Will the Momentum Continue? Tyme Technologies Inc (NASDAQ:TYME) Concludes Strategic Review

Tyme Technologies Inc (NASDAQ:TYME) continues to move higher in the pre-market session. The stock has soared 35% over the past month.

Market Reaction

As of 7:02, TYME is up 3.14% to $1.64 with 134K shares traded hands.

Major Trigger:

Tyme Technologies, Inc. Completes Strategic Review, Announces OASIS Breast Trial With Georgetown University, and Reports Fiscal Year 2021 Financial Results

Key Highlights:

  • reported its conclusions from its recently conducted comprehensive strategic review and its fourth quarter and fiscal year 2021 financial results.
  • Today we announce a breast cancer trial with Georgetown University named OASIS. This is an investigator-initiated prospective open-label Phase 2 trial evaluating the efficacy and safety of SM-88 for the treatment of metastatic hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer after treatment with a CDK4/6 inhibitor.
  • This trial is a two-stage trial, initially enrolling 30 patients, with expansion up to a total of 50 patients without standard background therapies. The primary endpoint of this trial is RECIST tumor response; collection of cell-free DNA from patients will also occur at several time-points in their treatment. The trial will be conducted at Georgetown University along with several satellite sites that are part of the MEDSTAR medical system.

Key Quote:

“Following my appointment as CEO of TYME, I assembled a group of independent key opinion leaders and industry experts alongside our internal team and launched a comprehensive strategic review. My goal was to take a fresh look at the key operating aspects of TYME – our pipeline composition and clinical development strategy, personnel needs, financial management and existing data. As a result of the review, we believe TYME has expanded its addressable market opportunity, offers stakeholders a more diversified clinical pipeline, added critical experience to its leadership team, is following a more data driven approach to clinical development and will continue to be fiscally vigilant,” stated Richie Cunningham, Chief Executive Officer of TYME.

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