Unicycive Therapeutics Inc (UNCY) Quote

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

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

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

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.

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

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?

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

says trial data in " next few weeks "
Kiwi

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

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

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

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.

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

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.

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

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

UNCY under $2

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.

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

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

Kiwi

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

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

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

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.

1 min read
SAVE
Legislation pushes for a delay in placing phosphate binders in the ESRD payment bundle

Add topic to email alerts


Key takeaways:
The Kidney Patient Act would delay placement of oral phosphate binders into the dialysis payment bundle.
Binders would be placed in the bundle if an injectable version receives FDA approval.
Congress is reviewing legislation that would delay inclusion of oral phosphate binders into the End-Stage Renal Disease Prospective Payment System bundled payment system.

NNI0324Carter_Graphic_01
CMS currently has plans to include oral binders in the bundle by Jan. 1, 2025, but the Kidney Patient Act (H.R. 5074), sponsored by U.S. Rep. Earl L. “Buddy” Carter, R-Ga., would amend the American Taxpayer Relief Act of 2012 to delay inclusion of the binders until 2033.

“Ensuing that the pending inclusion of oral-only drugs in the [End-Stage Renal Disease] Prospective Payment System (PPS) bundle meets the needs of the ESRD community is a priority for Kidney Care Partners, so we’re encouraged by the recent activity in the House of Representatives on this policy,” Mahesh Krishnan, MD, MPH, MBA, FASN, chair of Kidney Care Partners (KCP), told Healio.

“Without congressional action, this harmful policy would exacerbate the challenges the kidney community already faces, including diminished access to innovative therapies, insufficient reimbursement and limited or nonexistent choice of insurance coverage for patients,” KCP, a kidney community advocacy group, said in a press release.

According to language in the bill, placement of oral drugs indicated for the “reduction, management or control of the serum phosphate of an individual” would be delayed until 2033 unless “an intravenous drug indicated for the reduction, management or control of the serum phosphate of an individual has been approved by the [FDA].”

The General Accounting Office (GAO) released a report last November reviewing plans by CMS to include oral phosphate binders in the PPS by 2025. The report notes that dialysis organizations interviewed by the GAO “expressed concerns that the modified bundled payment may not fully account for the costs of acquiring, shipping and dispensing phosphate binders.”
References:

Nantahala Capital active in UNCY , RZLT and SLNO

In UNCY. increased their position from 1,207,416 shares to 3,475,713 on 2/14

Kiwi

Thanks Kiwi for that information. If I had speculate on some of that, I would say this: When comparing Fosrenol powder and tablets, the powder would possibly be better or more fully absorbed hence more negative reactions for the powder.

As far as comparing OLC and fosrenol tabs, there really shouldn't be much of a difference in side effects but it is always possible that in the studies with fosrenol tablets, there were compliance issues, which means that more of the subjects did not get the full dose of fosrenol and hence less side effects.

RMB. not sure as I haven't seen a detailed description on the trial design like we saw with AMRN's MITIGATE .
Some key pts .
This final trial is not about efficacy . The FDA has already accepted that OLC is the bioequivelant of Fosrenol . Fosrenol is powder or large chewable pills. OLC is a smaller " condensed " version.
The final trial ...with dialysis patients ...is only about tolerability.
The earlier trial showed that while the side effects were the same for Fosrenol and OLC ...there were more of them reported for those trying OLC .

So in the real world ....does this make a difference in patient compliance .
On Fosrenol they have to chew the pills ( or mix the powder with applesauce ) with each meal . Patients hate chewing the pills .
On OLC they can swallow 1 small pill per meal ......but may experience more side effects ( will attach what those are later ) . So will the patients put up with more side effects ...which may diminish over time ...if they can swallow the smaller pills instead of chewing the larger pills.

So they are enrolling 90 . Some will drop out or miss the occasional pill. Hopefully at least 60 will take all the pills as directed ......except for those that stop because they are experiencing side effects they don't want to try and tolerate.

