Completes new financing round, raising approximately $5.0 million

EVX-101 Proof-of-Concept Phase 2 Clinical Study in Obsessive-Compulsive Disorder (OCD) planned to commence in 1H 2026

The financing enables (i) the conduct of clinical, non-clinical, and CMC activities in anticipation of the EVX-101 Phase 2 OCD Study and (ii) the conduct of a Phase 1b target-engagement study to evaluate the increase in serotonin and its main metabolite in cerebrospinal fluid (CSF) following EVX-301 administration, with topline results expected in Q1 ’26

If successfully developed, EVX-101 could become the first novel mechanism-of-action drug introduced in OCD in the 21^st century and the first drug approved for OCD patients with inadequate response to first-line therapies

Through the development of EVX-101, Evecxia aims to introduce a new mechanism of action, brain Serotonin Synthesis Amplification, in the treatment of CNS disorders, including OCD and MDD

Evecxia Therapeutics, Inc., a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced it has completed a new financing round, with gross proceeds of approximately $5.0 million. This financing will fund clinical, non-clinical and CMC activities in anticipation of our plans to initiate an adequate, placebo-controlled Phase 2 clinical study evaluating EVX-101, as adjunctive therapy, in patients with obsessive-compulsive disorder (OCD) with inadequate response to first-line selective serotonin-reuptake inhibitors (SSRIs). Collage Venture Partners acted as the sole book-running manager for the offering with existing investors.

“We are proud of the progress we are making at Evexcia, including the successful completion of our EVX-101 Phase 1 safety study and the continuous strengthening of our intellectual property position/patent portfolio,” said Jacob Jacobsen, PhD, Chief Executive Officer of Evecxia Therapeutics. “We are committed to accelerating and maximizing the value of our leadership in brain Serotonin Synthesis Amplification by focusing on CNS indications for which there is a strong clinical and pharmacological rationale and important unmet needs. We look forward to initiating our EVX-101 Phase 2 program in OCD in 2026, and to subsequently expand into other indications, including MDD.”

EVX-101, the Company’s lead drug candidate, is an oral, gastro-retentive, sustained-release tablet formulation of 5-hydroxytryptophan (5-HTP, the natural immediate precursor to serotonin) and low-dose carbidopa (multiplies 5-HTP’s bioavailability). EVX-101 is designed to provide adequate 5-HTP plasma levels resulting in sufficient and sustained amplification of serotonin synthesis in the brain. Decades of clinical evidence support that amplifying serotonin synthesis in the brain can improve clinical outcomes when first-line serotonin reuptake inhibitor (e.g., SSRI) monotherapy is inadequate. Evecxia’s second drug candidate, EVX-301, is a proprietary intravenous infusion of 5-HTP being designed to achieve fast-onset brain Serotonin Synthesis Amplification.

Near-term clinical, non-clinical, and CMC goals:

In the second half of 2025, in preparation for the Phase 2 OCD study, the Company plans to finalize the automation of EVX-101’s (oral tablet) chemistry, manufacturing, and controls (CMC) processes to commercial scale, to be followed by a small bridging Phase 1 pharmacokinetics (PK) study in healthy volunteers. In addition, the Company plans to conduct a Phase 1 target-engagement study in MDD patients on an SSRI, evaluating the effects of EVX-301 on levels of serotonin and its main metabolite (5-HIAA) in the cerebrospinal fluid (CSF), a validated biomarker of brain serotonin. This study uses a dose of EVX-301 that obtains the 5-HTP plasma levels also obtained with oral doses of EVX-101 and believed to be therapeutically active. Patient enrollment in this Study is expected to start in Q4 ’25 with topline results anticipated in Q1 ’26.

About OCD and the Potential of EVX-101

Obsessive-Compulsive Disorder (OCD) is a chronic, disabling disorder characterized by uncontrollable and intrusive thoughts (obsessions) and repetitive behaviors (compulsions). OCD has profound personal, social, and economic consequences and is one of the leading causes of disability worldwide. OCD is highly prevalent affecting 1.2% (~3 million) of the adult population in the U.S.

Most OCD patients have severe symptomatology with about half living with serious impairment and one third with moderate impairment. Serotonin reuptake inhibitors, mainly SSRIs, are first-line and the only drugs approved by the FDA for the treatment of OCD. Among patients receiving initial first-line SSRI therapy only about one-third achieve a meaningful response. There are no FDA-approved drugs for OCD patients with inadequate response to first-line therapy.

In our Phase 1 clinical studies, EVX-101, as adjunctive to an SSRI, has shown evidence of elevating serotonin function beyond the SSRI effect, with a favorable safety and tolerability profile. The elevation of serotonin function beyond SSRIs has the potential to improve clinical outcomes for patients with OCD. EVX-101 could become the first FDA-approved drug for OCD patients with inadequate responses to first-line therapies.

About Evexcia Therapeutics

Evexcia is the first Company dedicated to realizing the therapeutic potential of Serotonin Synthesis Amplification—building a stronger, more resilient brain serotonin system—to treat central nervous system (CNS) disorders. Evecxia has two Phase 2 clinical-stage drug candidates in development. EVX-101 is being developed as a next-line adjunctive (add-on) therapy for obsessive-compulsive disorder (OCD) and depression patients for whom monotherapy with first-line serotonin reuptake inhibitor antidepressants (e.g., SSRIs such as Prozac®) is inadequate. EVX-301 is being developed as a rescue therapy for patients hospitalized for acute suicidal crisis.

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“We are committed to accelerating and maximizing the value of our leadership in brain Serotonin Synthesis Amplification by focusing on CNS indications for which there is a strong clinical and pharmacological rationale and important unmet needs"