What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2026-03-04 compared with 2025-03-13 · 95 added, 53 removed, 623 unchanged (19% of the section changed)

20 unchanged sentences

however, we may not be able to realize any value from such designation.

● Failure to meet the EU’s CMA conditions, in particular the unmet needs condition, means we will have to obtain a marketing authorization through the normal approval process;

this requires more robust data at the time of initial application submission.

● Clinical studies involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies may not be predictive of future study results.

28 unchanged sentences

As of December 31, 2025, our consolidated cash balance was approximately $13.2 million.

We believe our cash balance as of December 31, 2024, is adequate to fund our basic budgeted operations into the fourth quarter of 2025.

We believe our cash balance as of December 31, 2025, is adequate to fund our basic budgeted operations into the third quarter of 2026.

The Company’s ability to execute its current operating plan depends on its ability to obtain additional funding via the sale of equity and/or debt securities, a strategic transaction or other source of capital.

22 unchanged sentences

If we cannot secure adequate financing when needed, we may be required to delay, scale back or eliminate one or more of our research and development programs or to enter into license or other arrangements with third parties to commercialize products or technologies that we would otherwise seek to develop and commercialize ourselves.

In the event that additional funds are obtained through arrangements with collaborative partners or other sources, we may have to relinquish economic and/or proprietary rights to some of our technologies or products under development that we would otherwise seek to develop or commercialize by ourselves.

In the event that additional funds are obtained through arrangements with collaborative

partners or other sources, we may have to relinquish economic and/or proprietary rights to some of our technologies or products under development that we would otherwise seek to develop or commercialize by ourselves.

In such an event, our business, prospects, financial condition and results of operations may be adversely affected.

8 unchanged sentences

Risks Related to Manufacturing and Supply

We rely on a collaborative outsourced business model, and disruptions with our third-party collaborators may impede our ability to gain FDA approval and delay or impair commercialization of any products.

We rely on a collaborative outsourced business model, and disruptions with our third-party collaborators may impede our ability to gain marketing approval from the FDA, the European Commission (based on recommendation from the EMA), or other regulatory authorities and delay or impair commercialization of any products.

We are in the preclinical and clinical study phases of product development and commercialization.

3 unchanged sentences

In addition, we rely exclusively on contract research organizations to conduct research and development.

Any inability of these organizations to fulfill the requirements of their agreements with us may delay or impair our ability to gain FDA approval and commercialization of our drug delivery technology and products.

Any inability of these organizations to fulfill the requirements of their agreements with us may delay or impair our ability to gain marketing approval from the FDA, European Commission (based on recommendation from the EMA), or other regulatory authorities and commercialization of our drug delivery technology and products.

Our reliance on third-party collaborators exposes us to risks related to not being able to directly oversee the activities of these parties.

11 unchanged sentences

Manufacturing delays could postpone the filing of our IND applications and/or the initiation or completion of clinical trials that we have currently planned or may plan in the future.

Drug manufacturers are subject to ongoing periodic unannounced inspection by the FDA, the Drug Enforcement Administration, the EMA, national competent authorities in the EU and UK and other federal and state government and regulatory agencies to ensure strict compliance with cGMP and other government regulations and corresponding foreign standards.

Drug manufacturers are subject to ongoing periodic unannounced inspection by the FDA, the Drug Enforcement Administration, the EU Member States (coordinated by the EMA), and other comparable foreign regulatory authorities and other federal and state government and regulatory agencies to ensure strict compliance with cGMP and other government regulations and corresponding foreign standards.

We do not have control over third-party manufacturers’ compliance with these regulations and standards and they may not be able to comply.

1 unchanged sentence

It may be difficult or impossible for us to find a replacement manufacturer quickly on acceptable terms, or at all.

Additionally, if we are required to enter into new supply arrangements, we may not be able to obtain approval from the FDA of any alternate supplier in a timely manner, or at all, which could delay or prevent the clinical development and commercialization of any related product candidates.

Additionally, if we are required to enter into new supply arrangements, we may not be able to obtain approval from the FDA, the European Commission (based on recommendation from the EMA) or other comparable foreign regulatory authorities of any alternate supplier in a timely manner, or at all, which could delay or prevent the clinical development and commercialization of any related product candidates.

