Core Viewpoint - Acurx Pharmaceuticals is advancing its lead antibiotic candidate, ibezapolstat, into international Phase 3 clinical trials for the treatment of Clostridioides difficile Infection (CDI), supported by recent study findings that elucidate its selective activity against harmful bacteria while preserving beneficial gut microbiota [1][2][3] 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 [19] - The company's lead product candidate, ibezapolstat, is a Gram-Positive Selective Spectrum (GPSS®) antibacterial designed to inhibit DNA polymerase IIIC, leading to bacterial cell death [19][13] Clinical Trial Progress - Ibezapolstat is preparing to enter international Phase 3 clinical trials, having received positive regulatory guidance from the European Medicines Agency (EMA) confirming the adequacy of the clinical and non-clinical data submitted [5][6] - The Phase 3 trial will involve an estimated 450 subjects, randomized in a 1:1 ratio to receive either ibezapolstat or standard-of-care vancomycin, with the primary efficacy analysis focusing on clinical cure rates and recurrence reduction [6][10] Study Findings - Recent research published in the Journal of Antimicrobial Agents and Chemotherapeutics highlights the microbiome-restorative potential of ibezapolstat, showing that it allows for the regrowth of beneficial gut microbiota while effectively targeting C. difficile [1][2][3] - The study utilized in silico genomic analysis to explain the narrower than expected spectrum of activity of ibezapolstat observed in clinical trials, indicating that certain beneficial taxa are naturally resistant to the drug [2][3] Efficacy and Safety Data - In combined Phase 2 trials, ibezapolstat demonstrated a clinical cure rate of 96% (25 out of 26 patients), with no drug-related serious adverse events reported [9][10] - The treatment was well-tolerated, with mild gastrointestinal adverse events that resolved without treatment, and showed promising results in maintaining a healthy gut microbiome [9][12] Regulatory Designations - Ibezapolstat has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA, which facilitate its development as a treatment for CDI [14] - The CDC has classified C. difficile as an urgent threat, underscoring the need for new antibiotics to address this significant healthcare challenge [14][15]

Core Viewpoint - Acurx Pharmaceuticals, Inc. has successfully closed a registered direct offering of 2,463,058 shares of common stock at a price of $1.015 per share, raising approximately $2.5 million in gross proceeds, which will be used for working capital and general corporate purposes [1][2]. Group 1: Offering Details - The offering included a concurrent private placement of unregistered warrants to purchase up to 2,463,058 shares of common stock, with an exercise price of $0.90 per share, exercisable upon issuance and expiring five years after issuance [1][2]. - H.C. Wainwright & Co. served as the exclusive placement agent for the offering [2]. Group 2: 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 [6]. - The company's lead product candidate, ibezapolstat, is aimed at treating C. difficile infection and is Phase 3 ready, with plans to initiate international clinical trials [6]. - The R&D pipeline includes antibiotic candidates targeting Gram-positive bacteria, such as MRSA, VRE, and drug-resistant Streptococcus pneumoniae, as well as a preclinical oral product candidate for ABSSSI and a development program for inhaled anthrax [6].

Core Viewpoint - Acurx Pharmaceuticals, Inc. has announced a definitive agreement for the purchase and sale of 2,463,058 shares of its common stock at a price of $1.015 per share, along with a concurrent private placement of unregistered warrants to purchase the same number of shares at an exercise price of $0.90 per share [1][2]. Group 1: Offering Details - The total gross proceeds from the offering are expected to be approximately $2.5 million before deducting fees and expenses [2]. - The closing of the offering is anticipated to occur on or about January 7, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering are intended for working capital and other general corporate purposes [2]. Group 3: 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 [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]. - Acurx's research and development pipeline includes antibiotic candidates targeting Gram-positive bacteria, including MRSA, VRE, and anthrax [6].

