What changed in this filing

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Item 4. Controls and Procedures

2026-08-10 compared with 2026-05-11 · 177 added, 58 removed, 119 unchanged (66% of the section changed)

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LEG AL PROCEEDINGS

Except as discussed below, there are no material changes from the legal proceedings previously disclosed in our 2025 Annual Report during the three months ended March 31, 2026.

Except as discussed below, there are no material changes from the legal proceedings previously disclosed in our 2025 Annual Report during the three and six months ended June 30, 2026.

On June 14, 2022, the Company received a Paragraph IV notice of certification (the “Fresenius Kabi Notice”) from Fresenius Kabi advising that Fresenius Kabi had submitted an abbreviated new drug application (“ANDA”) to the U.S.

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Court of Appeals for the Federal Circuit.

On September 24, 2025, the briefing was completed, and the Company awaits a date for oral argument.

On September 24, 2025, the briefing was completed.

On July 21, 2026, the Company received notice that oral argument at the Federal Circuit is scheduled for September 10, 2026.

The Company intends to vigorously enforce its intellectual property rights relating to CINVANTI.

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On February 6, 2026, the post-trial briefing was completed, and, on March 24, 2026, the Court held closing arguments.

The Company awaits the Court’s decision.

On June 1, 2026, the Court issued a ruling holding that the asserted claims of the '255 Patent and the '520 Patent are invalid under 35 U.S.C.

The Court also entered a final judgment declaring that the asserted claims of U.S.

and 11,744,800 are not infringed.

On June 30, 2026, the Company appealed both final judgments to the U.S.

Court of Appeals for the Federal Circuit.

On July 31, 2026, the appeals were consolidated.

The consolidated appeal is in its early stages, and the parties have not yet submitted any briefing.

The Company intends to vigorously enforce its intellectual property rights relating to CINVANTI.

As a result of our initial complaint for patent infringement, the FDA may not approve Slayback’s NDA until the earlier of June 12, 2026 or resolution of the litigation.

On February 28, 2025, Azurity, Azurity Pharma India LLP, and Slayback requested Post-Grant Review ("PGR") of U.S.

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On November 19, 2025, the Company received a Paragraph IV notice of certification (the “Baxter Notice”) from Baxter Healthcare Corporation (“Baxter”) advising that Baxter had submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of CINVANTI (“Baxter’s ANDA for a generic version of CINVANTI”) in the U.S.

prior to the expiration of the Noticed CINVANTI Patents, which are listed in the Orange Book.

prior to the expiration of the

Noticed CINVANTI Patents, which are listed in the Orange Book.

On December 23, 2025, the Company filed a complaint for patent infringement of the Noticed CINVANTI Patents against Baxter and a related entity in the U.S.

District Court for the District of Delaware in response to the filing of Baxter’s ANDA for a generic version of CINVANTI.

The Company entered into a settlement

agreement with Baxter to resolve the ongoing patent litigation in the U.S.

The Company entered into a settlement agreement with Baxter to resolve the ongoing patent litigation in the U.S.

District Court for the District of Delaware related to Baxter’s ANDA for a generic version of CINVANTI.

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District Court for the District of Delaware requesting that the Court dismiss the pending litigation between the parties.

On June 26, 2026, the Company received a Paragraph IV notice of certification (the “Long Grove Notice”) from Long Grove Pharmaceuticals, LLC (“Long Grove”) advising that Long Grove had submitted an application seeking approval to manufacture, use, or sell a generic version of CINVANTI in the U.S.

(“Long Grove’s NDA”) prior to the expiration of the Noticed CINVANTI Patents, which are listed in the Orange Book for CINVANTI.

The Long Grove Notice alleges that the Noticed CINVANTI Patents are invalid, unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the Long Grove NDA product.

On August 7, 2026, the Company filed a complaint for patent infringement of the Noticed CINVANTI Patents against Long Grove and a related entity in the U.S.

District Court for the District of Delaware in response to Long Grove’s NDA filing.

The complaint seeks, among other relief, equitable relief enjoining Long Grove from infringing the Noticed CINVANTI Patents.

The Company intends to vigorously enforce its intellectual property rights relating to CINVANTI.

