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].

Financial Performance - The company reported a net loss of $59.9 million for Q4 2024, or $0.28 per share, with a full-year net loss of $257.6 million, or $1.32 per share[18]. - Net loss for the three months ended December 31, 2024, was $59.94 million, compared to a net loss of $85.78 million for the same period in 2023[25]. - Net loss per share, basic and diluted, was $(0.28) for the three months ended December 31, 2024, compared to $(0.51) for the same period in 2023[25]. - The company expects a decrease in cash, cash equivalents, and investments of approximately $170 million in 2025, with GAAP operating expenses projected at around $250 million[16]. - Total operating expenses for the three months ended December 31, 2024, were $60.49 million, a decrease from $85.13 million in the same period of 2023[25]. - Research and development expenses for the year ended December 31, 2024, were $192.30 million, down from $242.91 million in 2023[25]. - General and administrative expenses for the year ended December 31, 2024, were $65.21 million, compared to $71.67 million in 2023[25]. - Interest and other income, net, increased to $20.15 million for the year ended December 31, 2024, from $18.31 million in 2023[25]. Cash and Investments - Allogene Therapeutics ended Q4 2024 with $373.1 million in cash, cash equivalents, and investments, projecting a cash runway into the second half of 2026[18]. - Cash, cash equivalents, and investments decreased to $373.15 million as of December 31, 2024, from $448.70 million as of December 31, 2023[27]. - Total assets decreased to $548.71 million as of December 31, 2024, from $642.84 million as of December 31, 2023[27]. - Total stockholders' equity decreased to $422.18 million as of December 31, 2024, from $512.23 million as of December 31, 2023[27]. Research and Development - Research and development expenses for Q4 2024 were $45.0 million, totaling $192.3 million for the full year, which included $20.4 million in non-cash stock-based compensation[18]. - The pivotal Phase 2 ALPHA3 trial for cema-cel in large B-cell lymphoma (LBCL) has 40 sites activated and aims to enroll approximately 240 patients, with primary event-free survival data expected around year-end 2026[6][7]. - Allogene received FDA clearance for the IND application of ALLO-329, targeting autoimmune diseases, with trial initiation expected in mid-2025 and proof-of-concept data anticipated around year-end 2025[10][16]. - ALLO-316 demonstrated significant anti-tumor activity in advanced renal cell carcinoma (RCC) with positive Phase 1 data, and enrollment for the Phase 1b expansion cohort has been completed[12][13]. - The ALPHA3 trial is the first pivotal trial to potentially eradicate minimal residual disease (MRD) in LBCL, aiming to improve cure rates[5]. - The company aims to demonstrate that allogeneic CAR T therapies can surpass autologous CAR T therapies by reaching more patients with greater accessibility in 2025[3]. Collaborations and Revenue - Allogene's strategic partnership with Foresight Diagnostics has been expanded to support the development of MRD assays as companion diagnostics in multiple regions[8]. - Collaboration revenue from related parties was $21 million for the three months ended December 31, 2023, and $22 million for the year ended December 31, 2023[25].

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]

Core Insights - Allogene Therapeutics, Inc. will report its fourth quarter and full year 2024 financial results on March 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 provide readily available 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, Inc. is focused on developing allogeneic chimeric antigen receptor T-cells (CAR-Ts) for cancer and autoimmune disease treatment [1] Company Overview - Allogene is engaged in the genetic modification of immune cells (T-cells) sourced from healthy donors [1] - The company aims to address various clinical needs through novel Cell & Gene Therapies (CGT) [1] Analyst Background - The analyst has over 20 years of experience in research and development within the life sciences sector, particularly in CGT [1] - The analyst utilizes a strong background in life sciences to evaluate the potential of new treatments and their ability to generate shareholder returns [1]

Company Overview - Allogene Therapeutics, Inc. 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] Upcoming Events - Allogene Therapeutics will participate in the TD Cowen 45th Annual Health Care Conference on March 5, 2025, at 8:20 AM PT / 11:50 AM ET [1] - Webcasts of the conference will be available on the company's website, with replays accessible for approximately 30 days [1]

SOUTH SAN FRANCISCO, Calif., Feb. 25, 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 an expanded strategic collaboration with Foresight Diagnostics, Inc. to include the development of Foresight’s minimal residual disease (MRD) assay as a companion diagnostic to identify patients with large B-cell lymphoma (LBCL) for treatment wit ...

Core Insights - Allogene Therapeutics has published data from its Phase 1 ALPHA and ALPHA2 clinical studies of cemacabtagene ansegedleucel (cema-cel) for relapsed/refractory large B-cell lymphoma, marking a significant advancement in allogeneic CAR T therapy [1][2] Study Overview - The ALPHA/ALPHA2 studies were single-arm, multicenter, open-label, Phase 1 trials involving 87 heavily pretreated patients with relapsed/refractory non-Hodgkin lymphoma treated between May 2019 and September 2022 [3] - The focus was on 33 CD19 CAR T-naive patients who received cema-cel manufactured for pivotal studies [3] Efficacy Results - The overall response rate (ORR) was 58% and the complete response (CR) rate was 42% across the study, with the pivotal study regimen achieving ORR and CR rates of 67% and 58% respectively [4][5] - Among patients achieving CR, the median duration of response (DOR) was 23.1 months, with median overall survival (OS) not reached [4][5] Safety Profile - The safety profile was manageable and consistent with approved autologous CD19 CAR T therapies, with no cases of graft-versus-host disease (GvHD), immune effector cell-associated neurotoxicity syndrome (ICANS), or high-grade cytokine release syndrome (CRS) reported [4][5] - Common treatment-emergent adverse events included neutropenia (85%), anemia (67%), and infusion-related reactions (58%) [6] Treatment Timing - The median time to treatment initiation was two days from enrollment, significantly shorter than the typical wait times for autologous CAR T therapies [6] Low Disease Burden Potential - In patients with low disease burden, the CR rate was 100% for those with baseline tumor burden <1000 mm² and 82% for those with normal lactate dehydrogenase levels, indicating cema-cel's promise in treating minimal residual disease (MRD) [7] Foundation for Future Trials - The ongoing ALPHA3 trial is evaluating cema-cel as a consolidation therapy for LBCL patients in remission but positive for MRD, aiming to predict and intervene before relapse [8][9] - The ALPHA3 trial is designed to establish cema-cel as a potential standard "7th cycle" of frontline treatment for patients with MRD following initial therapy [11] Product Information - Cemacabtagene ansegedleucel (cema-cel) is an investigational anti-CD19 AlloCAR T™ product, which received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for relapsed/refractory LBCL [10]

Efficacy Comparable to Approved Autologous CD19 CAR Ts: Achieved Overall Response (ORR) and Complete Response (CR) Rates of 58% and 42% Across the Study and 67% and 58% with Pivotal Study Regimen, RespectivelyDurability of Response: Among Patients Who Achieved CR, Median Duration of Response (DOR) of 23.1 Months and Median Overall Survival (OS) Not ReachedManageable Safety Profile Consistent with Approved Autologous CD19 CAR T: No Graft-versus-Host Disease (GvHD), Immune Effector Cell-Associated Neurotoxici ...