What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2026-03-27 compared with 2025-03-26 · 83 added, 60 removed, 1009 unchanged (12% of the section changed)

10 unchanged sentences

We have incurred significant operating losses every year since our inception in September 1996.

We reported a net loss of approximately $0.44 million for the year ended December 31, 2024 and reported a net loss of approximately $16.05 million for the year ended December 31, 2023.

At December 31, 2024, we had an accumulated deficit of approximately $219.7 million.

We anticipate potentially

incurring substantial additional losses due to the need to spend substantial amounts on activities required for commercialization of PEDMARK ® in the U.S.

and regulatory approvals of PEDMARK ® outside of the U.S., as well as the preparation for potential commercial launch preparation of PEDMARK ® outside of the U.S., anticipated research and development activities, and general and administrative expenses, among other factors.

We reported a net loss of approximately $9,741 for the year ended December 31, 2025 and reported a net loss of approximately $436 for the year ended December 31, 2024.

At December 31, 2025, we had an accumulated deficit of approximately $229,422.

We anticipate potentially incurring substantial additional losses due to the need to spend significant amounts on activities required for the continued commercialization of PEDMARK in the U.S.

and for obtaining and maintaining regulatory approvals for PEDMARK outside of the U.S., as well as for anticipated research and development activities and general and administrative expenses, among other factors.

We may never achieve or sustain profitability on an ongoing basis.

8 unchanged sentences

We anticipate substantial regulatory review prior to the commercialization of PEDMARK ® outside of the United States.

Any disruption in manufacturing, supply, reimbursement, or adoption, or any adverse regulatory or competitive development, could materially harm our business.

We may require additional financing to obtain marketing approval of PEDMARK ® and commercialize PEDMARK ® abroad and a failure to obtain this capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development, other operations or commercialization efforts outside of the United States.

2 unchanged sentences

We may not be able to obtain additional financing in sufficient amounts or on acceptable terms when needed.

If we fail to arrange for sufficient capital on a timely basis, we may be required to curtail our business activities until we can obtain adequate financing.

If we fail to arrange for sufficient capital on a timely basis, we

may be required to curtail our business activities until we can obtain adequate financing.

Debt financing must be repaid regardless of whether or not we generate profits or cash flows from our business activities.

1 unchanged sentence

If we cannot raise sufficient capital when necessary, we will likely have to curtail operations and you may lose part or all of your investment.

Regulatory approval for any approved product is limited by the FDA and foreign regulatory authorities to those specific indications and conditions for which clinical safety and efficacy have been demonstrated as set forth on the product label.

If we market PEDMARK ® for uses beyond such approved indications, we could be subject to enforcement action, which could have a material adverse effect on our business.

The FDA strictly regulates marketing, labeling, advertising and promotion of prescription drugs.

These regulations include standards and restrictions for direct-to-consumer advertising, industry-sponsored scientific and educational activities, promotional activities involving the internet and off-label promotion.

Any regulatory approval that the FDA grants is limited to those specific diseases and indications for which a product is deemed to be safe and effective by the FDA.

If we are not able to obtain FDA approval for any desired future indications for PEDMARK ® , our ability to effectively market and sell PEDMARK ® may be reduced and our business may be adversely affected.

While physicians in the United States may choose, and are generally permitted, to prescribe drugs for uses that are not described in the product’s labeling and for uses that differ from those tested in clinical trials and approved by the regulatory authorities, our ability to promote PEDMARK ® is narrowly limited to those indications that are specifically approved by the FDA.

These “off-label” uses are common across medical specialties and may constitute an appropriate treatment for some patients in varied circumstances.

Further, the National Comprehensive Cancer Network (“NCCN”) guideline recommendations include patient populations and settings that may extend beyond PEDMARK’s current FDA-approved label.

Regulatory scrutiny regarding promotion, changes to guidelines, or payer coverage limitations for off-label uses could adversely affect demand and expose us to compliance risk.

International commercialization of PEDMARK ® requires successful partnerships.

Our international commercialization strategy depends on collaborative relationships with our third party development partners, including Norgine in Europe and other development partners or distributors in additional territories.

We have limited foreign regulatory, clinical and commercial resources.

Future partners are critical to our international success.

We may not be able to enter into collaboration agreements with appropriate partners for important foreign markets on acceptable terms, or at all.

