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Adaptimmune Provides Q4 and Full Year 2024 Business Update

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Adaptimmune Therapeutics (NASDAQ: ADAP) provided its Q4 and Full Year 2024 business update, highlighting progress in its sarcoma franchise. TECELRA®, their first commercial product, shows increasing momentum with 10 patients apheresed in Q1 2025 and 3 in 2024. The company has activated 20 Authorized Treatment Centers (ATCs) and achieved Q4 product revenue of $1.2m.

Their second product, lete-cel, met its pivotal trial primary endpoint with 42% ORR and is on track for BLA submission in late 2025, with anticipated approval in 2026. The company executed a 29% headcount reduction in Q1 2025, targeting approximately $300 million in cost savings over four years to achieve operating profitability by 2027.

However, Adaptimmune disclosed substantial doubt about their ability to continue as a going concern in their upcoming 2024 Annual Report. The company reported Total Liquidity of $152 million at the end of 2024 and has engaged TD Cowen to evaluate strategic options.

Adaptimmune Therapeutics (NASDAQ: ADAP) ha fornito un aggiornamento commerciale per il quarto trimestre e l'intero anno 2024, evidenziando i progressi nel suo settore dei sarcomi. TECELRA®, il loro primo prodotto commerciale, sta mostrando un crescente slancio con 10 pazienti aferesi nel primo trimestre del 2025 e 3 nel 2024. L'azienda ha attivato 20 Centri di Trattamento Autorizzati (ATC) e ha raggiunto un fatturato di prodotto nel quarto trimestre di 1,2 milioni di dollari.

Il loro secondo prodotto, lete-cel, ha raggiunto il suo obiettivo primario nello studio clinico cruciale con un tasso di risposta oggettiva (ORR) del 42% ed è in programma per la presentazione della BLA entro la fine del 2025, con un'approvazione prevista nel 2026. L'azienda ha effettuato una riduzione del personale del 29% nel primo trimestre del 2025, puntando a circa 300 milioni di dollari di risparmi sui costi in quattro anni per raggiungere la redditività operativa entro il 2027.

Tuttavia, Adaptimmune ha rivelato un significativo dubbio sulla propria capacità di continuare come entità in funzionamento nel prossimo Rapporto Annuale 2024. L'azienda ha riportato una liquidità totale di 152 milioni di dollari alla fine del 2024 e ha ingaggiato TD Cowen per valutare opzioni strategiche.

Adaptimmune Therapeutics (NASDAQ: ADAP) proporcionó su actualización comercial del cuarto trimestre y del año completo 2024, destacando los avances en su franquicia de sarcoma. TECELRA®, su primer producto comercial, muestra un creciente impulso con 10 pacientes aferesados en el primer trimestre de 2025 y 3 en 2024. La compañía ha activado 20 Centros de Tratamiento Autorizados (ATC) y logró ingresos por productos de $1.2 millones en el cuarto trimestre.

Su segundo producto, lete-cel, cumplió con el objetivo primario de su ensayo pivotal con un 42% de tasa de respuesta objetiva (ORR) y está en camino de presentar la BLA a finales de 2025, con una aprobación anticipada en 2026. La compañía ejecutó una reducción del 29% en su plantilla en el primer trimestre de 2025, con el objetivo de ahorrar aproximadamente $300 millones en costos durante cuatro años para lograr la rentabilidad operativa para 2027.

No obstante, Adaptimmune reveló dudas sustanciales sobre su capacidad para continuar como una entidad en funcionamiento en su próximo Informe Anual 2024. La compañía reportó una liquidez total de $152 millones al final de 2024 y ha contratado a TD Cowen para evaluar opciones estratégicas.

