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Organization
9 Months Ended
Sep. 30, 2014
Nature of Business  
Organization

1. Organization

 

Radius Health, Inc. (“Radius” or the “Company”) is a science-driven biopharmaceutical company focused on developing new therapeutics for patients with osteoporosis as well as other serious endocrine-mediated diseases. The Company’s lead product candidate is the investigational drug abaloparatide (BA058), a bone anabolic for the treatment of osteoporosis delivered via subcutaneous injection, which the Company refers to abaloparatide-SC and is currently in Phase 3 development. The Company is leveraging its investment in abaloparatide-SC to develop a line extension that is designed to improve patient convenience by enabling administration of abaloparatide through a short-wear-time patch, which the Company refers to as abaloparatide-TD. The Company has recently completed a successful Phase 2 proof of concept study of abaloparatide-TD.

 

The Company’s current clinical product portfolio also includes the investigational drug RAD1901, a selective estrogen receptor down regulator/degrader (“SERD”) and RAD140, a nonsteroidal selective androgen receptor modulator (“SARM”).  The Company is developing RAD1901 at higher doses for the treatment of metastatic breast cancer. At low doses, RAD1901 acts as a selective estrogen-receptor modulator (“SERM”). Low-dose RAD1901 has shown potential to be effective for the treatment of vasomotor symptoms such as hot flashes in a successful Phase 2 proof of concept study.  RAD140 resulted from an internal drug discovery program that began in 2005.  RAD140 has demonstrated potent anabolic activity on muscle and bone in preclinical studies and has clinical potential in a number of indications including the treatment of weight loss due to cancer cachexia, sarcopenia, frailty and oncology.

 

The Company is subject to the risks associated with emerging companies with a limited operating history, including dependence on key individuals, a developing business model, the necessity of securing regulatory approval to market its investigational product candidates, market acceptance of the Company’s product candidates, competition for its product candidates, and the continued ability to obtain adequate financing to fund the Company’s future operations. The Company has incurred losses and expects to continue to incur additional losses for the foreseeable future. As of September 30, 2014, the Company had an accumulated deficit of $326.3 million, and total cash, cash equivalents and marketable securities of $68.5 million. On October 7, 2014, the Company completed a public offering whereby the Company sold 2,750,000 shares of common stock at a price of $18.25 per share, for aggregate proceeds, net of underwriting discounts, commissions and offering costs, of approximately $46.9 million. On October 7, 2014, the underwriters purchased an additional 378,524 shares in the aggregate by exercising a portion of the over-allotment option granted to them in connection with the offering. As a result of the public offering and subsequent exercise of the over-allotment option, the Company received aggregate proceeds, net of underwriting discounts, commissions and offering costs of approximately $53.3 million.

 

The Company believes that the aggregate proceeds from the offering on October 7, 2014, together with its cash, cash equivalents and marketable securities as of September 30, 2014, will be sufficient to fund its operations into the fourth quarter of 2015. Accordingly, the Company expects to pursue strategic financing alternatives that could include, but are not limited to, partnering or other collaboration agreements, or additional financing opportunities, including the completion of a private placement or public offering in order to address its capital needs.  However, there is no guarantee that any of these strategic or financing opportunities will be executed or executed on favorable terms, and some could be dilutive to existing stockholders. If the Company fails to obtain additional future capital, it may be unable to complete its planned preclinical and clinical trials and obtain approval of any investigational product candidates from the U.S. Food and Drug Administration or other regulatory authorities. In addition, the Company could be forced to discontinue product development, reduce or forego sales and marketing efforts, forego attractive business opportunities or discontinue operations entirely.