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

ROSWELL, Ga., DUBLIN and HAMILTON, Bermuda, September 15, 2026 —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 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 Contact:

Saol Therapeutics
Anna Stallmann
media@ascentcomms.com

Oaktree
mediainquiries@oaktreecapital.com

• FDA confirmed the resubmission is a complete, Class II response to the Aug. 27, 2025 CRL.
• Saol remains committed to working with FDA toward approval of this treatment for PDCD, a rare, life-threatening mitochondrial disease with no approved therapies.

ROSWELL, Ga., DUBLIN and HAMILTON, Bermuda, July 28, 2026 — Saol Therapeutics, a privately held, clinical-stage pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the company’s resubmission of its New Drug Application (NDA) for SL1009, sodium dichloroacetate (DCA), for the treatment of pyruvate dehydrogenase complex deficiency (PDCD), a rare, life-threatening mitochondrial disease with no FDA-approved therapies. The FDA acknowledged the resubmission as complete, classified it as Class 2, and set a Prescription Drug User Fee Act (PDUFA) target action date of Dec. 30, 2026.

The acknowledgement moves SL1009 into its second FDA review cycle following the original NDA submission on Nov. 27, 2024, and the issuance of a Complete Response Letter (CRL) on Aug. 27, 2025. The CRL did not identify any concerns related to the safety profile or manufacturing of SL1009. Saol resubmitted the NDA on June 30, 2026, after a productive Type A meeting in December 2025 and a Type C meeting in March 2026. During these meetings, the FDA advised Saol to conduct additional survival analyses to support the application, which Saol provided.

“Having a confirmed action date matters greatly to the families of children living with PDCD, who have waited a long time for a potential treatment option,” said Dave Penake, chief executive officer of Saol Therapeutics. “We remain confident in the totality of evidence behind SL1009 and what it can mean for these patients.”

Penake added, “We’re grateful to the patients, families, investigators and clinicians who have carried this program forward, and to the FDA for its continued partnership throughout this process.”
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.

About SL1009, Sodium Dichloroacetate (DCA)
SL1009 is an investigational product that, if approved, will 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. Saol, in collaboration with Medosome Biotec, will be filing a 510K for the dose-determining genetic test that will serve as a required companion diagnostic for patients treated with SL1009.

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.

Media Contact
Mae Young
media@ascentcomms.com

Existing data supports direct path to resubmission following constructive FDA engagement

ROSWELL, Ga., DUBLIN and HAMILTON, Bermuda — July 7, 2026 — Saol Therapeutics, a privately held, clinical-stage pharmaceutical company, today announced the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for SL1009, sodium dichloroacetate (DCA), for the treatment of pyruvate dehydrogenase complex deficiency (PDCD), a rare, life-threatening mitochondrial disease with no FDA-approved therapies.

The resubmission follows a Type A meeting in December and a Type C meeting in March, during which the FDA provided guidance recommending additional survival analyses to support the application. This guidance enabled Saol to proceed directly to resubmission without conducting an additional trial, an outcome Saol believes reflects the FDA’s commitment to working constructively with sponsors to identify viable regulatory paths for programs serving patients with serious unmet needs.

Saol’s resubmission follows the receipt of a Complete Response Letter (CRL) in August 2025, which did not identify concerns related to safety or manufacturing, but requested additional evidence to support approval. In response Saol conducted further analyses of existing data, including functional outcomes, survival, mechanistic evidence, and long-term safety data.

“We are encouraged by the clarity and alignment achieved with the FDA during our recent interactions,” said Dave Penake, chief executive officer of Saol Therapeutics. “This resubmission reflects the totality of evidence supporting SL1009. We are committed to continuing to work collaboratively with the Agency and are encouraged by the FDA’s demonstrated willingness to apply regulatory flexibility.”

Penake added, “We are grateful for the continued engagement of the PDCD community and experts, whose efforts have helped communicate the impact of this disease on affected individuals and families. We remain focused on advancing our NDA resubmission while continuing to support the need for timely evaluation of therapies for rare, life-threatening conditions.”

SL1009 has been studied across multiple clinical trials, including two Phase 3 studies, and long-term open-label extension data, supporting a well-characterized safety profile. Saol believes the totality of evidence supports the potential for meaningful clinical benefit in patients with PDCD. The FDA will assign a new action (PDUFA) date upon acceptance of the file.

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.

About SL1009, Sodium Dichloroacetate (DCA)
SL1009 is an investigational product that, if approved, will 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. Saol, in collaboration with Medosome Biotec, also filed the Humanitarian Device Exemption (HDE) application for the dose-determining genetic test that will serve as a required companion diagnostic for patients treated with SL1009.

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.

Media Contact
Mae Young
media@ascentcomms.com