What changed in this filing

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Item 1. Business

2025-03-28 compared with 2024-04-16 · 577 added, 571 removed, 1174 unchanged (49% of the section changed)

September 22, 2023, a merger transaction between Conduit Pharmaceuticals Limited (“Old Conduit”), Murphy Canyon Acquisition

Corp (“MURF”) and Conduit Merger Sub, Inc., a Cayman Islands exempted company and a wholly owned subsidiary of MURF (“Merger

Sub”), was completed pursuant to the Agreement and Plan of Merger, dated November 8, 2022, as amended, (the “Merger Agreement”).

Pursuant to the terms of the Merger Agreement, at the closing, (i) Merger Sub merged with and into Old Conduit, with Old Conduit surviving

the merger as a wholly-owned subsidiary of MURF, and (ii) MURF changed its name from Murphy Canyon Acquisition Corp.

to Conduit Pharmaceuticals

(hereafter referred to, collectively with is subsidiaries as “Conduit”, the “Company”,

“we”, “us” or “our”, unless the context otherwise requires).

The common stock of the Company

commenced trading on The Nasdaq Global Market under the symbol “CDT” on September 25, 2023, and the Company’s warrants

commenced trading on The Nasdaq Capital Market under the symbol “CDTTW” on September 25, 2023 .

September 22, 2023, a merger transaction (the “Business Combination”) between Conduit Pharmaceuticals Limited (“Old

Conduit”), Murphy Canyon Acquisition Corp (“MURF”) and Conduit Merger Sub, Inc., a Cayman Islands exempted company

and a wholly owned subsidiary of MURF (“Merger Sub”), was completed pursuant to the Agreement and Plan of Merger, dated November

8, 2022, as amended, (the “Merger Agreement”).

Pursuant to the terms of the Merger Agreement, at the closing, (i) Merger

Sub merged with and into Old Conduit, with Old Conduit surviving the Business Combination as a wholly-owned subsidiary of MURF, and (ii)

MURF changed its name from Murphy Canyon Acquisition Corp.

to Conduit Pharmaceuticals Inc.

(“Conduit” or the “Company”).

has developed a unique business model that allows it to act as a conduit to bring clinical assets from pharmaceutical companies and

develop new treatments for patients.

Our novel approach addresses unmet medical needs and lengthens the intellectual property for our

existing assets through cutting-edge solid-form technology and then commercializing these products with life science

Our novel approach addresses unmet medical needs and lengthens the intellectual property for

our existing assets through cutting-edge solid-form technology and then commercializing these products with life science companies.

We continue to evaluate novel artificial intelligence (“AI”) and cybernetics approaches to drug re-purposing,

intellectual property and asset selection to give Conduit a competitive advantage.

are led by highly experienced pharmaceutical executives:

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LifeArc, our Chief Executive Officer.

Our management team includes active senior clinicians who have an extensive understanding of the

Our management team includes active senior scientists who have an extensive understanding of the

pharmaceuticals market, which supports our strategy of developing clinical assets in a cost-efficient manner while focusing on therapeutic

efficacy and patient safety.

We believe that we can leverage the capabilities of our Cambridge laboratory facility and highly experienced team of solid-form experts to

extend or develop proprietary solid-form intellectual property for our existing and future clinical assets.

Our own intellectual property

portfolio comprises a 20-year patent pending solid-form compound, the AZD1656 Cocrystal (a HK-4 Glucokinase Activator), targeting a wide

range of autoimmune diseases.

Our pipeline research includes a number of compounds that serve as promising alternatives to existing clinical

assets currently marketed and sold by large pharmaceutical companies, which we have identified as having an opportunity to develop further intellectual property positions through solid-form technology.

Simultaneously,

Conduit leverages the capabilities of our Cambridge laboratory facility and highly experienced team of solid-form experts to extend or

develop proprietary solid-form intellectual property for our existing and future clinical assets.

Our own intellectual property portfolio

comprises pending patent applications in several international jurisdictions describing a solid-form compound, including the AZD1656

Cocrystal (a HK-4 Glucokinase Activator), targeting a wide range of autoimmune disorders.

Our pipeline research includes a number of

compounds that serve as promising alternatives to existing clinical assets currently marketed and sold by large pharmaceutical companies,

which we have identified as having an opportunity to develop further intellectual property positions through solid-form technology.

connection with the funding and development of clinical assets, we evaluate and select the specific molecules to be developed and collaborate

with external contract research organizations (“CROs”) and Key Opinion Leaders (“KOLs”) to run clinical trials

with external CROs and Key Opinion Leaders (“KOLs”) to run clinical trials

that are managed, funded, and overseen by us.

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portfolio in combination with other potential sources of financing, including debt or equity financing.

of our proprietary owned patented clinical assets, we have an exclusive relationship and partnership with St George Street Capital

(“St George Street”), a biomedical charity based in the United Kingdom.

We have the option to fund 100% of the

development of clinical assets that were initially licensed to St George Street by AstraZeneca PLC (AZN.L)

(“AstraZeneca”).

AstraZeneca has conducted initial pre-clinical and, in some instances, clinical trials on these assets,

but has decided to license them for further development.

At present, the Company has not definitely determined whether to fund any of projects through St George Street,

although its ability to choose to remains at the present time.

Subject to the terms of the Global Funding Agreement and the project funding

agreements (described in further detail below), either we or St George Street may seek funding for projects from third parties.

addition to our patent pending solid-form compound targeting a wide range of autoimmune diseases, two assets which were licensed from

AstraZeneca to St George Street that may be developed by us include AZD5904 (a Myeloperoxidase Inhibitor) targeting idiopathic male

infertility and AZD1656 (a Glucokinase Activator) targeting autoimmune diseases or immunodeficient conditions including uveitis, premature

labor, renal transplant rejection, and Hashimoto’s thyroiditis.

the clinical assets have undergone initial pre-clinical and clinical testing conducted by AstraZeneca, we are able to use the safety

data generated in these clinical trials to assess which clinical assets to further develop and for which indications.

Through this relationship,

there are considerable active pharmaceutical ingredients (“APIs”) that were manufactured by AstraZeneca in conducting its clinical

trials available.

As a result, Conduit does not have to develop the API, which is often a time consuming and expensive process, and the

API already produced was subject to rigorous quality control measures.

Conduit is well positioned, and intends, to pursue additional relationships and/or partnerships with third parties for the licensing

of further assets which are currently deprioritized.

We plan to focus our efforts on developing clinical assets to address diseases that

impact a large population where there is no present treatment or the present treatment, carries significant unwanted side effects.

of our proprietary owned patented clinical assets, AstraZeneca agreed to grant a license to the Company under certain intellectual property

rights controlled by AstraZeneca related to HK-4 Glucokinase activators AZD1656 and AZD5658 in all indications and myeloperoxidase inhibitor

AZD5904 for the treatment, prevention, and prophylaxis of idiopathic male infertility.

The Company will be responsible for the development

and commercialization of the relevant products licensed under the related License Agreement (the “Licensed Products”).

Company is required to use commercially reasonable efforts to develop and commercialize the Licensed Products.

has conducted initial pre-clinical and, in some instances, clinical trials on these assets, but has decided to license them for further

As the clinical assets have undergone initial pre-clinical and clinical testing conducted by AstraZeneca, we are able to

use the safety data generated in these clinical trials to assess which clinical assets to further develop and for which indications.

this relationship, there are considerable APIs that were manufactured by AstraZeneca

(prior to conducting its clinical trials) available to Conduit.

As a result, Conduit may not have to develop the APIs, which is often

a time consuming and expensive process, and the APIs already produced were subject to rigorous quality control measures.

collaboration with SARBORG Limited (“Sarborg”), Conduit intends to leverage an advanced

artificial intelligence (AI) and cybernetics platform to evaluate key deliverables across multiple areas of the Company’s

operations, including drug repurposing, drug discovery, solid-form identification, and clinical trial monitoring.

Sarborg Agreement (defined and described below) is designed to address longstanding challenges in the pharmaceutical sector, in

particular by reducing human error in critical decision-making processes in both clinical development and asset identification.

integrating Sarborg’s algorithmic AI/cybernetics technology, Conduit aims to enhance efficiency, lower costs, and accelerate

timelines by minimizing human intervention, ultimately optimizing the drug development cycle and giving Conduit a competitive

advantage in the sector.

this relationship, Conduit will gain access to cutting-edge predictive models and dashboards, enabling the Company to evaluate drug candidates,

streamline clinical trials, and optimize asset management with real-time data.

These tools will drive faster, more accurate decisions,

improving efficiency and reducing costs.

By leveraging these insights, Conduit to differentiate itself in a competitive sector and gain

unique data-driven insights that position the Company for success across both its current and future asset portfolio.

addition, Conduit will retain a perpetual, non-exclusive, royalty-free, and assignable right to use any platform or technology developed

by Sarborg in association with the deliverables.

Ongoing support from Sarborg will ensure these systems evolve with Conduit’s needs,

driving long-term innovation in areas like IP creation, regulatory strategy, and clinical trial monitoring.

This partnership reinforces

Conduit’s commitment to leveraging AI-driven solutions to accelerate growth, deliver value to stockholders, and maintain a competitive

edge in the pharmaceutical sector.

Sarborg is considered to

be a related party of conduit, as Dr.

Andrew Regan, a stockholder of Conduit and member of Conduit’s board of directors,

also sits on the board of directors of Sarborg.

Refer to Note 16 to our financial statements included elsewhere in this Annual Report

for additional details on the relationship between Conduit and Sarborg.

strategic move reaffirms Conduit’s commitment to adopting forward-thinking solutions to stay at the forefront of innovation in

the pharmaceutical industry.

By reducing reliance on traditional, labor-intensive methods and harnessing the power of AI-driven technology,

Conduit is well-positioned to lead in areas such as drug repurposing, clinical trial monitoring, and IP creation, ensuring the Company’s

long-term growth and market leadership.

Conduit believes that it is well positioned to pursue, and intends to pursue, additional relationships and/or partnerships with

third parties for the licensing of further assets which are currently deprioritized.

We plan to focus our efforts on developing

clinical assets to address disorders that impact a large population where there is no present treatment or the present treatment,

carries significant unwanted side effects.

