UniCycive Therapeutics Inc (UNCY)

[rosemountbomber]

Thanks for posting Kiwi. Have a great weekend. Stock showed tiny signs of waking up this week.

[Whalatane]

Opinion by Dew who I think is ex Harvard Med

Member Level
Re: Whalatane post# 252682

Thursday, July 25, 2024 10:04:04 PM
Post# of 252696
ARDX/UNCY—As noted earlier, the reversal of the "Chevron" doctrine by the US Supreme Court should give the plaintiffs in this case a decent chance of prevailing, IMO. Absent the reversal of Chevron, the lawsuit probably would not have been filed.

The reversal of the Chevron doctrine has received a lot of criticism from various parties, but here we have a case where two (arguably) deserving drug companies are clear beneficiaries.

So I think UNCY has the most upside should ARDX prevail against the CMS as Dew expects .
ARDX is spending the legal $ ...UNCY gets to ride along for free
Should ARDX prevail ....Both ARDX and UNCY will have niche markets since they are competing against generics ...however UNCY's OLC is more effective at lowering serum pho and is likely to be less expensive ...so any legal win is likely to be a huge plus for UNCY .
JMO
Kiwi

[Whalatane]

Minority groups lining up to support the Kidney Patient Act ...which is good for UNCY when they get OLC approved

The National Minority Quality Forum, a health care research, education and advocacy organization, has joined a lawsuit against CMS to prevent the inclusion of oral phosphate-lowering therapies in the ESRD bundled payment.

The American Association of Kidney Patients (AAKP) is also part of this lawsuit. While not exclusively a minority group, AAKP advocates for all kidney patients, including minority populations who are disproportionately affected by kidney disease.

The Sickle Cell Disease Association of America supports keeping phosphate-lowering drugs out of the ESRD bundle. They note that 1 in 3 adults living with Sickle Cell Disease has chronic kidney disease, and keeping these drugs out of the bundle allows doctors and patients more control over their care regimen.

The National Consumers League, which advocates for patient-centered health care, expresses concern that changes in Medicare coverage will cause kidney patients to lose access to quality care and innovative treatments. This is likely to disproportionately affect minority patients.

Dr. Frita McRae Fisher, a nephrologist, argues that including phosphate-lowering therapies in the bundle would disproportionately affect Black patients, who make up more than 35% of dialysis patients but only 13.2% of the U.S. population.

Kiwi

[Whalatane]

My response to Dew on the biotech values board
Dew. Re the Kidney Patient Act , dialysis bundle and their impact on ARDX and UNCY .
Dialysis providers and dialysis patient groups are against CMS's endeavor to include oral phosphate binders in the dialysis bundle starting Jan 2025.
Dialysis providers are against this move primarily because phosphate binders are not part of the dialysis process and they feel storing , managing and dispensing of these drugs will be cumbersome , expensive and they aren't prepared for it .
Dialysis patient groups are against it as including the new oral pho drugs will limit their use and stifle further innovation .

Keep in mind that dialysis providers get to keep the difference between what the govt pays per dialysis and what it costs them to provide each service .
For private dialysis co's it's a huge incentive to use the cheapest pho binders the patient can tolerate ....if oral pho binders are in the dialysis bundle .

CMS monitors to see if changes result in lower patient care . Theres not the same effort applied to seeing if patient care has improved.

I have been buying ARDX and UNCY after their recent drops .
These are purely speculative plays on the Kidney Patient Act passing and the Oral pho binders being kept out of the dialysis bundle for at least another 2 -3 yrs .
Info only ...NOT investment advice
UNCY is likely to disappear if Oral pho drugs are included in the dialysis bundle and ARDX will live on a smaller version of itself based on their Ibresla sales
JMO
Kiwi

[Whalatane]

The dialysis bundle explained and its relevance to UNCY ( and ARDX )

