Expected term ​ 7 years Volatility ​ 98 % Dividend yield ​ — % Risk-free interest rate ​ 3.85 % Weighted average grant date fair value ​ $ 2.81 ​ ​ A summary of the Company’s stock option activity is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended Weighted Average ​ March 31, 2023 Exercise Price Outstanding at the beginning of the period 2,467,500 $ 6.12 Granted 467,500 ​ ​ 3.41 Exercised — ​ ​ — Forfeited ​ — ​ ​ — Outstanding at the end of the period ​ 2,935,000 ​ $ 5.69 Exercisable ​ 1,714,861 ​ $ 6.12 ​ The total compensation expense not yet recognized as of March 31, 2023 was $4,824,706. The weighted average vesting period for the unvested options is 1.88 years. The intrinsic value of the stock options as of March 31, 2023 was $23,375 with a remaining weighted average contractual life of 8.53 years. The Company records the impact of any forfeitures of options as they occur.

SHARE-BASED PAYMENTS TO VENDORS

SHARE-BASED PAYMENTS TO VENDORS	3 Months Ended
	Mar. 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. In January 2022, the Company granted 13,889 shares of common stock at grant date fair value, pursuant to the agreement and recorded general and administrative expenses of $0 and $75,000 for the three months ended March 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 will be expensed over the service period and the equity component expensed consistent with the contractual vesting. The Company recorded general and administrative expenses of $0 and $113,100 for the three months ended March 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 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 will be expensed over the service period and the equity component will be 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

NET LOSS PER SHARE

NET LOSS PER SHARE	3 Months Ended
	Mar. 31, 2023
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 three months ended March 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 shares, consisting of 4,217,809 warrants and 2,935,000 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	3 Months Ended
	Mar. 31, 2023
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). There were no additional milestones reached as of March 31, 2023 and 2022. The Company is also obligated to make royalty payments equal to 4% of net sales of ACX-362E for a period of time equal to the last to expire of any applicable patents, as defined in the purchase agreement.

SUMMARY OF SIGNIFICANT ACCOUN_2

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)	3 Months Ended
	Mar. 31, 2023
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation	Basis of Presentation The accompanying unaudited condensed interim financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and in accordance with the rules and regulations of the United States Securities Exchange Commission for interim reporting. In the opinion of management, these unaudited interim financial statements include all adjustments, consisting only of normal, recurring adjustments, necessary for a fair statement of the Company’s financial position, results of operations, and cash flows. The unaudited interim results of operations are not necessarily indicative of the results that may occur for the full fiscal year. The year-end condensed balance sheet data was derived from audited financial statements, but does not include all disclosures required by GAAP. Management believes that the disclosures provided herein are adequate when these unaudited condensed interim financial statements are read in conjunction with the audited financial statements and notes thereto as of December 31, 2022 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 months ended March 31, 2023, 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 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 March 31, 2023, the Company had cash of approximately $7.2 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 $1,015,583 and $818,888 for the three months ended March 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. 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 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 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 a major vendor that accounted for approximately 60% and 49% of the research and development expenditures for the three months ended March 31, 2023 and 2022, respectively. The same vendor also accounted for approximately 82% and 56% of the total accounts payable and accrued expenses as of March 31, 2023 and December 31, 2022, respectively. The Company continues to maintain this vendor relationship and anticipates incurring significant expenses with this vendor over the next 12 months.

