Clinical Trials and Product Development - Allogene Therapeutics is focused on developing genetically engineered allogeneic T cell product candidates for cancer and autoimmune diseases, with a pipeline targeting multiple hematological malignancies and solid tumors [90]. - The pivotal Phase 2 clinical trial (ALPHA3) for cemacabtagene ansegedleucel (cema-cel) in large B-cell lymphoma (LBCL) has initiated with almost 30 sites activated, targeting approximately 240 patients [90]. - The ALPHA3 trial aims to study the impact of treating minimal residual disease (MRD) positive patients, with a primary endpoint of event-free survival (EFS) and expected enrollment completion in the first half of 2026 [90]. - The Phase 1 trial (TRAVERSE) of ALLO-316 targeting CD70 in advanced renal cell carcinoma (RCC) has enrolled 39 patients, with 26 confirmed to have CD70 positive RCC [92]. - The best overall response rate (ORR) for ALLO-316 in patients with CD70 Tumor Proportion Score (TPS) of ≥50% was 50%, with a confirmed response rate of 33% [92]. - A biologics license application (BLA) submission for cema-cel is targeted for 2027, following efficacy analyses expected in 2026 [90]. - The Phase 1b expansion cohort for ALLO-316 is expected to include approximately 20 patients, with additional data anticipated in mid-2025 [92]. - The ALPHA2 trial for cema-cel has been deprioritized in favor of the earlier line ALPHA3 trial due to its potential [90]. - The company has implemented a diagnostic and treatment algorithm in the ALLO-316 trial to mitigate treatment-associated hyperinflammatory responses [92]. - The company plans to assess ALLO-647's contribution to the overall benefit-to-risk ratio in the pivotal ALPHA3 trial, with enrollment completion expected in mid-2025 [95]. - ALLO-329, a next-generation allogeneic CAR T cell product candidate, is expected to file an investigational new drug (IND) application in Q1 2025 and initiate a Phase 1 trial in mid-2025 [95]. - The company has significant development priorities focused on cema-cel (1L Consolidation), ALLO-316, and ALLO-329, while exploring partnership opportunities across its pipeline [95]. Financial Performance - The company reported net losses of $66.3 million and $197.7 million for the three and nine months ended September 30, 2024, respectively, with an accumulated deficit of $1.8 billion as of the same date [96]. - The company has $403.4 million in cash and cash equivalents, which is expected to fund operations into 2026 [96]. - The market opportunity for cema-cel is projected to increase by over 50%, expanding from more than $6.0 billion in the U.S. to over $9.5 billion across the U.S., European Union, and United Kingdom [96]. - For the three months ended September 30, 2024, collaboration revenue was $0, a decrease of 100% compared to $22,000 in the same period of 2023 [125]. - Research and development expenses for the three months ended September 30, 2024, were $44.7 million, a decrease of 3% from $46.0 million in the same period of 2023 [127]. - General and administrative expenses decreased to $16.3 million for the three months ended September 30, 2024, down 4% from $17.0 million in the same period of 2023 [130]. - The company recorded an impairment charge of $10.7 million for long-lived assets in the three months ended September 30, 2024, compared to no such expense in the same period of 2023 [131]. - Total operating expenses increased to $71.8 million for the three months ended September 30, 2024, up 14% from $63.0 million in the same period of 2023 [125]. - Interest and other income, net, increased to $6.7 million for the three months ended September 30, 2024, an increase of 8% from $6.2 million in the same period of 2023 [132]. - For the nine months ended September 30, 2024, total operating expenses were $212.7 million, a decrease of 12% from $242.7 million in the same period of 2023 [136]. - The net loss for the three months ended September 30, 2024, was $66.3 million, a 6% increase from a net loss of $62.3 million in the same period of 2023 [125]. - Research and development expenses decreased by $40.9 million to $147.3 million for the nine months ended September 30, 2024, compared to $188.3 million for the same period in 2023, primarily due to a $28.3 million reduction in personnel-related costs [138]. - General and administrative expenses were $49.7 million for the nine months ended September 30, 2024, down from $54.4 million in 2023, reflecting a decrease of $4.8 million mainly from personnel-related costs [139]. - Total impairment charges recognized during the nine months ended September 30, 2024, amounted to $15.7 million, with no such expense recorded in the same period of 2023 [140]. - Interest and other income increased by $5.1 million to $17.1 million for the nine months ended September 30, 2024, compared to $12.0 million in 2023, driven by higher yields on cash and investments [141]. - Cash used in operating activities was $163.6 million for the nine months ended September 30, 2024, an improvement from $184.0 million in 2023 [146]. - Net cash provided by investing activities was $20.8 million for the nine months ended September 30, 2024, compared to $95.8 million in 2023, reflecting a decrease in cash provided by investment maturities [149][150]. - Cash provided by financing activities increased to $110.9 million for the nine months ended September 30, 2024, from $95.5 million in 2023, primarily due to net proceeds from the issuance of common stock [151]. - The company sold 250,000 shares of common stock in ATM offerings during the nine months ended September 30, 2024, resulting in net proceeds of $1.0 million [144]. - As of September 30, 2024, the company had $403.4 million in cash and cash equivalents, sufficient to fund operations for at least the next 12 months [144]. - The company has non-cancellable purchase commitments of $2.3 million as of September 30, 2024, related to agreements with third-party contract manufacturers [153]. Internal Controls and Accounting - The company identified a material weakness in internal controls over financial reporting related to the technical accounting analysis of significant non-routine transactions [164]. - Remediation efforts for the identified material weakness are ongoing, with the engagement of third-party subject matter experts [164]. - Management concluded that the disclosure controls and procedures were not effective at a reasonable assurance level as of September 30, 2024 [163]. - There have been no new accounting pronouncements expected to materially impact the financial statements [158]. - The company does not utilize forward exchange contracts due to the uncertain timing of expected payments in foreign currencies [161]. - No significant changes in critical accounting policies and estimates have occurred compared to the previous annual report [157]. - The company believes that historical fluctuations in interest income have not been significant [160]. - A 10% change in interest rates would not have had a material effect on the fair market value of the company's cash equivalents and available-for-sale securities [160].

