On November 13, 2024 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, reported financial results and business updates for the third quarter ended September 30, 2024. The Company will host a live webcast at 4:30 p.m. EST (9:30 p.m. GMT) today (Press release, Adaptimmune, NOV 13, 2024, View Source [SID1234648259]).

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Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer: "With Tecelra’s encouraging launch and the new positive pivotal results for lete-cel to be presented at CTOS, Adaptimmune will redefine itself as a sarcoma-focused business. We have increased confidence in our $400 million peak year sales estimate for the combined sarcoma franchise. We’re creating a new leaner company, investing in only the highest potential programs and reducing our operating expenses by around $300 million over the next four years. With these actions we have a clear path to operating breakeven during 2027."

Company focuses on strategic business plan and restructuring

● Prioritization of commercial sarcoma franchise and R&D programs with highest potential for return on invested capital and transformational benefit to patients. Tecelra launch progress and lete-cel data both support the Company’s projection of combined U.S. peak year sales of $400 million for both products.
● The Company plans to reduce headcount by approximately 33% and total operating expenses by approximately 25% in the first year as compared to anticipated full year 2024 together with a focus towards operations in the U.S.
● The Company expects the aggregate savings over the 4-year period from 2025-2028 will be approximately $300 million, excluding one-time cost of restructuring.
● The Company will cease enrolment in the SURPASS-3 Phase 2 clinical trial (NCT05601752), investigating uza-cel for the treatment of platinum-resistant ovarian cancer.
● Adaptimmune’s collaboration with Galapagos is underway, and plans are progressing to conduct a clinical proof-of-concept trial to evaluate the safety and efficacy of uza-cel (next-generation engineered TCR T-cell therapy, formerly ADP-A2M4CD8) using Galapagos’ decentralized manufacturing platform in patients with head & neck cancer.
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

● ADP-600 (targeting PRAME) and ADP-520 (targeting CD-70) will continue preclinical development towards IND submissions. The Company is engaged in active discussions to partner and expand these programs.

Tecelra Launch

● Tecelra was approved by U.S. Food and Drug Administration (FDA) approved for the treatment of advanced MAGE-A4+ synovial sarcoma in adults with certain HLA types who have received prior chemotherapy.
● Tecelra, a single infusion, is the first new treatment option for synovial sarcoma in more than a decade and the first engineered cell therapy for solid tumors.
● 9 Sarcoma centers of excellence across the U.S. are available as Authorized Treatment Centers (ATCs) for Tecelra and are accepting patients and referrals from healthcare providers to initiate the Tecelra treatment journey. The Company is confident the full ATC network of approximately 30 ATCs will be active by the end of 2025, covering an estimated 80% of patients treated in sarcoma centers of excellence.
● The first patient has been apheresed and first manufacture of Tecelra is ongoing.

Lete-cel registrational data (details are in a separate press release issued today)

Full primary analysis on 64 patients with long term follow up from pivotal IGNYTE-ESO trial has been completed and will be presented at the Connective Tissue Oncology Society (CTOS) annual meeting, being held in San Diego, CA from November 13 to 16, 2024:

● "Planned Analysis of the Pivotal IGNYTE-ESO Trial of Lete-Cel in Patients with Synovial Sarcoma or Myxoid/Round Cell Liposarcoma (MRCLS)" by Dr. Sandra D’Angelo, M.D., Sarcoma Medical Oncology, Memorial Sloan Kettering Cancer Center, on Saturday, November 16, 10:30 AM – 12:00 PM PST, Session 12: Immunology.
● Data demonstrate 42% of people with advanced or metastatic synovial sarcoma or MRCLS had clinical responses with lete-cel; Results include six complete responses (6/64) and twenty-one partial responses (21/64). Responses are durable, with a median duration of response of just over a year overall.
● Adaptimmune plans to initiate a rolling Biologics License Application (BLA) for lete-cel for the treatment of advanced or metastatic MRCLS and synovial sarcoma by the end of 2025.
● Lete-cel will bolster Adaptimmune’s sarcoma franchise by expanding the addressable patient population to NY-ESO-1 positive MRCLS and synovial sarcoma solid tumors.
● Adaptimmune will host a virtual event to review the IGNYTE-ESO dataset and the impact of engineered cell therapies on the treatment landscape in sarcoma. The event will feature Dr. Sandra D’Angelo, sarcoma medical oncologist of Memorial Sloan Kettering Cancer Center, an investigating clinician in both the SPEARHEAD and IGNYTE-ESO clinical trials, lead author and presenter of the IGNYTE-ESO data update at CTOS. To register & Attend: Adaptimmune Virtual KOL Event – LifeSci Events.

