Cyclopharm Limited · ASX:CYC
Cyclopharm — Investor Presentation (April 2019)
26 slides from Cyclopharm's investor presentation, Apr 4, 2019
Slide 1: Cyclopharm (CYC) Investor Presentation
For personal use only CYCLOPHARM (CYC) Investor Presentation 4 April 2019 James McBrayer
Slide 2: Disclaimer
Disclaimer For personal use only Certain views expressed here contain information derived from publicly available sources that have not been independently verified. The presentation includes certain statements, estimates and projections with respect to the anticipated future financial performance of
Slide 3: Cyclopharm Overview
CYCLOPHARM OVERVIEW For personal use only Profitable & First in class Recurring USFDA Optionality Growing Technegas technology revenue approval expanding into MedTech generating sales from from high margin set to more than indications beyond 57 countries and consumable sales quadruple the PE could d
Slide 4: Company Overview
Company Overview For personal use only Cyclopharm Limited (CYC) is a leading diagnostic lung imaging company CYC : 5 year A world leader in functional lung ventilation imaging technology Recurring consumables , service and capital equipment revenue streams A profitable and growing company with a his
Slide 5: Special Protocol Assessment (SPA)
Special Protocol Assessment (SPA) For personal use only –advanced finding from the USFDA has been received that de-risks potential issues when filing our NDA Interim 40 patient read Technegas – results submitted with a face-to-face USFDA Phase 3 meeting on 11 October 2018 at USFDA Headquarters clini
Slide 6: FY2018 Results Highlights
FY2018 Results Highlights For personal use only Group Sales Revenue $13.40 million Gross Margin $10.85 million Net Loss After Tax ($0.04) million including USFDA investment Interim Dividend 1.0 cents per share Underlying Technegas EBITDA1 $1.90 million FDA Trial expenses ($2.96) million Strong balan
Slide 7: Technegas
Technegas For personal use only world’s best functional lung ventilation imaging agent Patient inhales Technegas: carbon particles labeled with Tc99m. Clinician can visualize functional ventilation using Technegas through to the alveolus: the site of gas exchange
Slide 8: Benefits of using Technegas
Benefits of using Technegas For personal use only Easy Only need 3D images No Cost to prepare and 3 to 4 breaths provide contraindications effective administer functional imaging through to the alveolus
Slide 9: Pulmonary Embolism
Pulmonary Embolism For personal use only Symptoms ~3 million are varied with diagnosis confirmed cases of PE p.a. either through CTPA or but could be 30% a nuclear medicine Nuclear Medicine much higher of pulmonary ventilation-perfusion using 3-D imaging is the embolisms are fatal if study most accu
Slide 10: Superior to competitive nuclear medicine products
Superior to competitive nuclear medicine products For personal use only Technegas Easy 3 to 4 breaths 3D images No Cost-effective contraindications Xenon - 133 DTPA Tc99m True No 3D images Wet Aerosol radioactive gas limited to planar impacts efficacy and inhaled with full imaging resulting clinicia
Slide 11: Diagnosing Pulmonary Embolism in the USA
Diagnosing Pulmonary Embolism in the USA For personal use only OPPORTUNITY TO DISPLACE CTPA: USA = 4 million studies p.a. High radiation burden to rule out PE CTPA delivers at least 27 times more radiation to the breast as compared to V/Q SPECT Nuclear Contraindications Medicine CTPA should not be p
Slide 12: FDA Clinical Trial Process and Design
Technegas FDA Clinical Trial Process and Design For personal use only Study • Non-inferiority structural ventilation study comparing Xe133 vs. Technegas • Special Protocol Assessment Granted Specifics • Total estimated trial cost $7.5 million USD with $5.5m USD spent to date • Assumes 240 patient st
Slide 13: Building from a strong & well established foundation
Building from a strong & well established foundation For personal use only Near term opportunities providing significant growth potential beyond PE toward patient management USA Market Targeting USA Half billion nuclear medicine CTPA PE market combined sufferers ventilation imaging opportunity to co
