Adaptimmune Q1 2024 Financial and Business Updates

Adaptimmune Therapeutics plc, a biopharmaceutical company focused on cell therapy for solid tumors, announced its financial results and business updates for the first quarter ending March 31, 2024. The company is poised for significant advancements in its sarcoma franchise, focusing on the therapies afami-cel and lete-cel.

Adaptimmune's CEO, Adrian Rawcliffe, highlighted the support from the sarcoma community and the company’s progress in preparing for the commercial launch of afami-cel, contingent upon FDA approval. The U.S. FDA has accepted the Biologics License Application (BLA) for afami-cel for advanced synovial sarcoma with a priority review and a Prescription Drug User Fee Act (PDUFA) date set for August 4, 2024. The mid-cycle review meeting with FDA occurred in April, followed by inspections under the FDA's Good Clinical Practice (GCP) Bioresearch Monitoring Program and Pre-license inspections (PLI) of Adaptimmune’s facilities.

The companion diagnostic for MAGE-A4, integral to afami-cel treatment, is also under FDA review, with an approval expected alongside the BLA. Adaptimmune is planning to initiate the afami-cel launch in the U.S. at select treatment centers, expanding from 6-10 to approximately 30 centers. The company has fully staffed its commercial and medical affairs teams to support this launch.

In addition to afami-cel, Adaptimmune is advancing the development of lete-cel, targeting synovial sarcoma and Myxoid Round Cell Liposarcoma (MRCLS). The pivotal IGNYTE-ESO trial for lete-cel has met its primary efficacy endpoint, with full analyses expected by late 2024. Adaptimmune anticipates that lete-cel will broaden its market reach, projected to achieve peak U.S. sales of $400 million.

The company also reported that data from the pivotal SPEARHEAD-1 trial with afami-cel has been published in The Lancet. Further, interim analysis data from the IGNYTE-ESO trial with lete-cel will be presented at the American Society of Clinical Oncology (ASCO) annual meeting in June 2024.

Adaptimmune's clinical pipeline includes uzatresgene autoleucel (uza-cel), currently in a Phase 2 trial for platinum-resistant ovarian cancer. Uza-cel received FDA's Regenerative Medicine Advanced Therapy (RMAT) designation in 2022. Other clinical studies involving uza-cel are ongoing, targeting head & neck and urothelial cancers in combination with checkpoint inhibitor therapy.

Preclinical activities are progressing with IND-enabling studies for ADP-600 (PRAME) and ADP-520 (CD70) programs. Furthermore, Adaptimmune is advancing its allogeneic pipeline, focusing on process development at its manufacturing facility in the UK.

On the corporate front, Adaptimmune secured up to $125 million in debt financing from Hercules Capital, with an initial tranche of $25 million available upon closing and an additional $25 million contingent on afami-cel approval. The company's cash runway extends into late 2025, bolstered by current cash reserves, anticipated revenues from afami-cel, and other non-dilutive capital sources.

Financially, Adaptimmune reported a decrease in revenue to $5.7 million for the first quarter of 2024, from $47.6 million the previous year, primarily due to the termination of a collaboration with Astellas. Research and development expenses increased to $35.2 million, driven by higher employee-related costs and additional lease expenses. General and administrative expenses were slightly reduced to $19.7 million. The net loss for the quarter was $48.5 million, compared to a profit of $1.0 million in 2023.

Adaptimmune's financial guidance remains positive, with expectations that existing cash, anticipated revenues, and the new debt facility will support operations until late 2025. This outlook is detailed further in its Quarterly Report on Form 10-Q for the period ended March 31, 2024.

Adaptimmune continues to advance its mission of developing and delivering cell therapies to treat cancer, leveraging its proprietary T-cell receptor platform to target and eradicate solid tumors.