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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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):
August 9, 2023
BiomX Inc. |
(Exact Name of Registrant as Specified in its Charter) |
Delaware |
|
001-38762 |
|
82-3364020 |
(State or other jurisdiction
of incorporation) |
|
(Commission File Number) |
|
(I.R.S. Employer
Identification No.) |
22 Einstein St., Floor 4
Ness Ziona, Israel |
|
7414003 |
(Address of Principal Executive Offices) |
|
(Zip Code) |
Registrant’s telephone number, including
area code: +972 723942377
n/a |
(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 |
|
NYSE American |
Shares of Common Stock, $0.0001 par value |
|
PHGE |
|
NYSE American |
Indicate by check mark whether the registrant
is an emerging growth company 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 2.02 Results of Operations and Financial Condition.
On August 9, 2023, BiomX Inc. (the “Company”)
issued a press release announcing its financial results for the second quarter ended June 30, 2023. A copy of the press release issued
in connection with the announcement is furnished pursuant to Item 2.02 as Exhibit 99.1 hereto.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
SIGNATURE
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. |
|
|
|
August 9, 2023 |
By: |
/s/ Jonathan Solomon |
|
|
Name: |
Jonathan Solomon |
|
|
Title: |
Chief Executive Officer |
2
Exhibit 99.1
BiomX
Reports Second Quarter 2023 Financial Results and Provides Business Update
Patient
Screening Completed in Part 2 of Phase 1b/2a Trial of BX004 with patient enrollment expected to exceed original estimates
FDA
grants BX004 Fast Track designation
Initial
Data from Part 2 Now Expected in November 2023
Company
Will Host a Conference Call and Webcast Today at 8:00 am ET
CAMBRIDGE,
Mass. and NESS ZIONA, Israel – Aug 9, 2023 – BiomX Inc. (NYSE American: PHGE) (“BiomX”
or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic
bacteria, today reported financial results and provided a business update for the second quarter ended June 30, 2023.
“Our
BX004 clinical program in cystic fibrosis (“CF”) continues to build significant momentum,” said Jonathan Solomon, Chief
Executive Officer of BiomX. “We recently completed patient screening in Part 2 of our ongoing Phase 1b/2a trial with
patient enrollment expected to exceed original estimates, which reflects continued execution by
our clinical team and a growing awareness within the CF patient community of the BX004 program. I am also pleased to announce that BX004
just received Fast Track designation from the FDA, which provides further recognition that our BX004 program is addressing one of the
most serious and challenging unmet medical needs facing the CF community.
“In
June, we presented our positive Part 1 results at the recent European Cystic Fibrosis Conference (“ECFC”) meeting, which
highlighted the excellent safety of BX004 along with its notable activity in reducing P. aeruginosa bacteria burden. In Part 2,
we are testing BX004 in a larger number of CF patients who are dosed twice a day and over a longer, 10-day treatment period compared
to Part 1. Part 2 of the study will provide additional data on safety and reduction in bacterial burden, along with other exploratory
clinical endpoints. Based on our current estimates, we now believe the Part 2 data analysis will take an additional 4-6 weeks to complete.
We therefore expect to report initial results from Part 2 in November 2023.”
Clinical
Program Updates
Cystic
Fibrosis (BX004)
| ● | In
August 2023, the U.S. Food and Drug Administration (“FDA”) granted BX004 Fast Track designation for the treatment of chronic
respiratory infections caused by Pseudomonas aeruginosa (PsA) bacterial strains in patients with CF. The FDA’s Fast Track designation
is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and address significant
unmet medical needs. The FDA defines addressing a significant unmet medical need as providing a therapy where none exists or providing
a therapy which may be potentially better than available therapies. The benefits of Fast Track designation include but are not limited
to early and frequent communication with the FDA throughout the entire drug development and review process. In addition, a drug with
Fast Track designation is eligible for rolling submission and priority review of its Biologics License Application and/or New Drug Application.
