In a March 15 research note, ROTH Capital Partners analyst Yasmeen Rahimi indicated that the recent drop in Soleno Therapeutics Inc.'s (SLNO:NASDAQ) stock represents a buying opportunity ahead of the company's Phase 3 DESTINY trial readout in Q4/19. "We know Soleno is diligently working behind the scenes to execute DESTINY to the finish line in 2019," he added.
Rahimi explained that the recent pullback in Soleno likely resulted from Zafgen's recent decision to stop filing an investigational new drug application for ZGN-1258, its second-generation MetAP2 inhibitor for Prader-Willi Syndrome, due to a side effect of degenerated muscle tissue in rodents in the vehicle and dose arms. Despite the company specifying that the toxicity seems to only be related to ZGN-1258, "we believe investors are extrapolating safety issues onto the entire therapeutic space," including Soleno's asset, the analyst commented.
"We strongly believe that ZFGN is going to figure out its Prader-Willi Syndrome clinical development over the next few months," and "we view the Soleno selloff (probably due to ZGN-1258 safety issues) as unjustified," Rahimi added.
As for Soleno's DESTINY trial in Prader-Willi Syndrome, 14 of 15 targeted United States locations are now involved. The study has two parts, both of which "should have expedited enrollment," noted Rahimi. The first is a three- to four-month placebo-controlled, parallel arm study evaluating DCCR, or diazoxide choline controlled release, in 105 individuals with a moderate to severe presentation of the condition.
The second component is C602, a nine-month, open-label extension safety study. In fact, DESTINY patients "continue to roll over into C602," which suggests that DCCR treatment is benefitting patients, Rahimi noted.
Also of note, the Data Safety Monitoring Board recently recommended the Phase 3 DESTINY study continue.
ROTH has a Buy rating and a $14 per share target price on Soleno; the current share price is about $2.35.
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Disclosures from ROTH Capital Partners, Soleno Therapeutics Inc., Company Note, March 15, 2019
Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.
Within the last twelve months, ROTH has received compensation for investment banking services from Soleno Therapeutics, Inc.
ROTH makes a market in shares of Soleno Therapeutics, Inc. and as such, buys and sells from customers on a principal basis.
Within the last twelve months, ROTH has managed or co-managed a public offering for Madrigal Pharmaceuticals.
Shares of Soleno Therapeutics, Inc. may be subject to the Securities and Exchange Commission's Penny Stock Rules, which may set forth sales practice requirements for certain low-priced securities.
ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months.
