Duality Bio's collaboration with BioNTech (BNT) provides a unique structure: retaining China rights for ADC programs while granting ex-China rights to BNT, which also covers ex- China development costs. For B7-H3 ADC, Duality holds an option to co-fund 50% of U.S. development, offering significant upside. This partnership enables Duality to leverage BNT's global infrastructure and BMS's IO expertise while maintaining strategic control in China and optionality in key global markets. B7-H3 and Trop-2 ADCs Pos ...

Core Insights - AstraZeneca (AZN) and Daiichi Sankyo's FDA acceptance of a supplemental biologics license application (sBLA) for Enhertu aims to expand its label for treating HER2-positive breast cancer [1][7] - The sBLA is based on positive results from the phase III DESTINY-Breast09 study, which showed Enhertu combined with Roche's Perjeta significantly improved progression-free survival (PFS) and objective response rate (ORR) compared to standard treatments [3][4] Group 1: FDA Approval and Study Results - The FDA has granted priority review for the sBLA, reducing the review period by four months, with a final decision expected in Q1 2026 [2] - The DESTINY-Breast09 study demonstrated a median PFS of nearly 41 months for the Enhertu-Perjeta combination, compared to about 27 months for the standard taxane chemotherapy with Herceptin and Perjeta [3][7] - The Enhertu-Perjeta regimen achieved an ORR of 85.1%, surpassing the 78.6% ORR of the standard treatment [4][7] Group 2: Market Potential and Strategic Importance - Enhertu is already approved in over 85 countries for second-line HER2-positive breast cancer treatment and has additional approvals for lung and gastric cancers [5] - Both Enhertu and Datroway are projected to achieve peak annual sales of at least $5 billion, contributing to AstraZeneca's goal of reaching $80 billion in annual revenues by 2030 [10] - The partnership between AstraZeneca and Daiichi Sankyo involves joint development and marketing responsibilities, with Daiichi retaining exclusive rights in Japan [9] Group 3: Competitive Landscape - ADCs are viewed as disruptive innovations in cancer treatment, allowing targeted delivery of cytotoxic drugs to tumors [11] - Daiichi Sankyo is developing several ADCs across various cancers and has a partnership with Merck for additional ADCs, indicating a competitive landscape with significant revenue potential [12] - Pfizer's acquisition of Seagen for $43 billion highlights the growing interest in the ADC space, with multiple ADCs contributing to its revenue [13]

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 ...

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 [28] - 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 [28] - 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 [28] 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 [4][30] - IPH4502 is currently in phase one development, with enrollment progressing well and expected to complete by the end of Q1 2026 [11][14] - Lacutamab is close to completing the phase three protocol, with potential accelerated approval in Sézary syndrome anticipated by 2027 [21][25] 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 [24][25] - The total agreement with AstraZeneca for Monalizumab is worth up to $1.275 billion, with $450 million already received in upfront and milestone payments [27] 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 [4][30] - The company is actively working with investors and partners to secure funding for the phase three trial of Lacutamab, while also exploring options for IPH4502 [38][39] Management 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 [30] - The restructuring plan is fully embedded into the cash runway, ensuring financial visibility through the end of Q3 2026 [54] Other Important Information - The Chief Scientific Officer, Eric Vivier, will transition to a role as an advisor to the R&D Committee of the Board of Directors, ensuring continued collaboration [5] - The company is exploring the potential of IPH4502 in urothelial cancer patients who have become refractory to enfortumab vedotin, with a focus on addressing high unmet medical needs [41] 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 engagers and will base future decisions on clinical data [32][33] 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 updates are expected soon [37] Question: Regarding the phase three start for Lacutamab, 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? - Management confirmed they are actively working with investors and partners to keep options open for moving forward with Lacutamab [38] 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 are refractory to enfortumab vedotin, with potential for accelerated market approval [41] Question: Can you provide an initial estimate of the investment requirements if you decide to go to trial without a partner? - Management stated they would not normally communicate specific costs but indicated it would be similar to other oncology phase 3 trials [56]

