Talis Biomedical Corporation
The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the Northern District of California on behalf of those who acquired Talis Biomedical Corporation (“Talis” or the “Company”) (NASDAQ: TLIS) common stock pursuant and/or traceable to the registration statement and prospectus (collectively, the “Registration Statement”) issued in connection with the Company’s February 2021 initial public offering (“IPO” or the “Offering”). Investors have until March 8, 2022 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
Talis develops diagnostic tests to enable accurate, reliable, low cost, and rapid molecular testing 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.
On February 12, 2021, the Company filed its prospectus on Form 424B4 with the SEC, which forms part of the Registration Statement. In the IPO, the Company sold 15,870,000 shares of common stock at a price of $16.00 per share. The Company received net proceeds of approximately $232.6 million from the Offering. The proceeds from the IPO were purportedly to be used for commercial activities (including the hiring and training of sales and marketing personnel), research and development, and working capital and other general corporate purposes.
On March 8, 2021, Talis announced that it had withdrawn its Emergency Use Authorization (“EUA”) application for the Talis One COVID-19 test.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 Talis’s 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 assay, which Talis believes will address the FDA’s concerns.” On this news, the Company’s stock price declined by $1.80 per share, or approximately 12.29%, from $14.65 per share 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 [Talis’s] 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 declined by $0.58 per share, or approximately 6.47%, from $8.97 per share to close at $8.39 per share on August 11, 2021.
On August 30, 2021, after the market closed, Talis announced that its Chief Executive Officer (“CEO”), Brian Coe, had “stepped down” as President, CEO, and Director. On this news, the Company’s stock price declined by $1.00 per share, or approximately 11.04%, from $9.06 per share to close at $8.06 per share on August 31, 2021.
On November 15, 2021, Talis announced that Brian Blaser was appointed as President, CEO, 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 positions. On this news, the Company’s stock price declined by $0.55 per share, or approximately 11.39%, from $4.83 per share to close at $4.28 per share on December 8, 2021.
The lawsuit alleges throughout the Class Period, Defendants made false and/or misleading statements and/or failed to disclose that: (1) the comparator assay in the primary study lacked sufficient sensitivity to support Talis’s EUA application for Talis One COVID-19 test; (2) as a result, Talis was reasonably likely to experience delays in obtaining regulatory approval for the Talis One COVID-19 test; (3) as a result, the Company’s commercialization timeline would be significantly delayed; and (4) 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.