What changed in this filing

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Item 1A. Risk Factors

2025-11-07 compared with 2025-08-07 · 97 added, 12 removed, 137 unchanged (44% of the section changed)

1 unchanged sentence

Other than the risks included below that have been amended and restated, there have been no material changes from the risk factors previously disclosed in our most recent Annual Report on Form 10-K as filed with the SEC on March 20, 2025.

Inadequate funding for the FDA, the SEC and other government agencies, including from government shutdowns, or other disruptions to these agencies’ operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

Currently, federal agencies in the U.S.

are operating under a continuing resolution that is set to expire on September 30, 2025.

Risks Related to the Contemplated Transactions with Clywedog

Our failure to complete the Contemplated Transactions would have a material adverse effect on our business, results of operations, financial condition and stock price.

Completion of the Contemplated Transactions is subject to the satisfaction of various conditions, including (i) the effectiveness of a registration statement to register the shares of Topco Common Stock to be issued in connection with the Combinations;

(ii) the absence of any law or order that enjoins, prevents, prohibits, or makes illegal the consummation of the Contemplated Transactions;

(iii) approvals by our shareholders of the Scheme Transaction and certain related matters, and sanction by the Court of the Scheme Transaction;

(iv) approval by Clywedog’s stockholders of the Merger Agreement, the Merger and Contemplated Transactions;

(v) the approval for listing by the Nasdaq Global Select Market (“Nasdaq”) of the shares of Topco Common Stock issuable in the Combinations;

(vi) certain consents, clearances and expirations or terminations of waiting periods under applicable antitrust laws;

(vii) the absence of a material adverse effect with respect to either party;

(viii) the completion of the Self-Tender Offer to the extent that Topco elects to commence the Self-Tender Offer;

(ix) minimum cash requirements for each party;

and (xi) subject to certain materiality and material adverse effect qualifiers, the accuracy of the representatives and warranties of the parties contained in the Merger Agreement and the compliance by each party with the covenants contained in the Merger Agreement.

As of the date of this report, the transaction is expected to close in the first half of 2026, subject to the satisfaction or waiver of these conditions.

There is no assurance that all of the various conditions will be satisfied or waived, or that the Contemplated Transactions will be completed on the proposed terms, within the expected timeframe, or at all.

The Contemplated Transactions may be delayed, and may ultimately not be completed, due to a number of factors, including the following:

• We may fail to obtain the approval of the Scheme Transaction by our shareholders.

Despite our board of directors having carefully and thoroughly considered a variety of strategic options and having determined that such strategic options either were unavailable to the Company, or would not provide value to shareholders greater than the value that would be provided in the Contemplated Transactions, we may be unable to secure the requisite approval of our shareholders.

• We may fail to obtain regulatory approvals from various governmental entities (or conditions, limitations or restrictions may be imposed on such approvals).

We cannot provide any assurance that we will not face regulatory hurdles, blocks or delays with respect to the Contemplated Transactions.

Material delays in obtaining any required approvals may result in the termination of the Contemplated Transactions, as either party may terminate the Contemplated Transactions if the Contemplated Transactions is not consummated by September 30, 2026, subject to certain extensions as further described in the Merger Agreement.

• Potential shareholder litigation and other legal and regulatory proceedings may delay or prevent the Contemplated Transactions.

• The parties may fail to satisfy one or more of the conditions to the completion of the Contemplated Transactions.

Additional risks if the Contemplated Transactions are not completed include:

• to the extent the current market price of our ADSs reflects an assumption that the Contemplated Transactions will be completed, the price of our ADSs could decrease;

• investor confidence could decline, stockholder litigation could be brought against us, relationships with existing and prospective customers, distributors, retailers, service providers, investors, lenders and other business partners may be adversely impacted, we may be unable to retain key personnel, and profitability may be adversely impacted due to costs incurred in connection with the Contemplated Transactions.

The failure to successfully integrate our business with that of Clywedog in the expected timeframe would adversely affect our future business and financial performance and the value of our stockholders’ investment following the Combinations.

The combination of two independent companies is a complex, costly and time-consuming process.

As a result, Topco will be required to devote significant management attention and resources to integrate our business practices and operations with those of Clywedog.

