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‘Poised for Two Key Readouts in Q1/22’ as Biopharma Advances Pipeline

September 21, 2021 (Investorideas.com Newswire) Rezolute’s two drug candidates, one for congenital hyperinsulinism and the other for diabetic macular edema, are discussed in an H.C. Wainwright & Co. report.

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In a Sept. 17 research note, H.C. Wainwright & Co. analyst Douglas Tsao reported that Rezolute Inc. (RZLT:NASDAQ) advanced its two lead drug candidates to the point of topline data readouts expected in Q1/22.

The first compound is RZ358, which Rezolute is developing as a treatment for congenital hyperinsulinism, to be delivered via weekly or biweekly infusions. Recently, Rezolute began dosing the cohort of patients receiving 3 milligrams per kilogram (mg/kg) in its Phase 2b RIZE trial. Next, it will treat the group getting 9 mg/kg once the dose escalation review committee approves it.

In commencing the Phase 2b dosing, Rezolute solidified its development lead over Crinetics, which is advancing an oral small molecule sst5 agonist for the same indication. Crinetics just released Phase 1 data, an event that overshadowed Rezolute’s earnings report and pressured its shares.

“That head start [of Rezolute], as well as the elegant mechanism of RZ358, should ensure it gets a strong beachhead in the congenital hyperinsulinism market, if not market leadership, in our view,” Tsao wrote.

Rezolute’s second drug is RZ402, a plasma kallikrein inhibitor the biopharma is developing for diabetic macular edema. Results of its MAD trial, in progress, also are expected in Q1/22.

“Although still very early in development, RZ402 has solid mechanistic rationale for use in diabetic macular edema or other retinopathies, with preclinical data showing similar efficacy to the standard of care, anti-VEGF monoclonal antibody, aflibercept. The latter, however, requires intravitreal injections whereas RZ402 would be administered orally.

“We could see use [of RZ402] as a first line, prophylaxis or even combination therapy,” Tsao wrote.

As for Rezolute’s Q4 FY21 financial results, Tsao reported the company posted a $6.5 million ($6.5M) net loss, slightly better than H.C. Wainwright’s $7.1M estimate. Research and development expenses during the quarter were $4.4M, just above the financial institution’s $4M estimate. Rezolute ended fiscal year 2021 with $41M of cash and cash equivalents.

H.C. Wainwright has a Buy rating and a $21 per share target price on Rezolute, the current share price of which is about $8.83.

Disclosures:

1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.

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5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of Rezolute Inc., a company mentioned in this article.

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Disclosures from H.C. Wainwright, Rezolute Inc., Sept. 17, 2021

Analyst Disclosure: I, Douglas Tsao , 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 Rezolute, Inc. and Crinetics Pharmaceuticals, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of August 31, 2021 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Rezolute, Inc. and Crinetics Pharmaceuticals, 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.

The firm or its affiliates received compensation from Rezolute, Inc. and Crinetics Pharmaceuticals, Inc. for non-investment banking services in the previous 12 months.

The Firm or its affiliates did not receive compensation from Rezolute, Inc. and Crinetics Pharmaceuticals, 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 Rezolute, Inc. and Crinetics Pharmaceuticals, 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.

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.

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