Adaptimmune Therapeutics Plc - ADAP STOCK NEWS

Adaptimmune Therapeutics plc (Nasdaq: ADAP) reported Q2 2024 financial results and business updates. Key highlights include:

1. U.S. FDA approval of Tecelra® (afami-cel), the first engineered cell therapy for solid tumors.

2. Total Liquidity of $214.8 million at the end of Q2.

3. Revenue increased to $128.2 million for Q2 2024, compared to $5.1 million in Q2 2023.

4. Net profit of $69.5 million for Q2 2024, compared to a loss of $21.3 million in Q2 2023.

5. Plans to initiate rolling BLA submission for lete-cel in 2025 and commercial launch in 2026.

6. Projected peak U.S. sales of $400 million for the sarcoma franchise.

Adaptimmune Therapeutics plc (Nasdaq: ADAP), a company focused on redefining solid tumor cancer treatment with cell therapy, has announced it will release its Q2 2024 financial results and business updates on Monday, August 12, 2024, before US markets open. The company will host a live webcast at 8:00 a.m. EDT (1:00 p.m. BST) on the same day to discuss the results.

Investors can access the press release on Adaptimmune's corporate website, and join the webcast at https://www.gowebcasting.com/13404. For those preferring to call in, the numbers are +1-844-763-8274 (US/Canada) or +1-647-484-8814 (International). Participants are advised to dial in 10 minutes before the scheduled start time.

Adaptimmune Therapeutics (NASDAQ: ADAP) has received FDA accelerated approval for TECELRA® (afamitresgene autoleucel), the first engineered cell therapy for a solid tumor approved in the U.S. TECELRA is approved for treating adults with advanced MAGE-A4+ synovial sarcoma who have specific HLA types and have received prior chemotherapy.

Key points:

• First new treatment for synovial sarcoma in over a decade
• 43% overall response rate in the SPEARHEAD-1 trial
• Approval based on response rate and duration; confirmatory trial required
• Adaptimmune plans to onboard ~30 treatment centers within two years
• Companion diagnostics for HLA type and MAGE-A4 expression approved

TECELRA can cause serious side effects, including cytokine release syndrome and neurotoxicity. Adaptimmune will hold a webcast on August 2 to provide additional details.

Adaptimmune Therapeutics (NASDAQ: ADAP) presented interim analysis data from its pivotal IGNYTE-ESO trial at ASCO. The study focuses on lete-cel, an engineered cell therapy targeting NY-ESO-1, in synovial sarcoma (SyS) and myxoid/round cell liposarcoma (MRCLS). The trial achieved a 40% overall response rate (ORR) across both cancer types and a median duration of response (mDOR) of approximately 11 months. These findings reinforce the potential of lete-cel to address unmet medical needs in these sarcoma indications. Full results are expected in late 2024, with a Biologics License Application (BLA) submission planned for 2025. Adaptimmune aims to commercialize afami-cel later this year and lete-cel in 2026.

Adaptimmune and Galapagos have entered a clinical collaboration to evaluate Adaptimmune's TCR T-cell therapy candidate, uza-cel, in head & neck cancer. The trial aims to leverage Galapagos' decentralized manufacturing platform to improve efficacy and durability. Initial trials showed an 80% response rate with partial responses in four out of five patients. Adaptimmune will receive $70M upfront, $30M in R&D funding, and potentially up to $465M in milestone payments, with additional tiered royalties. Galapagos has an option to license uza-cel for global development and commercialization.

Adaptimmune Therapeutics (NASDAQ: ADAP) reported Q1 2024 results, highlighting a cash runway through late 2025. Revenue fell to $5.7M from $47.6M YoY due to the termination of the Astellas collaboration. Net loss was $48.5M, compared to a $1.0M profit in Q1 2023. R&D expenses rose to $35.2M, driven by increased employee costs and lease properties from the TCR2 acquisition. G&A expenses decreased to $19.7M due to restructuring and lower corporate costs. The FDA is reviewing afami-cel for advanced synovial sarcoma with a PDUFA date of August 4, 2024. The company plans to launch afami-cel upon approval and lete-cel for synovial sarcoma and MRCLS in 2026, targeting peak U.S. sales of $400M. A $125M debt facility with Hercules Capital was secured.

Adaptimmune has secured a $125 million debt financing deal with Hercules Capital. The agreement includes an initial $25 million tranche available upon closing and an additional $25 million contingent on the approval of afami-cel. The remaining $75 million will be available subject to certain conditions. This financing aims to bolster the company's balance sheet as it prepares for the commercial launch of afami-cel later this year and lete-cel in 2026. Adaptimmune's CFO, Gavin Wood, expressed confidence in the potential impact of afami-cel on sarcoma treatment. A live webcast will provide further Q1 financial and business updates.

Adaptimmune Therapeutics plc (NASDAQ: ADAP) will report Q1 2024 financial results and business updates on May 15, 2024. The company specializes in solid tumor cancer treatment using cell therapy. A live webcast will follow the announcement at 8:00 a.m. EDT (1:00 p.m. BST) on the same day.