Core Insights - Acurx Pharmaceuticals is advancing its lead antibiotic candidate, ibezapolstat, to international Phase 3 clinical trials for treating C. difficile Infection (CDI) following positive regulatory guidance from the EMA and FDA [1][5][10] Regulatory Developments - The company received constructive feedback from the EMA during its Scientific Advice Procedure, confirming that the submitted clinical, non-clinical, and CMC information supports the advancement of the ibezapolstat Phase 3 program [1][5] - Acurx is preparing to submit requests for regulatory guidance to initiate clinical trials in the EU, UK, Japan, and Canada [2][5] Clinical Trial Design - The Phase 3 program will consist of two non-inferiority trials comparing ibezapolstat to vancomycin, with an estimated 450 subjects randomized in a 1:1 ratio [3][8] - The primary endpoint is Clinical Cure, assessed two days after a 10-day oral treatment [3][8] Phase 2 Clinical Trial Results - In the completed Phase 2 trials, ibezapolstat demonstrated a Clinical Cure rate of 96% (25 out of 26 patients) [7][8] - The Phase 2a segment showed 100% cure in 10 patients treated with ibezapolstat [6][8] - The Phase 2b segment reported that 14 out of 14 patients in the vancomycin control arm also achieved Clinical Cure [8] Mechanism of Action and Microbiome Impact - Ibezapolstat is a novel antibiotic that selectively targets Gram-positive bacteria, including C. difficile, while preserving healthy gut microbiota [10][14] - The treatment leads to favorable changes in bile acid metabolism, potentially reducing CDI recurrence [9][13] Market Context - CDI is a significant healthcare issue, with approximately 500,000 infections and 20,000 deaths annually in the U.S. [12] - The recurrence rate for current CDI treatments ranges from 20% to 40% [12]

Core Viewpoint - Acurx Pharmaceuticals, Inc. (ACXP) has experienced a 17.6% decline in share price over the past week, but the formation of a hammer chart pattern suggests potential support and a possible trend reversal in the future [1][2]. Technical Analysis - The hammer chart pattern indicates a potential bottoming out of the stock, with reduced selling pressure likely [2][4]. - This pattern typically forms during a downtrend, where the stock opens lower, makes a new low, but then closes near its opening price, indicating buying interest [3][4]. - Hammer candles can appear on various timeframes and are utilized by both short-term and long-term investors [4]. Fundamental Analysis - There has been a recent upward trend in earnings estimate revisions for ACXP, which is a bullish indicator [6]. - Over the last 30 days, the consensus EPS estimate for the current year has increased by 9.2%, indicating analysts expect better earnings than previously predicted [7]. - ACXP holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, suggesting it is likely to outperform the market [8].

Core Viewpoint - Acurx Pharmaceuticals has approved the purchase of up to $1 million in Bitcoin as a treasury reserve asset, reflecting the growing demand and acceptance of Bitcoin as a primary asset class [1][2]. 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, specifically Gram-positive bacteria [3]. Treasury Strategy - The company's President & CEO, David P. Luci, stated that Bitcoin's limited supply and inflation-resistant characteristics make it a functional store of value, and this new treasury strategy will not impact the company's drug development plans [2]. - The treasury strategy is aimed at cash that is not needed over the next 12 to 18 months, leveraging the recent approval of Bitcoin ETFs and increasing institutional support [2]. Research and Development Pipeline - Acurx's R&D pipeline includes antibiotic candidates targeting serious infections such as Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE), and drug-resistant Streptococcus pneumoniae (DRSP) [3].

Core Insights - Acurx Pharmaceuticals is advancing its lead antibiotic candidate, ibezapolstat, into international Phase 3 clinical trials for the treatment of C. difficile Infection (CDI) [1][4][13] - The company has received FDA QIDP and Fast-Track Designation for ibezapolstat, highlighting its potential in addressing urgent medical needs [1][14] - The Phase 2 clinical trials demonstrated a high Clinical Cure rate of 96% for ibezapolstat, suggesting its efficacy compared to standard treatments [9][10] 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 [17][18] - The company's approach involves developing antibiotics with a Gram-positive selective spectrum, specifically targeting Clostridioides difficile and other resistant bacteria [17][18] Clinical Trial Updates - Acurx has successfully completed Phase 2 trials, with a favorable safety profile and significant microbiome preservation observed in patients treated with ibezapolstat [3][11][12] - The upcoming Phase 3 trials will include an estimated 450 subjects, randomized to receive either ibezapolstat or standard-of-care vancomycin, to assess non-inferiority and potential superiority [5][6] Regulatory Progress - The company has reached an agreement with the FDA on key elements for the Phase 3 trial design and is preparing to submit requests for regulatory guidance in the European Union, Japan, Canada, and the United Kingdom [4][5] Industry Context - C. difficile Infection remains a significant healthcare challenge, with estimates of 500,000 infections annually in the U.S. and a mortality rate of approximately 9.3% [15] - The CDC has classified C. difficile as an urgent threat, underscoring the need for new antibiotics like ibezapolstat to combat this infection [14][15]

