Acurx Pharmaceuticals (ACXP) Q1 2025 Earnings Call May 13, 2025 08:00 AM ET Company Participants Robert Shawah - Co-Founder & CFODavid Luci - Co-Founder, President, CEO & DirectorJoanne Lee - Biotech Equity Research AssociateJames Molloy - Managing Director, Equity Research, Biotechnology & Specialty Pharmaceuticals Operator Greetings, and welcome to the Accurix Pharmaceuticals First Quarter twenty twenty five Financial Results and Business Update. At this time, all participants are in a listen only mode. A ...

Financial Data and Key Metrics Changes - The company ended Q1 2025 with cash totaling $4,600,000, an increase from $3,700,000 as of December 31, 2024 [15] - The net loss for Q1 2025 was $2,100,000 or $0.11 per diluted share, compared to a net loss of $4,400,000 or $0.28 per diluted share for Q1 2024 [17] - Research and development expenses decreased to $600,000 in Q1 2025 from $1,600,000 in Q1 2024, primarily due to lower manufacturing and consulting costs [16] - General and administrative expenses also decreased to $1,600,000 in Q1 2025 from $2,800,000 in Q1 2024, attributed to lower professional fees and share-based compensation costs [16] Business Line Data and Key Metrics Changes - The company announced positive regulatory guidance from the European Medicines Agency for the adezafulstat Phase III clinical trial program, indicating alignment with FDA on various aspects [6] - New publications highlighted the competitive advantage of ibezafolstat in treating C. Difficile infection, showing its potential to mitigate the need for expensive microbiome therapeutic agents [6][10] Market Data and Key Metrics Changes - The company noted that the annual US cost burden for C. Diff infection is $5,000,000,000, with $2,800,000,000 attributed to recurrent infections [14] - The company is positioned to address the urgent need for new classes of antibiotics as identified by the CDC, particularly for C. difficile infections [14] Company Strategy and Development Direction - The company is focused on advancing its Phase III clinical trial program for ibezafolstat, with plans to explore microbiome-related endpoints to differentiate its product in the CDI space [20] - The company is actively pursuing funding opportunities for its clinical trial programs, including a recent equity line of credit for up to $12,000,000 [11][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position relative to other biotech firms, despite the challenging macroeconomic environment [14][26] - The company is optimistic about the potential impact of its antibiotic treatments on reducing the recurrence of C. difficile infections and the associated economic burden [14] Other Important Information - The company closed a registered direct offering raising approximately $3,600,000 in gross proceeds during the quarter [15] - A new patent for DNA IL-3C inhibitors was granted by the Japanese patent office, which is significant for the company's ongoing development of its antibiotic program [10] Q&A Session Summary Question: Plans to explore microbiome-related findings further - The company is actively exploring the microbiome preservation and restoration as a secondary endpoint in the Phase III program design [20] Question: Trajectory of R&D and G&A costs through 2025 - The company expects both G&A and R&D costs to continue decreasing until the Phase III program starts, pending funding availability [26] Question: Updates on past due act and funding opportunities - Management is in touch with lobby groups and exploring various funding opportunities, including traditional grants and applications to ARPA-H [28] Question: Comments on ultra-rare path for approvals - The company is considering the implications of recent comments regarding alternative approval pathways for antibiotics [30]

Financial Performance - The company reported a net loss of $2.1 million, or $0.11 per diluted share, for Q1 2025, compared to a net loss of $4.4 million, or $0.28 per diluted share, in Q1 2024, representing a 52% improvement in net loss [7]. - Research and development expenses decreased to $0.6 million in Q1 2025 from $1.6 million in Q1 2024, a reduction of 63% primarily due to lower manufacturing and consulting costs [5]. - General and administrative expenses fell to $1.6 million in Q1 2025 from $2.8 million in Q1 2024, a decrease of 43% attributed to reduced professional fees and share-based compensation costs [6]. Cash Position - The company ended Q1 2025 with cash totaling $4.6 million, an increase from $3.7 million as of December 31, 2024, following gross proceeds of approximately $3.6 million raised through two registered direct offerings [4]. - The company announced the closing of a registered direct offering and concurrent private placement in March 2025, raising gross proceeds of $1.1 million [9]. - Acurx closed an equity line of credit with Lincoln Park Capital for up to $12 million in May 2025, providing additional funding for operations [9]. Clinical Development - Acurx received positive regulatory guidance from the European Medicines Agency for the ibezapolstat Phase 3 clinical trial program, aligning with FDA feedback, positioning the company to commence international trials [3]. - Acurx's lead antibiotic candidate, ibezapolstat, is advancing to international Phase 3 clinical trials for treating C. difficile infection, with a unique spectrum of activity that spares beneficial gut microbiota [11]. Intellectual Property - The Japanese Patent Office granted a new patent for DNA polymerase IIIC inhibitors in February 2025, expiring in December 2039, supporting the development of ACX-375C [9]. Shareholder Information - The company had 22,397,511 shares outstanding as of March 31, 2025, an increase from 17,030,686 shares at the end of 2024 [8].

