BiomX Announces Third Quarter 2024 Financial Results and Provides Business and Program Updates BX211 Phase 2 for treatment of Diabetic Foot Osteomyelitis (DFO) patient enrollment completed and on track to report topline

BiomX Announces Third Quarter 2024 Financial

Results and Provides Business and Program Updates

BX211 Phase 2 for treatment of Diabetic Foot

Osteomyelitis (DFO) patient enrollment completed and on track to report topline results in Q1 2025

BX004 Phase 2b study in Cystic Fibrosis (CF)

is now expected to report topline results in H1 2026 following resolved manufacturing delays

Company to host conference call and webcast

Ness Ziona, Israel, November 14, 2024 -- (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 announces financial results for its third quarter ended September 30,

2024, and provides program and business updates.

"We continue to be encouraged by the progress in diabetic foot

osteomyelitis (DFO), having achieved an important milestone by completing patient enrollment for the BX211 program. We remain on track

to share topline (through Week 13) Phase 2 results of BX211 in the first quarter of 2025," said Jonathan Solomon, BiomX's

Chief Executive Officer. "BX211 is a novel phage treatment for DFO and holds the potential to prevent amputations associated with

intractable infections that have penetrated the bone in patients with diabetic foot ulcers. In October 2024, we received additional non-dilutive

funding from the US Defense Health Agency ("DHA") to continue advancing the DFO program and are grateful for the continued

support provided by the DHA. During the last quarter, our CF program experienced manufacturing delays, which have been resolved, and we

now expect to report topline results for BX004 in our Phase 2b study in the first half of 2026. Results from our Phase 1b/2a study for

the BX004 program in CF continue to receive positive feedback at major scientific conferences, including those attended during the past

quarter, and we remain confident about the future of this program and its potential to address the significant unmet medical need of CF

Clinical Program Updates

BX211 - personalized phage for the treatment of DFO associated

with Staphylococcus aureus

BX004 - fixed phage cocktail for the treatment of CF in patients

with chronic pulmonary infections caused by Pseudomonas aeruginosa (P. aeruginosa)

Third Quarter 2024 Financial Results

Cash balance, short-term deposits and restricted cash as of

September 30, 2024, were $24.7 million, compared to $30.7 million as of December 31, 2023. The decrease was primarily due to net cash

used in operating activities and the repayment in April 2024, of the Company's prior debt facility, which was partially offset by

the Company's private placement financing of $50 million in March 2024. BiomX estimates its cash, cash equivalents and short-term

deposits are sufficient to fund its operations into the fourth quarter of 2025.

Research and development expenses, net were $7.3 million for

the third quarter of 2024, compared to $5.6 million for the third quarter of 2023. 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 grants BiomX received.

General and administrative expenses were $3.2 million for the

third quarter of 2024, compared to $2.2 million for the third quarter of 2023. The increase is primarily attributed to a full quarter

consolidation of expenses following APT's acquisition, incorporating the combined workforce, increased professional services, and

additional subcontractor expenses.

The Company recognized goodwill impairment expenses of $801

thousand in the third quarter of 2024, resulting from the fair value assessment of goodwill related to the 2024 APT acquisition. No comparable

goodwill impairment expenses were recorded in the same period of 2023.

Net income was $9.6 million for the third quarter of 2024, compared

to a net loss of $7.9 million for the third quarter of 2023. The increase is mainly due to the change in the fair value of the warrants

issued as part of the March 2024 financing.

Net cash used in operating activities for the nine months ended

September 30, 2024, was $30.7 million, compared to $15.0 million for the same period in 2023.

Conference Call and Webcast Details

BiomX will host a conference call and webcast on November 14, 2024,

at 8:00 a.m. ET to discuss its third quarter 2024 financial results and to provide a corporate update.

Participant Dial-In Number:

Participant International Dial-In

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 half of 2026. The U.S. Food and Drug Administration ("FDA") has granted

BX004 Fast Track designation and Orphan Drug Designation.

BX211 is a personalized phage treatment for the

treatment of DFO associated with S. aureus. The personalized 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.

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 for a randomized at a 2:1 ratio to BX211 or 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, followed by a second readout

at Week 52 evaluating amputation rates and resolution of osteomyelitis based on X-ray, clinical assessments, and established biomarkers

(ESR and CRP). These readouts are expected in the first quarter of 2025 and the first quarter of 2026, respectively.

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 its anticipated timing for reporting results

for its clinical assets as well as the design 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, BiomX's ability to regain compliance with the listing standards set forth in the NYSE American

Company Guide by November 23, 2025; 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