0001104659-21-137643.txt : 20211112 0001104659-21-137643.hdr.sgml : 20211112 20211112090337 ACCESSION NUMBER: 0001104659-21-137643 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20211112 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20211112 DATE AS OF CHANGE: 20211112 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Vaccitech plc CENTRAL INDEX KEY: 0001828185 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-40367 FILM NUMBER: 211400261 BUSINESS ADDRESS: STREET 1: THE SCHRODINGER BUILDING STREET 2: HEATLEY ROAD, THE OXFORD SCIENCE PARK CITY: OXFORD STATE: X0 ZIP: OX4 4GE BUSINESS PHONE: 44 (0) 1865 818808 MAIL ADDRESS: STREET 1: THE SCHRODINGER BUILDING STREET 2: HEATLEY ROAD, THE OXFORD SCIENCE PARK CITY: OXFORD STATE: X0 ZIP: OX4 4GE FORMER COMPANY: FORMER CONFORMED NAME: Vaccitech Ltd DATE OF NAME CHANGE: 20201014 8-K 1 tm2132715d1_8k.htm FORM 8-K
0001828185 false GA 0001828185 2021-11-12 2021-11-12 0001828185 VACC:AmericanDepositarySharesMember 2021-11-12 2021-11-12 0001828185 us-gaap:CommonStockMember 2021-11-12 2021-11-12 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549  

FORM 8-K 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934 

Date of Report (Date of earliest event reported): November 12, 2021

 

VACCITECH PLC

(Exact name of registrant as specified in its charter)

 

England and Wales 001-40367 Not Applicable

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(I.R.S. Employer

Identification No.)

 

Vaccitech plc

The Schrödinger Building

Heatley Road

The Oxford Science Park

Oxford OX4 4GE

United Kingdom

(Address of principal executive offices, including zip code)  

+44 (0) 1865 818 808

(Registrant’s telephone number, including area code)  

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class Trade Symbol(s) Name of each exchange on which
registered
American Depositary Shares VACC The Nasdaq Global Market
Ordinary shares, nominal value £0.000025 per share*    

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

 

Emerging growth company  x

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ¨

 

*American Depositary Shares may be evidenced by American Depositary Receipts. Each American Depositary Share represents one (1) ordinary share. Not for trading, but only in connection with the listing of the American Depositary Shares on The Nasdaq Global Market. The American Depositary Shares represent the right to receive ordinary shares and are being registered under the Securities Act of 1933, as amended, pursuant to a separate Registration Statement on Form F-6. Accordingly, the American Depositary Shares are exempt from the operation of Section 12(a) of the Securities Exchange Act of 1934, as amended, pursuant to Rule 12a-8.

 

 

 

 

 

Item 2.02. Results of Operations and Financial Condition.

 

On November 12, 2021, Vaccitech plc announced its financial results for the quarter ended September 30, 2021. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information in this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

99.1 Press Release dated November 12, 2021.
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  Vaccitech plc
     
Date: November 12, 2021 By: /s/ William Enright
    William Enright
    Chief Executive Officer

 

 

 

 

 EX-99.1 2 tm2132715d1_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

 

 

Vaccitech Reports Third Quarter 2021 Financial Results and Recent Corporate Developments

 

Oxford, United Kingdom, November 12, 2021 -- Vaccitech plc (NASDAQ: VACC) today announced its financial results for the third quarter, ended September 30, 2021, 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 and cancer.

 

“We continue to advance our promising pipeline with the recent publication of data on our MERS vaccine program. We also anticipate that initial clinical data on two of our chronic infectious disease therapeutic programs will be presented at scientific conferences next week,” commented Bill Enright, Vaccitech’s CEO. “As we continue to expand and advance our programs, we will need additional lab and office space for our talented staff so we have planned a move mid next year into a new, state of the art facility.”