Initial Pipeline:

HK-4 Glucokinase Activator Cocrystal, AZD1656 and AZD5904

wholly own the intellectual property and the rights to further develop the solid-form patent pending Cocrystals of AZD1656 (AZD1656 Cocrystal

WO2023084313 - Patent Expires 02/09/2042) which we intend to target a wide range of autoimmune diseases.

our agreements, we have the exclusive rights to fund the development of clinical assets, AZD1656 and AZD5904, which are licensed to St

George Street by AstraZeneca, in five indications.

has undergone testing in a total of 20 Phase I clinical trials and five Phase II clinical trials conducted by AstraZeneca since 2008

and 19 of which were conducted in the U.S.

HK-4 Glucokinase Activator Cocrystal, AZD1656, and its metabolite AZD5658 and AZD5904

wholly own the intellectual property and the rights to further develop the solid-form Cocrystals of AZD1656 (AZD1656 Cocrystal–

pending international patent applications, which, if granted should expire no earlier than 2042) that we intend to target a wide range

of autoimmune disorders.

addition, we currently have the exclusive rights to develop clinical assets, AZD1656 and AZD5658 in all human indications and AZD5904

in idiopathic male infertility which are licensed to us by AstraZeneca.

of our proprietary owned patented clinical assets, AstraZeneca granted a license to the Company of certain intellectual property rights

controlled by AstraZeneca related to HK-4 Glucokinase activators AZD1656 and AZD5658 in all indications and myeloperoxidase inhibitor

AZD5904 for the treatment, prevention, and prophylaxis of idiopathic male infertility.

The Company will be responsible for the development

and commercialization of the Licensed Products.

The Company is required to use commercially reasonable efforts to develop and commercialize

the Licensed Products.

to our relationship with AstraZeneca, we intend to leverage the data generated from these historical trials in order to investigate the

efficacy and safety to AZD1656 to potentially treat Lupus and ANCA Vasculitis patients, and the efficacy and safety of AZD5904 to treat

AZD1656 has undergone testing in a total of 20 Phase I clinical trials and five Phase II clinical trials conducted by AstraZeneca

since 2008 and 19 of which were conducted in the U.S.

Additional information about those clinical trials is available at the U.S.

National Library

of Medicine’s website at www.clinicaltrials.gov (however, the information contained on or otherwise accessible through such website

is not part of this Annual Report).

has undergone testing in five Phase I clinical trials conducted by AstraZeneca, one of which was conducted in the U.S.

While a significant

amount of clinical trial data has already been generated for both AZD1656 and AZD5904, some of this data was generated outside of the

Library of Medicine’s website at www.clinicaltrials.gov (however, the information contained on or otherwise accessible through

such website is not part of this annual report).

AZD5904 has undergone testing in five Phase I clinical trials conducted by AstraZeneca,

one of which was conducted in the U.S.

While a significant amount of clinical trial data has already been generated for both AZD1656

and AZD5904, some of this data was generated outside of the U.S.

and accordingly may not be accepted by the FDA.

In the event that such data is not accepted by the FDA, additional clinical trials

may be required, which would result in additional costs and time to develop these clinical assets.

initial development plan is to conduct a Phase II clinical trial on the selected AZD1656 Cocrystal (which we wholly own the intellectual

property rights to), that we believe has the potential to treat a wide range of autoimmune diseases.

Should we choose to develop AZD1656

or AZD5904, that development would be subject to the terms of the Global Funding Agreement, described in more detail below.

We anticipate

developing our Initial Pipeline (which has already undergone pre-clinical and clinical trials) through the Phase II stage and then monetizing

such clinical assets through a license, royalty, or other transaction at this stage.

At this time, we do not expect that we will commercialize

any clinical assets or seek marketing approval from the FDA (or similar organizations) as we intend to enter into agreements with third

parties following Phase II clinical trials for each such clinical asset that would provide that such third party would pursue the further

development, commercialization, and marketing of such assets.

In the event that such

data is not accepted by the FDA, additional clinical trials may be required to commercialize these assets in the United States, which

would result in additional costs and time to develop these clinical assets.

underwent Phase I and Phase II clinical trials consisting of 23 studies in 526 subjects, 446 of whom were dosed with AZD1656.

than for the intended effect of lowering glucose, there were no difference identified between the AZD1656-treated 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.

Based on these clinical trials, no safety signals were identified regarding vital signs, safety laboratory

values or electrocardiogram data.

No deaths occurred in any studies with healthy volunteers or patients.

AZD1656 was also subject to

Phase II clinical trials consisting of two studies where AZD1656 was given to patients with Type 2 Diabetes Mellitus for four months

In total, there were 754 randomized patients, 516 of whom were exposed to AZD1656 (316 men and 200 women).

There were no

clinically important differences in the adverse effects profile between the AZD1656 treatment group and the AZD1656 placebo group

and there were no deaths in either of the Phase II studies.

The efficacy of AZD1656 as a potential treatment for diabetes was also

assessed during the Phase II clinical trials, including whether the efficacy was statistically significant.

Clinically relevant and

statistically significant reductions in HbA1c were seen after four months;

however, the initial improvement in glucose control

deteriorated over time and the change in HbA1c levels after four months were not statistically different than the placebo.

decreasing efficacy over time was seen in both Phase II studies.

was subject to a randomized, single-blind, placebo-controlled, single-center, Phase I study to assess the safety, tolerability, pharmacokinetics,

pharmacodynamics and the effect of fasting after single ascending oral doses of AZD5658 in Type 2 Diabetes Mellitus patients.

six dose levels with eight patients in each cohort, six receiving AZD5658 and two receiving placebo.

The effect of fasting on the pharmacokinetics

of AZD5658 was also studied for two dose levels.

Each patient treated with metformin received a maximum of two single oral suspension

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

in the evaluation of the effect of fasting, who received a maximum of three single oral suspension doses.

For each patient the study

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).

Hence, the total duration of the study for each patient was approximately two and one-half months, assuming three weeks between dose

There were no deaths, serious adverse events, discontinuations due to adverse events, or adverse events of severe intensity during

Overall, there were 13 (61.9%) AZD5658-treated patients with adverse events compared to 2 (28.6%) patients who received placebo.

There were no trends noted with increasing dose in the number of adverse events overall or within any preferred term.

The most frequently

occurring adverse events were hypoglycemia and diarrhea, each occurring in three AZD5658-treated patients.

One adverse event of ear

pain (30 mg AZD5658 fed) was assessed by the study investigator as moderate in intensity;

all other adverse events were of mild intensity.

Five adverse events in AZD5658- treated patients were assessed by the investigator as causally related to investigational product, including

hypoglycemia in three patients (100 mg, 200 mg fasted, and 400 mg AZD5658), diarrhea in one patient (200 mg AZD5658 fasted), and headache

in one patient (30 mg AZD5658).

No adverse events in placebo-treated patients were assessed as causally related to investigational product.

The three patients who experienced hypoglycemia adverse events were treated with intake of food or orange juice and the episodes resolved

in less than one hour.

was subject to five Phase I clinical studies, with a total of 1,181 subjects being exposed to AZD5904.

Single doses of up to 1200 mg

and 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

clinical studies.

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

an “extended release” formulation.

The data from these studies did not identify any expected adverse drug reactions for AZD5904

and no adverse effects were reported as related to AZD5904.

In addition, the data revealed no clinically significant changes in blood

pressure or pulse rate related to AZD5904 and electrocardiogram data was within the physiological range for the population studied.

effect of AZD5904 on human myeloperoxidase, which we refer to as MPO, activity was evaluated by determination in an ex vivo assay of

MPO activity in plasma.

The correlation between MPO activity and plasma concentrations was assessed for single and multiple doses of

A relationship between plasma concentrations of AZD5904 and MPO activity was demonstrated, which indicates that AZD5904 may

be an effective inhibitor of MPO activity in humans.

However, Phase I trials do not assess statistical significance so additional Phase

II trials are necessary to determine if the inhibition of MPO activity as a result of AZD5904 is statistically significant.

initial development plan is to conduct a Phase II clinical trial on AZD1656 in Lupus (including Lupus Nephritis) and ANCA Vasculitis

Should we choose to develop AZD1656, AZD5658, or AZD5904, that development would be subject to the terms of the License Agreement,

described in more detail below.

We anticipate developing our Initial Pipeline (which has already undergone pre-clinical and clinical

trials) through the Phase II stage and then monetizing such clinical assets through a license, royalty, or other transaction at this

At this time, we do not expect that we will commercialize any clinical assets or seek marketing approval from the FDA (or similar

organizations) as we intend to enter into agreements with third parties following Phase II clinical trials for each such clinical asset

that would provide that such third party would pursue the further development, commercialization, and marketing of such assets.

enable us to monetize our clinical assets, we, in partnership with CROs and KOLs, intend to conduct additional clinical trials on our

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Development Strategy

strategy is to generate value through the development of new medicines, or clinical assets, for patients where our research indicates

that there are not effective pharmaceutical treatments available or such existing pharmaceutical treatments are not adequate due to,

among other things, cost of such pharmaceuticals and side effects.

We are working to develop new medicines in diseases where competitive

treatments carry a high incidence of unacceptable side effects resulting in tolerability and compliance issues.

We aim to extend and

develop solid-form intellectual property on assets which are licensed from pharmaceutical companies or generated within our facility

in Cambridge, UK.

We believe that our Cambridge facility positions us at the nexus of scientific advancement, providing an environment

to drive cutting-edge research and development initiatives.

strategy is to generate value through the development of new medicines, or clinical assets, for patients where our research

indicates that there are not effective pharmaceutical treatments available or such existing pharmaceutical treatments are not

adequate due to, among other things, cost of such pharmaceuticals and side effects.

We are working to develop new medicines in

disorders where competitive treatments carry a high incidence of unacceptable side effects resulting in tolerability and compliance

We aim to extend and develop solid-form intellectual property on assets which are licensed from pharmaceutical companies or

generated within our facility in Cambridge, United Kingdom (the“UK”).

We believe that our Cambridge facility positions us at the nexus of scientific

advancement, providing an environment to drive cutting-edge research and development initiatives.

is evidence that promising solid-form candidates can supersede original pharmaceutical products.

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previously indicated, our strategy also involves establishing strategic collaborations with globally recognized KOLs.

collaborate closely with disease specific KOLs to collectively assess and determine the most appropriate indications for all our

current and forthcoming assets.

This approach ensures that the selection of indications aligns with the KOLs’ insights, in

addition to our internal expertise, optimizing the development and success of Conduit’s diverse portfolio.

We will collaborate

closely with disease specific KOLs to collectively assess and determine the most appropriate indications for all our current and forthcoming

This approach ensures that the selection of indications aligns with the KOLs’ insights, in addition to our internal expertise,

optimizing the development and success of Conduit’s diverse portfolio.

unique relationships allow us to bypass certain traditional hurdles for the development of clinical assets.

