Latest news with #CD70
Yahoo
4 days ago
- Business
- Yahoo
Adaptimmune Announces Entry into Definitive Agreement for Sale of TECELRA, lete-cel, afami-cel and uza-cel Cell Therapies to US WorldMeds
Tecelra will continue to be available to patients without interruption US WorldMeds plans to bring lete-cel to market and will continue development of uza-cel in collaboration with Galapagos Purchase price is $55m in cash to be paid upon consummation of the sale with up to $30m in potential future payments upon achievement of certain milestones Adaptimmune will retain rights to its preclinical assets including PRAME, CD70, and its allogeneic program Adaptimmune will restructure to support the transition of these therapies to US WorldMeds and to maximize value from its remaining assets Adaptimmune's Board of Directors determined this transaction is in the best interest of all stakeholders following a comprehensive review of all strategic alternatives Philadelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - July 28, 2025) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, today announced its entry into a definitive agreement for the sale of TECELRA, lete-cel, afami-cel, and uza-cel cell therapies to US WorldMeds. Consummation of the sale is expected to occur before the end of the week. Adrian Rawcliffe, Adaptimmune's Chief Executive Officer: "Adaptimmune has been at the forefront of solid tumor cell therapy and delivering groundbreaking treatments to patients for more than a decade. We were the first company to obtain a marketing authorization for an engineered TCR T-cell therapy, TECELRA, and we have a second cell therapy, lete-cel, with approval anticipated in 2026. However, given the financial situation of the Company, it is clear that securing the right strategic option was critical to maximize value for all of our stakeholders and importantly ensure our patients continue to receive TECELRA. 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." Breck Jones, US WorldMeds Chief Executive Officer: "Anchored by a first-in-class commercial therapy and a promising pipeline, this acquisition is a meaningful step forward in our mission to bring hope and innovation to patients who need it most. US WorldMeds deeply respects the strong foundation Adaptimmune has built in the cell therapy space and is committed to carrying that work forward - advancing and delivering these important therapies to the people and families who are counting on them." Under the terms of the asset purchase agreement, US WorldMeds will purchase the TECELRA, uza-cel, afami-cel and lete-cel cell therapy assets of Adaptimmune (the "Assigned Assets") and all intellectual property rights exclusively relating to such Assigned Assets. In return, Adaptimmune will receive $55 million in cash upon consummation of the sale. In addition, US WorldMeds has agreed to make future payments of up to $30 million to Adaptimmune upon the achievement of certain milestones. Adaptimmune and US WorldMeds will also enter into a license agreement pursuant to which, among other things, US WorldMeds will be exclusively licensed residual intellectual property rights necessary for the manufacture and commercialization of the Assigned Assets and non-exclusively licensed intellectual property rights in Adaptimmune's vector manufacturing process. Adaptimmune will also provide certain transition services to US WorldMeds pursuant to a transition services agreement on terms specified therein. US employees involved in the development and commercialization of the Assigned Assets will be offered employment with US WorldMeds to ensure the ongoing success and ability to supply those Assigned Assets. Following the transaction Adaptimmune intends to restructure to support the continued development by US WorldMeds of lete-cel, TECELRA and uza-cel and to maximise value from its remaining assets including its PRAME and CD70 directed T-cell therapies. TD Cowen acted as financial advisor, and Ropes & Gray LLP provided legal counsel, to Adaptimmune. Gibson, Dunn & Crutcher LLP provided legal counsel to US transaction will be financed by debt financing led by funds managed by Oaktree Capital Management, L.P. ('Oaktree'), with participation from funds managed by Athyrium Capital Management, LP ('Athyrium'). Forward-Looking StatementsThis release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Actual events or results may differ materially from these forward-looking statements. Words such as "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "future," "opportunity" "will likely result," "target," variations of such words, and similar expressions or negatives of these words are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of such forward-looking statements include, but are not limited to, express or implied statements regarding: the proposed transaction and related matters; the impact of the proposed transaction on Adaptimmune's share price; the anticipated benefits of the proposed transaction for Adaptimmune's financial results and business performance; Adaptimmune's targets, plans, objectives or goals for future operations, including those