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ADAP - Adaptimmune Therapeutics News Story

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Sector
Healthcare
Size
Mid Cap
Market Cap £435.4m
Enterprise Value £207.1m
Revenue £2.61m
Position in Universe 3434th / 6938

Adaptimmune Reports First Quarter Financial Results and Business Update

Thu 6th May, 2021 12:30pm
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- Initial SPEARHEAD-1 data to be presented in an oral presentation at ASCO -

- First preclinical update from HLA-independent TCR (HiT) targeting mesothelin
at ASGCT -

- Enrollment momentum in SURPASS and ADP-A2AFP clinical trials increased in Q1
-

- Astellas nominates second target as part of allogeneic co-development and
co-commercialization agreement -

- Financial guidance confirmed: funded into early 2023 -

- Conference call to be held today at 9:00 a.m. EDT (2:00 p.m. BST) -

PHILADELPHIA and OXFORD, United Kingdom, May 06, 2021 (GLOBE NEWSWIRE) --
Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to
treat cancer, today reported financial results for the first quarter
ended March 31, 2021 and provided a business update.

“We will present initial data at ASCO 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 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), 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
(https://www.adaptimmune.com/investors-and-media/news-events/press-releases/detail/186/adaptimmune-to-showcase-market-potential-for-spear-t-cell)
* 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
(https://www.adaptimmune.com/investors-and-media/news-events/press-releases/detail/8/astellas-and-adaptimmune-enter-into-agreement-to-co-develop)
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)
on June 4(th) during the Sarcoma Session starting at 1:30 p.m. EDT (abstract #
11504)

 * At time of data cut-off for the abstract(1), 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's
Meeting Library and the Company plans to issue a press release(2)
* 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
(https://www.adaptimmune.com/investors-and-media/news-events/press-releases/detail/185/durable-responses-with-adp-a2m4-in-synovial-sarcoma-with)
* 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) 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) 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
(https://www.adaptimmune.com/investors-and-media/news-events/press-releases/detail/8/astellas-and-adaptimmune-enter-into-agreement-to-co-develop)
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 Liquidity(4) 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).

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 Annual Report on Form 10-K filed with the
Securities and Exchange Commission (SEC) on February 25, 2021 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 condensed consolidated
balance sheet. The U.S. GAAP financial measure most directly comparable to
Total Liquidity is cash and cash equivalents as reported in the condensed
consolidated financial statements, which reconciles to Total Liquidity as
follows (in millions):

                                                                                                 
                                                             March 31,         December 31,      
                                                             2021              2020              
 Cash and cash equivalents                                   $      32,432     $        56,882   
 Marketable securities - available-for-sale debt securities         285,512             311,335  
 Total Liquidity                                             $      317,944    $        368,217  

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.



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

                                                                                                        
                                                   Three months ended                                   
                                                   March 31,                                            
                                                   2021                        2020                     
 Revenue                                           $    434                    $    761                 
 Operating expenses                                                                                     
 Research and development                               (24,506      )              (21,264      )      
 General and administrative                             (13,817      )              (9,261       )      
 Total operating expenses                               (38,323      )              (30,525      )      
 Operating loss                                         (37,889      )              (29,764      )      
 Interest income                                        425                         730                 
 Other (expense) income, net                            (1           )              937                 
 Loss before income taxes                               (37,465      )              (28,097      )      
 Income taxes                                           (298         )              (70          )      
 Net loss attributable to ordinary shareholders    $    (37,763      )         $    (28,167      )      
                                                                                                        
 Net loss per ordinary share                                                                            
 Basic and diluted                                 $    (0.04        )         $    (0.04        )      
                                                                                                        
 Weighted average shares outstanding:                                                                   
 Basic and diluted                                      931,088,810                 739,753,371         
                                                                                                        



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

                                                                                                                                                                                                                                            
                                                                                                                                                                                            March 31,               December 31,            
                                                                                                                                                                                            2021                    2020                    
 Assets                                                                                                                                                                                                                                     
 Current assets                                                                                                                                                                                                                             
 Cash and cash equivalents                                                                                                                                                                  $     32,432            $      56,882           
 Marketable securities - available-for-sale debt securities                                                                                                                                       285,512                  311,335          
 Other current assets and prepaid expenses                                                                                                                                                        41,349                   29,935           
 Total current assets                                                                                                                                                                             359,293                  398,152          
                                                                                                                                                                                                                                            
 Restricted cash                                                                                                                                                                                  4,604                    4,602            
 Operating lease right-of-use assets, net of accumulated amortization                                                                                                                             18,326                   18,880           
 Property, plant and equipment, net of accumulated depreciation of $32,703 (2020: $31,097)                                                                                                        27,739                   27,778           
 Intangibles, net of accumulated amortization                                                                                                                                                     1,619                    1,730            
 Total assets                                                                                                                                                                               $     411,581           $      451,142          
                                                                                                                                                                                                                                            
