UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
☒ QUARTERLY REPORT PURSUANT TO SECTION
13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarter ended March 31, 2025
☐ TRANSITION REPORT PURSUANT TO SECTION
13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission file number: 001-38762
BiomX Inc.
(Exact Name of Registrant as Specified in Its Charter)
Delaware 82-3364020
(State or other jurisdiction of
incorporation or organization) (I.R.S. Employer
Identification No.)
22 Einstein St., Floor 4 , Ness Ziona , Israel 7414003
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including
area code: +972 723942377
Securities registered pursuant to Section 12(b)
of the Act:
Title of each class Trading Symbol(s) Name of each exchange on which registered
Common stock, $0.0001 par value PHGE NYSE American
Indicate by check mark whether the registrant
(1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant
has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405
of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes
☒ No ☐
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company.
See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company”
and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐ Accelerated filer ☐
Non-accelerated filer ☒ Smaller reporting company ☒
Emerging growth company ☐
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant
is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The number of shares outstanding of the Registrant’s shares of
Common Stock as of May 11, 2025 was 26,176,311 .
BIOMX INC.
FORM 10-Q FOR THE QUARTER ENDED MARCH 31, 2025
TABLE OF CONTENTS
Page
Part I. Financial Information
1
Item 1. Financial Statements
1
Condensed Consolidated Balance Sheets (unaudited)
F-1
Condensed Consolidated Statements of Operations (unaudited)
F-3
Condensed Consolidated Statements of Changes in Redeemable Convertible Preferred Shares and in Stockholders’ Equity (unaudited)
F-4
Condensed Consolidated Statements of Cash Flows (unaudited)
F-6
Notes to Condensed Consolidated Financial Statements (unaudited)
F-7
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
2
Item 3. Quantitative and Qualitative Disclosures About Market Risk
10
Item 4. Controls and Procedures
10
Part II. Other Information
11
Item 6. Exhibits.
11
Part III. Signatures
12
i
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING
INFORMATION
This Quarterly Report on
Form 10-Q, or the Quarterly Report, includes “forward-looking statements” within the meaning of the Private Securities
Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the
Securities Exchange Act of 1934, as amended, or the Exchange Act, and other securities laws. The statements contained herein that
are not purely historical, are forward-looking statements. Forward-looking statements include statements about our expectations,
beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Words or phrases such as
“anticipate,” “believe,” “continue,” “estimate,” “expect,”
“intend,” “may,” “ongoing,” “plan,” “potential,” “predict,”
“project,” “will” or similar words or phrases, or the negatives of those words or phrases, may identify
forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. For
example, we are making forward-looking statements when we discuss our business strategy and plans, our clinical and pre-clinical
development program, including timing, milestones and the design thereof, including acceptance of regulatory agencies of such
design, the potential opportunities for and benefits of the BacteriOphage Lead to Treatment, or BOLT, platform, the potential of our
product candidates and the sufficiency of financial resources and financial needs and ability to continue as a going concern.
However, you should understand that these statements are not guarantees of performance or results, and there are a number of risks,
uncertainties and other important factors that could cause our actual results to differ materially from those expressed in the
forward-looking statements, including, among others:
●
the ability to generate revenues, and raise sufficient financing to meet working capital requirements;
●
the unpredictable timing and cost associated with our approach to developing product candidates using phage technology and potential success thereof;
●
political, economic and military instability in the State of Israel, and in particular, the war in Gaza and Lebanon, additional potential conflicts with other middle eastern countries and the continuation of the proposed judicial and other legislation reform by the Israeli government;
●
political and economic instability, including, without limitation, due to natural disasters or other catastrophic events, such as the Russian invasion of Ukraine and world sanctions on Russia, Belarus, and related parties, terrorist attacks, hurricanes, fire, floods, pollution and earthquakes;
●
obtaining U.S. Food and Drug Administration, or FDA, acceptance of any non-U.S. clinical trials of product candidates;
●
our ability to enroll patients in clinical trials and achieve anticipated development milestones when expected;
●
the ability to pursue and effectively develop new product opportunities and acquisitions and to obtain value from such product opportunities and acquisitions;
●
penalties and market withdrawal associated with any unanticipated problems with product candidates and failure to comply with labeling and other restrictions;
●
general economic conditions, our current low stock price and other factors on our operations, the continuity of our business, including our preclinical and clinical trials, and our ability to raise additional capital;
●
expenses associated with compliance with ongoing regulatory obligations and successful continuing regulatory review;
●
market acceptance of our product candidates and ability to identify or discover additional product candidates;
●
our ability to obtain high titers for specific phage cocktails necessary for preclinical and clinical testing;
●
the availability of specialty raw materials and global supply chain challenges;
●
the ability of our product candidates to demonstrate requisite, safety and efficacy for drug products, or safety, purity and potency for biologics without causing adverse effects;
ii
●
the success of expected future advanced clinical trials of our product candidates;
●
our ability to obtain required regulatory approvals;
●
delays in developing manufacturing processes for our product candidates;
●
competition from similar technologies, products that are more effective, safer or more affordable than our product candidates or products that obtain marketing approval before our product candidates;
●
the impact of unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives on our ability to sell product candidates or therapies profitably;
●
protection of our intellectual property rights and compliance with the terms and conditions of current and future licenses with third parties;
●
infringement on the intellectual property rights of third parties and claims for remuneration or royalties for assigned service invention rights;
●
our ability to acquire, in-license or use proprietary rights held by third parties necessary to our product candidates or future development candidates;
●
ethical, legal and social concerns about synthetic biology and genetic engineering that may adversely affect market acceptance of our product candidates;
●
reliance on third-party collaborators;
●
our ability to attract and retain key employees or to enforce the terms of noncompetition agreements with employees;
●
the failure to comply with applicable laws and regulations other than drug manufacturing compliance; and
●
potential security breaches, including cybersecurity incidents.
For a detailed discussion
of these and other risks, uncertainties and factors, see Part I, Item 1A “Risk Factors” of our Annual Report on Form 10-K
for the year ended December 31, 2024. All forward-looking statements contained in this Quarterly Report speak only as of the date hereof.
Except as required by law, we are under no duty to (and expressly disclaim any such obligation to) update or revise any of the forward-looking
statements, whether as a result of new information, future events or otherwise, after the date of this Quarterly Report. Comparisons of
results between current and prior periods are not intended to express any future trends, or indications of future performance, and should
be viewed only as historical data.
iii
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
INDEX TO FINANCIAL STATEMENTS
Page
Condensed Consolidated Balance Sheets as of March 31, 2025 and December 31, 2024 (unaudited)
F-1-F-2
Condensed Consolidated Statements of Operations for the Three Months Ended March 31, 2025 and 2024 (unaudited)
F-3
Condensed Consolidated Statements of Changes in Stockholders’ Equity for the Three Months ended March 31, 2025 and 2024 (unaudited)
F-4-F-5
Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2025 and 2024 (unaudited)
F-6
Notes to Condensed Consolidated Financial Statements (unaudited)
F-7-F-21
1
BIOMX INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(USD in thousands, except share and per share data)
(unaudited)
As of
March 31,
2025
December 31,
2024
ASSETS
Current assets
Cash and cash equivalents
20,116
16,856
Restricted cash
953
958
Other current assets
2,464
2,706
Total current assets
23,533
20,520
Non-current assets
Non-current restricted cash
161
161
Operating lease right-of-use assets
5,209
5,457
Property and equipment, net
4,701
5,045
In-process Research and development asset
12,050
12,050
Total non-current assets
22,121
22,713
45,654
43,233
The accompanying notes are an integral part
of these unaudited condensed consolidated financial statements.
F- 1
BIOMX INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(USD in thousands, except share and per share data)
(unaudited)
As of
March 31,
2025
December 31,
2024
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Trade accounts payable
1,670
1,882
Current portion of lease liabilities
1,141
1,130
Other accounts payable
4,210
5,255
Total current liabilities
7,021
8,267
Non-current liabilities
Operating lease liabilities, net of current portion
8,151
8,454
Other liabilities
79
77
Warrants
5,904
2,287
Total non-current liabilities
14,134
10,818
Commitments and Contingencies (Note 6)
Stockholders’ equity
Preferred Stock, $ 0.0001 par value; Authorized – 1,000,000 shares as of March 31, 2025 and December 31, 2024. Issued and outstanding- 147,735 as of March 31, 2025 and December 31, 2024.
18,645
18,645
Common Stock, $ 0.0001 par value; Authorized – 750,000,000 shares as of March 31, 2025 and December 31, 2024. Issued and outstanding- 24,966,053 shares as of March 31, 2025 and 18,176,661 shares as of December 31, 2024.
7
6
Additional paid in capital
194,203
186,194
Accumulated deficit
( 188,356
)
( 180,697
)
Total stockholders’ equity
24,499
24,148
45,654
43,233
The accompanying notes are an integral part
of these unaudited condensed consolidated financial statements.
F- 2
BIOMX INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(USD in thousands, except share and per share data)
(unaudited)
Three Months Ended
March 31,
2025
2024
Research and development (“R&D”) expenses, net
5,250
4,105
General and administrative expenses
2,506
2,680
Operating loss
7,756
6,785
Other expenses (income)
6
( 88 )
Interest expenses
5
850
Loss (income) from change in fair value of warrants
( 914 )
8,010
Finance expense, net
805
1,765
Loss before tax
7,658
17,322
Tax expenses
1
5
Net loss
7,659
17,327
Basic and diluted loss per share of Common Stock
0.33
2.78
Weighted average number of shares used in computing basic and diluted loss per share of Common Stock
23,103,105
6,229,228
The accompanying notes are an integral part
of these unaudited condensed consolidated financial statements.
F- 3
BIOMX INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN
STOCKHOLDERS’ EQUITY
(USD in thousands, except share and per share data)
(unaudited)
Redeemable
Convertible
Preferred
Shares
Common stock
Additional
paid in
Accumulated
Total
Stockholder’
Shares
Amount
Shares
Amount
capital
deficit
equity
Balance as of January 1, 2025
147,735
18,645
18,176,661
6
186,194
( 180,697 )
24,148
Issuance of Common Stock, Registered Pre-Funded Warrants and Private Pre-Funded Warrants under the February 2025 SPA, net of issuance costs (**)
2,828,283
*
878
878
Issuance of Common Stock under Inducement Letter Agreements (**)
3,961,109
1
6,472
6,473
Stock-based compensation expenses
659
659
Net loss
-
-
-
( 7,659 )
( 7,659 )
Balance as of March 31, 2025
147,735
18,645
24,966,053
7
194,203
( 188,356 )
24,499
(*) Less than $1.
(**) See Note 9A.
The accompanying notes are an integral part
of these unaudited condensed consolidated financial statements.
