ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of our
financial condition and results of operations should be read in conjunction with our financial statements and the notes thereto contained
elsewhere in this report. Certain information contained in the discussion and analysis set forth below includes forward-looking statements
that involve risks and uncertainties. Our actual results may differ materially from those discussed in any forward-looking statement
because of various factors, including those described in the sections titled “Cautionary Statement Regarding Forward-Looking Statements”
and “Risk Factors” in this Annual Report.
We
are a clinical stage microbiome product discovery company developing products using both natural and engineered phage technologies designed
to target and destroy specific harmful bacteria associated with chronic diseases, such as CF, AD, as well as IBD, PSC and CRC. Bacteriophage
or phage are bacterial, species-specific, strain-limited viruses that infect, amplify and kill the target bacteria and are considered
inert to mammalian cells. By utilizing proprietary combinations of naturally occurring phage and by creating novel phage using synthetic
biology, we develop phage-based therapies intended to address both large-market and orphan diseases.
Since BiomX Ltd.’s inception in 2015, and
since the Business Combination, we have devoted substantially all our resources to organizing and staffing our company, raising capital,
acquiring rights to or discovering product candidates, developing our technology platforms, securing related intellectual property rights,
and conducting discovery, research and development and clinical activities for our product candidates. We do not have any products approved
for sale, and we have not generated any revenue from product sales. As we advance our product candidates, we expect our expenses to remain
significant. To date, we have funded our operations with proceeds from sales of Common Stock and preferred shares. Through December
31, 2021, we had received gross proceeds of approximately $146 million from sales of our securities. To date, we received approximately
$634 thousand from our collaboration agreements and recorded a reduction from research and development expenses of $634 thousand.
Since BiomX Ltd.’s inception in 2015, and
since the Business Combination, we have incurred significant operating losses. Our ability to generate revenue from product sales sufficient
to achieve profitability will depend on the successful development of, the receipt of regulatory approval for, and eventual commercialization
of one or more of our product candidates. Our net losses were approximately $36.2 million and $30.1 million for the years ended December
31, 2021 and 2020, respectively. As of December 31, 2021, we had an accumulated deficit of $108.5 million and expect that for the foreseeable
future we will continue to incur significant expenses as we advance our product candidates from discovery through preclinical development
and clinical trials and seek regulatory approval of our product candidates. In addition, if we obtain regulatory approval for any of our
product candidates, we expect to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution.
We may also incur expenses in connection with in-licensing or acquiring additional product candidates.
Because of the numerous risks and uncertainties
associated with product development, we are unable to predict the timing or amount of increased expenses or when or if we will be able
to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If we fail to become
profitable or are unable to sustain profitability on a continuing basis, we may be unable to continue our operations at planned levels
and be forced to reduce or terminate our operations. We may implement cost reduction strategies, which may include amending, delaying,
limiting, reducing or terminating one or more of our programs or ongoing or planned clinical trials of our product candidates.
On December 31, 2021, we had cash, cash equivalents
and restricted cash of $63.1 million. We believe that our existing cash and cash equivalents and short-term deposits will enable us to
fund our operating expenses and capital expenditure requirements until at least the end of 2023, as discussed further below under ”-Liquidity
and Capital Resources”
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Components of Our Consolidated Results of Operations
Revenue
To date, we have not generated any revenue from
product sales and do not expect to generate any revenue from product sales in the near future. If development efforts for our product
candidates are successful and result in any necessary regulatory approvals or otherwise lead to any commercialized products or additional
license agreements with third parties, we may generate revenue in the future from product sales or payments from collaboration or license
agreements with third parties.
Operating Expenses
Research and Development Expenses, net
Research and development expenses consist primarily
of costs incurred in connection with the discovery and development of our product candidates. We expense research and development costs
as incurred, offset by IIA grants and, to a lesser degree, income from research and development collaboration agreements. These expenses
include:
● development and operation of our proprietary platform;
● depreciation and other expenses.
We recognize external development costs based
on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers.
We do not allocate employee costs or facility
expenses, including depreciation or other indirect costs, to specific programs because these costs are deployed across multiple programs
and, as such, are not separately classified. We use internal resources primarily to oversee the research and discovery as well as for
managing our preclinical development, process development, manufacturing and clinical development activities. These employees work across
multiple programs and, therefore, we do not track their costs by program.
