0001493152-20-020291.txt : 20201102 0001493152-20-020291.hdr.sgml : 20201102 20201102113103 ACCESSION NUMBER: 0001493152-20-020291 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20201102 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20201102 DATE AS OF CHANGE: 20201102 FILER: COMPANY DATA: COMPANY CONFORMED NAME: VBI Vaccines Inc/BC CENTRAL INDEX KEY: 0000764195 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: A1 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37769 FILM NUMBER: 201279502 BUSINESS ADDRESS: STREET 1: 222 THIRD STREET STREET 2: SUITE 2241 CITY: CAMBRIDGE STATE: MA ZIP: 02142 BUSINESS PHONE: 617-830-3031 MAIL ADDRESS: STREET 1: 222 THIRD STREET STREET 2: SUITE 2241 CITY: CAMBRIDGE STATE: MA ZIP: 02142 FORMER COMPANY: FORMER CONFORMED NAME: SciVac Therapeutics Inc. DATE OF NAME CHANGE: 20150717 FORMER COMPANY: FORMER CONFORMED NAME: LEVON RESOURCES LTD. DATE OF NAME CHANGE: 20100910 FORMER COMPANY: FORMER CONFORMED NAME: LEVON RESOURCES LTD DATE OF NAME CHANGE: 19850305 8-K 1 form8-k.htm
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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 2, 2020

 

VBI VACCINES INC.

(Exact name of registrant as specified in its charter)

 

British Columbia, Canada   001-37769   N/A
(State or other jurisdiction
of incorporation)		   (Commission
File Number)		   (IRS Employer
Identification No.)

 

222 Third Street, Suite 2241

Cambridge, Massachusetts

   02142
(Address of principal executive offices)   (Zip Code)

 

(617) 830-3031

(Registrant’s telephone number, including area code)

 

N/A

(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   Trading Symbol(s)   Name of exchange on which registered
Common Shares, no par value per share   VBIV   The NASDAQ Stock Market LLC

 

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 ☒

 

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. ☒

 

 

 

 

 

 

Item 2.02 Results of Operations and Financial Condition.

 

On November 2, 2020, VBI Vaccines Inc. issued a press release announcing its financial results for the third fiscal quarter ending September 30, 2020 and provided a corporate update. A copy of this press release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.

 

In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.1, that is furnished pursuant to this Item 2.02 shall not be deemed to be “filed” for the 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, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.   Description
     
99.1   Press Release dated November 2, 2020*

 

* This exhibit is furnished pursuant to Item 2.02 and shall not be deemed to be “filed.”

 

 

 

 

SIGNATURES

 

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.

 

  VBI Vaccines Inc.
     
Date: November 2, 2020 By: /s/ Jeff Baxter
    Jeff Baxter
    President and Chief Executive Officer

 

 

 

 EX-99.1 2 ex99-1.htm

 

Exhibit 99.1

 

 

 

VBI Vaccines Announces Third Quarter 2020 Financial Results and Provides Corporate Update

 

- BLA and MAA on-track for Q4 submission for regulatory approval of Sci-B-Vac® in the U.S. and Europe
- Secured contributions from the Canadian Government (up to CAD$56 million) and the National Research Council of Canada (up to CAD$1 million) for development and scale-up manufacturing of coronavirus program
- Initial adaptive Phase 1/2 clinical study of coronavirus vaccine program expected to begin around year-end 2020
- Clinical data expected in Q4 2020 for vaccine immunotherapeutic candidates for both chronic hepatitis B and recurrent glioblastoma (GBM)
- $120 million in cash, cash equivalents, and short-term investments at the end of Q3 2020

 

CAMBRIDGE, Mass. (November 2, 2020) – VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today reported financial results for the third quarter ending September 30, 2020 and provided a corporate update.

