novel drug molecule for the treatment of Chronic Pain

Transcription

1 novel drug molecule for the treatment of Chronic Pain

2 Pandemic Problem Chronic Pain need adequate non opioid novel drug molecule to treat Chronic pain still a pandemic in the 21st century Chronic pain affects as many as 1,5 bn people in worldwide Economic healthcare costs for treating pain in US as high as $ 635 bn Source: WHO.iNT

3 Solution We built unique Drug candidate for treatment of pandemic Chronic Pain Novel small molecule contributes to: Treatment of pandemic Chronic Pain Indirect Reduce direct economic healthcare costs Positive social and economic impact Make people smile & healthy

4 Market Validation who.int who.int 116 mln people in the US suffer from chronic pain (2) 1,5 BN chronic pain suffers worldwide (1) Source: 1. GIA Inc. ( ) 2. AAPM (

5 Market Validation $60 bn+ 3.7% CAGR annually for treatment chronic pain in US market The global pain management therapeutics market is expected to expand at a 3.7% CAGR over the period between 2016 and The US market is expected to rise from a valuation of US$60.2 bn in 2015 to US$83.0 bn by Source: WHO.INT/FDA/EMA/paineurope.com

6 Pipeline We built unique drug candidate and has exclusive option to license and developing medicine targeting Chronic Pain disease. Other options are: - in the same patent ligand class we also developing medicine targeting Iminoglycinuria disease, but this is not completely confirmed and will discovering till Preclinical Phase next 6 month if investment is ready. - medicine targeting Chronic Pain disease can work and developing for Veterinary medicine, specially for Companion animals (dogs, cats, horses)

7 Product Novel small molecule is the KEY We built unique drug candidate and has exclusive option to license and developing medicine targeting Chronic Pain disease. Now we are on Pre-Clinical Phase Discovery Pre-Clinical IND Enabling Phase 1 Phase 2 Phase 3 Approval Marketing

8 Business Model Business model based on discovering and developing Chronic Pain drug until Phase 2a Proof of concept" (PoC) and licensing them to the best possible commercial partner. 100 mln upfront + 1 mln 10 mln 850 mln furthermore Discovery Pre-Clinical IND Enabling Phase 1 Phase 2 Phase 3 Approval Marketing

9 Roadmap The demonstration of true clinical proof-of-concept is a key value-creation step in the clinical development of a medicine. Bolka Pharmaceuticals are always open for Licensing deals / M&A / Strategic Collaboration / Development Veterinary drug companion animals (Licensing deals). Bolka Pharmaceuticals searching strategic Partnerships / Collaborations with other Biotech / Big Pharma / CRO in Neuroscience therapeutic area years Discovery Pre-Clinical IND Enabling Phase 1 Phase 2 Phase 3 Approval Marketing Target Validation Hit to Lead Lead Optimization Non-Clinical PoC PK/PD Pilot Tox GPL Tox Pharmacology CMC Phase 1 SAD/MAD Phase 2 Clinical PoC Accelerated Development Value Creation Proof of Concept or Phase 3 ready asset

10 Science data is spin off company of Bolka Pharmaceuticals Pipeline MIC4578 Chronic Pain (Preclinical) Micar Innovation Pipeline MIC4578 Chronic Pain (Preclinical) MIC9211 Alcoholism: AUD (Lead optimization) MIC2211 Hyperekplexia rare disease (Hit to Lead) MIC2231 Stiff PS rare disease (Hit to Lead) MIC2634 Iminoglycinuria rare disease (Hit to Lead) MIC6479 Pancreatic Cancer (Preclinical) MIC6701 Colorectal cancer (Preclinical) MIC2091 Cardiomyopathy (Hit to Lead) MIC8411 Melasma(Hyperpigmentation) (Preclinical) MIC8471 Acne (Preclinical) What is the proposed mechanism and why will it work in the clinic? We can provide all necessary science data if you have interest.

