−Removed: September 22, 2023, a merger transaction (the “Business Combination”) between Conduit Pharmaceuticals Limited (“Old
−Removed: Conduit”), Murphy Canyon Acquisition Corp (“MURF”) and Conduit Merger Sub, Inc., a Cayman Islands exempted company
−Removed: and a wholly owned subsidiary of MURF (“Merger Sub”), was completed pursuant to the Agreement and Plan of Merger, dated November
−Removed: 8, 2022, as amended, (the “Merger Agreement”).
−Removed: Pursuant to the terms of the Merger Agreement, at the closing, (i) Merger
−Removed: Sub merged with and into Old Conduit, with Old Conduit surviving the Business Combination as a wholly-owned subsidiary of MURF, and (ii)
−Removed: MURF changed its name from Murphy Canyon Acquisition Corp.
−Removed: to Conduit Pharmaceuticals Inc.
−Removed: (“Conduit” or the “Company”).
−Removed: has developed a unique business model that allows it to act as a conduit to bring clinical assets from pharmaceutical companies and
−Removed: develop new treatments for patients.
−Removed: Our novel approach addresses unmet medical needs and lengthens the intellectual property for
−Removed: our existing assets through cutting-edge solid-form technology and then commercializing these products with life science companies.
−Removed: We continue to evaluate novel artificial intelligence (“AI”) and cybernetics approaches to drug re-purposing,
−Removed: intellectual property and asset selection to give Conduit a competitive advantage.
−Removed: are led by highly experienced pharmaceutical executives:
−Removed: Freda Lewis-Hall, former Chief Medical Officer of Pfizer Inc., the Chair
−Removed: of our Board of Directors, and Dr.
−Removed: David Tapolczay, former Chief Executive Officer of the United Kingdom-based medical research charity
−Removed: LifeArc, our Chief Executive Officer.
−Removed: Our management team includes active senior scientists who have an extensive understanding of the
−Removed: pharmaceuticals market, which supports our strategy of developing clinical assets in a cost-efficient manner while focusing on therapeutic
−Removed: efficacy and patient safety.
+Added: Equity Inc., formerly Conduit Pharmaceuticals Inc., a Delaware corporation (“CDT”, “CDT Equity” or the “Company”),
+Added: is a data-driven pharmaceutical development, focused on identifying, enhancing, and advancing
+Added: high-potential therapeutic assets through scientific innovation and strategic partnerships.
+Added: The Company has evolved into a broader, more
+Added: agile platform that leverages artificial intelligence, solid-form chemistry, and efficient asset repositioning to accelerate the development
+Added: of novel treatments.
+Added: Company’s strategy is centered on unlocking the untapped value of clinical-stage compounds, particularly those deprioritized by
+Added: larger pharmaceutical companies with strong, supporting Phase I safety data.
+Added: Through advanced co-crystallization and solid-form technologies
+Added: developed at our Cambridge facilities, the Company improves drug properties and extends patent life by up to 20 years.
+Added: In partnership
+Added: with Sarborg Limited (“Sarborg”), the Company also applies AI-powered signature analysis to rapidly identify new therapeutic
+Added: applications and combinations for existing compounds.
+Added: Company’s pipeline includes candidates that target autoimmune disorders, as well as idiopathic male infertility, oncology,
+Added: dermatology, rare disease and animal health.
+Added: Ongoing in vitro and in vivo studies, guided by AI insights, are designed to support
+Added: licensing and commercialization partnerships.
+Added: The Company will seek an exit through third-party license deals following successful
+Added: in vitro and in vivo pre-clinical trials, by entering into agreements with third-parties to pursue further development, FDA
+Added: approval, commercialization and marketing of the Company’s assets.
+Added: with a lean, asset-agnostic model, the Company prioritizes speed, adaptability, and capital efficiency.
+Added: We avoid the cost burden of
+Added: early and late-stage clinical trials, focusing instead on high-leverage development strategies.
+Added: current pipeline includes candidates targeting inflammatory and autoimmune disorders, as well as idiopathic male infertility, dermatology,
+Added: and animal health.
+Added: The intellectual property portfolio comprises pending patent applications in several international jurisdictions describing
+Added: a solid-form compound, including the AZD1656 Cocrystal (a HK-4 Glucokinase Activator).
+Added: Our pipeline research includes a number of compounds
+Added: that serve as promising alternatives to existing clinical assets currently marketed and sold by large pharmaceutical companies, which
+Added: we have identified as potential opportunities to develop further intellectual property positions through solid-form technology.
+Added: December 12, 2024, Sarborg and the Company entered into an agreement (the “Sarborg Agreement”) designed to address longstanding
+Added: challenges in the pharmaceutical sector, in particular by reducing human error in critical decision-making processes in both clinical
+Added: development and asset identification.
+Added: By integrating Sarborg’s signature intelligence technology, the Company aims to enhance
+Added: efficiency, lower costs, and accelerate timelines by minimizing human intervention, ultimately optimizing the drug development cycle
+Added: and giving the Company a competitive advantage in the sector.
+Added: Through this relationship, the Company will gain access to cutting-edge
+Added: predictive models and dashboards, enabling the Company to evaluate drug candidates, streamline clinical trials, and optimize asset management
+Added: with real-time data.
+Added: These tools will drive faster, more accurate decisions, improving efficiency and reducing costs.
+Added: By leveraging these
+Added: insights, the Company can differentiate itself in a competitive sector and gain unique data-driven insights that position the Company
+Added: for success across both its current and future asset portfolio.
+Added: Our collaboration with Sarborg enables us to apply proprietary algorithms
+Added: utilizing AI-powered disease mapping to identify novel re-purposing opportunities across a database of more than 3,000 disease signatures.
+Added: Sarborg’s insights have directly informed two new combination patent filings, strengthening our intellectual property portfolio.
+Added: In addition, the Company has initiated pre-clinical in-vitro models to explore new indications, guided by AI-insights without human intervention.
+Added: We will seek an exit through third-party license deals following successful in vitro and in vivo pre-clinical trials, entering into agreements
+Added: with third parties to pursue further development, FDA approval, commercialization, and marketing of our assets.
+Added: We continue to evaluate
+Added: novel artificial intelligence and cybernetics approaches to drug re-purposing, intellectual property, and asset selection to give the
+Added: Company a competitive advantage.
+Added: Sarborg is considered to be a related party of CDT, as Dr.
+Added: Andrew Regan, Chief Executive Officer
+Added: of CDT, also sits on the board of directors of Sarborg, and Chele Chiavacci Farley, a director of CDT is also a shareholder of
+Added: Refer to Note 16 and Note 20 to our financial statements included elsewhere in this Annual
+Added: Report for additional details on the relationship between CDT and Sarborg.
+Added: further partnership with Manoira Corporation (“Manoira”) (as described more in this Annual Report) enables the Company to
+Added: expand the scope of its drug portfolio into the animal health market in a cost-efficient manner.
+Added: This collaboration allows us to accelerate
+Added: the understanding of the mechanism of action, safety, and potential efficacy of its portfolio across multiple species, while retaining
+Added: 100% ownership of all data and intellectual property generated relating to human applications.
+Added: This is expected to enhance the core human
+Added: therapeutic pipeline but also opens potential new revenue streams in the high-growth veterinary market.
+Added: Repositioning
+Added: the Company enables us to explore multiple opportunities in the healthcare, biotech and broader technology innovation.
+Added: with a lean disease-agnostic model, the Company prioritizes speed, adaptability, and capital efficiency.
+Added: We avoid the cost burden of
+Added: late-stage clinical trials, focusing instead on high-leverage development strategies.
+Added: Led by highly experienced executives:
+Added: Freda Lewis-Hall, former Chief Medical Officer of Pfizer Inc., the Chair of the Company’s Board;
+Added: Andrew Regan, CEO and
+Added: James Bligh, CFO;
+Added: our management team includes active senior executives who also have an extensive understanding of the
+Added: pharmaceutical market, supporting our strategy of developing clinical assets in a cost-efficient manner focused on therapeutic
Simultaneously,
−Removed: Conduit leverages the capabilities of our Cambridge laboratory facility and highly experienced team of solid-form experts to extend or
−Removed: develop proprietary solid-form intellectual property for our existing and future clinical assets.
−Removed: Our own intellectual property portfolio
−Removed: comprises pending patent applications in several international jurisdictions describing a solid-form compound, including the AZD1656
−Removed: Cocrystal (a HK-4 Glucokinase Activator), targeting a wide range of autoimmune disorders.
−Removed: Our pipeline research includes a number of
−Removed: compounds that serve as promising alternatives to existing clinical assets currently marketed and sold by large pharmaceutical companies,
−Removed: which we have identified as having an opportunity to develop further intellectual property positions through solid-form technology.
−Removed: connection with the funding and development of clinical assets, we evaluate and select the specific molecules to be developed and collaborate
−Removed: with external CROs and Key Opinion Leaders (“KOLs”) to run clinical trials
−Removed: that are managed, funded, and overseen by us.
−Removed: We intend to leverage our comprehensive clinical and scientific expertise in order to facilitate
−Removed: development of clinical assets through Phase II trials in an efficient manner by using CROs and third-party service providers.
−Removed: also collaborate closely with disease specific KOLs to collectively assess and determine the most appropriate indications for all our
−Removed: current and forthcoming assets.
−Removed: believe that successful Phase II trials of the clinical assets in our pipeline will increase the value of our assets.
−Removed: There is no assurance
−Removed: that any clinical trials on the assets owned or licensed by us will be successful, however, following a successful Phase II clinical
−Removed: trial, we would look to licensing opportunities with large biotech or pharmaceutical companies, typically for up-front milestone payments
−Removed: and royalty income streams for the life of the asset patent.
−Removed: We anticipate using any future royalty income stream to develop our asset
−Removed: portfolio in combination with other potential sources of financing, including debt or equity financing.
−Removed: of our proprietary owned patented clinical assets, AstraZeneca agreed to grant a license to the Company under certain intellectual property
−Removed: rights controlled by AstraZeneca related to HK-4 Glucokinase activators AZD1656 and AZD5658 in all indications and myeloperoxidase inhibitor
−Removed: AZD5904 for the treatment, prevention, and prophylaxis of idiopathic male infertility.
−Removed: The Company will be responsible for the development
−Removed: and commercialization of the relevant products licensed under the related License Agreement (the “Licensed Products”).
−Removed: Company is required to use commercially reasonable efforts to develop and commercialize the Licensed Products.
−Removed: has conducted initial pre-clinical and, in some instances, clinical trials on these assets, but has decided to license them for further
−Removed: As the clinical assets have undergone initial pre-clinical and clinical testing conducted by AstraZeneca, we are able to
−Removed: use the safety data generated in these clinical trials to assess which clinical assets to further develop and for which indications.