RIS K FACTORS

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The risks and uncertainties that we believe are most important for you to consider are discussed in Part I, Item 1A.

"Risk Factors" in our 2025 Annual Report, Quarterly Reports on Form 10-Q, and other reports, including our financial statements and the related notes thereto, "Management's Discussion and Analysis of Financial Condition and Results of Operations" and the information contained in the section entitled "Forward-Looking Statements." Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations.

Changes in government policies, laws, and regulations and with respect to the government workforce may have a negative impact on our business and the markets in which we operate.

The laws and regulations governing our operations, as well as their interpretation, may change from time to time, and new laws and regulations may be enacted.

Similarly, operational changes at government agencies, including actions intended to reduce government spending at agencies that regulate significant parts of our business, such as the FDA and CMS, could have a significant impact on the implementation of laws and regulations that impact our business.

For example, the layoffs and reorganizations at several U.S.

health agencies, including the FDA, the Department of Health and Human Services (the "HHS"), the Centers for Disease Control and Prevention and the National Institutes of Health, are expected to impact the FDA's ability to review and approve new medicines and conduct necessary inspections.

Over the last several years, the U.S.

government has also shut down several times and certain regulatory agencies, such as the FDA and SEC, have had to furlough employees, experience substantial funding cuts and pause or delay critical activities.

In addition, government funding of agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable, and spending allocations may undergo significant changes through congressional budgeting and appropriations processes.

Such disruptions at the FDA and other agencies may also increase the time necessary for new drugs or modifications to approved drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business.

There is also a great degree of uncertainty related to the impact of U.S.

Supreme Court decisions and executive orders on the enforcement and decision-making authority of regulatory agencies, including those in the FDA, which may lead to delays, if not cancellations, of pending and proposed regulations at federal agencies and subject significant regulatory actions by the agencies to presidential supervision and control.

Accordingly, any change in these laws or regulations, changes in their interpretation, or newly enacted laws or regulations and any failure by us to comply with these laws or regulations could require changes to certain of our business practices, negatively impact our operations, cash flow or financial condition, impose additional costs on us or otherwise adversely affect our business.

For example, significant changes to U.S.

trade policy, including potential new or increased tariffs, along with countermeasures by the affected countries, may impact global trade, create sourcing challenges with respect to raw materials and instruments and increase our costs, potentially harming our business.

has imposed increased tariffs on certain countries and other countries have responded by announcing retaliatory tariffs on U.S.

The tariffs have disrupted and may continue to disrupt the global markets and escalate geopolitical tensions between the U.S.

and other countries.

The extent of the impact of such tariffs and proposed regulations on our business specifically, or on the U.S.

market and global economy generally, are uncertain and unpredictable, and could adversely affect our business, financial condition and results of operations.

Further, the U.S.

may also enact other regulations or policies that affect trade or otherwise impact the pharmaceutical industry by restricting U.S.

pharmaceutical companies from contracting with certain countries for the development, research or manufacturing of pharmaceutical products.

For a discussion on the BIOSECURE Act and related risks, see "Risk Factors - Risks Related to Our Business - If we cannot maintain satisfactory pricing of our Products that is also acceptable to the U.S.

government, insurance companies, managed care organizations and other payors, or arrange for favorable reimbursement policies, our product sales may be adversely affected and our future revenue may suffer" in our Annual Report on Form 10-K for the year ended December 31, 2025.

In addition, the U.S.

Department of Commerce has initiated national security investigations into the importation of pharmaceuticals and pharmaceutical ingredients pursuant to Section 232 of the Trade Expansion Act of 1962, as amended (“Section 232”).

Further, the U.S.

announced a 100% tariff on any branded or patented pharmaceuticals imported into the U.S., from drug manufacturers that do not have, or are not in the process of building, a manufacturing facility in the U.S., which has been delayed as negotiations with large drug manufacturers continue.

Following the Section 232 investigations and other policy changes related to Most Favored Nation drug pricing, in April 2026, an executive order issued pursuant to Section 232, which seeks to impose up to a 100% tariff on imported patented pharmaceutics, subject to certain exceptions for certain products and for companies that have an agreement regarding Most Favored Nation drug pricing or onshore manufacturing.

