Case 1:21-cv-10051-GAO Document 1 Filed 01/11/21 Page 1 of 36
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`UNITED STATES DISTRICT COURT
`DISTRICT OF MASSACHUSETTS
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`YUTING AO, individually and on behalf
`of all others similarly situated,
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`Case No. 1:21-cv-10051
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`
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`Plaintiff,
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`v.
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`CLASS ACTION COMPLAINT
`FOR VIOLATION OF THE
`FEDERAL SECURITIES LAWS
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`MINERVA NEUROSCIENCES, INC.
`and REMY LUTHRINGER,
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`Jury Trial Demanded
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`Defendants.
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`
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`Plaintiff Yuting Ao (“Plaintiff”), by and through Plaintiff’s attorneys, alleges upon personal
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`knowledge as to Plaintiff’s own acts, and upon information and belief as to all other matters, based
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`upon the investigation conducted by and through Plaintiff’s attorneys, which included, among other
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`things, a review of documents filed by Defendants (as defined below) with the United States
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`(“U.S.”) Securities and Exchange Commission (the “SEC”), news reports, press releases issued by
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`Defendants, and other publicly available documents, as follows:
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`NATURE OF THE ACTION
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`1.
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`This is a federal securities class action on behalf of all investors who purchased or
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`otherwise acquired Minerva Neurosciences, Inc. (“Minerva” or the “Company”) securities
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`between May 15, 2017 and November 30, 2020, inclusive (the “Class Period”). This action is
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`brought on behalf of the Class (as defined below) for violations of Sections 10(b) and 20(a) of the
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`Securities Exchange Act of 1934 (the “Exchange Act”), 15 U.S.C. §§ 78j(b) and 78t(a), and Rule
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`10b-5 promulgated thereunder by the SEC, 17 C.F.R. § 240.10b-5.
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`2.
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`According to its most recent annual report filed on Form 10-K with the SEC,
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`Minerva purports to be a clinical-stage biopharmaceutical company focused on the development
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`Case 1:21-cv-10051-GAO Document 1 Filed 01/11/21 Page 2 of 36
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`and commercialization of a portfolio of product candidates to treat patients suffering from central
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`nervous diseases. The Company’s lead product candidate is roluperidone (also known as MIN-
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`101). Minerva common stock trades on the NASDAQ stock exchange under the ticker “NERV.”
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`The Company is headquartered in Waltham, Massachusetts.
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`3.
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`Minerva’s drug candidate roluperidone, MIN-101, is in development for the
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`treatment of negative symptoms in patients with schizophrenia. In October 2016, the Company
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`had previously reported positive results from a Phase 2b trial of roluperidone for this treatment,
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`asserting that the “[d]ata show continuous improvement in negative symptoms, stable positive
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`symptoms and extended safety profile.”1
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`4.
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`On May 15, 2017, the start of the Class Period, Minerva announced via press release
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`that it would proceed to a Phase 3 clinical trial for MIN-101 following a successful “end-of-Phase
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`2” meeting with the U.S. Food and Drug Administration (“FDA”). In this press release, Defendant
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`Rémy Luthringer (“Luthringer”) was quoted as saying that “[o]ur discussion with the [FDA] has
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`helped to confirm our Phase 3 trial design, which is similar to our previous Phase 2b trial design.
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`We believe that positive data from the Phase 3 trial, along with the positive data from the Phase
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`2b trial, may form the basis for the future submission of a New Drug Application for [roluperidone]
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`with the FDA.”
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`5.
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`The FDA, however, did not agree with Minerva that positive data from the Phase
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`2b trial could form the basis of a future New Drug Application (“NDA”) for MIN-101, or that the
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`Phase 3 trial was a well-designed trial. Thus, Luthringer’s statements about FDA feedback were
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`materially misleading.
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`1 https://www.sec.gov/Archives/edgar/data/1598646/000119312516747326/d255045dex991.htm.
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`Case 1:21-cv-10051-GAO Document 1 Filed 01/11/21 Page 3 of 36
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`6.
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`On May 29, 2020, Minerva released the results of its Phase 3 clinical trial. The
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`Company announced that the studied “doses were not statistically significantly different from
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`placebo at Week 12 on the primary endpoint . . . or the key secondary endpoint.” In other words,
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`the Phase 3 clinical trial failed.
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`7.
