Regulus RGLS Stock Research Page
- Click here to visit Regulus website
- Private company established as JV between ISIS and ALNY 9/2007 (each contributed IP and ALNY contributed $10m ato balance ownership). ISIS and ALNY have right to develop products that are not licensed to other partners on pre-negotiated terms
- IP: "Regulus exclusively controls many of the early fundamental patent portfolios in the microRNA field, including the "Tuschl III", "Sarnow" and "Esau" patent series. Our "Crooke" patent estate provides Regulus exclusive rights to RNA-based product compositions and methods of treatment in the field of microRNA-based therapeutics. The Regulus patent estate also includes claims to specific microRNA compositions that are optimized for therapeutic use, as well as therapeutic uses of these microRNA compositions, and exclusive rights to Isis' and Alnylam's chemical modification intellectual property estates for microRNA applications." >600 issued patents and hundreds of pending applications
- 3/2009 $20m Series A 50/50 investment by the two companies. 10/2010 SNY invests $10m, valuing Regulus at >$130m
- 12/31/10 ISIS own 46% valued at ~$60m (not on balance sheet)
- ISIS receives 7.5% of upfront and milestones from their deals, plus undisclosed royalties.
- 12/31/09: $30.7m cash on hand
Regulus - Internal Programs
- 9/2011: presented on miR-21 and miR-33 at OTS meeting (Click for abstract)
- 6/2011: Nature paper re miR-103,107 role in obesity and type 2 diabetes - click for PR
- 6/2011: J. Clinical Investigation (JCI) paper of preclinical studies showing that inhibiting miR-33 [master regulator of cholesterol transport genes including ABCA1] clears cholesterol from bloodstream and reduces plaques - click for PR
- 4/2010: preclinical data miR inhibition of Let-7 in diabetes.
- 3/2010: preclinical pub mi-10b in breast cancer metastasis.
- 1/2010: several preclinical presentations.
- 2010 10k: Program for fibrotic diseases targeting miR-21. Anti-miR-21 can reverse fibrosis and improve cardiac function in mice with failing hearts
- 2010 10k: other programs in cardiovascular, cancer, immune-inflammatory, metabolic diseases
Regulus - GSK collaboration #1
- 4/2008: 4 targets for inflammatory diseases such as RA and IBD.
- $20m upfront ($15m option fee and $5m promissory note that coverts to stock upon fundraising) and $144.5m potential milestones for each pgm, tiered royalties up to double digits.
- 5/2009 $0.5m discovery milestone for pharmacologic effect in immune cells.
- 7/2011: identified third (undisclosed) target for inflammation and/or HCV diseases, triggering preclinical milestone payment from GSK - click here for PR.
Regulus - GSK collaboration #2
- 2/2010: miR-122 antagonists (this is one of the 4 targets referenced above) for HCV and other indications.
- $3m upfront fee, additional undisclosed early milestones, up to $150m total, up to double digit royalties. Additional $5m note that coverts to stock upon fundraising.
- Preclinical: "Regulus and scientists demonstrated that an oligonucleotide-based molecule targeting miR-122, anti-miR-122, reduced cholesterol levels in blood and reversed hepatic steatosis, or fatty liver, in obese mice. Researchers also reported that miR-122 is essential for replication of HCV, suggesting that an anti-miR-122 drug may reduce HCV infection and improve HCV-associated pathologies like fatty liver. Regulus is advancing anti-miR-122 toward clinical studies for HCV." (2010 10k)
- Plan clinical devel candidate 2h2010 and IND 2011.
- "As part of the HCV collaboration, Regulus granted GSK a limited license to develop and commercialize the miR-122 antagonist SPC 3649, if GSK acquires rights to this compound. Regulus will receive development and regulatory milestones as well as royalties if GSK develops and commercializes SPC 3649." (2010 10k)....See Santaris section below
Regulus - SNY collaboration
- 6/2010: up to 4 targets for fibrosis. Initial lead pgm is MiR-21 for fibrosis.
- $25m upfront, $10m future equity investment, up to $720m miletones (nothing before IND approval), research funding for 3 yrs w/ 2 option yrs (or can terminate then).
- Also has $50m, 3 yr technology alliance license option.
- SNY pays 100% of development (ALNY described as clinical) costs, ?? royalty rates-did not say double digit this time.
- 9/2010 carried out equity investment, giving SNY a 9% stake, values Regulus at $130m, 100% premium to 2009 series A, valuing the stakes of ISIS and ALNY at ~$60m each
Regulus (updates via Alnylam ALNY)
- Privately-held joint venture founded by Isis Pharma and Alnylam.
