Financial Performance - The net loss for Q1 2025 was $59.7 million, or $0.28 per share, factoring in non-cash stock-based compensation of $12.2 million[13]. - Net loss for Q1 2025 was $59.7 million, compared to a net loss of $65.0 million in Q1 2024, representing an improvement of approximately 8.5%[19]. - Net loss per share, basic and diluted, improved to $0.28 in Q1 2025 from $0.38 in Q1 2024[19]. - Collaboration revenue from related parties was $0 for Q1 2025, down from $22 million in Q1 2024[19]. Cash and Investments - Allogene ended Q1 2025 with $335.5 million in cash, cash equivalents, and investments, extending its cash runway into the second half of 2027[11]. - The company expects a decrease in cash, cash equivalents, and investments of approximately $150 million for 2025, with GAAP operating expenses projected at approximately $230 million[11]. - Cash, cash equivalents, and investments decreased to $335.5 million as of March 31, 2025, down from $373.1 million as of December 31, 2024[21]. Expenses - Research and development expenses for Q1 2025 were $50.2 million, including $5.0 million of non-cash stock-based compensation[13]. - General and administrative expenses for Q1 2025 totaled $15.0 million, which included $7.1 million of non-cash stock-based compensation[13]. - Research and development expenses decreased to $50.2 million in Q1 2025 from $52.3 million in Q1 2024, a reduction of approximately 3.9%[19]. - General and administrative expenses decreased to $15.0 million in Q1 2025 from $17.3 million in Q1 2024, a reduction of approximately 13.9%[19]. - Total operating expenses decreased to $65.2 million in Q1 2025 from $69.5 million in Q1 2024, a reduction of approximately 6.3%[19]. Clinical Trials and Research - The ALPHA3 trial has nearly 50 activated sites across the U.S., with over 250 patients consented for MRD screening to date[6]. - The lymphodepletion regimen selection and futility analysis milestone has been shifted to the first half of 2026 due to site-related factors[6]. - The Phase 1 RESOLUTION trial with ALLO-329 in autoimmune disease is on track to start in mid-2025, with proof-of-concept data now expected in 1H 2026[9]. - ALLO-316 is the only allogeneic CAR T therapy showing potential in solid tumors, with updated Phase 1 trial results to be presented at the 2025 ASCO Annual Meeting[10]. Assets and Equity - Total assets decreased to $508.0 million as of March 31, 2025, from $548.7 million as of December 31, 2024[21]. - Total stockholders' equity decreased to $385.4 million as of March 31, 2025, down from $422.2 million as of December 31, 2024[21]. Strategic Focus - Allogene is focusing on advancing the Cema-Cel/ALPHA3 and ALLO-329/RESOLUTION clinical trials to key inflection points while implementing strategic cost realignment[11].

Core Insights - Allogene Therapeutics is advancing its allogeneic CAR T product pipeline for cancer and autoimmune diseases, with a focus on pivotal trials and strategic partnerships to enhance patient outcomes [2][3][5] Program Updates - The ALPHA3 trial for cema-cel as a first-line consolidation therapy for large B-cell lymphoma (LBCL) is ongoing, with nearly 50 activated sites across the U.S. and approximately 240 patients being randomized [3][5] - The trial has faced delays in site readiness, shifting the timeline for lymphodepletion regimen selection and futility analysis to the first half of 2026 [4][5] - The RESOLUTION trial for ALLO-329 in autoimmune diseases is set to begin in mid-2025, with proof-of-concept data expected in the first half of 2026 [9] - The TRAVERSE trial for ALLO-316 in renal cell carcinoma (RCC) has completed enrollment, with updated results to be presented at the 2025 ASCO Annual Meeting [10] Financial Results - As of March 31, 2025, the company reported a net loss of $59.7 million, or $0.28 per share, with total operating expenses of $65.2 million [13][20] - Research and development expenses for Q1 2025 were $50.2 million, while general and administrative expenses were $15.0 million [13][20] - The company ended Q1 2025 with $335.5 million in cash, cash equivalents, and investments, extending its cash runway into the second half of 2027 through strategic cost realignment [12][22]

