In a March 20 research note, H.C. Wainwright & Co. analyst Ram Selvaraju reported that Axsome Therapeutics Inc. (AXSM:NASDAQ) is speeding up completion of the ADVANCE-1 Phase 2/3 trial of AXS-05 in patients with Alzheimer's disease agitation. Also, "Axsome shares remain undervalued and an even more attractive entry point may have presented itself due to the recent market downturn," he added.
The biopharma's current share price is about $62.52 per share. In comparison, H.C. Wainwright's target price on the company is $200.
The purpose of Axsome Therapeutics accelerating completion of ADVANCE-1 is to keep the participants, a group at high risk from COVID-19, safe and ensure the study's integrity. The U.S.-based firm decided to proceed in this manner following the just released Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic by the U.S. Food and Drug Administration. At this point, more than 90% of enrolled patients are estimated to have finished the study.
Consequently, the topline results for ADVANCE-1 are expected in early Q2/20, perhaps even in April, as opposed to Q3/20 previously.
Selvaraju noted that Axsome Therapeutics does not have any study enrollments or randomizations planned for the next several months. As such, it will not experience possible disruptions to its clinical program resulting from the coronavirus pandemic. The company may start one or more clinical trials much later in 2020 if and when the COVID-19 crisis may have abated.
Also, if the firm's clinical activities this year end up being fewer than expected, this could translate to a lower cash burn, Selvaraju pointed out.
Data also are expected in the near term from the INTERCEPT study with AXS-07 and the STRIDE-1 trial with AXS-05. "The fact that ADVANCE-1 could generate data within only a few weeks of INTERCEPT and STRIDE-1 provides even greater incentive to own the stock," commented Selvaraju.[NLINSERT]
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Disclosures from H.C. Wainwright & Co., Axsome Therapeutics Inc., Company Update, March 20, 2020
Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.
I, Raghuram Selvaraju, Ph.D., certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.
None of the research analysts or the research analyst's household has a financial interest in the securities of Axsome Therapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position).
As of February 29, 2020 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Axsome Therapeutics, Inc..
Neither the research analyst nor the Firm has any material conflict of interest in of which the research analyst knows or has reason to know at the time of publication of this research report.
The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.
The firm or its affiliates received compensation from Axsome Therapeutics, Inc. for non-investment banking services in the previous 12 months.
The Firm or its affiliates did receive compensation from Axsome Therapeutics, Inc. for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.
H.C. Wainwright & Co., LLC managed or co-managed a public offering of securities for Axsome Therapeutics, Inc. during the past 12 months.
The Firm does not make a market in Axsome Therapeutics, Inc. as of the date of this research report.
H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report.