Pacific Edge CEO speaks with Proactive at the ASX SMIDcaps Conference

With me now live from the ASX small midcap conference is Pacific Edge CEO Dr. Peter Meches.

Pacific Edge is a global cancer diagnostics company leading the way in the development and commercialization of bladder cancer diagnostic and prognostic tests.

Peter, nice to meet you.

Uh great to be here, uh Lauren.

Now, firstly, can you tell us more about the business and the company's suite of non-invasive tests?

Yeah, absolutely. Uh Pacific Age is headquartered in Deneden in New Zealand. Um we have a clinical laboratory there that processes the tests for New Zealand, Australia and the Asia-Pacific region. Um and we also have a laboratory based in Hershey Pennsylvania, which processes all of the samples for our US business.

We have uh we have two primary products, two value propositions, two indications. Uh one for patients who have blood in the urine, and that's as a primary diagnostic tool. So patients with blood in the urine um are heuria patients. And if you go and see a physician with hematuria, the uh not the most common symptom, sorry, not the most common um cause of it is bladder cancer, but the most deadly uh one is bladder cancer. So physicians are most worried about

bladder cancer in those heuria patients. And our test Triage Plus can rule out the the presence of bladder cancer with 99.4% negative predictive value. So extremely high confidence that a patient doesn't have bladder cancer.

Uh we also have a product called Surveillance Plus. That is for patients who previously had cancer and have had the tumor removed and then they need to be on an a surveillance protocol for as as as frequently as every three months. And the current standard of care whether it is primary diagnosis or whether it is surveillance is a is a cystoscopy. and a cystoscopy is an invasive procedure. It is putting a camera up the urethra to go and have a look around at the inside of the bladder wall to see whether there is any red inflammation, possible tumors. And so our non-invasive alternative uh is in the surveillance setting is surveillance plus.

And uh that allowed allowed patients to undergo fewer of those invasive procedures.

Novitus issued positive draft coverage for triage and triage plus in May with a final decision expected by early 2027. How significant would that be for Pacific Edge?

Yeah, so so firstly it it will be tremendously significant. It is um it is Medicare is the largest single payer that we can go after. Um they set the benchmark for all of the subsequent commercial payer policy in the United States. So it will be tremendously valuable to get that coverage. And we are also targeting through our comments though, it it depends how they write that policy. Now they have obviously given an indication in the draft of how they wanted to write that policy, but we've had the opportunity to comment on that. And right now, the policy only um because of its focus on intermediate risk patients,

only women who are Medicare aged are eligible for reimbursement. And that's something that uh that that we understand Medicare would prefer uh to not make a policy that only that makes it only available to women and they want to make it available to men. So there is and we have made that point to them through our comments and we are modestly optimistic um that we could see greater inclusion language when the policy finalizes and that would be the bigger win than the policy finalizing itself

is to have expanded language for more indication.

Now, revenue fell in the FY 26, while you completed a $36.1 million capital raise to strengthen the balance sheet. How will funds be deployed?

Uh we we maintain an aggressive program to ensure that we have gold standard clinical evidence uh supporting our tests. This has allowed us to successfully come out the other side of the Medicare coverage process with that draft coverage. So we focus relentlessly on generating analytical validation, clinical validation, clinical utility data, also real world evidence data, not just randomized control trials and budget impact models. And so all of those things

are a meaningful cost within our cost base. But what's different now that we have draft coverage is that we can more aggressively uh start to look at how we invest in our commercial team. And our commercial team is focused on two objectives. One, selling uh triage Plus for the decision to refer between primary care and secondary care uh to integrated delivery networks. And those capitated systems make decisions similar to how we've sold in Kaiser Permanente today and in how we've sold in New Zealand and Australia today. So we're quite seasoned at that process. And the other side of it is private practice where we are focused on female specific call points and uh and call points other than the urologist. So for example,

advanced practice providers, nurses and uh and physician assistants as well as the the urologists and and urogynecologists.

With Triage Plus priced at $1,328 per test and a global market opportunity you size at 10.6 billion. What's the investment case for Pacific Edge for new investors?

Yeah, so we, uh, we welcome uh new investors who have uh joined us at the who want to join us at this particular moment. we're at the uh at the most important strategic milestone prior to commercial um expansion. And so exactly as you point out, the price of $1,328 per test provides us with the kind of operating leverage that our prior price for earlier generation products of 760 didn't offer us. And so as we have a confirmed indication from the guidelines and a confirmed indication with Medicare coverage and and can increasingly add commercial insurance companies to to the list of who cover our test, that price point and the operating leverage that that brings to our commercial team makes Pacific a compelling case. And while we don't disclose specifics about our gross margins, um we do expect to execute in the market with gross margins similar to to other companies that have been successful in adjacent cancers with similar tests.

Peter, thank you for the update.

You're very welcome, Lauren. Have a great rest of your afternoon.