Freenome Swings to $60.1 Million Profit as FDA Approval Delivers $100 Million

Freenome, Inc. (NASDAQ: FRNM) reported GAAP net income of $60.1 million for the third quarter of 2026, reversing a $64.5 million loss a year earlier, on revenue of $183.5 million that one approval largely built. The figures come from the earnings release furnished as Exhibit 99.1 to Form 8-K on Nov. 10, 2026. The number is real. The durability is the question.

Revenue rose from $1.0 million in the third quarter of 2025, a $182.5 million increase. Of the total, $180.0 million was recognized under Freenome's collaboration and license agreement, following FDA approval of SimpleScreen CRC.

What drove the quarter?

SimpleScreen CRC is a blood-based screening test for colorectal cancer in adults 45 and older at average risk. The FDA approved it on July 24. That triggered a $100 million milestone payment under an exclusive U.S. commercial license agreement with Exact Sciences, which Abbott assumed after acquiring that company. Abbott launched the test in the United States on Sept. 30.

Costs rose with revenue. Operating costs and expenses reached $113.5 million, up $47.2 million from $66.3 million a year earlier. Freenome attributes the increase mainly to transaction and stock-based compensation costs tied to the closing of the business combination. Stock-based compensation expense was $41.9 million, against $2.8 million in the prior-year quarter.

Adjusted EBITDA (a non-GAAP measure excluding stock-based compensation) was $117.9 million, compared with negative $56.3 million. GAAP net income also absorbed an $11.6 million loss from remeasuring convertible notes.

Nine-month results remain weaker. Freenome recorded a net loss of $72.5 million for the first nine months, against $181.1 million a year earlier. Third-quarter operating cash flow was positive at $38.4 million, and free cash flow was $35.7 million, compared with negative $44.8 million a year earlier.

How solid is the balance sheet?

Freenome went public on the Nasdaq Capital Market on July 21, raising approximately $310 million in gross proceeds. Cash, cash equivalents and marketable securities totaled $430.0 million at Sept. 30.

Two convertible notes turned into stock. Roughly $50.5 million of principal and accrued interest on the Abbott note became about 3.4 million shares at $15.00 per share. The Roche note became about 6.4 million shares at $12.00 when the business combination closed in July.

Total liabilities fell to $252.2 million at Sept. 30, from $406.6 million at Dec. 31, 2025. Stockholders' equity rose to $481.3 million from $100.4 million. The dilution was substantial: shares outstanding increased 63.2%, to 110,870,300 from 67,944,192. That arithmetic matters for anyone measuring per-share value.

What does the guidance imply?

Guidance of $192 million to $194 million in 2026 total revenue sits just above the $190.0 million already booked in the first nine months. By calculation from the filing, that implies fourth-quarter revenue of roughly $2 million to $4 million.

That is the counterargument in numbers. Approval-linked revenue drove the quarter, so the profit may overstate how the business performs without a comparable payment. Funding looks stronger after the listing and the note conversions. An operating record still has to be built.

Elsewhere in the portfolio, Freenome reported topline results from an updated version of SimpleScreen CRC that met all primary and secondary endpoints. In October it launched SimpleScreen Lung, a protein-based laboratory-developed test for adults 50 to 80 with a significant smoking history who are not in guideline-recommended screening.

What comes next?

Freenome expects its next two single-cancer readouts in December and its first asymptomatic multi-cancer detection readout in mid 2027. Positive results would supply pipeline evidence beyond this approval-driven quarter. Weak ones would leave the case resting on cash.

The company hosts a results call at 4:30 p.m. Eastern on Nov. 10. The next quarterly report will show whether fourth-quarter revenue lands within the range implied by guidance. Until then, the milestone has done its work.