Latest news with #ALLO-316
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
01-06-2025
- Business
- Yahoo
Allogene Therapeutics Provides Updated Phase 1 Data Highlighting Durable Responses with ALLO-316 in Heavily Pretreated Advanced Renal Cell Carcinoma at ASCO
Data Highlights Transformative Promise of CAR T in Solid Tumors Phase 1 Trial with ALLO-316 Demonstrated Potential to Provide Meaningful Clinical Benefit in Patients with CD70 TPS ≥ 50% Advanced or Metastatic RCC A Single Dose of ALLO-316 Achieved a 31% Confirmed Response Rate Four of Five Confirmed Responders Remain in Response Including One Ongoing Remission Over 12 Months Robust Expansion, Persistence, and Tumor Infiltration of ALLO-316 Seen with Standard Lymphodepletion, Showcasing Dagger® Technology as a Next-Generation Allogeneic Platform Phase 1 Safety Profile was Manageable; Proactive Diagnostic and Management Strategies Proved Effective in Mitigating IEC-HS While Preserving Efficacy SOUTH SAN FRANCISCO, Calif., June 01, 2025 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune disease, presented updated data from the Phase 1 TRAVERSE study of ALLO-316 in renal cell carcinoma (RCC) 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. 'ALLO-316 is showing clear evidence of targeted antitumor activity in patients who had failed most or all approved therapies for advanced or metastatic renal cell carcinoma,' said Zachary Roberts, M.D., Ph.D., EVP, Research and Development and Chief Medical Officer at Allogene. 'Our proprietary Dagger technology allows the use of a standard cyclophosphamide and fludarabine-based lymphodepletion regimen with a single dose of ALLO-316. Strong CAR T-cell kinetics and extensive infiltration of tumor tissue by CAR T cells are combining to generate deep and durable remissions. These are results that were previously considered out of reach for patients with advanced solid tumors.' 'Patients diagnosed with advanced or metastatic renal cell carcinoma often face a median survival in months after exhausting standard therapies,' said Samer A. Srour, MB ChB, MS, Associate Professor of Stem Cell Transplantation and Cellular Therapy at The University of Texas MD Anderson Cancer Center and lead investigator of the TRAVERSE trial. 'These updated results from a larger cohort of patients with confirmed CD70 positive tumors provide compelling evidence that treatment with ALLO-316 can reduce tumor burden, control disease, and in some cases deliver durable responses. These findings underscore the clinical promise of an allogeneic CAR T to address the significant unmet needs in solid tumors and offer hope to patients who have exhausted other options.' 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 (TKI), 82% had ≥2+ prior TKI, and 41% had prior belzutifan. Sixteen of the ALLO-316 treated patients had a high CD70 Tumor Proportion Score (TPS >50%). The Phase 1b expansion cohort evaluated the safety and efficacy of ALLO-316 at DL2 (80M CAR T cells) following a standard FC lymphodepletion regimen (fludarabine (30 mg/m2/day) and cyclophosphamide (500 mg/m2/day) for 3 days). The median time from enrollment to the start of therapy was four days. A single dose of ALLO-316 stabilized or reversed disease progression in the majority of patients. In the 16 patients with CD70 TPS ≥50%, the trial demonstrated a Confirmed Overall Response Rate (ORR) of 31% with 44% achieving a minimum of 30% reduction in tumor burden. Of the five confirmed responders, four maintain ongoing responses, with one in sustained remission for over 12 months. The median duration of response (mDOR) has not yet been reached, indicating the potential for long-term disease control. CD70+ patients Phase 1b(N=20) ORR (confirmed CR or PR per RECIST v1.1), n/N (%) 5/20 (25) CD70 TPS ≥50%CD70 TPS <50% 5/16 (31)0/4 (0) RECIST v1.1, Response Evaluation Criteria in Solid Tumors, version 1.1; TPS, tumor proportion score The safety profile of ALLO-316 was manageable and consistent with lymphodepletion and an active CAR T product. The most frequent Grade ≥3 events were hematologic and there were no treatment-related Grade 5 events. The most common all-grade adverse events were cytokine release syndrome (CRS) (68%; with no grade ≥3), neutropenia (68%), decreased white blood cell count (68%), anemia (59%), and thrombocytopenia (55%). Immune effector cell-associated neurotoxicity syndrome (ICANS) was 18% (with no grade ≥3) and no graft-versus-host disease (GvHD) occurred. Improved recognition of IEC-HS symptoms led to diagnosis in 36% of patients with 2 patients (9%) experiencing a short-term Grade 3 (one) or Grade 4 (one patient) event. Newly implemented diagnostic and management algorithms significantly mitigated IEC-HS, with no associated Grade 5 events. TEAEs ≥20% incidence in Phase 1b, n (%) Phase 1b (N=22a) All Grades Grade ≥3 Neutropenia 15 (68) 15 (68) White blood cell count decreased 15 (68) 15 (68) Anemia 13 (59) 9 (41) Thrombocytopenia 12 (55) 6 (27) Nausea 8 (36) 0 ALT increased 7 (32) 2 (9) Peripheral edema 7 (32) 0 Pyrexia 7 (32) 0 Arthralgia 6 (27) 0 AST increased 6 (27) 2 (9) Fatigue 5 (23) 0 Headache 5 (23) 0 AEs of Special Interest Any Grade Grade ≥3 CRS 15 (68) 0 Infection 10 (45) 8 (36) IEC-HS 8 (36) 2 (9)b ICANS 4 (18) 0 Graft-versus-host disease 0 0 IEC-HS includes the preferred terms immune effector cell-associated HLH-like syndrome and Hemophagocytic lymphohistiocytosis. a Includes 2 patients who received LD but did not receive ALLO-316 b One patient experienced G4 IEC-HS based on GI bleeding with subsequent improvement and 1 patient experienced G3 IEC-HS based on hypotension managed without pressors with subsequent improvement. About ALLO-316 (TRAVERSE)ALLO-316 is an AlloCAR T™ investigational product targeting CD70, which is highly expressed in renal cell carcinoma (RCC). CD70 is also selectively expressed in several cancers, creating the potential for ALLO-316 to be developed across a variety of both hematologic malignancies and solid tumors. The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic clear cell RCC. In October 2024 the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation based on the potential of ALLO-316 to address the unmet need for patients with advanced or metastatic RCC. The FDA previously granted Fast Track Designation (FTD) to ALLO-316 in March 2023. In April 2024, the Company announced an award from the California Institute for Regenerative Medicine (CIRM) to support the ongoing TRAVERSE trial with ALLO-316 in RCC. About Allogene TherapeuticsAllogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of 'off-the-shelf' CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit and follow @AllogeneTx on X and LinkedIn. Cautionary Note on Forward-Looking Statements for Allogene This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. This press release may, in some cases, use terms such as 'develop,' 'potential,' 'expect,' 'can,' 'enable,' 'showing,' 'generate,' 'may,' 'could,' 'designed to,' 'promise,' 'hope,' 'ongoing,' 'indicating,' 'mitigate,' 'evaluate,' 'pioneer,' 'goal' or 'will,' including alternative forms thereof, or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the potential of ALLO-316 to treat patients with advanced or metastatic RCC or to provide meaningful clinical benefit in patients with advanced RCC; the potential for ALLO-316 to be developed across a variety of both hematologic malignancies and solid tumors and to generate deep and durable remissions; the potential that ALLO-316 can reduce tumor burden, control disease, and deliver durable responses; the design and potential benefits of our Dagger technology; whether the Dagger® technology will become the next-generation allogeneic platform; ALLO-316 and the Dagger technology's ability to enable robust CAR T cell expansion and persistence and tumor infiltration; the potential of ALLO-316 to address the unmet need in solid tumors or offer hope to patients who have exhausted other options; the transformative potential of our AlloCAR T™ in solid tumors; the potential advantages of the RMAT and Fast Track designation; and our ability to deliver cell therapy on-demand, more reliably, and at greater scale to more patients. Various factors may cause material differences between Allogene's expectations and actual results, including, risks and uncertainties related to: the limited nature of our Phase 1 data from our clinical trials and the extent to which such data may or may not be validated in any future clinical trials; the extent to which the Food and Drug Administration disagrees with our clinical or regulatory plans or the import of our clinical results, which could cause future delays to our clinical trials or require additional clinical trials; we may encounter difficulties enrolling patients in our clinical trials; we may not be able to demonstrate the safety and efficacy of our product candidates in our clinical trials, which could prevent or delay regulatory approval and commercialization; RMAT and Fast Track designations may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval and the designations can be revoked if the criteria for eligibility cease to be met; and challenges with manufacturing or optimizing manufacturing of our product candidates. These and other risks are discussed in greater detail in Allogene's filings with the Securities and Exchange Commission (SEC), including without limitation under the 'Risk Factors' heading in its Quarterly Report on Form 10-Q for the year ended March 31, 2025. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. AlloCAR T™ and Dagger® are trademarks of Allogene Therapeutics, Inc. Allogene's investigational AlloCAR T™ oncology products utilize Cellectis technologies. The anti-CD70 AlloCAR T program is licensed exclusively from Cellectis by Allogene and Allogene holds global development and commercial rights to this AlloCAR T™ program. Allogene Media/Investor Contact:Christine CassianoEVP, Chief Corporate Affairs & Brand Strategy while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
22-05-2025
- Business
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Allogene Therapeutics Announces ASCO 2025 Abstract Publication Featuring Oral Presentation of ALLO-316 in Kidney Cancer and ALPHA3 TIP Poster for Cema-Cel
SOUTH SAN FRANCISCO, Calif., May 22, 2025 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune disease, today announced the publication of two abstracts on the American Society of Clinical Oncology (ASCO) website in advance of the 2025 ASCO Annual Meeting, taking place May 30-June 3 in Chicago, Illinois. An oral presentation will feature ALLO-316, an investigational AlloCAR T product targeting CD70. ALLO-316 is currently being studied in patients with advanced or metastatic renal cell carcinoma (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 upcoming presentation will share updated data from the Phase 1 TRAVERSE study with a focus on the Phase 1b expansion cohort in which patients were treated with a standard regimen of cyclophosphamide and fludarabine followed by a single dose of 80 million CAR T cells. In addition, a Trial-in-Progress (TIP) poster will highlight the innovative design of the ongoing pivotal Phase 2 ALPHA3 trial evaluating cemacabtagene ansegedleucel (cema-cel) as part of a first line (1L) consolidation strategy in patients with large B-cell lymphoma (LBCL) who remain minimal residual disease (MRD) positive at the completion of 1L chemoimmunotherapy. Allogene Presentations at the 2025 ASCO Annual Meeting: ALLO-316 in advanced clear cell renal cell carcinoma (ccRCC): Updated results from the phase 1 TRAVERSE Samer A. Srour, M.D., The University of Texas MD Anderson Cancer CenterSession Title: Oral Abstract Session – Genitourinary Cancer – Kidney and BladderAbstract: #4508Location: Hall D2Session Date and Time: Sunday, June 1, 9:45AM-12:45PM CTPresentation Time: 12:21 PM-12:33 PM CT ALPHA3: A pivotal phase 2 study of first line (1L) consolidation with cemacabtagene ansegedleucel (cema-cel) in patients with large B-cell lymphoma (LBCL) and minimal residual disease (MRD) after response to standard Jason Westin, MD, MS, FACP, The University of Texas MD Anderson Cancer CenterSession Title: Poster Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic LeukemiaAbstract: TPS7085Poster Board: #267a Location: Hall APoster Session Display Date and Time: Sunday, June 1, 9:00AM-12:00PM CT About Cemacabtagene Ansegedleucel (cema-cel)Cemacabtagene ansegedleucel, or cema-cel, is a next generation anti-CD19 AlloCAR T™ investigational product for the treatment of large B cell lymphoma (LBCL). In June 2022, the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to cema-cel in r/r LBCL. The ALPHA3 pivotal Phase 2 trial in first line (1L) consolidation for the treatment of LBCL launched in June 2024. Allogene has oncology rights to cema-cel in the US, EU and UK with options for rights in China and Japan. About ALLO-316 (TRAVERSE)ALLO-316 is an AlloCAR T™ investigational product targeting CD70, which is highly expressed in renal cell carcinoma (RCC). CD70 is also selectively expressed in several cancers, creating the potential for ALLO-316 to be developed across a variety of both hematologic malignancies and solid tumors. The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic clear cell RCC. In October 2024 the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation based on the potential of ALLO-316 to address the unmet need for patients with advanced or metastatic CD70+ RCC. The FDA previously granted Fast Track Designation (FTD) to ALLO-316 in March 2023. In April 2024, the Company announced an award from the California Institute for Regenerative Medicine (CIRM) to