- Compelling data in synovial sarcoma in the Phase 1 trial, and continued momentum in the Phase 2 SPEARHEAD-1 trial with goal to launch ADPA2M4 for sarcoma in 2022 -
- Encouraging demonstration of the potential of SPEAR T-cell platform in four new solid tumor indications -
- Co-development and co-commercialization agreement with Astellas to develop stem-cell derived off-the-shelf CAR-T and TCR T-cell therapies -
PHILADELPHIA and OXFORDSHIRE, United Kingdom, Feb. 27, 2020 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc(Nasdaq:ADAP), a leader in cell therapy to treat cancer, today reported financial results for the fourth quarter and year endedDecember 31, 2019, and provided a business update.
The last 12 months have been transformative. We reported responses in five different solid tumors, confirming that our SPEAR T-cell platform can treat a wide range of cancers. We also validated the potential of our allogeneic platform by demonstrating that we can generate functional T-cells from stem cells, and by signing our first major strategic deal in five years with Astellas, said Adrian Rawcliffe, Adaptimmunes Chief Executive Officer. With our passionate and skilled teams, and our world class capabilities, we are developing our cell therapy pipeline for a range of tumor indications, aiming to launch our first product in 2022 for people with sarcoma.
Responses in five solid tumor indications demonstrate SPEAR T-cell potential to treat cancerBased on compelling response data in synovial sarcoma from the Phase 1 trial announced in May of last year, and updated at ESMO and CTOS, the Phase 2 SPEARHEAD-1 trial was initiated with ADP-A2M4 in synovial sarcoma and myxoid/ round cell liposarcoma (MRCLS). The product was granted Orphan Drug Designation, for the treatment of soft tissue sarcomas, and Regenerative Medicine Advanced Therapy designation, for synovial sarcoma, by the US FDA. The Company aims to launch ADPA2M4 for sarcoma in 2022.
In January of this year, partial responses in liver, melanoma, gastro-esophageal junction, and head and neck cancers were reported. These early data in multiple indications demonstrate the potential of Adaptimmunes SPEAR T-cell platform across multiple targets and a range of solid tumors. Further updated data will be presented at upcoming medical / scientific meetings.
Partnerships to develop next-generation and off-the-shelf cell therapiesIn January of this year, a co-development and co-commercialization agreement with Astellas, through its wholly owned subsidiary Universal Cells, Inc., was announced for stem-cell derived allogeneic CAR-T and TCR T-cell therapies. The Company has received an upfront payment of $50 million under the agreement and is entitled to receive research funding of up to $7.5 million per year.
This agreement covers the co-development and co-commercialization of up to three T-cell therapies and leverages Astellas Universal Donor Cell Platform and Adaptimmunes stem-cell derived allogeneic T-cell platform. This new collaboration may encompass both CAR-T and TCR T-cell approaches, including Adaptimmunes novel HLA-independent TCR (HiT) platform.
In 2019, Adaptimmune announced agreements with Alpine Immune Sciences and Noile-Immune to develop further next-generation products.
Leadership, manufacturing and financial updates strengthen fully integrated cell therapy company positionAdrian Rawcliffe assumed the role of Chief Executive Officer effective September 1, 2019 and John Lunger became Chief Patient Supply Officer effective August 1, 2019. In January 2020, a series of changes to the R&D leadership were announced, including the appointment of Elliot Norry as Chief Medical Officer. These leadership changes strengthen the scientific and clinical organization from early to late stage and accelerate the application of translational science learnings to therapeutic candidates and trials, as Adaptimmune becomes a late-stage cell therapy company aiming to launch a commercial product in 2022.
Adaptimmunes in-house cell manufacturing facility located at the Navy Yard in Philadelphia, PA, is achieving a 25-day processing time for production of SPEAR T-cells. 95% of patient batches manufactured in 2019 met manufacturing criteria set for those batches. The Navy Yard facility was approved as a manufacturing source for a number of the Companys clinical trials in Europe. The Company also produced its first GMP batch of lentiviral vector using an in-house, proprietary suspension process at its dedicated manufacturing space within the Cell and Gene Therapy Catapult Manufacturing Centre at Stevenage, UK.
Finally, on January 24, 2020, the Company closed an underwritten public offering of 21,000,000 American Depository Shares (ADSs) which, together with the full exercise by the underwriters on February 7, 2020 of their option to purchase an additional 3,150,000 ADSs, generated net proceeds of approximately$89.8 million. Following the agreement with Astellas and the public offering of ADSs described above, the Company is funded into 2H 2021.
Planned 2020 milestonesFirst Half of 2020
Second Half of 2020
Financial Results for the fourth quarter and year ended December 31, 2019
Financial GuidanceThe Company believes that its existing cash and cash equivalents and marketable securities, Total Liquidity, together with the net proceeds received from the underwritten public offering in January 2020, the additional net proceeds generated from the exercise in full of the underwriters option in February 2020 and the upfront payment received under its agreement with Astellas in January 2020, will fund the Companys current operating plan into the second half of 2021.
Conference Call InformationThe Company will host a live teleconference and webcast to provide additional details at 8:00 a.m. EST (1:00 p.m. GMT) today, February 27, 2020. The live webcast of the conference call will be available via the events page of Adaptimmunes corporate website at http://www.adaptimmune.com. 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 (U.S. 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 (6083408).
About AdaptimmuneAdaptimmune is a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapy products for people with cancer. The Companys unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.
Forward-Looking StatementsThis 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 Quarterly Report on Form 10-Q filed with the SEC on November 6, 2019, and our other SEC filings. 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 is the total of cash and cash equivalents and marketable securities. Each of these components appears in the Companys Consolidated Balance Sheet. The U.S. GAAP financial measure most directly comparable to Total Liquidity is cash and cash equivalents as reported in the Companys Consolidated Financial Statements, which reconciles to Total Liquidity as follows (unaudited):
The Company believes that the presentation of Total Liquidity provides useful information to investors because management reviews Total Liquidity as part of its management of overall liquidity, financial flexibility, capital structure and leverage. The definition of Total Liquidity includes marketable securities, which are highly liquid and available to use in our current operations.
Consolidated Statement of Operations(unaudited, in thousands, except per share data)
Consolidated Balance Sheets(unaudited, in thousands)
Consolidated Cash Flow Statement(unaudited, in thousands)
Sbastien Desprez VP, Communications and Investor RelationsT: +44 1235 430 583M: +44 7718 453 176Sebastien.Desprez@adaptimmune.com
Juli P. Miller, Ph.D. Senior Director, Investor RelationsT: +1 215 825 9310M: +1 215 460 8920Juli.Miller@adaptimmune.com
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.
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