BiomX Reports Second Quarter 2025 Financial Results and Provides Program Updates
Rhea-AI Summary
BiomX (NYSE American: PHGE) reported significant clinical progress and Q2 2025 financial results. The company achieved positive Phase 2 results for BX211 in diabetic foot osteomyelitis, demonstrating >40% wound size reduction versus placebo. Their BX004 program showed promising results with a ~500-fold bacterial reduction in cystic fibrosis patients, as published in Nature Communications.
The company has initiated patient dosing in the Phase 2b trial of BX004, with topline results expected in Q1 2026. Financial highlights include a cash balance of $15.2 million as of June 30, 2025, with funding runway into Q1 2026. Q2 2025 showed reduced operating expenses, with R&D expenses at $5.0 million (down from $6.9M) and net loss of $6.0 million.
Positive
- Phase 2 BX211 showed >40% wound size reduction vs placebo with statistical significance
- BX004 demonstrated ~500-fold bacterial reduction with no detectable resistance
- Successfully initiated Phase 2b trial for BX004 in Cystic Fibrosis
- R&D expenses decreased from $6.9M to $5.0M year-over-year
- Publication in prestigious Nature Communications journal validating technology
Negative
- Cash balance decreased from $18M to $15.2M since December 2024
- Net loss of $6.0M compared to income of $4.5M in Q2 2024
- Limited cash runway only extending into Q1 2026
News Market Reaction – PHGE
In the Aug 13 session, PHGE declined 11.69%, reflecting a significant negative market reaction. Argus tracked a peak move of +11.5% during that session. Argus tracked a trough of -9.8% from its starting point during tracking. Our momentum scanner triggered 15 alerts that day, indicating notable trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
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Positive Phase 2 results for BX211 demonstrated >
Nature Communications publication of new BX004 Phase 1b/2a data demonstrated further ~500-fold (2.7 log₁₀)2 bacterial reduction versus placebo with no detectable emergence of resistance observed, highlighting strength of BiomX platform capabilities
Phase 2b trial of BX004 in Cystic Fibrosis (CF) has successfully commenced patient dosing; FDA feedback on real-world evidence strategy expected in H2 2025; Company expects to report topline results in Q1 2026
BiomX will host a conference call and webcast today at 8:00 AM ET
NESS ZIONA, Israel, Aug. 13, 2025 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies targeting specific pathogenic bacteria, today announced financial results for the second quarter ended June 30, 2025, and provided recent clinical and corporate updates.
“In the past few months, BiomX achieved several significant milestones that advance our pipeline and further validate our phage therapy platform,” said Jonathan Solomon, Chief Executive Officer of BiomX. “Positive Phase 2 results for BX211 in diabetic foot osteomyelitis demonstrated sustained, statistically significant improvements in wound size reduction, with over
Clinical Program Updates
BX211 – Phage for the treatment of patients with diabetic foot infections and osteomyelitis (DFI/DFO) associated with Staphylococcus aureus (S. aureus)
- BiomX reported positive topline results from the Phase 2 trial of BX211 in March 2025 just prior to the start of the second quarter, demonstrating that BX211 was safe and well-tolerated and produced sustained and statistically significant1 percentage area reduction (PAR) of ulcer size (p = 0.046 at week 12; p=0.052 at week 13) with separation from placebo starting at week 7 and a difference greater than
40% by week 10. - The Phase 2 trial results also showed that BX211 produced statistically significant improvements in both ulcer depth at week 13 in patients with ulcer depth defined as bone exposure at baseline (p=0.048) and in reducing the expansion of ulcer area (p=0.017) compared to placebo, with all patients receiving standard of care including systemic antibiotic therapy as appropriate over the 12-week treatment period.
- Planning for a potential registrational study of BX211 is underway, pending feedback from the U.S. Food and Drug Administration (FDA).
- Following strong Phase 2 results, the Company hosted a Virtual Key Opinion Leader event during the second quarter featuring leading clinical experts in diabetic foot infections and osteomyelitis. The discussion highlighted the clinical significance of the BX211 data, its potential role alongside standard of care, and perspectives on the path to registrational development. A replay of the webcast is available at the following Link, the content of which does not form a part of this press release.
- The Company is in continued discussions with the U.S. Defense Health Agency regarding next steps for the BX211 program following the positive Phase 2 results.
