Axsome Therapeutics Files for IPO

The sole underwriter for this offering that was mentioned in the filing was Ladenburg Thalmann.

This is a clinical stage biopharmaceutical company developing novel therapies for the management of pain and other central nervous system (CNS) disorders. By focusing on this therapeutic area, the company is addressing significant and growing markets where current treatment options are limited or inadequate.

The product candidate portfolio includes two late-stage candidates, AXS-02 and AXS-05, which are being developed for multiple indications. Axsome recently initiated a Phase 3 trial with AXS-02 in complex regional pain syndrome and plan to initiate a Phase 3 trial with AXS-05 in treatment resistant depression in or before the first quarter of 2016.

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

The first product candidate, AXS-02, is a potentially first-in-class, oral, targeted, non-opioid therapeutic for chronic pain. AXS-02 is a potent inhibitor of osteoclasts, which are bone remodeling cells that break down bone tissue. Axsome is initially developing AXS-02 for the treatment of pain in the following three conditions: complex regional pain syndrome (CRPS), knee osteoarthritis (OA) associated with bone marrow lesions (BMLs) and chronic low back pain (CLBP) associated with Modic changes (MCs).

As for the second product candidate, AXS-05 is an innovative fixed-dose combination of dextromethorphan (DM) and bupropion. The company is developing AXS-05 initially for the treatment of the following two conditions: treatment resistant depression (TRD) and agitation in patients with Alzheimer’s.

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The company intends to use the proceeds for the following reasons:

• Approximately $19 million to $25 million to fund clinical trials for AXS-02, including the completion of its ongoing Phase 3 trial in pain associated with CRPS and planned Phase 3 trial in the pain of knee OA associated with BMLs, and the launch of the planned Phase 3 trial in CLBP associated with MCs.
• Approximately $14 million to $17 million to fund the ongoing development of AXS-05, including the launch and completion of planned Phase 3 trial of AXS-05 in TRD.
• The remainder for further development of other product candidates, working capital, and general corporate purposes.