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Axsome Therapeutics (AXSM)

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                                                                          Axsome Therapeutics

                                                                                                                                                                                             https://axsome.com

We aim to become a fully integrated biopharmaceutical company that develops and commercializes differentiated medicines that expand the treatment options available to caregivers and improve the lives of patients living with CNS disorders.


Axsome Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders for which there are limited treatment options. Axsome's core CNS product candidate portfolio includes four clinical-stage candidates, which we are developing for six different CNS indications. The Axsome Pain and Primary Care business unit (Axsome PPC) houses Axsome's pain and primary care assets and intellectual property which includes three clinical-stage product candidates, which are being developed for multiple pain and primary care indications.

Our proprietary medicinal chemistry and formulation technologies allow us to continue to design new and innovative medicines to treat CNS conditions. These technologies and capabilities include:
 

Chiral and Formulation Chemistry. Our AXS-09 product candidate was developed using our chiral chemistry and formulation capabilities to identify, isolate and stabilize chirally pure enantiomers.
 
 
MoSEIC™ Technology. Our AXS-06 and AXS-07 product candidates incorporate our MoSEIC™ technology which is designed to substantially increase the solubility and speed the absorption of target drug molecules.

Learn more about our science

 
Metabolic Inhibition Technology. Our AXS-05 and AXS-09 product candidates incorporate our technology of using metabolic inhibition as a novel drug delivery method to increase the bioavailability and prolong the half-life of target drug molecules.

Learn more about our science

 
Proprietary Synthesis and Analysis. Our AXS-02 product candidate was generated using proprietary chemical synthesis and analysis to increase the solubility and enable the oral delivery of the target drug molecule. 
 



AXS-05

AXS-05 is a novel, oral, investigational drug product under development for the treatment of central nervous system (CNS) disorders. AXS-05 utilizes Axsome’s technology of combining bupropion and dextromethorphan. Dextromethorphan is an NMDA receptor antagonist, sigma-1 receptor agonist, and inhibitor of the serotonin and norepinephrine transporters. Bupropion serves to increase the bioavailability of dextromethorphan, and is a norepinephrine and dopamine reuptake inhibitor, and a nicotinic acetylcholine receptor antagonist. We are initially developing AXS-05 for the treatment of the following conditions: treatment resistant depression (TRD), agitation associated with Alzheimer’s Disease (AD), and smoking cessation. AXS-05 is an investigational drug product not approved by the FDA.

Learn more about AXS-05 and our target indications.

**On Jan. 7, 2019 Axsome Therapeutics reported that its lead drug candidate, AXS-05, hit its primary endpoint in a phase 2 trial evaluating it as a treatment for major depressive disorder (MDD).

AXS-05

Treatment Resistant Depression (TRD)

TRD occurs in individuals suffering from major depression who fail to respond to initial antidepressant treatments. AXS-05 is a novel, oral, investigational drug product, incorporating multiple mechanisms of action, under development for the treatment of TRD.

Learn more about TRD and AXS-05

AXS-05

Agitation Associated with Alzheimer's Disease

Individuals diagnosed with Alzheimer’s Disease typically experience behavioral and psychological symptoms including agitation and aggression. AXS-05 is a novel, oral, investigational drug product, incorporating multiple mechanisms of action, under development for the treatment of Alzheimer’s disease agitation.

Learn more about Agitation Associated With Alzheimer's Disease and AXS-05

AXS-07

AXS-07 is an oral, fixed-dose combination of MoSEIC™ meloxicam and rizatriptan being developed for the acute treatment of migraine. Meloxicam is a new molecular entity for migraine enabled by Axsome’s  proprietary MoSEIC™ (Molecular Solubility Enhanced Inclusion Complex) technology, which results in rapid absorption of meloxicam while maintaining a long plasma half-life. Meloxicam is a COX-2 preferential non-steroidal anti-inflammatory drug  with potent pain-relieving efficacy while rizatriptan is a 5-HT1B/D agonist currently approved as a single agent for the acute treatment of migraine. AXS-07 is designed to provide rapid, enhanced and consistent relief of migraine, with reduced symptom recurrence

Learn more about AXS-07 and our target indications.

