Financial Data and Key Metrics Changes - The company ended Q3 2025 with cash totaling $5.9 million, an increase from $3.7 million as of December 31, 2024 [11] - The net loss for Q3 2025 was $2 million, or $1.23 per diluted share, compared to a net loss of $2.8 million, or $3.45 per diluted share for Q3 2024 [14] - For the nine months ended September 30, 2025, the net loss was $6.4 million, or $5.01 per diluted share, compared to a net loss of $11.3 million, or $14.23 per share for the same period in 2024 [14] Business Line Data and Key Metrics Changes - Research and development expenses for Q3 2025 were $0.4 million, down from $1.2 million in Q3 2024, primarily due to a decrease in manufacturing and consulting costs [11][12] - General and administrative expenses remained consistent at $1.6 million for Q3 2025 compared to Q3 2024, with a slight decrease in compensation-related costs offset by an increase in legal fees [12] Market Data and Key Metrics Changes - The company regained compliance with NASDAQ listing requirements after a 1-for-20 reverse stock split on August 4, 2025 [4][5] - Acurx has obtained multiple patents for its DNA polymerase 3C inhibitors, including a new patent granted by the Australian Patent Office [5][8] Company Strategy and Development Direction - The company is focused on advancing its ibezapolstat program, which has shown promising results in treating C. diff infections [9][10] - Acurx is pursuing funding opportunities for a phase three clinical trial program for ibezapolstat and is considering alternative pathways for success [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating the macroeconomic environment and industry challenges while continuing to strengthen ibezapolstat's competitive profile [10] - The company recognizes November as C. diff Awareness Month and supports initiatives for education and prevention [10] Other Important Information - The company has FDA QIDP and FAST TRACK designations for ibezapolstat, which could significantly impact the economic burden of C. diff infections in the U.S. [10] - Acurx is actively engaged in scientific collaborations, with recent publications highlighting the structural biology of ibezapolstat [8] Q&A Session Summary Question: Potential for FDA to prioritize domestically manufactured novel antibiotics - Management sees potential for increased prioritization but noted uncertainty regarding the PASTOR Act and its impact on antibiotic funding [18][19] Question: Impact of proposed clinical priority review voucher framework - The regulatory approach and commercial strategy will remain the same, with plans to utilize the program at the appropriate time [21][22] Question: Filing for approval based on phase two ibezapolstat data - Management indicated that a safety database is required, and phase three trial data will be necessary for regulatory approval [23][25] Question: Timing around potential partnership discussions - Management expressed optimism about potential partnership news by the next earnings call but could not provide specific timelines [36][37] Question: QIDP and FAST TRACK designation expectations - Once obtained, these designations are maintained indefinitely without specific movement requirements [38] Question: Future operational expenses - Management anticipates that operational costs will continue to gradually decrease while maintaining a steady financial position [39]

Core Insights - Acurx Pharmaceuticals reported financial and operational results for Q3 2025, highlighting a cash position of $5.9 million, an increase from $3.7 million at the end of 2024, and a net loss of $2.0 million for the quarter, an improvement from a net loss of $2.8 million in Q3 2024 [2][6]. Financial Performance - Cash Position: The company ended Q3 2025 with $5.9 million in cash, up from $3.7 million at the end of 2024. The company raised approximately $1.7 million through an Equity Line of Credit and an additional $1.4 million from a warrant exercise post-quarter [2]. - R&D Expenses: R&D expenses for Q3 2025 were $0.4 million, down from $1.2 million in Q3 2024, primarily due to reduced manufacturing and consulting costs. For the nine months ended September 30, 2025, R&D expenses totaled $1.6 million compared to $4.6 million in the same period of 2024 [3]. - G&A Expenses: General and administrative expenses remained stable at $1.6 million for Q3 2025, consistent with Q3 2024. For the nine months ended September 30, 2025, G&A expenses were $4.9 million, down from $6.8 million in 2024 [4][5]. - Net Income/Loss: The company reported a net loss of $2.0 million or $1.23 per diluted share for Q3 2025, compared to a net loss of $2.8 million or $3.45 per diluted share in Q3 2024. For the nine months ended September 30, 2025, the net loss was $6.4 million, improving from $11.3 million in the same period of 2024 [6]. Operational Highlights - Patent Developments: In September 2025, Acurx received a new patent from the Australian Patent Office for its class of DNA polymerase IIIC inhibitors, adding to its existing patents in the U.S., Israel, Japan, and India [4]. - Stockholder Approval: Stockholders approved an amendment to increase the total number of authorized shares from 200 million to 250 million, which was filed with the Delaware Secretary of State [4]. - Conference Presentation: In October 2025, Acurx presented at IDWeek in Atlanta, discussing the microbiome-sparing properties of its lead antibiotic candidate, ibezapolstat [4]. - Scientific Publication: Acurx announced the publication of research in Nature Communications, detailing the structural biology of ibezapolstat, marking a significant milestone in its collaboration with Leiden University Medical Center [4]. Product Development - Ibezapolstat: The lead antibiotic candidate is preparing for international Phase 3 clinical trials to treat C. difficile Infection (CDI). It is a novel, orally administered antibiotic with a Gram-Positive Selective Spectrum [8][10]. - Regulatory Guidance: Acurx received positive regulatory guidance from the EMA, confirming that its clinical and non-clinical data supports the advancement of the ibezapolstat Phase 3 program [9].

