NEW YORK–(BUSINESS WIRE)– Tyme Technologies, Inc. (OTC QB: TYMI), a clinical-stage pharmaceutical
company focused on discovering and developing highly-targeted cancer
therapeutics for a broad range of oncology indications has reported
financial results for the year ended December 31, 2015.
« Our development program for our lead compound, SM-88, continues to
evolve as we work towards the initiation of our first Phase II clinical
trial. We are preparing protocols for a Phase II breast cancer study, as
well as other Phase II trials to be initiated in 2016, most likely to
include prostate, pancreatic and non-small cell lung cancers. These will
be multicenter, open-label, randomized clinical studies,” said Steve
Hoffman, President and Chief Executive Officer of Tyme. “In our
completed initial proof-of-concept trial, we believe we demonstrated
that our drug was well-tolerated and showed preliminary activity across
a number of different cancer types in terms of tumor regression,
biomarker improvement, and in overall survival.”
Continued Mr. Hoffman, “We have also been active in building our
internal infrastructure including bringing on a full-time Chief Medical
Officer and a full-time Chief Financial Officer. Our fundraising efforts
have also increased. In December we raised $3 million through the
issuance of common stock and warrants. In February we raised an
additional $3.1 million on similar terms.”
Fourth Quarter 2015 Financial Results
-
For the year ended December 31, 2015, operating costs and expenses
totaled $8,599,772, compared to $2,584,116 for the year ended December
31, 2014, representing an increase of $6,015,656 primarily due to
increased research and development efforts. -
Research and development expenses were $3,823,966 compared to $761,359
for the year ended December 31, 2014. All research and development
expenditures have been incurred in respect of our lead drug candidate,
SM-88, and its technology platform. -
General and administrative expenses were $4,775,806 compared to
$1,822,757 for the year ended December 31, 2014. -
Net loss for the year was $11,726,818, compared to $2,649,826 for the
year ended December 31, 2014.
As of December 31, 2015, Tyme had 86,836,370 shares outstanding and cash
of $4,446,284.
About Tyme
Tyme is a clinical-stage pharmaceutical company focused on discovering
and developing highly-targeted cancer therapeutics for a broad range of
oncology indications. Tyme’s research and development efforts are based
on a proprietary platform technology, for which the Company retains
global IP and commercial rights. Tyme’s lead program is SM-88, a
proprietary combination drug product and first-in-class oncology therapy
that is believed to increase the power of the body’s innate defenses to
utilize oxidative stress to kill cancer cells. SM-88 is designed to
penetrate only living cancer cells without toxic effects and without
involving healthy body tissue. Tyme believes that SM-88’s therapeutic
potential is based on its ability to increase the availability of free
radicals and promote their entry into cancer cells by stripping the
cancer cells of their normal barriers to these toxic electrons. SM-88 is
a combination of a proprietary novel molecule with three
currently-marketed drugs that are generally considered safe for their
already approved indications, which are in areas other than cancer
treatment.
For more information, visit our website: www.tymetechnologiesinc.com.
Safe Harbor Statement
This press release contains forward-looking statements. Readers can
identify forward-looking statements by sentences or passages involving
the use of terms such as « anticipates, » « believes, » “designed,” « could, »
« estimates, » « expects, » « intends, » « may, » « plans, » « potential, »
« predicts, » « projects, » « should, » « would » and similar expressions
intended to identify forward-looking statements. Forward-looking
statements within this press release include, without limitation,
statements regarding our drug development strategies, the therapeutic
mechanisms of our drug candidates and our completed and planned clinical
trials. 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, performances or achievements
expressed or implied by the forward-looking statements. These risks and
uncertainties include, but are not limited to, the factors described in
the section captioned « Risk Factors » of Tyme’s Annual Report on Form
10-K filed with the U.S. Securities and Exchange Commission on March 30,
2016 (available at www.sec.gov).
Forward-looking statements reflect Tyme’s current views with respect to
future events and are based on assumptions and subject to risks and
uncertainties. We are not necessarily obligated to update any
forward-looking statement due to any change or development that occurs
or may occur after the disclosure of such a statement. Given these
uncertainties, readers should not place undue reliance on these
forward-looking statements.
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Contacts
Tyme Technologies, Inc.
Robert Dickey, 646-205-1603
Chief
Financial Officer
InvestorRelations@tymeinc.com
Source: Tyme Technologies, Inc.
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