Dive Brief:

• Kyverna Therapeutics on Tuesday revealed plans to go public, testing the waters in a biotechnology market that hasn’t fully recovered from a downturn that started in 2021.
• The offering would fund Kyverna’s cell therapy work, which is led by an experimental lupus treatment that the company licensed from the National Institutes of Health in 2022. Should Kyverna complete the IPO, its shares would trade on the Nasdaq under the symbol KYTX.
• Kyverna is the fifth biotech company to file for an IPO in January, suggesting companies may be more willing to test investors’ appetite for new stock offerings amid recent market optimism. Last year, only 22 drugmakers priced offerings, the lowest total in at least six years, according to BioPharma Dive data. 

Dive Insight:

More than two years after the bottom fell out for biotech stocks, the market for IPOs is showing early signs of life, though investors are generally looking for more well-established companies than in the past. Four of the five companies who have filed for IPOs in January – including Kyverna – have drugs in Phase 2 testing or later.

Kyverna’s lead program is a CAR-T cell therapy called KYV-101 that originated within the NIH. Like many cell therapies for cancer, the treatment aims at a protein called CD19. But because it proved safe enough in an early lymphoma trial, KYV-101 appeared a good candidate for autoimmune diseases like lupus, which has recently become a research focus of several companies. Kyverna is developing its therapy with the rheumatology and neurology markets in mind.

The company is initially focusing on lupus nephritis and systemic sclerosis, with two trials underway in lupus and a Phase 1/2 trial set in systemic sclerosis after regulators in October cleared the study plan. The company also received approval late last year to undertake Phase 2 testing of the treatment in the neurologic conditions myasthenia gravis and multiple sclerosis.

Researchers are increasingly focused on the use of CAR-T therapy outside of oncology, spurred in part by an academic paper published in Sept. 2022 that suggested promise for lupus patients. Several programs are now in trials or near testing in humans.

Kyverna is also working with gene editing specialist Intellia Therapeutics on an off-the-shelf CAR-T candidate known as KYV-201 and has a number of other drug programs, including the “Treg” cell therapy research that the company initially prioritized before shifting gears to KYV-101.