Core Insights - Allogene Therapeutics is presenting updated data from the Phase 1 TRAVERSE trial of ALLO-316 at the 2025 ASCO Annual Meeting, focusing on advanced renal cell carcinoma (RCC) patients who have progressed after prior therapies [1][4] - The company is also showcasing a trial-in-progress poster for the pivotal Phase 2 ALPHA3 trial, which evaluates cemacabtagene ansegedleucel (cema-cel) as a first-line treatment for large B-cell lymphoma (LBCL) [1][4] ALLO-316 Overview - ALLO-316 is an allogeneic CAR T product targeting CD70, showing potential in solid tumors, specifically in advanced or metastatic CD70+ RCC [2][6] - The Phase 1 TRAVERSE trial has demonstrated a manageable safety profile and encouraging anti-tumor activity in heavily pretreated patients [2][7] - Enrollment is complete for the Phase 1b expansion cohort, which is assessing the safety and efficacy of ALLO-316 at a dose of 80 million CAR T cells [2][7] ALPHA3 Trial Details - The ALPHA3 trial is the first pivotal study to evaluate an allogeneic CAR T product as a consolidation strategy for eradicating minimal residual disease (MRD) in LBCL patients after first-line treatment [3][8] - The trial aims to improve first-line cure rates by identifying high-risk patients using a novel MRD test and enrolling approximately 240 patients [3][8] - Cema-cel is positioned as a potential "7th cycle" of frontline treatment for eligible patients with MRD following standard therapy [8] Regulatory Designations - Both ALLO-316 and cema-cel have received Regenerative Medicine Advanced Therapy (RMAT) designations from the FDA, indicating their potential to address unmet medical needs [7][5] - The ALPHA3 trial launched in June 2024, with cema-cel having previously received RMAT designation in June 2022 [5][7] Company Background - Allogene Therapeutics is a clinical-stage biotechnology company focused on developing allogeneic CAR T products for cancer and autoimmune diseases [9] - The company aims to provide readily available cell therapy on-demand, enhancing treatment accessibility and reliability for patients [9]

Core Insights - Allogene Therapeutics has announced that its investigational dual-targeted CD19/CD70 allogeneic CAR T product, ALLO-329, has received three Fast Track Designations from the FDA for treating adult patients with specific autoimmune diseases [1][2][5] - The company plans to initiate the Phase 1 RESOLUTION basket trial in mid-2025, aiming to evaluate the safety and preliminary efficacy of ALLO-329 in patients with systemic lupus erythematosus (SLE), idiopathic inflammatory myopathy (IIM), and systemic sclerosis (SSc) [1][5] - ALLO-329 utilizes CRISPR-based technology for dual CAR expression and incorporates Allogene's Dagger® technology to potentially reduce or eliminate the need for lymphodepletion, which is a significant barrier in CAR T cell therapy for autoimmune diseases [3][5] Company Overview - Allogene Therapeutics is a clinical-stage biotechnology company based in South San Francisco, focused on developing allogeneic CAR T products for cancer and autoimmune diseases [4] - The company aims to provide "off-the-shelf" CAR T cell therapies that are readily available, reliable, and scalable for a broader patient population [4] Product Details - ALLO-329 targets both CD19+ B cells and CD70+ T cells, which are involved in the pathogenesis of autoimmune diseases [3] - The innovative trial design of the RESOLUTION trial includes two distinct lymphodepletion arms, one using cyclophosphamide and another that eliminates lymphodepletion entirely [1][5]

Core Viewpoint - Allogene Therapeutics reported a narrower loss per share in Q4 2024 compared to the previous year, but did not generate any revenue during the quarter, indicating ongoing financial challenges for the company [1][2][5]. Financial Performance - In Q4 2024, Allogene incurred a loss of $0.28 per share, which is an improvement from a loss of $0.51 per share in the same quarter last year [1]. - The company did not generate any revenue in Q4 2024, while the Zacks Consensus Estimate was $0.07 million; in the previous year, revenues were $0.02 million [2]. - For the full year 2024, Allogene recorded total revenues of $0.2 million, a significant decline of 77% year over year, and reported a loss of $1.32 per share, improved from a loss of $2.09 per share in the prior year [5]. Expenses and Cash Position - Research and development (R&D) expenses for Q4 2024 totaled $45 million, down 18% from the previous year, while general and administrative (G&A) expenses decreased by 10% to $15.5 million [4]. - As of December 31, 2024, Allogene had $373.1 million in cash, cash equivalents, and investments, down from $403.4 million as of September 30, 2024, with a cash runway projected to fund operations into the second half of 2026 [4]. Future Guidance - Allogene anticipates operating expenses for 2025 to be around $250 million, which includes nearly $50 million in non-cash stock-based compensation expenses, and expects a cash burn of approximately $170 million [6]. Pipeline Developments - The company is focused on the pivotal phase II ALPHA3 study evaluating cema-cel for treating newly diagnosed large B cell lymphoma (LBCL) patients, with top-line data expected by the end of 2026 and a regulatory submission planned for 2027 [8]. - Updated data from deprioritized phase I studies indicated cema-cel's effectiveness in patients with low disease burden, reinforcing the management's strategy to develop it as a front-line therapy [9]. - The lymphodepletion selection and futility analysis from the ALPHA3 study is anticipated around mid-2025, which will provide insights into the company's approach [10]. - Allogene plans to explore allogeneic CAR-T cell therapies for autoimmune diseases, with an early-stage study for ALLO-329 in lupus expected to start in mid-2025 [11]. - New data from the phase I TRAVERSE study for ALLO-316 in advanced renal cell carcinoma showed a 50% overall response rate in patients with high CD70 expression, leading to FDA granting Regenerative Medicine Advanced Therapy designation [12].

