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Texas-Based Biopharma Gets PDUFA Date for Lead Orphan Disease Asset
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An H.C. Wainwright & Co. report covered the potential timeline to market and subsequent estimated revenue for this therapeutic, which addresses a rare disorder in collagen production.

In a Dec. 27, 2018, research note, analyst Ram Selvaraju reported that a new drug application for Acer Therapeutics's (ACER:NASDAQ) Edsivo (celiprolol) has been accepted by the FDA and assigned a PDUFA date of June 25, 2019. "We believe that the drug could be launched in summer 2019, if approved," he added.

Selvaraju noted that Edsivo, Acer's most advanced drug, is enough to move the company into profitability. Expected revenue is about $8.7 million in 2019, and roughly $74.1 million in 2020. "The company could reach cash flow break-even during the first half of 2020 (i.e.,) within a time frame that may be covered by its existing capital resources," he wrote.

To commercialize Edsivo, Acer hired Salma Jutt as its chief commercial officer. She has more than 20 years' experience in the life sciences industry at companies that include Allergan, Boehringer Ingelheim and Nalpropion Pharmaceuticals. "Ms. Jutt should not only be able to optimize the launch strategy for Edsivo but also potentially craft the strategy for an array of other products that Acer may advance to market in the future," Selvaraju commented.

Looking forward, catalysts expected to occur in the coming months include publication, in a peer reviewed journal, of the Edsivo patient registry data in vascular Ehlers-Danlos syndrome. Other catalyst include developing the infrastructure to commercially launch Edsivo, advancing clinical development of ACER-001 for treatment of urea cycle disorders and initiating additional programs.

H.C. Wainwright & Co. has a Buy rating and a 12-month target price of $55 per share on Acer, whose stock is currently trading at around $20.58 per share.


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Disclosures from H.C. Wainwright & Co., Acer Therapeutics Inc., Company Update, December 27, 2018

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 Acer Therapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position).

As of November 30, 2018 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Acer 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 did receive compensation from Acer 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 Acer Therapeutics, Inc. during the past 12 months.

The Firm does not make a market in Acer Therapeutics, Inc. as of the date of this research report.

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