Item
1. Condensed Consolidated Financial Statements
VBI
Vaccines Inc. and Subsidiaries
Condensed
Consolidated Balance Sheets
(in
thousands, except share amounts)
See
accompanying Notes to Condensed Consolidated Financial Statements
VBI
Vaccines Inc. and Subsidiaries
Condensed
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(in
thousands, except share and per share amounts)
See
accompanying Notes to Condensed Consolidated Financial Statements
VBI
Vaccines Inc. and Subsidiaries
Condensed
Consolidated Statements of Stockholders’ Equity
(Unaudited)
(in
thousands, except share amounts)
See
accompanying Notes to Condensed Consolidated Financial Statements
VBI
Vaccines Inc. and Subsidiaries
Condensed
Consolidated Statements of Cash Flows
(Unaudited)
(in
thousands)
See
accompanying Notes to Condensed Consolidated Financial Statements
VBI
Vaccines Inc. and Subsidiaries
Notes
to Condensed Consolidated Financial Statements
(Unaudited)
(in
thousands, except share and per share amounts)
1.
NATURE OF BUSINESS AND CONTINUATION OF BUSINESS
Corporate
Overview
VBI
Vaccines Inc. (the “Company” or “VBI”) was incorporated under the laws of British Columbia, Canada on April 9,
1965.
The
Company and its wholly-owned subsidiaries, VBI Vaccines (Delaware) Inc., a Delaware corporation (“VBI DE”); VBI DE’s
wholly-owned subsidiary, Variation Biotechnologies (US), Inc., a Delaware corporation (“VBI US”); Variation Biotechnologies,
Inc. a Canadian company and the wholly-owned subsidiary of VBI US (“VBI Cda”); and SciVac Ltd. an Israeli company (“SciVac”);
SciVac Hong Kong Limited (“SciVac HK”) and VBI Vaccines B.V a Netherlands company (“VBI BV”), are collectively
referred to as the “Company”, “we”, “us”, “our”, or “VBI”.
The
Company’s registered office is located at Suite 1700, Park Place, 666 Burrard Street, Vancouver, BC V6C 2X8 with its principal
office located at 160 Second Street, Floor 3, Cambridge, MA 02142. In addition, the Company has manufacturing facilities located in Rehovot,
Israel and research facilities located in Ottawa, Ontario, Canada.
Principal
Operations
VBI
Vaccines Inc. (“VBI”) is a commercial stage biopharmaceutical company driven by immunology in the pursuit of prevention and
treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped
VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed
to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases,
including hepatitis B (“HBV”), COVID-19 and coronaviruses, and cytomegalovirus (“CMV”), as well as aggressive
cancers including glioblastoma (“GBM”). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa,
Canada, and a research and manufacturing site in Rehovot, Israel.
The COVID-19 pandemic has materially negatively affected the global economy, and the ongoing effects of the COVID-19 pandemic, including
but not limited to, supply chain issues, global shortages of supplies, materials and products, volatile market conditions and rising global
inflation, continue to do so. As a result of the COVID-19 pandemic, the Company’s business and results of operations were adversely
affected and, as the ongoing effects of the COVID-19 pandemic continue to impact the global economy, may continue to adversely affect
our business and results of operations. The extent to which the effects of the COVID-19 pandemic will continue to impact our business
will depend on future developments, which are highly uncertain and cannot be predicted. We do not yet know the full extent of potential
delays or impacts on our business, our clinical studies, our research programs, the recoverability of our assets, and our manufacturing;
however, the effects of the COVID-19 pandemic may continue to disrupt or delay our business operations, including with respect to efforts
relating to potential business development transactions, and it could continue to disrupt the marketplace which could have an adverse
effect on our operations.
Liquidity
and Going Concern
The
Company faces a number of risks, including but not limited to, uncertainties regarding the success of the development and commercialization
of its products, demand and market acceptance of the Company’s products, and reliance on major customers. The Company anticipates
that it will continue to incur significant operating costs and losses in connection with the development and commercialization of its
products.
The
Company had an accumulated deficit of $468,468 as of September 30, 2022 and cash outflows from operating activities of $54,649 for the
nine months ended September 30, 2022.
The
Company will require significant additional funds to conduct clinical and non-clinical trials, commercially launch our products, and
achieve regulatory approvals. Additional financing may be obtained from the issuance of equity securities, the issuance of additional
debt, structured asset financings, government or non-governmental organization grants or subsidies, and/or revenues from potential business
development transactions, if any. There is no assurance the Company will manage to obtain these sources of financing, if required. The
above conditions raise substantial doubt about the Company’s ability to continue as a going concern. The condensed consolidated
financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of
assets or the amounts and classifications of liabilities that may result should the Company be unable to continue as a going concern.
On
July 1, 2022, we received a letter from the Listing Qualifications Department of the Nasdaq Stock Market (“NASDAQ”) indicating
that, based upon the closing bid price of our common shares for the 30 consecutive business day period between May 18, 2022 through September
30, 2022, we did not meet the minimum bid price of $1.00 per share required for continued listing on NASDAQ pursuant
to NASDAQ Listing Rule 5550(a)(2). The letter also indicated that we will be provided with a compliance period of 180 calendar days,
or until December 28, 2022 (the “Compliance Period”), in which to regain compliance pursuant to NASDAQ Listing Rule 5810(c)(3)(A).
In
order to regain compliance with NASDAQ’s minimum bid price requirement, our common shares must maintain a minimum closing bid price
of $1.00 for a minimum of ten consecutive business days during the Compliance Period. In the event that we do not regain compliance by
the end of the Compliance Period, we may be eligible for additional time to regain compliance. To qualify, we will be required to meet
the continued listing requirement for the market value of our publicly held shares and all other initial listing standards for NASDAQ,
with the exception of the bid price requirement, and will need to provide written notice of our intention to cure the deficiency during
the second compliance period, by effecting a reverse stock split if necessary. If we meet these requirements, we may be granted an additional
180 calendar days to regain compliance. We have not regained compliance as of the date of this Form 10-Q, and if we fail to regain compliance
during the Compliance Period or any subsequent grace period granted by NASDAQ, our common shares will be subject to delisting by NASDAQ,
which could seriously decrease or eliminate the value of an investment in our common shares and result in significantly increased uncertainty
as to the Company’s ability to raise additional capital.
On
August 26, 2022, the Company 1) filed a registration statement for a base prospectus which covers the offering, issuance and sale of
up to $300,000
of common shares, warrants, units and/or subscription rights; and 2) entered into an Open Market Sale Agreement with Jefferies LLC
(“Jefferies”), pursuant to which the Company may offer and sell its common shares having an aggregate price of up to
$125,000
from time to time through Jefferies, acting as agent or principal (the “ATM Program”). The ATM Program replaces Open
Market Sale Agreements previously entered into with Jefferies on July 31, 2020, and September 3, 2021, pursuant to each of which we
could offer and sell our common shares having an aggregate price of up to $125,000
from time to time, through “at the market” (“ATM”) equity offering programs. Both ATM programs were
terminated, effective as of August 26, 2022. Prior to termination, $27,022
of our common shares remained available for sale pursuant to the first ATM program, and $125,000
of our common shares remained available for sale pursuant to the second ATM program. Neither ATM program was utilized in
2022.
In
September 2022, the Company refinanced its existing term loan facility with K2 HealthVentures LLC (“K2”) to increase the
amount of term loans available to $100,000 among other items. See Note 9 for more details. The refinanced long-term debt has a maturity
date of September 14, 2026.
Financial
instruments recognized in the condensed consolidated balance sheet consist of cash, accounts receivable, other current assets, accounts
payable, and other current liabilities. The Company believes that the carrying value of its current financial instruments approximates
their fair values due to the short-term nature of these instruments. The Company does not hold any derivative financial instruments.
2.
SIGNIFICANT ACCOUNTING POLICIES
Basis
of Presentation and Consolidation
The
Company’s fiscal year ends on December 31 of each calendar year. The accompanying unaudited condensed consolidated financial statements
have been prepared in U.S. dollars (“USD”) and pursuant to the rules and regulations of the SEC, for interim reporting. Accordingly,
certain information and footnote disclosures normally included in the financial statements prepared in accordance with United States
of America generally accepted accounting principles (“U.S. GAAP”), have been condensed or omitted pursuant to such rules
and regulations. The December 31, 2021 consolidated balance sheet in this document was derived from the audited consolidated financial
statements. The condensed consolidated financial statements and notes included in this quarterly report on this Form 10-Q does not include
all of the disclosures required by U.S. GAAP and should be read in conjunction with the financial statements and notes included in the
Company’s Annual Report on Form 10-K for the year ended December 31, 2021 (the “2021 10-K”), as filed with the SEC
on March 7, 2022.
The
condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries: VBI DE, VBI US, VBI
Cda, SciVac, SciVac HK, and VBI BV. Intercompany balances and transactions between the Company and its subsidiaries are eliminated in
the condensed consolidated financial statements. Certain items previously reported in specific financial statement captions have been
reclassified to conform to the current presentation.
In
the opinion of management, these condensed consolidated financial statements include all adjustments and accruals of a normal and recurring
nature necessary to fairly state the results of the periods presented. The results for the periods presented are not necessarily indicative
of results to be expected for the full year or for any future periods.
Significant
Accounting Policies
The
significant accounting policies used in the preparation of these condensed consolidated financial statements are disclosed in the 2021
10-K, and there have been no changes to the Company’s significant accounting policies during the nine months ended September 30,
2022, other than the polices discussed below.
3.
NEW ACCOUNTING PRONOUNCEMENTS
Recently
Adopted Accounting Pronouncements
In
August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and
Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s
Own Equity (“ASU 2020-06”), which simplifies the accounting for certain financial instruments with characteristics of liabilities
and equity, including certain convertible instruments and contracts on an entity’s own equity. Specifically, the new standard has
removed the separation models required for convertible debt with cash conversion features and convertible instruments with beneficial
conversion features. It has also removed certain settlement conditions that are currently required for equity contracts to qualify for
the derivative scope exception and simplifies the diluted earnings per share calculation for convertible instruments.
On
January 1, 2022, the Company adopted ASU 2020-06 using the modified retrospective method and recognized a cumulative effect of initially
applying the ASU as an adjustment to the January 1, 2022 opening balance of accumulated deficit. Our conversion option that was previously
bifurcated and recorded as a debt discount and additional paid-in capital has now been combined as a single instrument classified as
a liability. The Company eliminated the beneficial conversion feature from additional paid-in capital; eliminated the interest accretion
on the beneficial conversion feature through December 31, 2021 from the opening balance of accumulated deficit; and eliminated the corresponding
debt discount. The prior period consolidated financial statements have not been retrospectively adjusted and continue to be reported
under the accounting standards in effect for those periods.
Accordingly,
the cumulative effect of the changes made on our January 1, 2022 condensed consolidated balance sheet for the adoption of the ASU was
as follows:
SCHEDULE
OF CUMULATIVE EFFECT OF CHANGES ON CONSOLIDATED BALANCE SHEETS
| |
Balance as at December 31, 2021 | | |
Adjustments from adoption of ASU 2020-06 | | |
Balance as at January 1, 2022 | |
Liabilities | |
| | | |
| | | |
| | |
Long-term debt, net of debt discount | |
$ | 28,441 | | |
$ | 681 | | |
$ | 29,122 | |
Stockholders’ equity | |
| | | |
| | | |
| | |
Additional paid-in capital | |
$ | 81,583 | | |
$ | (2,746 | ) | |
$ | 78,837 | |
Accumulated deficit | |
$ | (378,371 | ) | |
$ | 2,065 | | |
$ | (376,306 | ) |
Recently
Issued Accounting Standards, not yet Adopted
In
June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on
Financial Instruments (“ASU 2016-13”). The amendments in ASU 2016-13, among other things,
require the measurement of all expected credit losses for financial assets held at the reporting date based on historical experience,
current conditions, and reasonable and supportable forecasts. Financial institutions and other organizations will now use forward-looking
information to better inform their credit loss estimates. Many of the loss estimation techniques applied today will still be permitted,
although the inputs to those techniques will change to reflect the full amount of expected credit losses. ASU 2016-13 will be effective
for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. This ASU will be implemented
through a modified retrospective method of transition. The Company is currently evaluating the
potential impact of ASU 2016-13 on its condensed consolidated financial statements.
4.
INVENTORY, NET
Inventory
consists of the following:
SCHEDULE
OF INVENTORY
| |
September 30, 2022 | | |
December 31, 2021 | |
Finished goods | |
$ | 774 | | |
$ | - | |
Work-in-process | |
| 1,074 | | |
| 645 | |
Raw materials | |
| 3,948 | | |
| 1,931 | |
Total | |
$ | 5,796 | | |
$ | 2,576 | |
5.
OTHER CURRENT ASSETS
Other
current assets consisted of the following:
SCHEDULE
OF OTHER CURRENT ASSETS
| |
September 30, 2022 | | |
December 31, 2021 | |
Government receivables | |
$ | 2,350 | | |
$ | 1,438 | |
Other current assets | |
| 1,658 | | |
| 2,195 | |
Total | |
$ | 4,008 | | |
$ | 3,633 | |
6.
INTANGIBLE ASSETS, NET, AND GOODWILL
The
Company’s intangible assets determined to have indefinite useful lives including In-Process Research and Development (“IPR&D”)
and goodwill, are tested for impairment annually, or more frequently if events or circumstances indicate that the assets might be impaired.
Such circumstances could include but are not limited to: (1) a significant adverse change in legal factors or in business climate, (2)
unanticipated competition, or (3) an adverse action or assessment by a regulator.
The
Company has established August 31st as the date for its annual impairment test of IPR&D and goodwill. The costs of rights to IPR&D
projects acquired in an asset acquisition are expensed in the consolidated statements of operations unless the project has an alternative
future use. These costs include initial payments incurred prior to regulatory approval in connection with research and development agreements
that provide rights to develop, manufacture, market and/or sell pharmaceutical products.
The
IPR&D assets, which consist of the CMV and GBM programs, were acquired in a business combination, capitalized as an intangible asset
and are tested for impairment at least annually until commercialization, after which time the IPR&D will be amortized over its estimated
useful life. The impairment test compares the carrying amount of the IPR&D asset to its fair value. If the carrying amount exceeds
the fair value of the asset, such excess is recorded as an impairment loss. There was no IPR&D impairment as a result of the Company’s
annual testing on August 31, 2022. The fair value of the IPR&D assets included in the impairment test was determined using the income
approach method and is considered Level 3 in the fair value hierarchy. Some of the more significant estimates and assumptions inherent
in the estimate of the fair value of IPR&D assets including: 1)
the amount and timing of costs to develop the IPR&D into viable products; 2) the amount and timing of future cash inflows; 3) the
discount rate; and 4) the probability of technical and regulatory success. The discount rate used was 12% and the cumulative probability
of technical and regulatory success to achieve approval to market the products ranged from approximately 10% to 17%.
The fair value of our CMV asset was in excess of its
carrying value by approximately 25% as of August 31, 2022. In the event we continue to experience challenging market conditions, insufficient
internal resources due to competing programs, and changes in the competitive and technological landscape for CMV vaccines, this may give
rise to a triggering event that may require the Company to record impairment charges on our IPR&D assets in the future.
