Interesting read in relation to Protonomics with their announcement today indicating further scientific success with their PromarkerEndo for endometriosis: “……. achieved excellent diagnostic performance across earlier disease stages and a near perfect accuracy in distinguishing severe endometriosis from symptomatic controls”. As laoshi noted the share price went up some 20% today on this announcement.

I have not seen a satisfactory explanation (qualification: explanation enough that would encourage Scoonie to invest in PIQ) as to why their agreement for the Promarker D test for Diabetic Kidney Disease with Sonic in the US did not progress.  An exclusive licence for Sonic to distribute in the US was signed on the 10/5/23 - and then dropped by Sonic 16 months later.   

The ASX listed Sonic is number 3 in the US pathology market. So you would think would be a great fit for PIQ to market its tests.  The arrangement with Sonic was ultimately terminated and at the time of the announcement on the 11/9/24 PIQ stated the following:  “PIQ is now free to launch PromarkerD in the US via licensing to alternative pathology laboratories and service providers and/or direct to consumer/ patient (DTC/DTP)”.    From an outsider perspective it looks like a case of forsaking the substance to embrace the shadow.

Previously PIQ announced on the 10/5/23 an extension with Apacor to continue the exclusive distributorship of Promarker D in Great Britain, stating: “ Both parties are now workings towards the inclusion of PromarkerD in the NICE Guidelines and engaging with the NHS Supply Chain Tender process as part of the commercial roll-out of the test in the UK”.

Also on the 20/12/23 PIQ signed a licence agreement with a company called Omics to sell the Promarker D in Chile with: “Omics now targeting other markets in Central and South America.”

In the Sept 24 quarterly PIQ had unattributed revenues of just $253k.

Other ASX listed firms in the blood/body fluid cancer diagnostic market have met with little commercial or share price success. These include:

1) Rhythm Biosciences (ASX:RHY) – bowel cancer detection test  

Listed in December 17 at 20 cents, reached $1.80 in late 2021 and now shares at around 8 cents.

2) Bcal Diagnostics (ASX: ) -Breast cancer detection test.  

Listed in July 2021 for 20 cents now selling for around 9 cents.  

3) Pacific Edge (ASX: PEB) – Bladder cancer diagnostics

Listed in Sept 2021 at $1.50 now selling 14 cents.

The only company in this market that seems to have done much good from a share price perspective is Cleo Diagnostics (ASX:COV). They have an ovarian cancer test with US clinical trials underway and a FDA submission planned for CY25. COV listed in late 23 at 20 cents and are now selling for 36 cents.

With all these cancer diagnostics no one denies the need for the tests and all the above companies talk up the obviously huge size of their respective potential cancer diagnosis market/s.  Some of the company slide decks are crammed with information on the poor specificity/sensitivity of current tests (if they exist), or tell how awkward current tests are to perform, however seem to have much less detail about their own tests.

All 4 of the above have and are currently mightily struggling to get their tests to commercialisation.  I don’t want to take away from what these great Aussie scientists (and Kiwi in the case of PEB) have achieved - and Biotech is hard. However maybe there is a Strawman medical insider out there who can shed some light on just why this on this little corner of the ASX listed biotech space looks like Shipwreck Central. 

Further information on the progress of the Endometriosis test. Positive market response to the announcement with a +20% lift in the SP but still a long way off highs. Target clinic launch of Q2 25 and in discussion for licensing (hopefully works out better than DKD Sonic deal). Esophageal cancer (PromarkerEso) test launching Q1 25.

The concern as with the DKD test is the lack of comment about how the test will improve treatment outcomes but that should develop with increased use.

Long term hold for me in RL and SM. I do note the lack of significant revenue in the near term and watch with interest the success of this year's releases.

Plasma protein biomarker panel identifies all stages of endometriosis with high accuracy

Refined PromarkerEndo blood test able to distinguish healthy individuals and symptomatic cases from early stages of disease

A prototype PromarkerEndo model achieved excellent diagnostic performance across earlier disease stages and a near perfect accuracy in distinguishing severe endometriosis from symptomatic controls

Results from a study of 805 participant samples published in the prestigious medical journal Human Reproduction

Next steps

The Company is pursuing multiple avenues to bring its novel blood test for endometriosis to the clinic with a target launch date of Q2 CY25 in Australia, with other jurisdictions to follow thereafter.

Test status:

Analytical methodology is being adapted for use in a clinical environment with target launch date for PromarkerEndo of Q2 CY25 in Australia.

Diagnostic algorithm is being refined using ‘traffic light’ system to further improve test performance for clinical use.

Development of the PromarkerEndo cloud-based software hub for reporting patient results has commenced.

Discussions are advancing in key markets for licensing in women’s health and fertility.

Progressing direct-to-consumer/patient (DTC/P) by leveraging the Company’s framework for its predictive test for diabetic kidney disease (PromarkerD) and diagnostic test for esophageal cancer (PromarkerEso), which are planned to launch Q1, CY25 in Australia.

Continuing to build awareness of the test with clinicians, key opinion leaders (KOL’s) and advocacy groups in response to the upsurge in demand for better diagnosis of endometriosis.

Patents pending in all major jurisdictions.

I agree with your sentiments @ Bradbury, in relation to Proteomics (ASX:PIQ) having discontinued their agreement with Sonic Healthcare to sell in the US PIQ’s Diabetic Kidney Disease diagnosis test PromarkerD. 

This appeared to be a potentially a very successful test and a lucrative relationship with Sonic. The test could predict up to four years in advance, the likelihood of a diabetic patient developing the debilitating Diabetic Kidney Disease. What’s more there are drugs and actions available to the patient to prevent the onset of the disease, if detected early. In addition PIQ have obtained US Medicare reimbursement for the test.   A real winner you might think.

In May 2023 PIQ licenced the same test to Omic Global Solutions (OGS) for sale in Puerto Rico. Well, you have got to start somewhere. This was later extended to Chile in December 23. PIQ has not specifically reported or broken out just what the sales of the test by OGS have been to date. You could only surmise, not much.