Future collaborations with foreign development partners may not be effective or profitable for us.

We will need to obtain approval from the appropriate regulatory, pricing and reimbursement authorities to market PEDMARK ® internationally, and we may be unable to obtain foreign regulatory approvals.

Pursuing foreign regulatory approvals will be time-consuming and expensive.

The regulations can vary among countries and foreign regulatory authorities may require different or additional clinical trials than we conducted to obtain FDA approval for PEDMARK ® .

If our foreign development partners fail to execute effectively, we may not realize anticipated milestone payments, royalties, or meaningful revenue outside of the United States.

Our success depends on our ability to successfully commercialize PEDMARK ® .

6 unchanged sentences

The long term commercial success of PEDMARK ® depends on the extent to which patients and physicians accept and adopt PEDMARK ® .

For example, if the expected patient population is smaller than we estimate or if physicians are unwilling to prescribe or patients are unwilling to take PEDMARK ® , or if patients discontinue from use of the medication at rates that are higher than we expect, or if payers decide not to reimburse for our product, the commercial potential of PEDMARK ® will be limited.

commercial potential of PEDMARK ® will be limited.

Thus, significant uncertainty remains regarding the ultimate commercial potential of PEDMARK ® .

42 unchanged sentences

If we do not maintain current or enter into new collaborations with other companies, we might not successfully develop our product or generate sufficient revenues to expand our business.

We currently rely on scientific and research and development collaboration arrangements with academic institutions and other third-party collaborators, including an exclusive worldwide license from OHSU for PEDMARK ® .

The agreements with OHSU are terminable by either party in the event of an uncured breach by the other party.

We may also terminate our agreement with OHSU at any time upon prior written notice of specified durations to OHSU.

Termination of any of our collaborative arrangements could materially adversely affect our business.

For example, if we are unable to make the necessary payments under these agreements, the licensor might terminate the agreement which might have a material adverse impact.

In addition, our collaborators might not perform as agreed in the future.

We currently rely on scientific research and development collaboration arrangements with academic institutions and other third-party collaborators.

Since we conduct a significant portion of our research and development through collaborations, our success may depend significantly on the performance of such collaborators, as well as any future collaborators.

Collaborators might not commit sufficient resources to the research and development or commercialization of our product candidate.

Collaborators might not commit sufficient resources to the research and development or commercialization of our product.

Economic or technological advantages of products being developed by others, among other factors, could lead our collaborators to pursue other products or technologies in preference to those being developed in collaboration with us.

20 unchanged sentences

Further, manufacturing facilities, which we outsource to third parties, must be approved by the FDA before they can be used to manufacture our product, and they are subject to additional FDA inspection.

The complete response letters (“CRL”) that we received from the FDA in August 2020 and in November 2021 as a result of deficiencies in the

third-party manufacturing facility that manufactures PEDMARK ® on our behalf is a specific example of the risks associated with our third-party manufacturers.

The complete response letters (“CRL”) that we received from the FDA in August 2020 and in November 2021 as a result of deficiencies in the third-party manufacturing facility that manufactures PEDMARK ® on our behalf is a specific example of the risks associated with our third-party manufacturers.

If we fail to comply with any of the FDA’s continuing regulations, or any other regulations under which we may be required to comply outside of the United States, we could be subject to reputational harm and sanctions, including:

29 unchanged sentences

Litigation may also be necessary to enforce or defend patents issued or licensed to us or our collaborators or to determine the scope and validity of a third party’s proprietary rights.

By example we have outstanding litigation against CIPLA, as described elsewhere in this Annual Report.

By example we have concluded litigation against CIPLA, as described elsewhere in this Annual Report.

On March 16, 2026, Fennec announced that it has entered into an agreement with Cipla Limited and Cipla USA, Inc.

to settle the litigation between them regarding Cipla’s application to FDA for approval to market a generic version of Fennec’s PEDMARK® (sodium thiosulfate injection) product.

See Fennec Pharmaceuticals Inc.

Cipla Limited and Cipla USA, Inc ., C.A.

2:23-cv-00123-JKS-MAH (D.N.J.).

Under the terms of the agreement, the lawsuit will be dismissed with each party bearing their own costs, and Cipla will not enter the market with its generic sodium thiosulfate product until September 1, 2033, or earlier under certain circumstances.

