HLSQ 10-K & 10-Q changes, risk factors and insider trading
Tessera Defense & Homeland Security Inc. · NYSE · Services-Prepackaged Software · CIK 1739174 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “Our exploration of strategic alternatives could adversely affect our business and our stock price.”
New heading “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.”
Removed heading “Breakthrough Therapy Designation or Fast Track Designation by the FDA, even if granted for any of our product candidates developed for therapeutic indications, may not lead to a faster development, regulatory review or approval process, and it does not increase the likelihood that any of our product candidates will receive marketing approval in the United States.”
Removed heading “We may fail to obtain and maintain orphan drug designations from the FDA or equivalent foreign regulatory agencies for our current and future therapeutic product candidates, as applicable.”
Removed heading “The license agreements we maintain, including the Yeda 2015 License Agreement, with Yeda are important to our business. If we or the other parties to our license agreements fail to adequately perform under the license agreements, or if we or they terminate the license agreements, the development, testing, manufacture, production and sale of our phage-based therapeutic product candidates would be delayed or terminated, and our business would be adversely affected.”
Removed heading “We may become subject to claims for remuneration or royalties for assigned service invention rights by our employees, which could result in litigation and adversely affect our business.”
Removed heading “Risks Related to Our Operations in Israel”
Removed heading “Our headquarters, research and development and other significant operations are located in Israel, and, therefore, our results may be adversely affected by political, economic and military instability in Israel, including the recent war with Hamas and other terrorist organizations from the Gaza Strip.”
Removed heading “Our operations may be disrupted as a result of the obligation of management or key personnel to perform military service.”
Removed heading “The Israeli government grants we have received for research and development expenditures restrict our ability to manufacture products and transfer technology outside of Israel and require us to satisfy specified conditions. If we fail to satisfy these conditions, we may be required to refund grants previously received, together with interest and penalties.”
Removed heading “We have received, and may continue to receive, Israeli governmental grants to assist in the funding of our research and development activities. If we lose our funding from these research and development grants, we may encounter difficulties in the funding of future research and development projects and implementing technological improvements, which would harm our operating results.”
Removed heading “Exchange rate fluctuations between the U.S. Dollar, the New Israeli Shekel, the Euro and other foreign currencies, may negatively affect our future expenses.”
Removed heading “Under applicable employment laws, we may not be able to enforce covenants not to compete.”
Removed heading “The tax benefits that are available to us if and when we generate taxable income require us to meet various conditions and may be prevented or reduced in the future, which could increase our costs and taxes.”
Removed heading “It may be difficult to enforce a U.S. judgment against us or our officers and directors in Israel or the United States or to assert U.S. securities laws claims in Israel or serve process on our officers and directors.”
Largest changes
“The Israeli government grants we have received for research and development expenditures restrict our ability to manufacture products and transfer technology outside of Israel and require us to satisfy specified conditions. If we fail to satisfy these conditions, we may be required to refund grants previously received, together with interest and penalties.”see in full comparison
“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.”see in full comparison
“The Yeda 2015 License Agreement provides for an exclusive worldwide license to certain know-how and research information related to the development, testing, manufacture, production and sale of phage-based therapeutic product candidates, including candidates specified in the agreement, which are used in our phage discovery platform, as well as patents, research and other rights to phage product candidates resulting from the work of the consultants identified in the agreement and further research that we funded. …”see in full comparison
“We may become subject to claims for remuneration or royalties for assigned service invention rights by our employees, which could result in litigation and adversely affect our business.”see in full comparison
“We have received, and may continue to receive, Israeli governmental grants to assist in the funding of our research and development activities. If we lose our funding from these research and development grants, we may encounter difficulties in the funding of future research and development projects and implementing technological improvements, which would harm our operating results.”see in full comparison
“If and when we generate taxable income, we would be eligible for certain tax benefits provided to “Technologic Preferred Enterprise” and/or “Preferred Enterprise” as defined under the Encouragement of Capital Investment Law -1959, the Law, and its regulations, as amended and, accordingly, could be subject to a reduced corporate tax rate on its income that will meet the provisions of the Law (ranging between 7.5%-16%). To the extent that we are not eligible to obtain such statuses, our Israeli taxable income would be subject to regular Israeli corporate tax rates. …”see in full comparison
Full comparison: every changed paragraph (88)
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. WeSubject 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.
We are a clinical-stage biopharmaceutical company
with limited operating history compared to the long time it takes to develop phage based products. We have incurred losses in each year
since BiomX Ltd.’s inception in 2015. As of December 31, 2024,2025, our accumulated deficit was $180.7$216.9 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.million. We do not expect to generate
any revenue from the commercial sales of our product candidates
in the near term. 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, 20242025 and 2023,2024,
we had losses from operations of $44.5$41.5 million and $25.3$44.5 million, respectively. WeSubject to availability of sufficient financial and other
resources, we anticipate that the level of our expenses is expected
to increase and will continue to be significant if and as we:
As of December 31, 2024,2025, we had cash, cash equivalents
and restricted cash of $18$5.0 million, and we have had recurring losses from operations and negative operating cash flows since inception.
We will need to raise additional capital in the future to support our operations and product development activities. In the near term,
we expect to continue to fund our operations and other development activities relating to additional product candidates from the cash
held by us, governmental and other grants and through future equity and debt financing. We have explored and raised funds in multiple
manners since our inception. For instanceinstance, we filed in December 2023 a shelf registration statement on Form S-3 that was subsequently
declared effective by the SEC and entered into an At the Market Offering Agreement, or the ATM Agreement, with H.C. Wainwright & Co.,
Co., LLC, or Wainwright, as manager, pursuant to which we may issue and sell shares of our Common Stock having an aggregate offering price
price of up to $7.5 million$1,765,939 from time to time through Wainwright. We are not obligated to make any sales of Common Stock under the ATM
Agreement. 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, onOn February 27, 2025, we completed a registered direct offering and a concurrent private placement. Additionally,
certain warrant holders
agreed to exercise their warrants following our agreement to reduce the exercise price. Through these transactions,
we generated approximately
$12 millionmillion. In addition, in proceeds.March We15, anticipate2024, conductingconcurrently additional capital raises inwith the future.consummation Ifof the acquisition of APT, we enterconsummated into
a collaborationprivate 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 onegross or moreproceeds of our$3.0 current or future product candidates at an earlier development stage, the terms of such a collaboration
will likely be less favorable than if we were to enter the collaboration in later stages or if we commercialized the product independently.
If we raise additional funds through equity offerings, the terms of these securities may include liquidation or other preferences that
adversely affect our stockholders’ rights or cause significant dilution to our stockholders. If we raise additional capital through
debt financing, it would be subject to fixed payment obligations and may be subject to covenants limiting or restricting our ability
to take specific actions, such as incurring additional debt, making capital expenditures, declaring dividends or acquiring or licensing
intellectual property rights.million.
We anticipate conducting additional capital raises in the future. If we enter into a collaboration for one or more of our current or future product candidates at an earlier development stage, the terms of such a collaboration will likely be less favorable than if we were to enter the collaboration in later stages or if we commercialized the product independently. If we raise additional funds through equity offerings, the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights or cause significant dilution to our stockholders. If we raise additional capital through debt financing, it would be subject to fixed payment obligations and may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, declaring dividends or acquiring or licensing intellectual property rights.
We may evaluate various additional acquisition opportunities and strategic partnerships, including licensing or acquiring complementary or unrelated products, intellectual property rights, technologies or businesses. Any potential acquisition or strategic partnership may entail numerous risks, including:
Our financial statements contain
contain an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern. We have concluded that
there is
substantial doubt about our ability to continue as a going concern. We have accumulated a deficit of $180.7$216.9 million since our inception.
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. As of December 31, 2024,2025, we had $18
$5.0 million in cash
and cash equivalents.equivalents and restricted cash.
We believe our cash and cash equivalents on hand,
including the cash raised in theJanuary February 2025 Financing,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 intothrough the firstend 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 CF and DFI/DFO and our ability to repay our obligations when due. We cannot be sure that we will be able to obtain
any future funding,
and any such funding we may obtain may not be sufficient to finance our operations. If we are unable to obtain sufficient
funds, we may
be unable to continue as a going concern.
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,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. In particular, promising preclinical testing suggesting the potential
efficacy of prototype
phage products may not predict the ability of these products to address conditions in the human clinical settings.
For example, while
we have studied phage activity in vitro and in vivo, these results may not be replicated when our phage
cocktails are administered
to human subjects. Despite promising data in any preclinical studies, our phage technology may be found not
to be efficacious when studied
in clinical trials.
Delays
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.
Delays in our clinical trials could result in us not meeting anticipated clinical milestones and could materially impact our product development costs and delay regulatory approval of our product candidates. Planned clinical trials may not be commenced or completed on schedule, or at all. 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 delayeddelayed, or be subject to
a clinical hold, for a variety of reasons, including:
If we do not successfully commence or complete our clinical trials on schedule, the price of our securities may decline. 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.
Adverse effects could occur and cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of marketing approval by the FDA or equivalent foreign regulatory agencies. Results of our trials could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics. 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.
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 atby thisthird-party facility,manufacturers, thisthe manufacturing facilityfacilities used to produce such product candidates
will be
subjected to ongoing periodic inspection for compliance with European, FDA and cGMP regulations. Compliance with these regulations
and and
standards is complex and costly, and there can be no assurance that we will be able to comply. Any failure to comply with applicable
regulations could result in sanctions being imposed (including fines, injunctions and civil penalties), failure of regulatory authorities
to grant marketing approval of our product candidates, delays, suspension or withdrawal of approvals, license revocation, seizures or
recalls of product candidates or products, operating restrictions and criminal prosecution.
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.noncompetitive. These competitors also compete with us to recruit and retain qualified scientific
and management
personnel, establish clinical trial sites and patient registration for clinical trials, as well as to acquire technology
and technology
licenses complementary to our programs or advantageous to our business. Moreover, competitors that are able to achieve
patent protection,
obtain regulatory approvals and commence commercial sales of their products before we do, and competitors that have
already done so may
enjoy a significant competitive advantage.
Because
we have limited financial and managerial
resources, we intend to focus on developing product candidates for specific indications that
we identify as most likely to succeed, in
terms of both their potential for marketing approval and commercialization. As a result, we
may forego or delay pursuit of opportunities
with other product candidates or for other indications that may prove to have greater commercial
potential. For example, we spent significant
time and resources developing BX005,BX005 and BX004, which we discontinued.
Since
inception in 2015,2015 through its dissolution
in February 2026, 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. Such development efforts take very long periods of time before
they can be proved successful. We have not yet demonstrated our ability to successfully complete any clinical study or other pivotal clinical
clinical trials, obtain regulatory approvals, manufacture a commercial-scale product, or arrange for a third-party to do so on our behalf,
or conduct
sales and marketing activities necessary for successful product commercialization. Consequently, any predictions made about
our future
success or viability may not be as accurate as they could be if we had a longer operating history.
In addition, our ongoing evaluation of strategic alternatives may not result in any transaction or alternative that improves our prospects, or at all, on terms acceptable to us or our stockholders. If we are unable to identify and execute a viable strategic alternative or otherwise secure sufficient additional resources, we may be required to further reduce or discontinue our operations, delay, limit or terminate development activities, pursue an orderly wind-down, and our business, financial condition and results of operations could be materially and adversely affected.
Our product candidates are subject to significant regulatory approval requirements, including the risk of clinical holds, which could delay, prevent or limit our ability to market or develop our product candidates.
Our research and development activities, preclinical studies, clinical trials and the anticipated manufacturing and marketing of our drug product candidates are subject to extensive regulation by the FDA and other regulatory agencies in the United States and by comparable authorities in Europe and elsewhere. To satisfy FDA or equivalent foreign regulatory approval standards, we must demonstrate in adequate and well controlled clinical trials that our drug product candidates are safe and effective for their intended use. The regulatory approval process is expensive and time-consuming, and the timing of receipt of regulatory approval is difficult to predict. Given the uncertainties around phage therapy, our product candidates could require a significantly longer time to gain regulatory approval than expected or may never gain approval. We cannot be certain that, even after expending substantial time and financial resources, we will obtain regulatory approval for any of our product candidates. A delay or denial of regulatory approval could delay or prevent our ability to generate product revenue and to achieve profitability. In addition, the FDA or comparable foreign regulatory authorities may impose a clinical hold at any time if they determine that we have not satisfied applicable requirements or conditions, which could delay or prevent the initiation or continuation of our clinical trials and materially adversely affect our development timelines and costs.
Breakthrough
Therapy Designation or Fast Track Designation by the FDA, even if granted for any of our product candidates developed for therapeutic
indications, may not lead to a faster development, regulatory review or approval process, and it does not increase the likelihood that
any of our product candidates will receive marketing approval in the United States.
In
the United States, we may seek a Breakthrough Therapy Designation for some of our product candidates, including BX004 or another product
candidate under development. A breakthrough therapy is defined as a therapy that is intended, alone or in combination with one or more
other therapies, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the therapy
may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial
treatment effects observed early in clinical development. For therapies that have been designated as breakthrough therapies, interaction
and communication between the FDA and the sponsor of the trial can help to identify the most efficient path for clinical development
while minimizing the number of patients placed in ineffective control regimens. Breakthrough designation also provides sponsors with
the potential for rolling review of a BLA. Designation as a breakthrough therapy is within the discretion of the FDA.
