Financial Data and Key Metrics Changes - As of June 30, 2025, the company had approximately $93.9 million in cash, cash equivalents, short-term bank deposits, and investments in marketable securities [14] - Revenues for 2025 were approximately $1.3 million, a significant decrease from approximately $6.7 million in the comparable period in 2024 [15] - The net loss for 2025 was approximately $7.3 million, or $0.08 per basic and diluted share, compared to a net loss of approximately $2.1 million, or $0.02 per basic and diluted share in 2024 [16] Business Line Data and Key Metrics Changes - The company is advancing its immuno-oncology clinical and early-stage pipeline programs, including the potential first-in-class anti-PVRIG antibody COM701 [7] - The first patient was dosed in the ovarian maintenance immunotherapy trial, with plans to share interim analysis in 2026 [7] - Research and Development (R&D) expenses for 2025 were approximately $5.6 million, down from approximately $6.2 million in 2024 [16] Market Data and Key Metrics Changes - The company is observing increased competition in the platinum-sensitive ovarian cancer space, with a focus on improving treatment options for patients [8] - The initial opportunity in the platinum-sensitive maintenance setting is estimated to involve approximately 8,000 to 12,000 patients based on available epidemiology data [30] Company Strategy and Development Direction - The company aims to leverage its UniGen platform to identify novel mechanisms to activate the immune system against cancer [5] - The leadership transition is expected to provide a strong foundation for the company's next phase of growth, with a focus on corporate strategy and strategic collaborations [4] - The company is committed to advancing its extensive and differentiated early-stage pipeline focused on potential first-in-class drugs [13] Management's Comments on Operating Environment and Future Outlook - Management believes that the differentiated approach in immunotherapy can create significant value, addressing unmet medical needs in cancer treatment [5] - The company is well-positioned to capitalize on potential growth opportunities ahead, supported by a solid balance sheet and expected cash runway into 2027 [6] Other Important Information - The company has partnerships with AstraZeneca and Gilead, with potential milestone payments exceeding $1 billion [6] - The company has received milestone payments of $30.5 million and remains eligible for up to $170 million in future regulatory and commercial milestone payments [12] Q&A Session Summary Question: Can you provide an update on patient enrollment for the ovarian cancer trial? - The company has not disclosed the number of sites but has open sites in the US and Israel, actively enrolling with high investigator enthusiasm [22] Question: What should investors focus on regarding the upcoming presentation? - The focus will be on understanding the patients who had responses in prior studies, with more information on efficacy and safety to be presented [23] Question: What are the expectations from Merck's successful Phase III in ovarian cancer? - The Merck study provides insights into potential activity in earlier lines of treatment but does not change the company's current approach as it focuses on platinum-sensitive patients [36] Question: Can you provide more details on the interim analysis planned for 2026? - The interim analysis is to evaluate for futility and characterize the magnitude of effect size for COM701, with expectations that the study will be fully enrolled [41]

Core Insights - ImmunityBio reported a significant increase in revenue for Q2 2025, reaching $26.4 million, surpassing analyst expectations of $23.15 million, driven by strong sales of its immunotherapy product ANKTIVA [1][2] - The company narrowed its net loss per share to ($0.10), an improvement from the projected ($0.11) and a substantial reduction from ($0.20) a year prior, indicating better financial performance [1][2] Financial Performance - Revenue for Q2 2025 increased by 2,540% year-over-year from $1.0 million in Q2 2024 [2] - The GAAP revenue saw a 60% increase compared to Q1 2025, primarily due to rising sales of ANKTIVA for bladder cancer [5] - ANKTIVA unit sales surged 246% in the first half of 2025 compared to the second half of 2024, following the assignment of a J-code for easier reimbursement [5] - Research and Development expenses were reported at $52.4 million, reflecting the company's commitment to pipeline development [2] Business Focus and Strategy - ImmunityBio is focused on ramping up commercial sales of ANKTIVA for bladder cancer and expanding into global markets while investing in a diverse pipeline [4] - The company is pursuing regulatory approvals and maintaining robust sales growth for ANKTIVA, alongside advancing other product candidates into late-stage trials [4] - Recent regulatory developments include approval from the UK MHRA for ANKTIVA in BCG-unresponsive non-muscle invasive bladder cancer, while facing challenges from the FDA regarding a supplemental application [6] Pipeline Development - ImmunityBio launched a pivotal randomized trial for non-small cell lung cancer (NSCLC) combining its proprietary N-803 with BeOne Medicines' tislelizumab [7] - The company is expanding clinical trials into Europe and Asia and has received FDA support for its lymphopenia program [7] - Strategic collaborations with BeOne Medicines and the Serum Institute of India are enhancing manufacturing capabilities for bladder cancer therapies [8] Future Outlook - Management did not provide explicit guidance for the next quarter or fiscal 2025 but emphasized priorities around expanding ANKTIVA's market reach and advancing regulatory filings [9] - The company raised $80 million in equity in July 2025, which may extend its cash runway amid ongoing cash burn and fundraising needs [9][10]

