Unicycive Therapeutics Inc (UNCY)

Vigil Cash Position: Cash, cash equivalents, and marketable securities were $87.1 million as of March 31, 2025,
And were losing over $20m a Qt
So either sell or a large capital raise .
A P 3 Alzheimer's trial is years and a huge expense .

UNCY will have an approved drug ...best case by end of year . Worst case by mid 2026 ......and will have the cash to get there thru their ATM or a small capital raise .
Apples to oranges comparison

Kiwi

When do most biotech buyouts occur?
Biotech buyouts frequently occur around pivotal stages in a company's drug development, often within 12 months of robust Phase 3 data or FDA approval.
Here's a breakdown of the key timing factors:
Pivotal Milestones: The "sweet spot" for acquisitions is generally considered to be between strong Phase 3 data and the initial stages of product commercialization.
Post-Phase 2 or Pre-clinical: Buyouts also happen frequently after Phase 2 or during preclinical trials, with preclinical deals often being cheaper, according to one study analyzing 5 years of data, a Reddit thread states.
Beyond the Initial Window: While most deals happen relatively quickly after regulatory breakthroughs, some acquisitions, particularly of companies with strong commercial sales or established drug portfolios, can occur well beyond the 12-month window.
In essence, the timing reflects the delicate balance between the promise of a potential drug and the certainty of its clinical success and regulatory approval.


Phase 2 tells them the drug was safe and some window on efficacy .
To take an Alzheimer's drug from P 2 thru to approval is huge $ and huge risk ...Vigil probably didn't have the $ or didn't think they could raise it
JMO
Kiwi

Sanofi bought vigil way before vigil Alzheimer’s drug was approved…in fact I believe it was still in phase 2 of trials back in May when the offer was made

Re . I would be quite happy with $30 if it was relatively quick

WOW ...you are funny ...glad you conditioned it on being :"relatively quick "

OK. I'll accept 6X on my investment ..provided it's done relatively quickly ....:--)
Glad you aren't to demanding
Should I add a "chop chop "to that ...where did that come from ?
Well if you had an English sailing back ground you might have grown up with it

Kiwi

Well, looking at analysts' targets. I see the avg target is $63.  Heck I see the low target at $30. I have to assume those are NOT based on a BO.  I would be quite happy with $30 if it was relatively quick

Well a little on buyouts ...JMO
Very unlikely anyone buys before FDA approval .....because of what happened with ZSPH and their drug for high serum potassium used by dialysis patients .
ZSPH had done the trials etc ..all looked good ...into the last month before the PDUFA date ( just like UNCY ) ...AZN submitted an offer that ZSPH accepted ...and then
Yes a warning letter followed by a CRL for manufacturing issues .
Now I'm not going to tell you how long it took AZN to resolve those issues
RMB / Denisk ..if you're reading this ...Chromosome on the AMRN board was IIRC working for ZSPH during this period .

Vivo Capital is IMHO controlling / influencing anything to do with buyouts .
They have the controlling stake in SLNO .....my biggest F up of the year . Owned at $3 , sold in low $20's and its now trading at ...don't tell me
You would have thought they would have sold it by now ...but projections for sales keep increasing and they seem in no hurry to cash in .
But when they do it will be HUGE

How do you project sales in the first year in the US
Its 100% covered by Medicare and dispensed by the MD treating you in the dialysis clinic ...no prior approval hurdles , no trip to the pharmacy .
Your MD says ..".well here you go ...your 3 large pills per meal of Renvela ..or your 1 small pill of OLC per meal . OLC is 100% covered "
Which do you want ?

Would you want to sell the Co before you had a sense of how fast the uptake would be ?

Kiwi

Waiting for European approval for olc before any buyout….hope not …..that can take years from now ….but you make a good point for optimum share price

RMB. I doubt Vivo Capital ( their main financial backers ...also have someone on their BOD ) will entertain any offers until OLC is approved and possibly a start on EU approval is underway .
Then any of the large pharma's already distributing to dialysis clinics are candidates since OLC will be dispensed thru dialysis clinics .
At least in the US anyway assuming the new binders stay in the dialysis bundles .

In the EU and UK it'll be different so a Co that sells Valtessa ( for high serum potassium ) might be a candidate ...like Vifor Pharma ( including Vifor Fresenius Medical Care Renal ) . Fresenius is big in Renal care and I think are now part of Vifor .
By the way Valtessa is widely used throughout the EU ...as compared to Amarins, Vascepa for example .