In
the European Union, the PRIME (PRIority MEdicines) status is similar to the Breakthrough Therapy Designation. The EMA has implemented
the PRIME status to support the development and accelerate the approval of complex, innovative medicinal products addressing an unmet
medical need. The PRIME status enables early dialogue with the relevant EMA scientific committees and, possibly, some payors and thus
reinforces the EMA’s scientific and regulatory support. The PRIME status, which is granted at the EMA’s discretion, focuses
on medicinal products the marketing authorization of which qualifies for accelerated assessment (medicinal products of major interest
from a public health perspective, in particular from a therapeutic innovation perspective).
Accordingly,
even if we believe one of our product candidates meets the criteria for designation as a breakthrough therapy or for PRIME status, the
FDA or EMA, respectively, may disagree and instead determine not to make such designation. In any event, the receipt of a Breakthrough
Therapy Designation or PRIME status for a product candidate may not actually result in a faster development process, review or approval
compared to therapies considered for approval under conventional procedures and does not assure ultimate approval. In addition, even
if one or more of our product candidates qualify as breakthrough therapies or is granted PRIME status, the FDA or EMA, respectively,
may later decide that such product candidates no longer meet the conditions for qualification or decide that the time period for review
or approval will not be shortened.
In
the United States, we may seek Fast Track Designation for some of our product candidates for therapeutic indications. If a therapy is
intended for the treatment of a serious or life-threatening condition and the therapy demonstrates the potential to address unmet medical
needs for this condition, the therapy sponsor may apply for Fast Track Designation. The FDA has broad discretion whether or not to grant
this designation, so even if we believe a particular product candidate is eligible for this designation; we cannot assure you that the
FDA would decide to grant it. In August 2023, we obtained Fast Track Designation for BX004 in the United States. Although we received
Fast Track Designation, we may not experience a faster development process, review or approval compared to conventional FDA procedures.
The FDA may withdraw Fast Track Designation if they believe that the designation is no longer supported by data from our clinical development
program. Fast Track Designation alone does not guarantee qualification for the FDA’s priority review procedures.
Other
countries may have adopted schemes designed to ensure an accelerated approval of drugs that are especially important for patients. For
example, in the European Union, the EMA may agree to an accelerated assessment (150 days instead of 210 days) for medicinal products
of major interest from a public health perspective, in particular from a therapeutic innovation perspective). Furthermore, competent
regulatory authorities may grant market authorizations “under exceptional circumstances,” in cases where all the required
safety and efficacy data have not been and will not be collected, to medicinal products designed for unmet needs or orphan medicinal
products. Although a marketing authorization under exceptional circumstances is definitive, the risk-benefit balance of the medicinal
product must be reviewed annually and the marketing authorization is withdrawn if it becomes negative. Moreover, under the centralized
procedure, the European Commission may grant “conditional marketing authorizations” in cases where all the required safety
and efficacy data are not yet available. The conditional marketing authorization is subject to conditions to be fulfilled for generating
the missing data or ensuring increased safety measures. It is valid for one year and has to be renewed annually until fulfillment of
all the conditions. If the conditions are not fulfilled within the timeframe set by the EMA, the marketing authorization ceases to be
renewed. As with Fast Track Designation, the competent regulatory authorities in the European Union have broad discretion whether or
not to grant such an accelerated assessment or approval and, even if such assessment or approval is granted, we may not experience a
faster development process, review or approval compared to conventional procedures.
We
may fail to obtain and maintain orphan drug designations from the FDA or equivalent foreign regulatory agencies for our current and future
therapeutic product candidates, as applicable.
In
the United States, under the Orphan Drug Act, the FDA may grant orphan drug designation to a drug or biologic intended to treat a rare
disease or condition, which is defined as one occurring in a patient population of fewer than 200,000 in the United States, or a patient
population greater than 200,000 in the United States where there is no reasonable expectation that the cost of developing the drug or
biologic will be recovered from sales in the United States. In December 2023, we obtained orphan drug designation for BX004 in the United
States. In the United States, the orphan drug designation entitles a party to financial incentives, such as opportunities for grant funding
toward clinical trial costs, tax advantages and user-fee waivers. In addition, if a product that has the orphan drug designation subsequently
receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan drug exclusivity,
which means that the FDA may not approve any other applications, including an NDA, to market the same drug or biologic for the same indication
for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity
or where the original manufacturer is unable to assure sufficient product quantity.
In
addition, exclusive marketing rights in the United States may be limited if we seek approval for an indication broader than the orphan-designated
indication or may be lost if the FDA later determines that the request for designation was materially defective, or if we are unable
to assure sufficient quantities of the product to meet the needs of patients with the orphan-designated disease or condition. Further,
even if we obtain orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because
different drugs with different active moieties may receive and be approved for the same condition. Even after an orphan-designated product
is approved, the FDA can subsequently approve a later drug with the same active moiety for the same condition if the FDA concludes that
the later drug is clinically superior if it is shown to be safer, more effective or makes a major contribution to patient care. Orphan
drug designation neither shortens the development time or regulatory review time of a drug nor gives the drug any advantage in the regulatory
review or approval process. In addition, while we may seek the orphan drug designation for our product candidates, we may never receive
such designation.
An
orphan drug legal regime also exists in the European Union. The EMA’s Committee for Orphan Medicinal Products, or COMP, gives opinions,
and the European Commission takes decisions, on the granting of the orphan drug designation to the development of products that are intended
for the diagnosis, prevention or treatment of (i) a life-threatening or chronically debilitating condition affecting not more than five
in 10,000 persons in the European Economic Area (comprising the European Union, Iceland, Liechtenstein and Norway); or (ii) a life-threatening,
seriously debilitating or serious and chronic condition when, without incentives, it is unlikely that sales of the drug in the European
Economic Area would be sufficient to justify the necessary investment in developing the drug or biological product. The granting of the
orphan designation requires that there is no satisfactory method of diagnosis, prevention or treatment, or, if such a method exists,
that the future medicine is to be of significant benefit to those affected by the condition. The test for that later condition is stringent,
because the future product must be compared with all existing therapies for the rare condition, including surgical operations, already
authorized medicinal products and compounded preparations (subject to certain conditions). At the time of marketing authorization, the
orphan designation is reviewed again by the COMP in view of the maintenance of the orphan status. If the designation criteria are no
longer met, the European Commission withdraws the orphan designation. Maintenance of the orphan designation at the time of marketing
authorization means that all the drugs/biologicals authorized since the granting of the designation become relevant for determining the
lack of satisfactory therapy or the significant benefit.
If
obtained, the orphan drug designation would entitle us to financial incentives, such as reductions of fees or fee waivers and 10 years
of market exclusivity. Market exclusivity precludes the EMA or the national competent authorities from validating a marketing authorization
application, and the European Commission or a national competent authority from granting a marketing authorization, for a same or similar
drug/biological and the same therapeutic indication. The 10-year period may be reduced to six years if the orphan designation criteria
are no longer met, including where it is shown that the product is not sufficiently profitable to justify maintenance of market exclusivity.
The orphan exclusivity may also be lost vis-à-vis another drug/biological in cases where the manufacturer is unable to assure
sufficient quantity of the drug to meet patient needs or if that other product is proved to be clinically superior to the approved orphan
product. A drug/biological is clinically superior if it is safer, more effective or makes a major contribution to patient care.
Disruptions
at the FDA and other government agencies and entities,
such as the U.S. Department of Defense, caused by funding shortagesshortages, government shutdowns, global
health concerns or other causes could
hinder their ability to hire, retain or deploy key leadership and other personnel, or
otherwise prevent new or modified products from
being developed, approved or commercialized in a timely manner or at all, which
could negatively impact our business.
The ability of the FDA to review and or approve new products can be affected by a variety of factors, including government budget and funding levels, government shutdowns, statutory, regulatory, and policy changes, the FDA’s ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s ability to perform routine functions. Average review times at the FDA have fluctuated in recent years as a result. Any material reductions in the ability of FDA to perform these and other functions may delay the development and approval of our product candidates. Recent actions by the Trump administration have caused concern in the industry that this may occur. For example, beginning on February 13, 2025, the Department of Health and Human Services began firing a large number of its probationary employees, a category that includes new federal employees and employees recently promoted or transferred to new positions or agencies. Reports indicate that 5,000 out of 80,000 employees have been terminated. Although we cannot be certain at this early stage, these terminations and others, if they withstand legal challenges, may significantly delay and impede our interactions with FDA. Similar results may stem from the recent confirmed resignations of some senior FDA employees with responsibility for regulation of drugs and biologics, as well as possible future layoffs and resignations. There are also reports that the Trump administration intends to request Congress to reduce FDA funding in upcoming budgets. Such funding cuts may also delay the development and approval of our products.
In
addition, government funding of other government
agencies that fund research and development activities is subject to the political
process, which is inherently fluid and unpredictable.
For instance, we have funded our research and development from grants,
including grants from MTEC, a consortium working in partnership
with the U.S. Department of Defense. In connection therewith, in
2019, APT entered into the Research Agreement, with the USAMRAA,USAMRAA and the
USAMRDC, to advance personalized phage therapy from niche
to broad use and have received awards under this agreement. Cost cutting of
grants and other disruptions at the Department of
Defense, the FDA and other regulatory authorities may also lengthen the time necessary
for new drugs and biologics to be developed,
reviewed and/or approved by necessary regulatory authorities, which would adversely affect
our business, or require us to obtain alternative funding and other resources,
if available.
The
license agreements we maintain, including the Yeda 2015 License Agreement, with Yeda are important to our business. If we or the other
parties to our license agreements fail to adequately perform under the license agreements, or if we or they terminate the license agreements,
the development, testing, manufacture, production and sale of our phage-based therapeutic product candidates would be delayed or terminated,
and our business would be adversely affected.
The
Yeda 2015 License Agreement provides for an exclusive worldwide license to certain know-how and research information related to the development,
testing, manufacture, production and sale of phage-based therapeutic product candidates, including candidates specified in the agreement,
which are used in our phage discovery platform, as well as patents, research and other rights to phage product candidates resulting from
the work of the consultants identified in the agreement and further research that we funded. The Yeda 2015 License Agreement terminates
upon the later of the expiration of the last of the patents covered under the Yeda 2015 License Agreement and the expiry of a continuous
15-year period during which there has not been a first commercial sale of any product in any country. Yeda may also terminate the agreement
if we fail to observe certain diligence and development requirements and milestones as described in the Yeda 2015 License Agreement.
We or Yeda may terminate the agreement for the material uncured breach of the other party after a notice period or the other party’s
winding up, bankruptcy, insolvency, dissolution or other similar discontinuation of business. Upon termination of the agreement, other
than due to the passage of time, we are required to grant to Yeda a nonexclusive, irrevocable, perpetual, fully paid-up, sublicensable,
worldwide license in respect of our rights in know-how and research results as described in the Yeda 2015 License Agreement, provided
that, if Yeda subsequently grants a license to a third party that utilizes our rights, we are entitled to share in the net proceeds actually
received by Yeda arising out of that license, subject to a cap based on the development expenses that we incur in connection with the
Yeda 2015 License Agreement. For more information on the Yeda 2015 License Agreement, see “Business—Material Agreements—License
Agreements—License Agreement with Yeda.”
Termination
of our license agreements could cause significant delays in our product and commercialization efforts that could prevent us from commercializing
our product candidates, including our phage-based therapeutic product candidates, without first expanding our internal capabilities or
entering into other agreements with third parties. Any alternative collaboration or license could also be on less favorable terms to
us.
We
currently rely on licenses from third-party
collaborators for certain aspects of our technology and for certain of our existing programs.
In particular, we received exclusive, royalty-bearing
licenses to certain patents held by third parties, including Yeda. The Yeda 2015
License Agreement provide license to certain know-how and research information related to the development, testing, manufacture, production
and sale of phage-based therapeutic product candidates that are used in our phage discovery platform, as well as patents, research and
other rights to phage product candidates resulting from the work of the consultants identified in the agreement and further research
that we funded.parties.
If
we fail to comply with our obligations under
our license agreements, including payment terms, our licensors may have the right to terminate
our license agreements, in which event
we may not be able to develop, manufacture, market or sell the products covered by those license
agreements. We may also face other penalties
under our license agreements if we do not meet our contractual obligations. Such an occurrence
could materially adversely affect the value
of our products being developed under any such license agreements. Termination of one or
more of our license agreements, or reduction
or elimination of our rights under these license agreements, may result in us having to
negotiate new or reinstated license agreements,
which may not be available to us on equally favorable terms, or at all, which may mean
we are unable to commercialize the affected product
candidates. candidates.In addition, termination of our license agreements could cause significant delays in our product and commercialization efforts
that could prevent us from commercializing our product candidates, including our phage-based therapeutic product candidates, without first
expanding our internal capabilities or entering into other agreements with third parties. Any alternative collaboration or license could
also be on less favorable terms to us.
