NEW YORK
— Allay Therapeutics has corralled $57.5 million in a Series D to help it complete a Phase 2b pain trial and gear up for a Phase 3 next summer, the biotech exclusively told
Endpoints News
.
The startup is almost done with the Phase 2b, which would likely serve as the first of two registrational trials that Allay would package as part of an approval submission to the FDA, CEO Adam Gridley told Endpoints on the sidelines of the Jefferies Global Healthcare Conference in New York.
In February, the company said it had
collected
$45 million so far in the Series D, which had a target of $60 million.
The Series D arrives during a breakout year for the non-opioid pain field. Vertex secured a
landmark FDA approval
,
Latigo Biotherapeutics
raised a $150 million Series B, and then last week,
Eli Lilly bought SiteOne Therapeutics
for up to $1 billion.
Allay, born in Singapore about eight years ago, is developing a
long-acting analgesic
called ATX101. It also has an office in San Jose, CA.
ATX101 is a reconfigured version of the approved sodium ion channel blocker known as bupivacaine and is combined with a biopolymer. Surgeons place the thin, triangle-shaped investigational product on the patient during surgery. It takes about three minutes to place on the patient toward the end of the roughly 75-minute knee replacement surgery, Gridley said.
The goal is for the product to deliver the medicine over the course of 30 days, with most of the drug released into the body within the first two weeks, when patients’ pain is at its highest, Gridley said.
Allay aims to wrap up Phase 2b enrollment in the next month or so for the 200-patient trial, which focuses on patients undergoing total knee replacement surgery. Allay anticipates reporting trial results in the fourth quarter and then conducting an end-of-Phase 2 meeting with the FDA in the first few months of 2026, Gridley said.
After gathering the Phase 2b data, Allay plans to conduct its next fundraise to run a similarly designed Phase 3, Gridley said. That trial could begin around July 2026, with about four to six months for enrollment and about nine months total to collect data, the CEO said.
That next fundraise could likely be a crossover round, Gridley said. The startup is also open to the public markets, should the biotech downturn ease up or reverse course by that point.
“If next year the markets are open, I think this is a very nice public company, but we’ve got patient investors,” Gridley said.
Lightstone Ventures and ClavystBio co-led the Series D.
Existing supporters
also took part, including NEA, Arboretum Ventures, Vertex Growth, Vertex Ventures Healthcare and Brandon Capital. It collected capital from new investors like IPD Capital, EDBI and SGInnovate. Allay’s venture debt provider is HSBC Innovation Banking.
Beyond total knee replacement surgery, Allay envisions its product being applied to other joints, breast reconstruction surgery and potentially other applications, Gridley said.
“This could be a very interesting standalone company with products for everything from orthopedics to plastic surgery to gynecology,” Gridley said.
Allay has nearly 50 employees in the US and Singapore, Gridley said. The company controls its manufacturing process, which is in San Jose.