AXS-09

AXS-09 is a novel, oral medicine consisting of chirally pure esbupropion and dextromethorphan being developed for the treatment of central nervous system disorders. Esbupropion is the S-enantiomer of bupropion, a dopamine and norepinephrine reuptake inhibitor and nicotinic acetylcholine receptor antagonist which also serves to increase the bioavailability of dextromethorphan. Dextromethorphan is an NMDA receptor antagonist, sigma-1 receptor agonist, an inhibitor of the serotonin and norepinephrine transporters, and a nicotinic acetylcholine receptor antagonist.

Learn more about AXS-09 and our target indications.

AXS-12

AXS-12 (reboxetine) is a novel, oral, investigational medicine in development for the treatment of the symptoms of narcolepsy. AXS-12 is a highly selective and potent norepinephrine reuptake inhibitor. AXS-12 is an investigational drug not approved by the FDA.

Learn more about AXS-12 and our target indications.


 


Management Team

Herriot Tabuteau, MD

Chief Executive Officer

Dr. Tabuteau has served as our founder, Chief Executive Officer, and Chairman of our board of directors since our founding in January 2012. Prior to founding our company, Dr. Tabuteau was a Senior Analyst and Partner at Healthco/S.A.C. Capital (now known as HealthCor) where he was responsible for the biotechnology, genomics, and instrumentation portfolios. Previously, Dr. Tabuteau was the healthcare analyst at Kingdon Capital. Prior to that position, Dr. Tabuteau was a Senior Research Analyst at Banc of America Securities covering the hospital supplies sector. Prior to Banc of America, Dr. Tabuteau was part of the healthcare investment banking group at Goldman Sachs. Dr. Tabuteau earned his M.D. from Yale University School of Medicine and his Bachelor of Arts in molecular biology and biochemistry from Wesleyan University.

Nick Pizzie, CPA, MBA

Chief Financial Officer

Mr. Pizzie has served as our Chief Financial Officer since May 2018. Prior to joining Axsome, Mr. Pizzie was the Vice President and Chief Financial Officer of Pierre Fabre USA, the U.S. affiliate of Pierre Fabre. Previously, he was Senior Finance Director at Immucor. Prior to Immucor, he held positions of increasing responsibility in finance and accounting at Merck and Pfizer. Mr. Pizzie began his career at Arthur Andersen, where he served as staff auditor. He earned his BS in Accounting, BA in Economics, and MBA in Finance, and Supply Side Logistics, from Rutgers University.

Cedric O’Gorman, MD, MBA

SENIOR VICE PRESIDENT, CLINICAL DEVELOPMENT AND MEDICAL AFFAIRS

Dr. O’Gorman has served as our Senior Vice President, Clinical Development and Medical Affairs since September 2017. Prior to joining Axsome, Dr. O’Gorman was the Vice President of Medical Affairs at Intra-Cellular Therapies since December 2014. Before that, he was the U.S. medical lead for psychiatry at Genentech/Roche. Prior to Genentech/Roche, he spent 5 years at Pfizer representing medical affairs on several branded neuroscience products including Geodon for schizophrenia and bipolar disorder, and Pristiq for major depressive disorder. Dr. O’Gorman received his medical degree from the National University of Ireland, in Galway, Ireland, trained at the Institute of Psychiatry, in London, England, and earned his Master of Business Administration from the New York University Stern School of Business.

Mark Jacobson

SENIOR VICE PRESIDENT, OPERATIONS

Mr. Jacobson has served as our Senior Vice President, Operations since September 2017 and has been a member of the Axsome team since April 2014. Prior to joining Axsome, he was Director of Corporate Development at Stemline Therapeutics, Inc., where he played a critical role in advancing the company from a 3-person team in 2010 to the successful completion of an initial public offering and secondary public offering in 2013, which together raised approximately $100 million for the company. While at Stemline, Mr. Jacobson’s responsibilities spanned investor relations, public relations, corporate operations, and intellectual property. Mr. Jacobson began his career in healthcare communications at Publicis Healthcare Communications Group. Mr. Jacobson earned a Master of Arts in Biotechnology from Columbia University and a Bachelor of Science in Biology from Iowa State University.




