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AFTER HRS · 17:25 ET
Market ClerkRecap
Wed Oct 21 · after hours2 signals today106 insider buys this week · $305.5MCIRO short report next: Oct 31The week ahead

CDT

CDT Equity Inc.
NASDAQ · HEALTH CARE · PHARMACEUTICAL PREPARATIONS
0.14
−0.02 −11.38%
USD · close Oct 21

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How CDT rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025
Text kept
82%
of sentences unchanged
Added
33
new sentences
Dropped
67
sentences removed
Length
−943
words, now 18,597

New in FY2025

  • Our net losses were $39.2 million for the year ended December 31, 2025, and $17.8 million for the year ended December 31, 2024.
  • As of December 31, 2025, we had an accumulated deficit of $68.3 million.
  • As of December 31, 2025, our clinical assets are still in development and have not been approved by the FDA or any other regulatory body.
  • The preclinical, clinical and commercial success of our clinical assets will depend on a number of factors, including the following: ● the ability to raise additional capital to fund our current pre-clinical and clinical plans on acceptable terms, or at all; ● the timely completion of our clinical trials, which may be significantly slower or cost more than we currently anticipate and will depend substantially upon the performance of third-party contractors; ● the success that Manoira has in evaluating the CDT Assets’ applicability in animal health, explore veterinary market opportunities related to AZD1656; ● whether we are required by the FDA or similar foreign regulatory agencies to conduct additional preclinical or clinical trials beyond those planned to support the approval and commercialization of our clinical assets or any future clinical assets; ● the acceptance of our proposed indications and primary endpoint assessments relating to the proposed indications of our clinical assets by the FDA or similar foreign regulatory authorities; ● our ability to demonstrate the safety and efficacy of our clinical assets or any future clinical assets to the satisfaction of the FDA and similar foreign regulatory authorities; ● the prevalence, duration, and severity of potential side effects experienced in connection with our clinical assets or future approved products, if any; ● the timely receipt of necessary marketing approvals from the FDA and similar foreign regulatory authorities; ● achieving and maintaining, and, where applicable, ensuring that our third-party contractors achieve and maintain compliance with our contractual obligations and with all regulatory requirements applicable to our clinical assets or any future clinical assets or approved products, if any; ● the ability of third parties with whom we contract to manufacture clinical trial and commercial supplies of our clinical assets or any future clinical assets, remain in good standing with regulatory agencies, and develop, validate, and maintain commercially viable manufacturing processes that are compliant with cGMP; ● a continued acceptable safety profile during preclinical and clinical development and following approval of our clinical assets or any future clinical assets; ● our ability to successfully commercialize our clinical assets or any future clinical assets in the U.S. and internationally, if approved for marketing, sale, and distribution in such countries and territories, whether alone or in collaboration with others; ● the acceptance by physicians, patients, and payors of the benefits, safety, and efficacy of our clinical assets or any future clinical assets, if approved, including relative to alternative and competing treatments; ● our ability to comply with numerous post-approval regulatory requirements; ● our and our partners’ ability to establish and enforce intellectual property rights in and to our clinical assets or any future clinical assets; ● our and our partners’ ability to avoid third-party patent interference or intellectual property infringement claims; and ● our ability to in-license or acquire additional clinical assets or commercial-stage products that we believe can successfully develop and commercialize.
  • The report of our independent registered public accounting firm on the Company’s financial statements as of and for the year ended December 31, 2025, includes an explanatory paragraph indicating that there is substantial doubt about our ability to continue as a going concern for at least one year from the date of filing.
  • The Company has financed its working capital requirements since the Business Combination primarily through the PIPE Financing (the “PIPE Financing”) completed in September 2023, and through issuing of short-term and convertible notes, and via an at the market program with A.G.P./Alliance Global Partners.
  • Additionally, Manoira may not be successful in evaluating the CDT Assets’ applicability in animal health, explore veterinary market opportunities related to AZD1656, and as such we may never develop and commercialize such assets.
  • In connection with the preparation and audit of the financial statements as of and for the fiscal years ended December 31, 2025 and 2024, material weaknesses were identified in our internal control over financial reporting.
  • These material weaknesses primarily relate to the following matters that are relevant to the preparation of our financial statements: ● The segregation of duties is limited and heavily reliant on interim personnel and third-party consultants to perform these activities, including the lack of timely review and approval of travel and entertainment expenses. ● The Company lacks a formal process for review and approval of significant transactions and accounts on a contemporaneous basis and there have been numerous, recurring errors in account balances and disclosures. ● The Company has not designed adequate and appropriate and internal controls under an appropriate internal control over financial reporting framework. ● The Company did not appropriately review and evaluate the accounting implications of all material transactions that occurred during the period. ● The review controls around certain related party transactions did not operate consistently and the review of such transactions was not always contemporaneously documented.