Financial Results - The company ended Q1 2025 with cash totaling $4.6 million, an increase from $3.7 million as of December 31, 2024 [1] - Research and development expenses for Q1 2025 were $0.6 million, down from $1.6 million in Q1 2024, primarily due to decreased manufacturing and consulting costs [3] - General and administrative expenses for Q1 2025 were $1.6 million, a decrease from $2.8 million in Q1 2024, attributed to lower professional fees and share-based compensation costs [4] - The company reported a net loss of $2.1 million or $0.11 per diluted share for Q1 2025, compared to a net loss of $4.4 million or $0.28 per diluted share for Q1 2024 [5] Operational Highlights - The company received positive regulatory guidance from the European Medicines Agency (EMA) for the ibezapolstat Phase 3 clinical trial program, aligning with FDA feedback [2] - New publications in the Journal of Antimicrobial Agents and Chemotherapeutics highlighted non-clinical studies that differentiate ibezapolstat from other antibiotics for treating C. difficile infection [2] - A new patent for DNA polymerase IIIC inhibitors was granted by the Japanese Patent Office, expiring in December 2039, supporting the development of ACX-375C [2] - The company closed a registered direct offering and private placement, raising gross proceeds of $1.1 million in March 2025 [2] Product Development - Ibezapolstat is the lead antibiotic candidate advancing to international Phase 3 clinical trials for treating C. difficile infection [7] - Ibezapolstat is a novel, orally administered antibiotic with a Gram-Positive Selective Spectrum (GPSS®) that spares beneficial gut microbiota while targeting C. difficile [7] - The CDC has designated C. difficile as an urgent threat, emphasizing the need for new antibiotics [7] - The company’s R&D pipeline includes antibiotic candidates targeting Gram-positive bacteria, including MRSA and VRE [8]

Revenue Generation - The company has not generated any revenue since inception and does not expect to generate revenue from product sales in the near future[112]. - The company has generated no revenue from operations since inception[124]. Research and Development - The company plans to substantially increase research and development expenses to continue the development of product candidates and discover new ones[115]. - The lead antibiotic candidate, ibezapolstat, has shown positive clinical trial results in Phase 2 trials, targeting Gram-positive bacteria[96]. - The company has an early-stage pipeline of antibiotic candidates targeting Gram-positive bacteria, including ACX-375C[98]. - Research and development expenses decreased to $0.6 million for the three months ended March 31, 2025, down 61% from $1.6 million in the same period of 2024[120]. Financial Performance - Total operating expenses for the three months ended March 31, 2025, were $2.1 million, reflecting a 51% reduction compared to $4.4 million in the same period of 2024[119]. - Net loss for the three months ended March 31, 2025, was $2.1 million, a decrease of 51% from $4.4 million in the same period of 2024[123]. - General and administrative expenses were $1.6 million for the three months ended March 31, 2025, a decrease of 45% from $2.8 million in the prior year[121]. - As of March 31, 2025, the company had working capital of $2.3 million, consisting primarily of $4.6 million in cash[126]. - Net cash used in operating activities was $2.1 million for the three months ended March 31, 2025, compared to $3.1 million in the same period of 2024[128][129]. - Net cash provided from financing activities was $3.0 million for the three months ended March 31, 2025, primarily from registered direct offerings[130]. - Cumulative losses since inception reached approximately $69.5 million as of March 31, 2025[124]. - The company raised net proceeds of approximately $8.8 million under the ATM Program before suspending it on January 6, 2025[124]. Strategic Partnerships - The company expects to partner with a fully-integrated pharmaceutical company for late-stage clinical trials and commercialization of its lead antibiotic candidate, ibezapolstat[95]. - The company is currently evaluating strategic transactions, including potential partnerships for further development and commercialization of ibezapolstat[99]. Compliance and Challenges - The company received a notice from Nasdaq regarding non-compliance with the minimum stockholders' equity requirement, needing to maintain at least $2.5 million in stockholders' equity[105]. - The company is facing challenges due to the COVID-19 pandemic, which may impact operations and collaborations[111].

