Core Viewpoint - OS Therapies has terminated its Equity Purchase Agreement with Square Gate Capital Master Fund, effective August 26, 2025, and has successfully raised $4.2 million through a warrant exercise inducement and exchange offering to fund operations into mid-2026 [1][2]. Group 1: Financial Developments - The termination of the Equity Purchase Agreement (ELOC) with Square Gate Capital Master Fund is effective August 26, 2025 [1]. - The company raised $4.2 million in gross proceeds from a recent warrant exercise inducement and exchange offering, which will support operations through mid-2026 [2]. Group 2: Clinical Trials and Product Development - The treatment phases of the Phase 2b OST-HER2 clinical trial in osteosarcoma and the Phase 1b OST-504 clinical trial in prostate cancer are now complete, leading to a projected monthly burn rate in the second half of 2025 that is significantly lower than in the first half [3]. - OS Therapies plans to allocate capital primarily to drive towards approval for OST-HER2 in osteosarcoma while analyzing data from OST-504 for future development steps [3]. Group 3: Company Overview and Product Pipeline - OS Therapies is focused on developing treatments for osteosarcoma and other solid tumors, with its lead asset, OST-HER2, leveraging immune-stimulatory effects to target the HER2 protein [4]. - OST-HER2 has received multiple designations from the U.S. FDA, including Rare Pediatric Disease Designation and Fast-Track designation, and the company plans to submit a Biologics Licensing Application (BLA) for OST-HER2 in 2025 [4]. - The company is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced delivery of therapeutic payloads [5].

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $1.3 million, an increase from $1 million in Q2 2024 [28] - The company raised its full-year revenue guidance to between $6 million and $8 million for 2025 [28] - Total operating costs and expenses decreased to $13.4 million in 2025 from $47.4 million in 2024, a reduction of 72% year over year [29] - R&D expenses were $5.9 million in 2025, down from $32.4 million in 2024, representing an 82% decrease [29] - SG&A expenses decreased to $7.1 million in 2025 from $14.9 million in 2024, a 53% reduction [29] - The net loss from continuing operations was $13.7 million or $3.38 per share in 2025, compared to a net loss of $47.1 million or $11.79 per share in 2024 [29] - Cash and cash equivalents totaled $142.1 million, including balances in China, with the company being cash flow positive in Q2 2025 [30] Business Line Data and Key Metrics Changes - The sale of FibroGen China to AstraZeneca is expected to provide total consideration of approximately $210 million, an increase of $50 million from initial guidance [5][26] - The transaction is anticipated to extend the company's cash runway into 2028 [5][27] Market Data and Key Metrics Changes - The total addressable market for FG3246 in the U.S. is estimated to exceed $5 billion annually, targeting metastatic castration-resistant prostate cancer [9] - The company is focused on addressing the unmet need in late-stage prostate cancer, with a five-year survival rate of approximately 30% for patients [8] Company Strategy and Development Direction - The company is prioritizing the sale of FibroGen China, advancing FG3246 and FG3180 in metastatic castration-resistant prostate cancer, and refining the pathway for roxadustat in treating anemia due to lower-risk myelodysplastic syndromes [4][5] - FG3246 is positioned as a potential first-in-class antibody-drug conjugate targeting CD46, with a companion PET imaging agent FG3180 [10][11] - The company aims to finalize the Phase III trial design for roxadustat and submit the protocol in 2025 [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's refined focus and simplified capital structure, which are expected to create value for patients and shareholders [8] - The company anticipates multiple near-term catalysts, including the initiation of the Phase II monotherapy study for FG3246 and reporting top-line results from the Phase II IST for FG3246 in combination with enzalutamide [33] Other Important Information - The company recorded a significant decrease in operating costs, reflecting a strategic shift and operational efficiency [29] - The FDA provided positive feedback regarding the pivotal Phase III trial for roxadustat, aligning on key design elements [23] Q&A Session Summary Question: Insights on FG3246 and Phase III design considerations - Management acknowledged the evolving nature of the field and the potential inclusion of docetaxel in the control arm for Phase III trials, emphasizing the need for further discussions [36][39] Question: Updates on roxadustat's exclusivity and trial design - Management confirmed a minimum of seven years of exclusivity with orphan drug designation for roxadustat and stated that the Phase III trial will be placebo-controlled [44][48] Question: Feedback from the physician community on FG3246 Phase I data - Management reported positive feedback from clinical sites regarding FG3246, highlighting its potential in the unmet need space for metastatic castration-resistant prostate cancer [56][58]

