Acurx Pharmaceuticals, Inc. Reports Full Year and Fourth Quarter Results and Provides Business Update

Rhea-AI Summary

Acurx Pharmaceuticals (NASDAQ: ACXP) reported full-year 2025 results and a business update on March 13, 2026. Key items: cash $7.6M, gross equity-line proceeds ~$4.0M in 2025, net loss $8.0M for 2025, and 2,348,113 shares outstanding.

Clinical highlights include a planned open-label 20-patient rCDI pilot, Phase 2 ibezapolstat results (96% clinical cure of 26 patients, no recurrence), a new USPTO patent to Dec 2039, and structural biology publication supporting the Pol IIIC inhibitor program.

Positive

• Cash balance of $7.6M as of December 31, 2025
• Phase 2 ibezapolstat: 96% clinical cure of 26 patients, no recurrence
• USPTO patent granted extending protection to December 2039
• Research & development expenses decreased by $3.6M year-over-year
• General & administrative expenses decreased by $2.4M year-over-year

Negative

• Net loss of $8.0M for the twelve months ended December 31, 2025
• Cash modest at $7.6M, may limit near-term financing flexibility

Market Reaction – ACXP

+4.19% $5.22

15m delay 33 alerts

+4.19% Since News

+27.2% Peak Tracked

-13.8% Trough Tracked

$5.22 Last Price

$4.46 $5.56 Day Range

+$513K Valuation Impact

$13M Market Cap

0.1x Rel. Volume

Following this news, ACXP has gained 4.19%, reflecting a moderate positive market reaction. Argus tracked a peak move of +27.2% during the session. Argus tracked a trough of -13.8% from its starting point during tracking. Our momentum scanner has triggered 33 alerts so far, indicating elevated trading interest and price volatility. The stock is currently trading at $5.22. This price movement has added approximately $513K to the company's valuation.

Data tracked by StockTitan Argus (15 min delayed). Upgrade to Silver for real-time data.

Key Figures

Quarter-end cash: $7.6 million Equity line proceeds 2025: $4.0 million R&D expenses 2025: $1.8 million +5 more

8 metrics

Quarter-end cash $7.6 million Cash as of Dec 31, 2025 vs $3.7 million Dec 31, 2024

Equity line proceeds 2025 $4.0 million Gross purchases under Equity Line of Credit, full year 2025

R&D expenses 2025 $1.8 million Full-year 2025 vs $5.4 million in 2024

G&A expenses 2025 $6.3 million Full-year 2025 vs $8.7 million in 2024

Net loss 2025 $8.0 million Full-year 2025 vs $14.1 million in 2024

Clinical cure rate 96% Ibezapolstat Phase 2 acute CDI trial, 26 patients

Pilot rCDI sample size 20 patients Planned open-label pilot trial in multiply-recurrent CDI

Shares outstanding 2,348,113 Common shares outstanding as of Dec 31, 2025

Market Reality Check

Price: $5.01 Vol: Volume 6,377,229 is at 0....

normal vol

$5.01 Last Close

Volume Volume 6,377,229 is at 0.82x its 20-day average of 7,817,347, indicating no major volume spike. normal

Technical Shares at $5.01 are trading slightly below the 200-day MA of $5.10 and about 76% under the $21.00 52-week high.

Peers on Argus

ACXP fell 16.92% while 2 sector peers in the momentum set also moved down (media...

2 Down

ACXP fell 16.92% while 2 sector peers in the momentum set also moved down (median -3.6%), and several mapped peers were flat or modestly negative, pointing to a broader biotech/pharma risk-off backdrop amplifying the move.

Historical Context

5 past events · Latest: Mar 09 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Mar 09	rCDI trial launch	Positive	+44.8%	Announced new ibezapolstat rCDI pilot and Phase 3‑ready CDI program.
Feb 16	Earnings call notice	Neutral	+0.5%	Scheduled date and logistics for upcoming FY/Q4 2025 results call.
Feb 02	New USPTO patent	Positive	+0.6%	Reported broad U.S. patent grant covering DNA pol IIIC inhibitors.
Nov 18	Research grant	Positive	+2.8%	Disclosed ~$375K Health~Holland grant for structural biology project.
Nov 12	Q3 earnings update	Negative	-10.8%	Reported Q3 2025 results, reverse split, and noted ongoing financings.

