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JW tweeted that he had made money on POLX & SO4 responding on some other subject a year ago. I assumed then that he indeed had not had the stomach for binary decisions but had sold down a (big) proportion of his holding in POLX before the CRL while he was hyping the prospects to us all. He may have continued to hold a (small) proportion but he is not hyping it now because he has not bought back in a great extent as the outcome is unpredicatble and the market is less frothy so there is less to be made from talking it up before the decision (while selling down).

Besides, it does seem strange that the adjudication could have taken so long and led to the latest 3 month extension if it were plain sailing. Perhaps the FDA has been lobbyied against approval or really is there is a technical challenge. In either case, the need to raise capital post approval will tarnish the value of FDA approval more in this market than it would have 15 months ago so perhaps that is another reason for JW to be more on the sideline than he was.

They need someone to fight the claim like they want to actually press home a win.

They *****footed along hoping, like many dozey PIs, for an "easy & amicable" solution when the DHSC was being the exact opposite - breaching its undertakings, bullying & frustrating British diagnostics with red tape (what holding up approval of Winterplex by CTDA for a whole year achieved for public health?)

The board would have been better off asserting shareholder interests in the first place rather than treating investors as plebs & actually PIs would have been better off following the departure of IIs (even if PIs fought hard to quash open discussion on boards like this) .

Wait for someone more effective to take over!

Got the sack & thoroughly deserved the sack it

They have been rudderless since the dispute with DHSC started almost exactly 2 years ago. If you recall on 12 Nov 20 Mullis, McCarthy & Crinelli all invested ahead of the Promate launch announced 16 Nov & the DHSC suspended payments two weeks later. They were unable even to initiate legal action against the DHSC after the DHSC had taken their initiative. We had a long limbo, GM departure, limbo in DA finding his feet & another year of underdelivery.

Good bye DA, good bye camping casual cardigan, effective leadership was "not in your DNA" mate

Unfortunately, this leaves Gentle James in charge guided by big James Wakefield. & these guys were not able to activate sales with a super surplus of stock in a pandemic wave. At least Gentle James has bought into the business.

Hope so.

Cash now $26m ish? Q2 Rev 1.2m, loss (13m)? cash 31/12 $13m enough for another quarter and gambling on either FDA or MCIT replacement early 2023 to raise SP for their first $50m call (representing 19% dilution if SP was $3, 25% at $2, 30% at $1.50 or 40% at $1).

It did seem in answer to the questions that they could refer to Wake Atrium, Singing River and VA (1 center on stream, 1 giving task order, I a purchase order & another something close to a purchase order) so we, optimists, have ground to hope that growth will tip over & above 17%. How they can answer a question on who tests were placed by this quarter apart from Mt Sinai in the way they did seemed like a miracle in obscurity provided by that very stylised business speak they have devised for themselves.

The key numbers were not as clear to me from teh RNS as they might have been which perhaps is a bad sign in itself.

Can anyone help?

Cash
They admit to $41m being held in cash at 30 June but I could not find the Q1 23 balance at 30 Sep - what would it be fair to estimate is currently held?

This is my guess - 31 Mar $59m came down $18m in Q4 - so presumably a burn rate of c$12-15m plus one off cost incurred in reducing the cost base by the $12m pa. How do we get from $41m less say burn c$15m = $26m at 30 sep (or 2 quarters) to the Chairman & CEO’s joint statement :

"5. Continuing to lower net expense to maintain cash availability into the first half of fiscal 2024"

They are a year out aren’t they?

Test volume
Reevenue from testing reported as
Q1 $0.45 so say 473 tests at $950
Q2 $0.7 so say 736 tests
Q3 $0.8 so say 842 tests
Q4 $0.75* so say 789 test (*figure to agree with YE total $2.7m)

YE 22 $2.7m from testing (from Revenue section in Income statement) or about 2,842 tests with a further 1,200 tests in Q1 23 to 30 Sep (of which 80% billable) from Current quarter.

"Operational Progress
A full electronic health record (EHR) integrated deployment of KidneyIntelX with population health support in the Mount Sinai Health System has now yielded actionable reports on nearly 5,000 patients and growing"

Renalytix Reports Financial Results for Third Quarter of Fiscal Year 2022 reported on 30 June RNS
"·Continued KidneyIntelX testing volume growth

· Over 3,000 KidneyIntelX risk scores generated for Mount Sinai Health System patients and over 300 at Wake Forest Baptist Health"

Can anyone clarify the number of tests being made in Mt Sinai. Has it been a good or bad result? Has are orders better now? How are the numbers reported analysed? between those carried out for the Mt S utility study & those others perhaps in the utlity study but also with a report (billable/non-billable))?