This is unlike Botanica (BOT) where for their FDA approved drug Sofdra used for the treatment of hyperhidrosis, you can get a sense of how successful the US rollout might be. This is because they have been selling the same drug in Japan since late 2020.  BOT recently indicated 350,000 units of the drug being sold last year in Japan. Whilst the figure is somewhat opaque since you are not getting specifics on patient persistence and the like, it is at least something and helps engenders investor confidence in BOT.  You do not have to capture much of the US market for BOT to be very successful.

As another counterpoint to PIQ, the ASX listed Microbia (MAP) have a relationship with Sonic Healthcare to sell their gut health test kits in Australia, USA, UK and elsewhere. In November 2022 Sonic took at 19.9% interest in MAP. So Sonic are not adverse to partnering and taking ownership stakes in allied health testing companies they believe have promise.  

There are two other companies with roughly similar-in-intent tests that come time mind:

i)  Rhythm Biosciences (ASX:RHY) with a bowel cancer detection system using bloods samples,

ii) Pacific Edge (ASX:PEB) has a genomic test that analyses biomarker genes to help rule out bladder cancer. Testing is via a urine sample.

Both have seen their market caps decimated by over 90% from their respective highs as the initial optimism waned when the reality of commercialisation sunk in. You could probably add in BCAL Diagnostics (ASX:BDX) with their breast cancer detection via a blood test to the list, on the basis for now the market remains (overly) optimistic on their prospects. Maybe Chair and founder Jayne Shaw being a first rate networker and promoter could have something to do with this. 

Commercialisation of these type of tests has proved very difficult and what Australian investors are typically seeing is only the ASX listed companies of this type. There is a whole world of biotech companies working in this field, a very competitive area.    

PIQ in its ASX release of the 11/09/24 indicating they no longer will have any commercial relationship with Sonic and said: “Proteomics International is now free to launch PromarkerD in the US via licensing to alternative pathology laboratories and service providers and/or direct to consumer/ patient (DTC/DTP)”.   Right, let’s cease dating Taylor Swift and go check out the old people’s home. 

Whilst PIQ’s PromarkerD test is promising and the upcoming test for endometriosis looks very positive, however given their recent record it is difficult to get any sort of a woody over PIQ. (Apologies for the usage of highly technical finance terminology). 

Proteomics Promarker D test has hit another hurdle on its progress towards commercialisation in the US with the distribution agreement with Sonic Health being terminated.

https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02851159-6A1224801&v=fc9bdb61fe50ea61f8225e24ce041a0e155a9400

The fact that the company is now talking about direct to patient sales and marketing shows that they are really struggling to find a market for the product.

This is a deal breaker for me and I have now exited on this news. I still think there is a massive opportunity with the PromarkerEndo test, however I will watch from the sidelines for now and will see if they meet their next targets.

@Bear77 was quite timely with the feedback on my last valuation.

The Good

• Distribution agreement signed for France. This is only a small market comparatively, however continues to add to the % of population serviced. The agreement is also with a new partner as a sub-distribution agreement with Apacor, which may bring a new approach leading to the start of meaningful sales.
• PIQ has contracted a sales agency for searching out distribution partners. So far this has not been Proteomics strong point and has delayed commercialisation of ProMarkerD. Bringing on a third party is a recognition of the prior challenges and shows that they are willing to adapt. Not much information could be found on a brief search about any of Growth Medics previous work.

The Not So Good

• Cash balance at $6.6m - 3 quarters of cash left, with Q4 increasing to the highest operating costs of FY24 at $2.3m. Staff expenses appear to have been shifted into R&D. With multiple tests now coming to market this expense will likely only increase.

• Quarterly cash receipts are at the lowest in 3 years.

• No update to USA launch after ongoing delays.
• Still no sales (or meaningful sales) from the current distribution agreements in Dominican Republic / Puerto Rico

Watch Status:  

No Change

Valuation Status:

Increase in Bull case with potential future sales of ProMarkerEndo and ProMarkerEso

What to Watch

• Further clinical validation studies for wider Victoria Biobank PromarkerEso clinical study. Expected Q1FY25. No Change. Now targeting target launch in Q1FY25
• Results from wider Oxford University PromarkerEndo clinical study. Expected Q1FY25. No Change. Now targeting target launch in Q2FY25
• If there are no sales of any products in any regions by the end of H1FY25, then the thesis is broken.
• Expansion of the ProMarkerD test to Type 1 diabetes, validation ongoing.
• Growth Medics B.V engaged to further distribution partners across Europe. Current target regions Netherlands, Belgium, Italy and Spain.

The Good

• Positive results from the validation tests for both PromarkerEso and PromarkerEndo. This provides scope to widen the potential test panel provided by Proteomics. Further testing is underway for both of these tests, but what isn’t clear at this point is the commercial viability of the two tests. Given the wide impact and difficulties in diagnosis, I think there would be interest in the test for endometriosis, however Proteomics offering is not the only one in the works.

The Not So Good

• Delay to the USA launch of PromarkerD. The delays to rolling out the test in the U.S and the poor up take in existing regions are indicating that PromarkerD likely just doesn't have the commercial interest to overcome the ongoing issues that have challenged management over the last several years.
• Due to falling cash levels, a cap raise for $6.5m was carried out to sustain business until PromarkerD can be commercialised. Operational cash burn was $1.98m for the quarter, which left $9.044m or approximately a year of funds. Generally operating expenses have remained steady, however there is no significant incoming revenue to offset these.

• Several watchlist items carried over for over 1 year without an update.

