— New funds help advance memory drug candidate BPN14770 in Alzheimer’s disease and support Tetra’s development effort in depression

GRAND RAPIDS, Mich., Nov. 29, 2016 /PRNewswire/ — Tetra Discovery Partners today announced  that it has closed a $5 million Series A Venture Financing. The financing was co-led by the Apjohn Group and Grand Angels, with the participation of previous investors as well as Dolby Family Ventures, the Alzheimer’s Drug Discovery Foundation, and other private investors.  With conversion of two debt rounds, the total Series A financing rolls up to $7,277,825.

The company also announced the receipt of two new grants from the National Institutes of Health. The first, AG054243, a $2 millionPhase 2b Small Business Innovation Research grant from the National Institute on Aging, supports Tetra’s Phase 1 multiple-ascending dose study of BPN14770 in healthy older (age 60+) volunteers. The second, MH091791, from the National Institute of Mental Health, provides $3 million in support for Tetra’s discovery program in depression.

“We are very pleased to receive this new financing which will enable Tetra to complete the necessary preparations for a planned Phase 2a study of our lead drug candidate, BPN14770, in Alzheimer’s disease during the second half of 2017,” said Mark E. Gurney, Ph.D., Chairman and Chief Executive Officer of Tetra Discovery Partners.  “We have made significant progress over the last four years, advancing from initial discovery of BPN14770 through the completion of a sequence of Phase 1 clinical studies in young and elderly volunteers.  We sincerely thank our investors and the National Institutes of Health for their ongoing support of our efforts.”

Donald R. Parfet of Apjohn Group joins the Tetra Board of Directors as part of the Series A financing.

“I have been following Tetra’s progress since the company’s founding,” said Donald R. Parfet, Managing Director, Apjohn Group. “Based on Tetra’s experienced management team, their efficient progress from compound discovery into human clinical trials, and the strong support that the company’s efforts have received from the National Institutes of Health, we are very pleased to lead this Series A financing.”

“We are pleased to support Tetra Discovery on a novel target for Alzheimer’s disease,” said David Dolby, Managing Director, Dolby Family Ventures. “Best-in-class new ventures in the fields of Alzheimer’s disease and brain health therapeutics are the focus of our health care investments, and Tetra’s work to date has been impressive.”

About Tetra Discovery Partners
Tetra Discovery Partners is a clinical stage biotechnology company developing a portfolio of therapeutic products that will bring clarity of thought to people suffering from Alzheimer’s disease and other brain disorders. Tetra uses structure-guided drug design to discover mechanistically novel, allosteric inhibitors of phosphodiesterase 4 (PDE4), which plays a key role in memory formation and learning. Tetra was a recipient of a NIH Blueprint Neurotherapeutics Network cooperative research agreement, and also receives major funding through the National Institute on Aging, and the National Institute of Mental Health Small Business Innovation Research (SBIR) program. Tetra Discovery Partners is headquartered in Grand Rapids, Michigan and maintains a business office in Cambridge, Massachusetts. For more information, please visit the company’s website at http://www.tetradiscovery.com.
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Contact:
Mark Gurney, Ph.D., Chief Executive Officer
Tetra Discovery Partners
[email protected]

For Media
Joan Kureczka, Kureczka/Martin Associates

LIVONIA, Mich., Sept. 26, 2016 (GLOBE NEWSWIRE) — Gemphire Therapeutics Inc. (Nasdaq:GEMP), a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for the treatment of dyslipidemia, a serious medical condition that increases the risk of life threatening cardiovascular disease, and NAFLD/NASH (nonalcoholic fatty liver disease), today announced enrollment of its first patient in COBALT-1, a Phase 2b trial designed to investigate gemcabene in the treatment of homozygous familial hypercholesterolemia (HoFH).  The purpose of this study is to assess the efficacy, safety, and tolerability of multiple rising doses of gemcabene in patients with HoFH who are on stable, lipid-lowering therapy, including statins, ezetimibe and Repatha.

“We are pleased to begin patient enrollment in the COBALT-1 trial for HoFH,” said Mina Sooch, President and Chief Executive Officer of Gemphire.  “Many patients with HoFH have high levels of LDL-C despite the use of statins and other approved medications and remain at high risk for cardiovascular disease.  We believe that gemcabene, which is being developed as a convenient, once a day, oral cost-effective medication, has the potential to be a complementary add on therapy in this patient population.  Gemcabene has been well tolerated in 895 subjects treated across 18 clinical trials both as monotherapy and in combination with statins and other cardiovascular agents.”

