UniCycive Therapeutics Inc (UNCY)

[Whalatane]

RMB. The trial they referred to in healthy volunteers only had 32 patients I think .
So very small sample to try and get an accurate read of AE's .......not sure of stat sig ( p value if any ).
They emphasized that no one dropped out of the trial because of AE's .

All these binders have tolerability issues and it may be a worse version of Statins .

As you know I'm on max dose Statins and have adjusted . Some can't tolerate even the lowest dose .

Kiwi

[rosemountbomber]

You pose a good question. Not sure if we would need to know more about the various AE's they are talking about. Usually when science people write up a report, they are typically quite careful with the wording. Unless this was written by management LOL.

[Whalatane]

Mr Mister . My wife prescribes both Sevelamar and Fosrenol .
Most of her patients are Medicare / Medicaid
Since these are mostly low to moderate income patients Sevelamar is the least expensive .
Patients hate the drug for reasons mentioned before ...large pills often 2 per meal etc .
Those that absolutely refuse Sevelamar my wife will go thru the prior approval hoops and get them Fosrenol ...more expensive but fewer pills

Fosrenol ( from memory ) is either chewed or mixed with apple sauce .
Patients hate the taste .

OLC is a smaller pill version of Fosrenol thats SWALLOWED ...1 pill per meal

The issue with OLC is tolerability and if thats manageable ....cost of drug if approved

Kiwi

[Mr.Mister]

Why do or would patients refuse Sevelamar? Why would someone choose Forsenol over Sevelamar?

Part of my skepticism with UNCY is that they benchmarked Forsenol, which isn't the most prescribed binder.

[Mr.Mister]

Good question.

If this thing is going to compete or compliment with tenapanor and other legacy binders, they'll have to explain this better

[Whalatane]

Poster info presented today .
As far as I can tell ...AE's between Lanthanum and OLC were of the same type but occurred more ( 35% ) in the OLC group vs the LC ( 25% ) group.
So its all down to tolerability .
Will the preferred swallowed OLC in a 1 small pill with each meal compensate for more frequent AE;s
Were the numbers to small in this first trial to give an accurate read on frequency of side effects ...only 86 ? in the trial

From the presentation

The incidence of treatment-emergent adverse events (TEAEs) and related AEs were also the same in both groups at 35% and 25%, respectively.

How can the incidence be the same when in OLC 35% had AE's while in the LC group 25% had AE's ??

Kiwi

[Whalatane]

RMB. Thx ...Theres a lot of research going on in CKD . OT I've been doing some research on RGLS which has published some interesting clinical data recently
Kiwi

[rosemountbomber]

Thanks for the good primer Kiwi.

[Whalatane]

In case anyone should venture here
Whalatane
Member Level
Re: None
Monday, May 13, 2024 6:59:02 PM
Post# of 251809
UNCY pivotal trial update

“This is an exciting time for Unicycive as we progress towards the conclusion of our pivotal clinical trial for our lead asset oxylanthanum carbonate (OLC),” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “The trial is evaluating the tolerability, safety, and pharmacokinetics of clinically effective doses of OLC in patients with chronic kidney disease (CKD) on dialysis and it remains on track with topline data expected later this quarter.

By my calculations this pivotal trial will end this weekend.
What remains is data checking / cleaning and then publishing results

Some background . High serum phosphorous is a continuing problem for most ( 85 % ) on dialysis due to kidney failure .
This is because almost all the patients currently taking the Pho binders hate them either because of taste ( chewed with meals ) or pill burden ( up to 12 pills a day )
Recently ARDX managed to get Xphazoh approved ...2 small pills swallowed not chewed ( one at breakfast , 1 at dinner ) While many Nephrologist want to try this drug there are 2 problems .
1) Diarrhea in half the patients for the first 2-3 wks
2) Cost if you are on Medicare / Medicaid . Medicare / Medicaid means patients can't use the coupons ARDX is currently handing out and their copay pay ( This is a tier 5 drug ) is roughly $1,000 a month .
None of the patients my wife's sees are willing to pay the copay as most are Medicare / Medicaid.

