Zynerba Delivers Losses For Fourth Quarter, Full Year

Cannabis-based biotech company Zynerba (ZYNE) reported fourth quarter and full-year results on Monday morning. The press release lead with drug study highlights versus financial information because it delivered a net loss of $8.1 million or 60 cents per share. Zynerba delivered a $32 million loss for 2017 versus a $23 million loss for 2016.

There were no revenues to report for the fourth quarter or 2017 for that matter. This isn’t unusual for a biotech company that is in the development stage as it conducts studies for its drugs. The revenues will come later if the studies prove to work and their products prove effective. Zynerba is sitting on a pile of cash and should have enough to fund its operations into 2019.

The cash and cash equivalents as of December 31, 2017 were $62.5 million, compared to $31.0 million as of December 31, 2016. Research and development expenses for the fourth quarter of 2017 were $5.8 million and general and administrative expenses for the fourth quarter of 2017 were $2.4 million.

“We made significant corporate and clinical progress throughout 2017, and achieved our goal of utilizing data from three Phase 2 studies of ZYN002 to determine the direction and strategic focus of the Company,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “We enter 2018 with strong momentum including having completed a positive meeting with the FDA to discuss our clinical path for ZYN002 in Fragile X syndrome. We have a refined development and commercialization strategy focused on rare and near-rare neuropsychiatric conditions, and the expectation of achieving numerous milestones in the coming year including initiations of the pivotal Fragile X syndrome study and Phase 2 studies in developmental and epileptic encephalopathies, adult refractory focal seizures, and Tourette Syndrome.”

Zynerba stock struggled last year after two studies failed to deliver the intended results and shareholders exited the company. It was up 1% in early trading to $9.14

Pipeline

Zynerba is currently conducting a Phase 1 program to assess ZYN001, a pro-drug of THC delivered via a patch. The statement said that this first-in-man study is a randomized, double-blind, placebo-controlled trial designed to assess the safety, tolerability and pharmacokinetic profile of multiple formulations of ZYN001. Zynerba expects to complete its Phase 1 evaluation in the first half of 2018, and then move into a Phase 2 clinical trial in Tourette Syndrome late in the second half of 2018.

Zynerba recently announced that it had a positive meeting with the FDA giving it optimism for a new study of ZYN002 in Fragile X Syndrome. The company also announced that it intends to study this same compound in DEE, rare severe brain disorders manifesting with seizures. These results won’t be available until 2019.