Latest news with #AllogeneTherapeuticsInc
San Francisco Chronicle
3 days ago
- Business
- San Francisco Chronicle
Allogene Therapeutics: Q2 Earnings Snapshot
SOUTH SAN FRANCISCO, Calif. (AP) — SOUTH SAN FRANCISCO, Calif. (AP) — Allogene Therapeutics Inc. (ALLO) on Wednesday reported a loss of $50.9 million in its second quarter. The South San Francisco, California-based company said it had a loss of 23 cents per share. The results topped Wall Street expectations. The average estimate of nine analysts surveyed by Zacks Investment Research was for a loss of 28 cents per share. In the final minutes of trading on Wednesday, the company's shares hit $1.05. A year ago, they were trading at $2.35. _____
Yahoo
14-05-2025
- Business
- Yahoo
Allogene Therapeutics Inc (ALLO) Q1 2025 Earnings Call Highlights: Strategic Advances Amid ...
Cash and Investments: $335.5 million as of March 31, 2025. Research and Development Expenses: $50.2 million for Q1 2025, including $5 million in non-cash stock-based compensation. General and Administrative Expenses: $15 million for Q1 2025, including $7.1 million in non-cash stock-based compensation. Net Loss: $59.7 million for Q1 2025, or $0.28 per share, including $12.2 million in non-cash stock-based compensation. Cash Burn Guidance: Expected cash burn of approximately $150 million for 2025. Operating Expenses Guidance: Expected full year 2025 GAAP operating expenses of approximately $230 million, including $45 million in non-cash stock-based compensation. Cash Runway: Extended into the second half of 2027. Warning! GuruFocus has detected 3 Warning Signs with ALLO. Release Date: May 13, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Allogene Therapeutics Inc (NASDAQ:ALLO) has extended its cash runway into the second half of 2027, ensuring financial stability to advance its clinical programs. The ALPHA3 trial is gaining traction with nearly 50 activated US sites and plans for international expansion, indicating strong interest and collaboration from the clinical community. ALLO-316 shows promising efficacy in heavily pre-treated advanced renal cell carcinoma patients, offering hope in a challenging patient population. The company is actively evaluating strategic options for ALLO-316, including potential partnerships, which could enhance its development and commercialization prospects. Allogene Therapeutics Inc (NASDAQ:ALLO) is making targeted reductions in manufacturing operations to achieve cost savings while maintaining core capabilities, reflecting efficient resource management. The ALPHA3 trial has experienced delays due to site-level staffing shortages and operational constraints, impacting the timeline for lymphodepletion regimen selection and futility analysis. There is uncertainty regarding the conversion rate from consent to randomization in the ALPHA3 trial, which could affect enrollment timelines. The company faces logistical challenges in autoimmune disease trials, requiring collaboration between cell therapists and rheumatologists, which may complicate site activation. The macroeconomic environment and evolving regulatory landscape pose potential risks to Allogene Therapeutics Inc (NASDAQ:ALLO)'s strategic plans and clinical trial designs. The company has not provided specific guidance on the expected conversion rate from consent to randomization, creating uncertainty about trial progress and timelines. Q: Can you explain the logistical issues affecting the enrollment of the ALPHA3 study and how they are being resolved? Also, does the consent to screening mean patients will definitely enroll in the study? A: David Chang, CEO, explained that the delay in enrollment was due to site-related issues, particularly a lack of personnel to cover the study, causing a three to four-month delay from site activation to patient screening. This has been addressed, and patient consent for screening is now consistent with initial assumptions. Geoffrey Parker, CFO, added that the increase in patient screening activity validates their observations, although not all consented patients will enroll, as they must test positive for MRD to be randomized. Q: Are there differences in site-related factors between community and academic sites for ALPHA3, and what is the probability of an interim EFS readout by the end of next year? A: Zachary Roberts, CMO, noted no significant difference between community and academic sites regarding startup times and screening activity. David Chang mentioned that they are intentionally silent on the timing of the interim EFS readout, but plan to provide more guidance after the lymphodepletion selection and futility analysis in the first half of 2026. Q: Do all sites have sufficient staffing for ALPHA3, and what is the conversion rate from consent to randomization? A: Zachary Roberts stated that sites are generally well-staffed now, although initial setup took time. The conversion rate from consent to randomization is not disclosed, but the process from consent to randomization involves variability due to the timing of MRD testing and logistics. Q: How will the expansion to international sites impact the ALPHA3 study, and are there regulatory implications? A: Zachary Roberts explained that international expansion should not introduce heterogeneity in patient mix, as R-CHOP is the global standard for frontline DLBCL treatment. There are no regulatory implications expected, and the expansion is anticipated to enhance the study's robustness. Q: Given the cautious approach to cash burn, would you consider partnering the ALLO-329 program? A: David Chang expressed openness to partnering the autoimmune program, especially since it is not their core expertise. The timeline for proof of concept data has been extended to the first half of 2026 to include clinical updates, reflecting feedback from investigators and a cautious approach. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
