On March 6, 2023 Adaptimmune Therapeutics plc (NASDAQ: ADAP), a leader in cell therapy to treat cancer, reported financial results for the fourth quarter and full year ended December 31, 2022 and provided a business update (Press release, Adaptimmune, MAR 6, 2023, View Source [SID1234628208]).
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Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer: "The last twelve months have seen immense progress in autologous cell therapies for people with cancer. CAR-T therapies have established autologous T-cell therapy as viable businesses within the broader cell and gene therapy market, which has annual sales exceeding three billion dollars. Our progress with T-cell therapies in solid tumors is truly exciting, as solid tumors account for nearly 90% of all adult cancers. I think 2023 will be a breakout year for T-cell therapies to address the broader cancer market, with Adaptimmune at the forefront."
Adaptimmune’s first potential commercial product, afami-cel, for the treatment of synovial sarcoma
Adaptimmune initiated its BLA submission to the U.S. Food and Drug Administration (FDA) in the fourth-quarter 2022 and is on track to complete the BLA in mid-2023. This BLA is supported by data from Cohort 1 of the pivotal trial SPEARHEAD-1, which met its primary endpoint for efficacy. The Company has Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for afami-cel for the treatment of synovial sarcoma.
As reported in November 2022, data presented at the Connective Tissue Oncology Society (CTOS) annual meeting indicate continued clinical responses with an acceptable safety profile in heavily pre-treated patients with late-stage synovial sarcoma after a single dose of afami-cel.
Overall response rate was 39% in heavily pre-treated patients with synovial sarcoma, with a median duration of response of ~12 months
Afami-cel shown to drive tumor infiltration of activated and proliferative cytotoxic ("killer") T-cells into tumors – which likely contributes to antitumor responses.
Benefit:risk profile of afami-cel has been favorable, to date
Potential of next-gen MAGE-A4 TCR T-cell therapy (ADP-A2M4CD8) in multiple solid tumors
The following results were reported from 43 evaluable patients the Phase 1 SURPASS trial at the beginning of the year in heavily pre-treated patients with late-stage cancers after a single dose of ADP-A2M4CD8
37% overall response rate across multiple solid tumors
52% response rate in the focus indications of ovarian, bladder and head & neck cancers
75% response rate in these focus indications amongst patients who received ≤ 3 prior lines of therapy
The Company is initiating a Phase 2 trial, SURPASS-3, in 1H 2023 for people with ovarian cancer.
SURPASS-3 will be conducted in patients with platinum resistant ovarian cancer who have received ≤ 4 prior lines of therapy; ADP-A2M4CD8 will be investigated as monotherapy and also combined with the checkpoint inhibitor nivolumab.
SURPASS-3, which could become registrational, is supported by RMAT designation from the FDA and is being developed in collaboration with The GOG Foundation, Inc.
Adaptimmune is initiating two new cohorts in the Phase 1 SURPASS trial, combining ADP-A2M4CD8 with the checkpoint inhibitor pembrolizumab in 1) the second line treatment setting for bladder cancer and 2) in the first line treatment setting for head & neck cancer.
As announced last year, the Company has closed the SURPASS-2 trial in gastroesophageal cancers to further enrollment
Preclinical pipeline update
Last year, the Company announced that it will gain full control of the late-stage preclinical optimized PRAME TCR as well as the NY-ESO cell therapy program; discussions with GSK to finalize termination and transfer terms remain ongoing
The Company aims for the PRAME program to be IND-ready in 2023
Adaptimmune will continue to focus on its MAGE-A4 franchise while determining the optimal development path for complementary PRAME and NY-ESO programs
Partnered programs with Genentech continue with the allogeneic pipeline and the Company is also advancing its own wholly owned allogeneic programs
Last year, the Company took the decision to change the cell line being used to develop its MAGE-A4 allogeneic cell therapy. This change was due to the presence of a chromosomal abnormality in the original cell line and will delay the timing of the first allogeneic IND submission to 2025. This original cell line is not used in any of the Company’s partnered programs.