- Ownership is ALNY 45%, ISIS 46%, SNY 9%. See additional details regarding Regulus and its partnership deals on the Isis research page.
- Company is advancing microRNA therapeutics in several areas including fibrosis, hepatitis C virus, or HCV, infection, immuno-inflammatory diseases, metabolic and cardiovascular diseases, and oncology.
- See page 485-486 of 2010 ALNY 10k for Regulus financial statements. Notes (see below) pay interest at WSJ Prime rate. $0.6m accrued and unpaid interest at 12/31/10. 5.6m options @ $0.19 outstanding 12/31/10, 2.6m of these are exercisable. 34.5m shares common authorized, none issued.
- "The holders of the preferred stock have the right to convert their preferred stock, at any time, into shares of our common stock. The initial conversion rate is one-to-one into common stock. Any accrued but unpaid dividends convert into shares of common stock at the then applicable conversion price. The preferred stock, including any accrued but unpaid dividends, will automatically convert into common stock, at the then applicable conversion price, upon the earlier of (1) holders of at least 67% of the outstanding preferred stock consent to such a conversion or (2) upon the closing of an underwritten public offering of common stock if the per share public offering price is at least the greater of (a) two times the original purchase price of the Series A Preferred and (b) the original purchase price of the Series B Preferred (as adjusted for stock splits, dividends, recapitalizations and the like) and a total offering of at least $50 million (before deduction of underwriters commissions and expenses)."
- 1/2009: Series A Preferred Stock issued to Isis and ALNY upon reorganization to C corporation.
- 3/2009: 10 million more shares Series A, 5m each to ISIS and ALNY for $20m ($2.00 per share)
- 10/2010: 2.5m shares Series B Preferred issued to SNY for $10m ($4.00 per share, 2x valuation increase in ~18 months, valued Regulus at ~$130m - but note that the carrying value of ALNY's stake at 3/31/11 is just $2.7m)
- 2008 GSK deal: $15m upfront option fee plus $5m convertible promissory note (converts if achieve a minimum level of financing with institutional investors. 2/2011 amended due date to become 2/2013, matching that of the second note)
- 2010 GSK deal: $3m upfront fee plus second $5m note. This deal covers miR-122 in all indications, starting with HCV
- “Regulus' lead program for HCV infection is focused on microRNA-122, or miR-122. Regulus scientists and collaborators performed important studies demonstrating that anti-miR-122 can reduce cholesterol levels in blood and reverse hepatic steatosis, or fatty liver, in obese mice. More recent pre-clinical studies have shown that miR-122 is essential for replication of HCV. Together, these findings suggest that anti-miR-122 may both reduce HCV infection and improve HCV-associated pathologies like steatosis. Regulus is advancing anti-miR-122 to clinical studies for HCV.”
- 7/2011: announce that GSK and Regulus have selected a third (undisclosed) target for inflammation and/or HCV, triggering a preclinical milestone payment - click here for PR.
- 2010 SNY deal: SNY pays 100% of clinical development. Up to 4 targets for fibrosis, starting with miR-21
- “Regulus' lead program in fibrosis targets microRNA-21, or miR-21. Pre-clinical studies by Regulus scientists and collaborators have shown that anti-miR-21 can reverse fibrosis and significantly improve cardiac function in mice with failing hearts, and more recent studies have demonstrated similar therapeutic results in other models of fibrosis. Regulus is advancing antimiR- 21 to clinical studies for the treatment of fibrotic diseases.”
- “Regulus is also advancing additional programs towards clinical development, including programs targeting microRNA-155, or miR-155, for inflammatory diseases, microRNA-33, or miR-33, for cardiovascular disease, and microRNA-21, or miR-21, and microRNA-34, or miR-34, for the treatment of cancers.
- 6/2011: J. Clinical Investigation paper showed that blocking miR-33 [master regulator of cholesterol transport genes including ABCA1] in mice led to clearance of cholesterol from bloodstream and reduced atherosclerotic plaques. Click here for PR.
- 9/2011: data presentations on miR-33 and miR-21 programs - click for PR - click for abstracts.
- 10/2011: data publication and webcast pn miR-33 program for hypercholesterolemia - click for PR. Click for webinar.
- 10/2011: Note comparable deal signed for microRNA CV programs between Miragen and Servier with $45m upfront.