Financial Data and Key Metrics Changes - The company ended Q3 2025 with cash totaling $5.9 million, an increase from $3.7 million as of December 31, 2024 [11] - The net loss for Q3 2025 was $2 million, or $1.23 per diluted share, compared to a net loss of $2.8 million, or $3.45 per diluted share for Q3 2024 [14] - For the nine months ended September 30, 2025, the net loss was $6.4 million, or $5.01 per diluted share, compared to a net loss of $11.3 million, or $14.23 per share for the same period in 2024 [14] Business Line Data and Key Metrics Changes - Research and development expenses for Q3 2025 were $0.4 million, down from $1.2 million in Q3 2024, primarily due to a decrease in manufacturing and consulting costs [11][12] - General and administrative expenses remained consistent at $1.6 million for Q3 2025 compared to Q3 2024, with a slight decrease in compensation-related costs offset by an increase in legal fees [12] Market Data and Key Metrics Changes - The company regained compliance with NASDAQ listing requirements after a 1-for-20 reverse stock split on August 4, 2025 [4][5] - Acurx has obtained multiple patents for its DNA polymerase 3C inhibitors, including a new patent granted by the Australian Patent Office [5][8] Company Strategy and Development Direction - The company is focused on advancing its ibezapolstat program, which has shown promising results in treating C. diff infections [9][10] - Acurx is pursuing funding opportunities for a phase three clinical trial program for ibezapolstat and is considering alternative pathways for success [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating the macroeconomic environment and industry challenges while continuing to strengthen ibezapolstat's competitive profile [10] - The company recognizes November as C. diff Awareness Month and supports initiatives for education and prevention [10] Other Important Information - The company has FDA QIDP and FAST TRACK designations for ibezapolstat, which could significantly impact the economic burden of C. diff infections in the U.S. [10] - Acurx is actively engaged in scientific collaborations, with recent publications highlighting the structural biology of ibezapolstat [8] Q&A Session Summary Question: Potential for FDA to prioritize domestically manufactured novel antibiotics - Management sees potential for increased prioritization but noted uncertainty regarding the PASTOR Act and its impact on antibiotic funding [18][19] Question: Impact of proposed clinical priority review voucher framework - The regulatory approach and commercial strategy will remain the same, with plans to utilize the program at the appropriate time [21][22] Question: Filing for approval based on phase two ibezapolstat data - Management indicated that a safety database is required, and phase three trial data will be necessary for regulatory approval [23][25] Question: Timing around potential partnership discussions - Management expressed optimism about potential partnership news by the next earnings call but could not provide specific timelines [36][37] Question: QIDP and FAST TRACK designation expectations - Once obtained, these designations are maintained indefinitely without specific movement requirements [38] Question: Future operational expenses - Management anticipates that operational costs will continue to gradually decrease while maintaining a steady financial position [39]

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].

