Atara Biotherapeutics Provides Regulatory and Business Update on EBVALLOTM (tabelecleucel)
Atara Biotherapeutics (NASDAQ: ATRA) received a Complete Response Letter (CRL) from the FDA regarding EBVALLO™ (tabelecleucel). The CRL solely relates to inspection findings at a third-party manufacturer and did not identify any issues with clinical efficacy, safety data, or manufacturing process. No new clinical trials were requested.
The company is working with Pierre Fabre Laboratories and the manufacturer to address the feedback and expects potential approval within six months of resubmission. EBVALLO, already approved in Europe, demonstrated a 50% Objective Response Rate in the pivotal ALLELE study.
Atara has secured a potential $15 million funding through an equity line of credit from Redmile Group to support BLA approval activities. The company reported approximately $43 million in cash and equivalents as of year-end 2024. Atara remains eligible for a $60 million milestone payment upon FDA approval and double-digit tiered royalties from Pierre Fabre.
Atara Biotherapeutics (NASDAQ: ATRA) ha ricevuto una Lettera di Risposta Completa (CRL) dalla FDA riguardo a EBVALLO™ (tabelecleucel). La CRL si riferisce esclusivamente ai risultati dell'ispezione di un produttore terzo e non ha identificato problemi relativi all'efficacia clinica, ai dati di sicurezza o al processo di produzione. Non sono stati richiesti nuovi studi clinici.
L'azienda sta collaborando con Pierre Fabre Laboratories e il produttore per affrontare i feedback e si aspetta un potenziale approvazione entro sei mesi dalla riesamina. EBVALLO, già approvato in Europa, ha dimostrato un tasso di risposta obiettiva del 50% nello studio cruciale ALLELE.
Atara ha ottenuto un potenziale finanziamento di 15 milioni di dollari attraverso una linea di credito azionaria da Redmile Group per supportare le attività di approvazione del BLA. L'azienda ha riportato circa 43 milioni di dollari in contante e equivalenti alla fine del 2024. Atara rimane idonea per un pagamento di milestone di 60 milioni di dollari al momento dell'approvazione della FDA e diritti royalty a doppia cifra da Pierre Fabre.
Atara Biotherapeutics (NASDAQ: ATRA) recibió una Carta de Respuesta Completa (CRL) de la FDA con respecto a EBVALLO™ (tabelecleucel). La CRL se relaciona únicamente con los hallazgos de inspección en un fabricante externo y no identificó ningún problema con la eficacia clínica, los datos de seguridad o el proceso de fabricación. No se solicitaron nuevos ensayos clínicos.
La empresa está trabajando con Pierre Fabre Laboratories y el fabricante para abordar los comentarios y espera una posible aprobación dentro de seis meses después de la re-sumisión. EBVALLO, ya aprobado en Europa, demostró una Tasa de Respuesta Objetiva del 50% en el estudio pivotal ALLELE.
Atara ha asegurado un financiamiento potencial de 15 millones de dólares a través de una línea de crédito de capital de Redmile Group para apoyar las actividades de aprobación del BLA. La empresa reportó aproximadamente 43 millones de dólares en efectivo y equivalentes a finales de 2024. Atara sigue siendo elegible para un pago por hitos de 60 millones de dólares una vez que obtenga la aprobación de la FDA y regalías escalonadas de dos dígitos de Pierre Fabre.
Atara Biotherapeutics (NASDAQ: ATRA)는 EBVALLO™ (tabelecleucel)에 대한 FDA의 완전 응답 서한(CRL)을 받았습니다. 이 CRL은 타사 제조업체의 검사 결과와 관련이 있으며, 임상 효능, 안전성 데이터 또는 제조 과정에 관한 문제는 식별하지 않았습니다. 새로운 임상 시험은 요청되지 않았습니다.
회사는 피에르 파브르 연구소 및 제조업체와 협력하여 피드백을 해결하고 있으며, 제출 재전송 후 6개월 이내에 승인될 가능성을 기대하고 있습니다. EBVALLO는 이미 유럽에서 승인되었으며, 주요 ALLELE 연구에서 객관적 반응률이 50%로 나타났습니다.
Atara는 BLA 승인 활동을 지원하기 위해 레드마일 그룹으로부터 1천5백만 달러의 자금을 확보했습니다. 2024년 연말 기준으로 약 4천3백만 달러의 현금 및 현금성 자산을 보고했습니다. Atara는 FDA 승인을 받을 경우 6천만 달러의 마일스톤 지급금과 피에르 파브르로부터 두 자릿수 비율의 로열티를 받을 자격이 유지됩니다.
Atara Biotherapeutics (NASDAQ: ATRA) a reçu une Lettre de Réponse Complète (CRL) de la FDA concernant EBVALLO™ (tabelecleucel). La CRL concerne uniquement des résultats d'inspection chez un fabricant tiers et n'a identifié aucun problème d'efficacité clinique, de données de sécurité ou de processus de fabrication. Aucune nouvelle étude clinique n'a été demandée.
