PHGE

Risks Related to Our Business, Technology and Industry Our exploration of strategic alternatives could adversely affect our business and our stock price.
In December 2025, we announced that our Israeli subsidiary, BiomX Ltd., commenced insolvency proceedings in Israel.
On December 26, 2025, we entered into the 2025 Second SPA.
The initiation of such insolvency process, combined with the potential for the Investor from the 2025 Second SPA to become a majority shareholder upon stockholder approval, creates risks and uncertainties regarding our strategic direction, including our potential inability to consummate any proposed strategic alternative resulting from the process due to, among other things, insufficient funding, market, regulatory and other factors.
Such potential change in control, resulting from the 2025 Second SPA, could affect our ability to consummate proposed strategic alternatives, impact our market price and trading volatility, and potentially lead to a shift in the Company’s business, strategy, and objectives in accordance with any plans our Board may adopt.
If we fail to obtain stockholder approval required under NYSE American rules in connection with the 2025 Second SPA, we could be unable to access sufficient financing, and could be required to hold additional stockholder meetings and incur significant costs, potentially leading to the delisting of our Common Stock.
After extensive efforts to raise capital on more favorable terms, we believed that the 2025 Second SPA was the only viable financing alternative available to us at the time.
Pursuant to the terms of the 2025 Second SPA, we are required to obtain stockholder approval for this proposal within 60 calendar days from the closing date.
If we fail to obtain such stockholder approval for this proposal, we will be required to incur additional costs in order to hold additional stockholder meetings every 60 days to seek such approval as is required under the purchase agreement.
Further, until such time as we obtain stockholder approval for this proposal, we will not be able to issue more than 19.99% of our outstanding shares of Common Stock to the Series Y Preferred Stock and warrant holders in connection with the 2025 Second SPA.
If we are unable to obtain such stockholder approval on a timely basis, our ability to access sufficient financing on acceptable terms, or at all, could be materially and adversely affected, and we could be required to further reduce or discontinue our operations, which could materially and adversely affect our business, financial condition and results of our operations.
Additionally, failure to obtain the required stockholder approval could also lead to a determination by NYSE American that we do not maintain sufficient ongoing business operations, which could result in the delisting of our Common Stock.
Moreover, our inability to obtain such stockholder approval on a timely basis would severely constrain our financial flexibility and could significantly delay our ongoing efforts to evaluate and pursue strategic alternatives and other business opportunities.
We are a clinical-stage company and have incurred losses since our inception.
Subject to availability of sufficient financial and other resources, we anticipate that we will continue to incur significant expenses, and we will continue to incur significant losses for the foreseeable future.
As of December 31, 2025, our accumulated deficit was $216.9 million.
For the years ended December 31, 2025 and 2024, we had losses from operations of $41.5 million and $44.5 million, respectively.
Subject to availability of sufficient financial and other resources, we anticipate that the level of our expenses will continue to be significant if and as we: ● initiate and continue research, preclinical and clinical development efforts for any future product candidates; ● seek marketing and regulatory approvals for any product candidates that successfully complete clinical trials; ● require the manufacture of larger quantities of product candidates for clinical development and, potentially, commercialization; ● maintain, expand and protect our intellectual property portfolio; ● establish sales, marketing, distribution and other commercial infrastructure in the future to commercialize products for which we obtain marketing approval, if any; and ● add operational, financial and management information systems and personnel, including personnel to support our product development and commercialization and help us continue to comply with our obligations as a public company.
As of December 31, 2025, we had cash, cash equivalents and restricted cash of $5.0 million, and we have had recurring losses from operations and negative operating cash flows since inception.
Wainwright & Co., LLC, or Wainwright, as manager, pursuant to which we may issue and sell shares of our Common Stock having an aggregate offering price of up to $1,765,939 from time to time through Wainwright.
On February 27, 2025, we completed a registered direct offering and a concurrent private placement.
Through these transactions, we generated approximately $12 million.
In addition, in March 15, 2024, concurrently with the consummation of the acquisition of APT, we consummated a private placement of $50 million.
Most recently, on January 13, 2026, we completed a private placement of preferred stock and warrants under a Securities Purchase Agreement, or the 2025 Second SPA, with an investor for gross proceeds of $3.0 million.
We may evaluate various additional acquisition opportunities and strategic partnerships, including licensing or acquiring complementary or unrelated products, intellectual property rights, technologies or businesses.
We have accumulated a deficit of $216.9 million since our inception.
As of December 31, 2025, we had $5.0 million in cash and cash equivalents and restricted cash.
We believe our cash and cash equivalents on hand, including the cash raised in January 2026, as described under “Liquidity and Capital Resources” in Item 7 of this Annual Report, will be sufficient to meet our working capital and capital expenditure requirements through the end of the second quarter of 2026.
