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Freenome Records $183.5 Million After SimpleScreen CRC Approval

License and collaboration revenue of $182.5 million followed FDA approval of the colorectal-cancer blood test, flipping the quarter to GAAP net income of $60.1 million.

Freenome, Inc. (FRNM), a personalized cancer detection company using an AI-driven multiomics platform, reported third-quarter revenue of $183.5 million after the Food and Drug Administration approved SimpleScreen CRC, a blood-based screening test for colorectal cancer.

The result compared with $1.0 million of revenue in the third quarter of 2025. License and collaboration revenue was $182.5 million, versus none a year earlier, driven primarily by $180.0 million recognized under the collaboration and exclusive U.S. commercial license agreement with Exact Sciences, assumed by Abbott after its acquisition. Service and other revenue was $0.9 million.

FDA approval on July 24, 2026, triggered a $100 million milestone payment under that agreement. Abbott launched the Freenome-developed test in the United States on September 30, 2026.

GAAP net income was $60.1 million, or $0.58 a share on a diluted basis, compared with a GAAP net loss of $64.5 million, or $0.95 a share, a year earlier. Income from operations was $70.0 million, versus an operating loss of $65.3 million. Adjusted EBITDA was $117.9 million, compared with negative $56.3 million. Non-GAAP net income was $114.0 million.

Total operating costs and expenses were $113.5 million, up from $66.3 million, an increase the company said was primarily driven by transaction and stock-based compensation costs related to the closing of the business combination. Research and development expense was $68.4 million. General and administrative expense was $44.6 million. Stock-based compensation expense was $41.9 million. A convertible-note remeasurement loss of $11.6 million was recorded.

The company went public on the Nasdaq Capital Market on July 21, 2026, raising approximately $310 million in gross proceeds. Cash, cash equivalents and marketable securities totaled $430.0 million as of September 30, 2026. Net cash provided by operating activities was $38.4 million, compared with net cash used of $42.0 million a year earlier. Free cash flow was $35.7 million.

Freenome completed the conversion of approximately $50.5 million of principal and accrued interest under the Abbott convertible note into about 3.4 million shares at $15.00 a share. Upon the July 2026 business-combination close, the Roche convertible note was converted into about 6.4 million shares at $12.00 a share.

The company reported topline results from an updated version of SimpleScreen CRC, saying the study met all primary and secondary endpoints and showed improved detection of advanced precancerous lesions, including lesions with high-grade dysplasia. In October, after quarter-end, it launched SimpleScreen Lung and the option to add SimpleScreen CRC in a single blood draw for individuals eligible for both screenings. It also received FDA Breakthrough Device Designation for the multiomics version of the lung test under development.

Chief executive Aaron Elliott said Freenome made meaningful progress in its first quarter as a public company, executing on strategic partnerships and strengthening its operating foundation, and that with SimpleScreen CRC approved and the lung program advancing, the company remains focused on expanding access to blood-based early cancer detection.

Freenome said the next two single-cancer readouts are anticipated in December and the first asymptomatic multi-cancer detection readout in mid-2027. It expects full-year 2026 total revenue of $192 million to $194 million, reflecting contributions from license and collaboration agreements, research and development services, and early commercial activities.

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