Allogene Therapeutics Reports Second Quarter 2025 Financial Results and Business Update
Allogene Therapeutics (Nasdaq: ALLO) reported Q2 2025 financial results and provided significant updates across its clinical pipeline. The company announced the advancement of its pivotal Phase 2 ALPHA3 trial for Cema-Cel in LBCL, now proceeding as a two-arm randomized study with over 50 activated sites. Additionally, Allogene initiated the Phase 1 RESOLUTION trial for ALLO-329 in autoimmune diseases and presented updated ALLO-316 results in renal cell carcinoma at ASCO 2025.
Financial highlights include a Q2 2025 net loss of $50.9 million ($0.23 per share) and a strong cash position of $302.6 million, extending runway into 2H 2027. R&D expenses were $40.2 million, while G&A expenses totaled $14.3 million for the quarter.
[ "Strong cash position of $302.6 million with runway extended into 2H 2027", "Successful expansion to over 50 clinical sites across U.S. and Canada for ALPHA3 trial", "FDA alignment achieved on pivotal trial design for ALLO-316 in solid tumors", "Launch of first autoimmune disease trial with ALLO-329" ]Allogene Therapeutics (Nasdaq: ALLO) ha comunicato i risultati finanziari del secondo trimestre 2025 e importanti aggiornamenti sul suo portafoglio clinico. Ha annunciato l'avanzamento dello studio pivotale di Fase 2 ALPHA3 per Cema-Cel nel LBCL, ora condotto come studio randomizzato a due bracci con oltre 50 siti attivati negli USA e in Canada. Inoltre, Allogene ha avviato lo studio di Fase 1 RESOLUTION per ALLO-329 nelle malattie autoimmuni e ha presentato risultati aggiornati su ALLO-316 nel carcinoma a cellule renali all'ASCO 2025.
I dati finanziari mostrano una perdita netta nel 2T 2025 di $50.9 milioni ($0,23 per azione) e una solida posizione di cassa di $302.6 milioni, che estende la runway fino alla seconda metà del 2027. Le spese di R&S sono state di $40.2 milioni e le spese G&A di $14.3 milioni nel trimestre.
- Solida posizione di cassa di $302.6 milioni con runway estesa fino alla seconda metà del 2027
- Espansione riuscita a oltre 50 siti clinici negli USA e in Canada per lo studio ALPHA3
- Allineamento con la FDA raggiunto sul disegno pivotale dello studio per ALLO-316 nei tumori solidi
- Avvio del primo studio in malattie autoimmuni con ALLO-329
Allogene Therapeutics (Nasdaq: ALLO) presentó los resultados financieros del segundo trimestre de 2025 y ofreció actualizaciones relevantes de su pipeline clínico. Anunció el avance del ensayo pivotal de Fase 2 ALPHA3 para Cema-Cel en LBCL, que continúa como un estudio aleatorizado de dos brazos con más de 50 sitios activados en EE. UU. y Canadá. Además, Allogene inició el estudio de Fase 1 RESOLUTION para ALLO-329 en enfermedades autoinmunes y presentó resultados actualizados de ALLO-316 en carcinoma de células renales en ASCO 2025.
En lo financiero, registró una pérdida neta en el 2T 2025 de $50.9 millones ($0.23 por acción) y una sólida posición de caja de $302.6 millones, que extiende su runway hasta la segunda mitad de 2027. Los gastos en I+D fueron $40.2 millones y los gastos G&A alcanzaron $14.3 millones en el trimestre.
- Sólida posición de caja de $302.6 millones con runway extendido hasta la segunda mitad de 2027
- Expansión exitosa a más de 50 sitios clínicos en EE. UU. y Canadá para el ensayo ALPHA3
- Alineamiento con la FDA alcanzado respecto al diseño pivotal del estudio para ALLO-316 en tumores sólidos
- Lanzamiento del primer ensayo en enfermedades autoinmunes con ALLO-329
Allogene Therapeutics (Nasdaq: ALLO)가 2025� 2분기 실적� 발표하고 임상 파이프라� 전반� 걸쳐 주요 업데이트� 공개했습니다. 회사� LBCL� 대� Cema-Cel� 피보� 2� ALPHA3 시험� � � 무작� 배정 연구� 진행하며 미국� 캐나다에� 50� 이상� 사이트를 활성화했다고 밝혔습니�. 또한 자가면역질환 치료� ALLO-329� 1� RESOLUTION 시험� 시작했고, ASCO 2025에서 신세포암� 대� ALLO-316� 업데이트� 결과� 발표했습니다.