Financial Data and Key Metrics Changes - As of December 31, 2024, the company had $373.1 million in cash, cash equivalents, and investments, with a cash runway extending into the second half of 2026 [37] - Research and development expenses for Q4 2024 were $45 million, with full-year R&D expenses totaling $192.3 million [37] - The net loss for Q4 2024 was $59.9 million or $0.28 per share, with a full-year net loss of $257.6 million or $1.32 per share [38] Business Line Data and Key Metrics Changes - The pivotal phase two ALPHA3 trial for ALLO-501A in first-line consolidation large B cell lymphoma is progressing, with 40 sites activated [9][25] - ALLO-329, targeting autoimmune diseases, received FDA clearance for a Phase one resolution basket trial, marking the company's entry into this area [11][28] - ALLO-316 is showing promise in renal cell carcinoma, with plans to share updates from the phase one b cohort in mid-2025 [14][34] Market Data and Key Metrics Changes - The company is focusing on the allogeneic CAR T therapy market, aiming to disrupt multiple disease areas and compete with autologous therapies [16] - The ALLO-501A trial is the first randomized trial evaluating CAR T as first-line consolidation therapy for MRD-positive patients, potentially redefining treatment paradigms [24] Company Strategy and Development Direction - The company aims to establish off-the-shelf cell therapy as a new standard of care, with a differentiated pipeline in oncology and autoimmune diseases [9][11] - The strategy includes leveraging proprietary DAGR technology to enhance treatment efficacy and reduce lymphodepletion requirements [31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in reaching critical milestones in 2025, with a focus on operational excellence and scientific innovation [8][9] - The company anticipates that the ALLO-501A trial could redefine the standard of care in first-line large B cell lymphoma [24] Other Important Information - The company is expanding its strategic collaboration with Foresight Diagnostics to support the development of a companion diagnostic for ALLO-501A [27] - The ALLO-329 program is designed to address unique challenges in autoimmune diseases, with a focus on achieving lasting remission [12][31] Q&A Session Summary Question: Follow-up on the recent JCO publication and ALPHA3 trial - Management highlighted that lower disease volume correlates with higher response rates and lower adverse events, supporting the ALLO-501A's potential in the ALPHA3 study [42][44] Question: Mid-2025 futility and lymphodepletion decision - Management indicated that the trial is designed to assess the necessity of ALLO-647, with both scenarios having potential benefits [52][53] Question: ALLO-329 trial in autoimmune disease - Management expects to show biomarker-based proof of concept by year-end, focusing on B cell and T cell targeting [62][64] Question: Event-free survival in ALPHA3 - Management stated that the study is well-powered for event-free survival, with a focus on MRD conversion rates for futility analysis [75][86] Question: Patient enrollment timeline for ALPHA3 - Management confirmed that enrollment is tracking towards completion by the first half of 2026, with a balanced site distribution [91][93]