 Liabilities and stockholders’ equity                                                                                                                                                                                                       
 Current liabilities                                                                                                                                                                                                                        
 Accounts payable                                                                                                                                                                           $     4,116             $      6,389            
 Operating lease liabilities, current                                                                                                                                                             2,845                    2,773            
 Accrued expenses and other accrued liabilities                                                                                                                                                   22,263                   27,079           
 Deferred revenue, current                                                                                                                                                                        2,083                    2,832            
 Total current liabilities                                                                                                                                                                        31,307                   39,073           
                                                                                                                                                                                                                                            
 Operating lease liabilities, non-current                                                                                                                                                         19,897                   20,938           
 Deferred revenue, non-current                                                                                                                                                                    50,565                   49,260           
 Other liabilities, non-current                                                                                                                                                                   655                      644              
 Total liabilities                                                                                                                                                                                102,424                  109,915          
                                                                                                                                                                                                                                            
 Stockholders’ equity                                                                                                                                                                                                                       
 Common stock - Ordinary shares par value £0.001, 1,038,249,630 authorized and 932,817,168 issued and outstanding (2020: 1,038,249,630 authorized and 928,754,958 issued and outstanding)         1,331                    1,325            
 Additional paid in capital                                                                                                                                                                       941,569                  935,706          
 Accumulated other comprehensive loss                                                                                                                                                             (10,224   )              (10,048   )      
 Accumulated deficit                                                                                                                                                                              (623,519  )              (585,756  )      
 Total stockholders' equity                                                                                                                                                                       309,157                  341,227          
                                                                                                                                                                                                                                            
 Total liabilities and stockholders’ equity                                                                                                                                                 $     411,581           $      451,142          



Condensed Consolidated Cash Flow Statement
(unaudited, in thousands)

                                                                                                                                      
                                                                                         Three months ended                           
                                                                                         March 31,                                    
                                                                                         2021                    2020                 
 Cash flows from operating activities                                                                                                 
 Net loss                                                                                $    (37,763  )         $    (28,167  )      
 Adjustments to reconcile net loss to net cash used in operating activities:                                                          
 Depreciation                                                                                 1,436                   1,711           
 Share-based compensation expense                                                             5,334                   1,448           
 Unrealized foreign exchange losses (gains)                                                   1,249                   (1,745   )      
 Amortization on available-for-sale debt securities                                           1,499                   150             
 Other                                                                                        1,299                   175             
 Changes in operating assets and liabilities:                                                                                         
 Increase in receivables and other operating assets                                           (11,155  )              (3,193   )      
 Increase in non-current operating assets                                                     —                       (259     )      
 Decrease in payables and other current liabilities                                           (8,601   )              (2,708   )      
 Increase in deferred revenue                                                                 162                     49,445          
 Net cash (used in) provided by operating activities                                          (46,540  )              16,857          
                                                                                                                                      
 Cash flows from investing activities                                                                                                 
 Acquisition of property, plant and equipment                                                 (1,152   )              (192     )      
 Acquisition of intangibles                                                                   (133     )              (152     )      
 Maturity or redemption of marketable securities                                              84,646                  26,364          
 Investment in marketable securities                                                          (61,599  )              (97,967  )      
 Net cash provided by (used in) investing activities                                          21,762                  (71,947  )      
                                                                                                                                      
 Cash flows from financing activities                                                                                                 
 Proceeds from issuance of common stock, net of issuance costs                                —                       90,550          
 Proceeds from exercise of stock options                                                      534                     894             
 Net cash provided by financing activities                                                    534                     91,444          
                                                                                                                                      
 Effect of currency exchange rate changes on cash, cash equivalents and restricted cash       (204     )              (502     )      
 Net (decrease) increase in cash, cash equivalents and restricted cash                        (24,448  )              35,852          
 Cash, cash equivalents and restricted cash at start of period                                61,484                  54,908          
 Cash, cash equivalents and restricted cash at end of period                             $    37,036             $    90,760          
                                                                                                                                      

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) Data cut-off for the abstract was February 4, 2021. 
(2) “Once an abstract has been publicly released by ASCO and the embargo has
lifted, authors and research sponsors may widely distribute a press release
containing the full data, including any additional or updated data that will
be presented at the meeting even if not included in the abstract itself.”
(https://bit.ly/3dHgOcn) 
(3) All data updates subject to congress acceptance
(4) 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.

(https://www.globenewswire.com/NewsRoom/AttachmentNg/f61dc272-2f81-43b4-97ce-b387507030db)



GlobeNewswire, Inc. 2021
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