Oncotelic Therapeutics Inc · OTC:OTLC
Oncotelic Therapeutics — Mateon Therapeutics — IPO Roadshow (June 2017)
45 slides from Oncotelic Therapeutics's IPO roadshow presentation, Jun 19, 2017
Slide 1: Corporate Overview
Corporate Overview William D. Schwieterman, MD President and Chief Executive Officer June 2017 Filed pursuant to Rule 433 Registration Statement No. 333-217904 June 19, 2017
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation contains forward-looking statements under the meaning of the Private Securities Litigation Reform Act of 1995. These statements give our current expectations or forecasts and use words such as “anticipate,” “estimate,” "expect," “believe,” "can," and other wor
Slide 3: Company Overview
Company Overview Biopharmaceutical company developing vascular disrupting agents (VDAs) for treatment of cancer VDAs selectively disrupt abnormal blood vessels that sustain tumors Focusing on orphan oncology indications Clinical development candidates CA4P (fosbretabulin) OXi4503 Presenting clinical
Slide 4: Management Team
Team Member Experience William Schwieterman, MD President and Chief Executive Officer Perceptive Advisors; Chelsea Therapeutics; FDA – Chief of Immunology and Infectious Disease Branch, CBER David Chaplin, PhD Chief Scientific Officer Aventis; Rhône-Poulenc Rorer; Cancer Research United Kingdom; Uni
Slide 5: Board of Directors
Board Member Experience William Schwieterman, MD Chairman of the Board Perceptive Advisors; Chelsea Therapeutics; FDA – Chief of Immunology and Infectious Disease Branch, CBER David Chaplin, PhD Aventis; Rhône-Poulenc Rorer; Cancer Research United Kingdom; University College London Simon Pedder, PhD
Slide 6: Product Pipeline Summary
Product Pipeline Summary Program Indication Preclinical Phase 1 Phase 2 Phase 3 CA4P Platinum-resistant ovarian cancer OXi4503 Acute myeloid leukemia CA4P Combination with immuno-oncology agents CA4P Recurrent ovarian cancer CA4P Neuroendocrine tumors Phase 2/3 Phase 2 Phase 1/2 Phase 1b Investigato
Slide 7: 2017 Upcoming Milestones
2017 Upcoming Milestones Jul Oct Nov Aug CA4P FOCUS Interim Analysis #2 Dec CA4P FOCUS Interim Analysis #4 Sep CA4P FOCUS Interim Analysis #3 OXi4503 AML Cohort 5 Data
Slide 8: Vascular Targeted Therapies Mechanism of Action
Vascular Targeted Therapies Mechanism of Action
Slide 9: VDAs: Mechanism of Action
Direct anti-vascular effect Reversibly binds tubulin Changes endothelial cell structure Occludes tumor blood supply 10-30 times more selective for tumor vasculature VDAs: Mechanism of Action VDAs: vascular disrupting agents Tozer et al. Cancer Res. 1999 Apr 1;59(7):1626-34.
Slide 10: CA4P: Eliminates Tumor Vasculature
CA4P: Eliminates Tumor Vasculature Untreated After CA4P Malcontenti-Wilson et al. Clin Cancer Res. 2001;7(4):1052-60.
Slide 11: VDAs: Selectively Target Tumor Vasculature
VDAs: Selectively Target Tumor Vasculature Pericyte (support cell) Immuno-fluorescence Vascular Cast Normal Pericyte support Tumor No pericyte support VDAs: vascular disrupting agents McDonald DM, Choyke PL. Nat Med. 2003;9(6):713-25.