These assure that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.1 |
| ● | In
June 2023, during the Late-Breaking Science Session at the 46th ECFC, BiomX presented positive results from Part 1 of the Phase 1b/2a
trial evaluating BX004 for the treatment of chronic pulmonary infections caused by P. aeruginosa bacteria in patients with CF. Highlights
from the Part 1 data, which were initially reported in February 2023, were also presented at a poster session during the ECFC meeting
(link to poster)
and included: |
| o | No
safety events related to treatment with BX004 |
| o | Mean P.
aeruginosa colony forming units (CFU) at Day 15 (compared to baseline) were reduced
by more than 90%: -1.42 log10 CFU/g (BX004) vs. -0.28 log10 CFU/g (placebo).
This reduction occurred in the presence of standard of care inhaled antibiotics |
| o | Phages
were detected in the sputum of all patients treated with BX004 during the dosing period,
including in several patients up to Day 15 (one week after end of therapy); no phages were
detected in patients receiving placebo |
| | |
| o | There
was no emerging bacterial resistance to BX004 during or after treatment with BX004 |
| | |
| o | As
expected, likely due to the short course of therapy, there was no detectable effect on %
predicted FEV1 (First-second Forced Expiratory Volume) |
| ● | BX004
is being developed for the treatment of chronic respiratory infections caused by P.
aeruginosa, a main contributor to morbidity and mortality in patients with CF. The
Phase 1b/2a trial is composed of two parts. Part 1 of the study evaluated the safety, pharmacokinetics,
and microbiologic/clinical activity of BX004 in nine CF patients in a single ascending dose
and multiple dose design. Part 2 of the study will evaluate the safety and efficacy of BX004
in at least 24 CF patients randomized to a treatment or placebo cohort in a 2:1 ratio. Results
from Part 2 of the trial are expected in November 2023. |
| ● | As
previously announced, BiomX has received a Therapeutics Development Award of $5 million from
the Cystic Fibrosis Foundation. The award was structured as an equity investment in which
the Cystic Fibrosis Foundation purchased $5 million of BiomX common stock across two separate
tranches. |
Atopic
Dermatitis (“AD”) (BX005)
| ● | The
Company is collaborating with Maruho Co. Ltd., a leading dermatology-focused pharmaceutical
company in Japan, supporting a range of pre-clinical activities to move this program forward
and working
on evaluating timelines for a clinical trial. |
RECENT
CORPORATE HIGHLIGHTS
| ● | On
May 12, 2023, the Company announced the appointments of Jason
M. Marks and Michael E. Dambach, CFA to its Board of Directors. Mr. Marks most recently served
as Executive Vice President, Chief Legal and Compliance Officer & Corporate Secretary/Senior
Advisor with Amarin Corporation plc, and Mr. Dambach serves as Vice President and Treasurer
of Biogen Inc. |
| ● | On
May 5, 2023, the Company announced the second closing of its $7.5 million private placement
investment (“PIPE”). The Company expects to use the aggregate net proceeds from
the PIPE, together with existing cash and cash equivalents, to fund clinical development
of BX004 for the treatment of lung infections in patients with CF, the development of other
phage therapy programs and research activities, as well as working capital and other general
corporate purposes. |
Second
Quarter 2023 Financial Results
| ● | Cash
balance, short-term deposits and restricted cash as of June 30, 2023, were $30.7
million, compared to $34.3 million as of December 31, 2022. The decrease was primarily due
to net cash used in operating activities. The Company estimates its cash runway is sufficient
to fund operations into the third quarter of 2024. |
|
● |
Research and development (“R&D”) expenses, net were $3.8 million for the three months ended June 30, 2023, compared to $4.6 million for the same period in 2022. The decrease was primarily attributed to reduced salaries and related expenses and stock-based compensation expenses that resulted from a reduction in workforce, as part of a corporate restructuring the Company announced in May 2022 (the “Corporate Restructuring”); as well as deprioritizing pre-clinical and clinical activities related to the Company’s AD product candidate, BX005, and higher proceeds from collaboration agreements in the 2023 period. These were partially offset by expenses related to conducting the Phase 1b/2a clinical trial of the Company’s CF product candidate, BX004. |
|
|
|
|
● |
General and administrative expenses were $2.3 million for the three months ended June 30, 2023, compared to $2.4 million for the same period in 2022. The decrease primarily resulted from a reduction in the premium for the Company’s directors’ and officers’ insurance policy. |
|
|
|
|
● |
Net loss for the second quarter of 2023 was $6.4 million, compared to $7.5 million for the same period in 2022. |
|
|
|
|
● |
Net cash used in operating activities for the six months ended June 30, 2023, was $9.1 million, compared to $16.4 million for the same period in 2022. |
Conference
Call and Webcast Information
BiomX
management will host a conference call and webcast today at 8:00 am ET to report financial results and business updates for the second
quarter of 2023. To participate in the conference, please dial 1-877-407-0724 (U.S.), 1-809-406-247 (Israel), or 1-201-389-0898 (International).
