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Kardigan — Third Quarter 2026 Earnings Summary

  • Financial Performance:

    • Cash, cash equivalents, and investments totaled $591.4 million as of September 30, 2026, an increase from $335.5 million as of December 31, 2025, primarily driven by net proceeds from the June 2026 IPO.
    • Research and development expenses were $64.4 million for the quarter ended September 30, 2026, compared to $49.1 million in the prior-year period.
    • General and administrative expenses were $22.2 million for the quarter, compared to $9.9 million in the prior-year period.
    • Net loss was $58.6 million for the quarter ended September 30, 2026, compared to $60.2 million in the prior-year period.
    • Net loss per share (basic and diluted) was $0.64 for the quarter, compared to $4.43 in the prior-year period.
    • Total operating expenses were $64.8 million for the quarter, compared to $59.1 million in the prior-year period.
    • Loss from operations was $64.8 million for the quarter, compared to $59.1 million in the prior-year period.
    • Interest income was $6.2 million for the quarter, compared to $1.5 million in the prior-year period.
    • A change in fair value of contingent milestone liabilities resulted in a $21.8 million gain for the quarter, compared to no such item in the prior-year period.
    • Total assets were $649.3 million as of September 30, 2026, compared to $390.9 million as of December 31, 2025.
    • Total stockholders' equity was $572.5 million as of September 30, 2026, compared to a deficit of $250.3 million as of December 31, 2025.
    • Total redeemable convertible preferred stock was $0 as of September 30, 2026, compared to $586.2 million as of December 31, 2025.
  • Guidance and Future Outlook:

    • Topline data for the Phase 2b portion of the KINSHIP-DCM trial (danicamtiv) is expected in the second quarter of 2027.
    • Topline data for the Phase 2b KATALYST-AV trial (ataciguat) at Week 48 is expected in the second half of 2027.
    • Topline data for the Phase 2 KARDINAL-ASH trial (tonlamarsen) is expected in the second half of 2027.
    • An update on the Phase 3 trial for ataciguat is expected in the first half of 2027.
    • Cash runway supports continued advancement of all three programs through clinical data readouts and the initiation of Phase 3 clinical trials across all programs.
  • Business Segments and Product Lines:

    • Danicamtiv: Enrollment is complete in Cohort 2 of the Phase 2b portion of the KINSHIP-DCM adaptive trial; Phase 3 enrollment is underway across both cohorts. The drug targets genetic dilated cardiomyopathy (DCM) by restoring myosin function.
    • Ataciguat: Enrollment is complete in the Phase 2b KATALYST-AV trial (n=156) for aortic stenosis. The primary endpoint (aortic valve calcium) will be assessed at Week 48. Real-world data indicates patients with cardiac damage are more likely to progress rapidly, informing patient selection for future Phase 3 trials.
    • Tonlamarsen: Enrollment is ongoing in the Phase 2 KARDINAL-ASH trial for acute severe hypertension. The drug targets hepatic angiotensinogen. Early insights are being used to refine the study design.
    • Prolaio: The subsidiary continues to provide real-world physiologic data to optimize trial design and advance digital clinical endpoints.
  • Market and Competitive Landscape:

    • Real-world data analysis of approximately 45,000 people with mild-to-moderate aortic stenosis highlights the progressive nature of the disease in both the valve and myocardium, identifying a large addressable patient population for ataciguat.
    • The KINSHIP-DCM trial represents the first placebo-controlled trial of people with dilated cardiomyopathy to report data.
    • The adaptive 2b/3 study design for danicamtiv allows for adjustments to the Phase 3 registrational portion to increase the probability of success based on Phase 2b data.
  • Risks and Challenges:

    • Forward-looking statements are subject to risks including the ability to execute on strategy, obtain regulatory approvals, and complete development activities.
    • Risks include uncertainties in preclinical and clinical development, potential failure of interim results to predict final outcomes, and the need for substantial additional funds to commercialize products.
    • Specific risks include regulatory developments, intellectual property protection, and the ability to attract and retain key personnel.
  • Management Commentary and Tone:

    • CEO Tassos Gianakakos stated the company made "meaningful progress" in advancing its late-stage portfolio.
    • Management expressed confidence in the ataciguat program following new evidence presented at the AHA Scientific Session.
    • The company emphasized its ability to deliver "value-inflecting data" in 2027 for all three programs due to its current funding position.
  • Other Key Points:

    • On September 30, 2026, the Company appointed Kristin Reinke, former Vice President of Finance at Google, to its Board of Directors and as chair of the Audit Committee.
    • The Company completed its initial public offering in June 2026, which significantly increased its cash position.
    • Data from the KARDINAL trial regarding tonlamarsen was published in the American Journal of Preventive Cardiology and presented at the American Heart Association Scientific Sessions.
    • An archived webcast featuring independent perspectives from Dr. Philippe Pibarot and Dr. Sreekanth Vemulapalli regarding ataciguat findings is available on the investor relations website.
Company
KARDIGAN INC
Sector
Healthcare
Industry
Biotechnology