Slide 12: VDA Monotherapy
VDA Monotherapy VDA treatment leads to significant central tumor necrosis Tumor rim cells rely on surrounding normal blood vessels After treatment necrotic area can be re-vascularized by angiogenesis Untreated 1 day post CA4P 3 days post CA4P Murine Adenocarcinoma CaNT Model VDA: vascular disrupting
Slide 13: VDA + Anti-angiogenic Therapy Enhances Anti-vascular Effect
Enhances Anti-vascular Effect VDA + Anti-angiogenic Therapy Indirect anti-vascular mechanism of anti-angiogenic therapy complements the direct anti-vascular mechanism of VDAs Green = Hypoxia; Blue = Perfusion Untreated VEGFR Ab Monotherapy VDA Monotherapy Combination VDA: vascular disrupting agent S
Slide 14: Mateon Therapeutics
MATEON THERAPEUTICS
Slide 15: Response Rates in Previous Trials
FACT N=75 GOG-0186I n=81 FALCON n=57 Triple therapy shows best response rates Response Rates in Previous Trials Recurrent OC and NSCLC studies are rates in patients with measureable disease/confirmed response. CA4P + Bev + C/P CA4P + Bev C: carboplatin; P: paclitaxel; Bev: bevacizumab; ATC: anaplast
Slide 16: US Ovarian Cancer Landscape
US Ovarian Cancer Landscape PFS: progression-free survival; OS: overall survival; psOC: platinum-sensitive ovarian cancer; prOC: platinum-resistant ovarian cancer Source: Markman, M, Bookman, M, Second-line treatment of ovarian cancer. The Oncologist 2000, Locust Walk Partners interviews and analysi
Slide 17: Large Unmet Need in Ovarian Cancer Market
Large Unmet Need in Ovarian Cancer Market Patients with prOC have few treatment options, low survival rates Potential annual sales of a branded therapeutic in prOC are ~$500 Million in US, ~$200 Million in EU/Japan1 Platinum-sensitive market is ~50-100% larger Bevacizumab is approved for both psOC (
Slide 18: GOG-0186I Study Design
GOG-0186I Study Design Randomized, controlled, open-label Phase 2 study Funded by National Cancer Institute, conducted by Gynecologic Oncology Group Primary endpoint: Progression free survival (PFS) Secondary endpoints: Objective response rate (ORR), Overall survival (OS) Patient Population: recurre
Slide 19: GOG-0186I Results: Progression-free Survival (ITT)
Progression-free Survival (ITT) GOG-0186I Results: Primary Endpoint Analysis Months on Study 1.0 0.8 0.6 0.4 0.2 0.0 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 Proportion Progression-Free Events N Median (mos) CA4P + Bev 41 54 7.3 Bev 47 53 4.8 Treatment Comparison HR* 90% Cl 1-sided P Value Active
Slide 20: GOG-0186I Results: PFS (Platinum-resistant)
Progression-free Survival (Platinum-resistant) GOG-0186I Results Events n Median (mos) CA4P + Bev 10 13 6.7 Bev 13 14 3.4 Treatment Comparison HR* Log-rank P Value Active vs. Control 0.57 0.01 *Hazard Ratio of the experimental level to the reference level of the treatment comparison were stratified
Slide 21: GOG-0186I Results: PFS (Measurable Disease)
Progression-free Survival (Measurable Disease) GOG-0186I Results Nov2015 Treatment Comparison HR 95% Cl Log-rank P Value Active vs. Control 0.600 [0.38, 0.95] 0.027 42 39 Active Control 5 2 3 0 21 9 1 0 # at Risk Bev: bevacizumab; mos: months; HR: hazard ratio, CI: confidence interval Mateon Data on
Slide 22: GOG-0186I Results: Overall Survival (Measurable Disease)
Overall Survival (Measurable Disease) GOG-0186I Results Nov2015 Treatment Comparison HR 95% Cl Log-rank P Value Active vs. Control 0.777 [0.44, 1.36] 0.377 42 39 Active Control 28 21 16 11 38 33 4 3 1 0 Months on Study # at Risk Bev: bevacizumab; mos: months; HR: hazard ratio, CI: confidence interva
Slide 23: FOCUS Study Data