Watch Status:  

 Downgrade

Valuation Status:

Downgrade

What To Watch

• OxiDx granted a European patent. So far there hasn’t been many updates around commercial interest in the oxidative stress test.
• Further clinical validation studies for wider Victoria Biobank PromarkerEso clinical study. Expected Q1FY25 
• Results from wider Oxford University PromarkerEndo clinical study. Expected Q1FY25
• Current focus on distribution agreements in Europe
• Update on distribution in Chile
• Further distribution agreements in Japan, Hong Kong and the Middle East. (Carried Over x 3)
• Resubmission of MBS application. No timelines provided on when the company is targeting this. (Carried over)
• PromarkerD inclusion in NICE guidelines which will assist with the UK roll out (Carried over x 5) Funded report with Kidney Research UK.
• Engagement with NHS supply chain (Carried over x 5)
• Extending distribution agreement with Apacor into Europe (Carried over x 5)

PIQ announces delay in commercial US launch of Promarker D. SP has had a strong run lately but it will be hit by this news. However giving a positive spin on the experience with bringing other tests to market and continuing to pursue other global markets.

Proteomics International advises that, based on its latest assessment of the necessary technical and commercial work required to launch PromarkerD in the USA, the USA launch previously planned for Q2 2024, is now likely to be delayed.

Significantly, our experience with PromarkerD has provided the Company with invaluable knowledge and experience to accelerate the commercialisation of other tests in development. To this end, the necessary technical work has already commenced to prepare for the commercialisation of PromarkerEndo, the Company’s test for endometriosis, and PromarkerEso, the Company’s test for oesophageal cancer.

The Company remains focussed on executing further licensing and distribution deals in new jurisdictions for its PromarkerD test and is currently in discussions with a number of parties.

Q1FY24

The Good

• Industry tailwinds with the recent success of the use of Ozempic in the treatment of kidney disease trials. Increased range of treatments with improved efficacy are likely to lead to increased demand in screening for risk of DKD.

https://www.biopharmadive.com/news/novo-nordisk-ozempic-kidney-outcomes-trial-semaglutide/696273/

• PromarkerEso demonstrating promising results. Next steps through to the end of FY24

The Not So Good

• Cash receipts continue to remain low and will continue to do so until Promarker D starts to generate revenue.

• $4.9m cash remaining. Expenses haven’t changed significantly but will likely see a run up in product costs if there is take up in the soft launch with Sonic.

• TGA declined inclusion on the ATGR. Resubmission and acceptance is likely, however this will cost the company further money and resources.

What Status:  

What To Watch

• Outcome on final CMS payment rate for PromarkerD after the 30 day comment period.
• CMS payment rate going into effect. Target 1st Jan 2024.
• Update on PromarkerEndo in Q2FY24
• R&D tax incentive of $1.85m expected in Q2FY24
• Soft launch of PromarkerD in the US in Q4CY23. (Carried Over)
• Further PromarkerD distribution agreements in Japan, Hong Kong and the Middle East. (Carried Over)
• Resubmission of MBS application. No timelines provided on when the company is targeting this. (Carried over)
• PromarkerD inclusion in NICE guidelines which will assist with the UK roll out (Carried over x 3)



UPDATE - PIQ funded report with Kidney Research UK to promote diagnosis and treatment.

https://www.kidneyresearchuk.org/about-us/influencing-change/health-economics-report/

• Engagement with NHS supply chain (Carried over x 3)
• Extending distribution agreement with Apacor into Europe (Carried over x 3)
• Update on Israel distribution now that sales have commenced (Carried over x 3)

UPDATE - recent events are likely to impact any progress in this market

After a long trading halt announcement finally released on reimbursement price for US of $390 for DKD test effective CY24.

Total US/Europe diabetic population of 90+million. AUS 1.5 million

Australian TGA approval knocked back on what appears to be a technicality. Data supplied was from before the manufacturing moved to Europe. It seems the company thought they could get it through but will have to complete more testing.

IP protection for PIQ spin off OxiDx. OxiDx's next generation diagnostics technology offers a comprehensive solution for monitoring oxidative stress levels using a simple fingerprick blood test. Interesting that first trials are in elite athletes and racehorses!

First of a new family of patents for the OxiDx technology has been granted in Japan

Oxidative stress has been implicated in many chronic diseases - target applications include chronic fatigue, muscular dystrophy, high-performance athletes and the horse racing industry.

The Good

• Continuing research on expanding the product suite with new additions of DKD-T1D (Promarker D For Type 1 Diabetes) and Diabetic Neuropathy. While this is good for PIQ in the long run to diversify products and potential revenue sources, the increased R&D spend is hurting cash flow

The Not So Good

• Depressed cash receipts with only $198k received for Q4. This was slightly improved by the $140k of government rebates.

• Cash burn of $2.2m for the quarter, with only $6m in cash left. Even though the company does expect to receive an R&D rebate of $1.8m in Q2FY24, this leaves the company in a pretty tight cash situation. Can likely expect a capital raise announcement on the back of the final CMS announcement in Q3.

What Status:  Warning

What To Watch

• Oesophageal Cancer test update currently indicated for Q1FY24

• September CMS proposed pricing published for comment. If this timeline is not hit, it is unlikely the final CMS pricing will be published in January which the full market launch is waiting on.

• Soft launch of PromarkerD in the US in Q4CY23.
• Further distribution agreements in Japan, Hong Kong and the Middle East.
• “Looks forward to providing detailed updates on OxiDx as the year progresses''. This is a fairly vague statement, but any announced updates will validate it.
• Resubmission of MBS application. No timelines provided on when the company is targeting this. (Carried over)
• Outcome of the TGA application which was previously indicated around Q4 (Carried over. Now anticipated in H1FY24)
• PromarkerD inclusion in NICE guidelines which will assist with the UK roll out (Carried over x 2)
• Engagement with NHS supply chain (Carried over x 2)
• Extending distribution agreement with Apacor into Europe (Carried over x 2)
• Update on Israel distribution now that sales have commenced (Carried over x 2)

Continuing to build the suite of tests

Promarker pipeline - Oesophageal cancer diagnostic test update

Proteomics International invited to present latest results on blood test for oesophageal cancer at the 19th ISDE World Congress for Esophageal Diseases in Toronto, Canada

Test targets both oesophageal adenocarcinoma and pre-malignant condition Barrett’s oesophagus

Research expanded to include a further 350 cancer samples from the Victorian Cancer Biobank

“This technology has the potential to act as a screening test for oesophageal adenocarcinoma, providing earlier diagnosis without the need for an invasive endoscopy. We believe an externally-validated test will garner significant interest, both commercially and in the clinic.”

