PIQ proteomics international laboratories ltd

Ann: Updated Investor Presentation, page-11

  1. Eqz
    3,860 Posts.
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    I imagine we may have picked up a few new investors keen to learn more about PIQ.
    Below is my running summary of announcements made by the company over the last few years, I hope others find it useful in their research.

    Date

    ASX Announcement

    Announcement Details

    1

    20/10/16

    Proteomics applies Promarker platform to gastro-causing parasite

    Promarker platform successfully detects biomarkers of Giardia gasto parasite

    Next stage to asses commercial viabilityof the detection test.

    2

    11/11/16

    PromarkerD test kit production deal signed

    Signs contract with Monash Anti-body tech facility which will produce antibodies to recognise the fingerprints required for the PromarkerD test.

    3

    15/11/16

    Proteomics and Linear offer end-to-end testing and clinical trials

    Partnership deal with Liner Clinical Research to offer combined advanced Analytical testing.

    PILL will test patient response to drugs during clinical trials analyzing blood samples to determine how long a drug stays in a person system, it will become one of only 3 companies to provide the specialist testing in Australia.

    4

    02/12/16

    $1.44 million Placement and offers Share Purchase Plan

    $1.44 million from sophisticated investors.

    $480k from share purchase plan.

    Placement was priced at .24 per share.

    5

    15/15/16

    PromarkerD shows improved predictive ability and robustness

    Further analysis of the original 4 year clinical study data has confirmed 10% of patients experienced a rapid decline in their kidney function when measured according to a variety of definitions of kidney function decline refinement of the algorithm has enabled 61-97% or 84% on average of these people to be predicted up to 4 years in advance.

    6

    19/12/16

    Diabetic Kidney Disease patent granted in Russia

    The Russian Federation has the fifth largest number of adults with diabetes approximately 16.5 million.

    7

    08/02/17

    PromarkerD diabetic kidney disease diagnostic test validated by EU peer-reviewed scientific journal

    The study has been published in the peer-reviewed scientific journal EuPA Open Proteomics, the official journal of the European Proteomics Association (EuPA).

    8

    21/03/17

    Roll out in Asia with China and Singapore patents andcommercialisation partners

    Deals to advance for the commercialization of PromarkerD in Singapore and China with commercialization partners.

    9

    04/04/17

    PromarkerD Update

    PromarkerD rated the world's leading diagnostic test for diabetic kidney disease by global market research firm Frost & Sullivan

    First licensing income received Key patents secured and extended Clinical laboratory prototype manufacture on target for mid-2017.

    • First commercial sales are targeted for the end of 2017
    • Validationstudycompleted-announcementofresultspendingpublicationoftheprior predictive development study.
    • Development study shows PromarkerD correctly predicts 95% of otherwise healthy diabetics who will develop chronic kidney disease.
    • DiscussionscontinuewithprospectivediagnosticcompaniesintheUSA,China,Europe, Australia and Japan to secure licences for the commercialisation of PromarkerD
    10

    09/05/17

    Proteomics International becomes world’s most accredited protein testing laboratory, launches pharmacokinetic and companion diagnostic testing for clinical trials

    PILL Becomes the most accredited protein testing company in the world with the award of ISO 17025 Research & Development certification. It is comparable to the standard adhered to by forensic laboratories to ensure tests on evidence

    from crime scenes is able to stand up to interrogation in court, and is the most widely used accreditation standard by US federal testing laboratories.

    11

    13/05/17

    Clinical validation study confirms PromarkerD can predict diabetic kidney disease better than any current measure

    In the 4 year perspective study the 3 protein markup blood tests predicted 86% of previously disease-free patients who went on to develop chronic kidney disease. In comparison to the development study the results from the larger validation study showed slightly lower levels of predictive ability. However achieved a 10% improvement in levels of false positives.

    12

    14/06/17

    Proteomics Internationalwins major analytical services contract in new biosimilars area

    PILLsigns long-term agreement (12months) with BiosanaPharma to test a new asthma drug.

    Agreement is PILL’s largest biosimilars contract to date with a value in excess of $200,000.

