Psychedelic Therapeutics

Second generation therapies using psychedelic drugs to treat mental health, is moving to the forefront at a rapid pace. The conversation now is which psychedelic will hit the market first, to serve their unmet need. We initially wrote about the subject here Psychedelic-Based Therapeutics. 

Not all psychedelics are identical in nature. Psilocin, DMT, and MDMA are the popular ones, all produced to act quickly with minimal dosing requirements. Here’s a list of five companies furthest along in their clinical trials, that have successfully raised the needed capital to progress further toward FDA approval, and commercialization.

ATAIBeckley, Compass Pathways, Cybin, GH Research, and MindMed.

ATAIBeckley - BLP-003

ATAI is addressing treatment resistant depression with their psychedelic drug (BLP-003) mebufotenin benzoate, and their means of dosing is an intranasal inhalant. The company has completed Phase 2b Results and is now in the process of meeting with the FDA to discuss the design of their phase 3 clinical trials. Those phase 3 trials are expected to commence in the second quarter of 2026. BLP-003 has Breakthrough Therapy Designation.

Compass Pathways - COMP360

Compass is furthest along in their clinical trials addressing treatment resistant depression with their lead oral candidate psilocybin COMP360. Completion their first phase 3 clinical trial (COMP005) is posted here COMP360 Phase 3  With their second phase 3 clinical trial with (COMP006), to be completed in the first quarter of 2026. COMP360 has Breakthrough Therapy Designation.

Cybin - CYB003

Cybin is addressing adjunctive major depression disorder (MDD) with their lead deuterated psilocybin oral candidate CYB003. The company has completed Phase 2 Results and has recently raised the needed cash to fund the operation through phase 3 readouts. Cybin is currently running three phase 3 clinical trials with CYB003 as an adjunctive therapy for patients. The first phase 3 APPROACH will have data by the fourth quarter 2026. EMBRACE to begin a global phase 3 in the fourth quarter of 2025, and EXTEND which is the long-term open label study currently enrolling the completers of APPROACH and EMBRACE to confirm long-term safety and efficacy. CYB003 has Breakthrough Therapy Designation.

GH Research - GH001

Similar to ATAI, GH Research is addressing TRD with an intranasal inhalant with psychedelic mebufotenin. The company has completed Phase 2b Results, and is on schedule to meet with the FDA for a post phase 2 meeting to discuss phase 3 clinical design. The company is well funded, having raised capital after the announcement of phase 2 results. Their goal is to commence phase 3 testing in 2026.

Definium ( formerly MindMed) - DT120 

Definium’s lead candidate is lysergide D-tartrate (LSD) with DT120 for generalized anxiety disorder (GAD). The company has completed Phase 2b Results and currently has two phase 3 clinical trials running called Voyage and Panorama. The potential completion for Voyage is late 2026 and Panorama mid-year 2027. The long-term open label 40-week extension study Part B, is available for the completers of Voyage and Panorama. The company is well financed and has Breakthrough Therapy Designation for MM120 and GAD.

The companies listed have set up intervention protocols for the patients, after the dosing of their therapeutic. The five companies written about here hold great potential for new innovative therapeutics for mental health, and at the same time, there are many challenges getting the therapies approved. At this writing we are only interested in Cybin for investment. Thank you for reading. 

CYBN: Cybin - Update #3

Psychedelic drug company Cybin is tackling two unmet medical needs, MDD and GAD with investigative psychedelic drugs CYB003 and CYB004. We wrote about psychedelic based therapeutics here Psychedelic Based Therapeutics. Today, Cybin updated investors on their recent quarter ending September 30. Below are some highlights from the conference call.

CYB003 

• Phase 3 dosing for clinical trial APPROACH NCT06564818 continues
• APPROACH to complete and report results by 4th quarter 2026
• Global Phase 3 EMBRACE to begin 4th quarter 2025
• EXTEND long term safety study is currently enrolling completers 

CYB004

• Phase 2 study for GAD to report results first quarter 2026

CYB005

• Under early investigational studies

Financial

• $226 million current cash on hand
• 49,894 million shares outstanding
• 16,810 million warrants outstanding, avg weighted conversion price of $10.11

CYBN: Cybin

Cybin is in late stage psychedelic-based development, with drug CYB003 for depression. We wrote about psychedelic drug emergence last year, Psychedelic-Based Therapeutics. The drug was granted FDA Breakthrough Therapy Designation, after they completed phase 2 testing.

Current developments: The company raised $50 million US Dollars with a financing agreement with High Trail Special Situations on June 30th. With this current financing completed, their financial situation for ongoing clinical development is estimated to be.

Financial Statistics:

- US $120 million of cash on hand (approximation)

- Debt - minimal

- 23 million shares outstanding

- 182 million market cap

- 50 million convertible debt

Intellectual Property: 

- CYB003 Expected to expire in 2041

- CYB004 Expected to expire in 2041

Cybin is a high risk investment at this time, as they have zero commercial assets, and are in late stage clinical development with lead drug CYB003 with results expected in 2026. Thank you for reading. 

Psychedelic-Based Therapeutics

Therapies for mental health conditions are changing at rapid speed. Cybin.com (CYBN) is a biopharmaceutical company developing therapies for mental health conditions. Their lead drug CYB003 is a proprietary deuterated psilocybin analog, which the FDA has granted as Breakthrough Therapy Designation (BTD), for depression. WebMD describes Psilocybin as a schedule 1 drug. The scheduled list looks like this below.

• Schedule I: Drugs with no current medical use, high potential for abuse and/or addiction.
• Schedule II: Drugs with some medically acceptable uses, but with high potential for abuse and/or addiction. These drugs can be obtained through prescription.
• Schedule III: Drugs with low to moderate potential for abuse and/or addiction, but less dangerous than Schedule I or II. These drugs can be obtained through prescription, but generally are not available over the counter.
• Schedule IV: Drugs with viable medical use and low probability of use or misuse.
• Schedule V: Drugs with low potential for abuse (lower than Schedule IV).

The company has completed a phase 2 clinical trial with strong efficacy, and is now in the process of starting two large phase 3 clinical trials with combined over 500 participants. The first of two phase 3 trails is here NCT06564818.  The patent for CYB003 extends out to 2041.

Cybin is high risk, with a market cap of around 180 million, which fits into the micro capitalization category. The stock should be a small percentage of any portfolio suitable for those with high risk tolerance, and willing to hold the shares on a longer term basis. The stock trades around 9.00 per share. Chart of Cybin below. Thank you for reading.