FRACTYL HEALTH, INC. (GUTS) Earnings History

FRACTYL HEALTH, INC. - FY 2025 Earnings

Filed at: Jan 5, 2026, 7:05 AM EST|Read from source

EXECUTIVE SUMMARY

Fractyl Health is entering 2026 with a strategic focus on executing key clinical and regulatory milestones for its Revita and Rejuva programs, aiming to define the post-GLP-1 weight maintenance therapeutic category. The company has sufficient cash runway into early 2027 to support these planned advancements.

POSITIVE HIGHLIGHTS

  • •

    Approximately $85.6 million in cash and cash equivalents on hand as of January 2, 2026, providing runway into early 2027.

    positive
  • •

    Received gross proceeds of $4.1 million from exercises of Tranche A warrants from August 2025 financing.

    positive
  • •

    Revita program is advancing through pivotal validation in post-GLP-1 weight maintenance, with key data readouts and potential PMA filing expected in H2 2026.

    positive
  • •

    Rejuva gene therapy platform is progressing towards first-in-human evaluation of RJVA-001 in patients with inadequately controlled T2D.

    positive

CONCERNS & RISKS

  • •

    The company is still in the clinical development phase for both Revita and Rejuva, with significant milestones yet to be achieved and regulatory approvals pending.

    attention
  • •

    Financial results for the full year 2025 are preliminary and unaudited, and may differ materially from final audited statements.

    attention
  • •

    The success of the Revita program is dependent on positive data from ongoing cohorts and subsequent regulatory review, which carries inherent risks.

    attention

FINANCIAL METRICS

Revenue
Quarterly
N/A
N/A
Net Income
Quarterly
N/A
N/A
EPS (Diluted)
Quarterly
N/A
N/A
Operating Income
Quarterly
N/A
N/A
EPS (Basic)
Quarterly
N/A
N/A

MARGIN ANALYSIS

Margin metrics will be available once backend extracts data from insights_json

MANAGEMENT GUIDANCE

2026

clinical_milestones
"Anticipated 2026 Revita Milestones include: REMAIN-1 Midpoint Cohort 6-month data (Jan 2026), REVEAL-1 1-year data (Q2 2026), REMAIN-1 Midpoint 1-year data (Q3 2026), REMAIN-1 Pivotal Cohort 6-month data and potential PMA filing (H2 2026). Anticipated 2026 Rejuva Milestones include: Regulatory feedback on CTA for RJVA-001 (Q2 2026), First-in-human dosing and preliminary data for RJVA-001 (H2 2026)."

Forward-looking guidance is subject to change and does not constitute a guarantee. Actual results may differ materially from these estimates.

MANAGEMENT COMMENTARY

Fractyl is positioned for a definitional year in 2026 with an accelerating cadence of clinical and regulatory milestones.

— FRACTYL HEALTH, INC., FY 2025 2025 Earnings Call

Focus on disciplined execution to advance Revita as an outpatient endoscopic therapy addressing a root cause of obesity.

— FRACTYL HEALTH, INC., FY 2025 2025 Earnings Call

Weight loss maintenance is identified as the new unmet need in obesity care, following the expected trend of patients starting and stopping GLP-1 medications.

— FRACTYL HEALTH, INC., FY 2025 2025 Earnings Call

Commentary excerpts from earnings call transcripts provide management's perspective on performance, strategy, and outlook. Always review full transcripts for complete context.

OPERATIONAL METRICS

Cash And Cash Equivalents
85.6M
dollars

Operational metrics provide insight into business drivers and customer engagement beyond traditional financial measures.