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`On this news, the Company’s stock price fell from a May 28, 2020 closing price of
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`$13.47 per share to a May 29, 2020 closing price of just $3.71 per share, representing a one day
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`drop of approximately 72.5%.
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`8.
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`On a November 2, 2020 earnings call, Luthringer, in discussing an upcoming
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`November 10, 2020 meeting with the FDA to discuss whether the Phase 2b study combined with
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`the data from the Phase 3 study could form the basis of an NDA, said: “with all the data we have
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`generated and we put in the briefing book, we are extremely confident that the FDA will
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`understand that we have really very compelling data as you already have seen, when you combine
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`the 2 studies, Phase IIb and Phase III . . . .”
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`9.
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`On December 1, 2020, before the markets opened, Minerva issued a press release
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`revealing that it had “received official meeting minutes from the November 10, 2020 Type C
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`meeting with the” FDA. Minerva disclosed for the first time that the “FDA advised that the Phase
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`2b study is problematic because it did not use the commercial formulation of roluperidone and was
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`conducted solely outside of the United States. In addition, FDA commented that the Phase 3 study
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`does not appear to be capable of supporting substantial evidence of effectiveness . . . .” Indeed,
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`the “FDA cautioned that an NDA submission based on the current data from the Phase 2b and
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`Phase 3 studies would be highly unlikely to be filed and that at a minimum, there would be
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`substantial review issues due to the lack of two adequate and well-controlled trials to support
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`efficacy claims for this indication.”
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`Case 1:21-cv-10051-GAO Document 1 Filed 01/11/21 Page 4 of 36
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`10.
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`On this news, Minerva’s stock price fell from its November 30, 2020 closing price
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`of $3.89 per share to a December 1, 2020 closing price of $2.89 per share, representing a one day
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`drop of approximately 25.7%.
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`11.
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`Throughout the Class Period, Defendants made materially false and misleading
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`statements regarding the Company’s business. Specifically, Defendants made false and/or
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`misleading statements and/or failed to disclose: (i) the truth about the feedback received from the
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`FDA concerning the “end-of-Phase 2” meeting; (ii) that the Phase 2b study did not use the
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`commercial formulation of roluperidone and was conducted solely outside of the U.S.; (iii) that
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`the failure of the Phase 3 study to meet its primary and key secondary endpoints rendered that
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`study incapable of supporting substantial evidence of effectiveness; (iv) that the Company’s plan
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`to use the combination of the Phase 2b and Phase 3 studies would be “highly unlikely” to support
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`the submission of an NDA; (v) that reliance on these two trials in the submission of an NDA would
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`lead to “substantial review issues” because the trials were inadequate and not well-controlled; and
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`(vi) that, as a result, the Company’s public statements were materially false and misleading at all
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`relevant times.
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`JURISDICTION AND VENUE
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`12.
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`The federal law claims asserted herein arise under Sections 10(b) and 20(a) of the
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`Exchange Act, 15 U.S.C. §§ 78j(b) and 78t(a), and Rule 10b-5 promulgated thereunder by the
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`SEC, 17 C.F.R. § 240.10b-5, as well as under the common law.
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`13.
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`This Court has subject matter jurisdiction over this action pursuant to 28 U.S.C. §
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`1331 and Section 27 of the Exchange Act, 15 U.S.C. § 78aa.
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`14.
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`This Court has jurisdiction over each Defendant named herein because each
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`Defendant is an individual or corporation who has sufficient minimum contacts with this District
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`Case 1:21-cv-10051-GAO Document 1 Filed 01/11/21 Page 5 of 36
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`so as to render the exercise of jurisdiction by the District Court permissible under traditional
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`notions of fair play and substantial justice.
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`15.
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`Venue is proper in this District pursuant to Section 27 of the Exchange Act, 15
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`U.S.C. § 78aa, and 28 U.S.C. § 1391(b), as the Company has its principal executive offices located
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`in this District and conducts substantial business here.
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`16.
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`In connection with the acts, omissions, conduct and other wrongs in this Complaint,
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`Defendants, directly or indirectly, used the means and instrumentalities of interstate commerce,
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`including but not limited to the U.S. mail, interstate telephone communications and the facilities
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`of the national securities exchange.
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`PARTIES
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`17.
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`Plaintiff, as set forth in the attached Certification, purchased or otherwise acquired
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`Minerva securities at artificially inflated prices during the Class Period, and has been damaged by
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`the revelation of the Company’s material misrepresentations and omissions.