We could incur substantial costs if litigation is required to defend ourselves in patent suits brought by third parties, if we participate in patent suits brought against or initiated by our collaborators, or if we initiate such suits.

16 unchanged sentences

We intend to maintain a second source for back-up commercial manufacturing, wherever feasible.

However, if a replacement to our future internal or contract manufacturers were required, the ability to establish second-sourcing or find a replacement manufacturer may be difficult due to the lead times generally required to manufacture drugs and the need for FDA compliance inspections and approvals of any replacement manufacturer, all of which factors could result in production

delays and additional commercialization costs.

compliance inspections and approvals of any replacement manufacturer, all of which factors could result in production delays and additional commercialization costs.

Such lead times would vary based on the situation but might be twelve months or longer.

4 unchanged sentences

Foreign exchange controls may have a material adverse effect on our business and financial condition, since such controls may limit our ability to flow funds into or out of a particular country to meet obligations under licenses, clinical trial agreements or other collaborations.

Geopolitical instability and armed conflicts in Turkey and the Middle East could disrupt our product distribution and sales and adversely affect our business.

We depend on third-party logistics providers, distributors, and healthcare systems to store, transport, and dispense our products in Turkey and the broader Middle East region.

Geopolitical instability, regional tensions, and armed conflicts in these markets may disrupt shipping lanes and border crossings, increase freight, insurance, and security costs, or otherwise delay or prevent delivery of our products to patients, as well as negatively affect prescribing, reimbursement, and demand, any of which could materially and adversely affect our business, results of operations, and financial condition.

Our cash invested in money market funds might be subject to loss.

16 unchanged sentences

This risk is especially relevant for us because pharmaceutical companies like us have experienced significant stock price volatility in recent years.

Specifically, we were named in putative securities class action complaints as a result of the decline in our stock price following the August 2020 announcement that we had received a CRL from the FDA regarding our NDA for PEDMARK ® and as result of the decline in our stock price following the November 2021 announcement that we expected to receive another CRL from the FDA

regarding our NDA for PEDMARK ® .

Both of these cases have been dismissed and closed.

8 unchanged sentences

Ultimately, we may not be successful in such a transition.

During 2025, we delivered sequential quarterly revenue growth and achieved positive operating cash flow in the third quarter of 2025;

however, we may not be able to sustain this trajectory and our future results will depend on continued adoption, payer access, and disciplined cost management.

There are limitations on the liability of our directors, and we may have to indemnify our officers and directors in certain instances.

18 unchanged sentences

These limitations could negatively affect our business operations and continuity, and could negatively impact our development timelines and ability to timely perform basic business functions, including, without limitation, making SEC filings and preparing financial reports.

If our operations or those of third parties with whom we conduct business are impaired or curtailed as a result of these events, the development and commercialization of our product and product candidate could be impaired or halted, which could have a material adverse impact on our business.

If our operations or those of third parties with whom we conduct business are impaired or curtailed as a result of these events, the development and commercialization of our product could be impaired or halted, which could have a material adverse impact on our business.

Because the target patient population for PEDMARK ® is small, we must achieve significant market share and obtain relatively high per-patient prices for our product to achieve meaningful gross margins.

13 unchanged sentences

If we are sued for any injury allegedly caused by our product, our liability could exceed our ability to pay the liability.

Whether or not we are ultimately successful in any adverse litigation, such litigation could consume substantial

amounts of our financial and managerial resources, all of which could have a material adverse effect on our business, financial condition, results of operations, prospects and stock price.

Whether or not we are ultimately successful in any adverse litigation, such litigation could consume substantial amounts of our financial and managerial resources, all of which could have a material adverse effect on our business, financial condition, results of operations, prospects and stock price.

Business or economic disruptions or global health concerns could seriously harm our development efforts and increase our costs and expenses.

4 unchanged sentences

We have entered into, and may in the future enter into, strategic transactions for the research, development and commercialization of PEDMARK.

If any of these transactions are not successful, then we may not be able to capitalize on the market potential of such product candidates.

If any of these transactions are not successful, then we may not be able to capitalize on the market potential of such product.

Further, we may not be able to enter into future transactions on acceptable terms, if at all, which could adversely affect our ability to develop and commercialize our potential future product candidates and former lead product candidate, impact our cash position, increase our expense, and present significant distractions to our management.