Failure of our third-party manufacturers or us to comply with applicable regulations could result in sanctions being imposed on us, including fines, civil penalties, delays in or failure to grant marketing approval of our product candidates, injunctions, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of products and compounds, operating restrictions and criminal prosecutions, warning or similar letters or civil, criminal or administrative sanctions against the company, any of which could adversely affect our business.

1 unchanged sentence

However, should the situation change, we may be required to relocate these activities on short notice, and we do not currently have access to alternate facilities to which we could relocate our research, development and/or manufacturing activities.

The cost and time to establish or locate an alternate research, development and/or manufacturing facility to develop our technology would be substantial and would delay obtaining FDA approval and commercializing our products.

Furthermore, if our products are approved for commercial sale, we will need to work with our existing third-party collaborators to ensure sufficient capacity, or engage additional parties with the capacity, to commercially manufacture our products in accordance with FDA and other regulatory requirements.

There can be no assurance that we would be able to successfully establish any such capacity or identify suitable manufacturing partners on acceptable terms.

Risks Related to Research and Development and the FDA

We cannot assure the successful development and commercialization of our compounds in development.

Risks Related to Research, Development and Regulatory Approval of Our Product Candidates

All of our product candidates are in clinical development or in preclinical development.

If we are unable to advance our product candidates through clinical development, obtain regulatory approval and ultimately commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed.

At present, our success is dependent on one or more of the following to occur:

47 unchanged sentences

A number of companies in the pharmaceutical industry, including biotechnology companies, have suffered significant setbacks in advanced clinical trials, even after achieving promising results in earlier trials.

Before receiving FDA approval or similar approval in the European Union or other jurisdiction to market a product, we must demonstrate with substantial clinical evidence that the product is safe and effective in the patient population and the indication that will be treated.

Before receiving FDA approval or similar approval in the EU or other jurisdiction to market a product, we must demonstrate with substantial clinical evidence that the product is safe and effective in the patient population and the indication that will be treated.

Data obtained from preclinical and clinical activities are susceptible to varying interpretations that could delay, limit or prevent regulatory approvals.

Our clinical trials may fail to produce results satisfactory to the FDA or regulatory authorities in other jurisdictions.

Our clinical trials may fail to produce results satisfactory to the FDA, the EMA, or regulatory authorities in other jurisdictions.

The regulatory process also requires preclinical testing, and data obtained from preclinical and clinical activities are susceptible to varying interpretations.

3 unchanged sentences

● the clinical results may not replicate the results of earlier, smaller trials;

● we, or the FDA or similar foreign regulatory authorities, may delay, terminate or suspend the trials;

● we, or the FDA, the EMA, or similar foreign regulatory authorities, may delay, terminate or suspend the trials;

● our results may not be statistically significant;

15 unchanged sentences

In addition, delays or rejections may be encountered based upon additional government regulation from future legislation or administrative action or changes in FDA policy during the period of product development, clinical trials and FDA regulatory review.

Failure to comply with applicable FDA or other applicable regulatory requirements may result in criminal prosecution, civil penalties,

recall or seizure of products, total or partial suspension of production or injunction, adverse publicity, as well as other regulatory action against our potential products or us.

Failure to comply with applicable FDA or other applicable regulatory requirements may result in criminal prosecution, civil penalties, recall or seizure of products, total or partial suspension of production or injunction, adverse publicity, as well as other regulatory action against our potential products or us.

To conduct the clinical studies that are necessary to obtain approval by the FDA to market a product, it is necessary to receive clearance from the FDA to conduct such clinical studies.

5 unchanged sentences

We cannot assure you that any compound developed by us, alone or with others, will prove to be safe and efficacious in clinical trials and will meet all of the applicable regulatory requirements needed to receive marketing approval.

Even if we do ultimately receive FDA approval for any of our products, these products will be subject to extensive ongoing regulation, including regulations governing manufacturing, labeling, packaging, testing, dispensing, prescription and procurement quotas, record keeping, reporting, handling, shipment and disposal of any such drug.

Failure to obtain and maintain required registrations or to comply with any applicable regulations could further delay or preclude development and commercialization of our drugs and subject us to enforcement action.

The SAWP has advised that filing for a CMA for iopofosine I 131 as a treatment for post - BTKi refractory patients with WM could be acceptable.

