HMNC Brain Health to Present on Genetic Companion Diagnostics in Psychiatry at European Biomarker and CDx Summit

Company to Present Anticify™ Platform and Vision Across its Cortibon and Nelivabon Programs Ahead of Upcoming OLIVE Phase 2b Trial Results

MUNICH, Germany – April 8, 2025 – HMNC Brain Health (“HMNC” or the “Company”), a clinical stage precision psychiatry biopharma company, pioneering the development of personalized therapies powered by predictive companion diagnostics, announced that it will present at the 15th World Clinical Biomarkers & Companion Diagnostics Summit Europe, taking place April 8–10, 2025, in London.

The presentation will highlight HMNC’s Anticify™ companion diagnostic platform, which was used to develop the V1b companion diagnostic test, which aims to identify patients who are most likely to benefit from treatment with BH-200, a drug targeting the brain’s stress system. BH-200 is currently being studied in the Phase 2b OLIVE trial for Major Depressive Disorder (MDD). The OLIVE trial recently completed enrollment of 338 patients and is the largest global study so far to test a precision medicine approach for stress-related depression.

Dr. Daniel Gehrlach, Director of Biomarkers and Clinical Project Lead for the Nelivabon Program at HMNC, will speak on how integrating genetic CDx into clinical trials could shift psychiatry toward a more personalized, biology-driven model of care.

Presentation Details:

  • Presentation title: Bringing Precision to Psychiatry: Pioneering Genetic CDx Use in Major Depressive Disorder
  • Presenter: Dr. Daniel Gehrlach, Director of Biomarkers, HMNC Brain Health
  • Overview: The presentation will explore the role of CDx in overcoming the biological heterogeneity of MDD, and how HMNC’s Anticify™ framework guides CDx development using polygenic scoring to stratify patients and predict treatment response. Dr. Gehrlach will also address the impact of the European IVDR regulatory framework on a clinical biotech company.
  • Date & Time: Thursday, April 10, 2025, at 2:20 PM CEST (Day 2 - TRACK A: Biomarker Discovery & Clinical Development)

"The field of psychiatry has long operated without the benefit of biological precision, but that’s changing,” said Dr. Gehrlach. “I am looking forward to sharing how our Anticify™ platform is helping drive that shift by co-developing companion diagnostics with targeted treatments based on their biology. HMNC’s goal with companion diagnostics is to move beyond symptom-based care toward a more data-driven, precision approach. The upcoming OLIVE trial results could mark a significant inflection point in making precision psychiatry a clinical reality.”

About OLIVE Trial:

The OLIVE Phase 2b trial is a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of BH-200, a vasopressin V1b receptor antagonist, in combination with a predictive genetic companion diagnostic (V1b polygenic score) for patients with Major Depressive Disorder (MDD) linked to HPA-axis dysfunction—a biological stress system abnormality found in approximately 30% of MDD cases. The study enrolled 338 outpatients across multiple sites and follows a prospective-retrospective design aligned with FDA guidance for drug-CDx co-development. OLIVE is the largest biomarker-stratified clinical trial in psychiatry to date. Topline results are anticipated in Q2 2025.

About Anticify™:

Anticify™ is HMNC Brain Health’s proprietary framework for co-developing companion diagnostics (CDx) and psychiatric treatments. By integrating multi-omic biomarker discovery, it helps identify biological subtypes, such as HPA-axis dysfunction, that may respond better to targeted therapies. This fully integrated CDx and Rx approach ensures diagnostics and clinical development are aligned from the start, a model uniquely embedded within HMNC. Anticify™ also focuses on reviving clinically tested compounds that showed safety but failed efficacy endpoints, using biomarker-based patient stratification and novel formulations. Adaptable across CNS drug development, it provides a scalable path to precision psychiatry.

For more information on HMNC Brain Health or the OLIVE trial, please visit: www.hmnc-brainhealth.com.

About HMNC Brain Health

HMNC Brain Health (HMNC Holding GmbH) is a global precision psychiatry biopharma company pioneering the development of personalized therapies powered by predictive companion diagnostics, leading to far shorter treatments and higher remission rates. The Company develops a unique pipeline for targeting both major depressive disorder (MDD) and treatment-resistant depression (TRD). The Company has operations in both the US and Germany and is backed by a renowned global VC, several family offices and strategic healthcare investors. The Company now enters the next stage of its development with a large-scale licensing and fundraising agenda.

About the World Clinical Biomarkers & CDx Summit Europe

The World Clinical Biomarkers & Companion Diagnostics Summit Europe is a leading annual conference uniting pharmaceutical, biotech, diagnostic, and regulatory leaders. The summit focuses on accelerating precision medicine by fostering collaboration and sharing the latest advancements in the discovery, development, validation, and implementation of clinical biomarkers and companion diagnostics across various therapeutic areas.

Media contacts:

Anne Donohoe (U.S.)
+1 212-896-1265
hmnc[at]kcsa[dot]com