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Like an early-stage Gilead Sciences, but focused on developing groundbreaking antibiotics for difficult bacterial infections.

A small, specialized biotech aiming to pioneer a new generation of antibiotics, much like how Genentech blazed a trail for biologics.

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• ibezapolstat: A novel antibiotic candidate targeting the polymerase IIIC enzyme for the treatment of clostridium difficile infections.
• ACX-375C: A potential oral and parenteral treatment designed to target various gram-positive bacteria, including MRSA and VRE.

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Acurx Pharmaceuticals, Inc. (ACXP) is a clinical-stage biopharmaceutical company focused on the development of antibiotics. Its lead product candidates, such as ibezapolstat and ACX-375C, are currently in clinical trials and have not yet received regulatory approval for commercial sale.

As a result, Acurx Pharmaceuticals does not currently have major customers in the traditional sense of selling commercial products to other companies (e.g., pharmaceutical distributors, hospitals) or directly to individuals. The company is primarily engaged in research and development activities aimed at bringing its drug candidates to market.

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• Novotech
• PPD, Inc. (services now part of Thermo Fisher Scientific Inc. (Symbol: TMO))

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David P. Luci, President & CEO

Mr. Luci is a co-founder and has served as President & CEO of Acurx Pharmaceuticals. Before the company's IPO, he was a Managing Partner and Director since February 2018. Mr. Luci previously held the position of President and Chief Executive Officer of Dipexium Pharmaceuticals (Nasdaq: DPRX), a pharmaceutical company focused on antibiotic drug development, from February 2010 until its acquisition by PLx Pharma Inc. (Nasdaq: PLXP) in a $69 million merger in April 2017. He also served on the board of directors of Abeona Therapeutics and as a board member and President of MacroChem. Earlier in his career, he was Executive Vice President, Chief Financial Officer, General Counsel, and Corporate Secretary of Bioenvision, Inc., an international biopharmaceutical company. Mr. Luci began his career as a certified public accountant with Ernst & Whinney LLP and later practiced corporate law at Paul Hastings LLP, specializing in public and private mergers and acquisitions, corporate finance, restructurings, and private equity transactions within the healthcare industry. He has indicated a pattern of successfully leading and selling pharmaceutical companies he founded.

Robert G. Shawah, Co-Founder & Chief Financial Officer

Mr. Shawah is a co-founder and the Chief Financial Officer of Acurx Pharmaceuticals, having served as Chief Accounting Officer and Vice President of Finance from January 2018 to June 2021 before assuming his current role. Prior to Acurx, he was the Chief Accounting Officer of Dipexium Pharmaceuticals, Inc. (Nasdaq: DPRX) from 2014 until its sale to PLX Pharma (Nasdaq: PLXP) in April 2017. With over 30 years of experience in finance and accounting, his background includes positions at Arthur Andersen PC, WR Grace & Co., and other companies. He is a CPA (inactive) and holds a Bachelor of Science in Business Administration (Accounting) from Bucknell University.

Robert J. DeLuccia, Co-Founder & Executive Chairman

Mr. DeLuccia is a co-founder and the Executive Chairman of Acurx Pharmaceuticals, and prior to the company's IPO, he served as Managing Partner and Director since February 2018. He was previously the Executive Chairman of Dipexium Pharmaceuticals (Nasdaq: DPRX) from February 2010 until its sale to PLx Pharma Inc. (Nasdaq: PLXP) in April 2017 for $69 million. Mr. DeLuccia's extensive career also includes serving as Chairman, President, and Chief Executive Officer of MacroChem, a publicly traded pharmaceutical company, and as President and Chief Executive Officer of Immunomedics, Inc., another publicly-traded biopharmaceutical company. He also served as President of Sterling Winthrop, Inc. (later a U.S. subsidiary of Sanofi-Aventis). Mr. DeLuccia began his career at Pfizer, Inc. as a pharmaceutical sales representative. He holds a Bachelor of Business Administration and an MBA from Iona College.

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The key risks for Acurx Pharmaceuticals (ACXP) are:

1. Clinical Trial and Regulatory Approval Risk: As a clinical-stage biopharmaceutical company, Acurx Pharmaceuticals' success hinges entirely on the successful outcome of its lead drug candidate, ibezapolstat, in advanced clinical trials, particularly the upcoming Phase III for Clostridioides difficile infections. Failure to demonstrate efficacy and safety in these trials, or delays in trial completion, would severely impact the company. Even with positive trial results, there is no guarantee of obtaining regulatory approval from health authorities like the FDA, which is essential for commercialization.
2. Funding and Commercialization Risk: Developing and bringing a new drug to market is an extremely capital-intensive process. Acurx Pharmaceuticals will require significant additional financing to complete Phase III trials for ibezapolstat, advance its other candidate (ACX-375C), and build the infrastructure necessary for potential commercialization. There is a risk that the company may not be able to raise sufficient capital on favorable terms or at all. Furthermore, even if approved, the successful commercialization of new antibiotics can be challenging due to pricing pressures, reimbursement complexities, and the need for judicious use to combat antimicrobial resistance.
3. Limited Pipeline and Competition Risk: Acurx Pharmaceuticals currently has a limited pipeline, with its primary focus on ibezapolstat and an earlier-stage candidate, ACX-375C. This concentration on a few assets means that the company is highly dependent on their success. The antibiotic market is also competitive, with other pharmaceutical companies developing new treatments. There is a risk that competitors may develop more effective, safer, or more cost-effective treatments, or bring their products to market sooner, thereby limiting the potential market share and profitability of Acurx Pharmaceuticals' candidates.

