Company: GANX
Filing Date: 2025-07-15
Form Type: 424B5
Source: 0001104659-25-068103
Chunk: 10

Company: Gain Therapeutics, Inc.
Filing Date: 2025-07-15
Form: 424B5
Chunk 10
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 from all CSF and blood samples together during the fourth quarter of 2025, which is also earlier than originally planned.

Additionally, to facilitate the continued interest on the part of clinicians and patients currently aware of the Phase 1b study in Australia, we extended the screening window for participants through July 31, 2025. We are also planning to approach the local health authorities in Australia to extend the dosing period of the Phase 1b beyond the 90-day period currently allowed in the protocol. Long-term chronic toxicology studies required to support this extension of dosing are near completion, and we expect to provide an update on the progress of the extension before the end of the third quarter of 2025. We believe that the extension of the Phase 1b will also better inform Phase 2 protocol design and planning for early 2026.

Our Magellan™ Platform

We use our computational target and drug discovery platform, Magellan™, to discover novel allosteric binding sites on proteins implicated in a disease and to identify proprietary small molecules that bind these sites to modulate protein function and treat the underlying cause of the disease. We believe that Magellan™ is uniquely suited to identify allosteric binding sites on the protein surface, which are different from the active (or orthosteric) binding site where the natural ligand of the protein binds. Targeting an allosteric binding site instead of the active binding site of a protein provides numerous advantages, including: the ability to regulate proteins implicated in disease through several different mechanisms of action covering both functional and conformational effects, including stabilization, destabilization, targeted degradation, allosteric inhibition, and allosteric activation of the targeted protein; improved specificity of small molecules because binding to an allosteric binding site is non-competitive with the natural substrate that binds to the active binding site; and the ability to identify small molecules with more favorable drug-like properties. Discovering and targeting novel allosteric sites with our platform not only reduces traditional drug discovery timelines but enables rational drug design and offers the potential for superior small molecule drugs that are highly specific and that can penetrate hard to reach tissues and cross the blood-brain barrier.

#### Our Pipeline of STARs
We are leveraging our Magellan™ technology platform to develop a pipeline of novel small molecule drug candidates to address complex diseases. The platform is disease agnostic and provides us with the ability to expand our pipeline, quickly, efficiently and at low cost. We are currently focusing on progressing our clinical-stage lead program in