UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark one)

☒Quarterly Report Under Section 13 or 15(d) of the Securities Exchange Act of 1934

For the Quarterly Period Ended June 30, 2023

☐Transition Report Under Section 13 or 15(d) of the Securities Exchange Act of 1934

Commission File Number 001-40536

Acurx Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

Delaware		82-3733567
State or other jurisdiction of incorporation or organization		(I.R.S. Employer Identification No.)

259 Liberty Ave Staten Island, NY		10305
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code (917) 533-1469

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol		Name of each exchange on which registered
Common Stock, $0.001 par value per share		ACXP		The Nasdaq Capital Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☒Yes ☐No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒Yes ☐ No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐		Accelerated filer ☐

Non-accelerated filer ☒		Smaller reporting company ☒

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒ No

As of August 11, 2023, there were 13,005,128 shares of common stock, $0.001 par value, issued and outstanding.

Table of Contents

Acurx Pharmaceuticals, Inc.

Table of Contents

			Page

PART I -		FINANCIAL INFORMATION	5

	Item 1.	Condensed Interim Financial Statements	5

		Condensed Interim Balance Sheets as of June 30, 2023 (unaudited) and December 31, 2022	5

		Condensed Interim Statements of Operations for the Three Months and Six Months Ended June 30, 2023 and 2022 (unaudited)	6

		Condensed Interim Statements of Changes in Shareholders’ Equity for the Three Months and Six Months Ended June 30, 2023 and 2022 (unaudited)	7

		Condensed Interim Statements of Cash Flows for the Six Months Ended June 30, 2023 and 2022 (unaudited)	8

		Notes to the Condensed Interim Financial Statements (unaudited)	9

	Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	16

	Item 3.	Quantitative and Qualitative Disclosures about Market Risk	26

	Item 4.	Controls and Procedures	26

PART II -		OTHER INFORMATION	27

	Item 1.	Legal Proceedings	27

	Item1A.	Risk Factors	27

	Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	53

	Item 3.	Defaults Upon Senior Securities	53

	Item 4.	Mine Safety Disclosure	53

	Item 5.	Other Information	53

	Item 6.	Exhibits	54

		Signatures	55

		Certificates

Table of Contents

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q (“Quarterly Report”) and certain information incorporated herein by reference contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). In this Quarterly Report, we refer to Acurx Pharmaceuticals, Inc., together with its subsidiary, as the “Company,” “we,” “our” or “us.” All statements other than statements of historical facts contained herein, including statements regarding our future results of operations and financial position, strategy and plans, and our expectations for future operations, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect” or the negative version of these words and similar expressions are intended to identify forward-looking statements.

We have based these forward-looking statements on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, strategy, short- and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in Part II, Item 1A “Risk Factors.” In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances included herein may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Forward-looking statements include, but are not limited to, statements about:

●

our ability to enroll patients in our ongoing Phase2b clinical trial;

●

our ability to obtain and maintain regulatory approval of ibezapolstat and/or our other product candidates;

●

our ability to successfully commercialize and market ibezapolstat and/or our other product candidates, if approved;

●

our ability to contract with third-party suppliers, manufacturers and other service providers and their ability to perform adequately;

●

the potential market size, opportunity and growth potential for ibezapolstat and/or our other product candidates, if approved;

●

our ability to build our own sales and marketing capabilities, or seek collaborative partners, to commercialize ibezapolstat and/or our other product candidates, if approved;

●

our ability to obtain funding for our operations;

●

the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs;

●

the timing of anticipated regulatory filings;

●

the timing of availability of data from our clinical trials;

●

the impact of the ongoing COVID-19 pandemic and our response to it;

●

the accuracy of our estimates regarding expenses, capital requirements and needs for additional financing;

●

our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals;

●

our ability to advance product candidates into, and successfully complete, clinical trials;

●

our ability to recruit and enroll suitable patients in our clinical trials and the timing of enrollment;

Table of Contents

●

the timing or likelihood of the accomplishment of various scientific, clinical, regulatory and other product development objectives;

●

the pricing and reimbursement of our product candidates, if approved;

●

the rate and degree of market acceptance of our product candidates, if approved;

●

the implementation of our business model and strategic plans for our business, product candidates and technology;

●

the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;

●

developments relating to our competitors and our industry;

●

the development of major public health concerns, including the novel coronavirus outbreak or other pandemics arising globally, and the future impact of it and COVID-19 on our clinical trials, business operations and funding requirements;

●

the effects of the recent disruptions to and volatility in the credit and financial markets in the United States and worldwide from the conflict between Russia and Ukraine;

●

the volatility of the price of our common stock;

●

our financial performance; and

●

other risks and uncertainties, including those listed in “Risk Factors.”

Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance or achievements. In addition, neither we nor any other person assumes responsibility for the accuracy and completeness of any of these forward-looking statements. Any forward-looking statement made by us in this Quarterly Report speaks only as of the date on which it is made. We disclaim any duty to update any of these forward-looking statements after the date of this Quarterly Report to conform these statements to actual results or revised expectations.

Other risks may be described from time to time in our filings made under applicable securities laws. New risks emerge from time to time. It is not possible for our management to predict all risks. All forward-looking statements in this Quarterly Report speak only as of the date made and are based on our current beliefs and expectations. We undertake no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Table of Contents

PART I—FINANCIAL INFORMATION

ITEM 1. CONDENSED INTERIM FINANCIAL STATEMENTS.

ACURX PHARMACEUTICALS, INC.

CONDENSED INTERIM BALANCE SHEETS


	June 30,		December 31,
	2023		2022
	(unaudited)		(Note 2)
ASSETS

CURRENT ASSETS
Cash	$	9,145,835	$	9,111,751
Prepaid Expenses		89,942		264,955
TOTAL ASSETS	$	9,235,777	$	9,376,706

LIABILITIES AND SHAREHOLDERS’ EQUITY

CURRENT LIABILITIES
Accounts Payable and Accrued Expenses	$	3,019,408	$	2,061,685
TOTAL CURRENT LIABILITIES		3,019,408		2,061,685

TOTAL LIABILITIES		3,019,408		2,061,685

COMMITMENTS AND CONTINGENCIES

SHAREHOLDERS' EQUITY
Common Stock; $.001 par value, 200,000,000 shares authorized, 13,005,128 and 11,627,609 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively		13,005		11,628
Additional Paid-In Capital		51,192,646		45,944,478
Accumulated Deficit		(44,989,282)		(38,641,085)

TOTAL SHAREHOLDERS’ EQUITY		6,216,369		7,315,021

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY	$	9,235,777	$	9,376,706

See accompanying notes to the condensed interim financial statements.

Table of Contents

ACURX PHARMACEUTICALS, INC.

CONDENSED INTERIM STATEMENTS OF OPERATIONS


	Three Months Ended				Six Months Ended
	June 30,				June 30,
	2023		2022		2023		2022
	(unaudited)		(unaudited)		(unaudited)		(unaudited)
OPERATING EXPENSES
Research and Development	$	1,736,386	$	911,692	$	2,751,969	$	1,730,580
General and Administrative		1,708,854		1,708,841		3,596,228		3,560,090

TOTAL OPERATING EXPENSES		3,445,240		2,620,533		6,348,197		5,290,670
		<

SEC Form 10-Q filed by Acurx Pharmaceuticals Inc.