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The table below summarizes our research and development
expenses incurred by program:
Year Ended December 31,
USD In thousands
Salaries and related benefits (including stock-based compensation) 14,057 11,026
Total research and development expenses, net 22,676 19,417
Research and development activities are central
to our business. Product candidates in later stages of clinical development generally have higher development costs than those in earlier
stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. As a result, we expect
that our research and development expenses will increase substantially over the next several years, particularly as we increase personnel
costs, including stock-based compensation, contractor costs and facilities costs, as we continue to advance the development of our product
candidates. We also expect to incur additional expenses related to milestone and royalty payments payable to third parties with whom
we have entered into license agreements to acquire the rights to our product candidates.
General and Administrative Expenses
General and administrative expenses consist primarily
of salaries, related benefits, travel and stock-based compensation expenses for personnel in executive, finance, corporate, business
development and administrative functions. General and administrative expenses also include legal fees relating corporate and securities
matters; professional fees for accounting, tax and audit services; insurance costs; travel expenses; and facility-related expenses, including
rent, as well as operating related costs.
We anticipate that our general and administrative
expenses will increase in the future as we increase our headcount to support our continued research activities and development of our
product candidates. We also anticipate that we will continue to incur significant accounting, audit, legal, regulatory, compliance, directors’
and officers’ insurance costs as well as investor and public relations expenses associated with being a public company. We anticipate
the additional costs for these services will increase our general and administrative expenses in the future. Additionally, if and when
we believe a regulatory approval of a product candidate appears likely, we anticipate an increase in payroll and expenses as a result
of our preparation for commercial operations, especially as it relates to the sales and marketing of our product candidate.
Amortization
of intangible assets
Intangible assets consist of in-process research
and development, amortized for a period of three years, that started on January 1, 2020.
Interest expenses
Interest expense consists of interest incurred
under the Hercules Loan Agreement.
Financial expenses, net
Financial expenses, net consist primarily of income
or expenses related to revaluation of foreign currencies and interest income on our bank deposits and money market funds.
72
Results of Operations
Comparison of the Years Ended December 31,
2021 and 2020
The following table summarizes our consolidated
results of operations for the years ended December 31, 2021 and 2020:
Year ended December 31,
USD In thousands
Amortization of intangible assets 1,519 1,518
General and administrative expenses 11,267 9,323
Interest expenses 699 -
Financial income, net (2 ) (172 )
Tax expenses 67 -
R&D expenses, net (net of grants received
from the IIA and consideration from research collaborations) were $22.7 million for the year ended December 31, 2021, compared to $19.4
million for the year ended December 31, 2020. The increase of $3.3 million, or 17%, in the year ended December 31, 2021 compared to the
prior year, is primarily due to the following:
● a decrease of $3.2 million that resulted from receiving higher IIA grants.
The Company recorded grants from the IIA totaling
$3.7 million and $0.5 million for the years ended December 31, 2021 and December 31, 2020, respectively.
Amortization of intangible assets remained consistent
from 2020 to 2021.
General and administrative expenses were $11.3
million for the year ended December 31, 2021, compared to $9.3 million for the year ended December 31, 2020. The increase of $2.0 million,
or 22%, is primarily due to the following:
Interest expenses were $0.7 million for the year
ended December 31, 2021. The Company had no interest expenses for the year ended December 31, 2020. The increase of $0.7 million, or 100%,
is due interest payments accrued under the Hercules Loan Agreement, entered into in August 2021.
Financial income, net was $2 thousand for the
year ended December 31, 2021, compared to $172 thousand for the year ended December 31, 2020. The decrease of $170 thousand, or 99%,
is primarily due to U.S. dollar/NIS exchange rate differences and the decrease in interest rates on bank deposits and money market funds.
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Liquidity and Capital Resources
Sources of Liquidity
Since BiomX Ltd.’s inception in 2015, we
have not generated any revenue from sales of our products and have incurred significant operating losses and negative cash flows from
our operations. We have funded our operations to date primarily with proceeds from the sale of our Common Stock and preferred shares,
venture debt, IIA grants and funds from collaboration agreements and through the Business Combination. Through December 31, 2021, we had
received gross cash proceeds of approximately $146 million from sales of our Common Stock and preferred shares. In August 2021, we borrowed
$15.0 million under the Hercules Loan Agreement. In addition, in 2021 and 2020 we received approximately $3.2 million and $0.7 million
from our collaboration agreements and grants from the IIA, respectively.
Cash in excess of immediate requirements is invested
primarily with a view to liquidity and capital preservation.
On December 4, 2020, we filed a shelf registration
statement on Form S-3, which was declared effective by the SEC on December 11, 2020. In addition, on December 4, 2020, we entered into
the Sale Agreement, with Jefferies, pursuant to which we may issue and sell shares of our Common Stock having an aggregate offering price
of up to $50,000,000 from time to time through Jefferies. We are not obligated to make any sales of Common Stock under the Sale Agreement.
