BEDMINSTER, N.J., May 25, 2022 (GLOBE NEWSWIRE) — TYME Technologies, Inc. (Nasdaq: TYME) (the Company or TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs™), announced financial and operating results for its fourth fiscal quarter and full year ended March 31, 2022.
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In March the Company announced that its Board of Directors decided to explore potential strategic options to enhance stockholder value, and this process is active and ongoing. The Company plans to provide an update upon completion of this process.
Fourth Fiscal Quarter and Full Year 2022 Financial Results
As of the quarter ended March 31, 2022, the Company had approximately $84.0 million in cash and marketable securities, compared to $92.0 million as of the quarter ended December 31, 2021. TYME’s operational cash burn rate for the fourth quarter of fiscal year 2022 was $7.7 million compared to $4.5 million for the third quarter and $5.2 million for the fourth quarter of fiscal year 2021. The cash burn rate, which reflects the Company’s cash operating expenses, was somewhat higher than previous projections primarily due to severance costs of $2.2 million recognized in the period. Net loss for the year ended March 31, 2022 was $23.6 million, or ($0.14) per share compared to $29.0 million or ($0.22) per share for the year ended March 31, 2021. The decrease in net loss compared to the prior year reflected lower ongoing trial costs due to the discontinued TYME-88-Panc Part 2 third-line Metastatic Pancreatic Cancer and Precision Promise trials, partially offset by costs incurred related to the OASIS clinical trial as well as various preclinical studies that commenced in the fiscal year.
Adjusted net loss was $23.0 million, or ($0.13) per share for the year ended March 31, 2022 compared to the GAAP net loss of $23.6 million. The difference of $0.5 million was due to $2.4 million of amortization of employee, director, and consultant stock options substantially offset by the change in fair value of the warrant liability of $1.8 million. 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.
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.
About TYME Technologies, Inc.
TYME is an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs™) that are intended to be effective across a broad range of solid tumors and hematologic cancers, while also maintaining patients’ quality of life through relatively low toxicity profiles. Unlike targeted therapies that attempt to regulate specific mutations within cancer, the Company’s therapeutic approach is designed to take advantage of a cancer cell’s innate metabolic weaknesses to cause cancer cell death.
The Company is currently focused on developing its novel compound, SM-88, its preclinical pipeline of novel CMBT™ programs, as well as TYME-19 as a potential therapeutic for SARS CoV-2 diseases. The Company believes that early clinical results demonstrated by SM-88 in multiple advanced cancers, including prostate, sarcomas and breast, reinforce the potential of its emerging CMBT™ pipeline.
For more information about the Company, visit www.tymeinc.com and connect on Facebook, LinkedIn, and Twitter.
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 lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events. SM-88 is being evaluated in a Phase II study evaluating SM-88 in breast cancer (HR+/HER2-), as well as continuing enrollment of a Phase II study in high-risk metastatic sarcomas. SM-88 is an investigational therapy that is not approved for any indication in any disease.
Forward-Looking Statements
In addition to historical information, this press release contains forward-looking statements under the Private Securities Litigation Reform Act that involve substantial risks and uncertainties. Such forward-looking statements within this press release include, without limitation, statements regarding potential strategic options (and the Company’s exploration thereof) and statements regarding our drug candidates and technologies (including SM-88 and TYME-18) and their clinical potential and non-toxic safety profiles, our drug development plans and strategies, ongoing and planned preclinical or clinical trials, preliminary data results and the therapeutic design and mechanisms of our drug candidates. The words “believes,” “expects,” “hopes,” “may,” “will,” “plan,” “intends,” “estimates,” “could,” “should,” “would,” “continue,” “seeks,” “anticipates,” and similar expressions (including their use in the negative) are intended to identify forward-looking statements. Forward-looking statements can also be identified by discussions of future matters such as: expected releases of interim or final data from our clinical trials; possible collaborations; the timing, scope, status, or objectives of our exploration of strategic options or ongoing and planned trials; the success of management transitions and strategic initiatives; and other statements that are not historical. The forward-looking statements contained in this press release are based on management’s current expectations and projections which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. These statements involve known and unknown risks, uncertainties and other factors which may cause the Company’s actual results, performance or achievements to be materially different from any historical results and future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include but are not limited to: the Company’s process to evaluate strategic options; the terms, timing, structure, benefits and costs of any strategic transaction and whether any transaction will be consummated at all; the impact of any strategic transaction on the Company; the outcomes of any litigation, regulatory proceedings, inquiries or investigations to which the Company may be subject; the ability to obtain financing or third-party approvals for a transaction as needed; the severity, duration, and economic impact of the COVID-19 pandemic; our ability to achieve the intended benefits of our strategic initiatives; that certain information is of a preliminary nature and may be subject to change; uncertainties inherent in the cost and outcomes of research and development, including the cost and availability of acceptable-quality clinical supply, and the ability to achieve adequate start and completion dates, as well as uncertainties in clinical trial design and patient enrollment, dropout or discontinuation rates; the possibility of unfavorable study results, including unfavorable new clinical data, additional analyses of existing data and results that may lead to a discontinuation of trials; risks associated with early, initial data, including the risk that the final data from any clinical trials may differ from prior or preliminary study data or analyses and may not support further clinical development; and that past reported data are not necessarily predictive of future patient or clinical data outcomes; whether and when any applications or other submissions for SM-88 or other drug candidates may be filed with regulatory authorities; whether and when regulatory authorities may approve any applications or submissions; decisions by regulatory authorities regarding labeling and other matters that could affect commercial availability of SM-88 or other drug candidates; the ability of TYME and its collaborators to develop and realize collaborative synergies; competitive developments; the ability of TYME to maintain compliance with Nasdaq listing standards; and the factors described in the section captioned “Risk Factors” of each of TYME’s Annual Report on Form 10-K for the fiscal year ended March 31, 2022 filed with the U.S. Securities and Exchange Commission (“SEC”) on May 25, 2022, as well as subsequent reports we file from time to time with the U.S. Securities and Exchange Commission available at www.sec.gov.
