Dear MAPS supporter,
It’s with profound gratitude to the thousands of people in the MAPS community who selflessly contributed in any way over the decades to bring us to this point that I share some triumphant news. After a gestation period of nearly 38 years since I founded the nonprofit MAPS on April 8, 1986, there is much to celebrate. The MAPS Public Benefit Corporation, which MAPS created in December 2014 as a wholly-owned for-profit subsidiary, is transforming into Lykos Therapeutics, a for-profit, shareholder-owned public benefit psychedelic mental health company. Last week, we released a statement on Lykos’ announcement of its name change and the completion of an investment round of $100+ million. Lykos will continue to fundraise and have shareholder and public benefit interest in mind, including the potential for an IPO at some point in the future.
MAPS welcomed investors when we realized the greatest loss of public benefit would be if MDMA-assisted therapy for PTSD failed to become FDA-approved and available due to a lack of resources. MAPS was a victim of our own success. Through decades of philanthropy, when there was no government/public funding, and private investments made no financial sense given all the stigma and political obstacles, MAPS donors helped create the cultural context and the psychedelic renaissance that incubated hundreds of for-profit psychedelic companies, many publicly traded. Unintentionally, the rise of for-profit companies made it more difficult to raise additional donations.
On December 11, 2023, Lykos submitted a New Drug Application (NDA) to FDA for investigational MDMA-assisted therapy for PTSD with data from two published successful Phase 3 studies. 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 the FDA accepts the NDA for review, and decides that it will be subject to a priority review, then a decision regarding approval could take place around August 2024. In the event of FDA approval, rescheduling of the medical product by the Drug Enforcement Administration (DEA) must, by law, take place within 90 days after approval, to be followed by state rescheduling. In addition to managing the FDA NDA process, Lykos is also building commercial capabilities to integrate MDMA-assisted therapy into the healthcare system, in the event of approval of the NDA by the FDA.
A major reason to celebrate is the Series A investment round was led by impact investor Helena, ”a global problem-solving organization,” with Protik Basu from Helena becoming the representative of the investors on the Lykos Board of Directors. The other major investors along with Helena are also impact-oriented; many of the investors are putting returns back into foundations and the movement. I’ve come to trust Helena and Protik’s sincere commitment to balancing return to shareholders with public benefit, and to supporting nonprofit MAPS’ work to globalize MDMA-assisted therapy for PTSD for humanitarian purposes in high-trauma, low-resourced parts of the world. Protik’s mentor was Paul Farmer, founder of Partners in Health. To my surprise, delight, and relief, Protik understood what I meant by “liberation theology” when I explained the thinking behind Healing for All being one of MAPS’ core principles.
MAPS is currently the single largest shareholder in Lykos, with a little less than half the stock and a ten-to-one dual-class voting shares structure. MAPS currently has the right to appoint six of the eight members of the Lykos Board of Directors, of which I’m one, to help ensure Lykos includes public benefit considerations in all decisions. MAPS has given up day-to-day control to Lykos management and its Board of Directors, but will ensure that compensation incentives are linked to public benefit metrics.
MAPS leadership, including myself as President, Executive Director Kris Lotlikar, and Deputy Director Fede Menapace, own no Lykos’ stock nor have any stock options. This is to ensure we stay focused on public benefit, bolster accountability, and avoid any conflict of interest.
In addition to triumph and celebration, there is also failure and mourning mixed in with the creation of Lykos Therapeutics. My dream was to develop MDMA-assisted therapy entirely with philanthropic funds. That way, the for-profit MAPS Public Benefit Corporation would have remained wholly-owned by the nonprofit MAPS, my ideal corporate structure for the first-in-class psychedelic-assisted therapy potentially approved by FDA to be mainstreamed at a time in history when the world is on fire. Despite my best-sustained effort for several years, I failed to inspire enough philanthropists to donate the ever-increasing millions of dollars required to both obtain FDA approval and to build the infrastructure needed for patient access, especially since there were many newly created investment opportunities in the psychedelic ecosystem.
I agreed to the name change from MAPS Public Benefit Corporation to Lykos Therapeutics. The decisions to be made at Lykos, even though it is a public benefit corporation, will, of necessity, include responsibilities to private stockholders. These decisions will not always be the decisions that the nonprofit MAPS would have made if we had remained the sole owner of MAPS Public Benefit Corporation, responsible only to our donors and to advancing public benefit. It therefore felt necessary and made sense to reclaim the MAPS name from the for-profit pharmaceutical company.
