Radius Health Announces Scientific Presentations at 2019 San Antonio Breast Cancer Symposium (SABCS)

WALTHAM, Mass., Dec. 06, 2019 (GLOBE NEWSWIRE) -- Radius Health, Inc. (“Radius” or the “Company”) (Nasdaq: RDUS) today announced its scientific presentations on elacestrant and RAD140 at the upcoming 2019 San Antonio Breast Cancer Symposium, which will take place from December 10 – 14 in San Antonio, Texas.

The EMERALD Phase 3 study is currently enrolling ER+, HER2- metastatic breast cancer patients in multiple countries with a majority of sites open and activated. Radius expects to complete patient recruitment in the third quarter of 2020.

“Radius has committed to advance and complete the EMERALD Phase 3 study, which is evaluating elacestrant, the first oral selective estrogen receptor degrader (SERD) in a pivotal registrational study,” said Charles Morris, M.D., Chief Medical Officer of Radius. “We look forward to presenting data that highlights elacestrant’s preclinical and clinical profile and potential to benefit patients at this important meeting.”

Radius Health will be presenting the following abstracts at SABCS:

Final analysis of phase 1 study of elacestrant (RAD1901), a novel selective estrogen receptor degrader (SERD), in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 (HER2) negative advanced breast cancer

Poster Spotlight Discussion
Program Number: PD7-07
Session Title: Spotlight Session 7
Session Date: Thursday, December 12, 2019
Session Time: 5-7 PM

EMERALD: A randomized, open-label, phase 3 trial to evaluate the efficacy and safety of elacestrant (RAD1901), a novel oral selective estrogen receptor degrader (SERD), vs investigator’s choice of endocrine therapy for ER+/HER2- advanced breast cancer following CDK4/6 inhibitor therapy

Program Number: OT1-04-04
Session Title: Ongoing Clinical Trials: Endocrine Therapy
Session Date: Wednesday, December 11, 2019
Session Time: 5-7 PM

Elacestrant (RAD1901) inhibits growth of ex vivo cultured circulating tumor cells derived from hormone receptor-positive metastatic breast cancer (mBC) patients including those harboring ESR1 mutations

Program Number: P4-01-06
Session Title: Poster Session 4
Session Date: Friday, December 13, 2019
Session Time: 7-9 AM

Phase 1 dose escalation study of a novel selective androgen receptor modulator (SARM), RAD140, in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), metastatic breast cancer

Program Number: P5-11-01
Session Title: Poster Session 5
Session Date: Friday, December 13, 2019
Session Time: 5-7 PM

Novel mechanisms of action of selective androgen receptor modulator RAD140 in AR+/ER+ breast cancer models

Program Number: P5-05-01
Session Title: Poster Session 5
Date: Friday, December 13, 2019
Time: 5-7 PM

Genomic alterations detected by circulating tumor DNA and correlation with response to treatment with elacestrant, an oral selective estrogen receptor degrader, in phase 1 trials in postmenopausal women with ER+/HER2- advanced/metastatic breast cancer

Program Number: P5-01-05
Session Title: Poster Session 5
Date: Friday, December 13, 2019
Time: 5-7 PM

About Elacestrant (RAD1901)
Elacestrant is a selective estrogen receptor degrader (SERD), which is being evaluated for potential use as a once daily oral treatment for hormone-receptor positive breast cancer. Elacestrant is currently being investigated for potential use in patients with advanced or metastatic estrogen receptor positive, HER2 negative, breast cancer, the most common form of the disease. Studies completed to date indicate that the compound has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer.

About RAD140

RAD140 is an oral Selective Androgen Receptor Modulator (SARM) for the potential treatment of hormone receptor positive advanced or metastatic breast cancer. AR is expressed in approximately 90% ER+ breast cancer tumors.

About Radius

Radius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative endocrine therapeutics. Radius’ lead product, TYMLOS (abaloparatide) injection, was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture. The Radius clinical pipeline includes an investigational abaloparatide-patch for potential use in osteoporosis; the investigational drug elacestrant (RAD1901) for potential use in hormone-receptor positive breast cancer; and the investigational drug RAD140, a non-steroidal, selective androgen receptor modulator (SARM) under investigation for potential use in hormone-receptor positive breast cancer. For more information, please visit www.radiuspharm.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the potential clinical uses and therapeutic and other benefits of our product candidates, including abaloparatide-patch, elacestrant and RAD140; and our expectations regarding our clinical trials, including the design and timing thereof and our expectations to complete recruitment in our Phase 3 EMERALD trial of elacestrant in the third quarter of 2020.

These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we expect to need to raise additional funding, which may not be available; risks related to raising additional capital; our limited operating history; quarterly fluctuation in our financial results; our dependence on the success of TYMLOS, and our inability to ensure that TYMLOS will obtain regulatory approval outside the U.S. or be successfully commercialized in any market in which it is approved, including as a result of risk related to coverage, pricing and reimbursement; risks related to competitive products; risks related to our ability to successfully enter into collaboration or partnership agreements and any executed collaboration or partnership agreements failing to be successful; risks related to clinical trials, including our reliance on third parties to conduct key portions of our clinical trials and uncertainty that results will support our product candidate claims; the risk that adverse side effects will be identified during the development of our product candidates or during commercialization, if approved; risks related to manufacturing, supply and distribution; and the risk of litigation or other challenges regarding our intellectual property rights. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, or SEC, including under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ending December 31, 2018 and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release.  Any such forward-looking statements represent management's estimates as of the date of this press release.  While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.  These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

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