UniCycive Therapeutics Inc (UNCY)

[Whalatane]

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Legislation pushes for a delay in placing phosphate binders in the ESRD payment bundle

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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:

[Whalatane]

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

[rosemountbomber]

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.

[Whalatane]

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

[rosemountbomber]

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

[Whalatane]

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

[rosemountbomber]

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

[Whalatane]

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

[Whalatane]

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

Kiwi

[Whalatane]

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

[Whalatane]

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

[rosemountbomber]

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.

[Whalatane]

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

Kiwi

[Whalatane]

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

[rosemountbomber]

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.

[Whalatane]

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

[Whalatane]

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

[Whalatane]

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

[Whalatane]

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

[rosemountbomber]

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

[Whalatane]

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

[rosemountbomber]

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

[Whalatane]

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

[Whalatane]

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

[Whalatane]

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

[rosemountbomber]

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%?

[Whalatane]

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

[Whalatane]

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

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

Kiwi

[Whalatane]

Well the market will be getting nervous if they don't announce their trial is fully enrolled fairly soon
They have always said trial read out in Q2 / 24
Trial is 6 wks ( I mistakenly said 12 wks in my prior post ) and they will need 4-6 wks to collect , double chk all the data etc before presenting the results .
So say a total of 12 wks starting March 1st ...takes us into June ( last mth of Q2 )
Kiwi

[ErnieBilco]

Looks like next week should present the opportunity according to the chart

[ErnieBilco]

Thanks, I'm looking for a pullback so I can start building up shares in UNCY.

[Whalatane]

I sold my position in ARDX in the $4's....and have held a position in UNCY for some time.
ARDX's XPHOZAH (2 small pills a day ) is an obvious competitor to UNCY OLC ( 3 small pills a day )
The main reason I no longer own ARDX ( and I was surprised by the positive guidance on ISBRELLA ....basically the same drug just priced lower per gm ) is because of the pricing for XPHOZAH
ARDX has priced X at around $3,100 a month . Kaiser has X at Tier 5 which means a copay of around $1,000 a month to the patient
So without ARDX buying down the copay ...I doubt many of these dialysis patients ( who are often low / moderate income ) can afford it .

To date none of the 3 dialysis clinics my wife rounds are using XPHOZAH ...primarily because of the prior approval paper work and being unaffordable to her patients .
The Nephrologists are interested in X particularly for those considered intolerant to binders ...but PA's and cost are major hurdles.

UNCY has yet to announce their pivotal trial is fully enrolled ...that IMHO will be a major catalyst .
They need to carefully / slowly increase dosing of OLC to reduce serum phosphorous below 5 before the end of the 12 wk trial ......going slow will reduce side effects / AE's .
Assuming their pivotal trial succeeds I expect mgt / bod to sell the Co to a large Pharma already in the CKD space . If they go it alone they will raise capital ...and then on approval need to price OLC at a price patients and payers can afford.
JMO
No position in ARDX and currently long UNCY
Kiwi

[Whalatane]

Vivo Capital and Nantahala Capital each have significant positions in SLNO, UNCY and RZLT
There are some common features to the diseases both SLNO and RZLT treat ...Insulin production appears to be a key factor .
SLNO was a huge home runs for these funds ...hopefully UNCY and RZLT can do similar
Kiwi

[rosemountbomber]

Thanks Kiwi. Sure potential sometimes never materializes, but sometimes the market works focuses on potential, at least for a time.

I would think other professionals in the field might have the same outlook as your wife with respect to OLC. Hopefully the trial completes enrollment soon
and it is successful with a good safety profile.

I was fortunate to have some VKTX which I sold at a nice profit this past summer. I will have to look into RZLT but I like the chart - as long as no one purchased a couple of years ago. Not much to lose at this juncture. Thanks for the heads up.

[Whalatane]

Nantahala Capital ...the previous post was from Fintel data . Not sure how accurate it is . It may be reporting increases in shares throughout 2023 .
Anyone with more accurate data , please post
Kiwi
UPDATE. There is Nantahala Capital mgt and Nantahala Capital partners .. Increase is in Capital partners .
I think trying to keep each under 10% to reduce filing / disclose requirements

[Whalatane]

Nantahala Capital Management, LLC
UPDATE
2024-02-14 13G/A UNCY / Unicycive Therapeutics, Inc. 1,207,416 ( previous number of shares ) 3,475,713 ( new number of shares ) ...almost tripled their position



Kiwi

[Whalatane]

RMB The potential is over $1B in the US market ...$2B worldwide
I should emphasize POTENTIAL

First they have to show side effects close to Fosrenol ( its bioequivalnt ) in a dialysis population ....pivotal data due Q2 ...next catalyst is the Co announcing the trial is fully enrolled
Then they have to price it so patient copays are reasonable.......something ARDX failed to do with Xphazoh
Note about the trial . Goal is to get serum phosphorous below 5 .
I think they will go slow ( increase dose slowly ) to minimize side effects .

