Allogene Therapeutics (ALLO) 2025 Conference June 04, 2025 04:55 PM ET Speaker0 We are very pleased to have the CEO of Allogene here with us, Doctor. David Chang. Allogene, despite the volatility of the markets, is obviously continuing to execute on the, I call it phase three, but pivotal phase two randomized study in a consolidation approach to first line DLBCL. And they have been working on that study, but also had some recent announcements on the last earnings. And so maybe it would be a good place to st ...

Allogene Therapeutics (ALLO) Q1 2025 Earnings Call May 13, 2025 05:00 PM ET Company Participants Christine Cassiano - Executive VP, Chief Corporate Affairs & Brand Strategy OfficerDavid Chang - Co-Founder, President, CEO & DirectorZachary Roberts - Executive VP of Research & Development and Chief Medical OfficerGeoffrey Parker - Executive VP & CFOMichael Yee - Managing DirectorMatthew Biegler - Managing DirectorSamantha Semenkow - Vice PresidentReni Benjamin - Managing DirectorCaleb Stubbs - Biotechnology E ...

Financial Data and Key Metrics Changes - As of March 31, 2025, the company had $335.5 million in cash, cash equivalents, and investments [29] - Research and development expenses for Q1 2025 were $50.2 million, including $5 million in non-cash stock-based compensation [29] - General and administrative expenses for Q1 2025 were $15 million, including $7.1 million in non-cash stock-based compensation [29] - The net loss for Q1 2025 was $59.7 million, or $0.28 per share, including $12.2 million in non-cash stock-based compensation [29] - Updated guidance for 2025 indicates an expected cash burn of approximately $150 million, with full-year GAAP operating expenses projected at approximately $230 million [29] Business Line Data and Key Metrics Changes - The ALPHA-three trial has seen over 250 patients consented for MRD screening, with nearly half in the last three months, indicating improved site engagement [9][20] - ALLO-three sixteen is showing signs of efficacy in heavily pretreated advanced renal cell carcinoma, with a 50% best overall response rate in patients expressing high levels of CD70 [24] - ALLO-three 29 is set to launch the RESOLUTION trial mid-2025, aiming to change treatment for autoimmune diseases by potentially eliminating lymphodepletion [11][25] Market Data and Key Metrics Changes - Nearly 50 activated US sites are involved in the ALPHA-three trial, with plans for international expansion starting in Canada [21] - The company is experiencing strong enthusiasm from investigators, which is translating into increased patient screening activity [20][21] Company Strategy and Development Direction - The company is focused on making CAR T therapies more accessible through an allogeneic approach, with a strategy launched in January 2024 aimed at redefining cell therapy [6][13] - The company is prioritizing cash runway preservation, extending it into the second half of 2027, while driving forward with promising clinical trials [12][28] - The company is adapting its operational strategy to address macroeconomic challenges and enhance trial execution [12][28] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the evolving regulatory landscape and expresses confidence in the FDA's commitment to scientific integrity and patient-centered outcomes [14][15] - The company believes that strong science and meaningful clinical benefits will continue to prevail in the regulatory environment [16] - Management is optimistic about the potential of their allogeneic CAR T programs to reshape treatment paradigms in hematologic malignancies and solid tumors [27] Other Important Information - The company is making targeted reductions in manufacturing operations to achieve cost savings while maintaining core capabilities [28] - The ALLO-three sixteen data will be presented at ASCO on June 1, which is expected to be significant for the field [22] Q&A Session Summary Question: Progress of enrollment in the first line study and logistical issues - Management explained that site-related issues caused a 3-4 month delay in patient screening, but recent improvements in site engagement are translating into increased screening activity [35][36] Question: Differences in site-related factors between community and academic sites - Management indicated that there is no significant difference in the occurrence of site-related factors between community and academic sites, with both showing encouraging activity once operational [40][46] Question: Regulatory implications of expanding to international sites - Management stated that the global standard for frontline DLBCL treatment remains consistent, and the expansion is not expected to introduce significant heterogeneity [65] Question: Potential partnership for autoimmune programs - Management expressed willingness to partner on autoimmune programs to de-risk them, especially given the current market environment [68] Question: Expected data size for ALLO-three 29 - Management indicated that the expected data size for the initial readout will be limited due to the nature of the dose escalation study, but they are focused on ensuring robust data collection [75] Question: Overlap of site-related challenges in ex-US sites - Management believes that ex-US sites will be better equipped due to the integrated care model typically found in those regions [96]

Financial Data and Key Metrics Changes - As of December 31, 2024, the company had $373.1 million in cash, cash equivalents, and investments, with a cash runway extending into the second half of 2026 [26] - Research and development expenses for Q4 2024 were $45 million, with full-year R&D expenses totaling $192.3 million [26] - The net loss for Q4 2024 was $59.9 million, or $0.28 per share, while the full-year net loss was $257.6 million, or $1.32 per share [27][28] Business Line Data and Key Metrics Changes - The pivotal Phase II ALPHA3 trial for SemaCell in first-line consolidation large B cell lymphoma is progressing with 40 sites activated [9][19] - ALLO329, targeting autoimmune diseases, received FDA clearance for a Phase I resolution basket trial, marking the company's expansion into this area [10][20] - ALLO316 is showing promising results in renal cell carcinoma, with data expected to be shared in mid-2025 [24] Market Data and Key Metrics Changes - The company is focusing on the allogeneic CAR T therapy market, aiming to redefine treatment paradigms in oncology and autoimmune diseases [12][10] - The competitive landscape includes both autologous and allogeneic CAR T therapies, with the company positioning itself to surpass autologous therapies in accessibility and scalability [12] Company Strategy and Development Direction - The company has set a bold strategy for 2024, focusing on advancing its differentiated pipeline and achieving critical milestones in its key programs [7][8] - The strategy includes a commitment to making off-the-shelf cell therapy a new standard of care, particularly in large B cell lymphoma and autoimmune diseases [8][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to achieve significant milestones in 2025, which they believe will be a breakthrough year for allogeneic CAR T therapy [12][13] - The management highlighted the importance of early intervention with CAR T therapy for improved safety and efficacy outcomes [17] Other Important Information - The company is collaborating with Foresight Diagnostics to support the development of a companion diagnostic for its clinical programs [20] - The ALLO329 program is designed to potentially eliminate the need for lymphodepletion, which could significantly change treatment approaches in autoimmune diseases [22][23] Q&A Session Summary Question: Follow-up on the recent JCO publication and its implications for the ALPHA3 trial - Management highlighted a strong correlation between low disease burden and higher response rates, which bodes well for the ALPHA3 study [30][31] Question: Confirmation on the necessity of lymphodepletion in the ALPHA3 trial - Management indicated that the trial is designed to assess whether lymphodepletion is needed, with potential benefits regardless of the outcome [36][37] Question: Data expected from ALLO329 by year-end - Management expects to show biomarker-based proof of concept, including B cell depletion and CAR T cell expansion [45][46] Question: Follow-up on the duration of follow-up for ALLO329 - Management confirmed that longer follow-up will be necessary to assess durable efficacy, beyond initial biomarker data [84][85] Question: Insights on the futility analysis for ALPHA3 - Management clarified that the futility analysis will consider the totality of data, focusing on safety and MRD conversion rates [64][65]