SCHEDULE
OF INDEFINITE LIVED INTANGIBLE ASSETS INCLUDING CUMULATIVE IMPAIRMENT AND CURRENCY TRANSLATION
| |
| | |
September 30, 2022 | |
| |
Gross Carrying Amount | | |
Accumulated Amortization | | |
Cumulative Impairment Charge | | |
Cumulative Currency Translation | | |
Net Book Value | |
Patents | |
$ | 669 | | |
$ | (669 | ) | |
$ | - | | |
$ | 3 | | |
$ | 3 | |
IPR&D assets | |
| 61,500 | | |
| - | | |
| (300 | ) | |
| (3,476 | ) | |
| 57,724 | |
| |
$ | 62,169 | | |
$ | (669 | ) | |
$ | (300 | ) | |
$ | (3,473 | ) | |
$ | 57,727 | |
| |
| | |
December 31, 2021 | |
| |
Gross Carrying Amount | | |
Accumulated Amortization | | |
Cumulative Impairment Charge | | |
Cumulative Currency Translation | | |
Net Book Value | |
Patents | |
$ | 669 | | |
$ | (660 | ) | |
$ | - | | |
$ | 47 | | |
$ | 56 | |
IPR&D assets | |
| 61,500 | | |
| - | | |
| (300 | ) | |
| 835 | | |
| 62,035 | |
| |
$ | 62,169 | | |
$ | (660 | ) | |
$ | (300 | ) | |
$ | 882 | | |
$ | 62,091 | |
The
Company amortizes intangible assets with finite lives on a straight-line basis over their estimated useful lives.
The
change in carrying value for IPR&D assets from December 31, 2021 relates to currency translation adjustments which decreased by $4,311
for the nine months ended September 30, 2022.
Goodwill
represents the excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired in a
business combination. When evaluating goodwill for impairment, we may first perform an assessment qualitatively whether it is more likely
than not that a reporting unit’s carrying amount exceeds its fair value, referred to as a “step zero” approach. Subsequently
(if necessary, after step zero), if the carrying value of a reporting unit exceeded its fair value an impairment would be recorded. We
would perform our goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. There was no goodwill
impairment determined as a result of the Company’s annual testing on August 31, 2022. The fair value of the Company, which consists
of a single reporting unit, included in the impairment test was determined using the closing market stock price of VBI as of August 31,
2022.
SCHEDULE
OF GOODWILL
| | |
| | |
September 30, 2022 | |
| | |
Gross Carrying Amount | | |
Cumulative Impairment Charge | | |
Cumulative Currency Translation | | |
Net Book Value | |
Goodwill | | |
$ | 8,714 | | |
$ | (6,292 | ) | |
$ | (318 | ) | |
$ | 2,104 | |
| | |
| | |
December 31, 2021 | |
| | |
Gross Carrying Amount | | |
Cumulative Impairment Charge | | |
Cumulative Currency Translation | | |
Net Book Value | |
Goodwill | | |
$ | 8,714 | | |
$ | (6,292 | ) | |
$ | (161 | ) | |
$ | 2,261 | |
The
change in carrying value for goodwill from December 31, 2021 relates to currency translation adjustments which increased by $157 for
the nine months period ended September 30, 2022.
7.
OTHER CURRENT LIABILITIES
Other
current liabilities consisted of the following:
SCHEDULE
OF OTHER CURRENT LIABILITIES
| |
September 30, 2022 | | |
December 31, 2021 | |
Accrued research and development expenses (including clinical trial accrued expenses) | |
$ | 7,224 | | |
$ | 8,196 | |
Accrued professional fees | |
| 2,970 | | |
| 2,294 | |
Payroll and employee-related costs | |
| 2,392 | | |
| 4,805 | |
Deferred funding | |
| 7,479 | | |
| 10,183 | |
Other current liabilities | |
| 1,439 | | |
| 1,463 | |
Total | |
$ | 21,504 | | |
$ | 26,941 | |
8.
LOSS PER SHARE OF COMMON SHARES
Basic
loss per share is computed by dividing net loss applicable to common stockholders by the weighted average number of common shares outstanding
during each period. Diluted loss per share includes the effect, if any, from the potential exercise or conversion of securities, such
as warrants, and stock options, which would result in the issuance of incremental shares of common shares unless such effect is anti-dilutive.
In computing the basic and diluted net loss per share applicable to common stockholders, the weighted average number of shares remains
the same for both calculations due to the fact that when a net loss exists, dilutive shares are not included in the calculation as their
effect would be anti-dilutive. These potentially dilutive securities are more fully described in Note 10, Stockholders’ Equity
and Additional Paid-in Capital.
The
following potentially dilutive securities outstanding at September 30, 2022 and 2021 have been excluded from the computation of diluted
weighted average shares outstanding, as they would be antidilutive:
SCHEDULE
OF ANTI-DILUTIVE WEIGHTED AVERAGE SHARES OUTSTANDING
| |
September 30, 2022 | | |
September 30, 2021 | |
Warrants | |
| 3,564,882 | | |
| 1,384,469 | |
Stock options and restricted stock units | |
| 23,102,475 | | |
| 18,409,572 | |
K2 conversion feature | |
| 6,161,889 | | |
| 1,369,863 | |
Total | |
| 32,829,246 | | |
| 21,163,904 | |
9.
LONG-TERM DEBT
As
of September 30, 2022, and December 31, 2021, the long-term debt is as follows:
SCHEDULE
OF LONG-TERM DEBT
| |
September 30, 2022 | | |
December 31, 2021 | |
Long-term debt, net of debt discount of $7,281 ($3,783 at December 31, 2021) | |
$ | 48,418 | | |
$ | 28,441 | |
Less: current portion | |
| - | | |
| - | |
Long-term debt, net of current portion | |
$ | 48,418 | | |
$ | 28,441 | |
On
May 22, 2020, the Company (along with its subsidiary VBI Cda) entered into the Loan and Guaranty Agreement (the “Loan
Agreement”) with K2 and any other lender from time-to-time party thereto (the “Lenders”). On May 22, 2020, the
Lenders advanced the first tranche of term loans of $20,000.
Pursuant to the Loan Agreement, the Lenders originally had the ability to convert, at the Lenders’ option, up to $4,000 of
the secured term loan into common shares of the Company at a conversion price of $1.46 per
share until the original maturity date of June
1, 2024. On February 3, 2021, pursuant to
the Loan Agreement, the Lenders, converted $2,000 of
the secured term loan into 1,369,863 common
shares at a conversion price of $1.46 per
share.
On
May 17, 2021, the Company entered into the First Amendment to the Loan and Guaranty Agreement (“First Amendment”) with the
Lenders and received additional loan advances of $12,000.
On
September 14, 2022, the Company entered into the Second Amendment to the Loan Agreement (the “Second Amendment”) with
the Lenders to: (i) increase the amount of the term loans available under the Loan Agreement to $100,000
from $50,000,
which term loans are available in up to four tranches the subject to the achievement of milestones and other customary conditions,
(ii) add certain minimum net revenue covenants to the Second Amendment, (iii) extend the final maturity date for the term loans to
September 14, 2026, which may be extended to September 14, 2027, under certain circumstances, and (iv) to the extent that the
maturity date is extended, the term loans will begin amortizing on a monthly basis on September 14, 2026.
On
September 15, 2022, the Lenders advanced to the Borrowers the Restatement First Tranche Term Loan (as defined in the Second
Amendment) in an aggregate amount of $50,000
which included the refinancing of the $30,000
in term loans that were outstanding under the Loan Agreement as amended by the First Amendment. The second tranche of term loans of
up to $15,000
will be available from April 1, 2023, through June 30, 2023, subject to the achievement of certain clinical milestones and
compliance with a liquidity requirement which requires the Company to have sufficient cash on hand to funds its operations for at
least nine months (the “Liquidity Requirement”). The third tranche of term loans of up to $10,000
will be available from April 1, 2024, through June 30, 2024, so long as certain of the milestones for the second tranche of term loans
were achieved, no events of default under the Loan Agreement have occurred and are continuing, and the Liquidity Requirement is
satisfied. The fourth tranche of term loans of up to $25,000
shall be available at any time from September 14, 2022, until September 14, 2026, subject to the Lender’s review of the
Company’s clinical and financial plans and Lender’s investment committee approval.
Pursuant
to the Second Amendment, the Lenders have the ability to convert $7,000
into common shares, by which $2,000 of the term loans shall be convertible into 1,369,863
shares of common stock at a conversion price of $1.46
per share and $5,000
of the term loans shall be convertible into 4,792,026
shares of common stock at a conversion price of $1.0434
per share (“K2 conversion feature”).
In
connection with the Loan Agreement, on May 22, 2020, the Company issued the Lenders a warrant to purchase up to 625,000
common shares (the “Original K2 Warrant”) at an exercise price of $1.12
per share. On May 17, 2021, in connection with the First Amendment, the Company amended and restated the Original K2 Warrant to
purchase an additional 312,500
common shares for a total of 937,500
common shares (the “First Amendment Warrant”) with the same exercise price of $1.12
per share. On September 14, 2022, in
connection with the Second Amendment and the advance of the first tranche of term loans of $50,000 by the Lenders, the Company
issued the Lenders a warrant to purchase an additional 2,180,413 common shares (the “Second Amendment Warrant”) with a
warrant exercise price of $0.8026. If the full remaining $50,000 available in the K2 tranches is advanced pursuant to the Second
Amendment, up to an additional 2,180,413 common shares will be issuable pursuant to the Second Amendment Warrant. The First
Amendment Warrant and the Second Amendment Warrant may be exercised either for cash or on a cashless “net exercise”
basis. The First Amendment Warrant expires on May 22, 2030 and the Second Amendment Warrant expires on September 14,
2032.
The
Company is required to make a final payment equal to 6.95% of the aggregate term loan principal on the maturity date of the term loan,
or upon earlier prepayment of the term loans in accordance with the Second Amendment (the “Second Amendment Final Payment”).
The final payment related to the refinanced $30,000 in term loans that were outstanding under the Loan Agreement as amended by the First
Amendment of $2,224 remains and is due the earlier of June 1, 2024 or the earlier prepayment of the term loans in accordance with
the Second Amendment (the “Original Final Payment”).
Upon
receipt of additional funds, issuable pursuant to the second, third and fourth tranches, under the Second Amendment, additional
common shares will be issuable pursuant to the Second Amendment Warrant as determined by the principal amount of the second tranche,
third tranche and fourth tranche actually funded multiplied by 3.5% and divided by the warrant exercise price of $0.8026,
and the Second Amendment Final Payment will increase by
6.95% of the funds advanced.
The
Company accounted for the Second Amendment as a debt extinguishment and resulted in an extinguishment loss of $172,
which is included in interest expense, net of interest income in the condensed consolidated statement of operations and
comprehensive loss. The term loans under the Loan Agreement as amended by the First Amendment were derecognized and the term loan
under the Loan Agreement as amended by the Second Amendment was recorded at fair value of $48,340,
which resulted in a total debt discount of $7,359.
Fees paid to the Lender, including the fair value of the Second Amendment Warrant of $1,550
and the facility fee of $563,
were included in the calculation of extinguishment loss. Fees paid to third parties were de minimums and expensed as incurred in
general and administrative in the condensed consolidated statement of operations and comprehensive loss.
The
total principal amount of the loan under the Loan Agreement as amended by the Second Amendment, outstanding at September 30, 2022,
including the Original Final Payment of $2,224
and the Second Amendment Final Payment of $3,475
in connection with the Second Amendment, is $55,699.
The principal amount of the loan made under the Loan Agreement as amended by the Second Amendment accrues interest at an annual rate
equal to the greater of (a) 8.00%
or (b) prime rate plus 4.00%.
The interest rate as of September 30, 2022 was 10.25%.
The Company is required to pay only interest until September 14, 2026. The effective interest rate on the loan of $50,000,
excluding the Original Final Payment and Second Amendment Final Payment, is 13.63%.
Upon
the occurrence of an Event of Default, and during the continuance of an Event of Default, the applicable rate of interest, described
above, will be increased by 5.00%
per annum. The secured term loan maturity date is
September 14, 2026, or if the milestone for the Restatement Third Tranche Term Loan (as defined in the Second Amendment) has
been achieved, September 14, 2027, and the Loan Agreement as amended by the Second Amendment includes both financial and
non-financial covenants. The Company was in compliance with these covenants as of September 30, 2022.
The
obligations under the Loan Agreement as amended by the Second Amendment, are secured on a senior basis by a lien on substantially
all of the assets of the Company and its subsidiaries other than intellectual property. The subsidiaries of the Company, other than
VBI Cda, SciVac HK, and VBI BV, are guarantors of the obligations of the Company and VBI Cda under the Loan Agreement. The Loan
Agreement also contains customary events of default.
The
total debt discount related to the Second Amendment is $7,359. As of September 30, 2022, and December 31, 2021, the unamortized debt
discount was $7,281 and $3,783 respectively. The debt discount is being charged to interest expense, net of interest income in the condensed
consolidated statement of operations and comprehensive loss using the effective interest method over the term of the debt.
At
September 30, 2022 and December 31, 2021, the fair value of our outstanding debt, which is considered level 3 in the fair value hierarchy,
is estimated to be $47,080 and $30,406, respectively.
Interest
expense, net of interest income recorded in the three and nine months ended September 30, 2022 and 2021 was as follows:
SCHEDULE
OF INTEREST EXPENSE
| |
2022 | | |
2021 | | |
2022 | | |
2021 | |
| |
Three months ended September 30 | | |
Nine months ended September 30 | |
| |
2022 | | |
2021 | | |
2022 | | |
2021 | |
| |
| | |
| | |
| | |
| |
Interest expense | |
$ | 856 | | |
$ | 618 | | |
$ | 2,132 | | |
$ | 1,488 | |
Amortization of debt discount | |
| 416 | | |
| 487 | | |
| 1,237 | | |
| 2,499 | |
Extinguishment loss | |
| 172 | | |
| - | | |
| 172 | | |
| - | |
Interest income | |
| (486 | ) | |
| (79 | ) | |
| (742 | ) | |
| (304 | ) |
Total | |
$ | 958 | | |
$ | 1,026 | | |
$ | 2,799 | | |
$ | 3,683 | |
The
following table summarizes the future principal payments due under long-term debt:
SCHEDULE
OF FUTURE PRINCIPAL OF LONG-TERM DEBT
| |
Principal payments on Loan Agreement and final payment | |
Remaining 2022 | |
$ |
- | |
2023 | |
| - | |
2024 | |
| 2,224 | |
2025 | |
| - | |
2026 | |
| 53,475 | |
Total | |
$ | 55,699 | |
10.
STOCKHOLDERS’ EQUITY AND ADDITIONAL PAID-IN CAPITAL
Stock
option plans
The
Company’s stock option plans are approved by and administered by the Board and its Compensation Committee. The Board designates,
in connection with recommendations from the Compensation Committee, eligible participants to be included under the plan, and designates
the number of options, exercise price and vesting period of the new options.
