Clinical biotech Kyverna Therapeutics (KYTX) priced its upsized IPO at $22.00 – $1.00 above its recently increased range – on 14.5 million shares – the number of shares in the prospectus – to raise $319 million on Wednesday night (Feb. 7, 2024). The $22.00 IPO price exceeded Kyverna’s price range of $20.00 to $21.00, which was disclosed on Tuesday when the IPO was upsized. The Phase 2 clinical biotech is developing cell therapies to treat multiple sclerosis (MS) and other autoimmune disorders. Kyverna’s stock closed at $30.00 – up $8.00 or up 36.36 percent – from its $22.00 IPO price in its NASDAQ debut today – Thursday, Feb. 8, 2024. Volume was 6.02 million shares.
The stock took flight with its opening trade. Kyverna’s stock surged 55.68 percent to start trading at $34.25 at 1:35 p.m. EST today (Thursday, Feb. 8, 2024) on the NASDAQ. NASDAQ. Volume was a little over 900,000 shares on that opening trade, NASDAQ records showed. The stock later glided up to $34.90 – up $12.90 or 58.61 percent from its $22.00 IPO price. Volume was about 2.63 million shares in mid-afternoon trading.
J.P. Morgan, Morgan Stanley, Leerink Partners and Wells Fargo Securities were the joint book-runners.
Kyverna upsized its IPO by 48.5 percent early Tuesday (Feb. 6, 2024) – a day ahead of its pricing – to 14.5 million shares – up from 11.12 million shares – at $20.00 to $21.00 – up from $17.00 to $19.00 initially.
At the $22.00 IPO price, Kyverna’s initial public offering raised $21.75 million more than the $297.25 million in estimated IPO proceeds from its increased terms disclosed Tuesday (Feb. 6, 2024) in its S-1/A filing.
Kyverna plans to use the IPO proceeds to finance clinical trials and preclinical R&D work, the prospectus says.
The $22.00 IPO price gave Kyverna Therapeutics a market cap (valuation) of $898.04 million.
Big Pharma Backing from Gilead
Gilead Sciences, Inc. (GILD) has backed Kyverna since the biotech’s inception in 2018. Gilead’s pre-IPO stake in Kyverna represented 12.2 percent of the biotech’s outstanding stock. After the IPO, Gilead’s stake was set to drop to 7.9 percent, the prospectus says.
Gilead also had a research and development (R&D) collaboration agreement with Kyverna from January 2020 until Jan. 22, 2024. The agreement was terminated in late January 2024 due to completion of the collaborative research focused on Crohn’s disease and ulcerative colitis, the prospectus says.
Cell Therapy for MS and Lupus Nephritis
Kyverna Therapeutics, based in Emeryville, California, is evaluating its lead product candidate, KYV-101, as a cell therapy targeting autoimmune disorders in neurology and rheumatology. KYV-101 is an autologous CD19 CAR T-cell product candidate made from an underlying chimeric antigen receptor, or CAR, that Kyverna has licensed from the National Institutes of Health (NIH).
Kyverna is conducting Phase 2 clinical trials for multiple sclerosis (MS) and myasthenia gravis – its target diseases in the neurology field.
The California biotech is conducting two Phase 1 trials in the United States and Germany to evaluate KYV-101 as a cell therapy for patients with lupus nephritis (LN) – a target disease in the rheumatology field. The prospectus describes LN as “an autoimmune disease in which more than half of the patients do not achieve a complete response to current therapies and are at risk of developing kidney failure.”
Kyverna received an Investigational New Drug (IND) clearance from the FDA in October 2023 for a Phase 1/Phase 2 clinical trial to evaluate KYV-101 as a treatment for systemic sclerosis (SSc) – part of its rheumatology program – the prospectus says. The Merck Manual describes systemic sclerosis as “a rare chronic disease of unknown cause characterized by diffuse fibrosis and vascular abnormalities in the skin, joints and internal organs, especially the esophagus, lower GI tract, lungs, heart and kidneys.” Systemic sclerosis is about four times more common among women than men, the Merck Manual says, noting that the disease “is most common among people aged 20 to 50 and is rare in children.”
B cells, the culprits in autoimmune diseases, are the targets of Kyverna’s cell therapy program, according to the prospectus.
“We believe our approach may present a significant advantage over current standard-of-care therapies for autoimmune diseases by aiming to directly deplete B cells and potentially resetting disease-contributing B cells.,” the prospectus says.
A Partnership Focused on IBD Treatment
Kyverna is also in a partnership with Intellia Therapeutics, a leader in the field of gene editing. Kyverna and Intellia will work together to develop KYV-201, an allogeneic CD19 CAR T-cell product candidate, to treat other autoimmune diseases such as inflammatory bowel disease (IBD), which includes Crohn’s disease and ulcerative colitis.
The California biotech is not profitable. Kyverna reported a net loss of $48.1 million on $280,000 of collaboration revenue for the 12 months that ended Sept. 30, 2023, according to the prospectus.
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