TECELRA

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Biotech And Medtech Stocks Rally After-Hours Across Key Names
RTTNewsยท 2025-09-15 04:33
On September 12, several healthcare and biotech stocks experienced a surge in after-hours trading, marked by sharp price movements across the sector. From thrombectomy devices to AI-powered diagnostics and T-cell therapies, companies including Penumbra, Check-Cap, Adaptimmune Therapeutics, and NewAmsterdam Pharma posted notable gains after hours. While some moves were tied to strategic announcements or clinical milestones, others came without direct news, highlighting a volatile and active session for the ...
Adaptimmune Reports Q2 Financial Results and Provides Business Update
Newsfileยท 2025-08-13 11:30
Core Insights - Adaptimmune reported Q2 2025 financial results, highlighting significant growth in TECELRA sales and a strategic agreement with US WorldMeds for cell therapies [2][3] Financial Performance - TECELRA sales reached $11.1 million with over 150% growth compared to Q1 2025, driven by 16 patients invoiced [2][3] - Total revenue for Q2 2025 was $13.7 million, a decrease from $128.2 million in Q2 2024, primarily due to a 96% drop in development revenue following the termination of the Genentech collaboration [4][11] - R&D expenses for Q2 2025 were $23.0 million, down from $40.4 million in Q2 2024, reflecting a reduction in workforce and restructuring efforts [4][5] - SG&A expenses for Q2 2025 were $18.5 million, slightly lower than $19.1 million in Q2 2024, with increases attributed to restructuring charges [5][11] - The net loss for Q2 2025 was $30.3 million, compared to a profit of $69.5 million in Q2 2024 [5][11] Strategic Developments - Adaptimmune entered a definitive agreement to sell TECELRA and other cell therapies to US WorldMeds for $55 million upfront, with potential future milestone payments of up to $30 million [2][3] - The company has repaid its debt following the transaction and is restructuring to optimize the value of remaining assets, including PRAME and CD70 directed T-cell therapies [3][6] Liquidity and Cash Position - As of June 30, 2025, Adaptimmune had cash and cash equivalents of $26.1 million, a significant decrease from $91.1 million at the end of 2024 [4][9] - Total liquidity as of June 30, 2025, was $26.1 million, down from $151.6 million at the end of 2024, indicating a need for careful cash management moving forward [4][9] Operational Highlights - The manufacturing organization achieved a 100% commercial manufacturing success rate through Q2 2025 [3] - The network of ATCs is nearing completion, with 30 centers now accepting referrals for TECELRA [3]
Adaptimmune Announces Entry into Definitive Agreement for Sale of TECELRA, lete-cel, afami-cel and uza-cel Cell Therapies to US WorldMeds
Newsfileยท 2025-07-28 11:30
Core Viewpoint - Adaptimmune Therapeutics has entered into a definitive agreement to sell its cell therapy assets, including TECELRA, lete-cel, afami-cel, and uza-cel, to US WorldMeds for $55 million in cash, with potential future payments of up to $30 million based on milestone achievements [1][2][5] Group 1: Transaction Details - The sale includes all intellectual property rights related to the Assigned Assets, and Adaptimmune will retain rights to its preclinical assets such as PRAME and CD70 [1][2] - The transaction is expected to be completed before the end of the week, and Adaptimmune will provide transition services to US WorldMeds [1][4] - US WorldMeds plans to continue the development of lete-cel and other therapies, ensuring that patients have uninterrupted access to TECELRA [1][5] Group 2: Strategic Rationale - Adaptimmune's Board of Directors concluded that this transaction is in the best interest of all stakeholders after a comprehensive review of strategic alternatives [1][2] - The CEO of Adaptimmune emphasized the importance of securing the right strategic option to maximize value for stakeholders and ensure continued patient access to TECELRA [2][5] - US WorldMeds' CEO highlighted the acquisition as a significant step in their mission to innovate and provide hope to patients [2][5] Group 3: Financial Aspects - The transaction will be financed through debt led by Oaktree Capital Management and Athyrium Capital Management [6] - Adaptimmune will receive an initial payment of $55 million upon sale consummation, with additional milestone payments potentially reaching $30 million [1][2]
Adaptimmune(ADAP) - 2024 Q4 - Earnings Call Transcript
2025-03-20 21:11
Financial Data and Key Metrics Changes - The company reported Q4 product revenue of $1.2 million from TECELRA, with expectations to invoice 3 to 4 times as many patients in Q1 2025 compared to the previous quarter [9][10][17] - The consensus analyst forecast for 2025 sales is approximately $25 million, which the company believes is achievable [17][30] Business Line Data and Key Metrics Changes - The launch of TECELRA has seen significant momentum, with 20 authorized treatment centers (ATCs) established, ahead of the planned 30 by the end of 2026 [6][8] - The company has a pipeline of around 20 biomarker-positive patients expected to be treated in Q2 and Q3 2025, with over 80 patients having completed MAGE-A4 testing [11][12] Market Data and Key Metrics Changes - Over 70% of commercial and Medicare lives have established reimbursement policies for TECELRA, with no denials reported to date [12] - The company