    13

    16/08/17

    US PromarkerD patent expanded to all kidney disease

    Existing US patent was restricted to diabetic kidney disease only.However the broader patent will now provide protection for the use of the PromarkerD panel for all nephropathy.

    14

    31/08/17

    Annual Report

    Nothing new mentioned

    15

    10/10/17

    PIQ Receives $800,000 in R&D tax incentive

    The Federal R&D tax incentive encourages companies engaging in beneficial research to Australia by providing a cash rebate of 43.5% for qualifying activities

    16

    04/12/17

    Partnership with Busselton Health Study to target lung disease

    Research agreement targeting improved diagnosis and treatment of lung conditions such as asthma and COPD (Chronic obstructive pulmonary disease)

    Preliminary results due in 6-9months

    17

    14/12/17

    Dimerix and Proteomics partner to improve treatment of Chronic Kidney Disease

    Dimerix has completed a Phase2a clinical trail of DMX-200 (a therapeutic program for chronic kidney disease).

    PromarkerD test will be used to explore the response of healthy volunteers to the DMX-200 program.

    If successful Dimierix will have the option to licence PromarkerD for on-going use as a Companion Diagnostic test.

    18

    29/01/18

    Diabetic kidney disease patent granted in Japan

    7.2m adults are diabetic in Japan

    19

    02/02/18

    CPR Investment & Partnership (10% acquisition)

    CPR Pharma Services privately owned clinical services laboratory. ($15m turnover in FY17)

    4M PIQ shares sold at 30day VWAP with 12month escrow.($0.3045 per share)

    Partnership will:

    -Boost client reach

    -Enhances competitive position in the clinical services market

    20

    07/03/18

    PromarkerD launches in Dominican Republic

    The test is being provided using the published mass spectrometry technology platform, known as a Laboratory Developed Test (LDT), and the Company expects to conclude its next licensing deal for this version of PromarkerD with a certified laboratory within weeks. Following uptake by specialised facilities, Proteomics International is focused on finalising the development of the in vitro diagnostic (IVD)immunoassay version of PromarkerD, that can be used in clinical laboratories around the world.

    $1.5M in royalties over 9years ($166k pa)

    21

    14/03/18

    PIQ Options to raise $3.4M

    Alto Capital will underwrite $2m of any shares

    Directors will raise $1m

    22

    06/04/18

    PIQ Options exercised raises $3.1M

    Alto Capital underwrote $341,808 bringing total to $3.4M

    23

    19/04/18

    PromarkerD Europe Patent granted

    60 million diabetics

    Major European countries - Britain, Germany, Italy, France, Spain , Turkey

    24

    28/05/18

    PromarkerD United States Commercial Deal Announced

    Signed PrismHealthDx, Inc. (PHDx) to develop and commercialize PromarkerD in the US market.

    Confidential deal with no revenue figures provided

    PIQ will receive royalty payments from every test kit (LDT kit)

    First sales anticipated within 4 - 6months

    25

    18/06/18

    PromarkerD Mexico Commercial Deal Announced

    Signed Patia BioPharma to commercialize PromarkerD to the Mexican market

    PIQ will receive royalty payments from every test kit (LDT kit)

    Confidential deal with no revenue figures provided

    Initially introduced to private hospitals and then expanded to government hospitals

    First sales anticipated within 4 - 6months

    26

    17/07/18

    Major Contract Secured

    $260k USD (~$355k AUD) analytics contract secured with BiosanaPharma, biosimilar testing for allergic asthma

    Note this is the same firm that earlier gave PIQ a $200k analysis contract back in June 2017, this updated contract appears to be a renewal/extension of the original contract.

