Following a joint venture spin-off from Alnylam ALNY and Isis Pharma ISIS, Regulus Therapeutics was born to focus on drug discovery using microRNA technology. Their 9/7/2012 revised S-1 filing revealed a planned price range $10-12 (but the offering was actually priced at $4 and Regulus now trades as ticker RGLS). Continue reading below for some highlights from the prospectus about the company and its research programs.
Filing says seeking ~$57.5m IPO. AZN agreed to additional $25m investment in separate private placement equivalent to and at same time as IPO. SNY interested in buying $10m, ISIS and GSK $2m each.
RGLS was formed in 2007, and five miRNA programs
$1.7b potential partnership milestones: $106.5m preclinical/IND, $350m clinical, $420m regulatory, $850m commercial.
Plan to nominate two clinical candidates in next 12 months, first INDs in 2014. Plan to focus on niche/orphan indication.
SNY: mir21 for HCC and kidney fibrosis
GSK: mir122 for HCV (this is from 2010 deal, no announced targets from 2008 deal)
AZN: mir33 for atherosclerosis
internal: mir10b for glioblastoma
emerging growth company as defined by JOBS act- not required to comply with auditor attestation, no non-binding vote on executive compensation, reduced executive compensation disclosure. This status could last up to 5 yrs
Share amounts and post-IPO figures exclude these items: 7.24m options at 6/30/2012, weighted avg $0.53 per share. $5m convertible note outstanding from Feb 2010 (can convert for 3 yrs after IPO at IPO terms)
Share amounts and post-IPO figures include the following: conversion of all preferred stock into 27.4m common shares. Conversion of $5m note 4/2008 and $5m note 8/2012 into common shares.
Balance sheet: $27m cash at 6/30/12 (with $10.6m convertible debt) compared to $54.8m cash 12/31/2010 and $38.1m cash 12/31/2011. "If we are unable to successfully complete this offering, we will need to seek alternative financing or change our operational plans to continue as a going concern." Cash from this offering plus AZN placement good through end of 2015. Operating expenses of $21m in 2011 and $24m in 2010.
SNY can terminate whole deal or any target w/ 30 days notice for any reason. GSK same terms but 90 days, AZN 60 days.
Intellectual Property: "In particular, we are aware that Santaris Pharma A/S, or Santaris, has filed oppositions to patents owned by Stanford University and licensed to us and to a patent owned by us, in each case relating to miR-122, and to a patent owned by Isis relating to chemical modification of oligonucleotides. "
Competitors: groove biopharma, miragen, mirna, santaris
56 employees at 6/30/12 (44 r&d)
365 day lockup for executives/directors and 5 corporate owners from date of prospectus. all others 180 days.
GSK 4/2008: option deal for 4 programs (2 pre-selected) at POC (regulus responsible until then). $15m upfront plus $5m note. 2/2012 expand to HCV, $3m upfront plus another $5m note. $144.5m milsetones each program plus tiered royaltyies "up to the low end of the 10-20% range". $0.5m milestones earned 5/2009 and 6/2011. Option fee and later milestones depend on when in develop GSK options. Up to $15.5m preclinical, $87m clinical, $150m regulatory, $180m commercial miletsones. Preclinical milestones remaining: $0.5m select 4th target, $5m for 3x development candidates each. Then for each of 3: $4m for phase 1 initiation, $5m for phase 2, $20m option fee after POC. HCV: $5m preclinical, $29m clinical (same as above), $50m regulatory, $60m commercial
Sanofi SNY deal 6/2010 then revised 7/2012. $25m upfront plus $10m equity (series B). $5m funding for 1 year of research. $5m more each 6/2011 and 6/2012. Could receive additional annual payments. Up to $640m milestones: $75m preclinical, $95m each for 3 more candidates, $15m for each IND filing), $105m clinical, $220m regulatory, $240m commercial. Royalties mid single digits to low end of 10-20% range. Regulus responsible for development until start of phase 1. 4 targets, initially including pre-specified program around mir21 for fibrosis. Broader license opton thru 7/2013 - up to $50m payment in installments - low single digit royalty, milestone payment and opportunity to participate further.
