Autoimmune Hepatitis (AIH) & Primary Biliary Cirrhosis (PBC)
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1 ANANAS Liver
2 Autoimmune Hepatitis (AIH) & Primary Biliary Cirrhosis (PBC) Chronic rare Autoimmune Liver Diseases with unmet medical needs: 90% women PBC Therapy (UDCA or OCA) does not slow progression Strong Side effects 15% non respondent AIH Therapy (STEROIDS) Severe Side Effects: 5 % non respondent > 10 % stop therapy AIH-PBC overlap (10% of total) NO CURE Drug therapy FAILS Drug therapy WORKS Liver transplant or death year after diagnosis Life-long Severe side effects due to off-target drug effects
3 ANANAS-Liver A New solution for Autoimmune Liver Diseases without side effects Nanoparticle Biodegradable and biocompatible Releases drugs liver Works in animal model Low carrier immunogenicity and inflammatory One injection every two weeks
4 Benefits of ANANAS Liver NO more Systemic Drug SIDE EFFECTS STOPS DISEASES PROGRESSION INHIBITS FIBROSIS REDUCES AUTOIMMUNE MARKER SCALABLE
5 Market for Ananas Liver Nanoparticle Rx* PBC Non-respondent patients to Rx AIH Expanded Market 8,7 B 1,3 B PBC = 29k AIH = 25k 1,1 B Expanded Market 9,7 B Total PBC patients = 194K * Developed countries only Market Values have been calculated based on Cost of current Rx /yr Total AIH patients = 215K
6 Business model ANANAS: B2B with Pharma Technology Licensing $XX M Upfront and Milestones Access to Patent & Data on Validated Targets Sharing of R&D and Manufacturing Practices Royalty Fees 1-7% Depends on stage of development and market conditions
7 Competitors (drug delivery) 272 total companies, 21 nanoparticle based technologies, 5 addressing systemic or liver autoimmune disease, 0 in clinical or preclinical level or exploits a similar approach. NP Platform Biodegradable Liver Targeting No Off Target ANANAS Parvus Topas Arcturus Lipocure Phosphorex Protein based Iron SPION Iron SPION cationic lipds liposomes polymers a r r n.a. b b Immune cells & parenchina Immune cells Immune cells n.a. n.a. n.a. b b b r r r
8 Milestones achieved ANANAS platform Untreated ANANAS- Liver Start Cup& PNI prizes NanoChallange Prize NP platform consolidated Proof-of-Efficacy in AIH model IP protection-1 EU/USA IP protection-2 PCT TOT. INVESTMENTS ~ 500K business competition prizes, consultancieson other projects, revenues, personal In collaboration with
9 Milestones - Future History AIH and PBC Preclinical PoC Additional IP Preclinical GLP Phase I Clinical trial EXIT k (120k already committed by founders) 2023
10 Team Founders & Operations Advisory Board Davide Merlin CEO Business consultant, Strategy and business planning Margherita Morpurgo CSO Nanomedicine University of Padova Pietro Invernizzi, MD Hepatology Milano Bicocca Univ Giovanni Rizzo Business Advisor, Life Sciences, Start-Up Michel Bergh Business Advisor, Life Sciences, Intellectual property Paolo Bigini Mario Negri Institute Nanobiology Unit Head. Fabrizio Paganini CFO Fiscal and Tax Accountant Paolo Gubitta Business Organization & Investor Relations University of Padova Elisabetta Casarin CTO Nanotechnology & Colloidal Drug Delivery Mario Salmona Mario Negri Institute Head of Biochemistry Elena Pigato BS, Candidate Economics Chiara Tamburini BS candidate Economics
11 ANANAS-liver Extract of Scientific Data
12 IP portfolio Claims (in brief) ANANAS linked to drugs containing carbonyl groups through acid reversible hydrazone likers Claims (in brief) Application of the above to cancer, inflammatory and autoimmune diseases ANANAS general compoisition Application of the above for medical and diagnostic uses
13 ANANAS-Liver ANANAS-Hz-Dexametasone Healthy animal Patent pending The drug is liver only A LIVER Dexa Dexa_ANANAS AIH animal 13 WIP, In collaboration with Mario Negri Institute and Univ of Padova
14 ANANAS-Hz-Dex in a AIH model Fibrosis Effect on anti-cy2d6iggs (marker of AIH progression) AST/ALT (liver inflamation) Prevents No effect Free dexa (0.4 mg/kg) Minor reduction ANANAS-dexa (0.16 mg/kg dexa equiv.) Prevents Reduces/prevents build-up Major reduction ANANAS-dexa is more efficient than free dexa 14 WIP, Courtesy of Dr. Urs Christen (Univ Frankfurt) and Pietro Invernizzi
15 Thank You
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