Full Press Release Details
BiomX Reports Second Quarter 2025 Financial
Results and Provides Program Updates
Positive Phase 2 results for BX211 demonstrated >40% wound size reduction vs. placebo in diabetic foot osteomyelitis patients; Planning underway for potential registrational study
Nature Communications publication of new BX004
Phase 1b/2a data demonstrated further ~500-fold (2.7 log )2 bacterial reduction versus placebo with no
detectable emergence of resistance observed, highlighting strength of BiomX platform capabilities
Phase 2b trial of BX004 in Cystic Fibrosis
(CF) has successfully commenced patient dosing; FDA feedback on real-world evidence strategy expected in H2 2025; Company expects to
report topline results in Q1 2026
BiomX will host a conference call and webcast
Ness Ziona, Israel, August 13, 2025 -- BiomX Inc. (NYSE American:
PHGE) ("BiomX" or the "Company"), a clinical-stage company advancing novel natural and engineered phage therapies
targeting specific pathogenic bacteria, today announced financial results for the second quarter ended June 30, 2025, and provided recent
clinical and corporate updates.
"In the past few months, BiomX achieved several significant milestones
that advance our pipeline and further validate our phage therapy platform," said Jonathan Solomon, Chief Executive Officer of BiomX.
"Positive Phase 2 results for BX211 in diabetic foot osteomyelitis demonstrated sustained, statistically significant improvements
in wound size reduction, with over 40% reduction in ulcer size compared to placebo, and a favorable safety profile. In parallel, new peer-reviewed
data for BX004, published in Nature Communications, reported approximately 500-fold (2.7 log )2 further
bacterial reduction versus placebo and no detectable emergence of resistance, critical evidence supports the strength of our candidate
BX004. With BX004's Phase 2b trial now underway, FDA feedback on our real-world evidence plan expected later this year, and planning
for a potential registrational BX211 study in progress, BiomX is positioned for multiple value-driving catalysts over the next 12 months."
Clinical Program Updates
BX211 - Phage for the treatment of patients with diabetic
foot infections and osteomyelitis (DFI/DFO) associated with Staphylococcus aureus (S. aureus)
BX004 - Fixed phage cocktail for chronic Pseudomonas aeruginosa
(P. aeruginosa) in patients with CF
Second Quarter 2025 Financial Results
Cash balance and restricted cash as of June 30, 2025, were $15.2
million, compared to $18 million as of December 31, 2024. The decrease was primarily due to net cash used in operating activities. BiomX
estimates its cash, cash equivalents and restricted cash are sufficient to fund its operations into the first quarter of 2026.
Research and development expenses, net were $5.0 million for
the second quarter of 2025, compared to $6.9 million for the second quarter of 2024. The decrease was primarily driven by: reduced salary
expenses from workforce reductions; lower rent expenses following a right-of-use asset impairment in 2024; and increased grant funding
from the Medical Technology Enterprise Consortium (under the DHA) and the Israel Innovation Authority. This was partially offset by higher
expenses from initiating the Phase 2b clinical trial of the Company's CF product candidate, BX004.
General and administrative expenses were
$2.4 million for the second quarter of 2025, compared to $2.8 million for the second quarter of 2024. The decrease was primarily attributed
to a reduction in legal and other professional service fees, partially offset by increased share-based compensation expenses.
Net loss was $6.0 million for the second quarter of 2025, compared
to income of $4.5 million for the second quarter of 2024. The decrease was mainly due to the change in the fair value of warrants issued
as part of the Company's March 2024 financing.
Net cash used in operating activities for the six months
ended June 30, 2025, was $14.8 million, compared to $22.6 million for the same period in 2024.
Conference Call and Webcast Details
BiomX will host a conference call and webcast on August 13, 2025, at
8 AM ET to discuss its second quarter 2025 financial results and to provide a corporate update.
BX211 is a phage treatment for the treatment of DFO associated with
S. aureus. 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. In March 2025, BiomX announced positive topline results from the Phase 2 trial in which BX211 was
demonstrated to be safe and well-tolerated and patients receiving BX211 exhibited statistically significant1 and sustained
reduction of ulcer size (PAR)(p=0.046 at week 12; p=0.052 at week 13), with a separation from placebo starting at week 7 and a difference
greater than 40% by week 10. In addition, BX211 also produced statistically significant1 improvements in both ulcer depth at
week 13 (in patients with ulcer depth defined as bone at baseline, ulcer depth was classified according to deepest tissue involved as
measured by swab) (p=0.048), and in reducing the expansion of ulcer area (p=0.017). Over the 12-week treatment period, all patients (treatment
and placebo) were treated in accordance with standard of care, including with systemic antibiotic therapy as appropriate. BiomX is currently
planning a potential registrational study pending discussions and feedback from the FDA, and availability of cash resources.
BiomX is developing BX004, a fixed multi-phage cocktail,
for the treatment of CF patients with chronic pulmonary infections caused by P. aeruginosa, a main contributor to morbidity and
mortality in patients with CF. In February 2023, BiomX announced positive results from Part 1 of the Phase 1b/2a study, showing safety,
tolerability, and microbiologic activity. In November 2023, BiomX announced positive topline results from Part 2 of the Phase 1b/2a trial,
in which BX004 demonstrated improvement in pulmonary function associated with a reduction in P. aeruginosa burden compared to
placebo in a predefined subgroup of patients with reduced lung function (baseline FEV1<70%). BiomX is now enrolling up to approximately
60 patients in a randomized, double blind, placebo-controlled, multi center Phase 2b trial of BX004 in CF patients with chronic P.
aeruginosa lung infections. The 8-week study will assess lung function, bacterial load, and quality of life metrics. BX004 has received
FDA Fast Track and Orphan Drug Designations.
BiomX is a clinical-stage company leading the development
of natural and engineered phage cocktails and personalized phage treatments designed to target and destroy harmful bacteria for the treatment
of chronic diseases with substantial unmet needs. BiomX discovers and validates proprietary bacterial targets and applies its BOLT ("BacteriOphage
Lead to Treatment") platform to customize phage compositions against these targets. For more information, please visit www.biomx.com,
the content of which does not form a part of this press release.
This press release 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 anticipated timing for reporting results for its clinical assets as well as the design
of clinical trials thereof, future catalysts, potential timing and outcome of expected feedback from the FDA and discussions with the
U.S. Defense Health Agency, the potential safety, efficacy and toleration of BX004 and BX211, the potential benefits of BX004 and BX211,
future clinical development of BX004 and BX211, including conducting a registrational trial in BX211, the potential of its candidates
to address the substantial unmet needs of patients, and the estimates of the sufficiency of its cash, cash equivalents and short-term
deposits, 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.