F- 4
BIOMX INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN
REDEEMABLE CONVERTIBLE
PREFERRED SHARES AND IN STOCKHOLDERS’ EQUITY
(CAPITAL DEFICIENCY)
(USD in thousands, except share and per share data)
(unaudited)
Redeemable
Convertible
Preferred
Shares
Common Stock
Additional Paid in
Accumulated
Total
Stockholders’ Equity
(Capital
Shares
Amount
Shares
Amount
Capital
Deficit
Deficiency)
Balance as of January 1, 2024
-
-
4,723,380
3
166,048
( 162,970 )
3,081
Issuance of Common Stock, Merger Warrants and Redeemable Convertible Preferred Shares upon the APT acquisition, net of issuance cost (**)
40,470
12,561
916,497
1
3,227
-
3,228
Exercise of Pre-Funded Warrants into shares of Common Stock (**)
477,827
*
5
-
5
Issuance of Common Stock under At the Market Sales Agreement, net of $ 1 issuance costs (**)
7,518
*
19
-
19
Stock-based compensation expenses
-
-
909
-
909
Issuance of Redeemable Convertible Preferred Shares upon March 2024 PIPE, net of issuance costs (**)
216,417
19,859
-
-
541
541
Net loss
-
-
( 17,327 )
( 17,327 )
Balance as of March 31, 2024
256,887
32,420
6,125,222
4
170,749
( 180,297 )
( 9,544 )
(*) Less
than $1.
(**) See
Note 9A.
The accompanying notes are an integral part
of these unaudited condensed consolidated financial statements.
F- 5
BIOMX INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(USD in thousands, except share and per share data)
(unaudited)
For the Three Months Ended
March 31,
2025
2024
CASH FLOWS – OPERATING ACTIVITIES
Net loss
( 7,659 )
( 17,327 )
Adjustments required to reconcile cash flows used in operating activities:
Depreciation
236
229
Stock-based compensation
659
177
Finance income, net
( 53 )
( 456 )
Revaluation of contingent consideration
2
( 2 )
Loss (income) from change in fair value of warrants
( 914 )
8,010
Private Placement Warrants issuance cost
-
732
Loss from sale and disposal of fixed assets, net
57
-
Changes in operating assets and liabilities:
Other current assets
242
562
Trade accounts payable
( 212 )
( 1,775 )
Other accounts payable
( 1,076 )
( 122 )
Net change in operating leases
6
( 1,384 )
Net cash used in operating activities
( 8,712 )
( 11,356 )
CASH FLOWS – INVESTING ACTIVITIES
Cash and restricted cash acquired from the APT acquisition
-
663
Proceeds from sale of property and equipment
51
-
Net cash provided by investing activities
51
663
CASH FLOWS – FINANCING ACTIVITIES
Issuance of Common Stock under February 2025 SPA
996
-
February 2025 SPA issuance costs
( 87 )
-
Issuance of Common Warrants under February 2025 SPA
4,531
-
Issuance of Common Stock under Inducement Letter Agreements
6,473
-
Issuance of Private Placement Warrants under March 2024 PIPE
-
28,745
Issuance of Redeemable Convertible Preferred Shares under March 2024 PIPE
-
21,269
March 2024 PIPE issuance costs
-
( 316 )
Pre-Funded Warrants exercise
-
5
Issuance of Common Stock under Open Market Sales Agreement, net of issuance costs
-
19
Repayment of long-term debt
-
( 10,747 )
Net cash provided by financing activities
11,913
38,975
Increase in cash and cash equivalents and restricted cash
3,252
28,282
Effect of exchange rate changes on cash and cash equivalents and restricted cash
3
( 31 )
Cash and cash equivalents and restricted cash at the beginning of the period
17,975
15,864
Cash and cash equivalents and restricted cash at the end of the period
21,230
44,115
RECONCILIATION OF AMOUNTS ON CONSOLIDATED BALANCE SHEETS
Cash and cash equivalents
20,116
43,007
Restricted cash
1,114
1,108
Total cash and cash equivalents and restricted cash
21,230
44,115
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
Cash paid for interest
5
1,419
Taxes paid
1
3
SUPPLEMENTAL DISCLOSURE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
February 2025 SPA issuance costs included in accounts payable
31
-
Property and equipment purchases included in accounts payable and Trade payable
-
17
March 2024 PIPE Issuance cost
-
1,826
Issuance of Common Stock under the APT acquisition
-
3,041
Issuance of Redeemable Convertible Preferred Shares under the APT acquisition
-
12,610
Issuance of Merger Warrants under the APT acquisition
-
200
Issuance cost from the APT acquisition
-
62
The accompanying notes
are an integral part of these unaudited condensed consolidated financial statements.
F- 6
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 1 – GENERAL
A.
General information
BiomX Inc. (individually, and together
with its subsidiaries, BiomX Ltd. (“BiomX Israel”), RondinX Ltd. and Adaptive Phage Therapeutics LLC (“APT”),
the “Company” or “BiomX”) was incorporated in 2017. The Company’s shares of common stock , par value $ 0.0001
per share (“Common Stock”), are traded on the NYSE American under the symbol PHGE.
BiomX is developing both natural and
engineered phage cocktails designed to target and destroy harmful bacteria in chronic diseases, focusing its efforts, at this point, on
cystic fibrosis and diabetic foot osteomyelitis. BiomX discovers and validates proprietary bacterial targets and customizes phage compositions
against these targets. The Company’s headquarters are located in Ness Ziona, Israel.
On March 6, 2024, the Company entered
into an agreement and plan of merger (the “Merger Agreement”) with APT and certain other parties, as a result of which APT
became a wholly-owned subsidiary of the Company (the “Acquisition”), as further described in Note 1D.
On August 8, 2024, the Board of Directors
approved a 1-for-10 reverse stock split of the Company’s shares of Common Stock (the “Reverse Stock Split”), effective
on August 26, 2024. See Note 9A for further information.
B.
The war with Hamas and Hezbollah
On October 7, 2023, an unprecedented attack was launched
against Israel by terrorists from the Hamas terrorist organization that infiltrated Israel’s southern border from the Gaza Strip
and in other areas within the state of Israel attacking civilians and military targets while simultaneously launching extensive rocket
attacks on the Israeli population. These attacks resulted in extensive deaths, injuries and kidnapping of civilians and soldiers. In response,
the Security Cabinet of the State of Israel declared war against Hamas and a military campaign against these terrorist organizations commenced
in parallel to their continued rocket and terror attacks. In addition, Hezbollah, an Islamist terrorist group that controls large portions
of southern Lebanon, and Iran attacked military and civilian targets in Israel, both directly and through proxies such as the Houthi movement
in Yemen, armed groups in Iraq and other terrorist organizations. Additionally, following the fall of the Assad regime in Syria, Israel
has conducted limited military operations targeting certain Syrian military assets, Iranian military assets and infrastructure linked
to Hezbollah and other Iran-supported groups. Although a ceasefire agreement has been reached with Lebanon (with respect to Hezbollah)
there is no assurance that this agreement will be upheld. Military activity and hostilities continue to exist at varying levels of intensity,
and the situation remains volatile, with the potential for escalation into a broader regional conflict involving additional terrorist
organizations and possibly other countries. Furthermore, the fall of the Assad regime in Syria may create additional geopolitical instability
in the region.
BiomX headquarters are located in Ness Ziona, Israel, as
well as its operations. In addition, most of the key employees and officers are residents of Israel. Accordingly, political, economic
and military conditions in Israel and the surrounding region may directly affect its business.
While a few employees of the Company were called to
reserve duty in the Israel Defense Forces, the ongoing war with Hamas and Hezbollah has not, since its inception, materially
impacted BiomX’s business or operations. Furthermore, BiomX does not expect any delays to its programs as a result of the
situation. However, since this is an event beyond the Company’s control, its continuation or cessation may affect our
expectations. The Company continues to monitor its ongoing activities and will make any needed adjustments to ensure continuity of
its business.
F- 7
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 1 – GENERAL (Cont.)
C.
Going concern
The Company has incurred significant
losses and negative cash flows from operations and incurred an accumulated deficit of $ 188,356 as of March 31, 2025. These are expected
to continue in the foreseeable future. The Company plans to continue to fund its ongoing operations, as well as other development activities
relating to additional product candidates, through issuance of debt and/or equity securities, loans, and government grants. Management
believes that its current funds are not sufficient to fund its operations for at least one year from the issuance date of these financial
statements. Increased research and development, clinical, or operating expenses may require additional funding or expense postponement.
The Company’s ability to raise capital is subject to market conditions and other aspects, which may affect the terms and availability
of such funding. These factors raise substantial doubt about the Company’s ability to continue as a going concern. The unaudited
condensed consolidated financial statements have been prepared on a going concern basis and do not include any adjustments that may result
from the outcome of such circumstances.
D.
Merger Agreement
On March 6, 2024, the Company, entered
into the Merger Agreement with BTX Merger Sub I, Inc., a Delaware corporation and a wholly owned subsidiary of the Company (“First
Merger Sub”), BTX Merger Sub II, LLC, a Delaware limited liability company and wholly owned subsidiary of the Company (“Second
Merger Sub”), and APT. Pursuant to the Merger Agreement, First Merger Sub merged with and into APT, with APT being the surviving
corporation and becoming a wholly owned subsidiary of the Company (the “First Merger”). Immediately following the First Merger,
APT merged with and into Second Merger Sub, pursuant to which Second Merger Sub was the surviving entity. APT was a U.S.-based privately
held, clinical-stage biotechnology company pioneering the development of phage-based therapies to combat bacterial infection. As a result
of the Acquisition, the Company has a pipeline that includes two Phase 2 assets each aimed at treating serious infections with unmet medical
needs. See further information regarding the consideration transferred to APT’s former stockholders in Note 9A.
The Acquisition-related transaction
costs were accounted for as expenses in the period in which the costs were incurred. The Company incurred transaction costs of $ 741 during
the three months ended March 31, 2024, which were included in general and administrative expenses in the condensed consolidated statements
of operations.
The unaudited pro forma financial information below
summarizes the combined results of operations for BiomX Inc. (including its wholly owned subsidiaries, BiomX Israel and RondinX
Ltd.) and APT. The unaudited pro forma financial information includes adjustments to reflect certain business combination effects,
including: acquisition-related costs incurred by both parties and reversal of certain costs incurred by BiomX Inc. which would not
have been incurred had the acquisition occurred on January 1, 2023. The unaudited pro forma financial information as presented below
is for informational purposes only and is not necessarily indicative of the results of operations that would have been achieved if
the Acquisition had taken place at the beginning of fiscal 2023.
The following unaudited table provides certain pro forma
financial information for the Company as if the Acquisition occurred on January 1, 2023:
March 31,
2024*
Net loss
16,720
* The
pro forma amounts above are derived from historical numbers of the Company and APT.
F- 8
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES
A. Unaudited Condensed Financial Statements
The accompanying unaudited condensed
consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”)
for condensed financial information. They do not include all the information and footnotes required by GAAP for complete financial statements.
In the opinion of management, all adjustments considered necessary for a fair statement have been included (consisting only of normal
recurring adjustments except as otherwise discussed).
