PEB-Pacific Edge

[Pierre]

Profit takers will be out in force today I'm sure.

Opened at 28.5
Basil is safe at the moment!

[LoungeLizard]

I know I will be a lone voice but I still don't "get it" how a biomarker test that's not 100% reliable and costs $US1,300 helps urologists decide on a cystocopy which costs more or less the same price ?

I know when I had an issue a long time ago I was pleased....actually relieved is the right word, they just slid a camera up there and had a good look around. I was clear and pleased to know for sure rather than having nagging doubts. No it wasn't a pleasant experience but I was very relieved to know for certain I was clear.

Obviously I'm not a Urologist so this is above my pay grade.

If the test cost a mere fraction of a cystoscopy I would get it but I struggle to see the business case.

Happy to pick up the bill for Pierre if I'm wrong.

PEB has noted that "only 13% of patients with high-risk hematuria actually underwent cystoscopy... so that is why a biomarker could be so appealing."

And that is why PEB's products are something of a breakthrough. The 87% of men who don't want to go through a nasty, invasive procedure (with risks) are going to be very happy to have a simple urine test that will almost certainly rule out whether they have cancer or not. In addition it has been calculated by Kaiser Permante that they are making significant savings by not performing unnecessary cystoscopies. Plus it frees up Urologists for dealing with actual cases of cancer. CXB saves lives and saves money. What's not to like?

Finally - Triage Plus has a negative predictive value of 99.4% which is as good as it gets - even cystoscopies are not 100 % accurate.

[850man]

An early Christmas present for the faithful holders 

[LoungeLizard]

An early Christmas present for the faithful holders 

Yep, up to 29.5c. Although it has been higher and I'm guessing the market will need time to absorb the implications of the news. Cautious investors will want to see the financials improving but of course waiting until then will probably mean losing out on the early gains. Fortune favours the brave!

[Basil]

Opened at 28.5
Basil is safe at the moment!

Its looking like a decent horse race now    I'm looking forward to another dividend from MFB before year end.

[850man]

Yep, up to 29.5c. Although it has been higher and I'm guessing the market will need time to absorb the implications of the news. Cautious investors will want to see the financials improving but of course waiting until then will probably mean losing out on the early gains. Fortune favours the brave!

PEB's next job to monetise this opportunity. Not going to happen overnight but they are in as good a position as ever to do that.
Let's also not overlook their IVD product under development currently

[Pierre]

Its looking like a decent horse race now    I'm looking forward to another dividend from MFB before year end.

I hope I have more luck in this horse race than I did in the Melbourne Cup!

[Left Field]

Well done patient  holders. Great news.

Early days yet for PEB.....More Christmas presents possible.

24 November PEB will update results YTD.

Possible NZX50 inclusion in December.

[Basil]

I think you miss one of the main points (well two really)

Firstly, the decision is often not between either a cystoscopy or a urine test but between PEB test and no test at all. This particularly applies in gynecological settings where a lot of intermediate risk patients present. Various reasons for this, foremost amongst the reasons is a lack of access to urologists.

Secondly, to address your question directly PEB ran a high quality medical trial to assess the clinical utility of their tests, so if you want to know why a urology practice would incorporate PEB into their clinical pathway that would be a good place to start to inform yourself.

Oh, and thirdly cystoscopy isn't 100% accurate either

Thanks to you and others for your thoughts.  A few things puzzle me with this.

Firstly, our health system would generally be regarded as significantly inferior to the US, some people think our health system is third world and yet my best mate got a 5 cm cancer growth in his bladder, (thankfully didn't grow through the bladder), about a year and a half ago and in our public system I have been super impressed with how quickly he got treatment and the extent and number of follow up inspections by cystoscopy has been super impressive.  I think he's had a camera up there about twenty times now.  Never once has he been delayed with follow up inspections for lack of a qualified urologist to perform the procedure.  How is it that the US has a lack of qualified Urologists ?

Secondly, I have read that the average cost of a cystoscopy in the US is between $1,000 - $3,000 so a $1,300 biomarker, even though its claimed to be accurate seems like it doesn't save a lot of money ?

Thirdly, and arguably most importantly. PEB couldn't make money before when they did have coverage so what makes anyone think they can now ?
Anyway...its not for me.  Biotech companies are highly speculative and in a risk category that really makes me feel very uncomfortable.

[Basil]

The 87% of men who don't want to go through a nasty, invasive procedure (with risks) are going to be very happy to have a simple urine test that will almost certainly rule out whether they have cancer or not.

