OTC: AGTX

Overview

As a result of the Share Exchange Agreement, we plan to focus our business efforts on the development and commercialization of novel therapeutics to treat metabolic disease. Our principal business objective is to develop two key assets specifically designed to not cross the blood brain barrier (BBB); i.e., are “peripherally-restricted”. With these two assets, Agentix will endeavor to establish a firm presence in the area of metabolic syndrome.

Metabolic syndrome, variously known also as syndrome X, insulin resistance, etc., has been defined by the WHO as a pathologic condition characterized by abdominal obesity, insulin resistance, hypertension, and hyperlipidemia. Though it started in the Western world, with the spread of the Western lifestyle, it has become now a truly global problem. The prevalence of the metabolic syndrome is often more in the urban population of some developing countries than in its Western counterparts. The two basic forces spreading this malady are the increase in consumption of high calorie-low fiber fast food and the decrease in physical activity due to mechanized transportations and sedentary form of leisure time activities. The syndrome feeds into the spread of the diseases like type 2 diabetes, coronary diseases, stroke, and other disabilities1 (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5866840/).

The incidence of metabolic syndrome often parallels the incidence of obesity and incidence of type 2 diabetes (one of the outcomes of MetS). According to global survey of obesity in 195 countries, done in 2015, 604 million adults and 108 million children were obese. Since 1980, prevalence of obesity doubled in 73 countries and increased in most other countries. Of even greater concern was that the rate of increase was even higher in childhood obesity. According to IDF diabetes atlas, global prevalence of diabetes is 8.8% (415 m) as of 2015 and is expected to increase to 10.4% (642 m) by 2040. While there is difficulty on gathering the same quality of data for metabolic syndrome, some estimates have the global prevalence to be about one quarter of the world population – which amounts to over a billion people in the world are now affected with metabolic syndrome1.

The above factors will in part drive the global demand for biopharmaceuticals, along with an increase in the global acceptance of biopharmaceuticals to treat and manage these medical conditions. In addition, an increase in strategic partnerships between biopharmaceutical companies is also expected to complement the growth of the biopharmaceuticals industry. Furthermore, clearance for newer biopharmaceutical products and continuous R&D is also expected to improve this market positively. We envision that Agentix will play the part of developing new chemical entities to the initial stages of clinical efficacy and then partner with larger biopharma players for the pivotal stages of commercialization.

Cannabinoid type 1 receptor is expressed in several peripheral locations, such as the liver, adipose tissue, and pancreas, where it is involved in the regulation of various physiological effects, including glucose and lipid metabolism. It is also expressed in the central nervous system (CNS) where it regulates functions such as appetite and reward. Peripheral CB1 receptors have been demonstrated to regulate glucose and lipid metabolism. Blockade of peripheral CB1 receptors in preclinical animal models results in a significant reduction in lipogenesis and gluconeogenesis, enhancement of insulin sensitivity, decreased adiposity and hepatic steatosis, and protection in pancreatic β cells, demonstrating the potential of this strategy for amelioration of obesity and nonalcoholic fatty liver disease, and also reduced incidence of T2DM. Thus, developing antagonists targeting peripheral CB1 receptors, without inducing psychological adverse effects, is a potential therapeutic strategy in managing these conditions.

Previous attempts to target the peripheral CB1 receptor by Pfizer (otenabant), Merck (taranabant) and Sanofi (rimonabant) were terminated due to toxicities resulting from these drug candidates crossing the blood-brain barrier. A renewed pharmaceutical development effort is underway to target peripheral CB1 receptors by designing drug candidates that are restricted from crossing the blood-brain barrier, and exert their therapeutic effect only within the periphery. For example, Takeda has entered into a license agreement with Goldfinch Bio to develop a monoclonal antibody with targets the peripheral CB1 receptor. Inversago Pharma is developing a peripherally-restricted CB1 inverse agonist as a possible treatment for the rare genetic disorder Prader Willi Syndrome.

Our Pipeline

AGTX-2004

AGTX-2004 (also known as DBPR211) is a peripherally-acting CB1 receptor antagonist that has demonstrated efficacy in animal models of obesity and type 2 diabetes mellitus (T2DM). AGTX-2004 was well tolerated in animal models of toxicity, and did not cross the blood-brain barrier. An Investigational New Drug Application (IND application) was cleared by the Food & Drug Administration of the United States of America (FDA), and we are preparing to commence a Phase 1 safety and tolerability dose escalation assessment in humans. This study will take place under the management of our subsidiary Agentix Australia Pty Ltd.