Now comes UNCY's OLC .
OLC is a new form of Fosrenol that they wife already prescribes if patients refuse Selevmar ( lowest priced generic )
The advantage of OLC is that its 1 small pill with each meal ...SWALLOWED ( this makes a difference re adherence ) ...not chewed or in powder form mixed with applesauce.
OLC is very effective at lowering serum Pho .
The problem is stomach upsets / nausea .
UNCY's final trial ..results due soon see above ..is all about tolerability .
Can they slowly increase the dose to gradually get serum Pho down to target and keep patients on the drug ?

My guess is that PPS will either drop to 50c or head towards $5 ...depending on results
Risk only what you can afford to lose and forget me if this fails ..:--)

Kiwi

[Whalatane]

From ER

“This is an exciting time for Unicycive as we progress towards the conclusion of our pivotal clinical trial for our lead asset oxylanthanum carbonate (OLC),” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “The trial is evaluating the tolerability, safety, and pharmacokinetics of clinically effective doses of OLC in patients with chronic kidney disease (CKD) on dialysis and it remains on track with topline data expected later this quarter.

Recent interview the Ceo said data in next few weeks.
Based on reported time line the trial should be completely finished by the end of this week ...May 18th
So data checking / cleaning 2-4 wks ??

Kiwi

[Whalatane]

My comments on the ARDX board relevant to UNCY
Cosa. These are excellent first Qt numbers for XPHOZAH but keep in mind

1) They aren't revealing how many are getting the drug for free ( via their coupon plan ) . They simply say around 55% are Medicare ( who can't use the coupon )
So are those on Medicare paying the full patient copay of an estimated $1,000 a mth ( Tier 5 rating )
They have probably provided a lot of free samples for the first couple of months ( my guess )

2) Early adopters . One of the main complaints on the existing binders is constipation .
One of the main problems with XPHOZAH is diarrhea in the first 2 wks ...less over time.
So the Nephrologists will have identified this who complain of constipation the most and offered them X ...as they want a " looser " stool anyway.

3) We have the final UNCY trial with their binder completed ...data due probably late this month .
This is 1 small pill with each meal vs 1 small pill at breakfast and 1 with dinner . Diarrhea is less of a problem with OLC but some experience nausea , stomach upsets. UNCY's final trial is about tolerability not efficacy .
If UNCY's trial fails ARDX's XPHOZAH will be the only new serum pho lowering drug available.
If UNCY's trial succeeds X will have competition in about a yr

Kiwi

[rosemountbomber]

Wow that is a pretty high side effect rate. Appreciate the heads up.

[Whalatane]

RMB. chk my post on the ARDX board .
The fact that 60% of those trying XPHOZAH are Medicare patients and therefore can't use the coupon ...must pay the roughly $1,000 a mth copay ...shows you how much these patients hate the current Pho binders

Obviously a strong market demand .

We need the final UNCY trial to succeed ( low drop out rate due to tolerability )...data due late this mth hopefully

Re XPHOZAH ..they will start those complaining of constipation on this drug first ...due to 45% experiencing diarrhea

Kiwi

[rosemountbomber]

Thanks Kiwi. Interesting piece from their pr:

“ Among the 77 nephrologists surveyed, 98% rate XPHOZAH as an advance over currently available hyperphosphatemia therapies. 56% of surveyed nephrologists report initiating a patient on XPHOZAH, and among those reported users, 98% report satisfaction with treatment.”

Without Medicare coverage combined with giving the product away seems like a tough road making moolah on this.

As far as UNCY undercutting them, you seemed to indicate in a prior post that you thought UNCY would seek to sell itself before starting a marketing effort? You think that they may be already sending out feelers?