Through December 31, 2021, we sold an aggregate of 754,140 shares of Common Stock pursuant to the Sale Agreement for aggregate gross proceeds
of $5,413 thousands. From January 1, 2022 through March 25, 2022, we sold an aggregate of 26,011 shares of Common Stock pursuant to the
Sale Agreement for aggregate gross proceeds of $36,406. Subject to any limitations on aggregate amounts as a result of the value of our
Common Stock owned by non-affiliates that are imposed by SEC regulations, we may continue to sell shares under the Sale Agreement and
otherwise to use our shelf registration statement to raise additional funds from time to time.
On August 16, 2021 we entered into the Hercules
Loan Agreement with Hercules, with respect to a venture debt facility. Under the Hercules Loan Agreement, Hercules provided the Company
with access to a term loan with an aggregate principal amount of up to $30,000, available in three tranches, subject to certain terms
and conditions. The first tranche of $15,000 was advanced to the Company on the date the Hercules Loan Agreement was executed. Upon the
occurrence of specified milestones and continuing through December 31, 2022, a loan in the aggregate principal amount of up to $10,000,
and upon the occurrence of specified milestones and continuing through September 30, 2023, a loan in the aggregate principal amount of
up to $5,000, may become available. The milestones for the remaining tranches have not yet been reached as of December 31, 2021.
We believe that our existing cash resources will
be sufficient to meet our capital requirements and fund our operations for at least until the end of 2023. In the future we will likely
require or desire additional funds to support our operating expenses and capital requirements or for other purposes, such as acquisitions,
and may seek to raise such additional funds through public or private equity or debt financings or collaborative agreements or from other
sources, as we are doing now with the Sale Agreement and the Hercules Loan Agreement. However, the COVID-19 pandemic continues to rapidly
evolve and has already resulted in a significant disruption of global financial markets. If the disruption due to COVID-19 or other reasons,
such as the Russia–Ukraine military conflict, persists and deepens, we could experience an inability to access additional capital,
which could in the future negatively affect our capacity to support our operating expenses and capital requirements or to make investments
for other purposes, such as acquisitions.
We
have no other commitments to obtain additional financing, except for our commitment under the Securities Purchase Agreement with the
Cystic Fibrosis Foundation, signed in December 2021, and cannot assure you that additional financing will be available at all or, if
available, that such financing would be obtainable on terms favorable to us and would not be dilutive. Our future liquidity and cash
requirements will depend on numerous factors, including the introduction of new products as well as the ability to continue to maintain
controls over our operating expenditures.
Cash Flows
The following table summarizes our cash flows
for each of the periods presented:
Year Ended December 31,
USD In thousands
Net cash used in operating activities (27,573 ) (24,447 )
Net cash provided by (used in) investing activities 16,173 (10,857 )
Net cash provided by financing activities 37,280 134
Net increase (decrease) in cash and cash equivalents 25,855 (35,170 )
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Operating Activities
During the year ended December 31, 2021, operating
activities used $27.6 million of net cash, primarily due to a net loss of $36.2 million and by net cash used by changes in our operating
assets and liabilities of $3.2 million and non-cash charges of $5.6 million. Non-cash charges for the year ended December 31, 2021 mainly
consisted of stock-based compensation expenses of $3.2 million and depreciation and amortization of $2.6 million, partially offset by
revaluation of contingent liabilities expenses of $0.5 million. Net changes in our operating assets and liabilities for the year ended
December 31, 2021 consisted primarily of an increase in trade account payables of $0.4 million, and an increase in other account payables
of $2.7 million.
During the year ended December 31, 2020, operating
activities used $24.4 million of net cash, primarily due to a net loss of $30.1 million and by net cash used by changes in our operating
assets and liabilities of $0.5 million and non-cash charges of $5.2 million. Non-cash charges for the year ended December 31, 2020 mainly
consisted of stock-based compensation expenses of $2.9 million and depreciation and amortization of $2.2 million, partially offset by
revaluation of contingent liabilities expenses of $0.1 million. Net changes in our operating assets and liabilities for the year ended
December 31, 2020 consisted primarily of an increase in liabilities relating to operating leases of $1.4 million, and an increase in
other account payables of $1.4 million, partially offset by an increase of $1.5 million in other receivables and a decrease in trade
account payables of $0.8 million.
Investing Activities
During
the year ended December 31, 2021, investing activities provided net cash of $16.2 million, mainly consisting of proceeds from withdrawal
of short-term deposits of $19.8 million, partially offset by purchases of property and equipment of $3.7 million, primarily laboratory
equipment and leasehold improvements.
