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Jefferies Virtual Global Healthcare Conference November 2020
Jefferies VirtualGlobal Healthcare Conference
November 2020
Safe Harbor StatementIn addition to historical information, this presentation contains forward-looking statements under the Private Securities Litigation Reform Act that involvesubstantial risks and uncertainties. Such forward-looking statements within this presentation include, without limitation, statements regarding our drugcandidate SM-88 and its clinical potential and non-toxic safety profiles, our drug development plans and strategies, ongoing and planned clinical trials,preliminary data results and the therapeutic design and mechanisms of our drug candidates; and readers can identify forward-looking statements bysentences or passages involving the use of terms such “believes,” “expects,” “hopes,” “may,” “will,” “plan,” “intends,” “estimates,” “could,” “should,” “would,”“continue,” “seeks,” or “anticipates,” and similar words (including their use in the negative) or by discussions of future matters such as the development andpotential commercialization of our lead drug candidate and of other new products, expected releases of interim or final data from our clinical trials, possiblecollaborations, the timing, scope and objectives of our ongoing and planned clinical trials and other statements that are not historical. The forward-lookingstatements contained in this presentation are based on management’s current expectations, which are subject to uncertainty, risks and changes incircumstances that are difficult to predict and many of which are outside of TYME’s control. These statements involve known and unknown risks, uncertaintiesand other factors which may cause the Company’s actual results, performance or achievements to be materially different from any historical results and futureresults, performances or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to,that the information is of a preliminary nature and may be subject to change; uncertainties inherent in research and development, including the ability toachieve clinical study start and completion dates; the possibility of unfavorable study results, including unfavorable new clinical data and additional analyses ofexisting data; risks associated with early, initial data, including the risk that the final Phase II data may differ from prior study data or preliminary Phase II data;final results of additional clinical trials that may be different from the preliminary data analysis and may not support further clinical development; that pastreported data are not necessarily predictive of future patient or clinical data outcomes; whether and when any applications or other submissions for SM-88may be filed with regulatory authorities; whether and when regulatory authorities may approve any applications or submissions; decisions by regulatoryauthorities regarding labeling and other matters that could affect commercial availability of SM-88; the ability of TYME and its collaborators to develop andrealize collaborative synergies; competitive developments; and the factors described in the section captioned “Risk Factors” of TYME’s Annual Report onForm 10-K filed with the U.S. Securities and Exchange Commission on May 22, 2020, 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 presentation is as of this date and TYME assumes no obligation to update forward-looking statements contained in thispresentation as a result of future events or developments.
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TYME Technologies
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TYME is an emerging biotechnology company focused on exploring novel therapeutic
approaches designed totarget cancer’s unique metabolism
TYME is advancing proprietaryCancer Metabolism-Based Therapies (CMBTs™)
for difficult-to-treat cancers
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Fight Against COVID-19: Initiating proof-of-concept RESPOnD trial to investigate TYME-19 for safety and efficacy in recently diagnosed, symptomatic COVID-19 patients
Differentiated MOA: TYME is exploiting the extensively studied Warburg Effect by developing a first-in-class approach to kill cancer cells through disrupting cancer metabolism through multiple mechanisms of action. TYME believes this unique approach can provide broad therapeutic efficacy without unnecessary off-target toxicity
A leader in Cancer Metabolism-Based Therapies (CMBTs™):Over a decade of experience studying Cancer Metabolism-Based Therapies (CMBTs) with a strong patent portfolio broadly covering compositions, methods, manufacturing and use extending beyond 2032
Large Growing Markets with Limited Therapeutic Options: Targeting metastatic cancers for which there are limited options, including pancreatic, sarcoma, prostate, breast cancers and more