 

Third Quarter and Recent Corporate Developments

 

·Signed a clinical trial collaboration agreement with Arbutus Biopharma Corporation to evaluate an innovative therapeutic combination for the treatment of subjects with chronic hepatitis B virus infection (CHB) who are already receiving standard-of-care nucleoside or nucleotide analog (NA) therapy. The Phase 2a clinical trial will evaluate the safety, pharmacokinetics, immunogenicity, and antiviral activity of Arbutus’s RNAi therapeutic, AB-729, followed by the Company’s immunotherapy candidate, VTP-300, in NA-suppressed subjects with CHB.

·Preclinical research demonstrated that VTP-600, a ChAdOx1/MVA prime-boost immunotherapeutic, demonstrated potential as an anti-cancer therapeutic. The research was conducted by scientists at the University of Oxford and the Ludwig Institute for Cancer Research.

·Signed a lease for 31,000 square feet within the Zeus development at Harwell Science and Innovation Campus. The site will house the Company’s headquarters, state-of-the-art wet laboratory and offices. Vaccitech anticipates completing the relocation by mid-2022.

·Announced online publication in The Lancet Microbe of the results of a Phase 1 clinical trial of VTP-500, a vaccine candidate in development to prevent Middle East Respiratory Syndrome (MERS). The study, conducted by researchers at The King Abdullah International Medical Research Centre and Oxford University, showed that the vaccine candidate was generally well tolerated and induced both humoral and cellular immune responses.

 

Upcoming Milestones

 

·At the virtual AASLD’s The Liver Meeting® in November, two posters will present safety and immunogenicity data from the Phase 1 and Phase 1b/2a trials of VTP-300: HBV001, in healthy volunteers and patients with chronic hepatitis B (CHB) infection and HBV002 in patients with CHB infection. The posters become available for viewing by attendees at 8 a.m. EST on November 12.

 

 

 

 

·At the virtual 34th International Papillomavirus Conference in November, the Company expects to present safety and immunogenicity data from the lead-in portion of the Phase 1/2a clinical trial of VTP-200.

·In the fourth quarter, the Company expects to initiate dosing in a Phase 1/2a trial of VTP-600 in patients with non-small cell lung cancer in combination with a checkpoint inhibitor and chemotherapy. The trial is currently open for enrollment.

·In the first quarter of 2022, the Company intends to conduct an interim efficacy review of HBV002, the Phase 1b/2a clinical trial of VTP-300 in patients with chronic HBV infection.

·In the second quarter of 2022, the Company expects to initiate dosing in a Phase 1/2a clinical trial of VTP-800/850, in combination with a checkpoint inhibitor, in patients with prostate cancer.

·In the third quarter of 2022, the Company intends to conduct an interim efficacy review of HPV001, a Phase 1/2a clinical trial of VTP-200, a potential non-invasive treatment for persistent high-risk HPV infection.

 

Third Quarter 2021 Financial Highlights:

 

·Cash position: As of September 30, 2021, cash and cash equivalents were $233.9 million, compared to $43.3 million as of December 31, 2021. The increase was primarily due to completion of the Series B financing in the first quarter of 2021, which raised $168 million including the conversion of our previously issued convertible loan notes, and to the initial public offering in the second quarter, which raised gross proceeds of $110.5 million. The Company believes its cash and cash equivalents are sufficient to fund operations into the first half of 2024.

·Research and development (R&D) expenses: Research and development expenses were $4.4 million for the third quarter of 2021 compared to $3.7 million for the comparable period of the prior year. The increase in R&D expenses was primarily due to increased spending on progressing the development of VTP-300 and VTP-850.

·General and administrative expenses: General and administrative expenses were $1.2 million for the third quarter of 2021 compared to $1.0 million for the comparable period of the prior year. The third quarter of 2021 expense includes a $5.8 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 attributable to higher personnel costs, reflecting an increase in the Company’s headcount over the prior period and higher insurance costs associated with operating as a public company.

·Net loss: The Company generated a net loss attributable to its shareholders of $4.6 million, or ($0.13) per share on both basic and fully diluted bases, for the third quarter of 2021 compared to a net income of $0.2 million, or $0.02 per share a basic basis and $0.01 on a fully diluted basis, for the same period of the prior year.