The Good

• Operating expenses have stopped increasing QoQ.

• Post quarterly, the exclusive agreement with Sonic Health was finalised, however no specifics of the deal have been provided. The announcement date of 10th of May was considerably later than the original target of the end of FY22.
• Also post quarterly, test results showing canagliflozin reduces Promarker D risk scores were published, which show a provide a use case for the predictive and preventative uses for the test. These type of results should weigh positively in the future MSAC resubmission.
• The development of the endometriosis test continues to progress with positive results

The Not So Good

• Cash receipts for Q3 are down over previous reporting periods (through to start of FY22), which isn’t a great sign for the sales of Promarker D in Central America. The cash reserves, while boosted to $8m from the conversion of some options, still doesn’t provide a significant runway when cash burn is around $1.7m per quarter.

What To Watch

• Reduced product costs may indicate that there hasn’t been any ramp up in production of Promarker D
• Resubmission of MSAC application. No timelines provided on when the company is targeting this. Likely after an outcome of the TGA application which was previously indicated around Q4
• PromarkerD inclusion in NICE guidelines (Carried over)
• Engagement with NHS supply chain (Carried over)
• Extending distribution agreement with Apacor into Europe (Carried over)
• Update on Israel distribution now that sales have commenced (Carried over)

PIQ test used in research that supports the argument that PromarkerD test can be used to improve treatment and outcomes in prevention of diabetic kidney disease.

Canagliflozin lowers PromarkerD diabetic kidney disease risk prediction scores

Research conducted with Janssen Research & Development looked at PromarkerD results of patients taking diabetes medication canagliflozin in those who took the medication compared to placebo.

Effect was greatest in participants predicted by PromarkerD to be at high-risk of a decline in kidney function at the start of the study

Research published as a feature article in the peer-reviewed Journal of Clinical Medicine

Study shows the power of using PromarkerD as a Precision Medicine tool to assist in the treatment and prevention of diabetic kidney disease

”it's exciting that we can identify patients who are asymptomatic for diabetic kidney disease but still at high risk of developing the disease, and that canagliflozin significantly lowers their risk of developing diabetic kidney disease . It's an elegant example of using precision medicine to enable early intervention and slow or stop the onset of disease.”

An update from PIQ this morning from a recent conference. Essentially showing the blood test they have been developing as a screening test for endometriosis is is 90% effective at detecting endometriosis.

Important to note that the study was comparing no disease Vs endoscopically confirmed severe disease. However this is still a promising step forwards. Sensitivity was 89% (rules out) & specificity 95% (rules in). The test was reactive according to disease activity.

New-endometriosis-test-presented-at-international-conference.pdf

Currently, there is no diagnostic test, when a high level of suspicion is present and the symptoms are debilitating a diagnostic laparoscope is used to visualise endometrial tissue within the pelvic cavity (yet outside the uterus, which is the definition of the disease). The mainstay of treatment is NSAID pain relief for mild to moderate disease. For woman with more severe disease/ symptoms surgical intervention can be required. Important to note that this disease can severely affect fertility, and so can the treatments. In some cases surgical intervention is done in an effort to improve fertility efforts.

Next step would be for them to prove it can detect mild and moderate disease.

The most important thing would be to demonstrate how detecting the disease earlier would affect outcomes. Obviously earlier confirmation of diagnosis would assist in pain management, which is amazing for patients, however, I would argue that unless a new test actually changes the disease outcome via better interventions then this isn't going to reinvent the wheel.

Held on strawman (for the test for CKD, which earlier detection would improve outcomes because it is so insidious).

This is exactly the question I want to ask them if we can arrange an interview. How will this new test alter practice, and therefor patient outcomes. It is positive that MSAC acknowledge that long term this test could save money (translation: improve patient outcomes and reduce morbidity and hospital admissions) but without a clear positive impact on whether it would alter current clinical care for chronic kidney disease (CKD) this is up in the air.

I would think it would alter care, earlier intervention, earlier and more aggressive prescribing of nephroprotective drugs, better informed care for patients who with this knowledge may alter lifestyle factors (which are nephrotoxic in many cases).

I hold on SM because the money isn't real. But following IRL

:)

The Good

• First sales of PromarkerD achieved in Central America. This is likely at a very small scale so far as there hasn’t been an impact to the cash receipts this quarter and I would have expected the company to promote the milestone further. The Half Year results may provide a breakdown on PromarkerD to see what the revenue is like over the short period. At this point I will estimate a 1% market penetration for remainder of FY23, which results in around an additional $75k per quarter ($15USD/test, 1.3m TAM)

• Improved cash position with balance of $6.8m at the end of the quarter. Can also expect further cash improvements from the exercise of options (~$2m+) and the potentially also the second half of the facility upgrade payment ($850k)

The Not So Good

• As is standard with PIQ there were no new business updates provided in the announcement, just a summary of the announcements over the quarter. I.e No new updates from OxiDX
• Cash receipts although looking good for the quarter are actually lower than normal. This is after expansions to the analytical services. These are being expanded further with the WA Proteomics Facility partnership, so potentially there will be some small revenue growth from the upgrade.

• Operating expenses are increasing over previous quarters, however this could be in preparation for sales in the US. The current cash levels can support these increases for a short period.

What To Watch

• Finalise Exclusive Licence Agreement with Sonic Healthcare by 28 Feb
• CPT PLA code taking effect from 1 April. & addition of PromarkerD to clinical labs fees schedules
• PromarkerD inclusion in NICE guidelines
• Engagement with NHS supply chain
• TGA & MSAC approvals currently expected in Q4FY23.
• Extending distribution agreement with Apacor into Europe
• Update on Israel now that sales have commenced
• Progress of R&D for Promarker range. Both are currently indicated as H2FY23 in the presentation slides.

