Adaptimmune Therapeutics logo

ADAP - Adaptimmune Therapeutics News Story

$4.78 0.1  1.3%

Last Trade - 11/05/21

Sector
Healthcare
Size
Mid Cap
Market Cap £525.6m
Enterprise Value £300.8m
Revenue £2.57m
Position in Universe 3130th / 6853

Adaptimmune Reports Fourth Quarter / Full Year 2020 Financial Results and Business Update

Thu 25th February, 2021 12:30pm
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- Outlined strategy to build integrated cell therapy company and the
Company’s “2-2-5-2” five-year core value drivers -

- Reported compelling durable responses in patients with synovial sarcoma, and
initial responses in lung, head and neck, liver, esophagogastric junction, and
melanoma cancers confirming potential of SPEAR T-cells for solid tumors -

- Completed enrollment of SPEARHEAD-1 clinical trial, to support planned BLA
filing and commercialization in 2022 for ADP-A2M4 for people with synovial
sarcoma -

- Initiating Phase 2 trial (SURPASS-2) with ADP-A2M4CD8 in esophageal and
esophagogastric junction cancers in 1H 2021 -

- Demonstrated killing of cancer cells with T-cells derived from the
Company’s allogeneic platform. MAGE-A4 and mesothelin to be first allogeneic
programs into the clinic -

- Financial guidance confirmed: funded into early 2023 -

PHILADELPHIA and OXFORDSHIRE, United Kingdom, Feb. 25, 2021 (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
ended December 31, 2020, and provided a business update.

“We are building the cell therapy company of the future for people with
cancer. With our ‘2-2-5-2’ by 2025 strategic plan, we will deliver value
with marketed SPEAR T-cell products starting with ADP-A2M4 for people with
synovial sarcoma,” said Adrian Rawcliffe, Adaptimmune’s Chief Executive
Officer. “We completed enrollment in our SPEARHEAD-1 trial in approximately
12 months to support our first BLA, which is strong evidence of our ability
to execute rapidly. We are focusing the SURPASS trial, using our
next-generation ADP-A2M4CD8 product, on lung, gastroesophageal, head and neck,
and bladder cancers to identify new indications to take forward to late-stage
development.”

Planned 2021 data updates(1)
* SPEARHEAD-1 trial with ADP-A2M4 for people with synovial sarcoma * June:
preliminary data at American Society of Clinical Oncology (ASCO)
* November: full update at Connective Tissue Oncology Society (CTOS)
 
* SURPASS Phase 1 trial with ADP-A2M4CD8 (next-generation product targeting
MAGE-A4) * September: update at European Society for Medical Oncology (ESMO)
 
* Additional clinical updates * September: update at International Liver
Cancer Association (ILCA) conference for ADP-A2AFP Phase 1 trial for people
with liver cancer
* October: update at American Society for Radiation Oncology (ASTRO) for
radiation sub-study of the ADP-A2M4 Phase 1 trial(2)
* November: ADP-A2M4 translational data update at Society for Immunotherapy of
Cancer (SITC)
“2-2-5-2” by 2025 strategic plan
At an Investor Day held in November 2020, the Company outlined its
“2-2-5-2” by 2025 strategic plan encompassing:

“2” - Two marketed products targeting MAGE-A4
Estimated potential addressable population in tumor types with significant
MAGE-A4 expression, factored for HLA-A2(3), is ~39,000 patients per year in
the US and EU

