• Vaccitech Reports First Quarter 2022 Financial Results and Recent Corporate Developments

    ソース: Nasdaq GlobeNewswire / 11 5 2022 15:15:00   America/Chicago

    OXFORD, United Kingdom, May 11, 2022 (GLOBE NEWSWIRE) -- Vaccitech plc (NASDAQ: VACC) today announced its financial results for the first quarter ended March 31, 2022, and provided an overview of the Company’s recent corporate developments. Vaccitech is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases, autoimmunity, and cancer.

    “We’ve already made solid progress across the Company this year and are excited to share our plans to advance our recently acquired SNAPvax platform into the clinic in multiple disease indications including HPV cancer and celiac disease,” said Bill Enright, Vaccitech’s CEO. “These are devastating diseases where we believe this novel platform provides a unique opportunity for potential cures. In addition, we expect to announce efficacy data in our chronic infectious disease programs in both HBV and HPV later this year. Finally, the royalty and milestone payments that we have begun to receive related to the sales of AstraZeneca’s SARS CoV2 vaccine will contribute non-dilutive capital to these efforts.”

    First Quarter 2022 and Recent Corporate Developments

    • On April 6, 2022, the Company announced the notification of the commencement of royalty payments relating to commercial sales of Vaxzevria®. The Company’s share of milestone and royalty payments received by OUI from AstraZeneca in the first quarter of 2022 amounted to $15.0 million.
    • In April, the Company launched a program in HPV-associated cancer utilizing the SNAPvax™ platform and moved forward with an immunotherapeutic designed to induce regulatory T cells in patients with celiac disease. IND applications are expected to be filed for both programs during the first quarter of 2023.
    • On April 29, 2022, the Company received scientific advice from the EMA defining a licensure pathway for the candidate MERS vaccine, VTP-500, which allows the Company to estimate expenses of the development pathway more accurately.

    Upcoming Milestones

    • In the second quarter of 2022, the Company expects to present additional Phase 1b/2a interim efficacy data on VTP-300 in patients with chronic HBV infection at the European Association for the Study of the Liver (EASL) International Liver Congress on June 22 to 26, 2022, which is also expected to be followed by full efficacy data in the second half of this year.
    • In the third quarter of 2022, the Company expects to initiate dosing in a Phase 1/2 clinical trial of VTP-850 in patients with prostate cancer.
    • In the fourth quarter of 2022, the Company intends to conduct an interim efficacy review of HPV001, a Phase 1b/2 clinical trial of VTP-200, a potential non-invasive treatment for low grade HPV-related cervical lesions.

    First Quarter 2022 Financial Highlights:

    • Cash position: As of March 31, 2022, cash and cash equivalents were $200.6 million, compared to $214.1 million as of December 31, 2021. The decrease in cash was primarily due to $6.6 million of net cash being used in operating activities and a $5.6 million negative effect of exchange rates on cash and cash equivalents.
    • Research and development expenses: Research and development expenses were $10.7 million in the first quarter of 2022 compared to $4.6 million in the comparable period of the prior year. The increase in R&D expenses was primarily due to increased spending on the development of VTP-200, VTP-300, VTP-850 and VTP-600 and an increase in R&D personnel-related costs.
    • General and administrative expenses: General and administrative expenses were $3.7 million in the first quarter of 2022 compared to $1.8 million in the comparable period of the prior year. The first quarter of 2022 includes $4.3 million of personnel expenses, including a share-based payment charge of $3.1 million, and a $5.3 million unrealized foreign exchange gain on revaluation of Company’s cash balances. Net of this gain, the increase in general and administrative expenses between the periods was mainly attributable to higher personnel costs, reflecting an increase in the Company’s headcount over the period, and higher insurance costs associated with operating as a public company.
    • Net Income: For the first quarter of 2022, the Company generated a net income of $2.6 million, or $0.07 per share on both basic and fully diluted bases, compared to a net loss of $15.4 million, or $1.90 per share on both basic and fully diluted bases, for the comparable period of the prior year.

    About Vaccitech

    Vaccitech (“the Company”) is a clinical-stage biopharmaceutical company engaged in the discovery and development primarily of novel immunotherapies for the treatment of chronic infectious diseases, cancer and other diseases where the T cell arm of the immune system is believed to play an important role. The company’s proprietary platforms include modified simian adenoviral vectors (ChAdOx1 and ChAdOx2), other viral vectors including the well-validated Modified vaccinia Ankara (MVA) and synthetic nano-particle technologies (SNAPvax™ and Syntholytic™). The combination of different technologies in a mix and match approach (heterologous prime-boost) consistently generates significantly higher magnitudes of T cells compared with other technologies and approaches. The Company has a broad pipeline of both clinical and preclinical stage therapeutic programs to treat solid tumors, chronic viral infections, as well as a few prophylactic viral vaccine programs. Vaccitech co-invented a COVID-19 vaccine with the University of Oxford, now approved for use in many territories and exclusively licensed worldwide to AstraZeneca through Oxford University Innovation, or OUI. Vaccitech is entitled to receive a share of all milestone and royalty income received by OUI from AstraZeneca.

