For those looking to find strong Medical stocks, it is prudent to search for companies in the group that are outperforming their peers. Has Acurx Pharmaceuticals, Inc. (ACXP) been one of those stocks this year? By taking a look at the stock's year-to-date performance in comparison to its Medical peers, we might be able to answer that question.Acurx Pharmaceuticals, Inc. is a member of our Medical group, which includes 934 different companies and currently sits at #5 in the Zacks Sector Rank. The Zacks Secto ...

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]