Cullinan Therapeutics (NasdaqGS:CGEM) 2026 Conference February 19, 2026 10:00 AM ET Company ParticipantsJeffrey Jones - CMONadim Ahmed - President, CEO and DirectorSamantha Semenkow - VP of SMid Biotech Equity ResearchSamantha SemenkowGood morning, and thank you for joining our session of Citi's Virtual Oncology Leadership Summit. I'm Samantha Semenkow, one of the senior biotech analysts here at Citi, and it's my pleasure today to be hosting Cullinan Therapeutics CEO, Nadim Ahmed, and CMO, Jeff Jones. Nadim ...

Summary of Nuvalent Conference Call Company Overview - **Company**: Nuvalent (NasdaqGS:NUVL) - **Focus**: Development of kinase inhibitors targeting clinically validated cancer therapies, particularly ROS1 and ALK inhibitors [2][3] Regulatory Progress - **ROS1 Program**: - FDA accepted NDA for zidesamtinib in TKI-pretreated ROS1-positive non-small cell lung cancer (NSCLC) with a PDUFA date of September 18 [3] - Plans to submit data for TKI-naive ROS1 indication in the second half of the year [3][5] - **ALK Program**: - Completed pre-NDA meeting with FDA for neladalkib in TKI-pretreated ALK-positive NSCLC, with NDA submission planned for the first half of the year [3] - Ongoing phase 3 ALCAZAR study for TKI-naive ALK patients [4] Clinical Data and Differentiation - **Zidesamtinib**: - First drug with a profile targeting original fusion and ROS1 mutations, with CNS activity [8] - Demonstrated durable responses across treatment lines, particularly in CNS disease [9] - **Neladalkib**: - Shows double the durability of lorlatinib in second-line treatment, with over 60% of patients still responding at 1.5 years [10][11] - Well-tolerated with excellent CNS activity, allowing patients to remain on therapy longer [11] Market Strategy - **Commercialization**: - Nuvalent plans to go it alone for ex-U.S. commercialization, citing macro issues around pricing and the desire for flexibility [21][22] - Strong enrollment in clinical trials and positive durability data support the decision to build a global biotech company [22][24] - **Financial Position**: - Ended the previous year with approximately $1.4 billion in cash, providing operational runway into 2029 [36] - Current guidance does not include revenues from sales, indicating a strong position to build globally [36] Market Potential - **Sales Projections**: - ROS1 market could grow to resemble the current ALK market, estimated at over $2 billion [38] - ALK market could expand to match the EGFR market, potentially 2-3 times larger than current levels [38] - **Geographic Sales Distribution**: - Historically, 65%-70% of sales for similar drugs have come from outside the U.S., indicating a significant opportunity for Nuvalent [39] Future Developments - **HER2 Program**: - Focused on developing a drug that effectively targets HER2 mutations while minimizing side effects, with plans to showcase data in the future [44][46] - Potential for expansion beyond lung cancer into other solid tumors [46] - **Fourth Program**: - An unnamed program is set to be announced this year, focusing on unmet medical needs identified through physician feedback [47] Conclusion - Nuvalent is positioned to capitalize on its innovative drug portfolio with a strong regulatory strategy and a clear path to commercialization. The company aims to build a sustainable global biotech presence while addressing significant market needs in oncology.

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Summary of Nuvalent Conference Call Company Overview - **Company**: Nuvalent - **Focus**: Development of targeted therapies for cancer, specifically for ROS1 positive non-small cell lung cancer (NSCLC) with their product candidate, Zydastantinib [2][5][6] Industry Context - **Industry**: Oncology, specifically targeting ROS1 positive non-small cell lung cancer - **Current Landscape**: Four FDA approved therapies exist for ROS1 positive NSCLC, each with limitations such as inadequate CNS penetrance and resistance mutations [10][11] Key Points and Arguments Product Development and Clinical Trials - **Zydastantinib**: First and only ROS1 selective compound designed to address key medical needs, including CNS penetrance and resistance mutations [12][8] - **ARRIS-one Trial**: Ongoing clinical trial evaluating Zydastantinib, with a focus on heavily pretreated patients [12][13] - **Enrollment**: As of September 2023, enrollment in the Phase II portion began, targeting both TKI pretreated and naive patients [13][14] Clinical Data Highlights - **Efficacy**: - Overall response rate (ORR) in TKI pretreated patients was 44%, with a duration of response (DOR) rate of 62% at 18 months [17][18] - In patients who received prior crizotinib only, ORR was 68% with no progression events among responders [21][43] - In TKI naive patients, ORR was 89% with a DOR rate of 96% at 12 months [27][28] - **CNS Activity**: - Intracranial ORR was 48% in patients with measurable CNS lesions, with a complete response (CR) rate of 20% [23][24] - In patients who received crizotinib only, intracranial ORR was 85% [24][49] Safety Profile - **Adverse Events**: Zydastantinib was generally well tolerated, with low rates of dose modifications (10%) and discontinuations (2%) due to adverse events [25][26] - **Common Adverse Events**: Peripheral edema (36%), constipation (17%), and fatigue (16%) were the most frequently reported [25] Regulatory and Commercial Strategy - **NDA Submission**: Planned rolling submission for Zydastantinib in July 2025, targeting TKI pretreated patients [29] - **FDA Engagement**: Participation in the Real Time Oncology Review (RTOR) pilot program to expedite the review process [29] - **Commercial Readiness**: Preparations for a potential launch in 2026, including building commercial teams and identifying key prescribers [30] Future Directions - **Broader Portfolio**: Nuvalent is advancing additional programs for ALK positive NSCLC and HER2 altered NSCLC, with pivotal data expected later in 2025 [31][32][33] - **Clinical Development Speed**: Rapid enrollment and execution of the ARRIS-one study, reflecting strong interest and support from the medical community [78] Additional Important Insights - **Market Opportunity**: The unique design of Zydastantinib aims to address unmet needs in the ROS1 NSCLC space, potentially leading to a compelling commercial opportunity [30][31] - **Comparative Advantage**: Zydastantinib's selective design aims to minimize off-target effects and improve patient tolerability compared to existing therapies [60][61] This summary encapsulates the critical aspects of Nuvalent's conference call, highlighting the company's innovative approach to treating ROS1 positive NSCLC and the promising data emerging from their clinical trials.