During the year ended December 31, 2020, investing
activities used net cash of $10.9 million, mainly consisting of net change in investment in short-term deposits of $9.9 million and purchases
of property and equipment of $1.0 million, primarily laboratory equipment and leasehold improvements.
We have invested, and plan to continue to invest,
our existing cash in short-term investments in accordance with our investment policy. These investments may include money market funds
and investment securities consisting of U.S. Treasury notes, and high quality, marketable debt instruments of corporations and government
sponsored enterprises. We use foreign exchange contracts (mainly option and forward contracts) to hedge balance sheet items from currency
exposure. These foreign exchange contracts are not designated as hedging instruments for accounting purposes. In connection with these
foreign exchange contracts, we recognize gains or losses that offset the revaluation of the balance sheet items also recorded under financial
expenses, net. As of December 31, 2021, we had outstanding foreign exchange contracts in the amount of approximately $4.2 million
with a fair value of $62 thousand. As of December 31, 2020, we had outstanding foreign exchange contracts in the amount of approximately
$1.5 million, with a fair value of $90 thousand.
Financing Activities
During
the year ended December 31, 2021, financing activities provided net cash of $37.3 million, consisting of $5.2 million due to issuance
of Common Stock under the Sale Agreement, $17.7 million due to issuances of Common Stock under a registered direct offering, as described
below, as well as investments by Maruho and the CF Foundation,
$14.2 million proceeds from long-term debt and related to the Hercules Loan Agreement and $0.1 million from exercise of stock options.
During the year ended December 31, 2020, financing
activities provided net cash provided of $134 thousand, consisting of $75 thousand due to the Business Combination, $98 thousand from
issuance of Common Stock and $307 thousand from exercise of stock options.
Contractual Obligations, Commitments and Contingencies
Our contractual
obligations and commitments relate primarily to our Hercules Loan Agreement, operating leases and non-cancelable purchase obligations
under agreements with various research and development organizations and suppliers in the ordinary course of business. In September 2020,
we entered into a lease agreement for new office and laboratory space in Ness Ziona, Israel. See note 8, “Leases” and note
12, “Long term Debt,” to our financial statements for further information.
In the normal
course of business, we enter into contracts and agreements that contain a variety of representations and warranties and provide for general
indemnifications. Our exposure under these agreements is unknown because it involves claims that may be made against us in the future
but have not yet been made. To date, we have not paid any claims or been required to defend any action related to our indemnification
obligations. However, we may record charges in the future as a result of these indemnification obligations.
In accordance with our certificate
of incorporation and bylaws, as well as contractual indemnification agreements, we have potential indemnification obligations to our officers
and directors for specified events or occurrences, subject to some limits, while they are serving at our request in such capacities. There
have been no claims to date, and we have director and officer insurance that may enable us to recover a portion of any amounts paid for
future potential claims.
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Government Grants and Related Royalties
The Government of Israel, through the IIA, encourages
research and development projects by providing grants. We may receive grants from the IIA at the rates that range from 20% to 50%
of the research and development expenses, as prescribed by the research committee of the IIA. Through December 31, 2021, we had received
an aggregate of $5.6 million in the form of grants from the IIA. BiomX Ltd. was formed as an incubator company as part of the FutuRx incubator,
and, until 2017, the majority of its funding was from IIA grants and funding by the incubator, which is supported by the IIA. We continued
to apply for and receive IIA grants after we left the incubator. The requirements and restrictions for such grants are found in the Research
Law. Under the Research Law, royalties of 3% to 3.5% on the revenue derived from sales of products or services developed in whole or in
part using these IIA grants are payable to the Israeli government. We developed both of our platform technologies, at least in part, with
funds from these grants, and, accordingly, we would be obligated to pay these royalties on sales of any of our product candidates that
achieve regulatory approval.
Below is a description of
our obligations in connection with the grants received from the IIA under the Research Law:
Local Manufacturing Obligation
As
long as the manufacturing of our product candidates takes place in Israel and no technology funded with IIA grants is sold or out licensed
to a non-Israeli entity, the maximum aggregate royalties paid generally would not exceed 100% of the grants made to us, plus annual interest
equal to the 12-month LIBOR rate applicable to U.S. dollar deposits, as published on the first business day of each calendar year.
Under the terms of the Research
Law, the products may be manufactured outside of Israel by us or by another entity only if prior approval is received from the IIA (such
approval is not required for the transfer of up to 10% of the manufacturing capacity in the aggregate, in which case a notice must be
provided to the IIA and not be objected to by the IIA within 30 days of such notice).