We
may become subject to claims for remuneration or royalties for assigned service invention rights by our employees, which could result
in litigation and adversely affect our business.
A
significant portion of our intellectual property has been developed by our employees in the course of their employment for us. Under
the Israeli Patent Law, 5727-1967, or the Patent Law, inventions conceived by an employee during the term and as part of the scope of
his or her employment with a company are regarded as “service inventions,” which belong to the employer, absent a specific
agreement between the employee and employer giving the employee service invention rights. The Patent Law also provides that, if there
is no such agreement between an employer and an employee, the Israeli Compensation and Royalties Committee, a body constituted under
the Patent Law, shall determine whether the employee is entitled to remuneration for his or her inventions. We generally enter into assignment
of invention agreements with our employees pursuant to which such individuals assign to us all rights to any inventions created in the
scope of their employment or engagement with us. Although our employees have agreed to assign to our service invention rights, we may
face claims demanding remuneration in consideration for assigned inventions. As a consequence of such claims, we could be required to
pay additional remuneration or royalties to our current or former employees or be forced to litigate such claims, which could negatively
affect our business.
Risks
Related to Our Operations in Israel
Our
headquarters, research and development and other significant operations are located in Israel, and, therefore, our results may be adversely
affected by political, economic and military instability in Israel, including the recent war with Hamas and other terrorist organizations
from the Gaza Strip.
Our
executive offices and research and development facilities are located in Israel. In addition, the majority of our key employees and all
of our officers are residents of Israel. Accordingly, political, geopolitical, economic and military conditions in Israel may directly
affect our business. Since the establishment of the State of Israel in 1948, a number of armed conflicts have taken place between Israel
and its neighboring Arab countries, the Hamas (an Islamist terrorist militia and political group that controls the Gaza strip), the Hezbollah
(an Islamist terrorist militia and political group based in Lebanon) and other terrorist organizations active in the region. These conflicts
have involved missile strikes, hostile infiltrations and terrorism against civilian targets in various parts of Israel, which have negatively
affected business conditions in Israel. Any hostilities involving Israel or the interruption or curtailment of trade between Israel and
its trading partners could negatively affect business conditions in Israel in general and our business in particular, and adversely affect
our product development, operations and results of operations.
Following the October 2023 attacks by Hamas terrorists
in Israel’s southern border, Israel declared a war against Hamas and since then, Israel has been involved in military conflicts
with Hamas, Hezbollah, a terrorist organization based in Lebanon, and Iran, both directly and through proxies such as the Houthi movement
in Yemen, armed groups in Iraq and other terrorist organizations. Additionally, following the fall of the Assad regime in Syria, Israel
has conducted limited military operations targeting certain Syrian military assets, Iranian military assets and infrastructure linked
to Hezbollah and other Iran-supported groups. Although a ceasefire agreement has been reached with Lebanon (with respect to Hezbollah)
there is no assurance that this agreement will be upheld. Military activity and hostilities continue to exist at varying levels of intensity,
and the situation remains volatile, with the potential for escalation into a broader regional conflict involving additional terrorist
organizations and possibly other countries. Furthermore, the fall of the Assad regime in Syria may create additional geopolitical instability
in the region.
In
connection with the ongoing war against Hamas and Hezbollah and possible hostilities with other organizations, several hundred thousand
Israeli military reservists were drafted to perform immediate military service, including 5 employees, none of whom are management or
key employees, who were called up for reserve service, of which 5 have since returned to work full time and their pre-war military reserve
duty. So long as the war continues, our personnel may be called up for reserve service, whether for extended periods or periodically
for short-term periods. Military service call ups that result in absences of personnel for an extended period of time may materially
and adversely affect our business, prospects, financial condition and results of operations.
Since
the war broke out on October 7, 2023, our operations have not been adversely affected by this situation, and we have not experienced
disruptions to our business operations. As such, our product and business development activities remain on track. However, the intensity
and duration of Israel’s current war is difficult to predict at this stage, as are such war’s economic implications on our
business and operations and on Israel’s economy in general. If the war extends for a long period of time or expands to other fronts,
such as Syria and the West Bank, our operations may be adversely affected.
Any
armed conflicts, terrorist activities or political instability in the region could adversely affect business conditions, could harm our
results of operations and the market price of our Common Stock, and could make it more difficult for us to raise capital.
Our
commercial insurance does not cover losses that may occur as a result of an event associated with the security situation in the Middle
East. Although the Israeli government has in the past covered the reinstatement value of certain damages that were caused by terrorist
attacks or acts of war, we cannot assure you that this government coverage will be maintained or, if maintained, will be sufficient to
compensate us fully for damages incurred. Any losses or damages incurred by us could have a material adverse effect on our business.
The
global perception of Israel and Israeli companies, influenced by actions by international judicial bodies, may lead to increased sanctions
and other negative measures against Israel, as well as Israeli companies and academic institutions. There is also a growing movement
among countries, activists, and organizations to boycott Israeli goods, services and academic research or restrict business with Israel,
which could affect business operations. If these efforts become widespread, along with any future rulings from international tribunals
against Israel, they could negatively impact our business operations.
Finally,
political conditions within Israel may affect our operations. Prior to October 7, 2023, the Israeli government pursued extensive changes
to Israel’s judicial system, which sparked extensive political debate and unrest. Since October 7, 2023, these initiatives have
been put on hold; however, the Israeli government has recently renewed its efforts to effect such changes. Actual or perceived political
instability in Israel or any negative changes in the political environment, may individually or in the aggregate adversely affect the
Israeli economy and, in turn, our business, financial condition, results of operations and growth prospects.
Our
operations may be disrupted as a result of the obligation of management or key personnel to perform military service.
Management's Discussion & Analysis (MD&A)
New heading “Gain from early lease termination”
Removed heading “Local Manufacturing Obligation”
Removed heading “Know-How Transfer Limitation”
Removed heading “Change of Control”
Removed heading “Stock-Based Compensation”
Largest changes
Our financial statements contain an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern as we believe that our current funds, including the funds received from the 2025 Second SPA, will be sufficient to meet our working capital and capital expenditure requirements onlysee in full comparisonintothrough thefirstend of the second quarter of 2026. In the future, we will likely require or desire additional funds to support our operating expenses and capital requirements or for other purposes, such as acquisitions, and may seek to raise such additional funds through public or private equity or debt financings or collaborative agreements or from other sources, as we did with the ATM Agreement and the Hercules Loan Agreement.IfOurcertainabilitydisruptionsto secure such additional funds is contingent upon obtaining the stockholder approval required pursuantduetoto,thefor2025instance,SecondIsrael’sSPA.WarFailurewithtoHamasobtain such approval would severely constrain our financing options, potentially forcing us to cease our operations, andHezbollah,wouldorincreaseIsraelithepoliticalsubstantialinstabilitydoubtpersistsaboutandourdeepens, we could experience an inabilityability toaccess additional capital, which could in the future negatively affect our capacity to support our operating expenses and capital requirements or to make investments for other purposes, suchcontinue asacquisitions.a going concern.
“Other long-lived asset impairment was $1.7 million for the year ended December 31, 2025, compared to $4.0 million for the year ended December 31, 2024. The decrease of $2.3 million, or 58%, reflects impairment charges at BiomX Israel and APT. At BiomX Israel, impairment was recorded in connection with the commencement of insolvency proceedings and the subsequent sale of all property and equipment, based on sale proceeds. At APT, impairment was recorded after determining that expected sale proceeds for its equipment are negligible.”see in full comparison
“Any non-Israeli citizen, resident or entity that, among other things, (i) becomes a holder of 5% or more of our share capital or voting rights, (ii) is entitled to appoint our directors or our chief executive officer or (iii) serves as one of our directors or as our chief executive officer (including holders of 25% or more of the voting power, equity or the right to nominate directors in such direct holder, if applicable) is required to notify the IIA and undertake to comply with the rules and regulations applicable to the grant programs of the IIA, including the restrictions on transfer …”see in full comparison
“On December 26, 2025, we entered into the 2025 Second SPA with the Investor Pursuant to the 2025 Second SPA, we agreed to issue and sell, in a private placement transaction, an aggregate of 3,300 shares of our newly created Series Y Convertible Preferred Stock, as defined below, with an aggregate stated value of $3.3 million, and warrants to purchase up to 3,300,000 shares of the Company’s common stock, for aggregate gross proceeds of $3.0 million. …”see in full comparison
“During the year ended December 31, 2025, operating activities used $26.4 million of net cash, primarily due to a net loss of $36.2 million adjusted by non-cash charges of $9.8 million. Non-cash charges mainly consisted of $6.1 million related to income from change in fair value of the warrants and $2.9 million gain from early lease termination. These were partially offset by non-cash expenses including stock-based compensation of $2.1 million, depreciation of $2.9 million, and impairment charges of $11.8 million related to the IPR&D asset and $1.7 million related to other long-lived assets. …”see in full comparison
“Approval of transfer of IIA funded know-how to another Israeli company may be granted only if the recipient abides by the provisions of the Research Law and related regulations, including the restrictions on the transfer of know-how and manufacturing rights outside of Israel.”see in full comparison
Full comparison: every changed paragraph (87)
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 CF and DFO.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.
Since BiomX Ltd.’s inception in 2015, we
have devoted substantially all our resources to organizing and staffing our company, raising capital, acquiring rights to or discovering
product candidates, developing our technology platforms, securing related intellectual property rights, and conducting discovery, research
and development and clinical activities for our product candidates. We do not have any products approved for sale, and we have not generated
any revenue from product sales. AsIf we continue to advance our product candidates, we expect our expenses to remain significant. To date,
we have
funded our operations with proceeds from sales of our Common Stock, preferred shares and warrants, governmental grants, collaboration
agreements and debt. As of December 31, 2024,2025, we received gross proceeds of approximately $204$217.3 million from sales of our securities.
In In
addition, as of December 31, 2024,2025, we received $13.7$14.7 million from our collaboration agreements and grants from the IIA and MTEC.
In
addition, we have incurred significant operating
losses. Our ability to generate revenue from product sales sufficient to achieve profitability
will depend on the successful development
of, the receipt of regulatory approval for, and eventual commercialization of one or more of
our product candidates. Our net losses were
approximately $17.7$36.2 million and $26.2$17.7 million for the years ended December 31, 20242025 and 2023,
2024, respectively. As of December 31, 2024,2025, we
had an accumulated deficit of $180.7$216.9 million and expect that for the foreseeable future we
will continue to incur significant expenses as we advance our product candidates from discovery through preclinical development and clinical
trials and seek regulatory approval of our product candidates. In addition, if we obtain regulatory approval for any of our product candidates,
we expect to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution. We may
also incur expenses in connection with in-licensing or acquiring additional product candidates.million.
As
of December 31, 2024,2025, we had cash, cash equivalents
and restricted cash of $18$5.0 million. Our financial statements contain an explanatory
paragraph regarding substantial doubt about our ability
to continue as a going concern, as we believe our cash and cash equivalents on
hand will be sufficient to meet our working capital and
capital expenditure requirements only intothrough the firstend of the second quarter of 2026 as discussed
further below under “Liquidity
and Capital Resources”.
Concurrently
with the consummation of the Acquisition, BiomX consummated 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 shares of Redeemable Convertible
Preferred Shares, convertible into an aggregate of up to 21,641,700 shares of BiomX Common Stock, and (ii) 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 Redeemable
Convertible Preferred Shares and an accompanying Private Placement Warrant to purchase 500 shares of BiomX Common Stock. The Private
Placement Warrants are exercisable at any time after July 9, 2024, at an exercise price of $2.31 per share, and will expire on July 9,
2026.
Immediately
following the Acquisition, and without taking into account the shares of Convertible Preferred Stock issued in the March 2024 PIPE, and
assuming conversion of all of the Convertible Preferred Stock into Common Stock, our stockholders (including holders of the Pre-Funded
Warrants, as defined below) prior to the Acquisition owned approximately 55% of the share capital of the Company and APT’s stockholders
prior to the Acquisition owned approximately 45% of the share capital of the Company.
On July 9, 2024, the Company’s stockholders
approved a reverse stock split at a ratio within a range of 1-for-5 and 1-for-10 at such time as the Board shall determine,
in its sole discretion, at any time before July 9, 2025. On August 8, 2024, the Board approved a 1-for-10 Reverse Stock Split of the Company’s
shares of Common Stock, or the Reverse Stock Split. On August 20, 2024, the Company filed the Certificate of Amendment with the Delaware
Secretary of State to effect the Reverse Split, which became effective on August 26, 2024, orwe theeffected Effectivea Date.1-for-10 Thereverse
stock Company’s
Commonsplit, Stock began tradingand on November 25, 2025, we effected a Reverse1-for-19 Stockreverse Split-adjustedstock basissplit. on the NYSE American at the open of the markets on the Effective Date.
Unless otherwise indicated, all issuedshare and outstandingper shares share
amounts in this Annual Report have been retroactively adjusted to reflect thethese Reverse
Stockreverse Splitstock forsplits, allincluding periods presented. Proportionalproportional adjustments also were made
to shares underlying outstanding equity awards, warrants
and Redeemable Convertible Preferred Shares, and to the number of shares issued and issuable under the Company’s
stock incentive
plans and certain existing agreements.