BX004 – Fixed phage cocktail for chronic Pseudomonas aeruginosa (P. aeruginosa) in patients with CF
- In July 2025, BiomX successfully initiated dosing of patients in its Phase 2b trial of BX004. The Phase 2b trial is a randomized, double-blind, placebo-controlled, multicenter study in approximately 60 CF patients with chronic P. aeruginosa infections. Patients are randomized 2:1 to receive either BX004 or placebo via inhalation twice daily for 8 weeks. The trial is designed to measure multiple efficacy endpoints, including reduction in bacterial burden, improvements in lung function, and enhanced quality of life as measured by validated patient questionnaires.
- The Company expects to report topline results from the Phase 2b study in the first quarter of 2026.
- In the second half of 2025, BiomX expects to receive feedback from the FDA regarding the potential investigation and use of real-world evidence linking bacterial reduction to clinical outcomes. Successful alignment could potentially streamline approval pathway.
- Earlier in July, Nature Communications published new findings from the Company’s Phase 1b/2a trial, showcasing previously unreported antimicrobial efficacy data showing that BX004 achieved a substantially greater improvement of approximately 500-fold (2.7 log₁₀)2 in bacterial reduction compared with placebo in CF patients. The data also highlight that no bacterial resistance to BX004 was detected during the trial, and also detailed in the article are BiomX’s innovative approach to large-scale data analysis in order to optimize bacteriophage cocktails.
Second Quarter 2025 Financial Results
Cash balance and restricted cash as of June 30, 2025, were
Research and development expenses, net were
General and administrative expenses were
Net loss was
Net cash used in operating activities for the six months ended June 30, 2025, was
Conference Call and Webcast Details
BiomX will host a conference call and webcast on August 13, 2025, at 8 AM ET to discuss its second quarter 2025 financial results and to provide a corporate update.
Conference Call
https://register-conf.media-server.com/register/BI35d84b315cb147c78290b6b8f1fde487
Webcast Link
https://edge.media-server.com/mmc/p/89dfoxpe/
About BX211
BX211 is a phage treatment for the treatment of DFO associated with S. aureus. DFO is a bacterial infection of the bone that usually develops from an infected foot ulcer and is a leading cause of amputation in patients with diabetes. In March 2025, BiomX announced positive topline results from the Phase 2 trial in which BX211 was demonstrated to be safe and well-tolerated and patients receiving BX211 exhibited statistically significant1 and sustained reduction of ulcer size (PAR)(p=0.046 at week 12; p=0.052 at week 13), with a separation from placebo starting at week 7 and a difference greater than
About BX004
BiomX is developing BX004, a fixed multi-phage cocktail, for the treatment of CF patients with chronic pulmonary infections caused by P. aeruginosa, a main contributor to morbidity and mortality in patients with CF. In February 2023, BiomX announced positive results from Part 1 of the Phase 1b/2a study, showing safety, tolerability, and microbiologic activity. In November 2023, BiomX announced positive topline results from Part 2 of the Phase 1b/2a trial, in which BX004 demonstrated improvement in pulmonary function associated with a reduction in P. aeruginosa burden compared to placebo in a predefined subgroup of patients with reduced lung function (baseline FEV1<
About BiomX
BiomX is a clinical-stage company leading the development of natural and engineered phage cocktails and personalized phage treatments designed to target and destroy harmful bacteria for the treatment of chronic diseases with substantial unmet needs. BiomX discovers and validates proprietary bacterial targets and applies its BOLT (“BacteriOphage Lead to Treatment”) platform to customize 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 Harbor
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 refers to its anticipated timing for reporting results for its clinical assets as well as the design of clinical trials thereof, future catalysts, potential timing and outcome of expected feedback from the FDA and discussions with the U.S. Defense Health Agency, the potential safety, efficacy and toleration of BX004 and BX211, the potential benefits of BX004 and BX211, future clinical development of BX004 and BX211, including conducting a registrational trial in BX211, the potential of its candidates to address the substantial unmet needs of patients, and the estimates of the sufficiency of its cash, cash equivalents and short-term deposits, it is using 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. These risks and uncertainties include, but are not limited to, changes in applicable laws or regulations; the possibility that BiomX may be adversely affected by other economic, business, and/or competitive factors, including risks inherent in pharmaceutical research and development, such as: adverse results in BiomX’s drug discovery, preclinical and clinical development activities, the risk that the results of preclinical studies and early clinical trials may not be replicated in later clinical trials, BiomX’s ability to enroll patients in its clinical trials, and the risk that any of its clinical trials may not commence, continue or be completed on time, or at all; decisions made by the FDA, and other regulatory authorities; decisions made by investigational review boards at clinical trial sites and publication review bodies with respect to our development candidates; BiomX’s ability to obtain, maintain and enforce intellectual property rights for its platform and development candidates; its potential dependence on collaboration partners; competition; uncertainties as to the sufficiency of BiomX’s cash resources to fund its planned activities for the periods anticipated and BiomX’s ability to manage unplanned cash requirements; and general economic and market conditions. 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 25, 2025, 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.