Through relationships with

St George Street, and we anticipate, subsequently with AstraZeneca, our Initial Pipeline has already undergone initial pre-clinical,

and, in some instances, clinical testing conducted by AstraZeneca, this enables us to use the safety data generated in the prior trials

in order to assess which assets to continue to develop.

We regularly assess our asset portfolio to identify potential risks and take

steps to mitigate those risks, such as the repurposing of assets, which reduces development costs and timelines, as the clinical asset

has already undergone safety and toxicity testing in humans, as well as extending the remaining patent life by up to 20 years on all

assets which are licensed.

Through our relationship

with AstraZeneca, our Initial Pipeline has already undergone initial pre-clinical, and, in some instances, clinical testing conducted

by AstraZeneca, which enables us to use the safety data generated in the prior trials in order to assess which assets to continue to

We regularly assess our asset portfolio to identify potential risks and take steps to mitigate those risks, such as the repurposing

of assets, which reduces development costs and timelines, as the clinical asset has already undergone safety and toxicity testing in

humans, as well as extending the remaining patent life by up to 20 years on all assets which are licensed.

prior preclinical and clinical studies conducted by AstraZeneca allow us to reduce the costs, expenses, and time in the development of

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for the API, which is time consuming and expensive.

Funding Agreement – St George Street

and St George Street entered into an Exclusive Funding Agreement on March 26, 2021 (the “Global Funding Agreement”), pursuant

to which St George Street granted us the exclusive first right to provide to St George Street, or procure the provision of, all funding

for the performance of a drug discovery and/or development project in consideration for a share of the net revenue in respect of such

and St George Street currently have entered into five project funding agreements, which are subject to the terms of the Global Funding

Agreement, to develop certain clinical assets that have been licensed to St George Street by AstraZeneca.

The project funding agreements

for use in renal transplant,

for use in pre-term labor,

for use in Hashimoto’s thyroiditis,

for use in uveitis, and

for use in idiopathic male infertility.

present, the Company has not determined whether to fund any of these projects, although its ability to choose to remains at the present

Subject to the terms of the Global Funding Agreement and the project funding agreements, either we or St George Street may seek

funding for projects from third parties.

may be additional opportunities for us to partner with St George Street to fund the development of additional clinical assets in the

future, licensed from Astra Zeneca.

we choose to fund these projects through St.

George Street (“SGSC”), we are entitled to receive 100% of the Net Receipts (as defined in the

relevant project funding agreement) under each of the project funding agreements.

to its terms, the Global Funding Agreement remains effective in respect of each project until the expiration of the right of a party

to receive a share of the Net Revenue (as defined in the Global Funding Agreement) pursuant to the Global Funding Agreement.

Under certain

circumstances, St George Street may terminate a project (i) in the event of a material or persistent breach of the Global Funding Agreement

by us, subject to a cure period if the breach is capable of remedy, or (ii) in the event St George Street decides to cease development

of a project.

If an event of force majeure occurs and continues for a designated period of time, the innocent party may terminate the

Global Funding Agreement after a notice period.

party may terminate a project if a voluntary arrangement is proposed or approved or an administration order is made, or a receiver or

administrative receiver is appointed of any of the other party’s assets or undertakings or a winding-up resolution or petition

is passed (otherwise than for the purpose of solvent reconstruction or amalgamation, in particular with respect to any reorganization

of the structure of that party) or if any circumstances arise which entitle a court or a creditor to appoint a receiver, administrative

receiver or administrator or make a winding-up order or similar or equivalent action is taken against or by that other party by reason

of its insolvency or in consequence of debt.

Generally, each project funding agreement may be terminated by us if at any time St George

Street ceases the conduct of development or commercialization of the relevant products in accordance with the relevant development plan

for a designated period of time, provided that the termination is only effective with respect to the specified project and the Global

Funding Agreement continues in effect for all other projects.

They may also be terminated by either party upon written notice to other

party if the other party materially breaches the project funding agreement and does not fully cure the breach to the non-breaching party’s

satisfaction within 90 days.

Global Funding Agreement also contains customary representations and warranties.

Each party also agreed to keep secret and confidential

certain confidential information of the other party.

foregoing summary does not purport to be a complete description of all of the provisions of the Global Funding Agreement and related

project funding agreements and is qualified by reference to the full text of the Global Funding Agreement and the project funding agreements,

which are filed as exhibits to this Annual Report, and which are incorporated by reference in their entirety.

Agreement – St George Street and AstraZeneca

August 2019, St George Street entered into a license agreement with AstraZeneca (the “AZ License Agreement”), pursuant to

which AstraZeneca granted an exclusive worldwide license to St George Street, under certain AstraZeneca patents and know-how, to exploit

the pharmaceutical compounds known individually and together as AZD5904 (Myeloperoxidase Inhibitor) and AZD1656 (Glucokinase Activator).

The AZ License Agreement also included any additional compounds to be developed by St George Street and any product that is comprised

of or contains any such licensed compound pertaining to the field of idiopathic male infertility for the licensed compound AZD5904 and

in the field of renal transplant for the licensed compound for AZD1656.

the AZ License Agreement, for a period of 60 days following AstraZeneca’s receipt of a proof of concept study for any licensed

compound, AstraZeneca retains an exclusive right of first negotiation to transfer all development, commercialization, or other ongoing

planned activities related to such licensed compound, to AstraZeneca or any of its affiliates, and to undertake future exploitation of

such licensed compound.

Subject to the foregoing negotiation right, St George Street has the right and obligation to develop each licensed

compound at its sole cost and expense in accordance with the development plan set forth in the AZ License Agreement, and the right to

grant sublicenses to its affiliates and other persons with respect to each licensed compound.

Any sublicense shall be consistent with,

and expressly made subject and subordinate to, the terms and conditions of the AZ License Agreement, and St George Street shall cause

each sublicensee to comply with the applicable terms and conditions of the AZ License Agreement.

The development plan for each licensed

compound shall be managed by a joint coordination committee consisting of representatives from each party to the agreement.

George Street is required to pay AstraZeneca a share of any revenue payable to St George Street by any sublicensee according to the relevant

sublicense (the “Sublicense Revenue”), which shall be calculated based on the amounts payable to St George Street by the

sublicensee gross of tax, and shall include any upfront, milestone, or royalty payments payable.

The percentage of Sublicense Revenue

payable to AstraZeneca is 60% for Sublicense Revenue that is less than $10 million;

50% for Sublicense Revenue that is equal to or greater

than $10 million but less than $15 million;

and 40% for Sublicense Revenue that is equal to or greater than $15 million.

term of the AstraZeneca License Agreement commences on the effective date of that agreement and, unless earlier terminated in accordance

therewith, continues until the date of expiration of the last royalty term for the last licensed product.

Following the expiration (but

not earlier termination) of the royalty term for a licensed product in a country, the license grant set forth in this agreement shall

become non-exclusive, fully-paid, and irrevocable for such licensed product.

AZ Agreement is terminable by either party if the other party is in material breach of the agreement, and such breach has not cured the

breach 90 days of notice (or 10 days of notice with respect to a payment breach).

may immediately terminate the agreement, including the rights of any sublicensees, upon written notice if St George Street or any of

its affiliates or sublicensees, anywhere in the territory, institutes, prosecutes or otherwise participates in any claim, demand, action

or cause of action for declaratory relief, damages or any other remedy or for an enjoinment, injunction or any other equitable remedy

alleging that any claim in an AstraZeneca patent is invalid, unenforceable or otherwise not patentable or would not be infringed by St

George Street’s activities absent the rights and licenses granted under the agreement.

AstraZeneca may also terminate the agreement

upon 30 days’ prior written notice if St George Street ceases development of all licensed compounds and all licensed products and

a licensed product is not being commercialized in the territory by or on behalf of St George Street.

George Street may terminate its activities under the agreement for convenience, on a project-by-project basis, upon reasonable notice

to AstraZeneca.

St George Street may also cease its activities under any development plan of a licensed compound if the joint commercialization

committee determines that it is inappropriate to continue such plan for scientific, safety, or for ethical reasons, or that a licensed

product no longer meets an unmet medical need.

2020, St George Street and AstraZeneca entered into an amendment to the AZ License Agreement to add Covid-19 to the field for

licensed compound AZD1656.

St George Street and AstraZeneca entered into a second amendment and a third amendment to the AZ License

The second amendment, dated April 9, 2020, to the AZ

License Agreement added Schedule 1.36(a) to the AZ License Agreement, which describes additional terms and conditions that apply

only to the parties with respect to Covid-19 for the licensed compound AZD1656.

The third amendment, dated April 27, 2021, added

Hashimoto’s thyroiditis, uveitis, preterm labor, and Covid-19 to the field for AZD1656 and added Schedule 1.42(a) to the AZ

License Agreement, which describes additional terms and conditions that apply to the parties (i) only with respect to

Hashimoto’s thyroiditis, uveitis, and preterm labor for the licensed compound AZD1656, and (ii) with respect to all other

indications and Licensed Compounds (as defined in the AZ License Agreement) as set forth in the AZ License Agreement, except with

respect to Covid-19 for AZD1656, for which Schedule 1.36(a) of the AZ License Agreement applies.

The terms and conditions contained

in the second and third amendments to the AZ License Agreement also set forth the obligations and responsibilities of the parties

regarding supply of study drugs, conducting studies, and other matters.

Strategic Partnerships

Agreement – Conduit and AstraZeneca

August 7, 2024, the Company and AstraZeneca entered into the License Agreement.

Pursuant to such License Agreement, AstraZeneca agreed

to grant a license to the Company under certain intellectual property rights controlled by AstraZeneca related to HK-4 Glucokinase activators

AZD1656 and AZD5658 in all indications and myeloperoxidase inhibitor AZD5904 for the treatment, prevention, and prophylaxis of idiopathic

male infertility.

The Company will be responsible for the development and commercialization of the Licensed Products under the

related License Agreement.

The Company is required to use commercially reasonable efforts to develop

and commercialize the Licensed Products.

consideration for the grant of the license, the Company (i) granted AstraZeneca common stock pursuant to the Issuance Agreement (as further

set out below), (ii) paid AstraZeneca an up-front payment of $1.5 million, and (iii) is obligated to pay AstraZeneca a percentage (on

a tiered basis) of any amounts it may receive in connection with a grant of a sublicense (subject to various customary exceptions).

has been granted a right of first negotiation to develop, manufacture, and commercialize a Licensed Product if the Company receives an

offer for, or solicits, a transaction where a third party would obtain the right to develop, manufacture, or commercialize a Licensed

If AstraZeneca exercises such right, the parties would negotiate in good faith for an agreed period of time on an exclusive

party may terminate the License Agreement for material breach (subject to a cure period) or insolvency of the other party.

may terminate the License Agreement for convenience (in its entirety or on a Licensed Product-by-Licensed Product basis).