Antibiotic Development - The company is developing a new class of small molecule antibiotics targeting difficult-to-treat Gram-positive bacterial infections, with a focus on pathogens like MRSA and VRE[97]. - The company believes it is developing the first DNA pol IIIC inhibitor to enter Phase 3 clinical trials, with positive results from its Phase 2 clinical trial for its lead antibiotic candidate, ibezapolstat[100][104]. - The company has an early-stage pipeline of antibiotic candidates, including ACX-375C, targeting Gram-positive bacteria, which has shown proof of concept in animal studies[106]. - The company is evaluating strategic transactions for further development and potential commercialization of ibezapolstat, including partnerships and mergers[107]. Financial Performance - As of September 30, 2025, the company has incurred cumulative losses of approximately $73.7 million since inception[146]. - Research and development expenses for the three months ended September 30, 2025, were $0.4 million, a decrease of 64% compared to $1.2 million for the same period in 2024[137][138]. - General and administrative expenses remained consistent at $1.6 million for the three months ended September 30, 2025, compared to $1.6 million in 2024[139]. - The net loss for the three months ended September 30, 2025, was $2.0 million, a decrease of 29% from $2.8 million in the same period in 2024[140]. - For the nine months ended September 30, 2025, total operating expenses were $6.5 million, a decrease of 43% from $11.3 million in 2024[141]. - The company reported a net loss of $6.4 million for the nine months ended September 30, 2025, down 44% from $11.3 million in 2024[145]. - Net cash used in operating activities was $5.6 million for the nine months ended September 30, 2025, compared to $8.1 million in 2024[151][152]. - Interest income increased significantly to $36,000 for the three months ended September 30, 2025, compared to $5,000 in the same period in 2024, representing a 620% increase[137]. Stock and Compliance - A reverse stock split of 1-for-20 was executed on August 4, 2025, allowing the company to regain compliance with Nasdaq's minimum bid price requirement of $1.00 per share[108]. - The company regained compliance with Nasdaq Listing Rule 5550(b)(1) regarding stockholders' equity on August 26, 2025, after addressing previous deficiencies[121]. - The company has increased the total number of authorized shares of common stock from 200 million to 250 million following stockholder approval on September 16, 2025[109]. - The company has sold approximately $3.0 million worth of shares under the purchase agreement with Lincoln Park as of November 11, 2025, out of a total commitment of $12 million[115]. - The company raised net proceeds of approximately $8.8 million under the ATM Program before suspending it in January 2025[146]. - As of September 30, 2025, the company had working capital of $3.6 million, consisting primarily of $5.9 million in cash[149]. Accounting and Regulatory Matters - The company qualifies as an emerging growth company under the JOBS Act, allowing it to delay compliance with new accounting standards until they apply to private companies[161]. - Exemptions under the JOBS Act include not providing an auditor's attestation report on internal controls and certain executive compensation disclosures for five years post-IPO[162]. - The FASB issued ASU 2023-09, effective after December 15, 2024, which expands income tax disclosures, though the company believes it will not materially impact its disclosures[164]. - ASU 2024-03, effective after December 15, 2026, requires more detailed expense information in income statements, with the company currently evaluating its impact[165]. - As a smaller reporting company, the company is not required to provide quantitative and qualitative disclosures about market risk[166]. Compensation and Stock Options - Compensation expense related to stock options is recognized over the requisite service period based on the fair value at grant date, influenced by subjective assumptions like expected price volatility[159]. - The company utilizes the Black-Scholes option pricing model for estimating the fair value of options and warrants, with potential impacts on expenses and results of operations from changes in assumptions[160].

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential investment opportunities before the market opens [1] Premarket Gainers - Powell Max Limited (PMAX) increased by 115% to $5.59 - Solidion Technology, Inc. (STI) rose by 102% to $11.14 - ESS Tech, Inc. (GWH) saw a 44% increase to $6.11 - Aclarion, Inc. (ACON) gained 27% reaching $10.98 - Mannatech, Incorporated (MTEX) was up 20% at $10.80 - USA Rare Earth, Inc. (USAR) increased by 19% to $38.80 - Critical Metals Corp. (CRML) rose by 18% to $17.73 - United States Antimony Corporation (UAMY) gained 13% to $13.86 - Compass Diversified (CODI) increased by 12% to $9.46 - Forward Industries, Inc. (FORD) was up 11% at $22.69 [3] Premarket Losers - Yunhong Green CTI Ltd. (YHGJ) decreased by 24% to $7.00 - Kentucky First Federal Bancorp (KFFB) fell by 22% to $2.85 - One and One Green Technologies, Inc. (YDDL) dropped 20% to $5.23 - Safe & Green Holdings Corp. (SGBX) declined by 15% to $5.25 - Lazydays Holdings, Inc. (GORV) was down 14% at $2.12 - Acurx Pharmaceuticals, Inc. (ACXP) decreased by 10% to $6.69 - Top KingWin Ltd (WAI) fell by 10% to $3.82 - Super League Enterprise, Inc. (SLE) dropped 10% to $3.75 - Chanson International Holding (CHSN) decreased by 10% to $2.28 - Alaunos Therapeutics, Inc. (TCRT) was down 5% at $3.28 [4]