2006
VBI US Stock Option Plan
The
2006 VBI US Stock Option Plan (the “2006 Plan”), was approved by and was previously administered by the VBI US board of
directors which designated eligible participants to be included under the 2006 Plan, and designated the number of options, exercise
price and vesting period of the new options. The 2006 Plan was not approved by the stockholders of VBI US. The 2006 Plan was
superseded by the 2014 Plan (as defined below) following the PLCC Merger and no further options will be issued under the 2006 Plan.
As of September 30, 2022, there were 842,803 options
outstanding under the 2006 Plan.
2014
Equity Incentive Plan
On
May 1, 2014, the VBI DE board of directors adopted the VBI Vaccines Inc. 2014 Equity Incentive Plan (the “2014 Plan”). The
2014 Plan was approved by the VBI DE’s shareholders on July 14, 2014. The 2014 Plan was superseded by the 2016 Plan (as defined
below) and no further options will be issued under the 2014 Plan. As of September 30, 2022, there were 521,242 options outstanding under
the 2014 Plan.
2016
VBI Equity Incentive Plan
The
2016 VBI Equity Incentive Plan (the “2016 Plan”) is a rolling incentive plan that sets the number of common shares issuable
under the 2016 Plan, together with any other security-based compensation arrangement of the Company, at a maximum of 10% of the aggregate
common shares issued and outstanding on a non-diluted basis at the time of any grant under the 2016 Plan. The 2016 Plan is an omnibus
equity incentive plan pursuant to which the Company may grant equity and equity-linked awards to eligible participants in order to promote
the success of the Company by providing a means to offer incentives and to attract, motivate, retain and reward persons eligible to participate
in the 2016 Plan. Grants under the 2016 Plan include a grant or right consisting of one or more options, stock appreciation rights (“SARs”),
restricted share units (“RSUs”), performance share units (“PSUs”), shares of restricted stock or other such award
as may be permitted under the 2016 Plan. As of September 30, 2022, there were 21,727,860 options outstanding and 10,570 RSUs unvested
under the 2016 Plan.
The
aggregate number of common shares remaining available for issuance for awards under the 2016 Plan totaled 1,268,789 at September 30,
2022.
Activity
related to stock options is as follows:
SCHEDULE
OF STOCK OPTIONS ACTIVITY
| |
Number
of Stock Options | | |
Weighted Average Exercise Price | |
Balance outstanding at December 31, 2021 | |
| 18,534,379 | | |
$ | 2.63 | |
| |
| | | |
| | |
Granted | |
| 5,140,000 | | |
| 1.51 | |
Exercised | |
| (7,221 | ) | |
| 1.65 | |
Forfeited | |
| (575,253 | ) | |
| 2.28 | |
| |
| | | |
| | |
Balance outstanding at September 30, 2022 | |
| 23,091,905 | | |
$ | 2.38 | |
| |
| | | |
| | |
Exercisable at September 30, 2022 | |
| 14,536,140 | | |
$ | 2.52 | |
Information
relating to RSUs is as follow:
SCHEDULE
OF RESTRICTED STOCK UNITS
|
|
Number of
Stock Awards | | |
Weighted
Average
Fair Value
at Grant Date | |
Unvested shares outstanding at December 31, 2021 |
|
| 39,329 | | |
$ | 1.47 | |
|
|
| | | |
| | |
Forfeited |
|
| (695 | ) | |
| 1.46 | |
Vested |
|
|
(28,064 |
) |
|
|
1.48 |
|
Unvested shares outstanding at September 30, 2022 |
|
| 10,570 | | |
$ | 1.46 | |
In
determining the amount of stock-based compensation the Company used the Black-Scholes option pricing model to establish the fair value
of options granted by applying the following weighted average assumptions:
SCHEDULE
OF FAIR VALUE OF OPTIONS GRANTED BY USING BLACK-SCHOLES OPTION PRICING ASSUMPTIONS
| |
2022 | | |
2021 | |
Volatility | |
| 93.23 | % | |
| 96.99 | % |
Risk free interest rate | |
| 1.75 | % | |
| 0.57 | % |
Expected term in years | |
| 5.83 | | |
| 5.84 | |
Expected dividend yield | |
| 0.00 | % | |
| 0.00 | % |
Weighted average fair value per option | |
$ | 1.13 | | |
$ | 2.41 | |
The
fair value of the options is recognized as an expense on a straight-line basis over the vesting period and forfeitures are accounted
for when they occur. The total stock-based compensation expense recorded in the three and nine months ended September 30, 2022 and 2021
was as follows:
SCHEDULE
OF STOCK-BASED COMPENSATION EXPENSE
| |
Three months ended September 30 | | |
Nine months ended September 30 | |
| |
2022 | | |
2021 | | |
2022 | | |
2021 | |
| |
| | |
| | |
| | |
| |
Research and development | |
$ | 514 | | |
$ | 476 | | |
$ | 1,534 | | |
$ | 1,368 | |
General and administrative | |
| 1,868 | | |
| 2,029 | | |
| 5,751 | | |
| 5,656 | |
Cost of revenues | |
| 30 | | |
| 24 | | |
| 86 | | |
| 67 | |
Total stock-based compensation expense | |
$ | 2,412 | | |
$ | 2,529 | | |
$ | 7,371 | | |
$ | 7,091 | |
11.
REVENUES, NET AND DEFERRED REVENUE
Revenues,
net comprises the following:
SCHEDULE
OF REVENUE COMPRISED
| |
Three months ended September 30 | | |
Nine months ended September 30 | |
| |
2022 | | |
2021 | | |
2022 | | |
2021 | |
| |
| | |
| | |
| | |
| |
Product revenues, net | |
$ | 258 | | |
$ | 24 | | |
$ | 680 | | |
$ | 262 | |
R&D service revenues | |
| 59 | | |
| 83 | | |
| 109 | | |
| 288 | |
Total revenues, net | |
$ | 317 | | |
$ | 107 | | |
$ | 789 | | |
$ | 550 | |
The
following table presents revenues expected to be recognized in the future related to performance obligations, based on current estimates,
that are unsatisfied at September 30, 2022:
SUMMARY
OF REVENUE EXPECTED TO BE RECOGNIZED IN FUTURE RELATED TO PERFORMANCE OBLIGATIONS
| |
Total | | |
Current portion to September 30, 2023 | | |
Remaining portion thereafter | |
Product revenues, net | |
$ | 469 | | |
$ | - | | |
$ | 469 | |
R&D service revenues | |
| 2,132 | | |
| 597 | | |
| 1,535 | |
Total revenues, net | |
$ | 2,601 | | |
$ | 597 | | |
$ | 2,004 | |
The
following table presents changes in the deferred revenue balance for the nine months ended September 30, 2022:
SUMMARY
OF CHANGES IN DEFERRED REVENUE
Balance at January 1, 2021 | |
$ | 3,104 | |
Currency
translation |
|
|
- |
|
Balance at December 31, 2021 | |
| 2,803 | |
| |
| | |
Recognition of deferred revenue | |
| (57) | |
Currency translation | |
| (145) | |
| |
| | |
Balance at September 30, 2022 | |
$ | 2,601 | |
| |
| | |
Short Term | |
$ | 597 | |
Long Term | |
$ | 2,004 | |
Collaboration
and License Agreement – Brii Bio
On
December 4, 2018, the Company entered into a Collaboration and License Agreement (the “License Agreement”) with Brii Biosciences
Limited (“Brii Bio”), amended on April 8, 2021, whereby:
|
● |
the
Company and Brii Bio agreed to collaborate on the development of a HBV recombinant protein-based immunotherapeutic in the licensed
territory, which consists of China, Hong Kong, Taiwan and Macau (collectively, the “Licensed Territory”), and to conduct
a Phase Ib/IIa collaboration clinical trial for the purpose of comparing VBI-2601 (BRII-179), which is a recombinant protein-based
immunotherapeutic developed by VBI for use in treating chronic HBV, with a novel composition developed jointly with Brii Bio (either
being the “Licensed Product”); |
|
|
|
|
● |
the
Company granted Brii Bio an exclusive royalty-bearing license to perform studies, and regulatory and other activities, as may be
required to obtain and maintain marketing approval for the Licensed Product, for the treatment of HBV in the Licensed Territory and
to commercialize and promote the Licensed Product for the diagnosis and treatment of chronic HBV in the Licensed Territory; and |
|
|
|
|
● |
Brii
Bio granted the Company an exclusive royalty-free license under Brii Bio’s technology and Brii Bio’s interest in any
joint technology developed during the collaboration to develop and commercialize the Licensed Product for the diagnosis and treatment
of chronic HBV in the countries of the world other than the Licensed Territory. |
On
December 20, 2021, the Company and Brii Bio further amended the License Agreement (the “Second Amendment License Agreement”)
subject to the following additional terms and conditions:
|
● |
the
Company and Brii Bio agreed to conduct an additional Phase II combination clinical trial of VBI-2601 (BRII-179), both with and without
IFN-α, and BRII-835 (VIR-2218) (“Combo Clinical Trial”); and |
|
|
|
|
● |
Brii
Bio granted the Company a non-exclusive royalty free license under the Brii Bio technology arising from the data generated in the
Combo Clinical Trial solely for use in the development, manufacture or commercialization of the Licensed Product in combination with
an siRNA in the countries of the world other than the Licensed Territory. |
Pursuant
to the License Agreement, as amended, the Company is responsible for the R&D Services and Brii Bio is responsible for costs relating
to the clinical trials for the Licensed Territory.
The
Company and Brii Bio will jointly own all right, title and interest in the joint know-how development and the patents claiming joint
inventions made pursuant to the Second Amendment License Agreement.
The initial consideration of the License Agreement
consisted of an $11,000
non-refundable upfront payment. As part of the License Agreement, the Company and Brii Bio entered into a stock purchase agreement.
Under the terms of the stock purchase agreement, the Company issued to Brii Bio 2,295,082
shares of its common stock valued at $3,626
(based on the Company’s common stock price on December 4, 2018). The remaining $7,374,
deemed to be the initial transaction price, was allocated to two performance obligations: i) the VBI-2601 (BRII-179) license and ii)
R&D services. The R&D services were allocated $4,737
of the transaction price using an estimated selling price based on an expected cost plus a margin approach and the remaining transaction
price of $2,637
was allocated to the VBI-2601 (BRII-179) license using the residual method.
There
was no additional consideration contemplated in the Second Amendment License Agreement.
In
addition, the Company is also eligible to receive an additional $117,500 in potential regulatory and sales milestone payments, along
with royalties on commercial sales in the Licensed Territory. Milestone payments that are not within the control of the Company or the
licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. Therefore,
no variable consideration was included in the initial transaction price and no such amounts have been recognized to date.
The
R&D Services will be satisfied over time as services are rendered using the “cost-to-cost” input method as this method
represents the most accurate depiction of the transfer of services based on the types of costs expected to be incurred. As of September
30, 2022, R&D services related to Brii Bio that remain unsatisfied are $1,932, out of the $2,601 total deferred revenue.
Upon
termination of the Collaboration and License Agreement prior to the end of the term, there is no obligation for refund and any amounts
in deferred revenue related to unsatisfied performance obligations will be immediately recognized.
12.
COLLABORATION ARRANGEMENTS
GlaxoSmithKline
Biologicals S.A. (“GSK”)
On
September 10, 2019, the Company entered into a Clinical Collaboration Agreement (“Collaboration Agreement”) pursuant to which
we will investigate the use of GSK’s proprietary AS01B adjuvant system in our ongoing study of VBI-1901. As a result
of the Collaboration Agreement, a second study arm was added to Part B of the ongoing Phase Ib/IIa clinical study to accommodate the
AS01B adjuvant.
This
relationship is considered a collaborative relationship and not a customer relationship and is therefore accounted for outside the scope
of ASC Topic 606. Costs associated with the second study arm will be expensed as incurred in Research and Development expenses; three
and nine months ended September 30, 2022 are $0 and $139, respectively. Costs for the three and nine months ended September 30, 2021
are $48 and $374, respectively.
National
Research Council of Canada (“NRC”)
On
March 31, 2020, the Company announced a collaboration with the NRC, Canada’s largest federal research and development organization,
to develop a coronavirus vaccine candidate, targeting COVID-19, SARS, and MERS. The NRC and the Company are collaborating to evaluate
and select promising coronavirus vaccine candidates. The collaboration combines the Company’s viral vaccine expertise, eVLP technology
platform, and modified coronavirus antigens with the NRC’s proprietary SARS-CoV-2 antigens and assay development capabilities to
select the most immunogenic vaccine candidate for further development.
On
December 21, 2020, the Company signed an amendment to the collaboration agreement with the NRC to broaden the scope of collaboration
to include certain pre-clinical evaluations, bioprocess optimization, technology transfer, and the performance of additional scale up
work.
On
July 8, 2021, the Company signed a second amendment to the collaboration agreement with the NRC to broaden the scope of the collaboration
to include developing a vaccine against the Beta variant of SARS-CoV-2.
On
August 27, 2021, the Company signed a third amendment to the collaboration agreement with the NRC further broaden the scope to include
certain stable cell line work for our vaccine candidate against the Beta variant of SARS-CoV-2.
On
November 15, 2021, we signed a fourth amendment to the collaboration agreement with the NRC to further broaden the scope to include additional
animal studies and PRNT analysis for our vaccine candidate against the Beta variant of SARS-CoV-2.
On
February 8, 2022, we signed a fifth amendment to the collaboration agreement with the NRC to further broaden the scope to include additional
assays of new variants against SARS-CoV-2.
On
April 28, 2022, we signed a sixth amendment to the collaboration agreement with the NRC to further broaden the scope to include generation
and testing of stable pools of cells expressing SARS-CoV-2 spike protein.
The
expiry date of the collaboration agreement, as amended, is December 31, 2022.
This
relationship is considered a collaborative relationship and not a customer relationship and is therefore accounted for outside the scope
of ASC Topic 606. Costs associated with the collaboration will be expensed as incurred in Research and Development expenses; costs for
the three and nine months ended September 30, 2022 are $118
and $702,
respectively. Costs for the three and nine months ended September 30, 2021 are $712
and
$942,
respectively.
Coalition
for Epidemic Preparedness Innovations (“CEPI”)
On March 9, 2021, the Company and CEPI announced the CEPI Funding Agreement, to develop eVLP vaccine candidates against SARS-COV-2 variants, including the Beta variant, also known as the B.1.351 variant and as 501Y.V2, first identified in South Africa. CEPI agreed to provide up to $33,018 to support the advancement of VBI-2905, a monovalent eVLP candidate expressing the pre-fusion form of the spike protein from the Beta variant strain, through Phase I clinical development.
Under
the terms of the CEPI Funding Agreement, among other things, the Company and CEPI agreed on the importance of global equitable access
to any vaccines produced pursuant to the CEPI Funding Agreement. Any such vaccines, if approved, are expected to be procured and allocated
through global mechanisms as part of the Access to COVID-19 Tools (ACT) Accelerator, an international initiative launched by the WHO,
Gavi the Vaccine Alliance, CEPI, and other global non-governmental organizations and governmental leaders in 2021.
This
relationship is considered a collaborative relationship and not a customer relationship and is therefore accounted for outside the scope
of ASC Topic 606.