Lead Candidate, SM-88, in Pivotal Trials:⬣ Enrolling patients in pivotal TYME-88-Panc Part 2 trial for third-line pancreatic cancer⬣ Enrolling patients in Phase II/III Precision Promise pivotal trial in second-line pancreatic cancer⬣ Enrolling patients in HopES Sarcoma Phase II trial for Ewing’s & high-risk sarcomas ⬣ Preparing SM-88 for clinical programs in cancers where it has previously shown responses in early clinical trials,
including breast, prostate and blood cancers
TYME: Investment Rationale
Delivering on Key Milestones Positions TYME for Long-Term Success
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Advance enrollment in TYME-88-Panc Pivotal Study
Present and/or publish final data from Part 1 of TYME-88-Panc study
Advance SM-88 clinical programs into other tumor types potentially including metastatic breast, recurrent prostate and/or hematological cancers
Initiate enrollment in PanCAN’s Precision PromiseSM adaptive randomized Phase II/III trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy
Advance plans for TYME-18 IND-enabling program
Abstracts to be presented on preclinical data for SM-88 & TYME-18 at AACR
Publish SM-88 Phase II prostate study
Present Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR & ASCO
Complete enrollment in HopES Sarcoma study
Advance enrollment in the HopES Sarcoma Phase II Trial
Complete TYME-19 proof of concept trial
Complete enrollment in TYME-88-Panc pivotal study
Orphan Drug Designation for SM-88
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PROGRAM FORMULATION INDICATION DEVELOPMENT STAGE PHASE I PHASE II PHASE II/III
Brain/GliomaNasal
Advancing Innovative Pipeline of Cancer Metabolism-Based Compounds (CMBTsTM)
Digestively Compromised Patients
Pancreatic: Third-Line
Prostate: Biomarker Recurrent Completed
Metastatic Sarcomas* HopES: Enrolling
Future Trials: Breast and Prostate
Pancreatic: Second-Line Monotherapy
Pancreatic: First-Line Combo w/GA
Injectable
SM-88n
SM-88i
Solid TumorsIntra-tumoralTYME-18
Future Trials: Hematology
OralSM-88
Anti-viralOralTYME-19
Precision Promise: Initiate Following Second-Line
TYME-88-Panc Pivotal Part 2: Enrolling
Precision Promise: Enrolling Shortly
Expanding Breadth and Depth of Strong Patent Portfolio
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Patents broadly cover compositions, methods, manufacturing and use of the Company’s pipeline to 2032, and beyond2032
GLOBAL: 194 Patent Applications Granted and/or Pending
US
EU
APAC
Expanding Opportunities for Cancer Metabolism-Based Therapies to Transform Treatment of Metastatic Cancers
8source: IQVIA global oncology market trends 2019; American Cancer Society’s cancer facts & figures 2019; www.ncbi.nlm.nih.gov; drugs.com; ajmc.com; boneandjointburden.org
PANCREAS(Third-line)
10K$0.9B
INCIDENCE
MARKETOPPORTUNITY
PANCREAS(First, Second and Third-line)
57K$5.1B
INCIDENCE
MARKETOPPORTUNITY
SARCOMA
12K$1.1B
INCIDENCE
MARKETOPPORTUNITY
PROSTATE
450K$14.4B
PREVALENCE
MARKETOPPORTUNITY
BREAST(Metastatic)
150K$19.4B
INCIDENCE
MARKETOPPORTUNITY
HEMATOLOGY(DLBC, R/R AML)
48K$8.4B
INCIDENCE
MARKETOPPORTUNITY
(Recurrent)
(Ewing’s & High-Risk)
UNIQUE SCIENTIFIC APPROACH
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SM-88 SM-8
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SM-88
4. Decreased cellular defenses
Free Radicals
(ROS)
2. Protein synthesis fails1. Induce uptake of TYME’s
modified dysfunctional Tyrosine
3. Cell death from oxidative stress
Exploiting Warburg Effect Through Modified Dysfunctional Amino Acids Targeting Cancer’s Unique Metabolism
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5. Reduce Immunosuppressive Cells By Blocking Upstream
CLINICAL TRIALS:METASTATIC CANCER
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SM-88 Achieved Confirmed Clinical Responses Across 15 Tumor Types
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*NCI.org statistics for 2018
Success in pancreatic cancer may offer a path for SM-88 development into many of the 15 advanced cancers
where imaging responses were demonstrated
Cancers with Demonstrated Responses to SM-88
Pancreatic Breast Ovarian
Prostate Colon Glioma/Glioblastoma
Ewing’s Sarcoma Renal Appendix
Soft-Tissue Sarcoma Thyroid Hodgkin’s Lymphoma
Lung Head & Neck Non-Hodgkin’s Lymphoma
CLINICAL TRIALS:PANCREATIC CANCER
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U.S. Pancreatic Treatment Paradigm
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> 10,000Receive 3rd Line
> 20,000Receive 2nd Line
 Onivyde® +5FU/LV (GA-failed) GA (5FU-failed) Single agent (ECOG 2)
> 41,000Receive 1st Line
 Gemzar® / Abraxane® (“GA”); or FOLFIRINOX Single agent (ECOG 2)
8-11 months
4-6 months
2-3 months
~30%
~10%
~0%
Diagnosed (U.S.)