The dialysis bundle in the United States is a comprehensive payment system implemented by Medicare for end-stage renal disease (ESRD) treatment. Here's an explanation of the key aspects:
Purpose and Implementation:
The dialysis bundle, officially known as the End Stage Renal Disease (ESRD) Prospective Payment System (PPS), was implemented on January 1, 2011. Its purpose is to provide a single, bundled payment to dialysis facilities for renal dialysis services provided to Medicare beneficiaries.
What's Included in the Bundle:
The bundled per-treatment payment covers:
Dialysis treatment
Drugs and injectable medications
Laboratory services
Supplies
Capital-related costs
Equipment and supplies used for home dialysis
Oral drugs with injectable equivalents
Payment Structure:
The payment is made on a per-treatment basis and is adjusted for patient-level and facility-level factors. It includes provisions for:
A base rate
Adjustments for patient demographics and comorbidities
Quality incentives through the Medicare Quality Improvement Program (QIP)
Oral-Only Drugs:
Currently, oral-only drugs (those without injectable equivalents) are not included in the bundle. However, CMS plans to incorporate these, specifically phosphate binders, into the bundled payment starting January 1, 2025.
Innovative Treatments:
The system includes provisions for new treatments:
Transitional Drug Add-on Payment Adjustment (TDAPA) for new renal dialysis drugs and biologicals
Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES)
Impact on Clinical Care:
The bundled payment system has led to changes in clinical algorithms and quality improvement activities. For example, Fresenius Kidney Care reported optimizing the use of erythropoiesis-stimulating agents (ESAs) and vitamin D treatments while maintaining or improving quality outcomes.
Quality Metrics:
The bundle is tied to quality metrics through the QIP, which examines factors such as dialysis adequacy and management of complications like hypercalcemia.
Drug Designation Process:
CMS uses a drug designation process to determine how new renal dialysis drugs and biological products are incorporated into the bundled payment.
The dialysis bundle aims to incentivize efficient care delivery while maintaining or improving quality outcomes for ESRD patients. It has led to changes in clinical practices and resource allocation within dialysis facilities, with ongoing adjustments to incorporate new treatments and medications into the payment system.

Note high lighted area .
If included in the bundle , price caps would limit any use of OLC ( UNCY ) or Xphazoh (ARDX )

Outside the bundle the MD can get Medicare to cover 75% of the cost and the Co can issue coupons to reduce the copay to the patient

Kiwi

[Whalatane]

Thx. Didn't realize they were new investors ....deep pockets and now own 9.9 % of the Co

[molee]

Great Point Partners > ?

https://ir.unicycive.com/news/detail/65/unicycive-announces-50-million-private-placement

[Whalatane]

I usually ignore what Co's tell you ...and look at their balance sheet ...net loss's per qt etc .
I've been reading up on the dialysis bundle and how MD's charge Medicare for drugs they prescribe .
My understanding so far
Say OLC is kept out of the dialysis bundle and charge $1,000 a month for their OLC .
It would be a tier 5 drug so patient copay would be roughly 25% ( $250 ) a month with Medicare paying $750 a mth .
Co then offers a $200 coupon to the patient ... Patient then only pays $50 ....BUT ... Medicare is still paying the remainder $750 a mth

This only works if the new oral pho binders are kept out of the dialysis bundle . The bundle is a fixed payment dialysis centers need to operate in ...paid per patient dialysis . Theres no room there for new Brand drugs ....within the existing dialysis bundle

So ...thats the play ... out of the bundle or bust
JMO
Kiwi
PS Great Point Partners disclosed a 9.9 % stake recently ...Is this a new stake ...Anyway you can find out

[rosemountbomber]

Not sure where I saw it but I thought the company said it has funds to fund operations thru 2026.

[Whalatane]

Cash Position: As of March 31, 2024, cash and cash equivalents totaled $48.9 million.

So that should carry them until the Senate decides on the Kidney Patient act .
Act pass's this Co has a future ...if it doesn't ...another small biotech bites the dust
JMO
Kiwi

[Whalatane]

RMB. As I previously posted . I was disappointed with the trial results ...in particular the fact that close to 50% were OK with their current pho lowering drugs ...which are mostly cheap generics . Previously the opinion was that 80 % or greater hated their current meds.
So the potential market is smaller then I thought.
Given that the Co is low on cash ( IIRC ) and a reverse split is inevitable ....this stock is not appealing ....except for the potential upside if the Kidney Patient act pass's.
If this act pass's MD's will be free to bill Medicare for the new oral pho lowering drugs from ARDX and UNCY ( when UNCY final has their OLC on the market ) for a couple of years at least ....by them being kept out of the dialysis bundle .

