Oncotelic Therapeutics Inc · OTC:OTLC
Oncotelic Therapeutics — Investor Presentation (September 2021)
15 slides from Oncotelic Therapeutics's investor presentation, Sep 8, 2021
Slide 1: (AL-101) Apomorphine Licensing
(AL-101) Apomorphine Licensing 9-3-2021 WWW.ONCOTELIC.COM ONCOTELIC
Slide 2: Forward-looking Statements
‘ONCOTELIC 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, incl
Slide 3: 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 4: Example of a successful 505(b)2 Pathway
‘ONCOTELIC Example of a successtul 505(b)2 Patnway Product - Abraxane “The 505(b)(2) pathway represents an onpeaiing 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 complet
Slide 5: AL-101 (Intranasal Apomorphine)
‘ONCOTELIC 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 i
Slide 6: 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 7: Pharmacokinetic Comparison
‘ONCOTELIC Pharmacokinetic Comparison IN AL-101 is absorbed and delivered faster: sublingual (SL) tablet dissolution itself is time-limiting IN AL-101 is more efficient: IN higher C,,,, is related to rapid uptake and good absorption; IN lower drug exposure defined by AUC is related to total absorpti
Slide 8: CSF Uptake Via IN AL-101 versus Subcutaneous
CSF Uptake Via IN AL-101 versus Subcutaneous * The subcutaneous formulation produced 35 A 2.5-4.3% levels in the CSF compared to plasma 30 4 * The IN formulation CSF to } produces 26.7-44.1% Plasma =2 ic levels in the CSF relative Ratio (% '° ic to plasma 10 iA * The IN formulation 5 provides CSF le
Slide 9: Conclusions
‘ONCOTELIC Conclusions IN 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 IN Apomorphine is safe and effective in ED * EU- Uprima. Superior to Viagra
Slide 10: ED market potential
oncermle ED- market potential ED is the most prevalent male sexual disorder globally. The market will continue to grow due to increased vascular disorders followed by the aging population across the world. Furthermore, rising psychological problems, followed by chronic diseases like diabetes, alcoho
Slide 11: FSD / HSDD Market Potential
‘ONCOTELIC FSD / HSDD Market Potential In 2012, the FDA identified female sexual dysfunction as one of 20 disease areas of high priority and focused attention. In 2016, the FDA published a draft guidance titled “Low Sexual Interest Desire and/or Arousal in Women: Developing Drugs for Treatment,” to
Slide 12: Female Sexual Dysfunction
Female Sexual Dysfunction * 2004. A Double-Blind Randomized Placebo Control Study Comparing the Objective and Subjective Changes in Female Sexual Response Using Sublingual Apomorphine. SL Apomorphine seemed to produce more subjective and objective changes in the sexual arousal phase of women with or
Slide 13: Parkinson Market Potential
‘ONCOTELIC Parkinson Market Potential ¢ Parkinson's disease is a chronic neurodegenerative disease in which dopamine producing cells are lost. It is projected that 1.2 million Americans will be living with PD by 20301. Within the first four to six years after diagnosis, regardless of disease severit
Slide 14: Comparable deals
Comparable deals + Female Sexual Dysfunction/ 2017: AMAG and Palatin Technologies/ Bremelanotide/ $60 million of total upfront consideration, up to $80 million contingent upon achieving certain regulatory milestones and up to $300 million contingent upon meeting certain sales milestones. + Male Erec
Slide 15: Deal Structure
Deal Structure * Considering a recent deal for FSD, which has $28M in upfront in cash and $335M in milestone payments, the payments proposed below are back-end loaded and highly favorable to Oncotelic. + No upfront payments + $1M on $20M raise or uplisting to a National Stock Exchange. + $9M aggrega
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