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`18.
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`Defendant Minerva purports to be a clinical-stage biopharmaceutical company
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`focused on the development and commercialization of a portfolio of product candidates to treat
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`patients suffering from central nervous diseases. The Company’s lead product candidate is
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`roluperidone, in development for the treatment of negative symptoms in patients with
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`schizophrenia. Minerva common stock trades in an efficient market on the NASDAQ stock
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`exchange under the ticker “NERV.” The Company’s headquarters are located at 41601 Trapelo
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`Rd., Suite 286, Waltham, MA 02451, and the Company is incorporated under the laws of the State
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`of Delaware.
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`19.
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`Defendant Luthringer is Minerva’s Chief Executive Officer (“CEO”). He served
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`as a consultant for the Company from July 2010, and in May 2014, became an employee. In
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`Case 1:21-cv-10051-GAO Document 1 Filed 01/11/21 Page 6 of 36
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`November 2014, Dr. Luthringer was named Minerva’s President and CEO, and he served as
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`President until December 2017.
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`20.
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`Defendant Luthringer, because of his position at the Company, possessed the power
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`and authority to control the content and form of the Company’s annual reports, quarterly reports,
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`press releases, investor presentations, and other materials provided to the SEC, securities analysts,
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`money and portfolio managers and investors, i.e., the market. Defendant Luthringer authorized
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`the publication of the documents, presentations, and materials alleged herein to be misleading prior
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`to their issuance and had the ability and opportunity to prevent the issuance of these false
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`statements or to cause them to be corrected. Because of his position with the Company and access
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`to material non-public information available to him but not to the public, Defendant Luthringer
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`knew that the adverse facts specified herein had not been disclosed to and were being concealed
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`from the public and that the positive representations being made were false and misleading.
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`Defendant Luthringer is liable for the false statements pleaded herein.
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`21.
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`Defendants Minerva and Luthringer are collectively referred to herein as
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`“Defendants.”
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`SUBSTANTIVE ALLEGATIONS
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`Background
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`22.
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`In November 2013, Cyrenaic Pharmaceuticals, Inc. and Sonkei Pharmaceuticals,
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`Inc. merged and the combined company was renamed Minerva Neurosciences, Inc. Minerva’s
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`lead compound candidate is roluperidone, which is in development for the treatment of negative
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`symptoms in patients with schizophrenia.
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`23.
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`In October 2016, the Company reported positive results from a Phase 2b trial of
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`roluperidone for this treatment, asserting that the “[d]ata show continuous improvement in
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`negative symptoms, stable positive symptoms and extended safety profile.”
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`Case 1:21-cv-10051-GAO Document 1 Filed 01/11/21 Page 7 of 36
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`Materially False and Misleading Statements Issued During the Class Period
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`24.
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`The Class Period begins on May 15, 2017, when, as a result of the purportedly
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`successful Phase 2b trial, Minerva announced that it would proceed to a Phase 3 trial. Minerva
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`made this announcement in a press release filed on Form 8-K with the SEC, in which Minerva
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`stated: “Minerva Announces Outcome of End-of-Phase 2 Meeting with FDA.” The release
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`continued that:
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`[F]ollowing a recent “end-of-Phase 2” meeting with the [FDA], Minerva . . .
`announced its plans to initiate Phase 3 development of MIN-101, a drug targeting
`negative symptoms in schizophrenia patients. A pivotal Phase 3 trial with MIN-101
`is expected to be initiated in the second half of 2017.
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`* * *
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`The overall design of the planned Phase 3 trial is similar to the Phase 2b trial
`completed in 2016, in which improvement was observed in schizophrenic patients
`with negative symptoms treated with MIN-101 compared to placebo.
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`The Company shared pre-clinical and clinical efficacy and safety data at the FDA
`meeting, and safety and tolerability of MIN-101 will continue to be assessed during
`the duration of the Phase 3 trial . . . .
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`* * *
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`“Minerva is finalizing its plan for the Phase 3 development of MIN-101 . . .
`following our recent meeting with the FDA,” said [Defendant] Luthringer . . . .
`“Our discussion with the agency has helped to confirm our Phase 3 trial design,
`which is similar to our previous Phase 2b trial design. We believe that positive data
`from the Phase 3 trial, along with the positive data from the Phase 2b trial, may
`form the basis for the future submission of a[n] [NDA] for MIN-101 to the FDA.”
