공시 • May 06
Allogene Therapeutics, Inc. to Report Q1, 2026 Results on May 13, 2026 Allogene Therapeutics, Inc. announced that they will report Q1, 2026 results After-Market on May 13, 2026 공시 • Apr 23
Allogene Therapeutics Expands Pivotal Phase 2 ALPHA3 Trial to South Korea and Australia Allogene Therapeutics, Inc. had regulatory authorities in South Korea and Australia clear the Company to expand its pivotal Phase 2 ALPHA3 study evaluating cemacabtagene ansegedleucel (cema-cel) in first-line (1L) consolidation treatment for patients with large B-cell lymphoma (LBCL). The study, currently enrolling across more than 60 sites in North America, will expand to over 80 global sites with the addition of South Korea and Australia. The Company recently announced findings from a planned interim futility analysis of the ALPHA3 trial from the first 24 patients enrolled. In this analysis, cema-cel demonstrated a 58.3% (7/12) minimal residual disease (MRD) clearance versus 16.7% (2/12) in the standard-of-care (SOC) observation arm in the 1L consolidation setting. Cema-cel was generally well-tolerated, with no serious treatment-related adverse events and no cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS). There were no hospitalizations for treatment-related adverse events, suggesting consolidation of MRD+ remission with cema-cel may be suitable for a fully outpatient regimen. The ALPHA3 study is expected to enroll approximately 220 patients by the end of 2027. An interim analysis of event-free survival (EFS) is anticipated in mid-2027, followed by the primary EFS analysis in mid-2028. 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. Allogene has oncology rights to cema-cel in the US, EU and UK with options for rights in China and Japan. Over 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% will relapse and require subsequent treatment. The current standard of care 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. Allogene’s investigational AlloCAR T oncology products utilize Cellectis technologies. Cemacabtagene ansegedleucel (cema-cel) was developed based on an exclusive license granted by Cellectis to Servier. Servier has granted Allogene exclusive rights to cema-cel in the U.S., all EU Member States and the United Kingdom. 공시 • Apr 21
Allogene Therapeutics, Inc., Annual General Meeting, Jun 18, 2026 Allogene Therapeutics, Inc., Annual General Meeting, Jun 18, 2026. 공시 • Apr 17
Allogene Therapeutics, Inc. Announces Pre-Clinical Data For ALLO-329 Dual-Targeted CD19/CD70 Allogeneic CAR T For Autoimmune Diseases Allogene Therapeutics, Inc. announced the publication of pre-clinical data for ALLO-329 in Nature Communications. ALLO-329 is an investigational allogeneic CAR T product developed specifically for autoimmune diseases. The publication details the observed precision of ALLO-329 in targeting both CD19+ B cells and CD70+ activated T cells, which are implicated in a range of autoimmune diseases. These findings demonstrate a novel approach to enhance allogeneic CAR T cell activity and persistence in these settings, with a goal of reducing or eliminating significant cytotoxic lymphodepletion. Pre-clinical data show that allogeneic CD19 CAR T cells engineered with an anti-rejection CD70 CAR retain robust anti-CD19 activity, avoid rejection and promote CAR T cell expansion. This dual-targeting approach was also observed to improve therapeutic efficacy in tumor models of antigen loss and achieve suppression of antibody titers in an autoimmune disease model. Integrating both CARs into a single, off-the-shelf allogeneic product has the potential to offer a scalable, consistent manufacturing solution with the ability to expand clinical impact across hematologic malignancies and autoimmune diseases characterized by CD19 and CD70 expression. These findings further validate the potential of the Company’s clinically proven Dagger technology, designed to enhance CAR T cell expansion and persistence. In ALLO-329 for autoimmune disease, this approach is intended to enable robust expansion and persistence of allogeneic CAR T cells, while potentially reducing or eliminating the need for conventional cytotoxic lymphodepletion. The Phase 1 RESOLUTION trial is a 3+3 dose-escalation study enrolling patients across multiple autoimmune indications, including systemic lupus erythematosus, scleroderma, and inflammatory myositis. The trial is evaluating multiple dose levels, beginning at 20 million CAR T cells, in two parallel cohorts: one receiving reduced lymphodepletion consisting of cyclophosphamide only and one receiving no lymphodepletion. Competing CAR-T programs in autoimmune disease are evaluating autologous doses 5-10x higher, while other allogeneic approaches use cell doses up to approximately 50x higher than those in the RESOLUTION trial. Initial data from the first dosing cohort are expected in June 2026 and are expected to include translational data, including disease-related biomarkers, CAR T expansion, immune reconstitution, and early clinical outcomes. Assuming continued enrollment and follow-up, Allogene anticipates providing an additional clinical update later this year. ALLO-329 is a CD19/CD70 dual AlloCAR T investigational product being developed for the treatment of autoimmune diseases. In April 2025, the U.S. Food and Drug Administration granted three Fast Track Designations (FTD) to ALLO-329 for the treatment of adult patients with lupus, myositis, and scleroderma. ALLO-329 utilizes CRISPR-based site-specific integration for dual CAR expression. This approach targets both CD19+ B cells and CD70+ T cells, which play a role in autoimmune disease pathogenesis. Additionally, ALLO-329 incorporates Allogene's clinically validated Dagger technology, designed to reduce or eliminate the need for lymphodepletion, a pre-treatment regimen that may be a significant barrier to CAR T cell therapy adoption in autoimmune indications. ALLO-329 (CD19/CD70) in autoimmune disease uses CRISPR gene-editing technology. New Risk • Apr 16
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 52% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (18% average weekly change). Shareholders have been substantially diluted in the past year (52% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$195m net loss in 3 years). Significant insider selling over the past 3 months (US$534k sold). 공시 • Apr 16
Allogene Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $175 million. Allogene Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $175 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 87,500,000
Price\Range: $2
Discount Per Security: $0.12