We entered into a worldwide exclusive license agreement with Taiwan’s National Health Research Institute (NHRI) on March 21, 2021 for exclusive worldwide rights development and commercial rights to AGTX-2004. In exchange to global rights to the asset and its intellectual property, we will pay NHRI a series of development and commercialization milestones, and will pay royalties on product sales once obtaining market authorization from competent regulatory authorities.

AGTX-2003

AGTX-2003 (also known as RTI-1092769) is a peripherally-acting CB1 receptor inverse agonist that has demonstrated efficacy in animal models of obesity and non-alcoholic fatty liver disease (NAFLD). AGTX-2003 was well tolerated in animal models of toxicity, and did not cross the blood-brain barrier. We are currently advancing AGTX-2003 in additional enabling animal studies in preparation of filing an IND application with the FDA. These studies will be managed by our subsidiary Agentix Australia Pty Ltd.

We have entered into an exclusive worldwide license agreement for ABP-2003 with Research Triangle Institute (RTI) on March 16, 2020. In exchange to the global development and commercial rights, we will pay RTI a series of development and commercial milestones, and royalties on product sales once obtaining market authorization from competent regulatory authorities.

License Agreement

On May 21, 2021, we received notice of effectiveness of that certain License Agreement (the “License Agreement”), dated May 10, 2021, by and between the Company’s wholly-owned subsidiary, Applied BioPharma LLC, a Nevada limited liability company, and National Health Research Institutes, a Taiwan, Republic of China, entity, pursuant to which the Company purchased a worldwide, terminable, royalty-bearing, exclusive license for the technology and patent rights underlying patents and patent applications to make, have made, offer for sale, sell, have sold, use, have used, import or have imported products related to pyrazole compounds, to treat Type 2 diabetes, obesity and fatty liver disease. This technology is a peripherally restricted cannabinoid receptor 1 antagonist that has successfully completed preliminary pre-clinical and in vivo testing requirements for advancement into Phase I clinical trials.

The Company is required to pay a licensing fee and a document delivery fee within 30 days of the date of the License Agreement. Additionally, the Company is obligated to pay 16 product milestone payments related to Phase I, Phase II, Phase III and US Food and Drug Administration, European Union, European Medicines Agency, Pharmaceuticals and Medical Devices Agency and other market approvals, and upon achieving $100,000,000 in worldwide sales.

Additional payments the Company is obligated to pay are (i) an annual royalty equal to 4% of net sales of products sold using technology and patents rights under the License Agreement, and (ii) an annual license fee and quality and stability testing fees.

The term of the License Agreement is until the last of the licensed patent rights and the exclusive market approval for the products made or using the technology and rights underlying the licensed patents expire on a county-by-country basis. The terms of the patents subject to the License Agreement with the longest terms are 20 years.

Biopharma Industry

The global demand for biopharmaceuticals is driven by a number of factors like increase in the elderly population, an increase in the prevalence of chronic diseases like cancer and diabetes, and an increase in the global acceptance of biopharmaceuticals. In addition, an increase in strategic partnerships between biopharmaceutical companies is also expected to complement the growth of the biopharmaceuticals industry. Furthermore, clearance for newer biopharmaceutical products and continuous R&D is also expected to improve this market positively. However, the high costs of these medications are one of the main constraints on this industry and, in order to make them economically viable, the cost needs to be reduced greatly.

The global market for the biopharma is segmented into product, therapeutic area, application, and region. Based on product, the market is for biopharma is segmented into recombinant growth factors, monoclonal antibodies, recombinant proteins, vaccines, purified proteins, recombinant hormones, and other product types. The monoclonal antibodies market is further divided into anti-inflammatory monoclonal antibodies, anti-cancer monoclonal antibodies, and other monoclonal antibodies. The purified proteins market is further bifurcated into P38 protein, leukemia inhibitory factor, P53 protein, and other purified proteins. The recombinant proteins market is further divided into serum albumin, defensin, amyloid protein, and transferrin. Vaccines are further divided into conventional vaccines, recombinant vaccines, and recombinant enzymes. The recombinant growth factors are further divided into granulocyte colony stimulating factors, and erythropoietin. The recombinant hormones market is further divided into recombinant human growth hormones, recombinant insulin, and other recombinant hormones. The market for monoclonal antibodies held almost 28% share of the market in 2019. Monoclonal antibodies are used in cancer treatment areas. Their usage is becoming increasingly widespread in developed countries like the U.S. and the U.K. Contrary, the recombinant proteins segment is expected to show rapid growth over the forecast period.