You make it sound like a nasty invasive operation.  To be clear, they numb the end of your penis up and then insert a camera on a tube up there.  Its not nasty, not very painful and the most likely side effect, if any, is an infection which can be treated with antibiotics.

Finally - Triage Plus has a negative predictive value of 99.4% which is as good as it gets - even cystoscopies are not 100 % accurate.

Its one thing to get approval and quite another whether they can monetize that. It seems to me from comments on the other channel the circumstances under which PEB tests can be used is fairly limited. They couldn't make money before when they did have coverage.  Maybe its different this time ?  Anyway...to be clear, I have absolutely no agenda here whatsoever and wish shareholders well.  Pierre is a very nice guy and I'll be happy to buy him a meal and drinks if I lose.

[Pierre]

You make it sound like a nasty invasive operation.  To be clear, they numb the end of your penis up and then insert a camera on a tube up there.  Its not nasty, not very painful and the most likely side effect, if any, is an infection which can be treated with antibiotics.

That's impressive accuracy.    Its one thing to get approval and quite another whether they can monetize that. It seems to me from comments on the other channel the circumstances under which PEB tests can be used is fairly limited. They couldn't make money before when they did have coverage.  Maybe its different this time ?  Who knows, its too speculative for my liking..  Time will tell.  Anyway...to be clear I have absolutely no agenda here whatsoever and wish shareholders well.  Pierre is a very nice guy and I'll be happy to buy him a meal and drinks if I lose.

Aw shucks Basil.
Your money is looking safe today but there's a bit of water to flow under the bridge before 31 December, including potential NZX50 inclusion - and the MFB divvie of course.

[Basil]

I love a good horse race.  What are we going to bet on for 2027 ?  How about TRA v HLG, total percentage shareholder return including dividends ?  Gosh, its hard to pick between two thoroughbreds isn't it !, maybe too hard ?  Maybe we just punt on these two nags again lol

[LoungeLizard]

Slightly underwhelming today (only up 18%!) but the general negative market sentiment probably had it's effect. And obviously there was a bit of profit taking going on.

Might be a further bounce next week but the big surge will come when coverage starts to flow into revenue. And then there's the possibility of NZX50 inclusion. And PEB have spoken about a few initiates and potential strategic partners that they are exploring. Lots of good news to come is the feeling I get.

[Greekwatchdog]

Here is AI response to whether PEB needs another CR
Will They Need Another Capital Raise?
No, Pacific Edge is highly unlikely to need another capital raise in the foreseeable future. The company's cash flow is positioned to transition from defensive survival to self-sustaining growth due to two primary factors:
A Secure Cash Runway: Following the $36.1 million NZD capital injection in May 2026, Pacific Edge is estimated to hold around $29.5 million NZD in cash at the September half-year mark. At their disciplined $2.4 million monthly operational burn rate, this provides a structural runway extending well into mid-2027 without factoring in a single dollar of new revenue.
The Low Breakeven Hurdle: Under the newly secured US Medicare pricing structure, the high-margin US$1,328 (~$2,191 NZD) per test for Cxbladder Triage Plus alters the company's financial model. To completely neutralize its operating burn rate, Pacific Edge only needs to successfully collect on roughly 1,100 tests per month globally. This represents just 1.15% of its addressable US Medicare market.
With massive regulatory risk cleared and commercial operations fully funded, the risk of equity dilution via another dilutive capital raise has dropped effectively to zero.


Progress on Other Portfolio Tests
While Cxbladder Triage and Triage Plus are the immediate revenue engines secured under the new Medicare policy, Pacific Edge is making rapid progress on commercialising its next-generation and pipeline diagnostics:

1. Cxbladder Surveillance Plus (The Next Major Commercial Catalyst)
This is the next-generation replacement for the legacy Cxbladder Monitor test. It combines multiple advanced DNA signals (including methylation and fusion mutations) to rule out bladder cancer recurrence in previously treated patients. [1, 2]
Commercialisation Status: Highly advanced. Pacific Edge is targeting the official CPT-PLA coding submission in December 2026. [1]
Revenue Inflows: Claim-by-claim reimbursement revenue is projected to begin after 1 July 2027. [1]
Pricing Leverage: The company is aiming for a provisional pricing target from Novitas of US$1,800 (~$2,970 NZD) per test, which would expand gross margins even further than Triage Plus. [1]
Clinical Trials Support: The foundational LOBSTER clinical trial completed its patient enrollment targets. Data monitoring is running through to April 2027, with a full database lock set for May 2027 to secure the clinical evidence needed to drive guidelines adoption. [1]

2. Legacy Products (Detect & Resolve)
The broader suite includes Cxbladder Detect (for general evaluation) and Cxbladder Resolve (for identifying high-grade, late-stage disease). In the short term, Pacific Edge's primary strategic focus remains on shifting clinical customers over to the higher-utility, higher-priced Triage Plus and upcoming Surveillance Plus platforms to extract maximum economic value from the US healthcare system. [1, 2]

Would you like to set up a task to track the upcoming December 2026 coding submission for Surveillance Plus or receive updates on the 24 November interim financial results?