In December 2025, we discontinued the development of BX004 following an internal analysis and feedback from the DMC, which recommended consideration of alternative dosing regimens or treatment strategies in response to adverse events experienced by certain participants; however, pursuing such alternatives was beyond the Company’s available resource. Additionally, we implemented cost-cutting measures including a significant reduction in workforce while reviewing other strategic alternatives.
In December 2025, following the discontinuation of development of BX004, our Israeli subsidiary, BiomX Ltd., commenced insolvency proceedings in Israel. Prior to the commencement of these insolvency proceedings, BiomX Ltd. served as the core operational subsidiary of the Company, employing a significant portion of our workforce. As a result of BiomX Ltd.’s insolvency, our business has been materially impacted, and without additional resources, we have limited ongoing operations and limited ability to advance our programs as previously planned. Accordingly, we are actively evaluating and pursuing strategic alternatives and other business opportunities to exploit the expertise of our management staff, based on time, available resources and market conditions.
On December 26, 2025, we entered into the 2025 Second SPA with the Investor Pursuant to the 2025 Second SPA, we agreed to issue and sell, in a private placement transaction, an aggregate of 3,300 shares of our newly created Series Y Convertible Preferred Stock, as defined below, with an aggregate stated value of $3.3 million, and warrants to purchase up to 3,300,000 shares of the Company’s common stock, for aggregate gross proceeds of $3.0 million. The Series Y Convertible Preferred Stock has a stated value of $1,000 and is convertible into Common Stock at an initial conversion price of $2.00 per share (i.e., 1,650,000 shares of Common Stock), subject to adjustments. Accordingly, subject to receipt of approval of the stockholders of the Company, the Investor is expected to beneficially own the majority of the shares of common stock of the Company and will have control over the Company. Therefore, if the stockholders approval is obtained, the Investor is expected to cause the Company to change its business, strategy and objectives.
Research
and development activities are central
to our business. Product candidates in later stages of clinical development generally have higher
development costs than those in earlier
stages of clinical development, primarily due to the increased size and duration of later-stage
clinical trials. Our research and development
expenses reflect, among other things, programs that were discontinued or put on hold as
well as new development programs. As a result, we expect that our research and development expenses will increase substantially over
the next several years, particularly as we increase personnel costs, including stock-based compensation, contractor costs and facilities
costs, as we continue to advance the development of our product candidates. We also may incur additional expenses related to milestone
and royalty payments payable to third parties with whom we have entered into license agreements to acquire the rights to our product
candidates.
General and administrative expenses consist primarily of salaries, related benefits and stock-based compensation expenses for personnel in executive, finance, corporate, business development and administrative functions. General and administrative expenses also include legal fees relating to corporate and securities matters; professional fees for accounting, tax and audit services; insurance costs; travel expenses; and facility-related expenses, including rent, depreciation, as well as operating related costs.
Impairment
of Goodwill, Intangible
Asset and Other long-lived assetsasset
In connection with our acquisition of APT, we allocated a portion of the purchase price to goodwill and in-process research and development or, IPR&D intangible asset.
During the fourth quarter of 2025, the Company’s stock price declined significantly, in part following the Company’s announcement regarding the discontinuation of the CF Phase 2b clinical trial due to adverse events and the filing of the application to commence insolvency proceedings for BiomX Ltd. The discontinuation of the CF trial raised concerns that extended beyond the CF program itself, as the adverse events observed may have broader implications for the Company’s platform technology and pipeline programs. As a result, the Company performed an impairment assessment of its IPR&D acquired in the APT acquisition. Based on this assessment, we recognized an impairment charge of $11.8 million for the year ended December 31, 2025.
In
connection with our acquisition of APT, we allocated a portion of the purchase price to goodwill and in-process research and development
(“IPR&D”) intangible asset. During the third and fourth quarters of 2024,
we experienced a decline in our stock price
resulting in market capitalization being less than our stockholders’ equity, which we
concluded as an impairment indicator. As
a result, we performed a quantitative assessment for goodwill and IPR&D impairment and recognized
an impairment charge of $0.8 million
and $3.2 million, respectively.respectively, for the year ended December 31, 2024.
Long-lived
assetsOther long-lived asset impairment
On December 16, 2025, BiomX Ltd. filed an application for the commencement of legal insolvency proceedings. As a result, BiomX Ltd. sold all of its property and equipment subsequent to the balance sheet date. Accordingly, we recorded an impairment of $0.5 million for the year ended December 31, 2025, to reflect the sale proceeds.
On December 31, 2025, APT signed an amendment to terminate its lease agreement in Gaithersburg, Maryland. In addition, APT intends to dispose of all of its property and equipment. Based on purchase offers received for its equipment, we determined that the expected sale proceeds are negligible and wrote down the full carrying amount of the assets in amount of $1.2 million for the year ended December 31, 2025.
Gain from early lease termination
Following the termination of the lease agreement pursuant to an amendment executed by APT, the Company was required to settle the termination consideration. In accordance with the termination provisions of the agreement, the Company was required to pay the landlord $0.8 million, and the landlord was entitled to apply a lease security deposit in the amount of an additional $0.15 million. As a result of the early termination of the lease, we recognized a gain from early termination in the amount of $2.9 million.
Other expenses (income)
Other expenses (income) consistsprimarily consist of a
capital reversionloss from the sale of fixed assets, a reversal of the contract
liability associatedrelated withto the AD program whichthat has beenwas paused in 2024, and
proceeds from sub-leasingthe subleasing of a portion of our office space in Ness Ziona,
Israel, which sub-leasesublease ended in September 2024.
Interest expense consistsmainly ofrelated to interest on
the existing loan to APT from the U.S. Small Business Administration and interest incurred
under a Loan and Security Agreement with Hercules
Capital, Inc., or the Hercules Loan Agreement. Under the Hercules Loan Agreement, Hercules
Capital, Inc., or Hercules, provided the Company with access to a term loan with an aggregate principal amount of up to $30 million, or
the Term Loan Facility. On March 19, 2024, we prepaid all of the remaining loan balance under the TermHercules Loan Facility
Agreement in a total amount
of $10.4 million. The prepayment included an end of term charge of $983 thousand and accrued interest of $69 thousand.
Income
from change in fair value of Private Placement Warrantswarrants
Income
from change in fair value of Private Placement Warrantswarrants reflects
the revaluation that resulted from the accounting of the Private Placement
Warrantswarrants issued under the March 2024 PIPE.PIPE and the warrants issued under the February
2025 Financing.
Financial
expenses, net consist primarily of income or expenses related to revaluation of foreign currencies and interest
income on our bank deposits
and money market funds.funds and transaction costs incurred in connection with the February 2025 Financing and the
March 2024 PIPE.
R&D expenses,
net (net of grants received
from the IIA and MTEC, and consideration from research collaborations) were $24.7 million for the year ended
December 31, 2024, compared to $16.7$21.3 million for the year ended December 31, 2023.2025, compared
to $24.7 million for the year ended December 31, 2024. The increasedecrease of $8.0$3.4 million, or 48%,14%, in the year
ended December 31, 20242025 compared
to the prior year, is primarily due to the following:
The decrease was partially offset by an increase of $0.8 million associated with the initiation of the Phase 2b clinical trial for our CF product candidate, BX004, as well as by an increase of $0.8 million in depreciation expenses attributable to the accelerated depreciation of leasehold improvements resulting from the remeasurement of lease liability of our office lease agreement in Ness Ziona, Israel and the termination of APT’s lease agreement. In addition, we recorded $1.6 million of MTEC grants and $0.4 million of IIA grants for the year ended December 31, 2025, compared to $2.6 million of MTEC grants for the year ended December 31, 2024.
We
recorded $2.6 million of MTEC grants and no IIA grants for the year ended December 31, 2024,
compared to $1.1 million of IIA grants and $1.3 million of consideration from research collaborations for the year ended December 31,
2023.
General
and administrative expenses were $9.6 million
for the year ended December 31, 2025, compared to $11.8 million for the year ended December 31, 2024,2024. comparedThe to $8.7$2.2 million for the year ended December
31, 2023. The $3.1 million increase,decrease, or 36%, 19%,
is primarily driven by Acquisition-related expenses,expenses includingof $0.9 million in issuance
costs and $0.4 million inof legal fees associated with both the Acquisition
and the March 2024 PIPE. Additionally, the increase reflects
higher salary and share-based compensation expenses of $0.9 million related to the combined workforce,PIPE, as well as $0.3a decrease of $0.2 in other professional service fees. Additionally, we had a decrease of $0.5 million
in salaries and related expenses due to workforce reduction and a $0.2 million decrease in rent
expensespremium followingfor the Acquisition.Company’s directors’
and officers’ insurance policy.
Gain from early lease termination was $2.9 million, following the derecognition of the related right-of-use asset and lease liability, and the total consideration paid, as a result of APT’s lease termination.
Goodwill
impairment in the 2024 period was $0.8 million for the year ended December 31, 2024,
million, following an impairment of the Company’s goodwill that resulted from
the Acquisition. WeThe hadCompany’s nomarket 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 impairmentshould inbe the year ended December 31, 2023.impaired.
IPR&D
impairment was $11.8 million for the
year ended December 31, 2025, compared to $3.2 million for the year ended December 31, 2024, following our quantitative assessment for
IPR&D impairment. We
had no IPR&D impairment in the year ended December 31, 2023.
Other long-lived asset impairment was $1.7 million for the year ended December 31, 2025, compared to $4.0 million for the year ended December 31, 2024. The decrease of $2.3 million, or 58%, reflects impairment charges at BiomX Israel and APT. At BiomX Israel, impairment was recorded in connection with the commencement of insolvency proceedings and the subsequent sale of all property and equipment, based on sale proceeds. At APT, impairment was recorded after determining that expected sale proceeds for its equipment are negligible.
Long-lived
assets impairment was $4.0 million for the year ended December 31, 2024, after evaluating the right-of-use asset and related leasehold
improvements following our decision to cease the use of the property in Gaithersburg, Maryland and make it available for sublease. We
had no long-lived assets impairment in the year ended December 31, 2023.
Other incomeexpense was $2.1$0.1 million for the year ended
December 31, 2024,2025, compared to $0.4other income of $2.1 million for the year ended December 31, 2023.2024. The increasedecrease of $1.7$2.2 million, or 425%, 105%,
is primarily
due to the reversion of the contract liability associated with the Company’s AD program which has been suspended.suspended in
2024.
Interest expenses were $0.9 million$20,000 for the year ended
ended December 31, 2024,2025, compared to $2.4 million$873,000 for the year ended December 31, 2023.2024. The decrease of $1.5 million,$853,000, or 63%,98%, is due to
the full repayment of
the loan under the Hercules Loan Agreement.Agreement in March 2024. Interest in the 2025 period was related to an existing loan to APT from the
U.S. Small Business Administration.
Finance expense, net was $0.7 million for the year ended December 31, 2025, compared to $0.9 million for the year ended December 31, 2024. The decrease of $0.2 million, or 22%, was primarily attributable to lower transaction costs incurred in connection with the February 2025 financing, as compared to the March 2024 PIPE financing, partially offset by lower interest income in the current period.
Income from change in fair value of warrants was $6.1 million for the year ended December 31, 2025, compared to $26.5 million for the year ended December 31, 2024. The decrease of $20.4 million, or 77%, 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.
Finance
expense, net was $0.9 million for the year ended December 31, 2024, compared to finance income of $1.2 million for the year ended December
31, 2023. The increased expenses of $2.1 million, or 175% resulted mainly from the Private Placement Warrants transaction costs under
the March 2024 PIPE.
Income
from change in fair value of Private Placement Warrants reflects the revaluation that resulted from the accounting of the Private Placement
Warrants issued under the March 2024 PIPE.
In
December 2020, we entered into an Open Market Sale AgreementSM, or the Sale Agreement, with Jefferies LLC Jefferies, pursuant
to which we could issue and sell shares of our Common Stock having an aggregate offering price of up to $50 million from time to time
through Jefferies. We were not obligated to make any sales of Common Stock under the Sale Agreement. Through December 31, 2023, we sold
an aggregate of 98,339 shares of Common Stock pursuant to the Sale Agreement for aggregate gross proceeds of $5.8 million. We terminated
the Sale Agreement on December 7, 2023.
On
August 16, 2021 we entered into the Hercules
Loan Agreement with Hercules, with respect to a venture debt facility. Under the Hercules
Loan Agreement, Hercules provided us with access
to a term loan with an aggregate principal amount of up to $30 million, available in
three tranches, subject to certain terms and conditions.
The first tranche of $15 million was advanced to us on the date the Hercules
Loan Agreement was executed. The milestones for the second and third tranches were not reached and have expired and accordingly
we never received additional amounts under the Hercules Loan Agreement. We were required to make interest-only payments through March
1, 2023, and we were required to repay the principal balance and interest in monthly installments through September 1, 2025. On March
19, 2024, we
voluntarily prepaid the outstanding amount under the Hercules Loan Agreement and such agreement expired.
