Second Quarter Fiscal 2020 Investor Conference Call2020_FINAL-SLIDES...SM-88 used with MPS in...
Transcript of Second Quarter Fiscal 2020 Investor Conference Call2020_FINAL-SLIDES...SM-88 used with MPS in...
Second Quarter Fiscal 2020Investor Conference Call
November 4, 2019
NASDAQ: TYME
TYME Conference Call Participants
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General Comments Steve Hoffman, Chairman & Chief Executive Officer
Advancing Regulatory Strategy Michele Korfin, RPh, MBA, Chief Operating Officer
SM-88 Clinical Data Presented at Major Medical Meetings Giuseppe Del Priore, M.D., M.P.H., Chief Medical Officer
Preliminary Results on SM-88 and TYME-18 Preclinical Data Jonathan Eckard, Ph.D., Chief Business Officer
Q2 Fiscal 2020 Financial Results Ben Taylor, President & Chief Financial Officer
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 drug candidates (including SM-88 and TYME-18) and of other new products, expected releases of interim or final data fromour clinical trials, possible collaborations, the timing, scope and objectives of our ongoing and planned clinical trials and other statements that are nothistorical. The forward-looking statements contained in this presentation are based on management’s current expectations, which are subject to uncertainty,risks and changes in circumstances that are difficult to predict and many of which are outside of TYME’s control. These statements involve known andunknown risks, uncertainties and other factors which may cause the Company’s actual results, performance or achievements to be materially different fromany historical results and future results, performances or achievements expressed or implied by the forward-looking statements. These risks and uncertaintiesinclude, but are not limited to, that the information is of a preliminary nature and may be subject to change; uncertainties inherent in research anddevelopment, including the ability to achieve clinical study start and completion dates; the possibility of unfavorable study results, including unfavorable newclinical data and additional analyses of existing data; risks associated with early, initial data, including the risk that the final data from any clinical trials maydiffer from prior or preliminary study data; final results of additional clinical trials that may be different from the preliminary data analysis and may not supportfurther clinical development; that past reported data are not necessarily predictive of future patient or clinical data outcomes; whether and when anyapplications or other submissions for SM-88 may be filed with regulatory authorities; whether and when regulatory authorities may approve any applications orsubmissions; decisions by regulatory authorities regarding labeling and other matters that could affect commercial availability of SM-88; competitivedevelopments; 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 andExchange 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
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Steve Hoffman, Chairman & Chief Executive Officer
GENERAL COMMENTS ON Q2 FISCAL 2020 PERFORMANCE
Entering Pivotal Inflection Point with Multiple Value Drivers
 Promising Clinical Data on SM-88 Shared Worldwide
 Enrolling Key Pivotal Trials as Long-Term Value Drivers
 Renowned Hematologist Susan O’Brien, M.D. joined Medical Advisory Board
 Advancing Clinical Strategies in Sarcomas, Prostate, Breast and Hematology
 Reporting Preliminary Preclinical SM-88 Data
 Expected Access to Capital to Fund Pivotal Trials
 Strong Momentum in Preclinical, Clinical and Regulatory Developments Going Into 2020
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Michele Korfin, RPh, MBA, Chief Operating Officer
ADVANCING REGULATORY OPPORTUNITIES
SM-88 Overview
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 SM-88 is our lead investigational therapy in the TYME Cancer Metabolism-Based Therapies (CMBTsTM) platform.
 SM-88 is an oral modified dysfunctional tyrosine that is hypothesized to disrupt cancer cell metabolism.
 SM-88 has demonstrated encouraging efficacy and a well-tolerated safety profile in 15 different tumor types, including solid tumors and hematologic malignancies across four separate studies and 180 patients.
 TYME has multiple clinical trials evaluating SM-88 as a potential oral treatment for patients with advanced cancers, including pancreatic, prostate and sarcomas.
 Near-term focus aimed at disrupting cancer metabolism in metastatic pancreatic cancer; ~ 50,000 new cases annually in U.S. alone.
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
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Primary: OSSecondary*: PFS, CBR, and QoL Key Exploratory Endpoints*: Biomarker analysis, including CTCs
* Other secondary and exploratory endpoints will also be captured.
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.
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”– Pancreatic Cancer Action Network
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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: Q4 Enrolling Patients with Ultra-Rare Metastatic Sarcoma
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SM-88 CLINICAL DATA PRESENTED AT MAJOR MEDICAL MEETINGS
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Giuseppe Del Priore, M.D., M.P.H., Chief Medical Officer
TYME-88-Panc Overall Survival (OS)
 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
13ESMO PosterPhase II Monotherapy Efficacy of Cancer Metabolism Targeting SM-88 in Heavily Pre-Treated PDAC Patients
Data cutoff as of 4/25/19
TYME-88-Panc 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) Â 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
TYME-88-Panc Clinical Benefit Rate (CBR)
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 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
HR: 0.08 (95% CI 0.01 – 0.63)p = 0.02
ESMO GI PosterSM-88 Therapy in High-Risk Poor Prognosis Pancreatic Cancer
 60% (12/20) PERCIST Clinical Benefit Rate (SD or PR)
 Patients who achieved as least SD by first assessment demonstrated greater survival than PD patients
 Patients who achieved at least PERCIST SD had a 72% reduction in risk of death
RECIST Disease Control
Data cutoff as of 4/25/19
HR: 0.28 (95% CI 0.05 — 1.48)p = 0.11
PERCIST Disease Control
Data cutoff as of 4/25/19
TYME-88-Panc Weight Data: Important Prognostic Indicator
 Stabilization of weight is an important prognostic indicator in this patient population
 94.4% (34/36)1 of patients’ weight remained within 10% of baseline.
