Latest news with #ALLO
Business Insider
02-06-2025
- Business
- Business Insider
Allogene Therapeutics provides updated Phase 1 TRAVERSE study of ALLO-316
Allogene Therapeutics (ALLO) presented updated data from the Phase 1 TRAVERSE study of ALLO-316 in renal cell carcinoma during an oral presentation at the 2025 ASCO Annual Meeting. The Phase 1 TRAVERSE trial enrolled patients with advanced or metastatic renal cell RCC. Leveraging the proprietary Dagger technology to enable robust CAR T cell expansion, it stands as the first and only allogeneic CAR T product to show promise in treating solid tumors. The presentation focused on the Phase 1b expansion cohort from the Phase 1 TRAVERSE study in which patients were treated with a standard regimen of cyclophosphamide and fludarabine followed by a single dose of 80 million AlloCAR T cells. In the Phase 1b expansion cohort, 22 patients whose tumors had progressed on multiple prior therapies were treated with lymphodepletion and 20 were treated with ALLO-316. All patients had tumors resistant to immune checkpoint blockers and at least one tyrosine kinase inhibitor, 82% had greater than or equal to2+ prior TKI, and 41% had prior belzutifan. Sixteen of the ALLO-316 treated patients had a high CD70 Tumor Proportion Score. The Phase 1b expansion cohort evaluated the safety and efficacy of ALLO-316 at DL2 following a standard FC lymphodepletion regimen. The median time from enrollment to the start of therapy was four days.
Yahoo
15-05-2025
- Business
- Yahoo
Allogene (ALLO) Sinks 16% on Downgrade, Trial Delays
Allogene Therapeutics (ALLO, Financials) dropped nearly 16% to $0.95 on Monday after Citizens JMP downgraded the stock to Market Perform, citing delays in its ALPHA3 program and lack of near-term milestones. Warning! GuruFocus has detected 2 Warning Sign with ALLO. The company postponed LD selection and futility analyses for its ALPHA3 trial from mid-2025 to the first half of 2026. Analyst Reni Benjamin said the extended timeline and absence of catalysts prompted the downgrade. ALLO shares are trading near their 52-week low and have fallen over 54% in the last six months. Citizens JMP removed ALLO-501A revenue estimates from its valuation model. The stock is now valued at about 74% of its Q1 cash balance, in line with discounts applied to biotech peers facing similar uncertainty. Allogene posted a net loss of $59.7 million, or $0.28 per share, in Q1 2025matching expectations. It ended the quarter with $335.5 million in cash and a negative enterprise value of approximately -$88 million. The company expects to burn $150 million in cash this year and projects full-year GAAP operating expenses of $230 million. Despite headwinds, Allogene is expanding ALPHA3 internationally and anticipates proof-of-concept data for ALPHA3 and ALLO-329 in the first half of 2026. This article first appeared on GuruFocus. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
14-05-2025
- Business
- Yahoo
Allogene's Q1 Earnings In Line With Estimates, Sales Nil
Allogene Therapeutics ALLO incurred first-quarter 2025 loss of 28 cents per share, which matched the Zacks Consensus Estimate. In the year-ago period, the company had incurred a loss of 38 cents per share. As ALLO lacks a marketed product in its portfolio, it did not report any sales during the quarter. In the year-ago period, Allogene recorded collaboration revenues worth $0.02 million. Year to date, shares of Allogene have plunged 47% compared with the industry's 6% decline. Image Source: Zacks Investment Research Research & development (R&D) expenses totaled $50.2 million, down 4% from the year-ago quarter's level. General and administrative (G&A) expenses declined 13% year over year to $15.0 million. As of March 31, 2025, Allogene had $335.5 million in cash, cash equivalents and investments compared with $373.1 million as of Dec. 31, 2024. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar) In light of the dynamic macroeconomic environment and the need to preserve capital, Allogene recently implemented strategic cost realignment initiatives aimed at optimizing operations and extending its financial runway. As a result, the company has revised its 2025 guidance and now expects operating expenses for the full year to be around $230 million, including nearly $45 million in non-cash stock-based compensation. This compares favorably to the prior forecast of around $250 million, which included about $50 million in stock-based compensation. Cash burn for 2025 is expected to be around $150 million, down from the previous guidance of $170 million. Based on these expected savings, Allogene claims that its cash runway will now fund operations into the second half of 2027 — a full year beyond its earlier projection. Allogene's main focus is on the pivotal phase II ALPHA3 study, which is evaluating lead drug cema-cel as a potential first-line treatment for newly diagnosed and treated large B cell lymphoma (LBCL) patients who are likely to relapse and need further therapy. While the company was initially expected to provide lymphodepletion selection and futility analysis from this study around mid-2025, the delayed site readiness to initiate screening activities has pushed the timeline back by roughly two quarters. The analysis is now expected in the first half of 2026. ALLO is also planning to explore the potential of allogeneic CAR-T cell therapies in autoimmune diseases. It plans to start the phase I RESOLUTION basket study with a new candidate, ALLO-329, across various autoimmune diseases, including systemic lupus erythematosus, idiopathic inflammatory myopathies, and systemic sclerosis in mid-2025. Allogene has updated the timeline for its first data readout, now aiming for the first half of 2026 (compared to the previous guidance of a 2025-end update) to include both biomarker and clinical proof-of-concept data. Allogene intends to present updated data from a cohort of the phase I TRAVERSE study evaluating ALLO-316 in patients with heavily pretreated advanced or metastatic renal cell carcinoma (RCC) at the 2025 ASCO Annual Meeting on June 1. Allogene currently has a Zacks Rank #2 (Buy). Allogene Therapeutics, Inc. price | Allogene Therapeutics, Inc. Quote Some other top-ranked stocks from the industry are Adaptive Biotechnologies ADPT, Agenus AGEN and Elevation Oncology ELEV, each carrying a Zacks Rank #2 at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. In the past 60 days, estimates for Adaptive Biotechnologies' 2025 loss per share have improved from 92 cents to 87 cents. During the same timeframe, estimates for 2026 loss per share have narrowed from 69 to 65 cents. Adaptive Biotechnologies' earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 21.38%. Shares of ADPT have surged 55% year to date. Estimates for Agenus' 2025 loss per share have narrowed from $7.05 to $5.85 over the past 60 days, and the same for 2026 loss has improved from $7.14 to $5.74. Agenus' earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 22.71%. Year to date, its shares have gained 23%. In the past 60 days, estimates for Elevation Oncology's 2025 loss per share have narrowed from 82 cents to 61 cents. Loss per share estimates for 2026 have narrowed from 88 cents to 44 cents during the same timeframe. Year to date, shares of ELEV have lost 38%. Elevation Oncology's earnings beat estimates in two of the trailing four quarters and missed the mark on the remaining occasions, the average surprise being 5.10%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Agenus Inc. (AGEN) : Free Stock Analysis Report Adaptive Biotechnologies Corporation (ADPT) : Free Stock Analysis Report Allogene Therapeutics, Inc. (ALLO) : Free Stock Analysis Report Elevation Oncology, Inc. (ELEV) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Sign in to access your portfolio Error in retrieving data
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
Yahoo
14-03-2025
- Business
- Yahoo
Allogene Therapeutics Inc (ALLO) Q4 2024 Earnings Call Highlights: Financial Challenges Amid ...