AstraZeneca may terminate the License Agreement in certain circumstances, including (but not limited to) the Company ceasing development

of all Licensed Products (subject to certain exceptions for normal pauses or gaps between clinical studies).

addition, in connection with the execution of the License Agreement, the Company and AstraZeneca entered into the Issuance Agreement,

whereby the Company issued AstraZeneca 95,044 shares of the Company’s Common Stock.

The Issuance Agreement provides

AstraZeneca with resale registration rights for such shares.

Agreement – Conduit and Sarborg Limited

December 12, 2024, the Company entered into a Services Agreement (the “Sarborg Agreement”) with Sarborg, a Cayman

Islands company and related party of the Company.

Under the terms of the Sarborg Agreement, Sarborg will provide algorithmic and cybernetic technology services to

Conduit, including the development of decision-support tools and advanced cybernetic systems tailored to enhance Conduit’s

decision-making processes and maximize the value of its pharmaceutical asset portfolio.

will perform the services to Conduit comprised of three phases:

the Initial Phase (0-24 weeks) focuses on establishing a foundation for

collaboration and aligning Sarborg’s services with Conduit’s strategic goals;

the Development Phase (24-36 weeks) involves

building technological infrastructure, including dashboards and predictive models;

and the Ongoing Services Phase (36-52 weeks) ensures

the sustained functionality and relevance of Sarborg’s deliverables while supporting Conduit’s growth through iterative improvements

Sarborg will create specific deliverables, including reports, computer programs, software applications, APIs, mobile applications,

source code, written technical specifications and designs, operating and maintenance manuals, and other recorded data and information

arising from or relating to the services.

Sarborg will provide all necessary resources to perform the services and deliver the deliverables

in accordance with the Sarborg Agreement.

date, Conduit has successfully completed the Initial Phase of its collaboration with Sarborg, establishing a strong foundation for integrating

AI-driven solutions into our operations.

This phase focused on identifying key inputs for the algorithmic approach and ensuring alignment

between Sarborg’s services and Conduit’s strategic goals.

As part of this effort, Sarborg has successfully delivered three

key milestones.

First, they conducted detailed teach-in sessions with Conduit’s management team to gain a deeper understanding

of our objectives, challenges, and operational workflows, resulting in documented meeting agendas, minutes, and action plans.

they finalized and validated a set of proprietary inputs essential for their cybernetic models, tailored specifically to Conduit’s

portfolio and R&D pipeline.

Finally, they completed an in-depth market analysis of potential cocrystal candidates, assessing the

patent landscape, competitive positioning, and market size.

The insights from this Annual Report are now informing Conduit’s ongoing

strategic decision-making.

With these key milestones delivered, we are now progressing to the next phase of development.

has now commenced Phase II:

The Development Phase, which focuses on building the technological infrastructure necessary to integrate

AI into Conduit’s operations.

As part of this, Sarborg has successfully completed the first milestone, Dashboard Creation and Refinement,

delivering personalized dashboards that provide Conduit’s key personnel with real-time access to critical data related to deliverables,

clinical trials, and drug discovery.

These initial dashboards, along with user interface mock-ups and a dashboard user guide, will serve

as the foundation for further refinements.

Moving forward, the platform will continue to be optimized to maximize efficiency and ensure

seamless integration into Conduit’s workflows.

Service Agreement – Conduit and Charles River Laboratories

February 7, 2025, Conduit and Charles River Laboratories (“Charles River”) entered into a Master Services Agreement (the

“Charles River MSA”).

Under the Charles River MSA, Charles River agreed to provide preclinical testing and research

services to Conduit, including the evaluation of compounds in animal models and other related services.

The services are defined in

individual Statements of Work (“SOWs”) or Protocols, which outline the specific scope, design, and timelines for each

To date, one SOW, dated February 11, 2025, has been entered into.

Charles River will conduct the studies in compliance with

applicable laws and industry standards, and Conduit will provide necessary test articles and materials.

The Charles River MSA

includes provisions for confidentiality, intellectual property ownership, indemnification, and dispute resolution.

The Charles River

MSA has a term of five years and can be terminated by either party under specified conditions.

Biotechnology Industry

7 unchanged sentences

rate (“CAGR”) of 9.18% from 2024 to 2033.

The market is driven by strong government support through initiatives aimed at

the modernization of regulatory framework, improvements in approval processes and reimbursement policies, as well as standardization

1 The market is driven by strong government support through initiatives

aimed at the modernization of regulatory framework, improvements in approval processes and reimbursement policies, as well as standardization

of clinical studies.

18 unchanged sentences

Initial Pipeline:

AZD1656 and AZD5904

wholly own the intellectual property and the rights to further develop the solid-form patent pending Cocrystals of AZD1656 (AZD1656 Cocrystal

WO2023084313 - Patent Expires 02/09/2042) which we intend to target a wide range of autoimmune diseases.

we currently have the exclusive rights to develop clinical assets, AZD1656 and AZD5904, which are licensed

to St George Street by AstraZeneca, in five indications.

to our relationship with St George Street, we intend to leverage the data generated from these historical trials in order to investigate

the efficacy and safety to AZD1656 to potentially treat HT, uveitis, preterm labor, and renal transplant patients, and the efficacy and

safety of AZD5904 to treat IMI.

AZD1656 has undergone testing in a total of 20 Phase I clinical trials and five Phase II clinical trials

conducted by AstraZeneca since 2008 and 19 of which were conducted in the U.S.

Additional information about those clinical trials is

available at the U.S.

National Library of Medicine’s website at www.clinicaltrials.gov (however, the information contained on or

otherwise accessible through such website is not part of this Annual Report).

AZD5904 has undergone testing in five Phase I clinical

trials conducted by AstraZeneca, one of which was conducted in the U.S.

While a significant amount of clinical trial data has already

been generated for both AZD1656 and AZD5904, some of this data was generated outside of the U.S.

and accordingly may not be accepted

In the event that such data is not accepted by the FDA, additional clinical trials may be required, which would result in

additional costs and time to develop these clinical assets.

AZD1656, AZD5658 and AZD5904

wholly own the intellectual property and the rights to further develop the solid-form Cocrystals of AZD1656 (AZD1656 Cocrystal–

pending international patent applications if granted should expire no earlier than 2042) which we intend to target a wide range of autoimmune

addition, we currently have the exclusive rights to develop clinical assets, AZD1656 and AZD5658 in all human indications and AZD5904

in idiopathic male infertility which are licensed to us by AstraZeneca.

of our proprietary owned patented clinical assets, AstraZeneca granted a license to the Company of certain intellectual property rights

controlled by AstraZeneca related to HK-4 Glucokinase activators AZD1656 and AZD5658 in all indications and myeloperoxidase inhibitor

AZD5904 for the treatment, prevention, and prophylaxis of idiopathic male infertility.

The Company will be responsible for the development

and commercialization of the Licensed Products.

The Company is required to use commercially reasonable efforts to develop and commercialize

the Licensed Products.

to our relationship with AstraZeneca, we intend to leverage the data generated from these historical trials in order to investigate the

efficacy and safety to AZD1656 to potentially treat Lupus and ANCA Vasculitis patients, and the efficacy and safety of AZD5904 to treat

AZD1656 has undergone testing in a total of 20 Phase I clinical trials and five Phase II clinical trials conducted by AstraZeneca

since 2008 and 19 of which were conducted in the U.S.

Additional information about those clinical trials is available at the U.S.

Library of Medicine’s website at www.clinicaltrials.gov (however, the information contained on or otherwise accessible through

such website is not part of this annual report).

AZD5904 has undergone testing in five Phase I clinical trials conducted by AstraZeneca,

one of which was conducted in the U.S.

While a significant amount of clinical trial data has already been generated for both AZD1656

and AZD5904, some of this data was generated outside of the U.S.

and accordingly may not be accepted by the FDA.

In the event that such

data is not accepted by the FDA, additional clinical trials may be required, which would result in additional costs and time to develop

these clinical assets.

Biotechnology Market Size to Worth Around USD 3.54 Trillion by 2033 .

BioSpace.com.

https://www.biospace.com/press-releases/biotechnology-market-size-to-worth-around-usd-3-54-trillion-by-2033

IBISWorld Industry Report L6724-GL – Global Biotechnology, May 2021

table below sets forth the pre-clinical or clinical trials that have been conducted by or at the direction of AstraZeneca to date on

the particular clinical asset.

All of these pre-clinical or clinical trials were conducted by AstraZeneca prior to AstraZeneca entering

into its license agreement with St George Street.

None of the pre-clinical or clinical trials that have taken place to date were conducted

by or at the direction of the Company.

All of these pre-clinical or clinical trials were conducted by AstraZeneca prior to Conduit entering into

the License Agreement with AstraZeneca.

None of the pre-clinical or clinical trials that have taken place to date were conducted by or

at the direction of the Company.

of Development

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Exit Stage for Monetization (3)

Thyroiditis & Grave’s Disease

& ANCA Vasculitis

completion of Phase II

1 unchanged sentence

completion of Phase II

Autoimmune Disorders

completion of Phase II

2 unchanged sentences

already completed Phase I trials and is therefore considered Phase II ready.

do not intend to provide additional funding to develop AZD1656 for Covid-19.

However, we are entitled to a portion of the revenues

in the event that AZD1656 is further developed by St George Street (or another third party) and is monetized, whether through a

sale, license agreement, or otherwise.

do not intend to provide additional funding to develop AZD1656 for Covid-19, which is principally owned by third parties.

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

through a sale, license agreement, or otherwise.

the stage at which we currently anticipate that we will seek to monetize such assets through a license, royalty, or other transaction

6 unchanged sentences

will be monetized or commercialized.

was subject to Phase I and Phase IIa clinical trials consisting of 23 studies in 526 subjects, 446 of whom were dosed with AZD1656.

than for the intended effect of lowering glucose, there were no difference identified between the AZD1656-treated and placebo-treated

subjects relating to adverse events.

All of cases where low glucose levels were identified were managed by the patients and resolved.

Based on these clinical trials, no safety signals were identified regarding vital signs, safety laboratory values or electrocardiogram

was subject to Phase I and Phase II clinical trials consisting of 23 studies in 526 subjects, 446 of whom were dosed with AZD1656.

