Allogene Therapeutics Reports Second Quarter 2024 Financial Results and Business Update
Allogene Therapeutics reported Q2 2024 financial results and provided business updates. Key highlights include:
1. Initiation of pivotal Phase 2 ALPHA3 trial for cema-cel in 1L LBCL consolidation, with enrollment completion expected in 1H 2026 and potential BLA submission in 2027.
2. ALLO-329 IND application for autoimmune diseases on track for Q1 2025, with proof-of-concept data expected by YE 2025.
3. ALLO-316 Phase 1 TRAVERSE data update in RCC planned for YE 2024.
4. Q2 2024 ended with $444.6M in cash, cash equivalents, and investments, with runway projected into 2H 2026.
5. Q2 2024 net loss of $66.4M, or $0.35 per share.
6. 2024 guidance unchanged, expecting a decrease in cash of ~$200M and GAAP Operating Expenses of ~$300M.
Allogene Therapeutics ha riportato i risultati finanziari del secondo trimestre del 2024 e fornito aggiornamenti aziendali. I punti salienti includono:
1. Inizio del trial fondamentale di Fase 2 ALPHA3 per cema-cel nella consolidazione del LBCL in prima linea, con completamento dell'arruolamento previsto entro la prima metà del 2026 e possibile presentazione della BLA nel 2027.
2. L'applicazione IND per ALLO-329 per le malattie autoimmuni è in programma per il primo trimestre del 2025, con dati di prova di concetto attesi entro la fine del 2025.
3. Aggiornamento dei dati della Fase 1 TRAVERSE per ALLO-316 nel RCC previsto per la fine del 2024.
4. Il secondo trimestre del 2024 si è concluso con $444,6 milioni in contante, equivalenti di contante e investimenti, con una proiezione di liquidità fino alla seconda metà del 2026.
5. Perdite nette del secondo trimestre del 2024 pari a $66,4 milioni, ovvero $0,35 per azione.
6. Le previsioni per il 2024 rimangono invariate, prevedendo una diminuzione della liquidità di circa $200 milioni e spese operative GAAP di circa $300 milioni.
Allogene Therapeutics informó sobre los resultados financieros del segundo trimestre de 2024 y proporcionó actualizaciones comerciales. Los puntos destacados incluyen:
1. Inicio del ensayo pivotal de Fase 2 ALPHA3 para cema-cel en la consolidación de LBCL de primera línea, con la finalización de la inscripción esperada para la primera mitad de 2026 y posible presentación de la BLA en 2027.
2. La solicitud IND para ALLO-329 para enfermedades autoinmunes sigue en camino para el primer trimestre de 2025, con datos de prueba de concepto esperados para fines de 2025.
3. Actualización de datos de Fase 1 TRAVERSE para ALLO-316 en RCC planeada para fines de 2024.
4. El segundo trimestre de 2024 finalizó con $444,6 millones en efectivo, equivalentes de efectivo e inversiones, con una proyección de liquidez hasta la segunda mitad de 2026.
5. Pérdida neta del segundo trimestre de 2024 de $66,4 millones, o $0,35 por acción.
6. La guía para 2024 permanece sin cambios, esperando una disminución en el efectivo de aproximadamente $200 millones y gastos operativos GAAP de aproximadamente $300 millones.
Аллоґене Терапевтикс는 2024년 2분기 재무 결과를 보고하고 비즈니스 업데이트를 제공했습니다. 주요 하이라이트는 다음과 같습니다:
1. 1차 LBCL 통합을 위한 cema-cel의 주요 2상 ALPHA3 시험 시작, 등록 완료는 2026년 상반기로 예상되며 2027년에 BLA 제출이 가능할 수 있습니다.
2. 자가 면역 질환에 대한 ALLO-329 IND 신청은 2025년 1분기를 목표로 하며, 2025년 연말까지 개념 증명 데이터를 기대하고 있습니다.
3. 2024년 연말에 RCC에서 ALLO-316 1상 TRAVERSE 데이터 업데이트 예정입니다.