A live and archived webcast of the call will be available on the Investors section of the Company’s website at www.biomx.com,
the content of which does not form a part of this press release.
About
BiomX
BiomX
is a clinical-stage company developing both natural and engineered phage cocktails designed to target and destroy bacteria in the treatment
of chronic diseases. BiomX discovers and validates proprietary bacterial targets and customizes 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.
Safe
Harbor
This
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 discusses the
potential safety or efficacy of BX004, the expected timing , design and patient enrollment of Part 2 of the Phase 1b/2a study
and the potential of targeted phage therapy to treat infections in CF patients, when it refers to other programs, such as the program
to treat Atopic Dermatitis, and when it discusses the estimate of the sufficiency of its cash runway,
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 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 (the “SEC”) on March 29, 2023 and additional disclosures BiomX makes in its other 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 press release, and except as provided by law BiomX expressly disclaims
any obligation or undertaking to update forward-looking statements.
BiomX
Contacts
Investor Relations:
LifeSci Advisors, LLC
John Mullaly
(617)-698-9253
jmullaly@lifesciadvisors.com
BiomX,
Inc.
Anat Primovich
Corporate Project Manager
+972 (50) 697-7228
anatp@biomx.com
Source:
BiomX Inc.
1 | Source:
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track |
BIOMX
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(USD
in thousands, except share and per share data)
(unaudited)
| |
| |
As of | |
| |
Note | |
June 30, 2023 | | |
December 31, 2022 | |
ASSETS | |
| |
| | |
| |
| |
| |
| | |
| |
Current assets | |
| |
| | |
| |
| |
| |
| | |
| |
Cash and cash equivalents | |
| |
| 29,711 | | |
| 31,332 | |
Restricted cash | |
| |
| 951 | | |
| 962 | |
Short-term deposits | |
| |
| - | | |
| 2,000 | |
Other current assets | |
4 | |
| 2,528 | | |
| 2,587 | |
Total current assets | |
| |
| 33,190 | | |
| 36,881 | |
| |
| |
| | | |
| | |
Non-current assets | |
| |
| | | |
| | |
Operating lease right-of-use assets | |
| |
| 3,673 | | |
| 3,860 | |
Property and equipment, net | |
| |
| 4,390 | | |
| 4,790 | |
Total non-current assets | |
| |
| 8,063 | | |
| 8,650 | |
| |
| |
| 41,253 | | |
| 45,531 | |
BIOMX
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(USD
in thousands, except share and per share data)
(unaudited)
| |
| |
As of | |
| |
Note | |
June 30, 2023 | | |
December 31, 2022 | |
| |
| |
| | |
| |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| |
| | |
| |
| |
| |
| | |
| |
Current liabilities | |
| |
| | |
| |
Trade accounts payable | |
| |
| 2,228 | | |
| 820 | |
Current portion of lease liabilities | |
| |
| 654 | | |
| 687 | |
Other accounts payable | |
5 | |
| 3,394 | | |
| 2,150 | |
Current portion of long-term debt | |
7 | |
| 5,391 | | |
| 4,282 | |