Pattern Detected

Positive clinical or patent news has often seen upside (e.g., March 9 rCDI trial, November 2025 grant), while earnings-related updates have coincided with weakness.

Recent Company History

Over the past several months, Acurx has advanced ibezapolstat toward Phase 3, added IP protection, and bolstered funding. On Nov 12, 2025, Q3 results and a reverse split were followed by a -10.75% move. Subsequent patent and grant news in late 2025 drew modest gains, while the Mar 9, 2026 rCDI trial launch saw a sharp +44.81% reaction. Today’s full‑year 2025 report, with reduced operating expenses and higher cash, fits into this capital‑constrained but clinically advancing trajectory.

Regulatory & Risk Context

Active S-3 Shelf · $50 million

Shelf Active

Active S-3 Shelf Registration 2025-07-09

$50 million registered capacity

An effective Form S-3 shelf filed on Jul 9, 2025 permits Acurx to issue up to $50 million of various securities over three years, with usage already evidenced by 424B3 takedowns. Any future drawdowns could fund trials but would add dilution for existing shareholders.

Market Pulse Summary

This announcement combines a full-year 2025 financial update with progress on ibezapolstat, includin...

Analysis

This announcement combines a full-year 2025 financial update with progress on ibezapolstat, including strong Phase 2 data showing a 96% cure rate in 26 CDI patients and plans for an open-label rCDI pilot in 20 patients. Operating expenses and net loss declined year over year, while cash rose to $7.6M. Investors may watch how Acurx balances funding needs under its $50M shelf with advancement into Phase 3 trials and recurrent CDI development.

Key Terms

uspTO, phase 3, open-label, equity line of credit, +1 more

5 terms

uspTO regulatory

"In February 2026, we announced that the USPTO granted a new patent for our Pol IIIC inhibitors"

United States Patent and Trademark Office (USPTO) is the federal agency that reviews and issues patents for inventions and registers trademarks for brand names and logos. For investors, USPTO decisions act like a gatekeeper for a company’s legal right to exclude competitors — similar to a property deed for ideas and brands — which can protect revenue, support pricing power, and affect a company’s long‑term value and risk profile.

phase 3 medical

"This will inform elements of a planned active-controlled, Phase 3 registration trial in the rCDI indication"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

open-label medical

"This new clinical trial in rCDI begins with an open-label pilot trial to gain experience"

Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.

equity line of credit financial

"the Company raised a total of approximately $1.5 million of gross proceeds through purchases under the Equity Line of Credit"

An equity line of credit is a loan that allows homeowners to borrow money against the value of their property, similar to having a flexible credit card secured by their home. It matters to investors because it provides a way for property owners to access cash for various needs, which can influence real estate markets and overall economic activity. This type of credit offers ongoing borrowing capacity, making it a valuable financial tool for those with significant property equity.

limited population pathway for antibacterial and antifungal drugs regulatory

"under the FDA's Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry published in 2020)"

A U.S. regulatory route that lets companies seek approval for antibacterial or antifungal medicines aimed at small, clearly defined patient groups who lack good treatment options, using clinical studies scaled to those populations rather than large, general trials. For investors, it matters because the pathway can speed approval and create premium pricing for a narrowly focused product, but the total sales opportunity is limited and carries clinical and regulatory uncertainty—think of a specialized tool sold at a high price to a small set of customers.

AI-generated analysis. Not financial advice.

STATEN ISLAND, N.Y., March 13, 2026 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today certain financial and operational results for the full year and fourth quarter ended December 31, 2025.

Highlights of the fourth quarter ended December 31, 2025, or in some cases shortly thereafter, include:

• In October 2025, the Company received gross proceeds from the exercise of 170,068 Series F Warrants of approximately $1.4 million.
  
  
• Also in October 2025, we were one of five companies to make a formal presentation at IDWeek in Atlanta at the session entitled New Antimicrobials in the Pipeline. Presenting on behalf of Acurx were Dr. Michael Silverman, our Medical Director, and Dr. Kevin Garey, Professor and Chair, University of Houston College of Pharmacy and the Principal Investigator for microbiology and microbiome aspects of the ibezapolstat clinical trial program. The Company's presentation included an update on ibezapolstat and its microbiome sparing properties. Also, presented were new colonic-microbiome data from a "state-of-the-art" mouse infection model showing a potential microbiome-sparing class effect of representative compounds from our DNA pol IIIC inhibitor preclinical pipeline.
  