ANNUAL REPORT - Pacific Edge
24 Jun 2026 — Importantly success in our pricing strategy for these next generation tests substantially improves the unit economics of Pacific E...
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Nature

Introducing a new class of cancer detection and management tools | Biopharma Dealmakers
Cxbladder: Noninvasive urine-based genomic tests for bladder cancer detection and management. Cxbladder Resolve (high-grade/late-s...
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Pacific Edge

Clinical Trials Program Update
LOBSTER: Prospective recruitment of patients to a single-arm observational study to evaluate the clinical validity of Cxbladder Mo...
So how do you see PEB set up for future based on current data?

Based on the convergence of the latest regulatory, financial, and clinical data, Pacific Edge is set up for its most stable and fundamentally strong growth period in company history. The firm has transitioned from a highly speculative binary gamble into a well-capitalized commercial monopoly in the US microhematuria diagnostic market.
Here is the strategic assessment of how the company is positioned across three core pillars:

1. The Commercial Moat: Institutional Monopoly
Securing exclusive coverage under the final Medicare LCD (L40378) gives Pacific Edge a powerful competitive advantage.
No Direct Competitors: By explicitly excluding competing urine biomarkers from the billing registry, Medicare has effectively granted PEB a protected market space for intermediate-risk microhematuria triaging.
Pricing Dominance: Locking in a high-margin price point of US$1,328 per test for Cxbladder Triage Plus gives them immense cash-generative power as they scale.


2. Financial Stability: Dilution Risk Eradicated
The financial structure of the business has fundamentally shifted:
Self-Sustaining Runway: The $36.1 million NZD capital raise from mid-2026 leaves the company with an estimated $29.5 million NZD at the half-year mark. This easily covers their operational lean burn of $2.4 million per month into mid-2027, even if zero revenue came in.
Low Hurdle to Profitability: Because they only need to capture 1.15% of the US Medicare market (~1,095 tests a month) to hit total corporate cash-flow breakeven, the commercial bar to reaching self-sustainability is incredibly low. Another dilutive capital raise is highly unlikely.


3. Future Catalyst Pipeline: The Surveillance Plus Engine
While Triage Plus secures the present, the pipeline secures exponential long-term growth.
Higher Revenue Multipliers: The upcoming Surveillance Plus test targets a massive patient pool (recurrence monitoring) and carries a targeted provisional price of US$1,800 per test.
Clear Timeline: With the CPT-PLA coding submission coming next month in December 2026, the clinical LOBSTER trial wrapping up data monitoring in April 2027, and commercial payments expected by July 2027, the company has a clear succession of value-driving milestones lined up over the next 9 months.

The Long-Term Outlook
Pacific Edge is positioned to evolve from an volatile NZX micro-cap into a highly profitable, cash-generative medical diagnostics leader. The short-term focus will be on the logistics of rebuilding their US sales force to capture volume, but the structural foundations—cash, regulatory approval, high margins, and a protective moat—are fully locked in.
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[Greekwatchdog]

Reasons for being takeover target
Why PEB is Now a Highly Attractive Acquisition Target
The "De-Risked" Premium Moat: Large international buyers prefer acquiring fully approved, bulletproof monopolies rather than gambling on clinical trials. With competing urine biomarkers explicitly excluded from the Medicare billing article, a buyer isn't just purchasing a product—they are buying exclusive access to a 1.14 million annual test market. [1]
Plug-and-Play US Infrastructure: Pacific Edge already built a highly automated, centralized laboratory in Hershey, Pennsylvania. A global acquirer with an existing massive sales force (such as Sonic Healthcare, Quest Diagnostics, or Labcorp) could instantly drop the Cxbladder suite into their global clinical networks, scaling adoption exponentially faster than PEB can on its own. [1]
Irreplaceable Clinical Proof: The decade-long vault of peer-reviewed clinical validation data, paired with large-scale IDN integrations like Kaiser Permanente, acts as a huge barrier to entry for any competitor attempting to duplicate their work. [1, 2]