4. 2024년 2분기에는 현금, 현금성 자산 및 투자금이 $444.6M으로 종료되었으며, 2026년 하반기까지의 자산이 예상됩니다.
5. 2024년 2분기 순손실은 $66.4M인 $0.35 per share입니다.
6. 2024년 전망은 변경되지 않았으며, 약 $200M의 현금 감소와 약 $300M의 GAAP 운영비용이 예상됩니다.
Allogene Therapeutics a rapporté les résultats financiers du deuxième trimestre 2024 et a fourni des mises à jour commerciales. Les points clés incluent:
1. Lancement de l'essai pivôt de Phase 2 ALPHA3 pour cema-cel dans la consolidation du LBCL en première ligne, avec une finalisation de l'inscription prévue pour la première moitié de 2026 et une soumission potentielle de la BLA en 2027.
2. La demande IND pour ALLO-329 pour les maladies auto-immunes est sur la bonne voie pour le premier trimestre 2025, avec des données de preuve de concept attendues d'ici la fin de 2025.
3. Mise à jour des données de la Phase 1 TRAVERSE pour ALLO-316 dans le RCC prévue pour fin 2024.
4. Le deuxième trimestre 2024 s'est terminé avec 444,6 millions de dollars en liquidités, équivalents de liquidités et investissements, avec un budget prévu jusqu'à la deuxième moitié de 2026.
5. Perte nette du deuxième trimestre 2024 de 66,4 millions de dollars, soit 0,35 dollar par action.
6. Les prévisions pour 2024 restent inchangées, avec une diminution de la liquidité d'environ 200 millions de dollars et des dépenses d'exploitation GAAP d'environ 300 millions de dollars.
Allogene Therapeutics hat die finanziellen Ergebnisse des zweiten Quartals 2024 veröffentlicht und Geschäftsaktualisierungen bereitgestellt. Wichtige Höhepunkte umfassen:
1. Beginn der entscheidenden Phase 2 ALPHA3-Studie für cema-cel zur Konsolidierung von LBCL in der ersten Linie, mit einer erwarteten Einschreibung bis zur ersten Hälfte 2026 und möglicher BLA-Einreichung im Jahr 2027.
2. Der ALLO-329 IND-Antrag für Autoimmunerkrankungen ist für das erste Quartal 2025 auf Kurs, mit Konzeptnachweis-Daten, die bis Ende 2025 erwartet werden.
3. Update der Phase 1 TRAVERSE-Daten zu ALLO-316 in RCC ist für Ende 2024 geplant.
4. Das zweite Quartal 2024 endete mit 444,6 Millionen US-Dollar in Bar-, Baräquivalenten und Investitionen, mit einer prognostizierten Liquidität bis zur zweiten Jahreshälfte 2026.
5. Der Nett Verlust im 2. Quartal 2024 betrug 66,4 Millionen US-Dollar, also 0,35 US-Dollar pro Aktie.
6. Die Prognose für 2024 bleibt unverändert, es wird ein Rückgang des Bargelds von etwa 200 Millionen US-Dollar und GAAP-Betriebskosten von etwa 300 Millionen US-Dollar erwartet.
- Initiation of pivotal Phase 2 ALPHA3 trial for cema-cel in 1L LBCL consolidation
- ALLO-329 IND application for autoimmune diseases on track for Q1 2025
- Strong cash position of $444.6M with runway projected into 2H 2026
- $15M award from CIRM to support ALLO-316 TRAVERSE trial in RCC
- Q2 2024 net loss of $66.4M, or $0.35 per share
- Expected decrease in cash of ~$200M in 2024
- GAAP Operating Expenses expected to be ~$300M in 2024
Insights
Allogene's Q2 2024 results show a net loss of
The company's R&D expenses of
Investors should note the CIRM grant of
Allogene's progress with cema-cel in the ALPHA3 trial is noteworthy. The rapid activation of 10 trial sites in under two months suggests strong interest from both community and academic centers, potentially accelerating patient recruitment. The innovative approach of using CAR T therapy as first-line consolidation treatment in LBCL could be a game-changer if successful.