Other than for the intended effect of lowering glucose, there were no difference identified between the AZD1656-treated 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.

Based on these clinical trials, no safety signals were identified regarding vital signs, safety laboratory

values or electrocardiogram data.

No deaths occurred in any studies with healthy volunteers or patients.

AZD1656 was also subject to Phase II 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).

There were no clinically important differences in the

adverse effects profile between the AZD1656 treatment group and the AZD1656 placebo group and there were no deaths in either of the Phase

The efficacy of AZD1656 as a potential treatment for diabetes was also assessed during the Phase II clinical trials, including

whether the efficacy was statistically significant.

Clinically relevant and statistically significant reductions in HbA1c were seen after

however, the initial improvement in glucose control deteriorated over time and the change in HbA1c levels after four months

were not statistically different than the placebo.

This decreasing efficacy over time was seen in both Phase II studies.

AZD1656 was also subject to

Phase II clinical trials consisting of two studies where AZD1656 was given to patients with Type 2 Diabetes Mellitus for four months

In total, there were 754 randomized patients, 516 of whom were exposed to AZD1656 (316 men and 200 women).

There were no

clinically important differences in the adverse effects profile between the AZD1656 treatment group and the AZD1656 placebo group

and there were no deaths in either of the Phase II studies.

The efficacy of AZD1656 as a potential treatment for diabetes was also

assessed during the Phase II clinical trials, including whether the efficacy was statistically significant.

Clinically relevant and

statistically significant reductions in HbA1c were seen after four months;

however, the initial improvement in glucose control

deteriorated over time and the change in HbA1c levels after four months were not statistically different than the placebo.

decreasing efficacy over time was seen in both Phase II studies.

was subject to a randomized, single-blind, placebo-controlled, single-center, Phase I study to assess the safety, tolerability, pharmacokinetics,

pharmacodynamics and the effect of fasting after single ascending oral doses of AZD5658 in Type 2 Diabetes Mellitus patients.

six dose levels with eight patients in each cohort, six receiving AZD5658 and two receiving placebo.

The effect of fasting on the pharmacokinetics

of AZD5658 was also studied for two dose levels.

Each patient treated with metformin received a maximum of two single oral suspension

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

in the evaluation of the effect of fasting, who received a maximum of three single oral suspension doses.

For each patient the study

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).

Hence, the total duration of the study for each patient was approximately two and one-half months, assuming three weeks between dose

There were no deaths, serious adverse events, discontinuations due to adverse events, or adverse events of severe intensity during

Overall, there were 13 (61.9%) AZD5658-treated patients with adverse events compared to 2 (28.6%) patients who received placebo.

There were no trends noted with increasing dose in the number of adverse events overall or within any preferred term.

The most frequently

occurring adverse events were hypoglycemia and diarrhea, each occurring in three AZD5658-treated patients.

One adverse event of ear pain

(30 mg AZD5658 fed) was assessed by the study investigator as moderate in intensity;

all other adverse events were of mild intensity.

Five adverse events in AZD5658- treated patients were assessed by the investigator as causally related to investigational product, including

hypoglycemia in three patients (100 mg, 200 mg fasted, and 400 mg AZD5658), diarrhea in one patient (200 mg AZD5658 fasted), and headache

in one patient (30 mg AZD5658).

No adverse events in placebo-treated patients were assessed as causally related to investigational product.

The three patients who experienced hypoglycemia adverse events were treated with intake of food or orange juice and the episodes resolved

in less than one hour.

was subject to five Phase I clinical studies, with a total of 1,181 subjects being exposed to AZD5904.

15 unchanged sentences

II trials are necessary to determine if the inhibition of MPO activity as a result of AZD5904 is statistically significant.

in Autoimmune Diseases

diseases refers to a broad group of diseases and conditions that arise from an abnormal immune response to a functioning body part.

example, autoimmune diseases may arise from an abnormal immune response of major organs (i.e., the heart, kidneys, bladder, liver, lungs,

and skin), glands (i.e., the adrenal gland, pancreas, thyroid, or reproductive organs), digestive system, and tissue (i.e., blood, connective

tissue, muscle, eyes, ears, or vascular system).

Management believes that there are over 80 types of autoimmune diseases that have been

identified, including lupus, celiac disease, multiple sclerosis, rheumatoid arthritis, psoriasis, and inflammatory bowel disease.

diseases are often difficult to diagnose and often the cause of the disease is not known.

in Autoimmune Disorders

disorders refers to a broad group of disorders and conditions that arise from an abnormal immune response to a functioning body part.

For example, autoimmune disorders may arise from an abnormal immune response of major organs (i.e., the heart, kidneys, bladder, liver,

lungs, and skin), glands (i.e., the adrenal gland, pancreas, thyroid, or reproductive organs), digestive system, and tissue (i.e., blood,

connective tissue, muscle, eyes, ears, or vascular system).

Management believes that there are over 80 types of autoimmune disorders

that have been identified, including lupus, celiac disease, multiple sclerosis, rheumatoid arthritis, psoriasis, and inflammatory bowel

Autoimmune disorders are often difficult to diagnose and often the cause of the disorders is not known.

is estimated by the American Autoimmune Related Diseases Association (“AARDA”) that as many as 50 million Americans are living

with an autoimmune disease – at a cost of $86 billion a year and there is presently no totally effective treatment known to management.

The currently available treatments for autoimmune diseases include non-steroidal anti-inflammatory drugs (“NSAIDS”) or immune

The currently available treatments for autoimmune disorders include non-steroidal anti-inflammatory drugs (“NSAIDS”) or immune

suppressants.

4 unchanged sentences

in over 1,000 patients with both type I and II diabetes and no significant safety concerns have been raised.

It was most recently

tested in the ARCADIA Phase II trial in diabetic patients hospitalized with Covid-19 on the basis of new research into

immunometabolic modulation.

We believe that AZD1656 may be used to activate a patient’s own immune system in order to limit

harmful inflation.

We have identified several autoimmune diseases, which reflects good market potential, with a high level of need

that may be treatable using AZD1656.

We believe that our clinical assets have the potential to treat numerous autoimmune diseases.

We intend to initially focus on the indications below in order to maximize the commercial potential of our clinical

Hashimoto’s Thyroiditis Disease

Thyroiditis (“HT”) is an autoimmune disease involving the improper functioning of the thyroid.

HT is an autoimmune disease

driven by T cells, which are one of the types of white blood cells, where the immune system attacks the thyroid gland.

believes that HT is the most prevalent autoimmune thyroid disease worldwide and anticipates that the prevalence of HT will continue to

increase due to rising obesity and the rising prevalence of other autoimmune disorders that made patients more susceptible to HT.

current treatment for HT involves hormone replacement therapy with levothyroxine.

However, determining the appropriate dose for each

individual is complex with the individual needing to continue hormone replacement therapy for the rest of his or her life while still

suffering with some symptoms of HT.

Under the current treatment, the patient is monitored by measuring Thyroid-Stimulating Hormone levels

In addition, this difficulty in titrating the appropriate dose of levothyroxine leads to a high burden of medical

appointments and the risk of development of comorbidities, including cardiovascular disease.

believes that the global thyroid gland disorders treatment market was valued at $2.23 billion in 2021 and is set to grow from $2.37 billion

in 2023 to $2.95 billion by 2030, at a CAGR of 3.17% during the forecast period (2023-2030).

was previously subject to preclinical and clinical trials, including Phase I and Phase II trials, conducted by AstraZeneca relating to

its potential to treat type 2 diabetes.

As of the date hereof, no preclinical or clinical trials have been conducted on the use of AZD1656

intend to conduct further trials on AZD1656 relating to HT.

We plan to conduct further research on AZD1656 to investigate if AZD1656

is a treatment option for HT, including investigating any negative side effects in the use of AZD1656 as compared to the currently available

treatment options for HT.

We, in connection with a CRO, have prepared clinical trial protocols for the use of AZD1656 in HT in a Phase

II clinical trial:

a Phase II, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of AZD1656 in patients

with HT with an anticipated enrollment of 200 patients.

Pharmaceutical

companies typically find market entry for HT clinical assets challenging due to the manufacturing complexities and careful consideration

of manufacturing product, which are usually patented or trade secrets of companies.

Due to its relationship with St George Street, we

have sufficient API to conduct Phase II clinical trials on AZD1656 for the treatment of HT.

There can be no assurances that the clinical

trials that we intend to conduct on AZD1656 to treat HT will be successful.

is an autoimmune disease of the eye that refers to a number of intraocular inflammatory conditions and involves the swelling of the uvea,

the colored portion of the eyes.

Management believes that in the U.S.

uveitis causes an estimated approximately 30,000 new cases of blindness

per year and may be the third leading cause of blindness worldwide.

3 Unlike other leading causes of blindness, uveitis is

particularly prevalent in younger working-age people.

Uveitis has a prevalence of around 40-100 per 100,000 persons, and can be subdivided

into specific conditions, so it qualifies as a rare disease.

4 We believe that a treatment for non-infectious uveitis would

be eligible for orphan drug designation, which provides for market exclusivity of 10 years in the European Union and seven years in the

United States.

The global uveitis market size was valued at $456 million in 2022 and is estimated to reach $837 million by 2030, growing

at a CAGR of 4.8% during the forecast period (2023-2030).

“Epidemiology

of uveitis in a US population-based study,” by Marta Mora Gonzalez, Marisee Masis Solano, Travis C.

Porco, Catherine E.

Acharya, Shan C.

Lin, and Matilda F.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5904090/)

“Epidemiology

and risk factors in non-infectious uveitis:

a systemic review,” by Katherine A.

and Anne-Marie Lobo-Chan (Link:

It was most recently tested

in the ARCADIA Phase II trial in diabetic patients hospitalized with Covid-19 on the basis of new research into immunometabolic modulation.

We believe that AZD1656 may be used to activate a patient’s own immune system in order to limit harmful inflation.

We have identified

several autoimmune disorders, which reflects good market potential, with a high level of need that may be treatable using AZD1656.

believe that our clinical assets have the potential to treat numerous autoimmune disorders.

We intend to initially focus on the indications

below in order to maximize the commercial potential of our clinical assets.

Nephritis (“LN”) is a severe progression of Systemic Lupus Erythematosus (“SLE”) where the immune system attacks

the kidneys, often resulting in renal failure.

There is currently no cure or long-term remission treatment available.

LN is clinically

evident in 50-60% of patients with SLE, and is histologically evident in most SLE patients, even those without clinical manifestations

of kidney disease.

