On May 1, 2017 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq:RDUS), a fully integrated science-driven biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases, reported its financial results for the first quarter ended March 31, 2017, and provided a business update (Press release, Radius, MAY 1, 2017, View Source [SID1234518744]). As of March 31, 2017, Radius had $282.1 million in cash, cash equivalents and marketable securities. TYMLOS (abaloparatide)
On April 28, 2017, Radius announced that the U.S. Food and Drug Administration (FDA) approved TYMLOS (abaloparatide) injection for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. TYMLOS is the first new bone building therapy approved in nearly 15 years.
On February 1, 2017, results from the first six months of the recently completed 24- month ACTIVExtend trial were published in the Mayo Clinic Proceedings under the title of "Eighteen Months of Treatment With Subcutaneous Abaloparatide Followed by 6 Months of Treatment With Alendronate in Postmenopausal Women With Osteoporosis: Results of the ACTIVExtend Trial". The 24-month ACTIVExtend clinical trial has been completed and Radius expects to report the top-line results in the second quarter of 2017.
Radius’ marketing authorisation application (MAA) to the European Medicines Agency (EMA) for the treatment of postmenopausal women with osteoporosis is currently undergoing regulatory review, and we anticipate receiving an opinion from the Committee for Medicinal Products for Human Use (CHMP) in 2017.
In September 2016, at the annual meeting of the American Association for Bone Mineral Research (ASBMR), we presented the positive results from a human replicative clinical evaluation of an optimized abaloparatide transdermal patch. These results established an important demonstration of how we have changed the pharmacokinetic profile in our program to develop a bioequivalent transdermal patch. Currently, we are focused on completing the manufacturing, scale-up, and other required activities needed to initiate a pivotal study to evaluate bioequivalence to TYMLOS. We believe that the transdermal patch program has the potential to allow physicians who treat osteoporosis, but rarely use injectable drugs, an opportunity to expand their practices to include the use of anabolic therapy.
We recently completed enrollment in both of our ongoing Phase 1 studies of elacestrant in advanced metastatic breast cancer. In the first half of 2017, we plan to engage with regulatory agencies to gain alignment on defining the next steps for the elacestrant breast cancer program, which would include the design of a Phase 2 trial. We expect to complete and report results from our elacestrant Phase 2b vasomotor trial in mid-2017.
An investigational new drug application, or IND, submitted to the FDA for RAD140, a selective androgen receptor modulator, has been accepted. We expect to initiate a first-in-human Phase 1 clinical trial in women with hormone receptor positive breast cancer in 2017.
Radius Expects the Following Upcoming Milestones
Receive a CHMP opinion regarding the EMA’s review of the abaloparatide-SC MAA in 2017
Enter into a partnership for the potential commercialization of abaloparatide-SC prior to commercial launch
Report top-line results from the recently completed 24-month ACTIVExtend clinical trial in the second quarter of 2017
Complete ongoing Phase 1 breast cancer clinical trials
Engage with regulatory authorities in 2Q 2017 to gain alignment on defining next steps for the program, which would include the design of a Phase 2 breast cancer trial
Present a poster on June 4, 2017 at the American Society of Oncology Annual Meeting (ASCO) (Free ASCO Whitepaper)
Complete and report results from our ongoing Phase 2b vasomotor trial in mid-2017
Initiate a first-in-human Phase 1 study in 2017 in women with hormone receptor positive breast cancer
Radius Expects To Make Presentations at the Following Upcoming Conferences
On May 4, 2017, Radius President and CEO, Robert Ward will make a presentation and host one-on-ones at the 42nd Annual Deutsche Bank Healthcare Conference in Boston
On May 16-17, 2017, Radius President and CEO, Robert Ward will make a presentation and will host one-on-ones at the Bank of America Merrill Lynch 2017 Healthcare Conference in Las Vegas
On June 4, 2017, at the 2017 ASCO (Free ASCO Whitepaper) Annual Meeting, the following abstract will be presented as a poster and as part of the Poster Discussion Session: Abstract 1014
"Evaluation of Elacestrant (RAD1901), a novel investigational, selective estrogen receptor degrader (SERD), for the treatment of ER-positive (ER+) advanced breast cancer" Abstract 1014, 8:00 AM – 11:30 AM, Hall A, Poster Board #6, POSTER SESSION, Breast Cancer-Metastatic
Discussed at the Poster Discussion Session, 4:45 PM – 6:00 PM, Hall B1, Aditya Bardia, MD, MPH – First Author, Massachusetts General Hospital Cancer Center and Harvard Medical School
On June 13-14, 2017, Radius President and CEO, Robert Ward will make a presentation and will host one-on-ones at the Goldman Sachs 38th Annual Global Healthcare Conference in Palos Verdes, California
First Quarter 2017 Financial Results
For the three months ended March 31, 2017, Radius reported a net loss of $56.9 million, or $1.32 per share, as compared to a net loss of $40.5 million, or $0.94 per share, for the three months ended March 31, 2016. The increase in net loss for the three months ended March 31, 2017 as compared to the same period in 2016 was primarily due to an increase in general and administrative expenses, including the completion of the build out of our commercial organization in the first quarter of 2017, partially offset by a decrease in research and development expenses.
Research and development expenses for the three months ended March 31, 2017 were $19.5 million, compared to $27.5 million for the same period in 2016. This decrease was primarily driven by a decrease in TYMLOS/abaloparatide-SC, abaloparatide-TD and elacestrant program development costs, partially offset by an increase in RAD140 development costs.
General and administrative expenses for the three months ended March 31, 2017 were $38.1 million, compared to $13.6 million for the same period in 2016. This increase was primarily attributable to an increase in professional support costs, including the costs associated with increasing headcount in preparation for the commercialization of TYMLOS, including the completion of our build out of our commercial organization in the first quarter of 2017. This increase was also driven by an increase in compensation expense, including stock-based compensation, due to an increase in headcount from March 31, 2016 to March 31, 2017.
As of March 31, 2017, Radius had $282.1 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, subject to favorable regulatory review, of any of its investigational products, it has sufficient capital to fund its development plans, U.S. commercial scale-up and other operational activities for not less than twelve months from the date of this press release and into 2018.