The financial information contained
in this report should be read in conjunction with the annual financial statements included in the Company’s Annual Report on Form
10-K for the fiscal year ended December 31, 2024, that the Company filed with the U.S. Securities and Exchange Commission (the “SEC”)
on March 25, 2025. The year-end balance sheet data was derived from the audited consolidated financial statements as of December 31, 2024.
The significant accounting policies adopted and used in the preparation of the financial statements are consistent with those of the previous
financial year.
B. Principles of Consolidation
The condensed consolidated financial
statements include the accounts of the Company and its subsidiaries. Intercompany balances and transactions have been eliminated upon
consolidation.
C. Use of Estimates in the Preparation of Financial Statements
The preparation of financial
statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets
and liabilities and disclosure of contingent assets and liabilities in the financial statements and the amounts of expenses during
the reported years. The most significant estimates in the Company’s financial statements relate to accruals for research and
development expenses, valuation of stock-based compensation awards and warrants
fair value revaluation. These estimates and assumptions are based on current facts, future expectations, and various other factors
believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying
values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may
differ materially and adversely from these estimates.
The full extent to which Israel’s
war with Hamas and Hezbollah may directly or indirectly impact the Company’s business, results of operations and financial condition
will depend on future developments that are uncertain, as well as the economic impact on local, regional, national and international markets.
D. Basic and diluted loss per share
Basic loss per share is computed by
dividing net loss by the weighted average number of shares of Common Stock outstanding during the period, fully vested warrants with no
exercise price for the Company’s Common Stock and fully vested pre-funded warrants for the Company’s Common Stock at an exercise
price of $ 0.01 per share and $ 0.0001 per share, as well as A&R Warrants (as defined in Note 9A) at an exercise price of $ 0.0001 per
share, as the Company considers these shares to be exercised for little to no additional consideration. Diluted loss per share is computed
by dividing net loss by the weighted average number of shares of Common Stock outstanding during the period, plus the number of shares
of Common Stock that would have been outstanding if all potentially dilutive shares of Common Stock had been issued, using the treasury
stock and if-converted method, in accordance with Accounting Standards Codification (“ASC”) 260-10, “Earnings per Share.”
The Company computes net loss per share
using the two-class method required for participating securities. The two-class method requires income available to common stockholders
for the period to be allocated between shares of Common Stock and participating securities based upon their respective rights to receive
dividends as if all income for the period had been distributed. The Company considers its Redeemable Convertible Preferred Shares to be
participating securities as the holders of the Redeemable Convertible Preferred Shares would be entitled to dividends that would be distributed
to the holders of Common Stock, on a pro-rata basis assuming conversion of all Redeemable Convertible Preferred Shares into shares of
Common Stock. These participating securities do not contractually require the holders of such shares to participate in the Company’s
losses. As such, net loss for the periods presented was not allocated to the Company’s participating securities.
F- 9
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES (Cont.)
E. Recent Accounting Standards
Recently adopted accounting pronouncements
In June 2022, the Financial Accounting
Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2022-03 “Fair Value Measurement of Equity
Securities Subject to Contractual Sale Restrictions” (“ASU 2022-03”). ASU 2022-03 clarifies that a contractual restriction
on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered
in measuring its fair value. ASU 2022-03 also clarifies that an entity cannot, as a separate unit of account, recognize and measure a
contractual sale restriction. ASU 2022-03 also introduces new disclosure requirements for equity securities subject to contractual sale
restrictions. The Company adopted ASU 2022-03 on January 1, 2025 and it did not have a material impact on its consolidated financial statements.
Recently issued accounting pronouncements,
not yet adopted
In December 2023, the FASB issued ASU
2023-09 “Income Taxes (Topic 740): Improvements to Income Tax Disclosures” (“ASU 2023-09”). This guidance is intended
to enhance the transparency and decision-usefulness of income tax disclosures. The amendments in ASU 2023-09 address investor requests
for enhanced income tax information primarily through changes to disclosure regarding rate reconciliation and income taxes paid both in
the U.S. and in foreign jurisdictions. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024 on a prospective basis,
with the option to apply the standard retrospectively. Early adoption is permitted. The Company is currently evaluating this guidance
to determine the impact it may have on its consolidated financial statements disclosures.
In November 2024, the FASB issued ASU 2024-03 “Income
Statement: Reporting Comprehensive Income— Expense Disaggregation Disclosures,” which requires more detailed information about
specified categories of expenses (purchases of inventory, employee compensation, depreciation, amortization, and depletion) included in
certain expense captions presented on the face of the income statement, as well as disclosures about selling expenses. This ASU is effective
for fiscal years beginning after December 15, 2026 and for interim periods within fiscal years beginning after December 15, 2027. Early
adoption is permitted. The amendments may be applied either (1) prospectively to financial statements issued for reporting periods after
the effective date of this ASU or (2) retrospectively to all prior periods presented in the financial statements. The Company is currently
evaluating this guidance to determine the impact it may have on its consolidated financial statements disclosures.
NOTE 3 – FAIR VALUE OF FINANCIAL INSTRUMENTS
The Company accounts for
financial instruments in accordance with ASC 820, “Fair Value Measurements and Disclosures” (“ASC 820”). ASC
820 establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy
gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements)
and the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy under ASC 820
are described below:
Level 1 – Unadjusted quoted prices
in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities.
Level 2 – Quoted prices in non-active
markets or in active markets for similar assets or liabilities, observable inputs other than quoted prices, and inputs that are not directly
observable but are corroborated by observable market data.
Level 3 – Prices or valuations
that require inputs that are both significant to the fair value measurement and unobservable.
There were no changes in the fair value
hierarchy levelling during the three months ended March 31, 2025 and year ended December 31, 2024.
F- 10
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 3 – FAIR VALUE OF FINANCIAL INSTRUMENTS (Cont.)
The following table summarizes the
fair value of our financial assets and liabilities that were accounted for at fair value on a recurring basis, by level within the fair
value hierarchy:
March 31, 2025
Level 1
Level 2
Level 3
Fair Value
Assets:
Cash equivalents:
Money market funds
16,823
-
-
16,823
Liabilities:
Foreign exchange contracts payable
-
24
-
24
Contingent consideration
-
-
79
79
Warrants
-
-
5,904
5,904
-
24
5,983
6,007
December 31, 2024
Level 1
Level 2
Level 3
Fair Value
Assets:
Cash equivalents:
Money market funds
12,251
-
-
12,251
Foreign exchange contracts receivable
-
19
-
19
12,251
19
-
12,270
Liabilities:
Contingent consideration
-
-
77
77
Warrants
2,287
2,287
-
-
2,364
2,364
The changes in the fair value of the
Company’s Level 3 warrants, which are measured on a recurring basis are as follows:
Three Months Ended
March 31,
2025
Three Months Ended
March 31,
2024
Beginning balance
2,287
-
Issuance of Common Warrants
4,531
28,745
Repricing of warrants under the Inducement Letter Agreements (*)
3,300
-
Change in fair value
( 4,214 )
8,010
Ending balance
5,904
36,755
(*) Repricing and exercise of the warrants under the Inducement
Letter Agreements, which was charged to profit and loss. See Note 9A for further information.
The Company determined the fair value
of the liabilities for the warrants using the Black-Scholes model, a Level 3 measurement, within the fair value hierarchy.
The main assumptions used are as follows:
March 31,
2025
March 31,
2024
Underlying value of Common Stock ($)
0.56
4.5
Exercise price ($)
0.93 - 2.31
2.31
Expected volatility (%)
114.2 - 120.7
117.8
Expected terms (years)
1.25 - 5
2.25
Risk-free interest rate (%)
3.9 - 4
4.5
Financial instruments with carrying
values approximating fair value include cash and cash equivalents, restricted cash, other current assets, trade accounts payable and other
accounts payable, primarily due to their short-term nature.
F- 11
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 3 – FAIR VALUE OF FINANCIAL INSTRUMENTS
(Cont.)
The Company determined the fair
value of the liabilities for the contingent consideration based on a probability of discounted cash flow analysis. This fair value
measurement is based on significant unobservable inputs in the market and thus represents a Level 3 measurement within the fair
value hierarchy. The fair value of the contingent consideration is based on several factors, such as: the attainment of future
clinical, developmental, regulatory, commercial and strategic milestones relating to product candidates for treatment of primary
sclerosing cholangitis. The discount rate applied ranged from 3.89 % to 4.27 %. The contingent consideration is evaluated quarterly,
or more frequently, if circumstances dictate. Changes in the fair value of contingent consideration are recorded in consolidated
statements of operations. Significant changes in unobservable inputs, mainly the probability of success and cash flows projected,
could result in material changes to the contingent consideration liability. Changes in contingent consideration for the three months
ended March 31, 2025 and March 31, 2024, resulted from the passage of time and discount rate revaluation.
The Company uses foreign exchange contracts
(mainly options and forward contracts) to hedge cash flows from currency exposure. These foreign exchange contracts are not designated
as hedging instruments for accounting purposes. In connection with these foreign exchange contracts, the Company recognizes gains or losses
that offset the revaluation of the cash flows also recorded under financial expenses (income), net in the condensed consolidated statements
of operations. As of March 31, 2025, the Company had outstanding foreign exchange contracts for the exchange of USD to NIS in the amount
of approximately $ 1,990 with a fair value liability of $ 24 . As of December 31, 2024, the Company had outstanding foreign exchange contracts
for the exchange of USD to NIS in the amount of approximately $ 2,413 with a fair value asset of $ 19 .
NOTE 4 – OTHER CURRENT ASSETS
March 31,
2025
December 31,
2024
Government institutions
127
74
Prepaid insurance
664
959
Other prepaid expenses
349
322
Grants receivable
1,237
1,171
Other
87
180
Other current assets
2,464
2,706
NOTE 5 – OTHER ACCOUNTS PAYABLE
March 31,
2025
December 31,
2024
Employees and related institutions
762
854
Accrued expenses
2,679
3,771
Government institutions
740
630
Other
29
-
4,210
5,255
F- 12
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 6 – COMMITMENTS AND CONTINGENCIES
A. In May 2021, APT entered into a Collaboration and Option Agreement (the “Oyster Agreement”) with Oyster, a wholly owned subsidiary of Viatris Inc., to collaborate on the use of APT’s proprietary phage technology for the treatment of certain ophthalmic diseases. Upon execution of the Agreement, Oyster paid an upfront payment of $ 500 to APT, a portion of which APT claims it has spent in the course of performing its obligations under the Oyster Agreement. In April 2022 and September 2023, APT received letters from Oyster and Viatris Inc. raising concerns about APT’s actions, including allegations that APT had breached the Oyster Agreement. On December 18, 2024, APT and Oyster signed a settlement agreement (the “Settlement Agreement”), which includes a payment of $ 300 from APT to Oyster. On January 13, 2025, APT paid Oyster $ 300 according to the Settlement Agreement.
