As filed with the Securities and Exchange Commission on October 20, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ACURX PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) As soon as practicable after the effective date of this registration statement. If any of the securities being registered on this Form ...

Strategic Shift & Clinical Focus - SoftOx Solutions AS is refining its clinical focus towards chronic lung infections, particularly Cystic Fibrosis (CF), with SIS 003 as a Proof of Concept (PoC) [9, 15] - The Cystic Fibrosis (CF) pathway is a commercially valid and strategic first step, creating a foundation for long-term value creation in the inhaled pan-microbial pharmaceuticals space [17] - The company aims to transform antimicrobial therapy and combat antibiotic resistance with a novel mode of action that eradicates bacteria independent of metabolism [22] Market Opportunity & Commercial Potential - The Cystic Fibrosis (CF) addressable market is estimated to be greater than $600 million, with approximately 13,000 addressable patients in the US & EU4+UK, based on an annual treatment cost of $75,000/€20,000 [25, 53, 55] - The Non-Cystic Fibrosis Bronchiectasis (NCFB) addressable market is estimated to be greater than $5 billion, with approximately 445,000 addressable patients in the US & EU4+UK [31, 58] - Assuming a feasible market share of 15% in CF, the annual turnover potential is $90 million [55] Clinical Development & Investment - SoftOx plans to invest 7-8 million EUR to conclude Phase IIa and conduct partnership processes [45] - The company plans to submit a Clinical Trial Application (CTA) by the end of September 2025 for a Phase IIa PoC study in CF [45, 49] - The PoC study is designed to demonstrate a reduction in lung bacterial load in CF patients, with a primary endpoint of ≥ 2 log10 CFU/g reduction in bacterial load in expectorated sputum [41, 42, 51] Financial Flexibility - SoftOx has a financing facility with Long State Investment for a total commitment of NOK 50 million over 24 months, with the option to extend to NOK 80 million over 36 months [68]

Financial Data and Key Metrics Changes - The company reported over 50% year-over-year growth in the Innoviva Specialty Therapeutics (IST) business for Q2 [27] - The royalty portfolio has consistently exceeded analyst expectations, with projections of over $1 billion in royalty revenue over the next five years [27][28] - The IST business is expected to achieve over $100 million in net sales in the U.S. this year, with peak portfolio sales projected to exceed half a billion dollars [22] Business Line Data and Key Metrics Changes - The royalty portfolio includes two major products: RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®, which are expected to maintain stable revenues due to their characteristics as maintenance therapies [9][10] - The IST business has successfully launched products like GIAPREZA® and XACDURO®, with the latter being one of the most successful antibiotic launches in recent years [16][18] - The recent launch of ZEVTERA® is anticipated to contribute positively to the IST business moving forward [28] Market Data and Key Metrics Changes - The majority of sales for RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA® are generated outside the U.S., with these regions showing higher growth potential due to less competition [10][11] - The IST business is positioned to benefit from the growing threat of antimicrobial resistance, which is a significant public health concern [17] Company Strategy and Development Direction - The company has a unique business model that includes a royalty portfolio, a fully integrated biopharma business focused on critical care and infectious disease, and a portfolio of strategic healthcare assets [4][5] - The strategy involves identifying undervalued assets in areas of high unmet medical need, with a focus on long-term growth and profitability [24][26] - The company aims to leverage its stable revenue base from royalties to support growth in its therapeutics business and strategic investments [33][40] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the current macroeconomic uncertainty but views it as an opportunity to find attractive investments [6][8] - The company is optimistic about the upcoming FDA PDUFA decision for zoliflodacin, which targets a significant market need in treating gonorrhea [20][21] - The company expects continued growth in both the royalty and IST businesses, with a strong pipeline of products and strategic healthcare assets [30][31] Other Important Information - The company has a productive partnership with Glaxo Group Limited (GSK) for its royalty products, which are well-established and mature [11] - Recent achievements include a groundbreaking phase two clinical trial result from Armada Pharmaceutical, indicating a potential paradigm shift in treating difficult infections [28][29] Q&A Session Summary Question: What are the growth drivers for the IST business? - The major growth drivers include commercial execution for GIAPREZA® and the successful launch of XACDURO®, addressing high unmet medical needs [16][18] Question: How does the company prioritize capital allocation between different business segments? - The company is thoughtful about capital allocation, focusing on opportunities for growth in the IST business while also supporting strategic healthcare assets [32][33] Question: What areas is the company looking to expand in the IST business? - The company is open to evaluating opportunities in the hospital space, particularly in infectious disease and critical care, leveraging its operational expertise [39]

