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]