Slide 14: Clinical Study Strategy Beyond PE Underway
Clinical Study Strategy Beyond PE Underway For personal use only Hunter Medical Research Institute 100 patient trial targeting phenotyping and response to therapy in severe asthma. 99 patients enrolled as at 1/04/2019 Woolcock Institute 100 patient trial to commence 2Q 2019 targeting the diagnosis o
Slide 15: 2019 Strategic Priorities and Outlook
2019 Strategic Priorities and Outlook For personal use only Strategic Goals & Guidance Activity Timeframe United States Continue patient recruitment Ongoing FDA Approval & Finalise clinical trial sites (Mayo and Univ of Utah) 1H 2019 Commercialisation Finalise paediatric plan and submit to USFDA 1H
Slide 16: Business Case
CYCLOPHARM BUSINESS CASE For personal use only Profitable & First in class Recurring USFDA approval Optionality Growing proprietary product revenue set to quadruple the into indications MedTech sales to 57 from consumables size of the existing PE beyond PE into chronic countries with similar to an b
Slide 17: Clinical Information
For personal use only Clinical Information
Slide 18: Technegas is the preferred ventilation agent
Technegas is the preferred ventilation agent For personal use only Endorsed by the guidelines from the European5 and the Canadian6 Associations of Nuclear Medicine (EANM & CANM) “ Using 99m-Tc-Technegas is according to clinical experience better than the best aerosols ” “ Technegas is preferred to D
Slide 19: Diagnosing Pulmonary Embolism with V/Q SPECT
Diagnosing Pulmonary Embolism with V/Q SPECT For personal use only COMPARED TO CTPA: Less radiation burden V/Q SPECT delivers 27 times less radiation to the breast as compared to CTPA11 Minimal exclusion criteria V/Q SPECT can be performed in case of pregnancy11-12, renal impairment13, Primary imagi
Slide 20: Hybrid V/Q SPECT/CT
Hybrid V/Q SPECT/CT For personal use only Ventilation SPECT Low-dose CT Fused SPECT/CT V/Q SPECT provides functional information on ventilation and perfusion of the lungs14-15 Low-dose CT provides anatomical information Lobar distribution of ventilation such as fissures delineation16 Combination of
Slide 21: Beyond PE applications of V/Q SPECT/CT
Beyond PE applications of V/Q SPECT/CT For personal use only Diagnosis and Preoperative Preoperative assessment Planning radiation Advanced approach to follow-up of assessment of of lung resection therapy to target tumors phenotyping chronic Pulmonary Embolism3 Endoscopic Lung candidates with while
Slide 22: Treatment response in asthma patient
Treatment response in asthma patient For personal use only Case 1 BASELINE METHACHOLINE CLINICAL HISTORY Bronchoconstriction after methacholine challenge TREATMENT Male patient of 25 years old with life- long asthma worsened ventilation BEFORE function and increased ventilation heterogeneity. This w
Slide 23: Planning lung volume reduction surgery
Planning lung volume reduction surgery For personal use only Case 2 CLINICAL HISTORY Male patient of 64 years old with emphysema CORONAL FUSION SAGITTAL FUSION UPPER LOBES LOWER LOBES TRANSVERSE TRANSVERSE FUSION FUSION REFERRAL Assessment of lung ventilation function before planning endoscopic lung
Slide 24: Clinical Research: Ongoing studies
Clinical Research For personal use only 2018 Ongoing studies • FDA clinical trial phase 3 (Multiple sites, USA) The United States FDA (USFDA) phase 3 clinical trial is a non-inferiority structural ventilation study comparing Technegas with Xenon-133 in a total of 240 patients.19 • Hunter Medical Res
Slide 25: Clinical Research: Upcoming studies
Clinical Research For personal use only 2018 2019 Upcoming studies • Woolcock Institute - Sydney, Australia: Ventilation SPECT as a clinical tool to determine disease characterization and treatment response in 84 patients with asthma and COPD • The Centre hospitalier de l'Université de Montréal (CHU
Slide 26: References
References For personal use only 1. Fawdry RM, et al. Initial experience with Technegas – a new ventilation agent. Australas Radiol between V/Q lung scintigraphy in SPECT technique and multislice spiral CT. J Nucl Med 2004; 45: 1988; 32(2): 232-238 1501-1508 2. Senden TJ, et al. The physical and che