11 Intellectual property Patent family: Small Molecule for the treatment of Chronic Pain Priority date: April 2018 Publication number: W2018April Most Regulatory Exclusivities Start From Drug Approval Patent (20 years + extensions) Clinical testing 7 years Orphan Drug Exclusivity Patent filled Drug approved 5 years New Chemical Entity 3 years New Clinical Investigation Patent expiration Source: DrugPatentWatch.com

12 Exit strategy Strategic Collaboration (Partnership with CRO/ big Pharma) Between Preclinical to Clinical Phase I III Next rounds (Venture Capital A, B, C, D, E, F) Between Phase Preclinical Market Licensing deal Between Clinical Phase I Market M&A (Mergers and acquisitions) Between Clinical Phase I Market IPO (Initial Public Offering) Between Clinical Phase II Market Development Veterinary drug companion animals (Licensing deals & other exit options) Between Clinical Phase I Market

13 Competition Our competitors working hard to find the same treatment for Chronic Pain, but we focus our R&D to develop best-in-class and first-in-class differentiated therapeutics on its systematic, unbiased and comprehensive infrastructure and we constructed the best and completely new novel drug candidate fast & validated. Product Pharma class Companies Proprietary level Route of admin Phase III Tanezumab Anti-NGF MAb Pfizer/Ely Lilly NME Injection Phase III Fasinumab Anti-NGF MAb Teva/Regeneron/Mitsubishi Tanabe NME Injection BIIBO74 (raxatrigine) NaV 1.7 sofium channel blocker Biogen NME Oral CNTX-4975 (capsaicin) TRPV 1 agonist Centrexion Therapeutics NDA Injection EMA401 AT2 antagonist Novartis NME Oral VVZ-149 GlyT2 inhibitor, 5-HT2A & P2X3 antagonist Vivozon NDA Injection topicalinnovations.com We do not perceive these companies as our direct competitors because each of them has their unique expertise and others field of action. We are trying to build a Novel Approach to Treating Pain. We are advancing one of the largest, exclusively pain-focused clinical pipelines of novel, non-opioid therapies in order to bridge the safety and efficacy gaps in current chronic pain treatment. Source: June 2017, EvaluatePharma/ ( small molecule is the key

14 Competitive Advantage No real competitor carries on any research similar to Bolka Pharmaceuticals Our approach is totally innovative Small molecules are new developed ligands and the best type non opioid class small molecule is the key

15 Team We starting to build: Leadership management team Supervisory Board Scientific Advisory Board Team is multidisciplinary and bring more 60 years of experience in Drug Discovery & AI. Publications are only in highly visible prominent international scientific journals Awards CIDIC (cidic.be) is the European Centre of Economic Diplomacy and addresses the Diplomatic, Economic, Academic and Cultural world is pleased to inform you that Micar Innovation (Micar21) has been awarded a European CIDIC Award. Best Biotech Startup of the year 2017 in CEE Startup World Cup & Summit Regional Finals - TOP 8 Biotech Award - TOP 50 of the 2018 Startup - World Cup & Summit - Regional Finals!

16 Financial Invest in the future. Invest in life science. We are looking for next 15 months seed capital to financing & reach till Clinical Phase I with 2 scenarios. scenario 1: initial investment opportunity* scenario 2: 2 mln initial investment opportunity* Cover investment needs to reach and design the pre-clinical phase where the result of the solution discovered will be final confirmed, and prepare development of the first phase of the Chronic Pain for early stage of Phase I. * Depend of the risk and discovering other therapeutics' target such as Alcoholism - investment in Preclinical Phase is between mln euro. Process management / R&D project with Micar Innovation / Research and Development Process / Building the management & operational teams for growth - depends of investment. Please ask for two different Business Plans.

17 novel drug molecule for the treatment of Chronic Pain Thank you for your attention! small molecule is the key Dimitar Dimitrov