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S c i e n t i f i c S o l u t i o n s Wi th o u t C o mp ro m i s
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J u n e 1 0 , 2 0 2 1 C o n f e r e n c e C a l l a n d W e b c a s
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In addition to historical information, this presentation contains
forward-looking statements under the Private Securities Litigation
Reform Act that involve substantial risks and uncertainties. Such
forward-looking statements within this presentation 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,
including the proposed TYME-19 proof-of-concept study, 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 novel coronavirus (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
products; expected releases of interim or final data from our
clinical trials; possible collaborations; and the timing, scope,
status, objectives of our ongoing and planned trials; the success
of management transitions; and other statements that are not
historical. The forward-looking statements contained in this
presentation 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; that the 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;
final results of additional clinical trials that may be different
from the preliminary data analysis and may not support further
clinical development; 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 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.
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Team
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C U R R E N T E X E C U T I V E T E A M N E W T E A M M E M B E R
S
Jan Van Tornout, MD, MSC Acting CMO
Frank Porfido, CPA, MBA CFO
Richie Cunningham CEO
Steve Hoffman CSO
5
Would we benefit from more foundational pre-clinical & MOA
data?
What do external experts think of our current data and development
programs?
What are our capabilities and experience in drug development,
finance,
investor outreach and strategic vision?
Is our IP robust?
What is the best way to optimize our financial runway?
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E VA L U AT E D I N D I C AT I O N S : P a n c r e a t i c , B r e
a s t , P r o s t a t e , L u n g , S a r c o m a , C N S , I n f e
c t i o u s D i s e a s e
Healthcare Consulting Drug Discovery & Development
Research & Development Experts
Translational Medicine Experts
7
Responses seen in First-in-Human (FIH) study data in a wide range
of tumor types is a strong proof of principle
KOLs were impressed by the activity of SM-88 as a single agent in
the FIH trial
C O M P E L L I N G D ATA A S A S I N G L E A G E N T
SM-88 is well-positioned in the evolving oncology market
C L E A R L Y T H E D R U G I S A C T I V E G I V E N T H E R E S P
O N S E S A C R O S S D I F F E R E N T T U M O R T Y P E S . W H Y
A N D I N W H I C H S C E N A R I O N E E D S M O R E S T U D Y B U
T T H E B O T T O M L I N E I S T H E R E I S A C T I V I T Y
.
K O L , P a n c r e a t i c C a n c e r
SM-88’s favorable safety profile allows for potential combination
therapy with both well established chemotherapies as well as new
modalities like immuno-oncology
SM-88 ?
AT T R A C T I V E S A F E T Y P R O F I L E ; P O T E N T I A L T
O C O M B I N E
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Strategic Review Key Findings
Broad activity across 15 cancer types as seen in first-in-human
study and compassionate use program and confirmation of strong IP
portfolio provides development optionality
Focus on 2nd line pancreatic Precision Promise
Pipeline diversification outside of just pancreatic cancer
Breast cancer emerged as a priority indication for
development
Refinement of MOA of SM-88 and the development of biomarkers to
enhance targeting
Rapidly changing COVID landscape may optimize trajectory of
TYME-19
Capital position provides significant runway to execute development
goals
We would benefit from more internal experience in drug development
and finance
8
9
After a thorough evaluation, the high-level indications prioritized
for deep dive evaluation into specific subgroups and lines of
therapy were:
Strength of Existing Data
Prostate Cancer
Pancreatic Cancer
Breast Cancer
E V A L U A T E D I N D I C A T I O N S
C L I N I C A L L E A D I N D I C A T I O N S
CNS Cancers
E V A L U A T E D C R I T E R I A
Anti-Viral
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F O U N D AT I O N A L M O A & B I O M A R K E R S T R AT E G Y
T O S U P P O R T P I P E L I N E
*Assess potential partnership opportunities
P R O G R A M I N D I C A T I O N P R E C L I N I C A L P H A S E 1
P H A S E 2 P H A S E 3
O n c o l o g y
S M - 8 8 Oral
Pancreatic (Second-Line)
TYME - 1 8 Intra-tumoral Solid Tumors*
V i r a l
T Y M E - 1 9 Oral COVID-19*
PRECISION PROMISE
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The Strategic Review and KOL Ad-board feedback along with FIH study
and compassionate use program data identified the HR(+)/Her2(-)
breast cancer patients who failed 1st line treatment that includes
a CDK4/6 inhibitor as a priority setting for SM-88
Primary objective with this Phase 2 study is to confirm the
efficacy previously seen in the FIH study and compassionate use
program, with a secondary objective to generate pre-clinical data
on the mechanism of SM-88 and MPS
CDK4/6 inhibitor class migration towards 1st line and earlier
settings creates a significant market opportunity for SM-88 post
CDK4/6 failure
H R + / H E R 2 - S U B S E T O F PAT I E N T S
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HR+/HER2 – represents 73% of Breast Cancer molecular subtypes in
the U.S.
