STATEN ISLAND, N.Y., April 17, 2025 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections, today announced that a new patent has been granted by the Indian Patent Office in March 2025. This patent relates to DNA Polymerase IIIC Inhibitors, including compositions-of-matter. This is the latest in the series of granted patents and pending paten ...

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 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].

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]

Financial Performance - The company incurred net losses of $14.6 million for the year ended December 31, 2023, and $14.1 million for the year ended December 31, 2024, with no revenue generated from product sales [213]. - As of December 31, 2024, the company had approximately $3.7 million in cash and raised $9.2 million in gross proceeds from the sale of 2,830,328 shares under the ATM Program [217]. - The company expects to continue incurring significant operating expenses as it advances its product development activities and seeks regulatory approvals [216]. - The independent registered public accounting firm expressed substantial doubt about the company's ability to continue as a going concern due to significant accumulated deficits and negative operating cash flows [215]. - The company anticipates that its existing capital resources will not be sufficient to fund operations for at least 12 months from the issuance of its financial statements for the year ended December 31, 2024 [217]. Funding and Capital Needs - The company may need substantial additional funding to support ongoing operations and product development, with no committed source of additional capital currently available [221]. - The company completed an IPO in June 2021, raising net cash proceeds of $14.8 million, and subsequent offerings raised $3.7 million in July 2022 and $3.5 million in May 2023 [217]. Product Development and Market Risks - The company is reliant on the success of its lead product candidate, ibezapolstat, for the treatment of CDI, and any delays in commercialization could materially harm its business [208]. - The company faces high risks in clinical development, including potential adverse side effects that could lead to the abandonment of product candidates [230]. - Market acceptance of ibezapolstat and other product candidates is uncertain, and failure to achieve adequate acceptance could result in limited product revenues [232]. - Clinical trials for product candidates may face delays or negative results, impacting the timeline for regulatory approval and commercialization [270]. - The company must navigate extensive regulatory requirements for product candidates, which are costly and time-consuming, with no guarantee of obtaining necessary approvals [277]. Competition and Market Conditions - The company faces risks associated with competition from larger companies and potential adverse effects from global market conditions [209]. - The company may face competition from generic products sooner than anticipated, which could negatively impact future revenue and profitability [288]. - The Hatch-Waxman Amendments allow the FDA to approve generic drugs, which may lead to competition with the company's products [289]. Regulatory and Compliance Challenges - The company is subject to numerous foreign regulatory requirements, which may include risks associated with local regulations and approval processes [282]. - Legislative and regulatory actions affecting government prescription drug procurement and reimbursement programs could have a material adverse effect on the healthcare industry in the U.S. [296]. - The company must comply with ongoing regulatory requirements, and failure to do so could result in penalties, recalls, or withdrawal of approvals [286]. - The company faces significant risks related to compliance with healthcare laws, which could lead to civil and criminal penalties, including exclusion from government-funded healthcare programs [324]. Economic and Environmental Factors - Global economic conditions, including inflation and potential recessions, could negatively impact the company's business and financial condition [250]. - Climate change poses physical risks to the company’s operations, including increased frequency of natural disasters and extreme weather events, potentially leading to higher operational costs [259]. Intellectual Property and Litigation Risks - The company may be involved in costly and time-consuming lawsuits to protect its patents, which could distract management and technical personnel from their normal responsibilities [328]. - The company’s ability to enforce its intellectual property rights is crucial for commercialization, and failure to do so could lead to reduced market share and costly litigation [332]. - The company may incur significant expenses related to intellectual property litigation, which could increase operating losses and reduce resources for development activities [333]. Corporate Governance and Stockholder Issues - The concentration of ownership among major stockholders could limit the influence of other investors on corporate matters [352]. - The company is classified as an "emerging growth company," which allows it to take advantage of reduced reporting requirements, but this may make its stock less attractive to some investors [340]. - The company has never paid cash dividends on its common stock and intends to retain earnings for business growth, meaning capital appreciation will be the sole source of gain for investors [337]. Cybersecurity and Data Privacy - The company faces significant risks related to cybersecurity incidents, which could lead to financial loss and operational disruption [360]. - Legal claims or proceedings may arise from data breaches, potentially resulting in significant legal and financial exposure [366]. - The company may incur substantial costs and potential liabilities to comply with evolving privacy laws [371]. Operational Risks - The company relies on third-party manufacturers for clinical trials and commercialization, which poses risks related to supply and compliance with regulations [310]. - The company is dependent on third-party clinical investigators and CROs, which may lead to less control over the quality and timing of clinical trials [315]. - Internal control systems may fail to prevent errors or fraud, potentially harming the company's financial reporting and operations [390].

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].

Core Viewpoint - Acurx Pharmaceuticals has announced a definitive agreement for the purchase and sale of 2,745,000 shares of its common stock 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 of common stock [1][2] Group 1: Offering Details - The total gross proceeds from the offering are expected to be approximately $1.1 million before deducting fees and expenses [2] - The warrants will have an exercise price of $0.40 per share and will expire twenty-four months after stockholder approval [1] - The closing of the offering is anticipated to occur around March 10, 2025, subject to customary closing conditions [1] Group 2: Company Background - Acurx Pharmaceuticals is focused on developing a new class of small molecule antibiotics targeting difficult-to-treat bacterial infections [6] - The company's lead product candidate, ibezapolstat, is ready for Phase 3 trials for the treatment of C. difficile infection, with plans for international clinical trials this year [6] - The R&D pipeline includes antibiotic candidates targeting Gram-positive bacteria, including MRSA, VRE, and anthrax [6]

Core Viewpoint - Acurx Pharmaceuticals is advancing its lead antibiotic candidate, ibezapolstat, into international Phase 3 clinical trials for the treatment of C. difficile Infection (CDI), with recent study results indicating its potential competitive advantage over existing antibiotics [1][5][19] 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 CDI [19] - The company’s lead product candidate, ibezapolstat, is a Gram-Positive Selective Spectrum (GPSS®) antibacterial that inhibits DNA replication in Gram-positive bacteria [19][13] Clinical Trial Progress - Acurx has received positive regulatory guidance from the European Medicines Agency (EMA) for its Phase 3 program, which includes two planned international trials designed to demonstrate non-inferiority to vancomycin [5][6] - The Phase 2 clinical trials showed a Clinical Cure rate of 96% for ibezapolstat, with 100% of patients remaining cured one month after treatment [9][10] Study Findings - A recent study published in the Journal of Antimicrobial Agents and Chemotherapeutics compared the gut microbiome effects of ibezapolstat with other CDI antibiotics, revealing that ibezapolstat has a narrower spectrum of microbiome alteration compared to broader-spectrum antibiotics like vancomycin and metronidazole [2][3] - The study indicated that ibezapolstat treatment resulted in less pronounced changes in microbiome diversity and increased beneficial bacteria, which may contribute to its potential advantages in treating CDI [2][3][12] Regulatory Designations - Ibezapolstat has been granted FDA Qualified Infectious Disease Product (QIDP) and Fast-Track Designation, highlighting its importance in addressing urgent medical needs [14][19] - The CDC has classified C. difficile as an urgent threat, emphasizing the necessity for new antibiotics like ibezapolstat [14][15] Market Context - CDI is a significant healthcare issue, with estimates of approximately 600,000 infections annually in the U.S. and a mortality rate of about 9.3% [16][15] - The recurrence rate for current CDI treatments ranges from 20% to 40%, indicating a substantial market opportunity for more effective therapies like ibezapolstat [16]

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].