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`25.
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`On June 29, 2017, Minerva filed a Prospectus Supplement on Form 424B5 with the
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`SEC, announcing the public offering of five million shares of Minerva common stock at $7.75
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`each, for total proceeds to the Company, before expenses but after underwriting discounts and
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`commissions, of $36.425 million.2 This Prospectus Supplement provided, in relevant part:
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`2 https://www.sec.gov/Archives/edgar/data/1598646/000119312517217594/d382980d424b5.htm.
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`Case 1:21-cv-10051-GAO Document 1 Filed 01/11/21 Page 8 of 36
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`In May 2017, we announced the outcome of an “end of Phase 2” meeting with the
`FDA and announced our plans to initiate Phase III development of MIN-101. We
`expect that a pivotal Phase III trial with MIN-101 will be initiated in the second
`half of 2017.
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`The Phase III trial design will be a 12-week, double-blind, randomized, placebo-
`controlled, monotherapy study testing two doses of MIN-101 in patients with
`negative symptoms and a diagnosis of schizophrenia. To be eligible for the study,
`patients will be required to have stable negative and positive symptoms over several
`months prior to enrollment, with a specified minimum threshold baseline score on
`the PANSS negative sub-scale. After the double-blind phase, patients may enter a
`36-week open label extension phase in which all patients will receive active
`treatment. This multi-center, international trial is expected to enroll approximately
`500 patients at approximately 60 clinical sites across the U.S. and Europe.
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`26.
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`On August 3, 2017, the Company held an earnings call with analysts to discuss its
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`second quarter 2017 financial results. On this call, Defendant Luthringer stated:
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`Informed by feedback from the end of Phase II meeting with the FDA, we have
`confirmed the key elements of the Phase III trial design with MIN-101. To a
`significant degree, these parameters measure the design of our successful Phase IIb
`trial. So Phase III trial will consist of a 3 months randomized double-blind placebo-
`controlled core period followed by a 9 months open label extension period.
`Approximately 500 patients will be randomized 1 to 1 to 1, to 2 doses of MIN-101
`monotherapy versus placebo. The primary outcome will be improvement in
`negative symptoms as measured by the Marder score. The Marder score includes a
`question from the Positive and Negative Syndrome Scale, or PANSS scale that is
`well correlated with functional outcome in patients and not contained in the
`pentagonal score utilized in the Phase IIb trial.
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`In fact, a post-op analysis of our Phase IIb data utilizing the Marder score shows
`the improved effect sizes and p-values relative to placebo as compared to the
`pentagonal score. Approximately 1/3 of the patients recruited are expected to come
`from the U.S. with the remainder from the E.U. A total of approximately 60 clinical
`sites will be included in the trial. We plan to recruit patients who have been
`symptomatically stable in terms of positive and negative symptoms for 6 months
`with moderate-to-severe negative symptoms with a PANSS score of greater than
`20. We believe that this eligibility criteria represent a significant portion of
`schizophrenic patients suffering from negative symptoms, and thus cover most
`patients who are unable to function well during everyday life. We also recently
`completed a bridging study in healthy volunteers to identify an improved and final
`formulation of MIN-101 to be used in the Phase III trial, and in the CMC scale-up
`activities currently ongoing.
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`Case 1:21-cv-10051-GAO Document 1 Filed 01/11/21 Page 9 of 36
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`In summary, data from this study showed bioequivalent exposed between the
`improved formulation and the formulation used in Phase IIb study in terms of the
`parent compound. It is important to note that through PK-PD analysis of drug
`plasma levels versus negative score performed on our Phase IIb data, shows at
`MIN-101 efficacy is driven by exposure of parent compound. Reduction of the
`maximum concentration Cmax of the metabolite associated with transient
`(inaudible) increases, when a certain level is achieved. We believe this decreased
`Cmax of this metabolite confers an improved safety margin to MIN-101 (inaudible)
`cerebral fluid effect, which is a key element when MIN-101 is used in an everyday
`clinical practice. Following the completion of this study, we’re planning to initiate
`the Phase III trial on schedule in the second half of 2017 with the same doses used
`in the Phase IIb trial. Again, the improved formulation is expected to show an
`improved safety profile at equivalent doses. Coming back to our Phase III study
`safety, we continue to be monitored as it was into Phase IIb with specific attention
`to the side effects seen in standard of care, which were not observed as MIN-101
`in Phase IIb. We expect top line results from the 3 months double blind phase of
`this trial in the first half of 2019.