Safety and quality of life are priorities in later line
settings
B R E A S T C A N C E R S U B T Y P E S
Metastatic Breast Cancer is a large market opportunity
Within Breast Cancer there are several subtypes and treatment
approaches
U S B R E A S T ( M e t a s t a t i c )
~150K $7.7B
I N C I D E N C E
M A R K E T O P P O R T U N I T Y
B R E A S T C A N C E R M A R K E T O P P O R T U N I T Y
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The CDK4/6 class are great drugs, and they are moving up the
treatment paradigm
L A N D S C A P E
OASIS was designed with the upper boundary of efficacy represented
by the MONARCH-1 trial of SINGLE AGENT CDK4/6 INHIBITOR in a
similar patient group to our enrollment criteria ORR=19.5%
Commonly used before chemo despite minimum efficacy. Based on the
BOLERO-2 trial of a mTOR PLUS AROMATASE INHIBITOR where the
ORR=9.5%
M E A S U R E M E N T F O R S U C C E S S
S M - 8 8 B r e a s t C a n c e r
Hormonal Status Patients (n) CR PR SD ORR CBR Med OS (months)
Mean OS (months)
2 (17%)
4 (33%)
5 (42%)
(0%) 2
(40%) 2
(40%) 2
(40%) 4
(16%) 7
(28%) 8
(32%) 11
(44%) 19
CDK4/6 mainly moved to front- line and earlier
N E O - A D J U V A N T / A D J U V A N T
1 S T - L I N E M E T .
2 N D - L I N E M E T .
3 R D - L I N E M E T .
S M -88
Chemo primary remaining option
C H E M O
C U R R E N T S O C Chemo, endocrine, CDK4/6
CDK4/6, endocrine therapy
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2nd Line Pancreatic Cancer Remains a Priority
Last year >90% of TYME clinical investment was in pancreatic
cancer
ROI analysis
In addition, we reviewed enrollment/timing 3rd line slow
enrollment
The overall number of 3rd line patients are significantly less than
2nd line
14
PA N C R E A S ( U S ) * INCIDENCE MARKET OPPORTUNITY
1 s t L i n e ~42K $3.8B 2 n d L i n e ~22K $2.0B 3 r d L i n e ~6K
$0.5B
* 2019 estimates as per EvaluatePharma
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Market Opportunity
Time to Conclude
Observed a high drop-out rate in the 3rd line chemotherapy control
arm which has the potential to impact the overall results and
assessment of SM-88.