LN is the main cause of SLE related mortality.

Current therapy is based on long-term corticosteroid or immunosuppressive

therapy, with clinical efficacy of biological drugs not yet proven in LN.

Side effect issues of all current therapies demonstrate an

unmet need for a safer, patient compliant therapy in LN.

Company believes that LN presents a lucrative opportunity given the potential oversight of two conditions, as a Phase IIa trial can be

designed to allow readouts on the wider characteristics of SLE as well as the nephritis aspects, allowing assessment of the potential

of AZD1656 in the field of SLE as a whole.

Additionally, LN is an orphan disease that the Company believes has around 80,000 to 100,000

patients in the U.S., and one million patients worldwide, thereby offering additional incentives for investors.

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

billion by 2032, exhibiting a CAGR of 10.3% during the forecast period.

is characterized by dysregulation and a hyperactivity of immune response.

In LN, Teff subtype (TH17) has shown significant hyperactivation

leading to skewed T cell differentiation resulting in continued proinflammatory environment, leading to prolonged inflammation and subsequent

tissue damage and organ function loss.

TH17/Treg dysregulation has been characterized in lupus patients compared to healthy individuals.

a study in mice, findings showed that the IL2/CD25 fusion protein that selectively targets IL-2 on Treg cells induced immune suppression

in a preclinical LN model demonstrating inhibition of LN based on levels of proteinuria, autoantibody titers and kidney histology scores.

Vasculitis (“AAV”) is an orphan status autoimmune disease affecting small blood vessels which can lead to multiple organ

injury, especially the kidneys, lungs and peripheral nerves.

Undiagnosed AAV has a 90% mortality rate within two years.

maintenance therapies rely on combination of corticosteroid and rituximab, both known for long term use side effects.

Recently approved

drugs target specific subpopulations of AAV and have tolerability and side effect issues which demonstrate an unmet need for safer long-term

therapies applicable to all AAV sufferers.

imbalance of Th17/activated Treg cells has been shown in AAV and this has been correlated with renal involvement (with a positive correlation

in creatinine and BUN levels).

dose IL2 therapy in AAV patients, the Company believes, resulted in rebalance of Th17/Treg ration.

The levels of Erythrocyte Sedimentation

Rate (ESR) and C-Reactive Protein (CSR) were also significantly decreased, which the Company believes indicates an improvement in disease

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,

exhibiting a CAGR of 4.22% during 2024 to 2034.

Paquissi FC et al.

Front Med (Lausanne).

654912 ( https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8446428/ )

which can cause elevated intraocular pressures and cataracts, are often used to manage uveitis.

Most patients develop elevated intraocular

pressures and/or cataracts after long-term treatment with steroids and may have to switch therapies or the disease may become resistant

to steroid treatment.

Biological drugs have been developed but these are expensive and not always effective as many patients still go

blind every year.

was previously subject to preclinical and clinical trials, including Phase I and Phase II trials, conducted by AstraZeneca relating to

its potential to treat type 2 diabetes.

As of December 31, 2023, no preclinical or clinical trials have been conducted on the use of

AZD1656 to treat uveitis.

We, in connection with a CRO, have prepared clinical trial protocols relating to the use of AZD1656 in uveitis

in a Phase II clinical trial:

a Phase II, double-blind, placebo-controlled study to evaluate the efficacy and safety of ADZ1656 in patients

with non-infectious uveitis with an anticipated enrollment of 120 patients.

We intend to conduct further trials on AZD1656 in order to

investigate if AZD1656 is an option to treat uveitis without the side effects involved in the current treatment using steroids.

can be no assurances that the clinical trials that we intend to conduct on AZD1656 to treat uveitis will be successful.

Transplant Failure

transplant failure occurs when a patient’s body rejects a kidney transplant and involves the gradual decrease in kidney function

that starts following a kidney transplant surgery and often results in organ failure.

According to the United Network for Organ Sharing,

there are around 93,000 patients waiting for a kidney transplant in the U.S.

The United Network for Organ Sharing reports that the prevalence

of chronic kidney disease is rising due to other conditions, such as diabetes, and as a result of an aging population.

The Organ Procurement

& Transplantation Network reported that during 2023, over 46,000 individuals received an organ transplant and all-time volume records

were set for kidney transplants of 27,329.

6 Management believe that the global kidney transplant market is estimated to be

valued at $5.8 billion in 2021 and is expected to register a CAGR of 4.2% through to 2033.

current treatment for renal transplant failure involves using immunosuppressives to suppress the patient’s immune system, which

has numerous side effects including high blood pressure, weight gain, diabetes, dyslipidemia and some cancers.

Malignancy, which refers

to uncontrolled growth and division of abnormal cells, is one of the most common causes of death in kidney transplant recipients.

Immunosuppressives

are a major contributing factor to malignancy.

was previously subject to preclinical and clinical trials, including Phase I and Phase II trials, conducted by AstraZeneca relating to

its potential to impact on renal transplant patients with type 2 diabetes.

We believe that AZD1656 may facilitate the immune system in

tolerating or accepting the transplanted kidney.

We intend to conduct Phase II studies on AZD1656 to investigate if AZD1656 decreases

the rejection in kidney transplant patients.

We are currently working with a CRO to prepare protocols for clinical trials to investigate

the use of AZD1656 to reduce the rejection in kidney transplant patients.

There can be no assurances that the clinical trials that we

intend to conduct on AZD1656 to treat renal transplant patients will be successful.

labor refers to labor that begins before 37 weeks of pregnancy.

Preterm labor may result in premature birth and the earlier the

premature birth happens, the greater the of health risks for the baby.

According to an article published in PubMed, globally, 14.84

million babies were preterm births.

8 Preterm labor is a condition that may result in the death of the baby and/or the

There is no effective treatment for preterm labor that is known to us.

Management believes that approximately 60,000 babies

per year in the U.K.

according to the Mums and Midwives Awareness Academy and approximately 380,000 per year in the U.S.

preterm according to the Preeclampsia Foundation.

Globally, prematurity is the leading cause of death in children under the age of

five years, and preterm labor rates are increasing.

For example, according to the Centers for Disease Control and Prevention, in the

U.S., the preterm labor rate rose for the fifth straight year in 2019.

For 2021, the preterm labor rate in the U.S.

approximately 10.5%.

According to the World Health Organization, the rates of preterm labor by country range from approximately 5%

to approximately 18%.

Management believe that the global preterm birth prevention and management market size is estimated to stand

at $1.70 billion in 2024.

As both developed and developing countries embrace therapeutics for preventing and managing preterm birth,

the market is expected to exceed a valuation of $4.49 billion by 2034, registering a CAGR of 10.2%.

Preterm labor results in

increases costs, both higher costs of labor and neonatal care, and often results in additional medical care during the child’s

lifetime for those that are born prematurely.

Accordingly, the reduction in preterm labor would have a significant health and

economic impact.

https://optn.transplant.hrsa.gov/news/continued-increase-in-organ-donation-drives-new-records-in-2023-

new-milestones-exceeded/

19-29 (https://pubmed.ncbi.nlm.nih.gov/34108258/)

Hunter et al.

2020;369 (https://www.bmj.com/content/369/bmj.m1070)

19-29 (https://pubmed.ncbi.nlm.nih.gov/34108258/)

was previously subject to preclinical and clinical trials, including Phase I and Phase II trials, conducted by AstraZeneca relating to

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As of the date hereof, no preclinical or clinical trials have been conducted on the use of AZD1656

to treat preterm labor.

Specially, we intend to conduct a Phase II study on the use of AZD1656 to assist in maintaining pregnancy beyond

in connection with a CRO, have prepared clinical trial protocols relating to the use of AZD1656 in preterm labor in a Phase II clinical

a multicenter, randomized, double-bind, placebo-controlled Phase II clinical trial evaluating the efficacy and safety of AZD1656

in the prevent of preterm labor with an anticipated enrollment of 200 patients.

In the event that AZD1656 is shown to be able to effectively

treat preterm labor (of which there can be no assurance), AZD1656 could potentially maintain a pregnancy for longer, reduce the number

of babies that are born prematurely and reduce the costs associated with preterm labor.

There can be no assurances that the clinical

trials that we intend to conduct on AZD1656 to treat preterm labor will be successful.

drugs for preterm labor are only used for about 24-48 hours once a woman is already in labor, so that the patients can be treated with

corticosteroids to promote the functioning of the baby’s lungs.

These drugs are unable to sustain a pregnancy beyond this and are

not safe to be used for prolonged periods.

We believe that, in the event that AZD1656 is shown to be able to effectively treat preterm

labor (of which there can be no assurance), AZD1656 could potentially maintain a pregnancy for longer, reduce the number of babies that

are born prematurely and reduce the costs associated with preterm labor.

in Infectious Diseases – Covid-19 and Long Covid

is a disease caused by a virus named SARS-CoV-2, which refers to severe acute respiratory syndrome coronavirus 2, and is a strain of

the coronavirus, which is a respiratory illness.

We continue to have an economic interest in AZD1656 for treatment of Covid-19 and have

included AZD1656 for the treatment of Covid-19 in our pipeline.

However, at this time, we do not intend to provide additional funding

to develop AZD1656 for Covid-19.

However, we are entitled to a portion of the revenues in the event that AZD1656 is further developed

by St George Street or other third parties and is monetized, whether through a sale, license agreement, or otherwise.

While we do not

intend to further fund the research and development of the use of AZD1656 in Covid, we retain an economic interest in the clinical asset

and if such asset is further developed through funding provided by other third parties, then we may be entitled to receive compensation

from those development activities conducted by third parties.

There can be no assurances that AZD1656 will be further developed or commercialized

for the treatment of Covid-19 or Long Covid.

to treat autoimmune disorders.

intend to conduct further trials on AZD1656 relating to autoimmune disorders.

We plan to conduct further research on AZD1656 to investigate

if AZD1656 is a treatment option, including investigating any negative side effects in the use of AZD1656 as compared to the currently

available treatment options.

in Idiopathic Male Infertility

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an unknown cause.

8 According to the National Library of Medicine, male infertility accounts for 30% of infertility cases and

its prevalence in the general population approximately ranges between 9 and 15%.

9 Our management believes that male sperm

counts have declined in Western men and will continue to decline due, in part, to increasing rates of diseases such as obesity and diabetes

that can reduce fertility.

5 According to the National Library of Medicine, male infertility accounts for 30% of infertility cases

and its prevalence in the general population approximately ranges between 9 to 15%.