Core Insights - Several companies have experienced significant stock price increases, attracting investor attention and market analysis [1] Company Summaries - **Xenetic Biosciences, Inc.**: Achieved a 142.31% increase in stock price, closing at $10.39, with a trading volume of 45,373,947. The company focuses on immuno-oncology technologies and has expanded its partnership with The Scripps Research Institute to advance CAR T-cell therapies [2] - **bioAffinity Technologies, Inc.**: Stock price rose by 108.60% to $0.48, with a volume of 29,850. The company specializes in non-invasive cancer diagnosis and treatment, showcasing the clinical value of its CyPath® Lung in detecting early-stage lung cancer [3] - **GigCapital7 Corp.**: Recorded an 89.43% increase in stock price, ending at $1.58. This SPAC is gaining interest due to its business combination with BigBear.ai, which has a pro forma enterprise value of $1.378 billion and aims to capitalize on AI/ML market opportunities [4] - **AlphaTON Capital Corp.**: Experienced an 85.48% rise in stock price to $10.35. The company is transitioning to a digital asset treasury model focused on Toncoin (TON) and is exploring the tokenization of single-indication economics for mesothelioma [5] - **Acurx Pharmaceuticals, Inc.**: Stock price increased by 74.36% to $7.48. The company is developing antibiotics for bacterial infections and received a positive opinion from the European Medicines Agency for its Pediatric Investigation Plan, positioning it for international Phase 3 clinical trials [6] Market Dynamics - The performances of these companies illustrate the dynamic nature of the stock market and the potential for significant returns, prompting investors and analysts to monitor future developments closely [7][8]

Core Insights - New to The Street is set to broadcast a nationwide episode on Fox Business featuring interviews with innovative companies such as NeOnc Technologies, FLOKI, XION, Sharps Technology, and Aeries Technology, focusing on their growth and leadership in their sectors [1][2]. Group 1: Company Highlights - The episode will showcase NeOnc Technologies (NASDAQ:NTHI), FLOKI, XION, Sharps Technology (NASDAQ:STSS), and Aeries Technology (NASDAQ:AERT), emphasizing their innovations and market positions [1]. - New to The Street aims to spotlight cutting-edge companies and emerging leaders through investor-focused interviews [2]. Group 2: Programming and Reach - The broadcast is presented as sponsored programming, supported by national TV commercials, enhancing visibility for featured companies [3]. - New to The Street has been a premier platform for corporate storytelling for over 16 years, providing exposure on Fox Business and Bloomberg TV, and has a significant digital presence with over 3.5 million YouTube subscribers [4].

Core Insights - Acurx Pharmaceuticals has received a favorable opinion from the Pediatric Committee of the EMA regarding its Pediatric Investigation Plan (PIP) for ibezapolstat, aimed at treating children with C. difficile infection (CDI) [1][5][6] - The incidence of CDI in children is rising, with approximately 20,000 cases reported annually in the U.S., and there is a significant unmet need for effective treatments [2][15] - Ibezapolstat is positioned to potentially transform CDI treatment in children by demonstrating safety and efficacy, while also preserving the gut microbiome [2][12][13] Company Overview - Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections [17][18] - The company's lead product candidate, ibezapolstat, is a Gram-Positive Selective Spectrum (GPSS®) antibacterial targeting C. difficile and is set to advance to international Phase 3 clinical trials [13][17] Clinical Development - The PIP approval is a prerequisite for Acurx to initiate Phase 3 clinical trials in the EU, which are designed to demonstrate non-inferiority to vancomycin, a standard treatment for CDI [5][6][7] - Previous Phase 2 trials showed a Clinical Cure rate of 96% for ibezapolstat, with 100% of patients remaining free of CDI recurrence after treatment [10][12] - The Phase 2 trials also indicated favorable changes in the gut microbiome, suggesting that ibezapolstat may reduce the likelihood of CDI recurrence compared to vancomycin [11][16] Regulatory Pathway - Acurx has received both FDA QIDP and Fast-Track Designation for ibezapolstat, which provides incentives for the development of new antibiotics [14][17] - The company is preparing to submit an integrated PIP to the FDA, aligning its clinical trial programs with both EMA and FDA requirements [5][6] Market Context - CDI is a significant healthcare concern, with estimates of nearly 600,000 infections annually in the U.S. and a mortality rate of approximately 9.3% [15] - The need for new antibiotics is underscored by the CDC's designation of C. difficile as an urgent threat, highlighting the importance of Acurx's development efforts [14][15]

