DXd ADC Portfolio & Approvals - Daiichi Sankyo's DXd ADC technology received 3 World ADC Awards in 2025[21, 23, 25] - ENHERTU has achieved 15 new regulatory approvals across 15 countries/regions and 94 extension approvals across 45 countries/regions as of CY2025[31] - DATROWAY received 1 accelerated approval for TROPION-Lung05 based on Breakthrough Therapy Designation (BTD)[31] - I-DXd in SCLC and R-DXd in PROC received BTDs, totaling 13 BTDs for the DXd ADC portfolio[31] Clinical Trial Results & Advancements - DESTINY-Breast11 (Neoadjuvant) demonstrated statistically significant and clinically meaningful improvement in pCR vs ddAC-THP in patients with high-risk HER2+ eBC[39, 41] - DESTINY-Breast05 (Post Neoadjuvant) showed a 53% reduction in the risk of invasive disease recurrence or death for T-DXd compared with T-DM1 in patients with HER2+ eBC[42, 44] - In TROPION-Breast02, DATROWAY demonstrated a statistically significant and clinically meaningful improvement of ~5 months in both mOS (23.7 vs 18.7 months) and mPFS vs chemotherapy (OS HR: 0.79)[46, 48] - DATROWAY achieved an ORR of 62% vs 293% for chemotherapy in TROPION-Breast02[50] Oncology Business Performance & Strategy - Daiichi Sankyo aims to deliver 900 Billion JPY in 5 years (FY2021 to 2025)[131] - ENHERTU delivered ¥5528 Billion in revenue in FY2024, with US and EU leading the way[134] - ENHERTU has treated 194000 patients globally[132, 134] - DATROWAY global net sales exceeded 10 Billion JPY in Q2 FY'25[157] Manufacturing and Supply - Daiichi Sankyo is expanding production capacity and enhancing capabilities to maximize supply volume for 5 DXd ADCs[190, 191] - The company is utilizing both in-house manufacturing and multiple CMOs to establish diversified manufacturing and supply routes[197]

Exelixis (NasdaqGS:EXEL) 2025 R&D Day December 10, 2025 01:00 PM ET Company ParticipantsMichael M. Morrissey - President and CEODana T. Aftab - EVP of Research and DevelopmentAnwaar Saeed - Chief of GI OncologySusan Hubbard - EVP of Public Affairs and Investor RelationsP.J. Haley - EVP of CommercialJennifer Chan - Clinical Director of Gastrointestinal Cancer Treatment CenterToni Choueiri - Director of the Lank Center for Genitourinary OncologyOperatorWelcome to the Exelixis virtual event. Please welcome Exe ...

Core Insights - SystImmune Inc. and Bristol Myers Squibb announced the first safety and efficacy data from the global phase I US-Lung-101 study of iza-bren, a bispecific antibody-drug conjugate targeting EGFR and HER3, presented at the ESMO Congress 2025 [1][5] Study Results - The study evaluated 107 patients with advanced solid tumors, primarily those with heavily pre-treated metastatic or unresectable non-small cell lung cancer (NSCLC) [2] - At the data cut-off on July 23, 2025, 55% of patients receiving 2.5 mg/kg of iza-bren showed a confirmed response, with a median progression-free survival of 5.4 months [3] - The most common side effects were blood-related, such as neutropenia, which were manageable and did not lead to serious complications [2] Ongoing Research - Global registrational studies for first-line metastatic triple-negative breast cancer (TNBC), second-line metastatic EGFR-mutated NSCLC, and second-line metastatic urothelial cancer are ongoing, with plans for studies in other indications [4] Company Statements - SystImmune's Chief Medical Officer highlighted the consistent efficacy of iza-bren in a heavily pre-treated global population, supporting its potential as a treatment option across multiple tumor types [5] - Bristol Myers Squibb expressed commitment to developing innovative medicines that improve outcomes for patients with difficult-to-treat cancers, reinforcing confidence in iza-bren's potential [5] Product Overview - Iza-bren (BL-B01D1) is designed to target both EGFR and HER3, which are associated with cancer cell proliferation and survival, utilizing a dual mechanism of action to reduce cancer cell growth [8]

