Zynerba (NASDAQ: ZYNE) is pioneering the development and commercialization of patent-protected, next-generation synthetic cannabinoid therapeutics formulated for transdermal delivery. Its two lead product candidates in development include ZYN002 and ZYN001, which are being evaluated in five indications. ZYN002 is the first and only synthetic cannabidiol (CBD) formulated as a permeation-enhanced gel for transdermal delivery. In March 2017, the company completed enrollment in the STAR 1 Phase 2 clinical trial in refractory epilepsy patients and in the STOP Phase 2 clinical trial in patients with osteoarthritis of the knee. In December 2016, initiated the FAB-C exploratory, a Phase 2 clinical trial in patients with Fragile X syndrome.
ZYN001, a prodrug of THC that enables transdermal delivery through the skin and circulatory system via a patch, is in preclinical development. A Phase 1 clinical trial is planned in the first half of 2017 followed by the initiation of a Phase 2 clinical program in the second half of 2017.
In August 2015, Zynerba completed an initial public offering, raising net proceeds of $42.1 million. As of December 31, 2016, cash and cash equivalents totaled $31.0 million. In the first quarter of 2017, the Company completed a follow-on offering resulting in net proceeds of $54.3 million. The Company believes that the cash at year-end 2016 and the net proceeds from the Q1 2017 raise should be sufficient to develop five Phase 3 ready programs and, assuming feedback from the FDA supports a decision to move forward, initiate at least one Phase 3 program and fund operations and capital requirements into 2019.