WCLC 2025 Highlights DAIICHI SANKYO CO., LTD. September 17th (US)/ 18th (JP), 2025 Forward-Looking Statements Management strategies and plans, financial forecasts, future projections and policies, and R&D information that Daiichi Sankyo discloses in this material are all classified as Daiichi Sankyo's future prospects. These forward looking statements were determined by Daiichi Sankyo based on information obtained as of today with certain assumptions, premises and future forecasts, and thus, there are vario ...

Core Viewpoint - Summit Therapeutics Inc. (NASDAQ:SMMT) is identified as a promising stock for investment over the next three months, with a Buy rating and a price target of $40 initiated by Guggenheim [1][2]. Group 1: Stock Performance and Analyst Insights - The stock was previously favored when trading at $3 due to an overlooked progression-free survival readout for its drug Ivonescimab compared to Merck's Pembrolizumab in lung cancer [2]. - Currently trading at $24, the stock is still viewed positively, with expectations that successful outcomes in two first-line lung cancer trials could lead to significant price appreciation by 2027 and 2028 [2]. - Analysts project a 12-month average price target indicating a potential upside of 34.72% from current levels [3]. Group 2: Company Overview - Summit Therapeutics Inc. is a biopharmaceutical company dedicated to discovering, developing, and commercializing innovative medicinal therapies aimed at enhancing the quality and duration of life [3].

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]

Median PFS at 6.8 months, Disease Control Rate of 77.3%, 15 months OS% at 78% in Metastatic NSCLC Patients after Progression on PD-1/L1 Therapies Median Progression-Free Survival (PFS): 6.8 months — nearly double the 3.7 months seen with current standard of care (SOC) docetaxel Confirmed Objective Response Rate (ORR): 18.2% — higher than the 12.8% seen with SOC docetaxel Disease Control Rate (DCR: PR + SD > 4 months): 77.3% — indicating clinical benefit majority of patients who progressed on prior PD-1/L1 i ...

Company Overview - BeyondSpring Inc. is a clinical-stage global biopharmaceutical company focused on developing cancer therapies, particularly its lead asset Plinabulin, which is in late-stage clinical development for non-small cell lung cancer (NSCLC) and other cancer indications [3] Study Announcement - BeyondSpring announced a poster presentation on the 303 Study, an investigator-initiated study supported by Merck, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, scheduled from May 30 to June 3 in Chicago, IL [1] 303 Study Details - The 303 Study is an open-label, single-arm Phase 2 study evaluating the efficacy and safety of Plinabulin in combination with docetaxel and pembrolizumab for previously treated patients with metastatic NSCLC who have progressed after anti-PD-(L)1 inhibitor therapy [4] - The study involves 47 enrolled patients and is conducted at Peking Union Medical College Hospital in Beijing, China, with Dr. Mengzhao Wang as the principal investigator [4] - The primary endpoint is the investigator-based overall response rate (ORR), while secondary endpoints include progression-free survival (PFS), overall survival (OS), duration of response (DoR), and safety [4] Presentation Details - The presentation will take place on May 31, 2025, from 1:30 PM to 4:30 PM CDT at McCormick Place Convention Center, focusing on initial efficacy and safety results related to immune re-sensitization [5]

Core Insights - Merus N.V. announced interim clinical data for petosemtamab in combination with pembrolizumab, showing a 63% response rate among evaluable patients and a 79% overall survival rate at 12 months [1][2][3] Clinical Data Summary - The ongoing phase 2 trial included 45 patients, with 43 evaluable for efficacy, showing a confirmed overall response rate of 63% (27/43) [3] - The median progression-free survival was reported at 9 months, with a median follow-up of 14.3 months [3] - Among the evaluable patients, 6 achieved complete responses and 21 had partial responses, with responses observed across different PD-L1 levels [3] - The combination treatment was generally well tolerated, with 60% of patients experiencing grade ≥3 treatment-emergent adverse events [3] Future Outlook - The company anticipates sharing top-line interim readouts from one or both phase 3 trials in 2026, indicating a strong belief in the potential of petosemtamab to become a new standard of care for head and neck cancer [2][3]

Financial Data and Key Metrics Changes - As of December 31, 2024, the company had approximately $4 million in cash, cash equivalents, and marketable securities [20] - Research and development expenses for the year ended December 31, 2024, were $6.2 million, a decrease from $10.9 million for the year ended December 31, 2023 [21] - General and administrative expenses for the year ended December 31, 2024, were $13.7 million, down from $21.1 million for the year ended December 31, 2023 [21] Business Line Data and Key Metrics Changes - The company is advancing multiple clinical programs, including a Phase 2 trial for pancreatic cancer and a Phase 2 study for advanced ovarian cancer, both of which are nearing completion [14][15] - The AMP518 study for post-COVID conditions has been completed, and a follow-up study is being planned [18] Market Data and Key Metrics Changes - The company is actively evaluating options to maintain compliance with the New York Stock Exchange American listing requirements, including a potential reverse stock split [22][24] Company Strategy and Development Direction - The company is focused on advancing Ampligen across multiple areas of significant medical need, including collaborations with AstraZeneca and the University of Alabama Birmingham Medical Center [8][10] - The addition of experienced board members is expected to strengthen the company's leadership and strategic execution [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential of Ampligen to address high medical needs [19] - The company is committed to maintaining its NYSE listing, which is seen as essential for long-term success and access to capital [22] Other Important Information - The company has been granted new patents for the treatment of endometriosis and for addressing post-COVID fatigue, expanding its intellectual property estate [12] Q&A Session Summary Question: Does the company have adequate supply of Ampligen for clinical trials this year? - Management confirmed that there is a budget tied to ongoing clinical activities to ensure sufficient supply for current trials, and they do not anticipate issues unless unforeseen circumstances arise [28][30] Question: How easy would it be to obtain new supply of Ampligen? - Management indicated that while future clinical trials will require additional manufacturing of Ampligen, they are actively analyzing the process and working with manufacturers to ensure supply [30][31]