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].

Core Viewpoint - Acurx Pharmaceuticals has announced a 1-for-20 reverse stock split to increase its stock price and regain compliance with Nasdaq's minimum bid price requirement, effective August 4, 2025 [1][3]. Group 1: Reverse Stock Split Details - The reverse stock split will convert every twenty shares of common stock into one share, with no fractional shares issued; stockholders will receive cash for any fractional shares [2]. - The number of outstanding shares will decrease from approximately 30,764,540 to about 1,538,227, while the total authorized shares will remain unchanged [3]. - Stockholders holding shares electronically will not need to take action, while those with physical certificates will receive instructions for exchanging them [4]. Group 2: Company Overview - Acurx Pharmaceuticals is focused on developing a new class of antibiotics targeting difficult-to-treat bacterial infections, specifically Gram-positive bacteria [5]. - The lead product candidate, ibezapolstat, is ready for Phase 3 trials, with plans for international clinical trials next year, pending financing [5]. - The preclinical pipeline includes an oral product candidate for treating Acute Bacterial Skin and Skin Structure Infections and a development program for inhaled anthrax [5].

Core Viewpoint - Acurx Pharmaceuticals is preparing to discuss its Q2 2025 financial results and is advancing its lead antibiotic candidate, ibezapolstat, towards international Phase 3 clinical trials for treating C. difficile Infection (CDI) [1][4]. 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 [5]. - The company's lead product candidate, ibezapolstat, is designed to treat CDI and is ready for Phase 3 trials, with plans to initiate international clinical trials next year, pending financing [5]. Product Details - Ibezapolstat is a novel, orally administered antibiotic that acts as a Gram-Positive Selective Spectrum (GPSS®™) antibacterial, specifically targeting DNA polymerase IIIC to inhibit DNA replication in Gram-positive bacteria [3][5]. - The antibiotic has received positive regulatory guidance from the EMA, supporting its advancement to Phase 3 trials and potential submission for Marketing Authorization Application (MAA) in Europe [4]. Regulatory Status - Ibezapolstat has been designated as a Qualified Infectious Disease Product (QIDP) by the FDA, which provides incentives for the development of new antibiotics [4]. - The FDA also granted "Fast Track" designation to ibezapolstat for CDI treatment, highlighting the urgent need for new antibiotics in this area [4]. Upcoming Events - Acurx Pharmaceuticals will host a conference call on August 12, 2025, at 8:00 am ET to discuss its financial results and provide a business update [2].

Company Performance - Acurx Pharmaceuticals, Inc. (ACXP) has returned 0.8% year-to-date, outperforming the Medical sector, which has returned an average of -4.7% [4] - The Zacks Consensus Estimate for ACXP's full-year earnings has increased by 60.5% over the past quarter, indicating improved analyst sentiment and a stronger earnings outlook [4] Industry Ranking - Acurx Pharmaceuticals belongs to the Medical - Biomedical and Genetics industry, which has 502 stocks and is currently ranked 88 in the Zacks Industry Rank. This industry has lost an average of 4.8% year-to-date, showing that ACXP is performing better than its peers [6] - The Medical group, which includes Acurx Pharmaceuticals, is ranked 6 within the Zacks Sector Rank, indicating a relatively strong position among 16 sector groups [2] Comparison with Peers - BioCryst Pharmaceuticals (BCRX) has also outperformed the Medical sector with a year-to-date return of 32.6% and has a Zacks Rank of 2 (Buy) [5] - The consensus EPS estimate for BioCryst Pharmaceuticals has increased by 339.6% over the past three months, highlighting significant positive analyst sentiment [5]

Core Viewpoint - Acurx Pharmaceuticals has entered into a warrant inducement agreement to facilitate the exercise of existing warrants at a significantly reduced price, generating approximately $2.67 million in gross proceeds for the company [1][2]. Group 1: Warrant Inducement Agreement - The company has a warrant inducement agreement with a holder of existing warrants to purchase up to 4,445,435 shares at exercise prices between $3.25 and $3.26 per share, allowing the holder to exercise these warrants at a reduced price of $0.675 per share [1]. - In exchange for exercising the existing warrants, investors will receive 6,223,609 G-1 warrants and 2,667,261 G-2 warrants, totaling 8,890,870 new warrants [1]. - The G-1 and G-2 warrants are both exercisable at $0.425 per share and will expire five years from the issuance date [1]. Group 2: Use of Proceeds - The net proceeds from the warrant exercise are intended for working capital and general corporate purposes [2]. Group 3: Regulatory and Clinical Development - Ibezapolstat, the company's lead antibiotic candidate, is advancing to international Phase 3 clinical trials for treating C. difficile Infection (CDI) and has received FDA designations that may expedite its development [5]. - The antibiotic is part of a new class of drugs targeting Gram-positive bacteria, which includes significant pathogens like MRSA and VRE [6].

Core Viewpoint - Acurx Pharmaceuticals is advancing its lead antibiotic candidate, ibezapolstat, to pivotal Phase 3 clinical trials for the treatment of Clostridioides difficile infection (CDI), with promising results from previous trials indicating high efficacy and safety [2][11][15]. Group 1: 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 [23]. - The company's lead product candidate, ibezapolstat, is a DNA polymerase IIIC inhibitor designed to treat CDI and has received FDA QIDP and Fast-Track designations [2][19]. - Acurx's research and development pipeline includes antibiotic candidates targeting various multi-drug resistant bacteria, including MRSA and VRE [23]. Group 2: Clinical Trial Progress - Ibezapolstat is ready to advance to international pivotal Phase 3 clinical trials, following positive outcomes from Phase 2 trials, which demonstrated a Clinical Cure rate of 96% [2][15][16]. - The Phase 2 clinical trial included a multicenter, open-label segment and a double-blind, randomized segment, with a total of 42 patients treated for CDI [13][14]. - The Phase 2b trial showed that ibezapolstat-treated patients had a higher sustained clinical cure rate compared to those treated with vancomycin, indicating its potential superiority [16][17]. Group 3: Scientific Collaboration and Research - Acurx's research is conducted in collaboration with Leiden University Medical Center, focusing on the structural biology of DNA pol IIIC and its inhibitors, which has implications for developing new antibiotics [1][4][10]. - The unique conformation of ibezapolstat and its analogues suggests a conserved mechanism of action across Gram-positive bacteria, enhancing the understanding of its selectivity and efficacy [3][4]. - Ongoing research aims to elucidate the structure of pol IIIC from multidrug-resistant organisms, which will guide the rational design of new inhibitors [6][7]. Group 4: Market Need and Impact - CDI is a significant healthcare issue, with estimates of 500,000 infections annually in the U.S. and a mortality rate of approximately 9.3%, highlighting the urgent need for new treatment options [20]. - The CDC has classified CDI as an urgent threat, underscoring the importance of developing effective antibiotics like ibezapolstat to combat antimicrobial resistance [19][20]. - Ibezapolstat's mechanism of maintaining a healthy gut microbiome while treating CDI may reduce the likelihood of recurrence, addressing a critical gap in current treatment options [17][22].