Know-How Transfer Limitation
The Research Law restricts
the ability to transfer know-how funded by the IIA outside of Israel. Transfer of IIA funded know-how outside of Israel requires prior
approval of the IIA and may be subject to payments to the IIA, calculated according to formulae provided under the Research Law. The
redemption fee is subject to a cap of six times the total amount of the IIA grants, plus interest accrued thereon (i.e. the total liability
to the IIA, including accrued interest, multiplied by six). If we wish to transfer IIA funded know-how, the terms for approval will be
determined according to the nature of the transaction and the consideration paid to us in connection with such transfer.
Approval of transfer of IIA
funded know-how to another Israeli company may be granted only if the recipient abides by the provisions of the Research Law and related
regulations, including the restrictions on the transfer of know-how and manufacturing rights outside of Israel.
Change of Control
Any non-Israeli citizen, resident or entity that,
among other things, (i) becomes a holder of 5% or more of our share capital or voting rights, (ii) is entitled to appoint our directors
or our chief executive officer or (iii) serves as one of our directors or as our chief executive officer (including holders of 25% or
more of the voting power, equity or the right to nominate directors in such direct holder, if applicable) is required to notify the IIA
and undertake to comply with the rules and regulations applicable to the grant programs of the IIA, including the restrictions on transfer
described above.
Approval to manufacture products outside of Israel
or consent to the transfer of IIA funded know-how, if requested, is within the discretion of the IIA. Furthermore, the IIA may impose
certain conditions on any arrangement under which it permits us to transfer IIA funded know-how or manufacturing out of Israel.
The consideration available
to our shareholders in a future transaction involving the transfer outside of Israel of know-how developed with IIA funding (such as
a merger or similar transaction) may be reduced by any amounts that we are required to pay to the IIA.
As of December 31, 2021, no sales were generated
and the balance of the principal and interest in respect of our commitments for future payments to the IIA totaled approximately $5.4
million. As part of funding our current and planned product development activities, we have submitted follow-up grant applications for
new grants.
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Outlook
We
expect our expenses to remain substantially in the same level in connection with our ongoing activities.
Our expenses will remain substantial and may also increase as we:
● continue the development of our product candidates;
We believe that our existing cash and cash equivalents
will enable us to fund our operating expenses and capital expenditure requirements until at least the end of 2023. We have based these
estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. If we
receive regulatory approval for our product candidates, we expect to incur significant commercialization expenses related to product manufacturing,
sales, marketing and distribution, depending on where we choose to commercialize.
Until such time, if ever, that we can generate
product revenue sufficient to achieve profitability, we expect to finance our cash needs through public or private sales of our equity,
including under the Sale Agreement or the additional investment under the CF Foundation agreement, loans, including the second and/or
third tranches under the Hercules Loan Agreement, milestone payments, possibly additional grants from the IIA or other government or non-profit
institutions and other outside funding sources. Our ability to raise additional capital in the equity and debt markets is dependent on
a number of factors including, but not limited to, market volatility resulting from the COVID-19 pandemic, armed conflicts such as in
Ukraine or other disruptions, market demand for our securities, which itself is subject to a number of development and business risks
and uncertainties, as well as the uncertainty that we would be able to raise such additional capital at a price or on terms that are favorable
to the Company. To the extent that we raise additional capital through the sale of equity or convertible debt securities, our stockholders’
ownership interests may be materially diluted, and the terms of such securities could include liquidation or other preferences that adversely
affect their rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that
include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures
or declaring dividends. If we raise additional funds through government and other third-party funding, collaboration agreements, strategic
alliances, licensing arrangements or marketing and distribution arrangements, we may have to relinquish valuable rights to our technologies,
future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are
unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate
our product development or future commercialization efforts or grant rights to develop and market products or product candidates that
we would otherwise prefer to develop and market by ourselves. For more information regarding the risks related to our outlook, see “Risk
Factors — Risks Related to Our Business, Technology and Industry.”
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Foreign Exchange Contracts
We entered into forward and option contracts to
hedge against the risk of overall changes in future cash flow from payments of salaries and related expenses, as well as other expenses
denominated in NIS. As of December 31, 2021 and 2020, we had outstanding foreign exchange contracts in the nominal amount of approximately
$4.2 million and $1.5 million, respectively.
