BiomX Inc.
For the period ended Sep 30, 2025. Filed Nov 12, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 12, 2025
HLSQ$0.13+6.8%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-13.
0001213900-25-075328
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-12.
0001213900-25-109186
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 83 previous paragraphs and 87 current paragraphs.
38 unchanged; 37 reworded; 11 added; 5 removed; 3 previous and 1 current paragraphs rearranged.
Tables are not compared: 17 previous and 17 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (11)
Current report
On August 24, 2025, BiomX Israel filed an application with the Israeli Registrar of Companies for the expedited voluntary liquidation of RondinX Ltd. As of that date, RondinX had no significant operations. Pursuant to the Israeli Companies Law, if no objections are filed, RondinX Ltd is expected to be dissolved 100 days following the publication of the notice of the voluntary liquidation application, which is anticipated to occur on or about December 2, 2025.
Current report
In August 2025, the FDA placed a clinical hold on the Phase 2b study as it reviews data submitted by BiomX on third-party nebulizer used to deliver BX004; no concerns were raised in the clinical hold notification regarding the BX004 drug candidate. As a result of the FDA’s notification, patient screening and enrollment in the U.S. portion of the Phase 2b trial of BX004 was paused. In October 2025, BiomX received additional questions from the FDA, which questions were narrow in scope and pertained solely to the nebulizer device, with no concerns raised regarding the BX004 drug product itself. BiomX believes it has fully addressed the FDA queries relating to the third-party nebulizer. In Europe, all components of the third-party nebulizer device are CE marked and thus deemed to meet applicable regulatory requirements. The study in the EU has been approved, and enrollment and dosing of patients has continued in accordance with the protocol. Topline readout of the study results is expected in the first quarter of 2026.
Current report
In October 2025, BiomX received written feedback from the FDA recognizing that, even in the era of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) modulators, there remains a significant unmet need for therapies addressing chronic Pseudomonas aeruginosa infection in individuals with CF. The FDA outlined several potential development pathways, including opportunities to refine inclusion criteria and enrich patient populations in a Phase 3 program, with the aim of enhancing the ability to demonstrate therapeutic benefits.
Current report
BX011 is a fixed multi-phage cocktail, for the treatment of DFI associated with Staphylococcus aureus, or S. aureus, a key bacterium implicated in development and exacerbation of DFI. DFI is a serious bacterial infection commonly arising from an ulcer on the foot and is a leading cause of amputation in patients with diabetes. We previously reported positive statistically significant results targeting S. aureus in DFO patients. BX011 incorporates multiple proprietary phages, among them phage previously evaluated in the BX211 study, to provide broad and potent coverage against this S. aureus in DFI patients. BX011’s advancement will continue in alignment with ongoing discussions with the U.S. Defense Health Agency and subject to the availability of necessary financial resources, with plans to initiate a Phase 2a clinical trial in DFI.
Current report
Given the straightforward pathway for regulatory approval in DFI provided by the FDA, BiomX is prioritizing the development of BX011 for DFI before potential expansion to address DFO patient populations, which share the same S. aureus bacterial target, pending sufficiency of financial resources.
Current report
Such decrease was partially offset by an increase in depreciation expenses attributable to the accelerated depreciation of leasehold improvements resulting from the modification of our office lease agreement in Ness Ziona, Israel, as well as by lower grants received, which resulted in higher net expenses between the two periods. During the three months ended September 30, 2025, the Company recorded $0.3 million of MTEC grants, compared to $0.9 million grants recorded in the same period in 2024.
Current report
Goodwill impairment in the 2024 period was $0.8 million, following an impairment of the Company’s goodwill that resulted from the Acquisition. The Company’s market capitalization as of September 30, 2024, was lower in comparison to its stockholders’ equity and triggered an impairment assessment that concluded that the entire goodwill should be impaired.
Current report
Comparison of the Nine Months Ended September 30, 2025 and September 30, 2024
Current report
Goodwill impairment in the 2024 period was $0.8 million, following an impairment of the Company’s goodwill that resulted from the Acquisition. The Company’s market capitalization as of September 30, 2024, was lower in comparison to its stockholders’ equity and triggered an impairment assessment that concluded that the entire goodwill should be impaired.
Current report
Diluted loss per share of Common Stock was $0.80 for the nine months ended September 30, 2025, compared to $2.45 for the nine months ended September 30, 2024. The change of $1.65 was primarily driven by the fact that, in the prior period, the diluted loss per share calculation neutralized the revaluation effect of warrants that were considered dilutive at that time, whereas in the current period all warrants are considered anti-dilutive and therefore excluded from the calculation.
Current report
From August 13, 2025 through November 11, 2025, we sold 2,313,678 shares of Common Stock under the 2023 ATM Agreement, at an average price of $0.58 per share, raising aggregate net proceeds of approximately $1,305, after deducting an aggregate commission of $51.
Removed paragraphs (5)
Previous report
On May 1, 2025, APT’s Exclusive License with the United States Navy expired by its terms.
