Miami Biopharma Sells Part of Business and Begins New Clinical Trial
Research Report

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Disclosures for H.C. Wainwright & Co., Veru Inc., January 2, 2025

This material is confidential and intended for use by Institutional Accounts as defined in FINRA Rule 4512(c). It may also be privileged or otherwise protected by work product immunity or other legal rules. If you have received it by mistake, please let us know by e-mail reply to [email protected] and delete it from your system; you may not copy this message or disclose its contents to anyone. The integrity and security of this message cannot be guaranteed on the Internet. 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, Yi Chen, Ph.D. CFA and Raghuram Selvaraju, Ph.D. , 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 Veru, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of December 31, 2024 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Veru, Inc.. Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. Mr. Selvaraju, who is [the][an] author of this report, is the Chairman of and receives compensation from Relief Therapeutics Holding SA, a Swiss, commercial-stage biopharmaceutical company identifying, developing and commercializing novel, patent protected products in selected specialty, rare and ultra-rare disease areas on a global basis ("Relief"). You should consider Mr. Selvaraju's position with Relief when reading this research report. The firm or its affiliates received compensation from Veru, Inc. for non-investment banking services in the previous 12 months. The Firm or its affiliates did not receive compensation from Veru, Inc. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. The Firm does not make a market in Veru, Inc. as of the date of this research report. The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously. No part of this report may be reproduced in any form without the expressed permission of H.C. Wainwright & Co., LLC. Additional information available upon request. H.C. Wainwright & Co., LLC does not provide individually tailored investment advice in research reports. This research report is not intended to provide personal investment advice and it does not take into account the specific investment objectives, financial situation and the particular needs of any specific person. Investors should seek financial advice regarding the appropriateness of investing in financial instruments and implementing investment strategies discussed or recommended in this research report. H.C. Wainwright & Co., LLC’s and its affiliates’ salespeople, traders, and other professionals may provide oral or written market commentary or trading strategies that reflect opinions that are contrary to the opinions expressed in this research report. H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data on the company, industry or security discussed in the report. All opinions and estimates included in this report constitute the analyst’s judgment as of the date of this report and are subject to change without notice. Securities and other financial instruments discussed in this research report: may lose value; are not insured by the Federal Deposit Insurance Corporation; and are subject to investment risks, including possible loss of the principal amount invested.

In a January 2, 2025 research note, H.C. Wainwright & Co. analysts Dr. Yi Chen and Dr. Raghuram Selvaraju reiterated a Buy rating on Veru Inc. (VERU:NASDAQ) with a US$3.00 price target, following the sale of the company's FC2 Female Condom business and upcoming clinical trial data.

The company announced the sale of its FC2 Female Condom business to clients of Riva Ridge Capital Management LP for US$18 million. The report notes that this transaction will provide non-dilutive capital for the clinical development of enobosarm and reduce the company's headcount "by 90% from 210 to 22."

The Phase 2b QUALITY trial of enobosarm in combination with Wegovy (semaglutide) for sarcopenic obesity has enrolled 168 patients. According to the report, "The QUALITY trial is a multicenter, double-blind, placebo-controlled, randomized, dose-finding study designed to evaluate the safety and efficacy of enobosarm 3mg and 6mg as a treatment to preserve muscle and augment fat loss in elderly patients (>60 years of age) who are receiving semaglutide."

On the financial front, the FC2 sale is expected to generate approximately US$12.5 million in proceeds after deducting change of control premiums. Combined with the company's September 2024 cash position of US$24.9 million, the pro forma cash position is estimated at US$37.4 million. The analysts believe additional capital may be needed within the next 12 months.

The analysts outline several risks, including "failure of enobosarm in clinical trials for the treatment of obesity . . .  failure of enobosarm to obtain regulatory approval . . .  failure of enobosarm to achieve commercial success due to reimbursement, penetration rate, and/or competition . . . and dilution risk."

The US$3.00 price target is based on an estimated market value of US$554 million, derived from a discounted cash flow analysis using a 15% discount rate and 2% terminal growth rate.

The share price at the time of the report of US$0.65 represents a potential return of 362% to H.C. Wainwright's US$3.00 target price.