Critical
Accounting Policies and Significant Judgments and Estimates
Our consolidated financial statements are prepared
in accordance with US GAAP. The preparation of our consolidated financial statements and related disclosures requires us to make estimates
and judgments that affect the reported amounts of assets, liabilities, revenue, costs and expenses, and the disclosure of contingent
assets and liabilities in our financial statements. We base our estimates on historical experience, known trends and events and various
other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about
the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions
on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.
While our significant accounting policies are
described in more detail in Note 2 to our consolidated financial statements, we believe that the following accounting policies are those
most critical to the judgments and estimates used in the preparation of our consolidated financial statements.
Accrued research and development expenses
As part of the process of preparing our consolidated
financial statements, we are required to estimate our accrued research and development expenses. This process involves reviewing open
contracts and purchase orders, communicating with our applicable personnel to identify services that have been performed on our behalf
and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or
otherwise notified of actual costs. The majority of our service providers invoice us in arrears for services performed, on a pre-determined
schedule or when contractual milestones are met; however, some require advance payments. We make estimates of our accrued expenses as
of each balance sheet date in the consolidated financial statements based on facts and circumstances known to us at that time. We periodically
confirm the accuracy of these estimates with the service providers and make adjustments, if necessary. Examples of estimated accrued
research and development expenses include fees paid to:
● vendors in connection with preclinical development activities;
We measure the expense recognized based on our
estimates of the services received and efforts expended pursuant to quotes and contracts with multiple CROs and subcontractors that supply,
conduct and manage preclinical studies, human clinical studies and clinical trials on our behalf. The financial terms of these agreements
are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments
made to our vendors will exceed the level of services provided and result in a prepayment of the expense. Payments under some of these
contracts depend on factors such as the successful enrollment of patients and the completion of certain milestones. In accruing service
fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the
actual timing of the performance of services or the level of effort varies from the estimate, we adjust the accrual or the amount of
prepaid expenses accordingly. Although we do not expect our estimates to be materially different from amounts actually incurred, our
understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary
and may result in changes in estimates that increase or decrease amounts recognized in any particular period. To date, there have not
been any material adjustments to our prior estimates of accrued research and development expenses.
Stock-Based Compensation
We apply ASC 718-10, “Stock-Based Payment,”
which requires the measurement and recognition of compensation expenses for all stock-based payment awards made to employees and directors,
including employee stock options under our stock plans based on estimated fair values.
ASC 718-10 requires that we estimate the fair
value of equity-based payment awards on the date of grant using an option-pricing model. The fair value of the award is recognized as
an expense over the requisite service periods in our Consolidated Statements of Operations. We recognize stock-based award forfeitures
as they occur, rather than estimate by applying a forfeiture rate.
78
We recognize compensation expenses for the fair
value of non-employee awards over the requisite service period of each award.
We estimate the fair value of stock options granted
as equity awards using a Black-Scholes options pricing model. The option-pricing model requires a number of assumptions, of which the
most significant are share price, expected volatility and the expected option term (the time from the grant date until the options are
exercised or expire). We determine the fair value per share of the underlying stock by taking into consideration our most recent sales
of stock. BiomX Ltd. has historically been a private company and lacks company-specific historical and implied volatility information
of its stock. Expected volatility is estimated based on volatility of similar companies in the biotechnology sector. We have historically
not paid dividends and has no foreseeable plans to issue dividends. The risk-free interest rate is based on the yield from governmental
zero-coupon bonds with an equivalent term. The expected option term is calculated for options granted to employees and directors using
the “simplified” method. Grants to non-employees are based on the contractual term. Changes in the determination of each
of the inputs can affect the fair value of the options granted and the results of our operations.
Intangible assets
In-process research and development acquired in
a business combination were recognized at fair value as of the acquisition date and subsequently accounted for as indefinite-lived intangible
assets until completion or abandonment of the associated research and development efforts.
We accounted for the acquisition of RondinX Ltd.
using the acquisition method of accounting, which required us to estimate the fair values of the assets acquired and liabilities assumed. This
included acquired in-process research and development and contingent consideration. Adjustments to the fair value of contingent consideration
are recorded in earnings. On January 1, 2020, the in-process R&D efforts were completed. The Company had determined the useful life
of the R&D assets for three years and began amortizing these assets accordingly in the financial statements.
We review these intangible assets at least annually
for impairment, or whenever events or changes in circumstances indicate that the carrying amount may not be recoverable.
