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 and AD. 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, 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, preferred shares, warrants, governmental grants, collaboration agreements
and debt. Through December 31, 2022, we had received gross proceeds of approximately $146 million from sales of our securities. To date,
we received approximately $1,134,000 from our collaboration agreements and recorded a reduction from research and development expenses
of $921,000.
In addition, 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 $28.3 million and $36.2 million for the years ended December 31, 2022 and 2021, respectively. As of December 31, 2022, we
had an accumulated deficit of $136.8 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. In May 2022, we announced,
as part of our corporate restructuring plan, or the Corporate Restructuring, our intention to reduce our operating costs, including a
50% reduction in personnel, while prioritizing our ongoing CF program.
On December 31, 2022, we had cash, cash equivalents
and restricted cash of $32.3 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 middle of 2024, 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) 9,130 14,057
Total research and development expenses, net 16,244 22,676
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. Our research and development
expenses reflect, among other things, programs that were discontinued or put on hold as well as new development programs. 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 may 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 believe that our general and administrative expenses
may 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.
Other income
Other income consists of proceeds from sub-leasing
a portion of our office space in Ness Ziona, Israel starting in August 2022.
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.
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Results of Operations
Comparison of the Years Ended December 31,
2022 and 2021
The following table summarizes our consolidated
results of operations for the years ended December 31, 2022 and 2021:
Year ended December 31,
USD In thousands
Amortization of intangible assets 1,519 1,519
General and administrative expenses 9,456 11,267
Financial income, net (902 ) (2 )
Other income (134 ) -
R&D expenses, net (net of grants received
from the IIA and consideration from research collaborations) were $16.2 million for the year ended December 31, 2022, compared to $22.7
million for the year ended December 31, 2021. The decrease of $6.5 million, or 29%, in the year ended December 31, 2022 compared to the
prior year, is primarily due to the following:
These were partially offset by a decrease in IIA grants of $2.6 million.
We recorded grants from the IIA totaling $1.1 million and $3.7 million for the years ended December 31, 2022 and December 31, 2021, respectively.
Amortization of intangible assets remained consistent
from 2021 to 2022.
General and administrative expenses were $9.5 million
for the year ended December 31, 2022, compared to $11.3 million for the year ended December 31, 2021. The decrease of $1.8 million, or
16%, is primarily due to the following:
Interest expenses were $2.1 million for the year
ended December 31, 2022, compared to $0.7 million for the year ended December 31, 2021. The increase of $1.4 million, or 200%, is due
interest payments accrued under the Hercules Loan Agreement, entered into in August 2021, in addition to the increase of the U.S. prime
rate.
Financial income, net was $902,000 for the year
ended December 31, 2022, compared to $2,000 for the year ended December 31, 2021. The increase of $900,000 is primarily due to appreciation
of the U.S. dollar against the NIS and due to the rising interest rates, which resulted in higher interest income.
Other income was $134,000 for the year ended
December 31, 2022. The Company had no other income for the year ended December 31, 2021. The increase of $134,000, or 100%, is due to
a sublease agreement for a portion of our office space in Ness Ziona, Israel entered into in August 2022 following our Corporate Restructuring.
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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, preferred shares and
warrants, venture debt, IIA grants and funds from collaboration agreements and through the Business Combination. Through December 31,
2022, 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 2022 and 2021 we received approximately $1.9 million
and $3.2 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, 2022, we sold an aggregate of 983,184 shares of Common Stock pursuant to the Sale Agreement for aggregate gross proceeds
of $5.7 million. From January 1, 2023 through March 24, 2023, we did not sell any shares. 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 million, available in three tranches, subject to certain terms and
conditions. The first tranche of $15 million 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, we could receive a loan in the aggregate principal amount
of up to $10 million. However, such milestones for such tranche and for the extension of the period of interest only payments to September
1, 2023 did not occur by December 31, 2022 and have expired. Additionally, upon the occurrence of specified milestones and continuing
through September 30, 2023, we might be entitled to borrow a loan in the aggregate principal amount of up to $5 million. However, we do
not expect that such milestones will occur by September 30, 2023. The Company is required to make interest only payments through
March 1, 2023, and is required to repay the principal balance and interest in monthly installments through September 1, 2025.
On February 22, 2023, we entered into a securities
purchase agreement to issue and sell an aggregate of 30,608,163 shares of its common stock (or pre-funded warrants, and collectively,
the “Securities”) at a price of $0.245 per share or $0.244 per pre-funded warrant, through a private investment in public
equity, also referred to as PIPE, financing. The gross proceeds from this offering are expected to be approximately $7.5 million, before
deducting issuance costs. The financing is expected to close in two parts. The first closing, which covers 5,975,918 Securities for gross
proceeds of $1.5 million, occurred on February 27, 2023. The second closing for the remaining Securities, which is contingent upon approval
of the issuance of the additional Securities by our stockholders in accordance with NYSE American rules, is expected to take place in
the second quarter of 2023.