B. In March 2022, the Israeli Innovation Authority
("IIA") approved an application for a total budget of NIS 13,004 (approximately $ 4,094 ) in relation to the Company’s cystic
fibrosis product candidate. The IIA committed to fund 30 % of the approved budget. The program was for the period beginning January 2022
through December 2022. Through March 31, 2025, the Company received NIS 1,365 (approximately $ 395 ) from the IIA with respect to this program.
See note 12E for funds received after the balance sheet date.
In March 2023, the IIA approved an application for a total budget of NIS 11,283 (approximately $ 3,164 ) in relation to the Company’s cystic fibrosis product candidate. The IIA committed to fund 30 % of the approved budget. The program was for the period beginning January 2023 through December 2023. Through March 31, 2025, the Company received NIS 2,783 (approximately $ 768 ) from the IIA with respect to this program.
According to the agreement with the IIA, BiomX Israel will pay royalties of 3 % to 3.5 % of future sales up to an amount equal to the accumulated grant received including annual interest of the 12-month Secured Overnight Financing Rate (“SOFR”) as published on the first trading day of each calendar year. BiomX Israel may be required to pay additional royalties upon the occurrence of certain events as determined by the IIA, that are within the control of BiomX Israel. No such events have occurred or were probable of occurrence as of the balance sheet date with respect to these royalties. Repayment of the grant is contingent upon the successful completion of the BiomX Israel’s R&D programs and generating sales. BiomX Israel has no obligation to repay these grants if the R&D program fails, is unsuccessful or aborted or if no sales are generated. The Company had not yet generated sales as of March 31, 2025; therefore, no liability was recorded in these condensed consolidated financial statements. IIA grants are recorded as a reduction of R&D expenses, net.
Through March 31, 2025, total grants approved from the IIA aggregated to approximately $ 9,353 (NIS 32,068 ). Through March 31, 2025, the Company had received an aggregate amount of $ 8,003 (NIS 27,423 ) in the form of grants from the IIA. Total grants subject to royalties’ payments aggregated to approximately $ 7,413 . As of March 31, 2025, BiomX Israel had a contingent obligation to the IIA in the amount of approximately $ 8,403 including annual interest of SOFR applicable to dollar deposits.
F- 13
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 7 – U.S. GOVERNMENT CONTRACTS AND GRANTS
In 2019, APT entered into a Base Agreement
and Research Project Award (collectively, the “Agreement”) with the U.S. Army Medical Research Acquisition Activity (“USAMRAA”)
and the U.S. Army Medical Research & Development Command (“USAMRDC”) to advance personalized phage therapy from niche
to broad use. Awards under the Agreement are intended to lay the groundwork for rapid advancement of personalized phage therapy to commercialization
for the variety of clinical indications and bacterial pathogens representing un-met needs with a focus on infections with significant
military relevance. The competitive award was granted by USAMRAA and USAMRDC in collaboration with the Medical Technology Enterprise Consortium
(“MTEC”), a 501(c)(3) biomedical technology consortium working in partnership with the U.S. Department of Defense. Since Agreement
inception, APT entered into certain modifications to the Agreement to include additional activities and perform pre-clinical activities
to advance the Diabetic Foot Osteomyelitis (“DFO”) clinical program. Under the Agreement, MTEC reimburses APT for approved
costs as incurred that are based upon the achievement of certain milestones up to a contract value of $ 36,214 . In September 2024, the
Agreement was amended to extend the period of performance to continue and complete the pre-clinical activities for the DFO clinical program,
which increased the total contract value to $ 39,081 . In conjunction with this Agreement, APT is subject to an assessment fee of an amount
equal up to 3 % of the total funded value of the research project award which should be paid by the Company upon signing the agreement
or the modifications. For the period between the Acquisition and March 31, 2025, the Company received grants of $ 4,121 from MTEC with
respect to the cost reimbursement contract. During the three months ended March 31, 2025, the Company recorded $ 734 as a reduction of
R&D expenses, net. The remainder of the consideration the Company is entitled to receive is recorded as other current assets in the
condensed consolidated financial statements.
NOTE 8 – LONG-TERM DEBT
On August 16, 2021 (the “Closing
Date”), the Company entered into a Loan and Security Agreement (the “Loan Agreement”) with Hercules Capital, Inc. (“Hercules”),
with respect to a venture debt facility. Under the Loan Agreement, $ 15,000 was advanced to the Company on the date the Loan Agreement
was executed.
The Loan Agreement provided that the
Company could prepay advances under the Loan Agreement, in whole or in part, at any time subject to a prepayment charge equal to 1.0 %
after 24 months but prior to 36 months following the Closing Date. Upon prepayment or repayment of all or any of the term loans under
the Term Loan Facility, the Company was required to pay an end of term charge (“End of Term Charge”) equal to 6.55 % of the
total aggregate amount of the term loans being prepaid or repaid. On March 19, 2024, the Company prepaid the entire balance under the
Term Loan Facility in a total of $ 10,428 . The prepayment included the End of Term Charge of $ 983 and accrued interest of $ 69 . The Company
received from Hercules a waiver regarding the prepayment charge that should have been 1 % out of the prepaid principal amount that equals
to $ 94 .
Interest expense relating to the term
loan, which is included in interest expense in the condensed statements of operations was $ 850 for the three months ended March 31, 2024.
F- 14
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 9 – STOCKHOLDERS EQUITY
A. Share Capital:
Reverse Stock Split:
On July 9, 2024, the Company’s stockholders
approved a reverse stock split at a ratio within a range of 1-for-5 and 1-for-10 at such time as the Board of Directors shall
determine, in its sole discretion, at any time before July 9, 2025. On August 8, 2024, the Board of Directors approved a 1-for-10 Reverse
Stock Split of the Company’s shares of Common Stock.
On August 20, 2024, the Company filed
a Certificate of Amendment with the Delaware Secretary of State to effect the Reverse Stock Split, which became effective on August 26,
2024 (the “Effective Date”). The Company’s Common Stock began trading on a Reverse Stock Split adjusted basis on the
NYSE American at the opening of the markets on the Effective Date.
As a result of the Reverse Stock Split,
the number of shares of Common Stock outstanding was reduced from 178,958,447 shares to 18,021,173 shares. No fractional shares
of Common Stock or Units (which are no longer outstanding) were issued in connection with the Reverse Stock Split. Stockholders of the
Company who otherwise were entitled to receive fractional shares or Units, because they held a number of shares or Units, as applicable,
not evenly divisible by the Reverse Stock Split ratio were automatically entitled to receive an additional fraction of a share of the
Common Stock or Unit, as applicable, to round up to the next whole share. As a result, 125,328 shares of Common Stock were issued. The
Reverse Stock Split did not change the par value of the Common Stock nor the authorized number of shares of Common Stock, preferred stock
or any series of preferred stock.
Unless otherwise indicated, all amounts of issued
and outstanding stock contained in the accompanying condensed consolidated financial statements have been adjusted to reflect the 1-for-10
Reverse Stock Split for all prior periods presented. Proportional adjustments were also made to shares underlying outstanding equity
awards, warrants and Redeemable Convertible Preferred Shares, and to the number of shares issued and issuable under the Company’s
stock incentive plans and certain existing agreements.
Preferred Stock:
The Company is authorized to issue 1,000,000
shares of preferred stock with a par value of $ 0.0001 per share with such designations, rights and preferences as may be determined from
time to time by the Company’s Board of Directors.
On March 15, 2024, the Company issued 40,470 and 216,417 Redeemable
Convertible Preferred Shares, par value $ 0.0001 per share, as part of the Acquisition and the March 2024 PIPE, respectively. On July 15,
2024, 109,152 Redeemable Convertible Preferred Shares were converted into 10,915,200 shares of the Company’s Common Stock.
F- 15
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 9 – STOCKHOLDERS EQUITY (Cont.)
Private Investment in Public Equity:
On February 22, 2023, the Company entered
into a Securities Purchase Agreement to issue and sell an aggregate of 1,599,746 shares of its Common Stock and 1,461,072 pre-funded warrants
(the “Pre-Funded Warrants”) at a price of $ 2.45 per share and $ 2.44 per Pre-Funded Warrant in a private placement (the “February
2023 PIPE”). The net proceeds from the PIPE were approximately $ 7,152 , after deducting issuance costs of $ 333 . During the year ended
December 31, 2024, 533,031 Pre-Funded Warrants were exercised into 533,031 shares of Common Stock for total consideration of $ 6 at an
exercise price of $ 0.01 per share of Common Stock, and 928,041 Pre-Funded Warrants were exercised into 925,607 shares of Common Stock
through cashless mechanism with no consideration. As of March 31, 2025, there are no outstanding Pre-Funded Warrants.
On March 15, 2024, the effective date
of the Acquisition as described in Note 1D, the Company issued to APT’s former stockholders 916,497 shares of the Company’s
Common Stock 40,470 Redeemable Convertible Preferred Shares and warrants to purchase up to an aggregate of 216,650 shares of the Company
Common Stock (“Merger Warrants”). Each share of Redeemable Convertible Preferred Shares is convertible into an aggregate of
100 shares of Common Stock. The Merger Warrants became exercisable at any time after the date of the receipt of BiomX stockholder
approval, which was obtained on July 9, 2024, at an exercise price of $ 50.00 per share and will expire on January 28, 2027.
Concurrently with the consummation of
the Acquisition, the Company consummated a private placement (the “March 2024 PIPE”) with certain investors pursuant to which,
such investors purchased an aggregate of 216,417 Redeemable Convertible Preferred Shares (“PIPE Preferred Shares”) and warrants
to purchase up to an aggregate of 10,820,850 shares of the Company’s Common Stock (the “Private Placement Warrants”),
at a combined price of $ 231.10 per PIPE Preferred Share and an accompanying Private Placement Warrant to purchase 50 shares of common
stock. The PIPE Preferred Shares and the Private Placement Warrants were issued in a private placement pursuant to an exemption from registration
requirements under the Securities Act for aggregate gross proceeds of $ 50,000 . Each Private Placement Warrant’s exercise price equals
to $ 2.31 , subject to customary adjustments for stock dividends, stock splits, reclassifications and the like, became exercisable from
the date of the receipt of BiomX stockholder approval, which was obtained on July 9, 2024, and will expire on July 9, 2026. Under certain
circumstances, the Company may be required to pay to each holder of the Private Placement Warrants (i) an amount in cash equal to the
holder’s total purchase price for the shares of Common Stock purchased (the “Buy-In Price”) or credit such holder’s
balance account with the Depository Trust Company (“DTC”) for such shares of Common Stock shall terminate, or (ii) promptly
honor its obligation to deliver to such holder a certificate or certificates representing such shares of Common Stock or credit such holder’s
balance account with DTC, as applicable, and pay cash to such holder in an amount equal to the excess (if any) of the Buy-In Price over
the product of (A) such number of shares of Common Stock, times (B) Weighted Average Price (as defined in the Private Placement Warrant)
on the trading day immediately preceding the exercise date. On February 25, 2025, 6,955,528 Private Placement Warrants were repriced and
exercised under the Inducement Letter Agreements as defined and described below.
