Big Digital Energy, Inc. · NASDAQ:BGDE
Big Digital Energy — Wize Pharma — Investor Presentation (September 2019)
20 slides from Big Digital Energy's investor presentation, Sep 11, 2019
Slide 1: Planned Move Into Non-Viral Gene Therapy for Inherited Retinal Disorders
2019 © All Rights Reserved Planned Move Into Non - Viral Gene Therapy for Inherited Retinal Disorders September 11 , 2019
Slide 2: Cautionary Note Regarding Forward-Looking Statements
Cautionary Note Regarding Forward - Looking Statements . This presentation (both written and oral) contains forward - looking statements about our expectations, beliefs or intentions regarding, among other things, our product development efforts, business, financial condition, results of operations,
Slide 3: Corporate Overview
Wize Pharma, Inc. (OTCQB: WIZP) is a clinical - stage ophthalmology company expanding into treatment of rare retinal disorders through gene therapies. HQ: Israel Founded: 2015 Gene Therapy: 2019 Main shareholders: Ridge Valley Corp: ~ 10 % Other large investors: ~ 24 % CORPORATE Overview
Slide 4: Pipeline
• Potentially first - in - class, pre - clinical stage assets using non - viral gene therapy platform • Exclusive in - licensed technology from Copernicus to treat Choroideremia (CHM) • JV with Cannabics Pharmaceuticals Inc. (OTCQB: CNBX) • Development of new treatment for an ophthalmic disorder • L
Slide 5: Ophthalmic Non-Viral Gene Therapy Technology Exclusive License Agreement
• Gene therapy has been successful in eye diseases • First FDA - approved gene therapy for a genetic disease is for an inherited retinal disorder • The eye represents an ideal target organ for gene therapy: - easy visibility and accessibility - highly compartmentalized - ample research on genetic ba
Slide 6: Deal Terms & Financial Details
DEAL TERMS & Financial details • Wize agreed to license WP - REP 1 from Copernicus Therapeutics • Closing of transaction is contingent on meeting certain closing conditions • Expect to complete exclusive license in Q 4 2019 • Expected return on invested capital to exceed our weighted average cost of
Slide 7: Gene Therapy Ophthalmic Indication: Choroideremia
GENE THERAPY Ophthalmic Indication Choroideremia • X - linked autosomal recessive eye disease • Incidence: 1 in 50,000 , accounts for 4 % of blindness • Progressive vision loss begins in childhood • Night blindness • Tunnel vision • Visual acuity loss • Blindness by late adult • Caused by mutations
Slide 8: Significant Unmet Need in Choroideremia (CHM)
SIGNIFICANT UNMET NEED in Choroideremia (CHM) Rare, degenerative disease that leads to blindness; no treatment options Inherited X - linked monogenic retinal disease • Affects ~ 1:50,000 , primarily males • G 7 estimated prevalence of ~ 15,000 patients • Cause of 4 % of all blindness Progressive los
Slide 9: DNA Nanoparticle Treatment of Choroideremia
• DNA nanoparticle (NP)s encode a normal CHM gene • Ocular administration of CHM DNA NPs will express normal CHM in RPE and photoreceptor retinal cells • Visual deterioration halted, and potential improvements in vision anticipated Strong scientific rationale for intraocular delivery of gene therapy
Slide 10: DNA Nanoparticle Treatment of Choroideremia
DNA NANOPARTICLE TREATMENT of Choroideremia CHM DNA NP encoding normal CHM cDNA Diseased eye is dosed Retina converts light to vision RPE Photoreceptors Improved function of retina now express normal REP - 1
Slide 11: Clear Endpoints in Retinal Disease Clinical Trials
Visual Acuity • Routinely tested in clinical practice • Direct functional measure of vision loss/gain • Realtime imaging of entire macula • Automated eye tracking • Stimulation of same retinal loci across tests/visits • Higher sensitivity than visual acuity Microperimetry CLEAR ENDPOINTS IN RETINAL
Slide 12: WP-REP for Choroideremia: Potential for Product Launch
WP - REP 1 for Choroideremia • DNA nanoparticle Proof - of - Concept (non - viral gene therapy) • Potential to maintain and perhaps reverse vision loss • Approvals do not require large clinical trials • FDA Regenerative Medicine Advanced Therapy Designation (RMAT) • FDA and EMA Orphan Drug Designati
Slide 13: Copernicus: The Technology
Maybe we don’t need viral vectors 1 ? The purpose of a viral vector is to deliver DNA. But what if DNA and thus genes, could be packaged in nanoparticles and delivered to any cell type with an injection or an aerosol? Copernicus Therapeutics (private) has developed a non - viral approach for taking
Slide 14: Rethinking Gene Therapy: Long Term Treatments
RETHINKING GENE THERAPY LONG TERM TREATMENTS Utilizing Copernicus proprietary compacted nanoparticle delivery system to treat diseases without some of the drawbacks of AAV therapies. AAV therapies have limits when it comes to repeat administration. Non - immunogenic technology allows repeat dosing.
Slide 15: We Are Different
WE ARE DIFFERENT Not toxic Repeat dosing possible (virus vectors produce immune responses) Drug does NOT alter person’s DNA (no insertion) Efficient and consistent (≥AAV) delivery to cells, Both dividing AND non - dividing cells Magnitude and duration of expression ≥AAV vectors Commercializable form
Slide 16: Overcoming the Delivery Hurdle
OVERCOMING The Delivery Hurdle In collaboration with D. Kube and P. Davis, CWRU tight binding to cell surface nucleolin complex non - degradative, active trafficking pathway into nucleus Nanoparticle nucleolus nucleolin nuclear pore Released DNA
Slide 17: Robert C. Moen MD, PhD
Robert C. Moen MD, PhD Dr . Moen has served as Copernicus‘ President and CEO since 1998 . He has been involved in over three dozen cellular and gene therapy clinical trials (mostly involving viral - based systems) as VP of Clinical and Regulatory Affairs of the Gene Therapy Unit at Baxter Healthcare
Slide 18: Management Team
MARK SIECKAREK Chairman Joined 2019 Former President & CEO of Conceptus prior to its acquisition by Bayer Former CEO & Chairman of Solta Medical prior to its acquisition by Valeant Former Sr. VP & President of Americas for Bausch & Lomb Held senior exec positions at Bristol Myers Squibb, Sanofi, KOS
Slide 19: Scientific Advisory Board
DR. PENNY ASBELL KOL in the treatment of DES PI in clinical studies that led to development of pharmaceuticals for pivotal treatment of ocular conditions including DES Prof. of Ophthalmology at Icahn School of Medicine, Mount Sinai Established Mount Sinai's Lowenstein Foundation Sjogren's Center & F
Slide 20: Thank You
THANK YOU Visit wizepharma.com or email info@wizepharma.com 24 Hanagar St. Hod Hasharon, Israel Tel: + 972 72 2600536 Fax: + 972 72 2600537