Acurx Pharmaceuticals, Inc., a clinical stage biopharmaceutical company, develops antibiotics to treat bacterial infections. Its lead antibiotic candidate is ibezapolstat, a novel mechanism of action that targets the polymerase IIIC enzyme that has completed Phase II clinical trial to treat patients with clostridium difficile infections. The company is also developing ACX-375C, a potential oral and parenteral treatment targeting gram-positive bacteria, including methicillin-resistant staphylococcus aureus, vancomycin-resistant enterococcus, and penicillin-resistant streptococcus pneumoniae. Acurx Pharmaceuticals, Inc. was incorporated in 2017 and is headquartered in Staten Island, New York.
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Here are 1-3 brief analogies for Acurx Pharmaceuticals (ACXP):
- Moderna for new antibiotics.
- Vertex Pharmaceuticals for C. difficile and other resistant bacterial infections.
- An early-stage Gilead Sciences focused on bacterial infections.
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- ACX-362E: An investigational, oral antibiotic in clinical development for the treatment of *Clostridioides difficile* infection (CDI) and other serious Gram-positive bacterial infections.
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Acurx Pharmaceuticals (ACXP) is a clinical-stage biopharmaceutical company focused on developing new classes of antibiotics for drug-resistant bacterial infections.
According to its latest public filings, Acurx Pharmaceuticals has not generated any revenues from the sale of products to date and does not expect to do so for at least the next several years. The company is currently focused on the research, development, and clinical trials of its drug candidates.
Therefore, Acurx Pharmaceuticals does not currently have major commercial customers (either companies or individuals) in the traditional sense of buyers of its products. Its primary activities are centered on advancing its drug candidates through the regulatory approval process.
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David P. Luci, President & CEO
Mr. Luci is a co-founder and the President & CEO of Acurx Pharmaceuticals. Prior to Acurx's IPO, he served as Managing Partner and Director since February 2018. He was previously the President and Chief Executive Officer of Dipexium Pharmaceuticals (Nasdaq: DPRX), a pharmaceutical company focused on antibiotic drug development, from February 2010 until its sale to PLx Pharma Inc. (Nasdaq: PLXP) in a merger valued at $69 million in April 2017. Mr. Luci also served as President and CEO of Bioenvision, an international biopharmaceutical company. He has indicated a pattern of successfully selling pharmaceutical companies he founded. His career began as a certified public accountant with Ernst & Whinney LLP (now Ernst & Young LLP) in their Healthcare Practice Group. He later practiced corporate law at Paul Hastings LLP, where his work included public and private mergers and acquisitions, corporate finance, restructurings, and private equity transactions, primarily in the healthcare industry.
Robert G. Shawah, Chief Financial Officer
Mr. Shawah is a co-founder and the Chief Financial Officer of Acurx Pharmaceuticals. Before the company's IPO, he served as Chief Accounting Officer and Vice President of Finance from January 2018 to June 2021. From 2014 until April 2017, Mr. Shawah was the Chief Accounting Officer of Dipexium Pharmaceuticals, Inc. (Nasdaq: DPRX), which was subsequently sold to PLX Pharma (Nasdaq: PLXP). With over 30 years of experience in finance and accounting, his background includes positions at Arthur Andersen PC, WR Grace & Co., and various early to mid-sized companies. He also served as Vice President of Baldwin Pearson & Co, a commercial real estate firm, and as a director for Ameri100, a software integration company. Mr. Shawah is a CPA in the Commonwealth of Pennsylvania (inactive).
Robert J. DeLuccia, Executive Chairman
Mr. DeLuccia is a co-founder and the Executive Chairman of Acurx Pharmaceuticals. Prior to the IPO, he was a Managing Partner and Director since February 2018. He served as Executive Chairman of Dipexium Pharmaceuticals (Nasdaq: DPRX) from February 2010 until its sale to PLx Pharma Inc. (Nasdaq: PLXP) in a $69 million merger in April 2017. From 2004 to 2009, Mr. DeLuccia held various roles at MacroChem, a publicly traded pharmaceutical company, including Chairman of the board of directors, President, and Chief Executive Officer. He also previously served as President and Chief Executive Officer of Immunomedics, Inc., another publicly-traded biopharmaceutical company, and as President of Sterling Winthrop, Inc. Mr. DeLuccia began his career at Pfizer, Inc., where he advanced to Director of Marketing and then Vice President of Marketing and Sales Operations. He is currently a member of the board of directors of IBEX Technologies Inc.
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Acurx Pharmaceuticals (ACXP), a clinical-stage biopharmaceutical company, faces several significant business risks, primarily stemming from the inherent challenges of drug development and its financial position.
The most critical risks include:
- Clinical and Regulatory Risk: As a clinical-stage company, Acurx Pharmaceuticals' success is heavily dependent on its lead product candidate, ibezapolstat, successfully completing Phase 3 clinical trials and obtaining regulatory approvals. The pharmaceutical development process, particularly for anti-infectives, is characterized by a very high rate of failure, even after promising early-stage results. Negative outcomes in trials or failure to secure regulatory approval would severely impact the company's viability.