The Company accounted for the Private
Placement Warrants as liabilities as the Private Placement Warrants are not considered indexed to the entity’s own stock based on
the provision of ASC 815. The Private Placement Warrants are measured at fair value at inception and in subsequent reporting periods with
changes in fair value recognized in the condensed consolidated statements.
On July 15, 2024, 109,152 Redeemable Convertible
Preferred Shares that were issued under the Acquisition and the March 2024 PIPE were converted into 10,915,200 shares of the Company’s
Common Stock according to beneficial ownership limitations set by certain investors.
F- 16
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 9 – STOCKHOLDERS
EQUITY (Cont.)
In connection therewith, the Company issued
warrants to purchase shares of the Company’s Common Stock to the Placement Agents (the “Agents Warrants”). See Note
9B for further information.
On February 25, 2025, the Company entered
into a Securities Purchase Agreement with certain institutional and accredited investors, pursuant to which the Company agreed to issue
and sell in a registered direct offering (the “February 2025 Registered Direct Offering”) an aggregate of 2,828,283 shares
of the Company’s Common Stock, pre-funded warrants (the “Registered Pre-Funded Warrants”) to purchase up to an aggregate
of 805,231 shares of Common Stock, and in a concurrent private placement (the “February 2025 PIPE”, and together with the
February 2025 Registered Direct Offering, the “February 2025 SPA”), (a) unregistered pre-funded warrants (the “Private
Pre-Funded Warrants”) to purchase up to an aggregate of 2,305,869 shares of Common Stock at an exercise price of $ 0.0001 per share
and (b) unregistered warrants (the “Common Warrants”, and together with the Private Pre-Funded Warrants, the “Private
Warrants”) to purchase up to an aggregate of 5,939,383 shares of Common Stock at an exercise price of $ 0.9306 per share. Each share
of Common Stock (or Registered Pre-Funded Warrant in lieu thereof) and Private Pre-Funded Warrant were sold with an accompanying Common
Warrant. The combined effective purchase price of each share of Common Stock (or Registered Pre-Funded Warrant in lieu thereof) and accompanying
Common Warrant, and of each Private Pre-Funded Warrant and accompanying Common Warrant, is $ 0.9306 . The Common Warrants became exercisable
on the effective date of stockholder approval of the issuance of the shares of Common Stock upon exercise of the Private Warrants (the
“Stockholder Approval Date”), which was obtained on April 21, 2025, and will expire on the five-year anniversary of the Stockholder
Approval Date. The gross proceeds to the Company from the February 2025 SPA were $ 5,527 , before deducting placement agent fees and other
offering expenses payable by the Company of $ 657 .
The Company accounted for the Common
Warrants as liabilities as they are not considered indexed to the entity’s own stock based on the provision of ASC 815. The Common
Warrants will be measured at fair value at inception and in subsequent reporting periods with changes in fair value recognized in the
condensed consolidated statements.
The Company allocated the total consideration
from the February 2025 SPA first to the fair value of the Common Warrants and then to the Company’s Common Stock, Registered Pre-Funded
Warrants and Private Pre-Funded Warrants. The transaction costs were allocated in the same manner as the consideration. Issuance costs
which were allocated to the Common Warrants were $ 539 and were expensed immediately, and issuance costs that were allocated to the Company’s
Common Stock, Registered Pre-Funded Warrants and Private Pre-Funded Warrants were $ 118 and were deducted from Additional paid in capital.
Concurrently with the February 2025
SPA on February 25, 2025, the Company entered into inducement letter agreements (the “Inducement Letter Agreements”) with
certain holders (the “Holders”) of the Company’s Private Placement Warrants issued on March 2024 PIPE, to purchase an
aggregate of 6,955,528 shares of Common Stock, having an original exercise price of $ 2.311 per share (the “Existing Warrants”).
Pursuant to the Inducement Letter Agreements, the Holders agreed to exercise for cash the Existing Warrants at a reduced exercise price
of $ 0.9306 per share in consideration of the Company’s agreement to issue new unregistered warrants (the “Inducement Warrants”)
to purchase up to an aggregate of 6,955,528 shares of Common Stock. Under the Inducement Letter Agreements, the Company issued 3,961,109
shares of Common Stock and amended and restated warrants (the “A&R Warrants”) to purchase up to 2,994,419 shares of Common
Stock at an exercise price of $ 0.0001 per share. The Inducement Warrants have an exercise price of $ 0.9306 per share and became exercisable
on Stockholder Approval Date, which was obtained on April 21, 2025 and will expire on the five-year anniversary of the Stockholder Approval
Date. The benefit from the repricing in the amount of $ 3,300 was recorded as an expense within Loss (income) from change in fair value
of warrants in the condensed consolidated statements of operations. The gross proceeds to the Company from the Existing Warrants exercise
were $ 6,473 prior to deducting placement agent fees and offering expenses of $ 412 .
The terms of the Inducement Warrants
are substantially the same as those of the Common Warrants and were accounted for as liabilities.
At-the-Market Sales Agreement:
In December 2023, pursuant to a registration statement on
Form S-3 declared effective by the SEC on January 2, 2024, the Company entered an At the Market Offering Agreement with H.C. Wainwright
& Co., LLC (“Wainwright”), pursuant to which the Company was able to issue and sell shares of Common Stock having an aggregate
offering price of up to $ 7,500 from time to time through Wainwright. During the three months ended March 31, 2024, the Company sold 7,518
shares of Common Stock under this agreement, at an average price of $ 2.71 per share, raising aggregate net proceeds of approximately $ 19 ,
after deducting an aggregate commission of $ 1 . No sales were made during the three months ended March 31, 2025 under this agreement and
on February 24, 2025, the Company suspended the Open Market Offering Agreement and the related continuous offering by the Company under
its registration statement on Form S-3.
F- 17
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 9 – STOCKHOLDERS EQUITY (Cont.)
Warrants:
As of March 31, 2025, the Company had
the following outstanding warrants to purchase Common Stock issued to stockholders:
Warrant Issuance Date Expiration
Date Exercise
Price
Per Share Number of
Shares of
Common Stock
Underlying
Warrants
2021 Registered Direct Offering Warrants SPA ( July 28, 2021 ) January 28, 2027 50.00 281,251
Merger Warrants March 15, 2024 January 28, 2027 50.00 216,650
Private Placement Warrants March 15, 2024 July 9, 2026 2.31 3,865,322
Registered Pre-Funded Warrants February 25, 2025 April 21, 2030 0.0001 805,231
Private Pre-Funded Warrants February 25, 2025 April 21, 2030 0.0001 2,305,869
Common Warrants February 25, 2025 April 21, 2030 0.9306 5,939,383
Inducement Warrants February 25, 2025 April 21, 2030 0.9306 6,955,528
A&R Warrants February 25, 2025 April 21, 2030 0.0001 2,994,419
23,363,653
B.
Stock-based Compensation:
On March 15, 2024, the Company issued
Agents Warrants to purchase up to an aggregate of 952,381 shares of the Company’s Common Stock to the Placement Agents in connection
with the March 2024 PIPE. The exercise price of the Agents Warrants is $ 2.31 per share and they became exercisable at any time after the
date of the receipt of BiomX stockholder approval, which was obtained on July 9, 2024, and will expire on July 9, 2026.
The Company accounted for the Agents Warrants
under the scope of ASC 718-10 “Stock-Based Payment”, (“ASC 718-10”), and treated them as issuance costs of the
March 2024 PIPE as the Company considers these Warrants as consideration for receipt of Private Placement Services.
F- 18
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 9 – STOCKHOLDERS EQUITY (Cont.)
A
summary of options granted to purchase the Company’s Common Stock under the Company’s share option plans is as follows:
For the Three Months Ended
March 31, 2025
Number of
Options Weighted
Average
Exercise
Price Aggregate
Intrinsic
Value
Outstanding at the beginning of period 2,002,365 4.09 15
Granted -
-
Forfeited ( 45,810 ) 3.63
Expired ( 32,874 ) 2.85
Exercised -
-
Outstanding at the end of period 1,923,681 4.12 11
Exercisable at the end of period 353,482 6.09
Weighted average remaining contractual life of outstanding options – years as of March 31, 2025 8.40
Warrants:
As of March 31, 2025, the Company had
the following outstanding compensation related warrants to purchase Common Stock:
Warrant Issuance
Date Expiration
Date Exercise
Price
Per Share Number of
Shares of
Common Stock
Underlying
Warrants
Private Warrants issued to scientific founders November 27, 2017 -
-
298
Landlord Warrants March 15, 2024 January 28, 2027 50.00 25,000
Agents Warrants March 15, 2024 July 9, 2026 2.31 952,381
977,679
The
following table sets forth the total stock-based payment expenses resulting from options granted, included in the statements of operations:
Three Months Ended
March 31,
2025
2024
Research and development expenses, net
188
65
General and administrative
471
112
659
177
F- 19
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 10 – BASIC AND DILUTED LOSS PER SHARE
Basic loss per share is computed on
the basis of the net loss for the period divided by the weighted average number of shares of Common Stock outstanding during the period,
fully vested warrants with no exercise price for the Company’s Common Stock, fully vested pre-funded warrants for the Company’s
Common Stock at an exercise price of $ 0.01 per share and $ 0.0001 per share and A&R Warrants at an exercise price of $ 0.0001 per share,
as the Company considers these shares to be exercised for little to no additional consideration.
Diluted loss per share is based upon
the weighted average number of shares of Common Stock and of potential shares of Common Stock outstanding when dilutive. Potential shares
of Common Stock equivalents include outstanding stock options and warrants, which are included under the treasury stock method when dilutive.
The calculation of diluted loss per
share for the three months ended March 31, 2025 and March 31, 2024, does not include the shares underlying the following financial instruments
because their effect would be anti-dilutive:
Three Months Ended
March 31,
2025
2024
Options
1,923,681
519,335
Warrants
18,235,515
12,646,131
Contingent shares
200,000
200,000
Redeemable Convertible Preferred Shares
14,773,500
25,688,700
The following table presents the computation
of basic and diluted loss (earnings) per share:
Three Months Ended
March 31,
2025
2024
Basic and diluted loss per share of common stock
Numerator:
Net loss
7,659
17,327
Denominator:
Number of shares of common stock outstanding
20,770,361
5,245,684
Number of shares upon pre-funded warrants and A&R Warrants exercise
2,332,445
983,245
Number of shares upon Fully vested Warrants exercise
298
298
Total weighted-average number of shares of common stock, shares upon pre-funded warrants, A&R Warrants and Fully
vested Warrants exercise used in computing basic and diluted loss per share
23,103,105
6,229,228
Basic and diluted loss per share of common stock
0.33
2.78
F- 20
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 11 – SEGMENT INFORMATION
The Company operates as a single operating
segment, as a clinical stage product discovery company developing products using both natural and engineered phage technologies. The Company's
chief operating decision-maker (“CODM”) is its chief executive officer, who reviews financial information presented on a consolidated
basis. The CODM uses consolidated Net loss and Operating loss to monitor budget versus actual results in assessing segment performance
and the allocation of resources. Significant segment expenses are presented in the Company’s consolidated statements of operations.