−Removed: this relationship, there are considerable APIs that were manufactured by AstraZeneca
−Removed: (prior to conducting its clinical trials) available to Conduit.
−Removed: As a result, Conduit may not have to develop the APIs, which is often
−Removed: a time consuming and expensive process, and the APIs already produced were subject to rigorous quality control measures.
−Removed: collaboration with SARBORG Limited (“Sarborg”), Conduit intends to leverage an advanced
−Removed: artificial intelligence (AI) and cybernetics platform to evaluate key deliverables across multiple areas of the Company’s
−Removed: operations, including drug repurposing, drug discovery, solid-form identification, and clinical trial monitoring.
−Removed: Sarborg Agreement (defined and described below) is designed to address longstanding challenges in the pharmaceutical sector, in
−Removed: particular by reducing human error in critical decision-making processes in both clinical development and asset identification.
−Removed: integrating Sarborg’s algorithmic AI/cybernetics technology, Conduit aims to enhance efficiency, lower costs, and accelerate
−Removed: timelines by minimizing human intervention, ultimately optimizing the drug development cycle and giving Conduit a competitive
−Removed: advantage in the sector.
−Removed: this relationship, Conduit will gain access to cutting-edge predictive models and dashboards, enabling the Company to evaluate drug candidates,
−Removed: streamline clinical trials, and optimize asset management with real-time data.
−Removed: These tools will drive faster, more accurate decisions,
−Removed: improving efficiency and reducing costs.
−Removed: By leveraging these insights, Conduit to differentiate itself in a competitive sector and gain
−Removed: unique data-driven insights that position the Company for success across both its current and future asset portfolio.
−Removed: addition, Conduit will retain a perpetual, non-exclusive, royalty-free, and assignable right to use any platform or technology developed
−Removed: by Sarborg in association with the deliverables.
−Removed: Ongoing support from Sarborg will ensure these systems evolve with Conduit’s needs,
−Removed: driving long-term innovation in areas like IP creation, regulatory strategy, and clinical trial monitoring.
−Removed: This partnership reinforces
−Removed: Conduit’s commitment to leveraging AI-driven solutions to accelerate growth, deliver value to stockholders, and maintain a competitive
−Removed: edge in the pharmaceutical sector.
−Removed: Sarborg is considered to
−Removed: be a related party of conduit, as Dr.
−Removed: Andrew Regan, a stockholder of Conduit and member of Conduit’s board of directors,
−Removed: also sits on the board of directors of Sarborg.
−Removed: Refer to Note 16 to our financial statements included elsewhere in this Annual Report
−Removed: for additional details on the relationship between Conduit and Sarborg.
−Removed: strategic move reaffirms Conduit’s commitment to adopting forward-thinking solutions to stay at the forefront of innovation in
−Removed: the pharmaceutical industry.
−Removed: By reducing reliance on traditional, labor-intensive methods and harnessing the power of AI-driven technology,
−Removed: Conduit is well-positioned to lead in areas such as drug repurposing, clinical trial monitoring, and IP creation, ensuring the Company’s
−Removed: long-term growth and market leadership.
−Removed: Conduit believes that it is well positioned to pursue, and intends to pursue, additional relationships and/or partnerships with
−Removed: third parties for the licensing of further assets which are currently deprioritized.
−Removed: We plan to focus our efforts on developing
−Removed: clinical assets to address disorders that impact a large population where there is no present treatment or the present treatment,
−Removed: carries significant unwanted side effects.
+Added: CDT leverages the capabilities of our Cambridge laboratory facility and highly experienced team of solid-form experts to extend or develop
+Added: proprietary solid-form intellectual property for our existing and future clinical assets.
+Added: Our own intellectual property portfolio comprises
+Added: pending patent applications in several international jurisdictions describing a solid-form compound, including the AZD1656 Cocrystal
+Added: (a HK-4 Glucokinase Activator), targeting a wide range of autoimmune disorders.
+Added: Our pipeline research includes a number of compounds
+Added: that serve as promising alternatives to existing clinical assets currently marketed and sold by large pharmaceutical companies, which
+Added: we have identified as having an opportunity to develop further intellectual property positions through solid-form technology.
+Added: believe that successful pre-clinical trials of the assets in our pipeline
+Added: will increase the value of our assets.
+Added: There is no assurance that any pre-clinical trials on the assets owned or licensed by us will be
+Added: successful, however, following a successful pre-clinical trial, we would look to licensing opportunities with large biotech or pharmaceutical
+Added: companies, typically for up-front milestone payments and royalty income streams for the life of the asset patent.
+Added: We anticipate using
+Added: any future royalty income stream to develop our asset portfolio in combination with other potential sources of financing, including debt
+Added: or equity financing.
Initial Pipeline:
HK-4 Glucokinase Activator Cocrystal, AZD1656, and its metabolite AZD5658 and AZD5904
−Removed: wholly own the intellectual property and the rights to further develop the solid-form Cocrystals of AZD1656 (AZD1656 Cocrystal–
−Removed: pending international patent applications, which, if granted should expire no earlier than 2042) that we intend to target a wide range
−Removed: of autoimmune disorders.
−Removed: addition, we currently have the exclusive rights to develop clinical assets, AZD1656 and AZD5658 in all human indications and AZD5904
−Removed: in idiopathic male infertility which are licensed to us by AstraZeneca.
−Removed: of our proprietary owned patented clinical assets, AstraZeneca granted a license to the Company of certain intellectual property rights
−Removed: controlled by AstraZeneca related to HK-4 Glucokinase activators AZD1656 and AZD5658 in all indications and myeloperoxidase inhibitor
−Removed: AZD5904 for the treatment, prevention, and prophylaxis of idiopathic male infertility.
−Removed: The Company will be responsible for the development
−Removed: and commercialization of the Licensed Products.
+Added: August 2024, AstraZeneca granted a license to the Company under certain intellectual property rights controlled by AstraZeneca related
+Added: to HK-4 Glucokinase activators AZD1656 and AZD5658 in all indications and myeloperoxidase inhibitor AZD5904 for the treatment, prevention,
+Added: and prophylaxis of idiopathic male infertility.
+Added: The Company will be responsible for development and commercialization of the Licensed
+Added: Products under the related License Agreement.
The Company is required to use commercially reasonable efforts to develop and commercialize
the Licensed Products.
−Removed: to our relationship with AstraZeneca, we intend to leverage the data generated from these historical trials in order to investigate the
−Removed: efficacy and safety to AZD1656 to potentially treat Lupus and ANCA Vasculitis patients, and the efficacy and safety of AZD5904 to treat
−Removed: AZD1656 has undergone testing in a total of 20 Phase I clinical trials and five Phase II clinical trials conducted by AstraZeneca
−Removed: since 2008 and 19 of which were conducted in the U.S.
−Removed: Additional information about those clinical trials is available at the U.S.
−Removed: Library of Medicine’s website at www.clinicaltrials.gov (however, the information contained on or otherwise accessible through
−Removed: such website is not part of this annual report).
−Removed: AZD5904 has undergone testing in five Phase I clinical trials conducted by AstraZeneca,
−Removed: one of which was conducted in the U.S.
−Removed: While a significant amount of clinical trial data has already been generated for both AZD1656
−Removed: and AZD5904, some of this data was generated outside of the U.S.
−Removed: and accordingly may not be accepted by the FDA.
−Removed: In the event that such
−Removed: data is not accepted by the FDA, additional clinical trials may be required to commercialize these assets in the United States, which
−Removed: would result in additional costs and time to develop these clinical assets.
−Removed: underwent Phase I and Phase II clinical trials consisting of 23 studies in 526 subjects, 446 of whom were dosed with AZD1656.
−Removed: than for the intended effect of lowering glucose, there were no difference identified between the AZD1656-treated and
−Removed: placebo-treated subjects relating to adverse events.
+Added: has conducted initial pre-clinical and, in some instances, clinical trials on these assets, but has decided to license them for further
+Added: As the clinical assets have undergone initial pre-clinical and clinical testing conducted by AstraZeneca, we are able to
+Added: use the safety data generated in these clinical trials to assess which clinical assets to further develop and re-purpose.
+Added: June 3, 2025, the Company entered into a joint development agreement (the “Joint Development Agreement”) with Manoira for
+Added: a term of one year, which will be automatically renewed for successive one-year terms unless advance termination notice is provided in
+Added: accordance with the terms of the Joint Development Agreement.
+Added: Manoira is an entity controlled by Dr.
+Added: Andrew Regan, of which he is sole
+Added: director, and is therefore considered a related party of the Company.
+Added: to the Joint Development Agreement, the Company granted Manoira a non-exclusive, non-transferable, non-sublicensable, fully paid-up,
+Added: royalty-free license to the intellectual property rights related to the pharmaceutical compounds known individually and together as AZD1656
+Added: and AZD5658 (the “CDT Assets”).
+Added: Manoira will evaluate the CDT Assets’ applicability in animal health, explore
+Added: veterinary market opportunities, and provide data from the evaluations to inform the Company’s human clinical programs.
+Added: does not grant Manoira the right to distribute, market, promote or sell the products or services that are related to or incorporate the
+Added: addition, we currently have the exclusive rights to develop clinical assets, AZD1656 and AZD5658 in all human indications and AZD5904
+Added: in idiopathic male infertility which are licensed to us by AstraZeneca.
+Added: to the various programs, AZD1656 underwent Phase I and Phase II clinical trials consisting of 23 studies in 526 subjects, 446 of whom
+Added: were dosed with AZD1656.
+Added: Other than for the intended effect of lowering glucose, there were no difference identified between the AZD1656-treated
+Added: and placebo-treated subjects relating to adverse events.
All of the cases where low glucose levels were identified were managed by the
patients and resolved.
−Removed: Based on these clinical trials, no safety signals were identified regarding vital signs, safety laboratory
−Removed: values or electrocardiogram data.
+Added: Based on these clinical trials, no safety signals were identified regarding vital signs, safety laboratory values
+Added: or electrocardiogram data.
No deaths occurred in any studies with healthy volunteers or patients.
−Removed: AZD1656 was also subject to
−Removed: Phase II clinical trials consisting of two studies where AZD1656 was given to patients with Type 2 Diabetes Mellitus for four months
+Added: AZD1656 was also subject to Phase II
+Added: clinical trials consisting of two studies where AZD1656 was given to patients with Type 2 Diabetes Mellitus for four months or longer.
In total, there were 754 randomized patients, 516 of whom were exposed to AZD1656 (316 men and 200 women).