Currently, the various tariffs that have been announced and enacted are not expected to have a material impact on the Company.

However, new tariffs or changes in the facts and circumstances impacting the Company could have a material impact to the Company.

The terms and effects of such tariffs, if and as they are implemented, and other policy changes are uncertain and could have adverse implications on drug pricing, drug production levels and patient access, and may result in supply chain or other operational disruptions.

Further, if we are required to change our current manufacturing partners or suppliers now or in the future in order to avoid such tariffs, the terms of new agreements that we may enter into may not be favorable to us and related operational disruptions may heighten manufacturing and compliance risks and derail commercialization plans.

Moreover, uncertainty with respect to legislation, regulation and government policy at the federal, state and local levels, has introduced new and difficult-to-quantify macroeconomic and geopolitical risks with potentially far-reaching implications.

There are currently a number of laws and regulations in the U.S.

that have recently been adopted but not yet implemented, have been proposed or are being considered to which we or our customers may become subject, including healthcare reform initiatives and potential spending and tax proposals, but at this time their impact on our business and results of operations remains uncertain.

Changes in legislation, regulation or policy increase the likelihood that we will fail to appropriately adapt to changes in our compliance obligations, particularly when such changes happen abruptly, such as following a change in government.

Any of the foregoing changes could increase our litigation and regulatory exposure, directly impact our results of operations and cash flows, adversely affect our ability to provide our products, or adversely impact the demand for our Products.

Such changes may also impact our business by creating increased volatility and uncertainty in the markets in which we operate.

At this time, we cannot predict the ultimate content, timing, or effect of these changes, including any legislative, regulatory and other actions under the new U.S.

administration, or estimate the overall impact of any such changes on our business, results of operations and financial condition.

"Risk Factors" in our 2025 Annual Report, Quarterly Reports on Form 10-Q, and other reports, including our financial statements and the related notes thereto, "Management's Discussion and Analysis of Financial Condition and Results of Operations" and the information contained in the section entitled "Forward-Looking Statements." The occurrence of any of the events or developments described below could adversely affect our business, financial condition, results of operations and prospects.

In such an event, the market price of our common stock could decline and you may lose all or part of your investment.

Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations.

Other than the factors described below, there are no material changes to the risk factors described in our 2025 Annual Report.

Our Products may face competition from lower-cost generic products offered by our competitors, which may limit our ability to sell our Products or require us to reduce our pricing.

Pricing for therapeutics can be extremely competitive, and strict formulary guidelines enforced by payors may create significant challenges in the acceptance and profitability of branded products.

The market for generic products can be very lucrative, and it is dominated by companies that may have much larger distribution capabilities than we may have in the future.

It can be very difficult to predict the timing of the launch of generic products given the commonality of litigation with manufacturers over anticipated patent expiration.

Our inability to accurately foresee and plan for generic product launches that may compete with our Products may significantly impact our potential revenues from such Products.

On the expiration or loss of patent protection for a branded product, or on the "at-risk" launch (despite pending patent infringement litigation against the generic product) by a manufacturer of a generic version of a drug that may compete with one of our products, we could quickly lose a significant portion of our sales of that Product.

The inability for a branded Product we may sell to successfully compete against generic products could negatively impact sales of our Product, reduce our ability to grow our business and significantly harm our business prospects.

We face competition from newly developed generic products as the Hatch-Waxman Act seeks to stimulate competition by providing incentives to generic pharmaceutical manufacturers to introduce non-infringing forms of patented pharmaceutical products and to challenge patents on branded pharmaceutical products.

For example, we filed a complaint for patent infringement of certain CINVANTI patents against Fresenius Kabi USA, LLC ("Fresenius Kabi") in connection with its Abbreviated New Drug Application (“ANDA”), which seeks approval to manufacture, use or sell a generic version of CINVANTI in the U.S.

prior to expiration of certain CINVANTI patents.

While in December 2024, the District Court found that the Company’s ’229 Patent and ’794 Patent are valid and would be infringed by Fresenius Kabi’s proposed generic product, this decision is currently pending appeal and there is no guarantee that other similar or future litigation will be resolved in our favor.