Financial Data and Key Metrics Changes - As of December 31, 2024, the company had $373.1 million in cash, cash equivalents, and investments, with a cash runway extending into the second half of 2026 [26] - Research and development expenses for Q4 2024 were $45 million, with full-year R&D expenses totaling $192.3 million [26] - The net loss for Q4 2024 was $59.9 million, or $0.28 per share, while the full-year net loss was $257.6 million, or $1.32 per share [27][28] Business Line Data and Key Metrics Changes - The pivotal Phase II ALPHA3 trial for SemaCell in first-line consolidation large B cell lymphoma is progressing with 40 sites activated [9][19] - ALLO329, targeting autoimmune diseases, received FDA clearance for a Phase I resolution basket trial, marking the company's expansion into this area [10][20] - ALLO316 is showing promising results in renal cell carcinoma, with data expected to be shared in mid-2025 [24] Market Data and Key Metrics Changes - The company is focusing on the allogeneic CAR T therapy market, aiming to redefine treatment paradigms in oncology and autoimmune diseases [12][10] - The competitive landscape includes both autologous and allogeneic CAR T therapies, with the company positioning itself to surpass autologous therapies in accessibility and scalability [12] Company Strategy and Development Direction - The company has set a bold strategy for 2024, focusing on advancing its differentiated pipeline and achieving critical milestones in its key programs [7][8] - The strategy includes a commitment to making off-the-shelf cell therapy a new standard of care, particularly in large B cell lymphoma and autoimmune diseases [8][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to achieve significant milestones in 2025, which they believe will be a breakthrough year for allogeneic CAR T therapy [12][13] - The management highlighted the importance of early intervention with CAR T therapy for improved safety and efficacy outcomes [17] Other Important Information - The company is collaborating with Foresight Diagnostics to support the development of a companion diagnostic for its clinical programs [20] - The ALLO329 program is designed to potentially eliminate the need for lymphodepletion, which could significantly change treatment approaches in autoimmune diseases [22][23] Q&A Session Summary Question: Follow-up on the recent JCO publication and its implications for the ALPHA3 trial - Management highlighted a strong correlation between low disease burden and higher response rates, which bodes well for the ALPHA3 study [30][31] Question: Confirmation on the necessity of lymphodepletion in the ALPHA3 trial - Management indicated that the trial is designed to assess whether lymphodepletion is needed, with potential benefits regardless of the outcome [36][37] Question: Data expected from ALLO329 by year-end - Management expects to show biomarker-based proof of concept, including B cell depletion and CAR T cell expansion [45][46] Question: Follow-up on the duration of follow-up for ALLO329 - Management confirmed that longer follow-up will be necessary to assess durable efficacy, beyond initial biomarker data [84][85] Question: Insights on the futility analysis for ALPHA3 - Management clarified that the futility analysis will consider the totality of data, focusing on safety and MRD conversion rates [64][65]

