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.

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.

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. 

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 - 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

Axsome Therapeutics - Near Term Catalysts Expected

Axsome (AXSM) is expecting feedback from the FDA on two New Drug Application filings. First AXS-05 for Major Depressive Disorder, either labeling discussions, or outright approval or denial. Second, AXS-07 for Acute Migraine, which has an April 29th FDA decision date, either approval or denial.  My expectations is that we could hear feedback on both filings in this month of April. These could be the first of many New Drug Applications being filed from the company. The others, AXS-12 for Narcolepsy, AXS-14 for Fibromyalgia, and AXS-05 again, for Alzheimer's Agitation. Below is a daily chart of Axsome, thank you for reading.         

Axsome Therapeutics Second Quarter Update

Axsome released their second quarter results this morning, and an additional press release updating their depression clinical program here AXS-05 Depression Clinial Program. The company accomplished a significant amount of progress on all fronts. This post will focus on the companies lead drug AXS-05 for Treatment Resistant Depression or TRD. Summary below.

COMET TRD Trial - A phase 2 an open label sub-study evaluating the efficacy and safety in TRD patients. Approximately 70 patients will be enrolled. The trial endpoints will include the change from baseline in the Montgomery Asberg Depression Rating Scale or (MADRS) total score, clinical response and remission. Topline results from the COMET-TRD is expected in the fourth quarter of 2020.

MERIT Trial - A phase 2 double blind placebo controlled trial randomized withdrawal study in patients with TRD. Approximately 50 patients will be enrolled. The primary endpoint of the trial is the time to relapse of depressive symptoms. Topline first half 2021.                                           

AXS-07 Phase 3 Results for Acute Migraine (Momentum)

Axsome Therapeutics released phase 3 clinical data with AXS-07 for the treatment of acute migraine, for patients with an inadequate response to prior treatments.
The clinical trial met the two co-primary endpoints; Pain-Free at 2 hours after dose, and Absent most Bothersome Symptoms 2 hours after dose versus placebo. The clinical trial can be found here Momentum Phase 3. The trial also compared AXS-07 to Rizatriptan (a well known and effective generic drug for acute migraine) for these tough to treat patients, who have not responded to prior treatments. Comparisons below are AXS-07 versus Rizatriptan.

• Sustained pain freedom from 2 to 24 hours after dosing.  16.1% vs 11.2%  p=0.038
• Sustained pain relief from 2 to 24 hours after dosing.  53.3% vs 43.9%  p=0.006
• Sustained pain relief from 2 to 48 hours after dosing.  46.5% vs 36.5%  p=0.003
• Rescue medication was used for 23.0% of AXS-07 patients vs 34.7%  p=0.001
• Patient Global Impression of Change, AXS-07 vs Rizatriptan.                             p=0.022
• Return to normal function at 24 hours.                                                                      p=0.027

The clinical trial was a success, as AXS-07 above, compared well to the generic acute migraine drug Rizatriptan. The safety profile of AXS-o7 was similar to placebo. The company plans to file an NDA (new drug application) in the second half of 2020.

AXS-05 Phase 3 Results for MDD (GEMINI)

Axsome Therapeutics (AXSM) is higher today after releasing phase 3 results with AXS-05 for the indication of Major Depressive Disorder or (MDD). The press release is here, AXS-05 Achieves Primary Endpoint in Gemini Phase 3. Some major points from the outstanding results are as follows.

• AXS-05 at week 6 versus placebo  p=0.002
• Rate of remission of depression week 6 versus placebo  p=0.001
• Week 1 AXS-05 versus placebo p=0.007

All scores are based on the Montgomery-Asberg Depression Rating Scale or MADRS. The phase 3 clinical trial details can be found here NCT04019704. The company will file for FDA approval in the second half of 2020 for the indication of MDD, and potentially get approved for that indication in the first half of 2021. Below is the chart of the stock that appreciated +70% today.

AXS-12 Phase 2 Results for Narcolepsy

Axsome Therapeutics (AXSM) today, announced the results of their phase 2 clinical trial with drug AXS-12 (reboxetine) for Narcolepsy. The clinical trial is here clinicaltrials.gov. The trial results were better than anticipated. All comparisons of AXS-12 versus placebo were statistically significant.

• Reduction in Cataplexy attacks compared to placebo p=0.001
• Reduced daytime sleepiness compared to placebo p=0.003
• Improved cognitive function compared to placebo p=0.001
• Sleep quality and sleep related symptoms compared to placebo p=0.007

AXS-12 was safe and well tolerated.  Chart below.



Axsome Therapeutics Progress Update

We originally wrote about Axsome Therapeutics (AXSM) and their drug AXS-05 here AXS-05 A Novel Mechanism Of Action.  Some new information for Axsome occurred this week.  

• First the company completed an agreement for a term loan of up to $20 million dollars from Silicon Valley Bank, with minimal dilution.  This bolsters their cash to around $40 to $50 million.  The company plans to move AXS-05 into a phase 2/3 clinical trial for Alzheimer's patients with agitation symptoms with this new capital.
• Other news that could have an impact on Axsome and their NMDA / bupropion drug combination AXS-05 for TRD (treatment resistant depression), is that competitor Otsuka, who was also pursuing the same indication with AVP-786 (NMDA, Sigma-1), has decided not to advance the drug past their recently completed phase 2 clinical trial.  So at present, AXS-05 is one of the most advanced oral NMDA (dextromethorphan) drug in clinical trials for treatment resistant depression. 

Bottom Line:  The increased cash raise was needed to advance AXS-05 into other clinical trials.  The company is extremely lean, as their quarterly burn rate was just $6.8 million in the second quarter, but is expected to increase with more clinical trials planned.  AXS-05, drug combination for treatment resistant depression, should have phase 3 results mid 2017, with patent into 2034.  Thank you for reading.  

Contact:  586-431-8000

NMDA Receptor Modulators for CNS Disorders

We originally wrote about this topic here NMDA Receptor Modulators for Depression. There are now several companies interested in bringing a variety of NMDA drugs into the clinic, either as mono-therapy or coupled with enhancers.  Let's have a look at some of the companies, their drug, and indications that they are targeting.

Avanir:  Otsuka

AVP-786  Dextromethorphan + Quinidine
Ph 3  Agitation in Alzheimer's Disease
Ph 2  Residual Schizophrenia
Ph 2  Major depressive disorder (adjunct)

Axsome: AXSM

AXS-05  Dextromethorphan + Bupropion  

Ph 3 Treatment resistant depression

Ph 1 Agitation in Alzheimer's Disease

Cerecor:  CERC
CERC-301  NR2B Specific NMDA antagonist oral
Ph 2 Major depressive disorder (adjunct)

JNJ / Janssen
Esketamine  intranasal
Phase 3 adjunct with anti-depressant for TRD

Naurex:  Allergan
NMDA receptor partial agonist with selective properties
Ph 2 NRX-1074  IV
Ph 1 NRX-1074 Oral
Ph 3 GLYX-13 (Rapastinel) Weekly IV Major Depressive disorder

Vistagen:  VSTA
AV-101  NMDA selective antagonist oral
Ph 2 AV-101 Major depressive disorder 

Over the next couple years, we should see some meaningful clinical readouts from some of these companies.  Potentially NMDA drugs may provide for a more efficacious and safer, sustainable therapy, aside from current antidepressants for some of the above indications. Thank you for reading.