Financial Data and Key Metrics Changes - Total operating expenses increased to $5.5 million in Q2 2025 from $4 million in Q2 2024 [26] - Research and development (R&D) costs decreased to $1 million in Q2 2025 from $2.1 million in Q2 2024, primarily due to reduced costs associated with the ReAssure trial [26] - General and administrative (G&A) costs rose to $4.2 million in Q2 2025 from $1.9 million in Q2 2024, driven by pre-commercialization activities [26] - Net loss on a US GAAP basis was $6.5 million in Q2 2025 compared to a net loss of $5 million in Q2 2024 [27] - Non-GAAP net loss was $5.1 million in Q2 2025, up from $3.8 million in Q2 2024, mainly due to higher G&A expenses [27] - Cash and cash equivalents stood at $13 million as of June 2025, expected to fund operations into 2026 [28] Business Line Data and Key Metrics Changes - The company is preparing to launch Orlynda, targeting the uncomplicated urinary tract infection market in the U.S. [6][9] - The market generates approximately 40 million prescriptions annually, with about 26 million for at-risk patients [10] - The initial launch phase will focus on 20 targeted geographic territories, primarily in major metropolitan areas across seven states [12] Market Data and Key Metrics Changes - The uncomplicated urinary tract infection market has not seen a new branded oral treatment in over 25 years, indicating a significant opportunity for Orlynda [11] - Rising rates of antimicrobial resistance are eroding the efficacy of existing treatments, highlighting the need for new therapies [11] Company Strategy and Development Direction - The company aims to successfully launch Orlynda to address unmet needs in the uncomplicated urinary tract infection market [8] - A commercial supply agreement has been executed with ACS Dabfahr for the manufacturing of Orlynda, ensuring a reliable supply chain [18] - The company has received FDA market exclusivity for Orlynda, which will last until October 2034 [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming launch of Orlynda and its potential to meet significant market needs [24] - The company is focused on optimizing physician targeting and resource allocation in key geographies to maximize revenue generation [16] - Management highlighted the importance of speed to therapy for patients suffering from uncomplicated urinary tract infections [17] Other Important Information - The company has deferred a $20 million regulatory payment to Pfizer, now due in October 2029, alleviating near-term financial obligations [21] - The company is seeking authorization for an additional 80 million shares to ensure financial flexibility for strategic objectives [29] Q&A Session Summary - No questions were registered during the Q&A session, indicating a lack of immediate inquiries from investors [32]

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].