Previous report
BiomX has been in communication with the FDA and additional regulatory agencies regarding the potential to use Real-World Evidence, or RWE, to explore the link between P. aeruginosa reduction and improved clinical outcomes. RWE is clinical evidence on the usage, benefits, or risks of a medical product derived from real-world data, which includes sources such as electronic health records, claims data, patient registries, wearable devices, and observational studies. We anticipate feedback from the FDA and European Committee for Medicinal Products for Human Use in 2025 to discuss our proposed plan to use RWE to support potential future regulatory filings.
Previous report
BiomX is planning a potential registrational study of BX211, pending FDA feedback and availability of cash resources.
Previous report
Diluted loss per share of Common Stock was $0.19 for the three months ended June 30, 2025, compared to $0.69 for the three months ended June 30, 2024. The change of $0.50 was primarily driven by an increase in the weighted average shares of Common Stock outstanding, following issuances related to the February 2025 Financing.
Previous report
Comparison of the Six Months Ended June 30, 2025 and June 30, 2024
Reworded paragraphs (37)
Previous wording
We are a clinical stage product discovery company developing products using both natural and engineered phage technologies designed to target and kill specific harmful bacteria associated with chronic diseases, such as cystic fibrosis, or CF and diabetic foot osteomyelitis, or DFO. Bacteriophage or phage are bacterial, species-specific, strain-limited viruses that infect, amplify and kill the target bacteria and are considered inert to mammalian cells. By utilizing proprietary combinations of naturally occurring phage and by creating novel phage using synthetic biology, we develop phage-based therapies intended to address both large-market and orphan diseases.
Current wording
We are a clinical stage product discovery company developing products using both natural and engineered phage technologies designed to target and kill specific harmful bacteria associated with chronic diseases, such as cystic fibrosis, or CF, and diabetic foot infections, or DFI. Bacteriophage or phage are bacterial, species-specific, strain-limited viruses that infect, amplify and kill the target bacteria and are considered inert to mammalian cells. By utilizing proprietary combinations of naturally occurring phage and by creating novel phage using synthetic biology, we develop phage-based therapies intended to address both large-market and orphan diseases.
Previous wording
BiomX has initiated a randomized, double blind, placebo-controlled, multi-center Phase 2b study in CF patients with chronic P. aeruginosa pulmonary infections and announced first patient dosed on July 14, 2025. The study will enroll up to 60 patients randomized at a 2:1 ratio to BX004 or placebo. Treatment is expected to be administered via inhalation twice daily for a duration of 8 weeks. The study is designed to monitor the safety and tolerability of BX004 and is designed to demonstrate improvement in microbiological reduction of P. aeruginosa burden and evaluation of effects on clinical parameters such as lung function measured by FEV1 and patient reported outcomes. Topline readout of the study results is expected in the first quarter of 2026.
Current wording
BiomX has initiated a randomized, double blind, placebo-controlled, multi-center Phase 2b study in CF patients with chronic P. aeruginosa pulmonary infections and announced first patient dosed on July 14, 2025. The study will enroll up to 60 patients randomized at a 2:1 ratio to BX004 or placebo. Treatment is expected to be administered via inhalation twice daily for a duration of 8 weeks. The study is designed to monitor the safety and tolerability of BX004 and is designed to demonstrate improvement in microbiological reduction of P. aeruginosa burden and evaluation of effects on clinical parameters such as lung function measured by FEV1 and patient reported outcomes.
Previous wording
BX211 – Treatment of Diabetic Foot Infections & Osteomyelitis, or DFI/DFO
Current wording
Treatment of Diabetic Foot Infections, or DFI
Previous wording
BX211 is a phage therapy for the treatment of diabetic foot infections (DFI) and diabetic foot osteomyelitis (DFO) caused by Staphylococcus aureus (S. aureus), a key bacterium implicated in development and exacerbation of diabetic foot infections. The phage treatment tailors a specific phage selected from a proprietary phage-bank according to the specific strain of S. aureus biopsied and isolated from each patient. DFO is a bacterial infection of the bone that usually develops from a DFI from an infected foot ulcer and is a leading cause of amputation in patients with diabetes. We believe that scientific literature demonstrating the potential benefit in treating DFIs using phage in animal models as well as numerous successful compassionate cases using phage therapy to treat DFI and DFO patients support our approach of using phage therapy to treat DFI/DFO.
Current wording
BX211 is a phage therapy for the treatment of DFO caused by S. aureus, a key bacterium implicated in development and exacerbation of DFO. The phage treatment tailors a specific phage selected from a proprietary phage-bank according to the specific strain of S. aureus biopsied and isolated from each patient. 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. We believe that scientific literature demonstrates the potential benefit in treating DFO using phage in animal models as well as numerous successful compassionate cases using phage therapy to treat DFO patients support our approach of using phage therapy to treat DFO.
Previous wording
Chronic* P. aeruginosa *infections in NCFB patients are a main contributor to morbidity and mortality in this disease. Pending positive data of BX004 in our cystic fibrosis Phase 2B study, we expect to look to initiate studies into NCFB as an additional indication for BX004.
Current wording
Chronic* P. aeruginosa *infections in NCFB patients are a main contributor to morbidity and mortality in this disease. Pending positive data of BX004 in our CF Phase 2b study, we expect to look to initiate studies into NCFB as an additional indication for BX004.
