Financing will fund launch readiness for SL1009 and support lifecycle expansion into Congenital Lactic Acidosis and additional pain indications for SL1002

ROSWELL, Ga. and DUBLIN and HAMILTON, Bermuda, Sept. 15, 2026 /PRNewswire/ — Saol Therapeutics (“Saol”), a privately held, clinical-stage pharmaceutical company, today announced a definitive agreement under which funds managed by Oaktree will provide up to $115 million in milestone-based capital, with an initial tranche funding near-term launch readiness and the remainder released as milestones are met.

SL1009 (sodium dichloroacetate, DCA) is Saol’s investigational candidate in development for the treatment of pyruvate dehydrogenase complex deficiency (PDCD), a rare, life-threatening mitochondrial disease with no FDA-approved therapies. Saol filed an NDA resubmission on June 30, 2026, and the FDA has assigned a target action date of December 30, 2026. SL1009 is currently not approved by the FDA for any indication.

Additional capital, released upon achievement of specified regulatory, clinical and commercial milestones, would support lifecycle opportunities for Saol’s portfolio, including development of SL1009 for Congenital Lactic Acidosis (CLA) and expansion of SL1002 into additional pain indications and spasticity.

Separately, Saol announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) covering a method of administering SL1009 to patients following a ketogenic diet. The patent, once issued, is anticipated to expire in 2045.

“This financing gives Saol the capital to prepare a commercial organization for the launch of SL1009 while funding the next phase of our pipeline. We chose Oaktree because they understood the long-term opportunity across our portfolio, not just the near-term launch,” said Dave Penake, chief executive officer of Saol Therapeutics.

“We are excited to partner with Saol at this key stage in the company’s evolution and believe that SL1009 has the potential to become a life-saving treatment for patients suffering from rare mitochondrial diseases,” said Kent Bailey, Managing Director, Life Sciences Lending at Oaktree. “This new credit facility reflects Oaktree’s confidence in Saol’s experienced management team, and we look forward to supporting the company in their upcoming commercial and pipeline development activities.”

The transaction closed on September 11, 2026.

About SL1009, Sodium Dichloroacetate (DCA)

SL1009 is an investigational product that, if approved, would be used with a proprietary dose-determining genetic test to treat an orphan pediatric-onset mitochondrial disease, Pyruvate Dehydrogenase Complex Deficiency (PDCD). PDCD is a rare and life-threatening genetic disorder that can cause chronic energy deficit leading to lactic acidosis, profound developmental problems, and early childhood death. There are currently no FDA-approved therapies for PDCD.

SL1009 has received Priority Review, Orphan Drug Designation, and Rare Pediatric Disease Designation, and Saol anticipates receiving a Priority Review Voucher (PRV) under the Rare Pediatric Disease Statute upon approval.  Saol and Medosome Biotec will be filing a 510(k) for the dose-determining genetic test, which would serve as a required companion diagnostic for patients prescribed SL1009.

About SL1002

SL1002 is an investigational, novel perineural chemoneurolytic injection that utilizes Saol’s proprietary CYCLOPHLEX™ technology.  It is currently being advanced in development for the treatment of chronic knee pain related to osteoarthritis and for limb spasticity, both in the adult population (18+).

About Saol Therapeutics

Saol Therapeutics (pronounced “Sail”) is a privately held, clinical-stage, pharmaceutical company with operations in Roswell, Ga., Dublin, Ireland, and Hamilton, Bermuda. Saol is focused on development activity in CNS disorders such as spasticity and pain management, and orphan diseases. Saol is committed to providing and advancing therapeutic options for patients and the physicians treating these populations. For more information, visit www.saolrx.com.

About Oaktree

As a part of Brookfield’s $416 billion credit platform, Oaktree is a premier global credit manager emphasizing an opportunistic, value-oriented, and risk-controlled approach to investing across credit, equity, and real estate.  To learn more about our global business and investment ethos, please visit Oaktree’s website at http://www.oaktreecapital.com/.

Media Contacts

Saol Therapeutics
Anna Stallmann
media@ascentcomms.com

Oaktree 
mediainquiries@oaktreecapital.com 

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SOURCE Saol Therapeutics