Full Press Release Details
up to $130 Million Financing to Commercialize and Launch Investigational New Drug Renazorb
million financing upfront with up to an additional $100 million tied to satisfaction of milestones
by Vivo Capital with participation from RA Capital, BVF Partners, Logos Capital, and supported by existing investors Nantahala Capital
Partners and Rosalind Advisors Inc.
Capital's Gaurav Aggarwal, MD to join the Board
to implement mandatory dividend policy upon achievement of profitability
LOS ALTOS, Calif., March 6, 2023 -- 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.
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
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
"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:
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 Company intends to pay dividends to all stockholders, including holders of Series A Preferred Stock
on an as-if-converted-to-common-stock basis, on a quarterly basis in an amount of which the aggregate of all quarterly dividends shall
equal at least seventy-five percent (75%) of its annual net cash flow from operations following the approval of Renazorb by the FDA if
obtained, and the commencement of commercial sales.
EF Hutton, division of Benchmark Investments,
LLC acted as sole placement agent for the offering. Maxim Group LLC acted as financial advisor to the Company.
The securities to be issued in connection
with the offering described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended
(the "Act"), and Regulation D promulgated thereunder and have not been registered under the Act or applicable state securities
laws. Accordingly, such securities may not be offered or sold in the United States except pursuant to an effective registration statement
or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.
This press release shall not constitute an
offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities
in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification
under the securities laws of any such state or other jurisdiction.
For further information, please see the Company's
current report on Form 8-K to be filed with the Securities and Exchange Commission.
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company
developing novel treatments for kidney diseases. Unicycive's lead drug, Renazorb, is a novel investigational phosphate-binding agent
being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a patent-protected new
chemical entity in late preclinical development for the treatment of acute kidney injury. For more information, please visit www.unicycive.com.
statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These
statements may be identified using words such as "anticipate," "believe," "forecast," "estimated"
and "intend" or other similar terms or expressions that concern Unicycive's expectations, strategy, plans or intentions. These
forward-looking statements are based on Unicycive's current expectations and actual results could differ materially. There are several
factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include,
but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies
and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side
effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, including
the outbreak of COVID-19 coronavirus, which could seriously harm our financial condition and increase our costs and expenses; dependence
on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks
related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially
from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related
to market conditions and other factors described more fully in the section entitled Risk Factors' in Unicycive's Annual
Report on Form 10-K for the year ended December 31, 2021, and other periodic reports filed with the Securities and Exchange Commission.
Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims
any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Stern Investor Relations
SOURCE: Unicycive Therapeutics, Inc.