We have entered into, and may enter into in the future, strategic transactions, such as out-licensing of product candidates or technologies.

We have entered into, and may enter into in the future, strategic transactions, such as out-licensing of our product or technologies.

For example, in March 2024, we entered into a collaboration and license agreement with Norgine.

11 unchanged sentences

Our business is substantially dependent on our ability to complete the development of, obtain marketing approval for, and successfully commercialize our product candidate in abroad a timely manner.

We cannot commercialize our product

candidate outside of the United States without obtaining regulatory approval from comparable foreign regulatory authorities.

We cannot commercialize our product candidate outside of the United States without obtaining regulatory approval from comparable foreign regulatory authorities.

Our product could fail to receive marketing approval for many reasons, including the following:

13 unchanged sentences

After the submission of an NDA, but before approval of the NDA, the manufacturing facilities used to manufacture a product candidate generally must be inspected by the FDA to ensure compliance with the applicable cGMP requirements (for example, see the discussion elsewhere concerning the CRL we received from the FDA in August, 2020).

The FDA and the Competent Authorities of the Member States of the European Economic Area, or EEA, and comparable foreign regulatory authorities, may also inspect our clinical trial sites and audit clinical study data to ensure that our studies are properly conducted in accordance with the IND regulations, human subject protection regulations, cGCP.

properly conducted in accordance with the IND regulations, human subject protection regulations, cGCP.

In June 2023, we obtained approval for PEDMARQSI ® in the European Union and in October 2023 in the U.K.

46 unchanged sentences

In addition, we may be subject to physician payment transparency laws and patient privacy and security regulation by the federal government and by the U.S.

states and foreign jurisdictions in which we conduct our business.

and foreign jurisdictions in which we conduct our business.

The applicable federal, state and foreign healthcare laws that may affect our ability to operate include the following:

● the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be made, in whole or in part, under federal and state healthcare programs such as Medicare and Medicaid;

government, including the Medicare and Medicaid programs, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;

● federal civil and criminal false claims laws and civil monetary penalty laws, including the federal False Claims Act, which impose criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to the federal government, including the Medicare and Medicaid programs, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;

● the civil monetary penalties statute, which imposes penalties against any person or entity who, among other things, is determined to have presented or caused to be presented a claim to a federal health program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent;

8 unchanged sentences

A person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it.

In addition, the Affordable Care Act provided that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act.

In addition, the Affordable Care Act provided that the government may assert

that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act.

Efforts to ensure that our future business arrangements with third parties will comply with applicable healthcare laws and regulations may involve substantial costs.

1 unchanged sentence

If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, including, without limitation, damages, fines, imprisonment, exclusion from participation in government healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations, which could significantly harm our business.

may be subject to criminal, civil or administrative sanctions, including exclusion from participation in government healthcare programs, which could also affect our business.

If any of the physicians or other healthcare providers or entities with whom we expect to do business, including our current and future collaborators, if any, are found not to be in compliance with applicable laws, those persons or entities may be subject to criminal, civil or administrative sanctions, including exclusion from participation in government healthcare programs, which could also affect our business.

The impact of recent healthcare reform legislation and other changes in the healthcare industry and healthcare spending on us is currently unknown and may adversely affect our business model.

20 unchanged sentences

We cannot eliminate the risk of contamination, which could cause an interruption of our commercialization efforts, research and development efforts and business operations, environmental damage resulting in costly clean-up and liabilities under applicable laws and regulations governing the use, storage, handling, and disposal of these materials and specified waste products.

guarantee that this is the case or eliminate the risk of accidental contamination or injury from these materials.

Although we believe that the safety procedures utilized by us and our third-party manufacturers for handling and disposing of these materials generally comply with the standards prescribed by these laws and regulations, we cannot guarantee that this is the case or eliminate the risk of accidental contamination or injury from these materials.

In such an event, we may be held liable for any resulting damages and such liability could exceed our resources and state or federal or other applicable authorities may curtail our use of specified materials and/or interrupt our business operations.

52 unchanged sentences

Moreover, a third-party payor’s decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved.

Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate

return on our investment in product development.

Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development.

Additionally, coverage and reimbursement for drug products can differ significantly from payor to payor.