Additional disaggregated significant
segment expenses on a functional basis, that are not separately presented on the Company’s consolidated statements of operations,
regularly reviewed by the Company’s CODM, include salaries and clinical trials expenses and presented below.
Three months ended
March 31,
2025
2024
Operating expenses:
Salaries and related expenses, other than share-based compensation
1,977
2,227
Clinical trials
3,626
1,734
Stock based compensation
659
177
Depreciation expenses
236
229
Other segment items (*)
1,258
2,418
Total Operating expenses
7,756
6,785
(*) Other
segment items include all remaining costs necessary to operate the Company’s business, which primarily include external professional
services, rent, insurance and other administrative expenses, and are presented net of grants received.
The Company's Property and equipment, as well as the Company's
operating lease right-of-use assets recognized on the consolidated balance sheets were located as follows:
As of
March 31,
As of
December 31,
2025
2024
Israel
5,791
6,090
United States
4,119
4,412
Total
9,910
10,502
NOTE 12 – SUBSEQUENT EVENTS
A. On April 14, 2025, the Board of Directors approved the grant
of 1,210,114 options to 37 employees, three senior officers and seven directors under the Company’s 2019 Omnibus Long-Term Incentive
Plan (the “2019 Plan”), without consideration. Options were granted at an exercise price of $ 0.54 per share with a vesting
period of four years . Directors and senior officers are entitled to full acceleration of their unvested options upon the occurrence of
both a change in control of the Company and the end of their engagement with the Company.
B. On April 14, 2025, the Company granted 274,890 restricted stock units (“RSUs”)
to three senior officers. The RSUs were fully vested upon issuance and are not subject to continued service with the Company. Each RSU’s
fair value is the Company’s stock closing price as of the grant date, which was $ 0.54 .
C. On April 21, 2025, the Company’s stockholders approved the exercise of the Common Warrants and the
Inducement Warrants into shares of Common Stock of the Company, in accordance with Section 713 of the NYSE American LLC Listed Company
Guide, previously issued in February 2025 SPA and under the Inducement Letter Agreements.
D. From April 1, 2025 through May 11, 2025, 402,008 Private Pre-Funded Warrants
were exercised into 402,008 shares of Common Stock at an exercise price of $ 0.0001 and 533,453 Private Pre-Funded Warrants were exercised
into 533,360 shares of Common Stock through cashless mechanism with no consideration.
E. On May 12, 2025, the Company received the final fee of NIS 1,825 (approximately
$ 515 ) from the IIA in connection with the application approved in March 2022, as described in Note 6B.
F- 21
Item 2. Management’s Discussion and Analysis
of Financial Condition and Results of Operations
References in this Quarterly
Report to “the Company”, “BiomX”, “we”, “us” or “our”, mean BiomX Inc. and
its consolidated subsidiaries unless otherwise expressly stated or the context indicates otherwise.
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 Quarterly Report. The analysis of the financial condition and results of operations includes Adaptive
Phage Therapeutics LLC, a Delaware limited liability company (formerly Adaptive Phage Therapeutics Inc., a Delaware corporation), or APT,
from the date that we acquired it on March 15, 2024. 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 discussed in this Quarterly Report and in our other filings with the U.S. Securities
and Exchange Commission, or the SEC.
General
We are a clinical stage product
discovery company developing products using both natural and engineered phage technologies designed to target and kill specific harmful
bacteria associated with chronic diseases, such as cystic fibrosis, or CF and diabetic foot osteomyelitis, or DFO. 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.
Based on the urgency of treating
the infection (whether acute or chronic), the susceptibility of the target bacteria to phage (e.g. the ability to identify a phage cocktail
that would target a broad range of bacterial strains) and other considerations, we offer two phage-based product types:
(1)
Fixed cocktail therapy – in this approach a single product containing a fixed number of selected phage is developed to cover a wide range of bacterial strains, thus allowing treatment of broad patient populations with the same product. Fixed cocktails are developed using our proprietary BOLT platform, in which high throughput screening, directed evolution, and bioinformatic approaches are leveraged to produce an optimal phage cocktail.
(2)
Personalized therapy – in this approach a large library of phage is developed, of which a single optimal phage is personally matched to treat specific patients. Matching optimal phage with patients is carried out using a proprietary phage susceptibility testing, where multiple considerations are analyzed simultaneously – allowing for an efficient screen of the phage library while maintaining short turnaround times.
In our therapeutic programs,
we focus on using phage therapy to target specific strains of pathogenic bacteria that are associated with diseases. Our phage-based product
candidates are developed utilizing our proprietary research and development platform named BOLT. The BOLT platform is unique, employing
cutting edge methodologies and capabilities across disciplines including computational biology, microbiology, synthetic engineering of
phage and their production bacterial hosts, bioanalytical assay development, manufacturing and formulation, to allow agile and efficient
development of natural or engineered phage combinations, or cocktails. The cocktail contains phage with complementary features and is
optimized for multiple characteristics such as broad target host range, ability to prevent resistance, biofilm penetration, stability
and ease of manufacturing.
Our goal is to develop multiple
products based on the ability of phage to precisely target harmful bacteria and on our ability to screen, identify and combine different
phage, both naturally occurring and created using synthetic engineering, to develop these treatments.
2
On March 6, 2024, we entered
into a merger agreement with APT and certain other parties, as a result of which APT became our wholly-owned subsidiary, effective as
of March 15, 2024, or the Acquisition. The Acquisition was structured as a stock-for-stock transaction whereby all outstanding equity
interests of APT were exchanged in a merger for an aggregate of 9,164,968 shares of BiomX common stock, 40,470 shares of Series X Preferred
Stock, or Redeemable Convertible Preferred Shares, convertible upon stockholder approval into 4,047,000 shares of BiomX common stock,
and warrants, or the Merger Warrants, exercisable for 216,650 shares of BiomX common stock. Upon the consummation of the Acquisition,
a successor-in-interest of APT became a wholly-owned subsidiary of BiomX.
Clinical and Pre-Clinical Developments
Ongoing Programs
Cystic Fibrosis
BX004 is our therapeutic phage
product candidate under development for chronic pulmonary infections caused by Pseudomonas aeruginosa, or P. aeruginosa, a main contributor
to morbidity and mortality in patients with CF. Enhanced resistance to antibiotics develops, particularly in CF patients, due to extensive
drug use consisting of prolonged and repeated broad-spectrum antibiotic courses often beginning in childhood, and leading to the appearance
of multidrug-resistant strains. In preclinical in vitro studies, BX004 was shown to be active against antibiotic resistant strains of
P. aeruginosa and demonstrated the ability to penetrate biofilm, an assemblage of surface-associated microbial cells enclosed in an extracellular
polymeric substance and one of the leading causes for antibiotic resistance.
The Phase 1b/2a trial in CF
patients with chronic respiratory infections caused by P. aeruginosa. is comprised of two parts. The study design is based on recommendations
from the Cystic Fibrosis Therapeutic Development Network.
In February 2023, we
announced positive results from Part 1 of the Phase 1b/2a trial evaluating BX004. Part 1 evaluated the safety, tolerability, pharmacokinetics,
and microbiologic activity of BX004 over a 7-day ascending treatment period in nine CF patients (7 on BX004, 2 on placebo) with chronic
P. aeruginosa pulmonary infection in a single ascending dose and multiple dose design.
Results from Part 1 of the
Phase 1b/2a trial included the following findings: No safety events related to treatment with BX004 occurred; Mean P. aeruginosa colony
forming units, at Day 15 (compared to baseline): -1.42 log (BX004) vs. -0.28 log (placebo). This reduction was seen on top of standard
of care inhaled antibiotics; Phage were detected in all patients treated with BX004 during the dosing period, including in several patients
up to Day 15 (one week after end of therapy); no phage were detected in patients receiving placebo; there was no evidence of treatment-related
resistance to BX004 during or after treatment, compared to placebo; and as expected due to the short duration of treatment, there was
no detectable effect on % predicted forced expiratory volume in 1 second, or FEV1.
In November 2023, we announced
positive topline results from Part 2 of the Phase 1b/2a trial evaluating BX004. The objectives of Part 2 of the Phase 1b/2a trial were
to evaluate the safety and tolerability of BX004 in a larger number of CF patients dosed for a longer treatment duration than Part 1 of
the study. In Part 2, 34 CF patients were randomized in a 2:1 ratio with 23 CF patients receiving BX004 and 11 patients receiving placebo
via nebulization twice daily for 10 days.
3
Highlights from the Part 2
data of the Phase 1b/2a study included:
●
Study drug was safe and well-tolerated, with no related SAEs (serious adverse events) or related APEs (acute pulmonary exacerbations) to study drug.
●
In the BX004 arm, 3 out of 21 (14.3%) patients converted to sputum culture negative for P. aeruginosa after 10 days of treatment (including 2 patients after 4 days) compared to 0 out of 10 (0%) in the placebo arm (In patients that had quantitative colony-forming unit levels at study baseline).
●
BX004 vs. placebo showed a clinical effect in a predefined subgroup of patients with reduced baseline lung function (FEV1<70%). Difference between groups at Day 17: relative FEV1 improvement of 5.67% (change from baseline +1.46 vs. -4.21) and +8.87 points in CFQR respiratory symptom scale (change from baseline +2.52 vs. -6.35).
In August 2023, the FDA granted
BX004 Fast Track designation for the treatment of chronic respiratory infections caused by P. aeruginosa bacterial strains in patients
with CF. In addition, in December 2023, BX004 received orphan drug designation from the FDA.
BiomX expects to initiate
a randomized, double blind, placebo-controlled, multi-center Phase 2b study in CF patients with chronic P. aeruginosa pulmonary infections
in the second quarter of 2025. The study is designed to enroll approximately 60 patients randomized at a 2:1 ratio to BX004 or placebo.
Treatment is expected to be administered via inhalation twice daily for a duration of 8 weeks. The study is designed to monitor the safety
and tolerability of BX004 and is designed to demonstrate improvement in microbiological reduction of P. aeruginosa burden and evaluation
of effects on clinical parameters such as lung function measured by FEV1 and patient reported outcomes. During the third quarter of 2024,
we experienced manufacturing delays for BX004. As a result of these delays, study results are now expected in the first quarter of 2026.
BiomX has been in communication
with the FDA and additional regulatory agencies regarding the potential to use Real-World Evidence, or RWE, to explore the link between
P. aeruginosa reduction and improved clinical outcomes. RWE is clinical evidence on the usage, benefits, or risks of a medical product
derived from real-world data, which includes sources such as electronic health records, claims data, patient registries, wearable devices,
and observational studies. We anticipate further discussion with the FDA and European Committee for Medicinal Products for Human Use in
2025 to discuss our proposed plan to use RWE to support potential future regulatory filings.
