Oncotelic Therapeutics Inc · OTC:OTLC
Oncotelic Therapeutics — Investor Presentation (July 2021)
31 slides from Oncotelic Therapeutics's investor presentation, Jul 14, 2021
Slide 1: A TGF-beta Company
A TGF-beta Company July 14, 2021 W W W.O N C O T E L I C .C O M
Slide 2: Forward-looking Statements
Forward-looking Statements • This document contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in t
Slide 3: Management Team
Management Team • Vuong Trieu, PhD (CEO). Dr. Trieu, an expert in pharmaceutical development, currently serves as CEO/Chairman of Oncotelic Inc.. Previously he was President and CEO of Igdrasol- developer of 2nd generation Abraxane. When Igdrasol merged with Sorrento Therapeutics, he became CSO and
Slide 4: Overview of Oncotelic Therapeutics
Overview of Oncotelic Therapeutics JV: Apomorphine Animal Health -TGF-beta inhibitors (OT- -505(b)2 Fast to market -Oncology 101 and Artemisinin -Parkinson Disease -CA4P -Oncology & Virology -ED -Artemisinin -HK IPO -FSD Oncology/ Animal CNS Virology Health ONCOLOGY & COVID-19
Slide 5: OT-101/ Trabedersen
OT-101/ Trabedersen W W W.O N C O T E L I C .C O M 5
Slide 6: Antisense as Next Generation Drugs
Antisense as Next Generation Drugs Attributes Small Molecules mAb Antisense Inception 1850s to present 1920s to present 1990s to present Size 200-500 >150,000 5,000 to 7,000 Drug Discovery Random screening Focused screening Rationally designed Success Rate Low-~5% Moderate-~50% High-~90% Predictable
Slide 7: OT-101: Drug Product- TGF-β2 Antisense
OT-101: Drug Product- TGF-β2 Antisense. • Trabedersen (OT-101) is a single-stranded phosphorothioate antisense oligodeoxynucleotide (18-mer) targeting the human TGF-β2 messenger RNA • Ready for registration trials--Over 200 patients treated across 6 clinical trials • Strong Patent protection until 2
Slide 8: Clinical Efficacy: Glioblastoma
Clinical Efficacy: Glioblastoma Tr e a t m e n t f a i l u r e p a t i e n t s ( r e c a l c i t r a n t t o r a d i a t i o n , s u r g e r y, a n d c h e m o ) • Objective responses were observed among the 87 evaluable patients treated with OT-101: • Best Objective Responses were: 5 CR (5.9%), 14
Slide 9: Clinical Efficacy: Pancreatic Cancer
Clinical Efficacy: Pancreatic Cancer Phase 2 - treatment failure pts/ recalcitrant to Whipple and chemo • Patient 1006: CR as far out as 77 mos • Patient 1022: OS of 40 months • Surgery: Whipple’s procedure • Surgery: Whipple’s procedure • 1st line: 5-FU/LV, Dose 425 mg/m2 • 1st line: Radiation ther
Slide 10: Clinical Efficacy: COVID
Clinical Efficacy: COVID • Large surge in TGF-beta during active COVID infection • An established role of TGF-beta in scarring and late stage post-COVID symptoms • Strong in vitro activity against SARS-COV-2 on Vero cells • OT-101 is in phase 2 clinical trial against COVID Oncotelic C001-2020-01 IM
Slide 11: Vascular Distruptor Agent (VDA)
Vascular Distruptor Agent (VDA) W W W.O N C O T E L I C .C O M
Slide 12: OXi4503: Mechanism-of-Action in AML
OXi4503: Mechanism-of-Action in AML • Phase 1B study was to define the maximum tolerated dose and safety profile of OXi4503 and cytarabine administered in combination (OXA) in patients with relapsed/refractory AML. • The study was completed in August 2019 and met its primary endpoint. • The study sh
Slide 13: OX4503: Completed Cohort Results to Date
OX4503: Completed Cohort Results to Date Complete Remissions and Dose Response Clinical trial has shown initial evidence of efficacy Completed Cohort n CR% PR Rate ORR (Dose) Cohort 1 (3.75 mg/m2) 6 17% 0% 17% Cohort 2 (4.68 mg/m2) 4 25% 0% 25% Cohort 3 (6.25 mg/m2) 4 25% 25% 50% Cohort 4 (7.81 mg/m
Slide 14: CA4P: Significant Tumor Regressions and Improved Overall Survival
CA4P: Significant Tumor Regressions and Improved Overall Survival • Stable Disease (SD) of 5 melanoma pts treated with CA4P Single Agent Phase 1 studies • Partial Response (PR) was observed of 6 melanoma patients treated follow progressing during first-line trial therapy with dacarbazine and sorafen
Slide 15: OT-101 and Artemisinin/ COVID
OT-101 and Artemisinin/ COVID W W W.O N C O T E L I C .C O M
Slide 16: Conventional COVID-19 Therapeutics
Conventional COVID-19 Therapeutics Drug Name Mechanism/ Target Outcome Trial Name/N Lopinavir Antiviral/ Protease Inhibitor Fail WHO SOLIDARITY/ 1411 UK RECOVERY/ 1616 Hydroxychloroquine Antiviral/ Antimalarial/ TRL Fail WHO SOLIDARITY/ 954 UK RECOVERY/ 790 Remdesivir Antiviral/ RNA Polymerase Fail
Slide 17: TGF-beta is the right target for COVID -19
TGF-beta is the right target for COVID -19 • Large surge in TGF-beta during active COVID infection • An established role of TGF-beta in scarring and late stage post-COVID symptoms Oncotelic C001-2020-01 IM Presentation 17
