Soleno Therapeutics Provides Corporate Update and Reports Second Quarter 2019 Financial Results

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REDWOOD CITY, Calif., Aug. 07, 2019 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided a corporate update, and reported financial results for the second quarter and six months ended June 30, 2019.

“We are pleased with the progress in our ongoing Phase III clinical trial, DESTINY PWS, evaluating once-daily Diazoxide Choline Controlled-Release (DCCR) tablets for patients with Prader Willi Syndrome (PWS). We currently anticipate the availability of top-line data from DESTINY PWS in the first half of 2020,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics.  “Additionally, we are encouraged by the continued interest of families and investigators in keeping patients on DCCR, as 90% of those subjects completing the DESTINY PWS study have elected to continue in C602, our open-label safety extension study.  Moreover, 90% of those patients enrolled in study C602 have continued to receive DCCR treatment.”

Soleno’s current research and development efforts are primarily focused on advancing its lead product candidate, DCCR tablets for the treatment of PWS, into late-stage clinical development.

Research and development expenses were $3.7 million for the quarter ended June 30, 2019, compared to $1.7 million in the same period of 2018.  The increase was primarily due to increased activities related to the DCCR development program.

General and administrative expense was $1.7 million for the quarter ended June 30, 2019, generally consistent with the same period of 2018. 

The change in the fair value of contingent consideration results from Soleno’s obligation to make cash payments to Essentialis stockholders upon the achievement of certain future commercial milestones associated with the sale of Essentialis’ product in accordance with the terms of the Essentialis merger agreement. The fair value of the liability for the contingent consideration payable by Soleno was initially established as approximately $2.6 million at the time of the merger in March 2017, and was estimated at approximately $5.1 million at December 31, 2017, at $5.5 million at March 31, 2018, $5.4 million at June 30, 2018, $5.7 million at September 30, 2018, $5.6 million at December 31, 2018, and $5.9 million at March 31, 2019.  The fair value was estimated to be approximately $6.0 million at June 30, 2019, resulting in an increase in expense of approximately $0.4 million from the balance at December 31, 2018.

Total Other expense of $4.4 million and $3.2 million in 2019 and 2018, respectively, consisted primarily of the change in the fair value of the liability for warrants of approximately $4.3 million and $3.3 million in 2019 and 2018, respectively.

Net loss for the quarter ended June 30, 2019, was approximately $10.0 million, or ($0.31) per share, compared to a net loss of approximately $7.1 million, or ($0.35) per share, for the quarter ended June 30, 2018, which includes a Loss from Discontinued Operations of $0.4 million.

Research and development expenses were $6.5 million for the six months ended June 30, 2019, compared to $2.9 million in the same period of 2018.  The increase was primarily due to increased activities related to the DCCR development program.

General and administrative expense was $3.7 million for the six months ended June 30, 2019, generally consistent with the same period of 2018.

Total Other expense of $6.4 million and $3.0 million in 2019 and 2018, respectively, consisted primarily of the change in the fair value of the liability for warrants of approximately $6.2 million and $3.1 million in 2019 and 2018, respectively.

Net loss for the six months ended June 30, 2019, was approximately $17.0 million, or ($0.54) per share, compared to a net loss of approximately $10.9 million, or ($0.55) per share, for the six months ended June 30, 2018, which includes a Loss from Discontinued Operations of $0.9 million.

As of June 30, 2019, Soleno had cash and cash equivalents of approximately $15.5 million, as compared to $23.1 million at December 31, 2018.

For further information about DESTINY PWS (NCT03440814), please visit: .

For more information, please visit .

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Globe Newswire: 21:05 GMT Wednesday 7th August 2019

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