On February 4, 2021 Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported financial and operating results for its third quarter ended December 31, 2020 (Press release, TYME, FEB 4, 2021, View Source [SID1234574635]). During the quarter, TYME continued to build its leadership team with the announcement of Richie Cunningham as the new CEO; the Company continued to grow its global patent portfolio; expanded its body of peer-reviewed data presentations on SM-88 (racemetyrosine) at ASCO (Free ASCO Whitepaper) GI; continued enrolling patients in multiple studies including, second and third-line pancreatic cancer trials and the HopES Sarcoma Phase II trial; proceeded with next steps for initiation of the proof-of-concept trial (RESPOnD) evaluating TYME-19 as a potential new approach against COVID-19; advanced opportunities for clinical trials in metastatic breast cancer and hematological cancers.

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"TYME is at an exciting juncture in its history. As I am getting acquainted with the many facets of the Company, I am deeply impressed with the spirit of innovation and dedication towards the development of products that improve the lives of people," said Richie Cunningham, Chief Executive Officer of TYME. "I am currently fully engaged in an ongoing strategic business review with a focus on setting forth our operational priorities to determine the best path forward to maximize stakeholder value and look forward to sharing our corporate vision at the next business update."

Third Quarter Fiscal 2021 Financial Results

As of the third quarter ended December 31, 2020, the Company had approximately $13.5 million in cash and cash equivalents compared to $19.4 million as of the second quarter ended September 30, 2020. TYME’s operational cash burn rate for the third quarter of fiscal year 2021 was $5.9 million compared to $6.6 million for the second quarter of fiscal year 2021 and $4.5 million for the third quarter of fiscal year 2020. The burn rate was below current estimates and predominantly reflected expenses associated with the ongoing clinical trials in pancreatic and sarcoma cancers.

Based on active clinical trials in pancreatic and sarcoma cancers and other business developments, TYME continues to anticipate that its quarterly cash usage, or "cash burn rate", will average approximately $6.0 to $6.5 million per quarter during fiscal year 2021.

Anticipated Upcoming Key Events

At present, TYME currently expects the following key events in calendar year 2021:

Continue to advance enrollment in the HopES Sarcoma Phase II Trial; expect data readout in calendar year 2021
Present clinical data on SM-88 at a major medical meeting
Continue to advance enrollment in TYME-88-Panc pivotal study; full enrollment and data readout are not expected before calendar year 2022
Continue to advance enrollment in PanCAN’s Precision Promise℠ adaptive randomized Phase II/III registration-intent trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy
Initiate the proof-of-concept trial (RESPOnD) to evaluate TYME-19 as a potential new approach against COVID-19
Corporate Developments

On November 30, 2020, TYME announced that Richie Cunningham, former Icagen CEO and Boehringer Ingelheim executive was appointed as TYME’s Chief Executive Officer. The Company also announced that Steve Hoffman remains in the role of Chairman of the board of directors and continues as the Company’s Chief Science Officer, after his successful tenure as Chief Executive Officer since 2015.

Summary of Recent Developments

TYME Presented Data From TYME-88-Panc Study at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Gastrointestinal Cancers Symposium

On January 17, 2021, TYME presented preliminary supporting data from the TYME-88-Panc pivotal study, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual 2021 Gastrointestinal Cancers Symposium. The new data demonstrate the potential role of SM-88 (racemetyrosine) in advanced pancreatic cancer through the analysis of circulating tumor cells (CTCs) and passively acquired biometrics data from a wearable device. TYME is presently enrolling patients in a multicenter randomized controlled pivotal trial evaluating SM-88 in patients with third-line pancreatic cancer. Learn more at View Source

CTCs correlate with poor prognosis at baseline and throughout treatment may be a clinically relevant biomarker for patients with metastatic pancreatic cancer. These results demonstrated that CTC collection and enumeration were feasible for correlation with traditional trial outcomes. Furthermore, passively acquired biometrics from a wearable device can be collected for correlation with other clinically meaningful outcomes. Also, given that the longest lesion diameter was correlated with CTCs at baseline, additional radiologic feature analysis may prove to validate the importance of CTCs as a predictive biomarker for patients with pancreatic ductal adenocarcinoma.

As of September 15, 2020, the study reported that SM-88 was well tolerated with no treatment-related Grade 4 or 5 adverse advents (AEs). There was one Grade 3 AE that was deemed possibly related to SM-88. The poster presentation is available on our website at (www.tymeinc.com/data-publications).

The select data from the TYME-88-Panc trial are from an investigational study. SM-88 is not approved for the treatment of patients with any disease condition. Patients and physicians can access www.TYMETRIALS.com for more information about ongoing SM-88 clinical trials.

TYME Granted U.S. Patent Claims Covering Use of TYME-19 to Treat COVID-19 Infections

On February 3, 2021, TYME announced that it received notification that the United States Patent and Trademark Office had granted additional patent claims related to the Company’s metabolomic technology platform. U.S. Patent No. 10,905,698 is directed to methods for treating COVID-19 with TYME-19. This patent expands TYME’s patent portfolio to nearly 200 global granted and/or pending patents, broadly covering compositions, methods, manufacturing and use of the Company’s pipeline to 2032, and beyond.

TYME-19 is an investigational compound that is not approved in the U.S. for any disease indication. TYME intends to initiate the appropriate clinical trials to substantiate the safety and efficacy of TYME-19.

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. Learn more.

About TYME-18

TYME-18 is a CMBT compound under development that is delivered intratumorally. TYME-18 leverages a member of the bile acid family to create a potential treatment for inoperable tumors. Preliminary observations of the local administration of TYME-18, a combination of a proprietary surfactant system and natural sulfonic acid, suggested its potential as an important regulator of energy metabolism that may impede the ability of tumors to increase in size, which, in addition to its lytic functionality, could prove useful in difficult-to-treat cancers. In initial preclinical xenograft mouse studies, TYME-18 was able to completely resolve over 90 percent (11/12 mice) of established colorectal tumors within 12 days versus an average of over 600 percent growth in the control animals. Learn more.

About TYME-19

TYME-19 is an oral synthetic member of the bile acid family that the Company also uses in its anticancer compound, TYME-18. Because of its expertise in metabolic therapies, the Company was able to identify TYME-19 as a potent, well characterized antiviral bile acid and has performed preclinical experiments establishing effectiveness against COVID-19. Bile acids have primarily been used for liver disease; however, like all steroids, they are messenger molecules that modulate a number of diverse critical cellular regulators. Bile acids modulate lipid and glucose metabolism and can remediate dysregulated protein folding, with potentially therapeutic effects on cardiovascular, neurologic, immune, and other metabolic systems. Some agents in this class also have antiviral properties. In preclinical testing, TYME-19 repeatedly prevented COVID-19 viral replication without attributable cytotoxicity to the treated cells. Previous preclinical research has also shown select bile acids like TYME-19 have had broad antiviral activity.

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. Learn more.