1 | PromarkerD test kit production deal signed | Signs contract with Monash Anti-body tech facility which will produce antibodies to recognize the fingerprints required for the PromarkerD test. |
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2 | 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. |
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3 | $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. |
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4 | 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. |
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5 | Diabetic Kidney Disease patent granted in Russia | The Russian Federation has the fifth largest number of adults with diabetes approximately 16.5 million. |
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6 | 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). |
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7 | 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. |
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8 | 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
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9 | 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. |
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10 | 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. |
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11 | 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. |
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12 | 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. |
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13 | Annual Report | Nothing new mentioned |
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14 | 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 |
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15 | 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 |
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16 | 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. |
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17 | Diabetic kidney disease patent granted in Japan | 7.2m adults are diabetic in Japan |
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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 |
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19 | 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) |
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20 | PIQ Options to raise $3.4M | Alto Capital will underwrite $2m of any shares Directors will raise $1m |
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21 | PIQ Options exercised raises $3.1M | Alto Capital underwrote $341,808 bringing total to $3.4M |
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22 | PromarkerD Europe Patent granted | 60 million diabetics Major European countries - Britain, Germany, Italy, France, Spain , Turkey |
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23 | 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 |
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24 | 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 |
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25 | 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. |
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26 | Quarterly Report | - Highlights
- USA & Mexico PromarkerD Commercialization deals
- European patent secured
- $535k unaudited revenue
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27 | 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
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28 | 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. |
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29 | 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.
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30 | 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.
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31 | $834k R&D Grant | - R&D Grant via tax incentive for FY2017 - 2018.
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32 | 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
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33 | 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
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34 | ProMarkerD kit version completed and read for commercial release | - More licencing deals expected
- New immunoassay kit can be used by pathology labs globally
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35 | 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)
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36 | 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.
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37 | 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
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38 | 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.
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39 | 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
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40 | 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)
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