– First patient dosed in Phase II OASIS trial
evaluating the potential benefits of oral SM-88 for patients with
metastatic HR+/HER2- breast cancer after treatment with a CDK4/6
inhibitor –
– PanCAN Precision Promise trial to add five
new sites in early 2022 –
– Commenced preclinical initiative with Evotec,
a global leader in drug development, to evaluate the potential of
expanding our SM-88 platform to other indications –
– Maintained a well-capitalized position, with
$96.6 million in cash and marketable securities as of September 30
–
– Company to host live conference call and
webcast today, November 8, 2021, at 8:30 AM ET –
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 second fiscal quarter ended September 30, 2021.
Second Fiscal Quarter 2022 Business and Recent
Highlights:
- Commenced enrollment and dosed first patient in OASIS breast
cancer trial, a multicenter Phase II single-arm, open-label study
examining SM-88 with methoxsalen, phenytoin, and sirolimus (MPS) in
patients with metastatic disease who have received two prior
hormonal therapies. The trial is being conducted by Georgetown
University (NCT04720664) at five MedStar Health hospitals. (MedStar
Health is Georgetown’s academic clinical partner).
- Five new sites planned to be added in early 2022 with an
additional 10 sites expected by the end of 2022, on top of the 15
already participating (for a total of 30 sites), in the Precision
Promise trial, a Phase II/III randomized adaptive trial in
metastatic pancreatic cancer sponsored by the Pancreatic Cancer
Action Network (PanCAN). These sites are among the top research
institutions in the country for pancreatic cancer treatment.
- The HOPES Sarcoma trial, an investigator-sponsored trial, had a
meaningful increase in the rate of enrollment during the quarter.
We anticipate completing trial enrollment by the end of the first
half of calendar year 2022.
- Launched preclinical initiative with Evotec to evaluate the
potential of expanding SM-88 platform to other targeted
indications.
- Announced plans to explore the development of a Tyrosine-based
tumor targeted technology and the receipt of a patent on such
platform.
“Our second quarter was a period of significant action at TYME
as we continued to implement our strategic imperatives. We
commenced the OASIS breast cancer study with the first patient
dosed in late September, and initiated our preclinical work,
including our all-important biomarker research. We believe this
will provide us with a better understanding of how best to address
treatment opportunities. Our existing trials are also progressing,
as planned. PanCAN’s Precision Promise trial is in the process of
seeking five new sites early next year with plans to add 10 more by
the end of the year and enrollment continues in our HopES sarcomas
study. This is particularly noteworthy given how difficult it is to
recruit patients with this ultra-rare sarcoma. Finally, we began
early discovery work on a tyrosine-based tumor targeted technology
platform,” stated Richie Cunningham, Chief Executive Officer of
TYME.
“Given all the positive momentum, these are exciting times at
TYME, and we are in a strong financial position to advance these
programs. We look forward to sharing information on our progress in
the upcoming quarters,” concluded Cunningham.
Second Fiscal Quarter 2022 Financial Results
As of the quarter ended September 30, 2021, the Company had
approximately $96.6 million in cash and marketable securities,
compared to $101.5 million as of the quarter ended June 30, 2021.
TYME’s operational cash burn rate for the second quarter of fiscal
year 2022 was $5.0 million compared to $6.0 million for the first
quarter and $6.6 million for the second quarter of fiscal year
2021.
The burn rate was below the Company’s previous guidance and
reflected expenses associated with ongoing clinical trials in
pancreatic cancer (Precision Promise), breast cancer (Oasis), and
sarcoma cancers (HopES), as well as reduced costs associated with
our discontinued pancreatic cancer trial, 88-Panc-Part II. TYME
continues to anticipate that its quarterly cash usage or “cash burn
rate” will range from $6.0 to $8.0 million for the remaining
quarters of fiscal year 2022, based on costs associated with the
Company’s active clinical trials, the ongoing and close out
activities related to our discontinued pancreatic cancer study, our
pre-clinical studies in biomarker and mechanism of action research
of SM-88, and TYME-19 pre-clinical studies.
Net loss was $5.6 million for the quarter ended September 30,
2021, or ($0.03) per basic and diluted share, as compared to a net
loss of $6.9 million for the quarter ended September 30, 2020, or
($0.05) per basic and diluted share. The decrease reflected lower
ongoing trial costs primarily due to the discontinued TYME—88- Panc
Part 2 trial.
After adjusting for the change in fair value of warrant
liability, and amortization of employee, director and consultant
stock options, adjusted net loss for the three months ended
September 30, 2021, was $5.3 million, or ($0.03) per share,
compared to adjusted net loss of $6.5 million, or ($0.04) per
share, for the three months ended September 30, 2020. 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 September 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.