support the ongoing TRAVERSE trial with ALLO-316 in the ALPHA3 TrialOver 60,000 patients are expected to be treated for LBCL annually in the US, the EU and the UK. While first line (1L) R-CHOP or other chemoimmunotherapy is effective for most patients, approximately 30% who initially respond will relapse and require subsequent treatment. The current standard of care (SOC) after 1L treatment has been simply to 'watch and wait' to see if the disease relapses. The pivotal Phase 2 ALPHA3 study takes advantage of cema-cel as a one-time, 'off-the-shelf' treatment that can be administered immediately upon discovery of MRD following six cycles of R-CHOP or other chemoimmunotherapy, positioning it to become the standard '7th cycle' of frontline treatment available to all eligible patients with MRD. About Allogene TherapeuticsAllogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of 'off-the-shelf' CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit and follow Allogene Therapeutics on X and LinkedIn. Cautionary Note on Forward-Looking Statements for AllogeneThis press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. This press release may, in some cases, use terms such as 'develop,' 'potential,' 'expect,' 'can,' 'see if,' 'positioning,' 'become,' 'may,' 'could,' 'designed to,' or 'will,' including alternative forms thereof, or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: ALPHA3 being a pivotal trial and the extent to which it will support regulatory approval of cema-cel; the potential for cema-cel to be part of a first-line consolidation strategy in patients with large B-cell lymphoma (LBCL) and minimal residual disease (MRD); the potential for cema-cel to become the standard '7th cycle' of frontline treatment; that cema-cel can be administered immediately upon discovery of MRD following six cycles of R-CHOP or other chemoimmunotherapy; the timing for completion of ALPHA3 enrollment or cema-cel BLA submission; the incidence of LBCL including the extent to which patients will relapse and require subsequent treatment; the potential for our product candidates to be approved; the potential benefits of the ALPHA3 trial and of AlloCAR T™ products; the potential of ALLO-316 as a treatment for patients with advanced or metastatic CD70+ RCC; the potential for ALLO-316 and CAR T-cell therapy to treat hematologic malignancies and solid tumors; our ability to deliver cell therapy on-demand, more reliably, and at greater scale to more patients. Various factors may cause material differences between Allogene's expectations and actual results, including, risks and uncertainties related to: the limited nature of our Phase 1 data from our clinical trials and the extent to which such data may or may not be validated in any future clinical trials; the extent to which the Food and Drug Administration disagrees with our clinical or regulatory plans or the import of our clinical results, which could cause future delays to our clinical trials or require additional clinical trials; we may encounter difficulties enrolling patients in our clinical trials; we may not be able to demonstrate the safety and efficacy of our product candidates in our clinical trials, which could prevent or delay regulatory approval and commercialization; and challenges with manufacturing or optimizing manufacturing of our product candidates. These and other risks are discussed in greater detail in Allogene's filings with the Securities and Exchange Commission (SEC), including without limitation under the 'Risk Factors' heading in its Quarterly Report on Form 10-Q for the year ended March 31, 2025. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. AlloCAR T™ is a trademark of Allogene Therapeutics, Inc. Allogene's investigational AlloCAR T™ oncology products utilize Cellectis technologies. The anti-CD19 products are developed based on an exclusive license granted by Cellectis to Servier. Servier, which has an exclusive license to the anti-CD19 AlloCAR T™ investigational products from Cellectis, has granted Allogene exclusive rights to these products in the U.S., all EU Member States and the United Kingdom. Allogene Media/Investor Contact:Christine CassianoEVP, Chief Corporate Affairs & Brand Strategy Officer(714) 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
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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
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14-05-2025
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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