  • With the exception of our work at our Cambridge facilities, we do not currently have, nor do we plan to acquire, the infrastructure or capability to supply, manufacture, or distribute preclinical, clinical, or commercial quantities of drug substances or products.
  • We may choose not to continue developing or commercializing any of our clinical assets at any time during development or after approval, which would reduce or eliminate our potential return on investment for those clinical assets.
  • We are highly dependent on our management, including our Chief Executive Officer, Andrew Regan.
  • We have registered the domain name for the website that we use in our business, which is www.cdtequity.com.
  • In November and December 2024, the Company received a letter from St George Street Capital and formal complaints filed with the Intellectual Property Office claiming the Company was assigned the US Application, and was not the sole owner, of the AZD 1656 co-crystal patent.
  • In January 2025, Conduit issued a counter statement to the Intellectual Property Office disputing the claim filed by St George Street Capital.
  • As of December 31, 2025, the damages sought by St George Street Capital are unknown and the potential contingency is not considered probable.
  • As such, the Company has not accrued a loss contingency in the accompanying financial statements.
  • Regardless of its outcome, the litigation may impact our business due to, among other things, legal costs and the diversion of the attention of our management.
  • Conduit Pharmaceuticals Limited rejected and disputed the substance of the letter in full.
  • Following such rejection, on September 7, 2023, Strand filed a claim in the Business and Property Courts of England and Wales claiming it is entitled to be paid the sum of $2 million and, as a result of the event the Business Combination is completed, to be issued 21 shares of common stock.
  • On December 16, 2025, the High Court of Justice, Business and Property Courts of England and Wales, ultimately ruled in favor of Strand, with a judgment amount payable from CPL to Strand totaling $9.6 million.
  • Under the terms of the Sarborg Agreement, Sarborg agreed to provide algorithmic and cybernetic technology services to CDT, including the development of decision-support tools and advanced cybernetic systems tailored to enhance CDT’s decision-making processes and maximize the value of its pharmaceutical asset portfolio.
  • Sarborg agreed to perform the services to CDT comprised of three phases: the Initial Phase (0-24 weeks) focuses on establishing a foundation for collaboration and aligning Sarborg’s services with CDT’s strategic goals; the Development Phase (24-36 weeks) involves building technological infrastructure, including dashboards and predictive models; and the Ongoing Services Phase (36-52 weeks) ensures the sustained functionality and relevance of Sarborg’s deliverables while supporting CDT’s growth through iterative improvements and updates.
  • To date, Sarborg has successfully completed all phases and has achieved all milestones provided for pursuant to the Sarborg Agreement.
  • For more information on our dealings with Sarborg, see “Business- Principal Strategic Partnerships Services Agreement – CDT and Sarborg Limited”.
  • As a result, capital appreciation, if any, of the shares of our common stock will be stockholders’ sole source of gain, if any, for the foreseeable future.
  • As of December 31, 2025, we had an accumulated deficit of $68.3 million and our net loss was $39.2 million for the fiscal year ended December 31, 2025.
  • Our future funding requirements will depend on many factors, including, but not limited to: ● the progress, timing, scope, and costs of our clinical trials, including the ability to timely enroll patients in our potential future clinical trials; ● the outcome, timing, and cost of regulatory approvals by the FDA and comparable regulatory authorities, including the potential that the FDA or comparable regulatory authorities may require that we perform more studies than those that we currently expect; ● the amount of revenues, if any, from our current clinical assets or any future clinical assets; ● the terms and timing of any potential future collaborations, licensing, or other arrangements that we may establish; ● cash requirements of any future acquisitions and/or the development of other clinical assets; ● the costs of operating as a public company; ● the time and cost necessary to respond to technological and market developments; ● any disputes which may occur between us, employees, collaborators, or other prospective business partners; and ● the costs of filing, prosecuting, defending, and enforcing any patent claims and other intellectual property rights On April 15, 2026, the last quoted sale price for our common stock as reported on Nasdaq was $4.88 per share.
  • Currently, the exercise prices of the Company’s Public Warrants are significantly greater than the current market price of our common stock.
  • Accordingly, such Public Warrants are unlikely to be exercised and therefore the Company does not expect to receive any proceeds from such exercise of the warrants in the near term.
  • Whether any holders of Public Warrants determine to exercise such Public Warrants, which would result in cash proceeds to the Company, will likely depend upon the market price of our common stock at the time of any such holder’s determination.
  • We may issue additional shares of common stock or preferred stock, including issuances upon exercise of outstanding pre-funded warrants, in connection with capital raising transactions and under an employee incentive plan or under our existing at the market offering program, which would dilute the interest of our stockholders.
  • We may issue a substantial number of additional shares of common or preferred stock pursuant to the exercise of previously issued pre-funded warrants, under an employee incentive plan or under our ongoing at the market offering program.