Durable responses in synovial sarcoma – on track to file a Biologics License
Application (BLA) for ADP-A2M4 in 2022
* The first commercial opportunity for SPEAR T-cells targeting MAGE-A4 will be
in synovial sarcoma with plans to file a BLA in the US in 2022
* In 2020, the Company received positive endorsements from regulatory
authorities with Regenerative Medicine Advanced Therapy (RMAT) designation and
Orphan Drug Designation (ODD) in the US, and access to PRIority MEdicines
(PRIME) regulatory support and ODD in the EU
* Data from the Phase 1 trial with ADP-A2M4 (presented at CTOS 2020
(https://www.adaptimmune.com/investors-and-media/news-events/press-releases/detail/185/durable-responses-with-adp-a2m4-in-synovial-sarcoma-with))
* In 16 patients with synovial sarcoma, there was an Overall Response Rate of
44% and a Disease Control Rate of 94%
* Responses were durable with a median duration of response of 28 weeks with
ongoing responses beyond 72 weeks in two patients (median overall survival
had not been reached)
* These data are considerably superior(4) to response rates observed with
available second line therapies in synovial sarcoma
SURPASS-2 in esophageal and esophagogastric junction (EGJ) cancers in 1H 2021
* The Company will initiate a Phase 2 trial, SURPASS-2, with ADP-A2M4CD8
(next-generation SPEAR T-cells targeting MAGE-A4 that co-express CD8α
intended to increase potency) for patients with esophageal or EGJ cancers in
1H 2021
* SURPASS-2 is supported by encouraging data from the Phase 1 SURPASS trial
(presented at SITC 2020
(https://www.adaptimmune.com/investors-and-media/news-events/press-releases/detail/183/two-confirmed-responses-and-five-out-of-six-patients-with))
with one confirmed partial response (PR) in a patient with EGJ cancer and
tumor reductions in two additional patients (1 with esophageal and 1 with EGJ
cancer)
* The trial will be conducted at multiple centers in North America and the EU,
and is intended to enroll 45 people with esophageal or EGJ cancers to be
treated with doses up to 10 billion SPEAR T-cells
* The Company also presented preclinical data at SITC 2020 indicating that AKT
inhibition during the manufacture of SPEAR T-cells results in a more
consistent expansion and phenotype of the final product. This process is
currently being used for the Phase 1 SURPASS trial.
“2” - Two additional BLAs for SPEAR T-cell products
* Adaptimmune’s Phase 1 SURPASS trial with ADP-A2M4CD8 continues to enroll
patients, focusing on lung, gastroesophageal, head and neck, and bladder
cancers – indications for which the Company has reported responses or signs
of efficacy with its MAGE-A4 targeted products
* In 2020, Adaptimmune initiated SPEARHEAD-2 with its first-generation
SPEAR T-cells targeting MAGE-A4 in combination with pembrolizumab for people
with head and neck cancers
* The Phase 1 trial with ADP-A2AFP for people with liver cancer is ongoing. As
presented at ILC 2020
(https://www.adaptimmune.com/investors-and-media/news-events/press-releases/detail/179/promising-data-from-phase-1-trial-with-adp-a2afp-in-liver),
nine patients were treated as of the data cut-off and best responses were: *
One patient with a complete response, one with stable disease (SD), and two
with progressive disease (PD) among the four patients who received ~5 billion
or more SPEAR T-cells
* Five patients with SD who received doses of 100 million and 1 billion
SPEAR T-cells in the first two dose cohorts
“5” - Five new autologous products in the clinic
* Adaptimmune has a deep preclinical pipeline from which it expects to bring
five new products into the clinic.
* These include multiple possibilities for next-generation autologous SPEAR
T-cells such as: * ADP-A2AFP SPEAR T-cells co-expressing CD8α
* ADP-A2M4 SPEAR T-cells co-expressing IL-7, IL-15, dnTGFβ, and/ or PDE7
* Enhancing SPEAR T-cells with IL-7 for proliferation and survival and CCL19
for migration into tumor in collaboration with Noile-Immune Biotech, Inc.
* Enhancing SPEAR T-cells using transmembrane and surface immunoregulatory
mechanisms with Alpine Immune Sciences, Inc.
 
* The Company is also developing new products, including: * Expanding into
HLAs beyond HLA-A2 to increase the addressable patient population
* HLA-independent TCR (HiT) candidates for multiple targets including GPC3
* A new program for next-generation TILs co-expressing IL-7 in melanoma in
collaboration with leading TIL therapy center (CCIT, Denmark
(https://www.adaptimmune.com/investors-and-media/news-events/press-releases/detail/186/adaptimmune-to-showcase-market-potential-for-spear-t-cell))
“2” - Two allogeneic products in the clinic
* In January 2020, Adaptimmune announced
(https://www.adaptimmune.com/investors-and-media/news-events/press-releases/detail/8/astellas-and-adaptimmune-enter-into-agreement-to-co-develop)
it had entered into an agreement to co-develop and co-commercialize stem-cell
derived allogeneic cell therapies with Astellas * The first target nominated
is a HiT targeting mesothelin
 