Our continuation as a going concern is dependent upon many factors, including our ability to raise additional funds, the success of our clinical trial for DFI/DFO and our ability to repay our obligations when due.
Preclinical studies of our product candidates, such as BX011, including studies in animal disease models may not accurately predict the safety of the product candidate such that further human clinical trials would be allowed to proceed.
Delays, or clinical holds, in our clinical trials could result in us not achieving anticipated developmental milestones when expected, increased costs and delays in our ability to obtain regulatory approval for and commercialization of our product candidates.
Furthermore, our clinical trials may become subject to a clinical hold based on the evaluation of data and information submitted to the governing regulatory authorities.
Clinical trials can be delayed, or be subject to a clinical hold, for a variety of reasons, including: ● delays in the development of manufacturing capabilities for our product candidates to enable their consistent production at clinical trial scale; ● failures in our internal manufacturing operations that result in our inability to consistently and timely produce bacteriophage in sufficient quantities to support our clinical trials; ● the availability of financial resources to commence and complete our planned clinical trials; ● delays in reaching a consensus with clinical investigators on study design; ● delays in reaching a consensus with regulatory agencies on trial design or in obtaining regulatory approval to commence a trial; ● delays in obtaining clinical materials; ● slower than expected patient recruitment for participation in clinical trials; ● regulatory constraints or injunctions (for example, from supervisory authorities in case of noncompliance with cybersecurity and data privacy laws); ● failure by clinical trial sites, other third parties or us to adhere to clinical trial agreements and/or the trial protocol; ● delays in reaching agreement on acceptable clinical trial agreement terms with prospective sites or obtaining IRB or independent ethics committee approval; and ● adverse safety events experienced during our clinical trials.
Significant preclinical or clinical trial delays or suspensions could shorten any periods during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring products to market before we do, potentially impairing our ability to successfully commercialize our product candidates and harming our business and results of operations.
For example, adverse events experienced by participants in our Study contributed to our decision to discontinue further development of BX004, followed by additional internal analysis and feedback from the DMC, which recommended consideration of adjusting dosing regimen.
While we have selected an initial formulation of BX011, there can be no assurance that this initial formulation will be the final formulations of this product candidate for commercialization if approved.
If we submit marketing applications for any of our product candidates manufactured by third-party manufacturers, the manufacturing facilities used to produce such product candidates will be subjected to ongoing periodic inspection for compliance with European, FDA and cGMP regulations.
Our competitors may succeed in developing products that are more effective, have fewer side effects and are safer or more affordable than our product candidates, which would render our product candidates less competitive or noncompetitive.
For example, we spent significant time and resources developing BX005 and BX004, which we discontinued.
Since inception in 2015 through its dissolution in February 2026, BiomX Ltd. devoted substantially all of its resources to developing product candidates with phage technology through its preclinical programs, building its intellectual property portfolio, developing a supply chain, planning its business, raising capital and providing general and administrative support for these operations.

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Gone since FY2024

Risks Related to Our Business, Technology and Industry We are a clinical-stage company and have incurred losses since our inception.
We anticipate that we will continue to incur significant expenses, and we will continue to incur significant losses for the foreseeable future.
As of December 31, 2024, our accumulated deficit was $180.7 million, and we expect to incur increasingly significant losses for the foreseeable future.
Preclinical development and clinical trials and activities are costly.
We have devoted, and will continue to devote for the foreseeable future, substantially all of our resources to research and development and clinical trials for our product candidates.
In addition, as a result of the Acquisition, our future business, prospects, financial position and operating results could be significantly different than those in historical periods or projected by our management.
For the years ended December 31, 2024 and 2023, we had losses from operations of $44.5 million and $25.3 million, respectively.
We anticipate that the level of our expenses is expected to increase and will continue to be significant if and as we: ● initiate and continue research, preclinical and clinical development efforts for any future product candidates; ● seek to discover and develop additional product candidates and further expand our clinical product pipeline; ● seek marketing and regulatory approvals for any product candidates that successfully complete clinical trials; ● require the manufacture of larger quantities of product candidates for clinical development and, potentially, commercialization; ● maintain, expand and protect our intellectual property portfolio; ● expand our research and development infrastructure; ● establish sales, marketing, distribution and other commercial infrastructure in the future to commercialize products for which we obtain marketing approval, if any; and ● add operational, financial and management information systems and personnel, including personnel to support our product development and commercialization and help us continue to comply with our obligations as a public company.
As of December 31, 2024, we had cash, cash equivalents and restricted cash of $18 million, and we have had recurring losses from operations and negative operating cash flows since inception.
Wainwright & Co., LLC, or 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.
On February 24, 2025, we suspended the ATM Agreement.