ASCO Guidelines (Metastatic)
Metastatic at Diagnosis
# of Patients
55,400
~80%
Localized ~20%
“No data are available to recommend third-line (or greater)
therapy with a cytotoxic agent”
Historical Trial Medians
Source: 2018 American Cancer Society patient statistics; Metastatic Pancreatic Cancer: ASCO Clinical Practice Guidelines; Abrams et al 2017; Bachet et al 2009
ORR Survival
TYME-88-Panc Overall Survival (OS) and Clinical Benefit Rate (CBR)
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 Third-line PDAC has no established therapy
 Previously reported survival for third line PDAC patients is approximately 2.0 – 2.5 months (Manax et al. ASCO GI Poster 2019)
 The preliminary median Kaplan-Meier (KM) derived overall survival of the evaluable population is currently 6.4 months
ESMO GI PosterSM-88 Therapy in High-Risk Poor Prognosis Pancreatic Cancer
 44% (11/25) RECIST Clinical Benefit Rate (SD or PR)
 Patients who achieved at least SD by first assessment demonstrated statistically significant greater survival than PD patients
 Patients who achieved at least RECIST SD had a 92% reduction in risk of death
Data cutoff as of 4/25/19
HR: 0.08 (95% CI 0.01 – 0.63)p = 0.02
RECIST Disease Control
Data cutoff as of 4/25/19
 SM-88 has demonstrated well tolerated safety profile with only 4% of patients reporting serious adverse events (SAEs) across multiple clinical trials
 SM-88 has demonstrated a favorable safety profile in 15 different tumor types, including solid tumors and hematologic malignancies across four separate studies
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Data cutoff as of 4/25/19
Targeted Mechanism of Action Delivering Favorable Safety Profile Compared With Other Cancer Treatments
ENDPOINT(S)DESIGN
Enrolling Patients in TYME-88-Panc Pivotal Trial
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PIVOTAL SM-88 used with MPS in Patients with Metastatic Adenocarcinoma of the Pancreas Whose Disease Has Progressed or Reoccurred Study Identifier: NCT03512756
⬣ Histologically confirmed pancreatic adenocarcinoma
⬣ Received second-lines of prior systemic therapy
⬣ Adequate organ function
KEY ELIGIBILITY CRITERIA
SM-88(N=~125)
Investigator-chosen Therapy(N=~125)
R1:1
Treatment untilunacceptabletoxicity, diseaseprogression or any treatment discontinuation criteria are met
SCR
EENIN
G
Primary: OSSecondary*: PFS, CBR, and QoL Key Exploratory Endpoints*: Biomarker analysis, including CTCs
* Other secondary and exploratory endpoints will also be captured.
CLINICAL TRIALS:PRECISION PROMISESM
PANCREATIC CANCER
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PanCAN Precision PromiseSMClinical Trial Consortium Sites
PanCAN: World’s Largest Advocate Committed to Curing Pancreatic Cancer
Precision Promise is the first response-adaptive randomized clinical trial platform for pancreatic cancer patients in the world and the Pancreatic Cancer Action Network’s groundbreaking initiative to dramatically improve outcomes for pancreatic cancer patients and advance the organization’s goal to double survival.
“
”– Pancreatic Cancer Action Network
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CLINICAL TRIALS:PROSTATE CANCER
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SM-88 Demonstrated Potential To Postpone Hormone Therapy in Recurrent Prostate Cancer
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⬣ At 6 months, 100% (23/23) of patients were free of metastatic progression, and 87% of patients remained free of radiographic progression
⬣ After 3 months, 78% (18/23) of patients demonstrated a median 65% decrease in median CTCs from baseline
⬣ 52% (12/23) of patients showed improvement in median PSA doubling time
⬣ No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months
Benjamin Gartrell1 Mack Roach2 Giuseppe Del Priore3 Avi Retter4 Wen-Tien Chen5 Gerald H. Sokol6 Alexander Vandell3 Howard I. Scher7
1)Albert Einstein College of Medicine/Montefiore Medical Center 2)University of California San Francisco 3)TYME Inc. 4)ECCC/NY Cancer and Blood Specialists 5)LineaRx 6)Florida Cancer Specialist 7)Memorial Sloan-Kettering Cancer Center
Data cutoff as of September 2019
ESMO PosterPhase II Trial of SM-88 in Non-Metastatic Biochemical Recurrent Prostate Cancer
CLINICAL TRIALS:SARCOMAS
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 Ewing’s accounts for 30% of bone cancers in children
 Tumor of the bone or soft tissue, most often in the pelvis, thigh, lower leg, upper arm and chest wall
 30% 5-year survival rate for metastatic disease
 All sarcomas represent 12,000 new cases annually in U.S. alone
 TYME, Dr. Sant Chawla and The Joseph Ahmed Foundation (JAF) are addressing unmet need in ultra-rare metastatic sarcoma
 JAF is funding the trial and is using its nationwide network to assist potential patients and their families
 Based on compassionate use results in two metastatic Ewing’s sarcoma patients who achieved CR or PR, with no drug-related SAEs
 If proof-of-concept is demonstrated, a multi-site confirmatory study will be evaluated
Ewing’s and High-risk Sarcoma:
JAF HopES Trial: Enrolling Patients with Ultra-Rare Metastatic Sarcoma
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ENDPOINT(S)DESIGN
SM-88 for Advanced Ewing's Sarcoma and Salvage Therapy for Sarcoma Patients (HopES)
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Phase 2 SM-88 Used With MPS in Patients With High-Risk Ewing’s and Other Sarcoma Types Study Identifier: NCT03778996
⬣ Bx proven previously treated Sarcoma
⬣ High Risk for PD ie > 2 prior lines of systemic treatments
⬣ Ewing’s patients may be treated in SD immediately following 1st or 2nd line therapy
KEY ELIGIBILITY CRITERIA
SM-88 in Ewing’s(N=12) Treat until
Progressive disease or unacceptable toxicity
Primary: Response RateSecondary*: PFS, CBR
* Other secondary and exploratory endpoints will also be captured.
