Allay Therapeutics, a clinical-stage biotechnology company pioneering ultra-sustained analgesic products to transform post-surgical pain management and recovery, announced the completion of a $57.5 million Series D financing round with leading global investors. Lightstone Ventures and ClavystBio co-led the Series D financing with participation by existing investors NEA, Arboretum Ventures, Vertex Growth, Vertex Ventures Healthcare, and Brandon Capital. The new investors joining the round were IPD Capital, EDBI, and SGInnovate, and HSBC Innovation Banking also provided additional venture debt financing to the company.
Allay Therapeutics’ Japanese partner Maruishi Pharmaceutical has also expanded the territory of its license agreement to include South Korea and Taiwan, in addition to Japan. As part of the license amendment, Maruishi also made an additional investment in Allay as part of the Series D financing. Maruishi is currently conducting a Phase I/II multi-center open-label safety study of ATX101 in Japan.
Phase 2b registration trial: Allay’s Phase 2b registration trial of 200 participants undergoing total knee arthroplasty (replacement, or TKA surgery) is being conducted at multiple U.S. sites. And the trial was initiated in February 2025 and is a three-arm, randomized, controlled study evaluating treatment with ATX101 1,500 mg versus placebo and a bupivacaine active comparator.
A previous dose-ranging Phase 2b trial demonstrated clinically meaningful and durable treatment effects with ATX101 compared to standard-of-care bupivacaine, as evidenced by pain intensity reduction out to four weeks, reduced opioid use, and significant improvement in functional activities up to 60 days post-surgery. Based on those prior results, Allay’s ATX101 product has received Breakthrough Therapy designation from the FDA. Results from the registration trial will be available in the fourth quarter of 2025, and a Phase 3 trial is planned for 2026.
New board members: Allay also announced that Joe Zakrzewski, an experienced pharmaceutical executive, has been appointed Chairman of the Board of Directors, and Anselm Tan of ClavystBio will also join Allay’s board.
How the funding will be used: The proceeds from the funding support the company’s Phase 2b registration trial evaluating ATX101 for the treatment of post-surgical pain following total knee replacement (TKA) surgery and advance Allay’s ultra-sustained platform of products for other unmet needs after painful surgeries. And ATX101 is a novel investigational analgesic designed to provide extended pain relief after surgery, reducing the need for opioids and improving patient recovery.
KEY QUOTES:
“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. 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. It is rewarding to see Allay, which Lightstone Singapore helped to incubate alongside our partners at the Foundry, continue to grow and prosper.”
Mike Carusi, Managing Partner at Lightstone Ventures
“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. 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.”
Adam Gridley, President & CEO of Allay Therapeutics
“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. 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.”
Anselm Tan, Digital Health & MedTech Lead, ClavystBio
