Solriamfetol for ADHD Phase 3 Results

Axsome released phase 3 clinical data from the (FOCUS) study with drug Solriamfetol for Attention Deficit Hyperactivity Disorder (ADHD), with results being statistically significant, rated under the AISRS (primary endpoint) versus placebo. 

FOCUS Phase 3 Results:

• AISRS compared to placebo p=0.039 
• CGI-S compared to placebo p=0.017

The company will next have to run a pediatric phase 3 study scheduled for 2025. If positive then can submit to the FDA a new drug application. The advantage over current treatments, is that Solriamfetol is considered a non-stimulant drug, and potential improvement from a safety profile from currently approved ADHD drugs on the market. Thank you for reading.

Update to Stock Charts

Plenty if volatility in the markets at this time. Some updated charts below.  First chart is the asset class performance on a year to date basis, which includes Gold, Bonds, S&P 500, and Bitcoin. Gold has been an outperformer year to date so far versus other assets.

This next set charts include Axsome Therapeutics, and Cybin, both companies we have wrote about before.  Displayed as 60 minute charts.

With the first quarter almost completed, few investments and plenty of cash and gold was probably the best strategy to pursue, in hindsight. Thank you for reading.

GOLD Revaluation

Gold is trading at all-time highs, around $2,950 per ounce. Several catalyst may be at play driving the price higher. The revalue of gold reserves to higher prices, was mentioned by new Treasury Secretary Scott Bessent. The US is said to hold 8,133 metric tons of gold, but an audit would be necessary to verify the accuracy. Weekly chart of gold below. Thank you for reading.

Axsome Fourth Quarter Financial Results

Axsome released 4th quarter financial results today, a couple of highlights from the quarterly and year end release. 

• ADHD phase 3 results, first quarter of 2025
• AXS-05 for Alz Agitation NDA to be submitted 2nd half 2025
• AXS-12 for Narcolepsy NDA to be submitted 2nd half 2025
• $315 million in cash, end of 2024

Good quarter, and great 2024 completed. The stock is at an all-time high level around $130.00 per share chart below. Thank you for reading. 

 

Symbravo Receives FDA Approval for Acute Migraine

Axsome Therapeutics has received FDA approval for migraine drug AXS-07, or known commercially now as Symbravo. The drug's patent extends out to 2040, so there will be plenty years of runway for commercialization. The list of approved drugs that address unmet medical needs now extends to three, which include Auvelity, Sunosi, and now Symbravo. The company is operating at a very high level, of advancing through clinical trials to FDA approval. Click on chart below, as Axsome stock has closed at an all-time high price. Thank you for reading. 

MM120 for Generalized Anxiety Disorder

MindMed (MNMD) is a psychedelic company addressing unmet medical need GAD (Generalized Anxiety Disorder) with lead drug MM120. The companies website is here MindMed. Some quick facts regarding MindMed. 

• 540 Million Market Cap
• 80M Shares outstanding
• 295 Million cash
• MM120 Breakthrough Therapy Designation
• MM120 Patent to 2041
• MM120 in Phase 3 for GAD
• Share Price $7.20

The company has successfully completed a phase 2b for GAD, and received Breakthrough Therapy Designation for MM120 afterwards. The company is now in phase 3 for GAD. They will be using the HAM-A assessment at 12 weeks, after a single dose of MM120. Here is where you can find the company's medical Presntations. The goal of MindMed is to have two phase 3 clinical trials and a 40 week long-term extension study all completed by the end of 2026. Their past and current clinical trails MM-120 Clinical Trials. Thank you for reading.

AXS-05 for Alzheimer's Agitation - Phase 3 Results

Axsome released data for unmet medical need, Alzheimer's Agitation. The therapy may promote easier caregiver duties, so the person with Alzheimer's they are caring for, can remain in their home surroundings, rather than institution. The company hit on one of the two clinical trials completed. The studies were ADVANCE2 and ACCORD2, with the ACCORD2 trial delivering statistical significant results that should lead to a New Drug Application (NDA) and potential FDA approval. The company plans to file the NDA in the second half of 2025. With the completion of these two clinical trials, the company will have three positive studies, results below. 

ADVANCE 1 Results:

• Reduction in the CMAI (primary endpoint) vs placebo p=o.010

ACCORD 1 Results:

• Delayed time to relapse p=0.014
• Relapse prevention p=0.018

ACCORD 2 Results:

• Delayed time to relapse p=0.001
• Relapse prevention p=0.001

The safety profile was in line with previous company studies, which could indicate the absence of a black box label. Patent for AXS-05 runs from 2034 to 2043. Thank you for reading.

AXS-12 Long-Term Phase 3 Study

Axsome Therapeutics completed their phase 3 12 month long-term study with Narcolypsy drug candidate AXS-12. The results confirmed the prior phase 2 and phase 3 studies completed. 

• Phase 3 long-term reduced cataplexy attacks vs. placebo (p=0.017)
• Phase 3 significantly reduced cataplexy attacks vs. placebo (p=0.018)
• Phase 2 significantly reduced cataplexy attacks vs. placebo (p=0.001)

Based on these results, Axsome will file a new drug application (NDA) with AXS-12 for Narcolypsy patients experiencing cataplexy first half of 2025, and if approved will be on the market in 2026. AXS-12 has patent to 2039. This will be a smaller revenue producer compared to what Auvelity revenues will be producing for MDD, but still significant for a small but growing biotech company. Chart of Axsome below show's stock hovering around $100 per share. Thank you for reading.

Axsome Third Quarter Financial Results

Today, Axsome Therapeutics announced third quarter financial results. The results were positive as noted below.

• Total revenue was $104 million, their first quarter over $100 million
• Revenue exceeded analyst estimates, which were expecting $98 million
• Alzheimer's data to be released as previously guided in this 4th quarter
• Alzheimer's data for the two trials will be released simultaneously
• ADHD data to be released in the first quarter of 2025
• $325 million of cash on hand, end of the third quarter

The important information learned, is that the Alzheimer's clinical trial results will be released prior to years end 2024. Chart of Axsome below, as the stock had a strong day, and closed at $99.49 per share.

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. 

Auvelity Prescription Update

The third quarter has officially ended, and an update on how Auvelity (MDD) prescriptions faired in the quarter is illustrated by the graph below. The stats which are provided by IQVIA show a sequential quarter to quarter increase of around 14%. A rough estimate of the scripts for the quarter, could give us insight to what the revenue might be, which will be announced by Axsome Therapeutics during the 3rd quarter conference call, scheduled for early November. The script numbers to date have been achieved without any assistance from TV advertising. 

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.