MM120 for Generalized Anxiety Disorder

MindMed 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.

Auvelity Prescription Update

The weekly data for Axsome's lead drug Auvelity (which has been approved for Major Depression Disorder), has turned in a new weekly prescription high three weeks in row to 10,400, for the latest week ending. Data from IQVIA. Thank you for reading.

GOLD Closes at Historical High

It's not too often we get to witness an asset that has been around for centuries, closing at an all-time high over $2500 per ounce. Gold has become a storage of wealth as the US debt continues to increase, and has historically acted as a source of value, during economic uncertainty and inflation. A weekly chart of gold, thank you for reading.                                    

If inclined to learn more about inflation and currency depreciation, this book below is a short read written in 1912 about excess currency printing in France 1790, and how it destroyed the nation.  Fiat Money Inflation in France.

Axsome Second Quarter Financial Results

Axsome Therapeutics released impressive second quarter results this morning. The biggest positive was that ADVANCE 2 for Alzheimer's Agitation, is to be released second half of 2024. 

• Auvelity for MDD sales totaled $65 million for the quarter
• A New Drug Application for AXS-07 has been submitted
• Alzheimer's Agitation phase 3, to be released 2nd half 2024
• ADHD phase 3 clinical trial results, 2nd half 2024

The stock had a wild day due to overall market volatility, recording a low of 72.21 early, but closed at 83.21 end of day, outperforming the broader market sell-off. Thank you for reading.

Auvelity Prescription Update

Axsome's depression drug Auvelity was launched late 2022, after FDA approval. Weekly scripts are closing in on the 10,000 per week level, according to IQVIA tracking.  The week ending 7/19/24 had total prescriptions of 9,700, which is impressive as the company has yet to promote the drug via TV ad. Tracking the weekly progress of prescriptions, may give us insight into the revenues being reported for each quarter. Below is a chart of weekly prescriptions in 2024. Click on graph for sharper view.

Relmada Therapeutics Update

We recently wrote about the company, here. Relmada Therapeutics High Risk with Potential Reward in June. Relmada Therapeutics stock has moved higher under heavy trading volume. The company had mentioned, the Data Monitoring Committee (DMC), would take an interim look at Reliance II after 75-80% of patients have enrolled into the study. Assuming that is the reason for the upward move in the stock, could be good news for the ongoing clinical trial for drug REL-1017 for adjunctive treatment of MDD. We'll have to wait until their quarterly conference call in August to see if that is the case. Below is a chart of the stock that has moved higher by 49% under heavy volume to a high of 4.47, and has settled at 4.16.