Slide 18: COVID-19 Clinical Course After SARS-CoV-2 Infection and the OT-101 Trial
COVID-19 CLINICAL COURSE AFTER SARS-COV-2 INFECTION AND THE OT-101 TRIAL Eligible Hospitalized Patients Eligible Hospitalized Patients Positive for COVID-19: Positive for COVID-19: OT-101 IV • Mild Disease (WHO Ordinal Scale 3 and 4) • Severe Disease (WHO Ordinal Scale 5 and 6) x 7 days + S0C Primar
Slide 19: India ARTI-19 Protocol
India ARTI-19 Protocol • Patients with mild/ moderate COVID without oxygen support • Compatible with: Seven Star Hospital COVID protocol: Remdesivir/Sompraz D/Zifi CV/Zac D/CCM/Broclear/Budamate/Rapitus/Montek LC/ lower molecular weight heparin/prednisolone/Doxycylline • Compatible with Raje Hospita
Slide 20: India Heart Care Foundation Protocol
India Heart Care Foundation Protocol • According to Dr K K Aggarwal (Heart care foundation) • COVID treatment • Code 1 – CONTACT : Ivermectin 12 mg and doxycycline 100 mg daily x 3 days, Betadine or neem gargles, Vitamins and minerals, Colchine 0.5 mg one daily for 21 days if CRP > 1. High protein d
Slide 21: Outcomes of the Study – top line data of 120 pts
Outcomes (Primary/ Secondary) of the Study – top line data of 120 pts 500 mg daily for 5 days use cough app to monitor clinical and cough severity. Consult with physician if symptoms persist or if tested positive for COVID. Treatment under physician care = 5 day on / 5 day off for evaluation. Cont
Slide 22: Iran Iman Reza Hospital Protocol
Iran Iman Reza Hospital Protocol • Imam Reza Hospital, Sirjan Faculty of Medical Sciences, Iran with the reference number: IR.SIRUMS.REC.1399.033; IRCT registration number: IRCT20181030041504N1 Before After- Treatment • Intervention: Artemisinin, Hesperidin, Resveratrol, Noscapine, N-Acetyl Cysteine
Slide 23: Recommend Treatment Schema
Recommend Treatment Schema ARTI-19 Protocol/ Pts not requiring O2/ PulmoHeal along with Standard COVID protocol per physician recommendation Suspected COVID/ Respiratory Tested Positive for COVID or No Symptoms . PulmoHeal – Once Daily HCF Protocol/ Requiring Oxygen. improvement in symptoms after 5
Slide 24: 505(b)2/ PD/ED/FSD
505(b)2/ PD/ED/FSD 9-6-2021 24
Slide 25: Approved Apomorphine
Approved Apomorphine • Uprima (apomorphine). Erectile Dysfunction- EU. Sublingual. • Apokyn (apomorphine HCl injection) / dopamine agonist/ To help restore the balance of dopamine in the brain/ Parkinson OFF cycle. For the acute, intermittent treatment of hypomobility, “off” episodes (“end-of-dose w
Slide 26: Apomorphine as the anchor for Oncotelic pipeline
Apomorphine as the anchor for Oncotelic pipeline • AL-101- Apomorphine has a clear 505(b)2 regulatory pathway to approval. • SL Apomorphine is safe and effective in Parkinson • Global approval – Opens the way for a succesful 505(b)2 pathway based on Sunovion • AL-101 Apomorphine is safe and effectiv
Slide 27: Product - Abraxane
Example of a successful 505(b)2 Pathway Product - Abraxane • “The 505(b)(2) pathway represents an appealing regulatory strategy for some companies, and the only viable strategy for others. This creates an abundance of newfound time, saves money and resources. By utilizing previously completed resear
Slide 28: AL-101 (Intranasal Apomorphine)
AL-101 (Intranasal Apomorphine) • Unique nasal technology made up of anionic, cationic, & zwitter-ionic compounds capable of stabilizing difficult drug substances and providing rapid systemic absorption at a fraction of the oral dose. • Intra-nasal (IN) delivery avoids first pass metabolism in the l
Slide 29: Overall IN Apomorphine Safety Profile
Overall IN Apomorphine Safety Profile • Nasal apomorphine has a low adverse event profile • Over 200 patients (2,200 doses) have participated in our clinical trials for intranasal apomorphine (including geriatric patients up to 78 years old) • Very low incidence of nausea • To date no incidences of
Slide 30: Pharmacokinetic Comparison
Pharmacokinetic Comparison • AL-101 is absorbed and delivered faster: sublingual (SL) tablet dissolution itself is time-limiting • AL-101 is more efficient: IN higher Cmax is related to rapid uptake and good absorption; IN lower drug exposure defined by AUC is related to total absorption • AL-101 is
Slide 31: CSF Uptake Via IN AL-101 versus Subcutaneous
CSF Uptake Via IN AL-101 versus Subcutaneous • The subcutaneous formulation produced 34.9 35 2.5-4.3% levels in the CSF compared to plasma 30 25 • The IN formulation CSF to produces 26.7-44.1% Plasma 20 levels in the CSF relative Ratio (%) 15 to plasma 10 3.1 4.3 • The IN formulation 5 provides CSF
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