The use of the Foresight CLARITY™ MRD test to identify high-risk patients is a smart strategy, potentially improving patient selection and trial outcomes. With enrollment completion expected in 1H 2026 and a possible BLA submission in 2027, Allogene is positioning itself as a frontrunner in off-the-shelf CAR T therapy.
The expansion into chronic lymphocytic leukemia and renal cell carcinoma demonstrates a broad oncology strategy. However, investors should be aware that success in these additional indications is not guaranteed and will require careful monitoring of upcoming data readouts.
Allogene's pipeline showcases innovative approaches in cell therapy. The ALLO-329 program, targeting autoimmune diseases with a CD19/CD70 dual CAR incorporating Dagger® technology, represents a novel application of CAR T beyond oncology. This could open up a significant new market if successful, with proof-of-concept data expected by YE 2025.
The use of CRISPR technology in ALLO-329 to potentially reduce or eliminate lymphodepletion is a notable advancement. If effective, this could improve the safety profile and patient experience of CAR T therapies. The company's in-house manufacturing capabilities for all investigational products is also a strategic advantage, potentially reducing costs and improving control over production.
While promising, investors should recognize that these innovative approaches carry higher risk and will require robust clinical data to prove their efficacy and safety. The upcoming milestones in 2024 and 2025 will be critical in validating Allogene's technological platform.
- Cemacabtagene Ansegedleucel (Cema-Cel): 1L Consolidation in Large B-Cell Lymphoma (LBCL)
- Pivotal Phase 2 ALPHA3 Trial Initiated in June 2024
- Patient Screening for Minimal Residual Disease (MRD) and Enrollment Proceeding as Planned with Ten Community and Academic Sites Opened to Date Across the US
- Enrollment Completion Expected in 1H 2026 and Potential BLA Submission in 2027
- ALLO-329 in Autoimmune Disease (AID)
- Investigational New Drug (IND) Application for Next-Generation CD19/CD70 Dual CAR with Dagger® Technology Designed for AID on Track for Q1 2025 with Proof-of-Concept Data Expected by YE 2025
- ALLO-316 in Renal Cell Carcinoma (RCC)
- Phase 1 TRAVERSE Data Update Including Details on the Diagnostic and Treatment Algorithm Planned for YE 2024
- Ended Q2 2024 with
$444.6 Million in Cash, Cash Equivalents and Investments; Cash Runway Continues to be Projected into 2H 2026 - Conference Call and Webcast Scheduled for Today at 2:00 PM PT/5:00 PM ET
SOUTH SAN FRANCISCO, Calif., Aug. 07, 2024 (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, 2024.
“The second quarter has been an excellent example of the power of momentum, particularly as we bring into the fold community cancer centers who are eager to be a part of our pivotal Phase 2 ALPHA3 trial and we are now manufacturing all of our CAR T investigational products in-house,” said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. “Beyond the progress we’ve seen across our four core programs with cema-cel in blood cancers, ALLO-329 in autoimmune disease, and ALLO-316 in relapsed and refractory renal cell carcinoma, there is renewed energy from investigators, clinical trial sites, and top-tier investors as it becomes increasingly apparent that we have the potential to reshape the future of CAR T therapies.”
Program Updates
Cema-Cel: Pivotal ALPHA3 1L Consolidation Trial in Large B Cell Lymphoma (LBCL)
The pivotal Phase 2 ALPHA3 trial was initiated in June 2024 and site activation is ahead of schedule with ten community cancer and academic centers opened in less than two months. Patient screening for minimal residual disease (MRD) and enrollment are proceeding as planned.
This groundbreaking study is evaluating the use of cemacabtagene ansegedleucel (cema-cel) as part of the first line (1L) treatment regimen for patients with LBCL who are likely to relapse after standard 1L treatment. ALPHA3 is the first pivotal trial to offer CAR T as part of 1L treatment consolidation.
