H.C. Wainwright & Co. Shares Buy Rating on Biotech Co.
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Disclosures for H.C. Wainwright & Co., Unicycive Therapeutics Inc., October 9, 2024

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H.C. WAINWRIGHT & CO, LLC RATING SYSTEM: H.C. Wainwright employs a three tier rating system for evaluating both the potential return and risk associated with owning common equity shares of rated firms. The expected return of any given equity is measured on a RELATIVE basis of other companies in the same sector. The price objective is calculated to estimate the potential movements in price that a given equity could reach provided certain targets are met over a defined time horizon. Price objectives are subject to external factors including industry events and market volatility.

H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer. I, Ed Arce and Thomas Yip , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies. None of the research analysts or the research analyst’s household has a financial interest in the securities of Unicycive Therapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of September 30, 2024 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Unicycive Therapeutics, Inc..

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H.C. Wainwright & Co. analysts Ed Arce and Thomas Yip, in a research report published on October 9, 2024, maintained a Buy rating on Unicycive Therapeutics Inc. (UNCY:NASDAQ) with a price target of US$2.50. The report follows Unicycive's announcement of the successful completion of the Phase 1 study for UNI-494 in healthy volunteers.

Arce and Yip highlighted the significance of the study results, stating, "UNI-494 showed rapid metabolism, enabling the expected release of nicorandil and its linker." They added, "Importantly, PK results collected in the study showed fast absorption of UNI-494, with rapid metabolism leading to the expected release of nicorandil and its linker."

The analysts noted the safety profile of UNI-494, commenting, "UNI-494 was generally safe and well-tolerated; headache was the most common adverse event (AE), and all AEs were mild with no serious adverse events (SAEs) or AEs leading to withdrawal in Part 1."

Regarding Unicycive's strategic plans, the analysts stated, "Management plans to request a meeting with the FDA by year-end 2024 to review these Phase 1 results and discuss the design of a potential Phase 2 study in patients with acute kidney injury (AKI)."

The report also highlighted the pending milestone for Unicycive's other product candidate, Oxylanthanum Carbonate (OLC), noting, "We await the FDA's formal acceptance of the NDA for Oxylanthanum Carbonate (OLC) for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis (we expect by November 2) with a PDUFA date assignment to further narrow OLC's potential approval timing."

H.C. Wainwright & Co.'s valuation methodology for Unicycive is based on a risk-adjusted Net Present Value (rNPV) model. The analysts explained, "We employ a rNPV valuation model to estimate the value of UNCY shares and arrive at our US$2.50 PT based on: (1) about US$2.30 per share for royalties on net sales of OLC in the U.S. and EU (85% PoS, US$149.1M global peak revenue in 2034); and (2) about US$0.25 per share for royalties on net sales of UNI-494 in the U.S. and EU for AKI (20% PoS; US$195M global peak revenue in 2036)."

They added, "In our valuation model, we employ a 14.5% discount rate, which we believe adequately reflects the overall risks of the Unicycive development pipeline. We conservatively assume zero terminal value after the end of the market exclusivity period that runs through 2037."

The analysts also outlined several risk factors, including regulatory, commercialization, market, intellectual property, and funding risks.

In conclusion, H.C. Wainwright & Co.'s maintenance of a Buy rating and US$2.50 price target reflects a positive outlook on Unicycive Therapeutics' potential in developing UNI-494 for AKI and OLC for hyperphosphatemia. The share price at the time of the report of US$0.36 represents a potential return of approximately 594% to the analysts' target price, highlighting the upside potential if the company's clinical development and regulatory plans prove successful.