 

 

 

 

About Vaccitech

 

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 and cancer. The Company’s proprietary platform comprises proprietary modified simian adenoviral vectors, known as ChAdOx1 and ChAdOx2, as well as the well-validated Modified Vaccinia Ankara, or MVA, boost vector, both with demonstrable tolerability profiles and without the ability to replicate in humans. The combination of a ChAdOx prime treatment with subsequent MVA boost has consistently generated significantly higher magnitudes of CD8+ T cells compared with other technologies and approaches. The company has a broad pipeline of both clinical and preclinical stage therapeutic programs in solid tumors and viral infections and 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 plc through Oxford University Innovation, or OUI. Vaccitech is entitled to receive a share of the milestones and royalty income received by OUI from AstraZeneca plc.

 

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-800/850 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 and the impact that the current COVID-19 pandemic will have on the Company’s clinical trials and preclinical studies 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 first 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)

 

 

 

  

September 30,

2021

    

December 31,

2020

  
ASSETS              
Current assets:                
Cash and cash equivalents   $ 233,871     $ 43,266  
Accounts receivable     42       518  
Research and development incentives receivable     5,382       2,708  
Prepaid expenses and other current assets     6,684       1,409  
Total current assets     245,979       47,901  
Property and equipment, net     1,033       629  
Right of use assets, net     8,780       2,136  
Deferred tax assets     60       —  
Other assets     719       —  
Total assets   $ 256,571     $ 50,666  
                 
LIABILITIES, REDEEMABLE PREFERRED SHARES AND SHAREHOLDERS' DEFICIT                
                 
Current liabilities:                
Accounts payable   $ 1,337     $ 4,667  
Accrued expenses and other current liabilities     4,404       2,537  
Deferred revenue     196       245  
Current portion of lease liability     435       192  
Total current liabilities     6,372       7,641  
Convertible loan notes — non current     —       44,700  
Lease liability — non current     7,728       1,472  
Total liabilities   $ 14,100     $ 53,813  
Commitments and contingencies (Note 11)                
Series A redeemable convertible preferred shares (Series A shares); £0.10 nominal value; no shares issued and outstanding; (December 31, 2020: issued and outstanding: 22,065)   $ —     $ 33,765  
Series B redeemable convertible preferred shares (Series B shares); £0.10 nominal value; no shares issued and outstanding; (December 31, 2020: issued and outstanding: no shares issued or outstanding)   $ —     $ —  
Shareholders' equity:                
Ordinary shares, £0.000025 nominal value; 34,328,231 shares authorized, issued and outstanding (December 31, 2020: authorized, issued and outstanding: 7,960,458)     1     0 1
Deferred A shares, £1 nominal value; 63,443 shares authorized, issued and outstanding (December 31, 2020: no shares issued or outstanding)     86       —  
Deferred B shares, £1 nominal value; 570,987 shares authorized, issued and outstanding (December 31, 2020: no shares issued or outstanding)     8       —  
Deferred C shares, £0,000007 nominal value, 27,828,231 shares authorized, issued and outstanding (December 31, 2020: authorized, issued and outstanding: 7,960,458)     0 1     0 1
Additional paid-in capital     344,396       21,660  
Accumulated deficit     (93,472 )     (57,720 )
Accumulated other comprehensive loss — foreign currency translation adjustments     (9,041 )     (1,243 )
Noncontrolling interest     493       391  
Total shareholders' equity   $ 242,471     $ (36,912 )
Total liabilities, redeemable convertible preferred shares and shareholders' equity   $ 256,571     $ 50,666  

 

 

