MAGE-A4

Company Now Exclusively Focused on Development and Commercialization of Abecma CAMBRIDGE, Mass.--(BUSINESS WIRE)-- 2seventy bio, Inc. (Nasdaq: TSVT), announced today the completion of the asset purchase agreement (“APA”) by Regeneron Pharmaceuticals, Inc. Under the terms of the APA, Regeneron has acquired all oncology and autoimmune research and development programs and has hired approximately 160 employees from 2seventy bio as part of their newly launched cell medicines business. Going forward, 2seventy bio will focus exclusively on the commercialization and development of Abecma (idecabtagene vicleucel), its BCMA-targeted CAR T cell therapy for multiple myeloma, in collaboration with their partner Bristol Myers Squibb (BMS). “With the completion of the Regeneron transaction, 2seventy officially embarks on our new strategic path forward to focus on unlocking the value of Abecma,” said Chip Baird, CEO. “We are pleased to have successfully transitioned our innovative cell therapy pipeline to Regeneron and excited for the team members who have joined Regeneron Cell Medicines to continue their important work of developing new treatments for people with cancer. We are also extremely excited about our own future with the potential to bring Abecma to more patients in earlier lines.” Based on the Company’s recent strategic actions, 2seventy bio includes approximately 65 full-time, permanent employees, primarily in quality and supporting functions. With the resulting cost savings from reduced headcount and the sale of the pipeline assets to Regeneron, 2seventy bio has extended cash runway beyond 2027. The Company will continue to support quality control of lentiviral vector (LVV) for Abecma. About 2seventy bio Our name, 2seventy bio, reflects why we do what we do - TIME. Cancer rips time away, and our goal is to work at the maximum speed of translating human thought into action – 270 miles per hour – to give the people we serve more time. With a deep understanding of the human body’s immune response to tumor cells and how to translate cell therapies into practice, we’re applying this knowledge to deliver the first FDA-approved CAR T cell therapy for multiple myeloma to as many patients as possible. Importantly, we remain focused on accomplishing our mission by staying genuine and authentic to our “why” and keeping our people and culture top of mind every day. For more information, visit . Follow 2seventy bio on social media: X (Twitter) and LinkedIn. 2seventy bio is a trademark of 2seventy bio, Inc. Cautionary Note Regarding Forward-Looking Statements This release contains “forward-looking statements” within the meaning of applicable laws and regulations. These statements include, but are not limited to: statements about our financial position and cash runway; statements about our plans, strategies, timelines and expectations with respect to regulatory approval and related filings for ABECMA; statements regarding our plans to continue to advance our manufacturing strategy to expand capacity and increase manufacturing efficiency for ABECMA across the supply chain and our plans to increase the number of ABECMA treating sites; statements regarding expected benefits from our strategic collaboration. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, the risk that ABECMA will not be as commercially successful as we may anticipate; the risk that Abecma may not receive FDA approval for the indication described in this release in the currently anticipated timeline or at all, that any marketing approvals, if granted, may have significant limitations on their use; the risk that our strategic realignment to focus on the development and commercialization of Abecma may not be as successful as anticipated, may fail to achieve the anticipated cost savings, and may cause disruptions in our business that could make it difficult to achieve our strategic objectives; and the risk that we are unable to manage our operating expenses or cash use for operations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our annual report on Form 10-K for the year ended December 31, 2023 as supplemented and/or modified by our most recent Quarterly Report on Form 10-Q and any other filings that we have made or will make with the Securities and Exchange Commission in the future. All information in this press release is as of the date of the release, and 2seventy bio undertakes no duty to update this information unless required by law. View source version on businesswire.com: Contacts Investors: Elizabeth Pingpank Hickin, 860-463-0469 Elizabeth.pingpank@2seventybio.com Media: Jenn Snyder, 617-448-0281 Jenn.snyder@2seventybio.com Source: 2seventy bio, Inc. View this news release online at:

U.S. FDA accepted BLA for afami-cel for the treatment of advanced synovial sarcoma with priority review and a PDUFA date of August 4th, 2024 Confirmatory evidence for afami-cel full approval agreed with FDA; will use data from Cohort 2 of pivotal SPEARHEAD-1 trial, which is fully enrolled Company is targeting launch of afami-cel upon receipt of FDA approval with commercial, manufacturing, and supply chain teams preparing for product delivery Lete-cel program transitioned back to Adaptimmune and the Company is planning for US commercial launch in 2026 Sarcoma franchise of afami-cel and lete-cel leverages same development and commercial footprint with US peak year sales projected to be up to $400 million Cash runway into early 2026; with greater than $300 million including current cash on hand, future expected income from partners and projected other non-dilutive capital sources Webcast to be held today, March 6, 2024, at 8:00 a.m. EST. (1:00 p.m. GMT) Company will hold an investor day at its Navy Yard facility on April 18th – more details to follow Philadelphia, Pennsylvania and Oxford, United Kindgom--(News - March 6, 2024) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update on the progress made in establishing its sarcoma franchise. Adrian Rawcliffe, Adaptimmune's Chief Executive Officer: "Adaptimmune is poised to bring afami-cel to market – which will be the first ever engineered T-cell therapy for a solid tumor. Afami-cel is the first product in our sarcoma franchise, which, if approved, along with lete-cel, has the potential to redefine the landscape for the treatment of advanced synovial sarcoma and MRCLS. This franchise, which is only the beginning of our commercial ambitions, is projected to deliver up to $400 million in U.S. peak year sales." Sarcoma Franchise Afami-cel Adaptimmune is preparing to launch the first product in its sarcoma franchise, afami-cel, for the treatment of advanced synovial sarcoma pending review and approval by the FDA with a PDUFA date of August 4, 2024. Synovial sarcoma is a solid tumor cancer with high unmet medical need for which there has been no new effective treatment since 2013. Synovial sarcoma represents 5%-10% of the ~13,000 soft tissue sarcoma cases in the United States each year.a If approved, afami-cel would be the first engineered T-cell therapy for a solid tumor to receive commercial approval in the U.S. Data from Cohort 2 of the pivotal trial SPEARHEAD-1 will serve as confirmatory evidence for full approval. This cohort is fully enrolled. Adaptimmune does not anticipate an advisory committee meeting, at this time, based on feedback received from FDA. Adaptimmune is preparing to launch afami-cel in Q3 of 2024 in the U.S. Initially, launch will be focused on 6-10 selected treatment centers ("Authorized Treatment Centers" or "ATCs") and will expand to up to ~30 additional ATCs. Field teams are being recruited and are engaging with ATCs. The marketing application for the companion diagnostic for MAGE-A4 is currently under FDA review and is expected to be approved contemporaneously with the BLA. Adaptimmune is a fully integrated cell therapy company and will deliver afami-cel's commercial supply from the Company's Navy Yard cell therapy manufacturing facility in Philadelphia. Adaptimmune's manufacturing and supply chain organization has delivered hundreds of clinical cell therapy batches to people enrolled in the Company's clinical trials, to date. Lete-cel The second product in Adaptimmune's sarcoma franchise, lete-cel, is being investigated in the pivotal IGNYTE-ESO trial (NCT03967223), which at an interim analysis exhibited response in 18/45 of patients (ORR 40%). The primary efficacy endpoint requires 16/60 patients have responses, so this trial has met its primary endpoint for efficacy. The full pivotal analyses are anticipated in late 2024. Adaptimmune has received an upfront amount and will receive milestone-based payments totaling £30 million under the agreement with GSK. Lete-cel will enable Adaptimmune to expand its addressable