Emi-Le (XMT-1660) Clinical Development - Mersana is advancing Emi-Le to address the high unmet need in post-Topo-1 TNBC, with over 40 patients enrolled in the expansion phase at two doses and plans to present initial expansion data in the second half of 2025[5] - Confirmed objective responses were observed across various tumor types including HR+BC, endometrial cancer, ovarian cancer, and ACC-1[5] - In the intermediate dose range, an ORR of 31% (8/26) was observed in evaluable patients with B7-H4 high tumors, including a 23% (3/13) ORR in TNBC and a 50% (2/4) ORR in endometrial cancer[55] - In evaluable patients with B7-H4 high post-Topo-1 TNBC in the intermediate dose range, the confirmed ORR was 23% (3/13), and 29% (2/7) in patients with ≤4 prior lines of therapy[58] - Preliminary data in the high dose range suggest potential for even greater clinical activity, with 7 out of 11 evaluable patients achieving tumor reductions of ≥30% at doses >674 mg/m2[67] XMT-2056 and Platform Collaborations - XMT-2056, an Immunosynthen STING agonist HER2 ADC, is in Phase 1 dose escalation, with plans to present initial clinical pharmacodynamic STING activation data in 2025[5] - Mersana has a global license option agreement with GSK plc for XMT-2056[5] - Mersana has a Dolasynthen research collaboration with Johnson & Johnson and an Immunosynthen research collaboration with Merck KGaA, Darmstadt, Germany[5] Safety and Tolerability - Emi-Le was observed to be generally well-tolerated, with any treatment-related adverse event (TRAE) occurring in 830% (117/141) of patients, Grade 3 TRAEs in 369% (52/141), and TRAEs leading to treatment discontinuation in 35% (5/141)[43] - The most common TRAEs were transient AST increase, generally asymptomatic and reversible proteinuria, generally low-grade fatigue and nausea[47] Market Opportunity - The global relapsed/refractory TNBC market is projected to exceed $1 billion annually starting in 2025[28] ACC-1 Clinical Activity - In patients with ACC-1, the ORR was 556% (5/9) across all doses, unselected for B7-H4 expression[94]

Core Insights - ArriVent BioPharma, Inc. reported strong progress in its clinical pipeline, particularly with firmonertinib, which is advancing towards registration for treating EGFR-mutant NSCLC [2][6][12] - The company has a robust financial position with cash and investments totaling $254.5 million as of June 30, 2025, and an additional $81.1 million raised in a public offering [6][16] Financial Results - For the six months ended June 30, 2025, net cash used in operations was $94.1 million, an increase from $37.7 million in the same period of 2024, primarily due to a one-time payment of $40 million to Lepu Biopharma [16] - Research and development expenses rose to $89.0 million from $38.8 million year-over-year, driven by the collaboration with Lepu Biopharma and increased clinical expenses related to firmonertinib [16] - The net loss for the six months ended June 30, 2025, was $95.8 million, compared to $39.3 million for the same period in 2024 [16][23] Clinical Pipeline Progress - Firmonertinib has shown promising interim Phase 1b data for EGFR PACC mutant NSCLC, with plans to present final data at the World Conference on Lung Cancer in September 2025 [2][7][8] - The first patient has been dosed in the Phase 1 study for ARR-217, a CDH17-targeted ADC for gastrointestinal cancers, marking a significant milestone in the ADC pipeline [4][6] - The global pivotal Phase 3 ALPACCA study for firmonertinib is expected to enroll its first patient in the second half of 2025, with top-line data from the FURVENT Phase 3 study projected for early 2026 [6][9][14] Market Context - Lung cancer remains the leading cause of cancer-related deaths globally, with NSCLC accounting for approximately 85% of cases [15] - Uncommon EGFR mutations, including exon 20 insertions and PACC mutations, represent significant unmet medical needs, as patients with these mutations have limited treatment options [15][17]

Pipeline and Programs - MacroGenics' cash runway is extended through the first half of 2027[9, 10] - Lorigerlimab shows a confirmed Objective Response Rate (ORR) of 25.7% and a PSA50 response rate of 28.6% in mCRPC patients[23] - MGC026, a B7-H3 directed program, is in Phase 1 dose escalation, with dose expansion anticipated in selected indications in 2025[43] - MGC028, an ADAM9 ADC, shows potent anti-tumor activity in preclinical models, with a Phase 1 dose escalation study ongoing[50] - MGD024, a CD123 × CD3 DART molecule, is in Phase 1 dose escalation in hematological malignancies, with a Gilead collaboration commenced in October 2022[60] Financials and Partnerships - MacroGenics received $365 million in upfront and milestone payments[12] - MacroGenics is eligible to receive up to $210 million in potential regulatory milestones and up to $330 million in potential commercial milestones[12] - MacroGenics could receive 15-24% tiered royalty (after 20x cap reached)[12] - As of March 31, 2025, MacroGenics had $154.1 million in cash, cash equivalents, and marketable securities[9, 11, 72] - A $70 million upfront payment was received in June 2025[9, 12]