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     Nine months ended  
    September 30, 2021     September 30, 2020     September 30, 2021     September 30, 2020  
License revenue   $ 16     $ 2,663     $ 48     $ 2,705  
Service revenue     —       60       21       376  
Research grants and contracts     3       528       200       1,386  
Total revenue     19       3,251       269       4,467  
Operating expenses                                
Research and development     4,371       3,702       13,490       11,821  
General and administrative     1,184       977       15,332       3,059  
Total operating expenses     5,555       4,679       28,822       14,880  
Loss from operations     (5,536 )     (1,428 )     (28,553 )     (10,413 )
Other income (expense):                                
Change in fair value of derivatives     —       3       5,994       3  
Unrealized exchange gain on convertible loan notes     —       982       209       982  
Loss on extinguishment of convertible loan notes     —       —       (13,789 )     —  
Interest income     —       —       2       —  
Interest expense     —       (969 )     (2,650 )     (969 )
Research and development incentives     959       1,612       2,789       2,989  
Other     —       —       (3 )     —  
Total other (expense) income     959       1,628       (7,448 )     3,005  
Tax (expense)/benefit     7       —       60       —  
Net (loss)/ income     (4,570 )     200       (35,941 )     (7,408 )
Net loss/ (income) attributable to noncontrolling interest     13       (42 )     189       157  
Net (loss)/ income attributable to Vaccitech plc Shareholders     (4,557 )     158       (35,752 )     (7,251 )
                                 
Weighted-average ordinary shares outstanding, basic     34,843,154       7,937,384       22,697,462       7,886,488  
Weighted-average ordinary shares outstanding, diluted     34,843,154       15,867,533       22,697,462       7,886,488  
Net( loss)/ income per share attributable to ordinary shareholders, basic   $ (0.13 )   $ 0.02     $ (1.58 )   $ (0.92 )
Net (loss)/ income per share attributable to ordinary shareholders, diluted   $ (0.13 )   $ 0.01     $ (1.58 )   $ (0.92 )
                                 
Net (loss)/ income   $ (4,570 )   $ 200     $ (35,941 )   $ (7,408 )
Other comprehensive (loss) / income — foreign currency translation adjustments     (6,473 )     68       (7,803 )     (759 )
Comprehensive (loss)/ income     (11,043 )     268       (43,744 )     (8,167 )
Comprehensive loss/ (income) attributable to noncontrolling interest     25       (49 )     194       169  
Comprehensive (loss)/ income attributable to Vaccitech plc shareholders   $ (11,018 )   $ 219     $ (43,550 )   $ (7,998 )

 

 

 

 

Investors:

Vaccitech Investor Relations

ir@vaccitech.co.uk

 

Vaccitech Media Contacts: 

Katja Stout, Scius Communications (EU) 

Direct: +44 (0) 7789435990 

Email: katja@sciuscommunications.com

 

Robert Flamm, Ph.D. (US) / Harrison Wong, Burns McClellan, Inc. 

212-213-0006 ext. 364 / 316 

Email: rflamm@burnsmc.com / hwong@burnsmc.com

 

Henry Hodge, Vaccitech 

Email: henry.hodge@vaccitech.co.uk

 

 

 

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Cover
Nov. 12, 2021
Document Information [Line Items]  
Document Type 8-K
Amendment Flag false
Document Period End Date Nov. 12, 2021
Entity File Number 001-40367
Entity Registrant Name VACCITECH PLC
Entity Central Index Key 0001828185
Entity Tax Identification Number 00-0000000
Entity Incorporation, State or Country Code X0
Entity Address, Address Line One Vaccitech plc
Entity Address, Address Line Two The Schrödinger Building
Entity Address, Address Line Three Heatley Road
Entity Address, City or Town The Oxford Science Park
Entity Address, State or Province GA
Entity Address, Country GB
Entity Address, Postal Zip Code OX4 4GE
City Area Code +44 (0)
Local Phone Number 1865 818 808
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Entity Emerging Growth Company true
Elected Not To Use the Extended Transition Period false
American Depositary Shares[Member]  
Document Information [Line Items]  
Title of 12(b) Security American Depositary Shares
Trading Symbol VACC
Security Exchange Name NASDAQ
Common Stock [Member]  
Document Information [Line Items]  
Title of 12(b) Security Ordinary shares, nominal value £0.000025 per share*
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