As filed with the Securities and Exchange Commission on October 20, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ACURX PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) As soon as practicable after the effective date of this registration statement. If any of the securities being registered on this Form ...

Core Insights - Several companies have experienced significant stock price increases, attracting investor attention and market analysis [1] Company Summaries - **Xenetic Biosciences, Inc.**: Achieved a 142.31% increase in stock price, closing at $10.39, with a trading volume of 45,373,947. The company focuses on immuno-oncology technologies and has expanded its partnership with The Scripps Research Institute to advance CAR T-cell therapies [2] - **bioAffinity Technologies, Inc.**: Stock price rose by 108.60% to $0.48, with a volume of 29,850. The company specializes in non-invasive cancer diagnosis and treatment, showcasing the clinical value of its CyPath® Lung in detecting early-stage lung cancer [3] - **GigCapital7 Corp.**: Recorded an 89.43% increase in stock price, ending at $1.58. This SPAC is gaining interest due to its business combination with BigBear.ai, which has a pro forma enterprise value of $1.378 billion and aims to capitalize on AI/ML market opportunities [4] - **AlphaTON Capital Corp.**: Experienced an 85.48% rise in stock price to $10.35. The company is transitioning to a digital asset treasury model focused on Toncoin (TON) and is exploring the tokenization of single-indication economics for mesothelioma [5] - **Acurx Pharmaceuticals, Inc.**: Stock price increased by 74.36% to $7.48. The company is developing antibiotics for bacterial infections and received a positive opinion from the European Medicines Agency for its Pediatric Investigation Plan, positioning it for international Phase 3 clinical trials [6] Market Dynamics - The performances of these companies illustrate the dynamic nature of the stock market and the potential for significant returns, prompting investors and analysts to monitor future developments closely [7][8]

Core Insights - Acurx Pharmaceuticals has received a favorable opinion from the Pediatric Committee of the EMA regarding its Pediatric Investigation Plan (PIP) for ibezapolstat, aimed at treating children with C. difficile infection (CDI) [1][5][6] - The incidence of CDI in children is rising, with approximately 20,000 cases reported annually in the U.S., and there is a significant unmet need for effective treatments [2][15] - Ibezapolstat is positioned to potentially transform CDI treatment in children by demonstrating safety and efficacy, while also preserving the gut microbiome [2][12][13] Company Overview - Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections [17][18] - The company's lead product candidate, ibezapolstat, is a Gram-Positive Selective Spectrum (GPSS®) antibacterial targeting C. difficile and is set to advance to international Phase 3 clinical trials [13][17] Clinical Development - The PIP approval is a prerequisite for Acurx to initiate Phase 3 clinical trials in the EU, which are designed to demonstrate non-inferiority to vancomycin, a standard treatment for CDI [5][6][7] - Previous Phase 2 trials showed a Clinical Cure rate of 96% for ibezapolstat, with 100% of patients remaining free of CDI recurrence after treatment [10][12] - The Phase 2 trials also indicated favorable changes in the gut microbiome, suggesting that ibezapolstat may reduce the likelihood of CDI recurrence compared to vancomycin [11][16] Regulatory Pathway - Acurx has received both FDA QIDP and Fast-Track Designation for ibezapolstat, which provides incentives for the development of new antibiotics [14][17] - The company is preparing to submit an integrated PIP to the FDA, aligning its clinical trial programs with both EMA and FDA requirements [5][6] Market Context - CDI is a significant healthcare concern, with estimates of nearly 600,000 infections annually in the U.S. and a mortality rate of approximately 9.3% [15] - The need for new antibiotics is underscored by the CDC's designation of C. difficile as an urgent threat, highlighting the importance of Acurx's development efforts [14][15]