ACCOUNTS PAYABLE AND ACCRUED _2

ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Tables)	3 Months Ended
	Mar. 31, 2023
ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Summary of accounts payable and accrued expenses	​ ​ ​ ​ ​ ​ ​ ​ ​ March 31, 2023 December 31, 2022 Accrued compensation expenses ​ $ 20,390 ​ $ 542,895 Accrued research and development ​ 1,910,749 ​ 1,405,536 Accrued professional fees ​ 124,430 ​ 83,715 Other accounts payable and accrued expenses ​ 18,413 ​ 29,539 Total ​ $ 2,073,982 ​ $ 2,061,685

ISSUANCE OF EQUITY INTERESTS (T

ISSUANCE OF EQUITY INTERESTS (Tables)	3 Months Ended
	Mar. 31, 2023
ISSUANCE OF EQUITY INTERESTS
Summary of outstanding warrants	​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted Average ​ ​ Number of Warrants Exercise Price Balance, December 31, 2022 ​ ​ 4,217,809 ​ $ 3.29 Issued ​ — ​ ​ - Exercised ​ — ​ ​ - Balance, March 31, 2023 ​ 4,217,809 ​ $ 3.29 ​

SHARE-BASED COMPENSATION (Table

SHARE-BASED COMPENSATION (Tables)	3 Months Ended
	Mar. 31, 2023
SHARE-BASED COMPENSATION
Schedule of fair value of options assumptions	​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended ​ March 31, 2023 Expected term ​ 7 years Volatility ​ 98 % Dividend yield ​ — % Risk-free interest rate ​ 3.85 % Weighted average grant date fair value ​ $ 2.81 ​ ​
Schedule of stock option activity	​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended Weighted Average ​ March 31, 2023 Exercise Price Outstanding at the beginning of the period 2,467,500 $ 6.12 Granted 467,500 ​ ​ 3.41 Exercised — ​ ​ — Forfeited ​ — ​ ​ — Outstanding at the end of the period ​ 2,935,000 ​ $ 5.69 Exercisable ​ 1,714,861 ​ $ 6.12 ​

NATURE OF OPERATIONS (Details)

NATURE OF OPERATIONS (Details) - USD ($)			1 Months Ended
	Jul. 25, 2022	Jun. 29, 2021	Feb. 28, 2018	Mar. 31, 2023	Dec. 31, 2022
Shares issued during the period		2,875,000
Stock issue gross proceeds		$ 17,300,000
Share price (in dollars per share)		$ 6
Cash				$ 7,178,820	$ 9,111,751
Registered direct offering
Shares issued during the period	1,159,211
Stock issue gross proceeds	$ 4,200,000
Pre-funded Warrant Exercise (in shares)	130,769
Registered direct offering | Series A warrants
Number of warrants				1,289,980
Registered direct offering | Series B warrants
Number of warrants				1,289,980
Private Placement | Series A warrants
Number of warrants	1,289,980
Private Placement | Series B warrants
Number of warrants	1,289,980
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
	Mar. 31, 2023	Mar. 31, 2022	Dec. 31, 2022
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Effective tax rate	0%
Current federal or state income tax expense	$ 0
Cash	7,178,820		$ 9,111,751
Research and development expense	$ 1,015,583	$ 818,888

SUMMARY OF SIGNIFICANT ACCOUN_4

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Major Vendor (Details) - Supplier Concentration Risk - Vendor One	3 Months Ended		12 Months Ended
	Mar. 31, 2023	Mar. 31, 2022	Dec. 31, 2022
Research and development expenditures
Concentration
Concentration Risk (as a percent)	60%	49%
Accounts payable and accrued expense
Concentration
Concentration Risk (as a percent)	82%		56%

ACCOUNTS PAYABLE AND ACCRUED _3

ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Details) - USD ($)	Mar. 31, 2023	Dec. 31, 2022
ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accrued compensation expenses	$ 20,390	$ 542,895
Accrued research and development	1,910,749	1,405,536
Accrued professional fees	124,430	83,715
Other accounts payable and accrued expenses	18,413	29,539
Total	$ 2,073,982	$ 2,061,685

