Full Press Release Details
Reports First Quarter 2020 Financial Results and Provides Business Update
Phase 1 cosmetic clinical study results of BX001 in acne-prone skin reported; planned advance to Phase 2 study with readout expected
in the second quarter of 2021
BX002 Phase 1 clinical study readout in inflammatory bowel disease expected in the fourth quarter of 2020
and equivalents of $75.3 million expected to fund current operating plan for at least 24 months
to host conference call today at 8:00 a.m. Eastern Time
Ziona, Israel - May 14, 2020 - BiomX Inc. (NYSE: PHGE), a clinical-stage company developing natural and engineered
phage therapies that target specific pathogenic bacteria, today reported financial results and provided a business update for
the first quarter ended March 31, 2020.
highlight of the first quarter was the exciting positive topline data from our Phase 1 study of our lead candidate BX001 in subjects
with acne-prone skin. Both doses of BX001 demonstrated excellent safety and tolerability, and the higher dose achieved a statistically
significant reduction in target bacteria. These results represent an important step for the development of phage as a new modality
- as proof of concept of phage's potential to target bacteria in a safe and tolerable manner in a clinical setting,"
said Jonathan Solomon, BiomX Chief Executive Officer. "We are very much looking forward to advancing BX001 into the Phase
2 program, as well as progressing our pipeline in inflammatory bowel disease (IBD), and primary sclerosing cholangitis (PSC)."
positive Phase 1 cosmetic clinical study results in acne-prone skin, the Company is advancing BX001 to a Phase 2 cosmetic clinical
study, with a readout expected in the second quarter of 2021. The Phase 2 study in acne-prone skin is planned to be a 12-week
randomized, double-blind, placebo-controlled trial in 100 individuals with mild-to-moderate acne. Enrolled individuals will be
randomized into one of two cohorts: BX001 or placebo (vehicle). Findings from additional post hoc analyses of the Phase 1 data
identified that several subject populations with a higher bacterial load at baseline, and also those with characteristics associated
with a higher bacterial load at baseline, such as higher sebum levels, had an earlier and more pronounced reduction of Cutibacterium
acnes (C. acnes) levels after BX001 treatment when compared to placebo (vehicle). Higher levels of bacteria result
in an increased probability of interactions with phage, thereby potentially leading to a greater effect. As a result the Company
plans to enrich the Phase 2 study subject population for these characteristics.
continues to drive forward its development programs in IBD and PSC, a rare liver disease. The Company expects to initiate the
first-in-human Phase 1 clinical study of BX002 in IBD in 2020 and report pharmacokinetic and safety data from the study in healthy
volunteers by the fourth quarter of 2020.
light of the evolving COVID-19 pandemic, BiomX has implemented recommended measures to safeguard the health and safety of its
employees and the continuity of its business operations. Due to these precautions, along with challenges in clinical trial enrollment
due to COVID-19, BiomX's guidance on the timing of certain clinical milestones has evolved. Updates to key upcoming milestones
Quarter 2020 Financial Results
management will host a conference call and webcast today at 8:00 a.m. ET to report financial results for the first quarter of
2020 and provide business updates. To participate in the conference call, please register at http://dpregister.com/10144165 ahead
of the call to receive dial-in information or please dial 1-866-777-2509 for participants based in the United States, 1-412-317-5413
for participants based outside the United States, or 1-80-9212373 for participants based in Israel and ask to be joined into the
BiomX first quarter earnings conference call. A live webcast of the call will be available on the Investors section of the BiomX
website and a replay will be available after its completion.
the Phase 1 Cosmetic Clinical Study of BX001 in Acne-Prone Skin
Phase 1 cosmetic clinical study was a four-week randomized, double-blind, dose-finding, placebo-controlled single center trial
which enrolled 75 individuals with mild-to-moderate acne. Enrolled individuals were randomized into one of three cohorts: a high
dose cohort, a low dose cohort, and a placebo cohort (vehicle).
Bacteriophage, or phage, are viruses that target bacteria and are considered inert to mammalian cells. Phage are designed
to target and kill specific bacterial species or strains without disrupting other bacteria or the healthy microbiota. All of BiomX's
phage-based product candidates derive from its proprietary platform, which is first used to discover and validate the association
and biologic rationale of specific bacterial strains with human diseases or conditions, and is then used to develop rationally-designed
phage combinations ("cocktails") of naturally occurring or synthetic phage to target pathogenic bacteria. The phage
cocktails contain multiple phage with complementary functions optimized through in vitro and in vivo testing.
BiomX is a clinical-stage biotechnology company developing both natural and engineered phage cocktails designed to target
and destroy bacteria that affect the appearance of skin, as well as harmful bacteria in chronic diseases, such as inflammatory
bowel disease (IBD), primary sclerosing cholangitis (PSC), and colorectal cancer (CRC). BiomX discovers and validates proprietary
bacterial targets and customizes phage compositions against these targets.
This press release contains certain "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. 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 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 additional disclosures we make in the Company's filings with
the Securities and Exchange Commission (the "SEC"), which are available on the SEC's website at www.sec.gov.
VP, Investor Relations and Strategy