* At ASGCT 2020
(https://www.adaptimmune.com/investors-and-media/news-events/press-releases/detail/171/adaptimmune-reports-q1-financial-results),
Adaptimmune presented data with evidence of its allogeneic platform
demonstrating differentiation of functional T-cells from human-induced
pluripotent stem cells (hiPSCs) that can kill MAGE-A4 expressing target cells
in vitro –targeted to become the Company’s first allogeneic product in the
clinic
Corporate updates from 2020
* Despite the impact of the COVID-19 pandemic on the biotechnology industry,
Adaptimmune continued to see improved enrollment in its clinical trials
* In Q1, the Company received an upfront payment of $50 million from Astellas.
The Company is also entitled to receive research funding of up to $7.5 million
per collaboration target per year
* Underwritten public offering in Q1 generated net proceeds of approximately
$90 million
* Underwritten public offering in Q2 generated net proceeds of approximately
$244 million
Financial Results for the fourth quarter and year ended December 31, 2020
* Cash / liquidity position: As of December 31, 2020, Adaptimmune had cash and
cash equivalents of $56.9 million and Total Liquidity(5) of $368.2 million. 


* Revenue: Revenue for the fourth quarter and year ended December 31, 2020 was
$1.5 million and $4.0 million, respectively, compared to $0.7 million and $1.1
million for the same periods in 2019. The increase was due to revenue arising
under the collaboration agreement with Astellas, which was entered into in
January 2020.


* Research and development (R&D) expenses: R&D expenses for the fourth quarter
and year ended December 31, 2020 were $25.8 million and $91.6 million,
respectively, compared to $20.4 million and $97.5 million for the same periods
in 2019. R&D expenses in the year ended December 31, 2019 included the accrual
of a purchase commitment and higher costs for in-process research and
development; excluding the impact of these, research and development expenses
have increased as the Company progresses development of its cell therapies.


* General and administrative (G&A) expenses: G&A expenses for the fourth
quarter and year ended December 31, 2020 were $13.2 million and $45.8 million,
respectively, compared to $10.7 million and $43.4 million for the same periods
in 2019. The increase in G&A expenses was due to an increase in general
corporate costs, including professional fees and insurance.


* Net loss: Net loss attributable to holders of the Company’s ordinary
shares for the fourth quarter and year ended December 31, 2020 was $36.6
million and $130.1 million ($(0.15 per ordinary share), compared to
$29.4 million and $137.2 million ($(0.22) per ordinary share) for the same
periods in 2019.
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 Annual Report on Form 10-K for the year
ended December 31, 2020, 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 8:00 a.m. EST (1:00 p.m. GMT) today, February 25, 2021. 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 (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
(2099860).

About Adaptimmune
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. 

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 5, 2020, 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 (a non-GAAP financial measure) is the total of cash and cash
equivalents and marketable securities (available-for-sale debt securities).
Each of these components appears separately in the consolidated balance sheet.
The US GAAP financial measure most directly comparable to Total Liquidity is
cash and cash equivalents as reported in the consolidated financial
statements, which reconciles to Total Liquidity as follows (in millions):

                                                                                                     
                                                               December 31,        December 31,      
                                                               2020                2019              
 Cash and cash equivalents                                     $        56,882     $        50,412   
 Marketable securities - available-for-sale debt securities             311,335             39,130   
 Total Liquidity                                               $        368,217    $        89,542   

The Company believes that the presentation of Total Liquidity provides useful
information to investors because management reviews Total Liquidity as part of
its assessment of overall liquidity, financial flexibility, capital structure
and leverage.