[Whalatane]

RMB. I actually think the XPHOZAH results for ARDX today are a positive for UNCY ( assuming their pivotal trial is a success ) .
Their results demonstrate the need for a lower pill count to effectively address high serum Pho
UNCY can presumable underpriced price ARDX ..offer a lower price for a small 1 pill with every meal vs 1 small pill with breakfast and dinner .

XPHOZAH sales are driven right now by their coupon plan ...Co gives the drug for free to those on private insurance . Medicare / Medicaid aren't eligible which is why none of my wife's patients are trying it .
Most on dialysis needing a better drug to lower serum pho are over 65 ...Medicare / Medicaid

Kiwi

[rosemountbomber]

Gave some back today, but on much lower volume than yesterday, plus the overall market was a bloodbath overall.

[Whalatane]

RMB. IF the trial succeeds I expect them to seek buyout offers . I doubt they would try and recruit a sales force and launch this drug themselves .
JMO
Kiwi

[rosemountbomber]

Thanks for the link Kiwi. A few weeks either way is no big deal anyway. Turning 73 next year, so the first RMD from tax sheltered accounts will be based on amount this coming end of the year. So if a jump in stock price doesn't occur until Jan. 1, 2025, not a bad thing. But that of course won't happen here. If study is good and they apply to FDA then stock will jump.

[Whalatane]

Data due date . going by the recent comments of the CEO ( next few weeks ) I thought we might have the data by mid May 2024.
However looking at the trial design ...The secondary endpoints are followed for 10 wks. So full enrollment on March 7th ...plus 10 weeks ...takes us to May 16th before they have all the data
They will have the primary outcome data well before May 16th but how long it takes them to process the secondary outcome data ..????

Kiwi

[Whalatane]

Right at the end of this Noble presentation ...30 min mark in Q and A

https://www.channelchek.com/videos/unicycive-therapeutics-uncy-noble-capital-markets-virtual-healthcare-conference-replay?utm_source=Youtube&utm_medium=short&utm_campaign=VHC+

Top line data in next few weeks .....stated April 18th

Kiwi

[Whalatane]

Chertoff is one of the most respected CKD KOL's in the US
UNCY has some recent YouTube videos out discussing treatments for high serum pho

Kiwi

[Whalatane]

Thx for that link ....re

To this end, Rahimi rates UNCY an Overweight (i.e. Buy), while her $9 price target indicates room for a potential one-year upside of a whooping 791%. (To watch Rahimi’s track record, click here)

I'll be happy if Rahimi is only half right ...ie to $4.50 .
ARDX's current valuation is IMHO largely IBSRELA for irritable bowel syndrome ...not its high pho drug Xphazoh .

Data date ...Ceo had stated in the Noble presentation April 20th .. ".final data in next few weeks " ...so I'm assuming a few weeks is less than a mth .

Thx again for the link
Kiwi

[rosemountbomber]

Good to see today's price movement. From the link that Molee posted, it appears that the analyst covering UNCY seems to indicate data from the study coming late in the quarter, whereas you are pegging it for a month or so before. No matter, as long as it is good.

[molee]

Opinion posted :

https://finance.yahoo.com/news/2-strong-buy-penny-stocks-173700369.html

[Whalatane]

post repeated

[Whalatane]

As a reminder UNCY's final trial is an Open Label trial ( they know who's on the drug ) . It's a trial for tolerability ( how many will drop the med due to side effects ) ...not efficacy.
The trial has been completed and the final data should be published by mid / late May.
If the trial is seen as a failure stock will drop by at least 50% .
If trial is seen as a success ...stock pops ...my guess to $3-$5 and Co becomes a buyout candidate
JMO
Not investment advice other than risk only what you can afford to lose.
Do your own DD etc

[Whalatane]

Well that's more like it ...jump in PPS on heavy vol
Kiwi

[Whalatane]

Unfortunately this has turned into one ugly chart for a Co about to release results of an Open Label trial .
I still hold a small position ...ala bet only what you're ok with losing .....but not as gung - ho as I once was.

