Autobahn Therapeutics Announces Successful Financing to Support Strategic Advancement of ABX-002 for Treatment Resistant Depression

$32.7 Million Raise Supports Advancement of ABX-002 through Phase 1 and into Phase 2 Proof-of-Concept Clinical Studies in TRD

Expert Scientific Advisory Board Established to Inform Clinical Development Pathway for ABX-002 in TRD

Proprietary Brain-targeting Chemistry Platform Enables Pipeline of Future Clinical Candidates

SAN DIEGO--(BUSINESS WIRE)--Autobahn Therapeutics, a biotechnology company focused on restoring hope for people affected by CNS disorders, today announced the closing of a $32.7 million financing to support the company’s continued commitment to transforming the treatment of CNS disorders, led by a strategic prioritization on addressing treatment-resistant depression (TRD). Current shareholders ARCH Venture Partners, Cowen Healthcare Investments, BVF Partners L.P., Biogen, Bristol Myers Squibb, Pfizer Ventures, Invus, Section 32, Samsara BioCapital, Alexandria Venture Investments and GT Healthcare all participated in the round.

TRD is a subsegment of major depressive disorder (MDD) and is characterized by an inadequate response to treatment after using two or more approved medications. ABX-002 is a potent and selective, brain-boosting thyroid receptor beta (TRβ) agonist that is anticipated to enhance serotonin activity in the brain in TRD patients. Extensive clinical precedent provides strong evidence of thyroid hormone’s role in depression, suggesting that its augmentation could lead to jump-starting responses in people taking antidepressants. ABX-002 is expected to augment antidepressant treatments by potentiating the beneficial effects of these drugs on monoaminergic signaling. Autobahn plans to initiate a Phase 1 single- and multiple-ascending dose trial with ABX-002 in healthy volunteers in the second half of 2022.

“Since founding, our focus has been on advancing meaningful therapeutic options for people with CNS disorders, and this latest financing allows us to continue toward execution of that mission,” said Kevin Finney, Autobahn chairman, president and chief executive officer. “We have conducted comprehensive work with our lead asset, ABX-002, and followed the science, which led us to selecting TRD as the ideal indication for clinical development. Based on extensive literature supporting the role that thyroid hormone plays in depression, we have a significant opportunity to enhance the care of people with this challenging-to-treat disorder. I am thrilled to have the continued backing of our exceptional investors, and for the motivation and determination of the Autobahn team that has brought us to the important point of initiating our first clinical trial in the coming months. We look forward to exploring the therapeutic benefit of ABX-002 and the ultimate impact we can have on the many patients affected by CNS disorders.”

To support Autobahn’s advancement of ABX-002 for TRD, the company has also established a TRD-focused scientific advisory board (SAB), with experienced leaders in the fields of neurology, psychiatry and drug development:

• Maurizio Fava, M.D., psychiatrist-in-chief, Massachusetts General Hospital (MGH)
• Edmund Harrigan, M.D., former senior vice president of worldwide safety and regulatory for Pfizer Inc., and former practicing neurologist
• Thomas Laughren, M.D., former director, Division of Psychiatry Products, FDA

“TRD is the third most common cause of disability worldwide, and leaves many patients suffering with helplessness, grief and increased suicidality,” said Gudarz Davar, M.D., executive vice president and chief medical officer of Autobahn. “TRD is a particularly problematic subsegment of MDD that is characterized by an inadequate response to antidepressant treatment. The powerful combination of our breakthrough technology utilizing ABX-002, a selective, brain-enhanced thyroid hormone-beta agonist, compelling evidence for the use of thyroid hormone treatment to augment the actions of serotoninergic antidepressants, and collaboration with a world-class SAB offers hope that we could successfully address this significant area of unmet need.”

Beyond TRD, Autobahn continues to leverage its proprietary brain-targeting chemistry platform to identify additional programs and targets, while also evaluating strategic opportunities to further expand its pipeline. Based on findings from its Phase 1 study in TRD, Autobahn will evaluate the opportunities for development of ABX-002 in additional indications, including remyelination and multiple sclerosis.

About Treatment-Resistant Depression
Treatment-resistant depression (TRD), a significant subtype of major depressive disorder (MDD), is the third most common cause of disability worldwide, and causes patients to suffer from an exasperated state of helplessness, grief and increased suicidality. TRD is characterized as a condition that affects a person with MDD who has not responded to at least two types of medication. The cause of MDD is not fully understood but has centered around disruption of the monoaminergic system (e.g., serotonin and norepinephrine activity). Approved treatments that enhance monoaminergic signaling in the brain have shown beneficial effects in MDD, but many patients continue to suffer from an inadequate response to treatment that sustains their depressive symptoms and disabilities.

About Autobahn Therapeutics
Autobahn Therapeutics is focused on restoring hope for people affected by CNS disorders. Leveraging its proprietary brain-targeting chemistry platform, Autobahn aims to unlock new therapeutic opportunities through precision tuning of the central exposure of its molecules. The company’s pipeline is led by ABX-002, a thyroid hormone receptor beta agonist, being developed initially for people with treatment-resistant depression. Autobahn Therapeutics is based in San Diego. For more information, visit www.autobahntx.com.

Alicia Davis, THRUST Strategic Communications
alicia@thrustsc.com