Full Press Release Details
LA JOLLA, Calif. , Nov. 8, 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 third quarter ended September 30, 2018 and provided a summary of recent events.
Third Quarter 2018 Corporate Highlights and Recent Updates
"The recently announced Sanofi restructuring represents a significant achievement for Regulus, bringing non-dilutive capital and eliminating future spend for this partnered program. Importantly, we are eligible to receive approximately $17 million in upfront and milestone payments anticipated over the next twelve months," said Jay Hagan , President and Chief Executive Officer of Regulus. "In July, we established several near-term key objectives, including reducing our cash burn, restructuring the Sanofi collaboration, advancing our prioritized pipeline, including ADPKD, and positioning other programs for business development opportunities. Regulus has made significant progress towards completing all of these objectives, and we look forward to the continued advancement of our ADPKD and HBV programs."
Program Updates
Third Quarter 2018 Financial Results
Cash Position: As of September 30, 2018 , Regulus had $20.5 million in cash, cash equivalents and short-term investments. Under the terms of the Sanofi Amendment, Regulus is eligible to receive approximately $7 million in upfront and material transfer payments. Including these additional proceeds, the Company expects its cash runway to extend through Q2 2019.
Research and Development (R&D) Expenses: R&D expenses were $6.9 million and $28.7 million for the three and nine months ended September 30, 2018 , respectively, compared to $12.7 million and $42.7 million for the same periods in 2017. The decreases were primarily attributable to the pausing of the RG-012 and RGLS4326 programs early in the third quarter of 2018, the discontinuation of the RG-101 and RGLS5040 programs in 2017 and reductions in personnel-related expenses primarily attributable to our corporate restructurings.
General and Administrative (G&A) Expenses: G&A expenses were $3.0 million and $10.1 million for the three and nine months ended September 30, 2018 , respectively, compared to $2.7 million and $13.8 million for the same periods in 2017. The increase for the three months ended September 30, 2018 as compared to the three months ended September 30, 2017 was driven by non-recurring severance charges recorded in the third quarter of 2018 in connection with our July 2018 corporate restructuring. The decrease for the nine months ended September 30, 2018 as compared to the nine months ended September 30, 2017 was driven by non-recurring severance charges and non-recurring, non-cash stock-based compensation charges recorded in connection with our May 2017 corporate restructuring.
Revenue: Revenue was less than $0.1 million for each of the three and nine months ended September 30, 2018 and 2017.
Net Loss: Net loss was $10.3 million , or $1.18 per share (basic and diluted), and $40.1 million , or $4.62 per share (basic and diluted), for the three and nine months ended September 30, 2018 , respectively, compared to $15.8 million , or $2.11 per share (basic and diluted), and $57.5 million , or $10.52 per share (basic and diluted), for the same periods in 2017. Historical and current period net loss per share values have been retroactively adjusted to reflect our October 2018 reverse stock split.
Upcoming Events
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 September 30, | Nine months ended September 30, | |||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||
| Revenues: | ||||||||||||
| Revenue under strategic alliances | $ | 18 | $ | 18 | $ | 54 | $ | 54 | ||||
| Operating expenses: | ||||||||||||
| Research and development | 6,879 | 12,697 | 28,720 | 42,727 | ||||||||
| General and administrative | 2,993 | 2,736 | 10,115 | 13,752 | ||||||||
| Total operating expenses | 9,872 | 15,433 | 38,835 | 56,479 | ||||||||
| Loss from operations | (9,854) | (15,415) | (38,781) | (56,425) | ||||||||
| Other expense, net | (419) | (420) | (1,365) | (1,171) | ||||||||
| Loss before income taxes | (10,273) | (15,835) | (40,146) | (57,596) | ||||||||
| Income tax benefit | - | 7 | - | 139 | ||||||||
| Net loss | $ | (10,273) | $ | (15,828) | $ | (40,146) | $ | (57,457) | ||||
| Net loss per share, basic and diluted | $ | (1.18) | $ | (2.11) | $ | (4.62) | $ | (10.52) | ||||
| Weighted average shares used to compute basic and diluted net loss per share: | 8,703,626 | 7,506,529 | 8,688,831 | 5,463,096 |
| September 30, 2018 | December 31, 2017 | |||||
| (Unaudited) | ||||||
| Cash, cash equivalents and short-term investments | $ | 20,517 | $ | 60,074 | ||
| Total assets | 34,768 | 77,809 | ||||
| Term loan, less debt issuance costs | 19,069 | 19,859 | ||||
| Stockholders' equity | 1,578 | 35,216 |
SOURCE Regulus Therapeutics Inc.