Core Viewpoint - Acurx Pharmaceuticals reported its financial and operational results for Q2 2025, highlighting a significant reduction in losses and an increase in cash reserves, while continuing to advance its antibiotic development programs. Financial Highlights - The company raised approximately $2.7 million from warrant exercises, resulting in net proceeds of $2.5 million after fees [1] - Cash position improved to $6.1 million as of June 30, 2025, up from $3.7 million at the end of 2024 [2] - Total gross proceeds raised in Q2 2025 amounted to approximately $3.4 million through an equity line of credit and warrant inducement [2] Research and Development Expenses - R&D expenses for Q2 2025 were $0.5 million, a decrease of $1.3 million from $1.8 million in Q2 2024, primarily due to lower manufacturing and consulting costs [3] - For the first half of 2025, R&D expenses totaled $1.1 million, down from $3.4 million in the same period of 2024, reflecting a reduction in both manufacturing and consulting costs [3] General and Administrative Expenses - G&A expenses for Q2 2025 were $1.7 million, down from $2.3 million in Q2 2024, mainly due to a decrease in share-based compensation and professional fees [4][5] - For the first half of 2025, G&A expenses were $3.3 million compared to $5.1 million in the same period of 2024, indicating a significant reduction [5] Net Income/Loss - The company reported a net loss of $2.2 million or $1.89 per diluted share for Q2 2025, an improvement from a net loss of $4.1 million or $5.21 per diluted share in Q2 2024 [6] - For the first half of 2025, the net loss was $4.4 million or $4.01 per diluted share, compared to a net loss of $8.5 million or $10.84 per diluted share in the same period of 2024 [6] Operational Developments - Acurx received a new patent for its DNA polymerase IIIC inhibitors, expiring in December 2039, which supports its antibiotic development program targeting infections caused by MRSA, VRE, DRSP, and Anthrax [4] - The company closed an equity line of credit with Lincoln Park Capital for up to $12 million in May 2025 [4] - Acurx announced the publication of Phase 2b clinical trial data for ibezapolstat in a leading microbiology journal in June 2025 [4] - The company is preparing for international Phase 3 clinical trials for ibezapolstat, which has received positive regulatory guidance from the EMA [10] Share Structure - As of June 30, 2025, the company had 1,470,352 shares outstanding following a 1 for 20 reverse stock split [7]

Core Viewpoint - Acurx Pharmaceuticals has announced a 1-for-20 reverse stock split to increase its stock price and regain compliance with Nasdaq's minimum bid price requirement, effective August 4, 2025 [1][3]. Group 1: Reverse Stock Split Details - The reverse stock split will convert every twenty shares of common stock into one share, with no fractional shares issued; stockholders will receive cash for any fractional shares [2]. - The number of outstanding shares will decrease from approximately 30,764,540 to about 1,538,227, while the total authorized shares will remain unchanged [3]. - Stockholders holding shares electronically will not need to take action, while those with physical certificates will receive instructions for exchanging them [4]. Group 2: Company Overview - Acurx Pharmaceuticals is focused on developing a new class of antibiotics targeting difficult-to-treat bacterial infections, specifically Gram-positive bacteria [5]. - The lead product candidate, ibezapolstat, is ready for Phase 3 trials, with plans for international clinical trials next year, pending financing [5]. - The preclinical pipeline includes an oral product candidate for treating Acute Bacterial Skin and Skin Structure Infections and a development program for inhaled anthrax [5].