Previous wording
We are supporting a study conducted by the NIH and The Antibacterial Resistance Leadership Group targeting P. aeruginosa infections in CF patients under FDA emergency Investigational New Drug allowance. Phase 1b/2, multi-centered, randomized, double-blind, placebo-controlled trial is assessing the safety and microbiological activity of a single IV dose of bacteriophage therapy in cystic fibrosis subjects colonized with P. aeruginosa.
Current wording
We are supporting a study conducted by the NIH and The Antibacterial Resistance Leadership Group targeting P. aeruginosa infections in CF patients under FDA emergency Investigational New Drug allowance. Phase 1b/2, multi-centered, randomized, double-blind, placebo-controlled trial is assessing the safety and microbiological activity of a single IV dose of bacteriophage therapy in CF subjects colonized with P. aeruginosa.
Previous wording
BX005 is our topical phage product candidate targeting S. aureus. S. aureus is more abundant on the skin of AD patients than on the skin of healthy individuals and on lesional skin than non-lesional skin. It also increases in abundance, becoming the dominant bacteria, when patients experience flares. By reducing the load ofS. aureus, BX005 is designed to shift the skin microbiome composition to its ‘pre-flare’ state and potentially provide a clinical benefit. In preclinicalin vitro studies, BX005 was shown to eradicate over 90% of strains, including antibiotic resistant strains, from a panel ofS. aureus strains (120 strains isolated from skin of subjects from the U.S. and Europe). On April 8, 2022, the FDA approved the Company’s Investigational New Drug (IND) application for BX005.
Current wording
BX005 is our topical phage product candidate targeting S. aureus. S. aureus is more abundant on the skin of AD patients than on the skin of healthy individuals and on lesional skin than non-lesional skin. It also increases in abundance, becoming the dominant bacteria, when patients experience flares. By reducing the load of S. aureus, BX005 is designed to shift the skin microbiome composition to its ‘pre-flare’ state and potentially provide a clinical benefit. In preclinical in vitro studies, BX005 was shown to eradicate over 90% of strains, including antibiotic resistant strains, from a panel of S. aureus strains (120 strains isolated from skin of subjects from the U.S. and Europe). On April 8, 2022, the FDA approved the Company’s Investigational New Drug (IND) application for BX005.
Previous wording
In 2024, we discontinued the development of BX005, choosing instead to focus our resources on our Cystic Fibrosis and DFO programs.
Current wording
In 2024, we discontinued the development of BX005, choosing instead to focus our resources on our CF and DFO programs.
Previous wording
R&D expenses, net (net of grants received from the Medical Technology Enterprise Consortium (“MTEC”) and the Israel Innovation Authority (“IIA”)) were $5.0 million for the three months ended June 30, 2025, compared to $6.9 million for the same period in 2024. The decrease of $1.9 million, or 28%, is primarily due to the following factors:
Current wording
R&D expenses, net (net of grants received from the Medical Technology Enterprise Consortium, or MTEC, and the Israel Innovation Authority, or IIA) were $6.1 million for the three months ended September 30, 2025, compared to $7.3 million for the same period in 2024. The decrease of $1.2 million, or 16%, is primarily due to the following factors:
Previous wording
General and administrative expenses were $2.4 million for the three months ended June 30, 2025, compared to $2.8 million for the same period in 2024. The decrease of $0.4 million, or 14%, was primarily driven by a reduction in legal and other professional service fees, which was partially offset by an increase in share-based compensation expenses.
Current wording
General and administrative expenses were $2.4 million for the three months ended September 30, 2025, compared to $3.2 million for the same period in 2024. The decrease of $0.8 million, or 25%, was primarily driven by a reduction in salaries and share-based compensation expenses, as well as in legal and other professional service fees. This decrease was partially offset by an increase in depreciation expenses attributable to the accelerated depreciation of leasehold improvements resulting from the modification of our office lease agreement in Ness Ziona, Israel.
Previous wording
There was no material change to Interest expenses that impacted losses for the three months ended June 30, 2025 compared to the three months ended June 30, 2024.
Current wording
There were no material changes to other expenses (income) and interest expenses that impacted losses for the three months ended September 30, 2025 compared to the three months ended September 30, 2024.
Previous wording
Income from change in fair value of warrants was $1.5 million for the three months ended June 30, 2025, compared to $11.9 million for the three months ended June 30, 2024. The decrease of $10.4 million, or 87%, was primarily attributed to the revaluation resulting from the accounting treatment of the Company’s warrants that are classified as a liability.
Current wording
Loss from change in fair value of warrants was $0.7 million for the three months ended September 30, 2025, compared to income of $20.6 million for the three months ended September 30, 2024. The change of $21.3 million, or 103%, was primarily attributed to the revaluation resulting from the accounting treatment of the Company’s warrants that are classified as a liability, as well as to the issuance of warrants in the February 2025 Financing (as defined below).
Previous wording
Finance expense, net, was $25,000 for the three months ended June 30, 2025, compared to Finance income, net, of $0.3 million for the three months ended June 30, 2024. The increase was primarily attributable to exchange rate differences.
Current wording
Finance income, net, was $0.1 million for the three months ended September 30, 2025, compared to $0.3 million for the three months ended September 30, 2024. The decrease was primarily attributable to lower interest income.
