SAN JOSE, Calif. — Allay Therapeutics has raised $57.5 million in a Series D financing round to accelerate the development of its lead candidate, ATX101, an ultra-sustained analgesic for post-surgical pain management. The funding round, co-led by Lightstone Ventures and ClavystBio, includes participation from new and existing global investors such as NEA, Arboretum Ventures, Vertex Growth, Vertex Ventures Healthcare, Brandon Capital, IPD Capital, EDBI, and SGInnovate. HSBC Innovation Banking also contributed through additional venture debt financing.
The new capital will support Allay’s ongoing Phase 2b registration trial of ATX101 in patients undergoing total knee replacement surgery, with trial data expected by the fourth quarter of 2025. ATX101 is designed to deliver long-lasting pain relief, reducing opioid dependency and improving recovery times after surgery.
Alongside the funding news, Allay announced the appointment of Joe Zakrzewski as Chairman of the Board. Zakrzewski, a veteran pharmaceutical executive, brings over three decades of industry experience, including leadership roles at Amarin Pharmaceuticals, Xcellerex, and Eli Lilly.
The company also expanded its partnership with Japan-based Maruishi Pharmaceutical, which now includes rights to South Korea and Taiwan in addition to Japan. Maruishi is currently conducting a Phase I/II study of ATX101 in Japan and has made an additional equity investment as part of the Series D round.
ATX101, which has received Breakthrough Therapy designation from the FDA, is currently being evaluated in a 200-patient Phase 2b trial across multiple U.S. sites. The study compares ATX101 1,500 mg to both placebo and bupivacaine, a standard post-operative pain treatment. Previous trials demonstrated that ATX101 provided significant and lasting pain relief, reduced opioid use, and improved functional recovery up to 60 days post-surgery.
Allay CEO Adam Gridley highlighted the company’s momentum following a constructive Type B meeting with the FDA earlier this year. “We have a clear regulatory path for ATX101 in total knee arthroplasty and are exploring its application in other surgical areas, including orthopedics, plastic surgery, and anesthesiology,” he said.
ClavystBio’s Anselm Tan emphasized the broader significance of the company’s progress, noting that Allay’s pipeline, supported by international R&D and investor collaboration, exemplifies Singapore’s role in global life sciences innovation.
A Phase 3 trial of ATX101 is planned for 2026 as the company aims to deliver safer, more effective alternatives to opioids in managing surgical pain.