Emerging Growth Company Status
We are an “emerging growth company,”
as defined in the JOBS Act, and we may take advantage of certain exemptions from various reporting requirements that are applicable
to other public companies that are not emerging growth companies. We may take advantage of these exemptions until we are no longer an
emerging growth company. Section 107 of the JOBS Act provides that an emerging growth company can take advantage of the extended transition
period afforded by the JOBS Act for the implementation of new or revised accounting standards. We have irrevocably elected not to avail
ourselves of this extended transition period and, as a result, we will adopt new or revised accounting standards on the relevant dates
on which adoption of such standards is required for other public companies. We may take advantage of these exemptions up until the last
day of the fiscal year following the fifth anniversary of our first registration statement filed under the Securities Act, or such earlier
time that we are no longer an emerging growth company. We would cease to be an emerging growth company if we have more than $1.07 billion
in annual revenue, we have more than $700.0 million in market value of our shares held by non-affiliates or we issue more than $1.0 billion
of non-convertible debt securities over a three-year period.
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ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
As a smaller reporting company, we are not required
to make disclosures under this Item.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Our financial statements and the notes thereto
begin on page F-1 of this Annual Report.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING
AND FINANCIAL DISCLOSURE
None.
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our
Chief Executive Officer, or CEO, and our Senior Vice President of Finance and Operations (our principal executive officer and principal
financial officer, respectively), performed an evaluation of the effectiveness of our disclosure controls and procedures (as defined
in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of December 31, 2021. Based on the aforementioned evaluation, our management
has concluded that our disclosure controls and procedures were effective at a reasonable assurance level as of December 31, 2021.
Management’s Annual Report on Internal Control over Financial
Reporting
Our management is responsible for establishing
and maintaining adequate internal control over financial reporting. Our internal control over financial reporting has been designed to
provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting principles in the United States of America.
Our internal control over financial reporting
includes policies and procedures that pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect
transactions and dispositions of our assets; provide reasonable assurance that transactions are recorded as necessary to permit preparation
of financial statements in accordance with generally accepted accounting principles in the United States of America, and that receipts
and expenditures are being made only in accordance with authorization of our management and directors; and provide reasonable assurance
regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect
on our financial statements.
Because of its inherent limitations, internal
control over financial reporting may not prevent or detect misstatements. Therefore, even those systems determined to be effective can
provide only reasonable assurance with respect to financial statement preparation and presentation. Projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that
the degree of compliance with the policies or procedures may deteriorate.
Management assessed the effectiveness of our internal
control over financial reporting on December 31, 2021. In making this assessment, management used the criteria set forth by the Committee
of Sponsoring Organizations of the Treadway Commission 2013 framework, in Internal Control—Integrated Framework. Based on
that assessment under those criteria, management has determined that, as of December 31, 2021, our internal control over financial reporting
was effective.
This Annual Report does not include an attestation
report of our independent registered public accounting firm regarding internal control over financial reporting due to an exemption for
emerging growth companies provided in the JOBS Act.
Changes in Internal Control over Financial Reporting
There have been no changes in our internal control
over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the fourth quarter
of fiscal year 2021 that have materially affected, or are reasonably likely to materially affect, our internal control over financial
reporting.
ITEM 9B. OTHER INFORMATION
On March 29, 2022, Mr. Paul Sekhri informed the
Board of Directors of his resignation as a director of the Company, effective immediately. The resignation of Mr. Sekhri did not involve
any disagreement with the Company, the Company’s management or the Board of Directors.
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICITIONS THAT PREVENT
INSPECTIONS
Not applicable.
80
part
III
We intend to file a definitive proxy statement
for our 2022 Annual General Meeting of Stockholders, or the 2022 Proxy Statement, with the SEC, pursuant to Regulation 14A, not later
than 120 days after December 31, 2021. Accordingly, certain information required by Part III has been omitted under General Instruction
G(3) to Form 10-K. Only those sections of the 2022 Proxy Statement that specifically address the items set forth herein are incorporated
by reference.
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
Code of Business Conduct and Ethics
We have adopted a Code
of Business Conduct and Ethics that applies to all directors, officers and employees. The Code of Business Conduct and Ethics is available
on our website at www.biomx.com. If we make any substantive amendments to the Code of Business Conduct and Ethics or grants any waiver
from a provision of the Code to any director or executive officer, we will promptly disclose the nature of the amendment or waiver on
our website.
Other Information
The remaining information
required by this item will be included in our 2022 Proxy Statement, and such required information is incorporated herein by reference
into this Annual Report.
ITEM 11. EXECUTIVE COMPENSATION
The information required by this item will be
included in our 2022 Proxy Statement and is hereby incorporated by reference into this Annual Report.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
AND RELATED STOCKHOLDER MATTERS
Securities Authorized for Issuance Under Equity Compensation Plans
We have two equity incentive plans, the 2015 Employee
Stock Option Plan, or the 2015 Plan, and the Chardan Healthcare Acquisition Corp. 2019 Equity Incentive Plan, or the 2019 Plan. In October
2019, in connection with the Business Combination, we assumed the 2015 Plan with respect to each outstanding equity award thereunder.
