Current Report Filing (8-k)
October 18 2021 - 07:33AM
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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
FORM 8-K
CURRENT
REPORT PURSUANT
TO
SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Date
of report (Date of earliest event reported): October 18, 2021
BIOMX
INC.
(Exact
Name of Registrant as Specified in Its Charter)
Delaware
|
|
001-38762
|
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82-3364020
|
(State
or Other Jurisdiction
of Incorporation)
|
|
(Commission
File Number)
|
|
(IRS
Employer
Identification No.)
|
22
Einstein st., Floor 5
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|
|
Ness
Ziona, Israel
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7414003
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(Address
of Principal Executive Offices)
|
|
(Zip
Code)
|
(+972)
72 394 2377
(Registrant’s
telephone number, including area code)
Not
applicable
(Former
name or former address, if changed since last report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
☐
|
Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
☐
|
Soliciting material pursuant
to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
☐
|
Pre-commencement communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|
☐
|
Pre-commencement communications
pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
|
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
|
|
Trading
Symbol(s)
|
|
Name
of each exchange on which registered
|
Units, each consisting of
one share of Common Stock, $0.0001 par value, and one Warrant entitling the holder to receive one half share of Common Stock
|
|
PHGE.U
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|
NYSE American
|
Shares
of Common Stock, $0.0001 par value, included as part of the Unit
|
|
PHGE
|
|
NYSE American
|
Warrants
included as part of the Units
|
|
PHGE.WS
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|
NYSE American
|
Indicate
by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933
(§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
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.
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.
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BIOMX INC.
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By:
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/s/
Jonathan Solomon
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Name:
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Jonathan Solomon
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Title:
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Chief Executive Officer
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Date:
October 18, 2021
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