Allay Therapeutics, a clinical-stage biotech firm developing ultra-sustained non-opioid analgesics, has closed a $57.5 million Series D financing round to support late-stage development of its lead candidate, ATX101, for post-surgical pain.
The round was co-led by Lightstone Ventures and ClavystBio, with participation from returning investors NEA, Arboretum Ventures, Vertex Growth, Vertex Ventures Healthcare, and Brandon Capital.
New investors include IPD Capital, EDBI, and SGInnovate, with additional venture debt financing provided by HSBC Innovation Banking.
The funding will support Allay’s ongoing 200-patient Phase 2b registration trial for ATX101 in total knee arthroplasty (TKA), launched in February 2025 across multiple U.S. sites.
The study is comparing ATX101 to placebo and bupivacaine, a widely used anesthetic, to evaluate its extended pain relief effects. Previous studies have shown that ATX101 reduced opioid consumption and improved physical function for up to 60 days post-surgery.
The company expects to release trial results in Q4 2025, with a Phase 3 trial targeted for 2026.
ATX101, the company’s lead product, is a sustained-release analgesic designed to reduce post-operative pain and opioid dependency by delivering extended relief from a single administration at the surgical site.
The product has received Breakthrough Therapy designation from the U.S. Food and Drug Administration.
In tandem with the fundraising, Allay announced the appointment of seasoned pharmaceutical executive Joe Zakrzewski as Chairman of the Board. Anselm Tan of ClavystBio also joins the board, following the firm’s co-lead investment.
Additionally, Allay’s Japanese partner Maruishi Pharmaceutical has expanded its licensing agreement to include South Korea and Taiwan. Maruishi is currently conducting a Phase I/II trial of ATX101 in Japan and has also contributed to the Series D round.
The financing will also help advance Allay’s broader platform of non-opioid therapies targeting pain in orthopedics, plastic surgery, anesthesiology, and soft tissue procedures. The company operates dual R&D hubs in Singapore and the U.S., where it continues to build a pipeline aimed at reducing reliance on opioids and enhancing patient recovery.
Backed by a cross-border syndicate and a strategic global roadmap, Allay is positioning itself at the forefront of post-surgical pain management innovation.
Business News Asia