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Is This the Formal Implosion of Novan?

Chris Lange

Novan Inc. (NOVN) saw its shares get absolutely crushed on Friday after the company reported results from its late-stage treatment of acne vulgaris.

Out of its two Phase 3 trials, only one lived up to expectations. In the first trial, all three of the primary endpoints were met, while in the second trial only one out of the three was met. Analysts took this opportunity to weigh in on the future of this stock.

Wedbush downgraded the stock to a Neutral rating and lowered its price target to $6 from $33.

The brokerage firm commented in its report:

With most acne products approved on the basis of two successful Phase 3 trials, we do not believe SB204 would be approvable with latest dataset. The studies were well-powered, with 1,300 patients enrolled in each trial, and vehicle response was not particularly high; we attribute the failure to the inconsistencies in responses to nitric oxide-based therapy and general variability to treatment that makes acne a challenging indication. Novan did not hold a call, and said it would provide an update after analyzing the data; given the cost of running another Phase 3 program and the limited benefit observed with SB204 (even in the successful trial), we believe it is doubtful the program will be continued.

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Wedbush is also saying that cash might be a concern for Novan going forward. Including the $11 million upfront payment for the recent out-licensing of Japanese rights to SB204, the firm expects that Novan will end the first quarter of 2017 with $34 million in cash. A capital raise could be on the horizon if upcoming catalysts prove to be positive.

Looking to the future, Nathan Stasko, Ph.D., president and CEO of Novan, commented:

While we are pleased with the results of the NI-AC302 trial that met the regulatory requirement for statistically significant efficacy of SB204, we are disappointed with the discordant results of NI-AC301. Our team has not yet received the full data set and we intend to provide an update on the SB204 program after our complete analysis. Despite these discordant results, we believe in the potential of nitric oxide’s multiple, well-documented mechanisms of action and the data we have recently generated for our SB206 anti-viral and SB414 anti-inflammatory product candidates. We continue to look forward to near term clinical results from our SB208 anti-fungal program in the second quarter of 2017 and advancing our pipeline of innovative therapies for patients suffering from skin diseases.

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Shares of Novan closed Friday down 74% at $4.86, with a consensus analyst price target of $34.67 and a 52-week trading range of $3.52 to $5.38.

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