Regulus Therapeutics Announces Achievement of Interim Enrollment Milestone Under Collaboration with Sanofi
Regulus Therapeutics Inc. (Nasdaq: RGLS) announced the achievement of a $5 million milestone from its collaboration with Sanofi for the miR-21 programs, triggered by patient enrollment in the Phase 2 clinical study of RG-012 for Alport Syndrome. This funding will reduce the term loan with Oxford LLC to approximately $4.7 million and extend interest-only payments through 2021. The company previously reported positive trends in kidney disease markers from a Phase 1b study of RG-012, which has orphan designation in both the U.S. and Europe. Additionally, Regulus is eligible for another $25 million in 2023 upon reaching a development milestone.
- Achievement of a $5 million milestone from Sanofi for miR-21 programs.
- Reduction of term loan to approximately $4.7 million after milestone payment.
- Extension of interest-only payments on the loan through 2021.
- Positive trends observed in kidney disease markers from Phase 1b RG-012 study.
- RG-012 has received orphan designation in both the U.S. and Europe.
- Potential $25 million milestone payment anticipated in 2023.
- Risks associated with drug development and commercialization.
- Potential adverse impacts from COVID-19 on operations and financial results.
LA JOLLA, Calif., Nov. 2, 2020 /PRNewswire/ -- Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs, today announced that it has achieved the remaining
"We are very pleased with the commitment of our partner, Sanofi, to this important program," stated Jay Hagan, CEO of Regulus. "This is an important step in advancing a potential treatment for patients with Alport Syndrome, a rare genetic condition affecting the kidneys with no approved therapies."
Previously, the Company announced completion of the Phase 1b renal biopsy study, where patients with Alport Syndrome were dosed every other week for one year. Results from that study demonstrated kidney tissue concentrations that would be predictive of therapeutic benefit based on animal disease models as well as engagement of the target, miR-21. Over the course of the one year open-label study, promising trends in disease markers were observed and RG-012 was generally well tolerated with no serious adverse events. RG-012 has received orphan designation in both the U.S. and Europe.
Under the terms of the Collaboration and License Agreement, the Company is also eligible to receive an additional
About Regulus
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.
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 achievement of milestone payments from is collaboration partners and paydown of its debt with Oxford LLC. 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. In addition, while Regulus expects the COVID-19 pandemic to adversely affect its business operations and financial results, the extent of the impact on Regulus' ability to achieve its preclinical and clinical development objectives and the value of and market for its common stock, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the U.S. and in other countries, and the effectiveness of actions taken globally to contain and treat the disease. These and other risks 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.
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SOURCE Regulus Therapeutics Inc.
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