TDR Three Takeaways:
- Strategic Transition and Funding: MAPS PBC has evolved into Lykos Therapeutics, securing over $100 million in Series A funding, a key step towards launching the first FDA-approved psychedelic-assisted PTSD therapy.
- Emphasis on Mission-Aligned Investing: The investment in Lykos underscores the trend of mission-aligned investing, focusing on ethical and social impacts alongside financial returns. Lykos’ development of MDMA-assisted therapy for PTSD exemplifies this approach.
- Preparation for Post-FDA Approval: With two Phase 3 trials completed and an FDA application submitted, Lykos is focusing on strengthening clinical infrastructure to ensure effective deployment of MDMA-assisted therapy for PTSD post-approval, addressing a critical need in mental healthcare.
Founded in 2014, MAPS PBC was a subsidiary of the Multidisciplinary Association for Psychedelic Studies, a 501(c)(3) non-profit organization recently announced an oversubscribed Series A financing round, raising over $100 million, including the conversion of previous convertible notes. The funding was led by Helena, a global problem-solving organization, and included other mission-aligned and institutional investors like the Steven & Alexandra Cohen Foundation, Eir Therapeutics, and Vine Ventures.
Mission-aligned investing is the practice of choosing investments that not only promise financial returns but also align with an investor’s ethical, social, or environmental values. It involves supporting companies or projects that positively impact specific societal goals, like sustainability or social justice. This approach integrates personal principles with investment strategies, differing from traditional investing which focuses mainly on financial gain.
Understanding Helena provides insight into mission-aligned investing. The name “Helena,” a Greek noun, means “bright, shining light.” On their website, Helena describes their mission as “identifying potential solutions to societal problems and working to implement them through individual, one-on-one projects.”
Concurrent with this financial milestone, MAPS PBC is rebranding to Lykos Therapeutics (Lycos), marking a strategic shift from a development-stage company to one poised for the commercialization of potentially the first FDA-approved psychedelic-assisted therapy. The new name, derived from the Greek word for “wolf,” symbolizes qualities such as bravery and intelligence, aligning with the company’s future.
In Lykos press release Amy Emerson, CEO of Lykos, expressed gratitude for the support from Helena and other investors, emphasizing the transition to a focus on commercializing this innovative therapy for post-traumatic stress disorder (PTSD). The company’s rebranding reflects its evolution and commitment to integrating novel treatments into the healthcare system.
This morning I had a conversation with Cody Shandraw, President of Healing Realty Trust and Managing Partner at Ambria Capital. He shared his perspective that the entire industry should recognize the Lykos/MAPS team’s recent achievement as a manifestation of Rick’s long-term commitment. It marks a significant step forward in providing relief to PTSD sufferers, offering a new sense of hope. Despite the past two years being marked by declining stock prices and the devaluation of private companies in the psychedelic industry, he views this accomplishment as a potential catalyst for uplifting the entire sector. Shandraw also emphasized the importance of focusing on strengthening the clinical infrastructure and strategically preparing for the post-FDA approval phase, to ensure the maximum transformative impact of these medicines.
The board of directors at Lykos has also been restructured, now comprising eight members, including six from the Multidisciplinary Association for Psychedelic Studies (MAPS), the CEO of Lykos, and Suprotik Basu of Helena. Lykos is at the forefront of developing MDMA-assisted therapy for PTSD. This therapeutic approach combines MDMA with psychological interventions and support services. MDMA, classified as an entactogen, differs from classic psychedelics and is known for enhancing self-awareness and introspection.
The company has completed two Phase 3 trials and submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for MDMA-assisted therapy. If approved, this would be a ground-breaking development in the treatment of PTSD, addressing the needs of an estimated 13 million Americans suffering from this condition.
The NDA submission is bolstered by study results, including two placebo-controlled Phase 3 studies, demonstrating the therapy’s efficacy and safety. The recent funding will support the regulatory and pre-launch activities of this investigational treatment. Lykos is also seeking Priority Review from the FDA, which, if granted, could expedite the therapy’s availability for medical use.
Lykos, building on over three decades of psychedelic-assisted therapy research, is committed to transforming mental health care through innovative treatments and approaches. As a public benefit corporation, Lykos balances societal impact with financial considerations, maintaining a focus on public benefits in all its endeavors.
At TDR, we will closely follow this development and provide analytical research as soon as we obtain the necessary financial information for review.