Full Press Release Details
Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update
Announced Positive Results from Part 1 of Ongoing
Phase 1b/2a Trial of BX004 for Treatment of Lung Infections in Cystic Fibrosis ("CF")
Patient Enrollment Continues in Part 2 of Phase
1b/2a Trial with Results Expected in Third Quarter of 2023
Cash Runway Through at Least Mid-2024
Company Will Host a Conference Call and Webcast
CAMBRIDGE, Mass. and NESS ZIONA, Israel - March 29, 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 fourth quarter and full year ended December 31, 2022.
"2023 is shaping up to
be a very exciting year for our company, and the field of phage therapeutics. Based on the highly encouraging results from Part 1 of our
ongoing Phase 1b/2a trial, we believe the BX004 program is fast-emerging as one of the most promising new treatments for CF patients suffering
from chronic Pseudomonas aeruginosa infections," said Jonathan Solomon, Chief Executive Officer of BiomX. "BX004 not
only demonstrated excellent safety, but also resulted in notable reductions in bacterial load in the lungs of CF patients. We have
already dosed patients in Part 2 of the Phase 1b/2a study and remain on track to report results
in the third quarter of 2023.
"There is a growing body of clinical evidence, including data
from compassionate use programs, that phage-based therapies such as BX004 may represent an important new modality for treating the thousands
of CF patients who suffer from chronic, life-threatening lung infections. In Part 2, we will dose at least 24 CF patients with BX004 twice
a day and over a longer, 10-day treatment period. Results from Part 2 will provide important additional safety data and should provide
clinical insights, particularly regarding the reduction in Pseudomonas aeruginosa
bacterial burden, that will help us advance BX004 into pivotal testing. Other clinical endpoints including CF patients reported outcomes
and lung function also will be assessed."
Clinical Program Updates
Cystic Fibrosis (BX004)
Atopic Dermatitis (BX005)
RECENT CORPORATE HIGHLIGHTS
Fourth Quarter and Full Year 2022 Financial
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 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, the content of which does not form a part of this press
BiomX is a clinical-stage company developing
both natural and engineered phage cocktails designed to target and destroy bacteria that 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.
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 Part 2 of the Phase 1b/2a study and the potential of targeted phage therapy to treat infections in CF patients,
as well as other when it refers to other programs, such as the program to treat Atopic Dermatitis, 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
CONSOLIDATED BALANCE SHEETS
(USD in thousands, except share and per share data)
| As of December 31, | ||||||||
| 2022 | 2021 | |||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | 31,332 | 62,099 | ||||||
| Restricted cash | 962 | 996 | ||||||
| Short-term deposits | 2,000 | - | ||||||
| Other current assets | 2,587 | 3,543 | ||||||
| Total current assets | 36,881 | 66,638 | ||||||
| Non-current assets | ||||||||
| Operating lease right-of-use assets | 3,860 | 4,139 | ||||||
| Property and equipment, net | 4,790 | 5,694 | ||||||
| Intangible assets, net | - | 1,519 | ||||||
| Total non-current assets | 8,650 | 11,352 | ||||||
| 45,531 | 77,990 |
| As of December 31, | ||||||||
| 2022 | 2021 | |||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities | ||||||||
| Trade account payables | 820 | 2,795 | ||||||
| Current portion of lease liabilities | 687 | 819 | ||||||
| Contract liability | - | 1,976 | ||||||
| Other account payables | 2,150 | 5,453 | ||||||
| Current portion of long-term debt | 4,282 | - | ||||||
| Total current liabilities | 7,939 | 11,043 | ||||||
| Non-current liabilities | ||||||||
| Contract liability | 1,976 | - | ||||||
| Long-term debt, net of current portion | 10,591 | 14,410 | ||||||
| Operating lease liabilities, net of current portion | 3,798 | 4,787 | ||||||
| Other liabilities | 188 | 215 | ||||||
| Total non-current liabilities | 16,553 | 19,412 | ||||||
| Commitments and Contingencies | ||||||||
| Stockholders' equity | ||||||||
| Preferred Stock, $0.0001 par value; Authorized - 1,000,000 shares as of December 31, 2022 and December 31, 2021. No shares issued and outstanding as of December 31, 2022 and December 31, 2021. | - | - | ||||||
| Common stock, $0.0001 par value ("Common Stock"); Authorized - 120,000,000 shares as of December 31, 2022 and 60,000,000 shares as of December 31, 2021. Issued - 29,982,282 and 29,753,238 as of December 31, 2022 and 2021, respectively. Outstanding - 29,976,582 and 29,747,538 as of December 31, 2022 and 2021, respectively. | 2 | 2 | ||||||
| Additional paid in capital | 157,838 | 156,017 | ||||||
| Accumulated deficit | (136,801 | ) | (108,484 | ) | ||||
| Total Stockholders' equity | 21,039 | 47,535 | ||||||
| 45,531 | 77,990 |
CONSOLIDATED STATEMENTS OF OPERATIONS
(USD in thousands, except share and per share data)
| Year ended December 31, | ||||||||
| 2022 | 2021 | |||||||
| Research and development ("R&D") expenses, net | 16,244 | 22,676 | ||||||
| Amortization of intangible assets | 1,519 | 1,519 | ||||||
| General and administrative expenses | 9,456 | 11,267 | ||||||
| Operating loss | 27,219 | 35,462 | ||||||
| Other income | (134 | ) | - | |||||
| Interest expenses | 2,069 | 699 | ||||||
| Financial income, net | (902 | ) | (2 | ) | ||||
| Loss before tax | 28,252 | 36,159 | ||||||
| Tax expenses | 65 | 67 | ||||||
| Net Loss | 28,317 | 36,226 | ||||||
| Basic and diluted loss per share of Common Stock | 0.95 | 1.39 | ||||||
| Weighted average number of shares of Common Stock outstanding, basic and diluted | 29,854,003 | 26,007,947 |
LifeSci Advisors, LLC
Corporate Project Manager