anticipates that Lete-cel will expand the sarcoma franchise, potentially doubling the number of treatable patients in the US each year [25] Company Strategy and Development Direction - The company aims to build a successful business with two FDA-approved products in sarcoma and achieve cash flow breakeven by 2027 [26][30] - The company is exploring strategic options, including partnerships and collaborations, to optimize shareholder value and ensure financial stability [28][56] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the acceleration of TECELRA sales and the successful launch of Lete-cel, which is expected to be on the market by 2027 [17][18] - The company is focused on managing costs effectively while pushing towards profitability in 2027, with a significant reduction in cash flow demands due to paused preclinical programs [27][68] Other Important Information - The company has engaged TD Cowen to explore strategic options and financial opportunities [28] - The manufacturing process for TECELRA has exceeded expectations, with 100% of released products manufactured to specification and no capacity bottlenecks reported [14][16] Q&A Session Summary Question: Can you comment on the pace of apheresis during Q1? - The pace of apheresis has been increasing, with more patients being treated as additional ATCs come online [35] Question: What proportion of double positive patients have undergone apheresis? - The majority of double positive patients have started the treatment journey, with some expected to drop out for various reasons [40] Question: What are the assumptions for achieving profitability in 2027? - The company plans to reduce spending significantly and anticipates sales from TECELRA and Lete-cel to contribute to profitability [47][50] Question: Are there any updates on ex-US strategies? - The company is focused on establishing a viable business in the US first, while exploring opportunities for international expansion [66] Question: What is the status of PRAME and CD70 programs? - Both programs are of interest to various pharma companies, and the company is exploring monetization opportunities [82]
Adaptimmune(ADAP) - 2024 Q4 - Earnings Call Transcript
2025-03-20 16:10
Financial Data and Key Metrics Changes - The company reported Q4 product revenue of $1.2 million from TECELRA, with expectations to invoice approximately six to eight patients in Q1 2025, significantly higher than the previous quarter [9][10][17] - The consensus analyst forecast for 2025 sales is approximately $25 million, which the company believes is achievable based on current performance metrics [17][30] Business Line Data and Key Metrics Changes - The launch of TECELRA has seen strong momentum, with 20 authorized treatment centers (ATCs) established, ahead of the planned 30 by the end of 2025 [6][8] - The company has a pipeline of around 20 biomarker-positive patients expected to be treated in Q2 and Q3 2025, with over 80 patients having completed MAGE-A4 testing [11][12] Market Data and Key Metrics Changes - Over 70% of commercial and Medicare lives have established reimbursement policies for TECELRA, with no denials reported to date [12] - The company anticipates that Lete-cel will expand the sarcoma franchise, potentially doubling the number of treatable patients annually in the US [25] Company Strategy and Development Direction - The company aims to achieve cash flow breakeven by 2027, with a focus on building a successful business around two FDA-approved products in sarcoma [26][30] - The company is exploring strategic options, including partnerships and collaborations, to optimize shareholder value and ensure financial stability [28][56] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the accelerating sales of TECELRA and the anticipated launch of Lete-cel, which is expected to leverage existing commercial infrastructure [17][30] - The company is focused on managing costs effectively while pushing towards profitability in 2027, with a commitment to exploring all financial opportunities [30][56] Other Important Information - The company has paused spending on preclinical programs targeting PRAME and CD70, which is expected to reduce cash flow demands by approximately $75 million to $100 million through 2028 [27][68] - The company is part of the PRIME scheme in Europe for TECELRA and plans to submit a marketing application based on comprehensive trial results [80] Q&A Session Summary Question: Can you comment on the pace of apheresis during Q1? - The pace of apheresis has been increasing, with more patients being treated as additional ATCs come online [35] Question: What are the assumptions for profitability in 2027? - The company has not provided specific revenue guidance but expects to achieve profitability through the combination of TECELRA and Lete-cel sales [36][50] Question: What is the status of the ex-US strategy? - The primary focus remains on establishing a commercially viable business in the US, with discussions ongoing for potential partnerships in ex-US markets [66] Question: Can you provide insights on the financials for the quarter? - The company is finalizing its 10-K filing and expects to publish it soon, with anticipated cost reductions from restructuring [68] Question: Are there any capacity constraints affecting patient infusions? - There are currently no capacity limitations reported, and the company is confident in meeting its goals [111][112]