18 unchanged sentences

These companies also have significantly greater research and marketing capabilities than we do and may also have products that have been approved or are in late stages of development, and have collaborative arrangements in our target markets with leading companies and research institutions.

Established companies may also invest heavily to accelerate discovery and development of compounds that could make our product obsolete.

Established companies may also invest heavily to accelerate discovery

and development of compounds that could make our product obsolete.

As a result of all of these factors, maintaining orphan drug designation for our product is essential to our viability since our competitors may, among other things:

24 unchanged sentences

In some countries, we may be required to conduct a clinical trial or other studies that compare the cost-effectiveness of our product to other available therapies in order to obtain or maintain reimbursement or pricing approval.

Publication of discounts by third-party payors or authorities may lead to further pressure on the prices or reimbursement levels within the country of publication and other countries.

Publication of discounts by third-party payors or authorities may lead to further pressure on the prices or reimbursement levels within the country of

publication and other countries.

If reimbursement of our product is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be adversely affected.

5 unchanged sentences

Our business exposes us to potential liability risks that may arise from the clinical testing, manufacture, and/or sale of our pharmaceutical product.

Patients have received substantial damage awards in some jurisdictions against pharmaceutical companies based on claims for injuries allegedly caused by the use of pharmaceutical products used in clinical trials or

after FDA approval.

Liability claims may be expensive to defend and may result in large judgments against us.

27 unchanged sentences

As a result of this legislation and the expansion of federal coverage of drug products, there is additional pressure to contain and reduce costs.

While the MMA applies only to drug benefits for Medicare beneficiaries, private payors often follow

Medicare coverage policy and payment limitations in setting their own reimbursement rates, and any reduction in reimbursement that results from the MMA may result in a similar reduction in payments from private payors.

While the MMA applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates, and any reduction in reimbursement that results from the MMA may result in a similar reduction in payments from private payors.

These cost reduction initiatives and other provisions of the MMA could decrease the coverage and reimbursement that we receive for our product and could seriously harm our business.

3 unchanged sentences

The Health Care Reform Law also expanded the 340B drug discount program (excluding orphan drugs), including the creation of new penalties for non-compliance and included a discount (now 70%, on brand name drugs for Medicare Part D participants in the coverage gap, or “donut hole.” The Health Care Reform Law increased the Medicaid rebates for line extensions or reformulated drugs, which could substantially increase our Medicaid rebate rate (in effect limiting reimbursement for these patients).

Beginning in January 2017, former President Trump signed two Executive Orders and other directives designed to delay the implementation of certain provisions of the Health Care Reform Law or otherwise circumvent some of the requirements for health insurance mandated by the Health Care Reform Law.

Beginning in January 2017, President Trump, in his first term, signed two Executive Orders and other directives designed to delay the implementation of certain provisions of the Health Care Reform Law or otherwise circumvent some of the requirements for health insurance mandated by the Health Care Reform Law.

These actions include directing applicable federal agencies to waive, defer, grant exemptions from, or delay the implementation of any provision of the Health Care Reform Law that would impose a fiscal or regulatory burden on states, individuals, healthcare providers, health insurers, or manufacturers of pharmaceuticals or medical devices.

9 unchanged sentences

Additionally, in response to controversies regarding pricing of drug products, there has been a recent push to propose legislation, both on state and federal levels, that would require greater disclosure as to the reasoning behind drug prices and, in some cases, could give state or federal-level commissions the right to impose cost controls on certain drugs.

These and other new provisions are likely to continue the pressure on pharmaceutical pricing, may require us to modify our business practices with healthcare practitioners, and may also increase our regulatory burdens and operating costs.

These and other new provisions are likely to continue the pressure on pharmaceutical pricing, may require us to modify our

business practices with healthcare practitioners, and may also increase our regulatory burdens and operating costs.

In that regard, the President and members of Congress in both parties have expressed concerns about high drug prices.

127 unchanged sentences

The certifications allege these patents are invalid or will not be infringed by the manufacture, use, or sale of CIPLA’s sodium thiosulfate solution.

On March 16, 2026, Fennec announced that it has entered into an agreement with Cipla Limited and Cipla USA, Inc.

to settle the litigation between them regarding Cipla’s application to FDA for approval to market a generic version of Fennec’s PEDMARK® (sodium thiosulfate injection) product.

