UniCycive Therapeutics Inc (UNCY)

[Whalatane]

Ha. yes ....This place used to have great Bastille Day breakfasts .... mountain bike ride in
https://www.westpointinn.com

They still do

Pancake Breakfasts
Dates for 2024:
May 12 (Mother's Day), June 16 (Father's Day), July 14, Aug 11, Sept 8, Oct 13
?

Kiwi

[Whalatane]

Depends on how well it succeeds . ...ratio of mild / medium / extreme toxicities ....
Kiwi

[rosemountbomber]

So you’ll hold off on predictions until Bastille Day.

[rosemountbomber]

But if trial succeeds, wouldn’t the dilution be more than offset offset by the sales opportunity?

[Whalatane]

By the way. Cash Position

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

Co is losing about $20m a Qt running this trial ....so expect an immediate cash raise ...or warrant holders exercising some of their warrants if stock really pops on results .
Either way ...Co will need $ almost immediately if this trial succeeds . If it doesn't it's a wipe out .

Kiwi

[Whalatane]

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.

So the more patients in the trial the better ability to identify those who have " mild toxicity " .....and that " toxicity " is no worse than the current binders they're on .

Kiwi

[Whalatane]

RMB. No data is not late based on link provided by Mr Mister .
It will probably take them 4-6 weeks to " clean " , chk data etc even tho its all thru US Renal centers , so we may not see data until mid July .

By the way I thinks its a positive they enrolled more patients . FDA always wants more data on a drug that might be used by thousands and it also enables Co to identify sub groups that may tolerate the expected nausea side effect better.
Larger numbers should create more ethnic diversity and may be a sign that once some dialysis patients tried the drug and adjusted others wanted in on the trial .
Remember these folks are all sitting together 4 hrs at a time 3 days a week getting dialysis

Some will criticize increasing the trial size as data mining ...but I think it's a good thing.

Kiwi

[Whalatane]

THx ...I hadn't seen that
Kiwi

[rosemountbomber]

So Kiwi if trial really ended May 29 (I know hard to trust anything on CT site) can we now say that the results are not terribly late?

[Mr.Mister]

https://classic.clinicaltrials.gov/ct2/show/NCT06218290

update posted today.

106 participants.

I guess trial ended May 29th

[rosemountbomber]

Monday morning would be good news - usually so let’s hope for that.

[Whalatane]

RMB. re predictions ....I predict I am going to be really pissed off if they don't release the trial data before open on Monday .
Kiwi

[Whalatane]

Enough already ...publish the trial data ...good , bad or indifferent
Kiwi

[Whalatane]

Re RZLT. CFO buying into the raise ...open market purchases
http://archive.fast-edgar.com/20240614/AP2HR222E222H9V2222M2ZO2NA9TZ222B262/

UNCY ...given up predicting anything ....except predicting I'll sleep in past the market open ...once data is released :--)

Kiwi

[rosemountbomber]

I was thinking of your morning prediction. Morning releases are usually good news whereas after market releases, especially on a Friday night, are bad. I certainly hope this is not the case here tonight.

Hope we get more clarity on the RZLT capital raise.

[Whalatane]

Re RZLT ...as I posted last nite ...dont know if you saw it or not ...the OCUL data for DME and the interest they revealed in their presentation yesterday was a surprise ...and almost defeats the purpose of RZLT's capital raise ...if they were doing it for the DME indication.

OCUL up 18% as I type offsetting to some degree todays loss on RZLT

UNCY ...will be pissed if they wait till after the close to announce that the trial failed . Data way overdue IMHO

Kiwi

[rosemountbomber]

Well looks like that didn’t happen. But don’t stop with the predictions. Huge dilution with RZLT but we shall see. CEO fooled me if he was lying about interest in their DME drug. I thought it was a talk that gave confidence in the company but what the heck do I know.

[Whalatane]

Stock is trading as tho the trial has failed . The big surprise will be if it hasn't .
Kiwi

[Mr.Mister]

Now I am curious why this is taking so long. Wasn't tolerability a secondary endpoint during the phase 1 trial?