IMHO the EU / UK are likely to be better markets due to up to 10 yrs of exclusivity and those health providers providing better coverage
JMO
Kiwi

My response to a post re UNCY on Dew's board
Whalatane
Re: alertmeipp post# 255665
Tuesday, July 15, 2025 4:45:59 PM
Post# of 255666
UNCY. Thx for checking it out . The questions is ...will this be a Class 1 or Class 2 re submission ?
Class 1 OLC is approved by end of year
Class 2 requires the FDA to inspect / re certify the manufacturer ...so looking at early 2026 for approval.
Good news is that , as you said , it's a packaging issue . Everything including the manufacture of OLC ( the drug ) in power form was fine .
Really comes down to whether or not the FDA wants a re inspection ...and that we may not know till late Aug / Sept.
Odds according to ChatGPT favor a re inspection .

During the conference the Ceo mentioned how TDAPA was a tail wind for drug uptake once approved..
I've mentioned this before ....OLC will be dispensed in the dialysis clinic and 100% covered by Medicare for the first 2 yrs and 75% in the 3rd year .
So rather than taking up to 3 pho pills per meal , these dialysis patients will be offered OLC which is 1 small pill per meal ...swallowed .
Most of these patients aren't at pho level goals so fewer , smaller pills is expected to increase adherence .

So the question is when to add ?
Add soon on any retest of the recent low ...betting on a Class 1 re submission .
Or wait for the stock to tank on a Class 2 re submission .
Any opinion ?
Kiwi

All start up drug companies should be looked at as potential buyouts…..I was in vigil when sanofi bought them a few months ago….let the small start up go through the expense of clinical trial to prove a new drug is worthy and then have a larger pharmaceutical buy them and reap the rewards of the revenues…..in Uncy case having a EU pharmaceutical like norvatis or sanofi buy them it will expand olc patent length in Europe vs. USA …..let the bidding start….

I'd like to hear more about this BO some posters here are mentioning. Added today as well

I am doing the same, adding small amounts, including this a.m. at $4.66, etc. Hopefully, we get some kind of positive news by mid to end of August.

Thanks again Kiwi…you da man ….been adding small amounts regularly as sp goes down…..YES for EU buyout…..hello Novartis, Sanofi

Stumble They have a $50 m ATM established Nov 2024 .
They are limited to how much they can raise via the ATM per year .
In Q1 2025 they sold 4.5 m shares and raised $2.7m . We won't know if they have raised more $ until they file their Q2 report which I think is August 15th .
That report should also give you the outstanding share count
They talked about delaying the hiring of sales staff etc to conserve cash .

I dont think they have a cash issue unless approval is delayed into 2026 .
They also have the option of licensing OLC for other countries as a way to generate $ ...EU , Japan , Korea for instance ...however I expect them to keep the EU as part of eventual sale of the Co .

Co has to have the Type A meeting and find out what the FDA wants
Address those issues and re submit the NDA
Wait for the FDA to advise weither it's a Class 1 or Class 2 re submission . Class 2 requires a re inspection and puts us into 2026

Kiwi
Some info above via ChatGPT

Any idea how many shares were offered in the ATM….and approximately what then is Uncy outstanding share amount with this addition

Thanks for the fed back guys

The chat just finished. In my opinion Dr. Gupta did a superlative job addressing the CRL issue and the potential for delays. I'm much more confident that we're looking at a Class 1 re-submission and should be approved in the fall.

My notes from the presentation .
Should have response from the FDA re Type A meeting by Aug 15th .
Timeline is totally up to FDA .
Indicated problem was more a shipping / package issue with one of their vendors ...not the manufacture of the OLC powder itself ( before its made into pill form ) .
Said their 2nd vendor ..no problems and in good standing ...but up to FDA if a re inspection is required

Explained how TDAPA provided a tail wind . 100% reimbursed for first 2 yrs then 75% for the 3rd yr /
Mentioned ATM briefly near close ...had $ to mid 2026 ...easily enough to get them thru approval

Kiwi

Unfortunately those who pay for Wainwright promos generally do not do well after the staged event, but maybe this one will be different.

I see news links that the fireside chat with Gupta is today but others tomorrow the 15tn?

Ya there’s a couple others too….comes with the territory

ambulance chasers coming: Pomerantz LLP is investigating claims on
behalf of investors of Unicycive Therapeutics, Inc

Hope Gupta comes clean today at the fire side chat

We'll know more tomorrow: LOS ALTOS, Calif., July 07, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that Shalabh Gupta, M.D., Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright 4th Annual Kidney Virtual Conference on Monday, July 14, 2025 at 11 a.m. ET.