 

Jeff Baxter, VBI’s President and CEO commented: “Global knowledge and understanding of the COVID-19 pandemic continue to evolve, including with respect to correlate and durability of protection and the mutation potential of the virus. It is clear that an effective solution will need to both control the ongoing pandemic and provide long-term, sustainable protection. In the third quarter of 2020, we announced exciting preclinical immunologic data for our coronavirus vaccine program including that our trivalent candidate, VBI-2901, demonstrated broadened reactivity to a seasonal coronavirus not expressed in the vaccine, supporting the belief that VBI-2901 could offer potential protection from mutated strains of COVID-19 that may emerge over time. Vaccines continue to be a vital public health intervention, and we are resolute in our drive to be part of the solution for numerous unmet medical needs. The upcoming regulatory approval submissions for Sci-B-Vac®, our 3-antigen hepatitis B vaccine, are on-track to begin in Q4 2020, and we expect clinical data from both our therapeutic hepatitis B and glioblastoma programs later this year. To support our mission and activity, we are in a strong financial position with $120 million in cash and short-term investments, in addition to the contribution from the Canadian Government of up to CAD$56 million for our coronavirus program.”

 

Recent Highlights and Upcoming Program Milestones

 

Financial Update

 

  ● July 2020 : The National Research Council of Canada (NRC) agreed to contribute up to CAD$1 million for the scale-up of the technical manufacturing process for VBI’s coronavirus program, VBI-2900
  ● September 2020 : The Government of Canada, through its Strategic Innovation Fund, agreed to contribute up to CAD$56 million to support the development of VBI’s coronavirus program, VBI-2900, through Phase 2 clinical studies, to be contributed as expenses are incurred
  ● Throughout the third quarter of 2020, VBI raised total gross proceeds of $48.8 million, issuing 10.8 million shares at an average price of $4.4988 through its Open Market Sales AgreementSM, established July 31, 2020 with Jefferies LLC

 

Sci-B-Vac®: 3-Antigen Prophylactic HBV Vaccine

 

  ● August and October 2020: Presentations of Phase 3 data at The Digital International Liver Congress™ 2020 (ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL), and at ID Week 2020™. Multiple oral and e-poster presentations highlighted:

 

  ○ High serum levels of HBV surface antibodies (anti-HBs) titers:

 

  ● Sci-B-Vac induced higher Geometric Mean Concentrations (GMC) of anti-HBs titers than Engerix-B in all subjects across both recently completed Phase 3 registrational studies, PROTECT and CONSTANT, regardless of age, gender, or underlying comorbidity
  ● Persistence and durability of protective titers are believed to be dependent upon peak levels induced

 

 
 

 

  ○ Rapid onset of seroprotection in adults age 18-45:

 

  ● Sci-B-Vac was able to induce high seroprotection rates (SPR) after both two and three doses of vaccine compared to Engerix-B
  ● In the four controlled Phase 3 studies referenced, including the recently-completed pivotal PROTECT and CONSTANT studies, Sci-B-Vac achieved seroprotection rates (SPR) of 87.2-100.0% after two doses compared to 39.0-89.4% for Engerix-B

 

  ○ Safety: No new or unexpected safety signals were observed in either the PROTECT or CONSTANT study, and safety and tolerability remained consistent with the known profile of Sci-B-Vac

 

  ● Q4 2020: Submissions of applications for regulatory approvals in the U.S., Europe, and Canada expected to begin

 

VBI-2900: Prophylactic Coronavirus Vaccine Program

 

  ● August 2020: Announcement of pre-clinical data from three mouse studies enabling the selection of two clinical vaccine candidates: (1) VBI-2901, a trivalent pan-coronavirus vaccine targeting SARS-CoV-2, SARS-CoV, and MERS-CoV; and (2) VBI-2902, a monovalent coronavirus vaccine targeting SARS-CoV-2. Data highlights include:

 

  ○ Both vaccine candidates have the potential to be one-dose vaccines: After a single dose, VBI’s enveloped virus-like particle (eVLP) candidates expressing a modified, stabilized, pre-fusion form of the SARS-CoV-2 spike protein induced a neutralizing antibody (nAb) geometric mean titer (GMT) 4x higher than that induced by convalescent sera, increasing to 64x higher than high-titer convalescent sera after the second dose
  ○ Trivalent construct increased breadth of reactivity: VBI-2901 further induced antibody binding titers across each of the three expressed spike proteins and also broadened reactivity to HCoV-OC43, a seasonal circulating coronavirus associated with the common cold that was not expressed in the vaccine

 

  ● August 2020: Agreement announced with Therapure Biomanufacturing, an integrated Contract Development Manufacturing Organization (CDMO), for development and manufacturing services for production of coronavirus vaccine candidates
  ● Around Year-End 2020: Initiation of initial adaptive Phase 1/2 human clinical study expected, pending regulatory approvals