Summary of Key Points from the Conference Call Industry Overview - **Industry**: China Pharma and Biotech - **Focus**: Updates from ASCO 2025 regarding various cancer treatments, particularly in extensive stage small cell lung cancer (ES-SCLC) and non-small cell lung cancer (NSCLC) Core Insights and Arguments 1. **Zai Lab's ZL-1310 (DLL3 ADC)**: - Reported a 68% overall response rate (ORR) in the dose escalation group (n=28) for ES-SCLC - Notable results in 2L patients: 67% ORR across doses (n=33) and 79% ORR in the 1.6 mg/kg group (n=14) [1][8] - Safety profile shows 23% Grade ≥3 treatment-related adverse events (TRAE) [1] - Potential for best-in-class (BIC) status, pending survival data [1] 2. **Innovent's IBI363 (PD-1/IL-2 bispecific)**: - High ORR of 37% and median progression-free survival (mPFS) of 9.3 months in squamous NSCLC patients who failed PD-(L)1 treatment [2][10] - Efficacy significantly surpasses Dato-Dxd (Daiichi Sankyo/AstraZeneca) in cross-trial comparisons [2] 3. **Hengrui's SHR-1826 (c-met ADC)**: - Demonstrated a 29% confirmed ORR and 40% unconfirmed ORR in NSCLC patients with c-met alterations [2][10] - C-met alterations are prevalent in 10-60% of NSCLC globally, indicating a substantial market opportunity [2] 4. **Market Potential**: - NSCLC has a total addressable market (TAM) of approximately US$30 billion, with 1L treatment representing over 60% of this market [4] - Breast cancer market estimated at US$35 billion, with emerging products but no significant efficacy improvements over leading global products [4] 5. **Investment Ratings**: - Outperform ratings maintained for Akeso, Hansoh, Innovent, and Hengrui [6] - Market-Perform ratings for BeiGene, CSPC, Sino Biopharm, and Zai Lab [6] Additional Important Content - All updates are derived from Phase 1 trials, typically lacking control groups [3] - The competitive landscape includes various other companies and products, with specific mentions of Akeso, 3S Bio, and Kelun Biotech in relation to their respective therapies [4][7] - The report emphasizes the importance of survival data for ZL-1310 to validate its potential in the market [1][8] This summary encapsulates the critical developments and insights from the conference call, highlighting the advancements in cancer therapies and their implications for the market and investment opportunities.

Core Insights - ALX Oncology is advancing ALX2004, a potential best- and first-in-class antibody-drug conjugate (ADC) targeting EGFR-expressing solid tumors, designed to maximize therapeutic efficacy while minimizing toxicity [1][2] - The U.S. FDA has cleared the IND application for ALX2004, with clinical studies set to begin in mid-2025 and initial safety data expected in the first half of 2026 [1][6] - The company plans to initiate trials for its lead therapy, evorpacept, in breast and colorectal cancers around the same time, with significant milestones anticipated in 2026 [1] ALX2004 Development Overview - ALX2004 is developed using a proprietary linker-payload platform, featuring an affinity-tuned EGFR antibody and a stable linker-Top1i payload, aimed at enhancing anti-tumor activity and reducing toxicity [3][4] - Preclinical data indicates that ALX2004 has superior stability and a favorable safety profile compared to other ADCs, showing dose-dependent activity across various tumors and EGFR expression levels [5] Clinical Trial Plans - The Phase 1 clinical trial for ALX2004 will target EGFR-expressing solid tumors, including non-small cell lung cancer and colorectal cancer, focusing on patients with relapsed or refractory cancers [6] - The trial is expected to begin in mid-2025, with initial safety data anticipated in the first half of 2026 [1][6]

Core Insights - Pyxis Oncology, Inc. is a clinical-stage company focused on developing next-generation therapeutics for difficult-to-treat cancers [3] - The company will participate in the Stifel 2025 Virtual Targeted Oncology Forum on April 9, 2025, featuring a fireside chat with CEO Lara S. Sullivan [1] - The lead product candidate, micvotabart pelidotin (MICVO), is an antibody-drug conjugate targeting Extradomain-B Fibronectin, currently in Phase 1 clinical studies for various solid tumors [3] Company Overview - Pyxis Oncology is dedicated to creating differentiated mono and combination therapies for challenging cancers [3] - MICVO aims to combat difficult-to-treat cancers through multiple mechanisms, including direct cancer cell killing and enhancing anti-tumor immune response [3] - The company is focusing on recurrent and metastatic head and neck squamous cell carcinoma based on promising clinical signals [3] Event Participation - The company will hold one-on-one investor meetings during the Stifel 2025 Virtual Targeted Oncology Forum [1] - A live webcast of the fireside chat will be available on the company's Investor Relations website [2]