Adaptimmune Therapeutics (NASDAQ: ADAP)는 2024년 4분기 및 전체 연도 사업 업데이트를 제공하며, 자신의 육종 프랜차이즈에서의 진전을 강조했습니다. TECELRA®, 그들의 첫 상업 제품은 2025년 1분기에 10명의 환자가 아페레시스되었고 2024년에는 3명이 아페레시스되었습니다. 회사는 20개의 승인 치료 센터(ATC)를 활성화했으며, 4분기 제품 매출은 120만 달러에 달했습니다.

그들의 두 번째 제품인 lete-cel은 주요 시험의 주요 목표를 달성했으며, 객관적 반응률(ORR)은 42%입니다. 2025년 말에 BLA 제출이 예정되어 있으며, 2026년에 승인이 예상됩니다. 회사는 2025년 1분기에 인력을 29% 줄였으며, 4년 동안 약 3억 달러의 비용 절감을 목표로 하여 2027년까지 운영 수익성을 달성할 계획입니다.

그러나 Adaptimmune은 다가오는 2024년 연례 보고서에서 지속 가능한 기업으로서의 능력에 대한 상당한 의구심을 드러냈습니다. 회사는 2024년 말에 총 유동성이 1억 5200만 달러라고 보고했으며, 전략적 옵션을 평가하기 위해 TD Cowen과 협력했습니다.

Adaptimmune Therapeutics (NASDAQ: ADAP) a fourni sa mise à jour commerciale pour le quatrième trimestre et l'année entière 2024, mettant en avant les progrès dans sa franchise de sarcome. TECELRA®, leur premier produit commercial, montre un élan croissant avec 10 patients aphérisés au premier trimestre 2025 et 3 en 2024. L'entreprise a activé 20 Centres de Traitement Autorisés (ATC) et a réalisé un chiffre d'affaires de produit de 1,2 million de dollars au quatrième trimestre.

Leur deuxième produit, lete-cel, a atteint son objectif principal dans l'essai pivot avec un taux de réponse objective (ORR) de 42% et est sur la bonne voie pour la soumission de la BLA fin 2025, avec une approbation anticipée en 2026. L'entreprise a exécuté une réduction de 29% de ses effectifs au premier trimestre 2025, visant environ 300 millions de dollars d'économies de coûts sur quatre ans pour atteindre la rentabilité opérationnelle d'ici 2027.

Cependant, Adaptimmune a révélé des doutes substantiels concernant sa capacité à continuer en tant qu'entité en activité dans son prochain Rapport Annuel 2024. L'entreprise a rapporté une liquidité totale de 152 millions de dollars à la fin de 2024 et a engagé TD Cowen pour évaluer des options stratégiques.

Adaptimmune Therapeutics (NASDAQ: ADAP) hat sein Geschäftsupdate für das vierte Quartal und das gesamte Jahr 2024 veröffentlicht und dabei Fortschritte in seiner Sarkom-Franchise hervorgehoben. TECELRA®, ihr erstes kommerzielles Produkt, zeigt zunehmenden Schwung mit 10 Patienten, die im ersten Quartal 2025 und 3 im Jahr 2024 apherisiert wurden. Das Unternehmen hat 20 autorisierte Behandlungszentren (ATCs) aktiviert und einen Produktumsatz von 1,2 Millionen Dollar im vierten Quartal erzielt.

Ihr zweites Produkt, lete-cel, hat seinen primären Endpunkt in der entscheidenden Studie mit einer objektiven Ansprechrate (ORR) von 42% erreicht und ist auf Kurs für die Einreichung des BLA Ende 2025, mit einer erwarteten Genehmigung im Jahr 2026. Das Unternehmen hat im ersten Quartal 2025 eine Reduzierung der Mitarbeiterzahl um 29% durchgeführt, mit dem Ziel, in vier Jahren etwa 300 Millionen Dollar an Kosteneinsparungen zu erzielen, um bis 2027 die operative Rentabilität zu erreichen.

