Oncotelic Therapeutics Inc · OTC:OTLC
Oncotelic Therapeutics — MedInvest March 2022
22 slides from Oncotelic Therapeutics's conference presentation, Apr 1, 2022
Slide 1: Oncotelic Therapeutics – Rare and Orphan Drugs
ONCOTELIC MATEON THERAPEUTICS Rare.and Orphan Drugs (OTCQB:OFEC) MedInvest March 2022 WWW.ONCOTELIC.COM
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 (OTCQB:OTLC) ¢ 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 which was acquired by NantPharma for 1.3B. * Amit Shah
Slide 4: ODD and RPD Programs
ODD AND RPD PROGRAMS MARKET EXCLUSIVITY AND RPD VOUCHER
Slide 5: ODD and RPD Programs
ODD and RPD Programs * Orphan Drug Designation- rare disease or condition affecting less than 200,000 persons in the US" * FDA * 7-year marketing exclusivity (small molecule) or 12 yr marketing exclusivity (biologic) of approved orphan products * Waiver of Prescription Drug User Fee Act (PDUFA) fees
Slide 6: ODDs/RPDs Pipeline
ODDs/RPDs Pipeline + ODDs Granted: + OT-101 * Treatment of malignant glioma (FDA/EMA) + Treatment of pancreatic cancer (FDA/EMA) + Treatment of Stage IIB through Stage IV malignant melanoma (FDA) * OXi4503 + Treatment of acute myeloid leukemia (FDA/EMA) - CA4P * Treatment of anaplastic thyroid cance
Slide 7: OT-101: Drug Product- TGF-B2 Antisense
OT-101: Drug Product- TGF-B2 Antisense. * Trabedersen (OT-101) is a single-stranded phosphorothioate antisense oligodeoxynucleotide (18-mer) targeting the human TGF-B2 messenger RNA * Ready for registration trials--Over 200 patients treated across 7 clinical trials (6 in oncology and 1 in COVID) ¢ P
Slide 8: Glioblastoma Clinical Experience
A Tumor Volume a ONCOFPELIC®°° THERAPEUTICS astoma Clinical E G0O04- Phase | Objective responses were observed among the 87 evaluable patients treated with OT-101: Best Objective Responses were: 5 CR (5.9%), 14 PR (16.5%), 28 SD (31.8%), and 40 PD (45.9%) Confirmed Best Objective Responses were: 4 C
Slide 9: Pancreatic Cancer Clinical Experience
Pancreatic Cancer Clinical E P001-Phase I/II * Patient 1006: CR as far out as 77 mos * Surgery: Whipple's procedure ¢ 1S line: 5-FU/LV, Dose 425 mg/m2 * 2nd line: 5-FU/LV, Dose 2600 mg/m2/24hr ¢ 3'4 line: Gemcitabine, Dose 1000 mg/m2/week * OT-101- Liver mets/ Complete Response (Black Line -® Liver
Slide 10: Increased TGFB2 in pediatric DIPG patients
Increased TGFB2 in pediatric DIPG patients oe oo 2 beta among DIPG, OT-101 is a strong therapeutic candidate for DIPG 24042 = Log2 RMA Meancenteredto Normal i | A Anal ‘YAP1_224895_at YAP1_224804_at ‘SMAD4_1565703_at ‘SMAD4_202527__at TGFB2_220407_s_at ‘TGFB2_209900_s_at ‘TGFB2_228121_at NEDD4L_2413
Slide 11: 505(b)2 Regulatory Pathway
505(B)2 REGULATORY PATHWAY FAST TO MARKET/ ORPHAN DISEASE
Slide 12: Example of 505(b)2 Product- Abraxane
Example of 505(b)2 Product- Abraxane others. This creates an abundance of newfound time and money. By utilizing previously completed research as part of an FDA submission, companies can reduce their cost on a new drug application (NDA) via the 505(b)(2) pathway Tom potentially several billions of do
Slide 13: 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. Nasal delivery avoid first pass metabolism in the liver. It deliver
Slide 14: 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 clinical trials for intranasal apomorphine (including geriatric patients up to 78 years old) ¢ Very low incidence of nausea ¢ To date no incidences of vomi
Slide 15: Pharmacokinetic Comparison
Pharmacokinetic Comparison ¢ AL-101 (IN) is faster: sublingual (SL) tablet dissolution itself is limiting * AL-101 (IN) is more efficient: IN higher C,,,, is related to rapid uptake and good absorption; IN lower AUC is related to total absorption * AL-101 (IN) is less variable: “Safety may be diffic
Slide 16: Conclusions
Conclusions ¢ Aclear 505(b)2 regulatory pathway to approval. ¢ SL Apomorphine is safe and effective in Parkinson * Global approval- 505(b)2 pathway ie. Sunnovion ¢ Nasal Apomorphine is safe and effective in ED ¢ EU- Uprima. Superior to Viagra when combined ¢ Nasal Apomorphine shown in phase 2 trial
Slide 17: Financing Strategy
FINANCING STRATEGY JV / SPINOFF
Slide 18: Drug Development takes >10 yrs and > 2Billion
Drug Development takes >10 yrs and > 2Billion * The development of a new drugisaverylengthy Traditional drug R&D takes >10 years and >$2B* and complex process that OO can cost billions of dollars. It is one of those From the discovery to the launch of a new drug processes where the probability of fa
Slide 19: Mateon (aka Oxigene) history
Mateon (aka Oxigene) history ¢ Mateon (aka Oxigene) since 2004-2019 has spent $279Million on its pipeline (Oxi4503 and CA4P) * Oncotelic (previously Antisense Pharma) has spend close to $80Million on OT-101. ¢ To complete the development of the pipeline we are looking at another $100M per indication
Slide 20: GMP/ Oncotelic JV as win/win option
GMP/ Oncotelic JV as win/win option ¢ AJVis between GMP and Oncotelic ¢ GMP will fully funded the JV * Oncotelic will input asset and development capabilities ¢ The JV will be IPO either in HK or another platform ¢ The valuation could potentially be in the range of $1-2Billion basing on other compar
Slide 21: Conclusions
Conclusions Traditional Financing GMP/Oncotelic JV Amount Raise S50M > 2 yrs/ >100M % Dilution 75% 0% % Haircut 50% 0% Potential Upside 0) 7-14X Net Outcome/ Shareprice ¢ The proposed terms are being finalized
Slide 22: Vuong Trieu PhD
Vuong Trieu PhD = CEO/ Chairman = vtrieu@oncotelic.com = www.oncotelic.com THANK YOU