    27

    30/07/18

    Quarterly Report

      • Highlights
        • USA & Mexico PromarkerD Commercialization deals
        • European patent secured
        • $535k unaudited revenue
    28

    23/08/18

    Diagnostics Update

      • Endometriosis study to progress to proof of concept (POC stage takes 3-6months)and then moves into clinical studies if successful (clinical studies can take 12months)
      • Giardia study on-going (currently in proof of concept stage)
      • Asthma & COPD still in 'Pre-Start' stage
      • 1 Study was discontinued: Mesothelioma
    29

    28/08/18

    Annual Report

      • Total Current Assets including Cash: $3.8M
      • Liabilities: $800k
      • Equity: $4.6M

    *Note, U.S Commercialization deal with PrisimHealth is only valid for 1year.

    30

    12/08/18

    Sale of CPR holdings

      • Forced to sell holdings, CPR was bought out and PIQ obligated to sell holdings. Loss of around $200k however received $900k cash for holdings , boosting cash on hand to $3M.
    31

    19/09/18

    MoU with Atturos

      • Atturos developed OCProDx test which can identify if prostate cancer is organ contained or non-organ contained. Will assist patients in making treatment decisions.
      • MoU to 'expand the user of mass spectrometry for new diagnostic tests.
    32

    17/10/18

    $834k R&D Grant

      • R&D Grant via tax incentive for FY2017 - 2018.
        • PIQ spent $1.9M on R&D
    33

    24/10/18

    PromarkerD Europe Commercial Deal

      • Licence deal with Patia Europe for PromarkerD test in Spain.
        • 3.6m diabetics in Spain
        • 2 year contract
        • Laboratory Develop Test (LDT)
        • First sales within 6months
        • Royalty payments
    34

    30/10/18

    Quarterly Update - Q1

      • Receipts: $363k
        • Looks like they only had the 1 customer for the quarter? See ann 17/7/18 - Major contract from BiosanaPharama worth $350k… no other customers?
      • Opex: $970k
      • COH: $2.5M
      • Business Updates
        • Potential biomarker discovery for Endometriosis (in proof of concept stage) and Giardia (in proof of concept stage)
        • Partnership with Atturos
    35

    12/11/18

    ProMarkerD kit version completed and read for commercial release

      • More licencing deals expected
      • New immunoassay kit can be used by pathology labs globally
    36

    26/11/18

    Collab agreement with US Janssen Research & Development

      • Joint study to test performance of PromarkerD in predicting declining kidney function in patients from Janssen's clinical trails
        • Results will take 6-12months
      • Joint study to evaluate PromarkerD for predicting heart disease
      • The collaboration has the potential to establish PromarkerD as a Complementary Diagnostic (CDx)test for the therapeutic treatment of diabetes complications. If successful the PromarkerD test could be expected to be used every time Janssen diabetes drugs are prescribed (becoming a gold standard test)
    37

    24/1/19

    US Deal with PrismHealth terminated

      • Due to ongoing delays with Prism, PIQ pulled out
      • Now negotiating with other diagnostic companies that offer faster scale and deployment.
    38

    30/1/19

    Quarterly Update - Q2

      • Receipts: $500k
        • Increase in revenue came from analytical services not PromarkerD tests
      • Opex: $1M
      • COH: $2.9M
      • Production issues with the immunoassay kit version of the test in Puerto Rico delayed the commercial sales in Dominican Republic, another production run is scheduled in February.
      • Spain & Mexico sales expected within 3months

    • **Revenue from this may not hit the books until Q4 FY19 earnings report (March/April)
    • POC study for Endometriosis and Giardia is continuing
    39

    18/2/19

    Shares released from escrow

      • 3M shares at 24c exercise price from the CPR Investment will be released 5th March
      • **This may bring the SP down if those options are sold on the market.
    40

    21/2/19

    US Patent granted for abnormal kidney function drug development

      • Patent concerns the use of PromarkerD biomarkers as potential novel therapeutic drug target in the treatment of kidney disease
    41

    24/4/19

    Quarterly Update - Q3

      • Analysis of samples from Janssen clinical trial of Gliflozin, due to be completed mid-year
      • First invoice issues for PromarkerD test in Dominican Republic
      • Highest quarter receipts from analytics division
      • Targeting Mexico and Spain commercial roll-out in June quarter
      • Giardia POC being finalised
      • Endometriosis POC being finalised
      • COH $2.58M
      • Receipts: $606k
      • OPEX: $1M (600k on R&D Costs)
    42

    26/07/19

    Secures contracts for pharmacokinetic analysis

    Extended partnership with Linear Clinical Research securing 2 new analytics contracts worth $418k.
    Study to be undertaken over the next 3-10months.

