Gain Therapeutics, Inc. (NASDAQ:GANX) Special Call Transcript July 1, 2024 8:30 AM ET
Company Participants
Apaar Jammu – Manager, Investor Relations
Gene Mack – Chief Financial Officer & Interim Chief Executive Officer
Conference Call Participants
Operator
Hello, all. Thank you for joining us today for Gain Therapeutics Corporate and Business Update Call. A transcript and replay of this call will be available on the Gain Therapeutics website.
I would now like to pass this call over to Manager of Investor Relations, Apaar Jammu. You may begin.
Apaar Jammu
I would like to draw your attention to the legal disclosures regarding forward-looking statements. During this conference call and webcast, the company may make forward-looking statements regarding future events, including statements about financial, business, clinical milestones, potential future milestone payments, and commercialization and plans and strategies anticipated in the remainder of fiscal 2024 and beyond. We encourage you to review the company’s past and future filings with the SEC, which identify specific factors that may cause the actual results or events to differ materially from those described in the forward-looking statements. You can find the SEC filings in the EDGAR database at www.secgov.com or in the Investor Relations section at the company’s website at www.Gaintherapeutics.com.
Please note that any comments made on today’s call speak only as of today, July 1, 2024, and may not be accurate at the time of any replay or transcript rereading. As we won’t be able to answer any live questions, we encourage participants to direct any questions to ir@Gaintherapeutics.com.
And I will turn the call over to Gene Mack, the company’s Chief Financial Officer and Interim Chief Executive Officer.
Gene Mack
Thank you, Apaar, and thank you all for joining us this morning for the Gain Therapeutics Business Update call. My name is Gene Mack and I am the CFO [Technical Difficulty] for Gain Therapeutics. As you know, Gain Therapeutics is a clinical stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapeutics. Our lead molecule, GT-02287 is currently in Phase 1 clinical development for the treatment of Parkinson’s disease. We also have a portfolio of earlier stage molecules that we look forward to advancing into clinical development.
I would like to start by reviewing the recent changes to management. Last week, the company and Former CEO, Matthias Alder executed a separation agreement. We are thankful to — for Matthias’s leadership over the past three years as the company transitioned to a clinical-stage biotechnology company, culminating with the financing that was completed last month. Upon Matthias’s departure, the Board of Directors appointed me to take on the role of CEO on an interim basis. I will continue to oversee finance [Technical Difficulty] CFO. Additionally, Dr. Khalid Islam, Founder and Chairman of Gain Therapeutics, will step in as Executive Chairman to support myself and the other members of our management team, including our Chief Medical Officer, Jonas Hannestad, in our clinical planning and operations, as well as regulatory planning and strategy. Dr. Islam is an industry veteran with over 30 years of experience and co-founded Gain Therapeutics in 2017.
I and the entire Gain management team will take full advantage of the wealth of expertise available to us on the Gain Board led by Dr. Islam as we continue to advance GT-02287 from clinical development for the benefit of Parkinson’s disease patients and our new and existing shareholders. Importantly, we remain steadfast in our business and clinical approach, and there will be no deviation from our business strategy and objectives set by the Gain Board as a result of the management changes. Despite a historically difficult financing environment for the biotechnology sector, on June 13, we priced an $11 million public offering of a total of 8,148,149 shares of common stock and stock equivalents at $1.35 per share and per equivalent. After fees and expenses related to the offering, the total net proceeds to Gain were approximately $10 million. We expect to use the net proceeds to continue clinical and non-clinical development of GT-02287 for the treatment of neurodegenerative diseases, including GBA1 Parkinson’s disease, and for general corporate purposes. The recent financing will now allow us to initiate a Phase 1b proof of concept study in patients with Parkinson’s disease.
