TYME Technologies, Inc. Announces Exploration of Strategic Options
29 Março 2022 - 7:50AM
TYME Technologies, Inc. (Nasdaq: TYME) (the Company or TYME), an
emerging biotechnology company developing cancer metabolism-based
therapies (CMBTs™), today announced that its Board of Directors has
decided to explore potential strategic options to enhance
stockholder value. The Company has engaged Moelis & Company LLC
as its financial advisor and Faegre Drinker Biddle & Reath LLP
as its legal advisor.
On January 26, 2022, TYME announced the discontinuation of a
randomized Phase II/III trial of SM-88 in combination with
methoxsalen, phenytoin, and sirolimus (MPS) for patients with
metastatic pancreatic cancer upon learning that the trial sponsor
terminated the study arm due to futility. Notwithstanding the
discontinuation of its most advanced clinical trial, the Company
believes there are additional opportunities that could enhance
value for TYME stockholders. TYME believes that being
well-capitalized affords it the ability to consider a wide range of
strategic options and therefore has commenced a formal process with
Moelis & Company LLC.
The Strategic Planning Committee of the Board will act as a
Transaction Committee and will be led by TYME Board Member Timothy
C. Tyson, who possesses over 35 years of biotechnology and
pharmaceutical industry experience, including multiple M&A
transactions. There can be no assurance that this process will
result in any such transaction, and the Company does not intend to
disclose additional details unless and until it has entered into a
specific transaction.
“The goal of the strategic evaluation process is to ensure that
we are exploring a range of possible options to maximize value for
our stockholders. With $92 million in cash and marketable
securities as of December 31, 2021, we believe that TYME is in a
strong position to find an advantageous transaction,” stated Richie
Cunningham, Chief Executive Officer of TYME.
TYME continues to evaluate SM-88 in two separate Phase II
investigator-sponsored studies in HR+/HER2- breast cancer and
sarcoma. A poster presentation from the Phase II OASIS study of
SM-88 in patients with HR+/HER2- breast cancer will be presented at
the American Association for Cancer Research (AACR) Annual Meeting
on April 11, 2022. The Company is also conducting a comprehensive
translational preclinical program focused on SM-88 MOA and
Biomarker Identification/Validation and has engaged Evotec, a
leading global research and development company, to aid in the
execution of these activities.
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 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, 2021 filed with the U.S. Securities and Exchange
Commission (“SEC”) on June 10, 2021 and our Quarterly Report on
Form 10-Q for the period ended December 31, 2021 filed with the SEC
on February 11, 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.
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