IN RE Talis Biomedical Securities Litigation

District Court, N.D. California·Decided February 9, 2024·No. 3:22-cv-00105·Unknown

Opinion

IN RE TALIS BIOMEDICAL Case No. 22-cv-00105-SI CORPORATION SECURITIES ORDER RE: PLAINTIFF’S MOTION FOR CLASS CERTIFICATION Re: Dkt. No. 126

On February 9, 2024, the Court held a hearing on plaintiff’s motion for class certification. For the reasons set forth below, the Court GRANTS the motion. BACKGROUND1 In 2022, two class actions were filed in this court on behalf of investors who purchased securities of Talis Medical Corporation (“Talis”) in its February 2021 initial public offering (“IPO”). The cases were consolidated, and the Court appointed Martin Dugan, Leon Yu, and Max Wisdom Technology Ltd. as co-lead plaintiffs.2 The defendants include Talis Corporation and current and former Talis officers and board members who signed Talis’s Registration Statement for the IPO. Talis is a biotechnology company that was founded in 2010 to develop point-of-care (“POC”) diagnostic tests for infectious diseases. Talis developed the Talis One System, a diagnostic

1 A more detailed statement of the factual background is contained in prior orders and is incorporated herein. platform comprised of (1) single-use test cartridges that prepare and store patient samples, (2) a box- shaped instrument that analyzes the samples, and (3) software. In 2018, Talis was developing rapid POC diagnostic tests for sexually transmitted infections such as chlamydia and gonorrhea. After the onset of the COVID-19 pandemic in early 2020, Talis abandoned its original focus on sexually transmitted diseases, and by summer 2020 started to develop a molecular test for COVID-19. Talis’s COVID-19 test was slated to be the source of substantially all of Talis’s initial revenue. On February 11, 2021, Talis conducted its IPO of Talis common stock at $16 per share, raising $253.9 million. The amended consolidated complaint (“AC”) alleges that the Registration Statement filed the same day contained multiple false and misleading statements and two omissions of known, material uncertainties and risks. Plaintiff claims that the Registration Statement falsely claimed that Talis’s “products are manufactured by several third parties, including a single contract manufacturer that provisions the parts and assembles our instrument,” and Talis had “ordered 5,000 instruments from our instrument contract manufacturing partners to be delivered” from “the fourth quarter of 2020 through the first quarter of 2021” and that these statements were false because at the time of the IPO, “Talis had not ‘ordered’ any instruments, but merely had a capacity agreement with its third-party manufacturer” and “the manufacturer had not started to produce Talis One instruments, and none of the 5,000 instruments had been delivered to Talis.” AC ¶¶ 8-9. Plaintiff also claims that the Registration Statement falsely “touted Talis One as ‘reliable,’ ‘highly accurate,’ and designed ‘to provide central lab levels of accuracy at the point-of-care,’” and that these statements were false because at the time of the IPO, “Talis One had a high failure rate of up to 20% (meaning one in five results was unusable) and high invalid rates of up to 15%, which were viewed as unacceptable both internally and by the FDA.” Id. ¶¶ 12-13. As to material omissions, the AC alleges that the Registration Statement omitted the known, material uncertainty and material risk that the FDA would reject the comparator assay in Talis’s submission for Emergency Use Authorization (“EUA”) because it lacked “high sensitivity” and violated FDA requirements, and that the Registration Statement omitted the known, material risk posed by Talis One’s unreliability at the time of the IPO. Id. ¶¶ 16, 20. sensitive to support Talis’s EUA application, and on March 8, 2021, Talis issued a press release stating that it had withdrawn its application. The Talis One has never launched, and on the day this lawsuit was filed, the share price was $3.31. The AC asserts claims under Sections 11 and 15 of the Securities Act of 1933, 15 U.S.C. §§ 77k, 77o. As part of the IPO, stockholders who held Talis securities before the IPO entered into Lock- Up agreements with Talis’s underwriters. Shevlin Decl. ¶ 2. Those agreements restricted the sale or transfer of pre-IPO shares until August 11, 2021 at 11:59 p.m. Id. ¶ 9. After that date, the lock- up restrictions were removed, and both IPO and pre-IPO shares were available on the open market. Id. Lead plaintiff Dugan seeks certification of the following class: All persons or entities that purchased or otherwise acquired common stock issued by Talis pursuant and/or traceable to the registration statement and prospectus (collectively the “Registration Statement”) issued in connection with the Company’s February 11, 2021 initial public offering and were damaged thereby.3 At the hearing, plaintiff’s counsel clarified that the end date of the proposed class is January 7, 2022, the date that the first lawsuit was filed. In support of the class certification motion, Dugan has submitted the expert report of Zachary Nye, Ph.D., an economist who opines on whether damages under Section 11 for investors who purchased or otherwise acquired Talis common stock pursuant and/or traceable to the Registration Statement can be calculated using a method common to the class. Dkt. No. 127-1. Dugan also submitted, with the reply brief, the expert declaration of Professor Joshua Mitts, who addresses tracing.4 Dkt. No. 138-1. Defendants oppose class certification, contending that lead plaintiff Dugan is inadequate and 3 Excluded from the Class are (i) defendants and any affiliates or subsidiaries thereof, (ii) present and former officers and directors of Talis and its subsidiaries or affiliates, and their immediate family members (as defined in Item 404 of SEC Regulation S-K, 17 C.F.R. § 229.404, Instructions (1)(a)(iii) & (1)(b)(ii)); (iii) defendants’ liability insurance carriers, and any affiliates or subsidiaries thereof; (iv) any entity in which any defendant has or has had a controlling interest; (v) Talis’s employee retirement and benefits plan(s); and (vi) the legal representatives, heirs, estates, agents, successors, or assigns of any person or entity described in the preceding five categories.

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IN RE Talis Biomedical Securities Litigation, (N.D. Cal. 2024).

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