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.

MindMed - MM120

Mind Medicine’s lead candidate is lysergide D-tartrate (LSD) with MM120 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 ($6.28) - 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

NUVB: Nuvation Bio ($5.09) - Update #6

This morning Nuvation Bio gave investors a nice update of 3rd quarter financial results. In just their first quarter of commercialization with the FDA approved drug Obtrozi (taletrectinib) for ROS1 NSCLC, the company achieved 7.7 million in total revenue. The company also guided on their pipeline which includes oral drug Safusidenib for IDH1 high-grade gliomas. Key points of progress in the 3rd quarter report and conference call. 

Obtrozi (taletrectinib)

• Obtrozi 3rd quarter sales of $7.7 million 
• Obtrozi DOR (duration of response) has reached 50 months

Safusidenib

• Begin Phase 3 Safusidenib maintenance treatment high-grade 3 or 4 gliomas
• No other market entrants have been approved for high-grade gliomas
• Global phase 3 safusidenib trial has registrational potential

NUV-1511

• Clinical trial update 4th quarter

Financial

• $549 million cash on hand, end of 3rd quarter
• $25 million milestone payment fourth quarter

NUVB: Nuvation Bio ($4.50) - Update #5

A purely technical post regarding Nuvation Bio (NUVB). Technical analysis is the practice of using historical data and current price action, to predict future price movements. Since March of 2024 the stock has hit the $4.00 ceiling level and has turned back down on three occasions. It could be investors taking profits, or short sellers looking for opportunity at that level. NUVB finally broke out higher of that level this week, bringing in new technical strength of higher prices to the stock, chart below. The company will report third quarter earning's on November 3rd, when we'll get the fundamental investment details. 

 

Auvelity Prescription Update - 3rd Quarter

Axsome Therapeutic's drug, Auvelity was approved for depression in 2022, and completed it's first full year of commercialization in 2023. The chart below is quarterly prescription data derived from a couple different sources, Bloomberg and IQVIA. The numbers are climbing from quarter to quarter, which is positive. The third quarter of 2025 numbers have not been released yet, so a rough estimate (2221,000) has been created based on data tracking. See chart below of prescription data. Axsome reports third quarter results on November 3rd.

NUVB: Nuvation Bio ($3.22) - Update #4

Nuvation Bio's (NUVB) recently FDA approved drug (taletrectinib) known commercially as Obtrozi, has only been on the market for three month's since approval in June. Expectations for revenues are now just being released by research firms. S&P Global has released an estimated revenue projection for Obtrozi for ROS1-positive non-small cell lung cancer (NSCLC), versus it's competitors in the same space. Graph below is from Visible Alpha, part of S&P Global market intelligence. The entire article can be viewed here ROS1 Lung Cancer Market.

GOLD - New High $3448

You don't hear a lot about gold from the general press, but gold closed at an all-time, new high last week at $3448 / ounce. The usual reasons we posted here Gold - New High are in play and haven't changed. Chart below of gold, thank you for reading. 

NUVB: Nuvation Bio ($2.75) - Update #3

An update on Nuvaton Bio's progress the past few months, as the company and stock have been performing well since receiving FDA approval of Taletrectinib, a drug for ROS1-positive non small cell lung cancer (NSCLC). Another drug in their pipeline NUV-1511 is in clinical studies for five indications. 

 Financial Statistics: 

• $608 million cash
• Debt - minimal
• 341 million diluted shares outstanding
• 938 million market cap

Intellectual Property:

• Taletrectinib - Expected to expire from 2033 to 2042
• Safusidenib - Expected to expire from 2035 to 2041
• NUV-1511 - Expected to expire 2039 to 2043

Nuvation Bio's pipeline includes NUV-1511 a drug known as a DCC (drug-drug conjugate), which is in a phase 1/2 being tested for patients with advanced solid tumors in five separate indications here NUV-1511. This large study will include 466 patients to conclude in early 2027. The company expects more details forthcoming. Weekly chart below of Nuvation, thank you for reading. 

Axsome 2nd Quarter Financial Results ($103.59)

Axsome Therapeutics is getting closer to becoming a profitable company, on a cash and earnings per share basis.  An impressive 2nd quarter, with highlights below. 

• On target to file a supplemental NDA for Alzheimer's Agitation 3rd quarter
• 150 million in second quarter revenue
• 303 million in cash

Chart below of Axsome Therapeutics, with corrections that the stock has endured the last few years. The average correction falls in the range of around 30%. Thank you for reading.

Auvelity Prescription Update - 2nd Quarter

Axsome Therapeutic's drug, Auvelity was approved for depression in 2022, and completed it's first full year of commercialization in 2023. The chart below is quarterly prescription data derived from a couple different sources, Bloomberg and IQVIA. The numbers are climbing from quarter to quarter, which is positive. The second quarter of 2025 numbers have not been released yet, so a rough estimate has been created based on data tracking. See chart below of prescription data. Axsome reports second quarter results on August 4th.

CYBN: Cybin ($7.94)

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. 

NUVB: Nuvation Bio ($2.20) - Update #2

Today, Nuvation Bio's lead drug candidate Taletrectinib was approved for ROS1-Positive Non- Small Cell Lung Cancer. This is good news for cancer patients, good for the company and investors alike. The full press release from Nuvation Bio is here FDA Approval Press Release.  The newly commercialized product name, will be Ibtrozi. Thank you for reading.