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`With respect to our request for breakthrough therapy designation from MIN-101,
`the initial feedback we received from the FDA, while denying our request
`confirmed the treatment of negative symptoms of schizophrenia meets the criteria
`for a serious or life-threatening disease and consequently for breakthrough therapy
`designation. The FDA advised that they were not able to grant such designation at
`this time pending receipt of additional analysis of certain data from the Phase IIb
`study. We’re currently in dialogue with the agency to clarify why we believe the
`existing data provides the analysis the FDA is seeking.
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`27.
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`In December 2017, Minerva initiated the Phase 3 trial for MIN-101.3 In a January
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`8, 2018 presentation filed with the SEC, the Company stated: “Phase 3 efficacy study:
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`confirmatory study design guided by insights from Phase 2b and dialogue with FDA.”
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`28.
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`On March 12, 2018, Minerva filed its 2017 Annual Report on Form 10-K with the
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`SEC.4 In this 2017 Annual Report, Minerva stated:
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`In May 2017, we announced the outcome of an “end-of-Phase 2” meeting with the
`FDA and announced our plans to initiate Phase 3 development of roluperidone.
`This meeting and additional discussions with the FDA on the Phase 3 trial design
`and operational conduct led to the finalization of the protocol and design for that
`trial described above.
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`3 See https://www.sec.gov/Archives/edgar/data/1598646/000119312518005144/d509395dex991.htm (Corporate
`Presentation filed with the SEC on Jan. 8, 2018).
`4 https://www.sec.gov/Archives/edgar/data/1598646/000156459018005224/nerv-10k_20171231.htm.
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`Case 1:21-cv-10051-GAO Document 1 Filed 01/11/21 Page 10 of 36
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`29.
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`Also, on March 12, 2018, Minerva held an earnings call with analysts to discuss its
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`fourth quarter and full year results for 2017. On this call, Defendant Luthringer stated:
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`As you know, I mean, we already have a lot of chance because, at the end of Phase
`II meeting we had with the FDA, it was clearly discussed that, I mean, the Phase
`III should be as close as possible to the Phase IIb study we have run. So obviously,
`we could really learn a lot from the Phase IIb in order to design the right Phase III.
`This said, as everybody knows, I mean, in the Phase III we will have around 30%
`of the patients coming from the U.S. And here, we put a lot of efforts in this part in
`order to ensure that the patients who will be enrolled, we have access to their history
`because when you’re dealing with negative symptoms in schizophrenia, you really
`need to get a good hint about the history of the patient in order to show the stability
`of the symptoms. So all this has really focused -- the team has focused a lot on this
`and I really think that we have the right sites in place in the U.S. in order to come
`up with the right patients, with the same patients as the patients we will include in
`Europe. So this is really something very important.
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`30.
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`On November 20, 2018, Minerva held a special call with analysts. On that call,
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`Defendant Luthringer stated:
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`So basically, as you know, I mean we really had an extremely good exchange
`discussion with the FDA at the end of Phase II. And I think we achieved something
`which is quite unique, which is that, yes, the Phase IIb, if we are able in Phase III
`to reproduce the results with a study design which is extremely similar, this will be
`really the ground of moving forward and filing an NDA. So this is what we have
`obtained and yes, indeed, I mean the Phase III is really, I would like to say, copy
`paste of the Phase IIb.
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`So this is the study design. So as you know, this is a study in monotherapy. So the
`patients who are treated with antipsychotics and have not a good response in terms
`of functioning, in terms of negative symptoms, are switched to 2 doses of our
`molecule, 32 milligram and 64 milligram, basically the same dose strengths as in
`the Phase IIb.
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`The comparator is placebo, and I will address the reason why in developing a drug
`for negative symptoms you need to use placebo and not positive control. Because
`there is no basically positive control. And second, because we know very well that
`antipsychotics have side effects, which can be picked up. It is not a good control at
`the end of the day.
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`But so clearly, I mean, it is a 12-week double-blind study. And afterwards, the
`patients can go into an extension. And this extension is covering 12 months, the
`idea being here that, I mean, you need to have around 100 patients exposed for 12
`months. So this is the reason why we have this duration of extension. But this is
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`Case 1:21-cv-10051-GAO Document 1 Filed 01/11/21 Page 11 of 36
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`obviously, also to check again if once a patient is responding, how long the effect
`is maintained.