FDA - how much evidence of "real world utility" will have accumulated to support the FDA application? Can we guess 5,000 tests in Mt S + 300 reported in June for Wake Forest + those out of the 2,800 reports billed in the year not in Mt Sinai or WF totals? They seem quite optimistic about progress toward approval, its hard to know why.

The RNS does talk about how long the cash will last. What are they waiting for before getting the business away from research driven calls on investors & into commerciality with, dare I say, the objective of making returns to investors at long last? Is that too much to ask? AN talks about first mover advantage & the technology delivering clinical benefit to patients - why hold back, why not go for it with significant scale co-ventures rather than sheltering in regionally limited deals?

The SP goes down in step with cash burn, keeping Mcap in line with cash expected with nothing + or - for what anything the BoD have said. Doesn't that quite fairly reflects their delivery of news!

Lets hope for change, they must have something/anything to announce before raising cash.

Lets say current SPof 93p represents cash held £99m at 30 June less £1m pm (see below) = £96m/71 m shares in issue = 135p less a provision against business performance, lack of confidence in BoD including Jumper man DA) and the dark cloud of the dispute = (42)p x 71m = £(30)m to get to the current Mcap £67m

Cash burn: The cash movement between Dec 21 £101 & June 22 £99m was £2m but cash burnt was c6m as tax paid on account YE21 had been recovered 4m.

So lets say NCYT win the dispute, receive debt due from DHSC net of VAT 24m (34p p share) but it lifts the cloud & springs Jumper man into gear which the market currently prices as a penalty of (42)p x 71m = £(30)m, then the SP would be 93p+34p+42p = 170p before ADDING hopes for expansion (now the cash does not have to be conserved as contingency against loss to DHSC) & as someone said, future profit. My guess is SP of £2 seems possible FWIW.

what a grim feeling again

1.5m sold, 377k bought at 08.13.00

come on buyers
08.12.00 buy 50,000 at 41.78p,
08.09.51 buy 100,000 at 41.6

Paul Jourdan seemed to talk from Polx’s view point, i.e. FDA finding reason to delay but these sentences in the RNS suggests as Jaar & Deepjoy say the manufacturer’s output is misaligned somehow with Polx’s application information.

Aren’t they suggesting that the gas mix being producted requires further documentation but they do not rule out that it may work? i.e. all the meetings arranged to, I suppose, check actual output is as documented & has appropriate effects?

Paul has talked about the difficulty of initial production, perhaps alignment of manufacturing process by a partner falls into that aspect as is yet another risk.

Yup, it did seem like a leak & agree it seems like the FDA are trying to help.

How galling!

I am trying to piece together what we are told in the RNS from the sentences copied below.

FDA requests additional information from the gas blend manufacturing partner following a pre-approval inspection at the production facility. The information would mean a major ammendment to the application that would be eligible for a 90 day extension. The FDA has proposed frequent meetings during the extended review period to address any concerns that may arise from information submitted.

Does it seem like the inspection showed facets of gas blended that do not tally with the POLX application so the FDA have given the manufacturer the job of quantifying what gas mix it will actually contribute?

Does anyone know when the pre-approval inspection was or who the partner is? Surely they have a stake getting production going.

I wonder what POLX can say, it seems like the ball is in the manufacturer’s court. Galling.

From RNS:
FDA has requested additional information from Polarean's xenon-129 gas blend drug manufacturing partner.
This request is related to the recent cGMP (Current Good Manufacturing Practice) pre-approval inspection at the partner's production facility.
The FDA has suggested that the required information would constitute a major amendment to the New Drug Application ("NDA") that, if timely submitted, would allow for the FDA to grant a 90-day extension to the review timeline.
The FDA has proposed frequent meetings to occur during the extended review period to ensure that any questions that arise during the review can be rapidly addressed to provide the best chance at a positive review decision by the extended date.
The Company has received assurances from its drug manufacturing partner that they will address the concerns

& presumably cost reduction comes at its own cost where staff are involved (even not long after recruitment).

How do they not see the cataclysm?

Staff cost is the main driver - detail in Half Year Report under Note 9 is more informative than comment on Q3. Just briefly, staff cost, professional fees & contractors double in H1 22 vs H1 21 with those increased run rates continued through Q3. The danger is that "savings" announced recently are the offloading of under performers recruited at a handsome introduction fee & now + termination package(?). i.e. a resolution of mistake & not saving at all & sadly not including the CFO himself.