Well, we’ll, well, this seems very good news to start 2023 for Proteomics.

PIQ: CPT PLA reimbursement code approved in US for PromarkerD

The new code will take effect from 1 April 2023 and will herald in great news for diabetics at risk of developing diabetic kidney disease. Let’s hope this can create a situation where people are pre-diagnosed in time to do something to prevent this horrible disease from progressing to it’s inevitable life threatening end.

Going through the PIQ slides from the AGM I noticed that there is a new licencing agreement that has been secured for Central America. This was not on some of the slide decks from presentations at the start of November so it must be a reasonably new development. The potential market isn’t massive, however any new agreements are a step in the right direction.

The other interesting part is that it states first sales commenced. Commenced can be a bit of a grey description for pinning down a timeline on cash in the bank, but if this is the case, it could be a turning point after several drawn out sagas in Italy (Agreement now terminated), Israel and the UK. The other change in status is that product registration is now on hold pending first sales in other regions, where this previously was awaiting ISO13485 certification.

I haven’t been able to find a copy of the video of the presentation, so if anyone has any more details I would be interested to hear if this was elaborated on further.

Not much new information was presented in the PIQ quarterly update which was mostly a summary of the announcements over the last 4 months. 

The commercialisation milestones with Sonic Healthcare are supposedly still on track but no news on the UK or European licenses.

Cash burn continues but the companies capital position has been stabilised by a capital raise and grant funding with ~$9.2m in cash and a forecast ongoing operational cost of ~$1.5m for future quarters.

This continues to a speculative wait and see.

Announcement that expands PIQ / UWA collaboration into proteomics development that mentions agriculture and environment which are large potential markets. $1.7M of Commonwealth funds allocated.

Cutting-edge WA Proteomics Facility operated by Proteomics International and The University of Western Australia (UWA) receives new funding to expand precision diagnostics capability

Proteomics International and UWA in partnership with Bioplatforms Australia will invest A$2m over the next three years with Proteomics International’s contribution being $150,000.

Bioplatforms Australia (through the Commonwealth Government National Collaborative Research Infrastructure Strategy (NCRIS)) will contribute $1.7m to the Facility for capital and operational purposes, of which half the funds will be paid to Proteomics International to expand its laboratory capacity. Proteomics International and UWA will each invest a further $150,000 in cash.

Funding to help create a state-of-the-art analysis pipeline for industrial-scale screening to explore biological markers across medicine, agriculture and the environment

Dr Richard Lipscombe said “we are building on our recent successes in diagnostics development to create a state-of-the-art high-throughput analysis pipeline to address more real-world challenges in clinical and agricultural diagnostics.”

There are clinical samples sitting in biobanks and sample repositories all over Australia that can be used to help combat chronic diseases. Similarly, analysing seeds in national and international seed stores could help make breeding decisions that boost the world’s agricultural output. All these biological samples are a precious and limited resource. By analysing them faster and at greater scale we can accelerate the development of new precision diagnostic tests that could improve patient care or transform agriculture production.”

The expanded facility is expected to be fully-operational in 2023.

PIQ announcing positive results for early stage cancer test expanding the range of tests offered by the technology.

Dr Lipscombe said the next steps in commercialising the prototype test are to:

• further develop the statistical modelling to improve the test’s sensitivity and specificity. This will use the 'traffic light' system developed for the Company's PromarkerD predictive test for diabetic kidney disease;

• refine the reproducibility of the biomarker measurements to produce a test suitable for the US Laboratory Developed Test (LDT) pathway via CLIA certified clinical laboratories;

• confirm the clinical performance of the test in an additional independent patient cohort;

• conduct formal Economic Health Benefit Modelling and Clinical Utility Studies to demonstrate how the new test could significantly change doctors’ treatment decisions and improve outcomes for patients and healthcare systems.

The Company anticipates that these additional analyses will be completed in stages over the next 12 months. If successful, the outcome would be a clinically validated blood test able to offer simpler and earlier diagnosis of oesophageal adenocarcinoma and the pre-malignant sub-categories of the disease. Proteomics International believes a validated test will garner significant interest, both commercially and in the clinic.

New Promarker test for Oesophageal Cancer demonstrates strong diagnostic performance

• Prototype version of potential ground-breaking test for oesophageal cancer correctly identified up to 90 in 100 people with the disease

• Milestone a significant step in the development of a simple blood test for oesophageal cancer following the study of 300 patients across two independent clinical cohorts

• Results presented at the International Society for Diseases of the Esophagus 18th World Congress (ISDE 2022) held virtually and in Tokyo, Japan 26-28 September 2022

• Test targets both oesophageal adenocarcinoma and patients with pre-malignant condition Barrett’s oesophagus which affects 1-2% of adults and can arise from chronic acid reflux

• Current screening requires a specialist endoscopy procedure and the annual expenditure on treating oesophageal cancer in the US is $2.9 billion with a five-year survival rate <20%

@Bradbury picked it a CR leaving out retail holders. Good that funds have been raised to cover planned activities will most likely hold the SP down until significant revenue arrives.

Proteomics International Laboratories Ltd (Proteomics International; ASX: PIQ), a pioneer in predictive diagnostics, is pleased to advise that it has received firm commitments for a share placement to raise $8 million (before costs) through the issue of 9.41 million shares in the Company (the “Placement”).

The Placement was at an issue price of $0.85 per share, a discount of 11.1% to the 5 day VWAP and was heavily oversubscribed, supported by Australian-based institutions, and sophisticated and professional investors.

Funds from the Placement (after costs) will be used for:

Inventory build for the PromarkerD predictive test for diabetic kidney disease

Implement US sales and marketing for PromarkerD

Development of the PromarkerTM diagnostics pipeline

General working capital

“Proteomics International has reached a major inflexion point in its corporate development - substantial capital injection ensures our currently planned activities in these areas are fully funded, and I take this opportunity to thank existing shareholders for their continued support and to welcome new investors to the Proteomics International register.”