    43

    30/07/19

    Quarterly Update

      • Receipts: $245k
      • Opex: $1.3M
      • COH: $1.5M

        Expected burn next quarter is $950k

    • Updated to be released on commercialization efforts in Mexico, Dominican Republic & Spain in coming weeks.
    • ThePromarkerDpatentportfolionowcoversIndonesia,Australia,China,Europe,Japan,Russia, Singapore and USA, with other major jurisdictions pending
    • Recently secured TGAregulatory approvalfor thePromarkerDsoftwareasanin vitrodiagnostic(IVD)forexportuse.
    • Janssen collaboration ongoing with first phase of lab analysis near complete, data will further analysed with results due later this calandar year.
    • POC for Endometrosis delayed due to spectrometry machine failure
    • POC for Giardia moves towards prototype testing
    • Further investment engagement events in September
    44

    30/08/19

    Annual Report

      • Emphasis put on the possibility of PD being used a companion diagnostics test if Janssen Canagliglozin drug outcomes are successful.
      • Endometriosis still in POC stage nearing completion, delayed due to instrument breakdown.
      • Giardia POC being finalized
      • Asthma and Chronic Obstructive Pulmonary Disease research with Busselton Research group pending (no further update, stated as remains pending as company focuses resources on PD)

        Note: Company made a mention of a number of 'strategic collaborations' with Australian companies.
        • Harry Perkins Institute of Medical Research
          • PIQ in discussions to expand the relationship
        • BioPlatforms Australia
          • PIQ in discussions to expand the relationship
      • Revenue from services: $1.4M vs $1.2M FY18
      • Loss: $2M vs $1.4M FY18
      • Net Assets: $3M
      • Cash: $1.5M
    45

    10/09/19

    Results published in peer reviewed journal

      • Latest PromarkerD clinical validation results published in the Journal of Diabetes and its Complications
      • PromarkerD is the first test globally capable of predicting the onset of diabetic kidney disease In the 447 patient study, PromarkerD correctly predicted 86% of those who went on to develop chronic kidney disease (CKD) within four years
      • The latest results also show PromarkerD has an excellent negative predictive value, or "rule-out" capability, of 98% for four-year risk of developing diabetic kidney disease (DKD)
    46

    13/09/19

    PromarkerD ready for Europe Launch

      • Tech transfer to Atturos in Ireland
      • PromarkerD now available as a Mass spectrometry lab test for partners in the European market
    47

    13/09/19

    PromarkerD launched in Spain

      • Officially launched in Spain under a deal with Patia Europe (2 year term)
    48

    18/09/19

    PromarkerD IVD Successfully Developed

      • The new PromarkerD IVD technology can be manufactured as either a kit or configured to run on automated immunoassay platforms allowing it to service the needs of a greater number of clinical diagnostics laboratories around the world.
      • This is a major development milestone for the PromarkerD diabetic kidney disease test system and
      • will enhance the ease of use of the test in laboratories around the globe.
    49

    29/10/19

    $1.1M received in R&D Rebate

    $1.1M received

    50

    31/10/19

    Quarterly Update

      • Receipts: $373k
      • Opex: $963k
      • COH: $1.05M

        Expected burn next quarter is $750k

    Janssen statistical analysis results due Q3 FY20

    R&D rebate gives cash reserves exceeding $2M

    POC for Endometriosis put on hold.

    POC for Giardia continued with prototype testing, results now expected Q2/Q3 FY20.

    51

    12/11/19

    CE Mark for PromarkerD (MS)

    Secured CE Mark qualification for PromarkerD MS.
    CE mark allows PromarkerD to be sold throughout the European market.

    Registration is just for the mass spectrometry test.