Allerdings hat Adaptimmune erhebliche Zweifel an seiner Fähigkeit geäußert, als ein fortführendes Unternehmen in ihrem kommenden Jahresbericht 2024 weiterzumachen. Das Unternehmen berichtete zum Ende des Jahres 2024 über eine Gesamtliquidität von 152 Millionen Dollar und hat TD Cowen beauftragt, strategische Optionen zu bewerten.

Positive
  • Q4 2024 product revenue of $1.2m from TECELRA commercial launch
  • 100% success rate in manufacturing and reimbursement approvals
  • Lete-cel achieved 42% ORR with 6 complete responses in pivotal trial
  • Cost reduction initiatives targeting $375-400m savings over 4 years
Negative
  • Substantial doubt about ability to continue as going concern
  • 29% workforce reduction implemented in Q1 2025
  • Additional cost cuts required for PRAME and CD70 programs
  • liquidity of $152 million as of end of 2024

Insights

Adaptimmune's Q4/FY2024 update reveals mixed financial signals with serious underlying concerns. The glaring issue is the upcoming going concern warning in their 10-K, indicating substantial doubt about their ability to continue operations without additional funding. This explains why they've engaged TD Cowen to evaluate strategic options.

While they reported $152 million in liquidity at 2024 year-end, the aggressive cost-cutting measures—29% headcount reduction and additional program cuts—suggest this runway is insufficient. Management projects $300 million in savings over four years, with an additional $75-100 million from PRAME and CD70 program reductions.

The commercial launch of Tecelra shows early traction with $1.2 million Q4 revenue from just two invoiced patients. With 10 patients apheresed in Q1 2025 versus 3 in all of 2024, revenue growth should accelerate. Their 100% manufacturing success rate and zero reimbursement denials provide operational validation.

The profitability target of 2027 reflects a lengthy cash burn period ahead. The sarcoma franchise strategy makes strategic sense—using Tecelra's infrastructure for the upcoming lete-cel launch—but the financial situation appears precarious. Without additional capital or a strategic transaction, Adaptimmune faces significant survival challenges despite promising clinical progress.

Adaptimmune's clinical and commercial execution displays notable strengths amid financial constraints. Tecelra's launch exhibits positive operational metrics with 20 Authorized Treatment Centers activated and 10 patients apheresed in Q1 2025—a significant increase from just 3 patients in 2024. The flawless manufacturing record and reimbursement success demonstrate operational excellence in a complex cell therapy space.

The lete-cel program achieved a important clinical milestone with 42% overall response rate in its pivotal trial, including 6 complete responses. The BLA submission timeline remains on track for late 2025, with potential approval in 2026. This second product would expand their addressable sarcoma patient population, strengthening their franchise approach.

However, the company faces difficult prioritization decisions. The reduction in PRAME and CD70 program investment represents a strategic narrowing of their pipeline to conserve resources. While this increases focus on their sarcoma franchise, it reduces opportunities for diversification.

The recognition through multiple awards (Life Sciences PA Patient Impact Award, Fast Company's Most Innovative Companies of 2025) and scientific publications validates their technological approach. Nevertheless, the commercial success of Tecelra remains early-stage, and significant revenue growth is necessary to approach their 2027 profitability target. The going concern warning indicates the company requires either substantial commercial acceleration or strategic intervention to bridge their financial gap.

TECELRA® launch momentum accelerating – 10 patients apheresed in Q1 2025 and 3 in 2024;
20 ATCs available; all manufacturing and supply goals achieved

Lete-cel on track to initiate rolling BLA submission late 2025; approval anticipated 2026

Corporate restructure completed in February 2025 and implementing additional cost reduction for PRAME and CD70 programs

At the end of 2024, Adaptimmune had Total Liquidity1 of $152 million

Evaluating all strategic options to maximize shareholder value

Philadelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - March 20, 2025) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, today provided a Q4 and Full Year 2024 business update.

