Acurx Pharmaceuticals (ACXP) Q2 2025 Earnings Call August 12, 2025 08:00 AM ET Speaker0Greetings, and welcome to the Accurate Pharmaceuticals to discuss Second Quarter twenty twenty five Financial Results Conference Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce Robert Shawwal, Chief Financial Officer.Please go ahead.Speaker1Thank you, Stacy ...

FORM 10-Q (Mark one) ☒ Quarterly Report Under Section 13 or 15(d) of the Securities Exchange Act of 1934 For the Quarterly Period Ended June 30, 2025 Or ☐ Transition Report Under Section 13 or 15(d) of the Securities Exchange Act of 1934 Commission File Number 001-40536 Acurx Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) | Delaware | 82-3733567 | | --- | --- | | State or other jurisdiction of | (I.R.S. Employer | | incorporation or organization | Identification No.) | | 259 Li ...

STATEN ISLAND, N.Y., July 24, 2025 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a clinical stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today that the Company will discuss its second quarter 2025 financial results on Tuesday, August 12, 2025 at 8:00 am ET before the U.S. financial markets open. David P. Luci, President and Chief Executive Officer, and Robert G. Shawah, Chief Financial Of ...

Company Performance - Acurx Pharmaceuticals, Inc. (ACXP) has returned 0.8% year-to-date, outperforming the Medical sector, which has returned an average of -4.7% [4] - The Zacks Consensus Estimate for ACXP's full-year earnings has increased by 60.5% over the past quarter, indicating improved analyst sentiment and a stronger earnings outlook [4] Industry Ranking - Acurx Pharmaceuticals belongs to the Medical - Biomedical and Genetics industry, which has 502 stocks and is currently ranked 88 in the Zacks Industry Rank. This industry has lost an average of 4.8% year-to-date, showing that ACXP is performing better than its peers [6] - The Medical group, which includes Acurx Pharmaceuticals, is ranked 6 within the Zacks Sector Rank, indicating a relatively strong position among 16 sector groups [2] Comparison with Peers - BioCryst Pharmaceuticals (BCRX) has also outperformed the Medical sector with a year-to-date return of 32.6% and has a Zacks Rank of 2 (Buy) [5] - The consensus EPS estimate for BioCryst Pharmaceuticals has increased by 339.6% over the past three months, highlighting significant positive analyst sentiment [5]

Core Viewpoint - Acurx Pharmaceuticals has entered into a warrant inducement agreement to facilitate the exercise of existing warrants at a significantly reduced price, generating approximately $2.67 million in gross proceeds for the company [1][2]. Group 1: Warrant Inducement Agreement - The company has a warrant inducement agreement with a holder of existing warrants to purchase up to 4,445,435 shares at exercise prices between $3.25 and $3.26 per share, allowing the holder to exercise these warrants at a reduced price of $0.675 per share [1]. - In exchange for exercising the existing warrants, investors will receive 6,223,609 G-1 warrants and 2,667,261 G-2 warrants, totaling 8,890,870 new warrants [1]. - The G-1 and G-2 warrants are both exercisable at $0.425 per share and will expire five years from the issuance date [1]. Group 2: Use of Proceeds - The net proceeds from the warrant exercise are intended for working capital and general corporate purposes [2]. Group 3: Regulatory and Clinical Development - Ibezapolstat, the company's lead antibiotic candidate, is advancing to international Phase 3 clinical trials for treating C. difficile Infection (CDI) and has received FDA designations that may expedite its development [5]. - The antibiotic is part of a new class of drugs targeting Gram-positive bacteria, which includes significant pathogens like MRSA and VRE [6].

Financial Data and Key Metrics Changes - The company ended Q1 2025 with cash totaling $4.6 million, an increase from $3.7 million as of December 31, 2024 [14] - The net loss for Q1 2025 was $2.1 million or $0.11 per diluted share, compared to a net loss of $4.4 million or $0.28 per diluted share for Q1 2024 [16] Business Line Data and Key Metrics Changes - Research and development expenses for Q1 2025 were $600,000, down from $1.6 million in Q1 2024, primarily due to a decrease in manufacturing and consulting costs [15] - General and administrative expenses decreased to $1.6 million in Q1 2025 from $2.8 million in Q1 2024, attributed to lower professional fees and share-based compensation costs [15] Market Data and Key Metrics Changes - The company raised approximately $3.6 million in gross proceeds through two registered direct offerings during the quarter [15] - The company anticipates that the anti-recurrence effect of ibezafolstat could reduce the need for expensive microbiome therapeutic agents for C. difficile infection [6] Company Strategy and Development Direction - The company is well-positioned to commence its international Phase III registration program following positive regulatory guidance from both the European Medicines Agency and the FDA [5] - The company is exploring microbiome-related endpoints in its Phase III trial to reinforce differentiation in the CDI space [20] 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 [13] - The company is actively pursuing funding opportunities for its Phase III clinical trial program and has several initiatives underway [11] Other Important Information - The company closed an equity line of credit with Lincoln Park Capital for up to $12 million [9] - A publication summarizing positive Phase II results for ibezafolstat is expected to be published in the Lancet Micro [9] Q&A Session Summary Question: Plans to explore recent publication on microbiome preserving effects - Management confirmed that preservation and restoration of the microbiome is a secondary endpoint in the Phase III program design and is actively being explored [20] Question: Trajectory of R&D and G&A costs through 2025 - Management expects both G&A and R&D costs to continue decreasing until the Phase III program starts, but did not provide a specific start date due to pending funding [26][27] Question: Updates on past due act and funding opportunities - Management mentioned ongoing discussions with lobby groups and various funding opportunities, including applications to ARPA-H and interest from European FDA-type groups [29][30] Question: Comments on ultra-rare path for approvals - Management indicated that the possibility of following an ultra-rare path for antibiotic approvals is being discussed internally, although it would be a first for antibiotics [32]

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].