ISSUANCE OF EQUITY INTERESTS (D

ISSUANCE OF EQUITY INTERESTS (Details) - USD ($)	Jul. 25, 2022	Jun. 29, 2021	Mar. 31, 2023	Dec. 31, 2022	Jun. 23, 2021
Equity
Common stock, Authorized (in shares)			200,000,000	200,000,000	200,000,000
Common stock, Outstanding (in shares)			11,671,795	11,627,609
Shares issued during the period		2,875,000
Purchase price (in dollars per share)		$ 6
Proceeds from Initial Public Offering, net of issuance costs		$ 14,800,000
Cash issuance cost		2,400,000
Common stock, par value			$ 0.001	$ 0.001
Stock issue gross proceeds		$ 17,300,000
Members' Equity, Class A and Class B
Equity
Converted to shares of common stock		14,082,318
Converted shares of common stock		7,041,208
Members' Equity, Class A
Equity
Number of warrants		1,437,577
Warrant exercise price (in dollars per share)		$ 2.88
Underwriter
Equity
Number of warrants		150,000
Warrant exercise price (in dollars per share)		$ 7.50
Warrant exercisable term		4 years 6 months
Registered direct offering
Equity
Shares issued during the period	1,159,211
Common stock, par value	$ 0.001
Pre-funded Warrant Exercise (in shares)	130,769
Stock issue gross proceeds	$ 4,200,000
Proceeds from stock issue, net of costs	$ 3,700,000
Registered direct offering | Series A warrants
Equity
Number of warrants			1,289,980
Registered direct offering | Series B warrants
Equity
Number of warrants			1,289,980
Registered direct offering | Affiliate Investors
Equity
Shares issued during the period	59,211
Purchase price (in dollars per share)	$ 3.80
Warrant exercise price (in dollars per share)			$ 3.55
Registered direct offering | Affiliate Investors | Series A warrants
Equity
Number of warrants			59,211
Registered direct offering | Affiliate Investors | Series B warrants
Equity
Number of warrants			59,211
Registered direct offering | Investor
Equity
Shares issued during the period	1,100,000
Purchase price (in dollars per share)	$ 3.25
Warrant exercise price (in dollars per share)	$ 0.0001
Pre-funded Warrant Exercise (in shares)	130,769
Purchase price pre-funded warrant (in dollars per share)	$ 3.2499
Registered direct offering | Investor | Series A warrants
Equity
Number of warrants			1,230,769
Registered direct offering | Investor | Series B warrants
Equity
Number of warrants			1,230,769
Warrant exercise price (in dollars per share)			$ 3.25
Placement Agents
Equity
Cash issuance cost	$ 287,874
Number of warrants	63,018
Warrant exercise price (in dollars per share)	$ 3.60
Weighted average aggregate offering price (as a percent)	110%

ISSUANCE OF EQUITY INTERESTS -

ISSUANCE OF EQUITY INTERESTS - Fair Value (Details)	Jul. 25, 2022 USD ($) $ / shares Y	Jun. 29, 2021 USD ($) $ / shares Y
Underwriter
Warrants fair value
Fair value of Warrants		$ 618,000
Underwriter | Measurement Input, Expected Term
Warrants fair value
Measurement Input, Warrants | Y		4.5
Underwriter | Measurement Input, Risk Free Rate
Warrants fair value
Measurement Input, Warrants		0.79
Underwriter | Measurement Input, Share Price
Warrants fair value
Measurement Input, Warrants | $ / shares		6.26
Underwriter | Measurement Input, Volatility
Warrants fair value
Measurement Input, Warrants		94
Placement Agents
Warrants fair value
Fair value of Warrants	$ 171,409
Placement Agents | Measurement Input, Expected Term
Warrants fair value
Measurement Input, Warrants | Y	5
Placement Agents | Measurement Input, Risk Free Rate
Warrants fair value
Measurement Input, Warrants	2.82
Placement Agents | Measurement Input, Share Price
Warrants fair value
Measurement Input, Warrants | $ / shares	3.70
Placement Agents | Measurement Input, Volatility
Warrants fair value
Measurement Input, Warrants	95

