Full Press Release Details
Reports First Quarter 2023 Financial Results and Provides Business Update
Positive Results from Part 1 of Ongoing Phase 1b/2a Trial of BX004 for Treatment of Lung Infections in Cystic Fibrosis ("CF");
Results from Part 2 Expected in Third Quarter of 2023
and Final Closing of PIPE Investment Completed, Raising Total Gross Proceeds of $7.5 million; Cash Runway into the Third Quarter of 2024
M. Marks and Michael E. Dambach Appointed to Board of Directors
Will Host a Conference Call and Webcast Today at 8:00 am ET
Mass. and NESS ZIONA, Israel - May 15, 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 first quarter ended
on the better-than-expected results from Part 1 of our cystic fibrosis ("CF") trial, I am pleased to note that the BX004
program continues to gain increased visibility among patients and physicians," said Jonathan Solomon, Chief Executive Officer of
BiomX. "Part 1 results demonstrated that treatment with BX004 was safe, well-tolerated, and resulted in notable reductions in P.
aeruginosa bacterial counts. Part 2 of the study is underway with enrollment rate as planned. In Part 2 CF patients will be dosed
with BX004 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 P. aeruginosa bacterial burden, along with other exploratory clinical endpoints. We expect
to report results from Part 2 in the third quarter of 2023.
growing interest in our BX004 program has also allowed us to strengthen our balance sheet during the quarter, and I am pleased to announce
that we closed the second part of our private placement earlier this month. We would like to thank our existing shareholders, including
OrbiMed and the Cystic Fibrosis Foundation, for this continued financial support, which will provide us with additional funding through
the expected Part 2 data readout. I am also pleased to note the addition of Jason Marks and Michael Dambach to our Board of Directors,
who both bring a wealth of talent and experience spanning across multiple areas of finance, regulatory, governance and legal expertise."
Dermatitis ("AD") (BX005)
CORPORATE HIGHLIGHTS
Quarter 2023 Financial Results
Call and Webcast Information
management will host a conference call and webcast today at 8:00 am ET to report financial results and business updates for the first
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.
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 , 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.
CONSOLIDATED BALANCE SHEETS
in thousands, except share and per share data)
| As of | ||||||||
| March 31, 2023 | December 31, 2022 | |||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | 29,346 | 31,332 | ||||||
| Restricted cash | 956 | 962 | ||||||
| Short-term deposits | - | 2,000 | ||||||
| Other current assets | 2,632 | 2,587 | ||||||
| Total current assets | 32,934 | 36,881 | ||||||
| Non-current assets | ||||||||
| Other assets | 129 | - | ||||||
| Operating lease right-of-use assets | 3,767 | 3,860 | ||||||
| Property and equipment, net | 4,577 | 4,790 | ||||||
| Total non-current assets | 8,473 | 8,650 | ||||||
| 41,407 | 45,531 |
CONSOLIDATED BALANCE SHEETS
in thousands, except share and per share data)
| As of | ||||||||
| March 31, 2023 | December 31, 2022 | |||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities | ||||||||
| Trade accounts payable | 1,359 | 820 | ||||||
| Current portion of lease liabilities | 669 | 687 | ||||||
| Other accounts payable | 2,956 | 2,150 | ||||||
| Current portion of long-term debt | 5,216 | 4,282 | ||||||
| Total current liabilities | 10,200 | 7,939 | ||||||
| Non-current liabilities | ||||||||
| Contract liability | 1,976 | 1,976 | ||||||
| Long-term debt, net of current portion | 9,306 | 10,591 | ||||||
| Operating lease liabilities, net of current portion | 3,587 | 3,798 | ||||||
| Other liabilities | 192 | 188 | ||||||
| Total non-current liabilities | 15,061 | 16,553 | ||||||
| Commitments and Contingencies | ||||||||
| Stockholders' equity | ||||||||
| Preferred Stock, $0.0001 par value; Authorized - 1,000,000 shares as of March 31, 2023 and December 31, 2022. No shares issued and outstanding as of March 31, 2023 and December 31, 2022. | - | - | ||||||
| Common Stock, $0.0001 par value; Authorized - 120,000,000 shares as of March 31, 2023 and December 31, 2022. Issued -33,181,772 shares as of March 31, 2023 and 29,982,282 shares as of December 31, 2022. Outstanding -33,176,072 shares as of March 31, 2023 and 29,976,582 shares as of December 31, 2022. | 2 | 2 | ||||||
| Additional paid in capital | 159,306 | 157,838 | ||||||
| Accumulated deficit | (143,162 | ) | (136,801 | ) | ||||
| Total stockholders' equity | 16,146 | 21,039 | ||||||
| 41,407 | 45,531 |
CONSOLIDATED STATEMENTS OF OPERATIONS
in thousands, except share and per share data)
| Three Months Ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| Research and development ("R&D") expenses, net | 4,564 | 4,929 | ||||||
| Amortization of intangible assets | - | 380 | ||||||
| General and administrative expenses | 1,644 | 2,477 | ||||||
| Operating loss | 6,208 | 7,786 | ||||||
| Other income | (91 | ) | - | |||||
| Interest expenses | 565 | 461 | ||||||
| Finance income, net | (327 | ) | (87 | ) | ||||
| Loss before tax | 6,355 | 8,160 | ||||||
| Tax expenses | 6 | 9 | ||||||
| Net loss | 6,361 | 8,169 | ||||||
| Basic and diluted loss per share of Common Stock | 0.20 | 0.27 | ||||||
| Weighted average number of shares of Common Stock outstanding, basic and diluted | 32,125,227 | 29,754,240 |
LifeSci Advisors, LLC
Corporate Project Manager