−Removed: There were no
−Removed: clinically important differences in the adverse effects profile between the AZD1656 treatment group and the AZD1656 placebo group
−Removed: and there were no deaths in either of the Phase II studies.
−Removed: The efficacy of AZD1656 as a potential treatment for diabetes was also
−Removed: assessed during the Phase II clinical trials, including whether the efficacy was statistically significant.
−Removed: Clinically relevant and
−Removed: statistically significant reductions in HbA1c were seen after four months;
−Removed: however, the initial improvement in glucose control
−Removed: deteriorated over time and the change in HbA1c levels after four months were not statistically different than the placebo.
−Removed: decreasing efficacy over time was seen in both Phase II studies.
+Added: There were no clinically important
+Added: differences in the adverse effects profile between the AZD1656 treatment group and the AZD1656 placebo group and there were no deaths
+Added: in either of the Phase II studies.
+Added: The efficacy of AZD1656 as a potential treatment for diabetes was also assessed during the Phase II
+Added: clinical trials, including whether the efficacy was statistically significant.
+Added: Clinically relevant and statistically significant reductions
+Added: in HbA1c were seen after four months;
+Added: however, the initial improvement in glucose control deteriorated over time and the change in HbA1c
+Added: levels after four months were not statistically different than the placebo.
+Added: This decreasing efficacy over time was seen in both Phase
was subject to a randomized, single-blind, placebo-controlled, single-center, Phase I study to assess the safety, tolerability, pharmacokinetics,
14 unchanged sentences
occurring adverse events were hypoglycemia and diarrhea, each occurring in three AZD5658-treated patients.
−Removed: One adverse event of ear
−Removed: pain (30 mg AZD5658 fed) was assessed by the study investigator as moderate in intensity;
+Added: One adverse event of ear pain
+Added: (30 mg AZD5658 fed) was assessed by the study investigator as moderate in intensity;
all other adverse events were of mild intensity.
22 unchanged sentences
II trials are necessary to determine if the inhibition of MPO activity as a result of AZD5904 is statistically significant.
−Removed: initial development plan is to conduct a Phase II clinical trial on AZD1656 in Lupus (including Lupus Nephritis) and ANCA Vasculitis
−Removed: Should we choose to develop AZD1656, AZD5658, or AZD5904, that development would be subject to the terms of the License Agreement,
−Removed: described in more detail below.
−Removed: We anticipate developing our Initial Pipeline (which has already undergone pre-clinical and clinical
−Removed: trials) through the Phase II stage and then monetizing such clinical assets through a license, royalty, or other transaction at this
−Removed: At this time, we do not expect that we will commercialize any clinical assets or seek marketing approval from the FDA (or similar
−Removed: organizations) as we intend to enter into agreements with third parties following Phase II clinical trials for each such clinical asset
−Removed: that would provide that such third party would pursue the further development, commercialization, and marketing of such assets.
−Removed: enable us to monetize our clinical assets, we, in partnership with CROs and KOLs, intend to conduct additional clinical trials on our
−Removed: clinical assets in order to generate clinical data to support the further development of our clinical assets beyond the Phase II stage.
−Removed: In the event successful clinical trial data is generated for a clinical asset with a particular indication, at that point, we will seek
−Removed: to enter into a license, royalty, or other transaction with a third party whereby the third party would continue to pursue the development
−Removed: of the clinical asset in Phase III clinical trials.
−Removed: There is no assurance that any clinical trials on the assets owned or licensed by
−Removed: us will be successful.
−Removed: intend to use the income received from licensing clinical assets in our pipeline to fund the development of additional clinical assets,
−Removed: which will allow us to use the existing income stream from clinical assets that have been licensed to fund our on-going operations, including
−Removed: the development and commercialization of additional clinical assets, without having to rely solely on debt and/or equity financing.
Development Strategy
−Removed: strategy is to generate value through the development of new medicines, or clinical assets, for patients where our research
−Removed: indicates that there are not effective pharmaceutical treatments available or such existing pharmaceutical treatments are not
−Removed: adequate due to, among other things, cost of such pharmaceuticals and side effects.
−Removed: We are working to develop new medicines in
−Removed: disorders where competitive treatments carry a high incidence of unacceptable side effects resulting in tolerability and compliance
−Removed: We aim to extend and develop solid-form intellectual property on assets which are licensed from pharmaceutical companies or
−Removed: generated within our facility in Cambridge, United Kingdom (the“UK”).
−Removed: We believe that our Cambridge facility positions us at the nexus of scientific
−Removed: advancement, providing an environment to drive cutting-edge research and development initiatives.
−Removed: is evidence that promising solid-form candidates can supersede original pharmaceutical products.
−Removed: We are currently in the process of developing
−Removed: new solid-form intellectual property on clinical assets which we believe will serve as promising alternatives for existing products on
−Removed: We believe that our expertise and utilization of solid-form technology can potentially enhance the efficacy, bioavailability,
−Removed: solubility and delivery of existing products on the market.
−Removed: Once a candidate has been identified and patented, we will fund and conduct
−Removed: clinical trials through CROs.
−Removed: previously indicated, our strategy also involves establishing strategic collaborations with globally recognized KOLs.
−Removed: We will collaborate
−Removed: closely with disease specific KOLs to collectively assess and determine the most appropriate indications for all our current and forthcoming
−Removed: This approach ensures that the selection of indications aligns with the KOLs’ insights, in addition to our internal expertise,
−Removed: optimizing the development and success of Conduit’s diverse portfolio.
−Removed: unique relationships allow us to bypass certain traditional hurdles for the development of clinical assets.
−Removed: Through our relationship
−Removed: with AstraZeneca, our Initial Pipeline has already undergone initial pre-clinical, and, in some instances, clinical testing conducted
−Removed: by AstraZeneca, which enables us to use the safety data generated in the prior trials in order to assess which assets to continue to
−Removed: We regularly assess our asset portfolio to identify potential risks and take steps to mitigate those risks, such as the repurposing
−Removed: of assets, which reduces development costs and timelines, as the clinical asset has already undergone safety and toxicity testing in
−Removed: humans, as well as extending the remaining patent life by up to 20 years on all assets which are licensed.
−Removed: prior preclinical and clinical studies conducted by AstraZeneca allow us to reduce the costs, expenses, and time in the development of
−Removed: these assets by allowing us to continue the Phase Ib or Phase II stage, rather than the preclinical or Phase I stage, even if we are
−Removed: investigating the assets for a new indication.
−Removed: For example, if a clinical asset was subject to a Phase I trial, such clinical asset may
−Removed: be advanced to a Phase II trial even if the clinical asset is being investigated for a different indication.
−Removed: In addition, we have access
−Removed: to API manufactured by AstraZeneca and as a result, should we use their formulation, we do not have to develop a route of manufacture
−Removed: for the API, which is time consuming and expensive.
+Added: Company’s strategy is centered on unlocking the untapped value of clinical-stage compounds, particularly those deprioritized by
+Added: larger pharmaceutical companies with strong, supporting Phase I safety data.
+Added: Through advanced co-crystallization and solid-form technologies
+Added: developed at our Cambridge facilities, the Company improves drug properties and extends patent life by up to 20 years.
+Added: In partnership
+Added: with Sarborg Limited, the Company also applies AI-powered disease mapping to rapidly identify new therapeutic applications for existing
+Added: enable us to monetize our clinical assets, we, in partnership with CROs
+Added: and KOLs, intend to conduct additional pre-clinical trials on our assets in order to generate clinical data to support the further development
+Added: of our assets beyond the Phase I stage.
+Added: In the event successful pre-clinical trial data is generated for an asset with a particular indication,
+Added: at that point, we will seek to enter into a license, royalty, or other transaction with a third party whereby the third party would continue
+Added: to pursue the development of the clinical asset in clinical trials, including Phase I, where necessary, and beyond.
+Added: There is no assurance
+Added: that any pre-clinical trials on the assets owned or licensed by us will be successful.
+Added: We intend to use the income received from licensing
+Added: assets in our pipeline to fund the development of additional assets, which will allow us to use the existing income stream from assets
+Added: that have been licensed to fund our on-going operations, including the development and commercialization of additional assets, without
+Added: having to rely solely on debt and/or equity financing.
Strategic Partnerships
−Removed: Agreement – Conduit and AstraZeneca
−Removed: August 7, 2024, the Company and AstraZeneca entered into the License Agreement.
−Removed: Pursuant to such License Agreement, AstraZeneca agreed
−Removed: to grant a license to the Company under certain intellectual property rights controlled by AstraZeneca related to HK-4 Glucokinase activators
−Removed: AZD1656 and AZD5658 in all indications and myeloperoxidase inhibitor AZD5904 for the treatment, prevention, and prophylaxis of idiopathic
−Removed: male infertility.
−Removed: The Company will be responsible for the development and commercialization of the Licensed Products under the
−Removed: related License Agreement.
−Removed: The Company is required to use commercially reasonable efforts to develop
−Removed: and commercialize the Licensed Products.
−Removed: consideration for the grant of the license, the Company (i) granted AstraZeneca common stock pursuant to the Issuance Agreement (as further
−Removed: set out below), (ii) paid AstraZeneca an up-front payment of $1.5 million, and (iii) is obligated to pay AstraZeneca a percentage (on
−Removed: a tiered basis) of any amounts it may receive in connection with a grant of a sublicense (subject to various customary exceptions).
−Removed: has been granted a right of first negotiation to develop, manufacture, and commercialize a Licensed Product if the Company receives an
−Removed: offer for, or solicits, a transaction where a third party would obtain the right to develop, manufacture, or commercialize a Licensed
−Removed: If AstraZeneca exercises such right, the parties would negotiate in good faith for an agreed period of time on an exclusive
−Removed: party may terminate the License Agreement for material breach (subject to a cure period) or insolvency of the other party.
−Removed: may terminate the License Agreement for convenience (in its entirety or on a Licensed Product-by-Licensed Product basis).
−Removed: AstraZeneca may terminate the License Agreement in certain circumstances, including (but not limited to) the Company ceasing development
−Removed: of all Licensed Products (subject to certain exceptions for normal pauses or gaps between clinical studies).
−Removed: addition, in connection with the execution of the License Agreement, the Company and AstraZeneca entered into the Issuance Agreement,
−Removed: whereby the Company issued AstraZeneca 95,044 shares of the Company’s Common Stock.
−Removed: The Issuance Agreement provides
−Removed: AstraZeneca with resale registration rights for such shares.
−Removed: Agreement – Conduit and Sarborg Limited
−Removed: December 12, 2024, the Company entered into a Services Agreement (the “Sarborg Agreement”) with Sarborg, a Cayman
−Removed: Islands company and related party of the Company.