The information contained in this press release is as of its release date and TYME assumes no obligation to update forward-looking statements contained in this release as a result of future events or developments.
Investor Relations:
Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com
Source: Tyme Technologies, Inc.
Financial Tables Follow
Tyme Technologies, Inc. and Subsidiaries
Condensed Consolidated Statement of Operations and Comprehensive Loss
(Unaudited)
| Years Ended March 31, | ||||||||
| 2022 | 2021 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 13,444,101 | $ | 16,709,649 | ||||
| General and administrative (including $507,000 and $517,000 of related party legal expenses, respectively) | 9,632,103 | 10,185,537 | ||||||
| Severance expense | 2,437,379 | 321,825 | ||||||
| Total operating expenses | 25,513,583 | 27,217,011 | ||||||
| Loss from operations | (25,513,583 | ) | (27,217,011 | ) | ||||
| Other income (expense): | ||||||||
| Change in fair value of warrant liability | 1,807,441 | (3,915,393 | ) | |||||
| Gain on warrant exchange | — | 2,228,697 | ||||||
| Other income | 150,339 | 22,077 | ||||||
| Interest expense | (70,244 | ) | (97,133 | ) | ||||
| Total other income (expense) | 1,887,536 | (1,761,752 | ) | |||||
| Loss before income taxes | (23,626,047 | ) | (28,978,763 | ) | ||||
| Net loss | $ | (23,626,047 | ) | $ | (28,978,763 | ) | ||
| Basic and diluted loss per common share | $ | (0.14 | ) | $ | (0.22 | ) | ||
| Basic and diluted weighted average shares outstanding | 172,206,534 | 134,250,722 | ||||||
| Statements of Comprehensive Loss | ||||||||
| Net loss | $ | (23,626,047 | ) | $ | (28,978,763 | ) | ||
| Other comprehensive loss | ||||||||
| Unrealized loss on marketable securities, net of tax | (544,264 | ) | — | |||||
| Comprehensive loss | $ | (24,170,311 | ) | $ | (28,978,763 | ) | ||
| Reconciliation of Net Loss to Adjusted Net Loss | ||||||||
| For the Year Ended March 31, | ||||||||
| 2022 | 2021 | |||||||
| Net loss (GAAP) | $ | (23,626,000 | ) | $ | (28,979,000 | ) | ||
| Adjustments: | ||||||||
| Change in fair value of warrant liability | (1,807,000 | ) | 3,915,000 | |||||
| Gain on warrant exchange | — | (2,229,000 | ) | |||||
| Amortization of employees, directors and consultants stock options | 2,452,000 | 3,457,000 | ||||||
| Adjusted net loss (non-GAAP) | $ | (22,981,000 | ) | $ | (23,836,000 | ) | ||
| Reconciliation of Net Loss Per Share to Adjusted Basic and Diluted Net Loss Per Share | ||||||||
| For the Year Ended March 31, | ||||||||
| 2022 | 2021 | |||||||
| Net loss per share (GAAP) | $ | (0.14 | ) | $ | (0.22 | ) | ||
| Adjustments: | ||||||||
| Change in fair value of warrant liability | (0.01 | ) | 0.03 | |||||
| Gain on warrant exchange | — | (0.02 | ) | |||||
| Amortization of employees, directors and consultants stock options | 0.02 | 0.03 | ||||||
| Adjusted basic and diluted net loss per share (non-GAAP) | $ | (0.13 | ) | $ | (0.18 | ) | ||
