On November 5, 2015 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq:RDUS), a science-driven biopharmaceutical company focused on developing new therapeutics for patients with osteoporosis, hormone responsive metastatic breast cancer, and other postmenopausal conditions including vasomotor symptoms reported its financial results for the third quarter ended September 30, 2015, and provided recent corporate highlights (Filing, 8-K, Radius, NOV 5, 2015, View Source [SID:1234507984]). As of September 30, 2015, Radius had $500.8 million in cash, cash equivalents and marketable securities.
"Radius was pleased to have the opportunity to present the positive results of our Phase III ACTIVE and ACTIVExtend trials for our investigational drug abaloparatide-SC for the treatment of postmenopausal osteoporosis at the American Society for Bone and Mineral Research, and we are on track to submit our MAA in the EU and NDA in the U.S. by the end of this year," said Robert Ward, President and Chief Executive Officer of Radius Health. "During the quarter, David Snow joined our company as Chief Commercial Officer and will play a critical role as we prepare for commercialization of abaloparatide-SC, pending favorable regulatory review. At the same time, we have continued to make progress in advancing our portfolio, including the investigational drug RAD1901 for metastatic breast cancer and vasomotor symptoms, and the investigational drug abaloparatide-TD, a short-wear time transdermal patch."
Pipeline Updates
Abaloparatide-SC
On October 12, 2015, Dr. Felicia Cosman, Lead Investigator of the ACTIVExtend trial, presented detailed positive top-line data from the first six months of the ACTIVExtend trial at a plenary oral session during the American Society for Bone and Mineral Research 2015 Annual Meeting ("ASBMR"). The data showed that women who were previously treated with 18 months of abaloparatide-SC experienced no new vertebral fractures and increased bone mineral density ("BMD") during the first six months of treatment on alendronate ("ALN"). Dr. Cosman is a Professor of Clinical Medicine at Columbia University in New York and also serves as Senior Clinical Director at the National Osteoporosis Foundation.
Also at ASBMR, Dr. Lorraine Fitzpatrick, Chief Medical Officer at Radius Health, made an oral presentation of positive top-line data from the Phase 3 ACTIVE trial, which showed that women with postmenopausal osteoporosis who received 18 months of
daily abaloparatide-SC experienced a 70% reduction in the incidence of major osteoporotic fractures compared to placebo. A responder analysis showed greater increases in BMD at three combined anatomical sites (total hip, femoral neck and lumbar spine) compared to placebo or teriparatide at 6, 12 and 18 months.
During ASBMR, Radius presented a poster presentation of the pharmacokinetic profile from the transdermal patch primate studies. Radius expects to initiate the clinical evaluation of the optimized abaloparatide-TD patch by the end of 2015, with the goal of achieving bioequivalence to abaloparatide-SC.
Radius remains on track to submit a marketing authorization application ("MAA") in Europe and a new drug application ("NDA") in the United States for abaloparatide-SC by the end of 2015. Subject to a regulatory review and favorable regulatory outcome, Radius anticipates that first commercial sales of abaloparatide-SC will take place in 2016.
RAD1901
During the third quarter of 2015, Radius continued to enroll and dose patients in the United States in its Phase 1 multicenter, open-label, two-part, dose-escalation study of RAD1901 in postmenopausal women with advanced estrogen receptor positive and HER2-negative breast cancer. The study 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 at the San Antonio Breast Cancer Symposium ("SABCS") in San Antonio, TX, December 8-12, 2015 and to commence an additional Phase 1 FES-PET study in patients with metastatic breast cancer in the European Union by the end of 2015.
On September 24, 2015, Radius provided an update on the safety and tolerability profile of RAD1901 from the completed Phase I maximum tolerated dose ("MTD") study in 52 healthy volunteers. In the study, RAD1901 was administered to healthy postmenopausal women in doses ranging from 200mg to 1000mg, and the data showed that RAD1901 was well-tolerated and the overall safety was supportive of continued development.
Radius plans to make an oral and poster presentation of data from the RAD1901 clinical development program at AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) Meeting, November 5-9, 2015, in Boston, MA and three poster presentations at the SABCS In December.
Radius is also developing low dose RAD1901, which has shown the potential to be effective for the treatment of postmenopausal vasomotor symptoms such as hot flashes in a successful Phase 2 proof of concept study. Radius intends to commence a Phase 2b clinical study of RAD1901 for the potential treatment of postmenopausal vasomotor symptoms by the end of 2015.