The shares under the Placement are expected to be issued on or around 22 August 2022 pursuant to the Company’s 15% placement capacity under Listing Rule 7.1. Tranche 1 of the Placement ($7.75m) is expected to settle on or around 19 August and, subject to shareholder approval, Proteomics International Directors Neville Gardiner, Paul House and Roger Moore will participate in Tranche 2 of the Placement (total $0.25m).

 PIQ has had a stream of announcements recently, Endometriosis validation study results, published journal articles and now followed by a “Letter of Intent” for exclusive licencing of PromarkerD in the US with Sonic Healthcare.

All are good news on face value, however don’t provide any significant near term changes to short term business operations which resolve the cash balance issues.

• Agreement to be finalised by 31-12-22 after 15 months in progress.
• Progress milestones within the next 5 months:
• Optimising test for high throughput labs
• Preparing for PLA reimbursement code submission (Initially announced in May-21)
• Forecasting US sales targets 

The agreement with Sonic Healthcare does represent progress and it will be interesting to see what initial sales targets are released noting these will all need to be through the laboratory developed test as an FDA submission appears to have faded into the background in the "Share Price Catalysts" section of the investor presentations.

Investor Presentation April 22

Investor Presentation July 22

Given the company's precarious cash position, I think the timing of this announcement along with the milestone approach will be a setup for an upcoming capital raise in the near term, particularly if they can conjure up some meaty looking sales targets.

Exclusive licence with Sonic Healthcare for USA market to be finalised by end of CY. Has taken 15 months and another 2-5 months for revenue. No detail on financials just "industry-standard terms for payment for PromarkerD test reagents and describes the royalty terms on commercial sales of the test. The LOI is also subject to standard terms and conditions " Market received positively up 10% at time of writing but still down on highs.

PIQ is pleased to announce it has signed a binding and exclusive letter of intent (LOI) with Sonic Healthcare USA, Inc. (a division of Sonic Healthcare Limited; ASX: SHL) regarding entering into an exclusive licence for use of the Company's PromarkerD test for diabetic kidney disease in the United States.

The binding and exclusive LOI documents the preliminary terms and expectations for how Proteomics International and Sonic Healthcare USA will work together to bring the PromarkerD test to patients in the US (excluding Puerto Rico), and for finalising an Exclusive Licence Agreement by 31 December 2022 (which may be extended), subject to the parties formalising milestone events and timelines in relation to the commercialisation process.

Key milestones under the LOI include optimising the test for a high-throughput environment within Sonic Reference Laboratories to enable commercial sale of PromarkerD, preparing for a submission to secure a Proprietary Laboratory Analysis (PLA) reimbursement code for the PromarkerD test [ASX: 28 October 2021], and forecasting sales targets for PromarkerD in the US marketplace.

The Company anticipates each of these milestones to be completed within the next 2-5 months. The LOI also provides industry-standard terms for payment for PromarkerD test reagents and describes the royalty terms on commercial sales of the test. The LOI is also subject to standard terms and conditions (including confidentiality) and warranties typical for a document of its type.

Proteomics International Managing Director Dr Richard Lipscombe said this was a pivotal point in the global roll-out of PromarkerD. “The US is the world's premier healthcare market and we are delighted to be working with Sonic Healthcare USA, one of the world's leading diagnostic companies. It is rewarding for us to see their appreciation for what PromarkerD can offer diabetes patients. We have been working with Sonic Healthcare USA towards this goal for fifteen months, and now look forward to building upon this foundation and taking our world first predictive test for diabetic kidney disease into not only the US, but also Europe where the test already has regulatory approval.”

US Laboratory Developed Test (LDT) & Proprietary Laboratory Analyses (PLA) Reimbursement Code The PromarkerD test will be launched in the US via the LDT pathway using Sonic Healthcare USA's CLIA certified clinical laboratories. The Company will also seek a unique code for PromarkerD once the test is available in the US. New reimbursement codes are approved quarterly by the American Medical Association (AMA) and its Current Procedural Terminology (CPT) Editorial Panel, and follow assessment of the economic health benefit and clinical utility of a new test. A CPT Proprietary Laboratory Analyses (PLA) code uniquely identifies a test for the laboratory and the payors. 

Clinical Utility Study demonstrates PromarkerD test offers improved treatment options for doctors in the fight against diabetic kidney disease

Well covered by @laoshi regarding the endo update yesterday but interesting media release today regarding PLOS ONE.

 Results published today in the peer-reviewed journal PLOS ONE show the PromarkerD test ranked as more important to physicians than current standard-of-care tests

 78% of doctors were very or extremely likely to use PromarkerD in the future for the management of their diabetes patients

 The Clinical Utility Study shows the PromarkerD predictive test for diabetic kidney disease could significantly change doctors’ treatment decisions and improve outcomes for patients

 The published clinical utility study will form a key element of the dossier supporting a United States PLA code reimbursement application for PromarkerD

MEDIA RELEASE

PLOS ONE Conclusion

PromarkerD could increase adoption of renoprotective interventions in patients at high risk for renal decline and lower the likelihood of aggressive treatment in those at low risk. Further studies are needed to assess patient outcomes with PromarkerD in real-world practice

PLOS ONE

Positive initial results for endometriosis test. Early days and more R&D needed but aiming to solve a significant need.

The proprietary biomarker discovery platform called Promarker, searches for protein ‘fingerprints’ in a sample.The technology is so versatile it can be used to identify fingerprints from any biological source, from wheat seeds to human serum. Other tests in development include for asthma & COPD, oesophageal cancer, diabetic retinopathy and oxidative stress.

