Full Press Release Details
BiomX Reports First Quarter 2025 Financial Results
and Provides Business and Program Updates
In March 2025, BiomX announced positive topline
results of the phase 2 trial evaluating BX211 for the treatment of diabetic foot osteomyelitis (DFO)
BX004 Phase 2b study in Cystic Fibrosis (CF)
on track to report topline results in Q1 2026
In April 2025, shareholders approved exercise
of warrants issued in $12 million in financings announced in February 2025; funds expected to provide runway through topline Phase 2b
results for BX004 trial
The Company will host a conference call and
webcast today at 2:00 PM ET
Ness Ziona, Israel, May 15, 2025 -- (GLOBE NEWSWIRE) -- BiomX
Inc. (NYSE American: PHGE) ("BiomX" or the "Company"), a clinical-stage company advancing novel natural and engineered
phage therapies that target specific pathogenic bacteria, today announced financial results for the first quarter ended March 31, 2025,
and provided program and business updates.
"The first quarter of 2025 was a period of exceptional progress
for BiomX, both on the corporate front and across our clinical pipeline," said Jonathan Solomon, Chief Executive Officer of BiomX.
"The strength of the positive Phase 2 results from our BX211 program in diabetic foot osteomyelitis exceeded our expectations and
received resounding endorsement from key opinion leaders and industry experts. These positive results represent a significant milestone
for the field of bacteriophage therapy and further reinforce our platform's potential to address serious, resistant infections.
Notably, the BX211 program has been supported to date by approximately $40 million in non-dilutive funding from the U.S. Defense Health
Agency (DHA), which has identified an urgent need for new treatments to combat antibiotic-resistant infections in current and future conflict
environments. The work received DHA and Department of Navy funding under an Other Transaction
Authority (OTA) award through the Medical Technology Enterprise Consortium (MTEC) and managed by the Naval Medical Research Command
(NMRC) - Naval Advanced Medical Development (NAMD). We are currently in discussions regarding potential next steps in partnership
with the DHA to further advance this program. Looking ahead, we remain focused on our next major catalyst, which is the anticipated Phase
2b readout of BX004 in cystic fibrosis in the first quarter of next year, supported by the recent financings we secured to advance this
program and extend our operational runway."
Clinical Program Updates
BX211 - phage for the treatment of DFO associated
with Staphylococcus aureus (S. aureus)
BX004 - fixed phage cocktail for the treatment of CF in patients
with chronic pulmonary infections caused by Pseudomonas aeruginosa (P. aeruginosa)
On April 21, 2025, a BiomX Special Meeting
of stockholders took place during which shareholders approved the exercise of certain warrants issued as part of the Company's
$12 million financings announced in February 2025. The completed financings will provide runway expected to support the
Company's activities into the first quarter of 2026, when the Company anticipates the readout of topline Phase 2b results for
BX004 for the treatment of CF patients with chronic pulmonary infections caused by P. aeruginosa.
First Quarter 2025 Financial Results
Cash balance and restricted cash as of March 31, 2025,
were $21.2 million, compared to $18.0 million as of December 31, 2024. The increase was primarily due to funds raised in the February
2025 financings, partly offset by 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 $5.3 million
for the first quarter of 2025, compared to $4.1 million for the first quarter of 2024. 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 2024 acquisition of Adaptive Phage Therapeutics (APT). This increase was partly offset by higher grants BiomX received.
General and administrative expenses were $2.5 million for
the first quarter of 2025, compared to $2.7 million for the first quarter of 2024. The decrease is primarily attributed to expenses incurred
during 2024 in connection with the acquisition of APT completed in March 2024, partially offset by increased salaries and share-based
compensation expenses.
Net loss was $7.7 million for the first quarter of 2025,
compared to $17.3 million for the first quarter of 2024. The decrease is mainly due to the change in the fair value of the warrants
issued as part of the Company's financing completed in March 2024.
Net cash used in operating activities for the three months
ended March 31, 2025, was $8.7 million, compared to $11.4 million for the same period in 2024.
Conference Call and Webcast Details
BiomX will host a conference call and webcast on May 15, 2025, at 2:00
PM ET to discuss its first quarter 2025 financial results and to provide a corporate update.
Participant Dial-In Number:
Participant International Dial-In:
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 Phase 2/3 trial, pending discussions and feedback from the FDA.
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 FDA has granted BX004 Fast Track designation and Orphan
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 its anticipated timing for reporting results
for its clinical assets as well as the design thereof, expected discussions with the FDA and other regulatory authorities and the DHA
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