Highland completes US$25 million offering of Class A Common Shares

Oct 16 2014

Highland Therapeutics Inc. ("Highland"), a pharmaceutical company, today announced it has completed a US$25 million offering of Class A Common Shares. The financing was led by a private equity partner that is committed to Highland's long-term success.

The funds raised will provide, among other things, the necessary resources for Highland, through its wholly owned subsidiary Ironshore Pharmaceuticals & Development, Inc. to (i) complete the clinical development of HLD-200 (under development for the treatment of symptoms associated with ADHD) through to a New Drug Application, (ii) conduct a Phase IIB/III study of HLD-100 (amphetamine), (iii) expand manufacturing capacity and (iv) pursue pipeline expansion opportunities.

"I am delighted by the strong show of support evidenced by this financing, which recognizes the progress made by Highland in its evolution to becoming an international pharmaceutical company with a proprietary drug delivery technology and two late-stage products in development," said David Lickrish, Highland's President & Chief Executive Officer. "Looking forward, we anticipate reaching a number of critical near-term milestones, including Phase III data for HLD-200."

HLD-200 Phase III Clinical Trial Update
Highland's lead compound, HLD-200 (methylphenidate) is being investigated in an ongoing Phase III clinical trial entitled Clinical Endpoint Evaluation Study, or CEES. A total of 43 pediatric ADHD patients were enrolled in the study, all of whom have now completed their participation. Top-line results are anticipated in November 2014.

The primary objective of CEES is to generate data that will inform the design of a pivotal trial for HLD-200 that Highland anticipates initiating in the first half of 2015. The 'Clinical Endpoint' in the CEES title is in reference to a novel rating scale that is being used to measure early morning functioning as part of the trial's key secondary endpoint – to demonstrate that evening treatment with HLD-200 improves control of ADHD symptoms, compared to placebo, during the at-home morning routine in pediatric subjects with ADHD. Given the scale's relative novelty, data from CEES will be instrumental in properly powering the pivotal study.