KYTX: 1Q26 Recap—Miv-cel Rolling BLA Under Way for SPS; Launch Prep Continues

研报英文原文证据摘录

KYTX: 1Q26 Recap—Miv-cel Rolling BLA Under Way for SPS; Launch Prep Continues

Equity Research

Earnings Revised — May 12, 2026

Biotechnology

Kyverna Therapeutics, Inc.

1Q26 Recap—Miv-cel Rolling BLA Under Way for SPS; Overweight

Launch Prep Continues Price Target: $33.00

Notable Changes

Our Call $ (Dec) Current Prior % Chg

We remain bullish on miv-cel in SPS, as we believe investors under-appreciate the EPS 2026 (3.03) (2.44) -24.2%

combination of high unmet need, its differentiated efficacy/durability, and concentrated EPS 2027 (3.18) (2.31) -37.7%

treatment landscape that could support a rapid commercial ramp post-approval.

Ticker KYTX

Rolling BLA for SPS has been initiated with expected completion in 4Q26. Following Upside/(Downside) to Target 222.6%

FDA alignment on the core package (single arm + T2FW endpt, safety, CMC, etc.), the Price (05/12/2026) $10.23

filing will also include AAN data supporting potential disease modification (see note), 52 Week Range $2.06 - 13.67

upcoming 1-year follow-up data in 2H26, which will reinforce durability, and natural

Market Cap (MM) $482

history data (n=153) indicating minimal to no T25FW improvement. We believe the data

package is highly supportive of approval. Enterprise Value (MM) $270

Average Daily Value (MM) $9

Launch prep under way. Site activation, payer engagement, and HCP education have Dividend Yield 0.0%

begun, and mgmt expects its current manufacturing capacity to support the SPS launch.

Recall, KYTX expects to focus on 10 COEs that treat 50% of the initial ~2-2.5k target $ (Dec) Q1 Q2 Q3 Q4 FY

population, so we think the launch could ramp quickly (see here). In our follow-up with EPS

mgmt, they noted a ~50/50 split between public/commercial payers for SPS pts and 2026E (0.66) A (0.70) E (0.77) E (0.90) E (3.03) E