synovial sarcoma patient population by targeting the NY-ESO cancer antigen, in addition to MAGE-A4 targeted by afami-cel, as well as treating Myxoid Round Cell Liposarcoma (MRCLS) patients. Once approved and marketed, afami-cel and lete-cel have the potential to treat more than 1,000 people with soft tissue sarcomas annually in the United Statesb Clinical pipeline update As reported in ESMO 2023, ADP-A2M4CD8, Adaptimmune's next-generation engineered T-cell therapy exhibited 35% response rate in a broad range of solid tumors; 50% response rate in 26 patients with ovarian, urothelial, and head & neck cancers. ADP-A2M4CD8 is being investigated in the SURPASS-3 Phase 2 clinical trial (NCT05601752) for the treatment of platinum-resistant ovarian cancer. ADP-A2M4CD8 received FDA RMAT designation in 2022 for the treatment of patients with platinum resistant ovarian cancer. The SURPASS-3 trial is currently enrolling patients. Cohorts in the Phase 1 SURPASS trial are ongoing for people with head & neck and urothelial (bladder) cancers with ADP-A2M4CD8 in combination with standard of care checkpoint inhibitor therapy. Preclinical pipeline update IND-enabling studies are underway for ADP-600 (PRAME) and ADP-520 (CD70) programs Genentech collaboration to research and develop allogeneic cell therapies continues as planned Wholly owned allogeneic pipeline advancing; process development in progress at Adaptimmune's allogeneic manufacturing facility in Milton Park, UK. Corporate and other news Strategic combination with TCR2 Therapeutics completed in June of 2023 Cintia Piccina appointed as Chief Commercial Officer The Company received R&D tax credits from the UK government in January 2024 of $30.8m Financial Results for the three months and year ended December 31, 2023 Cash / liquidity position: As of December 31, 2023, Adaptimmune had cash and cash equivalents of $143.9 million and Total Liquidity1 of $146.9 million, compared to $108.0 million and $204.6 million, respectively, as of December 31, 2022. Revenue: Revenue for the three months and year ended December 31, 2023, was $0.2 million and $60.3 million, respectively, compared to $11.0 million and $27.1 million for the same periods in 2022. Revenue has increased in 2023, compared to the same period in 2022 primarily due to the termination of the Astellas collaboration, resulting in the remaining deferred income for the collaboration being recognized as revenue in March 2023. Research and development (R&D) expenses: R&D expenses for the three months and year ended December 31, 2023, were $33.2 million and $126.5 million, respectively, compared to $23.1 million and $127.7 million for the same periods in 2022. R&D expenses in the three months ended December 31, 2023 increased due to a decrease in offsetting reimbursements receivable for research and development tax and expenditure credits. R&D expenses in the year ended December 31, 2023 decreased due to a decrease in the average number of employees engaged in research and development following the restructuring completed in the first quarter of 2023, decreases in subcontracted expenditures, a decrease in share-based compensation expenses and a decrease in in-process research and development costs, which was mostly offset by a decrease in offsetting reimbursements receivable for research and development tax and expenditure credits. General and administrative (G&A) expenses: G&A expenses for the three months and year ended December 31, 2023, were $16.9 million and $73.5 million, respectively, compared to $15.2 million and $63.4 million for the same periods in 2022. G&A expenses in the year ended December 31, 2023 increased due to restructuring and charges recognised in the first quarter of 2023, an increase in other corporate costs due to an increase in accounting, legal and professional fees incurred in relation to the TCR2 Therapeutics, Inc merger agreement and severance and other related costs for former TCR2 Therapeutics leadership, offset by a decrease in share-based compensation expenses. Gain on bargain purchase: a $22.0 million gain on bargain purchase was recognised in the year ended December 31, 2023, from the strategic combination with TCR2 Therapeutics, Inc. Net loss: Net loss attributable to holders of the Company's ordinary shares for the three months and year ended December 31, 2023, was $47.9 million and $113.9 