Delix Therapeutics Closes Oversubscribed $100 Million Series C Financing to Advance Zalsupindole Into Phase II Development and Finance Broader Pipeline Advancement/Expansion

• Financing will support Phase II development of Zalsupindole on the back of strong Phase Ib results

• Funding will also further advancement of other programs in Delix’s neuroplastogen pipeline, including additional clinical trials and continued asset-specific pipeline expansion into neurological and neurodegenerative diseases

• Representatives of both lead investors will join Delix’s Board of Directors

BEDFORD, Mass.--(BUSINESS WIRE)--Delix Therapeutics, a clinical-stage neuroscience company pioneering the discovery and development of neuroplastogens, today announced the closing of an oversubscribed $100 million Series C financing. Delix has reverse-engineered and optimized psychedelics, designing novel medicines that promote rapid and sustained therapeutic efficacy through structural and functional repair of synapses in the brain without any accompanying hallucinatory or psychotomimetic effects. If successful, such compounds will represent a more scalable and patient-friendly approach to the rapid and durable treatment of psychiatric and psychological disorders relative to either standard of care, which must be taken chronically and can take weeks or months to be effective, or traditional psychedelics, which will be limited to in-clinic care, later-line therapies, and infrequent administration.

The round was led by Johnson & Johnson, through its corporate venture capital organization, Johnson & Johnson Innovation – JJDC, Inc., and SV Health Investors’ Dementia Discovery Fund (DDF), with participation from existing investors, such as RA Capital, UC Investments, Artis Ventures, OMX Ventures, Dolby Family Ventures, and Bail Capital, as well as the addition of several new investors including Adage Capital Management, Hamilton Square Partners Management, Vestal Point Capital, and YK Bioventures among others.

The financing provides Delix with additional capital to advance Zalsupindole through Phase IIb Proof of Concept in recurrent Major Depressive Disorder while supporting continued development of the company’s broader neuroplastogen pipeline. This includes advancement of additional development candidates and expansion of the neurodegeneration program with demonstrated preclinical efficacy signals.

Delix expects to initiate Zalsupindole’s Phase II trial in the first half of 2027. This placebo-controlled study represents the first Phase II evaluation of a novel true neuroplastogen.

“We are proud to welcome our new investors alongside the continued support of our existing shareholders as Delix enters its next stage of growth,” said Mark Rus, Chief Executive Officer of Delix Therapeutics. “The strength and validation of this syndicate reflects the growing conviction and data for neuroplastogens as an important new therapeutic class. This capital enables us to take Zalsupindole through Phase II Proof of Concept, advance a broader pipeline of differentiated medicines, and build Delix for the long term. We are particularly excited to partner with investor teammates who understand what it takes to translate breakthrough neuroscience into medicines that can reach patients at scale. Delix is more well positioned than ever to define the next chapter of true neuroplastogen medicine.”

Zalsupindole: Advancing an at-home neuroplastogen into Phase II development

Zalsupindole is an orally bioavailable neuroplastogen inspired by 5-MeO-DMT, also known as mebufotenin, and engineered to promote structural and functional neuroplasticity without hallucinatory, dissociative, sedative, or other psychotomimetic effects, making it a true neuroplastogen.

In a Phase Ib trial in adults with recurrent major depressive disorder, patients experienced an approximately 50 percent mean reduction in Montgomery-Åsberg Depression Rating Scale (MADRS, Day 8) scores after only one week of treatment with either daily or twice weekly dosing. These improvements were maintained through Day 36, four weeks after the final dose.

Across more than 120 participants studied to date, Zalsupindole has demonstrated a favorable safety and tolerability profile, with no hallucinatory, dissociative, or psychotomimetic effects observed as measured by numerous clinician-administered scales, patient reporting scales, and objective measures.

