ALX Oncology Holdings (ALXO) 2025 Conference June 05, 2025 01:25 PM ET Speaker0 People here with us. And I would love to give the opportunity for, perhaps Jason, to make some opening comments about, where ALX is at now. They obviously are interrogating an anti CD47 antibody. There was gastric results. They talked with FDA about it. But there's no doubt they continue to have a lot of promise on that with other modalities, ADCs, etcetera. Should talk a little bit about that and where you are with that program ...

ZL-1310 ASCO 2025 Highlights June 2, 2025 NASDAQ:ZLAB | HKEX:9688 © 2024. Zai Lab. All Rights Reserved. Associate Director of Drug Development, Sarah Cannon Research Institute Forward-Looking Statements This presentation contains forward-looking statements about future expectations, plans, and prospects for Zai Lab, including, without limitation, statements regarding product candidates in our pipeline including ZL-1310 and related clinical trials and preclinical studies, the potential benefits and safety an ...

Financial Data and Key Metrics Changes - The company reported a net loss of $22.6 million for Q1 2025, a decrease from a net loss of $31.7 million in Q1 2024, primarily due to increased revenue [11] - Revenue for Q1 2025 was $27.1 million, significantly up from $10 million in Q1 2024, driven by milestone revenues and development support [11][12] - Operating expenses increased to $52.7 million in Q1 2025 from $47.3 million in Q1 2024, reflecting a 10% rise [12][13] Business Line Data and Key Metrics Changes - Milestone revenue included $14 million from GSK and $3.1 million from Daiichi Sankyo, contributing to the overall revenue growth [11] - Research and development expenses rose to $35.7 million in Q1 2025 from $32 million in Q1 2024, mainly due to increased costs associated with ZW251 and other preclinical research [12] Market Data and Key Metrics Changes - The company anticipates increased royalty revenue from the potential approval of zanadatumab for advanced HER2 positive biliary tract cancer, with a final decision expected soon [10] - The company is also looking forward to presenting data at several upcoming medical conferences, which may enhance its market presence [9] Company Strategy and Development Direction - The company emphasizes a disciplined approach to cash burn and pipeline management, focusing on evidence-based decisions tied to clinical validation [8] - The R&D strategy includes advancing a diverse pipeline of ADCs and T cell engagers, with a focus on unmet needs in oncology and immunology [36][40] - The company plans to submit an IND for ZW251 by mid-2025, marking a significant milestone in its development strategy [36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate the dynamic biotech environment while delivering shareholder value [7][8] - The company remains well-capitalized with $321.6 million in cash and equivalents, projected to fund operations into the second half of 2027 [14][38] - Management highlighted the importance of clinical progress and disciplined capital allocation in creating long-term shareholder value [40] Other Important Information - The company presented six posters at the AACR annual meeting, showcasing advancements in its R&D pipeline [16][35] - The recent appointment of Dr. Sabine McCann as Senior VP of Clinical Development is expected to enhance the company's clinical strategy [37] Q&A Session Summary Question: What are the base case assumptions regarding milestone royalty revenues? - Management emphasized the importance of capital allocation and expressed excitement about the progress made by partners Jazz and Beijing, which could impact future revenues [44][46] Question: Can you provide details on the cytokine induction data for ZW209? - The design of ZW209 allows for localized T cell activation, which may limit cytokine release syndrome, presenting a favorable safety profile compared to other approaches [50][52] Question: How do you view the impact of ex-US patients in the Horizon GEA trial? - Management noted that there is generally no significant difference in efficacy across ethnicities, but they are monitoring the data closely [58][60] Question: What is the expectation for the KLK2 bispecific update at ASCO? - Management indicated that they are looking forward to the data presentation and highlighted the financial interest in the partnership with J&J [63][64] Question: How many internal programs can the company support? - The company can handle approximately five internal programs through phase one and about ten preclinical programs at any one time [87]

Summary of Seagen (SGEN) Conference Call on April 29, 2025 Company and Industry Overview - **Company**: Seagen (SGEN) - **Industry**: Oncology and Pharmaceutical Collaborations Key Points and Arguments 1. **Collaboration with Merck**: Seagen announced two significant collaborations with Merck, focusing on the development and commercialization of ladiratuzumab vedotin (LV) and TUKYSA, with a 50-50 cost and profit sharing agreement for LV worldwide [5][6][7] 2. **Financial Terms**: Seagen will receive an upfront payment of $600 million for LV and $125 million for TUKSA, along with a $1 billion equity investment from Merck at $200 per share. The total potential payments across both collaborations could reach approximately $4.5 billion [5][6][8] 3. **Clinical Development**: LV is currently in Phase I and II trials for breast cancer and other solid tumors, showing promising antitumor activity. The focus is on optimizing dosing schedules, particularly weekly administration [8][9][10] 4. **TUKYSA Commercialization**: TUKYSA is approved in five countries for HER2 positive breast cancer and is expected to expand its market presence in Asia, the Middle East, and Latin America through Merck's established commercial capabilities [11][12][13] 5. **Strategic Benefits**: The collaboration with Merck is expected to enhance the development and commercialization of both drugs, leveraging Merck's expertise in solid tumor clinical development and its global commercial presence [6][7][10] 6. **Regulatory and Market Expansion**: Seagen is actively building its international capabilities, with over 100 staff in Europe to support TUKYSA's launch in Canada and Europe. The EMA is currently reviewing TUKYSA's EU marketing authorization application [12][13] 7. **Pipeline Development**: Seagen has a robust pipeline with over a dozen drugs in development, including ADCETRIS, PADCEV, and TUKYSA. The company aims to expand its commercial drug portfolio significantly [15][43][46] 8. **Future Collaborations**: Seagen is open to future collaborations and acquisitions, focusing on expanding its global footprint and enhancing its pipeline with innovative ADCs and other cancer therapies [28][90][92] Additional Important Content 1. **Risk Factors**: The call highlighted potential risks, including the ability to close Merck's equity investment and uncertainties related to pharmaceutical development and regulatory approval processes [3] 2. **Market Potential**: The collaboration is expected to address significant patient populations, particularly in breast and gastric cancers, with a focus on optimizing treatment regimens [104][105] 3. **No Standstill Provisions**: The agreement does not include any standstill provisions that would limit Merck's ability to increase its stake in Seagen in the future [51] 4. **Biomarker Development**: Seagen has developed a biomarker for LIV1, which is highly expressed in various solid tumors, allowing for broader treatment opportunities [67][68] This summary encapsulates the key discussions and strategic directions outlined during the conference call, emphasizing Seagen's collaborations, financial outlook, and future growth potential in the oncology sector.

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