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 Viewpoint - Allogene Therapeutics, Inc. is set to report its first quarter 2025 financial results and provide a business update on May 13, 2025, followed by a live audio webcast and conference call [1] 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 [4] - The company aims to create a pipeline of "off-the-shelf" CAR T cell product candidates to deliver cell therapy on-demand, more reliably, and at greater scale to patients [4] Conference Call Details - The conference call will take place at 2:00 p.m. PT/5:00 p.m. ET, and a listen-only webcast will be available on the company's website [1][2] - Registration is required for those who wish to ask questions during the conference call, and participants will receive a personal PIN upon registration [3]

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].

Exhibit 99.1 Allogene Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Business Update SOUTH SAN FRANCISCO, Calif., March 13, 2025 – 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 provided corporate updates and reported financial results for the quarter and full year ended December 31, 2024. "In 2024, we focused on delivering on our bol ...