SM-88 in Other Sarcomas (N=12)
SCR
EENIN
G
CLINICAL TRIALS:BREAST CANCER
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Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer
 SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile. There was no indication of cross-resistance based on hormone receptor profile, prior treatments, or metastatic site A total of 25 mBC patients were treated with SM-88 between 2012–2017 All subjects had previously treated progressing mBC  Subjects had a median of 3 prior therapies (range of 1 – 8)
 Overall response rate was 44% (11/25)  16% (4/25) Experienced a Complete Response 79% Improved ECOG Performance Status  57% Pain Reduction (NRS-11)
 There were no unanticipated or drug-related adverse events
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TYME-19 DEVELOPMENT PROGRAM
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Clinical Development Plan
 Initiating a proof-of-concept study to evaluate efficacy of oral TYME-19 versus placebo (“RESPOnD”)
 Targeting newly diagnosed, symptomatic patients who are high-risk, but do not require hospitalization
 Evaluating safety as well as change in patient symptoms, viral levels, hospitalization and other efficacy endpoints
 Protocol developed in partnership with researchers from Mass General and Cornell
 Will be run as an investigator-initiated trial
ÂTYME has sourced cGMP drug substance to allow rapid clinical development
ÂThe Company is in discussions with the FDA to determine the appropriate regulatory strategy
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DEVELOPMENT PARTNERS
Why is This Important and Different? Doctors need more tools between hospital care and vaccines
 A simple, well tolerated anti-viral therapeutic could be used early after diagnosis to prevent the need for hospitalization
 Vaccines are a key part of the solution for a pandemic, but there needs to be better therapies available while the vaccines are being developed
 By using an endogenous cellular regulator that targets basic functions of viruses, there is potential for broad spectrum anti-viral effect It will be critical to have readily-available, effective drugs when the next viral outbreak or
pandemic occurs Potential use of TYME-19 or related drugs in other viruses
 TYME-19 is expected to be a shelf stable compound, relatively inexpensive to manufacture and suitable for global distribution
 TYME-19’s mechanism may support prophylactic use to protect our first responders and most at-risk populations
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TYME-19’s Antiviral Mechanisms
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Physically Degrades Viruses
InhibitsProduction of Viral Proteins
Inhibits Productionof Viral Lipids
2
4Upregulates Innate Immunity
1
3
Next Steps
 Initiating Proof-of-Concept RESPOnD Trial
 Ongoing discussions with FDA
 Pursuing government funding opportunities to advance TYME-19 development
 Building portfolio of antiviral metabolic agents
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KEY MILESTONES FOR FISCAL YEAR 2021
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Milestone Timing
Clinical Trial Milestones
Advance enrollment in TYME-88-Panc pivotal study, and the HopES Phase II Trial 2021
Advance enrollment in PanCAN’s Precision PromiseSM adaptive randomized Phase II/III Trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy 2021
Advance SM-88 clinical program as a potential oral treatment for patients with metastatic breast, recurrent prostate and/or hematological cancers 2021
Explore Opportunity with PanCAN’s Precision PromiseSM adaptive Phase II/III trial evaluating SM-88 in patients with first-line pancreatic cancer in combination with gemcitabine and Abraxane
2021
Complete enrollment in TYME-88-Panc pivotal study Not before 2022
Preclinical & Clinical Data Milestones
Present preclinical data for SM-88 1H’2020
Present preclinical data for TYME-18 1H’2020
Publish SM-88 Phase II prostate study 2H’2020
Present and/or publish final data from Part 1 of TYME-88-Panc study 1H’2021
Complete TYME-19 proof of concept trial 1H’2021
Other
Present preliminary Health Economic Outcomes study on total cost of care for pancreatic cancer patients 1H’2020
Orphan Drug Designation for SM-88 2H’2020
Advance plans for TYME-18 IND-enabling program 1H’2021
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2020 Creates Pivotal Inflection Point with Multiple Value Drivers
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