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 ...

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 ...

Allogene Therapeutics, Inc. (NASDAQ: ALLO ) is pioneering the development of allogeneic chimeric antigen receptor T-cells (CAR-Ts) for the treatment of cancer and autoimmune diseases. In other words, Allogene is genetically modifying immune cells (T-cells), obtained from healthy donors, inOriginally a Biologist, M.Sc in Biomedicine, PhD in Bioengineering, with +20 years experience in the research and development of novel Cell & Gene Therapies (CGT) tackling several clinical needs. As an investor, I have bee ...

SOUTH SAN FRANCISCO, Calif., Feb. 26, 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 participate in one upcoming investor conference in March. TD Cowen 45th Annual Health Care ConferenceWednesday, March 5, 20258:20AM PT/11:50AM ET Any available webcasts will be posted to the Company's website at www.allogene.com unde ...