Small molecule NCE Platform therapeutic potential Mortality data in 1 st TPP

Transcription

1 Small molecule NCE Platform therapeutic potential Mortality data in 1 st TPP

2 Headlines Novel combined anti- inflammatory and anti- infective Re- profiles cytokines - IL- 6, IL- 8, IL- 10 Broad- spectrum anti- infective without resistance Life- saving - adults and children

3 Product pipeline : clinical + discovery Discovery Phase 1 + Pre- clinical Clinical Proof of Concept Phase 3 PAC- B PAC- A PAC- G Orphan burns treatment : mortality data POC Surgical site treatment : infection reduction data POC Non- healing wounds: In human POC PAC- I Orphan VAP treatment : Healthy volunteers PAC- IC Cystic fibrosis PAC- CP Chronic pain PAC- G Fibrosis

4 anti- inflammatory + anti- fibrosis + pro- healing Minimal scar & Normal hair growth Intractable post- radiotherapy fistula

5 Orphan class burns treatment (2 nd 3 rd 4 th degree burns requiring surgery & grafting) Proven life- saving treatment for adults and children Prevents and reverses inflammatory sepsis Effective against multi drug resistant pathogens Reduces need for surgical intervention Significantly reduces scarring

6 Burns Market Size Mean Cost per Patient Mean Length of Stay Incidence Rate (per 100,000) 20, Days , billion 493, billion Projections based on Maasstad Hospital, Rotterdam

7 Study Group (PAC- B) Broomfield survival data vs comparator data

8 Anti- inflammatory + anti- infective + rapid healing + scar reduction Inflammation modulation Simultaneous cytokine re- profiling action IL- 6 inhibition IL- 8 inhibition IL- 10 unaffected Ratio correction prevents scar formation Antimicrobial efficacy Effective against drug resistant pathogens Kills Ps. Aeruginosa Kills MRSA, C. Diff, Candida Neutralizes virulence factors Preserves antibiotics of last- resort

9 Market potential and IP strategy Orphan class EU / FDA Deep partial thickness and full thickness burns In development Ventilator pneumonia Cystic fibrosis Patent protection NCE Method of production First filing 2010 with first grants Marks & Clerk since inception

10 Burns Market Size Mean Cost per Patient Mean Length of Stay Incidence Rate (per 100,000) 20, Days , billion 493, billion Projections based on Maasstad Hospital, Rotterdam

11 Competitor Analysis - Debridement Chemical Debridement Direct Competitor No damage to healthy tissue No surgery Fast eschar removal Targets collagen Gentle on viable cells Suitable for burns <15% TBSA Sensitisation with 2 nd application Allergic reactions are common No antibacterial properties Mechanical Debridement 3225 Less damage to healthy tissue Reduced dressing changes Faster healing Surgical theatre required Hard to manipulate in small areas Surgical Debridement 4614 Fast Effective Surgery and anesthesia required Traumatic, resulting in blood loss Very non- specific Prices shown are per treatment/per day

12 Judge Business School Valuation Non- Financial Value Anti- inflammatory and Anti- microbial action Improved patient outcomes Meets high unmet clinical need Financial Value Orphan Burns Only 200M 300M Total Burns 360M 500M Given asset value range based on base case scenario High financial returns expected on investment even in worst case scenario (extremely unlikely to happen) We strongly recommend investment in HypoStream

13 Hypo- Stream efficacy, safety and patent: Strategic partners The St Andrew s Centre Regional Burns Intensive Care Unit MHRA consultation EMA COMP U. Cambridge U. Cranfield U. Anglia Ruskin Broomfield Hospital Burns unit U. Cardiff School of Pharmacy U. Cardiff Medical School Marks & Clerk patent attorneys

14 Product pipeline : clinical + discovery Discovery Phase 1 + Pre- clinical Clinical Proof of Concept Phase 3 PAC- B PAC- A PAC- G Orphan burns treatment : mortality data POC Surgical site treatment : infection reduction data POC Non- healing wounds: In human POC PAC- I Orphan VAP treatment : Healthy volunteers PAC- IC Cystic fibrosis PAC- CP Chronic pain PAC- G Fibrosis

15 Management & development team CEO & Founder - Myles Dakin: Oral & Trauma surgery, research, teaching and private specialist practice UK and USA 25 years. Chairman - Keiron Sparrowhawk: GSK, PriceSpective, MyCognition, U. Cambridge JBS. 39 years in drug development & market access. CCO - Lee Farnsworth: 19 years at major pharma. Most recently Commercial VP EAME region at Allergan. CFO - Julian Dakin: 30 years corporate banking. USA, UK and Europe. CLO - Marc Dalby: Barrister and solicitor. Formerly legal counsel MSD Academic collaborators: Professor K Harding (Chronic Ulcers + wound healing); Professor P Dziewulski (Burns + plastic surgery); Professor R Aspinal (Immunology + ageing studies); Professor Martin Bootman (intra- cellular signaling + drug action mechanism); Dr N Brown (Microbiology + hospital infection control); Mr N Hall (General surgery).