In addition, we filed a complaint for patent infringement of certain CINVANTI patents against Azurity Pharmaceuticals, Inc., Azurity Pharmaceuticals India LLP f/k/a Slayback Pharma India LLP, and Slayback Pharma LLC (collectively, “Azurity”) in connection with its new drug application (“NDA”) submission to the FDA under

Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (the “FDCA”).

On June 1, 2026, the District Court issued a decision holding that the Company’s asserted claims of Azurity’s infringement of the ’255 Patent and the ’520 Patent are invalid under 35 U.S.C.

The Court also entered a final judgment declaring that the asserted claims of U.S.

and 11,744,800 are not infringed.

On June 30, 2026, the Company appealed both final judgments to the U.S.

Court of Appeals for the Federal Circuit.

On July 31, 2026, the appeals were consolidated.

The consolidated appeal is in its early stages, and the parties have not yet submitted any briefing.

While the Company intends to vigorously enforce its intellectual property rights relating to CINVANTI, there can be no assurance that this matter will be resolved in the Company’s favor.

An adverse outcome could have a material effect on the Company’s business, results of operations and financial position.

In addition, the Company has entered into settlement agreements in connection with patent infringement litigations related to ANDA filings from (i) Mylan with respect to CINVANTI and APONVIE, (ii) Qilu with respect to CINVANTI and APONVIE and (iii) Baxter with respect to CINVANTI, and such settlements are not impacted by the U.S.

District Court for the District of Delaware’s June 1, 2026 decision on the Company’s patent infringement litigation against Azurity with respect to certain CINVANTI patents.

For more information about the Company’s patent litigations, see “Part I.

Legal Proceedings” in our 2025 Annual Report and “Part II.

Legal Proceedings” in subsequent Quarterly Reports on Form 10-Q.

If the Company is unsuccessful in demonstrating infringement of its patents by an ANDA or 505(b)(2) product, or the validity of the Company’s patents is successfully challenged, lower-cost generic versions of our Products may be launched commercially and may compete with our Products, as they may be favored by insurers and third-party payors, which would significantly harm our business.

If we are unable to adequately protect or enforce our intellectual property rights, we may lose valuable assets or incur costly litigation to protect our rights.

Our policy is to actively seek patent protection in the U.S.

and selected foreign countries, to obtain coverage for novel technologies and compositions of matter that may be commercially important to the development of our business.

Granted patents include claims covering the product composition, methods of use and methods of preparation.

Our existing patents may not cover future products, additional patents may not be issued and current patents, or patents issued in the future, may not provide meaningful protection or prove to be of commercial benefit.

The patent positions of pharmaceutical companies, including ours, are uncertain and involve complex legal and factual questions.

In addition, the coverage claimed in a patent application can be significantly changed or reduced before the patent is issued.

Consequently, our patent applications may not issue into patents, and any issued patents may not provide sufficient protection for our product candidates or provide sufficient protection to afford us a commercial advantage against competitive technologies or may be held invalid if challenged or circumvented.

Patent applications in the U.S.

are maintained in confidence by the U.S.

Patent and Trademark Office for at least 18 months after their filing.

Consequently, we cannot be certain that the patent applications we are pursuing will lead to the issuance of any patent or that the claimed inventions will be free from infringement or other claims from other parties.

Our competitors may also independently develop products similar to ours or design around or otherwise circumvent patents issued to us or controlled (e.g., licensed) by us.

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

We may have to enforce and defend our intellectual property rights against third parties who infringe our patents and other intellectual property or who challenge our patents or trademarks.

For example, in the U.S., manufacturers of putative generics of innovator drug products (including products in which the innovation comprises a new drug delivery method for an existing product, such as the drug delivery market occupied by us) may file Abbreviated New Drug Applications ("ANDA") (or New Drug Applications pursuant to Section 505(b)(2) of the FDCA) and, in doing so, certify that their products either do not infringe the innovator’s patents and/or that the innovator’s patents are invalid.

