On July 13, 2020 Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported preliminary financial and operating results for its first fiscal quarter ended June 30, 2020 (Press release, TYME, JUL 13, 2020, View Source [SID1234561836]). 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.

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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

TYME Presents New Preclinical Data Supporting SM-88 Mechanism of Action at AACR (Free AACR Whitepaper) 2020

TYME announced new preclinical findings that describe the unique mechanism of action of its lead cancer metabolism-based candidate, SM-88 (racemetyrosine). The data were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2020 Virtual Meeting from June 22 to June 24, 2020. Key highlights are as follows:

Preclinical data demonstrated statistically significant tumor reduction in SM-88 treated arms versus controls
Builds on confirmed tumor responses achieved in human clinical studies across 15 different cancer types
Multiple monotherapy effects of SM-88 were shown, including increased oxidative stress, disruption of autophagy, and tumor immunomodulation
Preclinical results were demonstrated across multiple tumor types including, pancreatic, colon, breast, and ovarian
Reduction of immunosuppressive cells in the tumor microenvironment supports exploring combination with immuno-oncology treatments
Oral SM-88 is designed to selectively disrupt cancer’s metabolic process and cause cancer cell death; SM-88 is currently in a pivotal trial for third-line pancreatic cancer
TYME-18 Demonstrates Anti-Cancer Effect in New Preclinical Data Presented at AACR (Free AACR Whitepaper) 2020

TYME announced new preclinical findings that described the unique anti-cancer effects of its cancer metabolism-based pipeline candidate, TYME-18. The data were presented at the AACR (Free AACR Whitepaper) 2020 Virtual Meeting from June 22 to June 24, 2020. Key highlights are as follows:

TYME-18 leverages unique metabolism of cancer to create an intra-tumoral treatment for inoperable cancers
Preclinical animal studies demonstrated TYME-18’s potential to dramatically shrink and/or resolve tumors
TYME-18 treatment resulted in a 91.6% (11/12) complete resolution of established tumors within two weeks
Novel mechanism of action contributes to a strong anti-cancer effect while minimizing systemic and local toxicity
Preclinical studies are ongoing with a goal of identifying an IND-enabling program
TYME Announced Health Economic Research Study Presented at ISPOR and Published in the Journal Value in Health Demonstrated Reduction in Total Cost of Care with Increased Use of New Medicines for Treatment of Patients with Pancreatic Cancer

The results of a health economic outcomes study demonstrated that the therapeutic benefit of increasing the use of novel medicines is so great that it is driving a decrease in the actual total cost of healthcare. The supporting data from the study were presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Virtual Meeting held from May 18 to May 20 and published in the Society’s journal, Value in Health.

The study looked at treatment inflation-adjusted expenses per patient for pancreatic cancer care between 2009 and 2016 and found that for every additional $1 spent on medicines for pancreatic cancer in 2016, there was a reduction in non-drug spending of $8-$9.

About SM-88

SM-88 is an oral investigational modified proprietary tyrosine derivative that is believed to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. Clinical trial data have shown that SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events. SM-88 is an investigational therapy that is not approved for any indication in any disease.

About TYME-18

TYME-18 is composed of a proprietary surfactant delivery agent with a specific sulfonic acid component1. It is designed for intra-tumoral administration of difficult to treat tumors and leverages the acidic tumor microenvironment and signaling pathways to kill cancer cells. TYME-18 is distinct in composition, but like SM-88, aims to leverage susceptibilities of a cancer that are related to its altered metabolism. Initial preclinical data for TYME-18 in animal tumor models demonstrate rapid and complete tumor regression, with no reported local or systemic toxicities. TYME-18 continues to be studied as a potential therapy for difficult to treat tumors that may not be eligible for surgical or other interventions.

About TYME-88-Panc Pivotal Trial

The TYME-88-Panc pivotal trial applies the latest advances in the field of cancer metabolism by evaluating the efficacy and safety of an oral investigational compound that targets the metabolic mechanisms of the disease at its source. A prospective, open label pivotal trial in metastatic pancreatic cancer for patients who have failed two lines of any prior systemic therapy. The trial is designed to evaluate the safety and efficacy of SM-88 used with MPS (methoxsalen, phenytoin and sirolimus) in advanced pancreatic cancer and will measure multiple endpoints, including overall survival, progression free survival, relevant biomarkers, quality of life, safety, and overall response rate.