• Series D led by Lightstone Ventures and ClavystBio, supported by leading global syndicate of new and existing investors; Additional venture debt funding led by HSBC
• Funds to advance ATX101 Phase 2b registration trial of post-surgical pain management in total knee replacement patients, data anticipated in Q4 2025
• Joe Zakrzewski joins as Chairman of Allay Board of Directors
• Maruishi Pharmaceutical, Allay’s partner in Japan, expands license territory to S. Korea and Taiwan

SAN JOSE, Calif.–(BUSINESS WIRE)–Allay Therapeutics, a clinical-stage biotechnology company pioneering ultra-sustained analgesic products to transform post-surgical pain management and recuperation, today announced the completion of a $57.5M 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. 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.

Proceeds from the financing supports the Company’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.

“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,” stated Mike Carusi, Managing Partner at Lightstone Ventures. “It is rewarding to see Allay, which Lightstone Singapore helped to incubate alongside our partners at the Foundry, continue to grow and prosper.”

“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. “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.”

“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 R&D excellence, a strong collaboration among international teams, and a global syndicate of investors.”

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.

About Joe Zakrzewski:
Mr. Zakrzewski has over 30 years of leadership experience in the biotechnology and pharmaceutical industry and has founded a number of biotechnology companies and been an inventor on numerous patents. He currently serves on the Board of Directors of multiple public & privately held companies. During his operating career he was Chairman and CEO of Amarin Pharmaceuticals, a Venture Partner with Orbimed, Chairman, President & Chief Executive Officer of Xcellerex, a privately held company sold to GE Healthcare, and COO of Reliant Pharmaceuticals, a privately held company sold to GSK plc. Prior to this, Mr. Zakrzewski served in various executive roles including global leadership for Business Development at Eli Lilly & Company. He received a BS in Chemical Engineering and an MS in Biochemical Engineering from Drexel University, and an MBA in Finance from Indiana University.

About Lightstone Ventures
Lightstone Ventures is a global venture capital firm investing in biotech and medtech companies pioneering big ideas poised to transform patient outcomes. We were founded in 2012 to empower visionary entrepreneurs with the resources and operational guidance necessary to bring their innovative therapeutics and technologies to the patients who need them most. Our investment team has led deals resulting in 19 acquisitions and 20 initial public offerings over the last two decades. The firm has offices in Boston, Mass., Portola Valley, Calif., and Dublin, Ireland. For more information, please visit www.lightstonevc.com

About ClavystBio
ClavystBio is a life sciences investor and venture builder established by Temasek to accelerate the commercialization of breakthrough ideas into health impact. We invest and partner with innovators, entrepreneurs and founders to launch and grow global companies from Singapore. Our focus spans therapeutics, digital health and medtech, with an emphasis on first-in-class science and technology. Our collaborative space, Node 1, provides plug-and-play spaces for ventures that have graduated from incubators to progress to their next milestones. By bringing startups together, we foster a vibrant and supportive community. Since our inception in 2022, ClavystBio has committed over US $220 million in investments in the life sciences sector. For more information, please visit www.clavystbio.com

About ATX101
ATX101 is a novel investigational configuration of an approved, well-characterized, validated intracellular sodium ion channel blocker, bupivacaine, and a biopolymer that has been designed to provide weeks of pain relief following total knee arthroplasty (TKA, or replacement), a common orthopedic surgery. ATX101 has a high density of drug within its small footprint to allow for ultra-sustained analgesia. It is placed in minutes at the end of standard surgery to deliver its analgesic effect over weeks before eventually dissolving into water and carbon dioxide. The simple procedure does not require specialized training and is intended to replace the existing complex mix of analgesic products used for shorter-term pain management in the post-surgical setting. ATX101 is an investigational product that has not been approved by the U.S. Food and Drug Administration.

About Allay Therapeutics
Allay Therapeutics is pioneering ultra-sustained analgesic products to transform post-surgical pain management and recuperation for patients and physicians. Our proprietary technology platform combines validated non-opioid analgesics and biopolymers to create dissolvable candidates to deliver pain relief within a targeted site over weeks: an order of magnitude greater than the longest-lasting pain treatments currently available. Our platform and vision were shaped by The Foundry incubator and Lightstone Venture’s Singapore Fund. Allay unites a dynamic, global team of entrepreneurs, scientists, clinicians and innovators in the San Francisco Bay Area and Singapore. Learn more at allaytx.com.

Contacts

For further details, please contact:
Investors
Adam Gridley
adam.gridley@allaytx.com

Media
allay@tenbridgecommunications.com

(c)2025 Business Wire, Inc., All rights reserved.