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Kyverna Therapeutics, Inc. (KYTX)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 EPS of $-0.88 missed Wall Street consensus of $-0.82; revenue was $0.00 and in-line with expectations. Strong cash position ($286.0M cash, cash equivalents and marketable securities at 12/31/2024) supports runway into 2027 * .
  • The company aligned with FDA on a pivotal Phase 2 design for SPS (KYSA-8), is ~70% enrolled, and targets topline in 1H 2026 with a 2026 BLA filing, establishing a clear commercialization path; ElevateBio onboarded as manufacturer to strengthen CMC readiness .
  • Myasthenia gravis (KYSA-6) completed initial 6-patient cohort enrollment; interim Phase 2 data expected in 2H 2025 and registrational path update in 1H 2025 .
  • Lupus nephritis programs (KYSA-1/KYSA-3) continue at target dose with Phase 1 data expected in 2H 2025; ACR data highlighted sustained efficacy >6 months and tolerability (no high-grade CRS/ICANS) at the target dose .
  • Key stock-reaction catalysts: pivotal SPS progress, late-2025 MG data, LN Phase 1 data in 2H 2025, and KYV-102 IND filing in 2H 2025 .

What Went Well and What Went Wrong

What Went Well

  • FDA alignment on SPS pivotal Phase 2 design; 70% enrollment with ElevateBio onboarded for manufacturing, reinforcing regulatory and CMC readiness for first BLA in 2026. “We are pleased with our progress… following alignment with the FDA on our registrational trial, KYSA-8… advance KYV-101 toward its first BLA filing in 2026” — Warner Biddle, CEO .
  • MG program advanced: initial 6-patient cohort fully enrolled; interim Phase 2 data expected 2H 2025; RMAT and Fast Track designations plus Orphan Drug in US/EU support accelerated path .
  • LN program momentum: ACR 2024 symposium showed sustained efficacy and durability (>6 months) at target dose, stabilizing eGFR and enabling reduction of immunosuppressants; no high-grade CRS/ICANS observed .

What Went Wrong

  • EPS missed consensus for Q4 2024 (actual $-0.88 vs consensus $-0.82), reflecting higher operating expenses as late-stage development ramps [Q4 estimates table below]*.
  • Operating expenses rose year over year (FY 2024 total operating expenses $142.6M vs $62.4M in 2023) as programs advanced, pressuring losses (FY 2024 net loss $127.5M; net loss per share $3.33) .
  • Q4 transcript was not furnished; absence of a Q4 earnings call limits real-time commentary on quarterly puts/takes and near-term OpEx cadence (company furnished Q4 2024 via 8-K with Exhibit 99.1) .

Financial Results

Quarterly Comparisons vs Prior Periods and Estimates

MetricQ4 2023Q3 2024Q4 2024Q4 2024 ConsensusSurprise
Revenue ($USD Millions)$0.00*$0.00*$0.00*$0.00*In line*
Net Income ($USD Millions)$(20.67)*$(34.49)*$(37.49)*N/AN/A
Diluted EPS ($USD)$(25.94)*$(0.80)*$(0.88)*$(0.82)*Miss $(0.06)
Total Operating Expenses ($USD Millions)$21.38*$38.77*$43.84*N/AN/A
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$57.54 $321.60 $286.00 N/AN/A

Values marked with * retrieved from S&P Global.

Notes:

  • FY context: FY 2024 net loss $127.5M and total operating expenses $142.6M underline higher spend consistent with advancing pivotal and Phase 2 programs .
  • Cash runway guided into 2027, sufficient to reach key inflection points (SPS topline and BLA, MG interim and registrational path, LN Phase 1 data) .

KPIs

KPIQ4 2023Q3 2024Q4 2024
Cash and Equivalents ($USD Millions)$34.65 $104.66 $96.62*
Operating Cash Flow ($USD Millions)$(18.56)*$(27.49)*$(37.06)*
Research & Development Expense ($USD Millions)N/A$29.19 N/A
General & Administrative Expense ($USD Millions)N/A$9.58 N/A
Total Operating Expenses ($USD Millions)$21.38*$38.77*$43.84*

Values marked with * retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious Guidance (Q3 2024)Current Guidance (Q4 2024)Change
SPS Phase 2 KYSA-8 dosing/enrollmentLate 2024/2025Anticipated initiating dosing by end of 2024 ~70% enrolled; complete enrollment mid-2025 Updated (progress and timing specified)
SPS Topline1H 2026Not specified Topline pivotal Phase 2 data in 1H 2026 New specific timing
SPS BLA filing2026Not specified BLA filing targeted in 2026 New specific timing
MG registrational path1H 2025Dosing initiated; engaging FDA Confirm registrational path with regulators in 1H 2025 Maintained/clarified
MG interim Phase 2 data2H 2025Not specified Interim data in 2H 2025; initial 6-patient cohort enrolled New specific timing
LN Phase 1 data2H 2025Target dose treatment ongoing; ACR 2024 data presentation Phase 1 data in 2H 2025 Maintained/clarified
KYV-102 IND2H 2025Preclinical platform highlighted; no IND timing IND filing in 2H 2025 New specific timing

Earnings Call Themes & Trends

Note: A Q4 2024 earnings call transcript was not furnished. Themes below track narrative evolution across Q2 and Q3 press releases, with Q4 current-period derived from the Q4 2024 8-K press release content.

