In re Nektar Therapeutics Securities Litigation

District Court, N.D. California·Decided December 30, 2020·No. 4:18-cv-06607·Unknown

Opinion

JOHN MULQUIN, Case No. 18-cv-06607-HSG

Plaintiff, ORDER GRANTING MOTION TO DISMISS v. Re: Dkt. No. 86 NEKTAR THERAPEUTICS, et al., Defendants.

This is a consolidated securities class action brought by Plaintiffs Oklahoma Firefighters Pension and Retirement System and El Paso Firemen & Policemen’s Pension Fund (together, “Lead Plaintiffs”) against Defendant Nektar Therapeutics (“Nektar” or “the Company”) and Howard W. Robin, President and Chief Executive Officer; Stephen K. Doberstein, Senior Vice President and Chief Scientific Officer, and later Chief Research and Development Officer; and Jonathan Zalevsky, Senior Vice President of Research Biology and Preclinical Development, and later Chief Scientific Officer (“Individual Defendants,” and collectively with Nektar, “Defendants”). The Court previously dismissed Plaintiffs’ Consolidated Class Action Complaint with leave to amend. See In re Nektar Therapeutics, No. 18-CV-06607-HSG, 2020 WL 3962004, at *1 (N.D. Cal. July 13, 2020) (“Order); see Dkt. No. 54 (“CCAC”). In their Second Consolidated Class Action Complaint, Plaintiffs allege violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 promulgated thereunder. Dkt. No. 80 (“SAC”) ¶¶ 223–237. Pending before the Court is Defendants’ motion to dismiss the SAC, for which briefing is complete. Dkt. Nos. 86 (“Mot.”), 87 (“Opp.”), and 88 (“Reply”). For the following reasons, the Court GRANTS Defendants’ motion to dismiss, this I. BACKGROUND Plaintiffs bring this securities action “on behalf of a class of purchasers of the common stock of Nektar who bought their shares between January 10, 2017, and September 28, 2018, inclusive (the ‘Class Period’).” SAC at ¶ 1. The following facts are taken from the SAC. Nektar is a research-based biopharmaceutical company with a “research and development pipeline of new investigational drugs [that] includes treatments for cancer, autoimmune disease, and chronic pain.” Id. at ¶ 13. At issue in this case is Nektar’s development of its “flagship” drug, NKTR-214. Id. at ¶ 2. NKTR-214 was “a modified version of Interleukin-2,” a human protein that “triggers the body’s production of cancer-fighting cells.” Id. at ¶¶ 3–4. While Interleukin-2 “has long been an approved cancer therapy,” a patient would need “significant quantities of native [Interleukin]-2 to get any kind of effect, and at that point it’s wildly toxic.” Id. at ¶ 3 (quotations omitted). The Company designed NKTR-214 to address this problem and “produce significant quantities of cancer-fighting cells without affecting the production of immunosuppressive cells.” Id. at 4 (quotations omitted). A. EXCEL Clinical Trial i. Trial Data “In December 2015, Nektar announced that the first human patients had been dosed with NKTR-214 in a Phase I clinical trial, EXCEL, for patients with advanced solid tumors.” Id. at ¶ 50. EXCEL was a 28-patient monotherapy trial which dosed participants once every two to three weeks. Id. at ¶¶ 68, 107. “On January 10, 2017, Defendant Robin gave a presentation at the annual JP Morgan Healthcare Conference,” displaying results from the EXCEL clinical trial. Id. at ¶ 50. “One slide showed that cancer-fighting cells increased by an average of 30-fold in tumors of purportedly ten patients dosed with NKTR-214 every three weeks, with very little change in their immunosuppressive Treg cells.” Id. at ¶ 51. This chart, the “30-fold increase chart,” forms the basis of Plaintiffs’ securities claims. Id. at ¶¶ 105, 109, 113. This 30-fold increase chart was then presented in a similar or identical form at numerous subsequent conferences. Id. at ¶ 53. ii. Plainview Report “On October 1, 2018, Plainview [LLC] published a report titled ‘NKTR-214: Pegging the the Report that its authors ‘have short positions in and may own option interests on the stock of [Nektar] and stand to realize gains in the event that the price of the stock decreases.’” Id. at ¶ 75. The Report concluded that NKTR-214 is “too weak to work,” and found that “Nektar’s frequently cite[d . . .] 