FOCUS Study Data April 2017 MATEON THERAPEUTICS
Slide 24: prOC FOCUS: Phase 2/3 Study Design
prOC FOCUS: Phase 2/3 Study Design Initiate Study Interim Interim Interim Interim Study Startup Study Complete CA4P + Bev + PCC n=178 Bev + PCC n=178 ORR Data, PFS Data ORR Data Trigger Part 2 Trigger Part 2 Bev + PCC n=40 CA4P + Bev + PCC n=40 NCT Number: NCT02641639 Bev: bevacizumab (Avastin); PCC
Slide 25: FOCUS Results: Demographics
Interim Analysis 1 FOCUS Results: Demographics Active (CA4P) N=9 Control N=11 Age (years) 66.3 59.7 ECOG Status 0 44% 73% 1 56% 27% Mean Baseline Tumor Size (cm) 14.0 14.1 Number Prior Treatments 1 33% 37% 2 11% 46% 3 44% 0 ≥4 11% 18%
Slide 26: FOCUS Results: Adverse Events
Interim Analysis 1 FOCUS Results: Adverse Events >1 patient, more in active than control Active (CA4P) N=9 Control* N=10 Blood pressure increased 8 (89%) 2 (20%) Hypertension 5 (56%) 3 (30%) Fatigue 4 (44%) 2 (20%) Constipation 4 (44%) 1 (10%) Nausea 4 (44%) 1 (10%) Vomiting 4 (44%) 0 ( 0%) Abdomina
Slide 27: FOCUS Results: Adverse Events Grade 3-5
Interim Analysis 1 FOCUS Results: Adverse Events Grade 3-5 Active (CA4P) (N=9) Control (N=10) Grade 3 Grade 4 Grade 5 Grade 3 Grade 4 Grade 5 Blood pressure increased 44% 0% 0% 10% 0% 0% Hypertension 22% 0% 0% 30% 0% 0% Hyponatraemia 11% 0% 0% 10% 0% 0% Abdominal pain 11% 0% 0% 0% 0% 0% Anaemia 11%
Slide 28: FOCUS Results: Objective Response Rate
Interim Analysis 1 FOCUS Results: Objective Response Rate Numerical benefit in favor of CA4P in ORR Magnitude of tumor response better in CA4P arm CA4P patients with PRs had reductions of 76% and 64% versus 46% in Control PFS data immature, currently favors CA4P Active (CA4P) N=9 Control N=11 Partia
Slide 29: FOCUS Results: Per Patient Performance
Interim Analysis 1 FOCUS Results: Per Patient Performance* PD /Death Withdrew *Preliminary data as of Apr 14th; subject to continuing analyses Scan Scan shows PD PR SD Scan Not done
Slide 30: CA4P Safety Summary
CA4P Safety Summary CA4P is generally well tolerated, more than 475 patients dosed to date Adverse events of interest Acute post-infusion blood pressure increase (HTN) 30-89% of patients Transient (resolves in 2 - 6 hrs), consistent with PK (t½ = 2 hrs) On average ~20 mmHg; can be managed with anti-
Slide 31: Summary of Efficacy Data
Summary of Efficacy Data CA4P shows activity in multiple tumor types Maximum efficacy in combination with anti-angiogenic agents CA4P + bevacizumab improves PFS in recurrent ovarian cancer Greatest effects in patients with larger tumors Measurable disease Platinum-resistant disease Trends showing im
Slide 32: CA4P - Many Potential Indications
CA4P - Many Potential Indications Mechanism of action based on tumor vasculature, not tumor type Focus on ovarian cancer is based on clinical indication with most data Other potential orphan indications include: Cervical cancer Gastric cancer Glioblastoma multiforme Hepatocellular carcinoma Metastat
Slide 33: Combination with Immuno-Oncology Agents
CA4P-induced tumor necrosis may enhance antigen presentation Combination with Immuno-Oncology Agents Three additional studies provide evidence that CA4P may enhance anti-CTLA4, anti-PD1, and anti-PD-L1 antibody activity Data from OX-2015-005
Slide 34: OXi4503
OXi4503 MATEON THERAPEUTICS
Slide 35: Active Forms of Lead Products
Active Forms of Lead Products Cytotoxic properties Catechols are easily oxidized to ortho-quinones Second phenolic moiety in CA1 compared to CA4 combretastatin A4 (active form of CA4P) combretastatin A1 (active form of OXi4503) Folkes LK et al. Chem Res Toxicol. 2007;20(12):1885-94.