Under the Hatch-Waxman Act, the owners of patents listed in the FDA's publication "Approved Drug Products With Therapeutic Equivalence Evaluations ("Orange Book") and referenced by an ANDA applicant (or a 505(b)(2) applicant) may bring patent infringement suit, commonly known as "Paragraph IV Litigation," against the applicant after receipt of the applicant's notice of paragraph IV certification.

Paragraph IV litigations, of which there are often multiple in process by several applicants covering similar patents, could result in new or additional generic competition to any of our products and our product candidates and a potential reduction in product revenue.

For example, on July 27, 2022, we filed a complaint for patent infringement of certain CINVANTI patents against Fresenius Kabi and a related entity in the District of Delaware in response to Fresenius Kabi’s ANDA application seeking FDA approval to manufacture, use or sell a generic version of CINVANTI in the U.S.

prior to expiration of the CINVANTI patents, including U.S.

9,561,229 (the "'229 Patent") and 9,974,794 (the "'794 Patent").

While in December 2024, the District Court found that the Company’s '229 Patent and '794 Patent are valid and would be infringed by Fresenius Kabi’s proposed generic product, this decision is currently pending appeal and there is no guarantee that other similar or future litigation will be resolved in our favor.

Similarly, on January 24, 2024, we filed a complaint for patent infringement of certain CINVANTI patents, U.S.

12,115,255 (the "'255 Patent") and 12,290,520 (the "'520 Patent"), against Azurity in the District of Delaware in response to Azurity’s New Drug Application ("NDA") submission to the FDA under Section 505(b)(2) of the FDCA.

On June 1, 2026, the District Court issued a decision holding that the Company’s asserted claims of Azurity’s infringement of the ’255 Patent and the ’520 Patent are invalid under 35 U.S.C.

The Court also entered a final judgment declaring that the asserted claims of U.S.

and 11,744,800 are not infringed.

On June 30, 2026, the Company appealed both final judgments to the U.S.

Court of Appeals for the Federal Circuit.

On July 31, 2026, the appeals were consolidated.

The consolidated appeal is in its early stages, and the parties have not yet submitted any briefing.

While the Company intends to vigorously enforce its intellectual property rights relating to CINVANTI, there can be no assurance that this matter will be resolved in the Company’s favor.

An adverse outcome could have a material effect on the Company’s business, results of operations and financial position.

For more information about the Company’s patent litigations, see “Part I.

Legal Proceedings” in our 2025 Annual Report and “Part II.

Legal Proceedings” in subsequent Quarterly Reports on Form 10-Q.

We may enter into collaborative agreements that may subject us to obligations that must be fulfilled and require us to manage complex relationships with third parties.

In the future, if we are unable to meet our obligations or manage our relationships with our collaborators under these agreements our revenue may decrease.

The loss or diminution of our intellectual property rights could result in a decision by our third-party collaborators to terminate their agreements with us.

In addition, these agreements are generally complex and contain provisions that could give rise to legal disputes, including potential disputes concerning ownership of intellectual property and data under collaborations.

Such disputes can lead to lengthy, expensive litigation or arbitration, requiring us to divert management time and resources to such dispute.

Because the patent positions of pharmaceutical and biotechnology companies involve complex legal and factual questions, enforceability of patents cannot be predicted with certainty.

The ultimate degree of patent protection that will be afforded to products and processes, including ours, remains uncertain and is dependent on the scope of protection decided on by the patent offices, courts and lawmakers in the U.S.

and other countries in which we seek patent protection.

The America Invents Act, which was enacted in 2011 and reformed certain patent laws in the U.S., may create additional uncertainty.

Patents, if issued, may be challenged, invalidated or circumvented.

As more products are commercialized using our proprietary product platforms, or as any product achieves greater commercial success, our patents become more likely to be subject to challenge by potential competitors.

We also rely on trade secrets, technical know-how and continuing technological innovation to develop and maintain our competitive position.

We require our employees, consultants, advisors and collaborators to execute appropriate confidentiality and assignment-of-inventions agreements with us.

These agreements typically provide that all materials and confidential information developed or made known to the individual during the course of the individual’s relationship with us is to be kept confidential and not disclosed to third parties except in specific circumstances, and that all inventions arising out of the individual’s relationship with us shall be our exclusive property.