Contacts:
BiomX, Inc.
Ben Cohen
Head Corporate Communications
benc@biomx.com
1 All p-values described in this release are non-adjusted
2 A 2.7 log₁₀ reduction represents a 10^2.7 = ~500-fold reduction in bacterial load, which equates to approximately
BIOMX INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(USD in thousands, except share and per share data)
(unaudited)
| As of | ||||||||||||||
| June 30, 2025 | December 31, 2024 | |||||||||||||
| ASSETS | ||||||||||||||
| Current assets | ||||||||||||||
| Cash and cash equivalents | 14,046 | 16,856 | ||||||||||||
| Restricted cash | 979 | 958 | ||||||||||||
| Other current assets | 1,610 | 2,706 | ||||||||||||
| Total current assets | 16,635 | 20,520 | ||||||||||||
| Non-current assets | ||||||||||||||
| Non-current restricted cash | 161 | 161 | ||||||||||||
| Operating lease right-of-use assets | 4,959 | 5,457 | ||||||||||||
| Property and equipment, net | 4,245 | 5,045 | ||||||||||||
| In-process Research and development asset | 12,050 | 12,050 | ||||||||||||
| Total non-current assets | 21,415 | 22,713 | ||||||||||||
| 38,050 | 43,233 | |||||||||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||||||||
| Current liabilities | ||||||||||||||
| Trade accounts payable | 2,178 | 1,882 | ||||||||||||
| Current portion of lease liabilities | 1,233 | 1,130 | ||||||||||||
| Other accounts payable | 2,851 | 5,255 | ||||||||||||
| Total current liabilities | 6,262 | 8,267 | ||||||||||||
| Non-current liabilities | ||||||||||||||
| Operating lease liabilities, net of current portion | 8,143 | 8,454 | ||||||||||||
| Other liabilities | 80 | 77 | ||||||||||||
| Warrants | 4,405 | 2,287 | ||||||||||||
| Total non-current liabilities | 12,628 | 10,818 | ||||||||||||
| Commitments and Contingencies (Note 6) | ||||||||||||||
| Stockholders’ equity | ||||||||||||||
| Preferred Stock, | 18,645 | 18,645 | ||||||||||||
| Common Stock, | 7 | 6 | ||||||||||||
| Additional paid in capital | 194,901 | 186,194 | ||||||||||||
| Accumulated deficit | 194,393) | ) | (180,697 | |||||||||||
| Total stockholders’ equity | 19,160 | 24,148 | ||||||||||||
| 38,050 | 43,233 | |||||||||||||
BIOMX INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(USD in thousands, except share and per share data)
(unaudited)
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Research and development (“R&D”) expenses, net | 5,014 | 6,897 | 10,264 | 11,002 | |||||||||||
| General and administrative expenses | 2,419 | 2,828 | 4,925 | 5,508 | |||||||||||
| Operating loss | 7,433 | 9,725 | 15,189 | 16,510 | |||||||||||
| Other expenses (income) | 70 | (2,017 | ) | 76 | (2,105) | ||||||||||
| Interest expenses | 5 | 13 | 10 | 863 | |||||||||||
| Income from change in fair value of warrants | 1,498) | ( | (11,868 | ) | (2,412) | (3,858) | |||||||||
| Finance expense (income), net | 25 | (329 | ) | 830 | 1,436 | ||||||||||
| Loss (income) before tax | 6,035 | (4,476 | ) | 13,693 | 12,846 | ||||||||||
| Tax expenses | 2 | 5 | 3 | 10 | |||||||||||
| Net loss (income) | 6,037 | (4,471 | ) | 13,696 | 12,856 | ||||||||||
| Basic loss (earnings) per share of Common Stock | 0.19 | (0.14 | ) | 0.50 | 1.95 | ||||||||||
| Diluted loss per share of Common Stock | 0.19 | 0.69 | 0.50 | 1.95 | |||||||||||
| Weighted average number of shares used in computing basic loss (earnings) per share of Common Stock | 31,308,396 | 6,980,943 | 27,250,021 | 6,605,952 | |||||||||||
| Weighted average number of shares used in computing diluted loss per share of Common Stock | 31,308,396 | 10,750,194 | 27,250,021 | 6,605,952 | |||||||||||