Slide 36: OXi4503 Forces AML Cells Into Active Cell Cycle
OXi4503 Forces AML Cells Into Active Cell Cycle AML: acute myeloid leukemia; BMEC: bone marrow endothelial cells Bosse RC et al. Exp Hematol. 2016;44(5):363-77. Total Cells By Phase G0/G1 - Dormant S Phase – cytarabine susceptible G2/M – anthracycline susceptible KG1 KG1 + BMEC KG1 + BMEC + OXi4503
Slide 37: OXi4503: Preclinical Data in AML
Combination with Cytarabine OXi4503: Preclinical Data in AML Enhanced killing of AML with OXi4503 (CA1P) plus cytarabine (AraC) FSC: forward scatter (parameter in flow cytometry) Bosse K et al. Exp Hematol. 2016;44(5):363-377. FSC Human CD45
Slide 38: UF4503 Phase 1 Monotherapy Study
UF4503 Phase 1 Monotherapy Study Investigator-sponsored, single site study in patients with relapsed/refractory AML and MDS OXi4503 given as a monotherapy Preliminary evidence of effect 1 of 19 patients (5.3%) experienced a complete remission 1 of 19 patients (5.3%) experienced blast reduction Dual
Slide 39: OX1222 Study Data
OX1222 Study Data MATEON THERAPEUTICS
Slide 40: OXi4503 Phase 1b/2 Combination Study (OX1222)
Relapsed/Refractory AML and MDS Patients (OX1222) OXi4503 Phase 1b/2 Combination Study Phase 1 Phase 2 Will only initiate with a partner, following sufficient efficacy 3.75 mg/m2 4.68 mg/m2 6.25 mg/m2 9.76 mg/m2 7.81 mg/m2 NCT Number: NCT02576301 AML: acute myeloid leukemia; MDS: myelodysplastic syn
Slide 41: OX1222 Summary of Results
OX1222 Summary of Results Duration of complete remission 3.75 mg/m2: 12 months, then patient withdrew from study 4.68 mg/m2: 5 months, then progressed 6.25 mg/m2: 5 months, ongoing Cohort N CR% In Active Treatment Ongoing Response Progressed 3.75 mg/m2 6 17% 0 1 5 4.68 mg/m2 4 25% 0 0 4 6.25 mg/m2 4
Slide 42: Financial Highlights and Capitalization
($/000s) March 31, 2017 Cash and Short-term Investments $ 8,344 Total Current Assets 10,134 Total Assets 10,175 Short-term Liabilities $ 1,393 Long-term Debt -- Stockholders’ Equity 8,782 Total Liabilities and Stockholders Equity 10,175 Quarterly Cash Burn < $4 million Common Shares Outstanding* 26,
Slide 43: Key Takeaways
Key Takeaways Anti-vascular approach to targeting solid and hematological cancers Our drug candidates have largest effect in larger tumors New management team and Board of Directors with deep experience formed over last 2 years Meaningful data on both clinical candidates expected throughout remainde
Slide 44: 2017 Upcoming Milestones
2017 Upcoming Milestones Jul Oct Nov Aug CA4P FOCUS Interim Analysis #2 Dec CA4P FOCUS Interim Analysis #4 Sep CA4P FOCUS Interim Analysis #3 OXi4503 AML Cohort 5 Data
Slide 45: www.mateon.com
www.mateon.com 650.635.7000