While neither ARDX.s Xphazoh or UNCY's OLC are likely to be major sellers ...they both will find niche market shares largely dependent on their pricing .
The dialysis patients that have issues with constipation will want Xphazoh and those used to taking Fosrenol will find the switch to OLC fairly easy ....provided both have low copays .

This position only works IF the Kidney Patient act pass's
JMO
Info only
Kiwi

[Whalatane]

Great Point partners ....disclose 9.99% position
http://archive.fast-edgar.com/20240718/AN2ZRG2CZ22C2ZE2222M2ZO2QQ82ZZ22N262/

Kiwi

[rosemountbomber]

Thanks Kiwi. This certainly can’t hurt. Hopefully the negative sentiment with this stocks means that there is potential for upside.

[Whalatane]

True face plant ? With that sentiment maybe its time to buy into this a s a spec on the Kidney Patient Act passing
https://sewell.house.gov/2024/3/rep-sewell-s-kidney-patient-act-passes-out-of-the-house-ways-and-means-committee

This will be a high risk speculative trade that I think I'll put on .
Info only ...NOT investment advice
Kiwi

[molee]

I think this now qualifies as a true "faceplant" ...

[CosmicSamurai92]

Oh,it's a final flush alright. Wish I never bought this. I will hold tho.
AoN.

[molee]

Hopefully a final flush there on pretty high volume ... We'll see .

[Whalatane]

Uruguay vs Colombia ...OMG. Sunday will be a big soccer day .
Inflation data tomorrow

Kiwi

[ErnieBilco]

It gives me hope that my decision to add at these lows will payoff.

HC Wainwright, in my opinion, push failures which gives me some warm and fuzzies.

See you over a buck at least.

[Whalatane]

HC Wainwright & Co. Reiterates Buy on Unicycive Therapeutics, Maintains $4.5 Price Target....FWIW today

Kiwi

[Whalatane]

Thx. Need to watch that game . A key catalyst ( also for ARDX ) will be if the Kidney Patient Act pass's...approved by the house and now before the Senate ...passage by EOY hopefully .
Re OLC. they may prefer it but are they willing to pay the Brand label price for it ....we'll have to see how they price it once approved.
Co ( and my wife who prescribes to dialysis patients ) always maintained that the patients hate the current pho lowering drugs . So I was surprised to learn in their trial anyway ...49% were satisfied with the current meds
Started a position in FULC recently ...P 3 data in Q4. U might want to chk out
Kiwi

[rosemountbomber]

I meant to add Kiwi that I realize what you are saying in that with 49% satisfied with their current therapy it might minimize market potential to start with, but with education they can indicate that of those who tried OLC 79% preferred it and it might behoove someone to at least try it, even if they are satisfied with current therapy they more than likely will end up preferring OLC if they try it.

What a convoluted post, Sorry. Typed this while frantically watching England defeat the Netherlands in Euro 2024 semis. That is a tough job, because their opponents are stacked - Netherlands, Holland, the Dutch.

[rosemountbomber]

They may have been satisfied with prior therapy but 79% preferred OLC.

[Whalatane]

Thx for the info .
Being the Debbie Downer that I am ....what I didn't like was

while 49% were satisfied with their prior therapy.

The prior therapy most were on is the generic Renvela ....which is cheap ......so there goes half the market potential .
Of the 51% that weren't satisfied with their prior therapy ...how many are willing to pay for Brand OLC ?

