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 |