Company: AGTX
Filing Date: 2025-07-16
Form Type: 10-K
Source: 0001477932-25-005077
Chunk: 30

Company: Agentix Corp.
Filing Date: 2025-07-16
Form: 10-K
Item: Item 1
Chunk 30
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 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.

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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