Costs
associated with the collaboration are expensed as incurred in Research and Development and General and Administrative expenses; costs
for the three and nine months ended September 30, 2022 are $692 and $3,098 respectively. Costs for the three and nine months ended September
30, 2021 are $2,711 and $4,918, respectively. Such expenses, including administrative expenses, for the three and nine months ended September
30, 2022 and three and nine months ended September 30, 2021 were reduced by the same amount. Since inception of the CEPI Funding Agreement
in 2021, the Company received $19,327 from CEPI and the Company had $7,479 recorded as deferred funding, recorded in other current liabilities
on the condensed consolidated balance sheet.
Brii
Biosciences Limited
On
December 4, 2018, we entered into the Collaboration and License Agreement with Brii Bio, which was amended on April 8, 2021, as described
in Note 11.
As
described in Note 11, the Company and Brii Bio entered into the Second Amendment License Agreement on December 20, 2021. The Combo Clinical
Trial collaboration is considered a collaborative relationship and not a customer relationship and is therefore accounted for outside
the scope of ASC Topic 606. Costs associated with the Combo Clinical Trial collaboration will be expensed as incurred in Research and
Development expenses; costs for the three and nine months ended September 30, 2022, were $56 and $191 respectively.
13.
GOVERNMENT GRANTS
Grants
recognized in research and development expenses in the condensed consolidated statement of operations and comprehensive loss are as follows:
Industrial
Research Assistance Program (“IRAP”)
On
July 3, 2020, the Company and the NRC as represented by its IRAP signed a contribution agreement whereby the NRC agreed to contribute
up to CAD $1,000 for the transfer and scale-up of the technical production process for our prophylactic coronavirus vaccine program.
For
the three and nine months ended September 30, 2022 the Company recognized $0 and $0, respectively, as a reduction in expenses. As of
September 30, 2022, the Company had $41 recorded as deferred government grants, recorded in other current liabilities on the condensed
consolidated balance sheet.
For
the three and nine months ended September 30, 2021, the Company recognized $68 and $68, respectively as a reduction in expenses.
Strategic
Innovation Fund (“SIF”)
On
September 16, 2020, the Company and Her Majesty the Queen in Right of Canada as represented by the Minister of Industry (“ISED”)
signed a contribution agreement (the “Contribution Agreement”) for a contribution from SIF whereby ISED agreed to contribute
up to CAD $55,976 to support the development of the Company’s coronavirus vaccine program, through Phase II clinical studies, for
a period commencing on April 15, 2020 and ending on or before the first quarter of 2022 (the “Project Completion Date”).
On March 28, 2022, the Company and ISED signed an amendment to the Contribution Agreement, the main purpose of which was to extend the
collaboration and move the Project Completion Date from March 31, 2022 to December 31, 2023.
For
the three and nine months ended September 30, 2022, the Company recognized $1,831 and $3,783, respectively, as a reduction in expenses.
As of September 30, 2022, the Company had $716 recorded as deferred government grants, recorded in other current liabilities on the condensed
consolidated balance sheet.
For
the three and nine months ended September 30, 2021, the Company recognized $2,365 and $6,377, respectively as a reduction in expenses.
14.
COMMITMENTS AND CONTINGENCIES
Legal
Proceedings
From
time to time, the Company may be involved in certain claims and litigation arising out of the ordinary course and conduct of business.
Management assesses such claims and, if it considers that it is probable that an asset had been impaired or a liability had been incurred
and the amount of loss can be reasonably estimated, provisions for loss are made based on management’s assessment of the most likely
outcome.
On
September 13, 2018, two civil claims were brought in the District Court of the central district in Israel naming our subsidiary SciVac
as a defendant. In one claim, two minors, through their parents, allege, among other things: defects in certain batches of Sci-B-Vac
discovered in July 2015; that Sci-B-Vac was approved for use in children and infants in Israel without sufficient evidence establishing
its safety; that SciVac failed to provide accurate information about Sci-B-Vac to consumers; and that each child suffered side effects
from the vaccine. The claim was filed together with a motion seeking approval of a class action on behalf of 428,000 children vaccinated
with Sci-B-Vac in Israel from April 2011 and seeking damages in a total amount of NIS 1,879,500 ($530,483). The second claim is a civil
action brought by two minors and their parents against SciVac and the Israel Ministry of Health alleging, among other things, that SciVac
marketed an experimental, defective, hazardous or harmful vaccine; that Sci-B-Vac was marketed in Israel without sufficient evidence
establishing its safety; and that Sci-B-Vac was produced and marketed in Israel without approval of a western regulatory body. The claim
seeks damages for past and future losses and expenses as well as punitive damages.
SciVac
believes these matters to be without merit and intends to defend these claims vigorously.
The
District Court has accepted SciVac’s motion to suspend reaching a decision on the approval of the class action pending the determination
of liability under the civil action. Preliminary hearings for the trial of the civil action began on January 15, 2020, with subsequent
preliminary hearings held on May 13, 2020, December 3, 2020, September 30, 2021, and June 9, 2022. The next preliminary hearing is scheduled
to be held on January 12, 2023.
Operating
leases
The
Company has entered into various non-cancelable lease agreements for its office, lab, and manufacturing facilities, which are
classified as operating leases. The office facility lease agreement in the United States (“U.S.”) expires on October
31, 2024, with no option to extend. Our
manufacturing facility lease agreement in Israel has been extended for 5 years with a term now ending January 31, 2027. A
lease for additional office space in Israel has a term ending November 30, 2025 with an option to extend for two additional years. The
lease agreement for our research facility in Canada, which comprises office and laboratory space, has a term ending on December 31,
2022 with an option to extend the term for one additional period of three years. A lease for additional office space at our research
facility commenced on October 1, 2020 with a term ending April 30, 2023. In September 2022, we decided to extend the term of our
lease for our research facility in Canada for three additional years, which now has a term ending on December 31,
2025.
During
the three and nine months ended September 30, 2022, the Company entered into new lease agreements and recognized a ROU asset of $339 and
$1,134, respectively.
There
are no residual value guarantees, no variable lease payments, and no restrictions or covenants imposed by leases. The discount rate used
in measuring the lease liabilities and right of use assets was determined by reviewing our incremental borrowing rate at the initial
measurement date.
SUMMARY
OF LEASE COST AND OTHER INFORMATION
Lease cost: | |
| |
Operating lease costs: | |
| |
Three months ended September 30, 2022 | |
$ | 489 | |
Nine months ended September 30, 2022 | |
| 1,383 | |
Three months ended September 30, 2021 | |
| 385 | |
Nine months ended September 30, 2021 | |
| 1,069 | |
Other information: | |
| |
Weighted average remaining lease term | |
3.27 years | |
Weighted average discount rate | |
| 13 | % |
Operating
lease costs are included G&A expenses in the statement of operations and comprehensive loss.
The
following table summarizes future undiscounted cash payments reconciled to the lease liabilities:
SCHEDULE
OF FUTURE UNDISCOUNTED CASH PAYMENTS RECONCILED TO LEASE LIABILITIES
|
|
| | |
Remaining 2022 |
|
$ | 321 | |
2023 |
|
| 1,295 | |
2024 |
|
| 1,196 | |
2025 |
|
| 710 | |
2026 |
|
| 614 | |
2027 |
|
| 167 | |
Total |
|
$ | 4,303 | |
Effect of discounting |
|
| (818 | ) |
Total lease liability |
|
$ | 3,485 | |
Less: current portion |
|
| 914 | |
Lease liability, net of current portion |
|
$ | 2,571 | |
15.
SEGMENT INFORMATION
The
Company’s Chief Executive Officer (“CEO”) has been identified as the chief operating decision maker. The CEO evaluates
the performance of the Company and allocates resources based on the information provided by the Company’s internal management system
at a consolidated level. The Company has determined that it has only one operating segment.
Revenues,
net from external customers are attributed to geographic areas based on location of the contracting customers:
SCHEDULE
OF REVENUES FROM EXTERNAL CUSTOMERS
| |
Three Months Ended September 30 | | |
Nine Months Ended September 30 | |
| |
2022 | | |
2021 | | |
2022 | | |
2021 | |
| |
| | |
| | |
| | |
| |
United States | |
$ | 238 | | |
$ | - | | |
$ | 444 | | |
$ | - | |
Israel | |
| 60 | | |
| 44 | | |
| 281 | | |
| 300 | |
China / Hong Kong | |
| 19 | | |
| 63 | | |
| 58 | | |
| 246 | |
Europe | |
| - | | |
| - | | |
| 6 | | |
| 4 | |
Total | |
$ | 317 | | |
$ | 107 | | |
$ | 789 | | |
$ | 550 | |
There
was no revenue attributed to our country of domicile, Canada, for the three and nine months ended September 30, 2022 and 2021.
16.
SUBSEQUENT EVENTS
On
October 18, 2022, the Company, Ferring International Center S.A., a company incorporated pursuant to the laws of Switzerland and
SciVac, a wholly owned subsidiary of the Company, amended and restated that certain license agreement, dated as of June 3, 2004 and
amended by the parties on each of January 24, 2005, March 15, 2005, June 15, 2005 and February 14, 2012 (the “Amended and
Restated Ferring License Agreement”). The
Amended and Restated Ferring License Agreement amends and restates certain of the terms relating to the manufacture and marketing of
HBsAg products, which includes, among others, updates to the definition of net sales, and a reduction in the fixed royalty rate on
net sales of HBsAg products from seven percent (7%) to three and a half percent (3.5%) in consideration for the grant of the license
to utilize genetically engineered CHO cells encoding the hepatitis B antigen and certain information related to the manufacture of
hepatitis B vaccines (collectively, the “Technology”). In connection with the Amended and Restated Ferring
License Agreement, the Company has also agreed to act as the guarantor for SciVac’s obligations under the Amended and Restated
Ferring License Agreement, or if the Amended and Restated Ferring License Agreement is assigned to a third party, guarantor for
SciVac’s obligations that have accrued up until the date of such assignment.
In
October 2022, the Company received notice from the U.S. Food and Drug Administration (the “FDA”) that we qualified as a
small business and that the Prescription Drug User Fee Act program application fee of $2,876
for PreHevbrio would be refunded.
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The
following discussion and analysis summarize the significant factors affecting our operating results, financial condition, liquidity,
and cash flows as of and for the periods presented below. The following discussion and analysis of our financial condition and results
of operations should be read in conjunction with the audited consolidated financial statements and related notes included elsewhere in
this Form 10-Q. In addition to historical information, this discussion and analysis here and throughout this Form 10-Q contains forward-looking
statements that involve risks, uncertainties, and assumptions. Our actual results may differ materially from those anticipated in these
forward-looking statements.
Overview
VBI
Vaccines Inc. (“VBI”) is a commercial stage biopharmaceutical company driven by immunology in the pursuit of powerful prevention
and treatment of disease. Through our innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped
VLP (“eVLP”) platform technology, we develop vaccine candidates that mimic the natural presentation of viruses, designed
to elicit the innate power of the human immune system. We are committed to targeting and overcoming significant infectious diseases,
including hepatitis B (“HBV”), COVID-19 and coronaviruses, and cytomegalovirus (“CMV”), as well as aggressive
cancers including glioblastoma. We are headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research
and manufacturing site in Rehovot, Israel.
Product
Pipeline
VBI’s
pipeline is comprised of vaccine and immunotherapeutic programs developed by virus-like particle technologies to target two distinct,
but often related, disease areas – infectious disease and oncology. We prioritize the development of programs for disease targets
that are challenging, underserved, and where the human immune system, when powered and stimulated appropriately, can be a formidable
opponent.
VLP
vaccines are a type of sub-unit vaccine, in which only the portions of viruses critical for eliciting an immune response are presented
to the body. Because of their structural similarity to viruses presented in nature, including their particulate nature and repetitive
structure, virus-like particles (VLPs) can stimulate potent immune responses. VLPs can be customized to present any protein antigen,
including multiple antibody and T cell targets, making them, we believe, ideal technologies for the development of both prophylactic
and therapeutic vaccines. However, only a few antigenic proteins self-assemble into VLPs, which limit the number of potential targets.
Notably, HBV antigens are among those that are able to spontaneously form orderly VLP structures. Our eVLP platform technology expands
the list of potentially viable target indications for VLPs by providing a stable core (Gag Protein) and lipid bilayer (the “envelope”).
It is a flexible platform that enables the synthetic manufacture of an “enveloped” VLP, or “eVLP”, which looks
structurally and morphologically similar to the virus, with no infectious material.
Our
product pipeline includes an approved vaccine and multiple late- and early-stage investigational programs. The investigational programs
are in various stages of clinical development and the scientific information included about these therapeutics is preliminary and investigative.
The investigational programs have not been approved by the United States Food and Drug Administration, European Medicines Agency, United
Kingdom Medicines and Healthcare products Regulatory Agency, Health Canada, or any other health authority and no conclusion can or should
be drawn regarding the safety or efficacy of these investigational programs.
In
addition to our existing pipeline programs, we may also seek to in-license clinical-stage vaccines or vaccine-related technologies that
we believe complement our pipeline, as well as technologies that may supplement our efforts in both immuno-oncology and infectious disease.
Key
Targeted Disease Areas
Hepatitis
B Virus (“HBV”)
HBV
infection can cause liver inflammation, fibrosis, and liver injury, resulting in potentially life-threatening conditions through
acute illness and chronic disease, including liver failure, cirrhosis, and cancer. HBV remains a significant public health burden
with as many as 2.2 million chronically infected people in the United States (“U.S.”) alone. Worldwide, this number is
estimated to be as high as 350 million, with approximately 800,000 deaths resulting from the consequences of HBV infection each
year.
Despite
the highly infectious nature of HBV, due to its often-asymptomatic nature, it is estimated that as many as 67% of chronically infected
adults in the U.S. are unaware of their infection status. There is no cure available for HBV infection and while public health initiatives
highlight immunization as the most effective strategy for the prevention of HBV infections, the U.S. adult HBV vaccination rates remain
persistently low at only about 30% of all adults aged 19 years and older.
In
April 2022, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) implemented a change
to the adult HBV vaccine recommendations. As incorporated in the CDC’s 2022 Adult Immunization Schedule and as published in the
April 1, 2022, CDC Morbidity and Mortality Weekly Report (MMWR), adults aged 19 to 59 years are now universally recommended to be vaccinated
against HBV infection. Additionally, while adults aged 60 years and older with risk factors for HBV infection are still recommended to
receive HBV vaccinations, adults aged 60 years and older without known risk factors for HBV may now also receive HBV vaccinations.
In
addition to our approved vaccine, PreHevbrio (Hepatitis B Vaccine [Recombinant]), there are four other vaccines approved in the U.S.
for the prevention of HBV infection in adults: Engerix-B® and Twinrix®, manufactured by GSK, Recombivax
HB®, manufactured by Merck &. Co., and Heplisav-B®, manufactured by Dynavax Technologies Corporation.