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`Now so these are the key highlights of the study. And I will address all of these
`questions I had over the last few months since, I mean, we have started the study.
`So first one is a primary endpoint, yes. As you know, we moved in terms of the
`primary endpoint. We use, obviously, always the PANSS scale, which is the gold
`standard in assessing schizophrenia and negative symptoms. But we have moved
`from the pentagonal score to the model score, and in my next slide will really
`elaborate on this in order to just explain you why we came to this agreement with
`the FDA to use a model score.
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`31.
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`On March 18, 2019, Minerva held an earnings call with analysts to discuss the
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`Company’s fourth quarter and full year 2018 results. On that call, Defendant Luthringer stated:
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`Our study design and endpoint selection have been informed by insights gained in
`the recent Phase IIb trial and continuous dialogue with the FDA. We are working
`closely with approximately 60 clinical sites in the U.S. and Europe to ensure
`adherence to critical aspects of the conduct of the study. For example, we are
`working to minimize rating variability among clinical sites by carefully assessing
`on a regular basis throughout the study intra- and inter-rater variability, which is
`kept as low as possible. Achieving this goal, we helped reproduce the same
`separation between roluperidone and placebo observed in the Phase IIb study. We
`expect completion of enrollment during the first half of 2019 and top line results
`from the 12-week, double-blind period in mid-2019.
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`In parallel with the conduct of the Phase III study, we are working on key activities,
`the results of which will be integrated into our NDA submission package. This
`include, for example, clinical pharmacology trials and CMC scale-up. Furthermore,
`we are working with input of several KOLs on postapproval studies in
`schizophrenia and beyond.
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`32.
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`On October 1, 2019, Minerva announced that its Phase 3 trial would be delayed
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`“[d]ue to a cyber-attack on one of the Company’s external contractors that resulted in a disruption
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`to patient recruitment in the study . . . .” As a result, the Company said it expected to “complete
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`enrollment at approximately year-end and anticipates results from the 12-week, double-blind
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`portion of the study to be available in the first half of 2020.”5
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`5 https://www.sec.gov/Archives/edgar/data/1598646/000119312519259276/d813246dex991.htm.
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`Case 1:21-cv-10051-GAO Document 1 Filed 01/11/21 Page 12 of 36
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`33.
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`On January 6, 2020, Minerva issued a press release on Form 8-K with the SEC in
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`which it announced the completion of patient screening in its Phase 3 trial of roluperidone for the
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`treatment of negative symptoms in schizophrenia.6 Minerva stated:
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`A total of 857 patients have been screened, and the enrollment of at least 501
`patients is expected to be completed before the end of January 2020. Top-line
`results from the 12-week, double-blind portion of the trial are expected in the
`second quarter of 2020.
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`This trial is a multicenter, randomized, double-blind, parallel group, placebo-
`controlled, 12-week study to evaluate the efficacy and safety of 32 milligram (mg)
`and 64 mg doses of roluperidone as measured by the Positive and Negative
`Syndrome Scale Marder negative symptoms factor score, the primary endpoint.
`Secondary endpoints include the Personal and Social Performance Scale and
`Clinical Global Impression of Severity. Patients are being randomized 1:1:1 to the
`32 mg and 64 mg doses of roluperidone and to placebo. The core 12-week phase of
`the trial is followed by a 40-week, open-label extension period during which
`patients on the drug continue receiving their original dose and patients on placebo
`receive one of the two doses of roluperidone.
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`34.
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`In addition, Defendant Luthringer stated in the release: “[w]e are pleased to have
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`achieved the important milestone of having completed patient screening in the Phase 3 trial with
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`roluperidone . . . . Our consistent objectives throughout the trial have been to ensure the highest
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`quality of patient selection and the rigorous evaluation of the symptoms of schizophrenia,
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`including negative symptoms. We look forward to randomizing the last patient in January, 2020
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`and to having top-line results in the second quarter of 2020.”
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`35.
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`On February 5, 2020, Minerva issued a press release on Form 8-K with the SEC in
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`which it announced the completion of patient enrollment in its Phase 3 trial of roluperidone for the
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`treatment of negative symptoms in schizophrenia.7 Minerva stated:
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`A total of 515 patients have been randomized in this trial, compared to the original
`goal of 501 patients. The trial, which is being conducted at clinical sites in the U.S.