Kiwi

[Whalatane]

Todays action is what I'm looking for ahead of trial results .
Upside swing on increased vol .
I added back some this AM
From Piper earlier in the mth

-Piper Sandler Initiates Coverage on Unicycive Therapeutics With Overweight Rating, $9 Price Target

Kiwi

[Whalatane]

RMB. OLC is the bioequivlent of Fosrenol ( Lanthanum Carbonate ). . My wife has a few patients on Fosrenol .
The history with Lanthanum is roughly as follows ...from a large trial in China

The incidence of AEs was not significantly different between lanthanum carbonate and placebo during the maintenance phase.
The compliance of the present patients to the experimental drugs was quite good.
Compared with previous double-blind reports, lanthanum carbonate was better tolerated in the present study.
The present withdrawal rate during the titration and maintenance phases was the lowest, at only 10.8% and 6.2%, respectively (

So the highest drop out time is during titration .. while .increasing the dose to lower serum phosphorous to the target level with time of trial .
Based on trial history I'm sure they will be going as slow as possible to get to goal within trial design.

Lanthanum Carbonate has more side effects ( nausea etc ) when swallowed whole ...Fosrenol ..brand name ..is chewed or in powder form .

Ideally the drop out rate due to side effects will be at most 10% ...preferably less

Kiwi

[rosemountbomber]

Thanks. I was just looking at daily volumes. I mean the drug should work, but like you say will the Side effects be acceptable enough.

[Whalatane]

RMB. I was referring to the volume around the presentation on the 18Th
There was a large block purchase at the time of that presentation and then slow steady selling into the close on Friday .
I would have preferred constant buying into weeks close . It may have been just " risk off " due to over all market sell off.

One key thing from the presentation was the Ceo saying trial results in next few weeks . I read few weeks as 2-3 weeks where as originally I thought results not until after mid May ie 4-6 wks away.

I still hold a core position . May add more if market melts down next week .
The biotech spec funds I follow ... Vivo Capital , Nanathala , RA all have large positions in the Co and have not reduced them as far as I can tell.
I lean to wards the trial succeeding with patients accepting some minor AE's for the trade off of lower pill burden ....but it's really how much do I want to risk as failure will trash the stock
So there may be 3 X to the upside on good trial results and 80% to down side on trial failure .
For me it's how much of a loss I'm OK with if trial fails .......such is life investing in clinical trial outcomes

Kiwi

[rosemountbomber]

I think I see that higher volume if your avg volume is over the last 52 weeks, but it doesn’t look like higher volume compared to the last 3mo avg?? Am I looking correctly?

[Whalatane]

https://www.channelchek.com/videos/unicycive-therapeutics-uncy-noble-capital-markets-virtual-healthcare-conference-replay

says trial data in " next few weeks "
Kiwi

[Whalatane]

RMB. Well they had their presentation but now stock is heading lower on almost triple vol ...so I reduced my position .
Will hold some thru readout but todays action is not what I want to see following presentations
JMO
Kiwi

[Whalatane]

FWIW
Benchmark Reiterates Speculative Buy on Unicycive Therapeutics, Maintains $3 Price Target

[Whalatane]

RMB. volume to low to concern me. Theres some real market risk around the CPI report due tomorrow.
A bad inflation report will cause a sell off in small caps , biotech , long duration assets etc.
I raised cash today ...didnt sell any UNCY but I was way up on RZLT that I think you had looked at before ...so sold some of that as well as spec positions in FXI and IWM ( which are very liquid and easy to trade in and out of )

The case for UNCY still remains the same .
The risk is tolerability to new formulation . If the stomach upsets etc are worse then the original formulation ...are they bad enough for patients to stop taking OLC ...or does increasing the dose slowly counter act / minimize this and is the convenience of small pills SWALLOWED make it worth will.