[Whalatane]

OK. data before the open Friday morning ....my last prediction :--)
Kiwi

[rosemountbomber]

Thanks. Wow for a guy that I am guessing is within a few years of myself your prostate must be great considering you have to wake yourself up at that hour!!!

[Whalatane]

Hi RMB. Tough situation in Vancouver . Good of you to offer support .
UNCY ..wheres the F'n data . Tired of checking before the market opens each day ...5.30 am Pacific time ...geez .
I'm guessing they will PR the data up to an hr before the market opens .

Right now it will be a huge surprise if they release excellent data ...market is not expecting that at current PPS ...JMO

Re AMRN ......if you wanted to buy back the shares at the lowest possible price ...you do it slowly buying into sell off's . You have 6 trading days ( after June 6th ) to do that before you need to disclose . Once a hedge fund picks up on what you are doing its fair game . Or it's a co ordinated play .
Conspiracy theories abound .
AMRN needs to get PPS over $1 for at least 10 days within remainder of this yr ...or its a reverse split ( not pink sheets )

Kiwi

[rosemountbomber]

Hi Kiwi. Our UNCY doesn't seem to be moving much - at least not in an upward direction.
Got back last evening from Vancouver (traffic a bear from north of Seattle all the way down to Tacoma. Surgery was yesterday. I suppose the SWAV technique might have been more useful 3 years ago but not very familiar whether it would have been of any value now. He seems to be hanging in there today a day on from surgery. Like I said after reading mortality data on amputations at that age, I am pretty sure I would not have done it, but hopefully for his sake, my thinking is proven wrong and he goes on to live many more happy years.

As far as Amarin buying back on June 6, it appears doubtful to me (I could easily be wrong) and I say that because looking at the chart the stock price that day was weak.

[Whalatane]

Seth. I need to correct my previous post . Co will have burnt thru more cash then I mentioned running this trial....... so its effectively now valued as tho the trial has failed and is trading on the value of remaining cash on hand.
If the trial were to succeed they would need to immediately raise cash or , if trading above $1 , get cash from the warrants being converted to shares . ( last part is my understanding on how warrants can provide cash to the co ...correct if necessary )

Warrants provide cash to a company in two ways:

Upfront Cash: Companies can sell warrants directly to investors, lenders, or other parties for an upfront cash payment. This allows the company to raise capital immediately by issuing the warrants.

Future Cash from Exercise: When the warrant holder exercises their right to purchase shares at the predetermined strike price, they must pay the exercise price to the company. This provides the company with additional cash inflow when the warrants are exercised.

Kiwi

[sethjohn911]

Bad results will eat that money very quick, it pretty much a 1 trick pony SPAC It would be interesting to know if them warrant holder have R/S protection, they hold 50 million shares at $1.00 that is a lot of money. Dilution stopped this in its tracks, so many warrants overhanging.

[Tom turtles]

This is definitely taking a hurting. Time to start nibbling

[Whalatane]

Seth

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

Assume they are down to $40m cash now with a current market cap of $29m .

A company with $40m cash on hand is currently valued in the market at $29m ??

Even if this OLC trial is a complete failure , they still have Orphan drug designation for their delayed graft function drug UNI -494

This is a small Co . Easy for aggressive short hedge funds to push the PPS around floating things like " they are fishing for results they want ,which is why they increased the number in the trial "

Its a tolerability trial . Patients either adjusted to the med ...or they didn't and dropped out .
Data any day now ...which I've been saying for about a week ..:--)

Kiwi

[sethjohn911]

Well I guess if negative results you have not got far to fall to 20c,

[Mr.Mister]

Don't know if this a gap fill, bad news leak, someone shorting, or someone hedging.

[Whalatane]

Trading at 74c after hrs ...up 16% from the close !!

Now down to 61c .....I give up on predicting anything . :--)
Kiwi

[Whalatane]

Ugh. painful to be long this Co . Some negative spec on twitter ( X )
Not a large position but certainly a slap in the face if this totally fails

Wonder ( once again ) if they'll release data after the close ...its usually before the open
Kiwi

[sethjohn911]

I'm not trying to be funny, but every day this thing is down on high volume? I think many will prob break even if the news is good.