BX211
– Treatment of Diabetic Foot Osteomyelitis, or DFO
BX211 is a phage therapy for
the treatment of DFO associated with Staphylococcus aureus, or S. aureus, a bacterium associated with the development and exacerbation
of inflammation in atopic dermatitis. The phage treatment tailors a specific phage selected from a proprietary phage-bank according to
the specific strain of S. aureus biopsied and isolated from each patient. DFO is a bacterial infection of the bone that usually develops
from an infected foot ulcer and is a leading cause of amputation in patients with diabetes. We believe that scientific literature demonstrating
the potential benefit in treating osteomyelitis using phage in animal models as well as numerous successful compassionate cases using
phage therapy to treat DFO patient support our approach of using phage therapy to treat DFO.
4
In March 2025, we announced
positive results from the phase 2 trial evaluating BX211 for the treatment of DFO, or the DFO Trial. The DFO Trial is a randomized, double-blind,
placebo-controlled, multi-center study investigating the safety, tolerability, and efficacy of BX211 to treat individuals with DFO associated
with S. aureus. The DFO Trial enrolled a total of 41 patients randomized for treatment at a 2:1 ratio, 26 of whom received intravenous,
or IV, and topical administration of BX211 on week 1 followed by a topical weekly dose through week 12, while 15 patients were assigned
to the placebo arm. Over the 12-week treatment period, all subjects (treatment and placebo) were also treated in accordance with standard
of care, including with systemic antibiotic therapy as appropriate. A readout of the DFO Trial results at week 13 evaluated healing of
the wound associated with osteomyelitis. The primary efficacy endpoint was percent area reduction, or PAR, of study ulcer through week
13. Study design was guided in part by experience with numerous compassionate cases using phage therapy for the treatment of DFO and osteomyelitis.
Results from the DFO Trial
findings included:
● BX211 was found to be safe and well-tolerated.
● BX211 produced sustained and statistically significant
PAR of ulcer size (p = 0.046 at week 12; p=0.052 at week 13), with a separation from placebo (standard of care) starting at week 7 and
a difference greater than 40% by week 10.
● BX211 produced statistically significant improvements
in both ulcer depth at week 13 (in patients with ulcer depth defined as bone at baseline) (p=0.048), and in reducing the expansion of
ulcer area (p=0.017), compared to placebo.
● BX211 demonstrated favorable trends compared
to placebo across several additional clinical parameters, including: proportion of visits with no clinical evidence of infection; evidence
of resolving DFO by MRI/X-ray at week 12; proportion of patients with abnormal C-Reactive Protein, or CRP, at baseline that achieved a
reduction of CRP of at least 50% at any point in the study; and greater Wagner scale improvement. The Wagner Scale is a clinical grading
system used to classify the severity of diabetic foot ulcers, ranging from 0 (intact skin) to 5 (extensive gangrene).
● Through week 13, BX211 demonstrated comparable
efficacy against both Methicillin-susceptible and resistant strains, as well as against high and low biofilm producers—consistent
with the orthogonal mechanism of phage therapy to antibiotics and its inherent anti-biofilm capabilities.
All p-values described in the above
DFO Trial are non-adjusted.
BiomX is planning for a phase
2/3 trial of BX211, pending FDA feedback and availability of cash resources.
Non-CF Bronchiectasis, or NCFB
Chronic P. aeruginosa infections
in NCFB patients are a main contributor to morbidity and mortality in this disease. Pending positive data of BX004 in our cystic fibrosis
Phase 2B study, we expect to look to initiate studies into NCFB as an additional indication for BX004.
National Institutes of Health, or NIH, study
in Cystic Fibrosis
We are supporting a study
conducted by the NIH and The Antibacterial Resistance Leadership Group targeting P. aeruginosa infections in CF patients under FDA emergency
Investigational New Drug allowance. Phase 1b/2, multi-centered, randomized, double-blind, placebo-controlled trial is assessing the safety
and microbiological activity of a single IV dose of bacteriophage therapy in cystic fibrosis subjects colonized with P. aeruginosa.
5
Programs on hold
Prosthetic Joint Infections, or PJI
Our personalized phage therapy
for treating PJI targets multiple bacterial organisms such as Staphylococcus aureus, Staphylococcus epidermidis and Enterococcus faecium.
This treatment was granted Orphan-drug designation by the FDA in July 2020. As of the date of this Quarterly Report, we have paused development
efforts of this program due to prioritizing resources towards our CF and DFO programs, and we cannot provide guidance on resuming its
development.
Discontinued programs
BX005 – Treatment of Atopic Dermatitis,
or AD
BX005 is our topical
phage product candidate targeting S. aureus. S. aureus is more abundant on the skin of AD patients than on the skin of healthy
individuals and on lesional skin than non-lesional skin. It also increases in abundance, becoming the dominant bacteria, when
patients experience flares. By reducing the load of S. aureus , BX005 is designed to shift the skin microbiome
composition to its ‘pre-flare’ state and potentially provide a clinical benefit. In preclinical in vitro studies,
BX005 was shown to eradicate over 90% of strains, including antibiotic resistant strains, from a panel of S. aureus strains
(120 strains isolated from skin of subjects from the U.S. and Europe). On April 8, 2022, the FDA approved the Company’s
Investigational New Drug (IND) application for BX005.
In 2024, we discontinued
the development of BX005, choosing instead to focus our resources on our Cystic Fibrosis and DFO programs.
Consolidated Results of Operations
Comparison of the Three Months Ended March
31, 2025 and March 31, 2024
The following table summarizes
our consolidated results of operations for the three months ended March 31, 2025 and March 31, 2024:
Three Months ended
March 31,
2025
2024
USD in thousands
Research and development (“R&D”) expenses, net
5,250
4,105
General and administrative expenses
2,506
2,680
Operating loss
7,756
6,785
Other expenses (income)
6
(88 )
Interest expenses
5
850
Loss (income) from change in fair value of warrants
(914 )
8,010
Finance expense, net
805
1,765
Loss before tax
7,658
17,322
Tax expenses
1
5
Net loss
7,659
17,327
Basic and diluted loss per share of Common Stock
0.33
2.78
Weighted average number of shares used in computing basic and diluted loss per share of Common Stock
23,103,105
6,229,228
6
R&D expenses, net (net
of grants received from the Medical Technology Enterprise Consortium (“MTEC”) were $5.2 million for the three months ended
March 31, 2025, compared to $4.1 million for the same period in 2024. The increase of $1.1 million, or 27%, is primarily due to the following
factors:
●
preparations for Phase 2b in the clinical trial of our CF product candidate, BX004;
●
an increase in expenses relating to the DFO Trial; and
●
an increase in rent and related expenses following the APT Acquisition.
The increase was partly offset
by decreased salaries and share-based compensation expenses due to workforce reduction, as well as higher grants received. During the
three months ended March 31, 2025, the Company recorded $0.7 million of MTEC grants, compared to $0.2 million grants recorded in the same
period in 2024.
General and
administrative expenses were $2.5 million for the three months ended March 31, 2025, compared to $2.7 million for the same period in
2024. The decrease of $0.2 million, or 7%, is primarily due to expenses incurred during 2024 in connection with the Acquisition
completed in March 2024. Such decrease was partly offset by increased salaries and share-based compensation expenses.
Other expenses were $6,000
for the three months ended March 31, 2025, compared to Other income of $88,000 for the same period in 2024. The decrease in other income
resulted primarily from the termination of a sublease agreement for a portion of our office space in Ness Ziona, Israel.
Interest expenses were $5,000
for the three months ended March 31, 2025, compared to $850,000 for the three months ended March 31, 2024. The decrease of $845,000, or
99%, is due to repayment of the loan under the Loan and Security Agreement, or the Hercules Loan Agreement, with Hercules Capital, Inc.,
or Hercules, in March 2024. Interest in the 2025 period was related to an existing loan to APT from the U.S. Small Business Administration.
Income from change in fair
value of warrants was $0.9 million for the three months ended March 31, 2025, compared to a loss of $8 million for the three months ended
March 31, 2024. The increase of $8.9 million, or 111%, is primarily attributed to the revaluation resulting from the accounting treatment
of the Company’s warrants that are classified as a liability, as well as to the issuance of warrants under the February 2025 Financing,
as such term is defined below.
Finance expense, net, was
$0.8 million for the three months ended March 31, 2025, compared to $1.8 million for the three months ended March 31, 2024, and primarily
consisted of transaction costs incurred in connection with the February 2025 Financing and the March 2024 PIPE, respectively.
Basic and diluted loss per
share of Common Stock was $0.33 for the three months ended March 31, 2025, compared to $2.78 for the three months ended March 31,
2024. The decrease of $2.45 was primarily attributable to a lower net loss and an increase in the weighted average number of shares of
Common Stock outstanding due to share issuances under the February 2025 Financing.
7
Liquidity and Capital Resources
We believe our cash, cash
equivalents and restricted cash on hand will be sufficient to meet our working capital and capital expenditure requirements into the first
quarter of 2026. We currently plan to continue to focus primarily on the development of BX004, our product candidate for treating CF and
BX211, our product candidate for treating DFO. Although we recently completed the February 2025 Financing and before then the March 2024
PIPE, we will likely require additional funds to support our operating expenses and capital requirements. Accordingly, we have implemented
cost cutting measures, and are exploring and expect to further explore, raising such additional funds through public or private equity,
debt financing, loans, government or other grants or collaborative agreements or from other sources. If we are unable to obtain adequate
financing or financing on terms satisfactory to us, when we require it, our ability to continue to grow or support our business and to
respond to business challenges could be significantly limited. If there are increases in operating costs for facilities expansion, research
and development and clinical activity, we will need to use mitigating actions such as to seek additional financing or postpone expenses
that are not based on firm commitments. If certain disruptions due to, for instance, the war with Hamas and Hezbollah, or 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. As a result of these factors, management believes that
there is substantial doubt as to the Company’s ability to continue as a going concern.
Cash Flows
The following table summarizes
our sources and uses of cash for the three months ended March 31, 2025 and 2024:
Three Months Ended
March 31,
2025
2024
USD in thousands
Net cash used in operating activities
(8,712 )
(11,356 )
Net cash provided by investing activities
51
663
Net cash provided by financing activities
11,913
38,975
Net increase in cash and cash equivalents
3,252
28,282
Effect of exchange rate changes on cash and cash equivalents and restricted cash
3
(31 )
Operating Activities
Net cash used in operating
activities for the three months ended March 31, 2025 was $8.7 million, primarily driven by our R&D, general and administrative expenses,
as well as changes in our operating assets and liabilities of $1.0 million. Non-cash charges for the three months ended March 31,
2025 consisted primarily of income from change in fair value of warrants of $0.9 million, stock-based compensation expenses of 0.7 million
and depreciation expenses of $0.2 million. Net changes in our operating assets and liabilities consisted primarily of a decrease in trade
accounts payable of $0.2 million, as well as a decrease in other accounts payable of $1.1 million and a decrease in other current assets
of $0.2 million.