Core Viewpoint - Sensei Biotherapeutics is transitioning from early response-focused readouts to longer-term efficacy signals in its Phase 1/2 study of solnerstotug, which shows a favorable safety profile and potential for better patient adherence and outcomes [2][3] Clinical Program Highlights - Full data for the Phase 1/2 dose expansion cohort is expected by year-end 2025, with enrollment complete at 64 patients [6] - The ongoing trial evaluates solnerstotug as a monotherapy and in combination with cemiplimab in patients with advanced solid tumors [3] - Preliminary clinical data indicates favorable activity in PD-(L)1 resistant "hot" tumors, with solnerstotug well tolerated and no dose-limiting toxicities reported [6] Corporate Updates - Sensei's cash position was $28.6 million as of June 30, 2025, down from $41.3 million at the end of 2024, with expectations to fund operations into Q2 2026 [8] - Research and Development expenses decreased to $2.5 million in Q2 2025 from $4.6 million in Q2 2024, attributed to lower personnel and facility costs [9] - General and Administrative expenses also decreased to $2.7 million in Q2 2025 from $3.2 million in Q2 2024, primarily due to lower personnel costs [10] Financial Results - The net loss for Q2 2025 was $4.9 million, an improvement from a net loss of $7.1 million in Q2 2024 [10] - Total operating expenses for Q2 2025 were $5.2 million, down from $7.8 million in Q2 2024 [13]

Core Insights - Elicio Therapeutics announced that the Independent Data Monitoring Committee (IDMC) recommended the continuation of the Phase 2 AMPLIFY-7P trial for ELI-002 7P without modifications, indicating preliminary efficacy signals [1][5] - The final disease-free survival (DFS) analysis is expected in Q4 2025, and the company plans to request an End-of-Phase 2 meeting with the FDA to finalize the regulatory strategy for the Phase 3 study [2][5] - ELI-002 7P is an investigational immunotherapy targeting seven KRAS mutations, which are prevalent in 88% of PDAC patients and 25% of all solid tumors [3][8] Company Overview - Elicio Therapeutics is a clinical-stage biotechnology company focused on developing novel immunotherapies for high-prevalence cancers, including mKRAS-positive pancreatic and colorectal cancers [4] - The company utilizes its proprietary Amphiphile (AMP) technology to enhance the immune response against cancer, aiming for durable cancer immunosurveillance [4][9] - ELI-002 is designed as an off-the-shelf vaccine candidate targeting common KRAS mutations, with potential benefits including low cost and rapid availability for patients [4][6] Clinical Trial Details - The AMPLIFY-7P trial is a 2:1 randomized, open-label study involving 144 patients across 24 U.S. sites, comparing ELI-002 7P monotherapy to standard of care [2][5] - ELI-002 7P treatment consists of six doses followed by an eight-week observation period and four booster doses [2] - The trial aims to improve DFS in patients with PDAC who have undergone local therapy, surgery, and chemotherapy [2] Future Plans - Elicio plans to expand ELI-002 to other indications, including mKRAS-positive lung cancer and additional mKRAS-positive cancers [6] - The company is also developing other off-the-shelf therapeutic cancer vaccine candidates, such as ELI-007 and ELI-008, targeting BRAF-driven cancers and p53 hotspot mutations [6]

As filed with the Securities and Exchange Commission on August 4, 2025 Registration No. 333- Delaware 2834 82-5118368 (State or other jurisdiction of incorporation or organization) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 OS THERAPIES INCORPORATED (Exact name of registrant as specified in its charter) (Primary SIC Code) (IRS Employer Identification No.) 115 Pullman Crossing Road, Suite #103 Grasonville, Maryland ...

