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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Form 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934
Date of Report (Date of earliest event reported):
December 8, 2025
| BiomX Inc. |
| (Exact Name of Registrant as Specified in its Charter) |
| Delaware |
|
001-38762 |
|
82-3364020 |
(State or other jurisdiction
of incorporation) |
|
(Commission File Number) |
|
(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
| n/a |
| (Former name or former address, if changed since last report) |
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on which registered |
| Common Stock, $0.0001 par value |
|
PHGE |
|
NYSE American |
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the
Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01 Other Events.
As
previously reported, on November 25, 2025, BiomX Inc. (“BiomX” or the “Company”) announced that an independent
Data Monitoring Committee (“DMC”) completed a safety review and recommended continuation of the Company’s Phase 2b clinical
trial (the “Study”) that is designed to test the Company’s drug candidate BX004 (“BX004”) in treating Cystic
Fibrosis (“CF”) with an adjusted dosing regimen.
On
December 8, 2025, BiomX announced its discontinuation of the ongoing Study with CF associated with chronic Pseudomonas aeruginosa infections.
After evaluating the projected timelines and resources required to proceed with an alternative dosing strategy as was recommended by the
DMC, the Company determined that such requirements were beyond the Company’s available resources, leading to the decision to discontinue
the program. The Company is also taking cost-cutting measures, including a significant reduction of its workforce. Subject to availability
of sufficient financial and other resources, BiomX will now focus on advancing its bacteriophage-based therapeutics, particularly BX011
for diabetic foot infections. Simultaneously, the Company is reviewing other strategic alternatives.
Forward-Looking Statements
This
Current Report contains express or implied “forward-looking statements” within the meaning of the “safe harbor”
provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as:
“target,” “believe,” “expect,” “will,” “may,” “anticipate,” “estimate,”
“would,” “positioned,” “future,” and other similar expressions that predict or indicate future events
or trends or that are not statements of historical matters. For example, when BiomX refers to its focus on BX011, implications of conducting
a significant reduction of BiomX’s workforce, sufficiency of financial and other resources, and potential strategic alternatives,
it is using forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance.
Instead, they are based only on BiomX management’s current beliefs, expectations and assumptions. Because forward-looking statements
relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and
many of which are outside of BiomX’s control. These risks and uncertainties include, but are not limited to, changes in applicable
laws or regulations; the possibility that BiomX may be adversely affected by other economic, business, and/or competitive factors, including
risks inherent in pharmaceutical research and development, such as: adverse results in BiomX’s drug discovery, preclinical and clinical
development activities, the risk that the results of preclinical studies and early clinical trials may not be replicated in later clinical
trials, BiomX’s ability to enroll patients in its clinical trials, and the risk that any of its clinical trials may not commence,
continue or be completed on time, or at all; decisions made by the FDA, and other regulatory authorities; decisions made by investigational
review boards at clinical trial sites and publication review bodies with respect to our development candidates; BiomX’s ability
to obtain, maintain and enforce intellectual property rights for its platform and development candidates; its potential dependence on
collaboration partners; competition; uncertainties as to the sufficiency of BiomX’s cash resources to fund its planned activities
for the periods anticipated and BiomX’s ability to manage unplanned cash requirements; and general economic and market conditions.
Therefore, investors should not rely on any of these forward-looking statements and should review the risks and uncertainties described
under the caption “Risk Factors” in BiomX’s Annual Report on Form 10-K filed with the Securities and Exchange Commission
(the “SEC”) on March 25, 2025, and additional disclosures BiomX makes in its other filings with the SEC, which are available
on the SEC’s website at www.sec.gov. Forward-looking statements are made as of the date of this press release, and except as provided
by law BiomX expressly disclaims any obligation or undertaking to update forward-looking statements.
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
| |
BIOMX INC. |
| |
|
|
| December 8, 2025 |
By: |
/s/ Jonathan Solomon |
| |
|
Name: |
Jonathan Solomon |
| |
|
Title: |
Chief Executive Officer |
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