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the timing and advancement of the Company’s programs, including the clinical trials of VTP-200, VTP-300, VTP-600, and VTP-850, the expected benefits of the acquisition of Avidea Technologies, the benefits of the collaboration with Arbutus BioPharma Corporation and the Company’s cash runway. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to numerous risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation: the success, cost and timing of the Company’s product development activities and planned and ongoing clinical trials, the Company’s ability to execute on its strategy, regulatory developments, the Company’s ability to fund its operations, global economic uncertainty and the impact that the current ongoing COVID-19 pandemic will have on the Company’s clinical trials, preclinical studies and access to capital and other risks identified in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including its Quarterly Report on Form 10-Q for the third quarter of 2021 and subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company expressly disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.


    VACCITECH PLC
    CONDENSED CONSOLIDATED BALANCE SHEETS
    (IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS)
    (UNAUDITED)

          March 31,
    2022    		 December 31,
    2021
    ASSETS   
    Current assets:      
     Cash and cash equivalents  $200,596 $214,054 
     Accounts receivable   18,011  20 
     Research and development incentives receivable   4,778  6,229 
     Prepaid expenses and other current assets   7,398  6,462 
      Total current assets   230,783  226,765 
    Goodwill   12,630  12,630 
    Property and equipment, net   4,583  1,829 
    Intangible assets, net   30,640  31,430 
    Right of use assets, net   6,699  7,257 
    Other assets   788  804 
      Total assets  $286,123 $280,715 
             
    LIABILITIES AND SHAREHOLDERS’ EQUITY 
    Current liabilities:      
     Accounts payable  $4,660 $2,419 
     Accrued expenses and other current liabilities   11,330  7,875 
     Deferred revenue   162  182 
     Current portion of lease liability   331  523 
     Debt   -  159 
      Total current liabilities   16,483  11,158 
    Lease liability – non current   6,404  6,540 
    Contingent consideration   2,444  2,371 
    Deferred tax liability, net   7,221  8,084 
    Other non-current liabilities   434  - 
      Total liabilities  $32,986 $28,153 
    Commitments and contingencies      
    Shareholders’ equity:      
     Ordinary shares, £0.000025 nominal value; 37,193,367 shares authorized, issued and outstanding (December 31, 2021: authorized, issued and outstanding: 37,188,730)  $1 $1 
     Deferred A shares, £1 nominal value; 63,443 shares authorized, issued and outstanding (December 31, 2021: authorized, issued and outstanding: 63,443)   86  86 
     Deferred B shares, £0.01 nominal value; 570,987 shares authorized, issued and outstanding (December 31, 2021: authorized, issued and outstanding: 570,987)   8  8 
     Deferred C shares, £0.000007 nominal value, 27,828,231 shares authorized, issued and outstanding (December 31, 2021: authorized, issued and outstanding: 27,828,231)   01  01 
     Additional paid-in capital   373,087  369,103 
     Accumulated deficit   (105,989) (108,585)
     Accumulated other comprehensive loss – foreign currency translation adjustments   (14,456) (8,488)
     Noncontrolling interest   400  437 
      Total shareholders’ equity  $253,137 $252,562 
    Total liabilities and shareholders’ equity$286,123 $280,715 

    1 Indicates amount less than thousand


    VACCITECH PLC
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
    (IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS)
    (UNAUDITED)

       Three months ended
       March 31, 2022  March 31, 2021 
    License revenue $15,009 $16 
    Service revenue  -  21 
    Research grants and contracts  9  178 
     Total revenue  15,018  215 
    Operating expenses     
     Research and development  10,701  4,610 
     General and administrative  3,663  1,777 
     Total operating expenses  14,364  6,387 
    Income/(loss) from operations  654  (6,172)
    Other income (expense):     
     Change in fair value of derivatives  -  5,994 
     Unrealized exchange gain on convertible loan notes  -  209 
     Loss on extinguishment of convertible loan notes  -  (13,789)
     Interest income  83  2 
     Interest expense  (74) (2,650)
     Research and development incentives  1,048  955 
     Total other income (expense)  1,057  (9,279)
    Tax benefit  863  65 
    Net income/(loss)  2,574  (15,386)
     Net loss attributable to noncontrolling interest  22  118 
    Net income/(loss) attributable to Vaccitech plc Shareholders  2,596  (15,268)
          
    Weighted-average ordinary shares outstanding, basic  37,191,022  8,057,216 
    Weighted-average ordinary shares outstanding, diluted  38,346,668  8,057,216 
    Net income/(loss) per share attributable to ordinary shareholders, basic $0.070 $(1.90)
    Net income/(loss) per share attributable to ordinary shareholders, diluted $0.068 $(1.90)
          
    Net income/(loss) $2,574 $(15,386)
    Other comprehensive loss - foreign currency translation adjustments  (5,983) (1,416)
    Comprehensive loss  (3,409) (16,802)
    Comprehensive loss attributable to noncontrolling interest  37  114 
    Comprehensive loss attributable to Vaccitech Plc Shareholders $(3,372)$(16,688)


    Investors:
    Vaccitech Investor Relations
    ir@vaccitech.co.uk

    Vaccitech Media Contacts:

    Katja Stout, Scius Communications (EU)
    Direct: +44 (0) 7789435990
    Email: katja@sciuscommunications.com

    Katie Larch / Robert Flamm, Ph.D., Burns McClellan, Inc. (U.S.)
    Email: klarch@burnsmc.com / rflamm@burnsmc.com


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