On
February 22, 2023, we entered into a securities purchase agreement to issue and sell an aggregate of 1,599,746 shares of our Common Stock
and 1,461,072 pre-funded warrants, or the February 2023 Pre-Funded Warrants, and collectively, the February 2023 Securities, at a price
of $2.45 per share and $2.44 per Pre-Funded Warrant, through a private placement pursuant to an exemption from registration requirements
under the Securities Act, or the February 2023 PIPE, for net proceeds of approximately $7.2 million, after deducting issuance costs of
$0.3 million. As of December 31, 2024, 533,031 February 2023 Pre Funded Warrants were exercised into 533,031 shares of Common Stock for
a total consideration of $6 thousand at an exercise price of $0.01 per share of Common Stock, and 928,041 February 2023 Pre-Funded Warrants
were exercised into 925,607 shares of Common Stock through cashless mechanism with no consideration. As of December 31, 2024, there are
no outstanding February 2023 Pre-Funded Warrants.
In
On December 7, 2023, pursuantwe tofiled a shelf registration statement on Form
S-3, S-3which was declared effective by the SEC on January 2, 2024,2024. orIn theaddition, Effective
S-3,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 thean Effectiveeffective registration Statement on Form S-3. WeOn 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 resumeoffer useand sell under the 2023 ATM Agreement. Under the prospectus supplement,
we may issue and sell shares of theCommon ATMStock having an aggregate offering price of up to $1.7 million from time to time through Wainwright.
Agreement inDuring the future.year ended December 31, 2025, we sold 121,773 shares of Common Stock under the 2023 ATM Agreement, at an average price of $11.13
per share, raising aggregate net proceeds of approximately $1.3 million, after deducting an aggregate commission of $51.
In February and May, 2023, subsequent to the approval of the Company’s stockholders, we completed the
closing of the February 2023 PIPE, as defined below, with $7.5 million in gross proceeds. Additionally, onOn March 15, 2024, concurrently
with the consummation
of the Acquisition, we consummated a private placement, or the March 2024 PIPE, pursuant to an exemption from registration requirements
requirements under the Securities Act, with certain investors pursuant to which such investors purchased an aggregate of 216,417 shares
of our Series
X non-voting convertible preferred stock, par value $0.0001 per share, or the Convertible Preferred Stock, par value $0.0019 per share, with each Series X Convertible
Preferred Stock being convertible into 1006 shares
of our shares of Common Stock, after giving effect to the Reverse Split, and warrants,
or Private Placement Warrants, to purchase up to
an aggregate of 10,820,850569,519 shares of the Company’s Common Stock, for aggregate
gross proceeds of approximately $50 million.
On December 26, 2025, we entered into the 2025 Second SPA with the Investor, pursuant to which the Company agreed to issue and sell, in a private placement transaction, an aggregate of 3,300 shares of the Company’s newly created Series Y Convertible Preferred Stock, with an aggregate stated value of $3.3 million, and warrants to purchase up to 3,300,000 shares of the Company’s Common Stock, for aggregate gross proceeds to the Company of $3.0 million, before deducting placement agent fees and other offering expenses. Each share of Series Y Preferred Stock has a stated value of $1,000 and will be convertible into shares of Common Stock at a conversion price of $2.00 per share, subject to customary adjustments. Holders of Series Y Convertible Preferred Stock will be entitled to receive dividends on the stated value at a rate of 15% per annum, compounded quarterly, payable in arrears, which dividends may, at the Investor’s sole election, be paid in cash or shares of Common Stock. The Series Y Convertible Preferred Stock does not have voting rights (except as otherwise required by law or as expressly provided in the certificate of designations), and each share will have a maturity of one year from the closing date. Conversion is subject to beneficial ownership limitations of 19.99% of the Company’s outstanding Common Stock. Pursuant to the 2025 Second SPA, the Company also agreed to issue to the Investor warrants to purchase up to an aggregate number of shares of Common Stock equal to 200% of the number of shares of Common Stock issuable upon conversion of the Series Y Preferred Stock, or the “2025 Second SPA Warrants”, i.e., 3,300,000 shares of Common Stock. The 2025 Second SPA Warrants will be exercisable immediately upon issuance, subject to certain limitations and will have an initial exercise price of $2.00 and will expire five years from the date of issuance.
We are subject to restrictions pursuant to the
February 2025 Financing, including certain standstill periods preventing us from issuing any Common Stock or Common Stock equivalents
or filing any registration statement or any amendment or supplement to any existing registration statement until 30 days after the later
of (i) the date that the resale registration statement related to the February 2025 Financing is declared effective by the SEC and (ii)
the date of the stockholder approval required in connection with the February 2025 Financing. We also agreed, subject to certain exceptions,
not to effect or agree to effect any variable rate transaction until 90 days after the later of (i) the date that the resale registration
Statement is declared effective by the SEC and (ii) the stockholder approval. Following such restrictions and subject to applicable securities
law limits, we may continue to sell shares under the ATM Agreement and otherwise to use our shelf registration statement to raise additional
funds from time to time. We may also raise funds privately, as we did in February 2023, the March 2024 PIPE and the February 2025 PIPE.
We may also seek funds through arrangements with collaborators or others that may require us to relinquish rights to the product candidates
that we might otherwise seek to develop or commercialize independently.
Our
financial statements contain an explanatory
paragraph regarding substantial doubt about our ability to continue as a going concern as
we believe that our current funds, including
the funds received from the 2025 Second SPA, will be sufficient to meet our working capital and capital expenditure requirements only into
through the first
end of the second quarter of 2026. In the future, we will likely require or desire additional funds to support our operating
expenses and capital requirements
or for other purposes, such as acquisitions, and may seek to raise such additional funds through public
or private equity or debt financings
or collaborative agreements or from other sources, as we did with the ATM Agreement and the Hercules
Loan Agreement. IfOur certainability disruptionsto secure such additional funds is contingent upon obtaining the stockholder approval required pursuant
dueto to,the for2025 instance,Second Israel’sSPA. WarFailure withto Hamasobtain such approval would severely constrain our financing options, potentially forcing us to cease
our operations, and Hezbollah,would orincrease Israelithe politicalsubstantial instabilitydoubt persistsabout andour deepens, we could experience
an inabilityability to access additional capital, which could in the future negatively affect our capacity to support our operating expenses
and capital requirements or to make investments for other purposes, suchcontinue as acquisitions.a going concern.
During the year ended December 31, 2025, operating activities used $26.4 million of net cash, primarily due to a net loss of $36.2 million adjusted by non-cash charges of $9.8 million. Non-cash charges mainly consisted of $6.1 million related to income from change in fair value of the warrants and $2.9 million gain from early lease termination. These were partially offset by non-cash expenses including stock-based compensation of $2.1 million, depreciation of $2.9 million, and impairment charges of $11.8 million related to the IPR&D asset and $1.7 million related to other long-lived assets. Net changes in our operating assets and liabilities consisted primarily of a decrease in net change in operating leases of $0.1 million and in other account payables of $3.4 million, partially offset by a decrease in other current assets of $2.2 million and in trade account payables of $1.2 million.
During
the year ended December 31, 2023, operating activities used $21.3 million of net cash, primarily due to a net loss of $26.2 million and
by net cash used by changes in our operating assets and liabilities of $2.5 million and non-cash charges of $2.4 million. Non-cash charges
for the year ended December 31, 2023, mainly consisted of stock-based compensation expenses of $1.0 million, depreciation and amortization
of $0.9 million and amortization of debt issuance costs of $0.6 million. Net changes in our operating assets and liabilities for the
year ended December 31, 2023, consisted primarily of an increase in trade account payables of $0.6 million and an increase in other account
payables of $1.2 million, partially offset by a decrease in other current assets of $0.8 million.
During the year ended December 31, 2025, investment activities provided net cash of $0.1 million, mainly consisting of proceeds from the sale of property and equipment.
During
the year ended December 31, 2023, investment activities provided net cash of $2.0 million, proceeds from withdrawal of short-term
deposits of $2.0 million.
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 option 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 recognize gains or losses that offset the revaluation of the balance
sheet items also recorded under financial expenses (income),
expenses, net. As of December 31, 2025, we had no outstanding foreign exchange contracts. As of December 31, 2024, we had outstanding
foreign exchange contracts
in the amount of approximately $2.4 million with a fair value asset of $19 thousand. As of December 31, 2023, we had outstanding foreign
exchange contracts in the amount of approximately $4.1 million with a fair value asset of $0.3 million.
During the year ended December 31, 2025, financing activities provided net cash of $13.2 million, mainly consisting of the issuance of Common Stock and warrants under the February 2025 Financing as well as issuance of Common Stock under the ATM.
During
the year ended December 31, 2023, financing activities provided net cash of $3.0 million, mainly consisting of $7.2 million due to issuances
of Common Stock under the February 2023 PIPE, net of issuance costs, partially offset by the repayment of long-term debt of $4.3 million
under the Hercules Loan Agreement.
Our contractual
contractual obligations and commitments relate primarily to our operating leases and non-cancelable purchase obligations under agreements
with various
research and development organizations and suppliers in the ordinary course of business. In
August 2019, we entered into a lease
agreement for office and lab spaces in Gaithersburg, MarylandMaryland. andThis inlease agreement was terminated effective December 31, 2025. In
September 2020, we entered into a lease agreement for office and laboratory space in Ness Ziona, Israel. In November 2025, the
latter lease agreement for office and laboratory space in Ness Ziona, Israel, was terminated.
The Government of Israel, through the IIA, encourages research and development projects by providing grants. Through December 31, 2025, our Israeli subsidiary, BiomX Ltd., had received an aggregate of $8.9 million in the form of grants from the IIA. However, as further described above, BiomX Ltd. commenced insolvency proceedings in December 2025, and a trustee was appointed in January 2026 to administer these proceedings. As a result, BiomX Inc. no longer maintains operational control over BiomX Ltd. and does not expect to recover any significant value from its investment in BiomX Ltd. Consequently, the Company no longer considers the IIA grants received by BiomX Ltd., nor any related obligations or potential royalties, as relevant to its ongoing financial condition or operations.
The
Government of Israel, through the IIA, encourages research and development projects by providing grants. We may receive grants from
the IIA at the rates that range from 20% to 50% of the research and development expenses, as prescribed by the research committee of
the IIA. Through December 31, 2024, we had received an aggregate of $8.0 million in the form of grants from the IIA. BiomX Ltd was
formed as an incubator company as part of the FutuRx incubator, and, until 2017, the majority of its funding was from IIA grants and
funding by the incubator, which is supported by the IIA. We continued to apply for and receive IIA grants after we left the incubator.
The requirements and restrictions for such grants are found in the Research Law. Under the Research Law, royalties of 3% to 3.5% on the
revenue derived from sales of products or services developed in whole or in part using these IIA grants are payable to the Israeli government.
We developed both of our platform technologies, at least in part, with funds from these grants, and, accordingly, we would be obligated
to pay these royalties on sales of any of our product candidates that achieve regulatory approval.
What changed in the latest 10-Q
Risk Factors
New heading “We are not in compliance with the NYSE American continued listing standards relating to stockholders’ equity, and if we fail to regain compliance our Common Stock could be delisted.”
New heading “The low market price of our Common Stock limits our ability to raise capital under our at-the-market program, and sales under that program are substantially dilutive.”
Largest changes
“On March 25, 2026, we received notice from NYSE Regulation that we were not in compliance with Sections 1003(a)(i), 1003(a)(ii) and 1003(a)(iii) of the NYSE American Company Guide, based on our reported stockholders’ deficit of $(1.3) million as of December 31, 2025 and our losses from continuing operations and/or net losses in our five most recent fiscal years. On June 10, 2026, NYSE Regulation accepted our compliance plan and granted a plan period through September 25, 2027. We continue to report a capital deficiency. …”see in full comparison
“We are not in compliance with the NYSE American continued listing standards relating to stockholders’ equity, and if we fail to regain compliance our Common Stock could be delisted.”see in full comparison
“The low market price of our Common Stock limits our ability to raise capital under our at-the-market program, and sales under that program are substantially dilutive.”see in full comparison
“Other than as set forth in the May 5 8-K and as supplemented by the disclosures contained elsewhere in this Quarterly Report (including with respect to the Company’s NYSE American continued listing matters, the Company’s going-concern conclusion, the integration of the recently acquired operating subsidiaries, and the matters described in “Liquidity and Capital Resources” above), there have been no material changes to the risk factors set forth in the 2025 10-K.”see in full comparison
“Our Common Stock has traded at prices below $0.50 per share during the second quarter of 2026 and at lower prices thereafter. Because we are subject to the limitations of General Instruction I.B.6 of Form S-3, the aggregate amount we may sell under our shelf registration statement in any 12-month period is limited by reference to our public float, and the low price of our Common Stock means we must issue a large number of shares to raise a modest amount of capital. …”see in full comparison
In addition to the other information set forth in this Quarterly Report, including in the section captioned “Cautionary Statement Regarding Forward-Lookingsee in full comparisonInformationStatements,”above,you should carefully consider the risk factors discussed in Part I, Item 1A “Risk Factors” of the 2025 10-K, as updated and supplemented by the risk factors relating tothe Company’sour strategic transition and new business focus set forth in the May 5 8-K.TheseThose risks could materially affectthe Company’sour business, financial condition, results of operations, cashflows,flows and the trading price oftheour Common Stock. The risk factors set forth below update and supplement those risk factors. Other than as set forth below and as supplemented by the disclosures contained elsewhere in this Quarterly Report, there have been no material changes to the risk factors set forth in the 2025 10-K and the May 5 8-K.