재무 하이라이트로� 2025� 2분기 순손� $50.9 million($0.23/�)� $302.6 million� 견고� 현금 보유으로 2027� 하반기까지� 자금 운용 여력� 확보했습니다. R&D 비용은 $40.2 million, G&A 비용은 $14.3 million이었습니�.
- $302.6 million� 강한 현금 보유� 2027� 하반기까지� 러너웨이 확보
- ALPHA3 시험� 위해 미국·캐나다에� 50� 이상� 임상 사이트로 성공적으� 확장
- 고형� 대� ALLO-316 피보� 시험 설계� 대� FDA와 합의 달성
- ALLO-329� 자가면역질환 대� � 임상시험 개시
Allogene Therapeutics (Nasdaq: ALLO) a publié ses résultats financiers du deuxième trimestre 2025 et a annoncé des avancées importantes de son portefeuille clinique. La société a confirmé la progression de l'essai pivot de Phase 2 ALPHA3 pour ‑C dans le LBCL, désormais conduit comme un essai randomisé en deux bras avec plus de 50 centres activés aux États‑Unis et au Canada. Allogene a également lancé l'essai de Phase 1 RESOLUTION pour �329 dans les maladies auto‑immunes et présenté des données actualisées sur �316 dans le carcinome rénal lors de l'ASCO 2025.
Points financiers : une perte nette au 2T 2025 de $50.9 millions ($0,23 par action) et une trésorerie solide de $302.6 millions, prolongeant la visibilité financière jusqu'au second semestre 2027. Les dépenses R&D se sont élevées à $40.2 millions et les frais G&A à $14.3 millions pour le trimestre.
- Trésorerie solide de $302.6 millions avec visibilité étendue jusqu'au second semestre 2027
- Extension réussie à plus de 50 centres cliniques aux États‑Unis et au Canada pour l'essai ALPHA3
- Alignement obtenu avec la FDA sur le design pivotal pour �316 dans les tumeurs solides
- Lancement du premier essai en maladies auto‑immunes avec �329
Allogene Therapeutics (Nasdaq: ALLO) veröffentlichte die Finanzergebnisse für das zweite Quartal 2025 und gab bedeutende Updates zur klinischen Pipeline bekannt. Das Unternehmen kündigte den Fortschritt der pivotalen Phase�2‑Studie ALPHA3 für ‑C bei LBCL an, die nun als randomisierte Zweiarm‑Studie mit über 50 aktivierten Studienzentren in den USA und Kanada läuft. Darüber hinaus startete Allogene die Phase�1‑RESOLUTION‑Studie für �329 bei Autoimmunerkrankungen und stellte auf der ASCO 2025 aktualisierte Daten zu �316 beim Nierenzellkarzinom vor.
Finanzielle Highlights: ein Nettoverlust im 2Q 2025 von $50.9 Millionen ($0.23 je Aktie) und eine starke Cash‑Position von $302.6 Millionen, die die Finanzierung bis in die zweite Hälfte 2027 verlängert. F&E‑Aufwendungen beliefen sich im Quartal auf $40.2 Millionen, die G&A‑Kosten auf $14.3 Millionen.
- Starke Cash‑Position von $302.6 Millionen mit Laufzeit bis in die zweite Hälfte 2027
- Erfolgreiche Erweiterung auf über 50 Studienzentren in den USA und Kanada für die ALPHA3‑Studie
- Abstimmung mit der FDA zum Schlüsseldesign der pivotalen Studie für �316 bei soliden Tumoren erreicht
- Start der ersten Studie zu Autoimmunerkrankungen mit �329
- None.
- Net loss of $50.9 million in Q2 2025
- Expected cash burn of approximately $150 million for 2025
- Non-cash impairment of long-lived asset expense of $2.4 million
Insights
Allogene's Q2 shows strategic clinical trial progress and solid cash position extending runway into 2H 2027, despite continued losses.
Allogene Therapeutics reported significant clinical progress across its allogeneic CAR T pipeline in Q2 2025, with three key programs advancing toward critical milestones. The pivotal ALPHA3 trial for cema-cel has been streamlined to a two-arm study comparing standard FC lymphodepletion plus CAR T versus observation in first-line LBCL consolidation. This strategic simplification focuses on the most promising approach while potentially accelerating community adoption if successful. With over 50 sites activated across North America, enrollment appears on track for the futility analysis in 1H 2026.