This innovative ALPHA3 trial will identify patients at high risk for relapse after 1L treatment by utilizing the Foresight CLARITY™ Investigational Use Only (IUO) MRD test, powered by PhasED-Seq™. This randomized trial will enroll approximately 240 patients and is designed to demonstrate a meaningful improvement in event free survival (EFS) in patients treated with cema-cel relative to patients who receive the current standard of care (observation). ALPHA3 is expected to complete enrollment in 1H 2026. Efficacy analyses are expected to occur in 2026 and will include an interim EFS analysis monitored by the independent Data Safety Monitoring Board (DSMB) in 1H 2026 and the data readout of the primary EFS analysis YE 2026. A potential biologics license application (BLA) submission is targeted for 2027.
Cema-Cel: Phase 1 Trial in Chronic Lymphocytic Leukemia (CLL)
Enrollment is ongoing in the relapsed/refractory (r/r) CLL cohort of the Phase 1 ALPHA2 trial of cema-cel. Initial data readout from the CLL cohort is projected by early 2025.
ALLO-329: CD19/CD70 Dual CAR with Dagger® Technology in Autoimmune Disease (AID)
ALLO-329, the Company’s first CRISPR-based AlloCAR T™ investigational product for AID, incorporates the Dagger® technology, which is intended to reduce or eliminate the need for lymphodepletion while targeting CD19+ B-cells and CD70+ activated T-cells, both of which are likely to play a role in AID. The Company plans to file an investigational new drug (IND) application in Q1 2025 and expects to have proof-of-concept by YE 2025.
ALLO-316: TRAVERSE Trial in Renal Cell Carcinoma (RCC)
A Phase 1 data update from approximately 20 patients with CD70 positive RCC, which will include details on the diagnostic and treatment algorithm used to mitigate treatment-associated hyperinflammatory response seen in some patients, is planned by YE 2024. In April 2024, the Company announced a
2024 Second Quarter Financial Results
- Research and development expenses were
$50.4 million for the second quarter of 2024, which includes$5.3 million of non-cash stock-based compensation expense. - General and administrative expenses were
$16.1 million for the second quarter of 2024, which includes$8.2 million of non-cash stock-based compensation expense. - Net loss for the second quarter of 2024 was
$66.4 million , or$0.35 per share, including non-cash stock-based compensation expense of$13.6 million and$5.0 million in non-cash impairment of long-lived asset expense. - The Company had
$444.6 million in cash, cash equivalents, and investments as of June 30, 2024.
Based on the cash runway as of June 30, 2024, the Company continues to expect its cash runway to fund operations into the second half of 2026. Guidance remains unchanged from the most recent update with an expectation of a 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 PM PT/5:00 PM 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 this link 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 www.allogene.com 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 (formerly Twitter) 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 “proceeding as planned,” “on track,” “ahead,” “targeted,” “ongoing,” “likely to,” “believes,” “potential,” “continue,” “estimates,” “expects,” “plans,” “intends,” “designed to, “ “can, “, “become,” “may,” “could,” “will,” “should” 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: Allogene's belief that it has the potential to reshape the future of CAR T therapies; the potential market opportunity for Allogene’s product candidates; ALPHA3 being a pivotal trial; the design of ALPHA3; the potential of ALPHA3 to be administered as part of 1L treatment consolidation; the potential for cema-cel to become the part of the first line treatment regimen available to patients with LBCL who are likely to relapse after standard 1L treatment; plans to administer cema-cel in community cancer centers in the ALPHA3 trial; the potential outcomes of ALPHA3; the pace, timing and extent to which we may initiate or enroll patients in our clinical trials or release data from such trials, including ALPHA2, ALPHA3, ALLO-329, and TRAVERSE trials; clinical outcomes, which may materially change as more patient data become available; the design and potential benefits of our Dagger® technology, including the ability to reduce or eliminate the need for lymphodepletion, and the expected benefits therefrom, to treat autoimmune disease, and our plans to deploy the Dagger® technology; the potential for our product candidates