- Funding comes from mission-aligned and institutional investors to support regulatory and pre-launch activities for investigational MDMA-assisted therapy for post-traumatic stress disorder (“PTSD”)
- Company rebrands and changes name to reflect its new stage of focus—the integration of the potential first psychedelic-assisted therapy into the healthcare system if approved by FDA
SAN JOSE, Calif., January 5, 2024— MAPS Public Benefit Corporation (“MAPS PBC”), a company dedicated to transforming mental healthcare, announced an oversubscribed Series A financing. MAPS PBC raised more than $100 million including conversion of previously issued convertible notes.
The financing was led by Helena, a global problem-solving organization and investor, with participation from other mission-aligned and institutional investors, including, but not limited to: the Steven & Alexandra Cohen Foundation (led by Alex Cohen), Eir Therapeutics, Vine Ventures, True Ventures, Unlikely Collaborators Foundation, The Joe and Sandy Samberg Foundation, Bail Capital, KittyHawk Ventures and Satori Neuro. MAPS PBC also announced the company is rebranding and changing its name to Lykos Therapeutics (“Lykos”), effective immediately.
“We are incredibly grateful for Helena’s tremendous support and leadership as well as the contributions from other mission-aligned investors, which comes at this critical time as we are transitioning from a development-stage company to one focused on commercialization of the potential first psychedelic-assisted therapy,” said Amy Emerson, chief executive officer (“CEO”) of Lykos. “To reflect our company evolution, we selected a new name, Lykos which means wolf in Greek, to represent the qualities—bravery, courage, loyalty and intelligence—that resonate with our company.”
With the completion of the financing, there have been changes to the Lykos board of directors. The new eight-member board is comprised of six Multidisciplinary Association for Psychedelic Studies (“MAPS”) appointees, four of whom are independent directors, the CEO of Lykos, and Suprotik (Protik) Basu from Helena, who brings over two decades of public health financing experience to the board.
“We are inspired by the mission and work of Lykos and honored to be chosen as their trusted partner,” said Protik Basu, managing partner at Helena. “This strong funding round, combined with the Phase 3 results and recent new drug application submission to the FDA, position Lykos to continue its journey to help transform mental health, and to help address the large unmet need for the estimated 13 million Americans who suffer from PTSD1, should this investigational drug used in combination with therapy be approved by the FDA.”
New Name and Identity
As the Company transitions from a research-stage company to a public benefit corporation focused on integrating new therapies, if approved by the FDA, into the healthcare system, it is rebranding and has changed its name to Lykos Therapeutics. The name is derived from the Greek word, lykos, which means “wolf,” and is associated with the qualities of bravery, courage, loyalty and intelligence that resonate with the organization. Along with the name change, the new visual identity represents the overlap of innovative science combined with a focus on the whole person.
About MDMA-Assisted Therapy
MDMA-assisted therapy is an investigational modality being studied using a combination of MDMA, psychological interventionand other supportive services to treat PTSD. MDMA (3,4-methylenedioxy-methamphetamine) is an entactogen—a class of psychoactive compounds that are differentiated from classic psychedelics and are defined based on their mechanism and known effects of increasing self-awareness leading to introspection and personal reflection.2,3,4
Lykos has completed two Phase 3 trials for PTSD and submitted a new drug application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for MDMA (midomafetamine capsules) used in combination with psychological intervention, which includes talk therapy, and other supportive services provided by a qualified healthcare provider. If approved by the FDA, investigational MDMA-assisted therapy would be the first psychedelic-assisted therapy approved for PTSD. The NDA submission included results from numerous studies including two randomized, double-blind, placebo-controlled Phase 3 studies (MAPP1 and MAPP2) evaluating the efficacy and safety of MDMA-assisted therapy versus placebo with therapy in participants diagnosed with moderate or moderate and severe PTSD, respectively. Both MAPP1 and MAPP2 studies met their primary and secondary endpoints and were published in Nature Medicine.5,6 This new funding will help enable Lykos to finish regulatory and pre-launch activities for investigational MDMA-assisted therapy for PTSD. If approved, investigational MDMA-assisted therapy may offer healthcare providers a new option to consider for appropriate individuals with PTSD.
With Breakthrough Therapy designation given to MDMA in 2017, Lykos has requested the FDA grant Priority Review of the NDA. The FDA has 60 days to determine whether the NDA will be accepted for review and whether it will be a priority or standard review (six months or ten months, respectively). If approved by the FDA, the U.S. Drug Enforcement Administration (“DEA”) would be required to reschedule MDMA making it available for prescription medical use.
MDMA-assisted therapy has not been approved by any regulatory agency. The safety and efficacy of MDMA-assisted therapy have not been established for the treatment of PTSD.
Helena is a global problem-solving organization that seeks to implement solutions to critical societal challenges through nonprofit, for-profit, and legislative actions. Helena operates its projects alongside a small group of leaders called Helena Members. They include Nobel Laureates, Academy Award winners, former CIA Directors, technologists, entrepreneurs, explorers, and more. Helena supports mission-driven for-profit efforts through its investment arm, Helena Special Investments (HSI). Its portfolio includes innovations in grid-scale energy storage (Energy Vault); AI controls to dramatically reduce energy consumption in industrial processes and data centers (Phaidra); and Digital Twin technology enabling chronic metabolic disease reversals (Twin Health), among others. HSI is led by Managing Partners, Henry Elkus, Sam Feinberg and Suprotik Basu.
Helena’s nonprofit projects have included America in One Room, which garnered the attention of The New York Times and President Barack Obama; Biosecurity in the Age of AI, which focuses on risks emerging at the intersection of AI and biotechnology; and The COVID Project, which supplied tens of millions of units of personal protective equipment to frontline responders during the COVID-19 pandemic.
About Lykos Therapeutics (Formerly MAPS PBC)
At Lykos, formerly MAPS PBC, our mission is to transform mental health care. We aspire to challenge the status quo through the development of novel therapies and therapeutic approaches to treat mental health conditions. With 30+ years of experience researching psychedelic-assisted therapies, we remain committed to the rigorous pursuit of evidence-based development of novel approaches. Founded in 2014 by the non-profit MAPS, Lykos Therapeutics is a for-profit public benefit corporation (“PBC”) established to further the development of investigational psychedelic-assisted therapies. As a PBC, we consider the impact of our decisions on society just as we think about financial implications. Everything we do is viewed through a public benefit lens. To learn more visit us at www.lykospbc.com and on LinkedIn, X, Instagram and Facebook.
E. Blair Clark-Schoeb
Chief Communications Officer
1. National Center for PTSD. US Department of Veterans Affairs. Accessed January 3, 2024. https://www.ptsd.va.gov/understand/common/common_adults.asp
2. Nichols, David E.Entactogens: How the Name for a Novel Class of Psychoactive Agents Originated. Frontiers in Psychiatry. Vol 13, 2022. DOI= 10.3389/fpsyt.2022.863088.
3. Vollenweider, Franz X.,Dialogues Clin Neurosci. 2001 Dec; 3(4): 265–279.doi: 10.31887/DCNS.2001.3.4/fxvollenweider
4. O’Neil, M.J., The Merck Index: An Encyclopedia of chemicals, drugs and biologicals. Merck Research Laboratories, Merck and Co. Inc, Whitehouse station, New Jersey, 2006. 319
5. Mitchell JM, Bogenschutz M, Lilienstein A, et al. MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nat Med 609 2021;27:1025–33
6. Mitchell JM, Ot’alora MG et al. MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Nat Med. 2023 Sept 14 doi: 10.1038/s41591-023-02565-4. Online ahead of print.