Utah Biotech's Treatment Demonstrates Significant Survival Advantage for ALS Patients
Research Report

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Disclosures for D. Boral Capital, Clene Inc., March 12, 2025

Analyst Certification I, Jason Kolbert, certify that all of the views expressed in this research report accurately reflect my personal views about the subject security(ies) and subject company(ies). 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 research report. Company-Specific Disclosures General Disclosures The information contained in Research Reports or other Research products produced by D. Boral Capital LLC is for informational purposes only and does not constitute solicitation of the sale or purchase of securities or other investments. The information in such products is derived from sources that are believed to be reliable. Prices, numbers, and similar data include past results, estimates, and forecasts, all of which may differ from actual data. These prices, numbers, and similar data may also change without prior notification. D. Boral Capital holds the copyright on this research report. Any unauthorized use or transmission of any part of this research report for any reason, whether by digital, mechanical, or any other means, is prohibited. If you have any questions, please contact your sales representative. Additional information is available upon request. Certain company names, product and/or service names that appear in this research report are trademarks or registered trademarks of D. Boral Capital or other companies mentioned in the report. Copyright 2025 D. Boral Capital LLC. D. Boral Capital rating definitions are expressed as the total return relative to the expected performance of S&P 500 over a 12-month period. BUY (B) - Total return expected to exceed S&P 500 by at least 10% HOLD (H) - Total return expected to be in-line with S&P 500 SELL (S) - Total return expected to underperform S&P 500 by at least 10%

On March 12, 2025, D. Boral Capital analyst Jason Kolbert maintained a Buy rating and US$23.00 price target on Clene Inc. (CLNN:NASDAQ), citing new data that demonstrated a significant survival advantage for ALS patients receiving the company's CNM-Au8 treatment.

Clene has announced positive results from a post hoc cross-regimen analysis of the HEALEY ALS Platform Trial, showing that patients who received CNM-Au8 30 mg achieved a median survival of 951 days compared to 753 days in the control group, representing a 6.5-month survival gain. After adjusting for covariates, the restricted mean survival time (RMST) showed a statistically significant benefit of 124 days (4.1 months, p=0.045).

The survival benefit was even more pronounced in patients meeting the planned enrollment criteria for the upcoming RESTORE-ALS Phase 3 trial. In this subgroup, median survival improved from 628 days to 1,079 days, an increase of 451 days (14.8 months), with a 49% reduction in mortality risk (Cox HR: 0.514, 95% CI: 0.319-0.830, p=0.006).

CEO Rob Etherington emphasized the significance of these findings as the company prepares to advance CNM-Au8 toward its confirmatory Phase 3 RESTORE-ALS trial, which is planned to begin in mid-2025. The HEALEY ALS Platform Trial's design provides evidence supporting CNM-Au8's disease-modifying potential, potentially setting the stage for regulatory discussions with the FDA.

Kolbert's valuation model includes multiple indications with a 50% probability of success factor for ALS and 10% for multiple sclerosis (MS), using a 30% discount rate. The analyst applies these projections to free cash flow to the firm (FCFF), discounted EPS (dEPS), and sum-of-the-parts (SOP) models to derive the US$23.00 price target.

Key risk factors identified include clinical/regulatory risk, partnership and financial risk, commercial risk, legal and intellectual property risk, and market share risk.

With the share price at the time of the report at US$4.54, the US$23.00 target price represents a potential return of approximately 406%.