However, there can be no guarantee that the EMA will grant CMA in the EU for iopofosine for WM patients having received two or more prior treatment regimens.

Even if we are granted a CMA in the EU, we will be required to undergo annual renewal assessments to determine whether the risk-benefit balance remains positive.

During or in between such assessments, it may be determined that we do not meet the conditions, which would mean that the CMA is revoked, or that there is a need for additional or modified conditions and/or specific obligations.

Even if we do ultimately receive FDA approval or approval in the European Union for any of our products, these products will be subject to extensive ongoing regulation, including regulations governing manufacturing, labeling, packaging, testing, dispensing, prescription and procurement quotas, record keeping, reporting, handling, shipment and disposal of any such drug.

Failure to obtain

and maintain required registrations or to comply with any applicable regulations could further delay or preclude development and commercialization of our drugs and subject us to enforcement action.

Outside the US, our ability, or that of our collaborative partners, to market a product is contingent upon receiving a marketing authorization from the appropriate regulatory authorities.

1 unchanged sentence

There can be no assurance, however, that we or our collaborative partners will not have to provide additional information or analysis, or conduct additional clinical trials, before receiving approval to market product candidates.

We may seek Breakthrough Therapy designation by the FDA for one or more of our product candidates, which we may not receive.

Such designation may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that our product candidates will receive marketing approval.

On June 4, 2025, the Company announced that the FDA granted Breakthrough Therapy Designation for iopofosine I 131, as a radioconjugate monotherapy for the treatment of relapsed/refractory Waldenstrom macroglobulinemia.

In addition, we may seek Breakthrough Therapy designation for one or more of our product candidates, which, if granted, offers the potential for a rolling review of an NDA if a number of conditions are met, which would allow data to be submitted and reviewed as they become available rather than waiting for the full data package to become available to be submitted.

Rolling review is often faster than the FDA’s standard review process.

The FDA has broad discretion whether or not to grant Breakthrough Therapy designations, and even if we believe a particular product candidate is eligible for such a designation, we cannot be certain that the FDA would decide to grant it.

Even if we obtain such designations for one or more of our product candidates, we may not experience a faster development process, review or approval compared to non-expedited FDA review procedures.

In addition, the FDA may withdraw Breakthrough Therapy designations if it believes that such designations are no longer supported.

Although product candidates receiving Breakthrough Therapy designation are generally eligible for the FDA’s priority review procedures, receiving such designations does not guarantee that the NDA for such product candidates will receive priority review.

Fast track designation by the FDA may not actually lead to a faster development or regulatory review or approval process and does not assure FDA approval of our product candidates.

11 unchanged sentences

primarily under the age of 18 years old, or a patient population greater than 200,000 in the U.S.

when there is no reasonable expectation that the cost of developing and making available the drug in the U.S.

when there is no reasonable

expectation that the cost of developing and making available the drug in the U.S.

will be recovered from sales in the U.S.

11 unchanged sentences

It is possible that even if we obtain approval for iopofosine and qualify for a priority review voucher, the program may no longer be in effect at the time of such approval.

Furthermore, due to recent communications with the FDA regarding a confirmatory study to support accelerated approval and the regulatory submission for iopofosine, the Company is, in addition to determining the availability of funding for such a study, pursuing strategic options for the further development and commercialization of this product candidate.

Furthermore, to recent communications with the FDA regarding a confirmatory study to support accelerated approval and the regulatory submission for iopofosine, the Company is, in addition to determining the availability of funding for such a study, pursuing strategic options for the further development and commercialization of this product candidate.

Clinical studies involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies may not be predictive of future study results.

19 unchanged sentences

Delays of this sort could occur for the reasons identified above or other reasons.

If we have delays in conducting the clinical trials or obtaining regulatory approvals, our product development costs will

For example, we may need to make additional payments to third-party investigators and organizations to retain their services or we may need to pay recruitment incentives.

If we have delays in conducting the clinical trials or obtaining regulatory approvals, our product development costs will increase.

For example, we may need to make additional payments to third-party investigators and organizations to retain their services

or we may need to pay recruitment incentives.

If the delays are significant, our financial results and the commercial prospects for our product candidates will be harmed, and our ability to become profitable will be delayed.