Previous wording
Basic loss per share of Common Stock was $0.19 for the three months ended June 30, 2025, compared to earnings per share of $0.14 for the three months ended June 30, 2024. The change of $0.33 was primarily attributable to a net loss incurred in the current period, compared to earnings for the same period in 2024. The change was also driven by the increase in the weighted average number of shares of Common Stock outstanding due to share issuances under the February 2025 Financing (as defined below).
Current wording
Basic and diluted loss per share of Common Stock was $0.29 for the three months ended September 30, 2025, compared to basic and diluted earnings per share of $0.31 for the three months ended September 30, 2024. The change of $0.6 was primarily attributable to a net loss incurred in the current period, compared to earnings for the same period in 2024. The change was also driven by the increase in the weighted average number of shares of Common Stock outstanding due to share issuances under the February 2025 Financing.
Previous wording
The following table summarizes our consolidated results of operations for the six months ended June 30, 2025 and June 30, 2024:
Current wording
The following table summarizes our consolidated results of operations for the nine months ended September 30, 2025 and September 30, 2024:
Previous wording
R&D expenses, net (net of grants received from the MTEC and IIA) were $10.3 million for the six months ended June 30, 2025, compared to $11.0 million for the same period in 2024. The decrease of $0.7 million, or 6%, is primarily due to the following factors:
Current wording
R&D expenses, net (net of grants received from the MTEC and IIA) were $16.4 million for the nine months ended September 30, 2025, compared to $18.3 million for the same period in 2024. The decrease of $1.9 million, or 10%, is primarily due to the following factors:
Previous wording
The decrease is also attributed to higher grants received. During the six months ended June 30, 2025, the Company recorded $1.7 million of MTEC and IIA grants, compared to $1.0 million grants recorded in the same period in 2024. The decrease was partially offset by higher expenses associated with the initiation of the Phase 2b clinical trial for our CF product candidate, BX004.
Current wording
The decrease is also attributed to higher grants received. During the nine months ended September 30, 2025, the Company recorded $2.0 million of MTEC and IIA grants, compared to $1.8 million grants recorded in the same period in 2024. The decrease was partially offset by higher expenses associated with the initiation of the Phase 2b clinical trial for our CF product candidate, BX004, as well as by an increase in depreciation expenses attributable to the accelerated depreciation of leasehold improvements resulting from the modification of our office lease agreement in Ness Ziona, Israel.
Previous wording
General and administrative expenses were $4.9 million for the six months ended June 30, 2025, compared to $5.5 million for the same period in 2024. The decrease of $0.6 million, or 11%, is primarily due to expenses incurred during 2024 in connection with the Acquisition completed in March 2024. Such decrease was partially offset by increased share-based compensation expenses.
Current wording
General and administrative expenses were $7.3 million for the nine months ended September 30, 2025, compared to $8.8 million for the same period in 2024. The decrease of $1.5 million, or 17%, is primarily due to expenses incurred during 2024 in connection with the Acquisition completed in March 2024, as well as in legal and other professional service fees. The decrease was partially offset by an increase in depreciation expenses attributable to the accelerated depreciation of leasehold improvements resulting from the modification of our office lease agreement in Ness Ziona, Israel.
Previous wording
Other expenses were $0.1 million for the three months ended June 30, 2025, compared to Other income of $2.0 million for the same period in 2024. The decrease in other income resulted primarily from the reversion of the contract liability associated with the Company’s AD program which has been discontinued.
Current wording
Other expenses were $0.1 million for the nine months ended September 30, 2025, compared to other income of $2.2 million for the same period in 2024. The decrease in other income resulted primarily from the reversion of the contract liability associated with the Company’s AD program which has been discontinued.
Previous wording
Interest expenses were $10,000 for the six months ended June 30, 2025, compared to $863,000 for the six months ended June 30, 2024. The decrease of $853,000, or 99%, is due to repayment of the loan under the Loan and Security Agreement, or the Hercules Loan Agreement, with Hercules Capital, Inc. in March 2024. Interest in the 2025 period was related to an existing loan to APT from the U.S. Small Business Administration.
Current wording
Interest expenses were $15,000 for the nine months ended September 30, 2025, compared to $868,000 for the nine months ended September 30, 2024. The decrease of $853,000, or 98%, is due to repayment of the loan under the Loan and Security Agreement, or the Hercules Loan Agreement, with Hercules Capital, Inc. in March 2024. Interest in the 2025 period was related to an existing loan to APT from the U.S. Small Business Administration.
Previous wording
Income from change in fair value of warrants was $2.4 million for the six months ended June 30, 2025, compared to $3.9 million for the six months ended June 30, 2024. The decrease of $1.5 million, or 38%, is primarily attributed to the revaluation resulting from the accounting treatment of the Company’s warrants that are classified as a liability, as well as to the issuance of warrants in the February 2025 Financing.
Current wording
Income from change in fair value of warrants was $1.7 million for the nine months ended September 30, 2025, compared to $24.4 million for the nine months ended September 30, 2024. The decrease of $22.7 million, or 93%, is primarily attributed to the revaluation resulting from the accounting treatment of the Company’s warrants that are classified as a liability, as well as to the issuance of warrants in the February 2025 Financing.