Theres also a suspicion that the Co is using these upgrades to sell stock / raise funds ....either way they need to get the PPS over $1 or face a Naz delisting by EOY.
Theres probably a market for OLC provided the Kidney Patient Act pass's ....just not as large as I'd hoped for .
JMO
Kiwi

[ErnieBilco]

6 analysts moved UNCY up to outperform

[molee]

Unicycive Therapeutics Announces Initial Positive Patient Satisfaction Findings from Pivotal Clinical Trial of Oxylanthanum Carbonate (OLC)

– Patients preferred OLC more than 4 to 1 over their prior phosphate binder therapy –

– Median daily pill burden reduced by half after switch to OLC –

LOS ALTOS, Calif., July 10, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced the initial results from the patient reported outcome survey conducted during the UNI-OLC-201 pivotal clinical trial. The positive top-line results from the oxylanthanum carbonate (OLC) trial in patients with hyperphosphatemia who have chronic kidney disease on dialysis were reported on June 25, 2024.

The patient reported outcomes are being evaluated from a satisfaction questionnaire that was a pre-specified exploratory objective of the study. The questionnaire surveyed patients in the UNI-OLC-201 trial to assess characteristics of their current phosphate binder as compared to OLC after switching medications. The questions included patient satisfaction, ease of use, and preferred therapy and were taken at the start and conclusion of the study. In the survey, OLC consistently outperformed the other phosphate binders in all categories: 79% of patients preferred OLC while 18% preferred their prior therapy, 98% of patients said that OLC was easy to take compared to 55% for their prior therapy, 89% of patients said they were satisfied with OLC while 49% were satisfied with their prior therapy.

“We are gratified by the encouraging patient reported findings from our pivotal trial that mirror the better-than-expected topline clinical results that we reported last month,” said, Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “In the design of our pivotal clinical trial for OLC, we believed that it was important to consider the patient perspective and the personal challenges that they face in managing their hyperphosphatemia. Importantly, the results showed that patients preferred OLC greater than 4 to 1 over their prior phosphate binder therapy. Our focus is now directed toward filing our New Drug Application and making OLC available to patients who may benefit from its potential best-in-class profile, if approved.”

Pablo Pergola, MD, PhD, Research Director, Clinical Advancement Center, Renal Associates, P.A., and principal investigator for the UNI-OLC-201 trial, commented, “In this clinical study, our patients stated a clear preference for OLC over their prior phosphate lowering therapies. This positive patient reported experience with OLC is encouraging because hyperphosphatemia outcomes are often negatively impacted by non-adherence to phosphate lowering prescriptions due to side effects and high pill burden. At the end of the study, several of my patients asked not to be put back on their prior phosphate binder.”

Background

Patients screened to enter the trial were taking the following phosphate binder therapies (n=128): 52% Renvela® (sevelamer carbonate), 19% PhosLo® (calcium acetate, 15% Auryxia® (ferric citrate), 13% Velphoro® (sucroferric oxyhydroxide, and 1% Other. Once patients were enrolled into the trial, they went through a washout period for two weeks to clear their current phosphate binder from the body.

Key Findings

Preferred Therapy: In response to the question: Based on your experience in this clinical trial, do you prefer your current phosphate binder or OLC, 79% preferred OLC, 18% preferred their prior phosphate binder, and 3% preferred neither.

https://ml.globenewswire.com/Resource/Download/9a233ce4-0844-4e63-b22e-650fa9d140b6/image3.png

Ease of Use: In the trial, the median patient pill burden on OLC was reduced by half compared to their prior phosphate binder therapy. The pill burden on prior therapy at screening was a median of 6 (mean 6.5) pills per day. On OLC, the pill burden at the end of the study was a median of 3 (mean 3.9) pills per day.

In response to the question: My current phosphate binding medication is easy to take, 55% of patients agreed, 41% disagreed, and 4% neither agreed nor disagreed. In response to the question: Oxylanthanum carbonate (OLC) is easy to take, 98% of patients agreed, 1% disagreed, and 1% neither agreed nor disagreed.

https://ml.globenewswire.com/Resource/Download/39ea3031-e96f-488a-9212-331b53aa376f/image4.png

Patient Satisfaction: At screening, less than half of the patients in the study agreed with the statement, I am satisfied with my current phosphate binder medication. At the end of the study and after switching to OLC, 89% of patients agreed with the statement, I am satisfied with oxylanthanum carbonate. Only 6% expressed dissatisfaction with OLC.

https://ml.globenewswire.com/Resource/Download/1f4d052e-09f9-4043-bc89-b34cdc87ddcc/image5.png

The initial findings from the Oxylanthanum carbonate (OLC) pivotal trial satisfaction questionnaire are preliminary and subject to change based on further detailed analysis. Full survey results are expected to be presented at a future medical conference.