As a first study in patients, we plan to examine the pharmacokinetics and pharmacodynamics of GT-02287 and further determine its safety and tolerability, and also observe the impact of this drug candidate on certain biomarkers of Parkinson’s disease. This study will be the first exposure that Parkinson’s disease patients will have to GT-02287, and we are excited to determine the therapeutic potential of our drug candidates. Before that, we look forward to presenting results regarding the safety, tolerability, and pharmacokinetics of GT-02287 in healthy individuals from the multiple ascending dose phase of our Phase 1 trial that was initially reported in April. In the single ascending dose part of the Phase 1 trial, GT-02287 was generally well tolerated up to and including the highest planned dose level and there were no serious adverse events reported.
The good safety and tolerability profile and the observed range of plasma exposure levels achieved after oral administration further bolstered GT-02287’s best-in-class potential. The multiple ascending dose part of the Phase 1 trial was initiated in February in parallel to the last single ascending dose cohort that received GT-02287 based on a review of the safety and tolerability profile that was observed in the single ascending dose cohort. There has been no change to our expectation to complete all four cohorts of the multiple ascending dose portion of the trial by mid-year 2024. As with the single ascending dose portion in the multiple ascending dose study, no serious adverse events have been reported and there have been no discontinuations for adverse events and no indications of safety concerns.
This Phase 1 study is a double-blind placebo controlled study and we expect that once the last subject has completed dosing, we will lock the database and release the top line data in August. The full results will be presented at the upcoming International Congress of Parkinson’s Disease and Movement Disorders in Philadelphia at the end of September. What really excites us about the prospects of GT-02287 is that, we believe this drug candidate has the potential to slow disease progression. In preclinical models, GT-02287 has shown positive effects on locomotor activity, as well as neurodegeneration and cognition. Current therapies are based on improving symptoms only, and their efficacy wanes over time, and until now, there are no therapeutic options for patients which address the underlying disease progression.
Just this past week at the 2024 Annual Federation of European Neurosciences Forum in Vienna, Austria, in a late-breaking poster, we presented data we believe supports the improvement in cognitive performance with administration of GT-02287 in a mouse model of GBA1 Parkinson’s disease. This is relevant to patients with Parkinson’s disease and a GBA1 mutation, as they deteriorate faster, not just in their motor symptoms, but also in their cognitive function, frequently leading to the development of dementia. The improvement in cognitive function in mice was evidenced by improved nest building performance. Nest building in rodents is a natural spontaneous behavior that requires more complex interactions between motor and cognitive function. Nest building performance was assessed in these mice by scoring the quality of the nest. An example of the difference in nest quality in organization is shown in the available poster on the Gain website.
Biologic markers of Parkinson’s disease such as the neurodegeneration marker plasma NfL neurofilament, brain aggregated alpha synuclein, and markers of neuroinflammation were also measured and observed to be consistent with the improvement in cognitive and motor function that was displayed. This recent data is the latest in a broad preclinical development dossier that has been generated for GT-02287, and that supports its progression into patient studies. GT-02287 has consistently demonstrated properties of neuroprotection that include reduction in markers of stress in the endoplasmic reticulum, improvement in lysosomal storage, and mitochondrial health in appropriate models of Parkinson’s disease. The preponderance of evidence for GT-02287 gives us conviction that its benefits will translate to humans and slow or stop the progression of Parkinson’s disease in relevant patients.
The next crucial step in the development of GT-02287 will be the upcoming Phase 1b trial. We continue to remain focused on the advancement of GT-02287 through clinical development and beginning regulatory interactions with the FDA. Our confidence in the potential for GT-02287 to become a disease modifying treatment for Parkinson’s disease patients continues with the completion of its evaluation in healthy individuals. And we look forward to seeing these potential benefits in Parkinson’s disease patients in the near future.
On behalf of the board, Gain management and all our employees, we thank you for your interest and continued support as we work towards our goal in addressing the significant unmet medical need of Parkinson’s disease patients globally. We look forward to our next update with you around the time of our second quarter earnings release.
Now I’ll turn the call back over to the operator.
Operator
Thank you for attending today’s presentation of Gain Therapeutics, Inc. You may now disconnect.
Question-and-Answer Session
End of Q&A