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Addressable Markets for Acurx Pharmaceuticals (ACXP) Main Products

Acurx Pharmaceuticals' lead antibiotic candidate, ibezapolstat, targets Clostridioides difficile infections (CDI). The global market for Clostridioides difficile infections was valued at approximately USD 9.82 billion in 2024 and is projected to reach USD 16.88 billion by 2032, with a compound annual growth rate (CAGR) of 7.00% from 2025 to 2032. Another source estimates the global Clostridium difficile infection treatment market size at USD 1.91 billion in 2024, expected to grow at a CAGR of 5.9% to reach USD 2.87 billion by 2030. The 7 Major Markets (7MM), which include the United States, EU4 (Germany, Spain, Italy, and France), the United Kingdom, and Japan, for Clostridium difficile infection treatments reached USD 9.4 billion in 2024 and are anticipated to reach USD 15.4 billion by 2035, growing at a CAGR of 4.54% from 2025-2035. For the United States specifically, the Clostridium difficile infection (CDI) treatment market is estimated at USD 0.71 billion in 2024 and is projected to reach approximately USD 0.94 billion by 2030, with a CAGR of 4.8%. The U.S. also holds the largest patient pool for Clostridium difficile infection and represents the largest market for its treatment. Another report stated that the Clostridioides difficile infection market size across the 7MM was valued at USD 551 million in 2025 and is expected to reach approximately USD 1,715 million by 2034, growing at a CAGR of 13.5%. In the US alone, approximately 500,000 Americans are affected by C. difficile infection annually, costing the healthcare system an estimated $5 billion each year.

Acurx Pharmaceuticals is also developing ACX-375C, an oral and parenteral treatment targeting gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE), and penicillin-resistant Streptococcus pneumoniae (PRSP). The global market for gram-positive bacterial infections was estimated at USD 13.28 billion in 2026 and is forecast to reach USD 16.89 billion by 2031, growing at a 4.92% CAGR over 2026-2031. Another analysis valued the global Gram Positive Bacterial Infections Market at USD 8.96 billion in 2025, with a projected growth to USD 14.72 billion by 2033 at a CAGR of 6.40%. North America held a significant share of this market, with a market size of USD 3.32 billion in 2025. The global VRE and MRSA antibiotic market size was valued at USD 3.5 billion in 2023 and is expected to reach USD 5.8 billion by 2032, with a CAGR of 5.5%. Specifically for the MRSA drugs market, the global valuation was USD 2.15 billion in 2023, with an expected CAGR of 5.51% from 2024 to 2030. North America leads the VRE and MRSA antibiotic market, accounting for 45% of the market share.

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1. Successful Advancement and Regulatory Approval of Ibezapolstat for Recurrent C. difficile Infection (rCDI): Acurx's primary revenue driver hinges on the successful completion of Phase 3 clinical trials and subsequent regulatory approval of ibezapolstat for recurrent C. difficile infection. The company plans to initiate an open-label pilot trial for rCDI, with the first patient expected to enroll in Q4 2026, which will inform a subsequent pivotal Phase 3 registration trial. Ibezapolstat has received FDA Qualified Infectious Disease Product (QIDP) and Fast-Track designations, as well as EMA SME status, which aim to expedite its development and regulatory review pathways. The potential for FDA approval under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) could further accelerate market entry.
2. Formation of Commercialization or Licensing Partnerships for Ibezapolstat: Given Acurx's status as a clinical-stage company, a significant driver of future revenue will be the successful execution of commercialization or licensing agreements for ibezapolstat with larger pharmaceutical partners upon regulatory approval. Such partnerships are anticipated to provide upfront payments, milestone payments, and royalties from future sales, representing the company's initial and most substantial revenue streams.
3. Advancement of ACX-375C into Clinical Development: Progress in the development of ACX-375C, Acurx's preclinical candidate targeting serious Gram-positive bacterial infections like MRSA and VRE, could attract strategic collaborations or licensing opportunities. While earlier stage than ibezapolstat, successful advancement of this candidate into clinical trials within the next 2-3 years could generate revenue through milestone payments or partnership agreements, diversifying the company's future revenue potential.
4. Securing Non-Dilutive Funding through Government Grants and Collaborations: Although not direct product sales, the successful procurement of significant non-dilutive funding, such as government grants or strategic collaborations for pipeline development, will be crucial. This funding would enable the continuation and acceleration of clinical trials and research efforts for both ibezapolstat and ACX-375C, indirectly driving future revenue by de-risking and advancing potential commercial products.

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Share Issuance

• Acurx Pharmaceuticals refreshed its $50 million Form S-3 shelf registration statement in 2025, enabling the company to issue up to $50 million of various securities over the subsequent three years.
• In October 2025, Acurx Pharmaceuticals received approximately $1.4 million in gross proceeds from the exercise of 170,068 Series F Warrants.
• During the full year 2025, the company raised approximately $4.0 million in gross proceeds through its Equity Line of Credit.

Inbound Investments

• A warrant-inducement transaction on June 17, 2025, resulted in approximately $2.3 million net cash for Acurx from the exercise of existing warrants.
• The exercise of Series F Warrants in October 2025 generated approximately $1.4 million in gross proceeds for the company.
• Acurx Pharmaceuticals received approximately $4.0 million in gross proceeds from its Equity Line of Credit during the entirety of 2025.

Capital Expenditures

• Acurx Pharmaceuticals' financial statements consistently report "n/a" for capital expenditures, indicating they are not a significant reported financial outlay.
• As a clinical-stage biopharmaceutical company, the primary focus of its expenditures is on research and development activities for its antibiotic candidates.
• Research and development expenses for the twelve months ended December 31, 2025, were $1.8 million, representing a decrease from $5.4 million in 2024 due to reduced manufacturing and consulting costs.