N4 Pharma Investor Presentation

Transcription

1 N4 Pharma Investor Presentation November 2017

2 Introduction o Established in 2014 o Specialist pharmaceutical company with two divisions: o Reformulation of existing generic drugs and o Silica nanoparticle vaccine delivery system o Lower risk, less costly, quicker to market than traditional drug development o Lead product, sildenafil MR, well progressed o Focus on drugs which have the potential to reach gross annual sales of 300+ million o Built around a strong IP portfolio in both divisions o Highly experienced management team 2

3 Business Model o Develop new versions of existing drugs either already on market (generics) or in development (vaccines) o License to big pharmaceutical companies for milestones and royalties Rapid, Cost-effective return on investment Simplified regulatory pathway 1 Unmet patient 2 Make drugs better, safer 3 need and easier to take Global market potential Identify and select therapeutic products with side-effects, stability or efficacy issues Re-develop using proprietary technology platform License re-formulated products to global pharma market License technology to pharma & Biotech for own programs 3

4 Sildenafil MR 4

5 ED Patients (000s) Disease Prevalence and Treatment o There are an estimated 100m sufferers of erectile dysfunction (ED) of some form in USA and Europe alone o o including, mild, moderate and severe sufferers Sildenafil MR is aimed at moderate sufferers o Approx. 9 million people are treated with drugs 100,000 o Several drug treatments available for moderate erectile dysfunction. The recommended first line treatment is PDE5 inhibitors which work by blocking the enzyme which normally breaks down GMP (the substance needed to develop and maintain an erection) o Sildenafil is the most prescribed treatment * 90,000 80,000 70,000 60,000 50,000 40,000 30,000 98,878 Tadalafil Vardenafil Sildenafil 31% 25% 29% 34% 41% 41% UK USA 20,000 10,000 0 Total ED Patients 19,197 Presenting for Treatment 8,856 Drug treated for ED 6,506 Treated with PDE5i 2,647 Sildenafil 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% Patient Share of PDE5s * Source: Black Swan Analysis Epiomic Epidemiology database, Erectile Dysfunction Disease, Accessed February 2017; 1 T5 EU = France, Germany, Italy, Spain and UK 5

6 The Perfect Erectile Dysfunction Product o Sildenafil MR is specifically developed to meet the needs of those patients suffering from ED Onset of action Duration Affected by food Market size ** Sildenafil MR (N4 Pharma)* Viagra (Sildenafil) mins* hours* No In development 1 hour 4-6 hours Yes $1.6bn Cialis (Tadalafil) 2-4 hours 36 hours No $2.5bn Levitra (Vardenafil ) Stendra (Avanafil) MED2002 Gel (Futura) mins 5-7 hours Partial $0.2bn mins 4-6 hours Partial n/a 5-10 mins 30 mins No In development * Target ** Source: Evaluate Pharma

7 Switch Potential o N4 commissioned market research amongst US and UK clinicians. There was a potential favourable switch rate from clinicians across all three of the existing prescribed products to Sildenafil MR based on the product achieving its targeted profile. Percent of current usage likely to switch to Sildenafil MR 30% 25% 20% 15% 28% 25% USA UK 10% 19% 20% 19% 5% 12% 0% Sildenafil Vardenafil Tadalafil Source: Black Swan Analysis Primary market research, Feb 2017, n=15 7

8 Target Product Profile o Sildenafil MR targets a flatter faster onset and longer lasting plasma concentration in the effective therapeutic window Viagra Sildenafil MR 8

9 Our Product o Sildenafil MR is a multiple action tablet comprised of an inner core of sildenafil citrate (80%) with an outer coat of sildenafil base (20%) o Sildenafil MR placed under the tongue for 60 seconds o o o Initial release of sildenafil as outer coat partially dissolves Delivers drug straight to bloodstream bypassing stomach Rapid onset of action o Tablet then swallowed o Remainder of outer coat dissolves normally in the stomach o Inner core dissolves slowly in stomach and small intestine to enable the drug to last longer 9

10 Route to Market Commercialisation of sildenafil Easily replicable model for other products In-vitro reformulation Small scale human studies to demonstrate profile in plasma Funded from proceeds of 2017 Capital Raising Seek pre-ind guidance from the FDA / EMA Sign licensing agreement Upfront payment received a) Pharma partner completes work for regulatory marketing authorisation b) Further milestone payments to enable N4 to complete work Partner seeks marketing authorisation with relevant authorities Patent granted MILESTONE PAYMENT MILESTONE PAYMENT ROYALTY PAYMENT 10