6 Our management believes that male

sperm counts have declined in Western men and will continue to decline due, in part, to increasing rates of disorders such as obesity

and diabetes that can reduce fertility.

affects families worldwide and is inherent in problems of reproduction.

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a CAGR of 3.54% during the period 2023-2028.

unique view on male infertility around the globe,” by Ashok Agarwal, Aditi Mulgund, Alaa Hamada, and Michelle Renee Chyatte

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4424520/).

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10057583/#B1-jcm-12-02366

sperm are unable to successfully fertilize eggs due to factors including impaired motility, impaired ability to penetrate and/or DNA

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Clinical Assets

part of our strategic planning process, we intend to explore the efficacy of using AZD1656 to treat other diseases.

Specifically, we

intend to conduct research on whether AZD1656 may be effective treating other autoimmune diseases, include systemic lupus erythematosus,

ANCA vasculitis, rheumatoid arthritis, multiple sclerosis, motor neuron disease, and amyotrophic lateral sclerosis.

part of our strategic planning process, we intend to explore the efficacy of using AZD1656 and AZD5658 to treat other disorders.

Specifically, we intend to conduct research on whether AZD1656 and AZD5658 may be effective treating other autoimmune disorders,

include rheumatoid arthritis, multiple sclerosis, motor neuron disease, and amyotrophic lateral sclerosis.

As part of our strategic

planning process, we intend to explore the efficacy of using AZD1656 to treat other diseases.

We also plan to further develop the co-crystals

that we own from our prior development work on AZD1656, including to research the ability of the co-crystals developed from AZD1656 to

treat psoriasis, Crohn’s disease, lupus, sarcoidosis, diabetic wound healing, idiopathic pulmonary fibrosis, and nonalcoholic steatohepatitis.

planning process, we intend to explore the efficacy of using AZD1656 to treat other disorders.

We also plan to further develop the

co-crystals that we own from our prior development work on AZD1656, including to research the ability of the co-crystals developed

from AZD1656 to treat psoriasis, Crohn’s disease, lupus, sarcoidosis, diabetic wound healing, idiopathic pulmonary fibrosis,

and non-alcoholic steatohepatitis.

In addition, we currently intend to explore the use of AZD5904 for the treatment of glioma.

Due to our on-going relationship with St

George Street, from time to time, there may be additional clinical assets that we are able to partner with St George Street to develop.

We expect to seek to develop other clinical assets and determine based on pre-clinical and clinical data which clinical assets in order

expect to seek to develop other clinical assets and determine based on pre-clinical and clinical data which clinical assets in order

to determine which assets in our pipeline to continue to develop.

Accordingly, we believe that our management team will be able to effectively

allocate resources to the development of clinical assets that we believe show the most promise.

However, there can be no guarantee that

the clinical trials conducted by us of our clinical assets will be successful.

If we are unable to commercialize our clinical assets

or experience significant delays in doing so, our business will be materially harmed.

Accordingly, we believe that our management team will be able to

effectively allocate resources to the development of clinical assets that we believe show the most promise.

However, there can be no

guarantee that the clinical trials conducted by us of our clinical assets will be successful.

If we are unable to commercialize our

clinical assets or experience significant delays in doing so, our business will be materially harmed.

Manufacturing

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that we are developing or may seek to develop and do not currently have the capabilities to conduct such activities.

We currently plan

to rely on third parties to manufacture, store, and test the clinical assets that we seek to develop, including material manufactured

originally by AstraZeneca.

We will depend on third-party suppliers and manufacturing organizations for all our required raw materials

and drug substance and to formulate, manufacture, test, store, package, and distribute clinical trial quantities of clinical assets that

we may seek to develop.

We plan to continue to use third-party suppliers and manufacturing organizations and we anticipate expanding

our network of third-party suppliers and manufacturing organizations as our operations expand.

We currently rely

on third parties to manufacture, store, and test the clinical assets that we seek to develop, including material manufactured originally

by AstraZeneca.

We will depend on third-party suppliers and manufacturing organizations for all our required raw materials and drug substance

and to formulate, manufacture, test, store, package, and distribute clinical trial quantities of clinical assets that we may seek to

We plan to continue to use third-party suppliers and manufacturing organizations and we anticipate expanding our network of

third-party suppliers and manufacturing organizations as our operations expand.

“A unique view on male infertility around the globe,” by Ashok Agarwal, Aditi Mulgund, Alaa Hamada, and Michelle Renee

Chyatte (Link:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4424520/).

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10057583/#B1-jcm-12-02366

have internal personnel and utilize consultants with extensive technical, manufacturing, analytical, and quality experience to oversee

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research and development activities have included developing co-crystals of AZD1656 to increase patent life.

Some of this work was completed

by third-party CROs but all intellectual property is retained by us.

The successful completion of clinical trials increases the value

of clinical assets and may lead to the commercialization and/or licensing of such assets to other pharmaceutical companies.

no assurance that any clinical trials on the assets owned or licensed by us will be successful or any assurance our co-crystal development

will be successful.

Most of this work is conducted

in our laboratories based in Cambridge, UK, but parts of this work is completed by third-party CROs but all intellectual property is

retained by us.

The successful completion of clinical trials increases the value of clinical assets and may lead to the commercialization

and/or licensing of such assets to other pharmaceutical companies.

There is no assurance that any clinical trials on the assets owned

or licensed by us will be successful or any assurance our co-crystal development will be successful.

do not intend to further fund the research and development of the use of AZD1656 in Covid;

however, we retain an economic interest in

the clinical asset and if such asset is further developed through funding provided by other third parties, then we may be entitled to

receive compensation from those development activities conducted by third parties due to its economic interest in AZD1656 in Covid.

the AZD1656 in the indication of Covid and if AZD1656 is further developed in Covid through funding provided by other third parties,

then we may be entitled to receive compensation from those development activities conducted by third parties due to its economic interest

in AZD1656 in Covid.

and Marketing

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competitive advantage.

hold exclusive rights to develop AZD1656 and AZD5904 through our Global Funding Agreement with St George Street and we also own the intellectual

hold exclusive rights to develop AZD1656, AZD5658, and AZD5904 through our License Agreement with AstraZeneca and we also own the intellectual

property and the rights to further develop co-crystals resulting from our prior research and development work on AZD1656.

currently have one pending international patent application and two pending national patent applications.

Even though we have filed patent

applications, there is no guarantee that the validity of the patents will be upheld if challenged by a third party, that patents will

be granted on the applications filed in the respective jurisdictions, or that once granted, the patents will contain claims that encompass

our commercial products.

On December 18, 2024, Conduit UK Management Limited (“Conduit”) received a notification from the UK Intellectual

Property Office (“UK IPO”) notifying the company that St George Street Capital had initiated patent entitlement proceedings

with respect to patent application PCT/IB2022/00775 (“Patent Application”).

Conduit refutes the claims made by St George Street

Capital and filed a counterstatement on February 26, 2025 with the UK IPO.

In addition, each of the three inventors named in the Patent

Application filed simultaneous counterstatements fully supporting Conduit’s position, and assertions that the claims are without

Further updates will be made following notification by the UK IPO.

currently have eight pending patent applications in several international jurisdictions.

Even though we have filed patent applications,

there is no guarantee that the validity of the patents will be upheld if challenged by a third party, that patents will be granted on

the applications filed in the respective jurisdictions, or that once granted, the patents will contain claims that encompass our commercial

There can be no assurance that any of our intellectual property rights will afford us any protection from competition.

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101901 (family number)

to St George Street Capital from AstraZeneca for use in thyroiditis, uveitis, pre-term labor, renal transplant failure.

Brazil, Canada, Switzerland, China, Germany, European Procedure, Spain, France, United Kingdom, Hong Kong, India, Japan, South Korea,

Mexico, Netherlands, Russian Federation, Sweden, Turkey, United States

to Conduit from AstraZeneca for use in all human indications.

Granted and in force.

Canada, Switzerland, China, Germany, European Procedure, Spain, France, United Kingdom, Hong Kong, India, Japan, South Korea, Mexico,

Netherlands, Russian Federation, Sweden, Turkey, United States.

Granted in Australia

July 3, 2026.

103631 (family number)

to St George Street Capital from AstraZeneca for use in thyroiditis, uveitis, pre-term labor, renal transplant failure.

to Conduit from AstraZeneca for use in human applications.

Granted and in force.

and United States

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If granted, will expire September 2, 2042.

JP2022-176753

by Conduit Pharmaceuticals.

November 2, 2022.

November 2, 2042.

Male Infertility;

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[WO/2019/016074]

to St George Street Capital from AstraZeneca.

to Conduit from AstraZeneca.

International

July 12, 2038.

of Matter Patent;

101901 (family number)

to Conduit from AstraZeneca for use in all human indications.

Granted and in force.

Brazil, Canada, Switzerland, China, Germany, European Procedure, Spain, France, United Kingdom, Hong Kong, India, Japan, South Korea,

Mexico, Netherlands, Russian Federation, Sweden, Turkey, United States

have not filed any applications for trademark protection of any names or logos for products or technologies in development.

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and regulations have no guaranteed outcomes and require the expenditure of substantial time and financial resources.

development plan for each of AZD1656 and AZD5904 is to conduct clinical trials and if those trials are successful, we will then seek

to enter into a transaction with a third party with respect to AZD1656 orAZD5904, as applicable, for the particular indication.

not intend to continue development of such clinical assets beyond Phase II clinical trials.

Accordingly, we anticipate developing clinical

assets, which we own or license from third parties, that have undergone pre-clinical and clinical trials through the Phase II stage and

then monetizing such clinical assets through a license, royalty, or other transaction.

We do not expect that we will commercialize any

clinical assets or seek marketing approval from the FDA (or similar organizations) as we intend to enter into agreements with third parties

following Phase II clinical trials for each such clinical asset that would provide that such third party would pursue the further development,

commercialization, and marketing of such assets.

development plan for each of AZD1656, AZD5658 and AZD5904 is to conduct clinical trials and if those trials are successful, we will then

seek to enter into a transaction with a third party with respect to AZD1656, AZD5658 orAZD5904, as applicable, for the particular indication.

We do not intend to continue development of such clinical assets beyond Phase II clinical trials.

Accordingly, we anticipate developing

clinical assets, which we own or license from third parties, that have undergone pre-clinical and clinical trials through the Phase II

stage and then monetizing such clinical assets through a license, royalty, or other transaction.

We do not expect that we will commercialize

any clinical assets or seek marketing approval from the FDA (or similar organizations) as we intend to enter into agreements with third

parties following Phase II clinical trials for each such clinical asset that would provide that such third 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

2 unchanged sentences

States Government Regulation

the United States, the U.S.

