Gemphire Therapeutics announces review of strategic alternatives

Gemphire Therapeutics announced that its Board of Directors is conducting a review of a range of strategic alternatives focused on maximizing stockholder value. The Company has engaged Ladenburg Thalmann & Co. Inc. to act as its strategic financial advisor for this process. The Board of Directors has established a committee to oversee this review. Potential strategic alternatives that may be evaluated include, but are not limited to, an acquisition, merger, business combination, in-licensing, or other strategic transaction involving the Company. There can be no assurance that this process will result in Gemphire pursuing any transaction or that any transaction, if pursued, will be completed. The Company does not intend to discuss or disclose further developments regarding the strategic review process unless and until its Board of Directors has approved a specific action or otherwise determined that further disclosure is appropriate or required by law. “As we have previously disclosed, the recent request by the U.S. FDA for additional preclinical data on gemcabene means that our planned Phase 3 programs, initially focused in hypertriglyceridemia, are expected to start later than originally planned,” said Steven Gullans, Ph.D., CEO of Gemphire. “We continue to be encouraged by the results from 25 clinical trials in nearly 1,200 adult patients in which gemcabene demonstrated statistically significant signs of efficacy with no severe adverse events or drug-drug interactions. We remain confident that we will be able to meet the FDA’s requests to enable it to reconsider lifting the partial clinical hold on gemcabene. However, we believe it is prudent to fully leverage our resources by exploring strategic alternatives.” The Phase 2a study investigating gemcabene in Familial Partial Lipodystrophy disease recently completed enrollment. This open-label investigator-led study, being conducted by Dr. Elif Oral at the University of Michigan, is assessing gemcabene’s efficacy, including its effects on plasma triglyceride and inflammatory markers, as well as liver fat determined by MRI-PDFF. To date, no drug-related toxicities have been detected, and two patients have completed the 24 week gemcabene treatment regimen. Top-line results are expected in mid-2019. The Company continues to make progress with the ongoing preclinical studies recently requested by the FDA with the goal of providing the FDA with the data it requires to lift the partial clinical hold on gemcabene. Results are expected to be provided to the FDA in the second half of 2019.

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