Anticipated Near-Term Clinical Milestones
 
Clinical Trial Readouts

•Phase 3 CREATE-1 trial of AXS-02 in CRPS, interim efficacy analysis (late December 2017 to early January 2018)

•Phase 3 COAST-1 trial of AXS-02 in knee OA associated with BMLs, interim analysis (late December 2017 to early January 2018)

•Phase 3 STRIDE-1 trial of AXS-05 in TRD, top-line data (1H 2018)




7 x Phase 3 Programs in Pipeline 

AXS-02 COAST-1 Knee Osteoarthritis Associated with Bone Marrow Lesions in Phase 3 (SPA & Fast Track) ---7M patients in the U.S.


AXS-02 CREATE-1 Complex regional pain syndrome (CRPS) in Phase 3 (Orphan+Fast Track Status) ---No approved drug = high unmet need. 80,000 new cases per year in the U.S.


AXS-02 Chronic Low Back Pain Associated with Modic Changes in Phase 3 ---1.6M patients in the U.S.


AXS-05 Agitation in patients with Alzheimer’s disease(AD) in Phase 2/3 ---No approved medication = unmet medical need. 2M patients in the U.S.


AXS-05 STRIDE-1 Treatment resistant depression in Phase 3 ---Only 1 approved drug for TRD = unmet medical need. 3M patients in the U.S.


AXS-06(MoSEIC™ Mx + Eso) Acute and Chronic Pain Phase 3 Ready = 120M NSAID TRx per year in the U.S.



AXS-07 (meloxicam and rizatriptan) for the Treatment of Migraine Phase 3 Ready = Migraine attacks are disabling and affect more than 37 million Americans
 

Share Structure

Market Cap    
226,580,077       01/14/2019
Authorized Shares
150,000,000       09/28/2018
Outstanding Shares   
29,813,168         11/02/2018

