Monopar Therapeutics Inc. (MNPR:NASDAQ) finished enrolling enough patients for the required interim analysis in its Phase 2b/3 VOICE trial, and results of the impending review are expected in Q1/23, reported ROTH Capital Partners analyst Dr. Elemer Piros in an October 5, 2022 research note.
This biopharma is developing therapeutics to enhance clinical outcomes for cancer patients.
One of them, Validive, is clonidine in a mucobuccal tablet form. VOICE is evaluating the use of Validive to prevent severe oral mucositis in patients undergoing chemoradiation for oropharyngeal cancer, Piros relayed, an indication for which no approved treatment or preventative therapeutic exists in the U.S.
Monopar is currently trading at around $1.71 per share. ROTH's target price on it is almost 11 times that, at $18 per share. This gap suggests significant potential return investors in the company.
Monopar is currently trading at around $1.71 per share. ROTH's target price on it is almost 11 times that, at $18 per share. This gap suggests significant potential return investors in the company.
To date, the Illinois-based firm has enrolled more than the 130 patients needed for an independent data and safety monitoring board's investigation to determine whether the trial should continue through the completion of Phase 3, wrote Piros. Also, the company has recruited 68 sites to participate.
For the Phase 3 part of the trial, should it be greenlighted, a total of 260 patients will need to be enrolled.
Data also are expected in the near term, in the next three to six months, for Monopar's Phase 1b trial of camsirubicin, in advanced soft tissue sarcoma patients, Piros indicated. Camsirubicin is the biopharma's proprietary analog of doxorubicin.
"The company observed early signs of benefit for camsirubicin," added Piros.
ROTH rates Monopar Buy.
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Disclosures For ROTH Capital Partners, Monopar Therapeutics Inc., October 5, 2022
Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.
Disclosures: ROTH makes a market in shares of Monopar Therapeutics, Inc. and as such, buys and sells from customers on a principal basis. Shares of Monopar Therapeutics, Inc. may be subject to the Securities and Exchange Commission's Penny Stock Rules, which may set forth sales practice requirements for certain low-priced securities.
ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months. The material, information and facts discussed in this report other than the information regarding ROTH Capital Partners, LLC and its affiliates, are from sources believed to be reliable, but are in no way guaranteed to be complete or accurate.
This report should not be used as a complete analysis of the company, industry or security discussed in the report. Additional information is available upon request. This is not, however, an offer or solicitation of the securities discussed. Any opinions or estimates in this report are subject to change without notice. An investment in the stock may involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Additionally, an investment in the stock may involve a high degree of risk and may not be suitable for all investors. No part of this report may be reproduced in any form without the express written permission of ROTH.