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Evolving Akoya Biosciences Touts CDx Partnerships at JP Morgan Conference

SAN FRANCISCO – Recent partnerships centered on spatial proteomics-based companion diagnostics are helping Akoya Biosciences chart a course to becoming a clinical company, CEO Brian McKelligon said in his Wednesday morning talk at the JP Morgan Healthcare conference.

Last week, Akoya announced a partnership with Agilent Technologies to develop workflows for multiplex assays to be used as companion diagnostics. The firm also signed a deal to develop a spatial-based CDx for Acrivon Therapeutics in June for a targeted DNA damage response inhibitor, ACR-368.

"We're growing our capability to do more samples faster, to get to answers faster. That's the priorities of our entire portfolio," he said. "As a company that has clinical aspirations, we have to evolve to serve those [pharma] companies' needs."

Founded in 2015 to commercialize Codex spatial protein analysis technology developed by Stanford University professor Garry Nolan, Akoya has been offering protein detection technology since 2018. It acquired PerkinElmer's Phenoptics imaging platform for whole-slide imaging in 2018 and went public in 2021, the same year it received CLIA certification for its advanced biopharma solutions (ABS) laboratory.

Last year, Akoya moved into RNA analysis. Now, the Marlborough, Massachusetts-based firm is officially heading in a clinical direction, and McKelligon said these deals are important catalysts for its transformation.

The Acrivon CDx will be exclusively run on Akoya's PhenoImager platform. "It's a first foray for Akoya into the clinical market, which many thought was much farther off," McKelligon said. The partnership will help Akoya tick off boxes on the checklist of every future potential partner: throughput, reproducibility, standardized manufacturing, deployment in a CLIA environment, and regulatory approval.

The Agilent partnership could be even more important. "Agilent really is the leader in companion diagnostics in immuno-oncology," McKelligon said, and will bring a wealth of experience, contacts, and inroads into the clinical world that can help lead to further success down the road.

Most importantly in the near term, they have an "in vitro diagnostic-grade" autostainer, the Dako Omnis, "which we need [for us] to be in the clinic," McKelligon said.

Moreover, the partnerships are huge votes of confidence. They "give [potential biopharma partners] even more confidence we can support an on-market CDx for their drug," he said. There's material benefit as well, as Akoya believes such partnerships will drive more instrument and service revenue.

On Monday, Akoya previewed recent financial results with Q4 revenues between $20.7 million and $21.2 million, up from $16.2 million in Q4 2021, and total 2022 revenues between $74.3 million and $74.8 million, up from $54.9 million last year.

During the Q&A portion of the talk, McKelligon noted that its services unit, ABS, is "probably one of the highest-growth areas, on a percentage basis," though he didn't say how much it had grown year over year. He suggested the firm could "probably support doubling it without a lot more investment."

In 2022, Akoya brought its instrument installed base to 853, with 551 PhenoImager HTs, 229 PhenoCyclers, and 83 PhenoImager Fusions.

In the first half of 2023, the firm is on track to roll out its PhenoCycler-Fusion 2.0 upgrades, a joint effort with Bio-Techne's ACD to marry spatial RNA analysis via RNAscope technology to multiplex protein imaging.

Akoya will also look to grow its new PhenoCode Discovery and Signature panels. The discovery panels for the PhenoCycler-Fusion will cover both RNA and protein analytes and will come in sets of 10 or 20, which can be combined to do up to as many as 80 at a time, McKelligon said. Protein panels will see a rolling launch throughout the year with RNA panels launching in the second half.

Signature panels will be protein-only and feature around six "core immunoncology" markers for use in translational studies on the PhenoImager HT. The first five panels will be available this quarter.