Financial Data and Key Metrics Changes - The company ended Q3 2024 with cash totaling $5.8 million, down from $7.5 million as of December 31, 2023 [25] - The net loss for Q3 2024 was $2.8 million or $0.17 per diluted share, compared to a net loss of $3.1 million or $0.24 per diluted share for Q3 2023 [30] - For the nine months ended September 30, 2024, the net loss was $11.3 million or $0.71 per share, compared to a net loss of $9.5 million or $0.77 per share for the same period in 2023 [30] Business Line Data and Key Metrics Changes - Research and development expenses for Q3 2024 were $1.2 million, a slight decrease from $1.3 million in Q3 2023 [26] - General and administrative expenses for Q3 2024 were $1.6 million, down from $1.8 million in Q3 2023 [28] - For the nine months ended September 30, 2024, general and administrative expenses increased to $6.7 million from $5.4 million in the same period in 2023 [29] Market Data and Key Metrics Changes - The company has received FDA QIDP and Fast Track designation for ibezapolstat, which is aimed at treating C. difficile infection, categorized as an urgent threat by the U.S. CDC [23] - The potential economic impact of ibezapolstat, if approved, could reduce the annual U.S. cost burden for C. difficile infection by approximately $5 billion, with $2.8 billion attributed to recurrent infections [24] Company Strategy and Development Direction - The company is focusing on advancing ibezapolstat through Phase III clinical trials, with a roadmap for international regulatory filings starting in Europe [12][35] - Acurx is prioritizing the oral form of its gram-positive selective spectrum program for acute bacterial skin infections, including MRSA, to expedite lead product selection [14] - The company is exploring non-dilutive funding options, including partnerships and government grants, to support the Phase III trials [37][53] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing clinical results of ibezapolstat, which continue to outperform in treating C. difficile infections [22] - The company is confident that the best is yet to come, given the momentum in clinical trials and regulatory processes [24] - Management highlighted the importance of the predictive model for recurrent infections, which could lead to a new diagnostic tool [32] Other Important Information - Acurx received a new patent for ibezapolstat, which will expire in June 2042, providing a competitive advantage in the market [8] - The company is also developing ACX-375 for bioterrorism applications, specifically targeting Anthrax, with promising preliminary results [19] Q&A Session Summary Question: Can you discuss more about the predicted model that you discussed earlier on the call, a potential diagnostic tool? - Management explained that certain measurements from stool samples could predict reinfection risk by the end of the third day of treatment, which could help reduce costs associated with recurrent infections [32][34] Question: Can you discuss more details about the international regulatory filing initiatives ongoing this quarter? - The company is starting the regulatory process in Europe with the European Medicines Agency, aiming for a meeting to set the regulatory pathway for international Phase III trials [35][36] Question: Can you outline what are some top options that you will consider likely to be able to fund the pivotal trials? - Management prefers non-dilutive funding options, including partnerships and government grants, to support the Phase III trials [37][53] Question: What are the earliest potential sites for the first Phase III trial and any proposed study design or data readout timelines? - The design includes two international Phase III trials with 150 sites and 450 patients each, randomized against oral vancomycin [41] Question: Where are you currently in the development of the Anthrax bioterrorism program? - The program is in preclinical stages, with laboratory and animal studies planned to further develop the findings [44] Question: What are other future clinical development plans for the GPSS program targeting MRSA? - The initial focus will be on MRSA infections, followed by VRE and DRSP infections [46] Question: Can you talk a little more about the possibility of partnership in the near future? - Management indicated that they are exploring various partnership opportunities that would not dilute shareholder value, including territorial licenses and co-development agreements [50][52]