million, respectively ($(0.04) and $(0.09) per ordinary share), compared to $29.3 million and $165.5 million, respectively ($(0.03) and $(0.17) per ordinary share), for the same periods in 2022. Financial Guidance The Company believes that its existing cash, cash equivalents and marketable securities, together with the additional payments under the Strategic Collaboration and License Agreement with Genentech and payments under the Termination and Transfer Agreement with GSK, will fund the Company's current operations into early 2026, as further detailed in the Company's Annual Report on Form 10-K for the year ended December 31, 2023, to be filed with the Securities and Exchange Commission following this earnings release. Webcast Information The Company will host a live webcast to provide additional details at 8:00 a.m. EST (1:00 p.m. GMT) today, March 6, 2024. A live webcast of the conference call and replay can be accessed at . Call in information is as follows: 1-800-319-4610 (US or Canada) or +1-416-915-3239 (International and additional options available HERE). About Adaptimmune Adaptimmune is a clinical-stage biopharmaceutical company focused on designing, developing, and delivering cell therapies to transform the lives of people with cancer. The Company's unique engineered T-cell receptor (TCR) platform enables the engineering of T-cells to target and destroy cancers across multiple solid tumor types. Forward-Looking Statements This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking statements 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, 2022, 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. 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). Each of these components appears separately in the condensed consolidated balance sheet. The U.S. GAAP financial measure most directly comparable to Total Liquidity is cash and cash equivalents as reported in the condensed consolidated financial statements, which reconciles to Total Liquidity as follows (in thousands): December 31, December 31, 2023 2022 Cash and cash equivalents $ 143,991 $ 108,033 Marketable securities - available-for-sale debt securities 2,947 96,572 Total Liquidity $ 146,938 $ 204,605 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. Condensed Consolidated Statement of Operations (unaudited, in thousands, except per share data) Three months ended Year ended December 31, December 31, 2023 2022 2023 2022 Development revenue 231 11,028 60,281 27,148 Revenue $ 231 $ 11,028 $ 60,281 $ 27,148 Research and development (33,208 ) (23,052 ) (126,509 ) (127,726 ) General and administrative (16,879 ) (15,218 ) (73,513 ) (63,387 ) Total operating expenses (50,087 ) (38,270 ) (200,022 ) (191,113 ) Operating loss (49,856 ) (27,242 ) (139,741 ) (163,965 ) Interest income 1,596 523 5,964 1,542 Gain on bargain purchase — — 22,049 — Other income (expense), net (313 ) (1,537 ) (807 ) (536 ) Loss before income tax expense (48,573 ) (28,256 ) (112,535 ) (162,959 ) Income tax credit/(expense) 656 (994 ) (1,336 ) (2,497 ) Net loss attributable to ordinary shareholders $ (47,917 ) $ (29,250 ) $ (113,871 ) $ (165,456 ) Net loss per ordinary share Basic and diluted $ (0.04 ) $ (0.03 ) $ (0.09 ) $ (0.17 ) Weighted average shares outstanding: Basic and diluted 1,362,672,380 984,715,238 1,206,440,978 967,242,403 Condensed Consolidated Balance Sheets (unaudited, in thousands, except share data) December 31, December 31, 2023 2022 Assets Current assets Cash and cash equivalents $ 143,991 $ 108,033 Marketable securities - available-for-sale debt securities (amortized cost of $2,940 and $97,501) net of allowance for expected credit losses of $0 and $0 2,947 96,572 Accounts receivable, net of allowance for expected credit losses of $0 and $0 821 7,435 Other current assets and prepaid expenses 59,793 43,330 Total current assets 207,552 255,370 Restricted cash 3,026 1,569 Operating lease right-of-use assets, net of accumulated amortization of $13,220 and $9,470 20,762 18,019 Property, plant and equipment, net of accumulated depreciation of $46,020 and $38,588 50,946 53,516 Intangible assets, net of accumulated amortization of $5,155 and $4,676 330 442 Total assets $ 282,616 $ 328,916 Liabilities and stockholders' equity Current liabilities Accounts payable $ 8,128 $ 4,753 Operating lease liabilities, current 5,384 2,728 Accrued expenses and other current liabilities 