https://axsome.com/company/about/




 
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AXSM News: Statement of Changes in Beneficial Ownership (4) 07:20 AM
AXSM News: Axsome Therapeutics To Present Data From ASCEND Phase 2 Trial Of AXS-05 In Major Depressive Disorder At The 2019 American Soc... 05/21/2019 07:00:00 AM
AXSM News: Statement of Changes in Beneficial Ownership (4) 05/15/2019 07:22:36 AM
AXSM News: Prospectus Filed Pursuant to Rule 424(b)(5) (424b5) 05/09/2019 05:04:47 PM
AXSM News: Current Report Filing (8-k) 05/09/2019 07:37:20 AM
News News Alert: Statement of Changes in Beneficial Ownership (4) 05/24/2019 07:20:49 AM
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#244   $100M blu_1 05/24/19 12:01:34 PM
#243   AXSM ripe for a sell off. Price way blu_1 05/24/19 11:59:29 AM
#242   My calculations have it at 30.18b. chainma1l 05/24/19 10:16:48 AM
#241   Wainwright just increased target to 30 Paullee 05/24/19 07:10:52 AM
#240   Probably 30b Alan Brown 05/23/19 09:07:46 PM
#239   What kind of market cap could we be DesireToLearn 05/22/19 10:10:02 PM
#238   AXS-12 info. smallbio 05/22/19 04:55:04 PM
#237   Moderators on a power trip. Look at chainma1l 05/20/19 09:14:08 AM
#236   Motley Fool likes it Paullee 05/19/19 11:58:00 PM
#235   This is the current AXS-12 p2 study info. smallbio 05/19/19 10:52:45 AM
#234   I was looking at AXS-12 (reboxetine) for narcolepsy. smallbio 05/19/19 10:46:49 AM
#233   Why? Alan Brown 05/19/19 04:57:22 AM
#232   a director just bought $100,000 of stock on Paullee 05/15/19 11:56:18 AM
#231   Hottest stock on the planet. Too bad chainma1l 05/15/19 11:52:28 AM
#227   A Study to Assess the Efficacy and Safety BillyBahama 05/09/19 02:56:48 PM
#226   I am surprised that the board is so smallbio 05/09/19 02:14:54 PM
#225   Here's the correct link.. Thanks BillyBahama 05/09/19 08:47:21 AM
#224   Issuing more shares? Was it stated in qrtly report? DesireToLearn 05/09/19 08:34:30 AM
#223   QUARTERLY REPORT is OUT BillyBahama 05/09/19 07:40:36 AM
#222   Thank you for the clarification.. $AXSM BillyBahama 05/06/19 12:02:35 PM
#221   Axsome Therapeutics Announces Expedited Development and Pivotal Status BillyBahama 05/06/19 11:59:23 AM
#220   Major Depressive Disorder. STRIDE-1 trial of AXS-05 for TRD BillyBahama 05/06/19 11:58:47 AM
#219   The move from 1Q20 to 2H19 is the smallbio 05/06/19 11:25:37 AM
#218   $AXSM 18.48 +.53 BillyBahama 05/06/19 10:47:29 AM
#217   Based on the faster-than-expected enrollment in this trial, BillyBahama 05/06/19 10:45:41 AM
#216   so The STRIDE-1 topline result will be pushed smallbio 05/06/19 10:14:25 AM
#215   Axsome Therapeutics Announces Acceleration Of MOMENTUM Phase 3 BillyBahama 05/06/19 08:44:19 AM
#214   Earnings, Thursday Morning, May 9 BillyBahama 05/02/19 02:40:23 PM
#213   1st quarter earnings, Thursday, May 9, 2019 BillyBahama 04/29/19 10:08:21 AM
#212   Another strong day.. $AXSM 16.75 BillyBahama 04/25/19 02:48:11 PM
#211   Nice run today.. $AXSM BillyBahama 04/23/19 05:30:30 PM
#210   There is little more info about J&J TRD spray. smallbio 04/17/19 07:11:18 PM
#209   While we wait for TRD readout, I find smallbio 04/16/19 08:34:37 AM
#208   More and more good news. This company is Basil22 04/15/19 07:08:03 PM
#207   I figured it'd see $15 premarket on that chainma1l 04/15/19 09:26:27 AM
#206   Analysts expect earnings to be released on May BillyBahama 04/08/19 10:11:48 AM
#205   $AXSM CFO Purchases $67,932.00 in Stock BillyBahama 04/08/19 07:13:38 AM
#204   AXSM buy 14.50 stocktrademan 04/07/19 12:10:45 PM
#203   Axsome outlined an itinerary for key data readouts BillyBahama 04/06/19 07:39:20 AM
#202   Implied Volatility Surging for Axsome Therapeutics (AXSM) Stock Options BillyBahama 04/06/19 07:36:58 AM
#201   $AXSM 14.18 -0.43 (-2.94%) BillyBahama 03/28/19 08:51:19 PM
#200   $AXSM Axsome Therapeutics Receives FDA Breakthrough Therapy Designation $Pistol Pete$ 03/28/19 12:16:23 PM
#199   Little AM Profits. PM Should be Interesting Smart Dantheoneman 03/27/19 09:42:17 AM
#198   BIDS @ 16.15 premarket BillyBahama 03/27/19 09:28:08 AM
#197   Should Run Hard Today. Not even 10am Yet. Dantheoneman 03/27/19 09:22:28 AM
#196   Definite leak. Seems like more than two chainma1l 03/27/19 09:12:16 AM
#195   FDA grants breakthrough designation to depression drug BillyBahama 03/27/19 08:05:39 AM
#194   looks like somebody knew the news 2 days ago Paullee 03/27/19 07:54:25 AM
#192   Something Big is Happening Here Dantheoneman 03/25/19 02:31:31 PM
#191   https://finance.yahoo.com/news/apos-why-axsome-therapeutics-apos-181500992.html Dantheoneman 03/25/19 02:30:51 PM
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