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Kyverna IPO adds to biotech momentum with $319M fundraise

Dive Brief:

  • Kyverna Therapeutics raised $319 million in a larger-than-expected initial public offering Thursday, adding to an early, but notable, upturn in investor demand for new biotech stock issuances.
  • The company, a developer of cell therapies for autoimmune diseases, sold 14.5 million shares at $22 apiece, significantly beating projections it set earlier this week. The proceeds will fund development of a cell-based medicine in early testing for lupus. The treatment is set to start trials in three other inflammatory conditions as well.
  • Kyverna is the fifth biotech to go public in 2024, and all five have raised at least $100 million. It could be followed by two other drugmakers, Metagenomi and NeoOnc Technologies Holdings, setting a pace of listings that exceeds last year’s so far, according to BioPharma Dive data.

Dive Insight:

Kyverna’s offering proves at least some investors see a future in which cell therapies are used for autoimmune diseases, as well as the blood cancers they’re currently approved to treat.

They aren’t alone. At least a dozen clinical trials have launched since a 2022 Nature study showed a cellular medicine could drive a tough-to-treat form of lupus into remission. Some see those studies as a test of cell therapy’s potential to address other chronic inflammatory conditions, too.

Kyverna, a well-funded startup formed in 2018, is among the leaders. The company was founded to pursue so-called Treg cell therapy, another emerging method for treating autoimmune conditions. But the company later changed its strategy and licensed more conventional cell therapy technology from the National Institutes of Health. That deal yielded what is now its lead program, a therapy called KYV-101. Its Treg work “will take more time to mature,” CEO Peter Maag told BioPharma Dive last year.

Like many other cell therapies, KYV-101 targets a protein called CD19 that’s found on the antibody-making B cells that go haywire in lupus and other inflammatory conditions. Wiping these cells out may “reboot” the immune system without compromising its overall function, the authors of the 2022 Nature study hypothesized.

In its IPO prospectus, Kyverna claimed early NIH tests in lymphoma showed KYV-101 has a “differentiated safety profile” — necessary in autoimmune diseases where, unlike in cancer, “there may be lower tolerance” for serious side effects.

The company has started early testing in lupus nephritis, a form of the condition that affects the kidneys. The Food and Drug Administration has also cleared the company to begin early- to mid-stage studies in multiple sclerosis, myasthenia gravis and systemic sclerosis. Those trials should start “in the near term,” according to Kyverna.

Kyverna presented early results in lupus last year and, while it hasn’t said when to expect more data, a federal database indicated fuller findings could come in 2025.

The company is working with Intellia Therapeutics to make a version of its treatment from donor-derived cells. Its Treg cell therapy research is focused on inflammatory bowel disease, meanwhile.

Shares will begin trading Friday on the Nasdaq stock exchange under the ticker “KYTX.”