Financial Data and Key Metrics Changes - For the first half of 2025, the company reported total revenue of $4.9 million, primarily driven by collaborations with AstraZeneca and Sanofi, as well as governmental funding for research expenditures [31] - Operating expenses reached $30.3 million, with R&D expenses at $20.5 million, reflecting a 29% decrease compared to the prior year, while G&A expenses remained stable at $9.8 million [31] - As of June 30, 2025, the company had $70.4 million in cash, cash equivalents, and financial assets, providing a cash runway until the end of the third quarter of 2026 [31][33] Business Line Data and Key Metrics Changes - The company is focusing investments on three high-value clinical assets: IPH4502, Lacutamab, and Monalizumab, which are expected to create meaningful value [6][33] - IPH4502 is currently in phase one development, with enrollment on track to complete by the end of Q1 2026 [13][15] - Lacutamab has received FDA breakthrough therapy designation and is preparing for a phase three trial, with a clear regulatory pathway for accelerated approval in Sézary syndrome [17][22] Market Data and Key Metrics Changes - The company identified approximately 1,000 Sézary syndrome patients in the U.S., with around 300 new cases each year, representing a significant market opportunity for Lacutamab [26] - The total agreement with AstraZeneca for Monalizumab is worth up to $1.275 billion, with $450 million already received in upfront and milestone payments [29] Company Strategy and Development Direction - The company has made a strategic decision to streamline its organization and focus on high-value clinical assets to drive forward programs that can make a significant difference [6][33] - The company is actively working to secure financing for Lacutamab's phase three trial and is exploring partnerships to maximize value for both patients and shareholders [22][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strategic refocus and the potential of the clinical pipeline to deliver value for patients and shareholders [33] - The company is committed to advancing its ADC pipeline and expects to report preliminary safety and activity data for IPH4502 in the first half of 2026 [15][33] Other Important Information - The Chief Scientific Officer, Eric Vivier, will transition to a full-time academic role but will continue to support the company as an advisor [7] - The company is exploring the potential of IPH4502 in various tumor types with significant medical needs beyond urothelial cancer [12][15] Q&A Session Summary Question: What should we take away on the potential of targeting NK cells now that ANKET® assets are not included in your prioritization today? - Management clarified that while NK cells are not the main priority, they are still working on NK cell programs and will base future decisions on clinical data [36] Question: Any commentary on where Sanofi is with the assets that they currently are developing? - Management indicated that Sanofi continues to progress the BCMA-targeted ANKET® and expects updates in the near future [40] Question: Should we still assume that unless you have a partner signed up ahead of the start of the study, it'll still be a wait and watch till you get a partner? - Management confirmed they are actively working with investors and partners to keep options open for moving forward with Lacutamab [41] Question: Based on the preclinical data that you have generated so far, what potential indications do you think IPH4502 will be effective? - Management highlighted a focus on urothelial cancer patients who became refractory to enfortumab vedotin, with potential for accelerated market approval [42] Question: How is enrollment progressing for IPH4502? - Management reported that enrollment is going extremely well, with plans to finish by Q1 2026 and a pool of data expected from 50-60 patients [48] Question: Does the new strategic focus mean the ANKET® assets will not be progressed irrespective of clinical data? - Management reiterated that decisions on ANKET® assets will be based on clinical data and market relevance [50]

Core Viewpoint - OBI Pharma has initiated a Phase 1/2 clinical trial for OBI-902, the first antibody-drug conjugate (ADC) utilizing its proprietary GlycOBI® technology, targeting TROP2, an antigen overexpressed in various tumors [1][2][3] Group 1: OBI-902 Overview - OBI-902 is a TROP2-targeted ADC that carries a potent topoisomerase I inhibitor payload with a drug-antibody ratio (DAR) of 4, making it suitable for treating solid tumors such as breast, biliary, ovarian, and gastric cancers [4][5] - The ADC is designed using OBI's GlycOBI platform, which enhances stability and hydrophilicity, demonstrating significant antitumor efficacy and improved pharmacokinetic characteristics in animal models [5][10] Group 2: Clinical Trial Details - The clinical trial aims to enroll patients with advanced solid tumors to assess the safety, pharmacokinetics, and preliminary efficacy of OBI-902 [2] - The lead investigator for the study is Dr. Apostolia M. Tsimberidou from MD Anderson Cancer Center [2] Group 3: Technology and Development - OBI's GlycOBI technology allows for site-specific conjugation of ADCs, compatible with various antibodies, linkers, and payloads, achieving a DAR of up to 16 [7] - The technology improves conjugation efficiency, reduces aggregation, and maintains the biophysical characteristics of the native antibody, leading to better antitumor activity and stability compared to traditional ADCs [7][10] Group 4: Company Background - OBI Pharma, established in 2002 and headquartered in Taiwan, focuses on developing novel therapeutic agents for patients with high unmet medical needs [8] - The company holds exclusive worldwide rights to OBI-902, except for rights pertaining to the antibody in China, which is licensed from Biosion, Inc. [6]