Biotech Gets Cashed Up Ahead of Pivotal Phase 3 Readouts
Source: Streetwise Reports
April 18, 2018 (Investorideas.com Newswire) Ram Selvaraju, an analyst with H.C. Wainwright & Co., discussed the capital raise and upcoming clinical trial data.
In an April 17 research note, analyst Ram Selvaraju with H.C. Wainwright & Co. reported that Foamix Pharmaceuticals Ltd. (FOMX:NASDAQ) raised a gross $16.2 million that "should lengthen the company's operational window into H2/19." This was done via the sale of 2.94 million of Foamix's ordinary shares at about $5.50 per share to OrbiMed Partners Master Fund Ltd., an affiliate of OrbiMed Advisors, "a well-respected fundamental health care-focused investor," he noted.
The facts that a capital raise was done and at a premium to Foamix's then share price and that the investor has had ample success in the biotechnology/pharmaceutical arena "are bullish indicators ahead of Foamix's clinical trial readouts from several pivotal trials slated for later this year," concluded Selvaraju.
One expected readout is from a Phase 3 study of FMX101, or 4% minocycline foam, Foamix's most advanced clinical asset, in moderate to severe acne. Topline data are expected in late Q2/18 or early Q3/18. "Given the fact that two prior pivotal studies were already conducted with FMX101, one of which met all its endpoints and the second of which met all but one of its endpoints, we feel confident about the prospects for success with FMX101 in the third confirmatory trial," Selvaraju indicated. Foamix plans to file a new drug application (NDA) for use of FMX101 in acne by 2018E.
The other expected data readout is from the two concomitant Phase 3 pivotal trials of FMX103, or 1.5% minocycline foam, another of Foamix's most advanced candidates, in patients with moderate to severe papulopustular rosacea. Results from both studies are anticipated in H2/18. Filing of the NDA for FMX103 in this indication is slated for early 2019.
Should the data from these pivotal studies be positive, they could "position Foamix as a leading dermatology-focused company and potentially make the company an acquisition target for more established firms with a presence in the dermatology arena," Selvaraju purported.
H.C. Wainwright has a Buy rating and a $12 per share 12-month target on Foamix, whose stock is currently trading at less than half of that, at $5.30 per share.
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Disclosures from H.C. Wainwright & Co., Foamix Pharmaceuticals Ltd., April 17, 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 Foamix Pharmaceuticals Ltd. (including, without limitation, any option, right, warrant, future, long or short position).
As of March 31, 2018 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Foamix Pharmaceuticals Ltd.
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 not receive compensation from Protalix BioTherapeutics, Inc. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.
The Firm does not make a market in Foamix Pharmaceuticals Ltd. as of the date of this research report.
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