L'entreprise collabore avec Pierre Fabre Laboratories et le fabricant pour répondre aux retours et s'attend à une approbation potentielle dans les six mois suivant la nouvelle soumission. EBVALLO, déjà approuvé en Europe, a montré un Taux de Réponse Objectif de 50 % dans l'étude pivotale ALLELE.
Atara a sécurisé un financement potentiel de 15 millions de dollars grâce à une ligne de crédit en actions de Redmile Group pour soutenir les activités d'approbation du BLA. L'entreprise a rapporté environ 43 millions de dollars en liquidités et équivalents à la fin de 2024. Atara reste éligible à un paiement de jalon de 60 millions de dollars lors de l'approbation par la FDA et à des redevances à deux chiffres de Pierre Fabre.
Atara Biotherapeutics (NASDAQ: ATRA) erhielt einen Complete Response Letter (CRL) von der FDA bezüglich EBVALLO™ (tabelecleucel). Der CRL bezieht sich ausschließlich auf Prüfergebnisse eines Drittanbieters und hat keine Probleme mit klinischer Wirksamkeit, Sicherheitsdaten oder dem Herstellungsprozess identifiziert. Es wurden keine neuen klinischen Studien angefordert.
Das Unternehmen arbeitet mit Pierre Fabre Laboratories und dem Hersteller zusammen, um das Feedback anzugehen und erwartet eine potenzielle Genehmigung innerhalb von sechs Monaten nach der Einreichung. EBVALLO, das bereits in Europa zugelassen ist, zeigte eine objektive Ansprechrate von 50% in der entscheidenden ALLELE-Studie.
Atara hat eine potenzielle Finanzierung in Höhe von 15 Millionen Dollar durch eine Eigenkapitallinie von Redmile Group gesichert, um die Aktivitäten zur Genehmigung des BLA zu unterstützen. Das Unternehmen berichtete zum Ende des Jahres 2024 von etwa 43 Millionen Dollar in Bargeld und Äquivalenten. Atara bleibt berechtigt für eine Meilensteinzahlung von 60 Millionen Dollar nach der Genehmigung durch die FDA und für zweistellige gestaffelte Lizenzgebühren von Pierre Fabre.
- EBVALLO already received European Commission marketing authorization
- Potential $60 million milestone payment upon FDA approval
- Secured up to $15 million funding through equity line of credit
- No clinical efficacy or safety concerns identified in FDA review
- 50% Objective Response Rate in pivotal ALLELE study
- FDA Complete Response Letter delays EBVALLO approval
- Manufacturing facility inspection issues need resolution
- Cash position of $43 million may require additional funding
- Possible suspension of CAR-T programs if funding not secured by Q1 2025
- Potential shareholder dilution from equity line of credit
Insights
Atara received FDA Complete Response Letter (CRL) solely related to inspection findings at third-party manufacturer
CRL did not identify deficiencies related to clinical efficacy or safety data in the Biologics License Application (BLA), and the FDA did not request any new clinical studies to support approval
Atara remains committed to working with the FDA, Pierre Fabre Laboratories, and the third-party manufacturer to bring EBVALLO to patients in the
Atara has engaged a well-known financial advisor to support exploration of all strategic options
Atara remains focused on preserving future EBVALLO financial value for the benefit of all stockholders
Atara has entered into a non-binding term sheet with Redmile Group to provide up to
The CRL was solely related to observations as part of a standard pre-license inspection of a third-party manufacturing facility for EBVALLO. The CRL did not identify any deficiencies related to the manufacturing process, the clinical efficacy, or clinical safety data in the BLA, and the FDA did not request any new clinical trials to support the approval of EBVALLO.
“We are working closely with our partner Pierre Fabre Laboratories, the FDA, and the third-party manufacturer to address the feedback to support marketing approval for EBVALLO,” said Cokey Nguyen, Ph.D., President and Chief Executive Officer of Atara. “Once the third-party manufacturer GMP compliance issues have been adequately addressed, we will file for a resubmission, which we would expect to be potentially approved within six months of resubmission. Atara and its partner Pierre Fabre remain confident in the potential of EBVALLO and are committed to bringing this potential first-in-class medicine to
“We are disappointed by the delay and are willing to work with Atara on appropriate next steps to bring EBVALLO to
EBVALLO, which was granted marketing authorization by the European Commission in December of 2022, is an allogeneic, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells. The BLA in the
A second third-party manufacturer, FUJIFILM Diosynth Biotechnologies (FDB) manufacturing facility in
Corporate Updates
Review of Strategic Alternatives: The Board regularly reviews Atara’s strategic plan, priorities, and opportunities as part of its commitment to act in the best interest of Atara and its stockholders. Atara had previously engaged a well-known financial advisor to support the assessment of opportunities to advance and realize value from Atara’s CAR-T assets. The advisor’s scope has recently expanded to include a wider range of additional strategic alternatives which may include, but are not limited to, an acquisition, merger, reverse merger, other business combinations, sale of assets, or other strategic transactions. Through this process, Atara is already in active discussions with several potential parties. However, there can be no assurance regarding the results or outcome of this process. It is possible that Atara may not pursue a strategic alternative or transaction or that any strategic alternative or transaction, if pursued, will be completed on attractive terms, or that a strategic alternative or transaction may not ultimately be consummated.
