TYME Technologies, Inc. (NASDAQ:TYME) is an emerging biotechnology company developing Cancer Metabolism-Based Therapies (CMBTs) that aim to be effective across a broad range of solid tumors and hematologic cancers, while maintaining patients' quality of life through relatively low toxicity profiles. Unlike targeted therapies that attempt to regulate specific mutations within cancer, TYME's therapeutic approach is designed to take advantage of a cancer cell's innate metabolic requirements to cause cancer cell death through oxidative stress and exposure to the body's natural immune system.
Business Overview
TYME has been focused on developing its novel compound, SM-88, as well as further evaluating its preclinical pipeline of novel CMBT programs. The company believes that early clinical results demonstrated by SM-88 in multiple advanced cancers, including breast, sarcomas, pancreatic, and prostate, reinforce the potential of its emerging CMBT pipeline.Ongoing Studies
OASIS Trial in Metastatic HR+/HER2- Breast Cancer
TYME is collaborating with Georgetown University to support a Phase II trial, OASIS, for SM-88 in patients with metastatic breast cancer who have HR+ and HER2- disease. This trial is designed as a two-stage trial, enrolling up to 50 patients who have failed or progressed after receiving two hormonal agents and a CDK4/6 inhibitor to receive SM-88 with MPS without additional cancer therapies. The primary endpoint is ORR, with secondary endpoints including DOR, CBR at >24 weeks, PFS, and safety.HoPES Phase II Trial in Sarcoma
In early 2020, the open-label Phase 2 investigator-sponsored trial of SM-88 therapy in sarcoma, HoPES, opened. This trial has two cohorts, each expecting to enroll 12 patients. The first is SM-88 with MPS as salvage treatment in patients with mixed rare sarcomas, and the other is SM-88 with MPS as maintenance treatment for patients with metastatic Ewing's sarcoma who had not progressed on prior therapy. The primary objectives are to measure ORR and PFS.Preclinical Pipeline Programs
SM-88 MOA and Biomarker Research
In fiscal year 2022, TYME began a comprehensive translational preclinical program focused on SM-88 MOA and Biomarker Identification/Validation. The overall goal is to potentially identify actionable biomarkers of sensitivity and activity to SM-88 in various cancers, complementary combination drugs strategies for SM-88, and other cancer metabolism targets that could benefit from treatment.TYME-18 and TYME-19
TYME-18 is a CMBT compound that is delivered intratumorally, leveraging a member of the bile acid family to create a potential treatment for inoperable tumors. TYME-19 is an oral synthetic member of the bile acid family with potential antiviral properties.Tumor Targeting Technology
TYME has developed a technology by which the tyrosine isomer L metyrosine can be fused with a second therapeutic agent to create a fusion compound that may allow targeted accumulation of the treatment by the cancer cells.Discontinued Programs
Precision Promise Trial - SM-88 with MPS as 2nd Line Therapy in Metastatic Pancreatic Cancer
In January 2022, TYME announced the discontinuation of SM-88 with MPS in the Precision Promise trial in mPDAC upon learning from the trial sponsor, PanCAN, that it terminated the arm due to futility compared to the control of standard of care chemotherapy in second-line mPDAC.TYME-88-PANC (Part 2) - Third-Line Metastatic Pancreatic Cancer
In June 2021, the company stopped enrollment and began the process of closing down the TYME-88-PANC (Part 2) trial, which was evaluating SM-88 in the third-line treatment of pancreatic cancer.Financials
For the fiscal year ended March 31, 2023, TYME reported an annual net loss of $21,668,267, with no revenue generated. The company's annual operating cash flow and free cash flow were both -$21,242,745.In the latest quarter ended June 30, 2023, TYME reported a net loss of $6,494,933, with no revenue generated. The company's quarterly operating cash flow and free cash flow were both -$4,781,000.
Liquidity
As of June 30, 2023, TYME had cash and cash equivalents of $6.4 million and marketable securities of $70.7 million, providing the company with a strong liquidity position. Management expects the company's quarterly cash operating expense to average approximately $5.0 to $7.0 million during fiscal year 2024.TYME has historically funded its operations primarily through equity offerings, and the company continues to evaluate opportunities to raise additional capital as needed to support its ongoing clinical development activities and general operations.
Recent Developments
Exploration of Strategic Options and Diversification
In March 2022, TYME's board of directors decided to explore potential strategic options to enhance stockholder value, engaging financial and legal advisors to assist with the process. On July 3, 2022, the company entered into a merger agreement with Syros Pharmaceuticals, Inc. (NASDAQ:SYRS), under which Syros will acquire TYME.