On August 10, 2021 TYME Technologies, Inc. (Nasdaq: TYME) (the "Company" or "TYME"), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported financial and operating results for its fiscal first quarter ended June 30, 2021 (Press release, TYME, AUG 10, 2021, View Source [SID1234586255]).

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Fiscal First Quarter 2022 Business and Recent Highlights:

Completed strategic review and identified clinical priorities with a focus on metastatic hormone receptor positive, human epidermal growth factor receptor 2 negative ("HR+/HER2-") breast cancer, second-line pancreatic cancer and sarcomas as well as biomarker and mechanism of action ("MOA") studies.
Granted U.S. patent claims covering use of tyrosine-based drug delivery method to treat cancer. This early-stage technology, if proven, could provide TYME an opportunity to expand its current cancer-metabolism based approach with a drug delivery platform that aims to deliver toxic therapies in a targeted manner to offer improved safety and efficacy for a range of anticancer drugs.
Commenced a comprehensive biomarker initiative across several leading institutions, including Mayo Clinic and Georgetown University and the global drug development company Evotec. These studies have the potential to provide valuable information to help guide our future clinical development. In April 2021, Mayo Clinic established multiple human pancreatic organoid models.
Presented interim clinical data from the Phase II HopES Sarcoma trial at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") General Meeting. The Company expects enrollment of this trial to be completed this fiscal year.
Strengthened leadership team with the appointments of biopharmaceutical veterans, Dr. Jan M. Van Tornout as Acting Chief Medical Officer, and Frank Porfido as Chief Financial Officer.
"It was an active and productive fiscal first quarter at TYME. Having completed our comprehensive strategic review, we believe we are now better positioned with a more diversified pipeline and larger addressable market opportunities. We welcomed Dr. Van Tornout and Mr. Porfido to the leadership team and look forward to their contributions as we embark on a host of promising clinical initiatives. Importantly, we have been able to implement these strategies without increasing our projected clinical spend," stated Richie Cunningham, Chief Executive Officer of TYME.

"Looking ahead, we believe the recently granted patent on our drug delivery technology and the announcement of the Phase II OASIS breast cancer trial with Georgetown University are exciting opportunities for TYME that help position us for meaningful achievements ahead," concluded Cunningham.

First Quarter Fiscal 2022 Financial Results

As of the first quarter ended June 30, 2021, the Company had approximately $101.5 million in cash and marketable securities, compared to $107.5 million as of the fourth quarter ended March 31, 2021. In the first quarter, the Company invested approximately $74.1 million in a portfolio of highly liquid investments and marketable securities with the primary objectives of preserving capital and diversifying risk, while maintaining sufficient liquidity to meet cash flow requirements.

TYME’s operational cash burn rate for the first quarter of fiscal year 2022 was $6.0 million compared to $5.2 million for the fourth quarter of fiscal year 2021 and $6.7 million for the first quarter of fiscal 2021. The burn rate was below the Company’s previous projections and reflects expenses associated with ongoing clinical trials in pancreatic cancer (Precision Promise) and sarcoma cancers (HopES), as well as reduced costs associated with our discontinued pancreatic cancer trial, TYME-88-Panc Part II.

Based on the Company’s active clinical trials including OASIS, our new investigator-initiated open-label Phase II breast cancer trial, ongoing and close out costs related to our discontinued pancreatic cancer study, the upcoming pre-clinical studies in biomarker and mechanism of action research of SM-88 and TYME-19 pre-clinical studies; TYME continues to anticipate that its quarterly cash usage or "cash burn rate" will range from $6.0 to $8.0 million per quarter for the remainder of fiscal year 2022.

Net loss was $5.9 million for the first quarter ended June 30, 2021, or a net loss per basic and diluted share of ($0.03), as compared to a net loss of $8.8 million for the first quarter ended June 30, 2020, or a net loss per basic and diluted share of ($0.07). The decrease was substantially due to the year over year variance in the change in value of the warrant liability compared to prior years’ gain on the warrant exchange and decreased operating costs. The reduction in operating costs primarily reflected lower ongoing trial costs and employee related expenses. Adjusted net loss for the three months ended June 30, 2021, was $6.0 million, or an adjusted net loss per share of ($0.03), compared to adjusted net loss of $6.7 million, or an adjusted net loss per share of ($0.05), for the three months ended June 30, 2020, after adjusting for the change in fair value of warrant liability, amortization of employees, directors and consultants stock options, and the prior year’s gain on warrant exchange. Adjusted net loss and adjusted net loss per share are non-GAAP measures. See "Use of Non-GAAP Measures" below for a reconciliation to the comparable GAAP measures.

TYME has reported its full financial results for the quarter ended June 30, 2021 in the Company’s Form 10-Q filed with the Securities and Exchange Commission ("SEC"). TYME’s 10-Q is located in the SEC filings section of the Company’s website.

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Use of Non-GAAP Measures

Adjusted net loss and adjusted net loss per share as presented in this report are non-GAAP measures. The adjustments relate to the change in fair value of warrant liability, amortization of employees, directors and consultants stock options and gain on warrant exchange. These financial measures are presented on a basis other than in accordance with U.S. generally accepted accounting principles ("Non-GAAP Measures"). In the reconciliation tables that follow, we present adjusted net loss and adjusted net loss per share, reconciled to their comparable GAAP measures, net loss and net loss per share. These items are adjusted because they are not operational or because they are significant noncash charges and management believes these adjustments are meaningful to understanding the Company’s performance during the periods presented. These Non-GAAP Measures should be considered a supplement to, not a substitute for, or superior to, the corresponding financial measures calculated in accordance with GAAP. Our definitions of adjusted net loss and adjusted loss per share may not be comparable to similar measures reported by other companies.