Early version of potential world first non-invasive test for endometriosis correctly identified up to 78 in 100 people with the disease

Company to take a series of steps to further refine and validate the diagnostic results to enable the commercial and clinical development of the potential breakthrough test

“It is exciting to have a simple blood test that may be able to correctly diagnose endometriosis in 70- 80 per cent of cases. At the same time, we’re optimistic we can refine the test to further improve the sensitivity and specificity, and make it more accurate for patients.”

“Until now, the standard of care to test for endometriosis has been through an invasive surgical procedure,” he said. “The results are highly encouraging and a significant start in the development of a potential world first simple blood test, that could diagnose this disease earlier and without an invasive surgery”.

A series of diagnostic models were developed for diagnosing endometriosis, including a comparison to symptomatic controls without endometriosis as well as differentiating disease severity. These novel diagnostic tools demonstrated that the biomarkers added statistically significant (P<0.05) performance to the models, with performance for sensitivity (Sn) of 65-78% across selected categories, with specificity (Sp) of 68-86%, and Area Under the Curve (AUC) scores of 0.72 - 0.89.

Dr Lipscombe said the next steps are to:

further develop the statistical modelling to improve the tests sensitivity and specificity.

repeat the laboratory analysis to confirm and enhance the accuracy of the biomarker measurements. This process has already commenced, including the use of more sensitive analytical instruments;

explore the clinical classifications of endometriosis, which is a highly complex condition, consequently diagnostics tests that selectively target sub-categories of the disease may be more accurate and provide greater clinical utility;

to confirm the clinical performance of the test in an independent patient cohort

The Company anticipates that this additional analysis will be completed in stages over the next 2-6 months. If successful, the outcome would be a clinically validated blood test(s) able to offer simpler and earlier diagnosis of endometriosis or the disease's sub-categories. Proteomics International believes a validated test will garner significant interest, both commercially and in the clinic.

The Good

• “US licensing negotiations advance towards execution”. This statement sounds positive, but not alot can be taken from it yet. Is this though the laboratory developed test pathway that the company was targeting for some early sales or is it for the full Immunoassay Kit? I will take the optimistic view in this instance. The other potentially positive takeaway is discussions are occurring for distribution agreements across other European regions.

The Not So Good

• Once again still not Promarker D sales and now the distribution agreement in Italy has been terminated. Likely due to the fact that sales were not achieved by Medical Horizons. Management state that they have implemented new assessment systems for potential distribution partners, but the learning cost them a significant amount of time in a market that was available for sales. It is stated that the company is already in discussions with several new distribution partners for Italy, but I would guess that sales in this region will now be unlikely until CY23.
• Delays to R&D pipeline. For PIQ to maintain growth over the medium to long term, it will need an ongoing suite of test kits. Delays to the early stages can blow out further down the line. Management have said that these are now resolved and further updates are expected.
• $1m cash burn for operational activities, with only $2.1m in cash left. Things are starting to look pretty tight for PIQ, they are expecting an R&D rebate in the next 6 months, but it will be cutting it fine as they only have about 6 months worth of runway and no significant changes to revenue in the short term. I think there will be a capital raise coming in the near future, potentially off the back of a distribution agreement announcement.

What To Watch

• Endometriosis clinical study results to be presented at the Fertility Society of Australia conference over the upcoming weekend. PIQ is still using positive language around the potential of the tests, so potential further developments may be announced following the conference
• Progress of the Oesophageal Cancer test development. 
• FDA submission not completed in FY22 as per previous targets, with little reference in this report it is unlikely to be happening in the near future.

4C slight decline in revenue, acknowledging anylytical services and tax rebates are currently only income, delays to projects. Language suggests Promarker revenue still a way off. Tax rebate in H1 FY23 might avoid a raise if revenue increases but likely to have to raise in Q4 FY22?

Promarker pipeline update

Whilst significant advances in the Promarker diagnostics pipeline were achieved several projects have been delayed or are on-hold. This reflects instrument capacity constraints, in part caused by maintenance issues arising from border closures, and has also meant some datasets have not achieved levels of sensitivity that the Company desires for its development of novel diagnostics tests.

Proteomics International has instigated a number of initiatives to overcome these obstacles, which will yield improved results going forward, and looks forward to providing updates on the outcomes of these steps in due course.

Proteomics International's business model is to continue the commercialisation of PromarkerD whilst using its Promarker technology platform to create a pipeline of novel diagnostic tests, and offset the cash burn from R&D and product development through its analytical services revenue, coupled with the R&D tax incentive rebate.

Revenue & Expenditure

Proteomics International achieved receipts from customers for the June quarter of $292,000 (March quarter: $335,000) and an additional $340,000 in grants. Receipts continue to be driven by revenue from analytical services. In particular, the Company has observed a significant increase in demand for its pharmacokinetic testing services , and renewed interest in biosimilars testing.

The net operating cash outflow for the June quarter was $1.04 million (March quarter: $1.28 million).

Expenditure centred on the following areas: • Business development and commercialisation costs for the roll-out of PromarkerD Manufacturing costs for the PromarkerD immunoassay

Regulatory and reimbursement activities to support PromarkerD commercialisation

R&D for projects in the Promarker diagnostics pipeline

Cash position At 30 June 2022 the Company had cash reserves of $2.1 million (March $3.3 million). These reserves will be strengthened by a forecast R&D tax incentive rebate of circa $1.5 million to be received in the 1H FY23. The Company is confident that its diversified business model places it in a sound financial position to fund its current objectives.

PIQ data supports expanding testing of Endometriosis biomarkers.

Dr Lipscombe said, “The statistical modelling and subsequent independent study will prove if we have a viable, novel, non-invasive test for endometriosis, and we believe this program will garner significant interest, both commercially and in the clinic”. Proteomics International has already developed PromarkerD, the world’s first predictive diagnostic test for DKD. The Company's PromarkerTM pipeline contains further research programs targeting asthma and COPD, oesophageal cancer and more.

