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.
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.
Learn more.
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: 212-452-2793E:
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 |
) |
|
|
|
|
|
Tyme Technologies (NASDAQ:TYME)
過去 株価チャート
から 8 2024 まで 9 2024
Tyme Technologies (NASDAQ:TYME)
過去 株価チャート
から 9 2023 まで 9 2024