`and Europe, is a randomized, double-blind, parallel-group, placebo-controlled, 12-
`week study to evaluate the efficacy and safety of 32 milligram (mg) and 64 mg
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`6 https://www.sec.gov/Archives/edgar/data/1598646/000119312520002240/d862817dex991.htm.
`7 https://www.sec.gov/Archives/edgar/data/1598646/000119312520024917/d884459dex991.htm.
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`Case 1:21-cv-10051-GAO Document 1 Filed 01/11/21 Page 13 of 36
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`doses of roluperidone as measured by the Marder negative symptoms factor score
`of the Positive and Negative Syndrome Scale, the primary endpoint. Secondary
`endpoints include the Personal and Social Performance Scale and Clinical Global
`Impression of Severity. Patients are being randomized 1:1:1 to the 32 mg and 64
`mg doses of roluperidone and placebo. The core 12-week double-blind phase of the
`trial is followed by a 40-week, open-label extension period during which patients
`on the drug continue receiving their original dose and patients on placebo receive
`one of the two doses of roluperidone. Top-line results from the 12-week, double-
`blind portion of the trial are expected in the second quarter of 2020.
`
`36.
`
`In addition, Defendant Luthringer stated in the release: “[t]he completion of patient
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`enrollment marks a major milestone in the Phase 3 trial with roluperidone . . . . We believe the
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`data from this trial have the potential to lead to a significant new treatment option for
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`schizophrenia, as no pharmacological agent is approved to treat negative symptoms, which is the
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`single greatest unmet need for patients with this disease, their families and their physicians.”
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`37.
`
`On March 6, 2020, Minerva held a special conference call presentation with several
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`analysts. On this call, Defendant Luthringer stated:
`
`I will not bother you again with our Phase IIb data. But this is coming out from the
`publication in the American Journal of Psychiatry. On the left side, you have the
`results we obtained during the Phase IIb study, 12-week, double-blind, placebo
`monotherapy. So these patients are getting off antipsychotics. They are really
`treated in monotherapy. So you see that after 2 weeks, we already see an
`improvement of negative symptoms compared to placebo. And the things are
`becoming highly significant after 12 weeks. I have read in a paper recently that the
`effect sizes are not really very impressive. I think here we have to mention that the
`effect size we have here is more than 0.5, yes, I mean, overall. And when you’re
`going to the younger population, we have an effect size which are above 1.5. So I
`think we have here really a very, very important effect.
`
`38.
`
`Defendant Luthringer added: “[s]o these are the Phase IIb results. Very quickly,
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`also, we had secondary endpoints, which were focusing on cognition, and we published this as
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`well. So definitely, there is an effect on cognition. It’s the third line.”
`
`39.
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`Defendant Luthringer further stated: “We have really not changed the study design
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`between the Phase IIb and the Phase III. So it’s again monotherapy. It’s again – primary endpoint
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`Case 1:21-cv-10051-GAO Document 1 Filed 01/11/21 Page 14 of 36
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`will be after 12 weeks. Again, placebo versus 2 doses. The randomization is 1:1:1. The difference
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`is that, I mean, we have a longer extension, so the possibility to the patients to go into a 9 months
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`extension to have 12 months exposure.”
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`40.
`
`Last, Defendant Luthringer stated on this March 6, 2020 call:
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`I’m coming back from visiting sites in Ukraine last week. A lot of patients have
`completed 12 months, and I have a little bit of problem currently because the
`clinicians, the caregivers and the patients are telling me, so should I give up this
`drug because I’m good. But – so this is how it is in clinical development. But what
`I think – my key message here is that we are not reinventing the wheel for the Phase
`III. We are really doing something which is in line with what we have done in the
`Phase IIb.
`
`41.
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`In addition, Dr. Philip Harvey, the Leonard M. Miller Professor of Psychiatry and
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`director of the Division of Psychology at the University of Miami Miller School of Medicine and
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`a VA Senior Health Scientist, participated in the call. Dr. Harvey was asked: “what treatment
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`effect would you consider to be clinically meaningful on the PANSS Marder scores?” He
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`responded, in relevant part:
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`In terms of a clinically significant improvement on the Marder scale, what the FDA
`is going t