−Removed: Under the terms of the Sarborg Agreement, Sarborg will provide algorithmic and cybernetic technology services to
−Removed: Conduit, including the development of decision-support tools and advanced cybernetic systems tailored to enhance Conduit’s
+Added: Agreement – CDT Equity and Sarborg Limited
+Added: December 12, 2024, the Company entered into a Services Agreement (the “Sarborg Agreement”) with Sarborg, a Cayman Islands
+Added: company and related party of the Company.
+Added: Under the terms of the Sarborg Agreement, Sarborg agreed to provide algorithmic and cybernetic technology
+Added: 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.
−Removed: will perform the services to Conduit comprised of three phases:
+Added: agreed to perform the services to CDT comprised of three phases:
the Initial Phase (0-24 weeks) focuses on establishing a foundation for
−Removed: collaboration and aligning Sarborg’s services with Conduit’s strategic goals;
+Added: collaboration and aligning Sarborg’s services with CDT’s strategic goals;
the Development Phase (24-36 weeks) involves
1 unchanged sentence
and the Ongoing Services Phase (36-52 weeks) ensures
−Removed: the sustained functionality and relevance of Sarborg’s deliverables while supporting Conduit’s growth through iterative improvements
+Added: the sustained functionality and relevance of Sarborg’s deliverables while supporting CDT’s growth through iterative improvements
Sarborg will create specific deliverables, including reports, computer programs, software applications, APIs, mobile applications,
3 unchanged sentences
in accordance with the Sarborg Agreement.
−Removed: date, Conduit has successfully completed the Initial Phase of its collaboration with Sarborg, establishing a strong foundation for integrating
−Removed: AI-driven solutions into our operations.
−Removed: This phase focused on identifying key inputs for the algorithmic approach and ensuring alignment
−Removed: between Sarborg’s services and Conduit’s strategic goals.
−Removed: As part of this effort, Sarborg has successfully delivered three
−Removed: key milestones.
−Removed: First, they conducted detailed teach-in sessions with Conduit’s management team to gain a deeper understanding
−Removed: of our objectives, challenges, and operational workflows, resulting in documented meeting agendas, minutes, and action plans.
−Removed: they finalized and validated a set of proprietary inputs essential for their cybernetic models, tailored specifically to Conduit’s
−Removed: portfolio and R&D pipeline.
−Removed: Finally, they completed an in-depth market analysis of potential cocrystal candidates, assessing the
−Removed: patent landscape, competitive positioning, and market size.
−Removed: The insights from this Annual Report are now informing Conduit’s ongoing
−Removed: strategic decision-making.
−Removed: With these key milestones delivered, we are now progressing to the next phase of development.
−Removed: has now commenced Phase II:
−Removed: The Development Phase, which focuses on building the technological infrastructure necessary to integrate
−Removed: AI into Conduit’s operations.
−Removed: As part of this, Sarborg has successfully completed the first milestone, Dashboard Creation and Refinement,
−Removed: delivering personalized dashboards that provide Conduit’s key personnel with real-time access to critical data related to deliverables,
−Removed: clinical trials, and drug discovery.
−Removed: These initial dashboards, along with user interface mock-ups and a dashboard user guide, will serve
−Removed: as the foundation for further refinements.
−Removed: Moving forward, the platform will continue to be optimized to maximize efficiency and ensure
−Removed: seamless integration into Conduit’s workflows.
−Removed: Service Agreement – Conduit and Charles River Laboratories
−Removed: February 7, 2025, Conduit and Charles River Laboratories (“Charles River”) entered into a Master Services Agreement (the
+Added: To date, Sarborg has successfully completed all phases and has achieved all milestones provided for pursuant to the
+Added: Sarborg Agreement.
+Added: During the year ended December 31, 2025, the Company
+Added: incurred costs under the Sarborg Service Agreement, including $1.8 million of milestone payments related to the Services Agreement and
+Added: $0.4 million of expense to be capitalized related to the delivery and ongoing use of a diagnostic dashboard.
+Added: Of the total costs incurred,
+Added: $0.4 million was capitalized as a diagnostic asset associated with the dashboard, of which $0.2 million was amortized during the year
+Added: and recorded within general and administrative expenses in the consolidated statement of operations and comprehensive loss.
+Added: The remaining
+Added: $2.2 million, consisting of milestone payments and related services (including signature mapping reports), was expensed as incurred within
+Added: research and development expenses.
+Added: As of December 31, 2025, there were no outstanding payables under the Sarborg Service Agreement.
+Added: Additional Agreement
+Added: Effective March 31, 2025, the Company entered
+Added: into an additional license and use agreement (the “Sarborg Additional Agreement”) with Sarborg, a related party, for analysis
+Added: of acquired AstraZeneca assets.
+Added: The agreement provides for $2.0 million in total consideration, payable in cash or stock.
+Added: 2025, the Company prepaid $1.65 million through the issuance of 617 shares of Common Stock, recorded at fair value of $2,670 per share.
+Added: The term was extended from six to 12 months on May 2, 2025 at no additional cost.
+Added: Effective October 1, 2025, the term was extended to
+Added: be 12 months from the previous extension to extend the term of the license to March 31, 2027 at no additional cost to the Company.
+Added: Company recorded the fair value of $1.5 million as prepaid within the consolidated balance sheets.
+Added: During the year ended December 31,
+Added: 2025, the Company recorded research and development expense of $1.3 million within the consolidated statements of operations and comprehensive
+Added: loss related to the Sarborg Additional Agreement.
+Added: As of December 31, 2025, $0.6 million of the prepaid balance remains within the consolidated
+Added: balance sheet.
+Added: Addendum to the SARBORG Additional Agreement
+Added: July 1, 2025 the Company entered into an Addendum (the “First Addendum”) to the Additional Agreement with Sarborg, to expand
+Added: the scope to include third-party pharma asset analysis for drug re-purposing using Sarborg’s machine learning platform.
+Added: of work was expected to be completed in four weeks, with options for renewal by mutual agreement.
+Added: The Company paid $0.3 million during
+Added: the year ended December 31, 2025 and included the total in the consolidated statement of operations and comprehensive loss.
+Added: Addendum to the SARBORG Additional Agreement
+Added: August 11, 2025 the Company entered into Addendum 2 (the “Second Addendum”) to the Additional Agreement with Sarborg to integrate
+Added: a Cryptocurrency AI Agent for identifying, forecasting, and recommending digital currencies into CDT Equity’s treasury operations.
+Added: The term is a minimum of four months, renewable by mutual agreement.
+Added: The Company paid $0.3 million during the year ended December 31,
+Added: 2025 and included the total in the consolidated statement of operations and comprehensive loss.
+Added: Agreement with NJS Foresight Bio-Advisory, LLC
+Added: January 2, 2026, the Company entered into a Consulting Agreement, dated December 29, 2025 (the “NJS Agreement”) with NJS
+Added: Foresight Bio Advisory, LLC (“NJS”) pursuant to which NJS agreed to provide advisory and business development services
+Added: to the Company focused on identification, introduction and support of potential licensing partners in connection with the
+Added: out-licensing of the Company’s asset portfolio.
+Added: Work under the NJS Agreement commenced on December 30, 2025.
+Added: On February 23,
+Added: 2026 (the “NJS Effective Date”), the Company and NJS entered into Addendum No.
+Added: 1 to the NJS Agreement (the “NJS
+Added: Addendum”) to extend the term of the NJS Agreement an additional twelve months from its initial termination date, December 29,
+Added: 2026, to December 29, 2027, unless terminated earlier in accordance with its terms.
+Added: As consideration for entering into the NJS
+Added: Addendum, on the NJS Effective Date, the Company paid an additional one-time fixed retainer of $150,000 (the “NJS Extension
+Added: Retainer”) in the form of 7,989 shares of Common Stock (the “NJS Shares”) issued to NJS, valued at $18.77 per share,
+Added: the closing price of the Common Stock on February 20, 2026, the trading day prior to the NJS Effective Date.
+Added: All other terms and
+Added: conditions contained in the NJS Agreement remain the same.
+Added: The Company recorded the $0.2 million consideration to NJS as a prepaid
+Added: expense on the Company’s consolidated balance sheet as of December 31, 2025.
+Added: Service Agreement – CDT and Charles River Laboratories
+Added: February 7, 2025, CDT and Charles River Laboratories (“Charles River”) entered into a Master Services Agreement (the
“Charles River MSA”).
−Removed: Under the Charles River MSA, Charles River agreed to provide preclinical testing and research
−Removed: services to Conduit, including the evaluation of compounds in animal models and other related services.
−Removed: The services are defined in
−Removed: individual Statements of Work (“SOWs”) or Protocols, which outline the specific scope, design, and timelines for each
−Removed: To date, one SOW, dated February 11, 2025, has been entered into.
−Removed: Charles River will conduct the studies in compliance with
−Removed: applicable laws and industry standards, and Conduit will provide necessary test articles and materials.
−Removed: The Charles River MSA
−Removed: includes provisions for confidentiality, intellectual property ownership, indemnification, and dispute resolution.
−Removed: The Charles River
−Removed: MSA has a term of five years and can be terminated by either party under specified conditions.
+Added: Under the Charles River MSA, Charles River agreed to provide preclinical testing and research services
+Added: to CDT, including the evaluation of compounds in animal models and other related services.
+Added: The services are defined in individual
+Added: Statements of Work (“SOWs”) or Protocols, which outline the specific scope, design, and timelines for each study.
+Added: To date, all services provided for pursuant to the Charle s River MSA have
+Added: been completed.
+Added: For the year ended December 31, 2025, the Company recognized $0.2 million in research and development expense in
+Added: the consolidated statement of operations and comprehensive loss related to the Charles River MSA.
+Added: Consulting Agreement
+Added: Effective March 25, 2025, the Company entered
+Added: into a Consulting Agreement (the “Consulting Agreement”) with Thesprogen PC (“Thesprogen”), an expert in advising
+Added: clients on strategies for pharmaceutical and biotech development.
+Added: Consulting fees were settled through the issuance of fully vested unregistered
+Added: Common Stock shares, valued at the fair value of the shares based on the closing share price of the shares at issuance.
+Added: The Company recorded
+Added: the transaction as prepaid and recognized research and development expense through amortization during the periods ended December 31,
+Added: On February 24, 2026 (the “Thesprogen Effective Date”), the Company and Thesprogen entered into Addendum No.
+Added: Thesprogen Agreement (the “Thesprogen Addendum”) to extend the term of the Thesprogen Agreement an additional twelve months
+Added: from its initial termination date, June 28, 2026, to June 28, 2027, unless terminated in accordance with its terms.