15 unchanged sentences

Moreover, we could be subject to significant liability if any volunteer or patient suffers, or appears to suffer, adverse health effects as a result of participating in our clinical studies.

The biopharmaceutical industry is subject to extensive regulatory obligations and policies that are subject to change, including due to judicial challenges.

The biopharmaceutical industry is subject to extensive regulatory obligations and policies that are subject to change, including to judicial challenges.

On June 28, 2024, the U.S.

3 unchanged sentences

Any resulting changes in regulation may result in unexpected delays, increased costs, or other negative impacts on our business that are difficult to predict.

In addition, federal agency activities, priorities, leadership, policies, rulemaking, communications, spending, and staffing may be significantly impacted by election cycles and legislative developments.

For example, the current presidential administration’s commitment to significantly reduce government spending through cuts to federal healthcare programs and reductions in the workforces of key government agencies, such as HHS, FDA, and CMS.

Efforts by the current administration to limit federal agency budgets or personnel may result in reductions to agency budgets, employees, and operations.

The administration and agencies have also made abrupt announcements about new or changed regulatory policies, such as policies related to the use of artificial intelligence to review product applications.

And, the recent federal government shutdown may prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews or other regulatory activities, and may significantly impact the ability of the FDA to timely review and process our regulatory submissions.

These developments which may lead to greater uncertainty regarding FDA

policies, slower response times and longer review periods, potentially affecting our ability to progress development of our product candidate or obtain regulatory approval for our product candidate.

Risks Related to Legal Compliance and Litigation

3 unchanged sentences

The inability of our third-party collaborators to maintain the required licenses and permits for any reason will negatively impact our manufacturing, and research and development activities.

In addition, we may be

required to indemnify third-party collaborators against certain liabilities arising out of any failure by them to comply with such regulations and/or laws.

In addition, we may be required to indemnify third-party collaborators against certain liabilities arising out of any failure by them to comply with such regulations and/or laws.

If we or our third-party collaborators fail to comply with any of these regulations and/or laws, a range of consequences could result, including the suspension or termination of clinical studies, failure to obtain approval of a product candidate, restrictions on our products or manufacturing processes, withdrawal of our products from the market, significant fines, exclusion from government healthcare programs, or other sanctions or litigation.

20 unchanged sentences

We will not be able to rely on it to exclude other companies from manufacturing or selling products using the same principal molecular structural features for the same indication beyond these timeframes without our patent portfolio.

Even if we were the first to obtain marketing authorization for an orphan drug indication, there are circumstances under which a competing product may be approved for the same indication during the seven-year period of marketing exclusivity, such as if

the later product is shown to be clinically superior to the product with orphan exclusivity.

Even after an orphan product is approved, the FDA can subsequently approve the same drug with the same active moiety for the same condition if the FDA concludes that the later drug is safer, more effective, or makes a major contribution to patient care.

7 unchanged sentences

Any changes to the orphan drug provisions could change our opportunities for, or likelihood of success in obtaining, orphan drug exclusivity and would materially adversely affect our business, results of operations, financial condition and prospects.

We may also not be able to maintain our ODD in the EU.

In the EU, to maintain an ODD, a sponsor must demonstrate that it still satisfies the orphan designation criteria at the time of the marketing authorization.

This includes a requirement for the sponsor to demonstrate ‘significant benefit’ compared with any treatments that are authorized at the time of the re-evaluation of the orphan criteria.

Comparators may include products that are authorized after the sponsor has submitted its marketing authorization, but before the sponsor’s orphan designation criteria have be re-assessed.

We may face litigation from third parties claiming our products infringe on their intellectual property rights, particularly because there is often substantial uncertainty about the validity and breadth of medical patents.

14 unchanged sentences

To the extent we license patents from third parties, the early termination of any such license agreement would result in the loss of our rights to use the covered patents, which could severely delay, inhibit or eliminate our ability to develop and commercialize compounds based on the licensed patents.

Our competitors may also independently develop products similar to ours or

design around or otherwise circumvent patents issued or licensed to us.

Our competitors may also independently develop products similar to ours or design around or otherwise circumvent patents issued or licensed to us.

In addition, the laws of some foreign countries may not protect our proprietary rights to the same extent as U.S.

