US-based biotechnology company Allay Therapeutics has secured $57.5m in a Series D financing round, co-led by Lightstone Ventures and ClavystBio, to advance ATX101.

Other participants in the funding round include existing investors NEA and Arboretum Ventures and new investors including IPD Capital and EDBI.

The financing will support Allay’s Phase 2b registration trial of ATX101, targeting post-surgical pain relief following total knee replacement surgery.

ATX101, a configuration of bupivacaine and a biopolymer, is a novel investigational analgesic intended for post-surgical pain management.

Lightstone Ventures managing partner Mike Carusi said: “Lightstone Ventures is pleased to be joined by a strong syndicate of biotechnology and medical device investors in the U.S. and Asia to support Allay with this fundraise to advance the company’s platform of products into pivotal clinical development.”

ClavystBio Digital Health and MedTech Lead Anselm Tan said: “We are proud to support Allay as they advance best-in-class non-opioid solutions for patients suffering from pain and poor recovery outcomes after surgery.

“Allay exemplifies ClavystBio’s mission to accelerate life sciences technologies from Singapore to the world.”

Designed to deliver sustained analgesia for weeks after surgery, ATX101 aims to provide extended pain relief, reducing opioid dependency and enhancing patient recovery.

It is placed at the end of surgery and dissolves into water and carbon dioxide, offering a simpler alternative to existing pain management solutions.

The clinical trial, involving 200 participants, is underway at multiple US sites, and its results are expected in the fourth quarter of this year.

In addition to the financing, HSBC Innovation Banking has provided venture debt to Allay.

As part of the financing agreement, Allay appointed Joe Zakrzewski as its board of directors’ chairman, with Anselm Tan from ClavystBio as the board member.

Allay’s Japanese partner, Maruishi Pharmaceutical, has expanded its license agreement to include South Korea and Taiwan, alongside Japan.

Maruishi is conducting a Phase 1/2 safety study of ATX101 in Japan and has made an additional investment in Allay during the Series D round.

Allay Therapeutics president and CEO Adam Gridley said: “We have a clear roadmap to complete the ATX101 development program in TKA and are looking at additional indications and unmet needs in orthopaedics, plastic surgery, anaesthesiology and other soft tissue surgeries.

“We believe the ATX platform of products driven by our teams in Singapore and the U.S. can help improve patient outcomes, reduce opioid use and improve function more rapidly than currently available therapies.”