The Stock Exchange of Hong Kong Limited and the Securities and Futures Commission take no responsibility for the contents of this Application Proof, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this Application Proof. Application Proof of Elpiscience Biopharmaceuticals, Inc. 科望醫藥集團 (the "Company") (Incorporated under the laws of the Cayman Islands with ...

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]