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BiomX Reports Third Quarter 2023 Financial Results and Provides Business Update Analysis of Part 2 data from Phase 1b/2a trial of BX004 ongoing; Company expects to announce Part 2 data later this month BX004 received FDA

Key Takeaway: Reports Third Quarter 2023 Financial Results and Provides Business Update of Part 2 data from Phase 1b/2a trial of BX004 ongoing; Company expects to announce Part 2 data later this month received FDA Fast Track designation in August 1 data recently presented at the North Ameri

Full Press Release Details

Reports Third Quarter 2023 Financial Results and Provides Business Update
of Part 2 data from Phase 1b/2a trial of BX004 ongoing; Company expects to announce Part 2 data later this month
received FDA Fast Track designation in August
1 data recently presented at the North American Cystic Fibrosis Conference (NACFC)
MA and NESS ZIONA, Israel - Nov 14, 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 third quarter ended September 30, 2023.
to the continued execution of our clinical team, we are now analyzing data from Part 2 of the Phase 1b/2a trial of BX004 and expect to
announce the results later this month," said Jonathan Solomon, Chief Executive Officer of BiomX. "I am also pleased to note
that the positive data from Part 1 of our trial has been well received by physicians and patient advocacy groups at several prominent
medical meetings, reflecting the need to develop innovative new therapies for combating these persistent and deadly lung infections.
In addition, the U.S. Food and Drug Administration recently granted Fast Track designation for BX004, further underscoring the potential
of this promising program.
a reminder, Part 2 of the trial is evaluating BX004 in a larger number of cystic fibrosis patients who are dosed twice a day and over
a longer, 10-day treatment period compared to Part 1 of the trial. Part 2 of the trial will provide additional clinical data on safety
and reduction in bacterial burden, along with other exploratory clinical endpoints, all of which will help us guide our clinical development
strategy for the program. In light of the expected readout of the Part 2 data, we are forgoing our usual earnings call and will instead
host a conference call and webcast following the release of the Part 2 data."
Dermatitis ("AD") (BX005)
Quarter 2023 Financial Results
the close proximity between the Company's third quarter earnings report and the expected announcement of the Part 2 data from the
Phase 1b/2a trial, BiomX management will forgo holding a call to review its third quarter 2023 earnings and will instead host a conference
call and webcast following the release of the Part 2 data.
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.
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 of announcement of results from Part 2 of the Phase 1b/2a trial, the
potential benefits from Fast Track designation for BX004, and the potential of targeted phage therapy to treat infections in CF
patients, the potential timeline for 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.
LifeSci Advisors, LLC
Corporate Project Manager
CONSOLIDATED BALANCE SHEETS
in thousands, except share and per share data)
As of
September 30, 2023 December 31, 2022
ASSETS
Current assets
Cash and cash equivalents 22,450 31,332
Restricted cash 943 962
Short-term deposits - 2,000
Other current assets 1,908 2,587
Total current assets 25,301 36,881
Non-current assets
Operating lease right-of-use assets 3,576 3,860
Property and equipment, net 4,179 4,790
Total non-current assets 7,755 8,650
33,056 45,531
As of
September 30, 2023 December 31, 2022
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Trade accounts payable 1,066 820
Current portion of lease liabilities 632 687
Other accounts payable 5,504 2,150
Current portion of long-term debt 5,582 4,282
Total current liabilities 12,784 7,939
Non-current liabilities
Contract liability 1,976 1,976
Long-term debt, net of current portion 6,815 10,591
Operating lease liabilities, net of current portion 3,179 3,798
Other liabilities 148 188
Total non-current liabilities 12,118 16,553
Commitments and Contingencies
Stockholders' equity
Preferred Stock, $0.0001 par value; Authorized - 1,000,000 shares as of September 30, 2023 and December 31, 2022. No shares issued and outstanding as of September 30, 2023 and December 31, 2022. - -
Common Stock, $0.0001 par value; Authorized - 120,000,000 shares as of September 30, 2023 and December 31, 2022. Issued -45,979,730 shares as of September 30, 2023 and 29,982,282 shares as of December 31, 2022. Outstanding 45,974,030 shares as of September 30, 2023 and 29,976,582 shares as of December 31, 2022. 3 2
Additional paid in capital 165,630 157,838
Accumulated deficit (157,479 ) (136,801 )
Total stockholders' equity 8,154 21,039
33,056 45,531
CONSOLIDATED STATEMENTS OF OPERATIONS
in thousands, except share and per share data)
Three Months Ended September 30, Nine Months Ended September 30,
2023 2022 2023 2022
Research and development ("R&D") expenses, net 5,641 3,536 14,023 13,049
Amortization of intangible assets - 380 - 1,139
General and administrative expenses 2,154 2,633 6,053 7,471
Operating loss 7,795 6,549 20,076 21,659
Other income (89 ) (52 ) (270 ) (52 )
Interest expenses 574 555 1,884 1,504
Finance income, net (382 ) (280 ) (1,034 ) (706 )
Loss before tax 7,898 6,772 20,656 22,405
Tax expenses 8 8 22 26
Net loss 7,906 6,780 20,678 22,431
Basic and diluted loss per share of Common Stock 0.13 0.23 0.43 0.75
Weighted average number of shares of Common Stock outstanding, basic and diluted 60,587,718 29,907,812 48,196,566 29,812,542
Last updated: Nov 14, 2023