Previous wording
Finance expense, net, was $0.8 million for the six months ended June 30, 2025, compared to $1.4 million for the six months ended June 30, 2024, and primarily consisted of transaction costs incurred in connection with the February 2025 Financing and the March 2024 PIPE (as defined below), respectively.
Current wording
Finance expense, net, was $0.7 million for the nine months ended September 30, 2025, compared to $1.1 million for the nine months ended September 30, 2024, and primarily consisted of interest income and transaction costs incurred in connection with the February 2025 Financing and the March 2024 PIPE (as defined below), respectively.
Previous wording
Basic and diluted loss per share of Common Stock was $0.50 for the six months ended June 30, 2025, compared to $1.95 for the six months ended June 30, 2024. The decrease of $1.45 was primarily driven by the increase in the weighted average number of shares of Common Stock outstanding due to share issuances under the February 2025 Financing.
Current wording
Basic loss per share of Common Stock was $0.80 for the nine months ended September 30, 2025, compared to $0.32 for the nine months ended September 30, 2024. The change of $0.48 was primarily driven by a higher net loss incurred in the current period. Such change was also attributable to a higher weighted average number of shares of Common Stock outstanding due to share issuances under the February 2025 Financing.
Previous wording
We believe our cash, cash equivalents and restricted cash on hand will be sufficient to meet our working capital and capital expenditure requirements into the first quarter of 2026. We currently plan to continue to focus primarily on the development of BX004, our product candidate for treating CF and BX211, our product candidate for treating DFO. Although we recently completed the February 2025 Financing and before then the March 2024 PIPE, we will likely require additional funds to support our operating expenses and capital requirements. Accordingly, we have implemented cost cutting measures, and are exploring and expect to further explore, raising such additional funds through public or private equity, debt financing, loans, government or other grants or collaborative agreements or from other sources. If we are unable to obtain adequate financing or financing on terms satisfactory to us, when we require it, our ability to continue to grow or support our business and to respond to business challenges could be significantly limited. If there are increases in operating costs for facilities expansion, research and development and clinical activity, we will need to use mitigating actions such as to seek additional financing or postpone expenses that are not based on firm commitments. If certain disruptions due to, for instance, the war with Iran, Hamas and Hezbollah, or Israeli political instability persists and deepens, we could experience an inability to access additional capital, which could in the future negatively affect our capacity to support our operating expenses and capital requirements. As a result of these factors, management believes that there is substantial doubt as to the Company’s ability to continue as a going concern.
Current wording
We believe our cash, cash equivalents and restricted cash on hand will be sufficient to meet our working capital and capital expenditure requirements into the first quarter of 2026. We currently plan to continue to focus primarily on the development of BX004, our product candidate for treating CF and BX011, our product candidate for treating DFI. Although we completed the February 2025 Financing and before then the March 2024 PIPE, and recently have sold approximately $1,305,000 worth of our shares of Common Stock, net, under our ATM Agreement (as defined below), we will require additional funds to support our operating expenses and capital requirements. Accordingly, we have implemented cost cutting measures, and are exploring and expect to further explore, raising such additional funds through public or private equity, debt financing, loans, government or other grants or collaborative agreements or from other sources. If we are unable to obtain adequate financing or financing on terms satisfactory to us, when we require it, our ability to continue to grow or support our business and to respond to business challenges could be significantly limited. If there are increases in operating costs for facilities expansion, research and development and clinical activity, we will need to use mitigating actions such as to seek additional financing or postpone expenses that are not based on firm commitments. If certain disruptions due to, for instance, Israel’s conflicts in the Middle East, Israeli political instability persisting and deepening, the U.S. federal government shutdown, or market conditions, we could experience an inability to access additional capital, which could in the future negatively affect our capacity to support our operating expenses and capital requirements. As a result of these factors, management believes that there is substantial doubt as to the Company’s ability to continue as a going concern.
Previous wording
The following table summarizes our sources and uses of cash for the six months ended June 30, 2025 and 2024:
Current wording
The following table summarizes our sources and uses of cash for the nine months ended September 30, 2025 and 2024:
Previous wording
Net cash used in operating activities for the six months ended June 30, 2025 was $14.8 million, primarily driven by our R&D, general and administrative expenses, as well as changes in our operating assets and liabilities of $1.0 million. Non-cash charges for the six months ended June 30, 2025 consisted primarily of income from change in fair value of warrants of $2.4 million, stock-based compensation expenses of $1.4 million and depreciation expenses of $0.5 million. Net changes in our operating assets and liabilities consisted primarily of an increase in trade accounts payable of $0.3 million, a decrease in other accounts payable of $2.4 million and a decrease in other current assets of $1.1 million.
Current wording
Net cash used in operating activities for the nine months ended September 30, 2025 was $22.0 million, primarily driven by our R&D, general and administrative expenses, as well as changes in our operating assets and liabilities of $1.4 million. Non-cash charges for the nine months ended September 30, 2025 consisted primarily of income from change in fair value of warrants of $1.7 million, stock-based compensation expenses of $1.8 million and depreciation expenses of $1.8 million. Net changes in our operating assets and liabilities consisted primarily of a decrease in trade accounts payable of $0.4 million, a decrease in other accounts payable of $2.8 million and a decrease in other current assets of $1.8 million.
