Allay Therapeutics is a clinical-stage biotech pioneering ultra-sustained analgesic products that combine validated non-opioid analgesics (bupivacaine) with biopolymers to deliver weeks of localized pain relief. Its lead candidate, ATX101, is an investigational formulation of bupivacaine designed to provide extended analgesia after surgery and is placed at the end of standard surgery to dissolve over weeks. The company is enrolling a 200-participant Phase 2b registration trial in total knee arthroplasty (TKA) initiated in February 2025, with results anticipated in Q4 2025 and a Phase 3 planned for 2026. ATX101 previously showed durable treatment effects versus standard-of-care bupivacaine in a prior dose-ranging Phase 2b, with less opioid use and improved function, and has received FDA Breakthrough Therapy designation. Allay has R&D teams in Singapore and the U.S., and its partner Maruishi Pharmaceutical is conducting a Phase I/II safety study in Japan and has expanded its license territory to South Korea and Taiwan. Proceeds from the recent financing and venture debt will advance the ATX101 Phase 2b registration trial and the company’s broader ultra-sustained pain platform. Allay Therapeutics is developing thin, coin‑sized biodegradable implants that are placed around an implanted knee joint to deliver a validated non‑opioid local anesthetic in a controlled fashion for up to three weeks. The company’s novel active ingredient–polymer architecture extends analgesic delivery an order of magnitude beyond existing local systems and the implants gradually dissolve as they release drug. Evonik supplies the biodegradable polymers used in the devices and has invested in the company, and Allay is positioning the technology as an alternative to systemic opioids to improve and accelerate recovery. Allay’s products are in early stages of clinical development and the firm is developing a portfolio of candidates based on the same drug‑polymer architecture for other orthopedic and soft‑tissue surgeries. The technology was developed in Singapore and Allay maintains R&D facilities there while being headquartered in San Jose, California. The company highlights the large U.S. market—more than 1.2 million knee joint interventions per year and an estimated $10 billion treatment volume for severe postoperative pain—against the backdrop of the opioid crisis. Allay Therapeutics is a clinical-stage biotechnology company pioneering ultra-sustained analgesic products to transform post-surgical pain management and recuperation. Its proprietary platform combines validated non-opioid analgesics and biopolymers to create dissolvable candidates that deliver targeted pain relief over weeks. The company’s lead candidate, ATX-101, is being advanced into a Phase 2b study in total knee arthroplasties in the United States. R&D teams in Singapore and the Bay Area have developed proof-of-concept implant variants, injectable formulations, on-demand self-dosing formulations, and formulations incorporating additional small molecules and local analgesics. Allay intends to advance at least one new clinical candidate into trials each year and is building manufacturing capabilities in the Bay Area to support future product launches. The company completed an oversubscribed $60M Series C to support clinical and platform development.

Total raised

$118M

Funding rounds

4

Latest round

Series D

Latest activity

Jun 2025