Gone since FY2024

  • Our net losses were $17.8 million for the year ended December 31, 2024 and $0.5 million for the year ended December 31, 2023.
  • As of December 31, 2024, we had an accumulated deficit of $29.1 million.
  • As of December 31, 2024, our clinical assets are still in development and have not been approved by the FDA or any other regulatory body.
  • The preclinical, clinical and commercial success of our clinical assets will depend on a number of factors, including the following: ● the ability to raise additional capital to fund our current pre-clinical and clinical plans on acceptable terms, or at all; ● the timely completion of our clinical trials, which may be significantly slower or cost more than we currently anticipate and will depend substantially upon the performance of third-party contractors; ● whether we are required by the FDA or similar foreign regulatory agencies to conduct additional preclinical or clinical trials beyond those planned to support the approval and commercialization of our clinical assets or any future clinical assets; ● the acceptance of our proposed indications and primary endpoint assessments relating to the proposed indications of our clinical assets by the FDA or similar foreign regulatory authorities; ● our ability to demonstrate the safety and efficacy of our clinical assets or any future clinical assets to the satisfaction of the FDA and similar foreign regulatory authorities; ● the prevalence, duration, and severity of potential side effects experienced in connection with our clinical assets or future approved products, if any; ● the timely receipt of necessary marketing approvals from the FDA and similar foreign regulatory authorities; ● achieving and maintaining, and, where applicable, ensuring that our third-party contractors achieve and maintain, compliance with our contractual obligations and with all regulatory requirements applicable to our clinical assets or any future clinical assets or approved products, if any; ● the ability of third parties with whom we contract to manufacture clinical trial and commercial supplies of our clinical assets or any future clinical assets, remain in good standing with regulatory agencies, and develop, validate, and maintain commercially viable manufacturing processes that are compliant with cGMP; ● a continued acceptable safety profile during preclinical and clinical development and following approval of our clinical assets or any future clinical assets; ● our ability to successfully commercialize our clinical assets or any future clinical assets in the U.S. and internationally, if approved for marketing, sale, and distribution in such countries and territories, whether alone or in collaboration with others; ● the acceptance by physicians, patients, and payors of the benefits, safety, and efficacy of our clinical assets or any future clinical assets, if approved, including relative to alternative and competing treatments; ● our ability to comply with numerous post-approval regulatory requirements; ● our and our partners’ ability to establish and enforce intellectual property rights in and to our clinical assets or any future clinical assets; ● our and our partners’ ability to avoid third-party patent interference or intellectual property infringement claims; and ● our ability to in-license or acquire additional clinical assets or commercial-stage products that we believe that we can successfully develop and commercialize.
  • The report of our independent registered public accounting firm on the Company’s financial statements as of and for the year ended December 31, 2024, includes an explanatory paragraph indicating that there is substantial doubt about our ability to continue as a going concern for at least one year from the date of filing.
  • The Company has financed its working capital requirements since the Business Combination primarily through the PIPE Financing (the “PIPE Financing”) completed in September 2023, and through issuing of short-term and convertible notes.
  • It is difficult to predict the time and cost of development and of subsequently obtaining regulatory approval for AZD1656 as it employs newly developed technology.
  • AZD1656 uses a novel mechanism to reduce inflammation in many of the immune pathways.
  • We have concentrated our research and development efforts of AZD1656 on a limited number of initial targeted disease indications for AZD1656.
  • There can be no assurance that we will not experience problems or delays in developing our current or future indications for AZD1656 and that such problems or delays will not cause unanticipated costs, or that any such development problems can be solved.
  • Moreover, AZD1656 would also represent a novel approach for the treatment of uveitis as steroids are currently the most common treatment for uveitis even though there are numerous side effects associated with the use of steroids.
  • The clinical development of these novel technologies will require review and allowance by the FDA under an Investigational New Drug Application.
  • In connection with the preparation and audit of the financial statements as of and for the fiscal years ended December 31, 2024 and 2023, material weaknesses were identified in our internal control over financial reporting.
  • These material weaknesses primarily relate to the following matters that are relevant to the preparation of our financial statements: ● We have limited segregation of duties.
