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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 e
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 t
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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
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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
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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
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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
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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 e
Thank You! Investor Relations JTC Team 833.475.8247 tyme@jtcir.com