Adrian Rawcliffe, Adaptimmune's Chief Executive Officer: "2025 is the year of commercial execution for Tecelra, as we begin to generate value from our promising sarcoma franchise. The launch is going very well and each step in delivering this important medicine: activating our treatment network; identifying biomarker eligible patients; exceptional manufacturing quality and turn-around times, strengthens our sarcoma platform capabilities for both Tecelra and for lete-cel. These results give us confidence in our strategy to build value from our sarcoma franchise and our path to profitability in 2027. In the context of the current capital markets, we are assessing all strategic options to enable us to achieve these goals."

Tecelra launch momentum increasing – the first commercial product in Adaptimmune's sarcoma franchise

  • 20 Authorized Treatment Centers (ATCs) now accepting referrals
  • On track to have the full network of approximately 30 ATCs open by end of 2025
  • Apheresed 3 patients in 2024 and invoiced 2 with Q4 product revenue of $1.2m
  • Apheresed 10 patients in 2025 to date
  • Successful reimbursement with no denials to date
  • 100% success rate in manufacturing to date with no capacity constraints

Lete-cel – the next product in Adaptimmune's sarcoma franchise

  • Pivotal trial met primary endpoint with 42% ORR including 6 complete responses (CTOS 2024)
  • On track to initiate rolling BLA submission in late 2025; approval anticipated in 2026
  • Lete-cel will expand the addressable patient population for sarcoma franchise

Corporate updates

  • Executed on 29% reduction in headcount in Q1 2025 as part of approximately $300 million in aggregate cost savings over the next four years to enable goal of achieving operating profitability during 2027
  • Implemented additional cost reduction for the PRAME and CD70 programs. The Company anticipates this will generate an additional $75m to $100m in aggregate cost savings over the next 4 years
  • Engaged TD Cowen to evaluate strategic options for the Company and for all its programs

Upcoming milestones

  • Updates on Tecelra Launch momentum (ATCs, number of patients apheresed)
  • Initiate rolling BLA for lete-cel to treat synovial sarcoma and MRCLS in Q4 2025

Going Concern

  • Our 2024 Annual Report on Form 10-K (the "Annual Report"), which the Company plans to file on Monday, March 24, will disclose that there is substantial doubt about our ability to continue as a going concern. We are continuing to implement cost reduction measures and explore the strategic options outlined above. More information on these topics will be provided on today's webcast and in the Annual Report.

Total Liquidity (a non-GAAP financial measure)

  • Total Liquidity (a non-GAAP financial measure) is the total of cash and cash equivalents and marketable securities (available-for-sale debt securities). The U.S. GAAP financial measure most directly comparable to Total Liquidity is cash and cash equivalents, which reconciles to Total Liquidity as follows (in thousands):

December 31,
December 31,

2024
2023
Cash and cash equivalents$91,139
$143,991
Marketable securities - available-for-sale debt securities
60,466

2,947
Total Liquidity$151,605
$146,938

 

  • The Company believes that the presentation of Total Liquidity provides useful information to investors because management reviews Total Liquidity as part of its assessment of overall solvency and liquidity, financial flexibility, capital position and leverage.