16 unchanged sentences

We have taken steps, including entering into confidentiality agreements with our employees, consultants, outside scientific collaborators, sponsored researchers and other advisors, to protect our trade secrets and unpatented know-how.

These agreements generally require that the other party keep confidential and not disclose to third parties all confidential information developed by the party or made known to the party by us during the course of the party’s relationship with us.

These agreements generally require that the

other party keep confidential and not disclose to third parties all confidential information developed by the party or made known to the party by us during the course of the party’s relationship with us.

Also, we typically obtain agreements from these parties that inventions conceived by them in the course of rendering services to us will be our exclusive property.

36 unchanged sentences

If we are unable to sustain anticipated levels of sales growth from our products, if approved, we may need to reduce our operating expenses, access other sources of cash or otherwise modify our business plans, which could have a negative impact on our business, financial condition and results of operations.

Regulatory approval for any approved product is limited by the FDA, the European Commission, and other regulators, to those specific indications and conditions for which clinical safety and efficacy have been demonstrated, and we may incur significant liability if it is determined that we are promoting the “off-label” use of any of our future product candidates if approved.

Any regulatory approval is limited to those specific diseases, indications and patient populations for which a product is deemed to be safe and effective by the FDA, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency and other regulators.

In addition to the FDA approval required for new formulations, any new indication for an approved product also requires FDA approval.

Regulatory approval for any approved product is limited by the FDA, the European Commission (based on recommendation from the EMA), and comparable foreign authorities, to those specific indications and conditions for which clinical safety and efficacy have been demonstrated, and we may incur significant liability if it is determined that we are promoting the “off-label” use of any of our future product candidates if approved.

In addition to the FDA, EMA and other regulators’ approval required for new formulations, any new indication for an approved product also requires FDA approval.

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

10 unchanged sentences

If the FDA or other regulatory or enforcement authorities determine that our communications regarding our marketed product are not in compliance with the relevant regulatory requirements and that we have improperly promoted off-label uses, or that our communications regarding our investigational products are not in compliance with the relevant regulatory requirements and that we have improperly engaged in pre-approval promotion, we may be subject to significant liability, including civil and administrative remedies as well as criminal sanctions.

Any product for which we have obtained regulatory approval, or for which we obtain approval in the future, is subject to, or will be subject to, extensive ongoing regulatory requirements by the FDA, EMA and other comparable regulatory authorities, and if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products, we may be subject to penalties, we may be unable to generate revenue from the sale of such products, our potential for generating positive cash flow may be diminished, and the capital necessary to fund our operations may be increased.

Any product for which we have obtain regulatory approval in the future, along with the manufacturing processes and practices, post-approval clinical research, product labeling, advertising and promotional activities for such product, are subject to continual requirements of, and review by, the FDA, the EMA and other comparable international regulatory authorities.

Any product for which we have obtained regulatory approval, or for which we obtain approval in the future, is subject to, or will be subject to, extensive ongoing regulatory requirements by the FDA, the European Commission (based on recommendation from the EMA) and other comparable regulatory authorities, and if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products, we may be subject to penalties, we may be unable to generate revenue from the sale of such products, our potential for generating positive cash flow may be diminished, and the capital necessary to fund our operations may be increased.

Any product for which we have obtain regulatory approval in the future, along with the manufacturing processes and practices, post-approval clinical research, product labeling, advertising and promotional activities for such product, are subject to continual requirements of, and review by, the FDA, the European Commission (based on a recommendation from the EMA) and other comparable international regulatory authorities.

These requirements include submissions of safety and other post-marketing information and reports, registration and listing requirements, current good manufacturing practices (cGMP) requirements relating to manufacturing, quality control, quality assurance and corresponding maintenance of records and documents, requirements regarding the distribution of samples to physicians, import and export requirements and recordkeeping.

1 unchanged sentence

In addition, the FDA often requires post-marketing testing and surveillance to monitor the effects of products.

The FDA, the EMA and other comparable international regulatory agencies may condition approval of our product candidates on the completion of such post-marketing clinical studies.

These post-marketing studies may suggest that a product causes undesirable side effects or may

present a risk to the patient.

The FDA, the European Commission (based on a recommendation from the EMA) and other comparable international regulatory authorities may condition approval of our product candidates on the completion of such post-marketing clinical studies.

These post-marketing studies may suggest that a product causes undesirable side effects or may present a risk to the patient.

