In February 2021, Talis completed its IPO, selling 15,870,000 shares of common stock at a price of $16.00 per share. On March 8, 2021, Talis announced that it had withdrawn its EUA application for the Talis One COVID-19 test. In a press release, the Company revealed that [i]n late February, the FDA informed the company that it cannot ensure the comparator assay used in the primary study has sufficient sensitivity to support Taliss EUA application. As a result, Talis intends to initiate its previously planned clinical validation study in a point-of-care environment to submit its EUA application early in the second quarter of 2021. This study was designed with a different comparator study, which Talis believes will address the FDA’s concerns. On this news, the Company’s stock price fell $1.80, or 12%, to close at $12.85 per share on March 8, 2021. Then, on August 10, 2021, Talis revealed that its development timelines have been extended by delays in the launching of [Taliss] COVID-19 test and manufacturing scale. As a result, Talis expect[s] to see [its] first meaningful revenue ramp in 2022. On this news, the Company’s stock price fell $0.58, or 6%, to close at $8.39 per share on August 11, 2021, on unusually heavy trading volume. On August 30, 2021, after the market closed, Talis announced that its Chief Executive Officer, Brian Coe, had stepped down as President, CEO, and Director. On this news, the Company’s stock price fell $1.00, or 11%, to close at $8.06 per share on August 31, 2021, on unusually heavy trading volume. On November 15, 2021, Talis announced that Brian Blaser was appointed as President, Chief Executive Officer, and Director of Talis effective December 1, 2021. However, a week after his appointment, on December 8, 2021, Talis announced that Brian Blaser had stepped down from his position. On this news, the Company’s stock price fell $0.55 per share, or more than 11%, to close at $4.28 per share on December 8, 2021. By the commencement of this action, Talis stock has traded as low as $3.81 per share, a more than 76% decline from the $16 per share IPO price. The complaint filed in this class action alleges that the Registration Statement was false and misleading and omitted to state material adverse facts. Specifically, Defendants failed to disclose to investors: (1) that the comparator assay in the primary study lacked sufficient sensitivity to support Taliss EUA application for 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-19 test; (3) that, as a result, the Company’s commercialization timeline would be significantly delayed; and (4) that, as a result of the foregoing, Defendants positive statements about the Company’s business, operations, and prospects, were materially misleading and/or lacked a reasonable basis.
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