  
• In November 2025, the Company announced that the Nature Communications Scientific Journal published results from its scientific collaboration with Leiden University Medical Center (LUMC) demonstrating structural biology research that reveals for the first time a DNA pol IIIC inhibitor, ibezapolstat, bound to its target. The publication is entitled: "A unique inhibitor conformation selectively targets the DNA polymerase PolC of Gram-positive priority pathogens." This is an important milestone in Acurx's highly productive scientific collaboration with LUMC in advancing development of these "new-to-nature" compounds fortifying the foundation for the rational development of this innovative class of antimicrobials against other Gram-positive priority pathogens.
  
  
• In February 2026, we announced that the USPTO granted a new patent for our Pol IIIC inhibitors covering composition of matter and method of use. This patent extends to December 2039, subject to extension under US patent rules.
  
  
• On March 9, 2026 we issued a press release announcing that we are launching a ground-breaking ibezapolstat clinical trial program in patients with recurrent CDI (or rCDI) that has the potential to shift the paradigm of treatment and prevention of rCDI from two agents to one. When coupled with ibezapolstat ("IBZ") Phase 2 results of being highly effective (96% clinical cure of 26 patients) in treating acute CDI with no recurrence in patients while sparing the gut microbiome, this new trial will position ibezapolstat as a candidate to be the first agent to demonstrate clinical success in both the treatment of CDI and the prevention of rCDI.
  
  
• This new clinical trial in rCDI begins with an open-label pilot trial to gain experience with IBZ in patients with multiply-recurrent CDI with at least 3 episodes of CDI within the past 12 months. This will inform elements of a planned active-controlled, Phase 3 registration trial in the rCDI indication to be implemented following favorable results from the open-label 20 patient trial. Upon subsequent successful completion of the Ph3 pivotal rCDI trial, and per the operative FDA procedure, Acurx plans to request FDA approval for treatment and prevention of rCDI under the FDA's Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry published in 2020).
  
  
• Acurx's clinical program in the broader CDI patient population is ready to Advance to Phase 3 international pivotal clinical trials. In this regard, we are very excited about the FDA's recent announcement published in the New England Journal of Medicine '…that a one-trial requirement will be FDA's new default standard [that is, for registration]'. If formalized, this would end the long-standing two-trial Phase 3 trial dogma. We look forward to FDA's further clarification and the potentially favorable implications to our clinical development programs, such as the opportunity to seek marketing approval for the broader CDI population with one pivotal clinical trial.

Full Year and Fourth Quarter and 2025 Financial Results

Cash Position:
The Company ended the quarter with cash totaling $7.6 million, compared to $3.7 million as of December 31, 2024. During the fourth quarter, the Company raised a total of approximately $1.5 million of gross proceeds through purchases under the Equity Line of Credit, with gross proceeds of purchases under the Equity Line of Credit totaling approximately $4.0 million for the full year.

R&D Expenses:
Research and development expenses for the three months ended December 31, 2025 were $0.3 million compared to $0.8 million for the three months ended December 31, 2024, a decrease of $0.5 million. The decrease was due primarily to a decrease in manufacturing costs of $0.2 million, and a decrease in consulting costs of $0.3 million as a result of the prior year trial-related expenses. For the twelve months ended December 31, 2025, research & development expenses were $1.8 million versus $5.4 million for the twelve months ended December 31, 2024. The decrease of $3.6 million was primarily due to a reduction of $2.6 million in manufacturing costs, and a $1.0 million decrease in consulting costs as prior year had higher expenses related to Phase 2b and Phase 3 preparation costs.

G&A Expenses:
General and administrative expenses for the three months ended December 31, 2025 were $1.3 million compared to $2.0 million for the three months ended December 31, 2024, a decrease of $0.7 million. The decrease was primarily due to a $0.3 million decrease in compensation-related costs and a $0.3 million decrease in professional fees. For the twelve months ended December 31, 2025, general & administrative expenses were $6.3 million versus $8.7 million for the twelve months ended December 31, 2024, a decrease of $2.4 million. The decrease was primarily due to a $0.9 million decrease in professional fees and a $1.4 million decrease in share-based compensation and a $0.4 million decrease in compensation costs, offset by a $0.3 million increase in legal costs.