The open-label Phase 2b trial, “Efficacy and Safety of Gemcabene in Patients with Homozygous Familial Hypercholesterolemia on Stable, Lipid-Lowering Therapy (COBALT-1)” will enroll up to eight adult patients at clinical sites in the United States, Canada, and Israel.  Patients meeting eligibility requirements will be treated with an initial dose of 300 mg gemcabene, which will be increased to 600 mg at 4 weeks and then 900 mg at 8 weeks.  All patients will continue to receive their lipid-lowering background therapy. The primary endpoint will be the percent change from baseline of LDL-C at 4, 8, and 12 weeks.  Secondary endpoints include the change from baseline in non-HDL-C, total cholesterol, triglycerides, ApoB, and hsCRP at the same time points.

Gemphire currently anticipates the 12-week study to complete enrollment and all patient follow-up visits in the first half of 2017, with top-line data readout expected in June 2017.

Additional information on the trial design, including eligibility criteria and site locations, can be found at www.clinicaltrials.gov, using the NCT Identifier NCT02722408.

About Gemcabene
Gemphire’s product candidate, gemcabene (CI-1027), is a novel, once-daily, oral therapy that may be suitable for patients who are unable to achieve normal levels of LDL-C or triglycerides with currently approved therapies, primarily statins. Gemcabene’s mechanism of action is designed to enhance the clearance of very low-density lipoproteins (VLDLs) in the plasma and inhibit the production of cholesterol and triglycerides in the liver. The combined effect for these mechanisms has been observed to result in a reduction of plasma VLDL-C, LDL-C, and triglycerides, as well as markedly lowering C-reactive protein. Gemcabene is liver-directed and reduces apoC-III mRNA and plasma levels and may also inhibit acetyl-CoA carboxylase (ACC) which has applications in NASH/NAFLD. Gemcabene has been tested as monotherapy and in combination with statins and other drugs in 895 subjects across 18 Phase 1 and Phase 2 clinical trials and has demonstrated promising evidence of efficacy, safety and tolerability.

About Homozygous Familial Hypercholesterolemia (HoFH)
HoFH is a rare genetic disease that is usually caused by a mutation in both alleles of the LDL receptor gene. The LDL receptor is responsible for removing LDL from the blood. As a result, HoFH patients exhibit severely high LDL‑C levels, are at very high risk of experiencing premature cardiovascular events, such as a heart attack or stroke, and develop premature and progressive atherosclerosis. LDL‑C levels in HoFH patients are typically in the range of 500 mg/dL to 1,000 mg/dL, compared to a normal target range of 70 mg/dL to 100 mg/dL. Unless treated, most patients with HoFH do not survive adulthood beyond 30 years of age. There are approximately 300 to 2,000 HoFH patients in the United States and 6,000 to 45,000 patients in the rest of the world based on an estimated prevalence rate of one in 160,000 to one in one million.

About Gemphire
Gemphire is a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for the treatment of dyslipidemia, a serious medical condition that increases the risk of life threatening cardiovascular disease, and NAFLD/NASH (nonalcoholic fatty liver disease). Please visit www.gemphire.com for more information.

Forward Looking Statements 
Any statements in this press release about Gemphire’s future expectations, plans and prospects, including statements about Gemphire’s financial prospects, future operations and sufficiency of funds for future operations, clinical development of Gemphire’s product candidate, expectations regarding future clinical trials and future expectations and plans and prospects for Gemphire and other statements containing the words “believes,” “anticipates,” “estimates,” “expects,” “intends,” “plans,” “predicts,” “projects,” “targets,” “may,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995.  Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the success and timing of Gemphire’s regulatory submissions and pre-clinical and clinical trials; regulatory developments; changes to Gemphire’s clinical trial designs and regulatory pathways; changes in Gemphire’s capital resource requirements; Gemphire’s ability to obtain additional financing; Gemphire’s ability to successfully market and distribute its product candidate, if approved; Gemphire’s ability to obtain and maintain its intellectual property protection; and other factors discussed in the “Risk Factors” section of Gemphire’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2016,  and in other filings Gemphire makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent Gemphire’s views as of the date hereof. Gemphire anticipates that subsequent events and developments will cause Gemphire’s views to change. However, while Gemphire may elect to update these forward-looking statements at some point in the future, Gemphire specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Gemphire’s views as of any date subsequent to the date hereof.