- Financing and Liquidity Risk: Acurx is currently operating at a loss and has no products approved for commercial sale, meaning it generates no revenue. The company relies heavily on raising capital through equity offerings to fund its expensive clinical trials, which could lead to significant dilution for existing shareholders. Concerns exist regarding its relatively low cash balance and the substantial additional funding required for Phase 3 trials. Failure to secure adequate financing or a strategic partnership could jeopardize its operations and lead to potential bankruptcy. Additionally, the company received a notice from Nasdaq regarding non-compliance with minimum stockholders' equity, which could lead to delisting.
- Stock Price Volatility and Delisting Risk: The market price of Acurx's common stock is highly volatile, a common characteristic of biotechnology companies at the clinical development stage. This volatility is often influenced by news related to clinical trials, regulatory updates, and the broader sentiment toward the biotech sector. The risk of delisting from Nasdaq due to non-compliance with listing requirements further contributes to potential stock price fluctuations and could limit investors' ability to trade the company's securities.
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The recent approval and market entry of fecal microbiota-based therapies (FMTs) for the prevention of recurrent Clostridioides difficile infection (CDI) represent a clear emerging threat. Products such as Seres Therapeutics' Vowst (approved April 2023) and Ferring Pharmaceuticals' Rebyota (approved December 2022) offer a fundamentally different biological approach to managing a significant portion of the CDI patient population by restoring gut microbiota. While Acurx Pharmaceuticals' lead candidate, ibezapolstat, is an antibiotic aimed at treating active CDI, reducing recurrence is also a critical therapeutic objective for novel CDI treatments. As these FMTs become more widely adopted and integrated into clinical practice for recurrence prevention, they could potentially diminish the overall addressable market or the perceived value proposition for new antibiotics that aim to treat and prevent CDI recurrence by offering a non-antibiotic, microbiome-restoring alternative.
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Acurx Pharmaceuticals Addressable Market
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Acurx Pharmaceuticals (NASDAQ: ACXP) is a clinical-stage biopharmaceutical company that has not yet generated product revenue. Its future revenue growth over the next 2-3 years will be primarily driven by the advancement and potential commercialization of its lead antibiotic candidate, ibezapolstat, and the strategic activities supporting its pipeline.
Here are the key expected drivers of future revenue growth:
* Successful Completion of Phase 3 Clinical Trials for Ibezapolstat: The most significant driver of future revenue will be the successful completion of Phase 3 clinical trials for ibezapolstat, their lead antibiotic product candidate for the treatment of *C. difficile* infection (CDI). The company planned to initiate Phase 3 trials in June 2025. Positive results from these trials are crucial for regulatory approval and subsequent market entry.
* Regulatory Approval and Commercial Launch of Ibezapolstat: Following successful clinical trials, obtaining regulatory approval from bodies like the FDA will be a critical step. Once approved, the commercial launch of ibezapolstat will be the direct source of product revenue. The company has highlighted progress in its antibiotic development program, particularly for CDI, and has received positive regulatory feedback.
* Strategic Partnerships and Licensing Agreements: Acurx Pharmaceuticals is actively exploring potential partnerships and non-dilutive funding opportunities, including collaborations with governments and international organizations. Such partnerships could provide significant upfront payments, milestone payments, and/or royalties on future sales, thereby driving revenue growth.
* Development and Commercialization of Pipeline Candidates (e.g., ACX-375C): Beyond ibezapolstat, the company's preclinical antibiotic candidate, ACX-375C, targeting MRSA, VRE, and Anthrax infections, represents another potential, albeit longer-term, revenue driver. The granting of new patents for their DNA polymerase IIIC inhibitors, which expire in December 2039, constitutes a significant building block for ACX-375C's ongoing development. Successful progression of this or other candidates through clinical development and eventual commercialization would diversify and expand future revenue streams.
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Share Issuance
- Acurx Pharmaceuticals completed its Initial Public Offering (IPO) in June 2021, raising approximately $14.8 million in net proceeds through the sale of 2,875,000 shares at $6.00 per share.
- The company has conducted several registered direct offerings, including approximately $4.0 million in May 2023, $2.5 million in January 2025, and $1.1 million in March 2025, often accompanied by the issuance of warrants.
- In May 2025, Acurx entered into an equity line of credit agreement with Lincoln Park Capital Fund for up to $12 million in additional funding, and in July 2025, filed a shelf registration statement to enable the issuance of up to $50 million in various securities over the next three years.
Capital Expenditures
- Acurx Pharmaceuticals' financial statements consistently report "n/a" for capital expenditures, suggesting these are not a significant reported financial outlay for the company.
- As a clinical-stage biopharmaceutical company, the primary focus of its expenditures is on research and development activities for its antibiotic candidates, such as ibezapolstat.