Freenome Posts $183.489 Million in Third-Quarter Revenue After FDA Approval
Key Facts
Freenome said on November 10 that revenue reached $183.489 million in the third quarter of 2026, compared with $1.035 million in the same period of 2025, and that it recorded net income of $60.110 million, versus a loss of $64.469 million a year earlier. Diluted earnings per share were $0.58. The revenue surge, however, was largely concentrated in collaboration and licensing revenue, which totaled $182.547 million for the quarter. The company said $180 million of that amount was recognized primarily following U.S. Food and Drug Administration approval of the SimpleScreen CRC test. This means the period’s results reflected a significant contractual impact tied to the approval, alongside the company’s commercial activity.
Total operating expenses were $113.5 million in the third quarter, up from $66.3 million a year earlier. The company attributed the increase mainly to transaction costs and stock-based compensation related to the completion of the business combination. Despite higher expenses, Freenome recorded net cash provided by operating activities of $38.4 million, compared with cash used of $42.0 million in the year-earlier quarter. Free cash flow was also $35.7 million, versus negative cash flow of $44.8 million a year earlier. As of September 30, cash, cash equivalents and marketable securities totaled $430 million. These figures show improved cash flows and liquidity alongside the move to profitability, while quarterly revenue remains largely tied to recognition of revenue under the collaboration and licensing agreement.
The company set its 2026 revenue outlook at between $192 million and $194 million, after recording $183.489 million in the third quarter alone. Its statement links a major portion of the quarter’s revenue to the FDA’s July 24 approval of SimpleScreen CRC, which triggered a $100 million milestone payment under the exclusive U.S. commercial licensing agreement. Freenome and Abbott said when the approval was announced that Abbott would exclusively market the test in the United States. The announcement also noted that as many as 60 million Americans are overdue for recommended colorectal cancer screening. The FDA granted the test premarket approval to screen adults aged 45 and older at average risk, and said a positive result should be followed by a colonoscopy.
Abbott launched Freenome’s SimpleScreen CRC test in the United States on September 30. In the PREEMPT CRC study, which included more than 48,000 participants, the test recorded 81.1% sensitivity for detecting colorectal cancer and 13.7% for detecting advanced precancerous lesions, while specificity for advanced neoplasia was 90.4%, according to the company. The FDA describes the test as a screening tool, requires a positive result to be followed by colonoscopy, and says the test does not replace diagnostic colonoscopy. Elsewhere in its testing portfolio, Freenome announced on October 20 the launch of SimpleScreen Lung, a laboratory test intended for adults aged 50 to 80 with a smoking history of at least 20 pack-years who are not currently participating in recommended screening. The company said SimpleScreen Lung has not been reviewed, authorized or approved by the FDA, unlike the agency-approved SimpleScreen CRC.
Freenome reported that SimpleScreen Lung recorded 85% sensitivity at 50% specificity and a 99.8% negative predictive value in an independent sample of 172 lung cancer cases and 436 controls. Those results remain specific to the sample and study reported by the company, while the test has no FDA authorization or approval. The company said the next readouts for two single-cancer tests are expected in December. It also expects the first readout from its multi-cancer detection program in asymptomatic people in mid-2027. Freenome said it will discuss third-quarter results on a call and webcast on November 10 at 1:30 p.m. Pacific time, or 4:30 p.m. Eastern time.
EL7 data showed FRNM shares closed at $10.57 on November 9��, compared with $10.18 on November 6. Reliable data on the stock’s trading range during the November 9 session are not available in the documented information. These data also do not establish that the quarterly results or test launch caused the price move. The share-price reading is from the day before the results announcement published on November 10, so it does not represent a post-disclosure reaction. The reported revenue, liquidity and annual guidance remain the main elements of the company’s financial report.