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Acurx Pharmaceuticals to Discuss Full Year and Fourth Quarter 2025 Financial Results on March 13, 2026 Conference Call and Provide Business Update
Prnewswire· 2026-02-16 13:01
Core Viewpoint - Acurx Pharmaceuticals is set to discuss its full year and fourth quarter 2025 financial results on March 13, 2026, and will provide a business update during the conference call [1]. Group 1: Financial Results Announcement - The conference call will take place at 8:00 am ET before U.S. financial markets open [1]. - David P. Luci, President and CEO, and Robert G. Shawah, CFO, will host the call to discuss the financial results [1]. Group 2: Product Development - Acurx's lead antibiotic candidate, Ibezapolstat, is preparing for international Phase 3 clinical trials aimed at treating C. difficile Infection (CDI) [1]. - Ibezapolstat is a novel, orally administered antibiotic classified as a Gram-Positive Selective Spectrum (GPSS®) antibacterial, representing a new class of DNA polymerase IIIC inhibitors [1]. - The company has received final advice from both EMA and FDA regarding the Phase 3 trials, confirming the study design, patient population, and endpoints [1]. Group 3: Regulatory Status - Ibezapolstat has been designated as a Qualified Infectious Disease Product (QIDP) by the FDA, making it eligible for incentives under the GAIN Act [1]. - The FDA granted "Fast Track" designation to Ibezapolstat for CDI treatment in January 2019 [1]. - The CDC has classified C. difficile as an urgent threat, underscoring the need for new antibiotics [1]. Group 4: Company Overview - Acurx Pharmaceuticals focuses on developing a new class of small molecule antibiotics targeting difficult-to-treat bacterial infections [1]. - The company's R&D pipeline includes antibiotic candidates aimed at Gram-positive bacteria, including CDI, MRSA, VRE, and drug-resistant Streptococcus pneumoniae [1].
Acurx Pharmaceuticals, Inc. Reports Third Quarter Results and Provides Business Update
Prnewswire· 2025-11-12 12:01
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].
Acurx Pharmaceuticals to Discuss Fourth Quarter and Full Year 2024 Financial Results on March 18, 2025 Conference Call and Provide Business Update
Prnewswire· 2025-02-28 13:00
Core Viewpoint - Acurx Pharmaceuticals is preparing to discuss its fourth quarter and full year 2024 financial results on March 18, 2025, highlighting its focus on developing a new class of antibiotics for difficult-to-treat bacterial infections [1][2]. Group 1: Company Overview - Acurx Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing a new class of small molecule antibiotics targeting difficult-to-treat bacterial infections [4]. - The company's lead antibiotic candidate, Ibezapolstat, is preparing for international Phase 3 clinical trials aimed at treating patients with C. difficile Infection (CDI) [2][3]. - Ibezapolstat is a novel, orally administered antibiotic that selectively targets Gram-positive bacteria while preserving the gut microbiome [2][3]. Group 2: Regulatory and Clinical Development - Acurx has received positive regulatory guidance from the EMA, confirming that its clinical and non-clinical data supports the advancement of the Ibezapolstat Phase 3 program [3]. - The FDA has designated Ibezapolstat as a Qualified Infectious Disease Product (QIDP) and granted it "Fast Track" designation for CDI treatment, indicating the urgency and need for new antibiotics in this area [3]. - The CDC has classified C. difficile as an urgent threat, underscoring the critical need for new treatment options [3]. Group 3: Upcoming Events - Acurx will host a conference call on March 18, 2025, at 8:00 a.m. ET to discuss its financial results and provide a business update [2].