related to Adaptimmune's products or product candidates, research and development, product candidate introductions and product candidate approvals as well as cooperation in relation thereto; projections of or targets for revenues, costs, income (or loss), earnings per share, capital expenditures, dividends, capital structure, net financials and other financial measures; future economic performance, future actions and outcome of contingencies such as legal proceedings; the assumptions underlying or relating to such statements; and other risks and uncertainties contained in Adaptimmune's filings with the U.S. Securities and Exchange Commission (the "SEC"), including Adaptimmune's most recently filed Annual Report on Form 10-K and 10-Q. These forward-looking statements speak only as of the date of this release, and Adaptimmune undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by applicable laws. About OaktreeOaktree is a leader among global investment managers specializing in alternative investments, with $203 billion in assets under management as of March 31, 2025. The firm emphasizes an opportunistic, value-oriented, and risk-controlled approach to investments in credit, equity, and real estate. The firm has more than 1,200 employees and offices in 25 cities worldwide. For additional information, please visit Oaktree's website at AthyriumAthyrium is a specialized asset management company formed in 2008 to focus on investment opportunities in the global healthcare sector. Athyrium advises funds with over $4.6 billion in committed capital. The Athyrium team has substantial investment experience across a wide range of asset classes including public equity, private equity, fixed income, royalties, and other structured securities. Athyrium invests across all healthcare verticals including biopharma, medical devices and products, healthcare focused services, and healthcare information technology. For more information, please visit Investor Relations and Media RelationsAdrian Rawcliffe - Chief Executive Patient Advocacy and Medical AffairsLaura Gunn - Vice President, Global Medical To view the source version of this press release, please visit Sign in to access your portfolio
Business Recorder
02-07-2025
- Automotive
- Business Recorder
NEV levy: all vehicle categories' prices surge in Pakistan
KARACHI: The New Energy Vehicle (NEV) levy on all internal combustion engine motor vehicles and motorcycles has come into effect from July 1, 2025, increasing prices significantly. According to the details, the NEV levy covers all vehicle categories from basic motorcycles to luxury SUVs. Atlas Honda has released new prices after NEV implementation. The CD70 now costs Rs 159,900 compared to its previous price, with the NEV levy adding Rs 1,500. Higher-end models like the CB150F face levies of up to Rs 4,720. All major car manufacturers have also adjusted their pricing, which are going to be revealed in a day or two. FBR imposes new levy on locally-made, imported vehicles The policy exempts new energy vehicles (electric and hybrid cars), vehicles manufactured exclusively for export, diplomatic mission vehicles, and those belonging to international organizations with diplomatic privileges. 'This levy is designed to encourage the adoption of cleaner transportation alternatives while generating revenue for the federal government,' said a senior government official, speaking on condition of anonymity. However, consumers are now expected to face difficult choices between conventional vehicles and exploring electric and hybrid alternatives, he added. Copyright Business Recorder, 2025
Business Recorder
02-07-2025
- Automotive
- Business Recorder
NEV levy: all vehicle categories' prices surge
KARACHI: The New Energy Vehicle (NEV) levy on all internal combustion engine motor vehicles and motorcycles has come into effect from July 1, 2025, increasing prices significantly. According to the details, the NEV levy covers all vehicle categories from basic motorcycles to luxury SUVs. Atlas Honda has released new prices after NEV implementation. The CD70 now costs Rs 159,900 compared to its previous price, with the NEV levy adding Rs 1,500. Higher-end models like the CB150F face levies of up to Rs 4,720. All major car manufacturers have also adjusted their pricing, which are going to be revealed in a day or two. FBR imposes new levy on locally-made, imported vehicles The policy exempts new energy vehicles (electric and hybrid cars), vehicles manufactured exclusively for export, diplomatic mission vehicles, and those belonging to international organizations with diplomatic privileges. 'This levy is designed to encourage the adoption of cleaner transportation alternatives while generating revenue for the federal government,' said a senior government official, speaking on condition of anonymity. However, consumers are now expected to face difficult choices between conventional vehicles and exploring electric and hybrid alternatives, he added. Copyright Business Recorder, 2025
Yahoo
21-03-2025
- Business
- Yahoo
Adaptimmune Therapeutics PLC (ADAP) (Q4 2024) Earnings Call Highlights: Strategic Growth and ...