11 Nuvec: Silica nanoparticles vaccine delivery system 11

12 The Issues o DNA and RNA vaccines are seen as having huge potential for treatment in a wide range of cancers o Challenge is to deliver the plasmid DNA (pdna) and messenger RNA (mrna) effectively to antigen presenting cells, with a view to stimulating recognition and destruction of cancerous cells by the immune system o The most common state-of-the-art delivery vehicles for nucleic acids are lipid nanoparticles (LNPs) but suffer from many problems o Nuvec is a potential breakthrough technology in nucleic acid vaccine development 12

13 Our Solution Nuvec Lipid Nanoparticles (LPN) No in-vivo toxicity X Uniquely designed to work with the shape and structure of DNA / RNA X No unwanted inflammatory response through nucleic acid exposure X Provide high DNA loading capacity and efficiency for large nucleic acids X Protection of the DNA from enzymes X Delivery of high doses of large nucleic acids in in-vivo studies X 13

14 Unique Design o DNA has a unique looped structure o Difficult to attach to solid particles o Nuvec o Hollow silica sphere o Covered in thin silica spikes o Spikes trap the DNA o Spikes dissolve to release DNA o Particle then dissolves naturally in the body 14

15 Size of the Opportunity A range of platform technology companies which N4 can emulate o Scancell (AIM) 34m mkt cap o o Two different technologies to create cancer vaccines, based on antibody generation Avacta (AIM) 47m market cap o Platform technology as alternative to antibody production o Crescendo Biologics (private company) o Platform technology with multi-target application using special antibodies for cancer o Signed deal in 2016 with Takeda o $36m upfront payment, investment and research funding, along with preclinical milestones o Potential for further revenue through milestones and royalties up to $754m o Global nanotech drug delivery market forecast to reach $11.9bn by 2023; dominated by cancer applications* * Source: Technology market research

16 Route to Market Commercialisation of Nuvec In-vitro + in-vivo results Further studies to demonstrate nuvec point of difference Seek to begin initial industry collaborations Seek first licensing agreement Upfront payment Widespread commercial collaboration and licensing Patent granted First human studies Milestone payment o Nuvec has wider potential for investigation other than just cancer vaccines o Cancer therapeutics o Immunotherapy o Reduction in Antibiotic resistance 16

17 Summary o Two divisions with similar business models o Targeting significant addressable markets o Lead product, Sildenafil MR, well progressed o Lower risk, less costly, quicker to market than traditional drug development model o Strong patent portfolio and IP o Vaccine technology with potential to change cancer vaccine market o Highly experienced management team o Supported by experienced consultants with specialist knowledge in appropriate disciplines 17

18 Appendix 18

19 History of N4 Pharma Established by Nigel Theobald Patent applications for sildenafil, valsartan & aprepitant Investment by Onzima Ventures In-vitro transfection for Nuvec Listing on AIM No toxicity established for Nuvec Patent application for Duloxetine Sildenafil patent published Nuvec in-vivo Results expected Sildenafil in clinic* May June Oct Nov 2018 *Expected in

20 Existing Pipeline and Strength of IP Slidenafil MR Seeking to improve the speed at which sildenafil MR takes effect whilst extending the duration of action Nuvec Silica nanoparticle non-viral delivery system for DNA and RNA o UK patent filed 02 April 2016 o PCT patent filed 31 March 2017 o PCT patent published -5 October 2017 Patent licensed from University of Queensland o PCT patent filed 20 October 2016 o National phase applications October 2017 Sartans Used for the treatment of hypertension o UK patent filed 01 July 2016 o PCT patent filed 03 July 2017 Single Dose Hepatitis B Sub unit vaccine single does reformulation of Hepatitis B surface antigen Exclusive agreement with University of Queensland Duloxetine Reformulation of anti-depressant drug for the treatment of premature ejaculation. o UK patent filed 11 May 2017 Aprepitant An anti-emetic drug used in oncology. o UK patent filed 21 December 2016

21 The Board Nigel Theobald Chief Executive Officer Paul Titley Executive Director David Templeton Non-Executive Chairman Luke Cairns Non-Executive Director 25 years experience in healthcare & building businesses Previously head of healthcare brands at Boots UK Limited Grew Oxford Pharmascience Group to a 40m market cap company and managed the IPO on AIM Over 40 years experience in pharmaceutical industry Built R5 Pharmaceuticals Limited into a profitable business leading to its acquisition by Aesica Pharmaceuticals, which itself was acquired by Consort Medical for 230 million in 2014 Experienced R&D manager with specific expertise in early clinical development Previously worked for Pfizer, Xenova, Smithkline Beecham and GSK Appointed as director of clinical pharmacology of Eisai Limited in years experience in corporate finance and former head of corporate finance and MD at Northland Capital Partners Founder of LSC Advisory Limited Associate of the Chartered Institute of Secretaries 21