Protokinetix, Inc. · OTC:PKTX
Protokinetix — Shareholder Meeting (February 2022)
24 slides from Protokinetix's shareholder meeting presentation, Feb 11, 2022
Slide 1: Annual General Stockholders' Meeting February 11, 2022
Annual General Stockholders’ Meeting February 11, 2022
Slide 2: Cautionary Note Regarding Forward-Looking Statements
Cautionary Note Regarding Forward - Looking Statements The information discussed in this presentation includes “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act
Slide 3: Overview
Overview
Slide 4: Market Development
Market Development » Moving share price average + 28.6 % » TriPeak - price average + 101.8 % » Average Qrt . - Trading Vol. - 10.4 % » Average Qrt . Vol. 2019 - 21: ~ 6.3M » NDA Agreements + 25 » MTA Agreement + 3 » IP Security to year 2042 » A Growing Share - Holder Family: $PKTX 3yr Period 2016 -
Slide 5: Exclusive Patent Security Until 2042
Exclusive Patent Security Until 2042 ProtoKinetix has patent coverage for the composition of matter for the family of AAGP compounds including PKX - 001 in US, Europe & Canada, Internationally, along with processing IP shared with AmbioPharm Inc. to secure supply and meet distribution needs globally
Slide 6: AAGP development programs by indication
AAGP Diabetes Macular Degeneration Phase 1B Trial Dry AMD Wet AMD Partner Partner Dry Eye Disease Pulmono logyDermat ology Proof of Concept Proof of Concept Proof of Concept FORMULATION Formulation Formulation TOXICOLOGY ToxicologyToxicology IND/FDA IND/FDAIND/FDA Phase 1 Trial Phase 1 TrialPhase 1
Slide 7: Regenerative & Transplant Medicine and Topical Therapeutics updates
Regenerative & Transplant Medicine (AAGP as companion product): • Acquired approval from Health Canada for Phase - 1b clinical trial T1D islet cell grafting ( NOTE: Elective surgery Covid - induced slow - down continues ) • Completed & published pre - clinical AMD iPS - RPC graft restoring vision in
Slide 8: Looking Forward
Looking Forward • Continue engagements to P&L for DED & AMD • Further engage BrainTrusts & CRO for Pulmonary Route of Administration & Proof of Concept Studies. • Continue engagement in P&L for Regenerative/Transplant Medicine, Islets, Dermatology, & Pulmonary Medicine • Develop TAM/SAM Market forec
Slide 9: PKX-001 expected to reach peak annual net sales of ~$2.2B in US
PKX-001 is expected to reach peak annual net sales of ~$2.2B in US across all therapeutic areas (DED, Dry & Wet AMD) combined PKX-001 — Revenue Forecast Summary (Base Case) PKX-001: US Net Revenue Forecast ($M) 2400 base 2200 | DED 2,000 | My AMD Hi weano 2236 1.800 ig 1900 3 1400 2 1.200 202i 2022
Slide 10: PKX-001 well positioned to meet key unmet needs in ophthalmology
In summary, PKX-001 is well positioned to meet key unmet needs in ophthalmology as a differentiated, disease modifying treatment PKX-001 in DED presents a potentially attractive novel Addresses Market option addressing current therapy shortcomings; it also Unmet Needs holds the potential to improve
Slide 11: Thank You!
