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Adaptimmune Reports Fourth Quarter / Full Year 2019 Financial Results and Business Update - Compelling data in synovial sarcoma in the Phase 1 trial, and continued momentum in the Phase 2 SPEARHEAD-1 trial with goal to l

Key Takeaway: Adaptimmune Reports Fourth Quarter / Full Year 2019 Financial Results and Business Update - Compelling data in synovial sarcoma in the Phase 1 trial, and continued momentum in the Phase 2 SPEARHEAD-1 trial with goal to launch ADP A2M4 for sarcoma in 2022 - Encouraging demonst

Full Press Release Details

Adaptimmune Reports Fourth Quarter /
Full Year 2019 Financial Results and Business Update
- Compelling data in synovial sarcoma in
the Phase 1 trial, and continued momentum in the Phase 2 SPEARHEAD-1 trial with goal to launch ADP A2M4 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, Pa. and OXFORD, U.K., February 27, 2020 -
Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell therapy to treat cancer,
today reported financial results for the fourth quarter and year ended December 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, Adaptimmune's 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 cancer
Based 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 ADP A2M4 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 Adaptimmune's 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
In 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
Adaptimmune's stem-cell derived allogeneic T-cell platform. This new
collaboration may encompass both CAR-T and TCR T-cell approaches, including Adaptimmune's novel HLA-independent TCR
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 position
Adrian 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.
Adaptimmune's 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 Company's 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 milestones
Financial Results for the fourth quarter and year ended
Cash / liquidity position: As of December 31, 2019, Adaptimmune had cash and cash equivalents of $50.4 million and Total Liquidity 1 of $89.5 million.
Revenue: Revenue for the fourth quarter and year ended December 31, 2019 were $0.7 million and $1.1 million compared to $1.5 million and $59.5 million for the same periods of 2018. The revenue recognized for the year ended December 31, 2019 is due to development work on the third target program under the GSK Collaboration and License Agreement. Revenue for the year ended December 31, 2018 included $39.1 million of license revenue and $20.4 million of development revenue due to the performance under the NY-ESO transition program and the PRAME development plan, which were completed in 2018.
Research and development ("R&D") expenses: R&D expenses for the fourth quarter and year ended December 31, 2019 were $20.4 million and $97.5 million, compared to $22.8 million and $98.3 million for the same periods of 2018. The decrease in R&D expenses for the year ended December 31, 2019 was driven by a reduction in subcontracted expenses and clinical trial costs following the transfer of NY-ESO to GSK in 2018 and a decrease in share-based compensation expenditure, offset by recognition of accrued purchase commitments for clinical materials and payments for in-process research and development (following collaborations with Alpine Immune Sciences, Inc. and Noile-Immune Biotech, Inc.).
General and administrative ("G&A") expenses: G&A expenses for the fourth quarter and year ended December 31, 2019 were $10.7 million and $43.4 million, compared to $10.8 million and $43.6 million for the same periods of 2018.
Net loss: Net loss attributable to holders of the Company's ordinary shares for the fourth quarter and year ended December 31, 2019 was $29.4 million and $137.2 million ($(0.22) per ordinary share) compared to $36.2 million and $95.5 million ( $(0.16) per ordinary share) in the same periods of 2018.
The 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 Company's current operating plan
into the second half of 2021.
Conference Call Information
The 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 Adaptimmune's corporate website at 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).
Adaptimmune is a clinical-stage biopharmaceutical company
focused on the development of novel cancer immunotherapy products for people with cancer. The Company's 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.
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.
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
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 Company's Consolidated Balance Sheet. The U.S. GAAP financial
measure most directly comparable to Total Liquidity is cash and cash equivalents as reported in the Company's Consolidated
Financial Statements, which reconciles to Total Liquidity as follows (unaudited):
December 31, December 31,
2019 2018
Cash and cash equivalents $ 50,412 $ 68,379
Marketable securities 39,130 136,755
Total Liquidity $ 89,542 $ 205,134
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.
Last updated: Feb 27, 2020