[Whalatane]

OT. for those interested ...EWTX EDG-750 P1 data due Q3 chk that board for more details
UNCY and ARDX ---watch for passage of the Kidney Patient act ...currently before the Senate
Kiwi

[ErnieBilco]

Looks like most sellers are bailing out or will hold less than 1% while there are 5 funds that are selling a little but maintaining their 9.99% stakes so that equates to still having 50% institutional holding shares.

[molee]

Do we have any idea what those shares cost the owners ?

Company will still have to raise money it seems .

[rosemountbomber]

Are you seeing the price at 45 cents?

Thanks for posting by the way.

[Whalatane]

04:19 PM EDT, 07/05/2024 (MT Newswires) -- Unicycive Therapeutics ( UNCY ) on Friday filed a registration statement for the potential sale of up to 50 million shares by selling stockholders from time to time.
The company won't receive any proceeds from the sale of shares.

In case you're wondering why the PPS is down 9%
Kiwi

[molee]

$UNCY ... Found on Fidelity :

BRIEF-Unicycive Therapeutics Entered Into First Amendment To Manufacturing & Supply Agreement With Shilpa Medicare
REUTERS - 4:21 PM ET 7/2/2024
INVESTMENT NEWS
Email Facebook. Twitter. LinkedIn. Print
July 2 (Reuters) - Unicycive Therapeutics Inc ( UNCY ):

* UNICYCIVE THERAPEUTICS ( UNCY ): ENTERED INTO FIRST AMENDMENT TO MANUFACTURING & SUPPLY AGREEMENT WITH SHILPA MEDICARE

* UNICYCIVE THERAPEUTICS ( UNCY ): UNDER AMENDMENT, CO TO MAKE BINDING PURCHASE ORDER FOR TABLETS OF OLC, SHILPA AGREED TO DELIVER SUCH ORDER BY JUNE 30 2025

* UNICYCIVE THERAPEUTICS ( UNCY ): ALSO AGREED TO ORDER ADDITIONAL TABLETS FOR DELIVERY BETWEEN DEC 31, 2025 & JUNE 30, 2026

* UNICYCIVE THERAPEUTICS ( UNCY ): AGREED TO PROVIDE CERTAIN FUNDING TO SHILPA FOR NEW MANUFACTURING LINE Source text for Eikon: Further company coverage:

[Whalatane]

Aside from other issues ...The Kidney Care Act is looming large for all Co's selling new dugs to the dialysis population ...see my posts on ARDX which had a melt down today

[Whalatane]

Big sell off in a lot of biotechs due to Bidens USA today article about expanding Medicare negotiations for up to 50 drugs .
PBM's drive the cost of drugs in the US ...needs to address that
Kiwi

[rosemountbomber]

This (49 cents) might be it. Not very big volume.

[molee]

How far down will "they" push it this time ???

[Whalatane]

Well some forced buying as its going into the micro cap fund ...and theres also this
BENZINGA
12:12 PM ET Jun-25-2024
HC Wainwright & Co. analyst Ed Arce reiterates Unicycive Therapeutics (UNCY.NaE) with a Buy and maintains $4.5 price target.

Kiwi

[rosemountbomber]

More than average volume after only 1 hour.

[sethjohn911]

I sold that little pop for profit so i got some loss back, I will only trade this in and out till we get close to PDUFA they need more money so I expect them to give shares away and cash the price like the always do.

[Whalatane]

Well U called that right on ....short covering , dead cat bounce ...whatever does the trick
Kiwi

[sethjohn911]

Picked up a few today, think this is just too over done, it's still a huge drug and NDA is supposed to be here sooner than later according to CC call they had. But I am glad I stopped out when I did, or I would have lost a huge amount of cash, should get a dead cat bounce here.

