Tollen v. Geron Corporation

District Court, N.D. California·Decided April 12, 2021·No. 3:20-cv-00547·Unknown

Opinion

NORTHERN DISTRICT OF CALIFORNIA

JULIA JUNGE and RICHARD JUNGE, on behalf of themselves and a class of similarly No. C 20-00547 WHA situated investors,

Plaintiffs,

v. ORDER RE MOTION TO DISMISS AMENDED CONSOLIDATED GERON CORPORATION and JOHN A. CLASS ACTION COMPLAINT AND SCARLETT, REQUESTS FOR JUDICIAL NOTICE Defendants.

INTRODUCTION In this securities action, defendants move to dismiss for failure to state a claim on which relief can be granted, and for judicial notice. For the following reasons, defendants’ motions are GRANTED IN PART AND DENIED IN PART. The essence of the following long analysis is this: the amended complaint adequately alleges that Geron should have disclosed the bad news when it touted the good and that failure to do so was misleading. The purportedly good news was that more than 50% of those enrolled in IMbark, the imetelstat Phase 2 study, remained alive at 19 months (a metric called “median OS”). Geron This 19-month longevity was promising for the myelofibrosis patients, even though Scarlett warned investors that this promising news was tempered by a lack of control arm. The allegedly bad news was that other metrics under study — in particular, SVR, Total Symptom Score (TSS) reduction, and remission — did not look promising. TSS refers to patients’ self-report about the level of debilitating symptoms that myelofibrosis causes, and whether those symptoms improved. Defendants disclosed that imetelstat’s SVR result was, in fact, disappointing. But defendants failed to disclose the bad news about the other two metrics. The most important time to give investors an accurate account of the drug’s promise would have been the March 2018 investor call immediately following defendants’ final analysis of the IMbark data. Instead, Scarlett said the following:

[O]utcome measures for efficacy, including spleen volume responses and reductions in Total Symptom Score remain consistent with the prior data reviews; [and] with a median follow-up of approximately 19 months as of the January 2018 data cut, the median overall survival has not been reached in either dosing arm . . . . Janssen will amend the IMbark protocol to establish an extension phase of the trial to enable patients remaining in the treatment phase to continue to receive imetelstat per investigator discretion . . . . Patients will continue to be followed for survival (Exh. 16 at 6, emphasis added). “Prior data reviews” refer to defendants’ earlier disclosures. About the co-primary endpoint SVR, defendants had previously revealed, “[T]he spleen volume response rate observed to date was less than that reported in front-line MF patients treated in trials with other drugs.” (All prior front-line studies’ SVR results ranged from 48% to approximately 26.5%.) In fact, defendants publicly cautioned investors about the SVR metric at least seven times before and during the class period. They did so by repeating that SVR seen was less than prior first-line studies, or by referencing the prior data reviews. This sufficiently disclosed the bad news vis-a-vis SVR (Exhs. 9 at 6; 11 at 9, 13; 12 at 23; 16 at 6; 19 at 16; 20 at 8; Amd. Compl. ¶¶ 82, 83, 98, 100, 113, 122). This order turns now to prior data reviews of imetelstat’s effect on patients’ cancer symptoms, i.e. TSS. Geron disclosed, in its 2017 SEC Form 10K (released March 2018), and three more times, that IMbark patients in the study showed “reductions in” TSS. This statement suggested that the drug showed promise. Defendants neglected to mention, however, that the reduction in patients’ symptom scores was much poorer that what was seen in the pilot study, giving the impression of unqualified optimism about TSS (Exhs. 15 at 8; 9 at 6; 11 at 13; 12 at 23; 16 at 6; 18 at 10). Turning to remission, in March 2018, with the remission data already final, defendants warned investors that the very positive pilot study results “may not be seen.” To accurately characterize the remission data, Scarlett should have revealed the truth once the data were no longer “interim” (Amd. Compl. ¶¶ 26, 36, 105; Exhs. 9 at 6; 8 at 14–15; 12; 16 at 6, 10–11; 12 at 3). In summary, in the block quotation above, the company and Scarlett told investors that SVR results disappointed. They referenced early vague-but-positive assessments of TSS; the prior data reviews had not discussed remission results. Defendants did not reveal even the outlines of the true TSS and remission outcomes. Of course, defendants also said Geron and Janssen were redesigning IMbark to study what was looking best, survival (median OS). Defendants never stated, however, that the one- year study extension would focus exclusively on median OS. Had defendants so clarified, the study extension alone might have tipped off investors that imetelstat failed with respect to the other metrics. But defendants stated publicly in their SEC filing in March 2018, for example, that after the study extension defendants would evaluate the data, “including” survival outcomes. In the block quote above, they stated simply that patients would “be followed” for survival. Since investors may have reasonably believed other metrics (including TSS and remission) were still being studied, the study design change alone could not have corrected investors’ potentially inflated expectations of the TSS and remission results (Exh. 15 at 5; see also Exhs. 11 at 16; 16 at 6). Ultimately, the TSS disclosure and remission nondisclosure may have misled investors because the undisclosed news was pretty disappointing: as of September 2018 (the close of the class period) only 10% of IMbark patients showed a SVR reduction of at least 35% volume (compared to prior studies’ results of between 48% and 25.6% volume), only 32% (compared to 77% in the imetelstat pilot study) showed a TSS reduction of at least 50%, zero patients saw complete remission, and one saw partial remission (compared to 23% in the imetelstat pilot study). Geron did not disclose these specifics until September 27, 2018. Shortly thereafter, the bottom fell out for Geron’s stock prices. The complaint adequately alleges that defendants had to give the contours, or perhaps even the specifics, of the unpromising metrics. The reason Geron’s stock price later cratered was that Janssen bailed on the partnership. Although Geron warned investors that Janssen had the right to quit at any time; that median OS climbed higher still (to 23 months by September 2018); and that that imetelstat could (and did) go to a Phase 3 study largely on the strength of the survival data, Janssen may have bailed out in part because of the undisclosed discouraging metrics. The complaint sufficiently alleges that the market did not already know that these metrics lacked the expected promise. The complaint does not adequately allege, however, that Geron or Scarlett knew of Janssen’s supposedly likely departure. * * * On January 23, 2020, individual investor Michael Tollen filed a putative class action against defendant Geron and Scarlett, alleging false and misleading statements in violation of federal securities laws. That same day, Tollen’s counsel published a notice in PR Newswire informing investors that a class action lawsuit had been filed against Geron and that investors had 60 days from the publication of the notice to seek appointment as lead plaintiff. An individual, Eugene Connor, filed a second class action in this district in February 2020, which this Court later related. An earlier order herein appointed lead plaintiffs Julia and Richard Junge and consolidated the cases. Plaintiffs filed the first amended complaint and defendants responded with a motion to dismiss. They filed the second amended complaint in October This order follows full briefing and oral argument (telephonic due to COVID-19). 1. SECTION 10(b) When ruling on motions to dismiss brought under Section 10(b), “courts must, as with any motion to dismiss for failure to plead a claim on

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Tollen v. Geron Corporation, (N.D. Cal. 2021).

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