 

VBI-1901: Cancer Vaccine Immunotherapeutic Candidate

 

  ● September 2020: Additional biomarker data presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, highlighting:

 

  o Evaluation of human leukocyte antigen (HLA) restriction and T cell receptor (TCR) repertoires
  o Broadened analysis of the six tumor responders seen to-date, including a partial response, in the study continues to build upon potentially predictive biomarker strategy to help identify glioblastoma (GBM) patients most likely to respond to, and benefit from, treatment with VBI-1901

 

  ● Q4 2020: Initial immunologic and tumor response data expected from the Phase 2a VBI-1901 + AS01B study arm
  ● Results observed to-date support further clinical development – exploring potential registrational study, expected to initiate in 2021

 

VBI-2601 (BRII-179): HBV Immunotherapeutic Candidate

 

  ● Q4 2020: Initial human proof-of-concept data expected from ongoing Phase 1b/2a study conducted in chronically-infected hepatitis B patients, in collaboration with Brii Biosciences

 

 
 

 

Third Quarter 2020 Financial Results

 

  ● Cash Position: VBI ended the third quarter of 2020 with $120.4 million in cash, cash equivalents, and short-term investments compared to $44.2 million as of December 31, 2019.
  ● Net Cash Used in Operating Activities: Net cash used in operations for the nine months ended September 30, 2020 was $30.6 million compared to the $40.2 million for the same period in 2019. The decrease is largely the result of the completion of the Sci-B-Vac Phase 3 clinical studies, the first of which (PROTECT) was completed in June 2019, the second of which (CONSTANT) was completed in January 2020.
  ● Cash Used for Purchase of Property and Equipment: Cash used for the purchase of property and equipment for the nine months ended September 30, 2020 was $0.5 million compared to $3.5 million for the same period in 2019. The decrease was due to the completion of the modernization and capacity increase of VBI’s manufacturing facility in Rehovot, Israel, which re-commenced operations in May 2019.
  ● Revenue: Revenue in the third quarter of 2020 was $0.3 million compared to $0.6 million for the same period in 2019. The decrease was due to a decrease in product revenue of Sci-B-Vac in Israel and a decrease in supply of product on a named-patient basis in Europe during the three months ended September 30, 2020 compared to the three months ended September 30, 2019. The decrease was also related to a decrease in R&D services revenue for VBI-2601, as manufacturing and non-clinical research services completed as part of the ongoing collaboration with Brii Biosciences.
  ● Cost of Revenues: Cost of revenues for the third quarter of 2020 was $2.1 million, comparable to $2.0 million for the same period in 2019.
  ● Research and Development (R&D): R&D expenses were $4.5 million for the third quarter of 2020, compared to $5.4 million for the same period in 2019. The decrease in R&D expenses is the result of the completion of the Sci-B-Vac pivotal Phase 3 studies.
  ● General and Administrative (G&A): G&A expenses for the third quarter of 2020 were $5.6 million, compared to $9.4 million for the same period in 2019. The decrease is a result of the impairment charge relating to goodwill incurred in the third quarter of 2019 that did not reoccur in the third quarter of 2020. This was offset by an increase in pre-commercialization activities for Sci-B-Vac as well as an increase in insurance costs.
  ● Net Loss: Net loss and net loss per share for the third quarter of 2020 were $13.0 million and $0.06, respectively, compared to a net loss of $16.2 million and a net loss per share of $0.15 for the third quarter of 2019.

 

About VBI Vaccines Inc.

 

VBI Vaccines Inc. (Nasdaq: VBIV) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI is advancing the prevention and treatment of hepatitis B, with: (1) the only 3-antigen hepatitis B vaccine, Sci-B-Vac®, which is approved for use and commercially available in Israel and recently completed its Phase 3 program in the U.S., Europe, and Canada; and (2) an immunotherapeutic in development for a functional cure for chronic hepatitis B. VBI’s enveloped virus-like particle (eVLP) platform technology enables development of eVLPs that closely mimic the target virus to elicit a potent immune response. VBI’s lead eVLP programs include a vaccine immunotherapeutic candidate targeting glioblastoma (GBM), a prophylactic cytomegalovirus (CMV) vaccine candidate, and a prophylactic coronavirus vaccine program. VBI is headquartered in Cambridge, MA, with research operations in Ottawa, Canada, and research and manufacturing facilities in Rehovot, Israel. Website Home: http://www.vbivaccines.com/ News and Insights: http://www.vbivaccines.com/wire/ Investors: http://www.vbivaccines.com/investors/