The integration process may disrupt the business of either or both of the companies and, if implemented ineffectively, could preclude realization of the full benefits expected by us and our shareholders from the Contemplated Transactions.

The failure of Topco to meet the challenges involved in successfully integrating our operations with those of Clywedog or otherwise to realize the anticipated benefits of the Contemplated Transactions could cause an interruption of the activities of Topco and could seriously harm its results of operations.

In addition, the overall integration of the two companies may result in material unanticipated problems, expenses, liabilities, competitive responses, loss of customer relationships and diversion of management’s attention, and may cause Topco’s stock price to decline.

The difficulties of combining our operations with those of Clywedog include, among others:

• managing a significantly larger company;

• coordinating geographically separate organizations, including extensive international operations;

• the potential diversion of management’s focus and resources from other strategic opportunities and from operational matters;

• performance shortfalls at one or both of the companies as a result of the diversion of management’s attention caused by completing the Combinations and integrating the companies’ operations;

• aligning and executing the strategy of the combined companies;

• retaining existing business relationships and executing new strategic or commercial relationships;

• maintaining employee morale and retaining key management and other employees;

• the disruption of, or the loss of momentum in, each company’s ongoing business or inconsistencies in standards, controls, systems, procedures and policies;

• integrating two unique business cultures, which may prove to be incompatible;

• the possibility of faulty assumptions underlying expectations regarding the integration process;

• consolidating corporate and administrative infrastructures and eliminating duplicative operations;

• integrating IT, communications and other systems;

• changes in applicable laws and regulations;

• managing tax costs or inefficiencies associated with integrating the operations of each company;

• unforeseen expenses or delays associated with the Contemplated Transactions;

• taking actions that may be required in connection with obtaining regulatory approvals.

Many of these factors will be outside of our control and any one of them could result in increased costs and diversion of management’s time and energy, which could materially impact our business, financial condition and results of operations as Topco.

In addition, even if our operations are integrated successfully with those of Clywedog, Topco may not realize the full benefits of the Contemplated Transactions, including the synergies, cost savings or growth opportunities that we and our shareholders expect.

These benefits may not be achieved within the anticipated timeframe, or at all.

As a result, we cannot assure our shareholders that the Contemplated Transactions will be completed successfully, that the integration will be accomplished within the expected timeframe, or that Topco will realize the full benefits anticipated from the Contemplated Transactions, any of which could adversely affect the value of our shareholders’ investment.

Our shareholders and Clywedog’s stockholders may not realize a benefit from the Contemplated Transactions commensurate with the ownership dilution they will experience in connection with the Contemplated Transactions.

If Topco is unable to realize the full strategic and financial benefits currently anticipated from the Contemplated Transactions, our shareholders and Clywedog’s stockholders will have experienced substantial dilution of their ownership interests without receiving any commensurate benefit, or only receiving part of the commensurate benefit to the extent

Topco is able to realize only part of the strategic and financial benefits currently anticipated from the Contemplated Transactions.

Our shareholders and Clywedog’s stockholders will generally have a reduced ownership and voting interest in, and will exercise less influence over the management of, Topco following the completion of the Contemplated Transactions as compared to their current ownership and voting interests in the respective companies.

After the completion of the Contemplated Transactions, the our current shareholders and the current stockholders of Clywedog will generally own a smaller percentage of Topco than their ownership of their respective companies prior to the Contemplated Transactions.

Immediately after the Contemplated Transactions, our shareholders as of immediately prior to the Scheme Transaction are expected to own approximately 34% of the outstanding shares of Topco and former Clywedog stockholders are expected to own approximately 66% of the outstanding shares of Topco.

During the period prior to the closing of the Contemplated Transactions, our business is exposed to certain inherent risks due to the effect of the announcement or pendency of the Contemplated Transactions on our business relationships, financial condition, operating results and business.