Contact:
Andrew McDonald, Ph.D.
LifeSci Advisors, LLC
(646) 597-6987

Jeff Mathiesen, CFO
Gemphire Therapeutics
(734)-245-1700

Northville-based Gemphire Therapeutics Inc., a cardiovascular drug development company, has filed form S-1 with the U.S. Securities and Exchange Commission for a $60 million initial public offering.

It hopes to be listed on the Nasdaq Global Exchange under the symbol GEMP. No date has been set for the offering.

The clinical-stage company is developing a cardiovascular drug called gemcabene to lower levels of low-density lipoprotein cholesterol, the so-called bad cholesterol, and of triglycerides, which is fat in the blood. Gemcabene is taken orally once a day.

The drug, which was licensed from Pfizer in 2011, has been tested alone and in combination with other drugs in 895 subjects, both healthy volunteers and patients, in 18 phase one and phase two Food and Drug Administration trials.

Mina Sooch, the company’s president and CEO, previously was the CEO of Plymouth Township-based ProNAi Therapeutics Inc., which produced a drug for patients with non-Hodgkin’s lymphoma that in April 2014 set the record for the largest venture capital round in state history, $59.5 million. In January, Ann Arbor-based Millendo Therapeutics Inc. broke that record by raising a round of $62 million.

In September 2014, Sooch left ProNAi to join Gemphire, and Nick Glover, a veteran of publicly traded biotechs, was brought in to replace her.

Last July, ProNAi had an IPO of $158.4 million.

Co-founder Charles Bisgaier is Gemphire’s chairman and chief scientific officer. He was an associate research fellow in the department of vascular and cardiac disease at Warner-Lambert/Parke-Davis from 1990 to 1998, where he was involved in the discovery and development of Lipitor, a popular cholesterol-lowering drug. He and Roger Newton then co-founded Esperion Therapeutics Inc.

Gemphire is a combination of “gem,” for what founders hope will be a gem of a drug, and “sapphire,” a reference to the career that Bisgaier’s father, Abraham, had as a jewelry maker in New York, arriving in the United States from a concentration camp after World War II.

Pfizer spent tens of millions of dollars on gemcabene between 1999 and 2004. Before bringing gemcabene to trial, Pfizer decided to focus on another cardiovascular drug, spending $1 billion on torcetrapib, which was supposed to raise HDL, the so-called good cholesterol. During phase three trials, patients began dying and the trials halted. Soon after, in 2008, Pfizer ended all research and development on cardiovascular drugs.

The FDA has granted gemcabene status as an orphan drug to treat a condition called homozygous familial hypercholesterolemia. That status refers to a drug that treats patients with severe or deadly diseases that are rare and represent small markets. The designation allows drugs to get to market much faster.

Only two drugs have been approved for homozygous familial hypercholesterolemia, and both are extremely toxic to the liver, according to the FDA.
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Jefferies, Cowen and Co., Canaccord Genuity and Roth Capital are underwriting the IPO.

Executive search firmKingsley Gate Partners has placed Fumihide (Humi) Esaka as chief executive officer of Ambiq Micro, a provider of ultra-low power semiconductor solutions. He takes over from Mike Noonen who had been serving as interim CEO.

Mr. Esaka has 20 years of senior management experience in the semiconductor industry and held CEO roles in his last two companies, Nihon Inter Electronics Corp. and most recently power conversion specialist Transphorm Inc. He joined International Rectifier as a vice president in 1995, where he worked for 12 years. He also spent six years as a manager at consultancy firm Accenture.

“Humi brings a wealth of international semiconductor industry experience to Ambiq,” said Scott Hanson, co-founder and chief technology officer of Ambiq Micro. “He has a deep understanding of power efficiency issues and of their importance to our customers, particularly those that design and manufacture battery-powered devices. This experience is going to be invaluable as we develop Ambiq to be a world leader in ultra-low power semiconductor technology.”

“This is a most exciting time to be joining Ambiq Micro,” said Mr. Esaka. “The company has started full production of the world’s lowest power microcontroller and it’s already winning designs in leading consumer wearables and other IoT applications. Ambiq’s subthreshold technology is redefining low power in these applications and I look forward to being part of the great team that is driving this transformation in our industry.”