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Biotech to Advance New Type 1 Diabetes Drug Into Clinic
Research Report

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Dosing of the first patient is expected in Q4/23 in this Phase 1 trial to be done in Australia, noted an H.C. Wainwright & Co. report.

SAB Biotherapeutics Inc. (SABS:NASDAQ) got a greenlight from the Australian Human Research Ethics Committee to conduct a Phase 1 clinical trial of SAB-142, an immunotherapy targeting type 1 diabetes, reported H.C. Wainwright & Co. analyst Edward White in an October 19 research note.

"SAB-142 is a first-in-class, fully human, anti-thymocyte globulin being developed for delaying the onset of type 1 diabetes," White wrote.

223% Possible Return

Given the news, H.C. Wainwright reiterated its US$2 per share target price on the South Dakota-based biotech, trading now at about US$0.62 per share.

The difference between the current share price and the target price reflects a significant possible gain for investors of 223%.

SAB remains a Buy.

About the Study

The Phase 1 trial, to be conducted in Australia, will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of SAB-142.

The study will be double-blind and placebo-controlled. It will enroll about 40 healthy adult volunteers who will be randomized into five cohorts, eight people per group. Cohort 1 will be randomized at a 2:1 ratio, while the other groups will be randomized on a 3:1 basis.

The study will evaluate five doses of SAB-142 in ascending fashion: 0.03 milligrams per kilogram (0.03 mg/kg), 0.1m/kg, 0.5mg/kg, 1.5mg/kg, and 2.5mg/kg.

The time commitment for each participant is a maximum of 232 days. This period will include a 45-day screening component, a seven-day confinement, and a 173-day follow-up.

Adaptive Arm Included

White reported that the Phase 1 study includes an adaptive arm. This means that if the protocol-defined, adaptive criteria are met among the healthy volunteers, as determined by the safety review committee after examining clinical lab results, adverse events, and other data, then the trial will transition to patients with type 1 diabetes.

During this shift, the dosing of healthy volunteers will cease. In their place, type 1 diabetes patients will be enrolled, six per cohort, in a randomized fashion on a 2:1 basis and dosed.

Dates of Milestones

White outlined the anticipated timing of events up to and beyond regulatory approval.

Soon, SAB plans to file an investigative new drug application (IND) with the U.S. Food and Drug Administration for SAB-142.

IND approval, followed by the first dosing of a human patient, is expected to happen in Q4/23.

Looking further ahead, H.C. Wainwright forecasts a commercial launch of SAB-142 in 2029 and US$75 million (US$75M) in sales that year, increasing to US$200M in 2030.

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Important Disclosures:

  1. Doresa Banning wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor.
  2. The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
  3. This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

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Disclosures for H.C. Wainwright & Co., SAB Biotherapeutics Inc., October 19, 2023

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, Edward White , 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 SAB Biotherapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of September 30, 2023 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of SAB Biotherapeutics, 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 SAB Biotherapeutics, Inc. for non-investment banking services in the previous 12 months. The Firm or its affiliates did not receive compensation from SAB Biotherapeutics, 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 SAB Biotherapeutics, 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.

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