Radius Expects the Following Upcoming Milestones
· Abaloparatide-SC
· Submit an MAA and NDA for abaloparatide-SC by the end of 2015.
· Abaloparatide-TD
· Commence the clinical evaluation of the optimized abaloparatide-TD patch by the end of 2015.
· RAD1901
· Commence Phase 1 clinical development in the European Union for RAD1901 in metastatic breast cancer patients by the end of 2015.
· Commence a Phase 2b clinical trial for low-dose RAD1901 for the potential treatment of postmenopausal vasomotor symptoms by the end of 2015.
Radius Expects To Make Presentations at The Following Upcoming Conferences
· AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) Meeting, November 5-9, 2015, Boston, MA. The title of the poster and oral presentation is:
"RAD1901, an orally available selective estrogen receptor down regulator, has potent anti-tumor activity in in vitro and in vivo models of ER+ breast cancer."
· Radius Investor Day in New York City, November 17, 2015.
· Goldman Sachs SMID Cap Conference, New York City, November 19, 2015.
· Multiple oral and poster presentations at the SABCS, December 8-12, 2015, San Antonio, TX. The titles of the three poster presentations are as follows:
"RAD1901, a Novel Oral, Selective Estrogen Receptor Degrader ("SERD") with Single Agent Efficacy in ER+ Primary Patient Derived ERS1 Mutant Xenograft Model."
"A Phase 1 Dose Escalation Study of RAD1901, an Oral Selective Estrogen Receptor Degrader, in Healthy Postmenopausal Women."
"A Phase 1 Study of RAD1901, a Novel, Orally Available, Selective Estrogen Receptor Degrader, for the Treatment of ER Positive Advanced Breast Cancer."
Recent Corporate Highlights
· On September 9, 2015, Radius announced that it appointed David P. Snow as Chief Commercial Officer. Mr. Snow has more than 25 years of experience in the global commercialization of brands across numerous therapeutic areas and geographies. Most recently, Mr. Snow served as President of AstraZeneca’s China business.
· On August 18, 2015, Radius announced the appointment of Catherine Friedman to the Company’s Board of Directors. Ms. Friedman has also been appointed Chair of the Audit Committee of the Board of Directors. Catherine Friedman has served as an independent consultant serving public and private growth companies since 2006. Prior to that, Ms. Friedman held the position of Managing Director at Morgan Stanley from 1997 to 2006 and head of West Coast Healthcare and co-head of the Biotechnology Practice at Morgan Stanley from 1993 to 2006.
Third Quarter 2015 Financial Results
For the three months ended September 30, 2015, Radius reported a net loss of $28.3 million, or $0.68 per share, as compared to a net loss of $17.4 million, or $0.59 per share for the three months ended September 30, 2014. The increase in net loss for the three months ended September 30, 2015 as compared to the three months ended September 30, 2014 was primarily due to an increase in research and development, general and administrative expenses, and loss on retirement of note payable, partially offset by a decrease in interest expense.
Research and development expenses for the three months ended September 30, 2015 were $18.2 million, compared to $13.8 million for the same period in 2014. The increase for the 2015 period as compared to the 2014 period was primarily attributable to an increase in consulting costs incurred to support Radius’ MAA and NDA submissions for abaloparatide-SC and an increase in compensation costs, including non-cash stock-based compensation costs, due to an increase in research and development headcount from September 30, 2014 to September 30, 2015. These increases were partially offset by a decrease in the costs associated with the abaloparatide-SC Phase 3 ACTIVE and ACTIVExtend clinical trials.
General and administrative expenses for the three months ended September 30, 2015 were $8.5 million, compared to $2.8 million for the same period in 2014. The increase for the 2015 period as compared to the 2014 period was primarily attributable to an increase in professional support costs and legal fees, including the costs associated with growing Radius’ headcount and preparing for the potential commercialization of abaloparatide-SC.
For the three months ended September 30, 2015, loss on retirement of note payable was $1.6 million, while no loss on retirement of note payable was recognized for the same period in 2014. The loss on retirement of note payable for the 2015 period was a result of the prepayment of all amounts owed under Radius’ loan and security agreement on August 4, 2015.
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As of September 30, 2015, Radius had $500.8 million in cash, cash equivalents and marketable securities. Based upon Radius’ cash, cash equivalents and marketable securities balance, Radius believes that, prior to the consideration of revenue from the potential future sales of any of its investigational products, it has sufficient capital to fund its development plans, U.S. commercial scale-up and other operational activities into 2018.