My wife currently prescribes some Fosrenol , and thinks OLC could be a game changer as its one small pill with meals that can be swallowed not chewed .
Patients hate having to chew phosphate binders following a meal. ....so adherence is poor .

Re pricing . Most dialysis patients are on limited income ...they are in a dialysis chair 3 days a week ... 4 hrs at a time ...so 2 of those days are work week days .
So most rely on generics ...Sevelamer for instance ...but hate them as large pills etc etc .
So if approved pricing must be affordable.

Vivo Capital own about 10% of the Co . They are huge in SLNO that I told U about , and also significant position in RZLT ( think I'll start a position )

VKTX ...I have a position in that . Current take over spec , data due soon .

Good luck
Not investment advice etc etc
Kiwi

[rosemountbomber]

Thanks Kiwi. Is Noble saying that the entire market for phosphate binding agents is greater than 1B in US or the potential for OLC to garner 1B in US revenue?

If the latter, this would be blockbuster.

[Whalatane]

Very promising IF their pivotal trial shows OLC has side effect profile the same as Fosrenol ...its bioeqviulant .
One small pill ...swallowed not chewed ...with each meal
Far easier for patient to adhere to med schedule
Fosrenol is an approved drug currently being prescribed to lower phosphorous ...however its fairly large has to be chewed following a meal .... patients don't like the taste
Kiwi

[BurgerKing82]

Uncy looks promising...

[ErnieBilco]

Info is all I seek. Unvarnished information is very powerful.

I always make my own investment decisions - I know my risk tolerance is higher than most.

[Whalatane]

Well I know some MD's / PA's that treat them / round the dialysis clinics and have met ( around 40 ) patients .
Controlling serum phosphorous has always been a huge challenge as typically it requires taking a lot of large pills each day ...often chewed.
Patients hate the taste , are already taking a ton of other meds as most have heart disease and around 40% also have diabetes ( Most patients I've met are over 50 ...usually over 60 )
So patient adherence to current meds is poor ....most ( 75% roughly ) never reach serum phosphorous goal levels . .

Anyway ...all of this is high risk .
Consider my posts info only ...not investment advice
Good luck
Kiwi

[ErnieBilco]

You have a deep knowledge of these tickers, thanks for sharing.

[Whalatane]

Well they first have to announce that their pivotal trial is fully enrolled .
Then trial has to run 4 wks
Then results in Q2 at which time they may be close to running out of $.
They only had to enroll 60 patients , so if they haven't done that by March 1st ...some might be getting a little jumpy

Cash Position: As of September 30, 2023, cash and cash equivalents totaled $14.3 million which is expected to last into the second half of 2024 including completion of the pivotal clinical trial and topline data for OLC.

Kiwi

[ErnieBilco]

OK got this one on my radar now looking for best entry point. Hope I don't have to chase it.

[Whalatane]

Noble Capital🏁 $UNCY OP/$6~lead drug candidate OLC, is a phosphate binding agent for the Tx of high phosphate levels in renal dialysis pts; NC believes OLC will show advantages over the current phosphate binding drugs; sees pot 2b "the best drug" in a category w/ >$1B in US rev.
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Kiwi

[Whalatane]

12:50 PM ET Feb-14-2024
Noble Capital Markets analyst Robert LeBoyer initiates coverage on Unicycive Therapeutics (UNCY.NaE) with a Outperform rating and announces Price Target of $6.
---------
Kiwi

[Whalatane]

RMB. The near term catalyst is when they announced their pivotal trial is fully enrolled. .
That should occur this month ...for them to stay on track to read out results some time in Q2 2024 .

This trial is not about efficacy . Its the number and severity of adverse events ...if its greater then what they see in those taking Fosrenol .
OLC is a " condensed " version of Fosrenol ...smaller pills that can be swallowed ..one with each meal .
Fosrenol are large pills that need to be chewed .
Patients hate having to chew these pills with meals ...tastes like chalk apparently .
My wife has prescribed Fosrenol
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021468s016lbl.pdf
In the UNCY trial they will start at low dose and titrate ( adjust ) dose to reach serum phosphorous goal
Good luck
Kiwi

[rosemountbomber]

Bet a little on this move up. Not sure if it is a little early as we won’t get much news before 2Q. Hope it is not a pump just for them to raise cash. They will need to raise but when?

[Whalatane]

Logos Global position 13G filed
https://www.streetinsider.com/SEC+Filings/Form+SC+13G+Unicycive+Therapeutics%2C+Filed+by%3A+Logos+Global+Management+LP/22657192.html
Kiwi