COVID-19
and Other Coronaviruses
Coronaviruses
are a large family of enveloped viruses that cause respiratory illness of varying severities. Only seven coronaviruses are known to cause
disease in humans, four of which most frequently cause symptoms typically associated with the common cold. Three of the seven coronaviruses,
however, have more serious outcomes in people. These more pathogenic coronaviruses are (1) SARS-CoV-2, a novel coronavirus identified
as the cause of COVID-19; (2) MERS-CoV, identified in 2012 as the cause of Middle East Respiratory Syndrome (“MERS”); and
(3) SARS-CoV, identified in 2002 as the cause of Severe Acute Respiratory Syndrome (“SARS”).
The
virus that causes COVID-19 continues to evolve and several SARS-CoV-2 variants have emerged and certain of these variants have been
identified as having a significant public health impact. To date, notable Variants of Concern (“VOC”) have
included:
|
● |
Alpha
(B.1.1.7) – First identified as in the United Kingdom (“UK”), VOC in December 2020 |
|
● |
Beta
(B.1.351) – First identified in South Africa, VOC in December 2020 |
|
● |
Gamma
(P.1) – First identified in Brazil, VOC in January 2021 |
|
● |
Delta
(B.1.617.2) – First identified in India, VOC in May 2021 |
|
● |
Omicron
and subvairants – First identified in South Africa, VOC in November 2021 |
Glioblastoma
(“GBM”)
Glioblastoma
(“GBM”) is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, about 12,000
new GBM cases are diagnosed each year. The current standard of care for GBM is surgical resection, followed by radiation and chemotherapy.
Even with intensive treatment, GBM progresses rapidly and has a high mortality rate, with median overall survival for primary GBM of
about 14 months. Median overall survival for recurrent GBM is even lower, at about 8 months.
Cytomegalovirus
(“CMV”)
CMV
is a common virus that is a member of the herpes family. It infects one in every two people in many developed countries. Most CMV infections
are “silent”, meaning the majority of people who are infected exhibit no signs or symptoms. Despite its typically asymptomatic
nature in older children and adults, CMV may cause severe infections in newborn children (congenital CMV) and may also cause serious
infections in people with weakened immune systems, such as solid organ or bone marrow transplant recipients. Congenital CMV infection
can be treated – but not cured – and there are currently no approved vaccines available for the prevention of infection in
either the congenital or the transplant setting.
Zika
Zika
is a mosquito-borne virus that is spread primarily through the bite of an infected Aedes species mosquito, but can also be transmitted
sexually, during pregnancy, or during childbirth. Acute infections are typically mild, but Zika has been associated with a number of
neurological complications in newborns. The first formal description of Zika virus was published in 1952, but it was not until 2007 that
the first Zika outbreak in humans was recorded. Over the past decade, Zika has begun to spread globally, and between January 2014 and
February 2016, 33 countries reported circulation of the Zika virus, including in North America. There is currently no vaccine to prevent
Zika infection.
Pipeline
Programs
The
table below is an overview of our commercial vaccine and our investigational programs as of October 31, 2022:
Indication |
|
Program |
|
Technology |
|
Current
Status |
Approved
Vaccine
●
Hepatitis B |
|
PreHevbrio1,2,3
Hepatitis
B Vaccine |
|
VLP |
|
Registration/Commercial |
|
|
(Recombinant) |
|
|
|
|
Prophylactic
Candidates |
|
|
|
|
|
|
● Coronaviruses (Multivalent) |
|
VBI-2901 |
|
eVLP |
|
Ongoing Phase I |
●
COVID-19 (Beta variant) |
|
VBI-2905 |
|
eVLP |
|
Phase Ib |
●
COVID-19 (Ancestral) |
|
VBI-2902 |
|
eVLP |
|
Phase Ia |
● Coronaviruses (Multivalent) |
|
Undisclosed |
|
eVLP |
|
Pre-Clinical |
●
Cytomegalovirus |
|
VBI-1501 |
|
eVLP |
|
Phase
I Completed |
●
Coronaviruses (Multivalent) |
|
Undisclosed |
|
eVLP |
|
Pre-Clinical |
●
Zika |
|
VBI-2501 |
|
eVLP |
|
Pre-Clinical |
|
|
|
|
|
|
|
Therapeutic
Candidates |
|
|
|
|
|
|
●
Hepatitis B |
|
VBI-2601 |
|
VLP |
|
Ongoing
Phase II |
●
Glioblastoma |
|
VBI-1901 |
|
eVLP |
|
Ongoing
Phase I/IIa |
●
Other CMV-Associated Cancers |
|
Undisclosed |
|
eVLP |
|
Preclinical |
1Approved
for use in the U.S. for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older
2
Approved for use in the European Union/European Economic Area and the UK, under the brand name PreHevbri, for active immunization
against infection caused by all known subtypes of the hepatitis B virus (HBV) in adults. It can be expected that hepatitis B will also
be prevented by immunization with PreHevbri as hepatitis B (caused by the delta agent) does not occur in the absence of HBV infection.
3
Approved for use in Israel, under the brand name Sci-B-Vac, for active immunization against hepatitis B virus (HBV infection).
A
summary of our marketed product, lead pipeline programs, and recent developments follows.
Marketed
Product
PreHevbrio
(Hepatitis B Vaccine [Recombinant])
PreHevbrio
(Hepatitis B Vaccine [Recombinant]) was approved by the FDA on November 30, 2021 for the prevention of infection caused by all known
subtypes of HBV in adults aged 18 years and older. PreHevbrio contains the S, pre-S2, and pre-S1 HBV surface antigens, and is the only
approved 3-antigen HBV vaccine for adults in the U.S. On February 23, 2022, following discussion at the CDC’s ACIP meeting, PreHevbrio
joined the list of recommended products for prophylactic adult vaccination against HBV infection. The inclusion of PreHevbrio in the
ACIP recommendation was reflected in a CDC publication on April 1, 2022 and was a notable milestone as many insurance plans and institutions
require an ACIP recommendation before a vaccine can be reimbursed or is made available to patients. Additionally, PreHevbrio will
be included in the next annual update of the CDC Adult Immunization Schedule in 2023, which will summarize changes throughout the coming
year. VBI launched PreHevbrio in the U.S. at the end of the first quarter of 2022, and revenue generation began in the second quarter
of 2022.
Commercial
and regulatory activity for VBI’s 3-antigen HBV vaccine outside of the U.S. include:
|
● |
European Union (“EU”): On May 2, 2022, we announced
that the European Commission (the “EC”) granted Marketing Authorization for PreHevbri [Hepatitis B vaccine (recombinant,
adsorbed]. The European Commission’s centralized marketing authorization is valid in all EU Member States as well as in the
European Economic Area (“EEA”) countries (Iceland, Liechtenstein, and Norway). VBI expects PreHevbri will available in
certain European countries beginning in early 2023. On September 8, 2022, we announced a partnership with Valneva SE
(“Valneva”) in connection with the marketing and distribution of PreHevbri in select EU markets, initially including
Sweden, Norway, Denmark, Finland, Belgium and the Netherlands, as well as the UK. |
|
● |
United Kingdom (“UK”): On June 1, 2022, we announced that the UK Medicines and Healthcare Products Regulatory Agency (“MHRA”) granted marketing authorization for PreHevbri [Hepatitis B vaccine (recombinant, adsorbed)]. This follows the EC centralized marketing authorization received and was conducted as part of the EC Decision Reliance Procedures (“ESCDRP”). VBI expects to make PreHevbri available in the UK in early 2023 as part of the partnership with Valneva. |
|
● |
Israel: Approved and commercially available under the brand name Sci-B-Vac® |
|
● |
Canada: On December 9, 2021, we completed the filing of a New Drug Submission (“NDS”) to Health Canada for our 3-antigen hepatitis B vaccine candidate. Discussions are underway with regulatory agencies to determine the brand name for our 3-antigen HBV vaccine in Canada. |
Prophylactic
Investigational Candidates
VBI-2900:
Coronavirus Vaccine Program (VBI-2901, VBI-2902, VBI-2905)
In
response to the ongoing SARS-CoV-2 (COVID-19) pandemic, VBI initiated development of a prophylactic coronavirus vaccine program. Coronaviruses
are enveloped viruses by nature which make them a prime target for VBI’s flexible eVLP platform technology.
On
August 26, 2020, we announced data from three pre-clinical studies conducted to enable selection of optimized clinical candidates for
our coronavirus vaccine program. As a result of these studies, VBI selected two vaccine candidates, with the goal of bringing forward
candidates that add meaningful clinical and medical benefit to those already approved: (1) VBI-2901, a multivalent coronavirus vaccine
candidate expressing the SARS-CoV-2, SARS, and MERS spike proteins; and (2) VBI-2902, a monovalent vaccine candidate expressing an optimized
“prefusion” form of the SARS-CoV-2 spike protein.
In March 2021, a Phase I study of VBI-2902 was initiated
and on June 29, 2021, we announced initial positive data from the Phase Ia portion of this study that evaluated one- and two-dose regimens
of 5µg of VBI-2902 in 61 healthy adults aged 18-54 years. After two doses, VBI-2902 induced neutralization titers in 100% of participants,
with 4.3x higher geometric mean titer (“GMT”) than that of the convalescent serum panel (n=25), and peak antibody binding
GMT of 1:4,047. VBI-2902 was also well tolerated with no safety signals observed.
In
response to the increased circulation of SARS-CoV-2 variants, the Phase Ib portion of the ongoing Phase I study was initiated in September
2021 to assess VBI-2905, our eVLP vaccine candidate directed against the SARS-CoV-2 Beta variant. On April 5, 2022, we announced new
data from the Phase 1b study (n=53). A single-dose booster of VBI-2905 increased the geometric mean titer (“GMT”) of neutralizing
antibodies directed against the Beta variant 3.8-fold, at day 28, in participants who had previously received two-doses of an mRNA vaccine
(ancestral strain) – approximately 2-fold increases were also seen at day 28 in antibody GMTs against both the ancestral and delta
variant. New preclinical data announced at the same time showed that against a panel of coronavirus variants in mice, reactivity was
seen with VBI-2902 against all variants including the ancestral strain, Delta, Beta, Omicron, Lambda, and RaTG13 (a bat coronavirus that
is distant to circulating human strains). In this same panel, VBI-2901 was able to elicit an even stronger response against all variants
tested – as the strains became more divergent from the ancestral strain, VBI-2901 elicited a greater difference in GMT from VBI-2902,
ranging from 2.5-fold higher against the ancestral strain to 9.0-fold higher against the bat coronavirus. Additionally, a validated pseudoparticle
neutralization assay (“PNA”) benchmarked against the WHO reference standard demonstrated that VBI-2902 elicited neutralizing
antibody responses of 176 IU50/mL in its Phase 1a study – this international standard measure would predict a greater than 90%
efficacy, with two internationally approved vaccines estimated to have 90% efficacy at 83 and 140 IU50/mL (Gilbert, PB, 2021).
The clinical and preclinical data for all three candidates
continued to support the potential of the eVLP platform against coronaviruses. On September 29, 2022, we announced that we initiated the
first clinical study of VBI’s multivalent coronavirus candidate, VBI-2901, designed to increase breadth of protection against COVID-19
and related coronaviruses.
The
VBI-2900 program is supported by a partnership with CEPI (the “CEPI Funding Agreement”), with contributions of up to $33
million; a partnership with the Strategic Innovation Fund (“SIF”), established by the Government of Canada, with an award
of up to CAD $56 million; contribution of up to CAD $1 million from the Industrial Research Assistance Program (“IRAP”) of
the National Research Council of Canada (“NRC”); and a collaboration with the NRC.
VBI-1501:
Prophylactic CMV Vaccine Candidate
Our
prophylactic CMV vaccine candidate uses the eVLP platform to express a modified form of the CMV glycoprotein B (“gB”) antigen
and is adjuvanted with alum, an adjuvant used in FDA-approved products.
Following
the successful completion of the Phase I study in May 2018, and positive discussions with Health Canada, we announced plans for a Phase
II clinical study evaluating VBI-1501 on December 20, 2018. We received similarly positive guidance from the FDA in July 2019. The Phase
II study is expected to assess the safety and immunogenicity of dosages of VBI-1501 up to 20µg with alum. We are currently evaluating
the timing of the Phase II study.
Therapeutic
Investigational Candidates
VBI-2601:
HBV Immunotherapeutic Candidate
VBI-2601
(BRII-179) is our novel, recombinant, protein-based immunotherapeutic candidate in development for the treatment of chronic HBV infection.
VBI-2601 (BRII-179) is formulated to induce broad immunity against HBV, including T-cell immunity which plays an important role in controlling
HBV infection.
On
April 12, 2021 and June 23, 2021, we announced data from the completed Phase Ib/IIa clinical study in patients with chronic HBV infection,
which was conducted by our partner Brii Biosciences Limited (“Brii Bio”). The study was a randomized, controlled study designed
to assess the safety, tolerability, antiviral and immunologic activity of VBI-2601. The study was a two-part, dose-escalation study assessing
different dose levels of VBI-2601 (BRII-179) with and without an immunomodulatory adjuvant, conducted at multiple study sites in New
Zealand, Australia, Thailand, South Korea, Hong Kong SAR, and China.
The
data from the Phase Ib/IIa for 33 evaluable patients across all study arms suggest: (1) VBI-2601 (BRII-179) is well tolerated at all
dose levels with and without the adjuvant with no significant adverse events identified; (2) VBI-2601 (BRII-179) induced both B cell
(antibody) and T cell responses in chronically-infected HBV patients, (3) VBI-2601 (BRII-179) induced restimulation of T cell responses
to HBV surface antigens, including S, Pre-S1 and Pre-S2, in greater than 50% of the evaluable patients compared to no detectable response
in the control arm; (4) the T cell responses and antibody responses were comparable across the 20µg and 40µg unadjuvanted
study arms; and (5) T cell response rates between the adjuvanted and unadjuvanted cohorts were also comparable. Based on the acceptable
safety profile and vaccine-induced adaptive immune responses seen in this study, VBI-2601 (BRII-179) advanced to Phase II studies.
On April 21, 2021, we announced that the first patient
had been dosed in a Phase II clinical study evaluating VBI-2601 (BRII-179) in combination with BRII-835 (VIR-2218), an investigational
small interfering ribonucleic acid (siRNA) targeting HBV, for the treatment of chronic HBV infection. To the best of our knowledge, this
is the first clinical trial in the field to evaluate the combination of these two HBV mechanisms of action. The multi-center, randomized,
open-label study is designed to evaluate the safety and efficacy of this combination with and without interferon-alpha as a co-adjuvant.
Brii Bio has led the design and implementation of this functional cure proof-of-concept study with the support of VBI and Vir Biotechnology
(“VIR”). The study is being conducted at sites in Australia, China, Taiwan, Hong Kong SAR, South Korea, New Zealand, Singapore,
and Thailand. Interim topline clinical data from this study is expected by the end of 2022.
On January 5, 2022, we announced that the first patient
was dosed in a second Phase IIa/IIb clinical study evaluating VBI-2601 (BRII-179). This Phase II study assesses VBI-2601 as an add-on
therapy to the standard-of-care nucleos(t)ide reverse transcriptase inhibitor (nrtl) and pegylated interferon (PEG-IFN-α,) therapy.
Interim topline clinical data from part one of this Phase IIa/IIb clinical study is expected in the third quarter of 2023.
