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Monday, March 27, 2017

=Zynerba Pharma (ZYNE) reported earnings on Mon 27 March 2017 (b/o)




Zynerba Pharma misses by $0.05 :
  • Reports Q4 (Dec) loss of $0.71 per share, $0.05 worse than the Capital IQ Consensus of ($0.66).
  • As of December 31, 2016, cash and cash equivalents totaled $31.0 million, compared to $41.5 million as of December 31, 2015.
  • Cash outlook: In the first quarter of 2017, the Company completed a follow-on public offering, selling 3,220,000 shares of our common stock at an offering price of $18.00 per share, resulting in gross proceeds of $58.0 million. Net proceeds received after deducting underwriting and commissions and offering expenses were $54.3 million. Based on Zynerba's cash position of $31.0 million in cash and cash equivalents at year-end 2016, and including proceeds from the Company's follow-on public offering in the first quarter of 2017, the Company estimates that this balance is 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.
  • Anticipated 2017 Milestones
    • ZYN002, a patent-protected, synthetic CBD formulated as a permeation-enhanced gel for transdermal delivery
      • ZYN002 is currently being evaluated in three Phase 2 clinical trials in epilepsy patients with focal seizures, in osteoarthritis and in pediatric patients with FXS which has been designated as an Orphan drug by the US FDA. The Company expects to report top-line data for all three trials in 2017.
      • Top-line results from the Phase 2 STAR1 clinical trial in adult epilepsy patients with focal seizures and from the Phase 2 STOP clinical trials in patients with knee pain due to osteoarthritis are anticipated in July/August 2017;
      • Top-line results from the FAB-C exploratory Phase 2 clinical trial in pediatric patients with Fragile X syndrome are expected in the third quarter of 2017;
    • ZYN001, a patent-protected, pro-drug of THC that enables transdermal delivery via a patch
      • In the first half of 2017, Zynerba expects to initiate Phase 1 studies to evaluate the safety and pharmacokinetic (PK) profile and tolerability of ZYN001 in healthy volunteers
      • Zynerba expects to begin two Phase 2 clinical trials for ZYN001 in patients with fibromyalgia and peripheral neuropathic pain in the second half of the year.

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