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SomaLogic Plans New Data Products, Licensing and Test Development Agreements

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NEW YORK – SomaLogic plans to grow its business by introducing several new data products — including a way to help quantify noise introduced by sample collection and transport — and by licensing its protein-based diagnostic assets.

Company officials announced the plans in a Thursday call with investors following the release of the firm's first quarter financial results, in which SomaLogic reported 22 percent revenue growth year over year.

"We've had a number of opportunities come across the transom to us for both licensing and codevelopment," CEO Roy Smythe said on the call. "So there are a number of those active conversations right now. And again, this is without us actually doing serious business development on the side of diagnostics, which again, I take as a really good sign."

Licensing and test codevelopment deals for existing diagnostic assets would help provide a "substantial moat for our clinical products," he added. Though company officials did not disclose any information about who they're in conversation with, they said they expect some deals to be consummated this year. The company has also hired a licensing executive.

The sample quality data product is meant to be an accessory to the SomaScan aptamer-based proteomics assay. It will also provide information on which biological pathways have been activated and drug targets present in the sample. 

"This is the first in a planned number of many data products that we have in development to place alongside SomaScan," Smythe said.

The firm also spoke about interactions with the US Food and Drug Administration related to efforts to get the SomaSignal assay for risk of cardiovascular events into clinical trials.

Wall Street responded favorably to the Boulder, Colorado-based company's results. In Friday trading on the Nasdaq, shares of SomaLogic were up 27 percent at $5.80. The company showed "solid execution," Canaccord Genuity Analyst Kyle Mikson wrote in a note to investors, though he lowered the price target to $15 from $19.

"We suspect supply chain issues could have held back revenues," Cowen Analyst Dan Brennan wrote in a note to investors, "as customers were unable to ship samples to SomaLogic's Colorado lab in a timely fashion."

Smythe said the company has seen "unpredictability" in sample delivery, which may continue throughout the year. The firm itself has not seen supply chain or shipping disruptions, he said, but some customers have, resulting in unevenness in the number of samples processed from quarter to quarter.

Shipping of samples is one of the driving factors in launching the data product for sample quality.

"When I joined SomaLogic 12 years ago, the first experiment that we'd ever done was in lung cancer, and it turned out that the biggest effect in the samples we had was the difference between [those from] New York University and the University of Pittsburgh," SomaLogic Chief Medical Officer Stephen Williams said. "And it really all arises because when blood is a living tissue, and when you leave it out on the bench, the cells start to leak their products or their intracellular proteins, platelets get activated, complement gets activated."

He described this variation as "pre-analytic issues," which the company has studied and developed models "for each of the ways that blood might have been abused."

"I like to think of these pre-analytic variability models effectively as a criminal record for each sample," he said. "You can eliminate the worst samples, or you could choose to use proteins which are immune to those effects." Researchers running multicenter clinical trials may be among those beneficiaries of such data. "I think these are really important; they add a lot of statistical power and interpretability to your results," he said.

SomaLogic officials also touted the potential for its SomaSignal assay, the subject of a paper published in Science Translational Medicine last month. The 27-protein assay stratifies the risk of events related to cardiovascular disease, such as heart attack, up to four years in advance.

"The ability to accurately predict these events and sensitivity to change meets key requirements for a surrogate endpoint for clinical trials use," Smythe said. The company has also been interacting with FDA, but hasn't officially declared how it plans to address regulatory approval.

"As far as FDA requirements to use a test like this in clinical trials, it varies depending on how you're using it," Smythe said. "So a test like this can be used as a research-use only test. If you're looking back at data but if you're looking prospectively at data, there are FDA requirements, potentially, depending on which phase of trial you're working on. We are engaged with FDA currently on these questions."

"We've been very aligned with their requirements for the use of a test like this as a surrogate endpoint in drug development, and ultimately, if that's successful, it would enable accelerated approval of breakthrough drugs in cardiovascular and the assessment of safety for non-cardiovascular drugs for cardiovascular safety," Williams said.

The company presented data to the Cardiovascular Clinical Trialists Forum, an annual meeting, in a session attended by the FDA, "and we're presenting [to] them again at a workshop sponsored by the foundation of the National Institutes of Health later this month," Williams said.

Smythe said that preliminary findings from this initiative are expected later this year.

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