Your Breath: Your HealthTM

AI
Non-Invasive Deep Lung Sampling
for Diagnostics
& Personalised Treatment
A spin-out from Northumbria University
Problem
Lung tests are failing patients:
- Expensive, invasive, contaminated
- Infrequent monitoring
- Late & unclear diagnoses
- Trial & error treatment
Several Multi-US$ Bn markets
Target: Asthma Dx $6.7 Bn Globally
- 25 million US cases
- 50% of patients unserved
- Months to years for diagnosis
Other:
1. Lung cancer Dx ($2.61 Bn USA only)
2. Elderly lung infections ($2.6 Bn global)
Break even year 3, Trade sale Year 5
Solution Your Breath: Your HealthTM
Non-invasive sampling from the deep lung:
- Clinically-validated, uncontaminated
- Affordable, scalable, simple to use
- Perform targeted tests, identity disease cause
- Inform effective clinical action, quickly.
Business model
Clinical Dx (OEM)
- 1.5% of US asthma market = £58 M p.a.
Licensing to assay providers (POC systems)
- E.g. Asia ID market: est. £33 M p.a.
Research use customers (direct sales)
- 0.045% of US/UK market = £360k p.a. from Y1
- Lock-in new use cases e.g. Lung Ca.
Lung tests are failing patients
The problem: The reasons:
• No specific answers • Stethoscopes are non-specific

• Expensive or invasive tests • Nasal swab utility limited

• Mis- or late diagnoses • X rays once every 6 months

• Monitoring too infrequent • CT / MRI / PET are costly

• Trial-and-error treatments • Endoscopy is high risk

PBM-HALETM collects deep lung fluids

• Non-invasively • Low cost

• No contamination • Easy to use

• Access all markers • Clinically proven

Granted patents: WO2917153755A1, WO2019053423A1

Better lung health outcomes
• Accelerated diagnosis • Mass-producible

• Continued monitoring • Affordable

• Outside the NHS • Safe

• Effective treatments
Target market: Your Breath: Your HealthTM

Adult asthma (US$ 6.7 Bn) 0-5 year old wheeze (US$0.5Bn)
o 25.3M US patients o >1.6 M USA cases per year3
o 50% have no diagnostic option (T2 low)1,2. o Asthma and lung infections4
o Complex diagnosis, trial & error treatment o “No way to test right now”
o ”Can we classify asthma in one test?” o ”1/3 of all children under 3 years old”5

1. Kuruvilla ME Clin. Rev. Allergy Immunol. 2021; 2. Brand PL ERJ 2014; 3. Brand PL ERJ 2014; 4. Martinez FD NEJM 1995; 5. European Respiratory Society 2023
Our Customers: B2B pharma

“The future is in breath

diagnostics”

Dr Terry Fetterhoff
Head, US Chief Technology Officer Other market research:
Roche Diagnostics
Our Customers: asthma clinicians

“PBM-HALETM could solve

asthma diagnosis”

Prof. Omar Usmani

Professor of Respiratory Medicine
National Heart & Lung Institute
 PBM-HALETM is A Superior Product Your Breath: Your HealthTM

Exhalation Breath Turbo BioScreen NIOSH SKC

FEATURE InspectIR Rtube Technology Biopsy eNose PBM-HALE TM DECCS PExA II Bioaerosol biosampler1
Saliva-free √ √
No contamination √
No sample loss √
Reproducible √ √ √ √ √
Upper vs lower lung √ √ √ √
Operator safety √ √ √
All biomarker types √ √ √ √
Cold chain free √ N/A Soon √
Real time data √ √ Soon

Country USA USA GB GB NL GB ITA SE CN USA USA

1. Industry standard

All existing products suffer from one or more of the following limitations:
▪ Poor sample reproducibility ▪ Contamination (saliva / ambient) ▪ Sample loss ▪ Safety ▪ Upper
and deep lung separation ▪ and, importantly, inability to analyse all classes of biomarkers.
Sales in 4 Continents:
Lung Cancer (USA, EU) Elderly lung infections (CN, Australia)
o US$2.61Bn Diagnostic market globally o >960,000 p.a. USA hospital admissions1
o 236,000 new US cases p.a.1 o >120,500 p.a. cases among 65yo+ in UK3
o 12 tests for 18 personalised treatments2 o US$2.6 Bn global lung screening market

o “Biopsy or surgery needed” o “Cannot use swabs for TB & parasites”

o “Options limited in follow-up” o ”Antibiotics and hope for the best”