Net cash used in operating
activities for the three months ended March 31, 2024 was $11.4 million, primarily due to a net loss of $17.3 million, mostly due to our
R&D, general and administrative expenses, and due to changes in our operating assets and liabilities of $2.7 million. This was
partly offset by non-cash charges of $8.7 million. Non-cash charges for the three months ended March 31, 2024 consisted primarily of loss
from change in fair value of warrants of $8.0 million and Private Placement Warrants issuance cost in amount of $0.7 million. Net changes
in our operating assets and liabilities consisted primarily of a decrease in trade accounts payable of $1.8 million and net change in
operating lease of $1.4 million. Such decrease was partly offset by the change in other current and non-current assets of $0.6 million.
Investing Activities
During the three months ended
March 31, 2025, net cash provided by investing activities was $0.1 million, mainly consisting of proceeds from sale of property and equipment.
During the three months ended
March 31, 2024, net cash provided by investing activities was $0.7 million, consisting of cash and restricted cash acquired from the Acquisition.
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 options 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 record gains or losses that offset the revaluation of the balance sheet items under financial
income, net in our condensed consolidated statements of operations. As of March 31, 2025, we had outstanding foreign exchange contracts
for the exchange of USD to NIS in the amount of approximately $2.0 million with a fair value liability of $24,000. As of March 31, 2024,
we had outstanding foreign exchange contracts for the exchange of USD to NIS in the amount of approximately $1.7 million with a fair value
asset of $0.1 million.
8
Financing Activities
During the three months ended
March 31, 2025, net cash provided by financing activities was $11.9 million, mainly consisting of the issuance of Common Stock and warrants
under the February 2025 Financing as well as exercise of warrants.
During the three months ended
March 31, 2024, net cash provided by financing activities was $39.0 million, mainly consisting of the issuance of Redeemable Convertible
Preferred Shares and the Private Placement Warrants in the March 2024 PIPE in the amount of $21.3 million and $28.7 million, respectively.
This was partially offset by the prepayment of the long-term debt in the amount of $10.7 million.
On March 19, 2024, we prepaid the entire balance
due under the Hercules Loan Agreement of $10,428,000. The prepayment included an end of term charge of $983,000 and accrued interest of
$69,000. We received a waiver regarding the prepayment charge that should have been 1% out of the prepaid principal amount, equaling $94,000.
On December 7, 2023, we filed a shelf registration
statement on Form S-3, which was declared effective by the SEC on January 2, 2024. In addition, on December 7, 2023, we entered into an
At the Market Offering Agreement, or the 2023 ATM Agreement, with H.C. Wainwright & Co., LLC, or Wainwright, with Wainwright as manager,
pursuant to which we may issue and sell shares of our Common Stock having an aggregate offering price of up to $7.5 million from time
to time through Wainwright. We are not obligated to make any sales of Common Stock under the 2023 ATM Agreement. On February 24, 2025,
we suspended the ATM Agreement and the related continuous offering by us under an effective registration Statement on Form S-3. We may
resume use of the ATM Agreement in the future.
On March 15, 2024, concurrently
with the consummation of the Acquisition, we consummated the March 2024 PIPE with existing and new investors, resulting in aggregate gross
proceeds of approximately $50 million, in which the investors purchased (i) an aggregate of 216,417 Redeemable Convertible Preferred Shares,
convertible upon stockholder approval, which was obtained on July 9, 2024, into an aggregate of up to 21,641,700 shares of BiomX common
stock, and (ii) the Private Placement Warrants, to purchase up to an aggregate of 10,820,850 shares of BiomX common stock, at a combined
purchase price of $231.10 per share of Series X Preferred Stock and an accompanying Private Placement Warrant to purchase 50 shares of
BiomX common stock. The Private Placement Warrants are exercisable at an exercise price of $2.311 per share and will expire on July 9,
2026.
On February 25, 2025, we entered
into a Securities Purchase Agreement with certain investors, pursuant to which we agreed to issue and sell, (i) in a registered direct
offering, or the February 2025 Registered Direct Offering): (a) an aggregate of 2,828,283 shares of our Common Stock, and (b) pre-funded
warrants, or the Registered Pre-Funded Warrants, to purchase up to an aggregate of 805,231 shares of Common Stock, and (ii) in a concurrent
private placement, or the February 2025 PIPE and together with the February 2025 Registered Direct Offering, the February 2025 SPA, (a)
unregistered pre-funded warrants, or the Private Pre-Funded Warrants, to purchase up to an aggregate of 2,305,869 shares of Common Stock,
and (b) unregistered warrants, or the Common Warrants, to purchase up to an aggregate of 5,939,383 shares of Common Stock. Each Share
(or Registered Pre-Funded Warrant in lieu thereof) and Private Pre-Funded Warrant were sold with an accompanying Common Warrant. The
combined effective purchase price of each Share (or Registered Pre-Funded Warrant in lieu thereof) and accompanying Common Warrant, and
of each Private Pre-Funded Warrant and accompanying Common Warrant, is $0.9306. The gross proceeds to the Company from the February 2025
SPA were $5.5 million, before deducting placement agent fees and other offering expenses payable by the Company of $0.7 million. Through
May 11, 2025, 402,008 Private Pre-Funded Warrants were exercised into 402,008 shares of Common Stock at an exercise price of $0.0001
and 533,453 Private Pre-Funded Warrants were exercised into 533,360 shares of Common Stock through cashless for no additional consideration.
In addition, on February
25, 2025, we entered into inducement letter agreements, or the Inducement Letter Agreements, with certain holders, or the Holders,
of certain of their existing warrants to purchase an aggregate of 6,955,528 shares of Common Stock, originally issued to the Holders
on under the March 2024 PIPE, having an original exercise price of $2.311 per share, or the Existing Warrants. The shares of Common
Stock issued upon the exercise of the Existing Warrants are registered pursuant to an effective Registration Statement on Form S-3.
Pursuant to the Inducement Letter Agreements, the Holders agreed to exercise for cash the Existing Warrants at a reduced exercise
price of $0.9306 per share, or the February 2025 Warrant Exercise, in consideration of our agreement to issue new unregistered
warrants, or the Inducement Warrants, to purchase up to an aggregate of 6,955,528 shares of Common Stock at an exercise price of
$0.9306 per share. In connection with the February 2025 Warrant Exercise, we agreed that, in the event that any February 2025
Warrant Exercise would otherwise require the Company to issue a number of shares of Common Stock in excess of the number of shares
of Common Stock that the Holder may acquire without exceeding the beneficial ownership limitations, or the Beneficial Ownership
Limitation, set forth in the Existing Warrants (or, if applicable and at the Holder’s election, 9.99%) (such excess shares,
the Excess Existing Warrant Shares), (i) the Company shall issue to the Holder the maximum number of Existing Warrant Shares that
the Holder is entitled to receive without exceeding the Beneficial Ownership Limitation, as directed by the Holder, and (ii) in lieu
of issuing any Excess Existing Warrant Shares, (x) the Existing Warrant shall automatically be amended and restated in its entirety
as set in the Letter Agreement, or, following such amendment, the Amended and Restated Warrant. The gross proceeds to the Company
from the February 2025 Warrant Exercise were $6.5 million prior to deducting placement agent fees and offering expenses of $0.4
million. We refer to the February 2025 Warrant Exercise and the February 2025 SPA, as the February 2025 Financing.
9
Outlook
We have accumulated a deficit
of $188.4 million since our inception. To date, we have not generated revenue from our operations, and we do not expect to generate any
significant revenues from sales of products in the next twelve months. Our cash needs may increase in the foreseeable future. We expect
to generate revenues from the sale of licenses to use our technology or products, but in the short and medium terms any amounts generated
are unlikely to exceed our costs of operations. According to our estimates and based on our current operating plans, our liquidity resources
as of March 31, 2025, which consisted primarily of cash, cash equivalents and restricted cash of approximately $21.2 million will be sufficient
to fund our operations into the first quarter of 2026.
Consistent with our ongoing
R&D activities, we expect to continue to incur additional losses in the foreseeable future. To the extent we require funds above our
existing liquidity resources in the medium and long term, we plan to fund our operations, as well as other development activities relating
to additional product candidates, through future issuances of public or private equity, issuance of debt securities, loans, and possibly
additional grants from the Israeli Innovation Authority, or IIA, MTEC or other government or non-profit institutions. Our ability to raise
additional capital in the equity and debt markets is dependent on a number of factors including, but not limited to, the 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 us.
Item 3. Quantitative and Qualitative Disclosures
About Market Risk
As a smaller reporting company,
we are not required to make disclosures under this Item.
Item 4. Controls and Procedures
We maintain disclosure controls
and procedures (as that term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) that are designed to ensure that information
required to be disclosed by us in our Exchange Act reports is recorded, processed, summarized, and reported within the time periods specified
in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal
executive officer and principal financial officer or persons performing similar functions, as appropriate to allow timely decisions regarding
required disclosure.
Evaluation of Disclosure Controls and Procedures
Our management, with the
participation of our principal executive officer and principal financial officer, conducted an evaluation, as of the end of the
period covered by this Quarterly Report, of the effectiveness of our disclosure controls and procedures, as such term is defined in
Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based on this evaluation, our principal executive officer and principal
financial officer have concluded that our disclosure controls and procedures were effective as of March 31, 2025.
Changes in Internal Control over Financial
Reporting
There has been no change in
our internal control over financial reporting, as that term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act, during
the quarter ended March 31, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over
financial reporting.
10
PART II - OTHER INFORMATION
Item 6. Exhibits
No.
Description of Exhibit
3.1
Composite Copy of Amended and Restated Certificate of Incorporation of the Company, as amended to date (Incorporated by reference to Exhibit 3.1 to the Company’s Quarterly Report on Form 10-Q filed by the Company on November 14, 2024).
3.2
Amended and Restated Bylaws of the Company, as amended on April 11, 2024 (Incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed by the Company on April 15, 2024)
31.1*
Certification of Principal Executive Officer pursuant to Rule 13a-14 and Rule 15d-14(a)
31.2*
Certification of Principal Financial Officer pursuant to Rule 13a-14 and Rule 15d-14(a)
32**
Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350
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.
104*
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
*
Filed herewith.
**
Furnished herewith.
11
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
BIOMX INC.
Date: May 15, 2025
By:
/s/ Jonathan Solomon
Name:
Jonathan Solomon
Title:
Chief Executive Officer
(Principal Executive Officer)
Date: May 15, 2025
By:
/s/ Marina Wolfson
Name:
Marina Wolfson
Title:
Chief Financial Officer
(Principal Financial Officer and
Principal Accounting Officer)
12
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.