+Added: As consideration for
+Added: entering into the Thesprogen Addendum, on the Thesprogen Effective Date, the Company paid an additional one-time fixed retainer of $245,000
+Added: (the “Thesprogen Extension Retainer”) in the form of 13,668 shares of Common Stock (the “Thesprogen Shares”) issued
+Added: to Thesprogen, valued at $17.93 per share, the closing price of the Common Stock on February 23, 2026, the trading day prior to the Thesprogen
+Added: Effective Date.
+Added: All other terms and conditions contained in the Thesprogen Agreement remain the same.
+Added: During the year ended December 31,
+Added: 2025, the Company recorded research and development expense of $0.3 million within the consolidated statements of operations and comprehensive
+Added: loss related to the amortization of the prepaid expense.
+Added: Joint Development Agreement
+Added: June 3, 2025, the Company entered into the Joint Development Agreement with Manoira for a term of one year, which will be automatically
+Added: renewed for successive one-year terms unless advance termination notice is provided in accordance with the terms of the Joint Development
+Added: Manoira is an entity controlled by Dr.
+Added: Andrew Regan, of which he is sole director, and is therefore considered a related party
+Added: of the Company.
+Added: See Note 16 for additional details.
+Added: the agreement, the Company granted Manoira a non-exclusive, non-transferable, royalty-free license to intellectual property rights related
+Added: to pharmaceutical compounds AZD1656 and AZD5658.
+Added: Manoira will evaluate the compounds for animal health applications, explore veterinary
+Added: market opportunities, and provide data to inform the Company’s human clinical programs.
+Added: The license does not permit distribution,
+Added: marketing, promotion, or sale of related products.
+Added: Consideration was settled through the issuance
+Added: of Common Stock shares, valued at fair value based on the closing price of the shares.
+Added: The Company recorded the fair value of $0.4 million
+Added: as prepaid within the consolidated balance sheets.
+Added: During the year ended December 31, 2025, the Company recorded $0.1 million amortization
+Added: expense for research and development activities provided to date.
Biotechnology Industry
26 unchanged sentences
have reduced their drug reimbursements to control healthcare costs, such as implementing incentives for patients to use generic drugs.
−Removed: forward, revenue is forecast to grow an annualized 3.2% to $1.3 trillion over the next five years amid an anticipated persistence of
−Removed: global demand for industry products.
−Removed: Initial Pipeline:
−Removed: AZD1656, AZD5658 and AZD5904
−Removed: wholly own the intellectual property and the rights to further develop the solid-form Cocrystals of AZD1656 (AZD1656 Cocrystal–
−Removed: pending international patent applications if granted should expire no earlier than 2042) which we intend to target a wide range of autoimmune
−Removed: addition, we currently have the exclusive rights to develop clinical assets, AZD1656 and AZD5658 in all human indications and AZD5904
−Removed: in idiopathic male infertility which are licensed to us by AstraZeneca.
−Removed: of our proprietary owned patented clinical assets, AstraZeneca granted a license to the Company of certain intellectual property rights
−Removed: controlled by AstraZeneca related to HK-4 Glucokinase activators AZD1656 and AZD5658 in all indications and myeloperoxidase inhibitor
−Removed: AZD5904 for the treatment, prevention, and prophylaxis of idiopathic male infertility.
−Removed: The Company will be responsible for the development
−Removed: and commercialization of the Licensed Products.
−Removed: The Company is required to use commercially reasonable efforts to develop and commercialize
−Removed: the Licensed Products.
−Removed: to our relationship with AstraZeneca, we intend to leverage the data generated from these historical trials in order to investigate the
−Removed: efficacy and safety to AZD1656 to potentially treat Lupus and ANCA Vasculitis patients, and the efficacy and safety of AZD5904 to treat
−Removed: AZD1656 has undergone testing in a total of 20 Phase I clinical trials and five Phase II clinical trials conducted by AstraZeneca
−Removed: since 2008 and 19 of which were conducted in the U.S.
−Removed: Additional information about those clinical trials is available at the U.S.
−Removed: Library of Medicine’s website at www.clinicaltrials.gov (however, the information contained on or otherwise accessible through
−Removed: such website is not part of this annual report).
−Removed: AZD5904 has undergone testing in five Phase I clinical trials conducted by AstraZeneca,
−Removed: one of which was conducted in the U.S.
−Removed: While a significant amount of clinical trial data has already been generated for both AZD1656
−Removed: and AZD5904, some of this data was generated outside of the U.S.
−Removed: and accordingly may not be accepted by the FDA.
−Removed: In the event that such
−Removed: data is not accepted by the FDA, additional clinical trials may be required, which would result in additional costs and time to develop
−Removed: these clinical assets.
−Removed: Biotechnology Market Size to Worth Around USD 3.54 Trillion by 2033 .
−Removed: BioSpace.com.
−Removed: https://www.biospace.com/press-releases/biotechnology-market-size-to-worth-around-usd-3-54-trillion-by-2033
−Removed: IBISWorld Industry Report L6724-GL – Global Biotechnology, May 2021
−Removed: table below sets forth the pre-clinical or clinical trials that have been conducted by or at the direction of AstraZeneca to date on
−Removed: the particular clinical asset.
−Removed: All of these pre-clinical or clinical trials were conducted by AstraZeneca prior to Conduit entering into
−Removed: the License Agreement with AstraZeneca.
−Removed: None of the pre-clinical or clinical trials that have taken place to date were conducted by or
−Removed: at the direction of the Company.
−Removed: of Development
−Removed: Phase I and Phase II
−Removed: United States
−Removed: Transplant Patients with Type II Diabetes
−Removed: Phase I and Phase II
−Removed: Male Infertility
−Removed: United States
−Removed: following table sets forth the current asset development stage for each of AZD1656 and AZD5904 for the indications noted below.
−Removed: at Their Present Stage of Readiness (1)
−Removed: Stage of Development to be Conducted by Conduit
−Removed: Exit Stage for Monetization (3)
−Removed: & ANCA Vasculitis
−Removed: completion of Phase II
−Removed: Male Infertility
−Removed: completion of Phase II
−Removed: Autoimmune Disorders
−Removed: completion of Phase II
−Removed: that the asset is considered ready for this Phase.
−Removed: For example, if an asset is listed under Phase II, this means that the asset has
−Removed: already completed Phase I trials and is therefore considered Phase II ready.
−Removed: do not intend to provide additional funding to develop AZD1656 for Covid-19, which is principally owned by third parties.
−Removed: we are entitled to a portion of the revenues in the event that AZD1656 is further developed by a third party and is monetized, whether
−Removed: through a sale, license agreement, or otherwise.
−Removed: the stage at which we currently anticipate that we will seek to monetize such assets through a license, royalty, or other transaction
−Removed: with a third party, who would then seek to continue the development of such clinical asset until its potential commercialization
−Removed: after Phase III clinical trials were completed.
−Removed: There is no assurance that we will be able to monetize such assets by entering into
−Removed: a license, royalty, or other transaction with a third party.
−Removed: In addition, there is no assurance that any of the clinical assets licensed
−Removed: or owned by us will successfully complete Phase II or Phase III clinical trials or obtain regulatory approvals, or that such assets
−Removed: will be monetized or commercialized.
−Removed: was subject to Phase I and Phase II clinical trials consisting of 23 studies in 526 subjects, 446 of whom were dosed with AZD1656.
−Removed: Other than for the intended effect of lowering glucose, there were no difference identified between the AZD1656-treated and
−Removed: placebo-treated subjects relating to adverse events.
−Removed: All of the cases where low glucose levels were identified were managed by the
−Removed: patients and resolved.
−Removed: Based on these clinical trials, no safety signals were identified regarding vital signs, safety laboratory
−Removed: values or electrocardiogram data.
−Removed: No deaths occurred in any studies with healthy volunteers or patients.
−Removed: AZD1656 was also subject to
−Removed: Phase II clinical trials consisting of two studies where AZD1656 was given to patients with Type 2 Diabetes Mellitus for four months
−Removed: In total, there were 754 randomized patients, 516 of whom were exposed to AZD1656 (316 men and 200 women).
−Removed: There were no
−Removed: clinically important differences in the adverse effects profile between the AZD1656 treatment group and the AZD1656 placebo group
−Removed: and there were no deaths in either of the Phase II studies.
−Removed: The efficacy of AZD1656 as a potential treatment for diabetes was also
−Removed: assessed during the Phase II clinical trials, including whether the efficacy was statistically significant.
−Removed: Clinically relevant and
−Removed: statistically significant reductions in HbA1c were seen after four months;
−Removed: however, the initial improvement in glucose control
−Removed: deteriorated over time and the change in HbA1c levels after four months were not statistically different than the placebo.
−Removed: decreasing efficacy over time was seen in both Phase II studies.
−Removed: was subject to a randomized, single-blind, placebo-controlled, single-center, Phase I study to assess the safety, tolerability, pharmacokinetics,
−Removed: pharmacodynamics and the effect of fasting after single ascending oral doses of AZD5658 in Type 2 Diabetes Mellitus patients.
−Removed: six dose levels with eight patients in each cohort, six receiving AZD5658 and two receiving placebo.
−Removed: The effect of fasting on the pharmacokinetics
−Removed: of AZD5658 was also studied for two dose levels.
−Removed: Each patient treated with metformin received a maximum of two single oral suspension
−Removed: doses (one on a low dose of AZD5658/placebo and one on a high dose of AZD5658/placebo under fed conditions), except for patients participating
−Removed: in the evaluation of the effect of fasting, who received a maximum of three single oral suspension doses.
−Removed: For each patient the study
−Removed: included a pre-entry visit (Visit 1), two or three clinic-based treatment visits (Visit 2, 3, and 4) and a follow-up visit (Visit 5).
−Removed: Hence, the total duration of the study for each patient was approximately two and one-half months, assuming three weeks between dose
−Removed: There were no deaths, serious adverse events, discontinuations due to adverse events, or adverse events of severe intensity during
−Removed: Overall, there were 13 (61.9%) AZD5658-treated patients with adverse events compared to 2 (28.6%) patients who received placebo.
−Removed: There were no trends noted with increasing dose in the number of adverse events overall or within any preferred term.
−Removed: The most frequently
−Removed: occurring adverse events were hypoglycemia and diarrhea, each occurring in three AZD5658-treated patients.
−Removed: One adverse event of ear pain
−Removed: (30 mg AZD5658 fed) was assessed by the study investigator as moderate in intensity;
−Removed: all other adverse events were of mild intensity.
−Removed: Five adverse events in AZD5658- treated patients were assessed by the investigator as causally related to investigational product, including
−Removed: hypoglycemia in three patients (100 mg, 200 mg fasted, and 400 mg AZD5658), diarrhea in one patient (200 mg AZD5658 fasted), and headache
−Removed: in one patient (30 mg AZD5658).
