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TRANSCRIPT
N4 PharmaInvestor 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
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
• Unmet patient need
• Global market potential
Identify and select therapeutic products with side-effects, stability or efficacy issues
Make drugs better, safer and easier to take
Re-develop using proprietary technology platform
License re-formulated products to global pharma market
License technology to pharma & Biotech for own programs
Rapid, Cost-effective return on investment Simplified regulatory pathway
1 2 3
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Sildenafil MR
Disease Prevalence and Treatment
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* Source: Black Swan Analysis Epiomic™ Epidemiology database, Erectile Dysfunction Disease, Accessed February 2017; 1 T5 EU = France, Germany, Italy, Spain and UK
o There are an estimated 100m sufferers of erectiledysfunction (ED) of some form in USA and Europealone
o including, mild, moderate and severe sufferers
o Sildenafil MR is aimed at moderate sufferers
o Approx. 9 million people are treated with drugs
o Several drug treatments available for moderateerectile dysfunction. The recommended firstline treatment is PDE5 inhibitors which workby blocking the enzyme which normally breaksdown GMP (the substance needed to developand maintain an erection)
o Sildenafil is the most prescribedtreatment *
41%
34%
25%
41%
29%
31%
0% 5% 10% 15% 20% 25% 30% 35% 40% 45%
Sildenafil
Vardenafil
Tadalafil
Patient Share of PDE5s
UK
USA
98,878
19,197
8,8566,506
2,6470
10,000
20,000
30,000
40,000
50,000
60,000
70,000
80,000
90,000
100,000
Total EDPatients
Presenting forTreatment
Drug treatedfor ED
Treated withPDE5i
Sildenafil
ED P
atie
nts
(00
0s)
The Perfect Erectile Dysfunction Product
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o Sildenafil MR is specifically developed to meet the needs of those patients suffering from ED
* Target ** Source: Evaluate Pharma 2016
Onset of action Duration Affected by food Market size **
Sildenafil MR (N4 Pharma)*
15-30 mins* 12-20 hours* No In development
Viagra (Sildenafil)
1 hour 4-6 hours Yes $1.6bn
Cialis (Tadalafil) 2-4 hours 36 hours No $2.5bn
Levitra (Vardenafil )
40-50 mins 5-7 hours Partial $0.2bn
Stendra(Avanafil)
15-20 mins 4-6 hours Partial n/a
MED2002 Gel (Futura)
5-10 mins 30 mins No In development
Switch Potential
7
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.
Source: Black Swan Analysis Primary market research, Feb 2017, n=15
19%
28%
19%20%
25%
12%
0%
5%
10%
15%
20%
25%
30%
Sildenafil Vardenafil Tadalafil
USA
UK
Percent of current usage likely to switch to Sildenafil MR
Target Product Profile
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o Sildenafil MR targets a flatter faster onset and longer lasting plasma concentration in the effective therapeutic window
Viagra Sildenafil MR
Our Product
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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 Initial release of sildenafil as outer coat partially dissolves
o Delivers drug straight to bloodstream bypassing stomach
o Rapid onset of action
o Tablet then swallowedo 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
Route to Market
10
Commercialisation of sildenafil
In-vitro reformulation
Easily replicable model for other products
MILESTONE PAYMENT
ROYALTY PAYMENT
MILESTONE PAYMENT
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
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Nuvec: Silica nanoparticles
vaccine delivery system
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
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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
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
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Size of the Opportunity
A range of platform technology companies which N4 can emulate
o Scancell (AIM) £34m mkt cap
o Two different technologies to create cancer vaccines, based on antibody generation
o 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 2017
Route to Market
16
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
First human studies
Milestone payment
Widespread commercial collaboration and licensing
Patent granted
o Nuvec has wider potential for investigation other than just cancer vaccines
o Cancer therapeutics
o Immunotherapy
o Reduction in Antibiotic resistance
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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
18
Appendix
2014 2015 2016 2017 May June Oct Nov 2018
Established by Nigel Theobald
Investment by Onzima Ventures
Patent applications for sildenafil, valsartan
& aprepitant
Patent application for Duloxetine
Listing on AIM
No toxicityestablished for Nuvec
In-vitrotransfection for Nuvec®
History of N4 Pharma
19
Sildenafilpatentpublished
Nuvecin-vivoResults expected
Sildenafilin clinic*
*Expected in 2018
Existing Pipeline and Strength of IP
Slidenafil MRSeeking to improve the speed at which sildenafil MR takes effect
whilst extending the duration of action
o UK patent filed 02 April 2016
o PCT patent filed 31 March 2017
o PCT patent published -5 October 2017
SartansUsed for the treatment of hypertension
NuvecSilica nanoparticle non-viral delivery system for DNA and RNA
Single Dose Hepatitis BSub unit vaccine – single does reformulation of Hepatitis B surface
antigen
DuloxetineReformulation of anti-depressant drug for the treatment of
premature ejaculation.
o UK patent filed 01 July 2016
o PCT patent filed 03 July 2017
Patent licensed from University of Queensland
o PCT patent filed 20 October 2016
o National phase applications October 2017
Exclusive agreement with University of Queensland
o UK patent filed 11 May 2017
AprepitantAn anti-emetic drug used in oncology.
o UK patent filed 21 December 2016
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 AesicaPharmaceuticals, 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 2007
16 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
Nigel TheobaldChief Executive Officer
Paul TitleyExecutive Director
David TempletonNon-Executive Chairman
Luke CairnsNon-Executive Director
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The Board