8/2012 deal with AstraZeneca AZN for 3 targets. Regulus controls development until IND acceptance or 4 year anniversary. At that same point, AZN assumes costs for all programs. $3m upfront. up to $509m milestones: $10m preclinical ($5m for mir33 lead, $2.5 each for next 2 targets), $129m clinical, $370m commercial. Royalties mid single to low end of 10-20% range. $25m equity if IPO raises at least $50m (or if all preferred shares convert). Will negotiate alternative transaction if abandon IPO before 3/31/2013 - if cannot do so, whole deal terminates.
8/2012 deal with Biogen BIIB - biomarkets for MS. $0.75m upfront, milestones up to $1.3m. Convertible note of $5m - due 2/15/2013 or change in control. convert at next financing of at least $10m (private, then at BIIB discretion) or $50m (public, then automatic). BIIB can limit itself to 5% stake.
$56m r&d spend so far year-to-date as of 6/30.2012
determined/estimated that fair value of common stock inc from $0.87 at June 2010 to $1.33 at 12/31/11 to $2.66 in 5/2012 (this was a big hint the original proposed IPO pricing range was too high)
2009 Tuschl 3 patents license (Max-Planck) - up to $1.6m mielstones per product plus low single diigt royalty. Additional deal for diagnostic use with higher royalties due
2010 U. Wurzburg mir21 license: low single didigt royalty. E0.2m Euro upon SNY deal.
2005 Stanford mir122 HCV license: low single digit royaltyies and small milestones
2011 NYU mir33 license: milestones up to $0.925m, low single digit royalty
Detailed description of market opportunity, current treatments, and Regulus program for each program (not reviewed here)
use miRNA biomarkers to sleect patients for trials/companion diagnostic devleopment
drug product: powdered, then formulated in saline solution for injection
BOD has CEO, Greene (ALNY), Maraganore (ALNY), Crooke (ISIS), Parhsall (ISIS) plus David Baltimore, Bruce carter (Zymogenetics CEO), Stelios Papadopoulos (EXEL chairman)- have one year to go from 3/8 to majority indepdent
Executive goals in 2011 included selection of clinical candidate (failed), reorganize R&D around drug discovery/development (success)
6/2010 amended ISIS/ALNY agreement - lower royalties but get 7.5% of milestones from SNY
6/2012 GSK extended deadline for target selection for #4
if GSK notes not converted by 2/2013, must pay in cash or ISIS/ALNY stock (who guarantee the notes until a RGLS IPO)
exhibits of interest: 5.1, 10.13, 10.17
RGLS was formed in 2007, and five miRNA programs
$1.7b potential partnership milestones: $106.5m preclinical/IND, $350m clinical, $420m regulatory, $850m commercial.
Plan to nominate two clinical candidates in next 12 months, first INDs in 2014. Plan to focus on niche/orphan indication.
SNY: mir21 for HCC and kidney fibrosis
GSK: mir122 for HCV (this is from 2010 deal, no announced targets from 2008 deal)
AZN: mir33 for atherosclerosis
internal: mir10b for glioblastoma
emerging growth company as defined by JOBS act- not required to comply with auditor attestation, no non-binding vote on executive compensation, reduced executive compensation disclosure. This status could last up to 5 yrs
Share amounts and post-IPO figures exclude these items: 7.24m options at 6/30/2012, weighted avg $0.53 per share. $5m convertible note outstanding from Feb 2010 (can convert for 3 yrs after IPO at IPO terms)
Share amounts and post-IPO figures include the following: conversion of all preferred stock into 27.4m common shares. Conversion of $5m note 4/2008 and $5m note 8/2012 into common shares.
Balance sheet: $27m cash at 6/30/12 (with $10.6m convertible debt) compared to $54.8m cash 12/31/2010 and $38.1m cash 12/31/2011. "If we are unable to successfully complete this offering, we will need to seek alternative financing or change our operational plans to continue as a going concern." Cash from this offering plus AZN placement good through end of 2015. Operating expenses of $21m in 2011 and $24m in 2010.
SNY can terminate whole deal or any target w/ 30 days notice for any reason. GSK same terms but 90 days, AZN 60 days.
