NEW YORK – Cancer diagnostics firm Immunovia announced on Thursday that both its fourth quarter and full-year 2021 revenues had more than doubled year over year.
For the three months ended Dec. 31, the Swedish firm reported net sales of SEK 305,000 ($32,675), up from SEK 152,000 in Q4 2020. Sales of tests were SEK 278,000, compared to none the prior year, and royalties were SEK 27,000, down 82 percent compared to SEK 152,000 in Q4 2020.
Immunovia posted a Q4 net loss of SEK 47.1 million for the period, or SEK 2.08 per share, compared to a loss of SEK 46.1 million, or SEK 2.04 per share, in Q4 2020.
Total operating expenses for the quarter were SEK 51.2 million, up 32 percent compared to SEK 38.6 million in 2020.
For the full year 2021, Immunovia reported sales of SEK 844,000, more than doubling from SEK 362,000 in the previous year. Sales of tests were SEK 344,000, up from none in 2020, and royalties were SEK 500,000, up 38 percent from SEK 362,000 in 2020.
The net loss for the year totaled SEK 156.0 million, or SEK 6.89 per share, compared to SEK 146.0 million, or SEK 6.84 per share, in 2020.
Total operating expenses for the year were SEK 167.6 million, up 24 percent year over year from SEK 135.3 million.
Immunovia had SEK 287 million in cash and cash equivalents at the end of 2021.
During the year, Lund University spinout Immunovia launched its IMMray PanCan-d blood test for early detection of pancreatic cancer in the US. CEO Philipp Mathieu said in a statement that the near-term focus for the company will be the US market but that he sees "a strong potential in other markets," and the firm continues "to review market access."
Mathieu also said that the firm has "further refined its reimbursement plan" and feels "confident about Immunovia's ability to achieve positive reimbursement coverage decisions" in the US.
Part of that reimbursement plan includes the publication on Feb. 14 of validation study results in Clinical and Translational Gastroenterology. He added that Immunovia expects the volumes of tests to significantly increase once insurance coverage is available and that the goal of the company is to have coverage toward the end of 2022.
In a separate statement, Mathieu said, "This moves us a step closer towards our goal of reimbursement in the US and pursues our mission to improve survival rates for one of the deadliest cancers. Following the publication of this peer-reviewed study, we believe that established surveillance centers and gastroenterologists will now also be in a position to expand the usage of our IMMray PanCan-d test and recommend it to their patients."
Until payor coverage is achieved in the US, Mathieu said the firm sees self-pay tests continuing at moderate volumes. The assay is currently available as a laboratory-developed test in Immunovia's CLIA-certified lab in Marlborough, Massachusetts. It received approval from the Massachusetts Department of Public Health in August to begin testing patients in that state.
The firm is also analyzing clinical performance data from its PanFAM-1 multicenter prospective study of high-risk asymptomatic patients with hereditary risk factors for pancreatic cancer, Mathieu said, with results expected to be made public in mid-2022. Other studies are also in progress, with updates coming in the second quarter, he said.
Mathieu added that the IMMray's potential for other indications is in the discovery phase. In 2019, the firm inked deals with Leiden University Medical Center in the Netherlands to study the use of its test in patients with rheumatoid arthritis and an undisclosed pharmaceutical partner for use in lung cancer.