NEW YORK – Molecular diagnostic point-of-care testing firm Talis Biomedical reported after the close of the market on Tuesday that its second quarter revenues fell 86 percent year over year due to a reduction in grant revenue.
For the three months ended June 30, the Menlo Park, California-based company reported revenues of $117,000 compared to $820,000 in Q2 of 2020. Its revenue for the recently completed second quarter came from a National Institutes of Health grant.
The firm said that in Q2 it completed a clinical validation study for the Talis One COVID-19 assay at the point of care to support an Emergency Use Authorization application to the US Food and Drug Administration, which it submitted on July 23. It is also in the final stages of validation for the first set of automated production lines for the test's cartridges.
"As we prepare for commercial launch of this first assay [and] continue to optimize our manufacturing capabilities and broaden our test menu, we are building our core foundation for the future to meet the needs of the large and growing respiratory, sexual health, and women’s health testing markets," Brian Coe, CEO of Talis, said in a statement.
On a conference call to discuss the Q2 financial results, he added that tests that can provide results while the patient is still present could improve health outcomes, in particular for infectious diseases. He said that in time, he expects a transition away from centralized testing, and "Talis is well-positioned to be one of a small number of companies that will serve this increasingly decentralized global diagnostic testing market at scale."
Validation of its Talis One COVID-19 test using clinical samples exceed FDA guidance at 95 percent concordance with the test results for a comparator assay, including both the positive and negative percent agreement, but the firm cannot predict the timing of a potential EUA, Coe said.
Broadening the test menu "to meet the needs of customers and expand our addressable market" continues to be a primary objective, he said.
Talis had planned this year to seek EUA for a test that detects SARS-CoV-2 and influenza and initiate clinical trials for a test that detects Chlamydia trachomatis and Neisseria gonorrhoeae.
However, according to Coe, the company has had to extend its development timelines due to delays in the launch and the manufacturing scale-up of its COVID-19 test.
Talis reported a Q2 net loss of $64.5 million, or $2.51 per share, compared to a net loss of $10.0 million, or $4.75 per share, in Q2 2020, well short of the analysts' average estimate for a loss of $.91 per share. The company, which went public earlier this year, used 25,648,151 weighted average shares to calculate its loss-per-share figure for Q2 compared to 2,116,623 in the prior-year quarter.
Its Q2 R&D expenses rose more than sixfold year over year to $54.5 million from $8.2 million, while its SG&A costs rose 270 percent year over year to $10.0 million from $2.7 million.
Talis had $313.5 million in cash and $34.7 million in restricted cash as of June 30.
In Wednesday morning trading on the Nasdaq, Talis Biomedical's shares dropped more than 10 percent to $8.05.