Key Highlights

  • Third-quarter Revenue was USD 183.5 million against USD 1.0 million a year earlier, driven mainly by USD 180.0 million recognized under the collaboration and license agreement after FDA approval of SimpleScreen CRC.
  • GAAP Net Income was USD 60.1 million, or USD 0.58 per diluted share, versus a net loss of USD 64.5 million, or USD 0.95; non-GAAP net income was USD 114.0 million.
  • Adjusted EBITDA was USD 117.9 million, compared with a negative USD 56.3 million a year earlier, while net cash provided by Operating Activities was USD 38.4 million.
  • Cash, cash equivalents and marketable securities totaled USD 430.0 million at September 30, 2026, after the company raised about USD 310 million in gross proceeds when it listed on July 21, 2026.

SimpleScreen CRC Approval Triggers a One-Time Revenue Surge

Freenome (NASDAQ:FRNM) reported third-quarter 2026 results on November 10, 2026. The company is a cancer detection Business that uses an AI-driven multiomics platform to build blood tests. The FDA approved SimpleScreen CRC on July 24, 2026 as a blood-based colorectal cancer screening test for adults 45 and older at average risk. That triggered a USD 100 million milestone under its collaboration and exclusive U.S. commercial license agreement with Exact Sciences, which Abbott assumed after acquiring it. Abbott launched the test in the United States on September 30, 2026. License and collaboration revenue was USD 182.5 million against none a year earlier, and service and other revenue was USD 0.9 million.

A Milestone-Driven Profit Despite Higher Listing and Stock Costs

Operating costs and expenses rose to USD 113.5 million from USD 66.3 million, which the company attributed mainly to transaction and stock-based compensation costs tied to the business combination. Research and Development was USD 68.4 million and general and administrative expense was USD 44.6 million. Operating Income was USD 70.0 million against a loss of USD 65.3 million, and a USD 11.6 million convertible note remeasurement loss sat below that line. Over nine months, the picture is different: revenue was USD 190.0 million but the GAAP net loss was USD 72.5 million, or USD 0.92 a share. The quarter's profit therefore rests on a single approval event rather than on recurring product sales.

Guidance Implies a Steep Fourth-Quarter Revenue Drop

Freenome guided full-year 2026 revenue to USD 192 million to USD 194 million. With nine-month revenue at USD 190.0 million, that implies fourth-quarter revenue of about USD 2.0 million to USD 4.0 million, a calculation from two published numbers. Convertible notes were settled in equity: the Roche note into about 6.4 million shares at USD 12.00 and about USD 50.5 million of the Abbott note into about 3.4 million shares at USD 15.00. The company launched SimpleScreen Lung in October and expects two single-cancer readouts in December and a first multi-cancer readout in mid 2027. Risks include regulatory timelines, reimbursement, market adoption and the ability to raise more capital.

Where Things Stand

Not at this scale, on the company's own guidance. Freenome (NASDAQ:FRNM) booked USD 180.0 million under its license agreement after approval, and its own guidance points to far lower revenue in the fourth quarter, about USD 2.0 million to USD 4.0 million by calculation. The quarter's profit and USD 117.9 million adjusted EBITDA came from a milestone, while the nine-month net loss was USD 72.5 million. Cash of USD 430.0 million gives room to fund development. Next markers are the December single-cancer readouts, Abbott's rollout of SimpleScreen CRC and the first multi-cancer readout in mid 2027.