Inherent risks to our business during the period prior to the closing of the Contemplated Transactions that may adversely affect our business relationships, financial condition, operating results and business include:

• the possibility of disruption to our business and operations, including diversion of management attention and resources;

• the inability to attract and retain key personnel, and the possibility that our current employees could be distracted, and their productivity decline as a result, due to uncertainty regarding the Contemplated Transactions;

• the inability to pursue alternative business opportunities or make changes to our business pending the completion of the Contemplated Transactions, and other restrictions on our ability to conduct our business included in the Merger Agreement;

• our inability to solicit other acquisition proposals during the pendency of the Contemplated Transactions;

• the amount of the costs, fees, expenses and charges related to the Contemplated Transactions and the Contemplated Transactions;

• other developments beyond our control, including, but not limited to, changes in domestic or global economic conditions that may affect the timing or success of the Contemplated Transactions.

Litigation may arise in connection with the Contemplated Transactions, which could be costly, prevent consummation of the Contemplated Transactions, divert management’s attention and otherwise materially harm our business.

Regardless of the outcome of any future litigation related to the Contemplated Transactions, such litigation may be time-consuming and expensive and may distract our management from running the day-to-day operations of our business.

The litigation costs and diversion of management’s attention and resources to address the claims and counterclaims in any litigation related to the Contemplated Transactions may materially adversely affect our business, financial condition and operating results, including by decreasing our cash reserves for related expenses.

If the Contemplated Transactions are not consummated, for any reason, litigation could be filed in connection with the failure to consummate the Contemplated Transactions.

Any litigation related to the Contemplated Transactions may result in negative publicity or an unfavorable impression of our company, which could adversely affect the price of our common stock, impair our ability to recruit or retain employees, damage our relationships with our clients, or otherwise materially harm our operations and financial performance.

We are subject to restrictions on our business activities under the Merger Agreement.

While the Merger Agreement is in effect, we are generally required to conduct our business in the ordinary course consistent with past practice, and are restricted from taking certain actions without Clywedog’s prior consent, which is not to be unreasonably withheld, conditioned or delayed.

These limitations include, among other things, certain restrictions on our ability to amend our organizational documents, acquire other businesses and assets, dispose of our assets, make investments, repurchase, reclassify or issue securities, make loans, pay dividends, incur indebtedness, make capital expenditures, enter into, amend or terminate certain contracts, change accounting policies or procedures, initiate or settle certain litigation, change tax classifications and elections, or take certain actions relating to intellectual property.

Risks Related to Our Business and Industry and Risks Related to Clinical Development

Inadequate funding for the U.S.

Food and Drug Administration (the "FDA"), the SEC and other government agencies, including from government shutdowns, or other disruptions to these agencies’ operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business and timelines.

Without appropriation of additional funding to federal agencies, our business operations related to our product development activities for the U.S.

market could be impacted.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, shifting policy priorities as a result of changes in the Presidential administration and political appointees tasked to oversee the agency, and statutory, regulatory and policy changes.

Average review times at the agency have fluctuated in recent years as a result.

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Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

Currently, federal agencies in the United States are not operating due to expiration of a continuing resolution on September 30, 2025.

Disruptions at the FDA and other agencies may slow the time necessary for review and approval (including the Contemplated Transactions), which could adversely affect our business.

For example, over the last several years, the U.S.

government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have furloughed critical FDA, SEC and other government employees and stopped critical activities.

While the government has been shut down since October 1, 2025, it is uncertain how long such shutdown will last.

If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA and the SEC to timely review and process our submissions, which could have a material adverse effect on our business and timelines.

Congress, the Trump administration, or any new administration may make substantial changes to fiscal, tax, and other federal policies that may adversely affect our business.

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and significantly higher tariffs applicable to imports from many countries, which have resulted in other countries imposing additional tariffs on imports from the U.S., and is likely to continue to result in more retaliatory tariffs.

On April 9, 2025, the U.S.

announced a temporary pause on its tariffs applicable to many countries, while increasing the tariffs applicable to imports from China.

administration has threatened to continue to broadly impose tariffs, which could lead to corresponding punitive actions by the countries with which the U.S.

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government’s trade negotiations or the outcome of ongoing legal challenges to specific tariff policies.

For example, the United States has announced tariffs on many goods imported from specified nations, included China and those in the European Union.

In addition, there are currently

discussions concerning potential increased tariffs for pharmaceutical products, which may impact our supply chain and create uncertainty in the broader pharmaceutical industry.