Segmentation Analysis

Based on therapeutic application, the market is categorized into oncology, inflammatory and infectious diseases, neurological diseases, infectious diseases, cardiovascular diseases, metabolic disorders, hormonal disorders, and other diseases. The oncology segment held almost 25% share of the market in 2019. According to the International Agency for Cancer Research (IARC), there were almost 18 million new cases of cancer and 10 million deaths in 2018. In fact, the United Nations Program on HIV and AIDS (UNAIDS) estimated that 37 million people were living with HIV in 2017. Such disquieting statistics has raised an urgent need to change the situation by innovating new and successful medicines that can cure such deadly diseases consequently raising the number of deaths. Apparently, biopharmaceutical drugs are considered to be effective in curing these chronic diseases rather than merely treating the same symptoms.

Regional Analysis

Regionally, the market is divided into Asia Pacific, Europe, Latin America, North America, and Middle East & Africa. North America held almost 37% in 2019 due to the presence of sophisticated healthcare facilities, increasing geriatric population base, and increased healthcare expenditure in the country. Asia Pacific is likely to grow at high CAGR in the forecast period. Increased investment in R&D, increased acceptance and availability of biopharmaceuticals for disease treatment and increased understanding of disease diagnosis are some of the factors of market growth in this region. Moreover, this area offers tremendous prospects for venture capitalists and investors as developed markets are largely saturated.

Competition

The biopharma industry is characterized by fierce competition, is growing rapidly, evolving constantly, and the possibility for innovative companies to succeed within it is significant. The biopharma industry is, in all respects, global and Agentix will have competitors around the world, including but not limited to the following: Novo Nordisk A/S (Denmark), Johnson & Johnson (U.S.), Pfizer, Inc., (U.S.), Hoffmann-La Roche (Switzerland), Eli Lilly and Company, Ltd. (U.K.), Biogen, Inc. (U.S.), Merck & Co., Inc. (U.S.), Sanofi (France), Bristol Myers Squibb Company (U.S.), and Bayer AG (Germany) among others.

Intellectual Property

We will rely on a combination of trademark laws, trade secrets, confidentiality provisions and other contractual provisions to protect our proprietary rights, which are primarily our brand names, product designs and marks. We do not own any patents, although we may apply for some in the future based on the success of our business plan.

Government Regulation

The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources. Failure to comply with the applicable requirements at any time during the product development process, approval process or after approval, may subject an applicant to administrative or judicial sanctions. These sanctions could include the US FDA’s refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning letters, product recalls or withdrawals from the market, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement, or civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on us.

Any product development activities related to the Company or products that we may develop or acquire in the future will be subject to extensive regulation by various government authorities, including the FDA, other federal, state and local agencies and comparable regulatory authorities in other countries, which regulate the design, research, clinical and non-clinical development, testing, manufacturing, storage, distribution, import, export, labeling, advertising and marketing of pharmaceutical products and devices. Generally, before a new drug can be sold, considerable data demonstrating its quality, safety and efficacy must be obtained, organized into a format specific to each regulatory authority, submitted for review and approved by the regulatory authority. The data are often generated in two distinct development states: pre-clinical and clinical.

The products that the Company may develop or acquire in the future must be approved by the FDA before they may be legally marketed in the United States. For new chemical entities, the pre-clinical development stage generally involves synthesizing the active component, developing the formulation and determining the manufacturing process, as well as carrying out non-human toxicology, pharmacology and drug metabolism studies that support subsequent clinical testing. These pre-clinical laboratory and animal tests are often performed under the FDA’s Good Laboratory Practices regulations. A drug’s sponsor must submit the result of the pre-clinical tests, together with manufacturing information, analytical data and any available clinical data or literature and a proposed clinical protocol to the FDA as part of an IND application, which is a request for authorization from the FDA to administer an investigational drug or biological product to humans. Similar filings are required in other countries.