Corporate and other news
Adaptimmune announced a strategic combination with TCR² Therapeutics Inc. earlier today (please refer to separate press release dated March 6, 2023). As a result, and following the closing of the transaction, it is anticipated that the combined company’s cash runway will extend into early 2026.
Adaptimmune and Universal Cells have agreed to terminate the Collaboration and License Agreement dated January 13, 2020 under which the parties agreed to co-develop certain allogeneic cell therapies. Termination is effective as of March 6, 2023. Termination does not impact the development of our allogeneic cell lines for our internal allogeneic programs or for our collaboration with Genentech Inc.
Completed the majority of the expenditure on two capital projects to prepare manufacturing network for the next phase of growth.
Additional cleanroom space in the manufacturing facility at the Navy Yard in Philadelphia, PA for future commercial launch of afami-cel
Construction of a dedicated allogeneic manufacturing facility in the United Kingdom (co-located with its UK research headquarters) to supply future allogeneic products.
Completed restructuring with a reduction in headcount of approximately 25%.
In connection with the Company’s restructuring, Cintia Piccina separated from the Company as its Chief Commercial Officer effective March 5, 2023. Ms. Piccina remains engaged with Adaptimmune on a consultancy basis.
Financial Results for the fourth quarter and year ended December 31, 2022
Cash / liquidity position: As of December 31, 2022, Adaptimmune had cash and cash equivalents of $108.0 million and Total Liquidity1 of $204.6 million, compared to $149.9 million and $369.6 million, respectively, as of December 31, 2021.
Revenue: Revenue for the fourth quarter and year ended December 31, 2022 was $11.0 million and $27.1 million, respectively, compared to $1.4 million and $6.1 million for the same periods in 2021. Revenue has increased primarily due to an increase in development activities under our collaboration arrangements, in particular due to development activities under the Genentech Strategic Collaboration and License Agreement, which become effective in October 2021. Revenue also increased due to a $6 million payment receivable from GSK as a result of the termination and amendment to the GSK Collaboration and License Agreement.
Research and development (R&D) expenses: R&D expenses for the fourth quarter and year ended December 31, 2022 were $23.1 million and $127.7 million, respectively, compared to $29.5 million and $111.1 million for the same periods in 2021. R&D expenses increased due to an increase in the average number of employees engaged in research and development, increases in subcontracted expenditures and 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 fourth quarter and year ended December 31, 2022 were $15.2 million and $63.4 million, respectively, compared to $14.8 million and $57.3 million for the same periods in 2021 due to increases in employee-related costs and other corporate costs and restructuring charges.
Net loss: Net loss attributable to holders of the Company’s ordinary shares for the fourth quarter and year ended December 31, 2022 was $29.3 million and $165.5 million, respectively ($(0.03) and $(0.17) per ordinary share), compared to $38.9 million and $158.1 million, respectively ($(0.04) and $(0.17) per ordinary share), for the same periods in 2021.
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 reductions in the Company’s operating costs as a result of the restructuring of the Company that is expected to be completed in the first quarter of 2023, will fund the Company’s current operations into early 2025, as further detailed in the Company’s Quarterly Report on Form 10-K for the fourth quarter and year ended December 31, 2022, to be filed with the Securities and Exchange Commission following this earnings release.
On March 6, 2023 the Company announced entry into a merger agreement under which the Company will combine with TCR² Therapeutics Inc in an all-stock transaction. Following the closing of the transaction, we currently estimate that the cash runway of the combined company will extend into early 2026.
Webcast Information
The Company will host a live webcast to provide additional details at 8:00 a.m. EDT (1:00 p.m. GMT) today, March 6, 2023. A live webcast of the conference call and replay can be accessed at View Source Call in information is as follows: (800)-319-4610 (US or Canada) or +1 (416)-915-3239 (International and additional options available HERE). Callers should dial in 5-10 minutes prior to the scheduled start time and simply ask to join the Adaptimmune call.