Exhibit 99.1 Allogene Therapeutics Reports Third Quarter 2024 Financial Results and Business Update • Cemacabtagene Ansegedleucel (Cema-Cel): 1L Consolidation Large B-Cell Lymphoma (LBCL) ◦ Pivotal Phase 2 ALPHA3 Trial Continuing with Site Activation and Patient Screening/Enrollment ◦ Lymphodepletion Selection Planned for Mid-2025 ◦ Enrollment Completion Expected in 1H 2026 with Primary EFS Data by YE 2026 ◦ Potential BLA Submission in 2027 • ALLO-329 in Autoimmune Disease (AID) ◦ Pre-Clinical Data Highligh ...

Core Insights - The Phase 1 TRAVERSE trial demonstrated that a single infusion of ALLO-316 resulted in an Overall Response Rate (ORR) of 50% and a Confirmed Response Rate of 33% in patients with a CD70 Tumor Proportion Score (TPS) of greater than 50% [1][3] - ALLO-316 utilizes CD70 Dagger® technology, which promotes robust expansion and persistence of the CAR T cells, validating its potential as a next-generation allogeneic platform [1][2] - The safety profile of ALLO-316 was manageable, with a newly implemented diagnostic and management algorithm effectively reducing immune effector cell-associated neurotoxicity while preserving CAR T efficacy [1][7] Trial Details - The ongoing Phase 1 TRAVERSE trial is enrolling patients with advanced or metastatic renal cell carcinoma (RCC) who have progressed after treatment with immune checkpoint inhibitors and VEGF-targeting therapies [1][2] - As of October 14, 2024, 39 patients had been enrolled, with 26 confirmed to have CD70 positive RCC and evaluable for efficacy outcomes [2][3] - The trial includes a Phase 1b expansion cohort evaluating safety and efficacy at a dose level of 80 million CAR T cells following a standard lymphodepletion regimen [2][3] Efficacy Outcomes - Among patients with a TPS of ≥50%, 76% experienced a reduction in tumor burden, with two of six patients showing durable responses ongoing at four months [3][4] - The best overall response rate for CD70 positive patients was 27%, with a confirmed ORR of 19% across all patients evaluable for disease outcomes [4][5] Safety Profile - The most common adverse events included cytokine release syndrome (CRS) at 62%, fatigue at 59%, and neutropenia at 56%, with minimal incidence of immune effector cell-associated neurotoxicity [7][8] - Two dose-limiting toxicities (DLTs) were reported, including autoimmune hepatitis and cardiogenic shock, with three Grade 5 treatment-related adverse events [8][9] Regulatory Designation - The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-316, recognizing its potential to address unmet needs in advanced or metastatic RCC [1][10] - ALLO-316 also received Fast Track Designation from the FDA in March 2023, indicating its promising therapeutic potential [10] Company Overview - Allogene Therapeutics is a clinical-stage biotechnology company focused on developing allogeneic CAR T products for cancer and autoimmune diseases [11] - The company aims to provide "off-the-shelf" CAR T therapies that are readily available and scalable for patients [11]

Conference Call and Webcast Scheduled for November 7, 2024 at 2:00 p.m. PT/5:00 p.m. ET SOUTH SAN FRANCISCO, Calif., Oct. 30, 2024 (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 that it will report third quarter 2024 financial results and provide a business update on November 7, 2024, after the close of the market. The announcement wi ...

