Unicycive Therapeutics Inc (UNCY) Quote

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.

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

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.

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

Company will still have to raise money it seems .

Are you seeing the price at 45 cents?

Thanks for posting by the way.

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

$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:

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

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

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

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

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

More than average volume after only 1 hour.

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.

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

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.

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

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

Appreciate it

RMB. Sorry to hear
Kiwi

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.

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

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

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

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.”

$UNCY has now hit a new 52 week low ...

RMB. I've listened to plenty of CC's on Safari and never had this problem . Not a good day for them to have this kind of screw up .
Kiwi

Well I can't get it to work either. Won't load at all in Safari and in Chrome it works for 10 seconds and then says not supported. Frustrating. I often say, technology not ready for prime time.

Well there are reasons for warrant holders to short a stock after all

Warrant holders might short a stock for several strategic reasons:
Hedging: Warrant holders may short the underlying stock to hedge their position. This strategy can protect against potential losses if the stock price declines. By shorting the stock, they can offset the loss in the value of the warrants with gains from the short position.

Arbitrage Opportunities: If the warrants are deep in the money and the stock price is expected to remain stable or decline, warrant holders might short the stock to lock in a risk-free profit. This involves shorting the stock and using the proceeds to exercise the warrants, thereby covering the short position at a lower cost.

Leverage and Gearing: Warrants provide significant leverage, meaning small changes in the stock price can lead to larger percentage changes in the value of the warrants. By shorting the stock, warrant holders can take advantage of this leverage to amplify their returns, especially if they anticipate a decline in the stock price.
Market Sentiment: If warrant holders believe the stock is overvalued or expect negative news that could drive the stock price down, they might short the stock to profit from the anticipated decline. This speculative strategy can be risky but potentially lucrative if their market predictions are accurate.

Early Exercise and Forced Sales: In some cases, such as with Special Purpose Acquisition Companies (SPACs), warrants might be called for early exercise. If warrant holders expect this and believe the stock price will drop after the warrants are exercised, they might short the stock to benefit from the expected decline.
These strategies involve significant risk and require careful consideration of market conditions and the specific terms of the warrants.


Kiwi

Why would the warrant holders short it ?
I think the warrants had an exercise price of $1 .....so If market had ramped the PPS to $2 on the trial results , the warrant holders could have exercised their $1 warrants ( bought the stock issued by Co for $1 even tho existing stock was trading at $2 ) ...essentially doubling their money and also flooding the Co with cash reducing the risk of a capital raise.
Not an expert on warrants but I think thats how it's supposed to work .
The fear of dilution is real ...Co will need cash
JMO
Kiwi

Thx RMB. re In the study, 106 patients were enrolled, of which 86 patients entered titration and were followed as the Safety Population. Of the 86, 78 entered the maintenance period.
106 patients enrolled but only 78 made it to the maintenance period . This was a short trial so to lose roughly 25% of those enrolled fairly quickly ( for whatever reason ) raised questions on how well this drug would be received in the dialysis population .
The CC keeps being dropped as it's not conforming to my browser when I log in ...??? first time thats happened when I log into CC's.....so I wasn't able to follow all the Q & A
If you listen to the CC ...just skip to the Q & A portion

I'm not sure they were able to convincingly explain why they lost roughly 25% of the patients between enrollment and the maintenance phase. .....but as I said I wasn't able to access the entire Q & A

Kiwi

Ain’t that the truth. Bad enough when I guess wrong on the trial results, but to guess correctly and still get hammered. Sheesh.

Man,

Even when I "win" and guess right on clinical data I lose.

ARDX has been my only winner. Thought I could get lucky on UNCY. I guess too many warrants and fears of future dilution are keeping this down. Or maybe the warrant holders are shorting it

Kiwi, does this information help:

"Demographics and Enrollment Summary

In the study, 106 patients were enrolled, of which 86 patients entered titration and were followed as the Safety Population. Of the 86, 78 entered the maintenance period. Of the 78 patients that entered maintenance, 7 patients did not have phosphate control, leaving an Evaluable Population of 71 patients, exceeding the planned enrollment number of 60. Of the 86 patients, the trial enrolled 47 males and 39 females with a mean age of 62. Renvela® was the most prescribed phosphate binder for patients entering the study.