Recent data presentations

● Translational data from the pivotal SPEARHEAD-1 trial, describing mechanisms of anti-tumor activity, durability and persistence for afami-cel (Tecelra), was presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th annual meeting by Mihaela Druta, MD, Vice Chair, Sarcoma Center, Moffitt Cancer Center, on November 8.
● This presentation will also be encored at CTOS 2024 annual meeting, on Saturday, November 16 10:30 AM – 12:00 PM PST, Session 12: Immunology.
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● Jo Brewer, PhD., Adaptimmune’s Chief Scientific Officer, delivered a platform presentation and participated in a panel discussion during SITC (Free SITC Whitepaper)’s Biotech Breakthroughs – Solid Tumor IO at the Tipping Point session.

Today’s Webcast Details

A live webcast and replay can be accessed at View Source Call in information is as follows: +1-844-763-8274 (US or Canada) or +1-647-484-8814 (International). Callers should dial in 10 minutes prior to the scheduled start time and simply ask to join the Adaptimmune call.

Virtual KOL Webcast Details November 18th following CTOS

Join Adaptimmune on Monday, November 18, 2024 at 2:30 PM ET for a virtual KOL event featuring Dr. Sandra D’Angelo, M.D. (Memorial Sloan Kettering Cancer Center) who will discuss the unmet need and current treatment landscape for patients with sarcoma, including synovial sarcoma (SyS) and myxoid/round cell liposarcoma (MRCLS).Register & Attend: Adaptimmune Virtual KOL Event – LifeSci Events

Financial Results for the three and nine months ended September 30, 2024

● Cash / liquidity position: As of September 30, 2024, Adaptimmune had cash and cash equivalents of $116.7 million and Total Liquidity2 of $186.1 million, compared to $144.0 million and $146.9 million respectively, as of December 31, 2023.
● Revenue: Revenue for the three and nine months ended September 30, 2024, was $40.9 million and $174.8 million, respectively, compared to $7.3 million and $60.1 million for the same periods in 2023. Revenue has increased in 2024, compared to the same periods in 2023 primarily due to the termination of the Genentech collaboration in the second quarter of 2024, resulting in the majority of the remaining deferred income for the collaboration being recognized as revenue including a cumulative catch-up adjustment of $101.3 million, and the Mutual Release and Recognition Agreement in the third quarter of 2024 resulting in the remaining deferred revenue of $37.5 million of revenue, including the $12.5 million payment under the Mutual Release and Recognition Agreement, being recognized as revenue in the current quarter. This was significantly higher than the impact from the termination of the Astellas collaboration in 2023, which resulted in $42.4 million of revenue being recognized in March 2023. No revenue from commercial product sales was recognized in the three and nine months to September 30, 2024.
● Research and development (R&D) expenses: R&D expenses for the three and nine months ended September 30, 2024, were $34.3 million and $110.0 million, respectively, compared to $37.8 million and $93.3 million for the same periods in 2023. R&D expenses in the three months ended September 30, 2024, decreased due to a decrease in subcontracted expenditures primarily due to a decrease in clinical trial expenses, offset by a decrease in offsetting reimbursements receivable for research and development tax and expenditure credits. Conversely, R&D expenses in the nine months ended September 30, 2024, increased due to an increase in the average number of employees engaged in research and development following the acquisition of TCR2 in June 2023, annual salary increases, increases in property costs, increases in manufacturing facility expenditure, an increase in in-process research and development costs and a decrease in offsetting reimbursements receivable for research and development tax and expenditure credits.
● Selling, general and administrative (SG&A) expenses: SG&A expenses for the three and nine months ended September 30, 2024, were $21.2 million and $60.1 million, respectively, compared to $16.2 million and $56.6 million for the same periods in 2023. SG&A expenses increased due to an increase in accounting, legal and professional fees in due to fees relating to business development work and preparation for commercialization, offset by a decrease in restructuring charges recognised in the first quarter of 2023 that were not repeated in 2024 and an increase in offsetting reimbursements.
● Net (loss)/profit: Net (loss)/profit attributable to holders of the Company’s ordinary shares for the three and nine months ended September 30, 2024, was a loss of $17.6 million and a profit of $3.4 million, respectively ($(0.01) and $0.00 per ordinary share), compared to losses of $45.6 million and $66.0 million ($(0.03) and $(0.06) per ordinary share), for the same periods in 2023.