All depends on who they sign up with, our previous partnership with Phx as you know was cancelled due to the delays with commercialization.
We are all hoping the new partner has the capabilities for rapid commercialization of the test.
We are yet to see some licensing deals with immunoassay kit which was developed 7months ago, so one can only suspect that we are very much due for a string of licensing partnerships for other countries very soon.
There are so many things happening with PIQ, its very exciting and promising.
I have been watching closely, below are my notes from Oct, 2016 to the present day. Some of the new holders may find it useful!
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.
1 Signs contract with Monash Anti-body tech facility which will produce antibodies to recognize the fingerprints required for the PromarkerD test.
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.
3 $1.44 million from sophisticated investors.
$480k from share purchase plan.
Placement was priced at .24 per share.
4 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.
5 The Russian Federation has the fifth largest number of adults with diabetes approximately 16.5 million.
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).
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.
8 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
9 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.
10 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.
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.
12 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.
13 Nothing new mentioned
14 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
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
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.
17 7.2m adults are diabetic in Japan
18 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
19 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)
20 Alto Capital will underwrite $2m of any shares
Directors will raise $1m
21 Alto Capital underwrote $341,808 bringing total to $3.4M
22 60 million diabetics
Major European countries - Britain, Germany, Italy, France, Spain , Turkey
23 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
24 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
25 $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.
26
- Highlights
- USA & Mexico PromarkerD Commercialization deals
- European patent secured
- $535k unaudited revenue
27
- 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
28
- Total Current Assets including Cash: $3.8M
- Liabilities: $800k
- Equity: $4.6M
*Note, U.S Commercialization deal with PrisimHealth is only valid for 1year.
29
- 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.
30
- 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.
31
- R&D Grant via tax incentive for FY2017 - 2018.
- PIQ spent $1.9M on R&D
32
- 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
33
- 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
34 ProMarkerD kit version completed and read for commercial release
- More licencing deals expected
- New immunoassay kit can be used by pathology labs globally
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)
36
- Due to ongoing delays with Prism, PIQ pulled out
- Now negotiating with other diagnostic companies that offer faster scale and deployment.
37
- 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
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.
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
40
- 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)
- Forums
- ASX - By Stock
- Ann: PromarkerD to feature at world's largest diabetes conference
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proteomics international laboratories ltd
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