Radius Health Reports Second Quarter 2015 Financial And Operating Results

• Management to host conference call today at 7:30 am EDT

WALTHAM, Mass., Aug. 6, 2015 (GLOBE NEWSWIRE) -- Radius Health, Inc. ("Radius" or the "Company") (Nasdaq:RDUS), a science-driven biopharmaceutical company focused on developing new therapeutics for patients with osteoporosis as well as other serious endocrine-mediated diseases, including hormone responsive metastatic breast cancer, reported its financial results for the second quarter ended June 30, 2015, and provided recent corporate highlights. As of June 30, 2015, Radius had $224.0 million in cash, cash equivalents and marketable securities, and on July 28, 2015, raised approximately $323.8 million of net proceeds in a follow-on public offering of its common stock.

"Radius has achieved a number of significant milestones in the second quarter of 2015, including announcing positive top-line data from the first six months of the ACTIVExtend trial, and adding to the talent of our management team and Board of Directors," said Robert Ward, President and Chief Executive Officer of Radius Health. "This progress as well as the success of our recent follow-on public offering positions us well to execute on our top priorities; submit an MAA and NDA by the end of this year for the investigational drug abaloparatide-SC, continue our partnering discussions as part of our preparation for the potential commercial launch of abaloparatide-SC, and to advance the development of RAD1901 in multiple indications."

Recent Corporate Highlights

Follow On Public Offering

On July 28, 2015, Radius completed a public offering whereby it sold 4,054,054 shares of common stock at a public offering price of $74.00 per share, for aggregate proceeds, net of underwriting discounts, commissions, and estimated offering costs, of approximately $281.5 million. The underwriters purchased an additional 608,108 shares by exercising their option to purchase additional shares granted to them in connection with the offering.  As a result of the public offering and exercise of the underwriters' option to purchase additional shares, Radius received aggregate proceeds, net of underwriting discounts, commissions, and estimated offering costs of approximately $323.8 million. Radius plans to use these additional funds to expand the development of RAD1901 for potential use in metastatic breast cancer in combination with other approved therapies, to fund the continued development of the optimized abaloparatide transdermal patch and related manufacturing capabilities, and to continue to build the commercial infrastructure, inventory and manufacturing capabilities necessary for commercialization of abaloparatide-SC following regulatory approval.

Abaloparatide-SC

On July 14, 2015, we announced that four abaloparatide abstracts will be presented at the American Society for Bone and Mineral Research (ASBMR) 2015 Annual Meeting, October 9-12, 2015. Dr. Felicia Cosman will make an Oral Plenary presentation titled "Eighteen Months of Treatment with Abaloparatide Followed by Six Months of Treatment with Alendronate in Postmenopausal Women with Osteoporosis - Results of the ACTIVExtend Trial". Dr. Cosman is a Professor of Clinical Medicine at Columbia University in New York and also serves as a Clinical Director at the National Osteoporosis Foundation.  Dr. Lorraine Fitzpatrick will make an oral presentation titled "Effects of Abaloparatide on Major Osteoporotic Fracture Incidence in Postmenopausal Women with Osteoporosis - Results of the Phase 3 ACTIVE Trial". Dr. Fitzpatrick recently joined Radius where she holds the position of Chief Medical Officer. Additional posters on the results from the abaloparatide-SC responder analysis and transdermal development programs will be presented.

In June 2015, we announced new data from our ACTIVE trial, as well as the top-line data from the first six months of ACTIVExtend, the 24-month extension trial of the Phase 3 ACTIVE trial in which patients from the abaloparatide-SC and placebo groups of the ACTIVE trial received an approved alendronate therapy for osteoporosis management.  The results from the ACTIVExtend study showed that the group previously treated with abaloparatide had no new vertebral fractures during the first six months of receiving alendronate.  From the start of the ACTIVE study, this group showed a statistically significant 87% reduction in new vertebral fractures (p<0.0001), a 52% reduction in non-vertebral fractures (p=0.0168), a 48% reduction in clinical fractures (p=0.0139), and a 58% reduction in major osteoporotic fractures (p=0.0122) over the 25-month period, as compared to placebo.  This group also achieved a 12.8% increase in BMD at the lumbar spine, a 5.5% increase in BMD at total hip, and a 4.5% increase in BMD at the femoral neck.  In addition, 20.4% of patients achieved a 6% increase or greater in BMD at all three sites (i.e., lumbar spine, total hip and femoral neck).

A recent exploratory analysis of the ACTIVE trial showed that, for major osteoporotic fractures, there was a statistically significant 67% reduction in major osteoporotic fractures (p=0.0014) for the abaloparatide treatment group versus placebo, and a statistically significant 53% reduction in major osteoporotic fractures (p=0.0437) for the abaloparatide treatment group as compared to teriparatide over the 18-month period.

The results from the ACTIVE trial and the first six months of the ACTIVExtend trial will form the basis of Radius' planned submission of a marketing authorization application ("MAA") to the European Medicines Agency ("EMA") and a new drug application ("NDA") to the U.S. Food and Drug Administration ("FDA"), by the end of 2015. 

During the second quarter, Radius continued the non-human primate pharmacokinetic studies of the investigational drug abaloparatide‑TD, a short wear time transdermal patch form of abaloparatide. In December 2014, Radius reported that a prototype achieved a desirable pharmacokinetic profile, with comparable AUC, Cmax, Tmax and T1/2 relative to abaloparatide-SC.

RAD1901

Radius is continuing to enroll and dose patients in the United States in its Phase 1 clinical trial of the investigational drug RAD1901 for potential use in the treatment of metastatic breast cancer.  The Phase 1 study is a multicenter, open-label, two-part, dose-escalation study of RAD1901 in postmenopausal women with advanced estrogen receptor positive and HER2-negative breast cancer that is designed to determine the recommended dose for a Phase 2 clinical trial and includes a preliminary evaluation of the potential anti-tumor effect of RAD1901.  Radius expects to report further progress on this study in the second half of 2015. Radius plans to commence Phase 1 clinical development in metastatic breast cancer patients in the European Union in 2015. 

On July 15, 2015, Radius announced that early but promising preclinical data show that its investigational drug RAD1901, in combination with Pfizer's palbociclib, a CDK4/6 inhibitor, or Novartis' everolimus, an mTOR inhibitor, was effective in shrinking tumors. In patient-derived xenograft (PDx) breast cancer models with either wild type or mutant ESR1, treatment with RAD1901 resulted in marked tumor growth inhibition, and the combination of RAD1901 with either agent, palbociclib or everolimus, showed anti-tumor activity that was significantly greater than either agent alone.