Financial Data and Key Metrics Changes - The company ended Q2 2025 with cash totaling $6.1 million, an increase from $3.7 million as of December 31, 2024 [14] - The net loss for Q2 2025 was $2.2 million or $1.89 per diluted share, compared to a net loss of $4.1 million or $5.21 per diluted share for Q2 2024 [17] - For the first half of 2025, the net loss was $4.4 million or $4.01 per diluted share, down from $8.5 million or $10.84 per diluted share in the same period of 2024 [17] Business Line Data and Key Metrics Changes - Research and development expenses for Q2 2025 were $500,000, a decrease from $1.8 million in Q2 2024, primarily due to reduced manufacturing and consulting costs [14] - General and administrative expenses for Q2 2025 were $1.7 million, down from $2.3 million in Q2 2024, mainly due to a decrease in share-based compensation [15] Market Data and Key Metrics Changes - The company announced a new patent granted by the Indian Patent Office for its DNA polymerase 3C inhibitors, expiring in December 2039, which supports its antibiotic development program [6] - The publication of Phase 2 clinical trial data for ibezaprolstat in treating C. difficile infection was highlighted, showcasing its potential as a novel antibiotic treatment [8][10] Company Strategy and Development Direction - The company is pursuing a multi-step approach to raise capital through customary financings, warrant inducements, and public-private partnerships [7] - A reverse stock split was implemented to comply with NASDAQ listing requirements, indicating a focus on maintaining compliance and financial stability [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing development of ibezaprolstat and its potential to address urgent medical needs, particularly in the context of rising antimicrobial resistance [12] - The company anticipates continued cash preservation and a reduction in operating expenses, with a cash burn rate expected to remain around $400,000 per month [25] Other Important Information - The company is considering alternative financial pathways to support its Phase 3 clinical trial program for ibezapolumab [12] - The FDA has granted QIDP and fast track designations for Edezapolstat, emphasizing its importance in the treatment landscape for C. difficile infections [12] Q&A Session Summary Question: Will the trend of reduced operating expenses continue into 2025 and 2026? - Management confirmed that the trend of cash preservation and reduced operating expenses is expected to continue through the second half of 2025 and into 2026 [20][24] Question: When can partnerships be anticipated? - Management indicated that partnerships could be announced in the second half of 2025, but the timeline may extend into 2026 due to external factors [21][22] Question: Any feedback from the physician community regarding the recent publication? - Management noted that the only rate-limiting step ahead of the Phase III studies is related to the fill-finish process of ibezaprolstat supply, which is not expected to cause significant delays [30][31]

Core Viewpoint - Acurx Pharmaceuticals reported its financial and operational results for Q2 2025, highlighting a significant reduction in losses and an increase in cash reserves, while continuing to advance its antibiotic development programs. Financial Highlights - The company raised approximately $2.7 million from warrant exercises, resulting in net proceeds of $2.5 million after fees [1] - Cash position improved to $6.1 million as of June 30, 2025, up from $3.7 million at the end of 2024 [2] - Total gross proceeds raised in Q2 2025 amounted to approximately $3.4 million through an equity line of credit and warrant inducement [2] Research and Development Expenses - R&D expenses for Q2 2025 were $0.5 million, a decrease of $1.3 million from $1.8 million in Q2 2024, primarily due to lower manufacturing and consulting costs [3] - For the first half of 2025, R&D expenses totaled $1.1 million, down from $3.4 million in the same period of 2024, reflecting a reduction in both manufacturing and consulting costs [3] General and Administrative Expenses - G&A expenses for Q2 2025 were $1.7 million, down from $2.3 million in Q2 2024, mainly due to a decrease in share-based compensation and professional fees [4][5] - For the first half of 2025, G&A expenses were $3.3 million compared to $5.1 million in the same period of 2024, indicating a significant reduction [5] Net Income/Loss - The company reported a net loss of $2.2 million or $1.89 per diluted share for Q2 2025, an improvement from a net loss of $4.1 million or $5.21 per diluted share in Q2 2024 [6] - For the first half of 2025, the net loss was $4.4 million or $4.01 per diluted share, compared to a net loss of $8.5 million or $10.84 per diluted share in the same period of 2024 [6] Operational Developments - Acurx received a new patent for its DNA polymerase IIIC inhibitors, expiring in December 2039, which supports its antibiotic development program targeting infections caused by MRSA, VRE, DRSP, and Anthrax [4] - The company closed an equity line of credit with Lincoln Park Capital for up to $12 million in May 2025 [4] - Acurx announced the publication of Phase 2b clinical trial data for ibezapolstat in a leading microbiology journal in June 2025 [4] - The company is preparing for international Phase 3 clinical trials for ibezapolstat, which has received positive regulatory guidance from the EMA [10] Share Structure - As of June 30, 2025, the company had 1,470,352 shares outstanding following a 1 for 20 reverse stock split [7]

