FRACTYL HEALTH, INC. 8-K

What Happened

• Fractyl Health, Inc. filed a Form 8-K on January 5, 2026 (Items 2.02 and 8.01) announcing preliminary, unaudited cash balances and its strategic outlook for 2026. The company reported approximately $81.5 million in cash and cash equivalents as of December 31, 2025 and received an additional $4.1 million on January 2, 2026 from exercises of Tranche A warrants, giving a cash balance of about $85.6 million as of that date. Management says current cash is expected to fund operations through early 2027.

Key Details

• Preliminary cash and cash equivalents as of 12/31/2025: ~$81.5 million (unaudited).
• Additional proceeds from Tranche A warrant exercises received 1/2/2026: $4.1 million → cash balance ~$85.6 million as of that date.
• Shares outstanding as of 12/31/2025: 153,372,044 (includes shares issued on Tranche A warrant exercise); no Tranche A warrants remained outstanding as of 12/31/2025.
• Revita 2026 milestones (selected): late Jan 2026 — 6‑month randomized data from REMAIN‑1 Midpoint Cohort; early 2026 — complete randomizations for REMAIN‑1 Pivotal Cohort; Q2 2026 — 1‑year REVEAL‑1 cohort data; Q3 2026 — 1‑year REMAIN‑1 Midpoint cohort data; H2 2026 — topline 6‑month randomized data from REMAIN‑1 Pivotal Cohort and potential PMA filing in post‑GLP‑1 weight maintenance.
• Rejuva 2026 milestones (selected): Q2 2026 — regulatory feedback on CTA for RJVA‑001; H2 2026 — potential first‑in‑human dosing and preliminary data (subject to CTA authorization).
• Financial note: the reported amounts are preliminary and unaudited; audited consolidated financial statements for year ended 12/31/2025 are not yet available and may differ.

Why It Matters

• The company’s cash position and stated runway through early 2027 indicate it expects to fund planned 2026 clinical and regulatory activities without immediate financing, which is material for investors assessing near‑term dilution risk.
• Multiple upcoming data readouts and a possible PMA filing for Revita in H2 2026 are key operational milestones that could materially affect the company’s clinical progress and valuation.
• Investors should note the numbers are preliminary and unaudited and the filing reiterates standard forward‑looking risk language — actual results, timing, and regulatory outcomes may differ.