Full Press Release Details
LA JOLLA, Calif. , May 9, 2019 /PRNewswire/ -- Regulus Therapeutics Inc . (Nasdaq: RGLS ), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today reported financial results for the first quarter ended March 31, 2019 and provided a summary of recent events.
"I am proud of the significant progress we have made thus far in 2019 to reposition Regulus with a strengthened balance sheet, restructured term loan and reduced operating cash burn rate. Importantly, the team has maintained its focus in its engagement with FDA, and we look forward to resuming our ADPKD clinical program pending FDA alignment. We believe the total potential proceeds from the recent financing, highlighted by a strong investor syndicate, provides sufficient capital to fund planned activities into the second half of 2021," said Jay Hagan , CEO of Regulus. "We look forward to providing future updates on our ADPKD program, as well as further advancements from our promising preclinical pipeline."
First Quarter 2019 Corporate Highlights and Recent Updates
Program Updates
First Quarter 2019 Financial Results
Revenue: Revenue was $6.8 million for the three months ended March 31, 2019 , compared to less than $0.1 million for the three months ended March 31, 2018 . The increase was associated with revenue recognition of the upfront payments received under the 2018 Sanofi Amendment related to the transfer of RG-012 during the three months ended March 31, 2019 .
Cash Position: As of March 31, 2019 , Regulus had $10.3 million in cash and cash equivalents.
Research and Development (R&D) Expenses: R&D expenses were $6.0 million for the three months ended March 31, 2019 , compared to $11.8 million for the same period in 2018. The aggregate decrease was driven by a $3.8 million decrease in external development expenses during the three months ended March 31, 2019 , primarily attributable to the pausing of the RGLS4326 program in the third quarter of 2018 and commencement of the transfer of the RG-012 program to Sanofi under the 2018 Sanofi Amendment in the fourth quarter of 2018. In addition, personnel and internal expenses decreased by approximately $1.9 million , primarily as a result of a reduction in headcount and related costs subsequent to our corporate restructuring in the third quarter of 2018.
General and Administrative (G&A) Expenses: G&A expenses were $3.5 million for the three months ended March 31, 2019 compared to $3.8 million for the same period in 2018. These amounts reflect personnel-related and ongoing general business operating costs.
Net Loss: Net loss was $3.3 million , or $0.31 per share (basic and diluted), for the three months ended March 31, 2019 , compared to $16.0 million , or $1.85 per share (basic and diluted), for the same period in 2018. Historical and current period net loss per share values have been retroactively adjusted to reflect our October 2018 reverse stock split.
About Autosomal Dominant Polycystic Kidney Disease ( ADPKD)
ADPKD, caused by the mutations in the PKD1 or PKD2 genes, is among the most common human monogenic disorders and a leading cause of end-stage renal disease. The disease is characterized by the development of multiple fluid filled cysts primarily in the kidneys, and to a lesser extent in the liver and other organs. Excessive kidney cyst cell proliferation, a central pathological feature, ultimately leads to end-stage renal disease in approximately 50% of ADPKD patients by age 60. It is estimated that approximately 1 in 1,000 people bear a mutation in either PKD1 or PKD2 genes worldwide.
RGLS4326 is a novel oligonucleotide designed to inhibit miR-17 and designed to preferentially target the kidney. Preclinical studies with RGLS4326 have demonstrated direct regulation of PKD1 and PKD2 in human ADPKD cyst cells, a reduction in kidney cyst formation, improved kidney weight/body weight ratio, decreased cyst cell proliferation, and preserved kidney function in mouse models of ADPKD.
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 , California. 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, RGLS5579 or its other preclinical programs), Regulus' sales of securities, including timing, size and completion of the Milestone Closing, its 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 March 31, | ||||||
| 2019 | 2018 | |||||
| Revenues: | ||||||
| Revenue under strategic alliances | $ | 6,778 | $ | 18 | ||
| Operating expenses: | ||||||
| Research and development | 5,983 | 11,828 | ||||
| General and administrative | 3,533 | 3,773 | ||||
| Total operating expenses | 9,516 | 15,601 | ||||
| Loss from operations | (2,738) | (15,583) | ||||
| Other expense, net | (522) | (441) | ||||
| Loss before income taxes | (3,260) | (16,024) | ||||
| Income tax benefit | - | (1) | ||||
| Net loss | $ | (3,260) | $ | (16,025) | ||
| Net loss per share, basic and diluted | $ | (0.31) | $ | (1.85) | ||
| Weighted average shares used to compute basic and diluted net loss per share: | 10,379,830 | 8,668,695 | ||||
| March 31, 2019 | December 31, 2018 | |||||
| (Unaudited) | ||||||
| Cash and cash equivalents | $ | 10,320 | $ | 13,935 | ||
| Total assets | 19,877 | 27,927 | ||||
| Term loan, less debt issuance costs | 15,225 | 16,575 | ||||
| Stockholders' deficit | (6,069) | (5,854) |
SOURCE Regulus Therapeutics Inc.