Patients hate the current meds they have to chew with meals or mix as power into apple sauce with each meal.
Current pills taste like chalk. Imagine having to chew several of these following each meal . OLC is 1 small pill with each meal SWALLOWED.

Three always risk ...so risk only what U can afford to lose as this Co doesn't really have much of a back up plan.

Kiwi

[rosemountbomber]

So is this recent weakness an indication that the open label info is leaking out or is the volume way too low to jump to that conclusion? I would assume a much bigger drop in price if related to bad news from the trial rather than this consolidation as I might describe it.

[Whalatane]

Table saws ..oiy .....best to avoid . 2 friends have lost part of a finger each , using table saws
UNCY, TLPH and VERA are my current CKD / dialysis positions .
I just sold my SWAV ...the core position I'd kept since $40

Re UNCY. since this trial is open label , if stock goes south badly before results I'll probably bail ...at least most of position
Good luck
Kiwi

[rosemountbomber]

Well, have fingers crossed hoping the drug is tolerable at the dosages given. They know the drug works. As far as projects that you undertook lately, I know what you mean. As you know I recently (6 months ago) moved cross country. New home but crappy builder (long story why purchased) and huge family room with fireplace but I was charged with building built-ins on both sides of fireplace. Had gotten rid of table saw before moving so had to improvise and create guide for circular saw. Never good at finish work and was concerning -- but luckily it turned out good. Will have to send you a pic.

We should know relatively soon how this trial shapes up. UNCY, I am looking for at least a triple on good news.

[Whalatane]

Their pivotal trial is fully enrolled and over half have probably completed the trial by now .
This trial is Open Labeled ...they know who is on the drug ..so can see how they are doing

Brief Summary: The goal of this clinical study is to test the tolerability of oxylanthanum carbonate (OLC) in patients with chronic kidney disease on hemodialysis and have hyperphosphatemia (too much phosphorus in their blood). The main question it aims to answer is whether patients taking OLC for hyperphosphatemia are able to tolerate the drug.
Participants will continue with their scheduled dialysis treatments and replace their current phosphate binder drug with OLC.

Detailed Description: This is a 17-week study consisting of 4 parts. In Part 1, patients are screened for eligibility. In Part 2 patients undergo approximately 3-weeks of washout from previous phosphate binder therapy. Part 3 of the study is up to 6-week titration period where patients are treated with OLC starting at a dose level of 1500 mg/day. At the end of 2 weeks, the dose will be adjusted based on serum phosphate level, up to a maximum dose of 3000 mg/day. Part 4 of the study is a 4-week Maintenance Period with patients treated for 4 weeks on the clinically effective dose of oxylanthanum carbonate (OLC) identified in the Titration Period. Patients will return to the clinic for the End-of-Study Visit on the last day of the 4-week Maintenance Period before restarting their prescribed phosphate binder therapy. The primary endpoint will be to evaluate the tolerability of OLC (as assessed by rate of discontinuations due to treatment-related adverse events) and the secondary endpoints are the evaluation of the safety of clinically effective doses of OLC and evaluate the pharmacokinetics of OLC. Once weekly, at one of the patient's scheduled dialysis appointments and at the End-of-Study Visit, the tolerability will be assessed. After the End-of-Study Visit, patients will reinitiate standard therapy. Toxicity will be assessed during the study based on the severity grade (mild, moderate, or severe) as assessed by the Investigator.
Open or close this module Conditions
Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
Keywords: CKD, ESRD
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 90 [Anticipated]

Kiwi

[Whalatane]

Hi RMB. Well it's a ..".only risk what you can afford to lose " type situation .
OLC is the strongest phosphorous lowering drug for dialysis patients with the important convenience of being one small pill swallowed with meals.
The challenge will be tolerability .
How many report stomach upsets etc and if they are bad enough to stop taking OLC.
The Co has learnt from earlier trials and will start with a low dose , gradually increasing dose just enough to lower serum phosphorus to the desired zone .
The funds Nantahala and Vivo have some serious $ at risk here so I'm assuming they have done very extensive DD .