Promarker pipeline - Endometriosis update Diagnostic readout positive: Study expanded

Panel of statistically significant biomarkers for endometriosis clinically validated using samples from 857 patients

Research could lead to the world’s first non-invasive test for endometriosis

Study in collaboration with the Royal Women’s Hospital and University of Melbourne will now be expanded to include St John of God Health Care

Results will be presented at the Fertility Society of Australia and New Zealand Annual Conference (FSANZ 2022), being held 30 July - 2 August 2022

The next phase of analysis will use the validated biomarkers to build a diagnostic model, as was performed for PromarkerD, the Company's novel diagnostic test for diabetic kidney disease (DKD). This process of statistical modelling will determine the accuracy (sensitivity and specificity) of the new test and will take approximately one month. These results will also be presented at FSANZ 2022. The Company will then seek to confirm the clinical performance of the new test in an independent patient cohort. To support this independent validation, Proteomics International also announces an additional collaboration with St John of God Health Care. The Company has signed a material transfer agreement to access approximately 250 clinical samples from the St John of God Subiaco Hospital Gynaecological Cancer Research Group that were obtained from patients with either clinicallyconfirmed endometriosis or other benign (non-cancerous) conditions. Proteomics International managing director

Dr Richard Lipscombe said, “We are excited to have passed this significant milestone on our way to developing what we hope will be the world’s first noninvasive test for endometriosis. The clinical validation results are the foundation for turning the biomarkers into a new diagnostic test for endometriosis, and then the new collaboration with St John of God Health Care enables us to take another critical step in the commercialisation path by confirming the performance of our novel test in an external patient group.” In interpreting these initial results, it is important to recognise that endometriosis is a highly complex condition with a broad spectrum of clinical indications. Consequently, endometriosis is not necessarily a simple positive versus negative test, and further work may be required to detect these subtle variations.

PIQ secures license for oesophageal cancer markers.

PIQ oesophageal cancer license.pdf.

This one is particularly important to me as I have a brother who died of Oesophageal cancer and hence I need to get screened regularly for Barrett’s disease as it has a hereditary component.

I really appreciate how PIQ is being proactive in looking for markers for diseases, hopefully giving the sufferers time to prevent them. That is SO much better than the usual reactive responses of the medical community.

i.e. Having a predisposition to oesophageal cancer means you can change your diet and eating habits to reduce reflux and hence prolong your period of good health.

PIQ slowly moving towards scale manufacturing and sales

PromarkerD manufacturing tech-transfer completed - Successful production of components for over 50,000 tests

Pilot batch is a significant milestone in transfer of technology needed for large-scale global distribution

Increased production capacity will allow Proteomics International to meet anticipated demand for PromarkerD in the Northern Hemisphere

PIQ has finally submitted PromarkerD registration to TGA. With a guidance of 6-9 month review period provided, approval is not likely to happen until Q4FY23. As this is still a fair way off, I hope the company is not relying on TGA approval for too many other jurisdiction applications.

Announcement

The Good

• Medibank rebate review process underway with a decision expected in November.
• UK MHRA Registration achieved. Can now progress towards adoption of testing in UK health service.

The Not So Good

• Still not Promarker D sales.
• FDA submission on hold until ISO 13485 manufacturing and validation completed
• Second stage of TGA assessment being prepared, which puts approval likely into CY23. This has been ongoing for sometime, however, post the quarterly update PIQ was awarded a $400k grant for Australian manufacturing which the company has earmarked to assist with funding for TGA approval. PIQ is trying to use the TGA approval as a method of expediting approval in other jurisdictions.
• Ongoing cash burn over $1m per quarter with currently around $3.3m in cash. PIQ expect a R&D tax incentive of ~$1.5m in Q2FY23, however a capital raise may not be too far away.

What To Watch

• Endometriosis clinical study results scheduled to be released in Q2CY22. (1 month left)
• Next steps for asthma and oesophageal cancer tests.
• Progress of transfer of manufacturing to Biotem as several key milestones such as product registration in Israel, are pending completion of this.
• First sales in Italy? No recent updates. All reporting targets were H1CY22, however this slide from recent presentation pushes out into H2CY22. It’s been pretty quiet for PIQ and my previous deadline for sales by the end of FY22 is fast approaching.

Positive Government support for Australian manufacturing. SP still dropped 5% today!

Proteomics International will receive $413,516 funding to support manufacture of the PromarkerD test for diabetic kidney disease and other diagnostic tests in Australia

Funding awarded by MTPConnect as part of the Australian Government's $45 million BioMedTech Horizons program, a Medical Research Future Fund (MRFF) initiative

Funding will be used to establish local manufacturing supply chains, quality assurance procedures and support the PromarkerD application for TGA approval

It will support future manufacture of the PromarkerD test for Australia and South-East Asia by building upon Proteomics International's specialised ISO 13485 Quality Control and Quality Assurance certification. We see enormous sales potential in this region once we complete local regulatory and reimbursement approvals.

Impressive panel for a new Clinical Advisory Board to support PromarkerD global rollout. Hopefully the Italian board member helps with the delayed European rollout. Latest Investor presentation

Proteomics International establishes world class Clinical Advisory Board

Comprises highly-respected physicians specialising in diabetes and kidney disease care from the United States, Europe and Australia

New advisory board offers doctors’ viewpoint in commercialisation of the PromarkerD blood test for the prediction of diabetic kidney disease

Doctors will ultimately order PromarkerD for diabetes patients with the advisory board able to provide specific and tailored advice from the voice of the customer perspective

Proteomics International seeks FDA approval for PromarkerD

~ Pre-submission package for diabetic kidney disease (DKD) test lodged with the US Food and Drug Administration (FDA)

~ Proteomics International expected to meet with the FDA to progress clearance within 10 weeks

~ FDA pre-submission follows CE Mark regulatory approval for PromarkerD in Europe

~Globally there are 463 million adults living with diabetes, including 31 million in the US

~ The Covid-19 pandemic has increased public awareness of the importance of diagnostic testing but caused a backlog in diagnostic services for other serious illnesses such as DKD - an issue that healthcare systems and diagnostic companies are now looking to address