Although we cannot predict the impact, if any, of these changes to our business, they could adversely affect our business.

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We believe that our place of central management and control is not in the United Kingdom (or the Channel Islands or the Isle of Man) for the purposes of the jurisdictional criteria of the Takeover Code.

Accordingly, we believe that we are not currently subject to the Takeover Code and, as a result, our shareholders are not currently entitled to the benefit of certain takeover offer protections provided under the Takeover Code, including the rules regarding mandatory takeover bids.

Accordingly, we believe that we are not

currently subject to the Takeover Code and, as a result, our shareholders are not currently entitled to the benefit of certain takeover offer protections provided under the Takeover Code, including the rules regarding mandatory takeover bids.

In the event that this changes, or if the interpretation and application of the Takeover Code by the Panel on Takeovers and Mergers, (the "Takeover Panel"), changes (including changes to the way in which the Takeover Panel assesses the application of the Takeover Code to English companies whose shares are listed outside of the United Kingdom), the Takeover Code may apply to us in the future.

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Further, if an offeror acquires for cash any interest in shares during the offer period, a cash alternative must be made available at not less than the highest price paid for any interest in the shares of that class;

• if, after making an offer for a company, the offeror or any person acting in concert with them acquires an interest in shares in an offeree company (i.e., a target) at a price higher than the value of the offer, the offer must be increased to not less than the highest price paid for the interest in shares so acquired;

• if, after making an offer for a company, the offeror or any person acting in concert with them acquires an interest in shares in an offeree company ( i.e.

, a target) at a price higher than the value of the offer, the offer must be increased to not less than the highest price paid for the interest in shares so acquired;

• an offeree company must appoint a competent independent adviser whose advice on the financial terms of the offer must be made known to all the shareholders, together with the opinion of the board of directors of the offeree company;

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Changes to tax laws (which changes may have retroactive application) could adversely affect us or holders of our ordinary shares or ADSs.

We are evaluating the elections available under OBBBA.

Based on our current assessment, we do not expect the changes to Section 174 under the OBBBA to have a material impact on our financial position or results of operations.

For example, under Section 174 of the Internal Revenue Code of 1986, as amended, or the IRC, in taxable years beginning after December 31, 2021, expenses that are incurred for research and development performed outside the U.S.

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Forward-looking statements contained in this Quarterly Report include, but are not limited to, statements about:

• the Proposed Combinations with Clywedog and expectations regarding the timing and benefits of, and our ability to consummate, the Proposed Combinations;

• the success, cost and timing of our product development activities and clinical trials;

• the timing, scope or likelihood of regulatory filings and approvals, including timing of Investigational New Drug Application (“IND”), New Drug Application (“NDA”), and Biologics License Application (“BLA”) filings for our current and future product candidates, and final U.S.

Food and Drug Administration (“FDA”), European Medicines Agency (“EMA”), United Kingdom Medicines and Healthcare products Regulatory Agency (“MHRA”), or other foreign regulatory authority approvals relating to our current and future product candidates;

• our future expectations, plans and prospects, including the estimates of costs that we expect to incur in connection with the restructuring and the timing thereof;

• the timing, scope or likelihood of regulatory filings and approvals, including timing of IND, New Drug Application, and Biologics License Application filings for our current and future product candidates, and final FDA, European Medicines Agency, United Kingdom Medicines and Healthcare products Regulatory Agency, or other foreign regulatory authority approvals relating to our current and future product candidates;

• our future expectations, plans and prospects, including the estimates of costs that we expect to incur in connection with any future restructuring and the timing thereof;

• our ability to develop and advance our current and future product candidates and programs into, and successfully complete, clinical trials;

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presidential administration, the conflict in Ukraine, the conflict in Iran, the conflict in Israel and Gaza, disruptions in the banking industry, economic sanctions and economic slowdowns or recessions that may result from such developments;

• our expectations regarding the period during which we qualify as an emerging growth company under the Jumpstart Our Business Startups Act of 2012, as amended (“JOBS Act”).

• our expectations regarding the period during which we qualify as an emerging growth company under the JOBS Act.

If our forward-looking statements prove to be inaccurate, the inaccuracy may be material.

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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 1A. Risk Factors