Core Insights - Sonnet BioTherapeutics is expanding its clinical study of SON-1010 in combination with atezolizumab for patients with advanced platinum-resistant ovarian cancer, showing promising early results with a 66% tumor response rate at the highest dose [1][2] - The company is also exploring a higher maintenance dose of SON-1010 to assess its safety and efficacy before moving to a randomized Phase 2a trial [1][2] - SON-1010 is designed to enhance immune response in tumors by delivering IL-12 directly to the tumor microenvironment, potentially improving treatment outcomes for various cancers [3][4] Company Overview - Sonnet BioTherapeutics focuses on developing targeted biologic drugs using its Fully Human Albumin-Binding (FHAB) platform, which aims to optimize the safety and efficacy of immune-modulating therapies [6][7] - The company is currently evaluating SON-1210, another candidate using the FHAB platform, for the treatment of pancreatic cancer in collaboration with the Sarcoma Oncology Center [7] Clinical Trial Details - The SB221 trial is a Phase 1b/2a multicenter study assessing the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SON-1010, both alone and in combination with atezolizumab [5] - The trial aims to establish the maximum tolerated dose (MTD) and evaluate the potential for improved efficacy in patients with platinum-resistant ovarian cancer [5]

Core Viewpoint - Corvus Pharmaceuticals will host a conference call and webcast on August 7, 2025, to provide a business update and report its second quarter 2025 financial results [1]. Group 1: Conference Call Details - The conference call is scheduled for 4:30 pm ET (1:30 pm PT) [1]. - Access to the conference call can be made via a toll-free domestic number (1-800-717-1738) or an international number (1-646-307-1865) [2]. - A live webcast will be available on the investor relations section of the Corvus website, with a replay accessible for 90 days [2]. Group 2: Company Overview - Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company focused on ITK inhibition as a novel immunotherapy approach for various cancers and immune diseases [3]. - The lead product candidate is soquelitinib, an investigational oral small molecule drug that selectively inhibits ITK [3]. - The company is developing other clinical-stage candidates targeting a variety of cancer indications [3].

Core Insights - BriaCell Therapeutics Corp. has added UCLA Health Jonsson Comprehensive Cancer Center to its pivotal Phase 3 clinical study evaluating Bria-IMT™ in combination with a checkpoint inhibitor for advanced metastatic breast cancer [1][2] - The Phase 3 study aims to improve survival outcomes in patients with metastatic breast cancer, with overall survival as the primary endpoint [2] - The Bria-IMT combination regimen has received FDA Fast Track designation, indicating its potential to address significant unmet medical needs [2] Company Overview - BriaCell is a clinical-stage biotechnology company focused on developing novel immunotherapies to transform cancer care [4] - The company is currently conducting a pivotal Phase 3 study (Bria-ABC, NCT06072612) to evaluate the effectiveness of its treatment in a multi-center clinical setting [1][3] Clinical Study Details - The Phase 3 study will conduct an interim analysis after 144 patient events (deaths) have occurred [2] - The study design builds on positive survival data from a previous Phase 2 study, which was presented at ASCO 2025 [2] - The inclusion of UCLA Health is part of BriaCell's strategy to partner with top-tier institutions to enhance trial enrollment and execution [2]

Core Insights - Akeso, Inc. has initiated a pivotal Phase III clinical study for ivonescimab, a PD-1/VEGF bispecific antibody, in combination with docetaxel for treating locally advanced or metastatic non-small cell lung cancer (NSCLC) that has progressed after PD-1/L1 inhibitors and platinum-based chemotherapy [1][4] - Ivonescimab is currently the only bispecific immunotherapy antibody in Phase III trials for IO-resistant lung cancer, highlighting its unique position in the market [2] - The study aims to address the significant unmet need in treating IO-resistant NSCLC, as current options are limited and docetaxel's efficacy as a monotherapy is restricted [4][6] Industry Context - Immunotherapy has made substantial advancements in NSCLC treatment, with PD-1/L1 inhibitors becoming standard first-line therapies; however, 60%-70% of patients still experience disease progression within the first year [3] - There are no approved standard treatment options for IO-resistant NSCLC, making the development of ivonescimab particularly relevant [4] - Mechanistic studies indicate that combining PD-1 and anti-VEGF therapies may yield synergistic effects, enhancing anti-tumor immune responses and potentially improving treatment outcomes for IO-resistant tumors [5][6] Company Overview - Akeso is a leading biopharmaceutical company focused on developing innovative biological medicines, with a robust pipeline of over 50 assets across various disease areas, including cancer [11] - The company employs a unique integrated R&D innovation system and has developed a comprehensive drug development platform, positioning itself competitively in the global biopharmaceutical market [11] - Akeso's commitment to creating first-in-class and best-in-class drugs aims to provide affordable therapeutic options for patients worldwide, contributing to its goal of becoming a global leader in the biopharmaceutical industry [11]

The phenomenon could be harnessed to boost immunotherapy https://t.co/zjLZOymL4W ...