to be approved; the potential benefits of AlloCAR T™ products; the ability of our product candidates to treat various stages and types of cancers including hematological and solid tumors or to treat autoimmune disease; the potential ability of our diagnostic and treatment algorithm to address emerging safety findings or mitigate treatment-associated hyperinflammatory response without compromising CAR T function; our expectation that our cash runway extends into 2026; financial guidance for 2024; the modes of action or the biologic impacts of our product candidates; 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: changes in the macroeconomic environment or industry that impact our business; competition; risks related to third-party performance; 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 the Phase 1 data from our clinical trials and the extent to which such data may or may not be validated in any future clinical trial; preliminary results may not be indicative of results that may be observed in the future; our ability to maintain intellectual property rights necessary for the continued development of our product candidates, including pursuant to our license agreements; our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval or limit their commercial potential; the extent to which the Food and Drug Administration disagrees with our clinical or regulatory plans or the import of our clinical results, which could cause future delays to our clinical trials or require additional clinical trials; we may encounter difficulties enrolling patients in our clinical trials, including ALPHA2, ALPHA3, ALLO-329 and TRAVERSE trials; there is no guarantee that Foresight will successfully develop an MRD assay for use as a companion diagnostic with cema-cel, and without a companion diagnostic the prospects for cema-cel could be materially and negatively impacted; 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; challenges with manufacturing or optimizing manufacturing of our product candidates, including manufacturing our CAR T product candidates in-house, or any companion diagnostic for use with our product candidates; and our ability to obtain additional financing to develop our product candidates and implement our operating plans. 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, 2024, 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.
Caution should be exercised regarding statements comparing autologous CAR T data. There are differences in the clinical trial design, patient populations, published data, follow-up times and the product candidates themselves, and the results from the clinical trials of autologous products may have no interpretative value on our existing or future results.
AlloCAR T™ and Dagger® are trademarks of Allogene Therapeutics, Inc.
CLARITY™ and PhasED-Seq™ are trademarks of Foresight Diagnostics.
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, | |||||||
| 2024 | 2023 | ||||||
| Collaboration revenue - related party | $ | — | $ | 22 | |||
| Operating expenses: | |||||||
| Research and development | $ | 50,355 | $ | 62,038 | |||
| General and administrative | 16,087 | 18,524 | |||||
| Impairment of long-lived assets | 4,989 | — | |||||
| Total operating expenses | 71,431 | 80,562 | |||||
| Loss from operations | (71,431 | ) | (80,540 | ) | |||
| Other income (expense), net: | |||||||
| Interest and other income, net | 4,988 | 3,778 | |||||
| Other income and expense, net | 85 | (2,470 | ) | ||||
| Total other income (expense), net | 5,073 | 1,308 | |||||
| Net loss | (66,358 | ) | (79,232 | ) | |||
| Net loss per share, basic and diluted | $ | (0.35 | ) | $ | (0.54 | ) | |
| Weighted-average number of shares used in computing net loss per share, basic and diluted | 190,026,638 | 146,795,826 | |||||
| SELECTED BALANCE SHEET DATA | |||||||
| As of June 30, 2024 | As of December 31, 2023 | ||||||
| Cash, cash equivalents and investments | $ | 444,628 | $ | 448,697 | |||
| Total assets | 646,883 | 642,837 | |||||
| Total liabilities | 131,845 | 130,604 | |||||
| Total stockholders’ equity | 515,038 | 512,233 | |||||
Allogene Media/Investor Contact:
Christine Cassiano
EVP, Chief Corporate Affairs & Brand Strategy Officer
Christine.Cassiano@allogene.com
FAQ
What were Allogene Therapeutics' (ALLO) Q2 2024 financial results?
When is the ALPHA3 trial for cema-cel in LBCL expected to complete enrollment?
What is the timeline for ALLO-329 in autoimmune diseases?
When will Allogene (ALLO) provide an update on the ALLO-316 TRAVERSE trial in RCC?
