PEB-Pacific Edge

[Shareguy]

Well the market does not like it. I can see a share consolidation followed by a cap raise. Even then it's going to be heavily discounted. Chances of getting coverage again are very very slim in my opinion.  What's left...

[Shareguy]

the go-forward plans may include the following:
 
    - Pursuing a preliminary injunction and legal challenge to the finalization of the LCD. Pacific Edge notes and recognizes the inherent uncertainty of success in these endeavors though we will enjoy spending your money instructing lawyers at the best Michelin starred American restaurants.
 
    - Further review the structure of our operations and our strategy to reduce cash burn in line with our plan to regain reliable Medicare coverage however the executive team is safe till the money runs out.
 
    - Submit to Novitas a Medicare coverage reconsideration request on the basis of the Journal of Urology's publication of the STRATA study and the updated Analytical Validation studies of Triage, Detect and Monitor. Take that you ignorant fockers.
 
    - Continue to explore other strategic alternatives for Pacific Edge that could support the company through to receivership.

Love it. Sales growth going no where in years despite this huge market and over $200m of investors money spent so far.

[LoungeLizard]

Pretty good conference call I thought. My positive interpretation is that some form of AUA guidance inclusion seems to expected, and that (and the clinical trial evidence that supports the inclusion) should form a strong basis to challenge the Novitas decision. Seems like the major investors are still supportive at this stage.

[LoungeLizard]

Well the market does not like it. I can see a share consolidation followed by a cap raise. Even then it's going to be heavily discounted. Chances of getting coverage again are very very slim in my opinion.  What's left...

PEB say that they have sufficient funds to see through the appeal/re-application process, so a cap raise before that is unlikely and unwise. Negative market reaction was, of course, expected.

[Pierre]

the go-forward plans may include the following:
 
    - Pursuing a preliminary injunction and legal challenge to the finalization of the LCD. Pacific Edge notes and recognizes the inherent uncertainty of success in these endeavors though we will enjoy spending your money instructing lawyers at the best Michelin starred American restaurants.
 
    - Further review the structure of our operations and our strategy to reduce cash burn in line with our plan to regain reliable Medicare coverage however the executive team is safe till the money runs out.
 
    - Submit to Novitas a Medicare coverage reconsideration request on the basis of the Journal of Urology's publication of the STRATA study and the updated Analytical Validation studies of Triage, Detect and Monitor. Take that you ignorant fockers.
 
    - Continue to explore other strategic alternatives for Pacific Edge that could support the company through to receivership.

Pity about the cynicism when we have a New Zealand based company trying to make it big on the international stage with a product designed to benefit bladder cancer sufferers.

Navigating the US Healthcare minefield is proving to be a hell of a task and probably much more difficult than anyone in this part of the world ever envisaged.

Sure, there's been lots of money invested and miss-steps along the way, but the journey is not over yet. The company still has cash in the bank and the prospect of inclusion in the AUA Standard of Care Guidelines.

I'm a long-term holder and PEB supporter with fingers crossed for a positive outcome for CMS coverage, if not now, then within the next 2-3 years.

[Basil]

I think anyone investing in PEB knows it is high risk / high return. Many investors have a few "fun" stocks their portfolio (gold mining anyone?) akin to spending $500 a year in lottery tickets or having a few days at the races.

I think that's widely understood by professional or experienced investors and in particular in other much deeper markets with a vast number of biotech stocks such as America where most are well aware its either hit or miss and far more likely to be a miss and lose all your money.  That said, I do wonder whether one particular broker of note that writes supportive research just before they cash in on millions of underwriting fees, on a regular repeating basis doesn't draw in a new bunch of vulnerable or gullible investors each time?  Some of these newer investors are gullible enough to treat analyst reports like they're the ten commandments chiseled in stone brought down from the mountain.

The best analogy I can think of after drinking a few bottles of cider on the weekend, on the side of the bottle there was a bold and prominent warning to pregnant women.  Words to the effect, to the best of my recollection, that said WARNING CONSUMPTION OF ALCOHOL BY PREGANT WONEN CAN CAUSE SERIOUS LIFE LONG IRREVERSIBLE DAMAGE TO YOUR BABY.

Maybe these repetitive capital raises should come with a mandatory warning like this.  WARNING, ITS A WELL KNOWN FACT THAT THE VERY BEST WAY TO MAKE A SMALL FORTUNE WITH BIOTECH COMPANIES IS TO START WITH A MUCH BIGGER ONE.

You can't really get higher risk than unconsented gold mining ventures or biotech companies...you and I and many other experienced investors know this and allocate a very small percentage of our portfolio accordingly, but other less experienced vulnerable investors, maybe are risking lifelong irreversible damage to their retirement plans with a much bigger portfolio allocation, some of which may have been selected for them by not so well meaning brokers with full discretionary management of some clients funds.

[winner (n)]

Pity about the cynicism when we have a New Zealand based company trying to make it big on the international stage with a product designed to benefit bladder cancer sufferers.

Navigating the US Healthcare minefield is proving to be a hell of a task and probably much more difficult than anyone in this part of the world ever envisaged.

