HELUS Pharma: An Update

A reminder that Helus Pharma was formerly Cybin and changed the name in early 2026.

 

The psychedelic space is now under consolidation, as ATAI today has announced LLY to Acquire ATAI, for up to $3.8 billion consideration. This post is regarding Helus Pharma, ticker symbol (HELP), and the prospects of them being acquired in the future.

Helus's (HELP) main asset is HLP003, which is a deuterated form of psilocybin in phase 3 clinical trials for adjunctive MDD. The top line readout for the 1st phase 3 APPROACH is scheduled to be released by the end of 2026. The second phase 3 EMBRACE is scheduled to complete in 2027, and the company will seek FDA approval once completing.

 

There are a number of larger companies already approved for adjunctive MDD that might find interest in obtaining Helus's asset HLP003, as the patent runs until 2041. 

Here is a list in any order of the larger companies already approved for aMDD which might see value in obtaining a quick acting psychedelic drug, with a long patent runway of 2041.

AbbVie: Drug Vraylar is approved for aMDD with patent expiring in 2030. Vraylar is a valuable asset for AbbVie and is producing total annual revenue of $3.6 billion for the company. Revenue is not broken out per indication as Vraylar has been approved for adjunctive MDD, Bi-Polar Depression and Schizophrenia. The company has already expressed an interest in the psychedelic field, as they previously purchased Gilgamesh Pharmaceuticals psychedelic drug compound Bretisilocin here, Gilgamesh-Pharmaceutical.

Johnson & Johnson: January 13th 2025 is the date that J&J made the acquisition of Intra-Cellular. After that acquisition, lead Intra-Cellular drug Caplyta was approved for aMDD in November 2025. The patent expiration for composition of matter expires in 2028, with additional patents extending out to 2034 and 2040. 

Otsuka/Lundbeck: Rexulti has been approved for aMDD since 7/10/2015, with patent expiring in 2026.  

Definium Therapeutics: DFTX is a mid-cap psychedelic stock with a $6.2 billion market cap, and looks like the best bet to go it alone in the psychedelic space, as they have substantiated clinical data for GAD, and MDD with an abundance of cash on hand. Adding a potential approval of adjunctive MDD to their offering could make them a psychedelic powerhouse. Helus also has in their pipeline HLP004 for GAD, which might also appeal to Definium by eliminating competition from their main asset DT120, or potentially modifying clinical development of HLP004, to bring a second GAD option to patients. 

I would expect AbbVie and Definium Therapeutics, to be most interested in Helus Pharma as a potential buyout. The patent for Vraylar is expiring in 2030, which means generics can proceed with gaining access to selling a generic version. AbbVie may start seeking revenue replacement for the future patent cliff.

An acquisition of Helus Pharma would not be too complicated, as the company is small with 60 million shares outstanding, additional warrants outstanding, and little debt. 

It will be interesting to see how this sector plays out over the next year. Chart below of the five major psychedelic stocks and their year-to-date performance. Thank you for reading. 

Disclaimer: This stock, or any other stock referenced on this site, is for educational purposes only, not personalized advice. Consult with your investment advisor professional, prior to buying stocks, precious metals, commodity's, or crypto.

Definium Therapeutics

Definium Therapeutics (DFTX)  formerly MindMed, is in late stage psychedelic-based development, with drug DT120 for General Anxiety Disorder (GAD) and depression (MDD). We wrote about psychedelic drug companies last year, Psychedelic Therapeutics.  DT120 was granted FDA Breakthrough Therapy Designation for GAD, after they completed phase 2 testing. The year is full of catalyst's of clinical data readout, with expected timelines below. 

Catalysts:

- Phase 3 MDD study Emerge expected to read-out topline in late 2nd quarter
- Phase 3 GAD study Voyage expected to read-out topline early 3rd quarter
- Phase 3 GAD study Panorama expected to read-out topline 2nd half 2026

Clinical Trials: 

- Emerge NCT06941844

- Voyage NCT06741228

- Panorama NCT06809595

Financial Statistics:

- US $411 million of cash on hand (approximation)

- Debt - minimal

- 104 million shares outstanding

- 1.8 billion market cap

Intellectual Property: 

- DT120 Expected to expire in 2041

Definium's lead indication GAD, looks to be the only psychedelic company on the verge of completing pivotal clinical trials for that indication. The stock is a high risk investment at this time, as they have zero commercial assets, and are in late stage clinical development, with results expected in 2026. 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

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.

Axsome Therapeutics (AXSM)

Axsome will report 3rd quarter results on November 12th. What to listen for during the conference call will be the pending ADVANCE2 and ACCORD2 clinical trial readouts for Alzheimer's Agitation, an unmet medical need. Previously the company guided for the clinical trial results by year end 2024. 

Prescription data for Auvelity treating MDD, is still progressing strong and growing as seen from the chart below. The chart below depicts Auvelity's drug launch for MDD versus other recent drug launches at similar time frames. I'm using Morgan Stanley's Research chart below, capturing data from IQVIA on a quarterly basis, so credit goes to them for this data. Clicking on chart will show Auvelity's launch for MDD (in blue) has been strong in comparison to Trintellix, and Viibyrd, which are other drugs approved to treat the same symptoms. Thank you for reading. 