1. American Thoracic Society 2019. 2. US Federal Drug Administration 2022. 3. ONS 2019
The Team Your Breath: Your HealthTM

Ø Founder & CSO Dr Sterghios A. Moschos FRSC FIBMS

20 years pharma, academic, diagnostic SME experience, skilled in respiratory biomarker discovery,
companion diagnostics, & end-user oriented medical device design

Ø Chairman of the Board Dr Huw Edwards

30+ years global experience in emerging diagnostic technologies; CEO and Chairman experience
in life-science companies.

Ø CEO Dr Pete Hotten

25+ years business management experience; with CEO, Board and non-executive roles;
skilled IP strategist & commercial negotiator.

Ø NED Clinical Research Prof. Peter J Barnes FRS, FRCP, CFFP, FMedSci
Highest-cited respiratory clinician for the past 20 years, co-author of GINA (asthma) & GOLD
(COPD) clinical guidelines, & exhaled breath research guidelines & technical standards.

Ø NED Commercial & Manufacturing Dr Mark Sanders

10 years CTO & MD experience bring 17 respiratory medical devices from concept to market, and
6 of these in the USA; China supply chain experience.
£1 M for 20% equity
-3% Year 1
• £700k grant awarded -3% Year 1 Year 1 Year 2
-3%
Year 3
-5% -3%
-10%
-3% -3% -4% -3%
-4% -2% 0%

• £110k raised -10% -9%

-26%
-45%
-41%
-13%
-46%
-21%
-45%
• SEIS/EIS eligible
-36% -5%

-21% -8% -60% -3%

-15% -10%

-6% -10%
• 1.5% US asthma market = -4%

-6% -10% Staff Overheads IP Manufacturing R&D

£58M
Staff p.a.
Overheads IP Manufacturing R&D Marketing & BD Regulatory

• Exit: trade sale

1 sublicensing deal modelled; Break Even month 32; clinical asthma sales start year 5.
Use of funds Your Breath: Your HealthTM

Year 1: Faster market entry Year 3: Sublicensing revenues

- Injection moulding - Out-license to global sensor & IVD assay
- Class I/A FDA Registration companies
(equivalence)2,3 - Scale B2B sales world-wide
- USA B2B research use only (RUO) sales - Break even point
- Biomarker database tool
Year 4: Diversification
Year 2: Sales growth - Asthma enabling studies
- UK CA & EU CE mark - AI biomarker tool market entry
- Expand RUO sales
- Increase industry contracts Exit strategy: Trade sale Y5+
- External asthma use case data - IVD assay provider FDA submissions for
use on PBM-HALETM samples (asthma)2,3
- Month 58: Asthma clinical sales start

1. SEIS and EIS eligible; 2. Kinesys consulting (UK) 2021; 3. Proxima Clinical Research (TX, USA) 2022
 Profit & Loss Forecast
£98
Year of Operations

1 2 3 4 5 6 £73 Manufacturing
Staff
Costs 812 1,169 2,074 1,270 2,193 6,219 Sales
(£k)

Millions
£48 Regulatory
IP
R&D
Revenue 182 1,095 4,967 18,383 32,242 98,314 Overheads
£23
(£k) Marketing & BD
P&L
P/L -630 -74 2,892 17,113 30,049 92,095
-£2
(£k) 1 2 3 4 5 6

Year

NB: Data does not include additional equity investment,

Includes a single sub/out-licensing revenue stream
 Dr. Pete Hotten
Chief Executive Officer
+44 (0)7803 122 583

Your Breath: Your HealthTM

Winners

Dr. Sterghios A. Moschos FRSC FIBMS

Chief Scientific Officer Our supporters:
+44 (0)7950 380 928