Additionally, the FDA may require a REMS to help ensure that the benefits of the drug outweigh its risks.

17 unchanged sentences

If such regulatory actions are taken, the value of our company and our operating results will be adversely affected.

Additionally, if the FDA, the EMA or any other comparable international regulatory agency withdraws its approval of a product that is or may be approved, we will be unable to generate revenue from the sale of that product in the relevant jurisdiction, our potential for generating positive cash flow will be diminished and the capital necessary to fund our operations will be increased.

Additionally, if the FDA, the European Commission (based on a recommendation from the EMA) or any other comparable international regulatory agency withdraws its approval of a product that is or may be approved, we will be unable to generate revenue from the sale of that product in the relevant jurisdiction, our potential for generating positive cash flow will be diminished and the capital necessary to fund our operations will be increased.

Accordingly, we continue to expend significant time, money and effort in all areas of regulatory compliance, including manufacturing, production, product surveillance, post-marketing studies and quality control.

60 unchanged sentences

Until such time as our proposed products are further along in the development process, we will not devote any meaningful time and resources to this effort.

appropriate time, we will determine whether we will develop our own sales and marketing capabilities or enter into agreements with third parties to sell our products.

At the appropriate time, we will determine whether we will develop our own sales and marketing capabilities or enter into agreements with third parties to sell our products.

We have limited experience in developing, training or managing a sales force.

30 unchanged sentences

In the U.S., no uniform policy of coverage and reimbursement for products exists among third-party payors;

therefore, coverage and reimbursement

levels for products can differ significantly from payor to payor.

therefore, coverage and reimbursement levels for products can differ significantly from payor to payor.

As a result, the coverage determination process is often a time consuming and costly process that may require us to provide scientific, clinical or other support for the use of our products to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance.

13 unchanged sentences

A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach required goals, thereby triggering the legislation’s automatic reduction to several government programs.

This includes aggregate reductions of Medicare payments to providers of 2% per fiscal year, which went into effect in April 2013, and, a result of subsequent legislative amendments, will remain in effect into 2031, unless additional Congressional action is taken.

However, COVID-19 relief support legislation suspended the 2% Medicare sequester from May 1, 2020 through March 31, 2022 with a subsequent reduction to 1% implemented from April 1, 2022 until June 30, 2022.

27 unchanged sentences

comply with federal and state data privacy, security, fraud and abuse and other healthcare laws and regulations in the US and similar foreign fraudulent misconduct laws;

or report financial information or data accurately or to disclose unauthorized activities to us.

or report financial information or data accurately or to disclose unauthorized

activities to us.

It is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent inappropriate conduct may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations.

3 unchanged sentences

If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant civil, criminal and administrative penalties, damages, disgorgement, monetary fines, imprisonment, additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

Regulatory legislative reform measures may have a material adverse effect on our business.

The EU’s pharmaceutical legislation is currently changing.

In December 2025, the EU legislators reached an agreement on the proposed new rules.

This provisional agreement needs to be endorsed by both the Council of the EU and the European Parliament, before being formally adopted and entering into force upon publication in the EU’s Official Journal.

The final text is not yet available, but key changes will include:

● one year reduction in base-line regulatory market protection;

● re-coup option of lost regulatory market product with strict conditions;

● launch and supply obligations with non-compliance resulting in loss of regulatory data protection and market protection at Member State level;

● expansion of the Bolar exemption to health technology assessments, pricing, and reimbursement submissions;

● reduction in the “standard” orphan market exclusivity period;

● transferable data exclusivity voucher for priority antimicrobials;

● shortened EMA review timelines and other procedural reforms.

The new legislation is expected to enter into application in 24 months.

Other proposed EU acts, such as the Critical Medicines Act and the Biotech Act, may bring additional changes.

Risks Related to Internal Controls

We identified certain misstatements to our previously issued financial statements and have restated the financial statements described below, which has exposed us to additional risks and uncertainties.

We have restated our previously issued audited financial statements as of and for the years ended December 31, 2022 and 2023 and our interim financial statements as of and for the quarterly periods ended March 31, 2023 through September 30, 2023 and March 31, 2022 through September 30, 2022.