Conclusions: Treating patients earlier (2nd vs. 3rd line) offers
best opportunity for patients and SM-88
2nd line Pancreatic Cancer is a more viable commercial opportunity
for TYME and provides best cost benefit scenario
More efficient use of capital to pursue one trial
Discontinue 3rd line due to ROI and cost benefit
S T R AT E G I C R E V I E W PA N C R E AT I C C A N C E R 3 R D L
I N E D E E P E R D I V E
Focus Pancreatic Investment in 2nd line pancreatic cancer Precision
Promise offers best opportunity
The savings by discontinuing the 3rd line trial are expected to
completely fund the OASIS breast cancer trial
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HoPES: Metastatic Sarcomas
S A R C O M A E M E R G E D A S A S T R AT E G I C I N D I C AT I O
N W H E N C O N S I D E R I N G S E V E R A L FA C T O R S
• High unmet need
• Prior SM-88 activity in sarcomas
• Safety and quality of life are priorities in later line
settings
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S A R C O M A
12K U . S . I N C I D E N C E
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Metastatic Sarcomas
Interim data published in ASCO abstracts highlighted durable
duration of therapy in heavily pre-treated patients
Several cases of anti-tumor activity and other clinical benefits
were observed
Completing enrollment, allow the data to mature, and assess
potential pathways for advancement
Apply any learnings from biomarker initiative to potential future
trials
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EWS 11.9 4.3 N, Nr
EWS^ 6.2+ 2 na
EWS 6 5.7 T
Desmoplastic Small Round Cell 4 3.2 G, R
Follicular Dendritic Cell Sarcoma 3 0.8 Al
Leiomyosarcoma1 3 1.3 A, I
EWS 2 3 V, Ir, T
Angiosarcoma 1 6.5 O
Last Prior Tx*
Time on. SM-88 (mo)
*A -adriamycin; Al -alpelisib; Ap -apatinib; D -docetaxel; E
-etoposide; G -gemcitabine; I -ifosfamide; Ir -irinotecan; IT
-interferon; N -nivolumab; Nr -nab-rapamycin; O -other
experimental; R -ribociclib; T - temozolomide; V -vincristine
na–not yet available No disease progression; remains on SM-88 as of
Feb 5, 2021 1There was 1 death reported (disease
progression).
A S C O 2 0 2 1 A B S T R A C T R E S U LT S
Source: J Clin Oncol 39, 2021 (suppl 15; abstr e23505)
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The number of clinical trials incorporating pharmacogenomics /
pharmacogenetic analysis has more than doubled since 2010
U S E O F B I O M A R K E R S T O D E V E L O P TA R G E T E D T H
E R A P I E S
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Enables us to design more informed trials in patients with the best
chances for benefit with SM-88
Identify complementary combination approaches with existing
treatments to broaden our development options and leverage SM-88
safety / tolerability profile
U S E O F B I O M A R K E R S T O D E V E L O P TA R G E T E D T H
E R A P I E S CLINICAL
OUTCOMES
COMBINATION
BIOMARKERS
Established partnerships with credible leaders
NYU MAYO
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COVID-19 Landscape is Rapidly Evolving
I N C R E A S I N G VA C C I N AT I O N R AT E S R E D U C I N G N
E E D F O R T H E R A P E U T I C S
3 vaccines with emergency use authorization by the U.S. FDA
Pivotal trials suggest high efficacy at preventing
hospitalization
201:
https://www.whitehouse.gov/briefing-room/press-briefings/2021/06/03/press-briefing-by-white-house-covid-19-response-team-and-public-health-officials-40/;
2:
https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap
Multiple Large Pharmas Shifting Focus to Therapeutics
T H E R A P E U T I C P I P E L I N E I S G R O W I N G I N C R E A
S I N G LY C R O W D E D
1 treatment currently approved2
610+ total development programs2
Percentage of U.S. Population Vaccinated to Date
0% 20% 40% 60% 80% 100%
Complete: 52%1 Initial Dose: 63%1
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opportunities
Continue to assess the landscape
O R A L , S Y N T H E T I C A L LY P R O D U C E D M E M B E R O F
T H E B I L E A C I D FA M I LY T H AT I S B E I N G D E V E L O P
E D F O R T H E P O T E N T I A L T R E AT M E N T O F C O V I D -
1 9
F u r t h e r p r e p a r e d n e s s n e e d e d f o r n e x t c o
r o n a v i r u s o r f u t u r e p a n d e m i c
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W E L L - C A P I TA L I Z E D A S W E R O L L O U T O U R N E W C
L I N I C A L S T R AT E G Y
$107.5 M $24-$32 M $75-$83 M Expected cash burn for 2022
Expected cash at end of fiscal year 2022
At March 31, 2021 (Fiscal Year End)
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1H22
Pancreatic Cancer Data Update (PART 1) – 1H22
2H22
Decision - 2H22
Events are listed by calendar year timelines
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Robust pipeline and multiple shots on goal
A solid plan includes building a strong foundation of understanding
of the potential of SM-88
Focus and discipline: invest wisely and strategically in
data-driven development
Well funded to advance programs: Fiscal Year end cash at
$107M
Experienced Management Team with proven track record
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S c i e n t i f i c S o l u t i o n s Wi th o u t C o mp ro m i s
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Thank You! Investor Relations JTC Team 833.475.8247
[email protected]