Talis Biomedical Corporation (TLIS) Issued a Misleading Registration Statement in Connection with its IPO
A shareholder filed a class action on behalf of all persons and entities that purchased or otherwise acquired Talis Biomedical Corporation (NASDAQ: TLIS) common stock pursuant to or traceable to the Company’s February 2021 initial public offering (“IPO”). Talis purportedly develops diagnostic tests for infectious diseases and other conditions at the point-of-care. The Talis One tests are being developed for respiratory infections, infections related to women’s health, and sexually transmitted infections.
According to the complaint, Talis conducted its IPO in February 2021. In its Registration Statement, the Company disclosed that in January 2021, it had submitted a request for an Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for “our Talis One platform with COVID-19 molecular diagnostic assay for the automated detection of nucleic acid from the SARS-CoV-2 virus in nasal swab samples from individuals suspected of COVID-19 by their healthcare provider.” However, the Registration Statement failed to state: (i) that the comparator assay in the primary study lacked sufficient sensitivity to support Talis’s EUA application for the Talis One COVID-19 test; (2) that, as a result, Talis was reasonably likely to experience delays in obtaining regulatory approval for the Talis One COVID-test; and (iii) therefore, the Company’s commercialization timeline would be significantly delayed.
On March 8, 2021, Talis announced it had withdrawn its EUA application for the Talis One COVID-19 test after the FDA informed the Company “that it cannot ensure the comparator assay used in the primary study has sufficient sensitivity to support Talis’s EUA application.” On this news, the Company’s stock price fell 12%, to close at $12.85 per share on March 8, 2021. Then, on August 10, 2021, Talis reported its second quarter 2021 financial results, indicating the Company had “[s]ubmitted an EUA application for Talis One System and Talis One COVID-19 Assay to the FDA on July 23, 2021.” However, the Company’s “development timelines have been extended by delays in the launching of [Talis’s] COVID-19 test and manufacturing scale” and revenue is unpredictable. On this news, the Company’s stock fell 6%.
On August 30, 2021, Talis announced its CEO had “stepped down” as President, CEO, and Director. On this news, the Company’s stock fell 11%, to close at $8.06 per share on August 31, 2021. Talis appointed a new President, CEO, and Director effective December 1, 2021; however, that individual stepped down on December 8, 2021. On this news, the stock price fee more than 11%, to close at $4.28 per share on December 8, 2021.
By the commencement of the class action, Talis’s stock traded as low as $3.81 per share, a more than 76% decline from the $16 IPO price.
If you purchased shares of Talis Biomedical Corporation (TLIS) pursuant to the Company’s February 2021 IPO, you have until March 8, 2022, to ask the court to appoint you lead plaintiff for the class.
All representation is on a contingency fee basis. Shareholders pay no fees or expenses.