Conference Call and Webcast Details
Date: Monday, November 8, 2021 Time:
8:30 AM ET Toll-free (U.S.)
(866) 601-3896 International (636) 812-6499
Conference ID
5953454
The webcast will be accessible on the Events &
Presentations page of the Investors section of the TYME
website, tymeinc.com, and will be archived for 90 days
following the event.
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. The Company believes that early clinical results
demonstrated by SM-88 in multiple advanced cancers, including
pancreatic, 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 pancreatic, lung, breast, prostate and sarcoma
cancers with minimal serious grade 3 or higher adverse events.
SM-88 is being evaluated in an adaptive randomized Phase 2/3
clinical trial for patients with second-line pancreatic cancer. The
Company has begun enrollment in a Phase II study evaluating SM-88
in breast cancer (HR+/HER2-) in the third quarter of calendar year
2021, 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 our drug
candidates (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: the
effect of the COVID-19 pandemic and the associated impact on the
national and global economy as well as impacts on the Company's
ongoing clinical trials and ability to analyze data from those
trials; the cost of development and potential commercialization of
our lead drug candidate and of other new product candidates;
expected releases of interim or final data from our clinical
trials; possible collaborations; the timing, scope, status,
objectives of our 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 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 in 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 and additional
analyses of existing data; 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; and the factors
described in the section captioned “Risk Factors” 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 on June 10, 2021
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.
Financial Tables Follow
Tyme Technologies, Inc. and Subsidiaries Condensed
Consolidated Statement of Operations and Comprehensive Loss
(Unaudited) Three Months EndedSeptember 30,
Six Months EndedSeptember 30,
2021
2020
2021
2020
Revenues
$
—
$
—
$
—
$
—
Operating expenses: Research and development
3,495,416
4,707,448
7,679,827
9,422,743
General and administrative (including $151,000, $138,000, $266,000
and$341,000 of related party legal expenses, respectively)
2,433,099
2,613,689
4,901,258
5,670,761
Total operating expenses
5,928,515
7,321,137
12,581,085
15,093,504
Loss from operations
(5,928,515)
(7,321,137)
(12,581,085)
(15,093,504)
Other income (expense): Change in fair value of warrant liability
344,166
489,572
1,069,309
(2,773,699)
Gain on warrant exchange
—
—
—
2,228,697
Other income
39,007
7,011
58,530
17,513
Interest expense
(19,368)
(25,980)
(40,627)
(55,356)
Total other income (expense)
363,805
470,603
1,087,212
(582,845)
Net loss
$
(5,564,710)
$
(6,850,534)
$
(11,493,873)
$
(15,676,349)
Basic and diluted loss per common share
$
(0.03)
$
(0.05)
$
(0.07)
$
(0.12)
Basic and diluted weighted average shares outstanding
172,206,894
128,046,895
172,206,177
126,323,921
Statements of Comprehensive Loss Net loss
$
(5,564,710)
$
(6,850,534)
$
(11,493,873)
$
(15,676,349)
Other comprehensive loss Unrealized loss on marketable securities,
net of tax
(24,715)
-
(58,557)
-
Comprehensive loss
$
(5,589,425)
$
(6,850,534)
$
(11,552,430)
$
(15,676,349)
Reconciliation of Net Loss to
Adjusted Net Loss Three Months EndedJune 30,
Six Months EndedSeptember 30,
2021
2020
2021
2020
Net loss (GAAP)
$
(5,565,000)
$
(6,851,000)
$
(11,494,000)
$
(15,676,000)
Adjustments: Change in fair value of warrant liability
(344,000)
(490,000)
(1,069,000)
2,774,000
Amortization of employees, directors and consultants stock options
616,000
884,000
1,260,000
1,953,000
Gain on warrant exchange
—
—
—
(2,229,000)
Adjusted net loss (non-GAAP)
$
(5,293,000)
$
(6,457,000)
$
(11,303,000)
$
(13,178,000)
Reconciliation of Net Loss
Per Share to Adjusted Net Loss Per Share Three Months
EndedSeptember 30, Six Months EndedSeptember 30,
2021
2020
2021
2020
Net loss per share (GAAP)
$
(0.03)
$
(0.05)
$
(0.07)
$
(0.12)
Adjustments: Change in fair value of warrant liability * *
(0.01)
0.02
Amortization of employees, directors and consultants stock options
*
0.01
0.01
0.02
Gain on warrant exchange
—
—
—
(0.02)
Adjusted net loss per share (non-GAAP)
$
(0.03)
$
(0.04)
$
(0.07)
$
(0.10)
* The effect of the change was negligible to the adjusted net loss
per share.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211108005305/en/
Investor Relations: Lisa M. Wilson, In-Site
Communications, Inc. T: 212-452-2793 E: lwilson@insitecony.com
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