Core Viewpoint - Acurx Pharmaceuticals is advancing its lead antibiotic candidate, ibezapolstat, to pivotal Phase 3 clinical trials for the treatment of Clostridioides difficile infection (CDI), with promising results from previous trials indicating high efficacy and safety [2][11][15]. Group 1: Company Overview - Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics targeting difficult-to-treat bacterial infections, particularly those caused by Gram-positive bacteria [23]. - The company's lead product candidate, ibezapolstat, is a DNA polymerase IIIC inhibitor designed to treat CDI and has received FDA QIDP and Fast-Track designations [2][19]. - Acurx's research and development pipeline includes antibiotic candidates targeting various multi-drug resistant bacteria, including MRSA and VRE [23]. Group 2: Clinical Trial Progress - Ibezapolstat is ready to advance to international pivotal Phase 3 clinical trials, following positive outcomes from Phase 2 trials, which demonstrated a Clinical Cure rate of 96% [2][15][16]. - The Phase 2 clinical trial included a multicenter, open-label segment and a double-blind, randomized segment, with a total of 42 patients treated for CDI [13][14]. - The Phase 2b trial showed that ibezapolstat-treated patients had a higher sustained clinical cure rate compared to those treated with vancomycin, indicating its potential superiority [16][17]. Group 3: Scientific Collaboration and Research - Acurx's research is conducted in collaboration with Leiden University Medical Center, focusing on the structural biology of DNA pol IIIC and its inhibitors, which has implications for developing new antibiotics [1][4][10]. - The unique conformation of ibezapolstat and its analogues suggests a conserved mechanism of action across Gram-positive bacteria, enhancing the understanding of its selectivity and efficacy [3][4]. - Ongoing research aims to elucidate the structure of pol IIIC from multidrug-resistant organisms, which will guide the rational design of new inhibitors [6][7]. Group 4: Market Need and Impact - CDI is a significant healthcare issue, with estimates of 500,000 infections annually in the U.S. and a mortality rate of approximately 9.3%, highlighting the urgent need for new treatment options [20]. - The CDC has classified CDI as an urgent threat, underscoring the importance of developing effective antibiotics like ibezapolstat to combat antimicrobial resistance [19][20]. - Ibezapolstat's mechanism of maintaining a healthy gut microbiome while treating CDI may reduce the likelihood of recurrence, addressing a critical gap in current treatment options [17][22].

Core Insights - Acurx Pharmaceuticals has been granted a new patent in India for DNA Polymerase IIIC Inhibitors, adding to its portfolio of patents aimed at protecting its antimicrobial technologies [1][2] - The company is advancing its lead product candidate, ibezapolstat, which is Phase 3-ready for the treatment of C. difficile Infection, and is also developing second-generation compounds for various gram-positive bacterial infections [2][3] Patent Developments - The newly granted Indian patent is part of a series of patents that Acurx has secured, including three U.S. patents, one Israeli patent, and one Japanese patent, all related to the ACX-375C program [1][3] - The patent covers compositions-of-matter for DNA Polymerase IIIC Inhibitors, which are crucial for the company's proprietary technologies in antimicrobials [1] Product Pipeline - Acurx's R&D pipeline focuses on antibiotics targeting gram-positive bacteria, including C. difficile, MRSA, VRE, DRSP, and anthrax [3] - The company plans to initiate international clinical trials for ibezapolstat as soon as possible, with a preclinical pipeline also in development for treating ABSSSI and inhaled anthrax [3]

Core Insights - Acurx Pharmaceuticals reported significant clinical trial results for its lead antibiotic candidate, ibezapolstat, demonstrating comparable efficacy to vancomycin in treating C. difficile infections [1][2] - The company received positive regulatory guidance from the European Medicines Agency (EMA) for its Phase 3 clinical trial program, aligning with FDA feedback, which positions Acurx favorably for international trials [2][12] - Financial results showed a net loss reduction in Q4 2024 compared to Q4 2023, indicating improved financial management despite a decrease in cash reserves [5][8] Clinical Developments - Ibezapolstat exhibited a 96% clinical cure rate in Phase 2 trials, with 100% of patients remaining cured one month post-treatment, compared to 86% for vancomycin [1] - The drug's mechanism includes preservation of beneficial gut bacteria, which may prevent recurrence of C. difficile infections [1][2] - Acurx's studies indicate that ibezapolstat has a more selective impact on the gut microbiome compared to broader-spectrum antibiotics, potentially offering a competitive advantage [3][4] Financial Performance - The company ended 2024 with cash reserves of $3.7 million, down from $7.5 million in 2023, and raised $6.6 million through its ATM financing program [5][6] - Research and development expenses decreased to $5.4 million in 2024 from $6.0 million in 2023, primarily due to reduced consulting costs [6] - General and administrative expenses for Q4 2024 were $2.0 million, down from $3.2 million in Q4 2023, reflecting cost-cutting measures [7] Shareholder Information - Acurx reported a net loss of $2.8 million for Q4 2024, an improvement from a $5.1 million loss in Q4 2023, with a total annual net loss of $14.1 million for 2024 [8][17] - The company had 17,030,686 shares outstanding as of December 31, 2024, reflecting an increase in shares issued compared to the previous year [9][16] Regulatory and Patent Developments - Acurx received a new patent for its DNA polymerase IIIC inhibitors from the Japanese Patent Office, expiring in December 2039, which supports its ongoing antibiotic development efforts [10] - The company is preparing to file a Marketing Authorization Application following successful Phase 3 trials, with a focus on the treatment of C. difficile infections [2][12]