Full comparison: every changed paragraph (6)
In addition to the other information
set forth in this Quarterly Report, including in the section captioned “Cautionary Statement Regarding Forward-Looking InformationStatements,”
above, you should carefully consider the risk factors discussed in Part I, Item 1A “Risk Factors” of the 2025 10-K, as updated
and supplemented by the risk factors relating to the Company’sour strategic transition and new business focus set forth in the May 5 8-K.
These Those risks could materially affect the Company’sour business, financial condition, results of operations, cash flows,flows and the trading price
of theour Common Stock. The risk factors set forth below update and supplement those risk factors. Other than as set forth below and as supplemented by the disclosures contained elsewhere in this Quarterly Report, there have been no material changes to the risk factors set forth in the 2025 10-K and the May 5 8-K.
We are not in compliance with the NYSE American continued listing standards relating to stockholders’ equity, and if we fail to regain compliance our Common Stock could be delisted.
On March 25, 2026, we received notice from NYSE Regulation that we were not in compliance with Sections 1003(a)(i), 1003(a)(ii) and 1003(a)(iii) of the NYSE American Company Guide, based on our reported stockholders’ deficit of $(1.3) million as of December 31, 2025 and our losses from continuing operations and/or net losses in our five most recent fiscal years. On June 10, 2026, NYSE Regulation accepted our compliance plan and granted a plan period through September 25, 2027. We continue to report a capital deficiency. If we do not make progress consistent with the plan or regain compliance by the end of the plan period, the Exchange may commence delisting proceedings. Delisting would likely reduce the liquidity and market price of our Common Stock, impair our ability to raise capital.
The low market price of our Common Stock limits our ability to raise capital under our at-the-market program, and sales under that program are substantially dilutive.
Our Common Stock has traded at prices below $0.50 per share during the second quarter of 2026 and at lower prices thereafter. Because we are subject to the limitations of General Instruction I.B.6 of Form S-3, the aggregate amount we may sell under our shelf registration statement in any 12-month period is limited by reference to our public float, and the low price of our Common Stock means we must issue a large number of shares to raise a modest amount of capital. During the second quarter we sold 793,005 shares for net proceeds of approximately $0.3 million, and from July 1, 2026 through August 12, 2026 we sold an additional 8,902,611 shares for net proceeds of approximately $2.4 million. Continued sales under the program will be substantially dilutive to existing stockholders and may place further downward pressure on the market price of our Common Stock, which in turn further reduces the capital available to us under the program. In addition, our low share price may itself become the subject of continued listing concerns under Section 1003(f)(v) of the Company Guide, which could require us to effect a reverse stock split to maintain our listing.
Other than as set forth in
the May 5 8-K and as supplemented by the disclosures contained elsewhere in this Quarterly Report (including with respect to the Company’s
NYSE American continued listing matters, the Company’s going-concern conclusion, the integration of the recently acquired operating subsidiaries,
and the matters described in “Liquidity and Capital Resources” above), there have been no material changes to the risk factors
set forth in the 2025 10-K.
Management's Discussion & Analysis (MD&A)
New heading “Summary of Developments During the Quarter”
Removed heading “Intellectual Property”
Removed heading “Recent Developments”
Removed heading “NYSE American Deficiency”
Largest changes
“We submitted to NYSE American a compliance plan on April 24, 2026. As of the date of this report we have not received any update from NYSE American. There can be no assurance that our compliance plan will be accepted by NYSE American or that we will be able to regain compliance within the required timeframe. …”see in full comparison
“In July 27, 2026, the Company and Water IO entered into Amendment No. 1 and Waiver, dated as of July 24, 2026, to the Note pursuant to which (i) the maturity date of the Note was extended from July 10, 2026 to November 1, 2026; (ii) the Company agreed to pay $250,000 of principal within two business days after execution of the Amendment, and the remaining principal in four equal monthly installments of $250,000 each on August 1, September 1, October 1 and November 1, 2026, with the outstanding balance continuing to bear interest at the short-term Applicable Federal Rate payable with the final …”see in full comparison
“In connection with our non-compliance with Section 1003(a)(i), Section 1003(a)(ii) and Section 1003(a)(iii), the Company was required to submit a plan (the “Plan”) to the NYSE American by April 24, 2026, advising of actions it has taken or will take to regain compliance with the continued listing standards by September 25, 2027. If the NYSE American determines to accept the Plan, the Company will be notified in writing and will be subject to periodic reviews, including quarterly monitoring for compliance with the Plan. …”see in full comparison
“DFSL’s core intellectual property resides in its proprietary LADAR technology, including laser-based sensing systems and proprietary AI algorithms for detection, tracking, and classification of aerial and ground threats. DFSL’s technology was developed independently by DFSL since its founding in 1995 by Dr. Yaacov Frucht, who had previously served as a senior research leader at Rafael Advanced Defense Systems Ltd. …”see in full comparison
On May 13, 2026, the Company and Mandragola entered into a Line of Credit Agreement establishing a revolving line of credit of up to $2,000,000 (thesee in full comparison"“Credit Line"”) available to the Company or any operating subsidiary, including DFSL and ZorroNet. Each advance is evidenced by a convertible promissory note bearing simple annual interest at 12% and convertible into shares of theCompany'sCompany’s Common Stock at the closing price of the Common Stock on the trading day immediately preceding delivery of the notice of conversion. The maturity date of each Credit Line Note is May 13, 2029. The parties agreed that prior advances made by Mandragola in respect of the DFSL Acquisition are deemed to be advances within the Credit Limit. As additional consideration for making the Credit Line available, the Company also issued to Mandragola a five-year warrant to purchase up to 2,000,000 shares of Common Stock at an exercise price of $12.00 per share, which warrant includes a cashless exercise feature.TheUntilissuancesuchoftimeshares of Common Stock upon exercise of the warrant is subject to obtainingas stockholder approval as required by the applicable rules and regulations of the NYSE AmericanLLC.LLCTheisCompanyobtained,intendsthese warrants are not deemed tousebecommerciallylegallyreasonableineffortseffect.toAnobtainextraordinarysuch stockholder approval as promptly as practicable. The Audit Committee approved the Credit Line as a related party transaction on the basis that Mandragola is a holder of more than 5%meeting of theCompany'sstockholdersoutstandinghasCommonbeenStockscheduledfollowingto be held on August 25, 2026 to, among other things, approve theclosingissuance ofthecommonDFSLstockAcquisitionuponOurconversionprincipal/sourcesexerciseof liquidity for the foreseeable future are expected to include operating revenues from our new operating subsidiaries, proceeds from any future capital raises (including under any future at-the-market offering program), theby Mandragolacredit line entered into on May 13, 2026, non-dilutive government grants associated with retained legacy assets, and cost-discipline measures at the parent-company level. Because our new operating subsidiaries Zorronet and DFSL only became consolidated subsidiaries in April 2026, the financial statements included in this Quarterly Report do not yet reflect their performance. The Company expects that the operating results and cash flowsof thesebusinesses, and we expect those results to begin appearing in the Company’s consolidated financial statements beginning in the second quarter of 2026.securities.
“During the three months ended March 31, 2026, warrants held by Pyu Pyu in the gross amount of approximately $3.3 million were exercised by assignees of Pyu Pyu on March 19, 2026, following the amendment of those warrants on March 13, 2026 to reduce the exercise price from $2.00 per share to $1.00 per share and shorten the warrant term to December 31, 2026. …”see in full comparison
Full comparison: every changed paragraph (61)
References in this Quarterly
Report to “the Company”, “BiomX”, “we”, “us” or “our”, mean BiomX Inc. and
its consolidated subsidiaries unless otherwise expressly stated or the context indicates otherwise.
The following discussion and
analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated interim financial statements and the notes
thereto containedincluded elsewhere in this Quarterly Report.Report Theand analysiswith ofour audited consolidated financial statements and notes thereto included in the financial2025 condition and results of operations includes Adaptive
Phage Therapeutics LLC, a Delaware limited liability company (formerly Adaptive Phage Therapeutics Inc., a Delaware corporation), or
APT, from the date that we acquired it on March 15, 2024.10-K. Certain information contained inbelow the discussion and analysis set forth below
includes forward-looking statements that involve risks and uncertainties. OurSee actual“Cautionary resultsStatement mayRegarding differForward-Looking materially from those discussed
in any forward-looking statement because of various factors discussed in this Quarterly Report and in our other filings with the U.S.
Securities and Exchange Commission, or the SEC.Statements.”
Overview
General
Following the discontinuation of our legacy phage-therapy clinical programs and the commencement of insolvency proceedings of our former Israeli operating subsidiary, BiomX Ltd., in December 2025, we transitioned our strategic focus to the defense, security and critical infrastructure technology markets. Our operating activities are conducted through three Israeli subsidiaries: Dr. Frucht Systems Ltd., a provider of perimeter security and defense systems, of which we acquired 60% on April 13, 2026; Zorro Net Ltd., a provider of AI-powered detection and deterrence systems for critical infrastructure, which we acquired on April 10, 2026; and X Security & Defense Ltd., our wholly owned subsidiary focused on security, defense and first-response technologies. The three months ended June 30, 2026 is the first period in which the results of DFSL and ZorroNet are consolidated, in each case from the respective acquisition date, and the first period in which we recognize revenue from our defense and security operations.
In December 2025, we discontinued
the development of BX004, our lead phage product candidate for the treatment of chronic pulmonary infections in cystic fibrosis patients
caused by Pseudomonas aeruginosa, and on December 16, 2025, the Company’s former Israeli operating subsidiary, BiomX Ltd., filed for
insolvency proceedings in Israel. On January 25, 2026, the District Court of Tel-Aviv, Israel, appointed a trustee to BiomX Ltd. to handle
the administration of the insolvency proceedings. As a result of these proceedings, we no longer control BiomX Ltd. and do not deem it
to be part of our assets.
Adaptive Phage Therapeutics,
LLC (“APT”), the Company’s wholly-owned Delaware subsidiary acquired in March 2024 has retained limited non-dilutive grant
relationships associated with APT’s legacy BX011 program, patent rights related to the legacy phage therapy portfolio, and certain equipment
and other tangible assets. The Company is evaluating strategic alternatives for these retained legacy assets, including potential commercialization,
partnership, out-licensing or sale arrangements.
In the first quarter of 2026,
the Company underwent a complete transition of its management team and Board of Directors, appointed Michael Oster as Chief Executive
Officer and David Rokach as Chief Financial Officer, and adopted a new strategy focused on building a diversified portfolio of advanced
defense, security, and critical infrastructure technologies. We have executed this strategy through a series of acquisitions and the
establishment of new operating subsidiaries.
Also during the first
quarter of 2026, the Company completed a series of capital structure events involving Pyu Pyu Capital LLC (“Pyu Pyu”).
Between March 11, 2026 and March 17, 2026, Pyu Pyu converted all of its outstanding Series Y Convertible Preferred Stock (originally
issued in December 2025 for aggregate gross proceeds of $3.0 million) into 1,650,000 shares of our Common Stock (a non-cash transaction). On March 13, 2026,
the Company and Pyu Pyu amended the warrants held by Pyu Pyu to reduce the exercise price from $2.00 per share to $1.00 per share
and shorten the warrant term to December 31, 2026. On March 19, 2026, Pyu Pyu exercised the warrants in full for cash, resulting in
aggregate gross proceeds to the Company of approximately $3.3 million.
After the end of the quarterly
period covered by this Quarterly Report, the Company completed two strategic acquisitions in April 2026. On April 10, 2026, the Company
acquired 100% of the share capital of Zorro Net Ltd. (“Zorronet”). On April 13, 2026, the Company exercised an option (previously
granted on March 31, 2026) and acquired 60% of the voting equity capital of Dr. Frucht Systems Ltd. (“DFSL”) on a fully diluted
basis. The Company also formed X Security & Defense LTD (“X Security”) as a wholly-owned Israeli subsidiary focused on
security, defense and first-response technologies. As a result, the Company currently operates through three principal subsidiaries:
(i) DFSL, a majority-owned Israeli LADAR-based detection systems company; (ii) Zorronet, a wholly-owned Israeli AI-powered security platform
company; and (iii) X Security, the newly-formed wholly-owned Israeli subsidiary. The condensed consolidated financial statements included
in this Quarterly Report do not yet reflect the operations, assets, liabilities, results of operations or cash flows of DFSL or Zorronet,
which became subsidiaries of the Company subsequent to March 31, 2026.
TheThrough Companyour operatessubsidiaries, we operate at the
intersection of several rapidly growing sectors within the global defense, security, and critical infrastructure markets. TheOur Company’s
technology portfolio addresses the following key market segments:
The Company’sOur products
and technologies are marketed and sold through a combination of direct sales to government and military customers, co-development arrangements
with prime defense contractors, distribution agreements with strategic partners, and project-based engagements.