ISSUANCE OF EQUITY INTERESTS _2

ISSUANCE OF EQUITY INTERESTS - Warrants (Details) - $ / shares	3 Months Ended
	Mar. 31, 2023	Dec. 31, 2022
Equity
Warrants outstanding (in shares), beginning balance	4,217,809
Warrants outstanding (in shares), ending balance	4,217,809
Weighted Average
Equity
Warrant exercise price, outstanding (in dollars per share)	$ 3.29	$ 3.29
Warrant exercisable term	3 years 9 months 18 days

SHARE-BASED COMPENSATION - (Det

SHARE-BASED COMPENSATION - (Details) - USD ($)		1 Months Ended				3 Months Ended
	Jan. 31, 2022	Feb. 28, 2023	Apr. 30, 2022	Jul. 31, 2021	Jun. 30, 2021	Mar. 31, 2023	Mar. 31, 2022	Apr. 30, 2021
Share-based compensation
Stock options granted (in shares)						467,500
Grant exercise price (in dollars per share)						$ 3.41
Total compensation expense not yet recognized						$ 4,824,706
Weighted average vesting period						1 year 10 months 17 days
Intrinsic value of stock option						$ 23,375
Weighted average contractual life						8 years 6 months 10 days
June 2021
Share-based compensation
Share based compensation expense						$ 181,720	$ 181,720
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						490,916	490,916
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						18,950	88,433
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						5,378	$ 0
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						$ 36,507
Stock options granted (in shares)		467,500
Grant exercise price (in dollars per share)		$ 3.41
Vesting term of options		36 months
2021 Equity Incentive Plan
Share-based compensation
Common stock shares reserved								2,874,063
Common stock shares available (in shares)						535,868

SHARE-BASED COMPENSATION - Opti

SHARE-BASED COMPENSATION - Option pricing (Details)	3 Months Ended
	Mar. 31, 2023 $ / shares
SHARE-BASED COMPENSATION
Expected term	7 years
Volatility	98%
Risk-free interest rate	3.85%
Weighted average grant date fair value	$ 2.81

SHARE-BASED COMPENSATION - Op_2

SHARE-BASED COMPENSATION - Option activity (Details)	3 Months Ended
	Mar. 31, 2023 $ / shares shares
Options outstanding
Outstanding at the beginning of the period | shares	2,467,500
Granted | shares	467,500
Outstanding at the end of the period | shares	2,935,000
Exercisable | shares	1,714,861
Weighted Average Exercise Price
Weighted Average Exercise price, Beginning of the period | $ / shares	$ 6.12
Weighted Average Exercise price, granted | $ / shares	3.41
Weighted Average Exercise price, End of the period | $ / shares	5.69
Exercisable | $ / shares	$ 6.12

SHARE-BASED PAYMENTS TO VENDO_2

SHARE-BASED PAYMENTS TO VENDORS (Details) - USD ($)	1 Months Ended	3 Months Ended
	Jan. 31, 2022	Mar. 31, 2023	Dec. 31, 2022	Mar. 31, 2022	Dec. 31, 2021
Share-based compensation
Share-based vendor payments		$ 165,903		$ 188,100
Warrants outstanding (in shares)		4,217,809	4,217,809
Fourth Quarter 2021
Share-based compensation
Share-based vendor payments (in shares)	13,889
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
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		$ 119,160
Grant date fair value ($ per share)		$ 3.31
Contract term		6 months

NET LOSS PER SHARE (Details)

NET LOSS PER SHARE (Details)	3 Months Ended
	Mar. 31, 2023 shares
Warrant
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Potentially dilutive shares	4,217,809
Stock Options
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Potentially dilutive shares	2,935,000

COMMITMENTS AND CONTINGENCIES (

COMMITMENTS AND CONTINGENCIES (Details) - ACX362E	1 Months Ended
	Feb. 28, 2018 USD ($)
Contingency
Future commitment	$ 700,000
Royalty payments	$ 50,000
Royalty payments on net sales (as a percent)	4%