Previous wording
Net cash used in operating activities for the six months ended June 30, 2024 was $22.6 million, primarily driven by a net loss of $12.9 million, mostly attributable to our R&D, general and administrative expenses, as well as changes in our operating assets and liabilities of $5.0 million. This was partially offset by non-cash charges of $4.7 million. Non-cash charges for the six months ended June 30, 2024 consisted primarily of income from change in fair value of warrants of $3.9 million, and income from change in contract liability in amount of $2.0 million resulting from pausing the Company’s AD program. Additionally, we incurred depreciation and amortization expenses of $0.6 million and Private Placement Warrants (as defined below) issuance costs of $0.7 million. Net changes in our operating assets and liabilities consisted primarily of a decrease in trade accounts payable of $2.2 million and a decrease in other accounts payables of $2.9 million. These were partially offset by a decrease in other current and non-current assets of $0.8 million.
Current wording
Net cash used in operating activities for the nine months ended September 30, 2024 was $30.7 million, primarily driven by our R&D, general and administrative expenses, as well as changes in our operating assets and liabilities of $4.0 million, offset by non-cash charges of $23.2 million. Non-cash charges for the nine months ended September 30, 2024 consisted primarily of income from change in fair value of the Private Placement Warrants of $24.4 million and income from change in contract liability in amount of $2.0 million resulting from pausing the Company’s AD program. Additionally, there were depreciation expenses of $0.9 million, Private Placement Warrants issuance costs of $0.7 million and goodwill impairment of $0.8 million. Net changes in our operating assets and liabilities consisted primarily of a decrease in trade account payable of $2.7 million, as well as a decrease in other accounts payable of $1.2 million and a decrease in other current and non-current assets of $0.2 million.
Previous wording
During the six months ended June 30, 2025, net cash provided by investing activities was $0.1 million, mainly consisting of proceeds from sale of property and equipment.
Current wording
During the nine months ended September 30, 2025, net cash provided by investing activities was $0.1 million, mainly consisting of proceeds from sale of property and equipment.
Previous wording
During the six months ended June 30, 2024, net cash provided by investing activities was $0.7 million, mainly consisting of cash and restricted cash acquired from the Acquisition.
Current wording
During the nine months ended September 30, 2024, net cash provided by investing activities was $0.7 million, mainly consisting of cash and restricted cash acquired from the Acquisition.
Previous wording
We have invested, and plan to continue to invest, our existing cash in short-term investments in accordance with our investment policy. These investments may include money market funds and investment securities consisting of U.S. Treasury notes, and high quality, marketable debt instruments of corporations and government sponsored enterprises. We use foreign exchange contracts (mainly options and forward contracts) to hedge balance sheet items from currency exposure. These foreign exchange contracts are not designated as hedging instruments for accounting purposes. In connection with these foreign exchange contracts, we record gains or losses that offset the revaluation of the balance sheet items under financial income, net in our condensed consolidated statements of operations. As of June 30, 2025, we had outstanding foreign exchange contracts for the exchange of USD to NIS in the amount of approximately $1.6 million with a fair value asset of $0.1 million. As of June 30, 2024, we had outstanding foreign exchange contracts for the exchange of USD to NIS in the amount of approximately $0.6 million with a fair value asset of $17,000.
Current wording
We have invested, and plan to continue to invest, our existing cash in short-term investments in accordance with our investment policy. These investments may include money market funds and investment securities consisting of U.S. Treasury notes, and high quality, marketable debt instruments of corporations and government sponsored enterprises. We use foreign exchange contracts (mainly options and forward contracts) to hedge balance sheet items from currency exposure. These foreign exchange contracts are not designated as hedging instruments for accounting purposes. In connection with these foreign exchange contracts, we record gains or losses that offset the revaluation of the balance sheet items under financial expense (income), net in our condensed consolidated statements of operations. As of September 30, 2025, we had outstanding foreign exchange contracts for the exchange of USD to NIS in the amount of approximately $0.5 million with a fair value asset of $44,000. As of September 30, 2024, we had outstanding foreign exchange contracts for the exchange of USD to NIS in the amount of approximately $3.4 million with a fair value asset of $15,000.
Previous wording
During the six months ended June 30, 2025, net cash provided by financing activities was $11.9 million, mainly consisting of the issuance of Common Stock and warrants under the February 2025 Financing as well as exercises of warrants.
Current wording
During the nine months ended September 30, 2025, net cash provided by financing activities was $11.9 million, mainly consisting of the issuance of Common Stock and warrants under the February 2025 Financing as well as exercises of warrants.
Previous wording
During the six months ended June 30, 2024, net cash provided by financing activities was $39.0 million, mainly consisting of the issuance of Redeemable Convertible Preferred Shares and warrants in the March 2024 PIPE, or the Private Placement Warrants, in the amount of $20.8 million, net of issuance costs and $28.7 million, respectively. This was partially offset by the prepayment of the long-term debt in the amount of $10.7 million under the Hercules Loan Agreement.