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 Viewpoint - Acurx Pharmaceuticals, Inc. (ACXP) has experienced a 15.9% decline in share price over the past week, but the formation of a hammer chart pattern suggests a potential trend reversal as buying interest may be emerging to counteract selling pressure [1][2]. Technical Analysis - The hammer chart pattern indicates a possible bottoming out, with reduced selling pressure and a potential shift in control from bears to bulls [2][4]. - This pattern is characterized by a small candle body with a long lower wick, suggesting that after reaching a new low, buying interest has emerged to push the stock price up towards the opening price [3][4]. Fundamental Analysis - There has been a notable upward trend in earnings estimate revisions for ACXP, which is a bullish indicator as it typically leads to price appreciation [6]. - The consensus EPS estimate for the current year has increased by 44.7% over the last 30 days, indicating strong agreement among Wall Street analysts regarding the company's improved earnings potential [7]. - ACXP holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which historically outperforms the market [8].

Financial Data and Key Metrics Changes - The company ended 2024 with cash totaling $3.7 million, down from $7.5 million as of December 31, 2023 [25] - Research and development expenses for Q4 2024 were $0.8 million, a decrease of $1.1 million from $1.9 million in Q4 2023 [25] - General and administrative expenses for Q4 2024 were $2 million, down from $3.2 million in Q4 2023, primarily due to decreases in professional fees and share-based compensation [27] - The net loss for Q4 2024 was $2.8 million or $0.16 per diluted share, compared to a net loss of $5.1 million or $0.37 per diluted share in Q4 2023 [28] Business Line Data and Key Metrics Changes - The company is advancing its lead antibiotic candidate, ibezapolstat (IBZ), into international Phase 3 clinical trials for the treatment of C. difficile infection [8] - In Phase 2 trials, ibezapolstat demonstrated a clinical cure rate of 96%, with 100% of patients remaining cured one month after treatment [9] Market Data and Key Metrics Changes - The company raised a total of $6.6 million in gross proceeds under its ATM financing program for the year ended December 31, 2024 [25] - The FDA has granted ibezapolstat QIDP and Fast Track designations for the treatment of C. difficile infection, indicating a favorable regulatory environment [22] Company Strategy and Development Direction - The company is well-positioned to commence its international Phase 3 registration program following positive regulatory guidance from both the FDA and EMA [13] - Acurx aims to differentiate ibezapolstat from other antibiotics by demonstrating its microbiome-restorative potential and lower recurrence rates [14][18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential economic impact of ibezapolstat, which could reduce the annual cost burden of C. difficile infection in the US, estimated at $5 billion [23] - The company is actively pursuing funding opportunities for its Phase 3 clinical trial program, including partnerships and grants [42] Other Important Information - The Japanese Patent Office granted a new patent for the company's DNA polymerase IIIC inhibitors, expiring in December 2039 [19] - The company closed a registered direct offering and concurrent private placement, raising gross proceeds of $1.1 million [20] Q&A Session Summary Question: Differences and similarities between FDA and EMA for Phase 3 program - Management confirmed that the protocols for the Phase 3 program are identical for both FDA and EMA, as they aligned their strategies before approaching the EMA [35] Question: Geographic enrollment for Phase 3 program - The plan is to start with 150 clinical trial sites, with approximately 50% in Europe and the remainder in the US, Canada, and South America [37] Question: Upcoming data releases for ibezapolstat - A full set of Phase 2 data is expected to be published in a prestigious scientific journal within the next 30 days [40] Question: Funding options for development of ACX-375C - Management is exploring various funding opportunities, including partnerships and government grants, to support the Phase 3 trial [42] Question: Partnership environment and timeline for Phase 3 trials - The current tumultuous market conditions have made securing partnerships challenging, but management is optimistic about starting Phase 3 trials in 2025 [56] Question: Timeline for top-line data from Phase 3 trials - Management indicated that it would take approximately two years from the first patient enrolled to obtain top-line data [62] Question: Status of ATM program and NASDAQ listing - The ATM program was suspended in January but can be reactivated when management decides. There is confidence in maintaining the NASDAQ listing despite current share price challenges [70][72]