Presentations, publications, and awards

  • Adaptimmune had four poster presentations accepted at the upcoming Society for Immunotherapy of Cancer (SITC) Spring Conference (March 12-14, 2025):
    1. "Emerging T-Cell Receptor T-Cell Therapies for Solid Tumors: Differentiating from CAR-T." Locke et al.
    2. "Long-term survival of patients with advanced/metastatic synovial sarcoma or myxoid/round cell liposarcoma who received afamitresgene autoleucel T-cell receptor T-cell therapy in SPEARHEAD-1." D'Angelo et al. (TANDEM 2025 encore)
    3. "Translational analyses reveal mechanisms of afami-cel's anti-tumor activity in synovial sarcoma." Dupont et al. (SITC 2024 encore)
    4. "Primary analysis of the pivotal IGNYTE-ESO trial of letetresgene autoleucel in patients with synovial sarcoma or myxoid/round cell liposarcoma." D'Angelo et al. (CTOS 2024 encore)
  • Lete-cel MRCLS pilot study 208469 was published in the Journal of Clinical Oncology and "Melanoma-associated antigen A4: a cancer testis antigen as a target for adoptive T-cell receptor T-cell therapy" has been published in Cancer Treatment Reviews.
  • In December last year, Forbes Magazine named Tecelra as one of the 6 Revolutionary Tech Developments that Define 2024.
  • In March 2025, Adaptimmune was awarded the 2025 Life Sciences PA (Pennsylvania) Patient Impact Award and was recognized as one of Fast Company's Most Innovative Companies of 2025. Both awards recognize companies that are transforming industries and improving lives through groundbreaking innovation.
  • A virtual KOL event featuring Dr. Sandra D'Angelo, M.D. (Memorial Sloan Kettering Cancer Center) was held on November 18, 2024 to discuss the unmet need and current treatment landscape for patients with sarcoma, including synovial sarcoma (SyS) and myxoid/round cell liposarcoma (MRCLS). Replay available: Adaptimmune Virtual KOL Event - LifeSci Events

Today's Webcast Details
A live webcast and replay can be accessed at https://www.gowebcasting.com/13966. Call in information is as follows: 1-833-821-0158 (US or Canada) or 1-647-846-2266 (International). Callers should dial in 5-10 minutes prior to the scheduled start time and simply ask to join the Adaptimmune call.

About Adaptimmune
Adaptimmune is an integrated cell therapy company working to redefine how cancer is treated. With its unique engineered T cell receptor (TCR) platform, the Company is developing personalized medicines designed to target and destroy difficult-to-treat solid tumor cancers and to radically improve the patient's cancer treatment experience.

Forward-Looking Statements
This release contains "forward-looking statements" within the meaning of the safe harbor provisions of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements address our expected future business, financial performance, financial condition, as well as the results of operations and often contain words such as "anticipate" "believe," "expect," "may," "plan," "potential," "will," and similar expressions. Such statements are based only upon current expectations of Adaptimmune. Reliance should not be placed on these forward-looking statements because they involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Annual Report on Form 10-K filed with the Securities and Exchange Commission for the year ended December 31, 2023, our Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and other filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances.

Adaptimmune Contact

Investor Relations
Juli P. Miller, Ph.D. - VP, Corporate Affairs and Investor Relations
M : +1 215 460 8920
Juli.Miller@adaptimmune.com

Media Relations
Dana Lynch, Senior Director of Corporate Communications
M: +1 267 990 1217
Dana.Lynch@adaptimmune.com


1 Total liquidity is a non-GAAP financial measure, which is explained and reconciled to the most directly comparable financial measures prepared in accordance with GAAP below

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/245279

FAQ

What are the key performance metrics for TECELRA's commercial launch in 2024-2025?

TECELRA achieved 13 patient aphereses (10 in Q1 2025, 3 in 2024), generated Q4 2024 revenue of $1.2m, activated 20 ATCs, and maintained 100% manufacturing success rate with no denials in reimbursement.

What are the clinical results of lete-cel's pivotal trial for ADAP's sarcoma program?

Lete-cel's pivotal trial met its primary endpoint with a 42% Overall Response Rate (ORR), including 6 complete responses, as reported at CTOS 2024.

How much cost reduction is ADAP implementing through its restructuring initiatives?

ADAP targets $300 million in savings over 4 years through 29% headcount reduction, plus additional $75-100m savings from PRAME and CD70 program cost reductions.

What is Adaptimmune's current financial position and going concern status?

ADAP reported $152 million in Total Liquidity at end of 2024, but disclosed substantial doubt about continuing as a going concern in their upcoming 2024 Annual Report.
Adaptimmune Therapeutics Plc

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Biotechnology
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