VBI-1901:
Glioblastoma (GBM)
Our
cancer vaccine immunotherapeutic program, VBI-1901, targets CMV proteins present in tumor cells. CMV is associated with a number of solid
tumors including glioblastoma (“GBM”), breast cancer, and pediatric medulloblastoma.
In
January 2018, we initiated dosing in a two-part, multi-center, open-label Phase I/IIa clinical study of VBI-1901 in 38 patients with
recurrent GBM. Phase I (Part A) of the study was a dose-escalation phase that defined the safety, tolerability, and optimal dose level
of VBI-1901 adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF) in recurrent GBM patients with any number of prior
recurrences. In December 2018, this phase completed enrollment of 18 patients across three dose cohorts, the highest of which (10 µg)
was selected as the optimal dose level to test in the Phase IIa portion (Part B) of the study. Phase IIa of the study, which initiated
enrollment in July 2019, is a subsequent extension of the 10 µg doses level cohort. This phase is a two-arm study that enrolled
20 first-recurrent GBM patients to receive 10 µg of VBI-1901 in combination with either GM-CSF or GlaxoSmithKline Biologicals S.A.
(“GSK”) proprietary adjuvant system, AS01, as immunomodulatory adjuvants. AS01 is provided pursuant to a Clinical Collaboration
and Support Study Agreement (“Collaboration Agreement”) we entered into with GSK on September 10, 2019. Enrollment of the
10 patients in the VBI-1901 with GM-CSF arm was completed in March 2020 and enrollment of the 10 patients in the VBI-1901 with AS01 was
completed in October 2020.
Data
from the ongoing Phase IIa portion of the study was announced throughout 2020 and 2021, with the latest data presented in December 2021
at the World Vaccine & Immunology Congress. The data from the Phase IIa portion of this study demonstrate: (1) improvement in 6-month,
12-month, and 18-month overall survival (“OS”) data compared to historical controls; (2) 12-month OS of 60% (n=6/10) in the
VBI-1901 + GM-CSF study arm and 70% (n=7/10) in the VBI-1901 + AS01 study arm, compared to historical controls of ~30%; (3) 18-month
OS of 30% (3/10) in the VBI-1901 + GM-CSF study arm, 18-month OS not yet reached in the VBI-1901 + AS01 study arm; (3) 2 partial tumor
responses, one of which remains on protocol past week 86 with a 93% tumor reduction relative to initiation of treatment at the start
of the study, and 7 stable disease observations across both study arms; and (4) VBI-1901 continues to be safe and well tolerated at all
doses tested, with no safety signals observed.
On
June 8, 2021, we announced that the FDA granted Fast-Track Designation for VBI-1901 formulated with GM-CSF for the treatment of recurrent
GBM patients with first tumor recurrence. The designation was granted based on data from the Phase I/IIa study.
On
June 22, 2022, we announced that the FDA granted Orphan Drug Designation for VBI-1901 for the treatment of GBM.
Based
on the data seen to-date, as part of the next phase of development, we anticipate assessing VBI-1901 in randomized, controlled studies
in both primary and recurrent GBM patients. In the recurrent setting, we aim to expand the number of patients in the current trial and
add a control arm, with the potential to support an accelerated approval application based on tumor response rates and improvement in
overall survival. Subject to discussion with the FDA, the amended protocol is expected to initiate enrollment of additional patients
in early 2023.
In the primary setting, on October 12, 2022, we announced
a collaboration with Agenus to evaluate VBI-1901 in combination with Anti-PD-1 Balstilimab in a Phase II study as part of the INSIGhT
adaptive platform trial in patients first diagnosed with GBM. Subject to approval from regulatory bodies, we expect enrollment to initiate
in the VBI-1901 study arms in INSIGhT early 2023.
Third
Party License and Assignment Agreements
We
currently are dependent on licenses from third parties for certain of our key technologies, including the license granted pursuant to
an agreement between Savient Pharmaceuticals Inc. and SciGen Ltd dated June 2004, as subsequently amended (the “Ferring License
Agreement”) and a license from L’Universite Pierre et Marie Curie, now Sorbonne Université (“UPMC”), Institut
National de la Santé et de la Recherche Médicale (“INSERM”) and L’école Normale Supérieure
de Lyon.
On October 18, 2022, the Company amended and restated the Ferring License Agreement (the “Amended and Restated Ferring License Agreement”),
which amends and restates certain of the terms relating to the manufacture and marketing of HBsAg products, which includes, among others,
updates to the definition of net sales, and a reduction in the fixed royalty rate on net sales of HBsAg products (“Product”)
from seven percent (7%) to three and a half percent (3.5%) in consideration for the grant of the license to utilize genetically engineered
CHO cells encoding the hepatitis B antigen and certain information related to the manufacture of hepatitis B vaccines (collectively, the
“Technology”). In connection with the Amended and Restated Ferring License Agreement, the Company has also agreed to act as
the guarantor for SciVac’s obligations under the Amended and Restated Ferring License Agreement, or if the Amended and Restated
Ferring License Agreement is assigned to a third party, guarantor for SciVac’s obligations that have accrued up until the date of
such assignment. Under an Assignment Agreement between FDS Pharm LLP and SciGen Ltd., dated February 14, 2012 (the “SciGen Assignment
Agreement”), we are required to pay royalties to SciGen Ltd. equal to 5% of net sales (as defined in the original Ferring
License Agreement) of Product. Under the Ferring License Agreement and the SciGen Assignment Agreement, we originally were to pay royalties
on a country-by-country basis until the date 10 years after the date of commencement of the first royalty year in respect of such country.
In April 2019, we exercised our option to extend the Ferring License Agreement in respect of all the countries that still make up the
territory for an additional 7 years by making a one-time payment to Ferring of $0.1 million. Royalties under the Amended and Restated
Ferring License Agreement and SciGen Assignment Agreement will continue to be payable for the duration of the extended license periods.
Under
a license agreement with UPMC and other licensors relating to eVLP technology, we had an exclusive license to a family of patents
that expired in the United States in 2022 and expired in other countries in 2021. UPMC is also a co-owner of the patent family
covering our VBI-1501 CMV vaccine and we are currently negotiating an agreement with UPMC to cover this patent family. During the three
and nine months ended September 30, 2022, we did not make any milestone payments.
Financial
Operations Overview
At
present, our operations are focused on:
● |
continuing
our commercial launch of PreHevbrio in the United States; |
|
|
● |
manufacturing
our 3-antigen HBV vaccine at commercial scale to meet demand in the U.S., Europe, and Israel, where it is approved, and to prepare
for supply in markets where we may obtain marketing authorization; |
|
|
● |
preparing
for commercialization of our 3-antigen HBV vaccine in Europe where we have received regulatory approval under the brand name PreHevbri,
and in Canada, where we may obtain regulatory approval; |
|
|
● |
supporting
the ongoing review of the regulatory submissions for our 3-antigen HBV vaccine by Health Canada in Canada; |
● |
conducting
the Phase I/IIa clinical study of our GBM vaccine immunotherapeutic candidate, VBI-1901; |
|
|
● |
preparing
for the next phase of development for our GBM vaccine immunotherapeutic candidate, VBI-1901; |
|
|
● |
conducting
the Phase I clinical study of our prophylactic monovalent COVID-19 vaccine candidates, VBI-2902 and VBI-2905 (Beta
variant); |
|
|
● |
conducting
the Phase I clinical study of our multivalent coronavirus candidate, VBI-2901; |
|
|
● |
continuing
our development and scaling-up production processes for our prophylactic coronavirus vaccine candidates using a Contract Development
and Manufacturing Organization (“CDMO”) located in Canada; |
|
|
● |
developing
VBI-2601 (BRII-179), our protein-based immunotherapeutic candidate for treatment of chronic HBV, in collaboration with Brii Bio; |
|
|
● |
preparation
for further development of VBI-1501, our preventative CMV vaccine candidate; |
● |
continuing
the research and development (“R&D”) of our other pipeline candidates, including the exploration and development
of new pipeline candidates; |
|
|
● |
implementing
operational, compliance, financial, and management information systems, including through third party partners, to support our commercialization
activities; |
|
|
● |
maintaining,
expanding, and protecting our intellectual property portfolio; and |
|
|
● |
developing
our internal systems and processes for regulatory affairs, legal, and compliance. |
VBI’s revenue generating activities have been
the sale of our 3-antigen HBV vaccine in Israel under the name Sci-B-Vac, and the sale of PreHevbrio in the U.S. In addition,
we have sold through named patient programs in countries where our 3-antigen HBV vaccine was not approved, though those markets have generated
a limited number of sales. We have also generated revenue from various business development transactions and R&D services generating
fees. To date, we have financed our operations primarily with proceeds from sales of our common stock, our long-term debt agreements,
and contribution agreements and partnerships with CEPI and the Government of Canada.
VBI
has incurred significant net losses and negative operating cash flows since inception and expects to continue incurring losses and negative
cash flows from operations as we carry out planned clinical, regulatory, R&D, commercial, and manufacturing activities with respect
to the advancement of our 3-antigen HBV vaccine and new pipeline candidates. As of September 30, 2022, VBI had an accumulated deficit
of approximately $468.5 million and stockholders’ equity of approximately $83.8 million. Our ability to maintain our status as
an operating company and to realize our investment in our In Process Research & Development (“IPR&D”) assets, which
consist of our CMV and GBM programs, is dependent upon obtaining adequate cash to finance our clinical development, manufacturing, our
administrative overhead and our research and development activities, and ultimately to profitably monetize our IPR&D. We expect that
we will need to secure additional financing to finance our business plans, which may be a combination of proceeds from the issuance of
equity securities, the issuance of additional debt, structured asset financings, government or non-governmental organization grants or
subsidies, and revenues from potential business development transactions, if any. There is no assurance we will manage to obtain these
sources of financing, if required. These factors raise substantial doubt about our ability to continue as a going concern. The accompanying
financial statements have been prepared assuming that we will continue as a going concern. The financial statements do not include any
adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications
of liabilities that may result should we be unable to continue as a going concern.
We
have incurred operating losses since inception, have not generated significant product sales revenue and have not achieved profitable
operations. We incurred net losses of $92.2 million for the nine months ended September 30,
2022, and we expect to continue to incur substantial losses in future periods. We anticipate that we will continue to incur substantial
operating expenses as we continue our research and development and clinical studies, and as we continue the commercialization of PreHevbrio
in the United States, PreHevbri in Europe, and, if approved, our 3-antigen HBV vaccine in Canada. These include expenses
related to the focus of our operations highlighted above.
In
addition, we have incurred and will continue to incur significant expenses as a public company, which subject us to the reporting
requirements of the Exchange Act, the Sarbanes-Oxley Act, the rules and regulations of NASDAQ, and the Canadian securities
regulators. We have also incurred and will continue to incur regulatory compliance costs and general and administrative costs related to our clinical
regulatory operations and commercialization of our marketed product and product candidates.
Overall
Performance
The
Company had net losses of $25,209 and $15,847 for the three months ended September 30, 2022,
and 2021, respectively, and $92,162 and $50,970 for
the nine months ended September 30, 2022 and 2021, respectively. We had an accumulated deficit of $468,468 at September 30, 2022. We
had $83,550 of cash and net working capital of $61,535 as of September 30, 2022.
Revenues,
net
Revenues,
net consist of product sales of PreHevbrio in the U.S and Sci-B-Vac in Israel, as well as R&D services revenue recognized as part
of the License Agreement with Brii Bio and other R&D services.
In
the U.S., beginning in the second quarter, PreHevbrio was sold to a limited number of wholesalers and specialty distributors (collectively,
our “Customers”). We expect to continue to expand this group of Customers over the coming months. Revenues from product sales
are recognized when we have satisfied our performance obligations, which is the transfer of control of our product upon delivery to the
Customer. Our standard credit terms are short-term, and we expect to receive payment in less than one year, there is no significant financing
component on the related receivables. Taxes collected from Customers relating to product sales and remitted to governmental authorities
are excluded from revenues.
In
Israel, Sci-B-Vac is sold through procurement requests from four health funds (“HMOs”) (collectively, the “Sci-B-Vac
Customers”).
Overall,
product revenue, net, reflects our best estimates of the amount of consideration to which we are entitled based on the terms of the
contract. The amount of variable consideration is included in the net sales price only to the extent that it is probable that a significant
reversal in the amount of the cumulative revenue recognized will not occur in a future period. If our estimates differ significantly
from actuals, we will record adjustments that would affect product revenue, net in the period of adjustment.
Pursuant
to the License Agreement with Brii Bio, we provide R&D services to Brii Bio as part of the development of VBI-2601 (BRII-179).
In
addition, pursuant to an agreement with the Israel Innovation Authority (formerly the Office of the Chief Scientist of Israel), we are
required to make services available for the biotechnology industry in Israel. These services include relevant activities for development
and manufacturing of therapeutic proteins according to international standards and cGMP quality level suitable for toxicological studies
in animals. Service activities include analytics/bio analytics methods for development and process development of therapeutic proteins
starting with a candidate clone through manufacturing. These R&D services are primarily marketed to the Israeli research community
in academia and Israeli biotechnology companies in the life sciences industry lacking the infrastructure or experience in the development
and production of therapeutic proteins to the standards and quality required for clinical trials for human use. During the three and
nine months ended September 30, 2022, we provided services to biotechnology companies including analytical development.
Cost
of Revenues
Cost
of revenues consist primarily of costs incurred for manufacturing our 3-antigen HBV vaccine which includes cost of materials, consumables,
supplies, contractors, and salaries.
Research
and Development (“R&D”) Expenses
R&D
expenses, net of government grants and funding arrangements, consist primarily of costs incurred for the advancement of our lead programs,
including: our 3-antigen HBV vaccine; VBI-1901, our GBM vaccine immunotherapeutic candidate; VBI-1501, our CMV vaccine candidate; VBI-2601
(BRII-179), our hepatitis B immunotherapeutic candidate; and VBI-2900, our coronavirus vaccine program. These costs include:
|
● |
the
cost of acquiring, developing, and manufacturing clinical study materials, and other consumables and lab supplies used in our pre-clinical
studies; |
|
|
|
|
● |
expenses
incurred under agreements with contractors or CDMOs or Contract Research Organizations to advance the vaccines into and through completion
of clinical studies; and |
|
|
|
|
● |
employee-related
expenses, including salaries, benefits, travel, and stock-based compensation expense. |
We
expense R&D costs when we incur them.
General
and Administrative (“G&A”) Expenses
G&A
expenses consist principally of commercialization costs, salaries, and related costs for executive and other administrative personnel
and consultants, including stock-based compensation, and travel expenses. Other general and administrative expenses include professional
fees for legal, patent protection, consulting and accounting services, travel and conference fees, board of directors meeting costs,
scientific and commercial advisory board meeting costs, rent, maintenance of facilities, depreciation, office supplies, information technology
costs and expenses, insurance, and other general expenses. G&A expenses are expensed when incurred.
We
expect that our general and administrative expenses will increase in the future as a result of adding employees and scaling our operations
commensurate with commercializing products, advancing clinical candidates, and continuing to support a public company infrastructure.
These increases will likely include increased costs for insurance, hiring of additional personnel, board committees, outside consultants,
investor relations, lawyers and accountants, among other expenses.
Interest
Expense, Net of Interest Income
Interest
expense is associated with our long-term debt as discussed in Note 9 of the Notes to the Condensed Consolidated Financial Statements.
Results
of Operations
Three
and Nine Months Ended September 30, 2022 Compared to the Three and Nine Months Ended September 30, 2021
All
dollar amounts stated below are in thousands, unless otherwise indicated.
| |
Three months ending September 30 | | |
| | |
| |
| |
2022 | | |
2021 | | |
Change $ | | |
Change % | |
Revenues, net | |
$ | 317 | | |
$ | 107 | | |
$ | 210 | | |
| 196 | % |
| |
| | | |
| | | |
| | | |
| | |
Expenses: | |
| | | |
| | | |
| | | |
| | |
Cost of revenues | |
| 2,672 | | |
| 2,466 | | |
| 206 | | |
| 8 | % |
Research and development | |
| 4,983 | | |
| 2,972 | | |
| 2,011 | | |
| 68 | % |
General and administrative | |
| 14,220 | | |
| 9,693 | | |
| 4,527 | | |
| 47 | % |
Total operating expenses | |
| 21,875 | | |
| 15,131 | | |
| 6,744 | | |
| 45 | % |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (21,558 | ) | |
| (15,024 | ) | |
| (6,534 | ) | |
| 43 | % |
| |
| | | |
| | | |
| | | |
| | |
Interest expense, net of interest income | |
| (958 | ) | |
| (1,026 | ) | |
| 68 | | |
| (7 | )% |
Foreign exchange (loss) gain | |
| (2,693 | ) | |
| 203 | | |
| (2,896 | ) | |
| (1,427 | )% |
Loss before income taxes | |
| (25,209 | ) | |
| (15,847 | ) | |
| (9,362 | ) | |
| 59 | % |
| |
| | | |
| | | |
| | | |
| | |
Income tax expense | |
| - | | |
| - | | |
| - | | |
| - | % |
| |
| | | |
| | | |
| | | |
| | |
NET LOSS | |
$ | (25,209 | ) | |
$ | (15,847 | ) | |
$ | (9,362 | ) | |
| 59 | % |
| |
Nine months ending September 30 | | |
| | |
| |
| |
2022 | | |
2021 | | |
Change $ | | |
Change % | |
Revenues, net | |
$ | 789 | | |
$ | 550 | | |
$ | 239 | | |
| 43 | % |
| |
| | | |
| | | |
| | | |
| | |
Expenses: | |
| | | |
| | | |
| | | |
| | |
Cost of revenues | |
| 7,948 | | |
| 7,511 | | |
| 437 | | |
| 6 | % |
Research and development | |
| 12,988 | | |
| 14,392 | | |
| (1,404 | ) | |
| (10 | )% |
General and administrative | |
| 40,234 | | |
| 25,807 | | |
| 14,427 | | |
| 56 | % |
Total operating expenses | |
| 61,170 | | |
| 47,710 | | |
| 13,460 | | |
| 28 | % |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (60,381 | ) | |
| (47,160 | ) | |
| (13,221 | ) | |
| 28 | % |
| |
| | | |
| | | |
| | | |
| | |
Interest expense, net of interest income | |
| (2,799 | ) | |
| (3,683 | ) | |
| 884 | | |
| (24 | )% |
Foreign exchange loss | |
| (28,982 | ) | |
| (127 | ) | |
| (28,855 | ) | |
| 22,720 | % |
Loss before income taxes | |
| (92,162 | ) | |
| (50,970 | ) | |
| (41,192 | ) | |
| 81 | % |
| |
| | | |
| | | |
| | | |
| | |
Income tax expense | |
| - | | |
| - | | |
| - | | |
| - | % |
| |
| | | |
| | | |
| | | |
| | |
NET LOSS | |
$ | (92,162 | ) | |
$ | (50,970 | ) | |
$ | (41,192 | ) | |
| 81 | % |
Revenues,
net
Revenues,
net for the three months ended September 30, 2022 was $317 as compared to $107 for the three months ended September 30, 2021.
Revenues for the three months ended September 30, 2022 increased by $210 or 196% due to an increase in product revenue as a result
of the launch of PreHevbrio in the U.S. in late Q1 2022 with revenue generation beginning in Q2 2022. Over the coming months, VBI
expects to expand the number of Customers, continuing to broaden access to PreHevbrio in the U.S.
Revenues,
net for the nine months ended September 30, 2022 was $789 as compared to $550 for the nine months ended September 30, 2021.
Revenues, net for the nine months ended September 30, 2022 increased by $239 or 43% due to an increase in product revenue as a
result of the launch of PreHevbrio in the U.S. in late Q1 2022 with revenue generation beginning in Q2 2022, offset by a decrease
in R&D services revenue for VBI-2601, being developed in collaboration with Brii Bio, as fewer manufacturing and non-clinical
research services were required in the nine months ended September 30, 2022 compared to the nine months ended September 30,
2022.
Revenues,
net Composition
| |
Three months ended September 30 | | |
Nine months ended September 30 | |
| |
2022 | | |
2021 | | |
2022 | | |
2021 | |
| |
| | |
| | |
| | |
| |
Product revenue, net | |
$ | 258 | | |
$ | 24 | | |
$ | 680 | | |
$ | 262 | |
R&D service revenue | |
| 59 | | |
| 83 | | |
| 109 | | |
| 288 | |
Total revenues, net | |
$ | 317 | | |
$ | 107 | | |
$ | 789 | | |
$ | 550 | |
Revenues,
net by Geographic Region
| |
Three months ending September 30 | | |
| | |
| |
| |
2022 | | |
2021 | | |
$ Change | | |
% Change | |
Revenue, net in United States | |
$ | 238 | | |
$ | - | | |
$ | 238 | | |
| 100 | % |
Revenue, net in Israel | |
| 60 | | |
| 44 | | |
| 16 | | |
| 36 | % |
Revenue, net in China / Hong Kong | |
| 19 | | |
| 63 | | |
| (44 | ) | |
| (70 | )% |
Total Revenues, net | |
$ | 317 | | |
$ | 107 | | |
$ | 210 | | |
| 196 | % |
| |
Nine months ending September 30 | | |
| | |
| |
| |
2022 | | |
2021 | | |
$ Change | | |
% Change | |
Revenue, net in United States | |
$ | 444 | | |
$ | - | | |
$ | 444 | | |
| 100 | % |
Revenue, net in Israel | |
| 281 | | |
| 300 | | |
| (19 | ) | |
| (6 | )% |
Revenue, net in China / Hong Kong | |
| 58 | | |
| 246 | | |
| (188 | ) | |
| (76 | )% |
Revenue, net in Europe | |
| 6 | | |
| 4 | | |
| 2 | | |
| 50 | % |
Total Revenues, net | |
$ | 789 | | |
$ | 550 | | |
$ | 239 | | |
| 43 | % |
Cost
of Revenues
Cost
of revenues for the three months ended September 30, 2022 were $2,672 as compared to $2,466 for the three months ended September 30,
2021. The cost of revenues in the three months ended September 30, 2022 has increased compared to the three months ended September 30,
2021 due to the increase in sales.
Cost
of revenues for the nine months ended September 30, 2022 were $7,948 as compared to $7,511 for the nine months ended September 30, 2021.
The cost of revenues in the nine months ended September 30, 2022 has increased compared to the nine months ended September 30, 2021 due
to the increase in sales.
Research
and Development Expenses
R&D
expenses, net of government grants and funding arrangements, for the three months ended September 30, 2022 were $4,983 as compared to
$2,972 for the three months ended September 30, 2021. R&D expenses were offset by $2,354 for the three months ended September 30, 2022 and $5,144 for the three months ended September 30, 2021 due to government grants
and funding arrangements. The increase in net R&D expenses of $2,011 or 68% is mainly a result of (1) an increase in R&D expenses
related to continued development of our vaccine and vaccine candidates, specifically VBI-1901, our GBM vaccine immunotherapeutic candidate,
as we prepare for the next phases of development, offset by (2) a decrease in the costs related to our coronavirus vaccine program that
are not offset by government grants and funding arrangements, as we had two clinical trials ongoing, VBI-2902 and VBI-2905, during the
three months ended September 30, 2021 compared to only one clinical trial ongoing, VBI-2901, during the three months ended September
30, 2022.
R&D
expenses, net of government grants and funding arrangements, for the nine months ended September 30, 2022 were $12,988 as compared to
$14,392 for the nine months ended September 30, 2021. R&D expenses were offset by $6,210 for the nine months ended September
30, 2022 and $11,363 for the nine months ended September 30, 2021 due to government grants and funding arrangements. The decrease in
net R&D expenses of $1,404 or 10% is mainly a result of the items discussed above in addition to a decrease in U.S. regulatory fees
related to PreHevbrio that occurred during the nine months ended September 30, 2021, with no similar regulatory fees that occurred during
the nine months ended September 30, 2022.
General
and Administrative Expenses
G&A
expenses, net of government grants and funding arrangements, for the three months ended September 30, 2022 were $14,220 as compared to
$9,693 for the three months ended September 30, 2021. G&A expenses were offset by $148 for the three months ended September 30, 2022 and $111 for the three months ended September 30, 2021 due to government grants
and funding arrangements. The net G&A expense increase of $4,527 or 47% is mainly a result of the increase in commercial activities
related to our 3-antigen HBV vaccine, most notably the deployment of our commercial field teams and development of our distribution infrastructure,
as FDA regulatory approval of PreHevbrio occurred in late 2021. Additional increase in costs include increased insurance costs, increased
professional costs, and increased labor costs.
G&A
expenses, net of government grants and funding arrangements, for the nine months ended September 30, 2022 were $40,234 as compared to
$25,807 for the nine months ended September 30, 2021. G&A expenses were offset by $567 for the nine months ended September 30, 2022 and $306 for the nine months ended September 30, 2021 due to government grants
and funding arrangements. The net G&A expense increase of $14,427 or 56% is a result of the items discussed above.
Loss
from Operations
The
net loss from operations for the three months ended September 30, 2022 was $21,558 as compared to $15,024
for the three months ended September 30, 2021. The $6,534 increase in the net loss
from operations resulted from the items discussed above.
The
net loss from operations for the nine months ended September
30, 2022 was $60,381 as compared to $47,160 for the
nine months ended September 30, 2021. The $13,221 increase in the net loss from operations
resulted from the items discussed above.
Interest
Expense, Net of Interest Income
Interest
expense, net of interest income for the three months ended September 30, 2022 was $958 as compared to $1,026 for the three months ended
September 30, 2021. The decrease in interest expense, net of interest income of $68 or 7% is due to increased interest rates on our long-term
debt, offset by increased interest rates earned on cash.
Interest
expense, net of interest income for the nine months ended September 30, 2022 was $2,799
as compared to $3,683 for the three months ended September 30, 2021. The decrease in interest expense, net of interest income of $884
or 24% is due to the conversion of $2,000 of the secured term loan to common shares in the nine
months ended September 30 2021, which resulted in $1,161 of additional interest accretion being recognized in interest expense,
net of interest income and an increased interest rates earned on cash for the nine months ended September 30, 2022. This decrease is
partially offset by an increase in long-term debt of $12,000 beginning in May 2021 and an increase in interest rates on our long-term
debt during the nine months ended September 30, 2022.
Foreign
Exchange Loss
Foreign
exchange loss for the three months ended September 30, 2022 was $2,693 as compared to a gain of $203 for the three months ended September
30, 2021. Certain intercompany loans between us and our subsidiaries are denominated in a currency other than the functional currency
of each entity. The primary driver of the increase in foreign exchange loss was the impact of the relative strengthening of the U.S.
and Canadian Dollars against the New Israeli Shekel upon translation of these intercompany loans.
Foreign
exchange loss for the nine months ended September 30, 2022 was $28,982 as compared to $127
for the nine months ended September 30, 2021. The increase in foreign exchange loss is the
result of the changes discussed above.
Net
Loss
Net
loss for the three months ended September 30, 2022 was $25,209 compared to $15,847 for the three months ended September 30, 2021 and
was a result of the items discussed above.
Net
loss for the nine months ended September 30, 2022 was $92,162 compared to $50,970 for the
nine months ended September 30, 2021 and was a result of the items discussed above.
Liquidity
and Capital Resources
| |
September 30, 2022 | | |
December 31, 2021 | | |
$ Change | | |
% Change | |
| |
| | |
| | |
| | |
| |
Cash | |
$ | 83,550 | | |
$ | 121,694 | | |
$ | (38,144 | ) | |
| (31 | )% |
Current Assets | |
| 96,216 | | |
| 130,284 | | |
| (34,068 | ) | |
| (26 | )% |
Current Liabilities | |
| 34,681 | | |
| 32,586 | | |
| 2,095 | | |
| 6 | % |
Working Capital | |
| 61,535 | | |
| 97,698 | | |
| (36,163 | ) | |
| (37 | )% |
Accumulated Deficit | |
| (468,468 | ) | |
| (378,371 | ) | |
| (90,097 | ) | |
| 24 | % |
As
of September 30, 2022, we had cash of $83,550 as compared to $121,694 as of December 31, 2021. As of September 30, 2022, we had working
capital of $61,535 as compared to working capital of $97,698 at December 31, 2021. Working capital is calculated by subtracting current
liabilities from current assets.
Net
Cash Used in Operating Activities
The
Company incurred net losses of $92,162 and $50,970 in the nine months ended September 30, 2022
and 2021, respectively. The Company used $54,649 and $21,392 in cash for operating activities during the nine months ended September
30, 2022 and 2021, respectively. The increase in cash outflows is largely a result of an
increase in net loss attributable to commercial expenses for the launch of PreHevbrio, and a decrease in net change in operating working
capital related to purchase of inventory for commercial production of PreHevbrio and cash received in advance from the CEPI Funding Agreement
of $18,363 during the nine months ended September 30, 2021, compared to $964 cash received in advance from the CEPI Funding Agreement
during the nine months ended September 30, 2022.
Net
Cash Used in Investing Activities
Net
cash flows used by investing activities was $2,892 for the nine months ended September 30, 2022 compared to cash provided by investing
activities of $23,766 for the nine months ended September 30, 2021. The decrease in cash flows in investing activities is largely as
a result of the redemption of short-term investments of $25,151 during the nine months ended September 30, 2021.
Net
Cash Provided by Financing Activities
Net
cash flows provided by financing activities was $19,449 for the nine months ended September 30, 2022 compared to cash flows provided
by financing activities of $41,401 during the nine months ended September 30, 2021. During the nine months ended September 30, 2022 we
received proceeds from our refinanced long-term debt compared to the nine months ended September 30, 2021 whereby we issued common shares
for cash and received proceeds from our long-term debt amendment.
