Unicycive Announces up to $130 Million Financing to Commercialize and Launch Investigational New Drug Renazorb
March 06 2023 - 07:00AM
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Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that the Company has signed a securities purchase agreement with certain healthcare-focused institutional investors that will provide up to $130 million in gross proceeds to Unicycive through a private placement that includes initial upfront funding of $30 million.
The funding is being led by Vivo Capital with participation from RA Capital, BVF Partners, Logos Capital, and is supported by existing investors Nantahala Capital Partners and Rosalind Advisors Inc. In conjunction with the financing, Gaurav Aggarwal, M.D., Managing Director of Vivo Capital, will join the Unicycive Board of Directors.
“We are delighted to have the financial backing of both existing and new investors from these high profile, healthcare-focused funds as it provides strong validation of the best-in-class potential for Renazorb® and provides funding for its potential commercial launch, if approved. We remain on track to file a New Drug Application (NDA) for Renazorb marketing approval with the U.S. Food and Drug Administration (FDA) in mid-year,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive.
Commenting on their commitment to Unicycive, Dr. Aggarwal said, “We believe that dialysis patients are not well served with the phosphate lowering agents currently on the market, either due to high pill burden, suboptimal tolerability profiles or both. We are pleased to support Unicycive as it nears NDA submission and prepares to launch Renazorb, a phosphate binder that potently controls phosphate with only three small tablets per day. In addition, we have structured an investment that enables capital availability for the Company at increasing share prices upon achievement of milestones with a unique feature that mandates dividends to all shareholders as the company generates profitability.”
In December 2022, Unicycive announced that the primary endpoint was met in the Company’s pivotal bioequivalence (BE) study comparing Renazorb to Fosrenol®. Based on the topline results, pharmacodynamic (PD) BE of Renazorb to Fosrenol was established and met FDA’s regulatory criteria for PD BE in the healthy volunteer study. Unicycive previously received confirmatory guidance from the FDA that this single BE study in healthy volunteers would satisfy all clinical regulatory requirements and that no other clinical studies would be required for an NDA filing through the 505(b)(2) pathway.
“If approved, Renazorb may dramatically reduce the pill burden that patients endure with currently available medications. The global market opportunity for treating hyperphosphatemia is projected to be in excess of $2.5 billion in 2023, with the United States accounting for more than $1 billion of that total. Despite the availability of several FDA-cleared medications, 75 percent of U.S. dialysis patients fail to achieve the target phosphorus levels recommended by published medical guidelines. The timing of Renazorb’s expected launch coincides favorably with the pending expansion of Medicare patient access to phosphate binders in 2025 when these products are added to the ESRD PPS through the Center for Medicare and Medicaid’s Transitional Drug Add-On Payment Adjustment (“TDAPA”) program,” added Dr. Gupta.
About the Private Placement
Pursuant to the securities purchase agreement, the Company will issue to purchasers (i) $30 million in shares of the Company’s Series A Convertible Preferred Stock and (ii) three tranches of warrants that are exercisable for convertible preferred stock as follows:
The Tranche A warrants for an aggregate exercise price of approximately $25 million are exercisable until 21 days following the Company’s announcement of receipt of FDA approval for Renazorb;
The Tranche B warrants for an aggregate exercise price of approximately $25 million are exercisable until 21 days following the Company’s announcement of receipt of TDAPA approval for Renazorb; and
The Tranche C warrants for an aggregate exercise price of approximately $50 million are exercisable until 21 days following public disclosure of four quarters of commercial sales of Renazorb following receipt of TDAPA approval.
Shares of Series A Convertible Preferred Stock will be issued at a price of $1,000.00 per share. All of the shares of preferred stock, the warrants and the securities underlying such shares of preferred stock and warrants, are being offered by Unicycive.
Proceeds from the offering will be used to support the Company’s NDA submission with the FDA for approval of Renazorb for the treatment of hyperphosphatemia in the U.S. and, if approved, for the commercial launch of Renazorb in the U.S.
In addition, the Company shall modify its dividend policy to state that the
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