Axsome 1st Quarter 2023 Financial Results

Axsome released their first quarter financial results on Monday May 8th. Just a few highlights from the just completed impressive quarter, are below. 

• Auvelity for MDD sales totaled $15.7 million for the quarter
• Sunosi for narcolepsy sales totaled $12.9 million for the quarter
• $246 million in cash on hand, end of quarter
• AXS-12 clinical trial for cataplexy, to read out in the second quarter

Axsome's share price has been moving steadily higher the past couple weeks. Below is a monthly chart of AXSM stock, which has just closed at it's highest level seen in the past two years. Thank you for reading. 

Auvelity - First Quarter Prescription Data

Axsome's first quarter of 2023 (and first ever completed quarter) weekly prescription data for Auvelity, from IQVIA is below. Axsome's launch of Auvelity for MDD, has been strong to date. Notice that there were thirteen weeks in this first quarter of 2023. Total scripts = 29,780 via IQVIA for the first quarter. Thank you for reading.

1/06/23 1300     2/03/23 1850     3/03/23 2525     

1/13/23 1650      2/10/23 2499      3/10/23 2726

1/20/23 1835      2/17/23 2380      3/17/23  2819

1/27/23 1750      2/24/23 2546      3/24/23 3000

                                                                 3/31/23 2900

Auvelity - One Month Prescription Data

The first month, of their first quarter of 2023 prescription data from IQVIA is below. Note that there was a holiday in the week of 1/27/23 which may have accounted for the slight drop. Axsome's launch of Auvelity for MDD, has been strong to date.

1/06/2023 1300

1/13/2023 1650

1/20/2023 1835

1/27/2023 1750

Catalysts in 2022

Heading into 2022, there will be plenty of catalysts to look forward to. Axsome Therapeutics is in the midst of pending FDA decisions with the following.

• AXS-05 for Major Depression Disorder - Decision is forthcoming
• AXS-07 for Acute Migraine - Decision expected end of April

Additionally AXS-05 is also in a phase 3 clinical trial for the indication of Alzheimer's Agitation, with expected results in the first half of 2023. A phase 2/3 clinical trial involving AXS-05 for the indication of Smoking Cessation, is expected to be initiated in 2022. The potential approval for AXS-05 for MDD (major depressive disorder), could pave the way for future AXS-05 approvals for different indications.

Concert Pharmaceuticals CTP-543 for Alopecia Areata (an unmet need), is expected to complete at least one of the two, phase 3 clinical trials mid year 2022, with the second phase 3 completing close behind in the third quarter. These are pivotal studies that are expected to form the basis for their NDA (new drug application) for Alopecia Areata.

• Thrive AA1 phase 3 results mid year 2022
• Thrive AA2 phase 3 results 3rd quarter 2022

Thank you reading.

SAGE-217 Gets Expedited Development - $175.76

Very good news from SAGE Therapeutics this morning. The FDA has agreed to give SAGE Therapeutics an expedited pathway for oral drug SAGE-217 for the indications of Postpartum Depression (PPD) and Major Depressive Disorder (MDD). Below is copied directly from the press release this morning.

• Expedited SAGE-217 development plan to support potential NDA submission for MDD and PPD together
•  Previously completed placebo-controlled study in MDD considered as pivotal; initiation of one additional Phase 3 pivotal trial anticipated in 2H of 2018  
• Ongoing study in PPD designated as pivotal; results expected in 4Q 2018
• If successfully developed, SAGE-217 has the potential to be the first durable, rapid-acting, oral, short-course treatment for MDD and PPD

The second half of 2018 will be packed with clinical trial data for PPD and MDD. SAGE-217 is an oral once daily delivered drug with patent to April 2034. Thank you for reading.

Otsuka's Commitment to AVP-786

Otsuka a focused CNS company, and the producer of Abilify, purchased drug AVP-786 for $3.5 billion through their acquisition with Avanir on November 13, 2014.  To get a sense of just how committed the company is to AVP-786, we have to look at the clinical trials that have started since the acquisition, and compare that to the number of clinical trials the company has started with another Otsuka drug Brexpiprazole, deemed the second generation drug of Abilify, that would compete in the indications similar to AVP-786.

Clinical Trials Started Since Acquisition
(3)  Alzheimer's Agitation - U.S.        phase 3
(1)  Residual Schizophrenia                phase 2
(1)  Disinhibition                                   phase 2
(1)  Alzheimer's Agitation - Japan     phase 3

Ongoing Trials With AVP-786
(1)  Treatment Resistant Major Depression Disorder  phase 2

New Otsuka Clinical Trials with Brexpiprazole
(0)
The company was previously in clinical trials prior to the acquisition of AVP-786, for Alzheimer's Agitation, MDD, and Schizophrenia as co- partner with Lundbeck.  But has not initiated anything new since agreeing to acquire AVP-786 from Avanir late 2014.  

Bottom Line:  Some significance into the timing of initiating clinical trials, may help us identify a companies priority in their clinical pipeline.  Thank you for reading.