Full Press Release Details
BiomX Reports Fourth Quarter and Full Year 2024
Financial Results and Provides Business and Program Updates
Ness Ziona, Israel, March 25, 2025 -- (GLOBE NEWSWIRE) -- BiomX
Inc. (NYSE American: PHGE, the "Company" or "BiomX"), a clinical-stage company advancing novel natural and engineered
phage therapies that target specific pathogenic bacteria, today announced financial results for the fourth quarter and full year ended
December 31, 2024, and provided program and business updates.
"BiomX is in the process of finalizing the analysis of topline
results from the Phase 2 trial of BX211 in DFO, with readout expected by the end of the quarter," said Jonathan Solomon, Chief Executive
Officer of BiomX. "In the first quarter of 2025, we also completed a financing round that generated $12 million in gross proceeds.
We believe that these resources will enable readout of BX004 Phase 2b topline results, which are anticipated in the first quarter of 2026.
In addition, the funds will support the analysis of real-world evidence to assess the relationship between Pseudomonas aeruginosa
reduction and clinical outcomes in individuals with cystic fibrosis ahead of regulatory discussions expected in the second half of this
Clinical Program Updates
BX211 - phage for the treatment of DFO associated
with Staphylococcus aureus (S. aureus)
BX004 - fixed phage cocktail for the treatment of cystic fibrosis
(CF) in patients with chronic pulmonary infections caused by Pseudomonas aeruginosa (P. aeruginosa)
BiomX entered into a securities purchase agreement with investors in
February 2025 in connection with a registered direct offering, concurrent private placement of the Company's securities, and simultaneous
exercise of certain existing common stock purchase warrants. Aggregate gross proceeds were approximately $12 million, before deducting
placement agent fees and other offering expenses. Following these offerings, the Company expects to have sufficient funding to reach substantial
inflection points, including topline results of its Phase 2b study of BX004 in the first quarter of 2026.
Full Year 2024 Financial Results
Cash balance and restricted cash as of December 31, 2024
were $18.0 million, compared to $15.9 million as of December 31, 2023. The increase was primarily due to funds raised in the Company's
March 2024 financing, partly offset by net cash used in operating activities. The December 31, 2024 cash balance does not reflect
the additional $12 million in gross proceeds raised in the Company's February 2025 financing round. BiomX estimates its cash, cash
equivalents and short-term deposits are sufficient to fund its operations into the first quarter of 2026.
Research and development expenses, net were $24.7 million
for the year ended December 31, 2024, compared to $16.7 million for the prior year. The increase was primarily due to the following factors:
preparations for the Phase 2b clinical trial of the Company's CF product candidate, BX004; an increase in expenses relating to the
Phase 2 clinical trial of the Company's DFO product candidate, BX211; and an increase in rent and related expenses following the
March acquisition of Adaptive Phage Therapeutics (APT). This increase was partly offset by higher governmental grants BiomX received.
General and administrative expenses were $11.8 million
for the year ended December 31, 2024, compared to $8.7 million for the prior year. The increase is primarily attributed to a consolidation
of expenses following APT's acquisition, incorporating the combined workforce, increased professional services, and additional subcontractor
Goodwill impairment was $0.8 million for the year ended December
31, 2024, following an impairment of the Company's goodwill resulting from the APT acquisition. The Company had no goodwill impairment
in the year ended December 31, 2023.
IPR&D impairment was $3.2 million for the year ended December
31, 2024, following the Company's quantitative assessment for in process research and development (IPR&D) impairment. The Company
had no IPR&D impairment in the year ended December 31, 2023.
Long-lived assets impairment was $4.0 million for the year ended
December 31, 2024, after evaluating the right-of-use asset and related leasehold improvements following the Company's decision to
cease the use of the property in Gaithersburg, Maryland and make it available for sublease. The Company had no long-lived assets impairment
in the year ended December 31, 2023.
Net loss for 2024 was $17.7 million, compared to $26.2
million for the prior year. The decrease is mainly due to the change in the fair value of the warrants issued as part of the Company's
March 2024 financing.
Net cash used in operating activities for the year ended
December 31, 2024 was $37 million, compared to $21.3 million for the same period in 2023.
Conference Call and Webcast
to host a conference call and a live audio webcast at a later date to discuss its fourth quarter and full year 2024 financial results,
in conjunction with its expected announcement of initial topline results from its Phase 2 trial for subjects with DFO.
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 November 2023, BiomX announced positive topline results from Part 2 of
the Phase 1b/2a trial where 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 expects to initiate
a randomized, double blind, placebo-controlled, multi-center Phase 2b trial in CF patients with chronic P. aeruginosa pulmonary
infections. The trial 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 trial 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. Pending progress
of the trial, topline results are expected in the first quarter of 2026. The U.S. Food and Drug Administration ("FDA") has
granted BX004 Fast Track designation and Orphan Drug Designation.
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. The ongoing randomized,
double-blind, placebo-controlled, multi-center Phase 2 trial investigating the safety, tolerability, and efficacy of BX211 for
subjects with DFO associated with S. aureus has finished enrollment of patients, randomized at a 2:1 ratio of BX211 to placebo.
BX211 or placebo is designed to be administered weekly, by topical and IV route at Week 1 and by the topical route only at each of
Weeks 2-12. Over the 12-week treatment period, all subjects are expected to continue to be treated in accordance with standard of
care which will include antibiotic treatment as appropriate. A first readout of study topline results is expected at Week 13
evaluating healing of the wound associated with osteomyelitis. This readout is expected in the first quarter of 2025.
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.
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 thereof, expected
discussions with the FDA and results thereof, the potential of its candidates to address the substantial unmet needs of
patients with intractable infections, 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; 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