Saolrx

About Saolrx

Saol Therapeutics, pronounced "Sail," is a privately held, clinical-stage pharmaceutical company established in 2015 with operations in Roswell, GA, Dublin, Ireland, and Hamilton, Bermuda. The company was brought to life by a group of co-founders including Sharon Hamm, Brian Jennette, and Melinda Koehler, who now serve as Chief Development Officer, Chief Financial Officer, and Chief Administrative & Compliance Officer, respectively. Since 2016, the company has been under the leadership of CEO David Penake. Penake's background includes a Master of Science and an MBA from the Massachusetts Institute of Technology, with previous leadership roles at Genentech and Corcept Therapeutics, where he was pivotal in the commercial success of the Korlym® franchise. His experience in product development, finance, and commercial leadership has been instrumental in shaping Saol's strategy.

Initially, Saol Therapeutics managed a portfolio of five commercial products. However, the company has since divested these assets to concentrate exclusively on its core mission: developing new therapies for central nervous system (CNS) disorders and orphan diseases. This strategic shift allows the company to focus its resources on its late-stage clinical pipeline, which is fully funded through more than $100 million in aggregate financing and divestitures. Saol's business model centers on advancing its drug candidates through clinical trials to regulatory approval and then market launch, creating value by addressing unmet needs in niche patient populations. The company actively partners with academic institutions and other biopharmaceutical companies to advance its pipeline.

The company's development pipeline features two primary candidates. The first, SL-1009 (Dichloroacetate or DCA), is an oral solution being investigated for the rare pediatric mitochondrial disease, Pyruvate Dehydrogenase Complex Deficiency (PDCD). PDCD is a life-threatening genetic disorder with no currently approved treatments. SL-1009 has received Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the FDA and is paired with a proprietary genetic test to enable individualized dosing. An FDA decision on SL-1009 is anticipated by August 27, 2025. The second key asset is SL-1002, a novel, non-opioid, injectable agent utilizing the proprietary CYCLOPHLEX™ technology. This candidate is being evaluated in late-stage trials for treating chronic knee pain associated with osteoarthritis and for limb spasticity in adults, with the potential to offer a new standard of care in pain management and neurology.