Allay Therapeutics, a clinical-stage biotechnology company, announced last Thursday the completion of a $57.5 million Series D financing round with leading global investors.

The firm said in a statement that Lightstone Ventures and Temasek-backed ClavystBio co-led the Series D financing with participation by existing investors NEA, Arboretum Ventures, Vertex Growth, Vertex Ventures Healthcare, and Brandon Capital.

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 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, associated with the financing.

Allay Therapeutics’ Japanese partner Maruishi Pharmaceutical has expanded the territory of its license agreement to include South Korea and Taiwan, in addition to Japan.

As part of the amendment to the license, Maruishi has 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.

According to the statement, proceeds from the financing will support Allay Therapeutics’s Phase 2b registration trial evaluating ATX101 for the treatment of post-surgical pain following total knee replacement (TKA) surgery and advances Allay’s ultra-sustained platform of products for other unmet needs after painful surgeries.

ATX101 is a novel investigational analgesic designed to provide extended pain relief after surgery, reducing the need for opioids and improving patient recovery.

“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 and Chief Executive Officer of Allay Therapeutics.

“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,” he added.

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.

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 prior dose-ranging Phase 2b trial achieved clinically meaningful durable treatment effects with ATX101 versus standard-of-care bupivacaine based on pain intensity out to four weeks, with less use of opioids and meaningful improvement in functional activities up to 60 days following 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.

“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,” said Anselm Tan, Digital Health & MedTech Lead, ClavystBio.

“ATX101 is one of several offerings in a pipeline driven by Singapore‘s research and development (R&D) excellence, a strong collaboration among international teams, and a global syndicate of investors,” he added.

Meanwhile, Mike Carusi, Managing Partner at Lightstone Ventures, said the firm 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,” he added.

#BiotechInnovation #NonOpioidTherapy #SurgicalRecovery #HealthcareInvestment #PainManagement