Foamix Pharmaceuticals Ltd (FOMX)

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Biotech Gets Cashed Up Ahead of Pivotal Phase 3 Readouts

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.