Primary Endpoint - Tolerability:

The objective of the OLC-201 trial was to evaluate the tolerability of clinically effective doses of OLC in CKD patients on dialysis. A clinically effective dose was established when a patient achieved a serum phosphate level ≤5.5 mg/dL. Tolerability was assessed based on the incidence of treatment-related AEs leading to discontinuation from the study in the maintenance period. In the OLC-201 trial, there was only 1 discontinuation due to a treatment-related AE in the Evaluable Population, a rate of 1.4%. In the Safety Population of 86 patients there were only 3 treatment-related discontinuations, a rate of 3.5%. In total, 5 patients discontinued due to AEs in the Safety Population, 3 were related to OLC and 2 were deemed unrelated to OLC.

Secondary Endpoint - Safety:

The secondary endpoint assessing safety was reported as the treatment-related AEs occurring in ≥5% of patients. The safety analysis covered all 86 patients in the Safety Population. Consistent with the AEs observed with other phosphate binders, the AEs were gastrointestinal related with diarrhea and vomiting being the most common at 9% and 6% respectively. There were no treatment-related serious adverse events (SAEs). Six patients experienced SAEs but those were deemed not related to OLC treatment. Most treatment-related AEs were mild to moderate in severity with only 2 AEs reported as severe.

Unicycive continues to assess the pharmacokinetics from this trial and those final data will be included in the NDA package."

It also showed Net Loss: Net loss attributable to common stockholders for the three months ended March 31, 2024 was $21.2 million,
They will have lost at least another $20m-$28m due to running this trial etc in Q2.
So they are down to around 1 qtr cash on hand unless they drastically cut expenses and raise some funds

The CC cut off on me but during the Q & A I think they were trying to explain why 106 were enrolled but only 71 ?? were evaluated . That would create a sell first and ask questions later market reaction .
I'll try and listen to it again

Kiwi

Yes , 1st quarter financials showed $49 mil .

Molee. Was that at the end of Q1 ? Co is losing around $20m a Qt IIRC so now down to $29m ??? . End of trial will mean lower loss rate in Q3 but Co is gearing up for another trial in its other indication ....so a capital raise is inevitable and since stock is trading less then a $1 ...none of the warrants issued will be converted to stock ( generating cash for the Co ) .......so dilution and reverse split ( by end of year if stock stays below $1 ) unless they really bring off a miracle
Bummer
Kiwi

Read on another board where Piper Sandler reiterated the $9 price target. Not sure if that was after the study results came out or not.

On company conference call this morning it was stated they are looking to file NDA in “days, not weeks”.. it was only listed as occurring in Q3 since it is already end of June and Q3 starts just next week.

i.e. NDA filing should be a very near term catalyst.

Wouldn’t be surprised to see it trade slightly higher going into the close.

Financials show cash of $49 million ... ? Not accurate ?

Wow good news and heading for the 52 week low.

Well so much for that $10 price target !!
I listened to part of the CC .. then it cut out in the Q and A

One issue ...They enrolled 106 patients but only 71 were evaluated ?? Of those 71 the tolerability was similar or better than Fosrenol ....but if 106 were enrolled why only 71 evaluated ? ( my first take ...would need to confirm )

Co is also planning to start a new trial in their second indication later this yr

So expect dilution as Co is low on cash
Bummer
Kiwi

Shorts ( yes , shorts ) trying for max pain here .

Blood in the water ...

If the 6% discontinuation rate turns out to be acceptable to the market then this could still be a value proposition here. At 60 cents most everything is already discounted.

The news got leaked yesterday, see the volume, people expected a big run today, prob sold at a loss when it never blasted off.

Expected a bigger jump on news, dilution has killed SH value, and then at the SH meeting they put out more shares. This could have been an epic trade. I'm glad I got stopped out.

Well stock price this morning not acting like we expected. I know that there is a sell the news component, but usually that is when the stock price has risen in advance of the news. Not this.

Guess the market is figuring company will have to raise cash to launch this drug. Why not just sell it?

https://www.stocktitan.net/news/UNCY/unicycive-therapeutics-achieves-study-objective-in-oxylanthanum-4ntewqx6vr56.html

hot off the presses

So for your over the top PPS projection on wildly successful trial data
$10 PT out this morning (1462% upside) from Rodman & Renshaw.
Meanwhile Co is trading as tho trial is a failure ( under $1 )
Info only ....NOT investment advice

Kiwi