UniCycive Therapeutics Inc (UNCY)

[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.
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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

[Whalatane]

Huge Vol once again following Ceo's letter.
I'd like to see an update on enrollment status .
They still state Q2 for pivotal trial results
Kiwi
Ps. chk out EWTX

[Whalatane]

RMB The ARDX move is IMHO all about IBSRELA .....they doubled their estimate of peak sales for that drug / indication from $500m to $1Billion.
They aren't using Xphozah at the dialysis clinics my wife rounds at yet. She says the main issue is problems with insurance coverage for her medicare / medicaid patients . Remember Co wants close to $3,000 a mth for the drug so patients would have a copay of close to $1,000 as I believe they can't use company coupons .
Her patients can't afford that copay.

UNCY ...yes the drug is a bioequivalent to Fosrenol ...a lanthanum carbonate my wife does prescribe.
Issue with the existing drug is the size of the pill , taste as it has to be chewed , and cost vs Sevelamer
UNCY's drug OLC is a far smaller pill , swallowed not chewed with meals ...cost yet to be determined.

Being able to swallow one small pill with meals is seen as a big advantage re patient adherence.
An advantage for the prescribers such as my wife is that its considered almost the same ( but in improved form ) of a drug she already prescribes .

Challenges going forward .
They have to complete final trial with dialysis patients ...mid / late 2024 ...with an acceptable safety profile
After that ...overcome any patent challenges .
My time horizon currently is just to trial results ...will reassess then

Hedge funds definitely piling in given the vol we are seeing
JMO

Kiwi

[rosemountbomber]

Well, I see it is up another 5 cents in premarket (we know premarket can be useless or head fake). I wonder if the ARDX news yesterday buoyed UNCY a bit.

From what I understand the drug binds up phosphate to about the same degree as lanthanum carbonate but only takes up 1/4 of the volume hence making it easier for users (swallowing or less pills). If successful, they will still have a bit of an uphill road to squeeze into the market but with a market cap of only 32 m, and an indication that is quite large, they don't have to have much penetration to see their market cap quintuple at least.

[Whalatane]

Still very heavy vol
Stock up around 55% over past month
MKT cap only $32.2 m ??
Kiwi

[Whalatane]

Schedule 13D must be filed within ten days after a person or an organization acquires beneficial ownership of more than 5% of a voting class of a company’s equity securities

We should know which " whales " went on a buying spree by late next week ..or soon after
Kiwi

[Whalatane]

RMB. Happy , healthy and prosperous new year to you and your family also .
Re UNCY ...( while its fresh )
Recent heavy vol in a holiday week indicates ( to me at least ) a fund like Vivo Capital is increasing their stake.
Vivo is in Palo Alto not far from where UNCY is located.
Re serum phosphorus . High serum phosphorus levels in dialysis patients causes calcification in coronary arteries etc ...so Nephrologists always want their patients to control phosphorus levels. Problem is that most of the current binders to do that are large pills that often need to be chewed following meal ...like chewing chalk I'm told. So patients hate them , compliance is poor . Most don't meet their goals.

ARDX developed Xphozah which is 2 small pills a day . Problems with it is that most experience diarrhea trying to transition to it and Co want close to $3,000 a mth for the frug. At Tier 5 pharmacy level the patient needs to pay close to $1,000 a mth copay ......which will be difficult as most / many on dialysis have limited income due to the fact they are hooked up to a dialysis machine 4 hrs a day ...3 times a week .

UNCY's drug OLC is 1 small pill with each meal that can be swallowed ( not chewed ) , is an improved / condensed version of an existing binder ( Fosrenol ) that my wife currently prescribes to some of her patients .
OLC is the bio equivalent to Fosrenol however the FDA wants a final small trial with dialysis patients as an earlier trial has showed that altho the adverse events were the same in both drugs ...there were more of them in the earlier OLC trial compared to Fosrenol data .

So the final trial is enrolling and the results should be known by end of Q2 2024

My investment is a spec on this trial .
Its high risk .
If the trial is seen as a failure with low prospects of ever supporting FDA approval of this drug ......stock will tank .
If the trial is a success ...the Co will almost immediately raise funds .

I'm hoping for a SLNO like outcome . Vivo Capital is one of the largest shareholders in SLNO . I owned it at around $2 and sold it when it hit $20 on the trial read out ...and declared myself a genius ....however ...:--(
Stock is now trading around $40 and Vivo still owns it

Kiwi

[rosemountbomber]

Thanks a ton Kiwi. Happy, Healthy, and Prosperous New Year to you and yours.

[rosemountbomber]

Thanks a ton Kiwi. Happy, Healthy, and Prosperous New Year to you and yours.