TopicPrevious Mentions (Q-2: Q2 2024)Previous Mentions (Q-1: Q3 2024)Current Period (Q4 2024)Trend
Regulatory alignment (SPS)RMAT for SPS; progressing KYSA trials Anticipated initiating SPS dosing by end-2024 FDA-aligned pivotal Phase 2 design; ~70% enrolled; topline 1H 2026; BLA 2026 Strengthening
MG developmentRMAT for MG; dosing initiated Dosing initiated; EMA Orphan; expanding program Initial 6-patient cohort complete; interim 2H 2025; registrational path update 1H 2025 Advancing
LN clinical dataMulti-center Phase 1/2 ongoing; target dose ACR 2024 planned data sharing ACR 2024: sustained efficacy >6 months; safety tolerability; phase data 2H 2025 Positive momentum
Manufacturing readiness100% manufacturing success cited; platform maturation ElevateBio agreement as second-source supplier ElevateBio onboarded for SPS trial products; CMC readiness Scaling
Cash runwayStrong cash and securities ($346.2M) Strong cash and securities ($321.6M) $286.0M at 12/31/24; runway into 2027 Sufficient for milestones

Management Commentary

  • “Kyverna has entered 2025 and its next phase of growth with the right strategy and a strong team in place to advance late-stage development of KYV-101… We are pleased with our progress in our lead indication, stiff person syndrome, following alignment with the FDA on our registrational trial, KYSA-8… toward its first BLA filing in 2026.” — Warner Biddle, CEO .
  • LN at ACR: “Data reinforce that treatment with KYV-101 drives deep B cell depletion… stabilize eGFR, preserve kidney function… eliminating immunosuppressants… manageable safety profile.” — Prof. Georg Schett, M.D. .
  • Corporate scaling: ElevateBio manufacturing; Board additions (Christi Shaw, Mert Aktar) bolster strategy and cell therapy manufacturing expertise .

Q&A Highlights

  • No Q4 2024 earnings call transcript was furnished; management’s current-period messages come from the Q4 press release and ACR symposium materials .
  • Regulatory clarity: Explicit SPS pivotal timeline and BLA target help frame near-term milestones .
  • Data cadence: MG interim and LN Phase 1 data set expectations for 2H 2025 .
  • CMC and access: ElevateBio onboarding signals readiness; continued progress on next-gen KYV-102 rapid manufacturing (Ingenui-T) with IND targeted for 2H 2025 .

Estimates Context

MetricQ4 2024 ConsensusQ4 2024 ActualResult
EPS ($USD)$(0.82)*$(0.88)*Miss $(0.06)
Revenue ($USD Millions)$0.00*$0.00*In line*

Values marked with * retrieved from S&P Global.

Implications:

  • EPS miss reflects higher operating spend consistent with pivotal and Phase 2 program advancement; with no revenue, loss trajectory tracks OpEx scaling *.
  • With clear SPS pivotal/BLA pathway and 2025 data catalysts, estimate revisions are likely to focus on OpEx timing and potential pre-commercial build, not near-term revenue.

Key Takeaways for Investors

  • SPS is now on a pivotal track with FDA alignment; topline in 1H 2026 and BLA in 2026 create a concrete pathway to first commercialization in autoimmune CAR T .
  • MG and LN provide 2025 data catalysts (MG interim 2H 2025; LN Phase 1 2H 2025), diversifying the indication set and supporting platform value .
  • Cash runway into 2027 should fund pivotal SPS, MG interim, LN Phase 1, and KYV-102 IND, mitigating financing risk near term .
  • EPS miss in Q4 2024 is driven by investment in R&D and development scale-up; expect OpEx-heavy quarters ahead as programs progress *.
  • Manufacturing partnerships (ElevateBio) and CMC readiness reduce execution risk for pivotal delivery and eventual scale-up .
  • Regulatory designations (RMAT, Fast Track, Orphan) across SPS/MG/LN support expedited pathways and potential market access advantages .
  • Near-term trading: stock may be sensitive to enrollment completion updates in SPS and any interim safety/efficacy signals; medium-term thesis hinges on 2025 readouts and 2026 SPS BLA timing .
All values without explicit document citations are retrieved from S&P Global.

Sources

  • Q4 2024 8-K 2.02 + Press Release (Exhibit 99.1): alignment on SPS pivotal design, enrollment progress, guidance, FY 2024 financials, and balance sheet .
  • Q3 2024 8-K 2.02 + Press Release: program updates, manufacturing agreement, and quarter financials .
  • Q2 2024 8-K 2.02 + Press Release: RMAT designations, program breadth, and quarter financials .
  • ACR 2024 LN data press release: sustained efficacy/tolerability at target dose; manufacturing next-gen process (Ingenui-T) .
  • Board appointment press release: strategic manufacturing and corporate expertise added .