Net Income/Loss:
The Company reported a net loss of $1.6 million or $0.73 per diluted share for the three months ended December 31, 2025 compared to a net loss of $2.8 million or $3.29 per diluted share for the three months ended December 31, 2024, and a net loss of $8.0 million or $5.32 per diluted share for the twelve months ended December 31, 2025, compared to a net loss of $14.1 million or $17.45 per share for the twelve months ended December 31, 2024, all for the reasons previously mentioned.

The Company had 2,348,113 shares outstanding as of December 31, 2025.

Conference Call

As previously announced, David P. Luci, President and Chief Executive Officer, and Robert G. Shawah, Chief Financial Officer, will host a conference call to discuss the results and provide a business update as follows:

Date:	Friday, March 13, 2026
Time:	8:00 a.m. ET
Toll free (U.S.):	1-877-790-1503; Conference ID: 13758852
International:	Click here for participant international Toll-Free access numbers https://www.incommconferencing.com/international-dial-in

About Ibezapolstat

Ibezapolstat is the Company's lead antibiotic candidate preparing for international Phase 3 clinical trials to treat patients with C. difficile Infection (CDI). Ibezapolstat is a novel, orally administered antibiotic being developed as a Gram-Positive Selective Spectrum (GPSS^®) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome. Acurx previously announced that it had received positive regulatory guidance from the EMA during its Scientific Advice Procedure which confirmed that the clinical, non-clinical and CMC (Chemistry Manufacturing and Controls) information package submitted to EMA supports advancement of the ibezapolstat Phase 3 program and if the Phase 3 program is successful, supports the submission of a Marketing Authorization Application (MAA) for regulatory approval in Europe. The information package submitted to EMA by the Company to which agreement has been reached with EMA included details on Acurx's two planned international Phase 3 clinical trials, 1:1 randomized (designed as non-inferiority vs vancomycin), primary and secondary endpoints, sample size, statistical analysis plan and the overall registration safety database. With mutually consistent feedback from both EMA and FDA, Acurx is well positioned to commence our international Phase 3 registration program

In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In January 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI.

About Acurx Pharmaceuticals, Inc. 

Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram+ specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin- resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE), drug- resistant Streptococcus pneumoniae (DRSP) and B. anthracis (anthrax; a Bioterrorism Category A Threat-Level pathogen).

Acurx's lead product candidate, ibezapolstat, for the treatment of C. difficile Infection(CDI) is Phase 3 ready to advance to international clinical trials subject to obtaining appropriate financing.The Company recently announced the launch of a ground-breaking clinical trial with ibezapolstat in patients with multiply-recurrent CDI (rCDI) that has the potential to shift the paradigm of treatment and prevention of rCDI from two agents to one. This new clinical trial in rCDI begins with an open-label pilot trial to gain experience with IBZ in patients with multiply-recurrent CDI with at least 3 episodes of CDI within the past 12 months. This will inform elements of a planned active-controlled, Phase 3 registration trial in the rCDI indication to be implemented following favorable results from the open-label 20 patient trial. Upon subsequent successful completion of the Ph3 pivotal rCDI trial, and per the operative FDA procedure, Acurx plans to request FDA approval for treatment and prevention of rCDI under the FDA's Limited Population Pathway for Antibacterial and Antifungal Drugs (Guidance for Industry, 2020).

The Company's preclinical pipeline includes development of an oral product candidate for treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections), upon which a development program for treatment of inhaled anthrax is being planned in parallel.

To learn more about Acurx Pharmaceuticals and its product pipeline, please visit www.acurxpharma.com. 

Forward-Looking Statements

Any statements in this press release about our future expectations, plans and prospects, including statements regarding our strategy, future operations, prospects, plans and objectives, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether ibezapolstat will benefit from the QIDP designation; whether ibezapolstat will advance through the clinical trial process on a timely basis; whether the results of the clinical trials of ibezapolstat will warrant the submission of applications for marketing approval, and if so, whether ibezapolstat will receive approval from the FDA or equivalent foreign regulatory agencies where approval is sought; whether, if ibezapolstat obtains approval, it will be successfully distributed and marketed; and other risks and uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the year ended December 31, 2025, and in the Company's subsequent filings with the Securities and Exchange Commission. Such forward- looking statements speak only as of the date of this press release, and Acurx disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law.