    52

    1/11/19

    $3M Placement

      • Key use of funds
        • Reimbursement code for PromarkerD in USA **this allows the test to be subsidized by the government
        • Upgrading of facilities and equipment
        • Accelerate new IP projects
      • Issued at 28c per share

    53

    26/11/19

    Partnership with Western Australia Uni

      • Co-investment with UWA total of $4.4M over 4 years with PIQ contribution being $1.25M CAPEX and OPEX.
      • New facility to explore biological markers across a broad range of sectors including agriculture, marine etc.

    UWA’s analysis of crop plant proteomes underpin new protein biomarker analysis of wheat yield and response to harsh environments like salinity, drought and extreme temperature. The combined partnership will focus on emerging opportunities in clinical and agricultural proteomics. These are targeted quantitation of proteins across large sample sets and proteome flux

    measurements to assess the speed of protein synthesis and degradation processes in biological samples.

    54

    14/1/20

    CE Mark for PromarkerD HUB

      • CE Mark registration received for the PromarkerD Hub - a software tool used to calculate the risk of kidney disease in patients with type 2 diabetes
      • Anticipated to expediate execution of licencing and sale of PD throughout Europe (60M diabetic population)
      • CE Mark registration of PD Immunoassay now underway (PD Mass Spectromoy already CE mark registered) FDA application application by mid-year 2020
    55

    20/1/20

    Quarterly Report

      • Receipts: $74k
      • COH: $2.4M

    Stated $1.54M in receivables??

    • New specialists services for glycan analysis of biosimilars. Biosimilars in the treatment of cancer continuing to expand.
    • Giardia R&D update expected in Q3.
    • Statistical analysis of Jannsen data update due in Q3
    • US FDA CE Mark due mid-2020, key catalyst for partnership discussions in the US
    56

    10/2/20

    PromarkerD Presented at Australasian Proteomics Conference

    PromarkerD presented at Australasian Proteomics conference.

    57

    27/2/20

    4D Half Yearly

    Receipts: $542k
    COH: $2.4M
    Equity: $4.7M

    58

    23/3/20

    Patent for Endometriosis Biomarkers

      • Identified protein finger prints in blood that could be used to test for endometriosis.
        Successful POC study of 54 women.
        Next stage is to validate the biomarker panel in a larger clinical study, looking to partner with organisations who have access to a large number of samples.
    59

    31/3/20

    Janssen study expanded

      • Work from the first phase will be presented at the 80th scientific session of American Diabetes Association 13th June.
        Agreed to extend collaboration with Janssen to examine the PromarkerD score in patient samples after treatment of Invokana to asses if patients display an improved prognosis, I.e does their PromarkerD risk score decrease.
        The collaboration will continue until Nov, 2020.
    60

    7/4/20

    R&D Expanded (COVID19)

    /20

      • Endometriosis - pending clinical studies with larger group
      • Giardia - identified strain specific giardia and developed prototype immunoassary which is pending validation using field samples.Commercial viability will not be known until later this year.Collaboration with Murdoch University Veterinary School and US veterinary company.
      • COPD - discovery phase will commence shortly
      • Plant dieback - Discovery study on-going
      • Diabetic Retinopathy - Discovery study pending
      • Oxidative Stress - Clinical Validation pending, reviewing commercialisation opportunities.
      • Cancer Biomarkers - In-licencing discussion, clinical validation pending
      • Novel disease biomarkers - Discovery study pending
      • COVID19 - Program initiated


    61

    28/4/20

    Quarterly Report

    Positive $657
    - $537 grant income
    - $930 receipts(includes fees from analytics plus an extraordinary payment of operating and coinvestment funds from the WA Proteomics facility)

    Cash on hand over $3M .

    Burn of around $500k per quarter.

    62

    12/5/20

    Issue of Options

    550k employee options at 50c by 2023 = $275k

    *Note 1.1M employee options expire 31st May at 30c. -

    63

    25/5/20

    COVID19 Grant

    Two grants totalling $200k awarded for COVID19 research
    Develop a saliva test & isolate biomarkers to get insights into progression of COVID19 into why some people are more heavily affected

 
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