Tyme Technologies, Inc. (NASDAQ: TYME) Investor Securities Class Action Lawsuit 01/28/2019
An investor in shares of Tyme Technologies, Inc. (NASDAQ: TYME) filed a lawsuit in the U.S. District Court for the Southern District of New York over alleged violations of Federal Securities Laws by Tyme Technologies, Inc. in connection with certain allegedly false and misleading statements made between March 14, 2018 and January 18, 2019.
According to the complaint the plaintiff alleges on behalf of purchasers of Tyme Technologies, Inc. (NASDAQ: TYME) common shares between March 14, 2018 and January 18, 2019, that the defendants violated Federal Securities Laws. More specifically, the plaintiff claims that between March 14, 2018 and January 18, 2019, the defendants made false and/or misleading statements and/or failed to disclose that Tyme Technologies, Inc. had not adequately designed the Phase II Study to present reliable results on the efficacy of SM-88 on pancreatic cancer, that Tyme Technologies, Inc. had failed to include an appropriate control group in its open-label Phase II clinical trial for SM-88, that the omission of an appropriate control group distorted the reliability of data showing the efficacy of SM-88 in the Phase II Study, and that as a result, Tyme Technologies, Inc’s public statements were materially false and misleading at all relevant times.
New York based Tyme Technologies, Inc., a clinical-stage biotechnology company, develops novel cancer therapeutics. On March 14, 2018, Tyme Technologies, Inc. announced that the U.S. Food and Drug Administration (“FDA”) had accepted its Investigational New Drug (“IND”) application to initiate the Company’s Phase II clinical trial for SM-88 in pancreatic cancer (the “Phase II Study”).
On March 27, 2018, Tyme Technologies, Inc. commenced a Phase II Study of SM-88, officially titled “A Phase II Multi-Center Study of SM-88 in Subjects With Pancreatic Cancer Whose Disease Has Progressed or Recurred After/on First Line Chemotherapy” (the “Phase II Study”).
On January 18, 2019, Tyme Technologies, Inc. reported results from the Phase II Study. Although Tyme characterized the results as positive, stating that SM-88 “improves survival,” the trial did not include a control group, and Tyme’s announcement merely compared survival data to historical controls. Market commentators were quick to highlight this glaring deficiency in the Phase II Study.
Shares of Tyme Technologies, Inc. (NASDAQ: TYME) declined on January 18, 2019 to as low as $2.00 per share.