Company Overview - Allogene Therapeutics, Inc. is a clinical-stage biotechnology firm specializing in immuno-oncology, developing genetically engineered allogeneic T-cell products for cancer and autoimmune diseases [2] - The company's approach utilizes healthy donor cells, which broadens patient eligibility and scalability [2] - Key projects target lymphoma, leukemia, autoimmune diseases, and solid tumors, with revenue primarily derived from partnerships and licensing agreements [2] Financial Performance - Allogene Therapeutics recorded no revenue and a net loss of $66.36 million, with an earnings per share (EPS) of -$0.35 [1] - The company reported a gross loss of $3.64 million, resulting in a price-to-earnings (P/E) ratio of -1.60 [1] - The stock price fell 5.06% to $2.54 per share, with a trading volume of 1.41 million shares and a turnover rate of 0.67% [1] Market Sentiment - Among the 18 institutions covering Allogene Therapeutics, 72% recommended buying, 28% suggested holding, and none advised selling [1] - The broader biotechnology sector experienced a decline of 0.96%, with related stocks showing varied performances [2] - Stocks with high volatility included Pasithea Therapeutics Corp., Tevogen Bio Holdings Inc., and Apollomics Inc. [2]

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Company Overview - Allogene Therapeutics is a clinical-stage biotechnology company based in South San Francisco, focusing on the development of allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune diseases [2] - The company aims to create a pipeline of "off-the-shelf" CAR T cell product candidates to provide readily available cell therapy on-demand, more reliably, and at greater scale to a larger patient population [2] Recent Developments - Allogene Therapeutics will participate in a panel discussion on innovations in the allogeneic cell therapy landscape during the Goldman Sachs Cell Therapy Day on October 1, 2024, in New York [1] - The panel discussion is scheduled for 10:00 AM PT / 1:00 PM ET, and a webcast will be available on the company's website, with a replay accessible for approximately 30 days [1]

Core Insights - The FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to P-BCMA-ALLO1, an investigational allogeneic CAR-T cell therapy for relapsed/refractory multiple myeloma, based on positive clinical data from an ongoing Phase 1 study [1][2][3] - RMAT designation allows for increased dialogue with the FDA and includes benefits similar to Fast Track and Breakthrough Therapy designations, facilitating the development process [2][4] Company Overview - Poseida Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on advancing allogeneic cell therapies and genetic medicines for cancer and rare diseases [7] - The company utilizes proprietary genetic editing platforms and has formed strategic collaborations with Roche and Astellas to enhance its therapeutic offerings [7] Clinical Development - P-BCMA-ALLO1 is designed to target B-cell maturation antigen (BCMA) and has shown promising efficacy and safety in early clinical trials, particularly in patients who have received prior BCMA-targeted therapies [3][6] - New clinical data from the ongoing Phase 1 study will be presented at the 21st International Myeloma Society Annual Meeting from September 25-28, 2024 [3][6] Regulatory Insights - The RMAT designation is part of the 21st Century Cures Act, aimed at expediting the development and review of regenerative medicine therapies for serious conditions [4] - Therapies with RMAT designation may be eligible for accelerated approval based on surrogate or intermediate endpoints that predict long-term clinical benefits [5]

Allogene Therapeutics, Inc. (NASDAQ:ALLO) Q2 2024 Earnings Conference Call August 7, 2024 5:00 PM ET Company Participants Christine Cassiano - Executive Vice President, Chief Corporate Officer and IR David Chang - President, Chief Executive Officer and Co-Founder Zachary Roberts - Executive Vice President of Research & Development and Chief Medical Officer Geoffrey Parker - Executive Vice President and Chief Financial Officer Conference Call Participants Brian Chinn - JPMorgan Jenna Li - Jefferies Tyler Van ...

Allogene Therapeutics, Inc. (ALLO) incurred an adjusted loss (excluding impairment of long-lived asset) of 32 cents per share in second-quarter 2024, narrower than the Zacks Consensus Estimate of a loss of 35 cents.Inclusive of impairment charges, the company posted a loss of 35 cents in the second quarter. In the year-ago period, the company reported a loss of 54 cents. There was no impairment charge recorded in the year-ago period.ALLO did not generate any revenues during the quarter. The Zacks Consensus ...