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Zynerba Pharmaceuticals shares shine as it outlines 1Q highlights

Last updated: 04:25 12 May 2020 AEST, First published: 01:43 12 May 2020 AEST

Zynerba Pharmaceuticals -
212 children and adolescents with Fragile X syndrome (FXS) had now been randomized into the CONNECT-FX trial

Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE) shares surged in New York on Monday as the company outlined a raft of highlights in its first quarter to end March and said it had enough cash to sustain its operations into the second half of 2021.

The specialty pharma company is developing novel transdermal CBD treatments for patients suffering rare epilepsies and neurological disorders.

Its main product candidate is Zygel, a patent-protected CBD skin gel, and the company highlighted that now 212 children and adolescents with Fragile X syndrome (FXS) had now been randomized into CONNECT-FX, a multi-national, double blind, placebo-controlled trial.

READ: Zynerba reports $70M cash runway as it advances its flagship Zygel CBD Gel for Fragile X Syndrome

Enrollment began in February this year and the group expects to report topline results late in the second quarter. If successful, a New Drug Application (NDA) is expected to be submitted to the FDA in the second half of 2020, with potential approval by the middle of 2021.

Meanwhile, topline results from the Phase 2 BRIGHT Trial of Zygel in ASD (autism spectrum disorder) are expected in the second quarter this year, having completed the enrollment of patients in January this year.

Zynerba expects to report topline results from a Phase 2 study of Zygel for 22q11.2 Deletion Syndrome (22q) in the third quarter this year, while the outcome of discussions with FDA on the clinical pathway for Zygel in Developmental and Epileptic Encephalopathies (DEE) is expected in the second quarter of 2020.

The pharma group also noted that it, along with its contract research and manufacturing partners, had begun contingency planning for the COVID-19 (pandemic) outbreak in January 2020 in conjunction with clinical investigator sites.

As at the end of March, the group's cash and cash equivalents were $60.6 million, compared to $70.1 million at the end of 2019, while research and development expenses for the three months were $6.9 million, including stock-based compensation of $0.5 million.

The net loss was $12.3 million versus a loss of $9.1 million in the same period a year ago.

Included in that was $1.7 million in non-cash foreign currency losses, mainly due to the remeasurement of the group's Australian subsidiary’s assets and liabilities, it noted.

Looking ahead, the firm said: "Management believes that the cash runway is sufficient to fund operations and capital requirements beyond the expected NDA submission and potential approval of Zygel in FXS and into the second half of 2021."

Shares in New York shot up over 16% to US$4.66 but had earlier been 30% higher.

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