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Axsome Therapeutics Developing
Novel Therapies for CNS Disorders

Konrad Kuhn’s, publisher of The KonLin Letter, www.konlin.com, Featured Stock of the Month is Axsome Therapeutics, Inc. (AXSM) 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 five clinical-stage candidates, AXS-02, AXS-05, AXS-06, AXS-07, and AXS-09. AXS-05 is currently in a Phase 3 trial in treatment of resistant depression (TRD), a Phase 2/3 trial in agitation associated with Alzheimer's disease (AD), a Phase 2 trial in Major Depressive Disorder (MDD) and a Phase 2 trial in smoking cessation. AXS-02 is currently in a Phase 3 trial in knee osteoarthritis (OA) associated with bone marrow lesions (BMLs), with an additional Phase 3 trial planned in chronic low back pain (CLBP) associated with modic changes (MC). AXS-07 is being developed for the acute treatment of migraine. AXS-06 is being developed for the treatment of osteoarthritis and rheumatoid arthritis and for the reduction of the risk of NSAID-associated gastric ulcers.

AXSM is developing a portfolio of differentiated, innovative patent-protected CNS product candidates. CNS disorders are distressing and difficult to treat. The patients with them are often underserved, with many having no approved or satisfactory treatment options. AXSM accelerates the development of new CNS medicines by utilizing proprietary medicinal chemistry and formulation technologies, novel mechanisms of action and well-characterized molecules, combined with human proof-of-concept data and innovative clinical trial designs. AXSM's technologies include metabolic inhibition, MoSEIC™ delivery, chiral chemistry and formulation, and proprietary chemical synthesis and analysis.

In the Q2’18, AXSM advanced its pivotal trials, expanded its pipeline with the initiation of trials in new indications and highlighted its science at several medical conferences. Management expects to continue this momentum during the rest of this year with the anticipated initiation of a Phase 3 trial of AXS-07 in acute migraine and results from several clinical trials for AXS-05. Specifically, AXSM is on track to report results of the interim efficacy analysis of the Phase 3 STRIDE-1 trial of AXS-05in TRD, the interim futility analysis of the Phase 2/3 ADVANCE- 1 trial of AXS-05 in AD agitation and top-line results from the Phase 2 ASCEND trial of AXS-03 in MDD, all in the Q4. In addition, they expect top-line results from the Phase 2 trial of AXS-05 in smoking cessation in Q1'19.

AXSM has not generated any revenue since inception, and for the 1st half of FY’18, reported a net loss of $(0.51) per share vs. $(0.70) for the same period in the prior year. Ending June 30,'18, AXSM had $20.4 mil. in cash with 26,252,562 shares outstanding, of which 34.5% are held by insiders and 15.75 are owned by institutions. The stock is on the verge of breaking out of a 9-mo. double bottom consolidation trading period in the 3.00-3.20 area of purchase for a 1st target of 8.50-9.00. The stock reclaimed its 200-Day MA and must close above 3.95, which would signal higher prices in coming quarters. AXSM has been focusing on management of CNS disorders for which there are limited treatment options. By concentrating on this therapeutic area, they are addressing significant and growing markets where current treatment options are limited or inadequate and could be well-rewarding to shareholders. Ultimate target low-teens.

Editor’s Note: The KonLin Letter specializes in low price stocks under $10, with emphasis on emerging growth and special situations poised for explosive price appreciation. Each issue features 5 low-priced stock selections and a review of 30-35 different small caps while monitoring a broad range of technical indicators for the best possible Market Timing Advice. For more information visit www.konlin.com.

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