Praxis Bioresearch is pleased to announce the appointment of Adam Levy to its Board of Directors. Mr. Levy brings over 25 years of experience in biopharmaceutical financial operations, business development, and strategic planning.

Prior to joining Praxis Bioresearch's Board, Mr. Levy served as Chief Financial Officer at multiple publicly-traded biopharmaceutical companies, where he led successful financing initiatives, strategic partnerships, and corporate transactions. His extensive experience in guiding biotechnology companies through critical development and commercialization stages will be invaluable to Praxis Bioresearch as the company advances its clinical programs.

"We are thrilled to welcome Adam to our Board of Directors," said Dr. Sandeep Patil, President and CEO of Praxis Bioresearch. "His deep expertise in financial strategy and business development, combined with his track record of success in the biopharmaceutical industry, will be instrumental as we advance PRX-P4-003 through clinical development and pursue strategic growth opportunities."

"I am excited to join Praxis Bioresearch at this pivotal time in the company's development," said Mr. Levy. "The company's innovative approach to addressing significant unmet medical needs in neurological disorders, combined with its strong scientific foundation, positions it well for success. I look forward to contributing to the company's strategic direction and growth."

Praxis Bioresearch presented Phase 0 clinical data for PRX-P4-003 at the 14th Annual Clinical Trials on Alzheimer's Disease (CTAD) conference held in Boston, MA. The presentation highlighted the successful oral activation and pharmacokinetic profile of PRX-P4-003 in healthy human volunteers.

The Phase 0 microdose study demonstrated that PRX-P4-003 is effectively converted to its active metabolite following oral administration, with pharmacokinetic parameters supporting once-daily dosing. These findings provide important validation of the prodrug approach and support the continued development of PRX-P4-003 for the treatment of apathy in Alzheimer's Disease.

"The positive Phase 0 data presented at CTAD represent an important milestone in the development of PRX-P4-003," said Dr. Sandeep Patil, President and CEO of Praxis Bioresearch. "These results confirm the oral bioavailability and appropriate pharmacokinetic profile of our novel prodrug, supporting our development strategy and bringing us closer to clinical trials in patients with apathy in Alzheimer's Disease."

The CTAD conference is one of the premier scientific meetings focused on Alzheimer's Disease clinical trials, bringing together leading researchers, clinicians, and industry professionals from around the world.

Praxis Bioresearch announced today that it has been awarded a $2.9 million Fast-Track Small Business Innovation Research (SBIR) grant from the National Institute on Aging (NIA), part of the National Institutes of Health (NIH). The grant will support the clinical development of PRX-P4-003 for the treatment of apathy in Alzheimer's Disease.

This Fast-Track SBIR award will fund Phase 0/Phase 1 clinical studies to evaluate the safety, tolerability, and pharmacokinetics of PRX-P4-003 in healthy volunteers and Alzheimer's Disease patients. The funding will also support IND-enabling studies and manufacturing activities required for clinical trials.

"We are honored to receive this significant grant from the NIA," said Dr. Sandeep Patil, President and CEO of Praxis Bioresearch. "This funding validates the scientific merit and clinical potential of PRX-P4-003 and will enable us to advance our clinical development program. Apathy is a major unmet need in Alzheimer's Disease, and we are committed to developing innovative therapeutic solutions for patients and caregivers affected by this debilitating condition."

Apathy affects up to 70% of Alzheimer's Disease patients and is associated with increased caregiver burden, faster cognitive decline, and reduced quality of life. Despite its prevalence and impact, there are currently no FDA-approved treatments specifically for apathy in Alzheimer's Disease.

The Fast-Track SBIR program is designed to support early-stage research and development of innovative technologies with commercial potential and significant public health impact.

Praxis Bioresearch announced positive results from a Phase 0 clinical microdose study demonstrating successful oral activation of PRX-P4-003 in healthy human volunteers. The study confirmed that the prodrug is effectively converted to its active metabolite following oral administration.

The Phase 0 study was a single-center, open-label study in healthy volunteers designed to evaluate the pharmacokinetics and metabolic activation of microdoses of PRX-P4-003. Results showed that PRX-P4-003 was well-tolerated and efficiently converted to its active form, with pharmacokinetic parameters supporting once-daily oral dosing.

"These positive Phase 0 results represent an important validation of our prodrug approach and provide critical data to inform our clinical development strategy," said Dr. Sandeep Patil, President and CEO of Praxis Bioresearch. "The successful oral activation of PRX-P4-003 in humans, combined with the favorable pharmacokinetic profile, supports the continued development of this compound for treating motivational deficits in neurological disorders."

PRX-P4-003 is designed as a prodrug that requires enzymatic activation to release the active stimulant compound. This prodrug approach is intended to reduce the potential for abuse while maintaining therapeutic efficacy for conditions characterized by motivational deficits, such as apathy in Alzheimer's Disease and ADHD.

The company plans to advance PRX-P4-003 into Phase 1/2 clinical trials to evaluate safety, tolerability, and preliminary efficacy in target patient populations.

Praxis Bioresearch announced today the issuance of U.S. Patent No. 10,683,276 covering its novel prodrug stimulant PRX-P4-003 and related compositions and methods of use. This patent provides broad protection for the company's lead compound and strengthens its intellectual property position.

