On May 6, 2021 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer, reported financial results for the first quarter ended March 31, 2021 and provided a business update (Press release, Adaptimmune, MAY 6, 2021, View Source [SID1234579397]).
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"We will present initial data at ASCO (Free ASCO Whitepaper) from our SPEARHEAD-1 trial that will support BLA submission in 2022. We have seen good enrollment in the SURPASS and ADP-A2AFP trials and will present data later this year," said Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer. "We continue to deliver against our ambitions laid out in our 2-2-5-2 strategic plan to bring products forward for clinical development and launch. At ASGCT (Free ASGCT Whitepaper) next week, we will present preclinical data from our first HiT product targeting mesothelin. Results indicate that this HiT works as well or better than similar cell therapy constructs targeting the same antigen in in vitro killing assays as well as an animal model."
Upcoming confirmed data updates
Data from the Company’s HiT mesothelin program, being co-developed with Astellas, to be presented at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper), in a poster presentation that will be available on the conference’s website May 11 at 8:00 a.m. EDT
Important progress towards achievement of preclinical pipeline milestones laid out in the Company’s strategic five-year "2-2-5-2" product development plan presented at Investor Day in November 2020
Preclinical data validate that human T-cells expressing a TCR that targets mesothelin independent of peptide-HLA recognition, can kill human tumor cells
Presentation will include animal model data that demonstrate superiority of the Company’s HiT targeting mesothelin over a comparator T-cell therapy construct targeting the same antigen in an in vivo tumor xenograft study
This product was nominated by Astellas as the first candidate under the agreement to co-develop and co-commercialize iPSc (stem-cell) derived allogeneic CAR-T and TCR T-cell therapies
Oral presentation of initial data from the SPEARHEAD-1 trial with afamitresgene autoleucel (afami-cel, formerly ADP-A2M4) for people with synovial sarcoma and MRCLS at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) on June 4th during the Sarcoma Session starting at 1:30 p.m. EDT (abstract # 11504)
At time of data cut-off for the abstract1, 32 patients had received afami-cel. Twenty-five patients were evaluable for preliminary efficacy and 7 patients had insufficient follow-up
On May 19, 2021 at 5:00 p.m. EDT, abstracts will be released on ASCO (Free ASCO Whitepaper)’s Meeting Library and the Company plans to issue a press release2
The Phase 2 SPEARHEAD-1 trial was initiated after promising results from the Phase 1 trial showed durable responses with afami-cel in synovial sarcoma with confirmed responses in 44% of patients, disease control rate of 94%, and median duration of response of 28 weeks presented at CTOS 2020
The Company will submit an abstract with a further update for consideration at CTOS 2021
Planned data updates 3
SURPASS Phase 1 trial with ADP-A2M4CD8 (next-generation product targeting MAGE-A4) at European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) in September
ADP-A2AFP Phase 1 trial for people with liver cancer at the International Liver Cancer Association (ILCA) in September
Radiation sub-study of the ADP-A2M4 Phase 1 trial at American Society for Radiation Oncology (ASTRO) in October
Afami-cel translational data update at Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November
Other Corporate News
Astellas has nominated the second target as part of the co-development and co-commercialization agreement signed with Adaptimmune in January 2020
Financial Results for the first quarter ended March 31, 2021
Cash / liquidity position: As of March 31, 2021, Adaptimmune had cash and cash equivalents of $32.4 million and Total Liquidity4 of $317.9 million.
Revenue: Revenue for the first quarter ended March 31, 2021 was $0.4 million, compared to $0.8 million for the same period in 2020.
Research and development (R&D) expenses: R&D expenses for the first quarter ended March 31, 2021 were $24.5 million compared to $21.3 million for the same period in 2020. R&D expenses increased in the quarter ended March 31, 2021 due to an increase in the number of employees engaged in research and development, and increases in costs related to the development of a companion diagnostic assay and our Phase 2 clinical trial associated with ADP-A2M4CD8. These increases were offset by an increase in reimbursements receivable for research and development tax and expenditure credits.
General and administrative (G&A) expenses: G&A expenses for the first quarter ended March 31, 2021 were $13.8 million compared to $9.3 million for the same period in 2020 due to an increase in share-based compensation expense and an increase in employee related costs.
Net loss: Net loss attributable to holders of the Company’s ordinary shares for the first quarter ended March 31, 2021 was $37.8 million ($(0.04 per ordinary share), compared to $28.2 million ($(0.04) per ordinary share) for the same period in 2020.
Financial Guidance
The Company believes that its existing cash, cash equivalents and marketable securities will fund the Company’s current operations into early 2023, as further detailed in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, to be filed with the Securities and Exchange Commission following this earnings release.
Conference Call Information
The Company will host a live teleconference and webcast to provide additional details at 9:00 a.m. EDT (2:00 p.m. BST) today, May 6, 2021. A live webcast of the conference call and replay can be accessed at https://bit.ly/2Ry9DdR. An archive will be available after the call at the same address. To participate in the live conference call, if preferred, please dial (833) 652-5917 (US or Canada) or +1 (430) 775-1624 (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (9271335).