This week’s bulletin is later than usual as we’re attending Horizons’ 14th annual conference in New York City.
But, there’s plenty to cover: MAPS’ new funding stream, atai’s increased stake in COMPASS Pathways, a study on the interaction between an SSRI and psilocybin, and more…
Psychedelic Sector News
MAPS and Vine Ventures Announce $70m Investment Vehicle
At the close of Thursday’s Business Forum here at Horizons, Vine Ventures’ Ryan Zurrer announced The Regenerative Financing Vine, a $70m Special Purpose Vehicle (SPV) that intends to fund patient access infrastructure and research for MAPS’ MDMA-assisted therapy (MDMA-AT) for PTSD.
According to details released by MAPS and Vine Ventures (who have pledged a minimum of $13m to the SPV), this model “fully maintains both MAPS’ nonprofit mission and governance and MAPS Public Benefit Corporation’s (MAPS PBC) public benefit drug development and post-approval activities.”
Thus far, MAPS’ research has been funded via $130m in philanthropic donations over its 35-year history. This SPV represents a shift away from this donation-only approach, funding the next stretch of MAPS MDMA-AT for PTSD work via an investment vehicle.
Speaking to Lucid News, Doblin expressed feeling, “in some ways a sense of massive failure in that I hoped we would have this bridge to sustainability come through philanthropy.” But, as more for-profit entities have entered the space – no doubt benefitting from and to some extent relying on the clinical, political and cultural work that MAPS has trailblazed in the field – many former-donors are now asking themselves “Why should I donate? Let me just invest,” explained Doblin.
Doblin’s preference for donations over investment is, according to the founder, related to his broader plans to focus on “mass mental health.” This might include providing MDMA-AT to places around the world where “there’s a lot of trauma,” and he worries that having to return money to investors might change decision-making around the loftier goals.
Details on the SPV:
- Target size: $70m.
- The SPV receives 6.1% of North America MDMA revenue for 7 years following initial drug sales.
- ‘Reciprocity payment mechanism’: after paying back the principal, the SPV returns 15% of the revenue share back to MAPS. After hitting a 3x payback, the SPV returns 50% of the revenue share back to MAPS.
- Vine will not take any carry or fees on the SPV.
- Investors can share their details with Vine Ventures here.
This is somewhat akin to project financing: i.e., investments are structured and appraised on the basis of projected future cash flows, as opposed to the current balance sheet of the project’s sponsors. Investors do not gain equity in MAPS PBC, but rather a share of future revenues, as explained above. See McKinsey’s New frontiers in pharma R&D investment (PDF) for more on these types of model.
This $70m represents a portion of MAPS’ $150m fundraising target for the next three years. MAPS will hope to raise the remainder through non-investment means, such as via philanthropy but also partnerships and joint ventures.
Recommended reading: Lucid News spoke with Doblin shortly after the announcement. Read the interview here, where Doblin shares his thoughts on the new funding model, some further specifics on the mechanisms baked-in to the SPV, the uses of the funds, and more.
MindMed and Liechti Lab Explore Interactions Between SSRI and Psilocybin
Earlier this week, MindMed press released the publication of a study by the Liechti Lab that investigates the interaction of the SSRI antidepressant escitalopram with the acute response to psilocybin.
Although press released this week, the research was published earlier in November, and presented at INSIGHT 2021 conference prior to that.
The study appears to refute received wisdom that chronic administration of serotonergic antidepressants (such as SSRIs) dampen the subjective effects of psychedelics (e.g. Bonson and Murphy, 1996, in the case of LSD). This has also been documented in case reports, with some suggesting that co-administration of antidepressants and serotonergic psychedelics increasing the risk of adverse events.
Bonson and Murphy’s study looked at subjects who had taken an SSRI for over three weeks, of which there were 32 participants. Interestingly, they had one subject who had taken the SSRI fluoxetine for just 1 week, who reported an increased response to LSD.
The present study pretreated participants with the SSRI escitalopram for 14 days (7 days at a 10mg dose, followed by 7 days at a 20mg dose), or placebo pretreatment, and then administered psilocybin.
