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Biotech Co. Reports Encouraging ALS Data but FDA Wants More
Research Report

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Salt Lake City-based Clene Inc. reported both encouraging clinical data and a regulatory setback for its ALS drug candidate CNM-Au8, reported Roth MKM.

Salt Lake City-based Clene Inc. (CLNN:NASDAQ) reported both encouraging clinical data and a regulatory setback for its ALS drug candidate CNM-Au8, reported Roth MKM analyst Dr. Jonathan Aschoff in a December 21 research note.

In an update on the Phase 2 HEALEY trial, Clene noted that the neurofilament light (NfL) biomarker in patients consistently on 30mg of CNM-Au8 declined by 16% after 76 weeks of treatment. In contrast, patients initially on a placebo who switched to treatment saw NfL levels rise.

"Long-term NfL biomarker levels appear to correlate with clinical outcomes in ALS," Aschoff commented.

Clene also presented survival analyses estimating a 60% reduced mortality risk for patients randomized to CNM-Au8 versus placebo.

However, based on a recent meeting, the FDA declined Clene's request for accelerated approval of CNM-Au8 for ALS and asked for additional evidence. The company aims to provide supplemental data in the first half of 2024.

Despite the regulatory hurdle, Aschoff maintains a Buy rating and US$7 price target on Clene, seeing over 200% upside for the US$0.33 stock.

"Though the FDA wants more data, Clene's ALS program shows encouraging efficacy signals in both biomarkers and survival that warrant continuation," he concluded.

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Disclosures for Roth MKM, Clene Inc., December 21, 2023

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: Within the last twelve months, ROTH Capital Partners, or an affiliate to ROTH Capital Partners, has received compensation for investment banking services from Clene, Inc.. ROTH makes a market in shares of Clene, Inc. and as such, buys and sells from customers on a principal basis. Shares of Clene, 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. Copyright 2023. Member: FINRA/SIPC.

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