Item 8.01. Other Events.
On October 18, 2021, BiomX Inc., or BiomX, announced the results of its phase 2
cosmetic clinical study of BX001, or the Study. The Study was a 12-week
randomized, single center, double-blind, placebo-controlled trial in 140 women
with mild-to-moderate acne vulgaris. Subjects were randomized into two cohorts:
BX001 or placebo in a 1:1 ratio and self-administered BX001 or placebo twice
daily. Key endpoints from the Study evaluated the safety, tolerability and
efficacy of BX001.
BX001 was demonstrated to be safe and well-tolerated with no treatment-related
adverse events. A statistically significant improvement from baseline was
observed in appearance of acne-prone skin but no meaningful difference was
demonstrated relative to the placebo arm of the Study. Significant improvements
in the appearance of acne prone skin, as assessed by reduction in inflammatory
lesion counts (48.3%, p<0.0001), non-inflammatory lesion counts (36.3%,
p<0.0001), and by reduction in average Investigator's Global Assessment, or IGA,
score (-0.29, p<0.001), were observed when compared to baseline for both
cohorts. No meaningful difference was demonstrated for BX001 relative to
placebo. BiomX plans to further evaluate the data from the Study before
communicating potential next steps for the BX001 development program.
Warning Concerning Forward Looking Statements
This Current Report on Form 8-K 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. For example, when BiomX
discusses the safety, tolerability and efficacy of BX001, the results of further
evaluation of the data from the Study, and whether such results will be positive
as well as next steps for the BX001 development program and timing of reporting
thereof, BiomX is making forward-looking statements. Forward-looking statements
are neither historical facts nor assurances of future performance. Instead, they
are based only on BiomX's 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. Actual
results and outcomes may differ materially from those indicated in the
forward-looking statements. 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, or the SEC, March 31, 2021
and additional disclosures BiomX makes in its filings with the SEC, which are
available on the SEC's website at www.sec.gov. Forward-looking statements are
made as of the date of this Current Report on Form 8-K, and except as provided
by law BiomX expressly disclaims any obligation or undertaking to update
forward-looking statements.
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