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CALDERA Challenges of the Market Jim Watson February, 2014 The vast cauldron-like crater of a caldera marks a geological hot spot, a place where elemental.

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Presentation on theme: "CALDERA Challenges of the Market Jim Watson February, 2014 The vast cauldron-like crater of a caldera marks a geological hot spot, a place where elemental."— Presentation transcript:

1 CALDERA Challenges of the Market Jim Watson February, 2014 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 Confidential to Caldera Health Limited

2 CALDERA Who are we? Confidential to Caldera Health Limited We outsource Legal Patent, and Financial services Clinical Supported by a strong Board Skill factors

3 CALDERA 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. The Vision Confidential to Caldera3

4 CALDERA 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 The Opportunity Environment 4Confidential to Caldera

5 CALDERA Start-ups are difficult to value Confidential to Caldera Health Limited 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.

6 CALDERA 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

7 CALDERA So make the proposition understandable Confidential to Caldera Health Limited

8 CALDERA 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

9 CALDERA We start with Gleason scoring Confidential to Caldera Health Limited Healthy prostate gland

10 CALDERA Prostate adenocarcinoma Confidential to Caldera Health Limited Many large nucleoi are seen here in the nuclei of sheets of cells in prostatic adenocarcinoma. Prostate cancer – glands filling in

11 CALDERA We are completing our first clinical study  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

12 CALDERA To get to a Clinical Validation Study Our process for selecting RNA biomarkers is unique Our next generation sequencing (NGS)platform for simultaneous multi- biomarker 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

13 CALDERA We monitor other technology out there? 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

14 CALDERA Investment cash flow is everything  Confidential to Caldera Health Limited  Hiring and retaining staff Steady R&D progress Investor comfort Consistent financial plan All start-ups struggle with this single issue – investors impatient for investment returns – many don’t survive

15 CALDERA The impatience of market perception Confidential to Caldera Health Limited Too much science Not enough marketing

16 CALDERA 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 Corporate growth necessary as product is market – by company or partner Confidential to Caldera Health Limited From a science base to a corporate culture

17 CALDERA 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  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


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