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Will Axsome Therapeutics Make Big Strides?

axsome aug29 lt

Shares of Axsome Therapeutics Inc. (AXSM) have returned 15% so far this month while the iShares Nasdaq Biotechnology ETF (IBB) has gained just 3% for the same period.

Axsome is a clinical-stage biopharmaceutical company developing novel medicines for the management of central nervous system disorders.

The Company has two lead drug candidates namely, AXS-05 and AXS-02, and 5 ongoing clinical studies.


The components of AXS-05 are bupropion and dextromethorphan, each of which target different CNS (central nervous system) receptor systems. This compound is being studied in the following trials.

-- A phase III trial in patients with treatment resistant depression (TRD), known by the name STRIDE-1
-- A phase II/III trial for the treatment of agitation in patients with Alzheimer's disease, dubbed ADVANCE-1
-- A phase II trial in patients with major depressive disorder, dubbed ASCEND and
-- A phase II trial for smoking cessation treatment.


AXS-02 is a potentially first in class, oral, targeted, non opioid therapeutic for chronic pain. The active molecule in AXS-02 is a potent inhibitor of the bone-resorbing cells called osteoclasts.

A phase III trial of AXS-02 in knee osteoarthritis (OA) associated with bone marrow lesions, dubbed COAST-1, is ongoing.


AXS-06, a fixed-dose combination of MoSEIC meloxicam and esomeprazole, being developed to treat osteoarthritis and rheumatoid arthritis, and to reduce the risk of NSAID-associated upper gastrointestinal ulcers, is a phase III-ready compound.


AXS-07 is a fixed-dose combination of MoSEIC meloxicam and rizatriptan for the acute treatment of migraine. Axsome believes that only one phase III trial may be needed for the approval of this compound.


AXS-09 is a novel, oral medicine consisting of Esbupropion and Dextromethorphan being developed for the treatment of CNS disorders.

A phase I trial with AXS-09, the results of which were announced in February of this year, met the primary endpoint - demonstrating substantial increases in dextromethorphan plasma levels.

Near-term Catalysts:

* Results from final interim analysis of phase III trial of AXS-05 in treatment resistant depression, or TRD (STRIDE-1) are expected in the fourth quarter of 2018. Top-line results from this study are anticipated in the first half of 2019.

* Results of the first interim analysis of Phase 2/3 trial of AXS-05 in patients with agitation associated with Alzheimer's disease (ADVANCE-1) are expected in the fourth quarter of 2018.

* Top line results from a phase II trial of AXS-05 in patients with major depressive disorder (ASCEND) are anticipated in the fourth quarter of 2018.

* Top line results from a phase II trial of AXS-05 for smoking cessation treatment are anticipated in first quarter of 2019.

* Initiation of a phase III trial of AXS-07 for the acute treatment of migraine in the fourth quarter of 2018.

Key Numbers...

Accumulated deficit: $89.7 million
Debt (Face Value): $8.1 Million
Cash: $20.4 million

The cash on hand is expected to be sufficient to fund its operations into the third quarter of 2019.(The above data is of June 30, 2018).

AXSM has traded in a range of $2.05 to $6.45 in the last 1 year. The stock closed Tuesday's trading at $3.00, up 18.81%.

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