Adaptimmune Reports First Quarter Financial Results and Business Update

– Pooled data from Cohort 1 of the SPEARHEAD-1 trial and the Phase 1 trial of afami-cel in patients with sarcoma to be presented as a poster at ASCO –

– Preclinical data for two novel next-generation T-cell therapies to be presented in two posters at ASGCT –

– Updated MAGE-A4 expression levels from the Company’s screening protocol presented at AACR confirm the potential of this target in a broad range of solid tumors –

– Appointed Jo Brewer as Chief Scientific Officer –

– Financial guidance confirmed: funded into early 2024 –

– Conference call to be held today at 8:00 a.m. EDT (1:00 p.m. BST) –

PHILADELPHIA and OXFORDSHIRE, United Kingdom, May 09, 2022 (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, 2022 and provided a business update.

“We have four clear areas of focus this year: to file the BLA for afami-cel, continue to build our MAGE-A4 franchise, scale up our manufacturing capabilities, and continue to advance our allogeneic products. We have made good progress with each in 2022,” said Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer. “We remain funded into early 2024 and will continue to execute across these objectives.”

Roadmap to BLA submission for afami-cel1 in 2022 (first-generation product targeting MAGE-A4)

  • Adaptimmune is preparing the BLA and targeting submission to the US Food and Drug Administration (FDA) in Q4 2022 for the treatment of synovial sarcoma.
  • Updated data based on pooled analyses of characteristics associated with clinical responses from Cohort 1 of the SPEARHEAD-1 trial and the Phase 1 trial of afami-cel in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma to be presented in a poster at ASCO.

Preclinical data at the American Society for Cell and Gene Therapy (ASGCT) annual conference

  • Preclinical data from the next-generation SPEAR T-cell targeting MAGE-A4 incorporating IL-7 and CCL19 (ADP-A2M4N7X19), developed in collaboration with Noile-Immune, to be presented in a poster; the Company plans to file an IND for this next-generation SPEAR T-cell later this year.
  • Preclinical data from tumor-infiltrating lymphocytes (TILs) incorporating IL-7 (TIL-IL7), being developed in collaboration with the Center for Cancer Immune Therapy in Denmark, to be presented in a poster; a single-center clinical trial is planned for initiation in 2022.

Corporate
The Company appointed Dr. Joanna (Jo) Brewer as its Chief Scientific Officer effective May 4; Dr. Brewer previously served as the Company’s SVP Allogeneic Research.

Financial Results for the three months ended March 31, 2022

  • Cash / liquidity position: As of March 31, 2022, Adaptimmune had cash and cash equivalents of $89.5 million and Total Liquidity2 of $304.2 million, compared to $149.9 million and $369.6 million, respectively, as of December 31, 2021.
  • Revenue: Revenue for the three months ended March 31, 2022 was $3.6 million, compared to $0.4 million for the same period in 2021. Revenue has increased primarily due to an increase in development activities under our collaboration arrangements.
  • Research and development (R&D) expenses: R&D expenses for the three months ended March 31, 2022 were $36.8 million, compared to $24.5 million for the same period in 2021. R&D expenses increased due to an increase in the number of employees engaged in research and development, increases in subcontracted expenditures, increases in in-process research and development costs and a decrease in reimbursements receivable for research and development tax and expenditure credits.
  • General and administrative (G&A) expenses: G&A expenses for the three months ended March 31, 2022 were $16.8 million, compared to $13.8 million for the same period in 2021 due to increases in employee-related costs and other corporate costs.
  • Net loss: Net loss attributable to holders of the Company’s ordinary shares for the three months ended March 31, 2022 was $50.3 million ($(0.05) per ordinary share), compared to $37.8 million ($(0.04) per ordinary share) for the same period in 2021.

Financial Guidance
The Company believes that its existing cash, cash equivalents and marketable securities, together with the additional payments under the Strategic Collaboration and License Agreement with Genentech, will fund the Company’s current operations into early 2024, as further detailed in the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2022, 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. EDT (1:00 p.m. BST) today, May 9, 2022. 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 (6779362).

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 for the year ended December 31, 2021, our Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and other filings with the Securities and Exchange Commission. 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.

Adaptimmune Contacts:

Media Relations:

Sébastien Desprez — VP, Corporate Affairs and Communications
T: +44 1235 430 583
M: +44 7718 453 176
[email protected] 

Investor Relations:

Juli P. Miller, Ph.D. — VP, Investor Relations
T: +1 215 825 9310
M: +1 215 460 8920
[email protected] 

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, 
    2022   2021
Cash and cash equivalents   $ 89,539   $ 149,948
Marketable securities – available-for-sale debt securities     214,679     219,632
Total Liquidity   $ 304,218   $ 369,580

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 solvency and liquidity, financial flexibility, capital position and leverage.