The perfect outcome is for at least 60 to take all the pills as directed for the entire time of the trial...with no dropouts due to side effects
Kiwi

In an open-label, long-term 2-year extension study in 93 patients who had transitioned from other studies, resulting in a total of up to 6 years treatment, mean baseline values and changes in transaminases were similar to those observed in the earlier comparative studies, with little change during treatment.
The safety of FOSRENOL was studied in two long-term, open-label clinical trials, which included 1,215 patients treated with FOSRENOL and 944 with alternative therapy. Fourteen percent (14%) of patients treated with FOSRENOL discontinued treatment due to adverse events. Gastrointestinal adverse reactions, such as nausea, diarrhea, and vomiting were the most common types of event leading to discontinuation.
In pooled active comparator controlled clinical trials, hypocalcemia was noted with an incidence of approximately 5% in both lanthanum and active comparator groups. A nonclinical study and a phase 1 study have shown reduced absorption of calcium in the intestine with lanthanum carbonate treatment.
In a crossover study in 72 healthy individuals comparing FOSRENOL Chewable Tablets to FOSRENOL Oral Powder, gastrointestinal adverse reactions such as nausea, diarrhea, and vomiting were more common for the oral powder formulation (18%) than for the chewable tablets (7%).


Its an open label trial
Primary Outcome Measures :
Incidence of treatment-related AEs leading to discontinuation [ Time Frame: 4 weeks ]
Tolerability as assessed by incidence of treatment-related AEs leading to discontinuation

So no increase in power if still sticking with 60 to crunch data with.

RMB. they are enrolling up to 90 in the trial with aiming having 60 to evaluate
The trial is expected to have 60 evaluable patients.
These patients are taking a lot of meds already and I guess UNCY is concerned some may skip the occasional dose ( for whatever reason ) so they may not get a real read on tolerability .
So the aim is to get at least 60 who took OLC 3 times a day... every day ... with meals ...for at least 4 wks straight .
Kiwi

Thanks for the heads up Kiwi. That is good news on the trial considering they expanded it by 50%.

Trial now fully enrolled ..reported AH today
Data late Q2
Unusual AH action ...ran up to $2 which is what I expected ...but then sold off ...capital raise ???
Kiwi

HC Wainwright & Co. analyst Ed Arce reiterates Unicycive Therapeutics ( UNCY ) with a Buy and maintains $4.5 price target.

Kiwi

A little note about life expectancy for those on dialysis
“Individuals undergoing maintenance hemodialysis (MHD) are at high risk of mortality, with median life expectancy of approximately [4] years,” Benjamin A. Goldstein, PhD, of the department of biostatistics and bioinformatics at Duke University School of Medicine, and colleagues wrote. “However, somewhat less recognized is the substantial variability in mortality in which 20% of patients die within the first year of MHD initiation while 40% will live for more than 5 years.

Getting Serum phosphorous to goal ...along with many other treatments for co morbidities , are essential to extend life expectancy
Kiwi

RMB. Another trial I'm following is the RZLT P2 trial in DME . Results due around when I expects UNCY's trial results
Chk out the RZLT board and leave a comment if interested
Kiwi

I can live with a one quarter push back in terms of trial results. UNCY yesterday reversed the week long slide (the slide was actually constructive since it had gotten overbought) and hopefully Monday continues the upward trend.

On that occasion the heart valve/bypass operation for my mom ended well. Although she also had angioedema where they kept her intubated for a week in ICU and it was a bit of a scary moment when a large group of docs and nurses assembled around her to remove the tube. They said they were worried that her airway could collapse and were at the ready to perform a tracheotomy. Luckily that was not necessary. She went on to live another 12 years after that surgery, although the last few years were not that great and I might not be interested in hanging on through that. Thanks for asking.

More on the Orphan Drug designation
https://www.fool.com/investing/2020/10/04/what-you-need-to-know-about-orphan-drug-designatio/

Kiwi

RMB. my guess is that they won't finish their final pivotal trial in Q2 ...because of the increase in numbers to be enrolled ...more like Q3 .
They may get a hedge fund to do a private placement as no sign so far of a public raise .
Intense story about your mom . Hope all ended well .
Re Kiwi .....It goes back to the ANZAC's of WWI or WW2 ...to differentiate us ( New Zealanders ) from the Aussie's ( Australians ) ...as we were ( in English commanders eyes ) ...rough colonials.
I don't consider it derogatory ...so no worries
I was interested in why Cerevelo's kidneys shut down ...was it for reasons similar to your mom's heart procedure ...and what meds he was on now ?
Another Co I follow has a drug in trials to reduce risk of kidneys shutting down during surgery ...cant remember which one right now .

In the kidney space I also own VERA ..suggest you follow them ...functional cure for IgAN . Most who develop IgAN kidney disease in their 40's will need a new kidney or dialysis in their life time . VERA's drug is the first / only drug so far , to change that ...enable those with IgAN to retain kidney function . The rest just slow the decline.

UNCY mgt certainly needs to update us investors re any change in trial time line .