These agreements may be breached, and in some instances, we may not have an appropriate remedy available for such breach.

Furthermore, our competitors may independently develop substantially equivalent proprietary information and techniques, reverse engineer our information and techniques, or otherwise gain access to our proprietary technology.

We may be unable to meaningfully protect our rights in trade secrets, technical know-how and other non-patented technology.

We may have to resort to litigation to protect our intellectual property rights, or to determine their scope, validity or enforceability.

In addition, interference proceedings declared by the U.S.

Patent and Trademark Office may be necessary to determine the priority of inventions with respect to our patent applications.

Enforcing or defending our proprietary rights is expensive, could cause diversion of our resources and may not prove successful.

In addition, courts outside the U.S.

may be less willing to protect trade secrets.

Costly and time-consuming litigation could be necessary to seek to enforce and determine the scope of our proprietary rights.

Any failure to enforce or protect our rights could cause us to lose the ability to exclude others from using our technology to develop or sell competing products.

We may be subject to claims that we have infringed on the intellectual property rights of others, and any litigation could force us to stop developing or selling potential products and could be costly, divert management attention and harm our business.

We must be able to develop products without infringing the proprietary rights of other parties.

Because the markets in which we operate involve established competitors with significant patent portfolios, including patents relating to the composition of a variety of polymers, specific products, product groups and processing technology, it could be difficult for us to use our technologies or develop products without infringing the proprietary rights of others.

Therefore, there is risk that third parties may make claims of infringement against our products, our product candidates or our technologies.

We may not be able to design around the patented technologies or inventions of others, and we may not be able to obtain licenses to use patented technologies on acceptable terms, or at all.

If we cannot operate without infringing the proprietary rights of others, we will not be able to develop or commercialize some or all of our product candidates, and consequently will not be able to earn product revenue.

There is considerable uncertainty within the pharmaceutical industry about the validity, scope and enforceability of many issued patents in the U.S.

and elsewhere in the world.

We cannot currently determine the ultimate scope and validity of patents that may be granted to third parties in the future or which patents might be asserted to be infringed by any future manufacture, use or sale of our products and our product candidates.

In part, and as a result of this uncertainty, there has been, and we expect that there may continue to be, significant litigation in the pharmaceutical industry regarding patents and other intellectual property rights.

If we are required to defend ourselves in a patent-infringement lawsuit, we could incur substantial costs, and the lawsuit could divert management attention, regardless of the lawsuit’s merit or outcome.

These legal actions could seek damages and seek to enjoin testing, manufacturing and marketing of the accused product or process.

In addition to potential liability for significant damages, we could be required to redesign affected products or obtain a license to continue to manufacture or market the accused product or process and any license required under any such patent may not be made available to us on acceptable terms, if at all.

Competitors may sue us as a way of delaying the introduction of our products and our product candidates into the market.

Any litigation, including any interference or derivation proceedings to determine priority of inventions, oppositions or other post-grant review proceedings to patents in the U.S.

or in countries outside the U.S., or litigation against our partners may be costly and time-consuming and could harm our business.

We expect that litigation may be necessary in some instances to determine the validity and scope of certain of our proprietary rights.

Litigation may be necessary in other instances to determine the validity, scope and/or non-infringement of certain patent rights claimed by third parties to be pertinent to the manufacture, use or sale of our products and our product candidates.

For more information about the Company’s patent litigations, see “Part I.

Legal Proceedings” in our 2025 Annual Report and “Part II.

Legal Proceedings” in subsequent Quarterly Reports on Form 10-Q.

Ultimately, the outcome of such litigation could adversely affect the validity and scope of our patent or other proprietary rights or hinder our ability to manufacture and market our Products and our product candidates.

Periodically, we review publicly available information regarding the development efforts of others to determine whether these efforts may violate our proprietary rights.

We occasionally determine that litigation is necessary to enforce our proprietary rights against others.

Such litigation can result in substantial expense, regardless of its outcome, and may not be resolved in our favor.

Our business strategy may include acquisitions or dispositions of businesses, products or product licenses or entering into other strategic transactions.

