Tyme Technologies, Inc.
- Company Name
- Tyme Technologies, Inc.
- Stock Symbol
- Class Period
- March 14, 2018 to January 18, 2019
- Motion Deadline
- March 29, 2019
- Southern District of New York
The complaint charges Tyme and certain of its officers with violations of the Securities Exchange Act of 1934. Tyme is a clinical-stage biotechnology company that develops novel cancer therapeutics. Tyme is currently developing SM-88, a combination therapy based on dysfunctional metyrosine derivatives for metastatic pancreatic cancer and biomarker-recurrent prostate cancer.
On March 14, 2018, Tyme announced that the U.S. Food and Drug Administration had accepted its Investigational New Drug application to initiate the Company’s Phase II clinical trial for SM-88 in pancreatic cancer (the “Phase II Study”), which was commenced on March 27, 2018.
The complaint alleges that throughout the Class Period, defendants made materially false and misleading statements and/or failed to disclose adverse information regarding the Company’s business and prospects. Specifically, defendants failed to disclose that Tyme had not adequately designed the Phase II Study to present reliable results on the efficacy of SM-88 on pancreatic cancer and that Tyme had failed to include an appropriate control group in its open-label Phase II clinical trial for SM-88, which distorted the reliability of data showing the efficacy of SM-88 in the Phase II Study. As a result of this information being withheld from the market, Tyme securities traded at artificially inflated prices during the Class Period, with its stock reaching prices of more than $4 per share.
Then on January 18, 2019, Tyme reported results from the Phase II Study, and while 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. On this news, Tyme’s stock price fell $1.32 per share, or more than 35%, to close at $2.41 per share on January 18, 2019.