The issued patent covers the composition of matter for PRX-P4-003, its pharmaceutical formulations, and methods of using the compound to treat neurological and psychiatric conditions characterized by motivational deficits, including apathy in Alzheimer's Disease and ADHD.

"The issuance of this patent is an important milestone for Praxis Bioresearch and validates the novelty and inventiveness of our prodrug technology," said Dr. Sandeep Patil, President and CEO of Praxis Bioresearch. "This patent, along with our growing intellectual property portfolio, provides strong protection for PRX-P4-003 and positions us well for future development and commercialization activities."

PRX-P4-003 is a novel prodrug that is designed to provide therapeutic benefits for conditions involving motivational deficits while reducing the potential for abuse. The compound has demonstrated promising preclinical efficacy and safety profiles and is currently advancing through clinical development.

In addition to the issued U.S. patent, Praxis Bioresearch has filed patent applications in multiple international jurisdictions to protect its intellectual property globally.

Praxis Bioresearch announced today that it has been awarded a $1.5 million Fast-Track Small Business Innovation Research (SBIR) grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH). The grant will support the preclinical and early clinical development of PRX-P4-003, a novel prodrug stimulant with abuse-deterrent properties.

The Fast-Track SBIR award will fund preclinical studies evaluating the abuse liability, safety, and efficacy of PRX-P4-003, as well as IND-enabling toxicology studies and Phase 0 clinical studies in healthy volunteers. The goal is to advance PRX-P4-003 as a novel treatment option for ADHD with reduced potential for abuse and diversion.

"We are honored to receive this significant grant from NIDA," said Dr. Sandeep Patil, President and CEO of Praxis Bioresearch. "This funding recognizes the urgent need for ADHD treatments with improved abuse-deterrent properties and validates our innovative prodrug approach. Stimulant medications are highly effective for ADHD but carry significant risk for abuse and diversion. PRX-P4-003 is designed to maintain therapeutic efficacy while substantially reducing abuse potential."

ADHD affects approximately 6 million children and 10 million adults in the United States. Stimulant medications are the most effective treatments but are classified as Schedule II controlled substances due to their potential for abuse. The development of effective ADHD treatments with reduced abuse liability represents a significant public health priority.

PRX-P4-003 is designed as a prodrug that requires enzymatic activation to release the active stimulant. Preclinical studies have demonstrated that PRX-P4-003 has significantly reduced abuse potential compared to conventional stimulants while maintaining therapeutic efficacy.

Praxis Bioresearch announced today the publication of preclinical data for PRX-P4-003 in a peer-reviewed scientific journal. The publication presents comprehensive preclinical studies demonstrating the reduced abuse potential and maintained therapeutic efficacy of PRX-P4-003 compared to conventional stimulants.

The study evaluated PRX-P4-003 in multiple validated preclinical models of abuse liability, including drug discrimination, self-administration, and locomotor activity assays. Results showed that PRX-P4-003 had significantly reduced abuse-related behavioral effects compared to immediate-release amphetamine and methylphenidate, while maintaining equivalent efficacy in models of attention and cognitive function.

"We are pleased to share these important findings with the scientific community through peer-reviewed publication," said Dr. Sandeep Patil, President and CEO of Praxis Bioresearch. "The data demonstrate that our prodrug approach successfully reduces abuse liability while preserving therapeutic benefits, supporting the continued development of PRX-P4-003 as a novel treatment for ADHD with improved safety profile."

The publication also describes the mechanism of action of PRX-P4-003, including the enzymatic activation process and pharmacokinetic properties that contribute to its reduced abuse potential. The slow and sustained release of the active metabolite following oral administration of the prodrug results in a pharmacokinetic profile that is less conducive to abuse while providing therapeutic coverage throughout the day.

These published preclinical data form the foundation for the clinical development program for PRX-P4-003 and support the regulatory pathway forward.

Praxis Bioresearch presented preclinical data for PRX-P4-003 at the 56th Annual Meeting of the American College of Neuropsychopharmacology (ACNP) in Palm Springs, California. The presentation highlighted the reduced abuse potential and maintained therapeutic efficacy of PRX-P4-003 in preclinical models.

The poster presentation included data from multiple preclinical studies evaluating the pharmacology, efficacy, and abuse liability of PRX-P4-003. Key findings included:

• Significant reduction in abuse-related behavioral effects compared to conventional stimulants in drug discrimination and self-administration assays

• Maintained therapeutic efficacy in preclinical models of attention and cognitive function

• Favorable pharmacokinetic profile with slow and sustained release of the active metabolite

• Reduced locomotor stimulation compared to immediate-release stimulants

"We are pleased to present these data at ACNP, one of the premier scientific meetings in neuropsychopharmacology," said Dr. Sandeep Patil, President and CEO of Praxis Bioresearch. "The positive preclinical profile of PRX-P4-003 supports its potential as a novel treatment option for ADHD with reduced abuse liability, addressing a critical unmet need in the management of this common disorder."

The ACNP Annual Meeting brings together leading researchers and clinicians in the field of neuropsychopharmacology to share and discuss the latest advances in understanding and treating psychiatric and neurological disorders.