Full Press Release Details
LA JOLLA, Calif. , Aug. 9, 2018 /PRNewswire/ -- Regulus Therapeutics Inc . (Nasdaq: RGLS ), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs, today reported financial results for the second quarter ended June 30, 2018 and provided a summary of recent events.
Second Quarter 2018 and Recent Updates
Corporate Updates
Pipeline Updates
Financial Updates
"The recent period has been highlighted by a challenging set of circumstances and unexpected setbacks, however we remain committed to our specific near-term objectives, namely coming to an agreement with Sanofi concerning the development of the Alport syndrome program, advancing our investigative and preclinical work on RGLS4326 to enable the Phase 1 MAD to resume, advancing our HBV programs, extending our cash runway, and looking for additional ways to improve shareholder value," said Jay Hagan , President and Chief Executive Officer of Regulus.
Financial Results
Cash Position: As of June 30, 2018 , Regulus had cash, cash equivalents and short-term investments of $32.9 million .
Research and Development (R&D) Expenses: R&D expenses were $10.0 million and $21.8 million for the three and six months ended June 30, 2018 , respectively, compared to $14.3 million and $30.0 million for the same periods in 2017. The decreases were primarily attributable to reductions in program-related spend for RG-101 and RGLS5040, as these programs were discontinued in 2017, in addition to reductions in personnel-related costs.
General and Administrative (G&A) Expenses: G&A expenses were $3.3 million and $7.1 million for the three and six months ended June 30, 2018 , respectively, compared to $7.1 million and $11.0 million for the same periods in 2017. The decreases were primarily attributable to non-recurring severance and non-cash stock-based compensation charges in Q2 2017.
Net Loss: Net loss was $13.8 million , or $0.13 per share (basic and diluted), and $29.9 million , or $0.29 per share (basic and diluted), for the three and six months ended June 30, 2018 , respectively, compared to $21.6 million , or $0.41 per share (basic and diluted), and $41.6 million , or $0.78 per share (basic and diluted), for the same periods in 2017.
Regulus Therapeutics Inc. (Nasdaq: RGLS ) is a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs. Regulus has leveraged its oligonucleotide drug discovery and development expertise to develop a pipeline complemented by a rich intellectual property estate in the microRNA field. 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 the expected ability of Regulus to undertake certain activities and accomplish certain goals (including with respect to development and other activities related to RG-012, RGLS4326, or its Hepatitis B Virus program), Regulus' estimated cash runway and anticipated cost savings associated with its planned reduction in workforce, the projected timeline of clinical development activities, and expectations regarding future therapeutic and commercial potential of Regulus' business plans, 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.
| Regulus Therapeutics Inc | |||||||||||
| Selected Financial Information | |||||||||||
| Condensed Statement of Operations | |||||||||||
| (In thousands, except share and per share data) | |||||||||||
| Three months ended June 30, | Six months ended June 30, | ||||||||||
| 2018 | 2017 | 2018 | 2017 | ||||||||
| Revenues: | |||||||||||
| Revenue under strategic alliances | $ | 18 | $ | 18 | $ | 36 | $ | 36 | |||
| Operating expenses: | |||||||||||
| Research and development | 10,013 | 14,278 | 21,841 | 30,030 | |||||||
| General and administrative | 3,349 | 7,057 | 7,122 | 11,016 | |||||||
| Total operating expenses | 13,362 | 21,335 | 28,963 | 41,046 | |||||||
| Loss from operations | (13,344) | (21,317) | (28,927) | (41,010) | |||||||
| Other expense, net | (503) | (419) | (945) | (751) | |||||||
| Loss before income taxes | (13,847) | (21,736) | (29,872) | (41,761) | |||||||
| Income tax benefit (expense) | - | 128 | (1) | 132 | |||||||
| Net loss | $ | (13,847) | $ | (21,608) | $ | (29,873) | $ | (41,629) | |||
| Net loss per share, basic and diluted | $ | (0.13) | $ | (0.41) | $ | (0.29) | $ | (0.78) | |||
| Weighted average shares used to compute basic and diluted net loss per share: | 104,319,555 | 53,182,330 | 104,169,746 | 53,086,887 |
| Regulus Therapeutics Inc. | ||||||
| Condensed Balance Sheets | ||||||
| (In thousands) | ||||||
| June 30, 2018 | December 31, 2017 | |||||
| (Unaudited) | ||||||
| Cash, cash equivalents and short-term investments | $ | 32,856 | $ | 60,074 | ||
| Total assets | 49,170 | 77,809 | ||||
| Term loan, less debt issuance costs | 19,888 | 19,859 | ||||
| Stockholders' equity | 10,433 | 35,216 |
SOURCE Regulus Therapeutics Inc.