Lusaris Therapeutics Launches with $60 Million Series A Financing to Redefine the Treatment of Severe Neuropsychiatric and Neurological Disorders

Lusaris Therapeutics, a biotechnology company advancing next-generation serotonergic neuroplastogen therapeutics to treat severe neuropsychiatric and neurological conditions, launched today with a $60 million Series A financing. The company’s lead program, LSR-1019, is a best-in-class sublingual formulation of 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT), a fast-acting and rapidly clearing serotonergic psychedelic, in development for patients with treatment-resistant depression (TRD) and other severe neuropsychiatric disorders. RA Capital Management incubated Lusaris and led the Series A round with participation from leading healthcare investors including Venrock Healthcare Capital Partners, Deep Track Capital, Boxer Capital, and an additional undisclosed investor.

TRD occurs when patients with major depressive disorder do not respond adequately to two lines of therapy. There is a tremendous need for new therapies for patients not adequately controlled with currently available treatments. Serotonergic neuroplastogens have been shown to induce favorable structural and functional neural plasticity, resulting in rapid and dramatic improvement in patients with TRD. Existing clinical data suggest that 5-MeO-DMT has the potential to offer best-in-class efficacy in people with TRD.

Orally administered 5-MeO-DMT is pharmacologically inactive due to rapid metabolism by enzymes in the gut and liver. LSR-1019 is a proprietary sublingual tablet formulation of 5-MeO-DMT that dissolves under the tongue within seconds and is absorbed without the need for water. This approach is scalable, eliminates the need for burdensome drug delivery systems, simplifies administration, and offers the potential for more consistent exposure and more predictable therapeutic benefit in patients. Lusaris plans to develop LSR-1019 for the treatment of TRD and additional severe neuropsychiatric disorders. Phase 1 clinical studies of LSR-1019 are expected to initiate imminently with topline data available mid-year 2023.

Lusaris is also announcing it has entered into a strategic collaboration with Catalent under which Lusaris has been granted an exclusive worldwide license to Catalent’s Zydis® fast-dissolving tablet technology for the 5-MeO-DMT program. The Zydis ODT (orally disintegrating tablet) technology has been used in more than 35 commercial products in over 60 countries.

“We aim to develop best-in-class neurotherapeutics that have the potential to reach more patients in need by decreasing the treatment burden on both patients and physicians,” said Neil Buckley, Chief Operating Officer at Lusaris. “With encouraging preclinical data, a proven delivery technology, and an expected rapid and short psychotropic experience, LSR-1019 has the potential to be a transformative treatment for patients suffering from TRD and other serious mood disorders.”

In addition to LSR-1019, Lusaris is building a portfolio of novel serotonergic neuroplastogens for a wide range of neuropsychiatric and neurological conditions, including migraine and cluster headache.Leadership Team

Lusaris was founded by a team of highly experienced drug developers and company builders with extensive neuroscience experience. The company’s leadership team includes Andrew Levin, M.D., Ph.D., Interim Chief Executive Officer; Neil Buckley, M.S., Chief Operating Officer; Ed Monaghan, Ph.D., Chief Development Officer; Ramin Farzaneh-Far, M.D., Acting Chief Medical Officer; Kat Riesen, CPA, Chief Financial Officer; Ned Whittemore, Ph.D., Vice President, Regulatory Affairs; Matt Harding, Ph.D., Vice President, Discovery; K. George Mooney, Ph.D., Vice President, CMC; and Daniel Grau, MPhil, Chairman of the Board of Directors. Backed by world-class investors, the Lusaris team is well positioned to bring life-changing medicines—and renewed hope—to millions of patients and their families.

Lusaris is a biotechnology company advancing next-generation serotonergic neuroplastogen therapeutics to treat severe neuropsychiatric and neurological disorders. Our lead program, LSR-1019, is a proprietary sublingual formulation of 5-MeO-DMT, a rapidly acting and rapidly clearing serotonergic psychedelic in development for treatment-resistant depression and other neuropsychiatric conditions. In addition to LSR-1019, our pipeline includes novel neuroplastogens for a wide range of neuropsychiatric and neurological conditions including migraine and cluster headache.