Summary of CorMedix Conference Call Company Overview - CorMedix is a publicly traded, small-cap biotech company focused on commercializing its lead product, DefenCath, which is an FDA-approved, first-in-class, non-antibiotic antimicrobial catheter lock solution aimed at reducing catheter-related bloodstream infections (CRBSIs) in adult hemodialysis patients [2][3] Product Launch and Financial Guidance - DefenCath was soft-launched in April 2024 and is set for a full-scale launch in July 2024 [3] - The company has provided first-half revenue guidance of approximately $70 million from existing purchasing customers [3][21] - The total addressable market for DefenCath is estimated at around 40 million vials [14] Market Opportunity - The primary market for DefenCath includes outpatient hemodialysis, where the top five customers account for nearly 90% of the market [5][13] - Currently, DefenCath is being utilized in over 4,000 patients, with expectations for increased use in inpatient settings due to a dedicated field team [6][15] - The company is also exploring expanded indications for DefenCath, including total parenteral nutrition (TPN) and pediatric hemodialysis [17][19] Clinical Need and Impact of CRBSIs - Approximately 800,000 patients receive hemodialysis annually, with 25-33% experiencing CRBSIs, leading to increased hospitalizations and costs [7][9][10] - The healthcare system incurs costs exceeding $3.5 billion annually due to CRBSIs, with each hospitalization costing upwards of $60,000 [11][10] Clinical Efficacy - The largest study for a catheter lock solution demonstrated a 71% reduction in CRBSI risk with DefenCath, showing no significant difference in adverse events compared to standard care [12][13] Financial Metrics - As of the last quarter, CorMedix reported over $77 million in cash and achieved cash flow positivity in Q4 2024, with Q1 2025 net revenue of $39 million and adjusted EBITDA of over $23 million [21][20] - Full-year operating expense guidance is set between $72 million and $78 million [21] Future Outlook - The peak annual sales potential for DefenCath in the TPN market is estimated between $150 million and $200 million [20] - The company is also initiating an expanded access program to collect data on high-risk populations [18] Conclusion - CorMedix is positioned to address a significant unmet medical need in the dialysis community with its innovative product, DefenCath, while also demonstrating strong financial performance and growth potential in various therapeutic areas [2][21]

Financial Data and Key Metrics Changes - The company reported combined revenues of $11,700,000 for Q1 2025, representing a 38% increase compared to the prior year period [8][26] - Total assets improved to $70,000,000, with $50,000,000 in cash, and total liabilities decreased to $42,000,000, resulting in shareholders' equity of $51,000,000 [8][29] - Net profit for the quarter was $1,260,000, with adjusted earnings of $2,400,000 and cash flow from operations of $3,900,000 [8][26] Business Line Data and Key Metrics Changes - Revenue breakdown for Q1 2025 included $3,500,000 for Cristalos, $2,300,000 for SANKUSO, $1,400,000 for Vibativ, and $1,300,000 for Caldolor [26] - The company launched new marketing initiatives and expanded its sales force to support its FDA approved products [11][12] Market Data and Key Metrics Changes - The approval of Vibativ in China provides access to a significant pharmaceutical market, with expectations for launch later in the year [10] - The company is enhancing its presence in states with Medicaid coverage for Cristalos, contributing to its growth [14] Company Strategy and Development Direction - The company is focused on expanding its portfolio through strategic acquisitions and enhancing its marketing initiatives for existing products [32] - The management is optimistic about the positioning of Vibativ amid growing global concerns over antimicrobial resistance [32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's future, citing strong performance in Q1 and positive developments in the clinical pipeline [7][31] - The company anticipates continued momentum across its approved brands and further progress in its clinical pipeline [33] Other Important Information - The company continues to hold over $53,000,000 in tax net operating loss carryforwards, primarily from prior stock option exercises [29] - The company is implementing new trading plans for board members to increase their holdings in the company [29] Q&A Session Summary - There were no questions from participants during the Q&A session, and management encouraged private discussions with shareholders if desired [35][36]

As filed with the Securities and Exchange Commission on March 29, 2024 Registration No. 333-278028 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ACURX PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorporation or organization) 2834 (Primary Standard Industrial 82-3733567 (I.R.S. Employer Identification Number) 259 Liberty Avenu ...

As filed with the Securities and Exchange Commission on March 18, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ACURX PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) 82-3733567 (I.R.S. Employer Identification Number) 259 Liberty Avenue Staten Island, New York 10305 (917) 533-1469 Delaware (State or other jurisdiction of incorporation or organization) 2834 (Primar ...

As filed with the Securities and Exchange Commission on June 29, 2023 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ACURX PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorporation or organization) 2834 (Primary Standard Industrial Classification Code Number) 82-3733567 (I.R.S. Employer Identification Number) 259 Liberty Ave ...