Building a broad, multi-asset neuroplastogen pipeline

Beyond Zalsupindole, Delix is advancing a pipeline of neuroplastogens across psychiatric, neurological, and neurodegenerative diseases. With the Series C financing, the company expects to advance additional candidates toward and into clinical development while expanding into new indications. With the expanded round, Delix can more fulsomely progress their neurodegeneration program into clinical stages.

Board Appointments

In connection with the financing, Christian Jung, PhD, Partner at SV Health Investors, and a representative of JJDC have joined the Delix Board of Directors. The JJDC representative brings decades of neuroscience-specific experience investing in biotech innovation and helping companies navigate critical stages of growth and Dr. Jung has deep experience in neurodegeneration and track record of successful investments in biotech companies.

“We are thrilled with the addition of these outstanding new Board members,” said Nick Haft, Partner at OMX Ventures, and Delix Co-Founder. “Their combined perspectives add important strategic depth as Delix enters its next stages of clinical and corporate development.”

“We have been following the psychedelics field, and Delix is the first company we’ve seen to separate the neuroplastic benefits of psychedelics from their hallucinogenic effects,” commented Dr. Jung, Partner at SV Health Investors, DDF. “Alongside their encouraging clinical data, we are particularly excited by their ability to increase synaptic density across multiple preclinical models of Alzheimer’s and Parkinson’s disease, something of a holy grail for the field. I look forward to working with Mark, the Delix team and the other investors as they bring this pipeline forward.”

About Zalsupindole (DLX001)

Zalsupindole is a novel neuroplastogen isotryptamine engineered to promote structural and functional neural plasticity without hallucinatory, sedative, or dissociative effects. It is currently being evaluated for the treatment of Major Depressive Disorder (MDD). Preclinical data have demonstrated that Zalsupindole increases dendritic spine density in neurons in the prefrontal cortex and has rapid and enduring antidepressant-like effects in animal models after a single dose. Recent Phase I data have demonstrated that Zalsupindole is associated with robust signs of CNS engagement via an emerging biomarker of plastogens and has a favorable safety and tolerability profile, with no serious adverse events reported to date. Delix has completed a Phase Ib study in MDD patients demonstrating Zalsupindole’s rapid and durable effects on depression symptoms. Delix is preparing a Phase IIb trial in MDD.

About Neuroplastogens

Neuroplastogens are a novel class of potentially disease-modifying therapeutics for psychiatric and neurological conditions. These compounds promote rapid and sustained neuroplasticity in select neural circuits resulting in fast-acting therapeutic effects. Neuroplastogens are novel chemical entities inspired by compounds that are proving to be beneficial across a range of therapeutic areas including mood, anxiety, cognition, and neurodegenerative disorders in addition to other synaptopathies. Leveraging our deep mechanistic understanding and unique drug discovery engine to generate distinct compounds, Delix seeks to bring to market a pipeline of neuroplastogens that aim to be the faster, stronger, and more effective medicines of the future.

About Major Depressive Disorder (MDD)

Major Depressive Disorder (MDD) is a prevalent and debilitating condition affecting over 280 million people globally, with 21 million people suffering in the United States alone. MDD represents the primary cause of disability in the world and is typically characterized by persistent feelings of sadness and loss of interest. Even with available approaches, many patients do not experience an optimal response to treatment, resulting in a significant unmet need for new and differentiated treatments.

About Delix Therapeutics

Delix Therapeutics is a clinical-stage neuroscience company focused on harnessing the power of novel neuroplasticity‑promoting therapeutics to better treat patients struggling with difficult-to-treat neuropsychiatric and neurological disorders. The company’s compounds are easily manufactured small molecules capable of rapidly inducing structural and functional neural changes in targeted areas of the brain. Through its novel Neuroplastogen Platform, Delix is pioneering a new class of fast-acting outpatient pharmacotherapies and rapidly advancing through preclinical and clinical development to bring patients FDA-approved, take-home medicines that are intended to serve several unmet needs and enhance the psychiatric treatment paradigm for patients and providers.