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Zynerba Pharmaceuticals, Inc. (ZYNE) reported its first quarter financial results for the period that ended on March 31st and provided an overview of recent operational highlights.
Company Developments and Highlights
By the end of the first half of this year, the company expects to initiate Phase 1 trials of ZYN001. The Phase 1 program will evaluate the safety and tolerability through single and multiple rising dose trials in normal subjects and patients with fibromyalgia. Pending successful Phase 1 results, a Phase 2 program for ZYN001 in fibromyalgia and neuropathic pain is planned to start in the second half of 2017.
A total of 188 patients have been randomized in the Phase 2 STAR 1 double-blind, placebo-controlled clinical trial in adult patients with refractory epilepsy, exceeding the 180-patient enrollment target. The company expects to report top-line data from this trial in July/August 2017.
Insys Therapeutics (INSY) reported its first quarter financial results for the period that ended on March 31st. The shares continue to be under pressure as the company is at the center of several lawsuits pertaining to the illegal activity that led to the arrest of 11 former executives and managers, including the ex-CEO.
Since this scandal was reported, Insys has been consistently reporting significantly lower revenue on a quarter-over-quarter as well as year-over-year basis. During the quarter, Insys recorded a $6.5 million net loss off $36 million in revenue. In the prior year’s period, the company generated $2.3 in net income off $60 million in revenue. Although we are concerned with the company’s current trend, its balance sheet is strong enough to execute on its initiatives focused on its Cannabidiol Oral Solution. As of March 31st, Insys had $218.5 million in cash, cash equivalents and investments.
Nemus Bioscience, Inc. (NMUS) said its United States patent has been granted covering the company's proprietary prodrug of THC, THC-valine-hemisuccinate (THCVHS), as well as other amide-ester forms of cannabinoid-based molecules, for use in the treatment of glaucoma. This second patent, which is also licensed to Nemus by the University of Mississippi, further expands the intellectual property into methods of delivery into the eye. This newly issued patent adds an additional 23 claims related to the delivery of the amide ester family of cannabinoids already covered in the patent previously issued to the University of Mississippi in 2015 and in-licensed by Nemus. THCVHS is the active pharmaceutical ingredient in Nemus' glaucoma drug candidate known as NB1111.