[molee]

How low are these shorts gonna take this thing , eh ???

Averaging down almost on a daily basis = painful .

[Whalatane]

Tough situation . They use Shockwave catheters ( SWAV ) in some of these situations in the US , UK , EU but not sure if it's approved for this use in Canada or even appropriate here
BTK. Below the knee operations
Sorry to hear
Kiwi

[rosemountbomber]

Thanks. Not diabetic. Lifelong smoker and drinker until 3 yrs ago. 3 years ago had blood vessels pulled from all over his body and inserted to the leg. Seemed to work for a while but something happened this past Wednesday - extreme pain and could no longer walk. In hospital was told only 3 options. Palliative care, amputation, or MAID (medically assisted induced death). He is 79 1/2 yrs old. Found info that in these situations that mortality after this surgery is 44%, 66% after 1 and 3 yrs respectfully. Not sure that I would do it as you know that the first year after is going to be a bitch and then life may end. No way to live your last few months but that is strictly my viewpoint. I am here to support and not give advice or my opinions.

[Whalatane]

RMB. Sorry to hear about your BIL. Can U share any info ...is he a diabetic with occluded below the knee arteries .
No problem if you can't .
Kiwi

[rosemountbomber]

Thanks for the link. I will flesh this out a little more when I return home. In Vancouver BC right now as BIL is in hospital with leg amputation surgery today or tomorrow. Not sure I would do it but I am here for support not advice.

[Whalatane]

RMB. I've found problems with clinical trial.gov details before . During the MITIGATE trial I had an email connection with one of the PI's and alerted him to the clinical trials .gov site being slow to update certain things . He corrected in the following week. .
Ceo had said at a presentation late April ..data due in the next few weeks

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

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

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



Kiwi

[rosemountbomber]

That is a good question. Along with it is the other question I have (and this is where I am really confused) When the release says “fully enrolled” are they referring to the new 90 subject amount?

[rosemountbomber]

“Here it says ...expected to have 60 patients . Later we learn up to 90 patients ??? “

Ok, so here is where I am unsure. The dates you use and show I feel are related to when their trial size was only 60. If they added 30 later, surely the end date of the trial gets pushed out. So to me it seems that trial data is not late even if we don’t hear anything by the end of this month?

You thinking that results will be later than what you have been surmising?

[Whalatane]

Clinical trials.gov

Estimated Enrollment : 90 participants

....March 15 th update ...but they announced the trial is fully enrolled on March 7th ( and the trial is expected to have 60 evaluable patients

So if they expected to enroll up to 90 patients but only have 60 to evaluate ....are they anticipating a high drop out rate ??

Kiwi

[Whalatane]

Earlier thoughts on timing of data release

Looking at the trial design ...The secondary endpoints are followed for 10 wks. So full enrollment on March 7th ...plus 10 weeks ...takes us to May 16th before they have all the data
They will have the primary outcome data well before May 16th but how long it takes them to process the secondary outcome data ..????

Unicycive Therapeutics Completes Enrollment in Pivotal Clinical Trial for Oxylanthanum Carbonate (OLC)
March 07 2024 - 4:12PM

Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced enrollment has been completed in the open-label, single-arm, multicenter, multidose pivotal clinical trial with Oxylanthanum Carbonate (OLC). OLC is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
“The completion of enrollment in our pivotal OLC clinical trial is a critical achievement for Unicycive as we strive to bring an improved therapy to chronic kidney disease patients struggling with hyperphosphatemia,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “Positive results from the trial will provide the basis to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA). We remain on track with topline data expected from the trial towards the latter part of the second quarter of this year and plan to file the NDA shortly thereafter. We want to thank the clinical trial participants, investigators, and sites whose significant interest in OLC drove strong recruitment as we pursue the goal of improving treatment options in hyperphosphatemia.”

