Investment Highlights - Bicara Therapeutics is advancing ficerafusp alfa (FICERA), a bifunctional EGFR-directed antibody x TGF-β ligand trap, designed to enable tumor penetration by breaking barriers in the tumor microenvironment to drive deep and durable responses[8, 125] - FICERA + pembro offers a potential new 1L therapy for HPV-negative R/M HNSCC, with the FORTIFI-HN01 Ph 2/3 trial ongoing and enrolling[8, 125] - The company has a robust financial position with approximately $437 million in cash and equivalents[8, 125] Clinical Trial & Market Opportunity - There is a significant market opportunity with approximately 23,000 cases of R/M HNSCC annually in the U S, and a significant unmet need for better treatment options (13% 5yr survival)[8, 33, 125] - In a Ph 1b trial of FICERA + Pembrolizumab in HPV-neg, CPS≥1 1L R/M HNSCC, the confirmed ORR was 54% (15/28)[60, 75] - The same trial showed a median PFS of 9 9 months and a median OS of 21 3 months, with a 2-year OS rate of 46%[66, 72, 75] - The median DOR was 21 7 months, with DOR rates of 79% at 6 months, 65% at 12 months, and 57% at 18 months[69, 75] Expansion Opportunities - The company is expanding into other squamous cell carcinomas and solid tumors, with encouraging clinical activity observed in Ph 1b expansion cohorts to date[8, 125] - In 2L+ cutaneous squamous cell carcinoma (cSCC), FICERA monotherapy showed an ORR of 30% (7/23) and a mPFS of 7 0 months in PD-1-refractory patients[114] - In 2L+ squamous cancer of the anal canal (SCAC), FICERA + pembro showed a 25% ORR (7/28) and a 12-month PFS rate of 40 7%[118]

Core Insights - Sonnet BioTherapeutics Holdings, Inc. is set to present at the 6th Annual Cytokine-Based Drug Development Summit on May 15-16, 2025, focusing on managing toxicity related to cytokine overexpression to enhance therapeutic windows [1][2]. Company Overview - Sonnet is an oncology-focused biotechnology company that utilizes a proprietary platform called FHAB (Fully Human Albumin-Binding) for developing targeted biologic drugs [3]. - The FHAB technology employs a fully human single chain antibody fragment that binds to human serum albumin for targeted transport to tumor and lymphatic tissues, aiming to improve the safety and efficacy of immune-modulating biologic drugs [3]. Lead Programs - The lead program, SON-1010 (IL-12-FHAB), is in development for treating solid tumors, certain sarcomas, and ovarian cancer, currently undergoing a Phase 1/2a study in collaboration with Roche [4]. - A second program, SON-1210 (IL12-FHAB-IL15), is being evaluated for solid tumors, with plans for an investigator-initiated Phase 1/2a study for pancreatic cancer in collaboration with the Sarcoma Oncology Center [4]. Presentation Details - Dr. Richard Kenney, Chief Medical Officer, will discuss strategies for managing cytokine toxicity and optimizing therapeutic indices during the presentation [1][7]. - Key topics include receptor bias to reduce toxicity, optimizing cytokine potency, and examining factors influencing the therapeutic window [7].

Core Insights - Sonnet BioTherapeutics Holdings, Inc. announced positive safety results for SON-1010 in a Phase 1b/2a clinical trial for advanced solid tumors and platinum-resistant ovarian cancer [2][5] - The management team, including Interim CEO Raghu Rao and Chief Medical Officer Dr. Richard Kenney, discussed the implications of these results and future steps for the program [2] Company Overview - Sonnet is a clinical-stage biotechnology company focused on developing immunotherapeutic drugs targeting the tumor microenvironment (TME) [1][4] - The company utilizes a proprietary FHAB (Fully Human Albumin-Binding) platform designed to enhance the safety and efficacy of biologic drugs by targeting tumor and lymphatic tissues [4] Product Development - SON-1010 (IL-12-FHAB) is the lead program aimed at treating solid tumors, certain sarcomas, and ovarian cancer, currently in a Phase 1/2a study in collaboration with Roche [5] - The company is also developing SON-1210 (IL12-FHAB-IL15) for solid tumors, with plans for an investigator-initiated Phase 1/2a study for pancreatic cancer [5]