[rosemountbomber]

This business of 106 enrolled down to 71 evaluable patients in the study. So I still have not been able to listen to the Q&A to see if that question was answered, but looking at a slide presentation, makes me a little less concerned.

106 were enrolled, but they all had to go through a washout period that lasted up to 3 weeks. At the end of this period, only those whose serum phosphate levels were over 5.5 were then titrated. Those whose serum phosphate levels remained below 5.5 were considered "washout failures" and were not permitted to proceed in the trial. See page 12:

https://d1io3yog0oux5.cloudfront.net/_15f6b57fd286e47b8a141ca0970ba257/unicycive/db/1912/17749/pdf/OLC+201+Topline+Data+Presentation+-+Final+-+6.25.24+.pdf

[molee]

Since you mentioned it , I checked :

"Item 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year.

On June 20, 2024, stockholders of Unicycive Therapeutics, Inc. (the “Company”) approved an increase to the number of authorized shares of the Company’s common stock from 200,000,000 shares to 400,000,000 shares as set forth in the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on June 20, 2024. On June 21, 2024, the Company filed a Certificate of Amendment (the “Amendment”) to its Amended and Restated Certificate of Incorporation with the Delaware Secretary of State to increase its authorized shares of common stock from 200,000,000 shares to 400,000,000 shares."


https://www.otcmarkets.com/filing/html?id=17645573&guid=jXO-knJPBAGaJth

[rosemountbomber]

Appreciate it

[Whalatane]

RMB. Sorry to hear
Kiwi

[rosemountbomber]

Tried this morning and couldn’t get it to work. Frustrating. Last couple of hours in the middle of shocking news of the sudden death of wife’s very close friend and co-worker back in Fl. No information as to what happened and we are thinking it had to be something sudden like HA or aneurysm. 61 years old.

[Whalatane]

Did you find out the reasons why 106 patients were enrolled , but only 71 evaluated ?
Figure these patients are getting the med for free during the trial .....2 wks wash out then 4 wks ? on OLC ...but they lose roughly 25% of the enrollment during this short period ??? Raises questions on market acceptance assuming FDA approval.

I did see a tweet ( X ) that they intended to double the existing share count ...which I assume means a 50 % dilution .....not sure how reliable that info is.

Did U ever get the Q & A part of the CC working to listen to ? Q&A's is usually the only part I find worth listening to on CC's

RLZT ...insider open market purchase today I think

Kiwi
PS. post by Ernie on the ARDX board says UNCY doubled the share count

[rosemountbomber]

Yeah I did find that to be a rather incredulous statement, but I guess that means that he also can’t figure out the reason for this beating, so just uses the standard go-to profit taking

[molee]

"Profit-taking" ??? Who the hell is he kidding ???

[rosemountbomber]

Saw this on another board so can’t vouch for accuracy but no reason to not believe:

“Maxim Group analyst Jason McCarthy maintained a Buy rating on Unicycive Therapeutics) yesterday and set a price target of $4.00.
Jason McCarthy has given his Buy rating due to a combination of factors surrounding the performance and potential of Unicycive Therapeutics’ oxylanthanum carbonate (OLC). The positive results from the UNI-OLC-201 pivotal trial, demonstrating the safety and tolerability in patients with chronic kidney disease (CKD), exceeded expectations. Despite a recent drop in UNCY shares, which McCarthy attributes to profit-taking, the impressive trial outcomes suggest a strong case for FDA approval and subsequent filing in the third quarter of 2024. These developments, along with the drug’s potential to become a leading phosphate binder, provide a solid foundation for the Buy rating. Moreover, McCarthy’s optimism is bolstered by OLC’s performance in studies, notably outperforming fosrenol with a lower discontinuation rate due to adverse events. With approximately 90% phosphate control achieved in trial participants, OLC’s efficacy is evident. Additionally, the drug’s formulation as easy-to-swallow tablets positions it competitively in the market, potentially enabling it to capture significant market share from current treatments. McCarthy’s analysis suggests that OLC’s approval could disrupt the phosphate binder landscape, which underpins the positive outlook for Unicycive Therapeutics’ stock.”