Q4 2024 Product Revenue: $1.2 million from Tecelra sales. Authorized Treatment Centers (ATCs): 20 ATCs established, representing 2/3 of the planned network. Patient Apheresis in Q1 2025: 10 patients apheresed with 3 more scheduled, totaling 13 anticipated. Expected Q1 2025 Invoicing: 6 to 8 patients, three to four times the prior quarter. Projected 2025 Sales: Approximately $25 million, aligning with analyst forecasts. Manufacturing Performance: 100% of products manufactured to specification with no failures; turnaround time under 30 days. Reimbursement Success: Over 70% of commercial and Medicare lives covered with no denials. Cost Savings: $75 million to $100 million reduction in forward cash flow demands through 2028 by pausing pre-clinical programs. Cash Savings from Restructuring: $300 million over the period announced previously. Warning! GuruFocus has detected 6 Warning Signs with ADAP. Release Date: March 20, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Adaptimmune Therapeutics PLC (NASDAQ:ADAP) has successfully launched Tecelra, with 20 authorized treatment centers (ATCs) already operational, representing two-thirds of their planned network. The company has seen a significant increase in patient aphereses, with 10 patients apheresed in Q1 2025 compared to three in Q4 2024, indicating strong demand and operational efficiency. Over 70% of commercial and Medicare lives are in plans that cover Tecelra, with no reimbursement denials to date, showcasing effective payer engagement. Manufacturing processes have exceeded expectations, with 100% of products manufactured to specification and no capacity bottlenecks, ensuring reliable supply. The company anticipates achieving US peak sales of approximately $400 million for its sarcoma franchise, supported by strong clinical data and strategic commercial infrastructure. Adaptimmune Therapeutics PLC (NASDAQ:ADAP) has paused spending on pre-clinical programs targeting PRAME and CD70, which may impact future pipeline development. The company has not provided formal revenue guidance for 2025, creating uncertainty about financial projections. Despite the positive launch of Tecelra, the company acknowledges the need for additional capital to achieve profitability by 2027. The ex-US strategy remains unclear, with a focus primarily on the US market, potentially limiting international growth opportunities. The restructuring and cost-saving measures, while beneficial for cash flow, may impact the company's ability to invest in new opportunities or expand its workforce. Q: Could you comment on the pace of apheresis during Q1, specifically were patient numbers higher in March versus January? And how many patients per year do you think you'll need to treat to achieve profitability in 2027? A: The pace of apheresis has been increasing as we onboard more treatment centers. We had a greater number of apheresis in February and March than in prior months. Regarding profitability, we haven't provided specific revenue guidance for 2027, but the combination of Tecelra and Lete-cel sales will drive us to operating profitability. Q: Can you confirm what proportion of the 15 confirmed double positive patients as of November went on to undergo apheresis this year? A: The majority of the double positive patients have started the treatment journey, with 10 patients apheresed so far. Most of the others are still in the process, and while some dropouts are expected, we haven't seen many to date. Q: What are the assumptions and considerations for achieving profitability in 2027? A: We plan to reduce spending by about $50 million in 2025 and by $70 million to $80 million in 2026 and 2027. This will bring our cost base down significantly. The approval and launch of Tecelra and Lete-cel will offset these costs, with anticipated US peak sales of $400 million for our sarcoma franchise. Q: Do you have sufficient cash to reach profitability in 2027, or does it assume additional funding? A: We are exploring strategic options with TD Cowan to ensure we can finance the company appropriately to reach profitability in 2027. Q: What is the commercial strategy for Tecelra outside the US, and are there any timelines for filing in Europe? A: Our primary focus is establishing a commercially viable business in the US. We are exploring opportunities for ex-US commercialization, either independently or through partnerships. We haven't provided specific timelines for European filings. Q: How do the incremental savings from pausing PRAME and CD70 impact the timeline for reaching profitability? A: These savings will help accelerate the timeline to profitability, but other variables, such as the successful launch of Tecelra and Lete-cel, are also crucial. Q: How many ATCs have infused more than one patient, and are there any capacity constraints that could limit patient infusions? A: Several ATCs have infused more than one patient, and the pace of onboarding ATCs has been faster than expected. We have not encountered any capacity constraints in manufacturing or site capacity. Q: What is the conversion rate from double positive patients to those who get apheresed? A: It's more a matter of time than percentage, as each patient's journey varies. Most double positive patients are progressing through the treatment journey over time. Q: Are there any plans to file for Tecelra approval in the EU, and what is the interest level in PRAME and CD70 programs? A: We are part of the PRIME scheme in Europe and plan to report confirmatory evidence later this year. PRAME and CD70 are of interest to several pharma companies, and we are exploring all opportunities to support our sarcoma franchise. Q: How will the experience with Tecelra drive efficiencies for Lete-cel's approval and launch? A: Learnings from Tecelra's BLA review are being applied to Lete-cel's BLA preparation. We have breakthrough therapy designation for Lete-cel, allowing for expedited development and review. The established commercial infrastructure for Tecelra will also support Lete-cel's launch. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
Associated Press
20-03-2025
- Business
- Associated Press
Adaptimmune Provides Q4 and Full Year 2024 Business Update
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 Liquidity 1 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): [This table cannot be displayed. Please visit the source.] 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): 'Emerging T-Cell Receptor T-Cell Therapies for Solid Tumors: Differentiating from CAR-T.' Locke et al. '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) 'Translational analyses reveal mechanisms of afami-cel's anti-tumor activity in synovial sarcoma.' Dupont et al. (SITC 2024 encore) '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 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 M : +1 215 460 8920 Media Relations M: +1 267 990 1217