30-fold average change in tumor-infiltrating lymphocyte (TIL) CD8+ . . . is distorted by a single outlier patient who purportedly recorded an extreme change in TIL CD8+ [(cancer- fighting cells)] but saw no clinical benefit.” Id. at ¶ 64–65. This finding referred to the 30-fold increase chart. The Report also contended that “the [purported] source of the ‘30-fold’ increase claim was a single line chart from a poster that Nektar displayed at a February 2017 American Society of Clinical Oncology [ASCO] symposium.” Id. at ¶ 66. The line chart identified in the Report was Figure 6 of the February 2017 ASCO poster. Id. at ¶ 67. Pointing to Patient 14 in Figure 6, the Report explained: Nektar ran a 28-patient Phase 1 EXCEL trial, during which Nektar evaluated the change in tumor-infiltrating CD8+ T cells. None of the patients actually saw a 30-fold change in TIL CD8+: one single patient saw a ~300x increase, and this skewed the average. The reported average barely exceeded the standard error and was not even close to statistical significance; tell-tale signs of data driven by variation rather than efficacy. Id. at ¶ 68 (emphasis omitted). Plaintiffs allege that through the Report’s disclosure of the purported source of the data for the 30-fold increase chart, id. at ¶ 71, “investors finally had the opportunity to study the relevant line chart . . . as well as the patient information to the right of the [chart],” id. at ¶ 72. From the chart, investors deduced as follows: The lines for Patients 2, 4, 6 are orange and the lines for Patients 14 and 15 are purple. That means that Patients 14 and 15 were on a two- week dosing schedule, not a three-week dosing schedule as Nektar had said. The information to the right of the line chart makes clear that patients whose lines are purple are dosed “q2w” or every two weeks, and that patients whose lines are orange are dosed “q3w” or every three weeks. This shows that forty percent of the patients Nektar claimed to be on a three-week schedule were actually being dosed more often than Nektar claimed. Id. at ¶ 73. Thus, if the analysis was truly based on the “three patients dosed every three weeks— Patients 2, 4, and 6—the fold change” was “~1.8 fold, a dramatically lower multiple that undermines the central message Nektar repeatedly delivered during the Class Period.” Id. at ¶ 74. was published before the marked opened on Monday, October 1, 2018, and by the time the market closed, Nektar was trading at $56.65—a one day drop of 7% on heavy trading volume.” Id. at ¶ 76. B. PIVOT-2 Clinical Trial “In February 2018, Nektar and [Bristol-Myers Squibb (“BMS”)] announced a ‘Global Development & Commercialization Collaboration’ to evaluate NKTR-214.” Id. at ¶ 58. This second clinical trial, known as PIVOT-02, tested a combination of NKTR-214 and Opdivo, a cancer immunotherapy drug developed by BMS. Id. at ¶¶ 55, 62. “In connection with that collaboration, BMS agreed to pay Nektar $1.85 billion upfront, comprised of $1.0 billion in cash and the purchase of ~8.28 million shares of Nektar stock at $102.60 per share.” Id. at ¶ 58. Plaintiffs allege that “Nektar personnel, including Tagliaferri and Gergel, or others working at their direction, would reach out to PIVOT-02 investigators . . . to obtain data directly from study sites for the purpose of including new, good data in medical conference posters and presentations and investor presentations.” Id. at ¶ 187. “[B]ad patient data would be excluded when the data was received after a predetermined cut-off time, but . . . good patient data would be included in presentations via an extension of the deadline.” Id. “On November 11, 2017, Nektar hosted an ‘Investor Meeting’ to coincide with the Society of Immunotherapy of Cancer (‘SITC’) annual meeting at which limited data concerning the PIVOT-02 clinical trial was presented.” Id. at ¶ 55. “Following the November 2

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