30,303 31,215 Restructuring provision — 2,285 Deferred revenue, current 28,973 23,520 Total current liabilities 72,788 64,501 Operating lease liabilities, non-current 19,851 20,349 Deferred revenue, non-current 149,060 160,892 Other liabilities, non-current 1,404 1,296 Total liabilities 243,103 247,038 Stockholders' equity Common stock - Ordinary shares par value £0.001, 1,702,760,280 authorized and 1,363,008,102 issued and outstanding (2022: 1,282,773,750 authorized and 987,109,890 issued and outstanding) 1,865 1,399 Additional paid in capital 1,064,569 990,656 Accumulated other comprehensive loss (3,748 ) (875 ) Accumulated deficit (1,023,173 ) (909,302 ) Total stockholders' equity 39,513 81,878 Total liabilities and stockholders' equity $ 282,616 $ 328,916 Condensed Consolidated Cash Flow Statement (unaudited, in thousands) Year ended Year ended December 31, December 31, 2023 2022 Cash flows from operating activities Net loss $ (113,871) $ (165,456) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation 9,453 5,266 Amortization 387 809 Gain on bargain purchase (22,049 ) — Share-based compensation expense 11,773 18,240 Unrealized foreign exchange losses/(gains) 198 (2,438 ) (Accretion)/amortization on available-for-sale debt securities (1,986 ) 2,525 Other 167 816 Changes in operating assets and liabilities: Increase in receivables and other operating assets (1,291 ) (9,813 ) (Decrease)/increase in payables and other current liabilities (9,087 ) 4,408 (Increase)/decrease in deferred revenue (14,574 ) 3,874 Net cash used in operating activities (140,880 ) (141,769 ) Cash flows from investing activities Acquisition of property, plant and equipment (4,681 ) (29,496 ) Acquisition of intangible assets (199 ) (244 ) Cash from acquisition of TCR2 Therapeutics Inc. 45,264 — Maturity or redemption of marketable securities 210,983 166,994 Investment in marketable securities (75,953 ) (48,117 ) Other 1,124 — Net cash provided by investing activities 176,538 89,137 Cash flows from financing activities Proceeds from issuance of common stock from offerings, net of commissions and issuance costs 624 12,817 Proceeds from exercise of stock options 256 50 Net cash provided by financing activities 880 12,867 Effect of currency exchange rate changes on cash, cash equivalents and restricted cash 877 (2,299 ) Net increase/(decrease) in cash, cash equivalents and restricted cash 37,415 (42,064 ) Cash, cash equivalents and restricted cash at start of period 109,602 151,666 Cash, cash equivalents and restricted cash at end of period $ 147,017 $ 109,602 Supplemental cash flow information Interest received $ 4,748 $ 5,149 Accretion/(amortization) on available-for-sale debt securities 1,986 (2,525 ) Income taxes paid (4,000 ) (630 ) Adaptimmune Contacts Investor Relations Juli P. Miller, Ph.D. — VP, Corporate Affairs and Investor Relations T: +1 215 825 9310 M: +1 215 460 8920 Juli.Miller@adaptimmune.com Media Relations Dana Lynch, Senior Director of Corporate Communications M: +1 267 990 1217 Dana.Lynch@adaptimmune.com a - "Synovial Sarcoma." National Cancer Institute. Accessed 11 December 2023. b - 1: Aytekin MN, et al. J Orthop Surg (Hong Kong). 2020;28(2) 2: Disease-specific survival from Hoffman et al. (2013), Localized and metastatic 3: 67% of synovial sarcoma tumors express MAGE-A4. MAGE-A4 expression based on ADAP samples and expression cut off criteria of ≥30% tumor cells at ≥2+ intensity. Synovial sarcoma and MRCLS MAGE-A4 expression based on 1,043 patient samples at November 20, 2020 data cut-off and expression of all other tumor types on 6,167 patients, 1,543 tumor samples at November 19, 2021 data cut-off 4: 70-90% of SyS and MRCLS tumors express NY-ESO-1Endo M, de Graaff MA, Ingram DR, et al. NY-ESO-1 (CTAG1B) expression in mesenchymal tumors. Mod Pathol 2015; 28: 587-95. Jungbluth AA, Chen YT, Stockert E, Busam KJ, Kolb D, Iversen K, et al. Immunohistochemical analysis of NY-ESO-1 antigen expressionin normal and malignant human tissues. Int J Cancer 2001;92:856-60. 5: HLA A2 expression based on ADAP samples of 41% for synovial sarcoma and MRCLS (1,043 patient samples; data cut-off November 20, 2020) 1 Total liquidity is a non-GAAP financial measure, which is explained and reconciled to the most directly comparable financial measures prepared in accordance with GAAP below To view the source version of this press release, please visit