Kyverna sets IPO range, eyeing $180M haul to fund broad autoimmune CAR-T clinical trial program

Kyverna sets IPO range, eyeing $180M haul to fund broad autoimmune CAR-T clinical trial program

Kyverna Therapeutics has laid the foundations for the next major IPO of 2024. Having filed last month, the autoimmune cell therapy biotech set the terms for an offering that could gross around $180 million on Thursday.

California-based Kyverna previously received investment from Vida Ventures, the VC group set up by Kite Pharma founder Arie Belldegrun, M.D., and Gilead Sciences on the path to its IPO filing. The biotech has used the funding, which included a $145 million series B round, to move an autologous CD19-directed CAR-T therapy into the clinic in multiple indications while advancing an off-the-shelf option with Intellia Therapeutics.

Now, Kyverna has lined up an IPO that could provide a big boost to its coffers. The biotech plans to sell more than 11 million shares for between $17 and $19. If Kyverna hits the midpoint of the range, the IPO will gross around $182 million. Series B backers paid $1.87 a share to invest in the biotech.

Kyverna, which ended September with $23 million in cash and equivalents, plans to use $150 million of its anticipated IPO haul to push lead candidate KYV-101 through a broad suite of trials. The money will enable Kyverna to complete enrollment in a lupus nephritis trial that dosed its first patient in July and to keep recruiting participants in a similar study that got underway in Germany in November 2023.

As of the end of last year, Kyverna had data from three adults dosed across the two trials. The studies have provided very early evidence that KYV-101 can safely deplete CD19-positive B cells and allow lupus nephritis patients to discontinue immunosuppressive therapy.

Encouraged, Kyverna plans to start clinical trials of KYV-101 in systemic sclerosis, myasthenia gravis and multiple sclerosis using the IPO funds. The biotech has received FDA clearance to study the cell therapy in the three indications. A further $20 million is earmarked for taking the off-the-shelf CD19 cell therapy KYV-201 into the clinic.

Kyverna created KYV-201 by combining the CAR from its autologous candidate with Intellia’s CRISPR gene editing capabilities. The CAR, which Kyverna licensed from the National Institutes of Health, targets the same receptor as CD19-directed cancer therapies such as Gilead’s Yescarta. But the construct is designed to have better tolerability than oncology CARs, a factor that could be key to success beyond cancer.

Multiple other groups are advancing CD19-directed autoimmune CAR-T therapies, with lupus an early area of focus. Data published in September 2022 raised hopes that the approach may be feasible and effective in lupus. The same researchers shared more data late last year, showing that the first five patients stayed in remission over 14 months to 24 months of follow-up.

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