“In this pivotal trial, we are looking to evaluate the tolerability, safety and pharmacokinetics of clinically effective doses of OLC in patients with CKD on dialysis. We believe the novel characteristics of OLC show its potential to be a best-in-class product to treat hyperphosphatemia by reducing the pill burden volume by more than 4-fold compared to the most prescribed phosphate binder. If approved, OLC will target the multibillion-dollar hyperphosphatemia market and will be a new potential therapy for physicians to administer to their patients,” added Dr. Gupta.

About the Oxylanthanum Carbonate (OLC) Pivotal Clinical Trial

The trial is expected to have 60 evaluable patients. Once participants are enrolled into the trial, they will go through a washout period for two weeks to clear their current phosphate binder from their system. Participants will initially be dosed at 500 mg of OLC three times a day (TID) and be titrated to a clinically effective dose that is defined as the dose required to achieve a serum phosphate range of =5.5 mg/dL. The maximum dose of OLC tested will be 3000 mg/day (1000 mg TID). As a reminder, all approved phosphate binders, including Fosrenol®, are administered on a dose titration schedule based on the control of serum phosphate. Once titrated to a clinically effective dose, participants will then be treated for four weeks to evaluate serum phosphate levels.

The primary endpoint for the trial will evaluate the tolerability of clinically effective doses of OLC in patients with CKD on dialysis. The secondary endpoints will evaluate safety and pharmacokinetics. There is no statistical analysis required to demonstrate efficacy as bioequivalence to Fosrenol was previously established; and there is no other clinical trial required to submit an NDA under the 505(b)(2) regulatory pathway.

Here it says ...expected to have 60 patients . Later we learn up to 90 patients ???


Kiwi

[Whalatane]

Hi RMB. My wife has some patients on Lanthanum ( those who refuse the main generic ...sorry can't remember name at moment ) and says they are on so many meds already they don't want the anti nausea med . So they either tolerate the Lanthanum or not ....OLC is a derivative of Lanthanum.
These patients are often already on blood pressure meds , statins , blood thinners and a hand full of phosphorous binders .

What was interesting to me is how powerful OLC appears to be ....so maybe some will try lower doses ...just enough to get serum Pho below 6
Also ...70-80% of those needing Pho lowering meds ( total US population of around 400,000) ....could get to Pho goal of 6 .....on OLC ...!!!!
75 % of 400, 000 patients ....300,000 patients in the US
If 2/3 rds can tolerate =200, 000 patients ...reasonable priced to the health provider at $10,000 a yr = $2 B peak US revenue
If half can tolerate / adjust priced at $10,000 a yr = $1B US a year peak rev

So many ways to play with these numbers ....all depends on how many can tolerate / adjust to the drug

Kiwi

[rosemountbomber]

Is there not something they could be given along with the drug to keep the nausea at bay?

[Whalatane]

Nope Clinicalrials.gov are notoriously late on updates .
You can work it out from when the Co PR'd the trial was fully enrolled ....follow the trial design re how many weeks etc and you'll see ( from memory ) trial finished as per design about a month ago .
There is only 90 in the trial , all at US Renal centers ...so a month should be enough time to chk , re chk , clean the data etc etc .
Ceo said in a conference about a mth ago that data would be about in the next few weeks ......so it's DUE :--)

Just my take

IMHO ARDX has a problem with their pricing of Xphazoh . Medicare / Medicaid patients can't use the coupon and vast majority of them won't pay the $1,000 a mth copay.

Big risk for UNCY's OLC is the side effects ( mainly nausea ) referred to in the last half of that video

Kiwi

[Mr.Mister]

I'm guessing whenever this website updates is when we can get ready for updated results

https://clinicaltrials.gov/study/NCT06218290

[Mr.Mister]

Nice video.

Seems like ARDX and UNCY should join forces. Both of their medications seem complimentary to not competitive with one another

[Whalatane]

Video 3 https://www.healio.com/news/nephrology/20231110/video-drugs-in-the-pipeline-for-hyperphosphatemia-management

Trial results before Mondays open ???

Kiwi

[Whalatane]

Up 6% after hrs .....maybe data before the open tomorrow ??...it's due

Kiwi

[rosemountbomber]

More than quadruple avg vol so far and prob finish the day with 5x avg volume with no price movement.