BiomX Inc. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits
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Item 7.01 Regulation FD Disclosure.
On March 31, 2025, BiomX Inc., or the Company, issued a press release announcing positive results from its Phase 2 Trial evaluating BX211 for the treatment of Diabetic Foot Osteomyelitis, or DFO, a copy of which is furnished as Exhibit 99.1. In addition, on March 31, 2025, the Company posted an updated corporate slide presentation in the “Investors” portion of its website at www.biomx.com. A copy of the slide presentation is furnished as Exhibit 99.2 hereto. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.2.
Item 8.01 Other Events.
As disclosed above, on March 31, 2025, the Company announced positive results from Phase 2 Trial Evaluating BX211 for the treatment of DFO, or the Phase 2 Trial.
The Phase 2 Trial is a randomized, double-blind, placebo-controlled, multi-center study investigating the safety, tolerability, and efficacy of BX211 for individuals with DFO associated with S. aureus. The Phase 2 Trial enrolled a total of 41 patients randomized for treatment at a 2:1 ratio, 26 of whom received intravenous (IV) and topical administration of BX211 on week 1 followed by a topical weekly dose through week 12, while 15 patients were assigned to the placebo arm. Over the 12-week treatment period, all subjects (treatment and placebo) were also treated in accordance with standard of care, including with systemic antibiotic therapy as appropriate. A readout of study results at Week 13 evaluated healing of the wound associated with osteomyelitis. The primary efficacy endpoint was Percent Area Reduction, or PAR, of study ulcer through week 13. Study design was guided in part by experience with numerous compassionate cases using phage therapy for the treatment of DFO and osteomyelitis.
The topline Phase 2 Trial results included:
| ● | BX211 was found to be safe and well-tolerated. |
| ● | BX211 produced sustained and statistically significant1 PAR of ulcer size, (p = 0.046 at week 12; p=0.052 at week 13), with a separation from placebo (standard of care) starting at week 7 and a difference greater than 40% by week 10. |
| ● | BX211 produced statistically significant1 improvements in both ulcer depth at week 13 (in patients with ulcer depth defined as bone at baseline) (p=0.048), and in reducing the expansion of ulcer area (p=0.017), compared to placebo. |
| ● | BX211 demonstrated favorable trends compared to placebo across several additional clinical parameters, including: proportion of visits with no clinical evidence of infection; evidence of resolving DFO by MRI/X-ray at week 12; proportion of patients with abnormal C-Reactive Protein at baseline that achieved a reduction of CRP of at least 50% at any point in the study; and greater Wagner scale improvement2. |
| ● | Through week 13, BX211 demonstrated comparable efficacy against both Methicillin susceptible and resistant strains, as well as against high and low biofilm producers—consistent with the orthogonal mechanism of phage therapy to antibiotics and its inherent anti-biofilm capabilities. |
| 1 | All p-values described in this Form 8-K are non-adjusted. |
| 2 | The Wagner Scale is a clinical grading system used to classify the severity of diabetic foot ulcers, ranging from 0 (intact skin) to 5 (extensive gangrene). |
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit | Description | |
| 99.1 | Press Release dated March 31, 2025, titled “BiomX Announces Positive Results from Phase 2 Trial Evaluating BX211 for the Treatment of Diabetic Foot Osteomyelitis (DFO)” (furnished herewith) | |
| 99.2 | Investor Presentation Deck dated February 26, 2025 (furnished herewith) | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL documents) |
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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. | |||
| March 31, 2025 | By: | /s/ Jonathan Solomon | |
| Name: | Jonathan Solomon | ||
| Title: | Chief Executive Officer | ||
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