The study found that pretreatment with escitalopram had “no relevant effect on positive mood effects of psilocybin but significantly reduced bad drug effects, anxiety, adverse cardiovascular effects, and other adverse effects of psilocybin compared with placebo pretreatment.”
But, is a 14 day stepped pretreatment representative of real-world SSRI usage? The Psychedelic Pharmacists Association asked, “Is 14 days of pretreatment sufficient to draw conclusions about the need for antidepressant tapering and cessation before psilocybin administration?”
The authors of the study noted this limitation themselves, explaining that, “escitalopram pretreatment lasted only 14 days, which may have been too short to produce more chronic neuroadaptations and changes in receptor expression that can alter the response to psilocybin.” Authors also note that they did not test for HTR1A gene expression, which could be altered by antidepressant treatment.
COMPASS Pathways is running a similar study: a Phase 2 trial with 19 participants that aims to evaluate whether the company’s COMP360 psilocybin therapy can be administered as an adjunctive therapy (e.g., alongside SSRIs), or whether it should be administered as a monotherapy (i.e., participants taper off SSRIs and other antidepressants prior to commencing COMP360 therapy, as was the case in the company’s Phase 2b trial). Results from this trial are expected soon, and will likely inform the company’s Phase 3 trial design.
atai Increases Ownership Position in COMPASS Pathways
As retail investors appear bearish on COMPASS Pathways since its Phase 2b results were published, its largest shareholder atai Life Sciences has increased its ownership in the company to 20.8%.
The 1.4% increase in ownership by atai should be viewed as a vote of confidence in the company’s progress. Founder and Chairman Christian Angermayer said:
“In my personal opinion, the market doesn’t seem to appreciate the full upside potential given these impressive COMP360 data, the size of the unmet patient need and the potential of COMPASS’ broad patent portfolio.”
Sources close to atai suggest this is just the beginning, with the company seeking to increase its stake in COMPASS up to around 29%.
On paper, things are looking positive for COMPASS Pathways in the months ahead, following a sharp dip earlier this month following the readout. Analysts are rating CMPS a buy, and now its largest shareholder has increased its position.
The company also announced further results from its Phase 2b study. The additional results showed patient improvements beyond the reduction of depression symptoms such as reductions in anxiety and increases in positive affect.
But even this news failed to buoy CMPS stock, which was down a further 12.5% this week.
And the rest…
- Albert Labs receives conditional approval for CSE listing;
- Awakn Life Sciences shuffles executive leadership team;
- Bright Minds provides scientific update on novel 5-HT2A psychedelic program;
- COMPASS Pathways appoints new CFO, Michael Falvey;
- Cybin announces FDA IND and IRB approvals for co-funded Phase 2 trial;
- MYND Life Sciences announces funding for psilocybin research on neuroinflammation;
- Numinus develops proprietary psychedelic tests with new toxicity and potency scans;
- PharmaTher granted new Japanese patent;
- Wesana Health reports Q3 2021 financial results;
- Red Light Holland reports Q2 2021 results.
Read more on our News page.
Psychedelic Telemedicine Has Arrived. What Could Possibly Go Wrong?
This latest piece from Shayla Love at VICE takes a look at how the practices of psychedelic tech startups are “raising questions about the limits of telemedicine in this field.” And, there’s more at stake here than the prescribing rights of at-home ketamine services: safety concerns around such practices could have far-reaching consequences for the ability for other actors to prescribe controlled substances to those suffering a variety of illnesses.
This piece pulls at a number of threads that are going to be very important in the coming months and years, not just in psychedelics but in healthcare more generally.
DEA Increases 2022 Psychedelics Production Quotas
As we predicted two bulletins ago, the DEA has scaled-up its psychedelics production quotas for 2022 following two increases to 2021’s quotas.
A notice published in the Federal Register yesterday shows that the Administration has more than doubled the psilocybin, MDMA, DMT and 5-MeO-DMT quotas.
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