The company has expanded beyond oncology into autoimmune diseases with the RESOLUTION trial for ALLO-329, targeting both B cells and activated T cells. This dual-targeting approach, combined with their Dagger® technology, could reduce or eliminate lymphodepletion requirements—a potentially transformative advance for autoimmune applications.
For solid tumors, ALLO-316 in renal cell carcinoma has completed Phase 1b enrollment, with the company securing FDA alignment on pivotal trial design. This positions them for potential partnership discussions to advance this challenging but potentially groundbreaking program.
Financially, Allogene reported a
While Allogene continues to operate at a loss, their focused execution strategy has extended their runway while advancing three clinical programs toward value-inflection points. The next 12-18 months will be critical as multiple data readouts could validate their off-the-shelf allogeneic CAR T approach across multiple therapeutic areas.
Allogene makes strategic advances in three key clinical programs, simplifying ALPHA3 trial design while expanding into autoimmune indications.
The refinement of Allogene's clinical strategy across three programs demonstrates a thoughtful, data-driven approach to development challenges. For cema-cel, the decision to proceed with standard fludarabine/cyclophosphamide (FC) lymphodepletion rather than more intensive regimens reflects an important insight: in the first-line consolidation setting, where disease burden is minimal, standard FC may provide sufficient immunosuppression while maintaining a more favorable safety profile. This contrasts with relapsed/refractory settings where higher disease burden typically necessitates more aggressive lymphodepletion.
The ALPHA3 trial design simplification to a two-arm study (cema-cel with FC versus observation) is scientifically sound and operationally pragmatic. By selecting minimal residual disease (MRD) conversion as the futility analysis endpoint, Allogene is leveraging a well-established surrogate marker that correlates with long-term outcomes in lymphoma. This enables faster assessment of potential efficacy while maintaining clinical relevance.
For ALLO-329 in autoimmune disease, the trial design is particularly innovative. The inclusion of both a cyclophosphamide-only arm and a no-lymphodepletion arm will generate critical data on whether their Dagger® technology truly enables lymphodepletion-free CAR T therapy—a potential paradigm shift for autoimmune applications where minimizing immunosuppression is crucial. The basket trial approach across multiple rheumatologic conditions (lupus, myopathies, systemic sclerosis) efficiently tests the hypothesis that dual CD19/CD70 targeting can address shared immunopathology across these diseases.
The ALLO-316 program's advancement in renal cell carcinoma represents one of the few promising approaches for allogeneic CAR T in solid tumors. FDA alignment on pivotal trial design suggests the agency recognizes the potential significance of this approach despite the historical challenges CAR T has faced in solid tumors.
Collectively, these trial designs reflect sophisticated clinical development strategy that balances innovation, operational feasibility, and the generation of clinically meaningful endpoints.
- Pivotal Phase 2 ALPHA3 Trial with Cemacabtagene Ansegedleucel (Cema-Cel) in First Line (1L) Consolidation in Large B-Cell Lymphoma (LBCL)
- ALPHA3 Proceeding as a Two-Arm Randomized Trial Comparing Cema-cel After Standard Fludarabine and Cyclophosphamide (FC) Lymphodepletion vs. Observation
- More than 50 sites Activated Across the U.S. and Canada, with Additional International Expansion Underway; Scheduled Futility Analysis Remains on Track for 1H 2026
- Phase 1 RESOLUTION Trial with ALLO-329 in Autoimmune Disease (AID)
- Initiated RESOLUTION Basket Trial in Rheumatology
- Proof-of-Concept Data Remains Planned for 1H 2026
- Phase 1 TRAVERSE Trial with ALLO-316 in Renal Cell Carcinoma (RCC)
- Updated Phase 1B Results Presented at ASCO 2025 Highlighted Clinical Responses and the Potential of the Dagger® Technology Platform to Drive Robust Expansion and Persistence of Allogeneic CAR T Cells
- Aligned with FDA on Pivotal Trial Design, Supporting Potential Partnership Discussions to Advance the Program
- Ended Q2 2025 with
$302.6 Million in Cash, Cash Equivalents and Investments; Cash Runway Projected Into 2H 2027 - Conference Call and Webcast Scheduled forToday at 2:00 PM PT/5:00 PM ET
SOUTH SAN FRANCISCO, Calif., Aug. 13, 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 provided corporate updates and reported financial results for the quarter ended June 30, 2025.
