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].

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]

Core Viewpoint - Acurx Pharmaceuticals, Inc. has successfully closed a registered direct offering of 2,745,000 shares at a price of $0.40 per share, along with a concurrent private placement of unregistered short-term warrants to purchase up to 8,235,000 shares at the same exercise price, aiming to raise approximately $1.1 million for working capital and general corporate purposes [1][2]. Group 1: Offering Details - The registered direct offering involved 2,745,000 shares of common stock priced at $0.40 each, with a concurrent issuance of short-term warrants for 8,235,000 shares [1]. - The total gross proceeds from the offering were approximately $1.1 million before deducting fees and expenses [2]. - The warrants will be exercisable upon stockholder approval and will expire 24 months after such approval [1]. Group 2: Regulatory and Compliance Information - The shares were offered under a "shelf" registration statement filed with the SEC, which became effective on July 11, 2022 [3]. - The warrants and underlying shares have not been registered under the Securities Act and may not be sold in the U.S. without an effective registration statement or applicable exemption [4]. Group 3: Company Overview - Acurx Pharmaceuticals is focused on developing a new class of small molecule antibiotics targeting difficult-to-treat bacterial infections, particularly Gram-positive bacteria [6]. - The lead product candidate, ibezapolstat, is ready for Phase 3 trials for treating C. difficile infections, with plans for international clinical trials this year [6]. - The company's pipeline includes antibiotic candidates for various serious bacterial infections, including MRSA and drug-resistant Streptococcus pneumoniae [6].