Full Press Release Details
LA JOLLA, Calif. , Nov. 5, 2015 /PRNewswire/ -- Regulus Therapeutics Inc . (NASDAQ: RGLS ), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today reported financial results and highlights for the quarter ended September 30, 2015 and provided a summary of recent corporate highlights.
"Regulus' recent achievements reflect our steady progress in building a meaningful clinical portfolio based on microRNAs," said Paul Grint , M.D., President and CEO of Regulus. "Specifically, we expanded development of RG-101, advanced RG-012 through Phase I, and realized the full economic value of our biomarkers collaboration with Biogen. In the coming months, we look forward to presenting data on our programs at key medical meetings and continuing to execute on our plans."
Third Quarter 2015 and Recent Highlights
RG-101 Highlights
RG-012 Highlights
Additional Highlights
Third Quarter 2015 Financial Results & Highlights Regulus reported a net loss of $13.0 million and $48.5 million for the three and nine months ended September 30, 2015 , compared to a net loss of $9.8 million and $34.5 million for the same periods in 2014. Basic and diluted net loss per share was $0.25 for the three months ended September 30, 2015 , compared to basic and diluted net loss per share of $0.23 and $0.26 , respectively, for the same period in 2014. Basic and diluted net loss per share was $0.95 for the nine months ended September 30, 2015 , compared to $0.80 for the same period in 2014.
Regulus recognized revenue of $1.9 million and $9.9 million for the three and nine months ended September 30, 2015 , respectively, compared to $1.1 million and $3.5 million for the same periods in 2014. Revenue for the three and nine months ended September 30, 2015 included research milestones earned under Regulus' strategic alliances and collaboration agreements of $0.3 million and $3.2 million , respectively. Revenue from research services performed under Regulus' strategic alliances and collaborations was $0.9 million and $4.1 million for the three and nine months ended September 30, 2015 , respectively. Other revenue during these periods consisted of amortization of up-front payments from Regulus' strategic alliances and collaborations, which is recognized over the estimated period of performance.
Research and development expenses were $11.0 million and $43.6 million for the three and nine months ended September 30, 2015 , respectively, compared to $10.2 million and $30.6 million for the same periods in 2014. This increase was primarily driven by clinical trial costs for RG-101, pre-clinical study costs for RG-125, and an increase in salaries and related employee costs, including non-cash stock-based compensation.
General and administrative expenses were $4.2 million and $13.7 million for the three and nine months ended September 30, 2015 , respectively, compared to $2.6 million and $8.3 million for the same periods in 2014. This increase was primarily driven by an increase in salaries and related employee costs, including non-cash stock-based compensation.
As of September 30, 2015 , Regulus had $131.7 million in cash, cash equivalents and short-term investments and 52,342,653 shares of common stock outstanding.
2015 Financial Guidance Regulus' cash guidance remains unchanged and the company expects to end 2015 with greater than $100.0 million in cash, cash equivalents and short-term investments.
Conference Call & Webcast Information Regulus will host a conference call and webcast at 5:00 p.m. Eastern Standard Time today to discuss its third quarter 2015 financial results, recent company highlights and its expectations for the remainder of 2015. A live webcast of the call will be available online at www.regulusrx.com . To access the call, please dial (877) 257-8599 (domestic) or (970) 315-0459 (international) and refer to conference ID 66007834. To access the telephone replay of the call, dial (855) 859-2056 (domestic) or (404) 537-3406 (international), passcode 66007834. The webcast and telephone replay will be archived on the company's website following the call.
About Regulus Regulus Therapeutics Inc. ( NASDAQ: RGLS ) is a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs. Regulus has leveraged its oligonucleotide drug discovery and development expertise to develop a well-balanced microRNA therapeutics pipeline complemented by a maturing microMarkers SM biomarkers platform and a rich intellectual property estate to retain its leadership in the microRNA field. Under its 'Clinical Map Initiative', Regulus is developing RG-101, a GalNAc-conjugated anti-miR targeting microRNA-122 for the treatment of chronic hepatitis C virus infection, and RG-012, an anti-miR targeting microRNA-21 for the treatment of Alport syndrome, a life-threatening kidney disease driven by genetic mutations with no approved therapy. In addition, RG-125, a GalNAc-conjugated anti-miR targeting microRNA-103/107 for the treatment of NASH in patients with type 2 diabetes/pre-diabetes, has been selected for clinical development. Regulus is also advancing several programs toward clinical development in orphan disease indications, oncology and fibrosis. Regulus' commitment to innovation has resulted in multiple peer-reviewed publications in notable scientific journals and has resulted in the formation of strategic alliances with AstraZeneca and Sanofi and a research collaboration with Biogen focused on microRNA biomarkers. Regulus maintains its corporate headquarters in La Jolla , CA. For more information, please visit http://www.regulusrx.com .
Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with financial estimates (including Regulus' projected cash at the end of 2015), the projected sufficiency of Regulus' capital position for future periods, the expected ability of Regulus to undertake certain activities and accomplish certain goals (including with respect to development and other activities related to RG-101, RG-012 and RG-125), the projected timeline of clinical development activities, and expectations regarding future therapeutic and commercial potential of Regulus' business plans (including Regulus' expected future activities in 2015), technologies and intellectual property related to microRNA therapeutics and biomarkers being discovered and developed by Regulus. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Regulus' current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Regulus' financial position and programs are described in additional detail in Regulus filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Regulus undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Harvoni® is a registered trademark of Gilead Sciences, Inc., Olysio® is a registered trademark of Janssen Therapeutics and Daklinza® is a registered trademark of Bristol-Meyers Squibb.
| Regulus Therapeutics Inc. | ||||||||||||
| Selected Financial Information | ||||||||||||
| Condensed Statement of Operations | ||||||||||||
| (In thousands, except share and per share data) | ||||||||||||
| Three months ended September 30, | Nine months ended September 30, | |||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||
| (Unaudited) | ||||||||||||
| Revenues: | ||||||||||||
| Revenue under strategic alliances | $ | 1,865 | $ | 1,083 | $ | 9,899 | $ | 3,450 | ||||
| Operating expenses: | ||||||||||||
| Research and development | 10,965 | 10,173 | 43,593 | 30,572 | ||||||||
| General and administrative | 4,245 | 2,569 | 13,703 | 8,255 | ||||||||
| Total operating expenses | 15,210 | 12,742 | 57,296 | 38,827 | ||||||||
| Loss from operations | (13,345) | (11,659) | (47,397) | (35,377) | ||||||||
| Other income (expense), net | 329 | 1,861 | (1,147) | 866 | ||||||||
| Loss before income taxes | (13,016) | (9,798) | (48,544) | (34,511) | ||||||||
| Income tax benefit (expense) | 16 | — | 22 | (1) | ||||||||
| Net loss | $ | (13,000) | $ | (9,798) | $ | (48,522) | $ | (34,512) | ||||
| Net loss per share: | ||||||||||||
| Basic | $ | (0.25) | $ | (0.23) | $ | (0.95) | $ | (0.80) | ||||
| Diluted | $ | (0.25) | $ | (0.26) | $ | (0.95) | $ | (0.80) | ||||
| Weighted average shares used to compute net loss per share: | ||||||||||||
| Basic | 51,990,460 | 43,406,251 | 51,052,068 | 43,155,601 | ||||||||
| Diluted | 51,990,460 | 44,855,463 | 51,052,068 | 43,155,601 |
| Regulus Therapeutics Inc. Condensed Balance Sheets (In thousands) | ||||||
| September 30, 2015 | December 31, 2014 | |||||
| (Unaudited) | ||||||
| Assets | ||||||
| Cash, cash equivalents, short-term investments and restricted cash | $ | 131,726 | $ | 159,743 | ||
| Other current assets | 5,084 | 5,208 | ||||
| Non-current assets | 6,637 | 6,529 | ||||
| Total assets | $ | 143,447 | $ | 171,480 | ||
| Liabilities and stockholders' equity | ||||||
| Current liabilities | $ | 12,800 | $ | 8,698 | ||
| Total deferred revenue | 4,092 | 6,349 | ||||
| Convertible notes payable, at fair value | — | 23,397 | ||||
| Other long-term liabilities | 693 | 1,022 | ||||
| Stockholders' equity | 125,862 | 132,014 | ||||
| Total liabilities and stockholders' equity | $ | 143,447 | $ | 171,480 |
SOURCE Regulus Therapeutics Inc.