Preservation of Future EBVALLO Milestone and Royalty Income Value to Shareholders: Atara remains eligible to receive a
If a strategic resolution is not reached to provide funding for its CAR-T development programs in Q1 2025, Atara intends to suspend all CAR-T activities, and significantly reduce company expenses and activities to only those that support the approval of EBVALLO, including through a near-term progressive transfer of all operational activities related to EBVALLO to Pierre Fabre.
Atara has entered into a non-binding term sheet with Redmile Group to provide up to
“We are pleased to have the strong confidence from a key stockholder in the future of EBVALLO and access to the capital to support the transfer of EBVALLO activities to Pierre Fabre, creating opportunities for value creation through the anticipated
Financial Update
-
Cash, cash equivalents and short-term investments as of year-end 2024 totaled approximately
$43 million -
Entered into non-binding term sheet with Redmile Group to provide up to
$15 million - Several additional options are under consideration as part of the exploration of financial and strategic alternatives
This estimate of our cash, cash equivalents and short-term investments as of December 31, 2024 is preliminary, has not been audited and is subject to change upon completion of our financial statement closing procedures. Our independent registered public accounting firm has not audited or performed any procedures with respect to this estimate. Additional information and disclosure would be required for a more complete understanding of our financial position and results of operations as of December 31, 2024.
About Atara Biotherapeutics, Inc.
Atara is harnessing the natural power of the immune system to develop off-the-shelf cell therapies for difficult-to-treat cancers and autoimmune conditions that can be rapidly delivered to patients from inventory. With cutting-edge science and differentiated approach, Atara is the first company in the world to receive regulatory approval of an allogeneic T-cell immunotherapy. Our advanced and versatile T-cell platform does not require T-cell receptor or HLA gene editing and forms the basis of a diverse portfolio of investigational therapies that target EBV, the root cause of certain diseases, in addition to next-generation AlloCAR-Ts designed for best-in-class opportunities across a broad range of hematological malignancies and B-cell driven autoimmune diseases. Atara is headquartered in
Forward-Looking Statements
This press release contains or may imply "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, forward-looking statements include statements regarding: (1) the development, timing and progress of tab-cel, including the BLA and potential indications, the timing for FDA review of any resubmission of the BLA, the potential characteristics and benefits of tab-cel, and the results of, and prospects for, the global partnership with Pierre Fabre Laboratories involving tab-cel, and the potential financial benefits to Atara as a result of the global partnership with Pierre Fabre, including the receipt, timing and amount of any payments to be received by Atara thereunder; (2) the development, timing and progress of Atara’s AlloCAR-T programs (including ATA3219 and ATA3431), including potentially suspending such programs; (3) Atara’s cash, cash equivalents and short-term investments as of December 31, 2024, as well as Atara’s cash runway, the timing and receipt of potential milestone and other payments, and operating expenses; (4) Atara’s fundraising needs and the sufficiency of additional funding to support operations, and the availability of such funding, including the non-binding term sheet and Atara’s ability to enter into definitive documentation for such funding; (5) Atara’s planned transition of substantially all activities relating to EBVALLO to Pierre Fabre and the timing thereof; (6) Atara’s planned cost reduction strategies; and (7) Atara’s exploration of strategic alternatives and ability to consummate one or more strategic transactions. Because such statements deal with future events and are based on Atara’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Atara could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; risks related to FDA feedback and the ability of Atara and its third-party manufacturer to address the issues identified in the CRL; our ability to access capital; the sufficiency of Atara’s cash resources and need for and ability to obtain additional capital on favorable terms or at all; risks and uncertainties related to Atara’s financial close and audit procedures; the timing of the strategic review process; whether Atara will pursue any strategic alternatives; in the event Atara pursues a strategic alternative, that the strategic alternative may not be attractive or ultimately consummated; whether any strategic alternative will result in additional value for Atara and its shareholders; whether the process will have an adverse impact on Atara; and other risks and uncertainties affecting Atara’s and its development programs, including those discussed in Atara’s filings with the Securities and Exchange Commission , including in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings and in the documents incorporated by reference therein. Except as otherwise required by law, Atara disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.
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Investor and Media Relations
Jason Awe, Ph.D.
Head of Corporate Communications & Investor Relations
(805) 217-2287
jawe@atarabio.com
Source: Atara Biotherapeutics, Inc.
FAQ
What caused the FDA Complete Response Letter for ATRA's EBVALLO?
When can ATRA expect potential FDA approval for EBVALLO after resubmission?
What milestone payment will ATRA receive if EBVALLO gets FDA approval?
How much funding did ATRA secure from Redmile Group?
What was EBVALLO's efficacy rate in the ALLELE study?