16 Hypo- Stream A.P.I Cytokine re- profiling Toxin & pathogen neutralisation

17 Multiple data- sets offer multiple therapies

18 Infection elimination Enhanced healing 12 years safety & efficacy +400 treatments

19 Inflammation pathophysiology is universal in all tissue systems

20 Anti- inflammatory + anti- infective + rapid healing + scar reduction Inflammation modulation Simultaneous cytokine re- profiling IL- 6 inhibition IL- 8 inhibition IL- 10 unaffected Ratio correction prevents scar formation Antimicrobial efficacy Effective against drug resistant pathogens Kills Ps. Aeruginosa Kills MRSA, C. Diff, Candida Neutralizes virulence factors Preserves antibiotics of last- resort

21 Healing in non- healing wounds Minimal scar & Normal hair growth Intractable post- radiotherapy fistula

22 Resolution of Refractory leg ulcers

23 Unique mechanism profile Inflammatory cascade modulation Healing cascade modulation Modulation of scar formation Disrupts pathogen function (no known resistance) Safe, tested in humans >400 patients Data on request

24 Multi- cytokine modulation replicates innate resolution of inflammation Functional inhibition of IL- 6 Functional inhibition of IL- 8 No impact on IL- 10 Differential action on proteins DNA is shielded

25 Multi- cytokine re- profiling: Aspinall, 2014 Data on file: Hypo- Stream 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Function of IL- 6, IL- 8 & IL minutes 5 minutes 10 minutes 15 minutes 20 minutes 25 minutes 30 minutes 1. IL- 6 & IL- 8 inhibition 2. IL- 10 maintained function IL- 6 & IL- 8 function IL- 10 Function Aspinall R U. IL- 6, IL- 8, IL- 10 Cytokine assay

26 Cytokine re- profiling = scar prevention Cytokine hypothesis defines scar free healing milieu Illustration From King et al, Regenerative Wound Healing: The role of Interleukin 10 Advances in wound care. 2014; 3(4):

27 Nosocomial infection Global unmet need - Human cost - Economic cost

28 Zimlichman et al. J. Am Med. Assoc. Intern Medicine. 2013; 173(22): SSIs comprise 33.7% of the total US$9.8 billion cost of HAI Each SSI was responsible for a cost of US$20,700 and an additional 11.2 additional hospital day stays. MRSA SSIs cost is US$42,300 with an additional 23.0 hospital days stayed.

29 Additional therapy validation Effective in surgical site treatment (n=387) elimination of SSI and failed healing vs control (28% vs 0.7%) Intractable wounds. Venous ulcers, radiotherapy fistula

30 Surgical site data 20x reduction in SSI in over 350 patient study Reduction of infection from 28% to 0.7% SOC PAC % surgical site infection

31 Product pipeline : clinical + discovery Discovery Phase 1 + Pre- clinical Clinical Proof of Concept Phase 3 PAC- B PAC- A PAC- G Orphan burns treatment : compelling data POC Surgical site treatment : infection reduction data POC Non- healing wounds: In human POC PAC- I Orphan VAP treatment : Healthy volunteers PAC- IC Cystic fibrosis PAC- CP Chronic pain PAC- G I.B.D.

32 Hypo- Stream efficacy, safety and patent: Strategic partners The St Andrew s Centre Regional Burns Intensive Care Unit MHRA consultation EMA COMP U. Cambridge U. Cranfield U. Anglia Ruskin Broomfield Hospital Burns unit U. Cardiff School of Pharmacy U. Cardiff Medical School Marks & Clerk patent attorneys

33 Management & development team CEO & Founder - Myles Dakin: Oral & Trauma surgery, research, teaching and private specialist practice UK and USA 25 years. Chairman - Keiron Sparrowhawk: GSK, PriceSpective, MyCognition, U. Cambridge JBS. 39 years in drug development & market access. CCO - Lee Farnsworth: 19 years at major pharma. Most recently Commercial VP EAME region at Allergan. CFO - Julian Dakin: 30 years corporate banking. USA, UK and Europe. CLO - Marc Dalby: Barrister and solicitor. Formerly legal counsel MSD Academic collaborators: Professor K Harding (Chronic Ulcers + wound healing); Professor P Dziewulski (Burns + plastic surgery); Professor R Aspinal (Immunology + ageing studies); Professor Martin Bootman (intra- cellular signaling + drug action mechanism); Dr N Brown (Microbiology + hospital infection control); Mr N Hall (General surgery).

34 Contact Hypo- Stream Ltd 9 Beech House Melbourn Science Park Melbourn SG8 6HB Web: Myles Dakin: Julian Dakin: stream.com md@hypo- stream.com jd@hypo- stream.com Hypo- Stream Ltd College of Medicine Institute of Life Science Singleton Park Swansea SA2 8PP