Current wording
During the nine months ended September 30, 2024, net cash provided by financing activities was $39.0 million, mainly consisting of the issuance of Redeemable Convertible Preferred Shares and the Private Placement Warrants (as defined below) in the March 2024 PIPE in the amount of $20.8 million, net of issuance costs and $28.7 million, respectively. This was partially offset by the prepayment of the long-term debt in the amount of $10.7 million under the Hercules Loan Agreement.
Previous wording
On December 7, 2023, we filed a shelf registration statement on Form S-3, which was declared effective by the SEC on January 2, 2024. In addition, on December 7, 2023, we entered into an At the Market Offering Agreement, or the 2023 ATM Agreement, with H.C. Wainwright & Co., LLC, or Wainwright, with Wainwright as manager, pursuant to which we may issue and sell shares of our Common Stock having an aggregate offering price of up to $7.5 million from time to time through Wainwright. We are not obligated to make any sales of Common Stock under the 2023 ATM Agreement. On February 24, 2025, we suspended the ATM Agreement and the related continuous offering by us under an effective registration Statement on Form S-3. We may resume use of the ATM Agreement in the future.
Current wording
On December 7, 2023, we filed a shelf registration statement on Form S-3, which was declared effective by the SEC on January 2, 2024. In addition, on December 7, 2023, we entered into an At the Market Offering Agreement, or the 2023 ATM Agreement, with H.C. Wainwright & Co., LLC, or Wainwright, with Wainwright as manager, pursuant to which we may issue and sell shares of our Common Stock having an aggregate offering price of up to $7.5 million from time to time through Wainwright. We are not obligated to make any sales of Common Stock under the 2023 ATM Agreement. On February 24, 2025, we suspended the ATM Agreement and the related continuous offering by us under an effective registration Statement on Form S-3. On August 13, 2025, we filed a prospectus supplement to amend our prior prospectus dated January 2, 2024, and as previously supplemented on February 24, 2025. The prospectus supplement updated the maximum aggregate amount of securities we may offer and sell under the 2023 ATM Agreement. Under the prospectus supplement, we may issue and sell shares of Common Stock having an aggregate offering price of up to $1.7 million from time to time through Wainwright.
Previous wording
On March 15, 2024, concurrently with the consummation of the Acquisition, we consummated a private investment in public equity, or the March 2024 PIPE, with existing and new investors, resulting in aggregate gross proceeds of approximately $50 million, in which the investors purchased (i) an aggregate of 216,417 Redeemable Convertible Preferred Shares, convertible upon stockholder approval, which was obtained on July 9, 2024, into an aggregate of up to 21,641,700 shares of BiomX common stock, and (ii) the Private Placement Warrants, to purchase up to an aggregate of 10,820,850 shares of BiomX common stock, at a combined purchase price of $231.10 per share of Series X Preferred Stock and an accompanying Private Placement Warrant to purchase 50 shares of BiomX common stock. The Private Placement Warrants are exercisable at an exercise price of $2.311 per share and will expire on July 9, 2026.
Current wording
On March 15, 2024, concurrently with the consummation of the Acquisition, we consummated a private investment in public equity, or the March 2024 PIPE, with existing and new investors, resulting in aggregate gross proceeds of approximately $50 million, in which the investors purchased (i) an aggregate of 216,417 Redeemable Convertible Preferred Shares, convertible upon stockholder approval, which was obtained on July 9, 2024, into an aggregate of up to 21,641,700 shares of BiomX common stock, and (ii) warrants to purchase up to an aggregate of 10,820,850 shares of BiomX common stock, or the Private Placement Warrants, at a combined purchase price of $231.10 per share of Series X Preferred Stock and an accompanying Private Placement Warrant to purchase 50 shares of BiomX common stock. The Private Placement Warrants are exercisable at an exercise price of $2.311 per share and will expire on July 9, 2026.
Previous wording
On February 25, 2025, we entered into a Securities Purchase Agreement with certain investors, pursuant to which we agreed to issue and sell, (i) in a registered direct offering, or the February 2025 Registered Direct Offering): (a) an aggregate of 2,828,283 shares of our Common Stock, and (b) pre-funded warrants, or the Registered Pre-Funded Warrants, to purchase up to an aggregate of 805,231 shares of Common Stock, and (ii) in a concurrent private placement, or the February 2025 PIPE and together with the February 2025 Registered Direct Offering, the February 2025 SPA, (a) unregistered pre-funded warrants, or the Private Pre-Funded Warrants, to purchase up to an aggregate of 2,305,869 shares of Common Stock, and (b) unregistered warrants, or the Common Warrants, to purchase up to an aggregate of 5,939,383 shares of Common Stock. Each Share (or Registered Pre-Funded Warrant in lieu thereof) and Private Pre-Funded Warrant were sold with an accompanying Common Warrant. The combined effective purchase price of each Share (or Registered Pre-Funded Warrant in lieu thereof) and accompanying Common Warrant, and of each Private Pre-Funded Warrant and accompanying Common Warrant, is $0.9306. The gross proceeds to the Company from the February 2025 SPA were $5.5 million, before deducting placement agent fees and other offering expenses payable by the Company of $0.7 million. Through August 11, 2025, 400,091 Private Pre-Funded Warrants and 1,917 Common Warrants were exercised at an exercise price of $0.0001 and 0.9306 per share, respectively, into 402,008 shares of Common Stock. Additionally, 800,455 Private Pre-Funded Warrants were exercised into 800,306 shares of Common Stock through cashless mechanism for no additional consideration.