Financial Performance - The company reported a net loss for every period since inception and anticipates substantial net losses in the future[24]. - Net loss for 2024 was $257,590,000, compared to a net loss of $327,265,000 in 2023, representing a 21% improvement[638]. - The company expects to incur additional operating losses and recognizes the need to raise additional capital to implement its business plan[651]. - The Company has fully offset its net deferred tax assets with a valuation allowance due to historical operating performance and net losses[679]. - The Company recorded zero collaboration costs for the year ended December 31, 2024, compared to $1.8 million for 2023, with no milestones achieved in both years[743]. Cash and Investments - As of December 31, 2024, the company had cash, cash equivalents, and investments totaling $373.1 million[617]. - Cash and cash equivalents at the end of 2024 were $75,218,000, down from $83,155,000 in 2023, a decrease of about 10%[635]. - The total financial assets as of December 31, 2024, amounted to $368.7 million, compared to $444.1 million as of December 31, 2023[696]. - The fair value of available-for-sale securities decreased from $444.1 million in 2023 to $368.7 million in 2024, indicating a significant reduction in investment value[700]. - The Company has not experienced significant credit losses in its cash and investment accounts as of December 31, 2024 and 2023[657]. Research and Development - Research and development expenses decreased from $242,914,000 in 2023 to $192,299,000 in 2024, a reduction of about 21%[638]. - The Company has accrued liabilities for estimated research and development costs based on services provided but not yet invoiced[677]. - Research and development expenses include costs incurred for internal and sponsored collaborative research, totaling significant amounts but not specified in the provided content[688]. - The Company recorded $3.5 million in research and development expenses related to clinical trials start readiness milestones for the year ended December 31, 2024[769]. - The Company recorded $5.4 million in research and development expenses for the year ended December 31, 2024, upon achieving a regulatory milestone, compared to zero in 2023[734]. Liabilities and Equity - Total liabilities decreased slightly from $130,604,000 in 2023 to $126,531,000 in 2024, a decrease of approximately 3%[635]. - The total stockholders' equity decreased from $512,233,000 in 2023 to $422,179,000 in 2024, a decline of about 17%[635]. - The total operating lease liabilities as of December 31, 2024, were $90.756 million, a decrease from $95.121 million in 2023[775]. - The weighted-average number of shares used in computing net loss per share increased from 156,931,778 in 2023 to 194,811,756 in 2024, an increase of approximately 24%[638]. - The Company has a total of 212,210,597 shares of common stock issued and outstanding as of December 31, 2024, compared to 168,642,238 shares in 2023[789]. Impairment and Charges - An impairment charge of $15.7 million was recorded for the right-of-use asset and related leasehold improvements due to identified impairment indicators[630]. - The company incurred an impairment of long-lived assets of $15,717,000 in 2024, compared to $13,245,000 in 2023, an increase of about 19%[638]. - The Company recognized $2.0 million and $3.0 million in impairment losses for its equity investments in Notch for the years ended December 31, 2024, and 2023, respectively[785]. - The company recognized an aggregate long-lived asset impairment charge of $6.2 million for the right-of-use asset and leasehold improvements in 2024, following a discounted cash flow analysis[703]. - The expected sublease rental income for a property in South San Francisco was revised to $4.7 million through March 31, 2032, leading to an additional impairment charge of $9.5 million[705]. Financing and Capital Raising - The Company anticipates needing substantial additional financing to develop its products and implement operating plans[24]. - The Company intends to raise additional capital through equity securities, debt financings, or other sources to fund operations and product development[651]. - The Company sold an aggregate of 20,894,565 shares of common stock in ATM offerings during 2023, resulting in net proceeds of $91.1 million[648]. - In a registered offering on May 13, 2024, the Company sold 37,931,035 shares at a price of $2.90 per share, generating gross proceeds of $110.0 million[649]. - The Company has committed up to $15.0 million in funding for a strategic collaboration with The University of Texas MD Anderson Cancer Center, with $3.0 million paid upfront in both 2020 and 2023[745]. Agreements and Collaborations - The Company has potential milestone payments of up to $840.0 million under the Pfizer Agreement, with no payments made in 2024 or 2023[714]. - The Servier Agreement includes potential milestone payments of up to €75.0 million for regulatory milestones and first commercial sales in the U.S., EU, and UK, with €60.0 million remaining for the initial indication of cema-cel[729]. - Under the Notch Agreement, Notch is eligible to receive up to $283.0 million per exclusive target and cell type upon achieving certain clinical, regulatory, and commercial milestones[739]. - The Company has exclusive rights to commercialize products incorporating Antion technology developed during the collaboration with Antion Biosciences[760]. - The License Amendment with Overland Therapeutics includes up to $115.0 million in milestone payments and tiered mid single-digit to low double-digit royalties on net sales in the JV Territory[753]. Stock Options and Compensation - As of December 31, 2024, the company had 24,184,884 outstanding stock options with a weighted average exercise price of $8.14 and an aggregate intrinsic value of $1,000[795]. - The company granted 6,211,389 options in 2024, with an average exercise price of $3.08, while 357,993 options were exercised at an average price of $2.27[795]. - The aggregate intrinsic value of options exercised in 2024 was $0.6 million, compared to $2.3 million in 2023[795]. - The fair value of common stock for options granted in 2024 ranged from $1.40 to $3.32, with expected volatility between 72.85% and 74.09%[796]. - The expected term for stock options granted in 2024 was between 5.02 and 6.25 years[796].

Core Insights - Allogene Therapeutics is advancing its allogeneic CAR T therapy, cema-cel, showing promising results in treating relapsed/refractory large B-cell lymphoma (LBCL) and aiming to surpass autologous CAR T therapies in accessibility and patient reach [2][6][7] Program Updates - The pivotal Phase 2 ALPHA3 trial for cema-cel in LBCL has 40 sites activated and is designed to improve event-free survival (EFS) in patients with minimal residual disease after standard treatment [3][4] - The ALPHA3 trial will enroll approximately 240 patients, with efficacy analyses expected in 2026 and a potential biologics license application (BLA) submission targeted for 2027 [5][6] - The company has received FDA clearance for the ALLO-329 trial in autoimmune diseases, with trial initiation expected in mid-2025 and proof-of-concept data anticipated by year-end 2025 [9][10] - ALLO-316 has shown significant anti-tumor activity in advanced renal cell carcinoma (RCC), with data from the Phase 1b cohort expected in mid-2025 [11][12] Financial Results - As of December 31, 2024, the company reported a net loss of $257.6 million for the year, with a cash position of $373.1 million, projected to fund operations into the second half of 2026 [15][16][22] - Research and development expenses for Q4 2024 were $45.0 million, while general and administrative expenses were $15.5 million [16][22] - The company expects a decrease in cash reserves of approximately $170 million in 2025, with total operating expenses projected at $250 million [15][22]

Conference Call and Webcast Scheduled for March 13, 2025 at 2:00 p.m. PT/5:00 p.m. ET SOUTH SAN FRANCISCO, Calif., March 03, 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 that it will report the fourth quarter and full year 2024 financial results and provide a business update on March 13, 2025, after the close of the market. The ...