Sermonix Pharmaceuticals Announces Recent Closure of $4.2 Million Seed Preferred Equity Bridge to Fund Operations, Prepare for Phase II Breast Cancer Study

COLUMBUS, OH--(Marketwired - Oct 31, 2017) - Sermonix Pharmaceuticals LLC, a privately held biotechnology company focused on the development and commercialization of female-specific oncology products, today announced its recent completion of a $4.2 million Seed Preferred Equity Bridge financing round to fund ongoing operations and prepare for entry of investigational drug lasofoxifene into a Phase II clinical trial in Estrogen Receptor Positive (ER+) Metastatic Breast Cancer.

Lasofoxifene, a newer-generation selective estrogen receptor modulator (SERM), is one of the most well-studied drugs in its category and is being repurposed by Sermonix for metastatic breast cancer. New investors include Richard DeSchutter, former chief executive officer of G.D. Searle, DuPont Pharmaceuticals and vice chairman of Monsanto, as well as strategic investor Endoceutics Inc. of Quebec City, Quebec, Canada.

Metastatic breast cancer is a progressive, incurable form of breast cancer. Nearly 160,000 women in the U.S. alone live with the disease. As resistance inevitably develops during treatment, patients face fewer options and often must turn to cytotoxic chemotherapy as a debilitating choice. Hence, there is a recognized need for further lines of active, well-tolerated endocrine therapies.

"With new patent applications recently filed worldwide for lasofoxifene in the area of acquired endocrine resistance and our ongoing development, this bridge raise gives Sermonix the ability to execute key milestones as we move toward clinical trials with our well-studied phase II-ready compound, lasofoxifene," said Dr. David Portman, Sermonix founder and chief executive officer. "It potentially brings an important option to women seeking new and less toxic treatments for their advanced breast cancer."

Lasofoxifene has been evaluated in a comprehensive worldwide phase I-III clinical development program involving more than 15,000 women. An 83% reduction in ER+ breast cancer was seen in a five-year PEARL osteoporosis trial of over 8,500 women. Reductions in the risk of vertebral and non-vertebral fractures, and benefits on vulvovaginal atrophy (VVA) have been demonstrated as well (Cummings SR et al New England Journal of Medicine 2010). Sermonix is focused on novel activity recently identified in the treatment of endocrine-resistant breast cancer, with exclusive rights to new Duke University intellectual property in this area.

Seventy percent of the more than 240,000 U.S. women annually diagnosed with breast cancer are ER+ and there are estimated over 3 million breast cancer survivors in the U.S., including 160,000 living with stage 4 disease (Breast Cancer Facts & Figures 2015-2016 American Cancer Society).

"Many breast cancer patients suffer significant bone loss and osteoporosis due to the use of aromatase inhibitors and other agents," added Dr. Portman. "In addition to its activity on breast cancer, lasofoxifene's potential benefits on bone may confer added treatment advantages and value when compared to currently available therapies."

Dr. Fernand Labrie, Endoceutics founder and chief executive officer, has significant experience in the metastatic cancer arena, including his pivotal work on flutamide and the development and research of the Endoceutics' SERM, acolbifene, in breast cancer.

"Sermonix has the team and experience to identify novel uses for SERMs in the setting of resistance with their lead compound lasofoxifene," said Dr. Labrie. "We are excited to partner with Sermonix to see how we can best advance the field together as well as explore potential collaboration with acolbifene in this area of significant unmet medical need."

Sermonix is also currently working closely on new lasofoxifene studies with Dr. Geoffrey Greene, professor and chair, the Ben May Department for Cancer Research, University of Chicago. Dr. Greene recently joined the company's Oncology Steering Committee.

"Dr. Greene's lab is conducting several supportive animal model studies with lasofoxifene," said Sermonix Chairman Dr. Anthony Wild. "The Sermonix team plans to present this exciting new data in 2018."

About Sermonix
Sermonix Pharmaceuticals LLC is a biotechnology company with a targeted focus on bringing female-specific oncology products through proof of concept, clinical development, and regulatory approval. The company was founded in 2014 by David Portman, MD, a leading clinical researcher and expert in women's health, menopause and selective estrogen receptor modulator (SERM) therapy. Sermonix has as its lead product oral lasofoxifene, with exclusive worldwide licensing rights obtained from Ligand Pharmaceuticals, Inc. The Sermonix internal management team, led by Dr. Portman, has significant experience in all stages of the drug development and regulatory process. James Symons, MS, PhD, is Vice President of Clinical Development at Sermonix, and led the global lasofoxifene VVA program while at Pfizer. Paul Plourde, MD, VP Sermonix Oncology Clinical Development, was previously with Astra-Zeneca, where he was instrumental in the development and approval of tamoxifen, Arimidex^® and Faslodex^®. Barry Komm, PhD, Sermonix Chief Scientific Officer, was former head of the SERM program at Wyeth and Pfizer, playing a key role in the development and approval of bazedoxifene and Duavee®. Elizabeth Attias, MMSc, ScD, is Vice President of Business Development and has extensive experience in pharmaceutical drug commercialization. Miriam Portman, M.D., is the Chief Operating Officer of Sermonix. She is former Co-director and Founder of the Columbus Center for Women's Health Research. Sermonix Non-Executive Chairman of the Board is Anthony Wild, PhD, former president of both Parke-Davis Pharmaceuticals and Warner-Lambert's Pharmaceutical Division.