“This quarter marked a significant inflection point for Allogene as we advance the streamlined ALPHA3 trial toward its next key milestone, initiate clinical enrollment in our first autoimmune indications with ALLO-329, and aligned with the FDA on a pivotal path forward for ALLO-316 in solid tumors,� said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. “Our progress reflects a focused and disciplined execution strategy, and a clear path to value creation as we advance the next wave of scalable and accessible cell therapies with potentially durable results.�
Program Updates
Cema-Cel: Pivotal Phase 2 ALPHA3 1L Consolidation Trial in LBCL
The Company has selected standard fludarabine and cyclophosphamide (FC) as the lymphodepletion regimen to be used in its ALPHA3 study. The amended ALPHA3 trial now proceeds as a randomized study with two arms, comparing cema-cel after standard FC lymphodepletion to observation, the current standard of care.
The selection of FC as the lymphodepletion regimen in the ALPHA3 trial reflects strategic advantages supported by preliminary safety and biomarker data. Early observations indicate an encouraging minimal residual disease (MRD) conversion rate and a favorable safety profile when cema-cel is administered following standard FC. The regimen also offers operational benefits, including ease of administration and the potential for broader adoption within community cancer centers, and is enthusiastically supported by study investigators. In contrast to the relapsed/refractory setting, where a higher disease burden may necessitate more intensive lymphodepletion, standard FC may be sufficient to support the eradication of microscopic disease in earlier lines of treatment.
The next milestone will be the futility analysis comparing MRD conversion between the two arms and is expected to occur 1H 2026. The Company expects to provide the rates of MRD conversion between the two arms at the time of this announcement. To date, over 50 clinical sites are activated across the United States and Canada, including community cancer centers and major academic institutions.
ALLO-329: CD19/CD70 Dual CAR with Dagger® Technology in AID
The Phase 1 RESOLUTION basket trial in rheumatology launched in Q2 2025 and represents a significant step in evaluating CAR T therapy across multiple autoimmune conditions, including systemic lupus erythematosus (with or without lupus nephritis), idiopathic inflammatory myopathies, and systemic sclerosis. The trial features two lymphodepletion arms: one with cyclophosphamide alone and one with no lymphodepletion. The first clinical update, expected in 1H 2026, will include biomarker data and clinical proof-of-concept data.
ALLO-329 is a first-in-class allogeneic CD19/CD70 dual CAR T product designed to target both CD19+ B cells and CD70+ activated T cells, which are key drivers of autoimmune disease. It leverages CRISPR-based site-specific integration and incorporates the Company’s clinically validated Dagger® technology, which aims to reduce or eliminate the need for lymphodepletion to facilitate broader CAR T adoption in autoimmune indications.
ALLO-316: TRAVERSE Trial in RCC
ALLO-316 is the only allogeneic CAR T therapy to show potential in solid tumors. Enrollment has been completed in the Phase 1b cohort, which evaluated the safety and efficacy of ALLO-316 at DL2 (80M CAR T cells) in patients with heavily pretreated advanced or metastatic RCC.The Company presented updated Phase 1b cohort data in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and has since met with the FDA to align on the design of a pivotal trial, laying the groundwork for potential partnership discussions to advance the program.
2025 Second Quarter Financial Results
- Research and development expenses were
$40.2 million for the second quarter of 2025, which includes$2.6 million of non-cash stock-based compensation expense. - General and administrative expenses were
$14.3 million for the second quarter of 2025, which includes$6.1 million of non-cash stock-based compensation expense. - Net loss for the second quarter of 2025 was
$50.9 million , or$0.23 per share, including non-cash stock-based compensation expense of$8.7 million and non-cash impairment of long-lived asset expense of$2.4 million . - The Company had
$302.6 million in cash, cash equivalents, and investments as of June 30, 2025.
The Company’s cash runway is expected to extend into the second half of 2027. Guidance for 2025 is an expected decrease in cash, cash equivalents, and investments of approximately
Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 2:00 p.m. PT/5:00 p.m. ET to discuss financial results and provide a business update. If you would like the option to ask a question on the conference call, please use to register. Upon registering for the conference call, you will receive a personal PIN to access the call, which will identify you as the participant and allow you the option to ask a question. The listen-only webcast will be made available on the Company's website at under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company's website for approximately 30 days.