We may not be able to successfully manage such activities.

We may engage in strategic transactions that could cause us to incur contingent liabilities, commitments or significant expense.

In the course of pursuing strategic opportunities, we may evaluate potential acquisitions, dispositions, licenses or investments in strategic technologies, products or businesses or enter into other strategic transactions.

Future acquisitions, dispositions, licenses, investments or other strategic transactions could subject us to a number of risks, including, but not limited to:

our inability to appropriately evaluate and take into consideration the potential uncertainties associated with the other party to such a transaction, including, but not limited to, the prospects of that party and their existing products or product candidates and regulatory approvals;

difficulties associated with realizing the perceived potential for commercial success with respect to any acquired or licensed technology, product or business or strategic transaction;

our ability to effectively integrate any new technology, product and/or business including personnel, intellectual property or business relationships into our Company;

our inability to generate revenues from acquired or licensed technology and/or products sufficient to meet our objectives in undertaking the acquisition or license or even to offset the costs associated with any strategic transaction and/or assumption of

the distraction of our management from our existing product development programs and initiatives in pursuing an acquisition, disposition, license or other strategic transaction.

As disclosed in the Company’s press release dated August 10, 2026, the Company is considering strategic alternatives as it continues to execute on its current business plan.

This process is ongoing with no set timetable and there can be no assurance that the process will result in the consummation of any transaction, or that any transaction that may be completed will be on terms favorable to our stockholders, or at all.

This strategic review process may also adversely affect our relationship with employees, customers, lenders, business partners and other stakeholders, our ability to retain and motivate personnel, or our ability to execute our operational initiatives.

The uncertainty of the outcome of the strategic review process, including the possibility that no transaction will be completed, may also contribute to increased volatility in the market price of our common stock.

Further, the availability, timing and valuation of any strategic alternative may be adversely affected by our operating performance, liquidity, litigation and regulatory exposure and other risks as described in this Quarterly Report on Form 10-Q and in our most recent Annual Report on Form 10‑K, any of which could limit perceived strategic options or reduce potential transaction value.

Moreover, in connection with any acquisition, disposition, license or strategic transaction, we must estimate the value of the transaction by making certain assumptions that may prove to be incorrect, which could cause us to fail to realize the anticipated benefits of a transaction.

Any strategic transaction we may pursue may not result in the benefits we initially anticipate, may result in costs that end up outweighing the benefits and may adversely impact our financial condition and be detrimental to our future business prospects.

Provisions contained in our debt instruments may have a negative impact on our business.

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In addition, our Working Capital Facility Agreement contains a minimum cash covenant, a minimum revenue covenant and a minimum EBITDA covenant.

On August 7, 2026, we entered into a Waiver, Consent, and Fourth Amendment to the Working Capital Facility Agreement (the “Fourth Amendment to the Working Capital Facility Agreement”) to the Initial Working Capital Facility Agreement, as amended by the First Amendment to the Working Capital Facility Agreement, the Second Amendment to the Working Capital Facility Agreement and the Third Amendment to the Working Capital Facility Agreement.

The Fourth Amendment to the Working Capital Facility Agreement, among other things waives the minimum revenue and minimum EBITDA financial covenants for the fiscal quarter ended June 30, 2026 and revises the minimum revenue covenant, the minimum EBITDA covenant and the minimum cash covenant effective as of the reporting period ending August 31, 2026.

Our ability to comply with these restrictions and covenants, including meeting any financial ratios and tests, may be affected by events beyond our control.

We are in compliance with all covenants as of the period covered by this Quarterly Report on Form 10-Q.

We cannot provide any assurances that we will be able to maintain compliance with such restrictions and covenants in the future.

We cannot provide any assurances that we will be able to maintain compliance with such restrictions and covenants in the future or that we will be able to obtain waivers or amendments of such covenants.

In the event of a default under the Working Capital Facility Agreement or any future debt agreement, our lenders could declare all outstanding principal, together with accrued and unpaid interest, to be immediately due and payable.

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As a company listed on the Nasdaq Capital Market, we must meet certain financial and liquidity criteria to maintain such listing.