The Company generatesintends to generate revenues
through a combination of (i) project-based engagements and product sales, including the sale and deployment of DFSL’s LADAR detection
systems and Zorronet’s discrete project deliveries to defense prime contractors and end users; (ii) recurring software-as-a-service
revenues from Zorronet’s deployed AI software platform, scaling with active customer deployments; (iii) co-development engagements
with Israeli defense prime contractors, including Elbit Systems Ltd. and Rafael Advanced Defense Systems Ltd.; and (iv) cost-reimbursement
government research and development contracts at APT, including the legacy contract with the Medical Technology Enterprise Consortium
with respect to the BX011 program. X Security & Defense LTD. has not yet commenced commercial operations.
The Company’sOur customer
base includes military and defense agencies, defense prime contractors, homeland security authorities, transportation operators, municipalities,
energy companies, educational institutions, and commercial security providers. Key customer relationships include:relationships.
Intellectual Property
The Company’s intellectual
property consists of a combination of proprietary technologies, trade secrets, know-how, and software. The Company relies on trade secret
protections, confidentiality agreements, and contractual restrictions to protect its intellectual property rights.
DFSL’s core intellectual
property resides in its proprietary LADAR technology, including laser-based sensing systems and proprietary AI algorithms for detection,
tracking, and classification of aerial and ground threats. DFSL’s technology was developed independently by DFSL since its founding
in 1995 by Dr. Yaacov Frucht, who had previously served as a senior research leader at Rafael Advanced Defense Systems Ltd. The Company,
based on its diligence and inquiries made of DFSL, is not aware of any continuing license, assignment, or contractual arrangement between
DFSL and Rafael Advanced Defense Systems Ltd. with respect to the intellectual property underlying DFSL’s LADAR detection technology,
and DFSL owns its intellectual property exclusively, subject to (a) restrictions and conditions imposed under the IIA Law in respect
of know-how developed with IIA grant funding, as further described below, and (b) any restrictions imposed by Israeli defense export
control laws. DFSL has previously received grants from the IIA for the development of its anti-drone technology, and certain of DFSL’s
intellectual property may be subject to restrictions under the Encouragement of Research, Development and Technological Innovation in
Industry Law, 5744-1984 (the “IIA Law”).
Zorronet’s primary intellectual
property consists of its proprietary AI software platform, including algorithms for pattern-of-life analysis, anomaly detection, dynamic
scenario generation, and autonomous operational response. Zorronet does not currently hold any registered patents and relies primarily
on trade secret protections for its software and algorithms.
Summary of Developments During the Quarter
Recent Developments
NYSE American Deficiency
On
March 25, 2026, we received a written notice (the “Notice”) from the NYSE American LLC (the “NYSE American”)
indicating that we are not in compliance with the NYSE American continued listing standards set forth in Section 1003(a)(i) of the NYSE
American Company Guide (the “Company Guide”) requiring a company to have stockholders’ equity of at least $2.0 million
if it has reported losses from continuing operations and/or net losses in two of its three most recent fiscal years, Section 1003(a)(ii)
of the Company Guide requiring a company to have stockholders’ equity of at least $4.0 million if it has reported losses from continuing
operations and/or net losses in three of its four most recent fiscal years and Section 1003(a)(iii) of the Company Guide requiring a
company to have stockholders’ equity at least $6.0 million if it has reported losses from continuing operations and/or net losses
in its five most recent fiscal years. The Notice also indicates that the Company is also not currently eligible for any exemption in
Section 1003(a) of the Company Guide (including the exemption provided for companies with total value of market capitalization exceeding
$50 million among other things).
In
connection with our non-compliance with Section 1003(a)(i), Section 1003(a)(ii) and Section 1003(a)(iii), the Company was required to
submit a plan (the “Plan”) to the NYSE American by April 24, 2026, advising of actions it has taken or will take to regain
compliance with the continued listing standards by September 25, 2027. If the NYSE American determines to accept the Plan, the Company
will be notified in writing and will be subject to periodic reviews, including quarterly monitoring for compliance with the Plan. If
the Company does not submit a plan or if the Plan is not accepted, NYSE American will commence delisting proceedings. Furthermore, if
the Plan is accepted but the Company is not in compliance with the continued listing standards by September 25, 2027, or if the Company
does not make progress consistent with the Plan, the NYSE American will initiate delisting proceedings as appropriate. The Company may
appeal a staff delisting determination in accordance with Section 1010 and Part 12 of the Company Guide.
We submitted to NYSE American
a compliance plan on April 24, 2026. As of the date of this report we have not received any update from NYSE American. There can be no
assurance that our compliance plan will be accepted by NYSE American or that we will be able to regain compliance within the required
timeframe. If our Common Stock is delisted from NYSE American, it could significantly impair the liquidity and market value of our securities,
reduce the ability of our stockholders to purchase or sell shares, limit our ability to raise additional capital through public offerings,
and adversely affect the perception of our Company among investors, customers, and business partners. Delisting could also trigger defaults
or acceleration provisions under our outstanding convertible notes and other instruments, which could have a material adverse effect
on our financial condition.
ConsolidatedResults Results
of Operations
ComparisonThree ofand the ThreeSix Months Ended March
31,June 30, 2026 Compared to Three and MarchSix 31,Months Ended June 30, 2025
The comparability of our results between periods is limited: the 2025 periods reflect the operations of our legacy clinical-stage phage business, including BiomX Israel (deconsolidated February 4, 2026) and APT, while the 2026 periods reflect the wind-down of legacy activities and, from the April 2026 acquisition dates, the operations of DFSL and ZorroNet.
Revenues. Revenues for the three and six months ended June 30, 2026 were $332,000, attributable to DFSL and ZorroNet from their respective acquisition dates. We recorded no revenue in the comparable 2025 periods.
The following table summarizes
our consolidated results of operations for the three months ended March 31, 2026 and March 31, 2025:
Research and development expenses, net. R&D expenses,expenses netdecreased were
$(0.3)from million$5,014,000 forand $10,264,000 in the three and six months ended MarchJune 31,30, 2026, compared2025 to $5.3a net credit of $187,000 and expense of $128,000 in the corresponding 2026 periods. The decrease of approximately $5.2 million forand $10.1 million in the three and six months ended March 31, 2025. The decrease
of approximately $5.6 million was primarily attributable to (i) the reversal of previously recognized stock-based compensation expense
following the cancellation of unvested awards held by departing employees of BiomX Israel, (ii) the discontinuation of the Phase 2b clinical
trial of BX004 in December 2025 and the associated wind-down of program activities, and (iii) the deconsolidation of BiomX Ltd. effective
February 4, 2026.2026 partially offset by development activities of acquired defense business . Following the discontinuation of the BX004 program and the deconsolidation of BiomX Ltd., the Company does not anticipate
further grant-funded R&D under the MTEC Base Agreement and is evaluating strategic alternatives with respect to the MTEC-funded technology.
General and administrative
expenses. G&A expenses were $1.6$5,383,000 millionand $6,994,000 for the three and six months ended MarchJune 31,30, 2026, compared to $2.5$2,419,000 and $4,925,000 in the corresponding 2025 periods. The increase of approximately $3.0 and $2.1 million forin the three and six months ended March 31, 2025.
The decrease of approximately $0.9 million was primarily attributable to stock-based compensation expense related to issuance of shares to employees, directors and consultants during the second quarter of 2026 partially offset by the reversal in the first quarter of previously recognized stock-based compensation
expense following the cancellation of unvested awards held by departing employees of BiomX Israel as described above,above partiallyand offset
byan increase in insurance and management compensation of former management which was paid out in the first quarter of 2026.expenses.
As a result of the foregoing,
operating loss was $1.3 million for the three months ended March 31, 2026, compared to $7.8 million for the three months ended March
31, 2025, a decrease of approximately 83%.
Day 1 loss. Day 1 loss upon entering transaction was $5.2 million$5,226,000 for the three
and six months ended MarchJune 31,30, 2026, attributable to the issuance date fair value of the warrants and embedded conversion derivative issued in
connection with the January 2026 private placement of Series Y Convertible Preferred Stock and accompanying warrants. There was no comparable
amount in the three and six months ended MarchJune 31,30, 2025.
Loss from change in fair value. Income from change in fair value of derivatives was $14.1 million$1,598,000 for
the three months ended MarchJune 31,30, 2026 and loss from change in fair value of derivatives of $12,458,000 for the six months ended June 30, 2026, compared to income from change in fair value of derivatives of $0.9$1,498,000 millionand $2,412,000 for the three and six months
ended March 31, 2025. The change was primarily attributable to the warrants and embedded conversion derivative issued in connection with
the January 2026 private placement of Series Y Convertible Preferred Stock and the increase in the trading price of the Common Stock between
the issuance date of the warrants issued in the January 2026 private placement and the exercise date in March 2026, which increased the
fair value of the liability-classified warrants prior to their exercise.exercise partially offset by decrease in the fair value of liability classified warrant.
Finance expense,expenses. Finance expenses, net, waswere $0.4$377,000 for the three and six months ended MarchJune 31,
30, 2026, compared to $0.8$25,000 millionand $830,000 for the three and six months ended MarchJune 31,30, 2025. The decrease was primarily attributable reduction in transaction
costs in the quarter ended March 31, 2025 which consisted of transaction costs incurred in connection with the February 2025 compared
to transaction costs incurred in connection with the January 2026 private placement of Series Y Convertible Preferred Stock.
Net gain from deconsolidation
of subsidiary. Net gain from deconsolidation of subsidiary was $1.9 million$1,860,000 for the three and six months ended MarchJune 31,30, 2026, attributable to the deconsolidation of BiomX Ltd. following
the commencement of insolvency proceedings in December 2025 and the appointment of a Trustee to BiomX Ltd. by the District Court of the
Central District in Lod, Israel on January 25, 2026. As of February 4, 2026, following the deconsolidation, the assets and liabilities
of BiomX Ltd. were no longer included in the Company’s consolidated balance sheet. There was no comparable amount in the three and six months
ended MarchJune 31,30, 2025.
Net losslosses. wasNet $19.1losses millionwere $3,846,000 and $22,986,000 for the three and six months ended MarchJune 31,30, 2026,
of which $74,000 was attributable to non-controlling interests in DFSL, compared to $7.7$6,035,000 millionand $13,693,000 for the three and six months ended MarchJune 31,30, 2025. The increase in net loss was primarily attributable to the non-cash
warrant-related charges recognized in the three months ended March 31, 2026 (consisting of the $5.2 million$5,226,000 Day 1 loss upon issuance of
the January 2026 warrants and embedded conversion derivative and the $14.1 million$12,458,000 loss from change in fair value of the liability-classified
warrants prior to their exercise in March 2026), share based compensation expenses of $2,246,000, partially offset by the $1.9 million$1,860,000 net gain on the deconsolidation of BiomX Ltd. and
the $6.5 million decrease in operating loss between the periods.
Basic and diluted loss per share. Basic and diluted loss per share of Common Stock was $(7.38)$0.36 and $3.55 for the
three and six months ended MarchJune 31,30, 2026, compared to $(6.27)$3.66 and $9.55 for the three and six months ended MarchJune 31,30, 2025 (as retroactively adjusted to reflect
the 1-for-19 reverse stock split effected on November 25, 2025). The decrease in loss per share was primarily attributable to the increase
in the weighted average number of shares of Common Stock outstanding from 1,215,9531,647,810 and 1,434,212 shares for the three and six months ended March 31, 2025 to
2,603,807 10,556,585 and 6,479,738 shares for the three and months ended MarchJune 31,30, 2026, more than offsetting the increase in net loss between the periods.periods
As of December 31, 2025, we
had cash, cash equivalents and restricted cash of approximately $5.0 million,$4,955,000, and a stockholders’ capital deficiency of approximately
$1.3 million.$1,302,000. As of MarchJune 31,30, 2026, we had cash, cash equivalents and restricted cash of approximately $1.2 million.$347,000.
On December 7, 2023, we entered into the ATM Agreement with H.C. Wainwright, as sales agent or principal, providing for the offer and sale from time to time of up to $9,145,000 of our shares common stock under the ATM, which ATM offering was registered under our Shelf Registration Statement. During the quarter ended June 30, 2026, we raised approximately $291,000 (net of sales agent fees) from the sale of 793,000 shares of common stock under the ATM. Furthermore, in July and August 2026, we sold an aggregate of 8,902,611 shares of our common stock pursuant to the ATM Agreement, at an average price of $0.2836 per share, raising aggregate gross proceeds of approximately $2.5 million and net proceeds of approximately $2.4 million.
On July 7, 2026, the $1.25 million non-convertible promissory note
issued to Water IO Ltd. in connection with the ZorroNet Acquisition described in Note 13 is scheduled to mature. Repayment of this obligation
when due may require the Company to draw upon other sources of liquidity, including under the Mandragola Credit Line.
