Growing body of preclinical and clinical data support potential for elunetirom (ABX-002) to offer a rapid and enduring antidepressant effect with favorable safety and tolerability profile

Topline data anticipated from Phase 2 AMPLIFY-BD study in adjunctive bipolar depression in 2Q26 and Phase 2 AMPLIFY study in adjunctive major depressive disorder in 3Q26

Autobahn Therapeutics, a biotechnology company developing restorative treatments for people affected by neuropsychiatric and neuroimmunologic disorders, today announced the presentation of new preclinical data for elunetirom, the company’s lead asset currently in Phase 2 clinical development for adjunctive major depressive disorder (MDD) and bipolar depression, at the 64^th Annual American College of Neuropsychopharmacology (ACNP) Annual Meeting taking place in Nassau, Bahamas.

“These preclinical data demonstrate the potential for elunetirom to deliver rapid antidepressant effects by enhancing neuroplasticity and driving the persistent strengthening of neuronal synapses,” said Jonathan Meyer, MD, Voluntary Clinical Professor of Psychiatry at the University of California, San Diego. “Selective and potent activation of thyroid-beta hormone receptors in the brain (CNS-TRs) to modulate plasticity represents a different approach to treating depression than other strategies, including the nonselective TR agonist triiodothyronine. This new mechanism may address underlying neural dysfunction in patients who have not benefited from existing therapies. Given that millions of patients living with MDD and bipolar depression do not achieve adequate relief with their current treatment, novel pharmacological approaches like this are critically needed. I very much look forward to seeing the data emerging from elunetirom’s clinical development program.”

“We are pleased to highlight new preclinical data for elunetirom at ACNP which further characterize its direct impact on regulating the major drivers of synaptic formation and strengthening, such as BDNF,” said Gudarz Davar, M.D., Executive Vice President, Head of Research and Development for Autobahn. “These data provide strong mechanistic support for elunetirom’s role in driving energy-dependent neuroplasticity, increasing our confidence in our ongoing Phase 2 studies and the potential for elunetirom to offer a meaningful new treatment option for patients living with MDD and bipolar depression.”

Elunetirom is currently being evaluated as a potential adjunctive treatment for MDD in the ongoing Phase 2 AMPLIFY study and for bipolar depression in the ongoing Phase 2 AMPLIFY-BD study. Autobahn anticipates reporting topline data from AMPLIFY-BD and AMPLIFY in the second and third quarter of 2026, respectively.

ACNP Poster Presentation Summary

Title: Elunetirom, a first-in-class, brain-targeting, antidepressant candidate in Ph2 development, triggers robust hippocampal synaptogenesis and cognitive benefits in preclinical studies

• The effects of elunetirom were examined in a series of in vitro and in vivo assays relevant to neuroplasticity and the treatment of MDD and bipolar depression.
• In a primary culture of cortical neurons, the active metabolite showed significant increases in number of neurons, neurite length, number of roots, and number of neurite extremities. In a primary culture of mature hippocampal neurons, elunetirom also significantly increased markers of neuritogenesis and synaptogenesis, essential processes for building neuronal networks. In both experiments, the effects were comparable to those achieved with optimal concentrations of the positive control BDNF.
• Elunetirom significantly improved spontaneous alternation in aged mice (12-mo) and scopolamine-treated mice in a T-maze after seven days of treatment, indicating an improvement in cognition potentially stemming from improvements in neuronal plasticity.
• These potential therapeutic effects are likely the result of direct actions on the genes that drive restorative neuroplasticity in brain (e.g., BDNF).

About Autobahn Therapeutics

Autobahn Therapeutics is a biotechnology company developing a portfolio of neuropsychiatric and neuroimmunologic clinical candidates leveraging its brain-targeting chemistry platform. Autobahn aims to unlock new therapeutic opportunities through precision tuning of CNS exposure, pursuing validated clinical and biologic targets, and guiding development with biomarkers. The company’s pipeline is led by elunetirom (ABX-002), a CNS thyroid hormone receptor (CNS-TR) agonist being developed as a potential adjunctive treatment for people with major depressive disorder and bipolar disorder depression, including those with atypical depression, a highly prevalent and underserved subpopulation of depression. Autobahn Therapeutics is based in San Diego. For more information, visit www.autobahntx.com.

About Elunetirom

Elunetirom (ABX-002) is an oral, once daily, brain-penetrant small molecule prodrug that targets CNS thyroid hormone receptors (CNS-TRs). Elunetirom is designed to enhance beneficial neurobiological activity at CNS-TRs while also reducing the liabilities of peripheral thyroid hormone receptor activity from the administration of synthetic thyroid hormone (e.g., triiodothyronine, T3), a treatment which has shown efficacy in numerous placebo-controlled human studies across MDD and bipolar disorder depression. CNS-TR agonism is believed to uniquely boost energy and plasticity in the brain through both increasing the cellular production of energy and driving neuroplastic changes. In nonclinical and clinical studies, elunetirom has demonstrated optimized PK properties, target engagement in brain regions associated with depression, and an attractive safety and tolerability profile. Elunetirom is being evaluated in Phase 2 clinical studies as a potential adjunctive treatment for MDD and bipolar depression.

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