Based in Basking Ridge, NJ, Regado Biosciences (NASDAQ:RGDO) scheduled a $75 million IPO with a market capitalization of $219M at a price range mid-point of $15, for Wednesday, June 19, 2013.
Four other new IPOs are scheduled for the week of June 17th. The full IPO calendar is here.
- S-1A filed May 29, 2013
Manager, Joint Managers: Cowen; BMO Capital Markets
Co-Managers: Canaccord Genuity; Needham & Company; Wedbush PacGrow Life Sciences
RGDO is a biopharmaceutical company with an anticoagulant blood thinner that would, if approved, compete with blood thinners such as heparin.
The company plans to use the IPO funds to fund a Phase 3 clinical trial with 13,200 subjects, but RGDO has indicated no time estimate for completion.
RGDO has no on-going collaborations.
annualizing March qtr
RGDO has an accumulated deficit of $114 million.
Neutral-to-avoid on RGDO. The price-to-book value of 2.4 is attractive. However, compared to the other two biopharma/tech IPOs this week (which are priced in the same narrow range relative to book value), RGDO has no collaborators and no grant or collaboration revenue.
To put the above conclusions and observations in context, the following is reorganized, edited and summarized from the full S-1 referenced earlier:
RGDO is a biopharmaceutical company focused on the discovery and development of novel, first-in-class, actively controllable antithrombotic drug systems for acute and sub-acute cardiovascular indications.
We are pioneering the discovery and development of two-component drug systems consisting of a therapeutic aptamer and its specific active control agent. Our actively controllable product candidates have the potential to improve outcomes, enhance the patient experience and reduce overall treatment costs.
LEAD PRODUCT CANDIDATE
REG1 is an actively controllable anticoagulant targeting coagulation Factor IXa for use in patients with a wide variety of acute coronary syndromes, or ACS, undergoing a percutaneous coronary intervention, or PCI, a hospital-based procedure used to mechanically open or widen obstructed coronary arteries.
REG1 consists of pegnivacogin, an anticoagulant aptamer, and its specific active control agent, anivamersen.
Pegnivacogin achieves its maximal anticoagulant effect within five minutes of injection.
Anivamersen is an oligonucleotide, a biological polymer consisting of a relatively small number of nucleotides chemically bound in a linear sequence that forms a chain-like structure, or strand, and has no pharmacologic activity other than to bind to pegnivacogin.
Anivamersen rapidly and precisely reduces or eliminates the anticoagulant activity of pegnivacogin. Both pegnivacogin and anivamersen are administered by intravenous bolus injection using weight-based dosing. By adjusting the dose of anivamersen relative to pegnivacogin, the anticoagulant effect of pegnivacogin can be precisely and rapidly controlled or eliminated. The unprecedented level of control that REG1 provides permits physicians to achieve levels of anticoagulation in patients that would be unsafe to use with existing anticoagulants.
PCI procedures involve a significant risk of ischemic events, including death, stroke, myocardial infarction and the need for revascularization of the artery. Because of this risk, powerful anticoagulant drugs are administered prior to and throughout the PCI procedure. However, anticoagulants create a significant risk of major bleeding events. As a result, interventional cardiologists are forced to make a compromising medical decision because they lack the means to simultaneously reduce the risks of ischemic and major bleeding events.
COMPARE TO HEPARIN
REG1 is the first and only anticoagulant to demonstrate a reduction in both ischemic and major bleeding events in a clinical trial for PCI. In our randomized, partially blinded, dose-ranging Phase 2b trial involving 640 subjects, or the RADAR trial, when compared to standard of care heparin, REG1 demonstrated both a rapid and predictable anticoagulant effect and the ability to precisely modulate or eliminate that effect in real time. REG1 also demonstrated the following important clinical and pharmacoeconomic benefits:
An approximate 66.0% reduction in ischemic events;
A reduction of up to 60.0% in major bleeding events;
A substantial reduction in time from catheterization to catheter sheath removal from a median of 3.8 hours to a median of one hour;
A substantial reduction in time from completion of the PCI procedure to catheter sheath removal from a median of three hours to a median of 24 minutes; and
A substantial reduction in the time subjects were required to remain still following catheter sheath removal from a median of 5.7 hours to a median of 2.8 hours.
PHASE 3 TRIAL
Based on the above clinical results and after discussion with the U.S. Food and Drug Administration, or FDA, and the European Medicines Agency, RGDO intends to initiate a single, open-label, 13,200 subject Phase 3 trial of REG1, in the second half of 2013. REGULATE-PCI, if successful, will serve as the basis for product registration applications worldwide.
If REG1 is approved for the initial indication, RGDO intends to seek approval for the use of REG1 in other cardiovascular indications
As of April 29, 2013, RGDO is the owner of record of five issued or allowed U.S. patents and six issued or allowed non-U.S. patents, as well as the licensee of at least nine issued or allowed U.S. patents and at least ten issued or allowed non-U.S. patents.
RGDO is actively pursuing an additional 13 U.S. patent applications, of which four are provisional and nine are non-provisional, one international patent application and 39 non-U.S. patent applications in twelve jurisdictions as the owner of record, in addition to at least two U.S. patent applications and 14 non-U.S. patent applications under license.
If REG1 is approved, then it would compete with a number of currently-marketed anticoagulants, including bivalirudin, currently marketed and sold by The Medicines Company under the brand name Angiomax in the United States, and heparin, or UFH, and low molecular weight heparin, or LMWH, both of which are available as biosimilars and currently manufactured and sold by multiple manufacturers. Otamixaban, which is being developed by Sanofi, is being evaluated in a Phase 3 clinical trial for patients with unstable angina and non-ST elevated myocardial infarctions scheduled to undergo an early invasive strategy.
5% PRE-IPO SHAREHOLDERS
Aurora Funds, Inc., 8%
Entities affiliated with Domain Partners, 19%
Robert Kierlin, 27%
Quaker Bioventures, L.P., 13%
Edmond de Rothschild Investment Partners, 12%
RMI Investments, S.á.r.l., 14%
USE OF PROCEEDS
RGDO expects to net $68 million from its IPO.
$67 million is allocated to fund the single, open-label, 13,200 subject Phase 3 trial of REG1 and to support RGDO's operations.
The balance is allocated to fund working capital.
Disclaimer: This RGDO IPO report is based on a reading and analysis of RGDO's S-1A filing, which can be found here, and a separate, independent analysis by IPOdesktop.com. There are no unattributed direct quotes in this article.