Sure, there's been lots of money invested and miss-steps along the way, but the journey is not over yet. The company still has cash in the bank and the prospect of inclusion in the AUA Standard of Care Guidelines.

I'm a long-term holder and PEB supporter with fingers crossed for a positive outcome for CMS coverage, if not now, then within the next 2-3 years.

...and Bryan Williams is still a Director .....hanging in there and hoping for the best

[Pierre]

I see a Board and management that are at best permanently wearing rose tinted spectacles and at worst are economical with the truth.

Aroa looks a much better bet for making it big on the international stage to me.


 

Are you suggesting that a large number of experienced investors including those such as Tindall and ANZ have been sucked in by a bunch of liars?

[LoungeLizard]

I don't think anyone here would have invested in PEB not knowing the risks involved. And, given the risks, no-one is going to put their shirt on it. Buy a good chunk of shares for a few thousand dollars and see how it goes. And in the meantime support a NZ company producing an innovative, life saving product. We all do our own research and measure the risks and reward. Nothing naive or gullible about that.
I think PEB have got a strong chance of getting included in the new AUA guidelines, which would be a major breakthrough in itself, whilst also providing a firm basis for appeal of the Novitas decision. 

[winner (n)]

I wonder if PEB really has a future

[Greekwatchdog]

I wonder if PEB really has a future

Of course they have a future. Product works. It needs the AUA to get it in the guide lines.

[Greekwatchdog]

This out of the Herald this evening

At home, Pacific Edge fell 7.4c or 55.22% to 6c after telling the market that Medicare contractor Novitas finalised a non-coverage determination that would end reimbursement for its Cxbladder tests. If not challenged, the payments will finish on February 23.

Pacific Edge said Novitas continued to misunderstand the current standard of care in evaluating hematuria patients, and the important role biomarkers can play in stratifying patients with hematuria into those who would benefit from further potentially more invasive medical attention and those who would not.

The cancer diagnostic company said it would pursue a preliminary injunction and legal challenge, while further reviewing its operational structure and cash burn in line with the plan to regain reliable Medicare coverage.

Pacific Edge will submit a Medicare coverage reconsideration request to Novitas based on the Journal of Urology's publication of the Strata study and the updated Analytical Validation studies of Triage, Detect and Monitor.

Goodson said it was deeply frustrating for Pacific Edge, which has a product that appears to be a better widget but is having trouble commercialising it, and the clock is ticking on its cash reserves (of $28.5m).

"It has become even more important for the Cxbladder tests to be included in the American Urology Association standard of care guidelines which are due out any time now. If that happens, Pacific Edge will be well placed. It's not the end of the road for them," Goodson said.

[Greekwatchdog]

lol


Summary of substantial holding
Class of quoted voting products: Pacific Edge Limited Ordinary Shares (PEB)
Summary for Salt Funds Management Limited
For this disclosure,—
(a) total number held in class: 48,114,089
(b) total in class: 809,410,844
(c) total percentage held in class: 5.944%
For last disclosure,—
(a) total number held in class: 50,675,987
(b) total in class: 728,279,398
(c) total percentage held in class: 6.952%
Details of transactions and events giving rise to relevant event:
On 28 September Salt Funds Management took part PEBs institutional placement. This
amounted to 5,147,730 shares and a dollar value of $6,949,435.50. On 5 October Salt
Funds Management took part PEBs Share Purchase Plan. This amounted to 152,211 shares

These guys trade shares all the time, just like att the other firms. Thats all you have got? In 2.5 years since Novitas annouced that were cutting funding very few have sold. Good grief

[Basil]

Pity about the cynicism when we have a New Zealand based company trying to make it big on the international stage with a product designed to benefit bladder cancer sufferers.

Trust is destroyed when time after time after time they tell porkies that this capital raise will see us through to commercial success. You can only "cry wolf" so many times before people say, you're full of it. They can't even construct an NZX stock exchange release in proper English that's proofread before its released so why would you trust them to navigate all the intricate challenges involved with international certification? 

[Shareguy]

PEB is set to no longer receive reimbursement for its Cxbladder tests from CMS in the US from 23 February 2025. This represents ~60%–70% of its revenue. That's huge.

The upcoming American Urological Association (AUA) guidelines review. If positive, this will act as a key mechanism for PEB to lodge a coverage reconsideration request; if negative, the path forward looks challenged.

FB latest note not very positive and no longer offering a target price. I note that FB own a significant amount of shares on behalf of investors as at last annual report.

Craig's latest underperform (sell in my book) 5 cents.

Is it even worth 5 cents for "a punt" which is all it is. I don't think so. If I was interested I would wait for the upcoming review, if it's negative I reckon it's all over as far as a reversal of the Novitas decision.

A shame really. PEB harp on about how huge the market is in the world and US but it seems doctors are not really buying it. World sales are "corner dairy" stuff and the growth in the US was very small when you consider the market size.

Notice the ceo got $867 in cash remuneration and $22k in shares according to the 2024 annual report. In fact a pay rise from 2023 and was awarded 73 percent of his sti. All for a company that has a very low turn over and has lost over $240m of shareholders funds so far. I also note there are 25 employees earning over $300k. Maybe it's time to review this....

I just hope it survives and best of luck to holders