Full Press Release Details
LA JOLLA, Calif. , Aug. 8, 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 second quarter ended June 30, 2019 and provided a summary of recent events.
"With the completed financing and restructuring of our term loan, we believe we are in a good position to work expeditiously to address the clear requirements outlined by FDA to reinitiate the MAD clinical study for RGLS4326," said Jay Hagan , CEO of Regulus. "We will also be evaluating potential options to initiate single dose studies in order to further characterize the molecule."
Second Quarter 2019 Corporate Highlights and Recent Updates
Program Updates
Second Quarter 2019 Financial Results
Cash Position: As of June 30, 2019 , Regulus had $19.6 million in cash and cash equivalents.
Revenue: Revenue was less than $0.1 million and $6.8 million for the three and six months ended June 30, 2019 , respectively, compared to less than $0.1 million for each the three and six months ended June 30, 2018 . The increase for the six months ended June 30, 2019 was attributable to revenue recognition of the upfront payments received under the 2018 Sanofi Amendment related to the transfer of RG-012.
Research and Development (R&D) Expenses: R&D expenses were $1.8 million and $7.8 million for the three and six months ended June 30, 2019 , compared to $10.0 million and $21.8 million for the same periods in 2018. The decreases were driven by decreases in external development expenses, primarily attributable to the voluntary pause of the RGLS4326 Phase 1 MAD clinical study in the third quarter of 2018 and commencement of the transfer of the RG-012 program to Sanofi in the fourth quarter of 2018. Additionally, the decreases were driven by reductions in personnel and internal expenses, primarily attributable to a reduction in costs subsequent to our corporate restructuring in the third quarter of 2018.
General and Administrative (G&A) Expenses: G&A expenses were $2.9 million and $6.4 million for the three and six months ended June 30, 2019 , compared to $3.3 million and $7.1 million for the same periods in 2018. These amounts reflect personnel-related and ongoing general business operating costs.
Net Loss: Net loss was $5.0 million , or $0.30 per share (basic and diluted), and $8.3 million , or $0.61 per share (basic and diluted), for the three and six months ended June 30, 2019 , respectively, compared to $13.8 million , or $1.59 per share (basic and diluted), and $29.9 million , or $3.44 per share (basic and diluted), for the same periods 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.
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, 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, | |||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||
| Revenues: | ||||||||||||
| Revenue under strategic alliances | $ | 18 | $ | 18 | $ | 6,796 | $ | 36 | ||||
| Operating expenses: | ||||||||||||
| Research and development | 1,836 | 10,013 | 7,819 | 21,841 | ||||||||
| General and administrative | 2,850 | 3,349 | 6,383 | 7,122 | ||||||||
| Total operating expenses | 4,686 | 13,362 | 14,202 | 28,963 | ||||||||
| Loss from operations | (4,668) | (13,344) | (7,406) | (28,927) | ||||||||
| Other expense, net | (347) | (503) | (869) | (945) | ||||||||
| Loss before income taxes | (5,015) | (13,847) | (8,275) | (29,872) | ||||||||
| Income tax expense | (1) | - | (1) | (1) | ||||||||
| Net loss | $ | (5,016) | $ | (13,847) | $ | (8,276) | $ | (29,873) | ||||
| Net loss per share, basic and diluted | $ | (0.30) | $ | (1.59) | $ | (0.61) | $ | (3.44) | ||||
| Weighted average shares used to compute basic and diluted net loss per share: | 16,705,587 | 8,693,788 | 13,560,183 | 8,681,311 | ||||||||
| June 30, 2019 | December 31, 2018 | |||||||||||
| (Unaudited) | ||||||||||||
| Cash and cash equivalents | $ | 19,571 | $ | 13,935 | ||||||||
| Total assets | 25,691 | 27,927 | ||||||||||
| Term loan, less debt issuance costs | 14,621 | 16,575 | ||||||||||
| Stockholders' equity (deficit) | 4,743 | (5,854) |
SOURCE Regulus Therapeutics Inc.