Latest news with #CintiaPiccina
Yahoo
44 minutes ago
- Business
- Yahoo
Adaptimmune, seeking to stay afloat, sells off cell therapies
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Struggling cancer cell therapy developer Adaptimmune is backing out of commercial drug manufacturing, announcing Monday it will sell its approved medicine Tecelra and two late-stage assets to US WorldMeds in a deal worth up to $85 million. The deal is a lifeline for Adaptimmune, which in March initiated a strategic review because of 'substantial doubt' about the company's continued solvency. The transaction will send all employees involved in commercialization and development of Tecelra, as well as the clinical-stage lete-cel and uza-cel, to US WorldMeds. Per deal terms, Adaptimmune will receive $55 million upfront and could later receive $30 million in additional payments based on achievement of regulatory and commercial milestones. After the sale, Adaptimmune will retain possession of two T cell directed therapies now in preclinical studies to support human testing. In a regulatory filing, Adaptimmune said that, after the deal, it will cut its remaining workforce by 62% — layoffs that follow a 29% headcount reduction earlier this year that was forecast to save $300 million over four years. Chief Medical Officer Elliot Norry and Chief Commercial Officer Cintia Piccina will leave the company Aug. 8, while Chief Scientific Officer Joanna Brewer will leave Aug. 31. Tecelra gained Food and Drug Administration accelerated approval in 2024 for some patients with synovial sarcoma, a type of solid tumor. It was the first so-called T cell receptor, or TCR, cell therapy approved in the U.S. A half dozen cell therapies that use a different 'CAR-T' technology were approved earlier, but have so far only approved effective in blood cancers. Adaptimmune's innovation didn't translate into sales, however. Adaptimmune reported just over $4 million in product revenue in the first quarter of 2025, overshadowed by the company's nearly $29 million in research and development spending. It held $41 million in cash and equivalents at the end of March. 'After an extensive review of all strategic alternatives available to Adaptimmune we are convinced that this transaction represents the best path forward for Adaptimmune, our patients and stakeholders,' said CEO Adrian Rawcliffe in a statement. Adaptimmune shares fell by two-thirds following the announcement, changing hands at about 10 cents apiece in afternoon trading. While arguing Adaptimmune's deal was a 'net positive' due to its solvency concerns, Mizuho Securities analyst Graig Suvannavejh wrote in a client note that the size of the deal was 'disappointing.' Suvannavejh added that, even with the revenue from the deal and associated cost cuts, 'it is still unclear to us [the company's] liquidity concerns have been adequately addressed.' Recommended Reading Merck to buy Verona and its lung drug in $10B deal Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
14-05-2025
- Business
- Yahoo
Adaptimmune Therapeutics PLC (ADAP) Q1 2025 Earnings Call Highlights: Strong Tecelra Launch ...
Revenue Guidance: Full-year Tecelra sales projected between $35 million and $45 million. Net Sales for Q1 2025: $4 million from Tecelra treatments. Tecelra Treatments Invoiced: 14 treatments in 2025 to date, with 6 in Q1. Authorized Treatment Centers: 28 centers currently accepting referrals, with a target of approximately 30 by the end of 2025. Manufacturing Success Rate: 100% success from the US Tecelra manufacturing center. Average Turnaround Time: 27 days from apheresis to release, beating the target of 30 days. Peak Sales Projection: $400 million from combined Tecelra and Lete-cel sarcoma franchise. Warning! GuruFocus has detected 4 Warning Signs with ADAP. Release Date: May 13, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Adaptimmune Therapeutics PLC (NASDAQ:ADAP) reported strong momentum with the launch of Tecelra, achieving $4 million in net sales for Q1 2025. The company has successfully apheresed 21 patients in 2025, with 13 in Q1 and 8 in early Q2, supporting their revenue guidance of $35 million to $45 million for the year. Adaptimmune has established 28 authorized treatment centers (ATCs) for Tecelra, with plans to reach 30 by the end of 2025, a year ahead of schedule. The manufacturing success rate for Tecelra has been 100%, with no capacity issues and an average turnaround time of 27 days, beating the target of 30 days. There have been no patient denials for Tecelra, indicating effective patient access and a positive payer environment. Adaptimmune Therapeutics PLC (NASDAQ:ADAP) has a going concern warning, indicating less than 12 months of cash runway, which raises concerns about financial sustainability. The company has not provided detailed cash runway guidance due to various impacting factors, including the success of Tecelra's launch and ongoing cost reduction actions. The cost of goods sold (COGS) is expected to be higher in the initial quarters, affecting margins, although they are projected to normalize over time. There is uncertainty regarding the impact of potential regulatory changes on the business, although the company has not seen any negative indications from the FDA. The company is still exploring strategic options with Cowen, which could imply potential changes or uncertainties in their strategic direction. Q: Can you clarify if the apheresed patients in Q1 have already been treated and invoiced? A: Cintia Piccina, Chief Commercial Officer, explained that of the 21 apheresed patients year-to-date, at least six have been invoiced, with the majority expected to be invoiced in the coming months. Q: Should we expect an acceleration in the number of apheresed patients in Q2? A: Adrian Rawcliffe, CEO, stated that while they are comfortable with the sales guidance of $35 million to $45 million for 2025, they are not providing detailed quarterly breakdowns of apheresis numbers. Q: How has the pace of patient referrals and screening been trending, and do you expect incremental growth? A: Cintia Piccina noted that they expect quarter-over-quarter growth without specific seasonality, driven by increased awareness and the onboarding of more Authorized Treatment Centers (ATCs). Q: What are the key learnings from the early launch of Tecelra? A: Cintia Piccina highlighted the faster-than-expected onboarding of treatment centers and the 100% manufacturing success rate as positive surprises, with patient onboarding and biomarker testing proceeding smoothly. Q: How is the company managing its cash position and what are the implications of the recent debt paydown? A: Gavin Wood, CFO, explained that the debt paydown was part of managing the balance sheet and did not impact cash runway. The company has less than 12 months of cash, with ongoing strategic options being explored. Q: What gives you confidence in providing revenue guidance for the year? A: Adrian Rawcliffe mentioned the visibility into the patient funnel, successful manufacturing, and the increasing number of ATCs as factors supporting the $35 million to $45 million revenue guidance. Q: What is the drop-off rate for patients from apheresis to infusion? A: Adrian Rawcliffe confirmed that so far, 100% of apheresed patients have received infusions. Q: Are there any planned manufacturing maintenance activities this year? A: John Lunger, Chief Patient Supply Officer, stated that maintenance is conducted on a rolling basis without impacting capacity, and no significant shutdowns are planned for the year. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