Intellectual Property: "In particular, we are aware that Santaris Pharma A/S, or Santaris, has filed oppositions to patents owned by Stanford University and licensed to us and to a patent owned by us, in each case relating to miR-122, and to a patent owned by Isis relating to chemical modification of oligonucleotides. "
Competitors: groove biopharma, miragen, mirna, santaris
56 employees at 6/30/12 (44 r&d)
365 day lockup for executives/directors and 5 corporate owners from date of prospectus. all others 180 days.
GSK 4/2008: option deal for 4 programs (2 pre-selected) at POC (regulus responsible until then). $15m upfront plus $5m note. 2/2012 expand to HCV, $3m upfront plus another $5m note. $144.5m milsetones each program plus tiered royaltyies "up to the low end of the 10-20% range". $0.5m milestones earned 5/2009 and 6/2011. Option fee and later milestones depend on when in develop GSK options. Up to $15.5m preclinical, $87m clinical, $150m regulatory, $180m commercial miletsones. Preclinical milestones remaining: $0.5m select 4th target, $5m for 3x development candidates each. Then for each of 3: $4m for phase 1 initiation, $5m for phase 2, $20m option fee after POC. HCV: $5m preclinical, $29m clinical (same as above), $50m regulatory, $60m commercial
Sanofi SNY deal 6/2010 then revised 7/2012. $25m upfront plus $10m equity (series B). $5m funding for 1 year of research. $5m more each 6/2011 and 6/2012. Could receive additional annual payments. Up to $640m milestones: $75m preclinical, $95m each for 3 more candidates, $15m for each IND filing), $105m clinical, $220m regulatory, $240m commercial. Royalties mid single digits to low end of 10-20% range. Regulus responsible for development until start of phase 1. 4 targets, initially including pre-specified program around mir21 for fibrosis. Broader license opton thru 7/2013 - up to $50m payment in installments - low single digit royalty, milestone payment and opportunity to participate further.
8/2012 deal with AstraZeneca AZN for 3 targets. Regulus controls development until IND acceptance or 4 year anniversary. At that same point, AZN assumes costs for all programs. $3m upfront. up to $509m milestones: $10m preclinical ($5m for mir33 lead, $2.5 each for next 2 targets), $129m clinical, $370m commercial. Royalties mid single to low end of 10-20% range. $25m equity if IPO raises at least $50m (or if all preferred shares convert). Will negotiate alternative transaction if abandon IPO before 3/31/2013 - if cannot do so, whole deal terminates.
8/2012 deal with Biogen BIIB - biomarkets for MS. $0.75m upfront, milestones up to $1.3m. Convertible note of $5m - due 2/15/2013 or change in control. convert at next financing of at least $10m (private, then at BIIB discretion) or $50m (public, then automatic). BIIB can limit itself to 5% stake.
$56m r&d spend so far year-to-date as of 6/30.2012
determined/estimated that fair value of common stock inc from $0.87 at June 2010 to $1.33 at 12/31/11 to $2.66 in 5/2012 (this was a big hint the original proposed IPO pricing range was too high)
2009 Tuschl 3 patents license (Max-Planck) - up to $1.6m mielstones per product plus low single diigt royalty. Additional deal for diagnostic use with higher royalties due
2010 U. Wurzburg mir21 license: low single didigt royalty. E0.2m Euro upon SNY deal.
2005 Stanford mir122 HCV license: low single digit royaltyies and small milestones
2011 NYU mir33 license: milestones up to $0.925m, low single digit royalty
Detailed description of market opportunity, current treatments, and Regulus program for each program (not reviewed here)
use miRNA biomarkers to sleect patients for trials/companion diagnostic devleopment
drug product: powdered, then formulated in saline solution for injection
BOD has CEO, Greene (ALNY), Maraganore (ALNY), Crooke (ISIS), Parhsall (ISIS) plus David Baltimore, Bruce carter (Zymogenetics CEO), Stelios Papadopoulos (EXEL chairman)- have one year to go from 3/8 to majority indepdent
Executive goals in 2011 included selection of clinical candidate (failed), reorganize R&D around drug discovery/development (success)
6/2010 amended ISIS/ALNY agreement - lower royalties but get 7.5% of milestones from SNY
6/2012 GSK extended deadline for target selection for #4
if GSK notes not converted by 2/2013, must pay in cash or ISIS/ALNY stock (who guarantee the notes until a RGLS IPO)
exhibits of interest: 5.1, 10.13, 10.17
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