Compass Pathways (CMPS)-first FDA-approved psychedelic to market

Are there other investors in CMPS here? Comp360 is proprietary psilocybin, that’s being studied in treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD). Comp360 looks to be the first psychedelic to market. Their phase 3 studies (comp005 and comp006) in TRD are done, and they have been already doing rolling NDA for FDA. They guide to finalize their NDA (New Drug Application) in q4. I have reasons to believe the NDA will be submitting already in this month, because otherwise the best-case timeline projected by the company would not make sense (they say they will be launch ready by the end of this year, if the best case scenario happens). CMPS got FDA National Prority Voucher in the aftermath of Trump’s executive order in April. Voucher means, that FDA plans to approve (or not, as in case of any drug) the drug in 1-2 months after NDA filing. This means, that Compass might get FDA approval still this year. The study results are highly statistically significant and studies are large (they have studied around 1000 patients altogether, with all studies replicable and good safety). Especially as FDA gave the voucher after knowing the topline results, it seems very likely, that FDA will grant approval. With recent share price drop from $15,87 to 11’s, along the drop in XBI/biotech because of the rising interest rates, the investment looks compelling to me at the moment. The timeline is getting very compressed, and despite potential weakness in biotech, the likely FDA approval must catapult the price way above recent highs. The alarm clock for investors will ring when PR of NDA submission is given very soon, I’m hoping even next week. Then the CNPV process clock starts ticking, and I expect the share price to start climbing again in anticipation of approval. There is only one drug FDA-approved for TRD at the moment, Johnson&Johnson’s Spravato (esketamine nasal spray). It’s similar in the sense to comp360 psilocybin, that it’s deliver under monitoring in interventional psychiatry clinincs (around 8500 Spravato clinics in US at the moment and amount growing fast in anticipation of approved psychedelic therapies). They can offer comp360 in the same clinics and with same staff. There is about 40% spare capacity in these clinics atm, so they can start filling that capacity when comp360 is approved. Spravato is J&J’s fastest growing drug ATM and it’s looking to make 2,3 billion USD revenue this year. Comp360 is planned to be priced similarly to Spravato in terms of yearly cost per patieny, which by CMPS CCO Englebert means around **50-65,000 usd/patient/year or 17-22,000 usd per dosing of comp360.** Spravato is actually making this much money per patient, and comp360 looks highly differentiated and probably preferable for patients, as with Spravato you have to do a treatment weekly or biweekly (26-52 times a year) in a clinic, and you also need somebody to drive you by rules. This treatment goes on indefinitely, as the treatment effect wanes in 1-2 weeks. **Comp360 would be dosed on average only 3 times a year.** There are **4 million TRD patients in US** and with **even 2-3% penetration** this would make 80-120k patients on comp360 and **4,4-6,6 billion usd yearly revenue** (assuming $55k/patient/year). In addition, **CMPS** has phase 2b/3 (meant as a single phase 3 study to approval) going in **PTSD with 21 million patients in US.** You can play with different market penetrations in this population, too…there are no effective medicines for PTSD, patients mostly are on SSRI’s, and there hasn’t been an FDA approval for a drug in PTSD in about 20 years… The **market cap** after latest decline is only about **1,5 billion,** so there’s clearly potential for the stock price to multiply even in near future and especially, as investors start counting PTSD in TAM for comp360. Exciting months ahead!