I appreciate that Lykos, the Greek word for wolf, references its historical connection to MAPS and me personally. From the ages of 21-23, I was fortunate to have the deeply transformative experience of raising a full-blooded male Alaskan Timber Wolf from 8 weeks old to about two years. I named him Phaedrus from a character in the book Zen and the Art of Motorcycle Maintenance. Phaedrus is also the name of a character from the countryside in Plato’s dialogues, whose discussion alludes to the taming power of love. I gave Phaedrus up when the woods we used to run in together without a leash started getting developed, and when a spot opened up in a wolf sanctuary where a female wolf needed a mate (though Phaedrus was required to get a vasectomy so that there would be no more wolves born into captivity). I attribute much of MAPS’ success to lessons I learned from Phaedrus: confidence, courage, and seeing obstacles as opportunities for exercise. Wolves, like psychedelics, are often feared and hunted with cultural anxieties projected onto them, but when treated respectfully, are full of love, joy, and acceptance.
The heartbreak of not being able to fully realize my dream — of philanthropy entirely funding what I’d hoped to be MAPS’ 100% ownership of the MAPS Public Benefit Corporation — is tempered by the great promise ahead of what Lykos Therapeutics can accomplish. Lykos can build on the outstanding data created by the fully-trained and deeply dedicated therapists (with training including therapist self-experiences of MDMA within legal contexts), and by our courageous study volunteers. Lykos will have easier access to resources through the capital markets (though we need to remain vigilant that public benefit remains a priority). Lykos and the entire psychedelic ecosystem are being propelled by the cultural transformation regarding psychedelics that MAPS has helped create trending over time toward legal access for all purposes within federal and state-regulated contexts. My heartbreak is also tempered by all the momentum that is supporting MAPS’ effort to globalize access to the healing, spiritual, and celebratory potential of psychedelics, building toward a world of Net-Zero Trauma by 2070.
Going forward, MAPS will continue to require donations to fund its mission-related activities. As Lykos focuses on patient access in the Western world, MAPS will focus on humanitarian research with MDMA around the world in areas with a high prevalence of trauma and few resources. We’ll explore group therapy with local healers and conduct academic research into MDMA for conflict resolution and couples therapy. MAPS will also be working on its broader mission of drug policy reform and reducing criminal penalties for MDMA and other psychedelics through the US Sentencing Commission, and seeking to provide low-cost access outside of exclusively FDA-regulated medical contexts. To support drug policy reform, MAPS will be providing psychedelic harm reduction and public education within a science-based, non-prohibitionist view of psychedelics, including teaching police and first responders in Denver and other psychedelic decriminalization or legalization areas how to de-escalate situations in which they encounter people in the midst of difficult psychedelic experiences. MAPS will also conduct research on cannabis, for which we’ve received a $12.9 million grant from the State of Michigan for a study in 320 veterans with PTSD. The FDA has placed this study on Clinical Hold, refusing to let us study smoked marijuana or vaporized marijuana, with MAPS now preparing to file a Formal Dispute Resolution Request with FDA.
MAPS is also interested in studying other psychedelics. We are collaborating with many of the leading ibogaine treatment providers and are seeking to raise about $80 million over four years in public money and donations to conduct FDA drug development research into ibogaine for treating opiate dependence. We propose to do so in a truly open science manner, without seeking patents, and with the intention of immediately making the drug generic. This collaboration came together as a result of the State of Kentucky proposing to allocate $42 million to ibogaine research from the over $840 million it is receiving in settlement funds from the pharmaceutical companies that contributed to the opiate epidemic. Though this KY effort has been squashed by the new KY Attorney General, other states may take this up, with our coalition’s intention remaining to try to take ibogaine through the FDA with public money and donations fully within a public benefit context.
To conclude with a note of celebration, April 8, 2024, is MAPS’ 38th anniversary. The universe has decided to help celebrate by arranging for a full solar eclipse to take place that day through parts of the United States. Another full solar eclipse will not take place in the US until 2044. MAPS is working with seetexaseclipse.com festival organizers who are creating a camping event for about 30,000 people at a location under the path of totality about an hour outside of Austin, Texas. MAPS is organizing a psychedelic lecture series and will have an area for MAPS-affiliated people to camp together. You can enter MAPS38 in the registration form to receive a 10% discount. If you’d like to camp in the MAPS area, be sure to add a group car camping pass.
The sun has set on the MAPS Public Benefit Corporation and is rising on Lykos Therapeutics. After the eclipse, as the sun returns, MAPS will be reborn yet again. All the people who invest in Lykos, and much more importantly, all the people all over the world who will be treated by MDMA-assisted therapy, owe an enormous debt of gratitude to the donors and supporters of MAPS over the last 37 ½ + years. Without their support, none of these accomplishments would have been possible.
To Healing for All,
Rick Doblin, PhD
MAPS Founder and President