−Removed: No adverse events in placebo-treated patients were assessed as causally related to investigational product.
−Removed: The three patients who experienced hypoglycemia adverse events were treated with intake of food or orange juice and the episodes resolved
−Removed: in less than one hour.
−Removed: was subject to five Phase I clinical studies, with a total of 1,181 subjects being exposed to AZD5904.
−Removed: Single doses of up to 1,200 mg and
−Removed: multiple doses of up to 325 mg for up to three times per day for 21 days have been administered as an oral solution in the completed
−Removed: clinical studies.
−Removed: In addition, single doses of up to 1,400 mg and multiple doses of up to 600 mg for 10 days have been administered as
−Removed: an “extended release” formulation.
−Removed: The data from these studies did not identify any expected adverse drug reactions for AZD5904
−Removed: and no adverse effects were reported as related to AZD5904.
−Removed: In addition, the data revealed no clinically significant changes in blood
−Removed: pressure or pulse rate related to AZD5904 and electrocardiogram data was within the physiological range for the population studied.
−Removed: effect of AZD5904 on human myeloperoxidase, which we refer to as MPO, activity was evaluated by determination in an ex vivo assay of
−Removed: MPO activity in plasma.
−Removed: The correlation between MPO activity and plasma concentrations was assessed for single and multiple doses of
−Removed: A relationship between plasma concentrations of AZD5904 and MPO activity was demonstrated, which indicates that AZD5904 may
−Removed: be an effective inhibitor of MPO activity in humans.
−Removed: However, Phase I trials do not assess statistical significance so additional Phase
−Removed: II trials are necessary to determine if the inhibition of MPO activity as a result of AZD5904 is statistically significant.
−Removed: in Autoimmune Disorders
−Removed: disorders refers to a broad group of disorders and conditions that arise from an abnormal immune response to a functioning body part.
−Removed: For example, autoimmune disorders may arise from an abnormal immune response of major organs (i.e., the heart, kidneys, bladder, liver,
−Removed: lungs, and skin), glands (i.e., the adrenal gland, pancreas, thyroid, or reproductive organs), digestive system, and tissue (i.e., blood,
−Removed: connective tissue, muscle, eyes, ears, or vascular system).
−Removed: Management believes that there are over 80 types of autoimmune disorders
−Removed: that have been identified, including lupus, celiac disease, multiple sclerosis, rheumatoid arthritis, psoriasis, and inflammatory bowel
−Removed: Autoimmune disorders are often difficult to diagnose and often the cause of the disorders is not known.
−Removed: is estimated by the American Autoimmune Related Diseases Association (“AARDA”) that as many as 50 million Americans are living
−Removed: with an autoimmune disease – at a cost of $86 billion a year and there is presently no totally effective treatment known to management.
−Removed: The currently available treatments for autoimmune disorders include non-steroidal anti-inflammatory drugs (“NSAIDS”) or immune
−Removed: suppressants.
−Removed: These treatments often improve the symptoms but ultimately do not cure the disease and often involve side effects.
−Removed: is a highly specific glucokinase activator;
−Removed: originally developed by AstraZeneca for use in diabetes mellitus.
−Removed: It has now been tested
−Removed: in over 1,000 patients with both type I and II diabetes and no significant safety concerns have been raised.
−Removed: It was most recently tested
−Removed: in the ARCADIA Phase II trial in diabetic patients hospitalized with Covid-19 on the basis of new research into immunometabolic modulation.
−Removed: We believe that AZD1656 may be used to activate a patient’s own immune system in order to limit harmful inflation.
−Removed: We have identified
−Removed: several autoimmune disorders, which reflects good market potential, with a high level of need that may be treatable using AZD1656.
−Removed: believe that our clinical assets have the potential to treat numerous autoimmune disorders.
−Removed: We intend to initially focus on the indications
−Removed: below in order to maximize the commercial potential of our clinical assets.
−Removed: Nephritis (“LN”) is a severe progression of Systemic Lupus Erythematosus (“SLE”) where the immune system attacks
−Removed: the kidneys, often resulting in renal failure.
−Removed: There is currently no cure or long-term remission treatment available.
−Removed: LN is clinically
−Removed: evident in 50-60% of patients with SLE, and is histologically evident in most SLE patients, even those without clinical manifestations
−Removed: of kidney disease.
−Removed: LN is the main cause of SLE related mortality.
−Removed: Current therapy is based on long-term corticosteroid or immunosuppressive
−Removed: therapy, with clinical efficacy of biological drugs not yet proven in LN.
−Removed: Side effect issues of all current therapies demonstrate an
−Removed: unmet need for a safer, patient compliant therapy in LN.
−Removed: Company believes that LN presents a lucrative opportunity given the potential oversight of two conditions, as a Phase IIa trial can be
−Removed: designed to allow readouts on the wider characteristics of SLE as well as the nephritis aspects, allowing assessment of the potential
−Removed: of AZD1656 in the field of SLE as a whole.
−Removed: Additionally, LN is an orphan disease that the Company believes has around 80,000 to 100,000
−Removed: patients in the U.S., and one million patients worldwide, thereby offering additional incentives for investors.
−Removed: Company believes the global LN market was valued at $3.3 billion in 2022 and is projected to grow from $3.6 billion in 2023 to $6.78
−Removed: billion by 2032, exhibiting a CAGR of 10.3% during the forecast period.
−Removed: is characterized by dysregulation and a hyperactivity of immune response.
−Removed: In LN, Teff subtype (TH17) has shown significant hyperactivation
−Removed: leading to skewed T cell differentiation resulting in continued proinflammatory environment, leading to prolonged inflammation and subsequent
−Removed: tissue damage and organ function loss.
−Removed: TH17/Treg dysregulation has been characterized in lupus patients compared to healthy individuals.
−Removed: a study in mice, findings showed that the IL2/CD25 fusion protein that selectively targets IL-2 on Treg cells induced immune suppression
−Removed: in a preclinical LN model demonstrating inhibition of LN based on levels of proteinuria, autoantibody titers and kidney histology scores.
−Removed: Vasculitis (“AAV”) is an orphan status autoimmune disease affecting small blood vessels which can lead to multiple organ
−Removed: injury, especially the kidneys, lungs and peripheral nerves.
−Removed: Undiagnosed AAV has a 90% mortality rate within two years.
−Removed: maintenance therapies rely on combination of corticosteroid and rituximab, both known for long term use side effects.
−Removed: Recently approved
−Removed: drugs target specific subpopulations of AAV and have tolerability and side effect issues which demonstrate an unmet need for safer long-term
−Removed: therapies applicable to all AAV sufferers.
−Removed: imbalance of Th17/activated Treg cells has been shown in AAV and this has been correlated with renal involvement (with a positive correlation
−Removed: in creatinine and BUN levels).
−Removed: dose IL2 therapy in AAV patients, the Company believes, resulted in rebalance of Th17/Treg ration.
−Removed: The levels of Erythrocyte Sedimentation
−Removed: Rate (ESR) and C-Reactive Protein (CSR) were also significantly decreased, which the Company believes indicates an improvement in disease
−Removed: Company believes the seven major AAV markets reached a value of $339.0 million in 2023 and is expected to reach $534.3 million by 2034,
−Removed: exhibiting a CAGR of 4.22% during 2024 to 2034.
−Removed: Paquissi FC et al.
−Removed: Front Med (Lausanne).
−Removed: 654912 ( https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8446428/ )
−Removed: 19-29 (https://pubmed.ncbi.nlm.nih.gov/34108258/)
−Removed: Hunter et al.
−Removed: 2020;369 (https://www.bmj.com/content/369/bmj.m1070)
−Removed: 19-29 (https://pubmed.ncbi.nlm.nih.gov/34108258/)
−Removed: was previously subject to preclinical and clinical trials, including Phase I and Phase II trials, conducted by AstraZeneca relating to
−Removed: its potential to treat type 2 diabetes.
−Removed: As of the date hereof, no preclinical or clinical trials have been conducted on the use of AZD1656
−Removed: to treat autoimmune disorders.
−Removed: intend to conduct further trials on AZD1656 relating to autoimmune disorders.
−Removed: We plan to conduct further research on AZD1656 to investigate
−Removed: if AZD1656 is a treatment option, including investigating any negative side effects in the use of AZD1656 as compared to the currently
−Removed: available treatment options.
−Removed: in Idiopathic Male Infertility
−Removed: Male Infertility (“IMI”) is defined as failure of a couple to conceive after one year of regular sexual intercourse where
−Removed: the physical examination and endocrine laboratory testing of the male are normal, but semen analysis reveals sperm abnormalities.
−Removed: Approximately
−Removed: 15% of couples globally, or 48.5 million couples globally, are infertile and that 30% of infertility cases can be attributed solely to
−Removed: the female, 30% can be attributed solely to the male, 30% can be attributed to a combination of both partners, and 10% of cases have
−Removed: an unknown cause.
−Removed: 5 According to the National Library of Medicine, male infertility accounts for 30% of infertility cases
−Removed: and its prevalence in the general population approximately ranges between 9 to 15%.
−Removed: 6 Our management believes that male
−Removed: sperm counts have declined in Western men and will continue to decline due, in part, to increasing rates of disorders such as obesity
−Removed: and diabetes that can reduce fertility.
−Removed: affects families worldwide and is inherent in problems of reproduction.
−Removed: Currently, there are no specific treatments for male infertility,
−Removed: and we are not aware of any other company that is developing a treatment for male infertility.
−Removed: There are no approved pharmacotherapies
−Removed: for idiopathic male infertility.
−Removed: Lifestyle medicine and unproven supplements are often used.
−Removed: Intracytoplasmic sperm injection, a form
−Removed: of in vitro fertilization, is the only treatment currently available for male infertility.
−Removed: This process is not a treatment of male infertility
−Removed: but rather is an alternative means of fertilizing the egg.
−Removed: In vitro fertilization places a significant burden on the woman as it requires
−Removed: the induction of egg production and harvesting of eggs.
−Removed: In vitro fertilization is costly and time consuming and has modest success rates.
−Removed: Management believes that the male infertility market size is expected to grow from $3.72 billion in 2023 to $4.42 billion by 2028, at
−Removed: a CAGR of 3.54% during the period 2023-2028.
−Removed: sperm are unable to successfully fertilize eggs due to factors including impaired motility, impaired ability to penetrate and/or DNA
−Removed: damaged sperm that is unable to form a viable fetus.
−Removed: Our development pipeline for AZD5904 includes a potent, irreversible inhibitor of
−Removed: human myeloperoxidase, which we refer to as MPO, that has the potential to treat idiopathic male infertility.
