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Challenges of the Market The vast cauldron-like crater of a caldera marks a geological hot spot, a place where elemental forces once surged to Earth’s surface in a massive volcanic eruption, leaving behind compelling evidence of their destructive power. Caldera Health exists to help identify cancerous “hot spots” www.calderahealth.co.nz Jim Watson February, 2014 Confidential to Caldera Health Limited CALDERA HEALTH CALDERA HEALTH Who are we? Skill factors We outsource • • • Supported by a strong Board • Confidential to Caldera Health Limited Legal Patent, and Financial services Clinical CALDERA HEALTH The Vision • A molecular diagnostic business providing a range of cancer diagnostic tests based on gene expression profiling. • A game-changing technology platform. • First targets are to diagnose prostate cancer and the staging or progression of the disease. • Achieve global reach by partnership with an established multinational diagnostic company. Confidential to Caldera 3 CALDERA HEALTH The Opportunity Environment • Prostate cancer is becoming the most frequently diagnosed cancer in men globally • It is a disease of many phenotypes • The PSA (prostate specific antigen) test, is controversial due to the inability to diagnose all prostate cancer or distinguish cancer from other non-cancerous prostatic diseases • Rather than defining a cancer by its tissue of origin and morphology under the microscope Caldera seeks to define prostate cancer by its genetic properties Confidential to Caldera 4 Start-ups are difficult to value CALDERA HEALTH NPV can be described as the “difference amount” between the sums of discounted: cash inflows and cash outflows. It compares the present value of money today to the present value of money in the future, taking inflation and returns into account. Investors can calculate risks and likely returns. Straightforward to make investment decisions. Confidential to Caldera Health Limited CALDERA HEALTH Diagnostic markets are mature • Molecular technologies are like a tsunami sweeping through many business fields • Diagnostic markets are not isolated from the changes coming but are slow to respond • That’s because they have already a significant investment tied up in current diagnostic laboratories • Often in the form of equipment and long-term reagent contracts • So investors look at start-ups and see the problems with the birth of a new molecular science business Confidential to Caldera Health Limited CALDERA HEALTH So make the proposition understandable Confidential to Caldera Health Limited CALDERA HEALTH Caldera is a science-based business • We develop RNA biomarkers for gene transcript profiling to diagnose cancer • We seek a urine or blood diagnostic and prognostic test to replace DRE’s and biopsies • We are going through a scientific process to get there Confidential to Caldera Health Limited CALDERA HEALTH We start with Gleason scoring Healthy prostate gland Confidential to Caldera Health Limited Prostate adenocarcinoma Prostate cancer – glands filling in Confidential to Caldera Health Limited CALDERA HEALTH Many large nucleoi are seen here in the nuclei of sheets of cells in prostatic adenocarcinoma. We are completing our first clinical study CALDERA HEALTH The study involved screening 88 RNA biomarkers Using tissue samples from donor prostate gland tissue with Gleason scores from 5 – 10 From each donor tissue we selected a cancerous tissue sample and an adjacent “normal” tissue sample And analysed RNA expression profiles in cancerous versus healthy samples Confidential to Caldera Health Limited To get to a Clinical Validation Study CALDERA HEALTH • Our process for selecting RNA biomarkers is unique • Our next generation sequencing (NGS)platform for simultaneous multibiomarker analysis is unique • We developed a novel bioinformatics tool with Biomatters Ltd to specifically process and analyse the output data from NGS • We discovered random selection of RNA biomarkers can be linked based on biology • This has implications in other cancers Confidential to Caldera Health Limited We monitor other technology out there? CALDERA HEALTH • Real time PCR technology used,for example, by Genomic Health, Illumina, Pacific Edge • RT-qPCR is limited in its fluorescence detection range, compared to NGS based sequencing detection methods • The cost per sample analysis will be lower than achieved by RT PCR • And we file new patents on our processes and continually evaluate other’s patents Confidential to Caldera Health Limited Investment cash flow is everything Consistent financial plan Hiring and retaining staff Steady R&D progress CALDERA HEALTH Investor comfort All start-ups struggle with this single issue – investors impatient for investment returns – many don’t survive Confidential to Caldera Health Limited The impatience of market perception Too much science Not enough marketing Confidential to Caldera Health Limited CALDERA HEALTH CALDERA HEALTH It’s an evolutionary process R&D focus to get product line established – What’s there to market at the start? Growth of business development and marketing – A tangible product to market From a science base to a corporate culture Confidential to Caldera Health Limited Corporate growth necessary as product is market – by company or partner There are common threads to all market questions R&D focus to get product line established – What’s to market? Growth of business development and marketing – A tangible product to market Corporate growth necessary as product is market – by company or partner Are there others doing this? Yes – academic groups and other companies Why do we believe we are leaders? Academics focused on seeking communication through peer review Companies seek communication through are market focused Start-ups seek both? Why doesn’t PBRF recognise patents as communication? Our technology platform is unique. We are unaware of any group using a NCS platform for cancer diagnostics CALDERA HEALTH We can migrate the technology to other cancer diagnostics Key Aspirations First to market with an accurate prostate cancer test that provides both diagnostic and prognostic applications; First to market with a high volume routine diagnostic assay for a cancer utilising next generation sequencing; Strong patents to protect the technology