Summary of ADC Therapeutics Conference Call Company Overview - ADC Therapeutics is an antibody drug conjugate company with capabilities from research to commercialization, focusing on two main pillars: ZIMMANTA and an early-stage solid tumor pipeline targeting PSMA and Claudine six [3][4] Market Performance and Strategy - ZIMMANTA is approved as a monotherapy in the third line plus setting for DLBCL, capturing approximately 10% market share, which translates to 25% of the broadly accessible therapies segment [7][8] - The market for DLBCL therapies is segmented into complex therapies (60% market share) and broadly accessible therapies (40% market share) [6][7] - ADC Therapeutics aims to expand ZIMMANTA's use into earlier lines of therapy, with ongoing studies showing promising results [14][19] Clinical Data and Studies - The LOTUS five study, combining ZIMMANTA with rituximab, has shown a 50% complete response (CR) rate in early safety run-in data, with expectations for top-line results by early next year [14][24] - The LOTUS seven study, combining ZIMMANTA with glafitamab, reported an overall response rate of over 95% and a CR rate of 91% in the first 22 evaluable patients [15][19] - The company plans to engage with the FDA regarding the LOTUS studies and potential phase three designs in the second half of the year [20][27] Financial Projections - The potential market opportunity for ZIMMANTA in the second line setting is estimated at $200 million to $300 million, with a total opportunity (including LOTUS five and current indications) projected to reach $500 million to $800 million [25][27] - The company reported a cash position of $196 million, providing a runway until the second half of 2026, with a quarterly cash burn of $30 million to $35 million [39][41] Expansion Opportunities - ADC Therapeutics is exploring additional indications in indolent lymphomas, with promising data from ASH showing a 77% CR rate in high-risk follicular lymphoma patients [29][30] - The marginal zone lymphoma (MZL) opportunity is estimated at $500 million in peak sales, with a 70% CR rate observed in early studies [31][32] Future Outlook - The company anticipates significant data releases and derisking events in the coming months, setting the stage for a growth trajectory starting in early 2027 [27][49] - ADC Therapeutics is open to partnerships for advancing solid tumor assets, emphasizing the need for collaboration to unlock value [43][44]

Core Viewpoint - OS Therapies has announced positive data for its treatment OST-HER2 in dogs with unresected osteosarcoma, indicating potential for use as a frontline therapy in humans, aiming to prevent or delay limb amputation and reduce the need for chemotherapy [2][4][8] Group 1: Treatment Efficacy - OST-HER2 combined with palliative radiation showed clinical and radiographic arrest of primary tumors in dogs, leading to prolonged time to metastasis without surgery or chemotherapy [2][4] - The treatment demonstrated a significant improvement in overall survival, with 5 out of 15 dogs surviving over 500 days [6] - Positive data published in "Molecular Therapy" correlates immune responses to OST-HER2 with prevention of metastasis and long-term survival benefits [3][6] Group 2: Safety and Tolerability - Treatment with OST-HER2 was found to be safe and well tolerated in both studies conducted [4][6] Group 3: Future Plans and Approvals - The company plans to submit data to the USDA for conditional approval of the new manufacturing process for OST-HER2, aiming for sales to begin in 2025 [7] - A pivotal clinical study is planned to gain full approval by 2026 [7] - The company is focused on obtaining Accelerated Approval for OST-HER2 in recurrent, fully resected, lung metastatic human osteosarcoma by the end of 2025 [8] Group 4: Company Background - OS Therapies is a clinical-stage oncology company specializing in treatments for osteosarcoma and other solid tumors, with OST-HER2 as its lead asset [9] - The company has received various designations from the FDA, including Rare Pediatric Disease Designation and Fast-Track status [9] - OST-HER2 has shown statistically significant benefits in previous clinical trials for lung metastatic osteosarcoma [9]