Financial Performance - Acurx Pharmaceuticals reported a net loss of $2.8 million or $0.17 per diluted share for Q3 2024, compared to a net loss of $3.1 million or $0.24 per diluted share for Q3 2023[12]. - General and administrative expenses for Q3 2024 were $1.6 million, down from $1.8 million in Q3 2023, while total G&A expenses for the nine months ended September 30, 2024, increased to $6.7 million from $5.4 million in the same period of 2023[11]. - Research and development expenses for Q3 2024 were $1.2 million, a decrease from $1.3 million in Q3 2023, while total R&D expenses for the nine months ended September 30, 2024, were $4.6 million, up from $4.1 million in the same period of 2023[10]. Cash Position - The company ended Q3 2024 with cash totaling $5.8 million, down from $7.5 million as of December 31, 2023, after raising approximately $1.6 million through its ATM financing program during the quarter[9]. - Acurx has 16,770,378 shares outstanding as of September 30, 2024[13]. Product Development - Acurx received a new patent for ibezapolstat, which will expire in June 2042, providing a competitive advantage in treating C. difficile infection[2]. - The company anticipates convening a meeting with the FDA regarding manufacturing processes in Q4 2024 to commence Phase 3 clinical trials for ibezapolstat[3]. - In the Phase 2b clinical trial, ibezapolstat demonstrated comparable clinical cure rates to vancomycin, with 5 out of 5 patients showing no recurrence after treatment[7]. - The company is developing ACX-375 DNA pol IIIC analogues for potential treatment against Anthrax, a Bioterrorism Category A pathogen[6]. Regulatory Initiatives - The company plans to continue international regulatory filing initiatives in Q4 2024[8].

Core Insights - Acurx Pharmaceuticals reported financial and operational results for Q3 2024, highlighting advancements in their antibiotic development program, particularly for ibezapolstat targeting C. difficile infections [1][2][3]. Financial Results - The company ended Q3 2024 with cash of $5.8 million, down from $7.5 million at the end of 2023, with an additional $1.6 million raised through an ATM financing program during the quarter [8]. - Research and development expenses for Q3 2024 were $1.2 million, a slight decrease from $1.3 million in Q3 2023, while total R&D expenses for the nine months ended September 30, 2024, increased to $4.6 million from $4.1 million in the same period of 2023 [9]. - General and administrative expenses for Q3 2024 were $1.6 million, down from $1.8 million in Q3 2023, with total G&A expenses for the nine months ended September 30, 2024, rising to $6.7 million from $5.4 million in the prior year [10]. - The company reported a net loss of $2.8 million or $0.17 per diluted share for Q3 2024, compared to a net loss of $3.1 million or $0.24 per diluted share for Q3 2023 [11]. Operational Highlights - In July 2024, Acurx presented Phase 2 clinical trial results for ibezapolstat at a major conference, and received a new patent for the drug, which is expected to provide a competitive advantage [1][2]. - Acurx submitted a request for a CMC meeting with the FDA to review manufacturing processes, aiming to commence Phase 3 clinical trials [2]. - The company participated in several scientific congresses in September 2024, showcasing their roadmap for Phase 3 clinical programs and updates on their GPSS® program for treating other gram-positive infections [3][4]. - Acurx announced in September that selected ACX-375 DNA pol IIIC analogues showed in vitro activity against ciprofloxacin-resistant Anthrax, indicating potential for a bioterrorism development program [5]. - At IDWeek in October 2024, Acurx presented data showing that ibezapolstat had comparable efficacy and safety to vancomycin in treating C. difficile infections [6]. Regulatory and Development Initiatives - The company plans to continue international regulatory filing initiatives in Q4 2024 [7]. - Ibezapolstat has received FDA designations as a Qualified Infectious Disease Product and Fast Track designation, emphasizing its potential in addressing urgent public health threats [13].