Investor Contact:

Acurx Pharmaceuticals, Inc.
David P. Luci
President & Chief Executive Officer
Tel: 917-533-1469
Email: davidluci@acurxpharma.com

ACURX PHARMACEUTICALS, INC. BALANCE SHEETS AS OF DECEMBER 31, 2025 and 2024
		December 31,			December 31,
		2025			2024
ASSETS
CURRENT ASSETS
Cash		$	7,556,100		$	3,706,713
Other Receivable			48,417			51,127
Prepaid Expenses			85,018			100,123
TOTAL ASSETS		$	7,689,535		$	3,857,963
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES
Accounts Payable and Accrued Expenses		$	2,420,943		$	3,242,842
TOTAL CURRENT LIABILITIES			2,420,943			3,242,842
TOTAL LIABILITIES			2,420,943			3,242,842
COMMITMENTS AND CONTINGENCIES
SHAREHOLDERS' EQUITY
Preferred Stock; $0.001 par value, 10,000,000 shares authorized, no shares issued and outstanding at December 31, 2025 and 2024			—			—
Common Stock; $0.001 par value, 250,000,000 shares authorized, 2,348,113 shares issued and outstanding at December 31, 2025 and 200,000,000 shares authorized, 851,534 shares issued and outstanding at December 31, 2024			2,348			852
Additional Paid-In Capital			80,554,738			67,936,225
Accumulated Deficit			(75,288,494)			(67,321,956)
TOTAL SHAREHOLDERS' EQUITY			5,268,592			615,121
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY		$	7,689,535		$	3,857,963

 

ACURX PHARMACEUTICALS, INC. STATEMENTS OF OPERATIONS YEARS ENDED DECEMBER 31, 2025 AND 2024
		Years Ended
		December 31,
		2025			2024
OPERATING EXPENSES
Research and Development		$	1,834,506		$	5,403,836
General and Administrative			6,257,477			8,719,391
TOTAL OPERATING EXPENSES			8,091,983			14,123,227
OPERATING LOSS			(8,091,983)			(14,123,227)
OTHER INCOME
Interest Income			125,445			20,124
NET LOSS		$	(7,966,538)		$	(14,103,103)
LOSS PER SHARE
Basic and diluted net loss per common share		$	(5.32)		$	(17.45)
Weighted average common shares outstanding, basic and diluted			1,498,793			808,168

 

View original content:https://www.prnewswire.com/news-releases/acurx-pharmaceuticals-inc-reports-full-year-and-fourth-quarter-results-and-provides-business-update-302712070.html

SOURCE Acurx Pharmaceuticals, Inc.

FAQ

What did Acurx (ACXP) report for cash and equity-line proceeds on March 13, 2026?

Acurx reported $7.6M cash on December 31, 2025 and gross equity-line proceeds of ~$4.0M for 2025. According to the company, October warrant exercises added roughly $1.4M and equity-line purchases totaled about $1.5M in Q4.

What are the Phase 2 ibezapolstat clinical results Acurx (ACXP) disclosed?

Ibezapolstat achieved a 96% clinical cure in 26 treated CDI patients with no recurrences observed. According to the company, these results also showed gut microbiome sparing, supporting further development into rCDI prevention trials.

What is Acurx's (ACXP) planned clinical path for recurrent CDI (rCDI)?

Acurx plans an open-label 20-patient pilot in multiply-recurrent CDI, then a planned active-controlled Phase 3 registration trial pending pilot results. According to the company, the program aims to pursue FDA approval for treatment and prevention under the LPAD pathway.

How does Acurx's (ACXP) new patent affect its Pol IIIC inhibitor program?

The USPTO granted a patent covering composition and method of use extending to December 2039. According to the company, this patent strengthens IP protection for Pol IIIC inhibitors and supports longer-term development plans.

How did Acurx (ACXP) perform financially in 2025 compared with 2024?

Acurx reported a $8.0M net loss in 2025 versus a $14.1M net loss in 2024, and reduced R&D and G&A expenses year-over-year. According to the company, cost reductions were driven by lower manufacturing and consulting expenses.