As a result of the misstatements discussed and the Restatement, we have become subject to a number of additional risks and uncertainties and unanticipated costs for accounting, legal and other fees and expenses, including risks of lawsuit relating to securities offered by us in public and private offerings as well as claims by purchasers of our shares of common stock in the public market.

actions, lawsuits or other legal proceedings related to the misstatements or the Restatement could result in liabilities, reputational harm and defense and other costs, regardless of the outcome of the lawsuit or proceeding.

We have restated our previously issued audited financial statements as of and for the years ended December 31, 2022 and 2023 and our interim financial statements as of and for the quarterly periods ended March 31, 2024, March 31, 2023 through September 30, 2023 and March 31, 2022 through September 30, 2022 (Restatement).

As a result of the misstatements discussed and the Restatement, we have become subject to a number of additional risks and uncertainties and unanticipated costs for accounting, legal and other fees and expenses, including risks of lawsuits relating to securities offered by us in public and private offerings as well as claims by purchasers of our shares of common stock in the public market.

Any actions, lawsuit or other legal proceedings related to the misstatements or the Restatement could result in liabilities, reputational harm and defense and other costs, regardless of the outcome of the lawsuit or proceeding.

We cannot ensure that litigation or other claims by stockholders will not be brought in the future arising out of the Restatement.

1 unchanged sentence

Any such further actions could be expensive and damaging to our business, results of operations and financial condition.

Failure to maintain effective internal controls could adversely affect our ability to meet our reporting requirements.

We identified material weaknesses in our internal control over financial reporting.

If we are unable to remediate these material weaknesses, or if we identify additional material weaknesses in the future or otherwise fail to maintain effective internal control over financial reporting, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect our business and share price.

We are required to establish and maintain appropriate internal controls over financial reporting.

13 unchanged sentences

Failure to meet Nasdaq’s continued listing requirements could result in the delisting of our common stock, negatively impact the price of our common stock and negatively impact our ability to raise additional capital.

We must continue to satisfy Nasdaq continued listing requirements, including, among other things, certain corporate governance requirements and a minimum closing bid price requirement of $1.00 per share.

We must continue to satisfy Nasdaq continued listing requirements, including, among other things, certain corporate governance requirements, minimum stockholders’ equity of $2.5 million, and a minimum closing bid price requirement of $1.00 per share.

If a company fails for 30 consecutive business days to meet the $1.00 minimum closing bid price requirement, Nasdaq will send a deficiency notice to the company, advising that it has been afforded a “compliance period” of 180 calendar days to regain compliance with the applicable requirements.

1 unchanged sentence

The Nasdaq deficiency letter had no immediate effect on the listing of our common stock.

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have been given 180 calendar days, or until July 29, 2025, to regain compliance with the minimum closing bid price requirement by causing our stock to close above $1.00 for a minimum of 10 consecutive trading days.

If we do not regain compliance with the minimum closing bid price requirement by July 29, 2025, we may be afforded a second 180 calendar day period to regain compliance.

To qualify, we would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for Nasdaq, except for the minimum bid price requirement.

In addition, we would be required to notify Nasdaq of our intent to cure the deficiency during the second compliance period.

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we were given 180 calendar days, or until July 29, 2025, to regain compliance with the minimum closing bid price requirement by causing our stock to close above $1.00 for a minimum of 10 consecutive trading days.

On June 24, 2025, we effected the 1-for-30 Reverse Stock Split to regain compliance with the bid price requirement prior to the July 29, 2025 compliance deadline.

On July 9, 2025, we received a letter from Nasdaq confirming that we regained compliance with the minimum bid price requirement in Nasdaq Listing Rule 5550(a)(2), as it was determined that for the last 10 consecutive business

days, from June 24, 2025 to July 8, 2025, the closing bid price of our common stock was at $1.00 per share or greater.

There is no assurance we will maintain compliance with Nasdaq continued listing requirements.

If our common stock becomes subject to delisting, it would be subject to rules that impose additional sales practice requirements on broker-dealers who sell our securities.

2 unchanged sentences

These factors could contribute to lower prices and larger spreads in the bid and ask prices for our common stock.

If we seek to implement a further reverse stock split in order to remain listed on Nasdaq, the announcement or implementation of such a reverse stock split could negatively affect the price of our common stock.

Our stock price has experienced, and may continue to experience, price fluctuations.

49 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