See Fennec Pharmaceuticals Inc.

Cipla Limited and Cipla USA, Inc ., C.A.

2:23-cv-00123-JKS-MAH (D.N.J.).

We plan to vigorously defend our intellectual property rights related to PEDMARK ® .

However, we are unable to predict the outcome of these petitions, and an invalidation of one or both of these patents may have a material adverse effect on our ability to protect our rights in PEDMARK ® beyond the market exclusivity granted from Orphan Drug Designation and PUMA.

Further, on October 29, 2021, Hope filed a petition for inter partes review (IPR2022-00123) with the PTAB to invalidate the 190 patent, which is exclusively in-licensed from OHSU and relates to a method of using PEDMARK ® .

The US ‘190 patent was issued on March 24, 2020.

On December 5, 2022, we filed a Motion to Amend the single claim of the US ‘190 patent focusing on the treatment of medulloblastoma.

On April 18, 2023, the PTAB invalidated the only claim of the US ‘190 patent.

The final written decision became effective June 20, 2023.

The 190 patent was listed in the Orange Book, but in light of PTAB’s final written decision on the invalidity of the US ‘190 patent, we requested that the FDA remove the US ‘190 patent from the Orange Book.

Under our license agreements, we have the right to bring legal action against any alleged infringers of the patents we license.

13 unchanged sentences

However, we may fail to apply for patents on important technologies or product in a timely fashion, or at all.

Our existing patents and any future patents we obtain may not be sufficiently broad to prevent others from practicing our technologies or from developing competing products and technologies.

Our existing patents and any future patents we obtain may not be sufficiently broad to prevent others from practicing our technologies or from developing competing

products and technologies.

We cannot be certain that our patent applications will be approved or that any patents issued will adequately protect our intellectual property.

260 unchanged sentences

At March 17, 2026, our current shareholders separately representing more than 5% ownership of our common shares collectively represented beneficial ownership of approximately 41% of our common shares.

In particular, Southpoint Capital Advisors LP (“Southpoint Capital”) owns or exercises control over approximately 4.0 million shares, representing approximately 14.81% of our issued and outstanding common shares;

In particular, Essetifin SpA, owns approximately 4.0 million shares, or approximately 11.6% of our issued and outstanding common shares, Rosalind Advisors Inc.

reported beneficial ownership of 2.7 million shares, or approximately 8.0% of our outstanding common shares, Southpoint Capital Advisors LP (“Southpoint Capital”) owns or exercises control over approximately 2.7 million

shares, representing approximately 8.0% of our issued and outstanding common shares;

Sonic Fund II, LP, owns approximately 2.6 million shares, or approximately 7.6% of our issued and outstanding common shares;

Essetifin SpA, owns approximately 4.0

million shares, or approximately 14.51% of our issued and outstanding common shares;

and Solas Capital Management, owns approximately 2.3 million shares, or approximately 8.18% of our issued and outstanding common shares;

and Southpoint Capital, Rosalind Advisors, Sonic Fund II, LP, Solas Capital Management and our other significant shareholders, and other insiders, acting alone or together, might be able to influence the outcomes of matters that require the approval of our shareholders, including but not limited to certain equity transactions (such as a financing), an acquisition or merger with another company, a sale of substantially all of our assets, the election and removal of directors, or amendments to our incorporating documents.

and our other significant shareholders, and other insiders, acting alone or together, might be able to influence the outcomes of matters that require the approval of our shareholders, including but not limited to certain equity transactions (such as a financing), an acquisition or merger with another company, a sale of substantially all of our assets, the election and removal of directors, or amendments to our incorporating documents.

These shareholders might make decisions that are adverse to your interests.

3 unchanged sentences

It may also impair our ability to obtain additional financing.

At March 17, 2025, we had 0.2 million warrants outstanding to purchase and 0.2 million shares of our common shares at an exercise price of $7.71 per common share.

At March 17, 2026, we had 0.1 million warrants outstanding to purchase 0.1 million shares of our common shares at an exercise price of $8.11 per common share.

In addition, as of March 17, 2026, there were approximately 5.9 million common shares issuable upon the exercise of outstanding stock options with a weighted average exercise price of $6.38 per common share.

101 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors