Nugen Medical Devices Inc · TSXV:NGMD
Nugen Medical Devices — Investor Presentation (December 2020)
45 slides from Nugen Medical Devices's investor presentation, December 2020
Slide 1: Needlefree Intradermal Powder Injection Technology overview
Needlefree Intradermal Powder Injection Technology overview @ Inolife. INNOVATION FOR LIFE
Slide 2: Outline
Outline Biolistic delivery principle Inolife Powder Injector technology Family of injector devices Formulation methods Ability to target epidermis (pre-clinical and ex-vivo) Pain and local tolerance (clinical) DNA vaccine delivery (pre-clinical) Conventional vaccine delivery + stability (pre-clinica
Slide 3: Technology Platform
Technology Platform = Principle: Gas-propelled supersonic acceleration of microparticles into epidermis and/or dermis (i.e., biolistic or “gene gun” method of delivery). = Pain-free/Fast/Easy « Effective =» Thermostable =» Family of devices based on this platform @ Inolife. INNOVATION FOR LIFE
Slide 4: Intradermal particle delivery
Intradermal particle delivery “Says > Sk DOae Go ‘ol | Ye) OL ° Ia he bal wees eee ot = Inolife Powder Injector = Accurate dose delivery at skin target depth controlled via particle size and density (formulation) and velocity (delivery). @ Inolife. INNOVATION FOR LIFE
Slide 5: Powder injection platform
Powder injection platform New needletree injection principle for solids (powders) | Membrane Dose of powder / 0 inject _ Pamticles having Pressurized — 5 > penetrated the inert gas : skin at a controled and uniform depth Skin Guide tube si | ~ To start the apparatus, the membrane is abruptly punctur
Slide 6: Family of devices
Family of devices ® Single-dose pre-filled disposable = Multi-dose pre-filled disposable/refillable =» Single-dose reusable sterilizable @ Inolife. INNOVATION FOR LIFE
Slide 7: Single-dose device before injection
rn) f . | iQ ‘eala.™ = ~~ ~~ i. A i «7 —_ ~ y Lae ‘7s CC Fa iG eel 1 @) ~ An i - LA ‘ Before injection Safety feature = <1$ per injector * Clinical or self-administered applications @ Inolife. — INNOVATION FOR LIFE
Slide 8: Single-dose device
nale-dose —_ = A! Fe bert . Cc | m™ Q : _— 5 e I é: + a i ~ — A i Before injection = <1$ per injector # Clinical or self-administered applications @ Inolife. = INNOVATION FOR LIFE
Slide 9: Single-dose device after injection
——— * SINGLE -aose — = 4 maro. £ ~ On r - i , i ~~ A i , After injection = <1$ per injector * Clinical or self-administered applications @ Inolife. = INNOVATION FOR LIFE
Slide 10: Laboratory injector
Laboratory injector Gas microcylinder = Single dose reusable and autoclave sterilisable. = Built-in pressurized gas reservoir or pre-filled gas cartridge. = Same device for animal and human trials. @ Inolife. INNOVATION FOR LIFE
Slide 11: Laboratory injector
Laboratory injector » Single dose reusable and autoclave sterilisable. « Built-in pressurized gas reservoir or pre-filled gas cartridge. » Same device for animal and human trials. @ Inolife. INNOVATION FOR LIFE
Slide 12: Multi-dose pre-filled disposable device
Multi-dose pre-filled disposable device =» 50 doses at <0,50$ per injection = Individual dose capsules = Mass vaccination, chronic self-administered applications @ Inolife. INNOVATION FOR LIFE
Slide 13: Patent portfolio
portfolio Patent Patent Technology awarded IP protection in Canada, U.S. and Europe Inolife. INNOVATION FOR LIFE
Slide 14: InoLife Powder Injector vs. Powderject/Powdermed
InoLife Powder Injector vs. Powderject/Powdermed = Powderject/Powdermed: ® Uses converging-diverging nozzle (steady flow) = Complex device, high part count, expensive ® Proprietary (discontinued) gas cylinder = Works poorly for conventional (protein) vaccines - formulation not suitable InoLife Powde
Slide 15: Technological advantages
Technological advantages = Safety/Convenience of device: = No pain + no bleeding + no bruising, fast/easy, no sharps. = Improved Efficacy of delivery: = Demonstrated dose reduction for conventional and = DNA vaccines. = Thermostable powder formulated vaccines eliminate cold supply chain. = Can also
Slide 16: Better safety and convenience
Better safety and convenience = Eliminates pain and fear associated with needles. ® Reduces infection risks - no skin response, no bleeding, no bruising. ® Simple and quick delivery - can rapidly treat a large number of patients, can facilitate self-administration, can improve treatment compliance.
Slide 17: Improved efficacy
Improved efficacy = Can target specific skin layers: reduces quantity of API, eliminates the need for costly adjuvants, achieves faster response. ® Can inject pure drugs, without response delaying excipients or can tailor formulation for controlled release. = Can potentially achieve direct intracell
Slide 18: Improved efficacy for vaccines
Improved efficacy For vaccines ® Epidermis is rich in antigen-presenting cells (APC) (Langerhans cells). ® Elicits both antibody and CTL responses. = Dose reduction by a factor of 2.5-10 for conventional vaccines. = Dose reduction by a factor of 100-1000 for DNA vaccines. * as compared with IM needl
Slide 19: Improved stability
Improved Stability = Conventional vaccines and biologics are formulated with sugar-based solutions that are subsequently lyophilized, spray-dried or spray-freeze-dried. = Demonstrated long-term stability at room temperature. = Facilitate combination formulations since powders with different APIs can
Slide 20: Formulation methods
Formulation methods = DNA vaccines (plasmids): = Precipitation onto gold beads = Conventional vaccines (virus, sub-units, proteins): = Proprietary thermostable formulation (based on spray-freeze-dry technique) - ability to produce dense mono-disperse particles that stabilize the antigen at elevated
Slide 21: DNA on inert beads formulation
DNA on inert beads formulation = Precipitation of DNA plasmids on 3 mm gold beads Before formulation (SEM) After formulation SEM) ® Inolife. INNOVATION FOR LIFE
Slide 22: DNA on beads formulation results
beads formulation DNA plasmid (HBsAg) deposition on either 3 mm gold beads or 15 mm glass beads. Recovered DNA after submerging beads in 50 ml TE as measured with NanoDrop spectrophotometer. i < 2 z < oe : o 2 4 2 4 3 3s = 2 zt ‘ P : ‘ Time (Gays) Time (days) Effective DNA plasmid formulation method
Slide 23: Proprietary thermostable protein formulation
Proprietary thermostable protein formulation = Spray-freeze-dry formulation = carbohydrate substrate + excipients + weighing agent + active agent: = Long term stability at room temperature = Free-flowing (non clumping) = Proper size and density for biolistic delivery @ Inolife. INNOVATION FOR LIFE
Slide 24: Proprietary thermostable protein formulation
Proprietary thermostable protein formulation " Spray-freeze-dry formulation = carbohydrate substrate + excipients + weighing agent + active agent @ Inolife. INNOVATION FOR LIFE
Slide 25: Thermostable formulation
Thermostable formulation SDS Page after 11 months HbSAg Hepatitis B protein antigen on weighed carbohydrate particles. MW kDa } 2 3 Ba Quantity/band = ol ae Shag 160 j= ae 6 =) 1: HBs Ag 0 ~ 2: HBS Ag powder lot Feb 2011 ee | “i 3; HBS Ag powder lot Jun 2011 oi) ne 4: HBS Ag powder lot Dec 2011 a Ce
Slide 26: Thermostable formulation
Thermostable formulation SDS Page after 45 days - HA-New York Influenza inactivated virsu antigen with various adjuvants on carbohydrate particles. = Influenza vaccine stability at room temperature after 45 days. yea eees 11: Akan onthy = Demonstrated similar stability for interferon-beta. @ Inolife
Slide 27: Safety and convenience
Safety and convenience Eliminates pain and fear associated with needles. Reduces infection risks - no skin response, no bleeding, no bruising. Simple and quick delivery - can rapidly treat a large number of patients, can facilitate self-administration, can improve treatment compliance. Eliminates da
Slide 28: Pain-free delivery
Pain-free delivery (Human trial - IM saline vs pure salt powder injection) al Ml Needle syringe (n=10) (Powder injector (n=10) ull “Aniitipated pain Pain felt Patient discomfort ad & Pain scale (0-100) 8 Marked difference between powder and IM needle injections. Powder = no bleeding, no bruising. 10
Slide 29: Pain-free delivery
Pain-free delivery (Human trial - IM saline vs pure salt powder injection) Skin reaction Tah 1 ® fe pees Veesiien Neopet 1 ee PN pert 3S eee Ver eects mei (ight thoodams ue Lipte Beodey MADE (ight bonding, rod ypot an } cm Send blondes oxit Wer Lephe Moco care Lig Stordamy. vectling om } wom Sef por
Slide 30: Ability to target epidermis
Ability to target epidermis Gold beads - Ex-vivo Human Skin surface Limit of Gold beads epidermis @ Inolife. INNOVATION FOR LIFE
Slide 31: Ability to target epidermis
Ability to target epidermis Gold beads - Ex-vivo hie @ Inolife. INNOVATION FOR LIFE
Slide 32: Ability to target epidermis
Ability to target epidermis Gold beads - In-vivo Mice NT ‘ _ Skin surface ” i. Meee ty [eS Em Inolife. INNOVATION FOR LIFE
Slide 33: Injection depth
injection depth Injection of 3 mm gold beads or 15 mm glass beads in live mice. Depth of penetration for various injection conditions ory s ¢ 3 r % & Changing injection parameters allows control over depth (target) of delivery. Inolife. INNOVATION FOR LIFE
Slide 34: Ability to target epidermis
Ability to target epidermis Thermostable particles - In-vivo Mice Skin surface ™—F = @ Inolife. INNOVATION FOR LIFE
Slide 35: Thermostable particles - Ex-vivo Pig
B . + pF : AroliitV ‘ J ; & ad V/ Thermostable particles - Ex-vivo Pig Skin surface - - . “Kd ; yr = . Particles “Kes @ Inolife. SS INNOVATION FOR LIFE
Slide 36: Delivered dose
Delivered dose = Measure from ex-vivo or in vivo pre-clinical tests (mice, pig, human skin samples) = For gold/tantalum particles: = 50% injected dose for 2-20 mg » For weighed carbohydrate particles: = 30-50% injected dose for 2 mg @ Inolife. INNOVATION FOR LIFE
Slide 37: Efficacy for vaccines
Efficacy for vaccines = Epidermis is rich in antigen-presenting cells (APCs) (Langerhans cells). * Elicits both antibody and CTL responses. = Dose reduction by a factor of 2.5-10 for conventional vaccines. = Dose reduction by a factor of 100-1000 for DNA vaccines. * as compared with IM needle inject
Slide 38: DNA vaccine (Mice)
DNA vaccine (Mice) HBsAg DNA plasmid (Aldevron) in Balb-C mice Gold bead (n=6) vs. IM liquid delivery (n=4). Prime (7 mcg ) at Day 0, Boost (10 meg) at Day 28. 3S at 28 and 42 days Powder = Significantly greater response than IM plasmid delivery - consistent with previous studies. @ !nolife. INNOVAT
Slide 39: DNA vaccine (Rabbit)
DNA vaccine {Rabbit) HBsAg DNA plasmid (Aldevron)in New Zealand White rabbit Gold bead (n=6)vs. lM liquid delivery (n=6)vs Inert Gold bead control (n=6). Prime (10 mcg )at Day 0, Boost (10 mcg) at Day 28 and Day 42. Immune responses at 0, 15, 29, 36 and 43 days Samplesdlluted1/500 ■ Group1(injo,ctor
Slide 40: Protein vaccine + thermostability (Mice)
Protein vaccine+ thermostability (Mice) HBsAg protein (Aldevron) in Balb-C mice Thermostable formulation 10 mcg (nominal) (n=5) vs. Thermostable formulation 10 mcg (nominal) (1] months at 22°C) (n=6) vs. IM liquid delivery 10 mcg (control) (m=4). Prime at Day O, Boost at Days 14 and 28. Immune respo
Slide 41: Conventional vaccine efficacy (Mice)
Conventional vaccine efficacy (Mice) Powder vaccine delivery in mice (Influenza A/Aichi/68 H3N2 - Charles River on trehalose particles) vs. SC liquid influenza vaccine + TiterGold Max adjuvant (MF59). |_2Tter tom mdwidustomce — eeitenn Ther | : , : : 3 ° _* » Et 4 T = ¢ $ ’ Z Es : a Teas of 38 Gaye
Slide 42: Fast Response for Small Molecules
Fast Response for Small Molecules (animal trial '07) Systemic drug delivery (captopril powder in rats) = Fast response capability (comparable to IV injection) @ Inolife. INNOVATION FOR LIFE
Slide 43: Market opportunities
Market opportunities = InoLife Powder Injector device + drug/vaccine = High value combination product: = Added convenience for existing vaccines. = Mass vaccination - e.g., Avian flu, HIV. = New prophylactic vaccines. = New therapeutic vaccines. = Super-generics using off-patent drugs. = Patent exte
Slide 44: Commercialization pathway
Commercialization pathway Identify pharma partner! { Co-development or pharma ormulation study (contract) { Animal study { Human study Co-development or pharma (contract + milestone payments) Co-development or pharma (contract + milestone payments) Pharma ( milestone payments) Pharma (sales and/or l
Slide 45: Because, at the end of the day, it's all about making a difference!
Because, at the end of the day, it's all about making a difference! info@inolifesciences.com http://inolifesciences.com
Nugen Medical Devices — Investor Presentation (December 2020) on 6ix