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. 

Axsome Therapeutics - ADVANCE 2 and ACCORD 2 Clinical Trials

While the company is in the final stages of their Alzheimer's Disease Agitation clinical trials, ADVANCE 2 and ACCORD 2, a reminder of the results of already completed ADVANCE 1 and ACCORD 1 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

Both ADVANCE 1 and ACCORD 1 results bode well for the eminent release of the two follow on clinical trials ADVANCE 2 and ACCORD 2, expected in the second half of 2024. Both follow-on clinical trials will be using the same endpoint criteria as the previous. Thank you f0r reading.

Tracking Weekly Auvelity Prescriptions

Axsome Therapeutics lead drug Auvelity, recorded a new prescription high of 9,125 this past week. The FDA approved Auvelity for MDD late 2022, and commercial launch followed. Data reported from IQVIA. Weekly prescription chart below. Thank you for reading.

Relmada Therapeutics - High Risk with Potential Reward

Relmada Therapeutics (RLMD) is in phase 3 clinical trials testing REL-1017, for the adjunctive treatment of MDD. Adjunctive treatment is used in addition to primary treatment to help it work better. Relmada's clinical trials can be viewed here Relmada Clinical Trials. The most important event from an investment point of view, is the release of top line data, for clinical trial RELIANCE II, estimated second half of 2024. 

Risk assessment for investment purposes, is extremely high. Relmada is currently a $3.00 stock, so a successful readout of RELIANCE II could propel the shares much higher. On the other hand, a failure to show efficacy, would result in the stock trading around $1.00 per share. 

REL-1017 is a NMDA receptor antagonist drug, in a similar category of already approved J&J's Spravato and Axsome Therapeutics Auvelity. So having this mechanism of action successfully approved, and on the market is a positive for REL-1017.  We currently hold shares in Axsome Therapeutics and Relmada Therapeutics. Chart of Relmada below, thank you for reading. 

AXS-14 for Fibromyalgia

Axsome's vast pipeline includes AXS-14, (esreboxetine) a novel treatment for fibromyalgia. AXS-14 brings a new mechanism of action, a highly selective and potent norepinephrine reuptake inhibitor which was successful in phase 2 and 3 clinical trials. There are currently three FDA approved drugs to treat fibromyalgia. 

• Lyrica (2007
• Cymbalta (2008)
• Savella (2009)

Axsome currently has AXS-14 patent pending, Google Patent. If approved, the patent would expect to extend out to around 2042. Another smaller company Tonix is expected to apply for FDA approval for their fibromyalgia drug, TNX-102 SL, in the second half of 2024. Below is a chart of Axsome which has trended around the $75.00 level most of 2024. Thank you for reading.

Axsome First Quarter Financial Results

Axsome Therapeutics released impressive first quarter results this morning. The biggest positive was that four Alzheimer's Agitation clinical trials are to be completed, which will lead to a NDA (new drug application) for that indication. Two clinical trials ADVANCE 1 and 2, have been designed as parallel assignment, and two clinical trials ACCORD 1, and 2, as randomized withdrawal trials. Both ADVANCE 1 and ACCORD 1 have successfully completed. ADVANCE 2 and ACCORD 2 are expected to complete this year. Upon completion, an NDA will be filed with the FDA for approval. Below are some positive points learned from the company's conference call this morning. 

• Auvelity for MDD sales totaled $53.4 million for the quarter
• Sunosi for narcolepsy sales totaled $21.6 million for the quarter
• A second GPO (group purchasing organization) signed
• 331 million in cash on hand, end of first quarter