Although no shares of our Common Stock are available for future issuance under the 2015 Plan, the 2015 Plan will continue to govern outstanding
awards granted thereunder. As of December 31, 2021, options to purchase 2,466,533 shares of our Common Stock remained outstanding under
the 2015 Plan.
The 2019 Plan was adopted by the Board of Directors
and approved by our stockholders in connection with the Business Combination. As of December 31, 2021, there were 216,036 shares of our
Common Stock available for issuance under the 2019 Plan. The aggregate number of shares of our Common Stock available for issuance pursuant
to the 2019 Plan automatically increases on January 1 of each year, for a period of not more than ten years, commencing on January 1,
2020 and ending on (and including) January 1, 2029, in an amount equal to 4% of the total number of shares of Common Stock outstanding
on December 31 of the preceding calendar year. Accordingly, on January 1, 2022, 1,190,129 additional shares of our Common Stock were
made available for issuance pursuant to the 2019 Plan.
81
For additional information regarding the 2015
Plan and the 2019 Plan, as of December 31, 2021, please see Part II – Item 8 – Financial Statements and Supplemental Data
– Notes to consolidated financial statements – Note 12B – Stock-Based Compensation.
Equity Compensation Plan Information
Equity compensation plans not approved by security holders 2,466,533 2.19
The other information required by this item
will be included under the “Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters” in
our 2022 Proxy Statement and is hereby incorporated by reference into this Annual Report.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE
The information required by this item will
be included in our 2022 Proxy Statement and is hereby incorporated by reference into this Annual Report.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The information required by this item will
be included in our 2022 Proxy Statement and is hereby incorporated by reference into this Annual Report.
82
part
IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a) The following are filed with this report:
(2) Not applicable
(b) Exhibits
The following exhibits are filed as part of this
Annual Report or are incorporated by reference.
EXHIBIT INDEX
Exhibit Description
83
101.INS Inline XBRL Instance Document
101.SCH Inline XBRL Taxonomy Extension Schema Document
101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document
** Indicates a management contract or a compensatory plan or agreement.
*** Furnished herewith
Item 16. Form 10-K Summary
None.
84
SIGNATURES
Pursuant to the requirements of Section 13
or 15(d) of the Exchange Act of 1934, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly
authorized.
BIOMX INC.
Dated: March 30, 2022 By: /s/ Jonathan Solomon
Name: Jonathan Solomon
Title: Chief Executive Officer
Pursuant to the requirements of the Securities
Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Company and in the capacities and on
the dates indicated.
Signature Title Date
/s/ Dr. Russell Greig Chairman of the Board of Directors March 30, 2022
Dr. Russell Greig
/s/ Jonathan Solomon Chief Executive Officer March 30, 2022
Jonathan Solomon (Principal Executive Officer) and Director
Marina Wolfson (Principal Financial Officer and Principal Accounting Officer)
/s/ Dr. Gbola Amusa Director March 30, 2022
Dr. Gbola Amusa
/s/ Jonas Grossman Director March 30, 2022
Jonas Grossman
/s/ Dr. Alan Moses Director March 30, 2022
Dr. Alan Moses
/s/ Lynne Sullivan Director March 30, 2022
Lynne Sullivan
85
BIOMX INC.
CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2021
BIOMX INC.
CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2021
CONTENTS
Page
CONSOLIDATED FINANCIAL STATEMENTS:
Consolidated Balance Sheets F-4 - F-5
Consolidated Statements of Operations F-6
Consolidated Statements of Changes in Stockholders’ Equity F-7
Consolidated Statements of Cash Flows F-8 - F-9
Notes to the Consolidated Financial Statements F-10 - F-35
F-1
Report of Independent Registered Public Accounting
Firm
To the Board of Directors and stockholders of BiomX Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheet of BiomX
Inc. and its subsidiaries (the “Company”) as of December 31, 2021, and the related consolidated statements of operations,
changes in stockholders' equity and cash flows for the year then ended, including the related notes (collectively referred to as the “consolidated
financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial
position of the Company as of December 31, 2021, and the results of its operations and its cash flows for the year then ended in conformity
with accounting principles generally accepted in the United States of America.
Basis for Opinion
These consolidated financial statements are the responsibility of the
Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based
on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and
are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules
and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit of these consolidated financial statements in
accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance