In a December 23, 2024 research note, Roth MKM analyst Dr. Boobalan Pachaiyappan reiterated a Buy rating on Gain Therapeutics Inc. (GANX:NASDAQ) with a US$7.00 price target following Australian regulatory approval to begin GT-02287 evaluation in Parkinson's disease (PD) patients.
The company announced approval to initiate a Phase 1b study of GT-02287 in Parkinson's disease patients with GBA1 mutations (GBA1-PD) or without it (idiopathic; iPD). According to the report, "the signal-finding (hypothesis-generating) Phase 1b study (NCT06732180) is designed to explore the safety, tolerability and preliminary efficacy (i.e., biomarker analysis)" of GT-02287, an allosteric modulator of glucocerebrosidase.
The Phase 1a healthy volunteer study demonstrated promising results, with the report noting that "GT-02287 treatment (13.5mg/kg/day; oral; 14 days treatment) increased GCase activity up to 53% (p<0.001; Day 14)." The analyst expects the Phase 1b study to enroll approximately 20 PD patients, with interim data anticipated in mid-2025.
On market potential, Pachaiyappan estimates "combined GT-02287-revenue exceeding >US$4B in 2040 (market penetration: 26.6% for GBA1-PD and 11.6% for iPD), with revenue to Gain >US$1.4B." The analyst projects potential U.S. launches for GBA1-PD in 2031 and iPD in 2032.
Key upcoming catalysts include "mid-2025: GT-02287 Phase 1b interim analysis... 4Q24: GT-02287 Phase 1b full analysis... 4Q24: preparations for Phase 2 study, including a meeting with the FDA."
The analyst outlined several risks, including, "clinical and/or commercial failure of GT-02287 in GBA1-PD and/or iPD indications, competition, financing, equity dilution, and regulatory setbacks."
The US$7.00 price target is "derived using a 75:25 weighted DCF (US$6) and SOTP (US$9) analysis using a 12% discount rate."
The share price at the time of the report of US$1.56 represents a potential return of 349% to Roth MKM's US$7.00 target price.
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Disclosures for Roth MKM, Gain Therapeutics Inc., December 23, 2024
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: Shares of Gain 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.
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