Post-Marketing Requirements

Following approval of a new product, a pharmaceutical company and the approved product are subject to continuing regulation by the FDA and other federal and state regulatory authorities, including, among other things, monitoring and recordkeeping activities, reporting to applicable regulatory authorities of adverse experiences with the product, providing the regulatory authorities with updated safety and efficacy information, product sampling and distribution requirements, and complying with promotion and advertising requirements, which include, among others, standards for direct-to-consumer advertising, restrictions on promoting drugs for uses or in patient populations not described in the drug’s approved labeling (known as “off-label use”), and limitations on industry-sponsored scientific and educational activities. Although physicians may prescribe legally available drugs for off-label uses, manufacturers may not market or promote such off-label uses. Modifications or enhancements to the products or labeling or changes of site of manufacture are often subject to the approval of the FDA and other regulators, which may or may not be received or may result in a lengthy review process. The FDA regulations require the products be manufactured in specific approved facilities and in accordance with current good manufacturing practices, and NDA holders must list their products and register their manufacturing establishments with the FDA. These regulations also impose certain organizational, procedural and documentation requirements with respect to manufacturing and quality assurance activities. Drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with current good manufacturing practice and other laws. NDA holders using contract manufacturers, laboratories or packagers are responsible for the selection and monitoring of qualified firms. These firms are subject to inspections by the FDA at any time, and the discovery of violative conditions could result in enforcement actions that interrupt the operation of any such facilities or the ability to distribute products manufactured, processed or tested by them.

Other Regulatory Matters

Manufacturing, sales, promotion and other activities following product approval are also subject to regulation by numerous regulatory authorities in addition to the FDA, including, in the United States, the Centers for Medicare & Medicaid Services, or CMS, other divisions of the Department of Health and Human Services, the Drug Enforcement Administration, the Consumer Product Safety Commission, the Federal Trade Commission, the Occupational Safety & Health Administration, the Environmental Protection Agency, and state and local governments. These regulations include:

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the federal healthcare program anti-kickback law which prohibits, among other things, persons from soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral of an individual, for an item or service or the purchasing or ordering of a good or service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;

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federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other government reimbursement programs that are false or fraudulent. The government may assert that a claim including items or services resulting from a violation of the federal healthcare program anti-kickback law or related to off-label promotion constitutes a false or fraudulent claim for purposes of the federal false claims laws;

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the Federal Physician Payments Sunshine Act within the ACA, and its implementing regulations, require that certain manufacturers of drugs, devices, biological and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report information related to certain payments or other transfers of value made or distributed to physicians and teaching hospitals, or to entities or individuals at the request of, or designated on behalf of, the physicians and teaching hospitals and to report annually certain ownership and investment interests held by physicians and their immediate family members; and

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the Health Insurance Portability and Accountability Act, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations, imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information. Among other things, HITECH makes HIPAA’s privacy and security standards directly applicable to “business associates”—independent contractors or agents of covered entities that receive or obtain protected health information in connection with providing a service on behalf of a covered entity. HITECH also created four new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions.

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applicable child-resistant packaging requirements under the U.S. Poison Prevention Packaging Act;

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The Lanham Act and federal antitrust laws;

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state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third party payer, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by federal laws, thus complicating compliance efforts.

Distribution of pharmaceutical products is subject to additional requirements and regulations, including extensive record-keeping, licensing, traceability, and storage and security requirements intended to prevent the unauthorized sale of pharmaceutical products.

Research and Development Activities and Costs

We incurred $125,079 and $180,987, respectively, in research and development costs for the fiscal years ended March 31, 2026 and 2025.

Employees

As of March 31, 2026, and as of the date of this filing, we had no full-time or part-time employees. Our business is operated by Rehan Huda, one of our two directors.

Properties

We currently do not rent any real property or offices. Our current business address is 32932 Pacific Coast Highway, #14-254, Dana Point, California 92629, which is a virtual office.

Legal Proceedings

From time to time, we may become involved in various lawsuits and legal proceedings which arise in the ordinary course of business. However, litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm our business. Except as noted below, we are currently not aware of any such legal proceedings or claims that we believe will have, individually or in the aggregate, a material adverse effect on our business, financial condition or operating result.

There are no material proceedings in which any of our directors, officers or affiliates or any registered or beneficial shareholder of more than 5% of our common stock is an adverse party or has a material interest adverse to our interest.

Facilities

We currently do not rent any real property or offices. Our current business address is 32932 Pacific Coast Highway, #14-254, Dana Point, California 92629.

OUR EXECUTIVE OFFICES

Our executive offices are located at 32932 Pacific Coast Highway, #14-254, Dana Point, California 92629.