Thank You! from • Additional information on efficacy, safety and manufacturing of PKX - 001 is available under CDA • ProtoKinetix Inc. is seeking collaboration and licensing partners to further the development of PKX - 001. For information please contact: L. Grant Young Co - founder, ProtoKinetix In
Slide 12: PKX-001 in Dry Eye Disease Program Updates
PKX - 001 in Dry Eye Disease Program Updates Dana Nohynek, MSc., RAC Regulatory Consultant February 11, 2022
Slide 13: Forward-Looking Statements
1 The information discussed in this presentation includes “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”). All statements, other than statements of historic
Slide 14: Dry Eye Disease (DED)
2 • Dry eye results from failure to produce enough quality tears to lubricate and nourish the eye , leading to corneal surface abrasion, inflammation and vision problems • ~22.2 million patients in United States have chronic dry eye (5 - 30% of the population) • Dry eye disease is multifactorial dis
Slide 15: PKX-001 target indication and development plan
3 • PKX - 001 Target Indication: “For the treatment of the signs and symptoms of dry eye disease (DED)” • Development efforts focused on enabling PKX - 001 to be evaluated in the clinic in a First - In - Human (FIH) Phase 1/2 study • Phase 1/2 study is planned in Canada with future clinical evaluati
Slide 16: Current PKX-001 GMP Product Status
4 Drug Substance (PKX - 001 Powder) • Route of synthesis for drug substance (peptide) established and suitable for GMP manufacture • ~1 kg of drug substance needed to support toxicology studies and clinical supplies Drug Product (PKX - 001 Ophthalmic Solution) • Drug product formulation development
Slide 17: Estimated Timeline to GMP Drug Product for Clinical Use
5 Estimated Timeline to GMP Drug Product for Clinical Use GMP DS manufacture M1 M2 M3 M4 M5 M6 M7 M8 M9 M10 M11 M12 DS analytical development Non - GMP DS manufacture GMP DS manufacture GMP DS stability Non - GMP DP stability DP analytical development GMP DP manufacture Non - GMP DP manufacture GMP
Slide 18: Pharmacology: PKX-001 efficacious in mouse DED model
6 • PKX - 001 efficacy demonstrated in murine dry eye disease model conducted by eyeCRO - PKX - 001 formulated as 5% topical solution in Balanced Salt Solution and administered as ocular drops to mice with induced dry eye disease - PKX - 001 solution was compared to vehicle (placebo) and positive co
Slide 19: Initial Nonclinical Studies: PKX-001 is safe and not genotoxic
7 Local tolerance: PKX - 001 does not cause eye irritation • Ocular irritation study in rabbits • Ocular irritation and tolerance study in mice General toxicology: PKX - 001 is well tolerated • Single dose exploratory intravenous study in mice • Repeat - dose exploratory ocular toxicology study in r
Slide 20: Nonclinical Toxicology Program
8 Requirements • Before initiation of any clinical studies, standard package of nonclinical toxicology studies must be completed • Objectives of nonclinical studies are to determine safe doses, characterize target toxicity and effects on vital organs, assess reversibility of adverse effects, and def
Slide 21: Additional pharmacology, in vitro and analytical studies
9 Secondary pharmacology and safety pharmacology studies • Broad selectivity screen (a panel of receptors, ion channels, transporters and enzymes), non - GLP • In vitro cardiotoxicity ( hERG and Ion channels) and in vivo cardiovascular study in dogs, GLP • Respiratory study and central nervous syste
Slide 22: Phase 1/2 clinical trial in Canada
10 • Phase 1/2 clinical trial will be conducted in Canada, taking advantage of a less burdensome regulatory dossier requirement - Study will be run by a Contract Research Organization with prior experience in conducting ocular studies - At least 2 clinical centers will be engaged: a Phase I unit wit
Slide 23: Phase 1/2 Clinical Study: Preliminary Design
11 Phase 1/2 Clinical Study: Preliminary Design Objectives: Primary: Safety and Tolerability, Pharmacokinetics Secondary: Efficacy Study Design: Multi - center, randomized, double - masked, vehicle - controlled, dose - escalation study Stage 1: a) Single - dose administration of PKX - 001 or vehicle
Slide 24: Timeline and Key Milestones
12 Timeline and Key Milestones 2022 2023 2024 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 DP formulation selected GMP product manufacturing GMP product ready for clinical trial Toxicology program execution Phase 1/2 Clinical Trial Health Canada consultation CTA Submission CTA: Clinical Trial Application DP: Dr