Something else for you to consider ...TLPH ...starting a short pivotal trial .
Chk with me on that board if interested .
Nantahala is a major investor with a seat on the BOD
Kiwi

[Monksdream]

UNCY under $2

[rosemountbomber]

Thanks Kiwi. I found it interesting that they are quoting Gupta saying they will be discussing 2 ongoing clinical trials. Wonder what info they will divulge. On another note, I know you had been mentioned the company raising cash and I am sure you saw they they did a private placement:
https://csimarket.com/news/unicycive_announces_50_million_private_placement_expanding_investor_base_and_progressing_towards_key_milestones2024-03-14110308

Another thing. Technical analysis is very iffy and mostly useless with these bios, but if you look at a 1 or 2 yr chart of UNCY, it has formed a huge cup and is about 4-5 weeks into the handle. Hoping for the best.

[Whalatane]

https://www.healio.com/news/nephrology/20231110/video-drugs-in-the-pipeline-for-hyperphosphatemia-management?utm_source=selligent&utm_medium=email&utm_campaign=news

Kiwi

[Whalatane]

https://healthstockshub.com/news/nasdaq/uncy/unicycive-therapeutics-to-be-featured-in-multiple-presentations-at-the-upcoming-european-renal-association-congress

Kiwi

[Whalatane]

Budgetary Constraints: The Medicare dialysis bundle operates within a predefined budget allocated by the government. This budgetary constraint imposes a limit on overall spending for dialysis care, which helps control healthcare expenditures at the national level. Dialysis facilities must manage their resources effectively to operate within this budget while providing quality care to patients.

--------------------------------------------
My understanding is that it forces MD's to prescribe lower cost generics in order to stay within the predefined budget allocated by Medicare .
Staying outside the bundle allows a more direct access for the patient provided the Co pay is reasonable
just my take
Kiwi

[rosemountbomber]

Thanks, I didn’t catch or understand the whole thing about the payment bundle.

[Whalatane]

RMB. It's good news if they can keep the new phosphorous lowering drugs out of the dialysis bundle . My understanding is that the bundle ( essentially a fixed price medicare / medicaid will pay for dialysis ) forces patients to the lowest cost generics.

ChatGPT
The dialysis bundle itself does not directly limit access to brand drugs. Instead, it focuses on optimizing care practices and resource utilization in the management of patients undergoing dialysis treatment, particularly those with end-stage renal disease (ESRD). However, there are broader healthcare policies and initiatives that may indirectly impact access to brand drugs for dialysis patients.

One of the ways access to brand drugs can be limited is through healthcare payers, such as insurance companies or government payers like Medicare or Medicaid, implementing formularies that preferentially cover generic drugs over brand-name drugs. Formularies are lists of medications that insurers cover, and they often include tiered structures where generics are placed on lower-cost tiers with lower copayments or coinsurance compared to brand-name drugs.
[/I]
And
The Medicare End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) is used to reimburse dialysis facilities for Medicare beneficiaries with ESRD. This system sets a base rate for dialysis treatments, with adjustments made for factors such as patient demographics, comorbidities, and geographic location.[/I]
---------------------------------------------------
Little confusing but generally if the new drugs are in the bundle it limits what the govt will cover if at all ...just my take


Looks like a good funding deal this am .
Private placement with existing funds plus some new ones added . Vivo still in and added ...they in my experience ( SLNO ) are cutting edge in these niche speciality drugs .
This final trial is open label. The early patients enrolled have already completed most of the trial ...if not all of it.
I'm speculating that these investors must have had some indication that things were going well in the trial
JMO
Kiwi

[rosemountbomber]

Kiwi, a little confusing to me (the rationale) but isn’t this bad news for UNCY? Hopefully disfunction reigns supreme in the House and this does not come to pass. Unless I don’t clearly undrrstand.