  • For the periods under audit, the Company did not have any internal personnel in the financial accounting and reporting department, instead relied upon third party consultants to perform these activities. ● We lack a formal process for review and approval of financial statements.
  • For the periods under audit, especially prior to the business combination, numerous, recurring errors in account balances and disclosures were detected in the financial statements that resulted in a reasonable possibility that a material misstatement would not have been detected on a timely basis. ● We did not design adequate and appropriate internal controls, including monitoring controls, to review and evaluate the accounting implications of all material transactions that occurred in the audit period.
  • We do not currently have, nor do we plan to acquire, the infrastructure or capability to supply, manufacture, or distribute preclinical, clinical, or commercial quantities of drug substances or products.
  • We currently rely on agreements with third parties for the purpose of licensing our clinical assets.
  • In the near-term, we intend to rely on third parties for the licensing of clinical assets and those which may arise through future partnerships.
  • We currently rely on agreements with third parties for the purpose of licensing clinical assets from large pharmaceutical companies.
  • For example, we have agreements with AstraZeneca pursuant to which we license clinical assets from AstraZeneca.
  • If we are in breach of the agreements, the termination of such agreement(s) could materially adversely affect our business, financial condition, operating results, and prospects.
  • Our business strategy heavily depends on our ability to commercialize our clinical assets and our ability to enter into license agreements relating to such clinical assets is critical to the success of our operations We may choose not to continue developing or commercializing any of our clinical assets at any time during development or after approval, which would reduce or eliminate our potential return on investment for those clinical assets.
  • We are highly dependent on our management, including our Chief Executive Officer, David Tapolczay.
  • We have registered the domain name for the website that we use in our business, which is www.conduitpharma.com.
  • Conduit rejected and disputed the substance of the letter in full.
  • Following such rejection, on September 7, 2023, Strand filed a claim in the Business and Property Courts of England and Wales claiming it is entitled to be paid the sum of $2 million and, as a result of the event the Business Combination is completed, to be issued 65 thousand shares of common stock.
  • Regardless of its outcome, the litigation may impact our business due to, among other things, defense legal cost and the diversion of the attention of our management.
  • Under the terms of the Sarborg Agreement, Sarborg will provide algorithmic and cybernetic technology services to Conduit, including the development of decision-support tools and advanced cybernetic systems tailored to enhance Conduit’s decision-making processes and maximize the value of its pharmaceutical asset portfolio.
  • Sarborg will perform the services to Conduit comprised of three phases: the Initial Phase (0-24 weeks) focuses on establishing a foundation for collaboration and aligning Sarborg’s services with Conduit’s strategic goals; the Development Phase (24-36 weeks) involves building technological infrastructure, including dashboards and predictive models; and the Ongoing Services Phase (36-52 weeks) ensures the sustained functionality and relevance of Sarborg’s deliverables while supporting Conduit’s growth through iterative improvements and updates.
  • To date, Conduit has successfully completed the Initial Phase of its collaboration with Sarborg, establishing a strong foundation for integrating AI-driven solutions into our operations.
  • This phase focused on identifying key inputs for the algorithmic approach and ensuring alignment between Sarborg’s services and Conduit’s strategic goals.
  • As part of this effort, Sarborg has successfully delivered three key milestones.
  • First, they conducted detailed teach-in sessions with Conduit’s management team to gain a deeper understanding of our objectives, challenges, and operational workflows, resulting in documented meeting agendas, minutes, and action plans.
  • Second, they finalized and validated a set of proprietary inputs essential for their cybernetic models, tailored specifically to Conduit’s portfolio and R&D pipeline.
  • Finally, they completed an in-depth market analysis of potential cocrystal candidates, assessing the patent landscape, competitive positioning, and market size.
  • The insights from this market analysis are now informing Conduit’s ongoing strategic decision-making.
  • With these key milestones delivered, we are now progressing to the next phase of development.
  • Sarborg has now commenced Phase II: The Development Phase, which focuses on building the technological infrastructure necessary to integrate AI into Conduit’s operations.
  • As part of this, Sarborg has successfully completed the first milestone, Dashboard Creation and Refinement, delivering personalized dashboards that provide Conduit’s key personnel with real-time access to critical data related to deliverables, clinical trials, and drug discovery.

and 27 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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