Full Press Release Details
Reports Second Quarter 2023 Financial Results and Provides Business Update
Screening Completed in Part 2 of Phase 1b/2a Trial of BX004 with patient enrollment expected to exceed original estimates
grants BX004 Fast Track designation
Data from Part 2 Now Expected in November 2023
Will Host a Conference Call and Webcast Today at 8:00 am ET
Mass. and NESS ZIONA, Israel - Aug 9, 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 second quarter ended June 30, 2023.
BX004 clinical program in cystic fibrosis ("CF") continues to build significant momentum," said Jonathan Solomon, Chief
Executive Officer of BiomX. "We recently completed patient screening in Part 2 of our ongoing Phase 1b/2a trial with
patient enrollment expected to exceed original estimates, which reflects continued execution by
our clinical team and a growing awareness within the CF patient community of the BX004 program. I am also pleased to announce that BX004
just received Fast Track designation from the FDA, which provides further recognition that our BX004 program is addressing one of the
most serious and challenging unmet medical needs facing the CF community.
June, we presented our positive Part 1 results at the recent European Cystic Fibrosis Conference ("ECFC") meeting, which
highlighted the excellent safety of BX004 along with its notable activity in reducing P. aeruginosa bacteria burden. In Part 2,
we are testing BX004 in a larger number of CF patients who are dosed 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 bacterial burden, along with other exploratory
clinical endpoints. Based on our current estimates, we now believe the Part 2 data analysis will take an additional 4-6 weeks to complete.
We therefore expect to report initial results from Part 2 in November 2023."
Dermatitis ("AD") (BX005)
CORPORATE HIGHLIGHTS
Quarter 2023 Financial Results
| Research and development ("R&D") expenses, net were $3.8 million for the three months ended June 30, 2023, compared to $4.6 million for the same period in 2022. The decrease was primarily attributed to reduced salaries and related expenses and stock-based compensation expenses that resulted from a reduction in workforce, as part of a corporate restructuring the Company announced in May 2022 (the "Corporate Restructuring"); as well as deprioritizing pre-clinical and clinical activities related to the Company's AD product candidate, BX005, and higher proceeds from collaboration agreements in the 2023 period. These were partially offset by expenses related to conducting the Phase 1b/2a clinical trial of the Company's CF product candidate, BX004. | ||
| General and administrative expenses were $2.3 million for the three months ended June 30, 2023, compared to $2.4 million for the same period in 2022. The decrease primarily resulted from a reduction in the premium for the Company's directors' and officers' insurance policy. | ||
| Net loss for the second quarter of 2023 was $6.4 million, compared to $7.5 million for the same period in 2022. | ||
| Net cash used in operating activities for the six months ended June 30, 2023, was $9.1 million, compared to $16.4 million for the same period in 2022. |
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 second
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.
LifeSci Advisors, LLC
Corporate Project Manager
CONSOLIDATED BALANCE SHEETS
in thousands, except share and per share data)
| As of | ||||||||||
| Note | June 30, 2023 | December 31, 2022 | ||||||||
| ASSETS | ||||||||||
| Current assets | ||||||||||
| Cash and cash equivalents | 29,711 | 31,332 | ||||||||
| Restricted cash | 951 | 962 | ||||||||
| Short-term deposits | - | 2,000 | ||||||||
| Other current assets | 4 | 2,528 | 2,587 | |||||||
| Total current assets | 33,190 | 36,881 | ||||||||
| Non-current assets | ||||||||||
| Operating lease right-of-use assets | 3,673 | 3,860 | ||||||||
| Property and equipment, net | 4,390 | 4,790 | ||||||||
| Total non-current assets | 8,063 | 8,650 | ||||||||
| 41,253 | 45,531 |
CONSOLIDATED BALANCE SHEETS
in thousands, except share and per share data)
| As of | ||||||||||
| Note | June 30, 2023 | December 31, 2022 | ||||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||||
| Current liabilities | ||||||||||
| Trade accounts payable | 2,228 | 820 | ||||||||
| Current portion of lease liabilities | 654 | 687 | ||||||||
| Other accounts payable | 5 | 3,394 | 2,150 | |||||||
| Current portion of long-term debt | 7 | 5,391 | 4,282 | |||||||
| Total current liabilities | 11,667 | 7,939 | ||||||||
| Non-current liabilities | ||||||||||
| Contract liability | 1,976 | 1,976 | ||||||||
| Long-term debt, net of current portion | 7 | 8,159 | 10,591 | |||||||
| Operating lease liabilities, net of current portion | 3,396 | 3,798 | ||||||||
| Other liabilities | 190 | 188 | ||||||||
| Total non-current liabilities | 13,721 | 16,553 | ||||||||
| Commitments and Contingencies | 6 | |||||||||
| Stockholders' equity | 8 | |||||||||
| Preferred Stock, $0.0001 par value; Authorized - 1,000,000 shares as of June 30, 2023 and December 31, 2022. No shares issued and outstanding as of June 30, 2023 and December 31, 2022. | - | - | ||||||||
| Common Stock, $0.0001 par value; Authorized - 120,000,000 shares as of June 30, 2023 and December 31, 2022. Issued -45,979,730 shares as of June 30, 2023 and 29,982,282 shares as of December 31, 2022. Outstanding 45,974,030 shares as of June 30, 2023 and 29,976,582 shares as of December 31, 2022. | 3 | 2 | ||||||||
| Additional paid in capital | 165,435 | 157,838 | ||||||||
| Accumulated deficit | (149,573 | ) | (136,801 | ) | ||||||
| Total stockholders' equity | 15,865 | 21,039 | ||||||||
| 41,253 | 45,531 |
CONSOLIDATED STATEMENTS OF OPERATIONS
in thousands, except share and per share data)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||||
| Note | 2023 | 2022 | 2023 | 2022 | ||||||||||||||
| Research and development ("R&D") expenses, net | 3,818 | 4,584 | 8,382 | 9,513 | ||||||||||||||
| Amortization of intangible assets | - | 379 | - | 759 | ||||||||||||||
| General and administrative expenses | 2,255 | 2,361 | 3,899 | 4,838 | ||||||||||||||
| Operating loss | 6,073 | 7,324 | 12,281 | 15,110 | ||||||||||||||
| Other income | (90 | ) | - | (181 | ) | - | ||||||||||||
| Interest expenses | 745 | 488 | 1,310 | 949 | ||||||||||||||
| Finance income, net | (325 | ) | (339 | ) | (652 | ) | (426 | ) | ||||||||||
| Loss before tax | 6,403 | 7,473 | 12,758 | 15,633 | ||||||||||||||
| Tax expenses | 8 | 9 | 14 | 18 | ||||||||||||||
| Net loss | 6,411 | 7,482 | 12,772 | 15,651 | ||||||||||||||
| Basic and diluted loss per share of Common Stock | 9 | 0.12 | 0.25 | 0.31 | 0.53 | |||||||||||||
| Weighted average number of shares of Common Stock outstanding, basic and diluted | 51,552,923 | 29,774,709 | 41,860,338 | 29,764,588 |