Sources
of Liquidity
Jefferies
Open Market Sale Agreement
On
August 26, 2022, the Company 1) filed a registration statement for a base prospectus which covers the offering, issuance and sale of
up to $300,000 of common shares, warrants, units and/or subscription rights; and 2) entered into an Open Market Sale Agreement with
Jefferies LLC (“Jefferies”), pursuant to which the Company may offer and sell its common shares having an aggregate
price of up to $125,000 from time to time through Jefferies, acting as agent or principal (the “ATM Program”). The ATM
Program replaces the Open Market Sale Agreements previously entered into with Jefferies on July 31, 2020 and September 3, 2021,
pursuant to each of which we could offer and sell our common shares having an aggregate price of up to $125,000 from time to time,
through “at the market” (“ATM”) equity offering programs. Prior to termination, $27,022 of our common shares
remained available for sale pursuant to the first ATM program, and $125,000 of our common shares remained available for sale
pursuant to the second ATM program. Neither ATM program was utilized in 2022. We have not made any sales under the ATM Program
during the three months ended September 30, 2022.
K2
HealthVentures LLC Long Term Debt
On May 22, 2020, the Company (along with its
subsidiary VBI Cda) entered into the Loan and Guaranty Agreement (the “Loan Agreement”) with K2 and any other lender
from time-to-time party thereto (the “Lenders”). On May 22, 2020, the Lenders advanced the first tranche of term loans
of $20,000. Pursuant to the Loan Agreement, the Lenders originally had the ability to convert, at the Lenders’ option, up to
$4,000 of the secured term loan into common shares of the Company at a conversion price of $1.46 per share until the original
maturity date of June 1, 2024. On February 3, 2021, pursuant to the Loan Agreement, the Lenders, converted $2,000 of the secured
term loan into 1,369,863 common shares at a conversion price of $1.46 per share.
On
May 17, 2021, the Company entered into the First Amendment to the Loan and Guaranty Agreement (“First Amendment”) with the
Lenders and received additional loan advances of $12,000.
On September 14, 2022, the Company entered into the
Second Amendment to the Loan Agreement (the “Second Amendment”) with the Lenders to: (i) increase the amount of the term loans
available under the Loan Agreement to $100,000 from $50,000, which term loans are available in up to four tranches the
subject to the achievement of milestones and other customary conditions, (ii) add certain minimum net revenue covenants to the Second
Amendment, (iii) extend the final maturity date for the term loans to September 14, 2026, which may be extended to September 14, 2027,
under certain circumstances, and (iv) to the extent that the maturity date is extended, the term loans will begin amortizing on a monthly
basis on September 14, 2026.
On
September 15, 2022, the Lenders advanced to the Borrowers the Restatement First Tranche Term Loan (as defined in the Second
Amendment) in an aggregate amount of $50,000 which included the refinancing of the $30,000 in term loans that were outstanding under
the Loan Agreement as amended by the First Amendment. The second tranche of term loans of up to $15,000 will be available from April
1, 2023, through June 30, 2023, subject to the achievement of certain clinical milestones and compliance with a liquidity
requirement which requires the Company to have sufficient cash on hand to funds its operations for at least nine months (the
“Liquidity Requirement”). The third tranche of term loans of up to $10,000 will be available from April 1, 2024, through
June 30, 2024, so long as certain of the milestones for the second tranche of term loans were achieved, no events of default under the
Loan Agreement have occurred and are continuing, and the Liquidity Requirement is satisfied. The fourth tranche of term loans of up
to $25,000 shall be available at any time from September 14, 2022, until September 14, 2026, subject to the Lender’s review of
the Company’s clinical and financial plans and Lender’s investment committee approval.
Pursuant
to the Second Amendment, the Lenders have the ability to convert $7,000 into common shares, by which $2,000 of the term loans shall
be convertible into 1,369,863 shares of common stock at a conversion price of $1.46 per share and $5,000 of the term loans shall be
convertible into 4,792,026 shares of common stock at a conversion price of $1.0434 per share (“K2 conversion
feature”).
In connection with the Loan Agreement, on
May 22, 2020, the Company issued the Lenders a warrant to purchase up to 625,000 common shares (the “Original K2
Warrant”) at an exercise price of $1.12 per share. On May 17, 2021, in connection with the First Amendment, the Company
amended and restated the Original K2 Warrant to purchase an additional 312,500 common shares for a total of 937,500 common shares
(the “First Amendment Warrant”) with the same exercise price of $1.12 per share. On September 14, 2022, in connection
with the Second Amendment and the advance of the first tranche of term loans of $50,000 by the Lenders, the Company issued the
Lenders a warrant to purchase an additional 2,180,413 common shares (the “Second Amendment Warrant”) with a warrant
exercise price of $0.8026. If the full remaining $50,000 available in the K2 tranches is advanced pursuant to the Second Amendment,
up to an additional 2,180,413 common shares will be issuable pursuant to the Second Amendment Warrant. The First Amendment Warrant
and the Second Amendment Warrant may be exercised either for cash or on a cashless “net exercise” basis. The First
Amendment Warrant expires on May 22, 2030 and the Second Amendment Warrant expires on September 14, 2032.
The
Company is required to make a final payment equal to 6.95% of the aggregate term loan principal on the maturity date of the term loan,
or upon earlier prepayment of the term loans in accordance with the Second Amendment (the “Second Amendment Final Payment”).
The final payment related to the refinanced $30,000 in term loans that were outstanding under the Loan Agreement as amended by the First
Amendment of $2,224 remains and is due the earlier of June 1, 2024 or the earlier prepayment of the term loans in accordance with
the Second Amendment (the “Original Final Payment”).
Upon
receipt of additional funds, issuable pursuant to the second, third and fourth tranches, under the Second Amendment, additional
common shares will be issuable pursuant to the Second Amendment Warrant as determined by the principal amount of the second tranche,
third tranche and fourth tranche actually funded multiplied by 3.5% and divided by the warrant exercise price of $0.8026, and the
Second Amendment Final Payment will increase by 6.95% of the funds advanced.
The total principal amount of the loan under the Loan
Agreement as amended by the Second Amendment, outstanding at September 30, 2022, including the Original Final Payment of $2,224 and the
Second Amendment Final Payment of $3,475 in connection with the Second Amendment, is $55,699. The principal amount of the loan made under
the Loan Agreement as amended by the Second Amendment accrues interest at an annual rate equal to the greater of (a) 8.00% or (b) prime
rate plus 4.00%. The interest rate as of September 30, 2022 was 10.25%. The Company is required to pay only interest until September 14,
2026.
CEPI
Partnership
On March 9, 2021, the Company and CEPI announced the CEPI Funding Agreement, to develop eVLP vaccine candidates against SARS-COV-2 variants,
including the Beta variant, also known as the B.1.351 variant and as 501Y.V2, first identified in South Africa. CEPI agreed to provide
up to $33,018 to support the advancement of VBI-2905, a monovalent eVLP candidate expressing the pre-fusion form of the spike protein
from the Beta variant strain, through Phase I clinical development.
Plan
of Operations and Future Funding Requirements
The
report of our independent registered public accounting firm on our consolidated financial statements for the year ended December 31,
2021 contains an explanatory paragraph regarding our ability to continue as a going concern. VBI has incurred significant net losses
and negative operating cash flows since inception and expects to continue incurring losses and negative cash flows from operations as
we carry out our planned clinical, regulatory, R&D, commercial, and manufacturing activities with respect to the advancement of our
3-antigen HBV vaccine and pipeline candidates. As of September 30, 2022, VBI had an accumulated deficit of $468,468 and stockholders’
equity of $83,817
Our
ability to maintain our status as an operating company and to realize our investment in our IPR&D assets is dependent upon obtaining
adequate cash to finance our clinical development, manufacturing, our commercialization activities, our administrative overhead and our
research and development activities. We expect that we will need to secure additional financing to finance our business plans, which
may be a combination of proceeds from the issuance of equity securities, the issuance of additional debt, structured asset financings,
government or non-government grants or subsidies, and revenues from potential business development transactions, if any. There is no
assurance we will manage to obtain these sources of financing. The accompanying financial statements have been prepared assuming that
we will continue as a going concern; however, the above conditions raise substantial doubt about our ability to do so. The financial
statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or
the amounts and classifications of liabilities that may result should we be unable to continue as a going concern. Our long-term success
and ability to continue as a going concern is dependent upon obtaining sufficient capital to fund the research and development of our
products, to bring about their successful commercial release, to generate revenue, and, ultimately, to attain profitable operations,
or, alternatively, to advance our products and technology to such a point that they would be attractive candidates for acquisition by
others in the industry.
We
will require additional funds to conduct clinical and non-clinical trials, achieve regulatory approvals, and, subject to such approvals,
commercially launch our products, and will need to secure additional financing in the future to support our operations and to realize
our investment in our IPR&D assets. We base this belief on assumptions that are subject to change, and we may be required to use
our available cash and cash equivalent resources sooner than we currently expect. Our actual future capital requirements will depend
on many factors, including the progress and results of our ongoing clinical trials, the duration and cost of discovery and preclinical
development, laboratory testing and clinical trials for our pipeline candidates, the timing and outcome of regulatory review of our products,
product sales outside of Israel, the costs involved in preparing, filing, prosecuting, maintaining, defending, and enforcing patent claims
and other intellectual property rights, the number and development requirements of other pipeline candidates that we pursue, and the
costs of commercialization activities, including product marketing, sales, and distribution.
We
expect to finance our future cash needs through public or private equity offerings, debt financings, government grants or non-government
funding, structured asset financings, or business development transactions. Pursuant to the Contribution Agreement, we will receive up
to CAD $55,976 as a government grant to support the development of the Company’s coronavirus vaccine program, though Phase II clinical
studies, and pursuant to the CEPI Funding Agreement, we will receive up to $33,018 in funding to support the development of the Company’s
coronavirus vaccine program, specifically SARS-COV-2 variants. We may need to raise additional funds more quickly if one or more of our
assumptions prove to be incorrect or if we choose to expand our product development efforts more rapidly than we presently anticipate.
We may also decide to raise additional funds even before we need them if the conditions for raising capital are favorable. Additional
equity, debt, structured asset financing, government grants or non-government funding, or business development transactions may not be
available on acceptable terms, if at all. If adequate funds are not available, we may be required to delay, reduce the scope of or eliminate
our R&D programs, reduce our planned commercialization efforts or obtain funds through arrangements with collaborators or others
that may require us to relinquish rights to certain pipeline candidates that we might otherwise seek to develop or commercialize independently.
To
the extent we raise additional capital by issuing equity securities or obtaining borrowings convertible into equity, ownership dilution
to existing stockholders will result and future investors may be granted rights superior to those of existing stockholders. The incurrence
of indebtedness or debt financing would result in increased fixed obligations and could also result in covenants that would restrict
our operations. Our ability to obtain additional capital may depend on prevailing economic conditions and financial, business, and other
factors beyond our control. The COVID-19 pandemic and the continuing armed conflict between Russia and Ukraine, and inflation
has caused an unstable economic environment globally. Disruptions in the global financial markets may adversely impact the availability
and cost of credit, as well as our ability to raise money in the capital markets. Current economic conditions have been, and continue
to be, volatile. Continued instability in these market conditions may limit our ability to access the capital necessary to fund and grow
our business.
The
Company’s long-term success and ability to continue as a going concern are dependent upon obtaining sufficient capital to fund
the research and development of its pipeline candidates, to bring about their successful commercial release, to generate revenue and,
ultimately, to attain profitable operations or, alternatively, to advance its products and technology to such a point that they would
be attractive candidates for acquisition by others in the industry.
To
date, the Company has been able to obtain financing as and when it was needed; however, there is no assurance that financing will
be available in the future, or if it is, that it will be available at acceptable terms.
As
of September 30, 2022, we have no off-balance sheet transactions, arrangements, obligations (including contingent obligations), or other
relationships with unconsolidated entities or other persons that have, or may have, a material effect on our financial condition, changes
in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources.
NASDAQ
Minimum Bid Price Requirement
On
July 1, 2022, we received a letter from the Listing Qualifications Department of the Nasdaq Stock Market (“NASDAQ”) indicating
that, based upon the closing bid price of our common shares for the 30 consecutive business day period between May 18, 2022 through June
30, 2022, we did not meet the minimum bid price of $1.00 per share required for continued listing on NASDAQ pursuant
to NASDAQ Listing Rule 5550(a)(2). The letter also indicated that we will be provided with a compliance period of 180 calendar days,
or until December 28, 2022 (the “Compliance Period”), in which to regain compliance pursuant to NASDAQ Listing Rule 5810(c)(3)(A).
In
order to regain compliance with NASDAQ’s minimum bid price requirement, our common shares must maintain a minimum closing bid price
of $1.00 for a minimum of ten consecutive business days during the Compliance Period. In the event that we do not regain compliance by
the end of the Compliance Period, we may be eligible for additional time to regain compliance. To qualify, we will be required to meet
the continued listing requirement for the market value of our publicly held shares and all other initial listing standards for NASDAQ,
with the exception of the bid price requirement, and will need to provide written notice of our intention to cure the deficiency during
the second compliance period, by effecting a reverse stock split if necessary. If we meet these requirements, we may be granted an additional
180 calendar days to regain compliance. We have not regained compliance as of the date of this Form 10-Q, and if we fail to regain compliance
during the Compliance Period or any subsequent grace period granted by NASDAQ, our common shares will be subject to delisting by NASDAQ,
which could seriously decrease or eliminate the value of an investment in our common shares and result in significantly increased uncertainty
as to the Company’s ability to raise additional capital.
Known
Trends, Events, and Uncertainties
As with other companies that are in the process of
developing and commercializing novel pharmaceutical and biologic products, we will need to successfully manage normal business and scientific
risks. Research and development of new technologies is, by its nature, unpredictable. We cannot assure you that our technology will be
adopted, that we will ever earn revenues sufficient to support our operations, or that we will ever be profitable. The impact of the ongoing
COVID-19 pandemic, including the Omicron variant of COVID-19, which appears to be the most transmissible variant to-date, and the new
subvariant, BA.5, is currently indeterminable and rapidly evolving, and has adversely affected and may continue to adversely affect our
operations and the global economy. In addition, the consequences of the ongoing conflict between Russia and Ukraine, including related
sanctions and countermeasures, are difficult to predict, and could adversely impact geopolitical and macroeconomic conditions, the global
economy, and contribute to increased market volatility, which may in turn adversely affect our business and operations. Furthermore, other
than as discussed in this report, we have no committed source of financing and may not be able to raise money as and when we need it to
continue our operations. If we cannot raise funds as and when we need them, we may be required to severely curtail, or even to cease,
our operations.
Other
than as discussed above and elsewhere in this report, we are not aware of any trends, events or uncertainties that are likely to have
a material effect on our financial condition.
Critical
Accounting Policies and Estimates
There
have been no changes to our critical accounting policies during the nine months ended September 30, 2022. Critical accounting policies
and the significant accounting estimates made in accordance with such policies are regularly discussed with the Audit Committee of the
Company’s board of directors. Those policies are discussed under “Critical Accounting Policies” in our “Management’s
Discussion and Analysis of the Financial Condition and Results of Operations” included in Item 7 of our Annual Report on Form 10-K
for the year ended December 31, 2021, as well as in our consolidated financial statements and the footnotes thereto, included in the
Annual Report on Form 10-K.
Recent
Accounting Pronouncements
See
Note 3 of Notes to the Condensed Consolidated Financial Statements in this Form 10-Q.