Total current liabilities | |
| |
| 11,667 | | |
| 7,939 | |
| |
| |
| | | |
| | |
Non-current liabilities | |
| |
| | | |
| | |
Contract liability | |
| |
| 1,976 | | |
| 1,976 | |
Long-term debt, net of current portion | |
7 | |
| 8,159 | | |
| 10,591 | |
Operating lease liabilities, net of current portion | |
| |
| 3,396 | | |
| 3,798 | |
Other liabilities | |
| |
| 190 | | |
| 188 | |
Total non-current liabilities | |
| |
| 13,721 | | |
| 16,553 | |
| |
| |
| | | |
| | |
Commitments and Contingencies | |
6 | |
| | | |
| | |
| |
| |
| | | |
| | |
Stockholders’ equity | |
8 | |
| | | |
| | |
| |
| |
| | | |
| | |
Preferred Stock, $0.0001 par value; Authorized - 1,000,000 shares as of June 30, 2023 and December 31, 2022. No shares issued and outstanding as of June 30, 2023 and December 31, 2022. | |
| |
| - | | |
| - | |
Common Stock, $0.0001 par value; Authorized - 120,000,000 shares as of June 30, 2023 and December 31, 2022. Issued –45,979,730 shares as of June 30, 2023 and 29,982,282 shares as of December 31, 2022. Outstanding 45,974,030 shares as of June 30, 2023 and 29,976,582 shares as of December 31, 2022. | |
| |
| 3 | | |
| 2 | |
| |
| |
| | | |
| | |
Additional paid in capital | |
| |
| 165,435 | | |
| 157,838 | |
Accumulated deficit | |
| |
| (149,573 | ) | |
| (136,801 | ) |
Total stockholders’ equity | |
| |
| 15,865 | | |
| 21,039 | |
| |
| |
| 41,253 | | |
| 45,531 | |
BIOMX
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(USD
in thousands, except share and per share data)
(unaudited)
| |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
Note | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| |
| | |
| | |
| | |
| |
Research and development (“R&D”) expenses, net | |
| |
| 3,818 | | |
| 4,584 | | |
| 8,382 | | |
| 9,513 | |
Amortization of intangible assets | |
| |
| - | | |
| 379 | | |
| - | | |
| 759 | |
General and administrative expenses | |
| |
| 2,255 | | |
| 2,361 | | |
| 3,899 | | |
| 4,838 | |
| |
| |
| | | |
| | | |
| | | |
| | |
Operating loss | |
| |
| 6,073 | | |
| 7,324 | | |
| 12,281 | | |
| 15,110 | |
| |
| |
| | | |
| | | |
| | | |
| | |
Other income | |
| |
| (90 | ) | |
| - | | |
| (181 | ) | |
| - | |
Interest expenses | |
| |
| 745 | | |
| 488 | | |
| 1,310 | | |
| 949 | |
Finance income, net | |
| |
| (325 | ) | |
| (339 | ) | |
| (652 | ) | |
| (426 | ) |
| |
| |
| | | |
| | | |
| | | |
| | |
Loss before tax | |
| |
| 6,403 | | |
| 7,473 | | |
| 12,758 | | |
| 15,633 | |
| |
| |
| | | |
| | | |
| | | |
| | |
Tax expenses | |
| |
| 8 | | |
| 9 | | |
| 14 | | |
| 18 | |
| |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
| |
| 6,411 | | |
| 7,482 | | |
| 12,772 | | |
| 15,651 | |
| |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted loss per share of Common Stock | |
9 | |
| 0.12 | | |
| 0.25 | | |
| 0.31 | | |
| 0.53 | |
| |
| |
| | | |
| | | |
| | | |
| | |
Weighted average number of shares of Common Stock outstanding, basic and diluted | |
| |
| 51,552,923 | | |
| 29,774,709 | | |
| 41,860,338 | | |
| 29,764,588 | |
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