−Removed: was investigated by AstraZeneca for the treatment of idiopathic male infertility in Phase I trials, which confirmed the suitability to
−Removed: progress to Phase II trials.
−Removed: While AZD5904 is Phase II ready, our management intends to conduct a Phase Ib “proof of mechanism”
−Removed: trial to verify AZD5904 has the intended biological effect in semen (as well as in blood) prior to commencing a Phase II trial for the
−Removed: use of AZD5904 to treat idiopathic male infertility.
−Removed: Specifically, our management intends to conduct the Phase Ib study in order to see
−Removed: if the trial will provide evidence that AZD5904 has its intended effect of inhibiting myeloperoxidase and reduce oxidative stress in
−Removed: We believe that AZD5904 has the potential to be used to create a tablet that could treat IMI and would be the first drug developed
−Removed: to directly treat IMI.
−Removed: We, in connection with a CRO, have prepared clinical trial protocols relating to the use of AZD5904 to treat IMI
−Removed: in a Phase Ib clinical trial:
−Removed: a Phase Ib, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety,
−Removed: tolerability and preliminary efficacy of AZD5904 in adult men with IMI with an anticipated enrollment of 60 patients, and a Phase II
−Removed: clinical trial:
−Removed: a Phase II, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of AZD5904
−Removed: in the treatment of IMI with an anticipated enrollment of 200 patients.
−Removed: There can be no assurances that the clinical trials that we intend
−Removed: to conduct on AZD5904 to treat idiopathic male infertility will be successful.
−Removed: Clinical Assets
−Removed: part of our strategic planning process, we intend to explore the efficacy of using AZD1656 and AZD5658 to treat other disorders.
−Removed: Specifically, we intend to conduct research on whether AZD1656 and AZD5658 may be effective treating other autoimmune disorders,
−Removed: include rheumatoid arthritis, multiple sclerosis, motor neuron disease, and amyotrophic lateral sclerosis.
−Removed: As part of our strategic
−Removed: planning process, we intend to explore the efficacy of using AZD1656 to treat other disorders.
−Removed: We also plan to further develop the
−Removed: co-crystals that we own from our prior development work on AZD1656, including to research the ability of the co-crystals developed
−Removed: from AZD1656 to treat psoriasis, Crohn’s disease, lupus, sarcoidosis, diabetic wound healing, idiopathic pulmonary fibrosis,
−Removed: and non-alcoholic steatohepatitis.
−Removed: In addition, we currently intend to explore the use of AZD5904 for the treatment of glioma.
−Removed: expect to seek to develop other clinical assets and determine based on pre-clinical and clinical data which clinical assets in order
−Removed: to determine which assets in our pipeline to continue to develop.
−Removed: Accordingly, we believe that our management team will be able to
−Removed: effectively allocate resources to the development of clinical assets that we believe show the most promise.
−Removed: However, there can be no
−Removed: guarantee that the clinical trials conducted by us of our clinical assets will be successful.
−Removed: If we are unable to commercialize our
−Removed: clinical assets or experience significant delays in doing so, our business will be materially harmed.
+Added: Industry revenue has expanded at a compound annual
+Added: growth rate of approximately 5.4% over the past five years to $857.1 billion, with continued growth of approximately 3.4% expected in
+Added: 2025, supported by sustained global demand for biotechnology products.
+Added: However, growth remains dependent on clinical success, regulatory
+Added: approvals, manufacturing execution and access to capital, as companies increasingly prioritize capital efficiency, differentiated pipelines
+Added: and strategic partnerships in a more selective funding environment.
+Added: Biotechnology Market Size, Share, and Trends 2026 to 2035.
+Added: Precedenceresearch.com
+Added: https://www.precedenceresearch.com/biotechnology-market.
+Added: IBISWorld Industry Report L6724-GL – Global Biotechnology, January 2026
Manufacturing
−Removed: do not currently own or operate any facilities to formulate, manufacture, test, store, package, or distribute any of the clinical assets
−Removed: that we are developing or may seek to develop and do not currently have the capabilities to conduct such activities.
−Removed: We currently rely
−Removed: on third parties to manufacture, store, and test the clinical assets that we seek to develop, including material manufactured originally
−Removed: by AstraZeneca.
−Removed: We will depend on third-party suppliers and manufacturing organizations for all our required raw materials and drug substance
−Removed: and to formulate, manufacture, test, store, package, and distribute clinical trial quantities of clinical assets that we may seek to
−Removed: We plan to continue to use third-party suppliers and manufacturing organizations and we anticipate expanding our network of
−Removed: third-party suppliers and manufacturing organizations as our operations expand.
−Removed: “A unique view on male infertility around the globe,” by Ashok Agarwal, Aditi Mulgund, Alaa Hamada, and Michelle Renee
−Removed: Chyatte (Link:
−Removed: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4424520/).
−Removed: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10057583/#B1-jcm-12-02366
+Added: Company has a lease agreement for approximately 2,100 square feet of space in Cambridge, England, with a term from March 2024 to January
+Added: At the Cambridge facility aforementioned, we are developing advanced co-crystallization and solid-form technologies.
+Added: otherwise do not currently own or operate any facilities to formulate, manufacture, test, store, package, or distribute any of the clinical
+Added: assets that we are developing or may seek to develop and do not currently have the capabilities to conduct such activities.
+Added: rely on third parties to manufacture, store, and test the clinical assets that we seek to develop.
+Added: We will depend on third-party suppliers
+Added: and manufacturing organizations for all our required raw materials and drug substance and to formulate, manufacture, test, store, package,
+Added: and distribute clinical trial quantities of clinical assets that we may seek to develop.
+Added: We plan to continue to use third-party suppliers
+Added: and manufacturing organizations and we anticipate expanding our network of third-party suppliers and manufacturing organizations as our
+Added: operations expand.
have internal personnel and utilize consultants with extensive technical, manufacturing, analytical, and quality experience to oversee
5 unchanged sentences
and Development
−Removed: research and development activities have included developing co-crystals of AZD1656 to increase patent life.
+Added: research and development activities have included developing co-crystals of AZD1656, and other products, to increase patent life.
Most of this work is conducted
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property and the rights to further develop co-crystals resulting from our prior research and development work on AZD1656.
−Removed: On December 18, 2024, Conduit UK Management Limited (“Conduit”) received a notification from the UK Intellectual
−Removed: Property Office (“UK IPO”) notifying the company that St George Street Capital had initiated patent entitlement proceedings
−Removed: with respect to patent application PCT/IB2022/00775 (“Patent Application”).
−Removed: Conduit refutes the claims made by St George Street
−Removed: Capital and filed a counterstatement on February 26, 2025 with the UK IPO.
−Removed: In addition, each of the three inventors named in the Patent
−Removed: Application filed simultaneous counterstatements fully supporting Conduit’s position, and assertions that the claims are without
+Added: December 18, 2024, Conduit UK Management Limited (“Conduit UK”) received a notification from the UK Intellectual Property
+Added: Office (“UK IPO”) notifying the company that St George Street Capital had initiated patent entitlement proceedings with
+Added: respect to patent application PCT/IB2022/00775 (“Patent Application”).
+Added: Conduit UK refutes the claims made by St George
+Added: Street Capital and filed a counterstatement on February 26, 2025 with the UK IPO.
+Added: In addition, each of the three inventors named in
+Added: the Patent Application filed simultaneous counterstatements fully supporting Conduit UK’s position, and assertions that the
+Added: claims are without merit.
Further updates will be made following notification by the UK IPO.
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101901 (family number)
−Removed: to Conduit from AstraZeneca for use in all human indications.
+Added: to CDT from AstraZeneca for use in all human indications.
Granted and in force.
4 unchanged sentences
103631 (family number)
−Removed: to Conduit from AstraZeneca for use in human applications.
+Added: to CDT from AstraZeneca for use in human applications.
Granted and in force.
2 unchanged sentences
PCT/IB2022/00075
−Removed: by Conduit Pharmaceuticals.
September 2, 2022.
2 unchanged sentences
JP2022-176753
−Removed: by Conduit Pharmaceuticals.
November 2, 2022.
4 unchanged sentences
[WO/2019/016074]
−Removed: to Conduit from AstraZeneca.
+Added: to CDT from AstraZeneca.
International
2 unchanged sentences
101901 (family number)
−Removed: to Conduit from AstraZeneca for use in all human indications.
+Added: to CDT from AstraZeneca for use in all human indications.
Granted and in force.
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and regulations have no guaranteed outcomes and require the expenditure of substantial time and financial resources.
−Removed: development plan for each of AZD1656, AZD5658 and AZD5904 is to conduct clinical trials and if those trials are successful, we will then
−Removed: seek to enter into a transaction with a third party with respect to AZD1656, AZD5658 orAZD5904, as applicable, for the particular indication.
−Removed: We do not intend to continue development of such clinical assets beyond Phase II clinical trials.
−Removed: Accordingly, we anticipate developing
−Removed: clinical assets, which we own or license from third parties, that have undergone pre-clinical and clinical trials through the Phase II
−Removed: stage and then monetizing such clinical assets through a license, royalty, or other transaction.
−Removed: We do not expect that we will commercialize
−Removed: any clinical assets or seek marketing approval from the FDA (or similar organizations) as we intend to enter into agreements with third
−Removed: parties following Phase II clinical trials for each such clinical asset that would provide that such third party would pursue the further
−Removed: development, commercialization, and marketing of such assets.
+Added: development plan for AZD5904 is to conduct clinical trials and if those trials are successful, we will then seek to enter into a transaction
+Added: with a third party with respect to AZD5904, as applicable, for the particular indication.
+Added: Pursuant to the Joint Development Agreement,
+Added: the Company granted Manoira a non-exclusive, non-transferable, royalty-free license to intellectual property rights related to pharmaceutical
+Added: compounds AZD1656 and AZD5658.
+Added: Manoira will evaluate the compounds for animal health applications, explore veterinary market opportunities,
+Added: and provide data to inform the Company’s human clinical programs.
+Added: The license does not permit distribution, marketing, promotion,
+Added: or sale of related products.
+Added: anticipate developing clinical assets, which we own or license from third parties, that have undergone pre-clinical and clinical trials
+Added: through the Phase II stage and then monetizing such clinical assets through a license, royalty, or other transaction.
+Added: We do not expect
+Added: that we will commercialize any clinical assets or seek marketing approval from the FDA (or similar organizations) as we intend to enter
+Added: into agreements with third parties following Phase II clinical trials for each such clinical asset that would provide that such third
+Added: party would pursue the further development, commercialization, and marketing of such assets.
following description of the process relating to obtaining regulatory approvals in the United States and in foreign countries is intended
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States Government Regulation
−Removed: the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic
−Removed: Act (“FDCA”) and implementing regulations.
−Removed: Failure to comply with the applicable United States requirements at any time during
−Removed: the product development process, approval process or after approval, may subject an applicant to a variety of administrative or judicial
−Removed: sanctions, such as the FDA’s refusal to approve pending New Drug Applications (“NDAs”), withdrawal of an approval,
−Removed: imposition of a clinical hold, issuance of warning letters, product recalls, product seizures, total or partial suspension of production
−Removed: or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement or civil and/or criminal penalties.
+Added: the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act (“FDCA”) and implementing regulations.
+Added: Failure to comply with the applicable United States requirements at any time during the product development process, approval process
+Added: or after approval, may subject an applicant to a variety of administrative or judicial sanctions, such as the FDA’s refusal to
+Added: approve pending New Drug Applications (“NDAs”), withdrawal of an approval, imposition of a clinical hold, issuance of warning
+Added: letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of
+Added: government contracts, restitution, disgorgement or civil and/or criminal penalties.
process required by the FDA before a drug may be marketed in the United States generally involves the following steps, each of which
33 unchanged sentences
subjects are being exposed to an unacceptable health risk.
−Removed: Similarly, an IRB can suspend or
−Removed: terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s
−Removed: requirements or if the drug candidate has been associated with unexpected serious harm to patients.
+Added: Similarly, an IRB can suspend or terminate approval of a clinical trial at
+Added: its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the drug candidate
+Added: has been associated with unexpected serious harm to patients.
trials involve the administration of the investigational new drug to human subjects under the supervision of qualified investigators
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funds from the federal government.
−Removed: The government has begun enforcing these registration and results reporting requirements
−Removed: against non-compliant clinical trial sponsors.
+Added: The government has begun enforcing these registration and results reporting requirements against non-compliant
+Added: clinical trial sponsors.
clinical trials are typically conducted in at least three sequential phases and occasionally four or more, which may require repetition,
15 unchanged sentences
There is no assurance that any clinical trials
−Removed: on the assets owned or licensed by Conduit will be successful.
+Added: on the assets owned or licensed by CDT will be successful.
with FDA During the Clinical Development Program
91 unchanged sentences
The FDA will also conduct a pre-approval inspection of the manufacturing facilities for the new product to determine
−Removed: whether the manufacturing processes and facilities comply with cGMPs.
+Added: whether the manufacturing processes and facilities comply with GMPs.
The FDA will not approve the product unless it determines that
152 unchanged sentences
approval must meet the same statutory standards for safety and effectiveness as those granted traditional approval.
−Removed: accelerated approval pathway is usually contingent on a sponsor’s agreement to conduct, in a diligent manner, additional
−Removed: post-approval confirmatory studies to verify and describe the drug’s clinical benefit.
−Removed: As a result, a therapeutic candidate
−Removed: approved on this basis is subject to rigorous post-marketing compliance requirements, including the completion of Phase 4 or
−Removed: post-approval clinical trials to confirm the effect on the clinical endpoint.
−Removed: Failure to conduct required post-approval studies, or
−Removed: to confirm the predicted clinical benefit of the product during post-marketing studies, would allow the FDA to withdraw approval of
−Removed: All promotional materials for drug products being considered and approved under the accelerated approval program are
−Removed: subject to prior review by the FDA.
−Removed: Lawmakers, FDA officials, and other stakeholders continually evaluate the accelerated approval
−Removed: program which may lead to legislative and/or administrative changes in the future.
+Added: accelerated approval pathway is usually contingent on a sponsor’s agreement to conduct, in a diligent manner, additional post-approval
+Added: confirmatory studies to verify and describe the drug’s clinical benefit.
+Added: As a result, a therapeutic candidate approved on this
+Added: basis is subject to rigorous post-marketing compliance requirements, including the completion of Phase 4 or post-approval clinical trials
+Added: to confirm the effect on the clinical endpoint.
+Added: Failure to conduct required post-approval studies, or to confirm the predicted clinical
+Added: benefit of the product during post-marketing studies, would allow the FDA to withdraw approval of the drug.
+Added: All promotional materials
+Added: for drug products being considered and approved under the accelerated approval program are subject to prior review by the FDA.
+Added: FDA officials, and other stakeholders continually evaluate the accelerated approval program which may lead to legislative and/or administrative
+Added: changes in the future.
Post-Approval
57 unchanged sentences
and impose requirements to ensure accountability in distribution.
−Removed: The Drug Supply Chain Security Act (the “DSCSA”),
−Removed: was enacted with the aim of building an electronic system to identify and trace certain prescription drugs distributed in the United
−Removed: The DSCSA mandated phased-in and resource-intensive obligations for pharmaceutical
−Removed: manufacturers, wholesale distributors and dispensers by November 2023, but, so as not to disrupt supply chains, the FDA has granted certain
−Removed: exemptions from enhanced drug distribution security requirements for eligible trading partners for particular periods of time.
−Removed: From time to time, new legislation and regulations
−Removed: may be implemented that could significantly change the statutory provisions governing the approval, manufacturing and marketing of products
+Added: The Drug Supply Chain Security Act (the “DSCSA”), was enacted
+Added: with the aim of building an electronic system to identify and trace certain prescription drugs distributed in the United States.
+Added: DSCSA mandated phased-in and resource-intensive obligations for pharmaceutical manufacturers, wholesale distributors and dispensers by
+Added: November 2023, but so as not to disrupt supply chains, the FDA has granted certain exemptions from enhanced drug distribution security
+Added: requirements for eligible trading partners for particular periods of time.
+Added: From time to time, new legislation and regulations may be
+Added: implemented that could significantly change the statutory provisions governing the approval, manufacturing and marketing of products
regulated by the FDA.
308 unchanged sentences
Agreement, which went into effect on January 1, 2021.
−Removed: We are currently evaluating the potential
−Removed: impacts on our business of the Trade and Cooperation Agreement and guidance issued to date by the United Kingdom’s MHRA regarding
−Removed: the requirements for licensing and marketing medicinal products in the United Kingdom.
+Added: We are currently evaluating the potential impacts on our business of the Trade
+Added: and Cooperation Agreement and guidance issued to date by the United Kingdom’s MHRA regarding the requirements for licensing and
+Added: marketing medicinal products in the United Kingdom.
the regulatory framework for pharmaceutical products in the United Kingdom covering the quality, safety and efficacy of pharmaceutical
49 unchanged sentences
an important decision that has led to further and more aggressive efforts by states in this area.
−Removed: On August 16, 2022, President
−Removed: Biden signed into the law the Inflation Reduction Act of 2022, or the IRA.
−Removed: Among other things, the IRA has multiple provisions that can
−Removed: impact the prices of drug products that are both sold into the Medicare program and throughout the United States.
−Removed: Beginning in 2023, a
−Removed: manufacturer of drugs covered by Medicare Parts B or D must pay a rebate to the federal government if their drug product’s price
−Removed: increases faster than the rate of inflation.
−Removed: This calculation is made on a drug product by drug product basis and the amount of the rebate
−Removed: owed to the federal government is directly dependent on the volume of a drug product that is paid for by Medicare Parts B or D.
−Removed: Additionally,
−Removed: starting for payment year 2026, CMS will negotiate drug prices annually for a select number of single source Part D drugs without generic
−Removed: or biosimilar competition.
−Removed: CMS will also negotiate drug prices for a select number of Part B drugs starting for payment year 2028.
−Removed: a drug product is selected by CMS for negotiation, it is expected that the revenue generated from such drug will decrease.
+Added: August 16, 2022, President Biden signed into the law the Inflation Reduction Act of 2022, or the IRA.
+Added: Among other things, the IRA has
+Added: multiple provisions that can impact the prices of drug products that are both sold into the Medicare program and throughout the United
+Added: Beginning in 2023, a manufacturer of drugs covered by Medicare Parts B or D must pay a rebate to the federal government if their
+Added: drug product’s price increases faster than the rate of inflation.
+Added: This calculation is made on a drug product by drug product basis
+Added: and the amount of the rebate owed to the federal government is directly dependent on the volume of a drug product that is paid for by
+Added: Medicare Parts B or D.
+Added: Additionally, starting for payment year 2026, CMS will negotiate drug prices annually for a select number of single
+Added: source Part D drugs without generic or biosimilar competition.
+Added: CMS will also negotiate drug prices for a select number of Part B drugs
+Added: starting for payment year 2028.
+Added: If a drug product is selected by CMS for negotiation, it is expected that the revenue generated from
+Added: such drug will decrease.
addition, in some foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed.
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Union to ourselves or third parties outside of the European Union.
−Removed: The EU GDPR is an EU Regulation
−Removed: and it no longer applies to the UK.
−Removed: If you operate inside the UK, you need to comply with the Data Protection Act 2018 (DPA 2018).
−Removed: provisions of the EU GDPR have been incorporated directly into UK law as the UK GDPR.
−Removed: On 28 June 2021, the EU approved adequacy decisions
−Removed: for the EU GDPR and the Law Enforcement Directive (LED).
−Removed: This means data can continue to flow freely from the EU to the UK, in the majority
+Added: EU GDPR is an EU Regulation and it no longer applies to the UK.
+Added: If you operate inside the UK, you need to comply with the Data Protection
+Added: Act 2018 (DPA 2018).
+Added: The provisions of the EU GDPR have been incorporated directly into UK law as the UK GDPR.
+Added: On 28 June 2021, the EU
+Added: approved adequacy decisions for the EU GDPR and the Law Enforcement Directive (LED).
+Added: This means data can continue to flow freely from
+Added: the EU to the UK, in the majority of cases.
Cayman Islands Government enacted the Data Protection Act on May 18, 2017 (as amended, the “DPA”).
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interpreted or enforced, nor can we ensure we will be able to obtain or maintain any required licenses or permits.
−Removed: of December 31, 2024, we had a total of six full-time employees.
+Added: of December 31, 2025, we had a total of four full-time employees.
currently rely on several consultants who provide services to our Company.
12 unchanged sentences
of the Business Combination in September 2023.
+Added: Effective August 5, 2025, the Company changed its name from Conduit Pharmaceuticals Inc.
+Added: to CDT Equity Inc.
+Added: Our change to CDT Equity Inc.
+Added: reflects the evolution of our strategy as a data-driven biotech development company
+Added: focused on identifying, enhancing, and advancing high-potential therapeutic assets through scientific innovation and strategic partnerships.
principal executive offices are located at 4581 Tamiami Trail North, Suite 200 Naples, Florida.
Our telephone number is +1 (646)-491-9132,
−Removed: and our website can be found at https://www.conduitpharma.com.
+Added: and our website can be found at https://www.cdtequity.com.
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.