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BiomX Reports Second Quarter 2023 Financial Results and Provides Business Update

August 9, 2023 6:30 AM

Patient Screening Completed in Part 2 of Phase 1b/2a Trial of BX004 with patient enrollment expected to exceed original estimates

FDA grants BX004 Fast Track designation

Initial Data from Part 2 Now Expected in November 2023

Company Will Host a Conference Call and Webcast Today at 8:00 am ET

CAMBRIDGE, Mass. and NESS ZIONA, Israel, Aug. 09, 2023 (GLOBE NEWSWIRE) -- 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.

“Our 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.

“In 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.”

Clinical Program Updates

Cystic Fibrosis (BX004)

Atopic Dermatitis (“AD”) (BX005)


Second Quarter 2023 Financial Results

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 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.

About BiomX BiomX 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.

Safe HarborThis 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.

BiomX Contacts

Investor Relations:LifeSci Advisors, LLCJohn Mullaly(617)-698-9253[email protected]

BiomX, Inc.Anat PrimovichCorporate Project Manager+972 (50) 697-7228[email protected]

Source: BiomX Inc.

1 Source: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track

BIOMX INC.CONDENSED CONSOLIDATED BALANCE SHEETS(USD in thousands, except share and per share data)(unaudited)
As of
Note June 30,2023 December 31,2022
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

BIOMX INC.CONDENSED CONSOLIDATED BALANCE SHEETS(USD in thousands, except share and per share data)(unaudited)
As of
Note June 30, 2023 December 31, 2022
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

BIOMX INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(USD in thousands, except share and per share data)(unaudited)
Three Months EndedJune 30, Six Months EndedJune 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

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Source: BiomX


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