Full Press Release Details
Reports Third Quarter 2022 Financial Results and Provides Business Update
Continued Progress Enrolling Patients in Phase
1/2 Trial of BX004 for Treatment of Lung Infections in Cystic Fibrosis; Results from Part 1 of the
Trial Now Expected in Q1 2023
Announced Publication in Cell of Research
Demonstrating Proof-of-Concept Assessment of Orally Administered Phage Treatment in Preclinical Model of Inflammatory Bowel Disease
Cash Runway Through at Least Mid-2024
Company Will Host a Conference Call and Webcast
NESS ZIONA, Israel - November 9, 2022 - BiomX
Inc. (NYSE American: PHGE) ("BiomX" or the "Company"), a clinical-stage microbiome 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, 2022.
"Despite encountering challenges
early in the quarter in recruiting cystic fibrosis patients following the COVID-19 pandemic, we have recently put in place important mechanisms
to accelerate screening and enrollment and are encouraged by the recent increased enrollment into BX004 that will impact both parts of
the trial," said Jonathan Solomon, Chief Executive Officer of BiomX. "Based on these latest trends, we now anticipate
that enrollment for Part 1 of the study will be complete by year-end. Factoring in a modest impact from the U.S. holiday season and the
time required for data analysis following each patient's treatment period, we now expect to announce results from Part 1 of the
trial in the first quarter of 2023, followed by results from Part 2 in the third quarter of 2023. We believe that we remain financially
and operationally positioned to execute on our business plan with respect to our CF program, with cash runway anticipated to take us through
at least mid-2024. We appreciate the continued support of our shareholders and look forward to providing our initial data from the CF
Clinical Program Updates
Cystic Fibrosis (BX004)
Atopic Dermatitis (BX005)
RECENT CORPORATE HIGHLIGHTS
Third Quarter 2022 Financial Results
Conference Call and Webcast Information
will host a conference call and webcast today at 8:00 am ET to report financial results and business updates for the third quarter 2022.
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.
BiomX is a clinical-stage microbiome 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.
Additional information is available at www.biomx.com,
the content of which does not form a part of 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 future updates on its CF and Atopic Dermatitis
programs, its expectations regarding the timing of the completion of enrollment and results of the CF trial, the potential safety, tolerability
and potential treatment effect of its product candidates, the potential to achieve the applicable clinical milestones required to receive
an additional $2 million investment from CFF, and its cash runway and financial and operational position, 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 30, 2022 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.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(USD in thousands, except share and per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||
| Note | 2022 | 2021 | 2022 | 2021 | ||||||||||||||
| Research and development expenses, net | 3,536 | 6,608 | 13,049 | 16,102 | ||||||||||||||
| Amortization of intangible assets | 380 | 380 | 1,139 | 1,139 | ||||||||||||||
| General and administrative expenses | 2,633 | 2,845 | 7,471 | 8,436 | ||||||||||||||
| Operating loss | 6,549 | 9,833 | 21,659 | 25,677 | ||||||||||||||
| Other income | (52 | ) | - | (52 | ) | - | ||||||||||||
| Interest expenses | 555 | 172 | 1,504 | 172 | ||||||||||||||
| Financial expenses (income), net | (280 | ) | 16 | (706 | ) | (96 | ) | |||||||||||
| Loss before tax | 6,772 | 10,021 | 22,405 | 25,753 | ||||||||||||||
| Tax expenses | 8 | 10 | 26 | 16 | ||||||||||||||
| Net loss | 6,780 | 10,031 | 22,431 | 25,769 | ||||||||||||||
| Basic and diluted loss per share of Common Stock | 6 | 0.23 | 0.37 | 0.75 | 1.03 | |||||||||||||
| Weighted average number of shares of Common Stock outstanding, basic and diluted | 29,907,812 | 27,077,903 | 29,812,542 | 25,120,037 |
CONDENSED CONSOLIDATED BALANCE SHEETS
(USD in thousands, except share and per share data)
| As of | ||||||||||
| Note | September 30, 2022 | December 31, 2021 | ||||||||
| ASSETS | ||||||||||
| Current assets | ||||||||||
| Cash and cash equivalents | 37,067 | 62,099 | ||||||||
| Restricted cash | 960 | 996 | ||||||||
| Short-term deposits | 3,500 | - | ||||||||
| Other current assets | 1,003 | 3,543 | ||||||||
| Total current assets | 42,530 | 66,638 | ||||||||
| Property and equipment, net | 5,034 | 5,694 | ||||||||
| Intangible assets, net | 382 | 1,519 | ||||||||
| Operating lease right-of-use assets | 3,955 | 4,139 | ||||||||
| Total non-current assets | 9,371 | 11,352 | ||||||||
| 51,901 | 77,990 | |||||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||||
| Current liabilities | ||||||||||
| Trade accounts payable | 1,781 | 2,795 | ||||||||
| Other accounts payable | 2,023 | 5,453 | ||||||||
| Contract liability | - | 1,976 | ||||||||
| Current portion of operating lease liabilities | 687 | 819 | ||||||||
| Current portion of long-term debt | 4 | 2,989 | - | |||||||
| Total current liabilities | 7,480 | 11,043 | ||||||||
| Non-current liabilities | ||||||||||
| Contract liability | 1,976 | - | ||||||||
| Long-term debt, net of current portion | 4 | 11,799 | 14,410 | |||||||
| Operating lease liabilities, net of current portion | 3,882 | 4,787 | ||||||||
| Other liabilities | 206 | 215 | ||||||||
| Total non-current liabilities | 17,863 | 19,412 | ||||||||
| Commitments and Contingencies | 3 | |||||||||
| Stockholders' equity | 5 | |||||||||
| Preferred Stock, $0.0001 par value; Authorized - 1,000,000 shares as of September 30, 2022 and December 31, 2021. No shares issued and outstanding as of September 30, 2022 and December 31, 2021. | - | - | ||||||||
| Common Stock, $0.0001 par value; Authorized - 120,000,000 shares as of September 30, 2022 and 60,000,000 shares as of December 31, 2021. Issued - 29,982,282 shares as of September 30, 2022 and 29,753,238 shares as of December 31, 2021. Outstanding - 29,976,582 shares as of September 30, 2022 and 29,747,538 shares as of December 31, 2021. | 2 | 2 | ||||||||
| Additional paid in capital | 157,471 | 156,017 | ||||||||
| Accumulated deficit | (130,915 | ) | (108,484 | ) | ||||||
| Total stockholders' equity | 26,558 | 47,535 | ||||||||
| 51,901 | 77,990 |
LifeSci Advisors, LLC
Corporate Project Manager