In re Neurotrope, Inc. Sec. Litig.

315 F. Supp. 3d 721
CourtDistrict Court, S.D. Illinois
DecidedJune 4, 2018
Docket17 Civ. 3718 (LGS)
StatusPublished
Cited by3 cases

This text of 315 F. Supp. 3d 721 (In re Neurotrope, Inc. Sec. Litig.) is published on Counsel Stack Legal Research, covering District Court, S.D. Illinois primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In re Neurotrope, Inc. Sec. Litig., 315 F. Supp. 3d 721 (S.D. Ill. 2018).

Opinion

LORNA G. SCHOFIELD, District Judge:

Lead Plaintiffs Sean Hinshaw and Daniel Hovasse, individually and on behalf of all other persons similarly situated, bring this putative class action against Defendants Neurotrope, Inc. ("Neurotrope" or the "Company"), Susanne Wilke and Daniel Alkon (collectively, the "Individual Defendants"), alleging violations of § 10(b) and § 20(a) of the Securities Exchange Act of 1934 (the "Exchange Act"). Defendants move to dismiss the First Amended Complaint (the "Complaint") pursuant to Federal Rule of Civil Procedure 12(b)(6). For the following reasons, the motion is granted.

I. BACKGROUND

The following facts are taken from the Complaint and accepted as true for the purposes of this motion. See Doe v. Columbia Univ. , 831 F.3d 46, 48 (2d Cir. 2016).

A. Background

Neurotrope is a clinical stage biopharmaceutical company that specializes in developing therapeutic drugs for neurodegenerative disease, such as Alzheimer's Disease ("AD" or "Alzheimer's"). Bryostatin-1 ("Bryostatin") is Neutrotrope's lead drug candidate for AD treatment. Neurotrope claims that Bryostatin promotes protein kinase C isozyme epilson ("PKC protein"), which may have a role in growing synapses and in preventing synaptic loss that may correlate with the cognitive impairments associated with AD.

At all relevant times, Neurotrope has employed only about five individuals, including Defendant Wilke, its Chief Executive Officer ("CEO"), and Defendant Alkon, who has been Chief Scientific Officer ("CSO") since August 2013 and President since September 2016.

Before presenting a new drug to the United States Food and Drug Administration (the "FDA"), pharmaceutical companies are required to engage in three phases of clinical trials, each phase growing in sample size and complexity. 21 C.F.R. § 312.21 ; see also The FDA's Drug Review Process: Ensuring Drugs are Safe and Effective, https://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm (last visited April 24, 2018). Phase 1 studies typically include 20 to 80 subjects and are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and early evidence on effectiveness. 21 C.F.R. § 312.21(a)(1). Phase 2 studies are designed to evaluate the effectiveness, common short-term side effects and risks associated with the drug. Id. at § 312.21(b). Phase 2 studies' usually include no more than several hundred subjects. Id. Phase 1 and 2 studies are conducted to obtain preliminary evidence of effectiveness. See id. at § 312.21(c). Phase 3 studies are expanded controlled and uncontrolled trials, designed to gather additional information about effectiveness and safety to evaluate the benefit-risk relationship of the drug and provide a basis for *727physician labeling. Id. Phase 3 studies usually include several hundred to several thousand subjects. Id.

The medical industry standard for statistical significance is p < 0.05,1 and one-sided tests are uncommon because they do not address whether the test drug is actually worse than the control.2

B. Events Prior to the Class Period

On March 17, 2015, Neurotrope issued a press release announcing that it had completed its Phase 2a study that preliminarily evaluated Bryostatin's safety, tolerability, and efficacy, as reflected by the correlation between PKC protein levels and Bryostatin plasma levels.

On January 7, 2016, Neurotrope issued a press release announcing that it had initiated its Phase 2b study to further evaluate the safety, tolerability, and efficacy of Bryostatin. The press release stated that the study would evaluate two different doses of Bryostatin (20 or 40 µg) versus placebo, with two efficacy end points: the primary efficacy endpoint based on Severe Impairment Battery ("SIB") scale, a benchmark used in severe Alzheimer's drug trials; and the secondary efficacy endpoints based on Activities of Daily Living ("ADL"), Neuropsychiatric Inventory ("NPI") and Mini-Mental State Exam ("MMSE").

On November 22, 2016, Neurotrope issued a press release announcing that it had completed the enrollment for the Phase 2b study. Shortly thereafter, Neurotrope received the clinical results from the study. The clinical results showed that, compared to the placebo group, patients on the 40 µg dose did not show a statistically significant increase on SIB, neither at p < 0.1 nor at p < 0.05. Those on the 20 µg dose, in contrast, showed a mean increase on SIB of 1.5, compared to a decrease in the placebo group of -1.1. This improvement was statistically significant at p < 0.1, but not at p < 0.05. The Phase 2b study was a one-sided test.

C. The Alleged Material Omissions and Misrepresentations

During the period from January 30, 2017 to July 18, 2017 (the "Class Period"), Plaintiffs acquired Neurotrope's securities. Plaintiffs allege that Defendants made material omissions and misrepresentations on five occasions during the Class Period: (1) at the Noble Financial Capital Markets' 13th Annual NobleCON Conference for investors on January 30, 2017; (2) at the 2017 BIO CEO & Investor Conference on February 13, 2017; (3) in a March 24, 2017, press release and (4) in a May 1, 2017, press release.

*728The Complaint's allegations of material omissions and misstatements fall into three categories. The first category-which makes up the majority of the alleged misleading statements-consists of instances where Defendants failed to disclose that the Phase 2b study used a one-tailed test with p < 0.1 for statistical analysis, instead of the alleged industry norm of two-tailed test with p < 0.05. The Complaint alleges that this nondisclosure rendered misleading Defendants' statements touting positive results based on a showing of "statistically significant" efficacy in the Phase 2b study.

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Bluebook (online)
315 F. Supp. 3d 721, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-neurotrope-inc-sec-litig-ilsd-2018.