• Adaptimmune Reports First Quarter Financial Results and Business Update

    Source: Nasdaq GlobeNewswire / 09 May 2022 06:30:00   America/Chicago

    - 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
    Sebastien.Desprez@adaptimmune.com 

    Investor Relations:

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

    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

     


    Primary Logo

Share on,