 

 
 

 

Cautionary Statement on Forward-looking Information

 

Certain statements in this press release that are forward-looking and not statements of historical fact are forwardlooking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). The Company cautions that such statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry or political conditions in the United States or internationally; the impact of the ongoing COVID-19 pandemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company’s products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 5, 2020, and filed with the Canadian security authorities at sedar.com on March 5, 2020, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.

 

 
 

 

VBI Vaccines Inc. and Subsidiaries

Selected Condensed Consolidated Balance Sheet

(In Thousands)

 

   September 30, 2020   December 31, 2019 
   (Unaudited)     
Assets          
Cash and cash equivalents  $95,158    44,213 
Short-term investments  $25,220    - 
Accounts receivable, net  $27    201 
Inventory, net   1,542    1,075 
Prepaid expenses and other current assets   4,446    1,474 
Total current assets   126,393    46,963 
Property and equipment, net   9,577    10,195 
Intangible assets, net   59,168    60,756 
Goodwill   2,152    2,208 
Other non-current assets   2,264    2,079 
Total Assets   199,554    122,201 
           
Liabilities and stockholder’s equity          
Accounts payable  $3,356    1,127 
Other current liabilities   10,594    28,630 
Total current liabilities   13,950    29,757 
Total non-current liabilities   19,798    4,189 
Total liabilities   33,748    33,946 
Total stockholders’ equity   165,806    88,255 
Total liabilities and stockholders’ equity   199,554    122,201 

 

 
 

 

VBI Vaccines Inc. and Subsidiaries

Condensed Consolidated Statement of Operations and Comprehensive Loss

(In Thousands Except Share and Per Share Amounts)

 

   Three Months Ended
September 30		   Nine Months Ended
September 30		 
   2020   2019   2020   2019 
   (Unaudited) 
Revenues  $298   $647   $897   $1,647 
Operating expenses                    
Cost of revenue   2,111    1,977    6,747    5,319 
Research and development   4,478    5,401    10,035    21,989 
General and administrative   5,562    9,412    13,520    16,570 
Total operating expenses   12,151    16,790    30,302    43,878 
Loss from operations   (11,853)   (16,143)   (29,405)   (42,231)
Interest income (expense), net   (742)   (626)   (2,006)   (1,672)
Foreign exchange gain (loss)   (402)   607    543    (35)
Loss before income taxes   (12,997)   (16,162)   (30,868)   (43,938)
Income tax benefit   -    -    -    - 
Net Loss  $(12,997)  $(16,162)  $(30,868)  $(43,938)
Basic and diluted net loss per share  $(0.06)  $(0.15)  $(0.15)  $(0.44)
Weighted-average number of shares used to compute basic and diluted net loss per share   234,709,403    105,742,073    210,044,126    99,627,345 
Other comprehensive income (loss) - currency translation adjustments   1,696    (1,165)   (1,988)   2,308 
Comprehensive Loss  $(11,301)  $(17,327)  $(32,856)  $(41,630)

 

VBI Contact

 

Nicole Anderson

Director, Corporate Communications & IR

Phone: (617) 830-3031 x124

Email: IR@vbivaccines.com

 

 

 

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Nov. 02, 2020
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Nov. 02, 2020
Entity File Number 001-37769
Entity Registrant Name VBI Vaccines Inc/BC
Entity Central Index Key 0000764195
Entity Incorporation, State or Country Code A1
Entity Address, Address Line One 222 Third Street
Entity Address, Address Line Two Suite 2241
Entity Address, City or Town Cambridge
Entity Address, State or Province MA
Entity Address, Postal Zip Code 02142
City Area Code (617)
Local Phone Number 830-3031
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Shares, no par value per share
Trading Symbol VBIV
Security Exchange Name NASDAQ
Entity Emerging Growth Company true
Elected Not To Use the Extended Transition Period true
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