Consolidated Statement of Operations
(unaudited, in thousands, except per share data)

                                                                                                                                                                                                                       
                                                                                                              Three months ended                                         Year ended                                    
                                                                                                              December 31,                                               December 31,                                  
                                                                                                              2020                        2019                           2020                     2019                 
 Revenue                                                                                                           1,502                       728                           3,958                    1,122            
 Operating expenses                                                                                                                                                                                                    
 Research and development (including losses accrued on firm purchase commitments of $0, $0, $0 and $5,000)         (25,777      )              (20,354      )                (91,568      )           (97,501      )   
 General and administrative                                                                                        (13,238      )              (10,729      )                (45,795      )           (43,391      )   
 Total operating expenses                                                                                          (39,015      )              (31,083      )                (137,363     )           (140,892     )   
 Operating loss                                                                                                    (37,513      )              (30,355      )                (133,405     )           (139,770     )   
 Interest income                                                                                                   538                         448                           2,313                    2,772            
 Other income (expense), net                                                                                       414                         631                           1,162                    75               
 Loss before income taxes                                                                                          (36,561      )              (29,276      )                (129,930     )           (136,923     )   
 Income taxes                                                                                                      (52          )              (88          )                (162         )           (242         )   
 Net loss attributable to ordinary shareholders                                                               $    (36,613      )         $    (29,364      )            $   (130,092     )       $   (137,165     )   
                                                                                                                                                                                                                       
 Net loss per ordinary share                                                                                                                                                                                           
 Basic and diluted                                                                                            $    (0.04        )         $    (0.05        )            $   (0.15        )       $   (0.22        )   
                                                                                                                                                                                                                       
 Weighted average shares outstanding:                                                                                                                                                                                  
 Basic and diluted                                                                                                 928,676,161                 630,994,079                   854,783,763              629,805,218      

Consolidated Balance Sheets
(unaudited, in thousands, except share data)

                                                                                                                                                                                                                                              
                                                                                                                                                                                            December 31,              December 31,            
                                                                                                                                                                                            2020                      2019                    
 Assets                                                                                                                                                                                                                                       
 Current assets                                                                                                                                                                                                                               
 Cash and cash equivalents                                                                                                                                                                  $      56,882             $      50,412           
 Marketable securities - available-for-sale debt securities                                                                                                                                        311,335                   39,130           
 Accounts receivable, net of allowance for doubtful accounts of $0 and $0                                                                                                                          139                       —                
 Other current assets and prepaid expenses (including current portion of clinical materials)                                                                                                       29,796                    30,947           
 Total current assets                                                                                                                                                                              398,152                   120,489          
                                                                                                                                                                                                                                              
 Restricted cash                                                                                                                                                                                   4,602                     4,496            
 Clinical materials                                                                                                                                                                                —                         2,503            
 Operating lease right-of-use assets, net of accumulated amortization                                                                                                                              18,880                    20,789           
 Property, plant and equipment, net of accumulated depreciation                                                                                                                                    27,778                    31,068           
 Intangibles, net of accumulated amortization                                                                                                                                                      1,730                     2,198            
 Total assets                                                                                                                                                                               $      451,142            $      181,543          
                                                                                                                                                                                                                                              
 Liabilities and stockholders’ equity                                                                                                                                                                                                         
 Current liabilities                                                                                                                                                                                                                          
 Accounts payable                                                                                                                                                                           $      6,389              $      6,357            
 Operating lease liabilities, current                                                                                                                                                              2,773                     2,493            
 Accrued expenses and other accrued liabilities                                                                                                                                                    27,079                    23,363           
 Deferred revenue, current                                                                                                                                                                         2,832                     2,128            
 Total current liabilities                                                                                                                                                                         39,073                    34,341           
                                                                                                                                                                                                                                              
 Operating lease liabilities, non-current                                                                                                                                                          20,938                    22,966           
 Deferred revenue, non-current                                                                                                                                                                     49,260                    —                
 Other liabilities, non-current                                                                                                                                                                    644                       598              
 Total liabilities                                                                                                                                                                                 109,915                   57,905           
                                                                                                                                                                                                                                              
 Stockholders’ equity                                                                                                                                                                                                                         
 Common stock - Ordinary shares par value £0.001, 1,038,249,630 authorized and 928,754,958 issued and outstanding (2019: 785,857,300 authorized and 631,003,568 issued and outstanding)            1,325                     943              
 Additional paid in capital                                                                                                                                                                        935,706                   585,623          
 Accumulated other comprehensive loss                                                                                                                                                              (10,048   )               (7,264    )      
 Accumulated deficit                                                                                                                                                                               (585,756  )               (455,664  )      
 Total stockholders' equity                                                                                                                                                                        341,227                   123,638          
                                                                                                                                                                                                                                              