Financial Data and Key Metrics Changes - The company ended 2024 with cash totaling $3.7 million, down from $7.5 million as of December 31, 2023 [25] - Research and development expenses for Q4 2024 were $0.8 million, a decrease of $1.1 million from $1.9 million in Q4 2023 [25][26] - General and administrative expenses for Q4 2024 were $2 million, down from $3.2 million in Q4 2023, primarily due to decreases in professional fees and share-based compensation [27] - The company reported a net loss of $2.8 million or $0.16 per diluted share for Q4 2024, compared to a net loss of $5.1 million or $0.37 per diluted share for Q4 2023 [28] Business Line Data and Key Metrics Changes - The company is advancing its lead antibiotic candidate, ibezapolstat (IBZ), into international Phase 3 clinical trials for the treatment of C. difficile infection [8] - In Phase 2 trials, ibezapolstat demonstrated a clinical cure rate of 96%, with 100% of patients remaining cured one month after treatment [9][10] Market Data and Key Metrics Changes - The company raised a total of $6.6 million in gross proceeds under its ATM financing program for the year ended December 31, 2024 [25] - The FDA has granted ibezapolstat QIDP and Fast Track designations for the treatment of C. difficile infection, indicating a favorable regulatory environment [22] Company Strategy and Development Direction - The company is well-positioned to commence its international Phase 3 registration program following positive regulatory guidance from both the EMA and FDA [13] - The company aims to differentiate ibezapolstat from other antibiotics by demonstrating its microbiome-restorative potential and lower recurrence rates [14][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for partnerships and funding opportunities to support the Phase 3 trial, emphasizing the importance of government and quasi-government partnerships [42][43] - The company believes that ibezapolstat could significantly reduce the annual cost burden of C. difficile infections in the US, which is estimated at $5 billion [23] Other Important Information - The Japanese Patent Office granted a new patent for the company's DNA polymerase IIIC inhibitors, expiring in December 2039 [19] - The company closed a registered direct offering and concurrent private placement, raising gross proceeds of $1.1 million [20] Q&A Session Summary Question: Differences and similarities between FDA and EMA for Phase 3 program - Management confirmed that the protocols are identical and there is complete agreement from both agencies [35] Question: Geographic enrollment for Phase 3 program - The plan is to have 150 clinical trial sites, with half in Europe and the other half in the US, Canada, and South America [37] Question: Upcoming data releases for ibezapolstat - A full set of Phase 2 data is expected to be published in a prestigious scientific journal within the next 30 days [40] Question: Funding options for development of ACX-375C - Management is exploring partnerships and grants from government bodies as primary funding sources [42] Question: Partnership environment and timeline for Phase 3 trials - Management noted challenges in securing partnerships but remains optimistic about potential collaborations in 2025 [56] Question: Timeline for top-line data from Phase 3 trials - It is expected to take two years from the first patient enrolled to obtain top-line data [62] Question: Status of the ATM program and NASDAQ listing - The ATM program was suspended but can be reactivated, and management is confident in maintaining the NASDAQ listing [70][72]

Financial Performance - The company reported a net loss of $2.8 million or $0.16 per diluted share for Q4 2024, compared to a net loss of $5.1 million or $0.37 per diluted share for Q4 2023[11]. - Net loss for 2024 was $14,103,103 compared to a net loss of $14,577,768 in 2023, indicating an improvement in financial performance[20]. - Loss per share improved to $(0.87) in 2024 from $(1.15) in 2023, reflecting a reduction in loss per share of approximately 24.3%[20]. Cash and Financing - The company ended 2024 with cash totaling $3.7 million, down from $7.5 million as of December 31, 2023[6]. - The company raised a total of $6.6 million in gross proceeds under its ATM financing program for the year ended December 31, 2024[6]. - The company closed a $2.5 million registered direct offering in January 2025[3]. Research and Development - Research and development expenses for Q4 2024 were $0.8 million, a decrease of $1.1 million from $1.9 million in Q4 2023[9]. - Research and Development expenses decreased to $5,403,836 in 2024 from $6,043,597 in 2023, a decline of about 10.6%[20]. - Ibezapolstat demonstrated a 96% clinical cure rate in combined Phase 2 trials for patients with CDI, with 100% of treated patients remaining cured one month after treatment[3]. - The company received positive regulatory guidance from the European Medicines Agency for the ibezapolstat Phase 3 clinical trial program, aligning with FDA feedback[3]. - A new patent for DNA polymerase IIIC inhibitors was granted by the Japanese Patent Office, expiring in December 2039[8]. Operating Expenses - General and administrative expenses for Q4 2024 were $2.0 million, down from $3.2 million in Q4 2023[10]. - Total operating expenses decreased to $14,103,103 in 2024 from $14,577,768 in 2023, representing a reduction of approximately 3.2%[20]. - General and Administrative expenses increased slightly to $8,699,267 in 2024 from $8,534,171 in 2023, an increase of approximately 1.9%[20]. Shares Outstanding - The company had 17,030,686 shares outstanding as of December 31, 2024[12]. - Weighted average common shares outstanding increased to 16,163,366 in 2024 from 12,671,572 in 2023, an increase of about 27.6%[20].