Furthermore, on March 15, 2024, concurrently with the consummation of the Acquisition, we consummated a private placement of $50 million in consideration of 216,417 shares of our Series X non-voting convertible preferred stock, par value $0.0001 per share, with each such convertible preferred stock being convertible into 100 shares of our shares of Common Stock and warrants, or Private Placement Warrants, to purchase up to an aggregate of 10,820,850 shares of the Company’s Common Stock.
Most recently, on February 27, 2025, we completed a registered direct offering and a concurrent private placement.
Through these transactions, we generated approximately $12 million in proceeds.
We have accumulated a deficit of $180.7 million since our inception.
As of December 31, 2024, we had $18 million in cash and cash equivalents.
We believe our cash and cash equivalents on hand, including the cash raised in the February 2025 Financing, as described under “Liquidity and Capital Resources” in Item 7 of this Annual Report, will be sufficient to meet our working capital and capital expenditure requirements into the first quarter of 2026.
Our continuation as a going concern is dependent upon many factors, including our ability to raise additional funds, the success of our clinical trial for CF and DFO and our ability to repay our obligations when due.
On February 1, 2025, President Trump announced a 10% additional tariff on imports from China and has expressed the possibility of imposing tariffs on imports from the European Union and India.
In addition, on February 13, 2025, President Trump announced a plan to establish reciprocal tariffs with nations that impose tariffs on U.S. products, and directed relevant segments of the U.S. government to assess harm of non-reciprocal trade arrangements and to generate a report of that assessment within 180 days.
Reciprocal tariffs may be imposed prior to completion of the report.
There also have been statements by the Trump administration regarding a 25% tariff on pharmaceutical products.
For the year ending December 31, 2025, we estimate the impact of tariffs currently imposed on our imports from China will not be material.
We are unable to estimate the impacts of any tariffs that have not yet been imposed by the U.S. government.
Preclinical studies of our product candidates, such as BX004 and BX211, including studies in animal disease models may not accurately predict the safety of the product candidate such that further human clinical trials would be allowed to proceed.
Delays in our clinical trials could result in us not achieving anticipated developmental milestones when expected, increased costs and delays in our ability to obtain regulatory approval for and commercialization of our product candidates.
Clinical trials can be delayed for a variety of reasons, including: ● delays in the development of manufacturing capabilities for our product candidates to enable their consistent production at clinical trial scale; ● failures in our internal manufacturing operations that result in our inability to consistently and timely produce bacteriophage in sufficient quantities to support our clinical trials; ● the availability of financial resources to commence and complete our planned clinical trials; ● delays in reaching a consensus with clinical investigators on study design; ● delays in reaching a consensus with regulatory agencies on trial design or in obtaining regulatory approval to commence a trial; ● delays in obtaining clinical materials; ● slower than expected patient recruitment for participation in clinical trials; ● regulatory constraints or injunctions (for example, from supervisory authorities in case of noncompliance with cybersecurity and data privacy laws); ● failure by clinical trial sites, other third parties or us to adhere to clinical trial agreements and/or the trial protocol; ● delays in reaching agreement on acceptable clinical trial agreement terms with prospective sites or obtaining IRB or independent ethics committee approval; and ● adverse safety events experienced during our clinical trials.
Significant preclinical or clinical trial delays could shorten any periods during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring products to market before we do, potentially impairing our ability to successfully commercialize our product candidates and harming our business and results of operations.
While we have selected an initial formulation of BX004, there can be no assurance that this initial formulation will be the final formulations of this product candidate for commercialization if approved.
In 2019, we established our own manufacturing facility at our headquarters in Ness Ziona, Israel and we have executed cGMP manufacturing for our first in human clinical study.
In March 2021, we moved into a new manufacturing facility at our headquarters in Ness Ziona, Israel.
During 2024, the use of the manufacturing facility was put on hold as part of the Company strategic decision and clinical trial material was transferred to an outsourced company.
We have the option to return our own facility to full GMP activity if needed and subject to sufficient funding.
In that case, we may need to fund additional modifications to our manufacturing process and conduct additional validation studies.
As a backup we believe that we can find alternative manufacturing facilities.
Each of the options above might result in significant cost to us as well as a delay of up to several years in obtaining approval for such product candidate.
If we submit marketing applications for any of our product candidates manufactured at this facility, this manufacturing facility will be subjected to ongoing periodic inspection for compliance with European, FDA and cGMP regulations.
Our competitors may succeed in developing products that are more effective, have fewer side effects and are safer or more affordable than our product candidates, which would render our product candidates less competitive or noncompetitive and would prevent the granting or maintenance of an orphan designation.
For example, we spent significant time and resources developing BX005, which we discontinued.
Since inception in 2015, BiomX Ltd. has devoted substantially all of its resources to developing product candidates with phage technology through its preclinical programs, building its intellectual property portfolio, developing a supply chain, planning its business, raising capital and providing general and administrative support for these operations.

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