 Total liabilities and stockholders’ equity                                                                                                                                                 $      451,142            $      181,543          

Consolidated Cash Flow Statement
(unaudited, in thousands)

                                                                                                                                                   
                                                                                                 Year ended                Year ended              
                                                                                                 December 31,              December 31,            
                                                                                                 2020                      2019                    
 Cash flows from operating activities                                                                                                              
 Net loss                                                                                        $      (130,092  )        $      (137,165  )      
 Adjustments to reconcile net loss to net cash used in operating activities:                                                                       
 Depreciation                                                                                           6,627                     7,172            
 Amortization                                                                                           967                       838              
 Share-based compensation expense                                                                       10,414                    11,053           
 Unrealized foreign exchange (gains) losses                                                             (1,333    )               1,076            
 Amortization (accretion) on available-for-sale debt securities                                         3,836                     (185      )      
 Other                                                                                                  (55       )               (13       )      
 Changes in operating assets and liabilities:                                                                                                      
 Decrease (increase) in receivables and other operating assets                                          1,747                     (1,436    )      
 Decrease (increase) in non-current operating assets                                                    2,458                     (1,450    )      
 Increase (decrease) in payables and other liabilities                                                  3,867                     5,508            
 Increase (decrease) in deferred revenue                                                                47,973                    2,095            
 Net cash used in operating activities                                                                  (53,591   )               (112,507  )      
                                                                                                                                                   
 Cash flows from investing activities                                                                                                              
 Acquisition of property, plant and equipment                                                           (2,341    )               (1,592    )      
 Acquisition of intangibles                                                                             (565      )               (1,482    )      
 Maturity or redemption of marketable securities                                                        105,022                   125,303          
 Investment in marketable securities                                                                    (381,040  )               (27,284   )      
 Net cash (used in) provided by investing activities                                                    (278,924  )               94,945           
                                                                                                                                                   
 Cash flows from financing activities                                                                                                              
 Proceeds from issuance of shares in the January offering                                               78,616                    —                
 Proceeds from issuance of shares upon exercise of the overallotment for the January Offering           11,938                    —                
 Proceeds from issuance of shares in the June Offering                                                  209,986                   —                
 Proceeds from issuance of shares upon exercise of the overallotment for the June Offering              33,848                    —                
 Proceeds from exercise of stock options                                                                5,663                     366              
 Net cash provided by financing activities                                                              340,051                   366              
                                                                                                                                                   
 Effect of currency exchange rate changes on cash, cash equivalents and restricted cash                 (960      )               (372      )      
 Net increase (decrease) in cash, cash equivalents and restricted cash                                  6,576                     (17,568   )      
 Cash, cash equivalents and restricted cash at start of period                                          54,908                    72,476           
 Cash, cash equivalents and restricted cash at end of period                                     $      61,484             $      54,908           

Adaptimmune Contacts:

Media Relations:

Sébastien Desprez — VP, Communications and Investor Relations
T: +44 1235 430 583
M: +44 7718 453 176
Sebastien.Desprez@adaptimmune.com

Investor Relations:

Juli P. Miller, Ph.D. — Senior Director, Investor Relations
T: +1 215 825 9310
M: +1 215 460 8920
Juli.Miller@adaptimmune.com

(1) All data updates subject to congress acceptance
(2) The main portion of the ADP-A2M4 Phase 1 trial is closed for enrollment 
(3) Mortality figures based on American Cancer Society 2020 (US) and Global
Can (EU) – synovial sarcoma data based on internal market research; MAGE-A4
expression ranges based on Adaptimmune samples and expression cut-off criteria
of ≥30% tumor cells at ≥2+ intensity; HLA-A2 expression of 41% based on
Adaptimmune samples (1,043 patient samples); serum AFP expression ranges based
on internal samples (62 patients) and expression cut off >100ng/mL
(4) Pollack S, et al. Cancer Medicine. 2020; 9:4593–4602; Seto T, et al Med.
Sci. 2019, 7, 48; van der Graaf WT, et al. 2012, Lancet, 379(9829), 1879-1886
(5) 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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