During the three months
ended March 31, 2026, warrants held by Pyu Pyu in the gross amount of approximately $3.3 million were exercised by assignees of Pyu
Pyu on March 19, 2026, following the amendment of those warrants on March 13, 2026 to reduce the exercise price from $2.00 per share
to $1.00 per share and shorten the warrant term to December 31, 2026. At the request of the Company, the warrant exercise proceeds
were remitted in April 2026, directly to Mandragola and to DFSL in order to pay in part the cash component of the DFSL acquisiton
and to satisfy the $3 million note that Mandraola paid to DFSL as part of the acquisition. In addition, between March 11, 2026
and March 17, 2026, Pyu Pyu converted all of its outstanding Series Y Convertible Preferred Stock into 1,650,000 shares of our
Common Stock, which conversion was non-cash. We did not make any sales of Common Stock under our 2023 ATM Agreement (as defined
below) during the three months ended March 31, 2026.
On April 10, 2026, we completed
the acquisition of Zorronet in exchange for 1,300,000 shares of our Common Stock and a non-convertible promissory note in the principal
amount of $1,250,000 maturing July 7, 2026, plus the assumption of an earnout payment obligation payable not later than March 31, 2027
and certain key-employee retention commitments. On April 13, 2026, we exercised our option and acquired a 60% interest in DFSL in consideration
for $750,000 in cash (of which $450,000 had been previously advanced), which cash consideration was funded in part with proceeds received
in April 2026 from the warrant exercises described above, an unsecured convertible promissory note in the principal amount
of $3,000,000, pre-funded warrants and five-year warrants exercisable for shares of our Common Stock, and a revenue-based bonus right,
in each case subject in part to stockholder approval under NYSE American rules. InAs connectionof withJune 30, 2026, our obligations under the DFSLnote acquisition,have Mandragolabeen agreed
to provide a credit line on mutually agreed terms to support DFSL’s development and debt payments.satisfied. We have also committed to fund X Security’s
2026 operations with over $3.0 million from internal funds. On July 7, 2026, the $1.25 million non-convertible promissory note issued to Water IO Ltd. in connection with the ZorroNet Acquisition described in Note 7 was scheduled to mature.
In July 27, 2026, the Company and Water IO entered into Amendment No. 1 and Waiver, dated as of July 24, 2026, to the Note pursuant to which (i) the maturity date of the Note was extended from July 10, 2026 to November 1, 2026; (ii) the Company agreed to pay $250,000 of principal within two business days after execution of the Amendment, and the remaining principal in four equal monthly installments of $250,000 each on August 1, September 1, October 1 and November 1, 2026, with the outstanding balance continuing to bear interest at the short-term Applicable Federal Rate payable with the final installment; (iii) in satisfaction of accrued interest and as consideration for the waiver and extension, the Company agreed to issue to Water IO 800,000 restricted shares of common stock, subject to clearance of an additional listing application with the NYSE American, with an August 31, 2026 longstop after which such amount is payable in cash and no shares will be issued; and (iv) Water IO irrevocably waived, retroactively to the original maturity date, any default arising from the non-payment of the note at its original maturity;.
On August 5, 2026, we entered into a Share Purchase and Option Agreement with Mayers Ventures LLC pursuant to which we agreed to purchase 10% of the fully diluted equity interests of M.E.A. Testing Systems Ltd., an Israeli developer of advanced electric motor testing and validation systems, together with 10% of its Indian affiliate, for $50,000 and 1,300,000 restricted shares of Common Stock, with an exclusive option, exercisable through June 30, 2028, to acquire the remaining holdings of Motomova Inc. therein. The closing is subject to NYSE American approval of a supplemental listing application and the execution of an exclusive worldwide license of the MEA companies’ technology to us. See the subsequent events note to the condensed consolidated interim financial statements.
As of June 30, 2026, the aggregate principal amount outstanding under the Mandragola credit facility was $0 and the remaining undrawn availability was $2,000,000.
Under our At The Market Offering Agreement, during the six months ended June 30, 2026 we issued and sold 793,005 shares of Common Stock for net proceeds of $291,000, and in July and August 2026 we issued and sold 8,902,611 additional shares for net proceeds of approximately $2.4 million.
Several outstanding instruments may dilute existing stockholders and
affect our future liquidity and capital structure. As of MarchJune 31,30, 2026, the Company had 147,51251,598 shares shares of Series X Redeemable Convertible
Preferred Stock outstanding, which are convertible into shares of our Common Stock at a conversion ratio of approximately 5.2655.26 shares
of Common Stock per share of Series X (or approximately 776,648271,568 shares of Common Stock in the aggregate). Following the April 13, 2026
acquisition of DFSL, the Company is obligated, subject to stockholder approval under NYSE American rules and within 120 days of closing,
to seek the stockholder approvals required to issue Common Stock above the 19.99% threshold in connection with the Mandragola convertible
note (principal amount of $3,000,000), the Mandragola pre-funded warrants and the Mandragola five-year warrant. There can be no assurance
that such stockholder approvals will be obtained, and a failure to obtain such approvals could affect the availability of the Mandragola
credit line and the Company’s ability to satisfy its obligations to Mandragola.
Following the April 13, 2026 acquisition of DFSL, the Company is obligated, subject to stockholder approval required to issue Common Stock above the 19.99% threshold in connection with the Mandragola convertible note, part of the Mandragola pre-funded warrants and the Mandragola five-year warrant. An extraordinary meeting of the stockholders has been scheduled to be held on August 25, 2026 to, among other things, approve the issuance of common stock upon conversion / exercise by Mandragola of these securities.
On May 13, 2026, the Company and Mandragola entered into a Line of
Credit Agreement establishing a revolving line of credit of up to $2,000,000 (the "“Credit Line"”) available to the Company or
any operating subsidiary, including DFSL and ZorroNet. Each advance is evidenced by a convertible promissory note bearing simple annual
interest at 12% and convertible into shares of the Company'sCompany’s Common Stock at the closing price of the Common Stock on the trading day
immediately preceding delivery of the notice of conversion. The maturity date of each Credit Line Note is May 13, 2029. The parties agreed
that prior advances made by Mandragola in respect of the DFSL Acquisition are deemed to be advances within the Credit Limit. As additional
consideration for making the Credit Line available, the Company also issued to Mandragola a five-year warrant to purchase up to 2,000,000
shares of Common Stock at an exercise price of $12.00 per share, which warrant includes a cashless exercise feature. TheUntil issuancesuch oftime shares
of Common Stock upon exercise of the warrant is subject to obtainingas stockholder approval as required by the applicable rules and regulations
of the NYSE American LLC.LLC Theis Companyobtained, intendsthese warrants are not deemed to usebe commerciallylegally reasonablein effortseffect. toAn obtainextraordinary such stockholder approval as promptly as
practicable. The Audit Committee approved the Credit Line as a related party transaction on the basis that Mandragola is a holder of more
than 5%meeting of the Company'sstockholders outstandinghas Commonbeen Stockscheduled followingto be held on August 25, 2026 to, among other things, approve the closingissuance of thecommon DFSLstock Acquisitionupon Ourconversion principal/ sourcesexercise of liquidity for the foreseeable future are expected
to include operating revenues from our new operating subsidiaries, proceeds from any future capital raises (including under any future
at-the-market offering program), theby Mandragola credit line entered into on May 13, 2026, non-dilutive government grants associated with
retained legacy assets, and cost-discipline measures at the parent-company level. Because our new operating subsidiaries Zorronet and
DFSL only became consolidated subsidiaries in April 2026, the financial statements included in this Quarterly Report do not yet reflect
their performance. The Company expects that the operating results and cash flows of these businesses, and we expect those results to begin
appearing in the Company’s consolidated financial statements beginning in the second quarter of 2026.securities.
Our principal sources of liquidity for the foreseeable future are expected to include sales under our ATM program, operating revenues from our operating subsidiaries, proceeds from any future capital raises (including under any future at-the-market offering program) andthe Mandragola credit line and cost-discipline measures at the parent-company level.
The following table summarizes
our sources and uses of cash for the threesix months ended MarchJune 31,30, 2026 and 2025:
Net cash used in operating activities for the threesix months ended March
June 31, 2026 was $5.4$6.6 million, primarily driven by the net loss for the period of $19.1$23.0 million, adjusted for non-cash items including the
$14.1 $12.5 million loss from change in fair value of liability-classified warrants, the $5.2 million Day 1 loss recognized upon issuance of
the January 2026 warrants, and $0.2 million of value attributable to warrants issued in connection with the private placement, partially
offset by the $1.9$2.1 million reversal of previously recognized stock-based compensation expense andpartially offset by the $1.9 million gain on deconsolidation
of BiomX Ltd. Operating cash flows were further affected by an increasedecrease in other current assets of $1.4 million and a decrease in other
accounts payable of $1.2$1.6 million, partially offset by an increase in trade accounts payable of $0.3$0.4 million and in trade receivables of $0.5 million.
Net cash used in operating
activities for the threesix months ended MarchJune 31,30, 2025 was $8.7$14.8 million ,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 threesix months ended MarchJune 31,
30, 2025 consisted primarily of income from change in fair value of warrants of $0.9$2.4 million, stock-based compensation expenses of 0.7$1.4 million
and depreciation expenses of $0.2$0.5 million. Net changes in our operating assets and liabilities consisted primarily of aan decreaseincrease in trade
accounts payable of $0.2$0.3 million, as well as a decrease in other accounts payable of $1.1$2.4 million and a decrease in other current assets
of $0.2$1.1 million.
During the threesix months ended
March 31,June 30, 2026, net cash used in investing activities was $1.0$1.6 million, consisting of the cash and cash equivalents derecognized upon
the loss of control of BiomX Ltd. on February 4, 2026 and cash used in purchase of our subsidiaries during April 2026.
During the threesix months ended
March 31,June 30, 2025, net cash provided by investing activities was approximately $51 thousand, consisting of proceeds from the sale of property
and equipment.
During the threesix months ended
March 31,June 30, 2026, net cash provided by financing activities was $2.6$3.3 million, consisting of net proceeds from the January 2026 private
placement of Series Y Convertible Preferred Stock and accompanying warrants.warrants of $2.6 million, $0.3 million from net proceeds from the Issuance of Common Stock under At the Market Sales Agreement and $656 million received from Mandargola under our line of credit. The Company also received $3.3 million of gross proceeds
from the exercise of warrants by the holder of the Series Y Convertible Preferred Stock on March 19, 2026; as of MarchJune 31,30, 2026, those
proceeds$3.0 million were offset against the principal balance promissory note issued to Mandragola in connection with the DFSL acquisition and the balance of $0.3 were recorded as a receivable on account of shares in the Company’s condensed consolidated balance sheets and were collected
after the period end.
The Company has incurred significant losses and negative cash flows
from operations since inception and has an accumulated deficit of approximately $236.0$239.8 million as of MarchJune 31,30, 2026. The Company expects
to continue to incur losses for the foreseeable future. Management believes that the Company’s current funds, including the $3.0
million in gross proceeds raised in January 2026 from the issuance of Series Y Convertible Preferred Stock and the $3.3 million in gross
proceeds raised in March 2026 from the cash exercise of the warrants issued in connection with the Series Y Convertible Preferred Stock,
together with sales receipts under our Atm Progran and revenue and cash flows expected to be generated by the Company’s recently acquired operating subsidiaries DFSL and
ZorroNet will be sufficient to fund operations only for the next several months from the date of issuance of the condensed consolidated
interim financial statements. The Company’s ability to continue as a going concern depends on its ability to obtain additional financing
or to generate sufficient operating cash flows from its newly acquired subsidiaries, neither of which can be assured. These factors raise
substantial doubt about the Company’s ability to continue as a going concern. The condensed consolidated interim financial statements
have been prepared on a going concern basis and do not include any adjustments that may result from the outcome of these uncertainties.
We have incurred an accumulated deficit of approximately $236.0$239.8 million
as of MarchJune 31,30, 2026, compared with approximately $216.9 million as of December 31, 2025, substantially all of which is attributable to
our legacy phage therapy operations and pre-restructuring corporate expenses. To date, we have not generated material revenue from operations.
Ouroperations.. cash needs are expected to increase as we integrate our recently acquired operating subsidiaries and fund the launch of X Security.
We expect to generate revenues from the sale and deployment of DFSL’s LADAR-based detection systems, from project-based and recurring
software-as-a-service engagements at Zorronet, and from X Security’s contemplated distribution arrangements, beginning in the second
quarter of 2026.arrangements. We also expect to receive non-dilutive grant funding associated with APT’s legacy BX011 program. There can be no
assurance, however, that revenue generated during 2026 will exceed our cost of operations.
Consistent with our anticipated
near-term operating losses, we expect to continue to incur 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, the integration of the new operating subsidiaries,
and the build-out of X Security through future issuances of public or private equity, issuance of debt securities, the pending Mandragola
credit line, and possibly additional grants from the Israel Innovation Authority, the Medical Technology Enterprise Consortium (“MTEC”),
or other government or non-profit institutions.Authority. Our ability to raise additional capital in the equity and debt markets is dependent on
a number of factors including, but not limited to, market demand for our securities, the trading price and trading volume of our Common
Stock, our compliance with the continued listing standards of the NYSE American, the dilutive impact of any contemplated offering on
existing stockholders, and the timing and outcome of any NYSE Regulation review of our compliance posture under Sections 1003(a) and
1003(c) of the NYSE American Company Guide.
HLSQ insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
No Form 4 stock transactions in this period.
Well-known investors holding HLSQ (13F)
None of the 59 investors we track reported a position in their latest 13F.