If we violate Nasdaq’s maintenance requirements for the continued listing of our common stock, our common stock may be delisted.

For the 27 consecutive business days from March 10, 2026 through April 16, 2026, the closing bid price of our common stock did not meet the $1.00 per share minimum bid price required for continued listing on Nasdaq.

Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), a failure to meet the continued listing requirement for minimum price shall be determined to exist if the deficiency continues for a period of 30 consecutive business days.

Upon receipt of notice from Nasdaq of such failure, a registrant has an initial 180-calendar day compliance period to regain compliance, and if a registrant is unable to regain compliance during this initial period, such registrant may be eligible for an additional 180-day compliance period, subject to meeting other continued listing standards and providing written notice to Nasdaq of its intent to cure the deficiency.

A registrant regains compliance by having a closing bid price of at least $1.00 per share of common stock for a minimum of 10 consecutive business days, unless Nasdaq exercises its discretion to extend this 10-day period pursuant to Nasdaq Listing Rule 5810(c)(3)(H).

Although we are currently in compliance with all continued listing requirements through the period covered by this Quarterly Report on Form 10-Q, we cannot provide any assurances that we will continue to satisfy these requirements in the future.

If our common stock is delisted, it may result in reduced liquidity of our common stock, limited availability of market quotations for our common stock, limited news and analyst coverage of our common stock, and a decreased ability to issue additional securities or raise capital through financing sources on terms that are acceptable to us, or at all.

On June 25, 2026, we received a letter from Nasdaq, notifying us that, for the previous 30 consecutive business day period prior to the date of the letter, the closing bid price of our common stock was below $1.00 and that we did not meet the minimum bid price required for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2).

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have been provided an initial period of 180 calendar days, or until December 22, 2026, to regain compliance with Nasdaq’s bid price requirement.

If, at any time before December 22, 2026, the bid price for our common stock closes at $1.00 or more for a minimum of 10 consecutive business days, we will regain compliance with the bid price requirement.

If we are unable to regain compliance during this initial 180-calendar day compliance period, we may be eligible for an additional 180-calendar day

compliance period, subject to meeting other continued listing standards and providing written notice to Nasdaq of our intent to cure the deficiency.

While the Company intends to monitor the closing bid price of its common stock and is considering its options to regain compliance on or before December 22, 2026, there are no assurances that the Company will be able to regain compliance with the minimum bid price requirement or that it would continue to meet other requirements for continued listing on Nasdaq.

If we are unable to satisfy the Nasdaq criteria for continued listing, our common stock would be subject to delisting.

Any perception that we may not regain compliance or a delisting of our common stock could negatively impact us by, among other things, reducing the liquidity and market price of our common stock;

reducing the number of investors willing to hold or acquire our common stock, which could negatively impact our ability to raise equity financing;

decreasing the amount of news and analyst coverage of us;

and limiting our ability to issue additional securities or obtain additional financing in the future.

In addition, delisting from Nasdaq may negatively impact our reputation and, consequently, our business.

Present and future healthcare legislative and regulatory reimbursement reform measures may have a material adverse effect on our business and results of operations.

On October 31, 2025, the Centers for Medicare and Medicaid Services (“CMS”) issued its final rule for the 2026 calendar‑year Physician Fee Schedule (“BFSF Certification Final Rule”), which requires manufacturers to obtain certifications from their third‑party vendors confirming that Bona Fide Service Fees (“BFSFs”) associated with Part B drug sales are not passed through, in whole or in part, to any client or customer, regardless of whether that entity takes title to the drug.

Initially, manufacturers were required to comply with the BSFS Certification Final Rule beginning January 1, 2026, but the requirement for compliance was later delayed to April 1,2026.

In addition to submitting these certifications to CMS, manufacturers must maintain detailed documentation supporting the reasonable assumptions used to calculate Average Sales Price (“ASP”), including the methodologies used to classify BFSFs for each applicable contract.

These new requirements may increase the risk that certain fees could be reclassified as price concessions, which would negatively affect a product’s ASP.

Any such reclassification could reduce future reimbursement for our product(s) under Medicare Part B, which may materially and adversely impact our revenue.

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-Q

Item 4. Controls and Procedures