Kiwi

Kiwi, I agree that they will need more funds. Question is, will the raise be before or after Q2 trial results?

Couple of other items. On another board you were questioning Cervelo about his kidneys and mentioning you had a friend whose kidneys shut down after some procedure. It reminded me of when my mom had a heart valve replacement (and a couple of arteries bypassed at the same time). The doc came out to talk to me after the procedure to tell me that all went well but that since they had to stop my mom's heart and put her on a machine, that the kidneys stopped functioning and that they were monitoring them for when they returned to full function. He seemed to indicate that it was normal in that type of surgery.

Also I suddenly was wondering if calling you Kiwi all these years was derogatory, so I googled it. Most search results indicated that it was not considered derogatory but there were one or two that did. Hopefully it is not as you know I do not wish that.

RMB. I added some back in on the Orphan drug designation. I still think they need to raise cash to fund completion of their pivotal trial ...but this new designation should help them raise funds on better terms.
JMO
Kiwi

Re UNCY. Orphan drug designation
Orphan drug status (designated by the FDA) gives a company exclusive marketing rights for a seven-year period, along with other benefits to recoup the costs of researching and developing drugs to treat rare diseases.
The Orphan Drug Act was designed to encourage companies to develop drugs for rare diseases.

Kiwi

Orphan drug designation
https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=990223

The present invention relates to the synthesis and application of novel chiral/ achiral substituted methyl formyl reagents to modify pharmaceutical agents and/or biologically active substances to modify the physicochemical, biological and/or pharmacokinetic properties of the resulting compounds from the unmodified original agent.

Kiwi

Thx. Got stopped out of half of my UNCY position . With 90 patients to enroll now ( not 60 as per original design ) this Co needs to raise cash to complete the trial and release results ...probably in Q3 now ...not Q2 as claimed in most recent PR
JMO
Kiwi

Congrats on VKTX. I made some coin a year ago there but never got back in.

No sign of a capital raise. The selloff may have just been due to its high RSI reading . Some traders just sell once a stock is trading above 80 on the RSI ,,,or set stops close in case theres a large sell order . Then stop loss' s get triggered in a step down fashion.
I think the RSI got as high as 87 ...highest in a year
Kiwi
ps
I own / owned some VKTX ...nice day to wake up to

Agree with your thinking. If results of trial are good, any capital raise won't matter. I just added more.

Reasons for sell off ...my guess ...a capital raise as now they are enrolling 90 patients so pivotal trial will take longer and burn $.
2nd guess ...but less likely ...patent challenge

I added 10 min before close. Enrolling more , increasing power etc are good things . That this trial will now cost more should be expected. If Co raises $ they will add just enough to fully fund trial and readout
JMO
Kiwi

Reasons for increasing the trial size ...from ChatGPT
Increased Statistical Power:
A larger sample size generally provides greater statistical power, allowing researchers to detect smaller, yet clinically significant, differences between treatment groups or outcomes.
This enhances the reliability of the study results.
Enhanced Generalizability:
With a larger and more diverse participant pool, findings from the trial are more likely to be representative of the broader population, improving the generalizability of the results.

---------------------------------
Trial will now take longer ...but the results will be more definitive / actionable
JMO
Kiwi

RMB. thx for the link. IMHO the trial size was increased to increase " powering " .
I'll try and find a link that explains powering in clinical trial ....but bottom line IMHO it's great they have increased to the trial size .
Downside is that the trial will now take longer and cost more ...but the result ( what ever it is ) will have a higher probability of being accurate / less due to chance .

The end point is " How many stop taking OLC over a 4 wk period ...for whatever reason ".

Kiwi

This is old but a good reminder of what we have here:

https://karger.com/ajn/article/54/5-6/219/843793/High-Phosphate-Binding-Capacity-of-Oxylanthanum

Also wondering if UNCY was requested by the FDA or thought it better to increase trial size by 50%?

Second Update on the UNCY trial ( note earlier post on ARDX / UNCY )
https://classic.clinicaltrials.gov/ct2/show/NCT06218290
Estimated Enrollment : 90 participants

Not sure of the completion of trial date March 31st 2024 and I think they have increased the number in the trial from 60 to 90 patients .
Study Completion
2024-03-31 [Estimated]

Will need to chk further
https://ir.unicycive.com/news/detail/58/unicycive-therapeutics-announces-enrollment-of-first
The trial is expected to enroll 60 evaluable participants.

So they have increased trial from 60 ( in this PR ) to 90 in the clinical trial.org Jan 2024 update

Kiwi