Allay Therapeutics, a clinical-stage biotechnology company developing ultra-sustained analgesic products, announced the completion of a $57.5M Series D financing round to advance its breakthrough pain management platform. The financing was co-led by Lightstone Ventures and ClavystBio, with participation from existing investors NEA, Arboretum Ventures, Vertex Growth, Vertex Ventures Healthcare, and Brandon Capital, alongside new investors IPD Capital, EDBI, SGInnovate, and HSBC Innovation Banking.
The funding will primarily support Allay's Phase 2b registration trial evaluating ATX101 for post-surgical pain management following total knee arthroplasty (TKA) surgery. The company expects to complete enrollment and report results from this pivotal trial in the fourth quarter of 2025, with a Phase 3 trial planned for 2026.
FDA Breakthrough Therapy Designation Validates Platform
ATX101 has received Breakthrough Therapy designation from the FDA based on compelling clinical data from prior studies. A previous dose-ranging Phase 2b trial demonstrated clinically meaningful durable treatment effects with ATX101 versus standard-of-care bupivacaine, showing sustained pain relief for up to four weeks with reduced opioid use and meaningful improvement in functional activities extending to 60 days following surgery.
"With our recent breakthrough therapy designation (BTD) by FDA and constructive Type B meeting discussions held in March 2025, we have a clear roadmap to complete the ATX101 development program in TKA and are looking at additional indications and unmet needs in orthopedics, plastic surgery, anesthesiology and other soft tissue surgeries," stated Adam Gridley, President & CEO of Allay Therapeutics.
Novel Ultra-Sustained Technology Platform
ATX101 represents a novel investigational configuration combining bupivacaine, an approved intracellular sodium ion channel blocker, with a proprietary biopolymer system. The technology is designed to provide weeks of pain relief following surgery, delivering an order of magnitude greater duration than currently available pain treatments.
The system features a high density of drug within a small footprint to enable ultra-sustained analgesia. ATX101 is placed in minutes at the end of standard surgery and delivers its analgesic effect over weeks before eventually dissolving into water and carbon dioxide. The procedure does not require specialized training and is intended to replace the complex mix of analgesic products currently used for shorter-term post-surgical pain management.
Current Registration Trial Design
Allay's ongoing Phase 2b registration trial involves 200 participants undergoing total knee arthroplasty at multiple U.S. sites. The trial, initiated in February 2025, is a three-arm, randomized, controlled study evaluating treatment with ATX101 1,500 mg versus placebo and a bupivacaine active comparator.
"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," Gridley added.
International Expansion and Leadership Changes
As part of the financing announcement, Allay revealed that its Japanese partner Maruishi Pharmaceutical has expanded its license agreement territory to include South Korea and Taiwan, in addition to Japan. Maruishi is currently conducting a Phase I/II multi-center open-label safety study of ATX101 in Japan and made an additional investment in Allay as part of the Series D financing.
The company also announced significant leadership changes, with Joe Zakrzewski joining as Chairman of the Board of Directors. Zakrzewski brings over 30 years of leadership experience in the biotechnology and pharmaceutical industry, having previously served as Chairman and CEO of Amarin Pharmaceuticals and in various executive roles at companies including Eli Lilly & Company.
Investor Perspective on Market Opportunity
"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," stated Mike Carusi, Managing Partner at Lightstone Ventures. "The Company is enrolling its Phase 2b registration trial ATX101 in the US for TKA surgeries and are expecting early completion of this trial in the coming months."
Anselm Tan, Digital Health & MedTech Lead at ClavystBio, emphasized the global significance of the platform: "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. ATX101 is one of several offerings in a pipeline driven by Singapore's R&D excellence, a strong collaboration among international teams, and a global syndicate of investors."