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

             
           
       Three months ended
    March 31, 
       2022      2021
Revenue   $ 3,575     $ 434  
Operating expenses            
Research and development     (36,752 )     (24,506 )
General and administrative     (16,804 )     (13,817 )
Total operating expenses     (53,556 )     (38,323 )
Operating loss     (49,981 )     (37,889 )
Interest income     338       425  
Other income (expense), net     12       (1 )
Loss before income tax expense     (49,631 )     (37,465 )
Income tax expense     (634 )     (298 )
Net loss attributable to ordinary shareholders   $ (50,265 )   $ (37,763 )
             
Net loss per ordinary share            
Basic and diluted   $ (0.05 )   $ (0.04 )
             
Weighted average shares outstanding:            
Basic and diluted     940,029,247       931,088,810  
             

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

             
    March 31,    December 31, 
       2022      2021
Assets            
Current assets            
Cash and cash equivalents   $ 89,539     $ 149,948  
Marketable securities – available-for-sale debt securities     214,679       219,632  
Accounts receivable, net of allowance for doubtful accounts of $0 and $0     1,826       752  
Other current assets and prepaid expenses     53,417       45,126  
Total current assets     359,461       415,458  
             
Restricted cash     1,716       1,718  
Operating lease right-of-use assets, net of accumulated amortization     21,145       20,875  
Property, plant and equipment, net of accumulated depreciation of $36,671 and $36,253     36,689       30,494  
Intangible assets, net of accumulated amortization of $4,209 and $4,051     788       1,000  
Total assets   $ 419,799     $ 469,545  
             
Liabilities and stockholders’ equity            
Current liabilities            
Accounts payable   $ 7,017     $ 8,113  
Operating lease liabilities, current     2,735       2,320  
Accrued expenses and other current liabilities     31,627       29,909  
Deferred revenue, current     24,772       22,199  
Total current liabilities     66,151       62,541  
             
Operating lease liabilities, non-current     23,220       23,148  
Deferred revenue, non-current     166,613       177,223  
Other liabilities, non-current     670       673  
Total liabilities     256,654       263,585  
             
Stockholders’ equity            
Common stock – Ordinary shares par value £0.001, 1,240,853,520 authorized and 940,866,006 issued and outstanding (2021: 1,240,853,520 authorized and 937,547,934 issued and outstanding)     1,342       1,337  
Additional paid in capital     965,227       959,611  
Accumulated other comprehensive loss     (9,313 )     (11,142 )
Accumulated deficit     (794,111 )     (743,846 )
Total stockholders’ equity     163,145       205,960  
             
Total liabilities and stockholders’ equity   $ 419,799     $ 469,545  

Condensed Consolidated Cash Flow Statement
(unaudited, in thousands)

             
    Three months ended
    March 31, 
       2022      2021
Cash flows from operating activities            
Net loss   $ (50,265 )   $ (37,763 )
Adjustments to reconcile net loss to net cash used in operating activities:            
Depreciation     1,386       1,436  
Amortization     209        
Share-based compensation expense     5,586       5,334  
Unrealized foreign exchange (gains)/losses     (244 )     1,249  
Amortization on available-for-sale debt securities     999       1,499  
Other     220       1,299  
Changes in operating assets and liabilities:            
Increase in receivables and other operating assets     (10,759 )     (11,155 )
Increase/ (decrease) in payables and other current liabilities     964       (8,601 )
(Decrease)/ increase in deferred revenue     (2,497 )     162  
Net cash used in operating activities     (54,401 )     (46,540 )
             
Cash flows from investing activities            
Acquisition of property, plant and equipment     (7,114 )     (1,152 )
Acquisition of intangible assets           (133 )
Maturity or redemption of marketable securities     44,536       84,646  
Investment in marketable securities     (42,197 )     (61,599 )
Net cash (used in)/ provided by investing activities     (4,775 )     21,762  
             
Cash flows from financing activities            
Proceeds from exercise of stock options     35       534  
Net cash provided by financing activities     35       534  
             
Effect of currency exchange rate changes on cash, cash equivalents and restricted cash     (1,270 )     (204 )
Net decrease in cash, cash equivalents and restricted cash     (60,411 )     (24,448 )
Cash, cash equivalents and restricted cash at start of period     151,666       61,484  
Cash, cash equivalents and restricted cash at end of period   $ 91,255     $ 37,036  
             

1 Afamitresgene autoleucel “afami-cel” (formerly ADP-A2M4)
2 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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