Regado Biosciences Inc.'s initial public offering (IPO) may not have made quite the splash that others have made in recent months, but the sale of about 10.7 million shares at $4 each provided $43 million that will help the firm's REG1, on the runway for Phase III trials, move ahead in percutaneous coronary intervention for acute coronary syndrome.
Basking Ridge, N.J.-based Regado's shares (NASDAQ:RGDO) closed Thursday at $4.70, up 17.5 percent.
After setting the per-share target range at $14 to $16, Regado lowered its sights, next aiming to sell 8.4 million shares at $5 each, but ultimately dropped the price by a dollar and hiked the number of shares. (See BioWorld Today, and Dec. 20, 2012, and May 1, 2013.)
Of about 30 IPOs this year, Regado's stands as one of the less spectacular, along with Sophiris Bio Inc., of La Jolla, Calif., which recently knocked its IPO price down from $13 per share to $5 per share, while increasing the number of shares offered in order to end up with $65 million in gross proceeds. (See BioWorld Today, Aug. 19, 2013.)
The technology enabling REG1 originated with Archemix Corp., of Cambridge, Mass., from which in 2003 Regado licensed, for undisclosed terms, exclusive worldwide rights to the method of finding and making antidote-controlled aptamers. Archemix's approach supplemented work done at Duke University, from which Regado is a spinout.
Called SELEX a rough acronym for "systematic evolution of ligands by exponential enrichment" Archemix's process involves a library of oligonucleotide sequences, incubated with a specific target protein and nucleic acid aptamers, their optimal structural and binding properties isolated.
Duke researchers determined that, once an aptamer's nucleotide sequence is figured out, it can be used to design an active control agent in the form of an oligonucelotide complementary to that sequence.
With REG1 , the single-stranded, nucleic acid pegnivacogin selectively binds to Factor IXa, blocking clot formation. Anivamersen, a nucleotide sequence complementary to pegnivacogin, binds to the latter, unhooking it from Factor IXa to reverse the anticoagulant effect to a degree that doctors can control by adjusting the dose.
That aspect brings up a likely advantage over such products as heparin or Angiomax (bivalirudin, The Medicines Co.). Given as intravenous drips, the compounds entail a wait while they are metabolized. With REG1, all the equipment can be taken out of the patient as soon as the procedure is done.
Regado already has a roadmap for the Phase III trial, which the company has said would probably start next month and cost about $120 million. Enrolled will be 13,200 patients at 400 to 500 global sites, dosed exactly like the Phase IIb patients in the 650-subject trial known as Radar, and for the same duration of follow-up. Radar tested REG1 against heparin.
Pegnivacogin will be given at a dose of 1 mg/kg, with an 80 percent reversal dose of anivamersen, with the timing of the remaining 20 percent to be at the discretion of the physician. The idea is to prove a bleeding benefit at least as good as Angiomax, while offering the upside in how Regado's drug is given.
The first interim look at Phase III data would happen after the first 1,000 patients are enrolled, likely around the end of the first quarter of next year. The second would take place after 25 percent enrollment, and the third after half the patients are signed up in the third quarter of 2014 and in September of that year, respectively.
Regado's IPO is expected to close next Tuesday. Cowen and Co. LLC and BMO Capital Markets Corp. are acting as joint book-running managers for the offering. Co-managing the deal are Canaccord Genuity Inc., Needham & Co. LLC and Wedbush PacGrow Life Sciences.
In other financing news:
Antibe Therapeutics Inc., of Toronto, completed its third and final closing under its initial public offering prospectus, raising gross proceeds of $269,799.75 and issuing 490,545 common shares at a price of 55 cents each. Adding the amount to previous tranches brings the total amount raised to $3 million.
Stellar Biotechnologies Inc., of Port Heuneme, Calif., disclosed its intent to close a private placement of up to about 11.4 million units to raise gross proceeds of up to $12 million in a private placement. Each unit will have a purchase price of $1.05 and will consist of one common share in the capital of the company and one-half of a transferable share purchase warrant. Each warrant will entitle the holder to purchase one additional common share in the capital of the company at a purchase price of $1.35 for a period three years from the date of issuance of the warrants. Proceeds will be used for product research, capital expenditures and as working capital. The company makes keyhole limpet hemocyanin for therapeutic and diagnostic use.