TYME Provides Business Update and Announces Preliminary First Quarter Fiscal 2021 Financial and Operating Results
Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), announced preliminary financial and operating results for its first fiscal quarter ended June 30, 2020. During first quarter fiscal 2021, the Company presented a growing body of preclinical and clinical data at major international medical meetings; continued enrolling patients in multiple studies including, second and third-line pancreatic cancer trials and the HopES Sarcoma Phase II trial; advanced planning for clinical trials in metastatic breast cancer and hematological cancers; and continued ongoing preclinical and mechanism data studies.
As of June 30, 2020, the Company had approximately $21.3 million in cash and cash equivalents compared to $26.7 million as of March 31, 2020.
TYME’s operational cash burn rate for the first quarter of fiscal year 2021 was $6.7 million compared to $5.9 million for the fourth quarter of fiscal year 2020 and $6.2 million for the first quarter of fiscal 2020. The burn rate was below our previous projections and predominantly reflected costs associated with our ongoing TYME-88-Panc Phase II trial, as well as the launch of the pivotal phase of our TYME-88-Panc trial to evaluate SM-88 as a potential treatment for patients with third-line pancreatic cancer. Based on active clinical trials and other business developments, TYME continues to anticipate that its quarterly cash usage, or “cash burn rate”, will average between $7.0 to 8.0 million per quarter for fiscal year 2021.
Anticipated Upcoming Key Events
TYME currently expects the following key events in calendar year 2020:
- Continue to advance enrollment in TYME-88-Panc pivotal study
- Continue to advance enrollment in the HopES Sarcoma Phase II Trial
- Continue to advance enrollment in PanCAN’s Precision PromiseSM adaptive randomized Phase II/III registration-intent trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy
- Publish final data for SM-88 Phase II prostate study
- Initiate plans for SM-88 clinical programs into other tumor types potentially including metastatic breast, recurrent prostate and/or hematological cancers
- Provide guidance on PanCAN’s Precision Promise SM adaptive Phase II/III trial evaluating SM-88 in patients with first-line pancreatic cancer in combination with gemcitabine (Gemzar ) and nab-paclitaxel (Abraxane )
- Present and/or publish final data from Part 1 of TYME-88-Panc study
- Continue proof-of-concept and IND-enabling activities for TYME-18
Summary of Recent Developments