Professional fees & consulting H1 22 $6.4m were double H1 21 but come back in line over Q3. Contractors $3.3m in H1 22 also doubling on H1 21 - my guess on Mt Sinai IT & then there is an insurance cost $2.3m not incurred in H1 21.

To continue my theme of scatty management, their presence in Utah, Mt Sinai, Wake Forest? for VA? & now Chicago? all add to cost & difficulty in staffing up.

Mistakes happens in start ups but I suppose the market expects dilution of $50m by Xmas (50/70 = 70%) at least.

I bet AndyPa might be informative on this : )

What would we give for a reliable version of those revenue projections you mention eh!

Have a good weekend.

Agree with Size82 view & glad for his point that effectiveness might not have been ruined.

ViciousH - it is registration for more than one day.

Maintaining a share register is a labourious process, millions of shareholders involved potentially, changes & occassional statutory notices to file but it can be outsourced so long as the register is available for inspection. From what I gather, Computershare carried out the task on behalf of EVR and were able to interface the link with the trading information service CREST by which brokers interface with the official Stock Exchange. The suspension of listing meant that EVR was still paying for its service by Computershare with CREST & perhaps a subscription direct to CREST (not sure). That whole aspect of functionality is not being used so EVR brought the cost & contract to a close BUT either continued, or offerred a variation of its existing share registy service to EVR. Brokers HL & et al offerred a means for the their clients to apply to Computershare to have shares directly in their name (rather than holding X in the broker nominee holding). The certificate issued evidences the change in title & the Computershare invitation enables a SH to see their holding in their system. I don’t know about their trading functionality, it can not via a listing on the official market, but as others have said there is no impediment to a shareholder selling their holding to another investor.

That’s my go at interpretation of what has gone on. Not much change except for EVR closing down functionality for market dealings & brokers obliging SHs to be holders in their own names outside their nominee account.

The ability to make predictions is often indicative of how well, or otherwise, business is planned, controlled & managed.

The 300 test per week in Mt Sinai is so far wrong that it seems to have been a top down estimate on some theorectical basis and not methodically constructed from expectations "bottom up". Someone said, something like Mt Sinia covers 3m lives so perhaps 0.5% will be tested, that’ll be 15,000 pa so let’s say 300pw & THEY ACTUALLY TOLD THE MARKET!!!

If your credibility was on the line, wouldn’t you sanity check such an important expectation by building it up from what you know by physician/team/or centre so undelivery could be managed where it unfolded? I fear this may be indicative of the managerial culture & particularly the CFO’s effectiveness.

Let’s proper management goes into commericalisation & that they have reasons we do not know about to expect SP rise before capital is raised. I also hope that there was some exceptional cost in H1 "crossing rivers" in system roll out at Mt Sinai that release a wave of demand from the wider community of practicioners, although even this seems quite unmanaged if the test is so useful.

I presumed Iowa comes from the Blue Cross relationship in Illinois.

How is Sir Chris Mills not more on top of this?

Sorry to go on, great that savings have been made & there may be more. $12m is not to be sneezed at indeed, but how was cut-able resource taken on in such a short time?! In other situations one might be concerned whether the right $12m has been cut, that seems less of a concern here apart from the CFO still being aboard.

SB you are right about missing sales targets & they finally recognising the issue of burn.

They do not seem that much more likely to avoid having a huge dilution by December if my calcs are close.

They start with cash 59m in March at a burn rate of $10-15m for Q4 22 ($49-$44m) and Q1 23 ($39-$29m) less associated one costs of annual savings (call it $10m) less another quarter of $15-10m cost reduced by say $2m of annualised savings to be $12pa = $26-11m cash at Sep plus sales revenue from IL/IA push plus Mt Sinai/Wake testing push if any. $26-11m covers them until about 15 May 23 or 15 Dec 22 depending on whether their annulaised normal expenditure is $40 or $60m pa.

Roll on partnership or other game change announcement.

I came to the same conclusion as Agricore & sold out on the basis that I was willing to jump back in. Good to see SP moving in right direction.

FWIW Harman talks about doubling rep numbers, Madison hopes the 10 new reps will be more effective than the last 10 and comments about under resourcing presales promotion so I am still not convinced the available finances can tap as much from Acufer as distributing through an established network of a partner that might also have economy of scale in providing promotion as well.