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Corporate PresentationJanuary 2020
NASDAQ: TYME
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 June 12, 2019, 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
TYME Investment Rationale (NASDAQ: TYME)
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Oral Therapy Advantage: Ease of administration is a key benefit for patients with advanced cancers
Differentiated MOA: TYME is exploiting the extensively studied Warburg Effect by developing a first-in-class approach to kill cancer cells through disrupting cancer protein synthesis. TYME believes this MOA 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 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⬣ Initiating Phase II/III Precision Promise pivotal trial in second-line pancreatic cancer⬣ Enrolling patients in Phase II 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
Delivering on Key Milestones PositionsTYME for Long-Term Success
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Advance Enrollment in Sarcoma Study
PresentInitial Health
Economics Analyses
Present TYME-88-Panc
Part 1 Data
Advance SM-88 Clinical Program In Hematology and Prostate Cancers
Advance Enrollment in PanCANPrecision Promisesm Second-Line SM-88 Arm
Advance PanCANPrecision PromiseSM
First-Line SM-88 Arm in Combination with
Abraxane/Gemcitabine
Complete Enrollment in TYME-88-Panc Part 2 Pivotal Study
Present Pre-Clinical Data for TYME-18
Publish Prostate Phase II Study
Advance SM-88 Clinical Program Into Metastatic Breast Cancer
Update Planning For IND Submission For
TYME-18
Brain/GliomaNasal
Expanding Innovative Pipeline of Cancer Metabolism-Based Compounds (CMBTsTM)
PROGRAM FORMULATION CANCER INDICATION DEVELOPMENTSTAGE
PHASE I PHASE II PHASE II/III
Digestively Compromised Patients
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Pancreatic: Third-Line TYME-88-Panc Pivotal Part 2: Enrolling
Prostate: Biomarker Recurrent Completed
Metastatic Sarcomas* HopES: Enrolling
Future Trials: Breast and Prostate To Be Disclosed
Pancreatic: Second-Line Monotherapy Precision Promise: Initiating Shortly
Pancreatic: First-Line Combo w/GA Precision Promise: Initiate Following Second-Line
Injectable
SM-88n
SM-88i
Solid tumorsIntra-tumoralTYME-18
*Investigator-initiated trial GA = gemcitabine/Abraxane®
Future Trials: Hematology To Be Disclosed
OralSM-88
UNIQUE SCIENTIFIC APPROACH
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SM-88 SM-88
SM-88
3. Decreased cellular defenses
Free Radicals
(ROS)
2. Protein synthesis fails1. Induce uptake of TYME’s
modified dysfunctional Tyrosine
4. Cell death from oxidative stress
Exploiting Warburg Effect Through Modified Dysfunctional Amino Acids Targeting Cancer’s Unique Metabolism
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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: 173 Patent Applications Granted and/or Pending
US
EU
APAC
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
Overall Survival (months)RECIST Designation1
Median OS of 29.8 Months
First Human Study in Metastatic CancerSM-88 has been evaluated in more than 200 patients
 Phase 1 with 30 patients who had actively progressing metastatic cancer and received only SM-88 used with M2PS2
 29.8 month median overall survival
 13 months of progression free survival (PFS) without additional therapy
 33% (10/30) achieved RECIST CR/PR with mean time to best response of 3.3m3
 57% (17/30) achieved RECIST stable disease with a median duration of 11m
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1. Five year analysis as of September 20172. SM-88 = D,L-alpha-metyrosine; SM-88 used with M2PS is D,L-alpha-metyrosine used with low dose
methoxsalen, melanin, phenytoin, and sirolimus3. Response based on RECIST 1.1 criteria. CR = complete response;
PR = partial response; SD = stable disease; PD = progressive disease; OS = overall survival; ORR = Objective response rate
A first-in-human study of the novel metabolism-based anti-cancer agent SM-88 in subjects with advanced metastatic cancer. Invest New Drugs. 2019 Mar 30. doi: 10.1007/s10637-019-00758-8.
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
 Focus on 3rd line patients
 Trial design reflects FDA protocol evaluation
 Randomized with overall survival as primary endpoint
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SM-88 Monotherapy in Patients with Radiographically Progressing Metastatic Pancreatic Cancer (Phase II/III)
Structure: Part 1 single-arm, ~25 sites across the US Part 2 randomized, 10 – 15 sites planned
Primary Endpoint for Part 2: Overall Survival CRO: IQVIA Biotech
Dosing Part 1
 Randomized to 920 mg or 460 mg dose tyrosine
 Completed enrollment ahead of expectations by Sep 2018
 Measuring multiple indicators of efficacy and safety
Initial data analysis presentedat ASCO GI 2019
Completed FDA discussions on 3rd line pivotal trial design
TYME-88-Panc Overview
Pivotal Part 2
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
Part 1 Circulating Tumor Cells (CTCs)
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HR: 0.4 95%CI (0.11 – 1.5)p = 0.18
Best CTC Response by % Reduction (n=24)
 Emerging biomarker in pancreatic cancer
 Patients who had at least an 80% CTC reduction trended towards greater survival
 These patients demonstrated a 60% decrease in risk of death
ESMO GI PosterSM-88 Therapy in High-Risk Poor Prognosis Pancreatic Cancer
Data cutoff as of 4/25/19
63% median CTC decrease at nadir across all patients
Note: Patient numbers based on those with CTC response data available on April 25, 2019
Ongoing Favorable Safety Profile Compared with Other Treatments in this Patient Population
 SM-88 was well tolerated with only 4.0% of patients (2 of 49) reporting serious adverse events (SAEs) deemed at least possibly related to SM-88
 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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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 2 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 PromiseSM
Clinical 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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⬣ 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
ESMO PosterPhase II Trial of SM-88 in Non-Metastatic Biochemical Recurrent Prostate Cancer
Prostate Clinical Trial Results Demonstrated Potential of SM-88 To Postpone Hormone Therapy
Data cutoff as of September 2019
Clinical Trial Demonstrates Potential To Postpone Hormone Therapy Based on Encouraging Clinical Data
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• At 6 months, 100% of patients were free of metastatic progression, and 87% of patients remained free of radiographic progression
• After 3 months, 78% of patients demonstrated a median 65% decrease in median CTCs from baseline
• 52% 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
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