We believe that our existing cash resources will be
sufficient to meet our capital requirements and fund our operations for at least until the middle of 2024. In the future, in addition
to the remaining funds under the PIPE, 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. If certain disruptions due to, for instance, the Russia–Ukraine military conflict, or the Israeli political instability
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, other than with respect to the closing of the second part of the PIPE, 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 (29,092 ) (27,573 )
Net cash provided by (used in) investing activities (2,107 ) 16,173
Net cash provided by financing activities 292 37,280
Net increase (decrease) in cash and cash equivalents (30,801 ) 25,855
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Operating Activities
During the year ended December 31, 2022, operating
activities used $29.1 million of net cash, primarily due to a net loss of $28.3 million and by net cash used by changes in our operating
assets and liabilities of $4.4 million and non-cash charges of $3.7 million. Non-cash charges for the year ended December 31, 2022, mainly
consisted of stock-based compensation expenses of $1.5 million and depreciation and amortization of $2.5 million. Net changes in our operating
assets and liabilities for the year ended December 31, 2022, consisted primarily of a decrease in trade account payables of $2.0 million
and a decrease in other account payables of $3.3 million, partially offset by a decrease in other current assets of $1.0 million.
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.
Investing Activities
During the year ended December 31, 2022, investing
activities used in net cash of $2.1 million, mainly consisting of investment in short-term deposits of $13.5 million, partially offset
by proceeds from withdrawal of short-term deposits of $11.5 million.
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.
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, 2022, we had outstanding foreign exchange contracts in the amount of approximately $4.5 million
with a fair value liability of $55,000. As of December 31, 2021, we had outstanding foreign exchange contracts in the amount of approximately
$4.2 million, with a fair value asset of $62,000.
Financing Activities
During the year ended December 31, 2022, financing
activities provided net cash of $0.3 million, mainly consisting of $0.3 million due to issuances of Common Stock under the Sale Agreement.
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.
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, 2022, we had received
an aggregate of $6.9 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, 2022, 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 $6.6
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 middle of 2024. 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 second part of the PIPE, 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, 2022 and 2021, we had outstanding foreign exchange contracts in the nominal amount of approximately
$4.5 million and $4.2 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.
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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. We used an average historical stock price volatility based on a combined weighted average of our historical average volatility
and that of a selected peer group of comparable public companies within the biotechnology and pharmaceutical industry that were deemed
to be representative of future stock price trends as we do not have a sufficient historical trading history of our Common Stock. We will
continue to apply this process until a sufficient amount of historical information regarding the volatility of our stock price becomes
available. 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. As of December 31, 2022,
the intangible asset was fully amortized.
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 $1.235 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. We shall cease to be an emerging growth company commencing on January 1,
2024.
80
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 Chief Financial Officer (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, 2022. 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, 2022.
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, 2022. 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, 2022, 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 2022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial
reporting.
ITEM 9B. OTHER INFORMATION
None.
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICITIONS THAT PREVENT
INSPECTIONS
Not applicable.
81
part
III
We intend to file a definitive proxy statement
for our 2023 Annual General Meeting of Stockholders, or the 2023 Proxy Statement, with the SEC, pursuant to Regulation 14A, not later
than 120 days after December 31, 2022. Accordingly, certain information required by Part III has been omitted under General Instruction
G(3) to Form 10-K. Only those sections of the 2023 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 2023 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 2023 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, 2022, options to purchase 2,110,800 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, 2022, there were 380,189 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, 2023, 1,199,291 additional shares of our Common Stock were made
available for issuance pursuant to the 2019 Plan.
82
For additional information regarding the 2015 Plan
and the 2019 Plan, as of December 31, 2022, please see Part II – Item 8 – Financial Statements and Supplemental Data –
Notes to consolidated financial statements – Note 13B – Stock-Based Compensation.
Equity Compensation Plan Information
Equity compensation plans not approved by security holders 2,110,800 2.23
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 2023 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 2023 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 2023 Proxy Statement and is hereby incorporated by reference into this Annual Report.
83
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
84
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.
85
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 29, 2023 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/ Jonathan Solomon Chief Executive Officer March 29, 2023
Jonathan Solomon (Principal Executive Officer) and Director
/s/ Marina Wolfson Chief Financial Officer March 29, 2023
Marina Wolfson (Principal Financial Officer and Principal Accounting Officer)
/s/ Russell Greig Chairman of the Board of Directors March 29, 2023
Dr. Russell Greig
/s/ Alan Moses Director March 29, 2023
Dr. Alan Moses
/s/ Lynne Sullivan Director March 29, 2023
Lynne Sullivan
86
BIOMX INC.
CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2022
CONTENTS
Page
CONSOLIDATED FINANCIAL STATEMENTS:
Consolidated Balance Sheets F-3 - F-4
Consolidated Statements of Operations F-5
Consolidated Statements of Changes in Stockholders’ Equity F-6
Consolidated Statements of Cash Flows F-7 - F-8
Notes to the Consolidated Financial Statements F-9 - F-34
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 sheets of BiomX Inc
and its subsidiaries (the “Company”) as of December 31, 2022 and 2021 and the related consolidated statements of operations,
changes in stockholders' equity and cash flows for each of the two years in the period ended December 31, 2022, 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, 2022 and 2021 and the results of its
operations and its cash flows for each of the two years in the period ended December 31, 2022 in conformity with accounting principles
generally accepted in the United States of America.
Basis for Opinion