Food and Drug Administration (“FDA”) regulates drugs under the Federal Food, Drug, and Cosmetic

the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic

Act (“FDCA”) and implementing regulations.

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subjects are being exposed to an unacceptable health risk.

Similarly, an Institutional Review Board (“IRB”) can suspend or

Similarly, an IRB can suspend or

terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s

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Failure to timely register a covered clinical study or to submit study results

as provided for in the law can give rise to civil monetary penalties and also prevent the non-compliant party from receiving future grant

as provided for in the law can give rise to civil monetary penalties and prevent the non-compliant party from receiving future grant

funds from the federal government.

The government has recently begun enforcing these registration and results reporting requirements

The government has begun enforcing these registration and results reporting requirements

against non-compliant clinical trial sponsors.

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approval must meet the same statutory standards for safety and effectiveness as those granted traditional approval.

accelerated approval pathway is usually contingent on a sponsor’s agreement to conduct, in a diligent manner, additional post-approval

confirmatory studies to verify and describe the drug’s clinical benefit.

As a result, a therapeutic candidate approved on this

basis is subject to rigorous post-marketing compliance requirements, including the completion of Phase 4 or post-approval clinical trials

to confirm the effect on the clinical endpoint.

Failure to conduct required post-approval studies, or to confirm the predicted clinical

benefit of the product during post-marketing studies, would allow the FDA to withdraw approval of the drug.

All promotional materials

for drug products being considered and approved under the accelerated approval program are subject to prior review by the FDA.

FDA officials, and other stakeholders have recently been evaluating the accelerated approval program and have proposed potential reforms

to improve certain aspects.

Scrutiny of the accelerated approval pathway is likely to continue and may lead to legislative and/or administrative

changes in the future.

accelerated approval pathway is usually contingent on a sponsor’s agreement to conduct, in a diligent manner, additional

post-approval confirmatory studies to verify and describe the drug’s clinical benefit.

As a result, a therapeutic candidate

approved on this basis is subject to rigorous post-marketing compliance requirements, including the completion of Phase 4 or

post-approval clinical trials to confirm the effect on the clinical endpoint.

Failure to conduct required post-approval studies, or

to confirm the predicted clinical benefit of the product during post-marketing studies, would allow the FDA to withdraw approval of

All promotional materials for drug products being considered and approved under the accelerated approval program are

subject to prior review by the FDA.

Lawmakers, FDA officials, and other stakeholders continually evaluate the accelerated approval

program which may lead to legislative and/or administrative changes in the future.

Post-Approval

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and impose requirements to ensure accountability in distribution.

More recently, the Drug Supply Chain Security Act (the “DSCSA”),

The Drug Supply Chain Security Act (the “DSCSA”),

was enacted with the aim of building an electronic system to identify and trace certain prescription drugs distributed in the United

The DSCSA mandates phased-in and resource-intensive obligations for pharmaceutical manufacturers, wholesale distributors, and

dispensers over a 10-year period that were expected to culminate in November 2023.

The DSCSA mandated phased-in and resource-intensive obligations for pharmaceutical

manufacturers, wholesale distributors and dispensers by November 2023, but, so as not to disrupt supply chains, the FDA has granted certain

exemptions from enhanced drug distribution security requirements for eligible trading partners for particular periods of time.

From time to time, new legislation and regulations

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products (such as gene-therapy, somatic cell-therapy or tissue-engineered medicines) and products with a new active substance indicated

for the treatment of certain diseases.

For products with a new active substance indicated for the treatment of certain diseases and products

that are highly innovative or for which a centralized process is in the interest of patients, the centralized procedure may be optional.

for the treatment of certain disorders.

For products with a new active substance indicated for the treatment of certain disorders and

products that are highly innovative or for which a centralized process is in the interest of patients, the centralized procedure may

Under the centralized procedure the maximum timeframe for the evaluation of an MAA by the European Medicines Agency (“EMA”)

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Agreement, which went into effect on January 1, 2021.

It remains to be seen how, if at all, Brexit and the Trade and Cooperation Agreement

will impact regulatory requirements for product candidates and products in the United Kingdom.

We are currently evaluating the potential

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the regulatory framework for pharmaceutical products in the United Kingdom covering the quality, safety and efficacy of pharmaceutical

products, clinical trials, marketing authorization, commercial sales and distribution of medicinal products is derived from EU Directives

and Regulations, Brexit could materially impact the future regulatory regime which applies to such products and the approval of product

candidates in the United Kingdom.

Such outcomes could make it more difficult and expensive for us to do business in Europe, complicate

our clinical, manufacturing and regulatory strategies and impair our ability to obtain and maintain regulatory approval for, and, if

approved, commercialize, our products and product candidates in Europe.

products, clinical trials, marketing authorization, commercial sales and distribution of medicinal products has only recently changed,

it is difficult to draw comparisons about the impact of the new regulatory regime and impact on the approval of product candidates in

the United Kingdom.

In addition, even if a drug is licensed in the UK by the MHRA, it must further be approved by the National Institute

for Health & Care Excellence to ensure use within the UK’s National Health Service (NHS).

Pharmaceutical

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an important decision that has led to further and more aggressive efforts by states in this area.

recently, on August 16, 2022, President Biden signed into the law the Inflation Reduction Act of 2022, or the IRA.

Among other things,

the IRA has multiple provisions that may impact the prices of drug products that are both sold into the Medicare program and throughout

the United States.

Starting in 2023, a manufacturer of drugs covered by Medicare Parts B or D must pay a rebate to the federal government

if their drug product’s price increases faster than the rate of inflation.

This calculation is made on a drug product by drug product

basis 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 Medicare Parts B or D.

Additionally, starting for payment year 2026, CMS will negotiate drug prices annually for a select number

of single source Part D drugs without generic or biosimilar competition.

CMS will also negotiate drug prices for a select number of Part

B drugs starting for payment year 2028.

If a drug product is selected by CMS for negotiation, it is expected that the revenue generated

from such drug will decrease.

On August 16, 2022, President

Biden signed into the law the Inflation Reduction Act of 2022, or the IRA.

Among other things, the IRA has multiple provisions that can

impact the prices of drug products that are both sold into the Medicare program and throughout the United States.

Beginning in 2023, a

manufacturer of drugs covered by Medicare Parts B or D must pay a rebate to the federal government if their drug product’s price

increases faster than the rate of inflation.

This calculation is made on a drug product by drug product basis 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 Medicare Parts B or D.

Additionally,

starting for payment year 2026, CMS will negotiate drug prices annually for a select number of single source Part D drugs without generic

or biosimilar competition.

CMS will also negotiate drug prices for a select number of Part B drugs starting for payment year 2028.

a drug product is selected by CMS for negotiation, it is expected that the revenue generated from 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.

The EU GDPR is an EU Regulation

and it no longer applies to the UK.

If you operate inside the UK, you need to comply with the Data Protection Act 2018 (DPA 2018).

provisions of the EU GDPR have been incorporated directly into UK law as the UK GDPR.

On 28 June 2021, the EU approved adequacy decisions

for the EU GDPR and the Law Enforcement Directive (LED).

This means data can continue to flow freely from the EU to the UK, in the majority

Cayman Islands Government enacted the Data Protection Act on May 18, 2017 (as amended, the “DPA”).

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authorizing the payment of money or anything of value to a foreign official in order to influence any act or decision of the foreign

official in his or her official capacity or to secure any other improper advantage in order to obtain or retain business for or

with, or in order to direct business to, any person.

The prohibitions apply not only to payments made to “any foreign

official,” but also to those made to “any foreign political party or official thereof,” to “any candidate

for foreign political office” or to any person, while knowing that all or a portion of the payment will be offered, given, or

promised to anyone in any of the foregoing categories.

“Foreign officials” under the FCPA include officers or employees

of a department, agency, or instrumentality of a foreign government.

The term “instrumentality” is broad and can include

state-owned or state-controlled entities.

Importantly, United States authorities deem most healthcare professionals and other

employees of foreign hospitals, clinics, research facilities and medical schools in countries with public healthcare and/or public

education systems to be “foreign officials” under the FCPA.

When we interact with foreign healthcare professionals and

researchers in testing and marketing our products abroad, should any of our product candidates receive foreign regulatory approval

in the future, we must have policies and procedures in place sufficient to prevent us and agents acting on our behalf from providing

any bribe, gift or gratuity, including excessive or lavish meals, travel or entertainment in connection with marketing our products

and services or securing required permits and approvals.

The FCPA also obligates companies whose securities are listed in the United

States to comply with accounting provisions requiring us to maintain books and records that accurately and fairly reflect all

transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal

accounting controls for international operations.

official in his or her official capacity or to secure any other improper advantage in order to obtain or retain business for or with,

or in order to direct business to, any person.

The prohibitions apply not only to payments made to “any foreign official,”

but also to those made to “any foreign political party or official thereof,” to “any candidate for foreign political

office” or to any person, while knowing that all or a portion of the payment will be offered, given, or promised to anyone in any

of the foregoing categories.

“Foreign officials” under the FCPA include officers or employees of a department, agency, or

instrumentality of a foreign government.

The term “instrumentality” is broad and can include state-owned or state-controlled

Importantly, United States authorities deem most healthcare professionals and other employees of foreign hospitals, clinics,

research facilities and medical schools in countries with public healthcare and/or public education systems to be “foreign officials”

under the FCPA.

When we interact with foreign healthcare professionals and researchers in testing and marketing our products abroad,

should any of our product candidates receive foreign regulatory approval in the future, we must have policies and procedures in place

sufficient to prevent us and agents acting on our behalf from providing any bribe, gift or gratuity, including excessive or lavish meals,

travel or entertainment in connection with marketing our products and services or securing required permits and approvals.

The FCPA also

obligates companies whose securities are listed in the United States to comply with accounting provisions requiring us to maintain books

and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise

and maintain an adequate system of internal accounting controls for international operations.

are also subject to U.K.

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interpreted or enforced, nor can we ensure we will be able to obtain or maintain any required licenses or permits.

of December 31, 2023, we had a total of seven full-time employees and two consultants.

of December 31, 2024, we had a total of six full-time employees.

currently rely on several consultants who provide services to our Company.

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of the Business Combination in September 2023.

principal executive offices are located at 4995 Murphy Canyon Road, Suite 300, San Diego, CA 92123.

principal executive offices are located at 4581 Tamiami Trail North, Suite 200 Naples, Florida.

Our telephone number is +1 (646)-491-9132,

1 unchanged sentence

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business