Cash, Cash Equivalents, and Investments: $373.1 million as of December 31, 2024. Research and Development Expenses (Q4 2024): $45 million, including $5.6 million in non-cash stock-based compensation. Research and Development Expenses (Full Year 2024): $192.3 million, including $20.4 million in non-cash stock-based compensation. General and Administrative Expenses (Q4 2024): $15.5 million, including $7.3 million in non-cash stock-based compensation. General and Administrative Expenses (Full Year 2024): $65.2 million, including $31.3 million in non-cash stock-based compensation. Net Loss (Q4 2024): $59.9 million, or $0.28 per share, including $12.9 million in non-cash stock-based compensation. Net Loss (Full Year 2024): $257.6 million, or $1.32 per share, including $51.7 million in non-cash stock-based compensation and $15.7 million in non-cash impairment of long-lived asset expense. Cash Burn Guidance for 2025: Approximately $170 million. Expected GAAP Operating Expenses for 2025: Approximately $250 million, including an estimated $50 million in non-cash stock-based compensation. Warning! GuruFocus has detected 5 Warning Signs with ALLO. Release Date: March 13, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Allogene Therapeutics Inc (NASDAQ:ALLO) is approaching critical milestones in its key programs, including large B-cell lymphoma, autoimmune disease, and renal cell carcinoma. The pivotal Phase 2 ALPHA3 trial for cema-cel in large B-cell lymphoma is considered groundbreaking, with 40 sites activated and a critical milestone expected by mid-2025. ALLO-329, a dual-targeting allogeneic CAR T product candidate for autoimmune diseases, has received FDA clearance for a Phase 1 trial, showcasing innovation in the field. ALLO-316 shows promise in renal cell carcinoma, with encouraging Phase 1 data and a potential to redefine treatment for advanced cases. The company maintains a strong financial position with $373.1 million in cash and a cash runway extending into the second half of 2026. The company reported a net loss of $257.6 million for the full year of 2024, highlighting ongoing financial challenges. There is uncertainty regarding the need for lymphodepletion in the ALPHA3 trial, which could impact the trial's outcome and future strategy. The competitive landscape in the CAR T space, particularly in autoimmune diseases, poses challenges for differentiation and market positioning. The success of the ALLO-329 program is contingent on achieving biomarker-based proof-of-concept, which carries inherent risks. The timeline for achieving significant clinical outcomes, such as durable efficacy in the ALLO-329 trial, remains uncertain and could affect investor confidence. Q: How do patients with low disease burden in the JCO publication compare to those being enrolled in the ALPHA3 trial, and how might this affect the complete response rate? A: David Chang, CEO, explained that patients with lower disease volume tend to have higher response rates and fewer adverse events. The MRD positivity in ALPHA3 is about 200-fold less than in second-line treatment settings, suggesting a similar low disease volume as seen in the JCO publication, which bodes well for high complete response rates in ALPHA3. Q: Regarding the mid-2025 futility and lymphodepletion decision, is 647 likely to be needed, and what should we expect from the interim DSMB efficacy analysis in 2026? A: Zachary Roberts, EVP of R&D, stated that the trial is designed to determine if 647 is necessary. Both outcomes have benefits, with or without 647. The interim DSMB analysis will formally test efficacy with minimal ALPHA spend, potentially allowing for early FDA discussions if significant results are achieved. Q: For ALLO-329 in autoimmune disease, what data are you looking to show by year-end to demonstrate proof-of-concept, and how is your approach differentiated? A: David Chang highlighted that the proof-of-concept will focus on biomarker data, such as CAR T cell expansion and B-cell depletion. ALLO-329 is differentiated by its allogeneic nature and dual targeting of B-cells and activated T-cells, potentially offering longer remissions and applicability to a broader range of autoimmune conditions. Q: Can you provide more comments on incorporating milder lymphodepleting agents or removing standard cy/flu, and what is the timeline for this? A: David Chang noted that the Phase 1 study will address these questions. The study includes a cohort with cyclophosphamide alone and another without any lymphodepletion, aiming to determine if milder or no lymphodepletion can achieve the desired outcomes. Q: How should we think about the futility analysis in ALPHA3, and what metrics will be used to evaluate it? A: David Chang explained that the futility analysis will consider the totality of data, focusing on safety and MRD conversion rates. The expectation is that MRD conversion will be significantly higher in the treatment arms compared to the control, guiding the decision on lymphodepletion. 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