Current wording
On February 25, 2025, we entered into a Securities Purchase Agreement with certain investors, pursuant to which we agreed to issue and sell, (i) in a registered direct offering, or the February 2025 Registered Direct Offering): (a) an aggregate of 2,828,283 shares of our Common Stock, and (b) pre-funded warrants, or the Registered Pre-Funded Warrants, to purchase up to an aggregate of 805,231 shares of Common Stock, and (ii) in a concurrent private placement, or the February 2025 PIPE and together with the February 2025 Registered Direct Offering, the February 2025 SPA, (a) unregistered pre-funded warrants, or the Private Pre-Funded Warrants, to purchase up to an aggregate of 2,305,869 shares of Common Stock, and (b) unregistered warrants, or the Common Warrants, to purchase up to an aggregate of 5,939,383 shares of Common Stock. Each Share (or Registered Pre-Funded Warrant in lieu thereof) and Private Pre-Funded Warrant were sold with an accompanying Common Warrant. The combined effective purchase price of each Share (or Registered Pre-Funded Warrant in lieu thereof) and accompanying Common Warrant, and of each Private Pre-Funded Warrant and accompanying Common Warrant, is $0.9306. The gross proceeds to the Company from the February 2025 SPA were $5.5 million, before deducting placement agent fees and other offering expenses payable by the Company of $0.7 million. As of September 30, 2025, 547,728 Private Pre-Funded Warrants and 1,917 Common Warrants were exercised at an exercise price of $0.0001 and 0.9306 per share, respectively, into 549,645 shares of Common Stock. Additionally, 879,761 Private Pre-Funded Warrants were exercised into 879,599 shares of Common Stock through cashless mechanism for no additional consideration. No additional warrants were exercised subsequent to September 30, 2025, through November 11, 2025
Previous wording
We have accumulated a deficit of $194.4 million since our inception. To date, we have not generated revenue from our operations, and we do not expect to generate any significant revenues from sales of products in the next twelve months. Our cash needs may increase in the foreseeable future. We expect to generate revenues from the sale of licenses to use our technology or products, but in the short and medium terms any amounts generated are unlikely to exceed our costs of operations. According to our estimates and based on our current operating plans, our liquidity resources as of June 30, 2025, which consisted primarily of cash, cash equivalents and restricted cash of approximately $15.2 million will be sufficient to fund our operations into the first quarter of 2026.
Current wording
We have accumulated a deficit of $203.6 million since our inception. To date, we have not generated revenue from our operations, and we do not expect to generate any significant revenues from sales of products in the next twelve months. Our cash needs may increase in the foreseeable future. We expect to generate revenues from the sale of licenses to use our technology or products, but in the short and medium terms any amounts generated are unlikely to exceed our costs of operations. According to our estimates and based on our current operating plans, our liquidity resources as of September 30, 2025, which consisted primarily of cash, cash equivalents and restricted cash of approximately $8.1 million will be sufficient to fund our operations into the first quarter of 2026.
Previous wording
Consistent with our ongoing R&D activities, we expect to continue to incur additional losses in the foreseeable future. To the extent we require funds above our existing liquidity resources in the medium and long term, we plan to fund our operations, as well as other development activities relating to additional product candidates, through future issuances of public or private equity, issuance of debt securities, loans, and possibly additional grants from the Israeli Innovation Authority, or IIA, MTEC or other government or non-profit institutions. Our ability to raise additional capital in the equity and debt markets is dependent on a number of factors including, but not limited to, the market demand for our securities, which itself is subject to a number of development and business risks and uncertainties, as well as the uncertainty that we would be able to raise such additional capital at a price or on terms that are favorable to us.
Current wording
Consistent with our ongoing R&D activities, we expect to continue to incur additional losses in the foreseeable future. To the extent we require funds above our existing liquidity resources in the medium and long term, we plan to fund our operations, as well as other development activities relating to additional product candidates, through future issuances of public or private equity, issuance of debt securities, loans, and possibly additional grants from the Israeli Innovation Authority, or IIA, MTEC or other government or non-profit institutions. Our ability to raise additional capital in the equity and debt markets is dependent on a number of factors including, but not limited to, the U.S. federal government shutdown and the market demand for our securities, which itself is subject to a number of development and business risks and uncertainties, as well as the uncertainty that we would be able to raise such additional capital at a price or on terms that are favorable to us.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Treatment of Diabetic Foot Osteomyelitis, or DFO
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Previous report — wording carried elsewhere
The decrease is also attributed to higher grants received. During the three months ended June 30, 2025, the Company recorded $1.0 million of MTEC and IIA grants, compared to $0.8 million grants recorded in the same period in 2024. The decrease was partially offset by increased expenses due to the initiation of the Phase 2b in the clinical trial of our CF product candidate, BX004.
Previous report — wording carried elsewhere
Other expenses were $0.1 million for the six months ended June 30, 2025, compared to Other income of $2.1 million for the same period in 2024. The decrease in other income resulted primarily from the reversion of the contract liability associated with the Company’s AD program which has been discontinued.