About Allogene Therapeutics
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T�) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf� CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow Allogene Therapeutics on X and LinkedIn.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as “expected,� “projected,� “potential,� “targeted,� “believes,� “will,� “aims to,� “scheduled,� “drive,� “guidance,� “estimated,� “may,� “could,� “designed to,� “can,� or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the potential of our product candidates to offer scalable and accessible cell therapy with potentially durable results; ALPHA3 being a pivotal trial and the extent to which it will support regulatory approval of cema-cel; plans to expand the ALPHA3 trial footprint outside of the U.S.; the expected timing for biomarker and proof-of-concept data; the expected timing for the announcement of the MRD conversion rate; the expected timing for the futility analysis milestone in the ALPHA3 trial; the potential advantages of the FC lymphodepletion regimen and the potential MRD conversion rate and safety profile indicated by early observations, as well as the potential sufficiency of standard FC to support the eradication of microscopic disease in earlier lines of treatment; the potential benefits of our Dagger® technology; the potential for partnership discussions for ALLO-316; the pace, timing and extent to which we may initiate or enroll patients in our clinical trials or release data from suchtrials; our expectation that our cash runway extends into the second half of 2027; financial guidance for 2025; and other statements related to future events or conditions. Various factors may cause material differences between Allogene’s expectations and actual results, including, risks and uncertainties related to: our product candidates are based on novel technologies, which makes it difficult to predict the time and cost of product candidate development and obtaining regulatory approval; the limited nature of our pre-clinical and Phase 1 data and the extent to which such data may or may not be validated in any future clinical trial; our product candidates may cause undesirable side effects, including serious adverse events, or have other properties that could result in clinical holds, otherwise halt their clinical development, prevent their regulatory approval or limit their commercial potential; the potential for theFDAto disagree with our clinical or regulatory plans or the import of our clinical results, which could cause future delays to our clinical trials, including initiation of clinical trials, or require additional clinical trials; we may encounter difficulties enrolling or retaining patients in our clinical trials; we may not be able to demonstrate the safety and efficacy of our product candidates in our clinical trials, which could prevent or delay regulatory approval and commercialization; competition in our industry; we have in the past and may in the future decide to deprioritize certain programs as a result of program and cash resource considerations; and the challenges with manufacturing or optimizing manufacturing of our product candidates. These and other risks are discussed in greater detail in Allogene’s filings with the Securities and Exchange Commission (SEC), including without limitation under the “Risk Factors� heading in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, being filed with the SEC today. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
AlloCAR T� and Dagger® are trademarks ofAllogene Therapeutics, Inc.
Allogene’s investigational AlloCAR T� oncology products utilize Cellectis technologies. The anti-CD19 oncology products are developed based on an exclusive license granted by Cellectis to Servier. Servier, which has an exclusive license to the anti-CD19 AlloCAR T investigational products from Cellectis, has granted Allogene exclusive rights to these products in the U.S., all EU Member States and the United Kingdom. The anti-CD70 AlloCAR T program is licensed exclusively from Cellectis by Allogene and Allogene holds global development and commercial rights to this AlloCAR T program. ALLO-329 (CD19/CD70) in autoimmune disease uses CRISPR gene-editing technology.
ALLOGENE THERAPEUTICS, INC. SELECTED FINANCIAL DATA (unaudited; in thousands, except share and per share data) | |||||||
STATEMENTS OF OPERATIONS | |||||||
Three Months Ended June 30, | |||||||
2025 | 2024 | ||||||
Operating expenses: | |||||||
Research and development | $ | 40,156 | $ | 50,355 | |||
General and administrative | 14,281 | 16,087 | |||||
Impairment of long-lived assets | 2,382 | 4,989 | |||||
Total operating expenses | 56,819 | 71,431 | |||||
Loss from operations | (56,819 | ) | (71,431 | ) | |||
Other income (expense), net: | |||||||
Interest and other income, net | 6,187 | 4,988 | |||||
Interest expense | (268 | ) | � | ||||
Other income (expenses), net | (43 | ) | 85 | ||||
Total other income (expense), net | 5,876 | 5,073 | |||||
Net loss | $ | (50,943 | ) | $ | (66,358 | ) | |
Net loss per share, basic and diluted | $ | (0.23 | ) | $ | (0.35 | ) | |
Weighted-average number of shares used in computing net loss per share, basic and diluted | 218,929,548 | 190,026,638 |
SELECTED BALANCE SHEET DATA | |||||
As of June 30, 2025 | As of December 31, 2024 | ||||
Cash, cash equivalents and investments | $ | 302,630 | $ | 373,149 | |
Total assets | 470,593 | 548,710 | |||
Total liabilities | 126,032 | 126,531 | |||
Total stockholders� equity | 344,561 | 422,179 |
Allogene Media/Investor Contact:
Christine Cassiano
EVP, Chief Corporate Affairs & Brand Strategy Officer