 38.9% (14/36)1 of patients gained weight after one cycle of SM-88.
1Two patients did not report weight.
ESMO PosterPhase II Monotherapy Efficacy of Cancer Metabolism Targeting SM-88 in Heavily Pre-Treated PDAC Patients
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Data cutoff as of 4/25/19
TYME-88-Panc PK/Radiomics Data
 SM-88 is composed of D- and L-isomers, and the effects of each isomer on CTC response were investigated. These analyses included all 11 patients who had both CTC and PK data available.
 Steady state levels of D- and L-metyrosine Cmax and AUC0-6 were correlated with changes in CTCs from baseline to nadir, with slightly stronger correlations for the D-metyrosine.
 CTC reduction may be considered a potential tumor marker for patients treated for pancreatic cancer.
 CTC response, OS and baseline tumor characteristics were associated on an exploratory radiomics analysis.
 Additional prospective trials are needed to confirm these hypotheses.
AACR PosterCTC-based Efficacy of SM-88 Correlates with Overall Survival in Advanced Pancreatic Cancer 17
Data cutoff as of 4/25/19
Targeted Mechanism of Action Delivers Favorable Safety Profile Compared with Other Cancer Treatments
 In TYME-88-Panc, 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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Data cutoff as of 4/25/19
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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
CTC Nadir on SM-88 and PSA or Radiographic PD
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Progression included regional radiographic PD and PCWG3 PSA progression.
Data cutoff as of September 2019
⬣ Achieving CTCs of <10 cells/4mL correlated with improved progression-free survival
⬣ Reductions in CTC number may be a more informative indicator of benefit than changes in PSA
ESMO PosterPhase II Trial of SM-88 in Non-Metastatic Biochemical Recurrent Prostate Cancer
SM-88 & TYME-18 PRELIMINARY PRECLINICAL DATA
Jonathan Eckard, Ph.D., Chief Business Officer
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 SM-88 has shown monotherapy anti-tumor activity from in vitro and in vivo models
 Established a research agreement with NYU Langone Medical Center
 Dr. Diane Simeone, Director of the Pancreatic Cancer Center and Associate Director of Translational Research at Perlmutter Cancer Center
 Ongoing collaboration with Dr. Matrin Fernandez-Zapico from Mayo Clinic
 Expect to present preclinical data at major medical meeting in 2020
Understanding SM-88’s Mechanism of Action
TYME-18: Advancing Pipeline Candidates
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Days Post Treatment Initiation
Average Percent Change in Tumor Size (+/- SEM)Control Injection (n=12) TYME-18 (n=12)
 Novel mechanism aimed to have strong anti-cancer effect while minimizing systemic and local toxicity
 Encouraging initial efficacy and tolerability findings
 Two preclinical studies each reported 11 of 12 mice had tumors completely resolve in TYME-18 treatment group vs 0 of 12 in control
 Goal to be IND ready during 2020 and explore development options
SECOND QUARTER FISCAL 2020 FINANCIAL RESULTS
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Ben Taylor, President & Chief Financial Officer
Q2 Fiscal 2020 Financial Results
 Expected Average Quarterly Cash Burn for Fiscal 2020: $5 - 6 MM
 Cash & Cash Equivalents: $15.3 MM
 Transferred ATM to Jefferies
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Q2 2020 Q1 2020
Cash & Cash Equivalents $15.3 MM $19.5 MM
Q2 2020 Q2 2019
Cash Burn $4.2 MM $4.7 MM
Delivering on Key Milestones PositionsTYME for Long-Term Success
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Major Medical Meetings: Presentation of TYME-88-Panc Data at ESMO, ESMO GI & AACR PancJuly – Sept. 2019
Expect to enroll Patients in JAF Ewing’s and High-Risk Sarcoma Trial, Q4’2019
SM-88 Preclinical Data at Medical Meetings in 2020
Expect to open trial site in PanCAN Precision PromiseSM Trial in 2nd-line Pancreatic Cancer, Q4’2019
TYME-18 Update
Expect to enroll Patients in TYME’s Pivotal Trial in 3rd-line Pancreatic Cancer, Q4’2019
Final Phase II Results of Prostate Cancer Study ESMO. Sept 30, 2019
Advance Clinical Strategy for SM-88 in Recurring Prostate Cancer
Q&A
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