[Whalatane]

RMB. a post on the biotech values board that may answer some of your questions
more DD later

BioBS2012
Re: Whalatane post# 250148
Friday, December 22, 2023 6:21:59 AM
Post# of 250202
Kiwi - I have looked at $UNCY and also keep an eye on it since their last setback which caused it to drop below $1. From my quick take, they are pursuing a 505(2) path to regulatory approval us PK data - with their sales pitch being a reduced pill burden given their technology.
This is really the only claim they can make, as under the regulatory pathway they have chosen, their label will be essentially identical to that of the reference product (Fosrenol). From a pill burden advantage, my take is that they fall in-between the current binders and Tenapanor (XPHOZAH). Some other points to keep in mind

* their current study will finish in 2Q 2024 and NDA filing to follow so lets say 3Q 2024, plus 10 months for approval assuming no CRL - so approval in late 1Q 2025 at the earliest or in 2Q 2025 if it is all smooth sailing.
* based on their cash position at the end of 3Q 2023 they will need to raise capital soon - either following data release or before, but I doubt that the raise would be at prices greater than a $1 so stock is going to hover around here for a while - buy opportunities on the dips if you strongly believe in the company or love to trade.
* management - a few Spectrum alumini in senior roles, so not very comforting. Their commercial guy is up there - only he won't have much to do for at least another year so the Q is - will he hang around?
* from a commercial success, I see the following hurdles (I do not know the answers to these Q's) - how do they prices it vis-a-vis Fosrenol, and other generic binders, once they do get approval? Will insurance cover, based on no clinical advantage over Fosrenol, beyond just a reduced pill burden - where XPHOZAH still beats it?
* the biggest UNKNOWN risk in my view is the following - under the 505(b)2 regulatory route, $UNCV will have to certify that they do not infringe any Fosrenol patents in the Orange Book when they submit their NDA. Takeda will then have the option not do anything (best case scenario for $UNCV), or they may choose to sue for infringement (even they don't think they will win). If Takeda sues, the FDA immediately puts things in the deep freeze for 30 months or until a patent dispute resolution is reached (whichever is earlier).

I think the above covers most of the issues one can use to make their own investments decisions.

Cheers and best wishes for the Holidays to all.

May everyone's investments prosper in 2024 !!

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Kiwi

[rosemountbomber]

Read somewhere (could have been on a Yahoo board) where someone claimed that the CEO has stated he has no intention to rollout the drug after approval but rather sell the company. Do you know if that is true? And does Spectrum Pharma hold the patent for oxylantham carbonate?

[Whalatane]

Huge volume between Xmas and New Years ...whales ( hedge funds ( establishing or expanding positions ) while most are away for the holidays
JMO
Kiwi

[Whalatane]

https://ir.unicycive.com/news/detail/58/unicycive-therapeutics-announces-enrollment-of-first

[Whalatane]

UNCY will either do a reverse split to get in compliance for Naz listing ( trading over $1 by March for I think at least 10 days ) or get more funding to raise its cash on hand / market cap . Their drug is an improved version of Fosrenol ( Lanthanum ) ...1 pill with meals , swallowed instead of chewed ...with is a lot more patient friendly . Fosrenol is not cheap compared to the other phosphorous binders so expect insurance push back for the new improved version if its ever prescribed .
Kiwi

[Whalatane]

https://ir.unicycive.com/news/detail/55/unicycive-therapeutics-reaches-alignment-with-the-fda-on

Kiwi

[Whalatane]

Vivo discloses 9.99% stake as of July 11th 2023 Vivo was a big investor in SLNO .
Co is awaiting guidance from the FDA re their request for more safety data . This could break either way . If FDA wants a new trial stock tanks. If they can satisfy the FDA with in-house data stock probably jumps
High risk
Do your own DD.
Very cheap at current market cap given size of market
Kiwi

[Whalatane]

Does anyone here understand the RA Capital mgt 13 g filing re UNCY

BRIEF-RA Capital Management L.P. Reports 9.99% Passive Stake In Unicycive Therapeutics As Of June 26
REUTERS

It looks as tho their preferred shares will be converted into common stock on July 11th .
Looking for clarity .
I think their drug will eventually get approved , be behind ARDX's drug by at least 10 mths , but will find use by those that don't make the transition with ARDX's XPHOZAH .
Cheap spec buy at these levels ...just over $1
Not much cash on hand so they may need some bridge financing to carry them thru to approval / launch
Kiwi

[The Night Stalker]

watching

[The Night Stalker]

watching

[The Night Stalker]

entry

[The Night Stalker]

rip

[The Night Stalker]

soon

[The Night Stalker]

nice

[The Night Stalker]

slow

[The Night Stalker]

entry

[The Night Stalker]

nice

[The Night Stalker]

slow

[The Night Stalker]

volume spike

[The Night Stalker]

for now

[The Night Stalker]

for now

[subslover]

Two sweet up days in a row! Keep it going

[subslover]

Heading back up!

[harry crumb]

Pullback today, theres alot of profit on the tables to be had $$$$$$

[Alan Brown]

Based on its pipeline value, $1.5 is max. Right now is all bubble.