Antibiotic Development - The company is developing a new class of small molecule antibiotics targeting difficult-to-treat Gram-positive bacterial infections, including Clostridioides difficile and MRSA[95]. - The company believes it is developing the first DNA pol IIIC inhibitor to enter Phase 3 clinical trials, with positive results from its Phase 2 clinical trial[98]. - The lead antibiotic candidate, ibezapolstat, targets the pol IIIC enzyme, which is necessary for the replication of certain Gram-positive bacteria[102]. - The company has an early-stage pipeline of antibiotic candidates targeting Gram-positive bacteria, including ACX-375C[104]. - The company is evaluating strategic transactions, including partnerships for the development and commercialization of ibezapolstat[105]. Financial Performance - Research and development expenses decreased to $0.5 million for the three months ended June 30, 2025, from $1.8 million in the same period of 2024, a reduction of 71%[134]. - General and administrative expenses were $1.7 million for the three months ended June 30, 2025, down 24% from $2.3 million in the same period of 2024[136]. - Net loss for the three months ended June 30, 2025, was $2.2 million, a decrease of 46% compared to a net loss of $4.1 million for the same period in 2024[137]. - Total operating expenses for the three months ended June 30, 2025, were $2.3 million, down 45% from $4.1 million in the same period of 2024[134]. - Cumulative losses since inception reached approximately $71.7 million as of June 30, 2025, with no revenue generated from operations[144]. - Net cash used in operating activities was $3.7 million for the six months ended June 30, 2025, compared to $5.9 million for the same period in 2024[149]. - Net cash provided from financing activities was $6.1 million for the six months ended June 30, 2025, attributed to net proceeds from recent equity offerings[151]. Compliance and Regulatory Matters - The company is currently not in compliance with Nasdaq's minimum stockholders' equity requirement, which requires at least $2.5 million in stockholders' equity[120]. - The company received a notice from Nasdaq regarding non-compliance with the minimum bid price requirement, with a grace period until August 25, 2025, to regain compliance[122]. Capital and Funding - As of June 30, 2025, the company raised $0.7 million from the sale of 72,000 shares at a weighted-average price of $9.85 per share under a purchase agreement with Lincoln Park[115]. - The company has entered into a warrant inducement agreement, resulting in net proceeds of approximately $2.5 million from the exercise of existing warrants[119]. - The company plans to substantially increase research and development expenses in the foreseeable future to support product candidate development[131]. - As of January 6, 2025, the company suspended its ATM Program, which had raised approximately $8.8 million prior to suspension[144]. Accounting and Reporting Standards - The company qualifies as an emerging growth company under the JOBS Act, allowing it to delay compliance with new accounting standards until they apply to private companies[159]. - Exemptions under the JOBS Act include not providing an auditor's attestation report on internal controls and certain executive compensation disclosures for up to five years post-IPO[162]. - The FASB issued ASU 2023-09, effective after December 15, 2024, which expands income tax disclosures, though the company believes it will not materially impact its disclosures[163]. - ASU 2024-03, effective after December 15, 2026, requires more detailed expense information in the income statement, with the company currently evaluating its impact[164]. - As a smaller reporting company, the company is not required to provide quantitative and qualitative disclosures about market risk[165]. Stock Options and Compensation - Compensation expense related to stock options is recognized over the requisite service period based on the fair value at grant date, influenced by subjective assumptions like expected price volatility[157]. - The company utilizes the Black-Scholes option pricing model for estimating the fair value of options and warrants, with potential impacts on expenses and results of operations from changes in assumptions[158]. Public Health Context - The CDC estimates that antibiotic-resistant pathogens infect one individual every 11 seconds and result in one death every 15 minutes in the U.S.[97].