A link to the webcast may be accessed on the Unicycive website under the Investors section: Events and Presentations.
https://ir.unicycive.com/news/detail/105/unicycive-therapeutics-to-present-at-the-h-c-wainwright

Thx but re .you’re the man to go to for knowledge I'll have to disagree .
UNCY's PDUFA date was June 28th and I had assumed that once we were in June, we were home free .
Not the case
Poster Denisk had mentioned IIRC the risk cGMP issue ....and I dismissed that .....once we were in June.

It turns out the FDA often conducts pre approval inspections just 1-2 mths before PDUFA and that a form 483 / warning letter almost always leads to a CRL .
The warning letter came on June 10th ...just 18 days before the PDUFA date .
This left UNCY little time to effectively respond / fix the issue and made the CRL inevitable

The only positive I can find regarding our current predicament is that the second manufacturer has already been identified as having produced OLC... and has a good history with the FDA .

Kiwi

Thanks that’s similar to what I read also…..you’re the man to go to for knowledge…..always appreciate your input

Stumble If an inspection of a manufacturing facility is required ...either to re certify the original or certify a new manufacturer ...its almost always a Class 2 re submission .
Just my understanding of the process

However Grok 3 might agree with you
Analysis of Resubmission ClassificationThe CRL focuses exclusively on cGMP deficiencies at a third-party manufacturing vendor, not on the drug’s efficacy, safety, or clinical data. This suggests that the resubmission will likely involve addressing manufacturing-related issues, such as:Providing evidence that the second manufacturing vendor complies with cGMP standards.
Submitting updated CMC documentation to reflect the new vendor or corrective actions at the original vendor.
Potentially providing validation data for the manufacturing process at the new vendor.

The classification as Class 1 or Class 2 depends on the complexity of the corrective actions:Class 1 Resubmission (2-month review): If the FDA determines that switching to the second manufacturing vendor requires only minor updates to the NDA (e.g., updated CMC documentation, vendor qualifications, or batch records) and no significant new data (e.g., new clinical or stability studies), the resubmission would likely be classified as Class 1.
The fact that the second vendor has already produced OLC drug product suggests that minimal additional validation may be needed, supporting a Class 1 classification.

Class 2 Resubmission (6-month review): If the FDA requires extensive new data, such as additional stability testing, process validation, or significant manufacturing process changes, the resubmission would be classified as Class 2. This could occur if the second vendor’s processes differ substantially from the original or if the FDA requests additional assurance of manufacturing consistency.

Given that the CRL explicitly states no concerns with preclinical, clinical, or safety data and that Unicycive has a second vendor ready, the resubmission is likely to involve straightforward CMC updates rather than extensive new studies. This leans toward a Class 1 resubmission. However, the final classification depends on the FDA’s feedback during the Type A meeting, as the agency may impose additional requirements (e.g., new stability data or inspections of the second vendor).


Kiwi

Reading the different between a class 1 and class 2 filing ……there is no reason it should be a class 2

Thanks for all your info Kiwi.  UNCY should send those study details to ARDX - so as to get them thinking about BO.  But they are probably aware.  

Some more thoughts on a Xphozah / OLC combo
https://ir.unicycive.com/news/detail/94/unicycive-therapeutics-announces-the-publication-of

Study was in rats so obviously would need human trials for side effects
but impressive data so far
Treatment with tenapanor in combination with OLC demonstrated a more pronounced 41.3% reduction in urinary phosphate excretion compared to vehicle.
The combination of OLC and tenapanor was synergistic and statistically significant (p=0.009 for 0.75% OLC + tenapanor and p=0.010 for 1.5% OLC + tenapanor).

Kiwi

I just read a CRL from another ticker(can't remember which one) but it laid out the full scope of the CRL for all their shareholders to view and make decisions on.

I don't understand why UNCY management is so against letting shareholders know the full scope of the situation. IT IS BOTHERSOME FOR ME.

Found the ticker mentioned above:
MIST
https://www.otcmarkets.com/filing/conv_pdf?id=18607425&guid=iCi-k6amqswfJth

Much more informing than the generic one put out by UNCY.

Just some quick comments ...from memory
5 yr US exclusivity starts on FDA approval ...I expect the patents to be challenged after that
10 yr exclusivity is possible in the EU
OLC is about 1/3rd of the cost of Xphozah ....and is 100% covered in TDAPA for the first 2-3 yrs ( although there might be a small copay )
ARDX has a CMS appeal hearing coming up this fall . That decision will also affect UNCY .
From a patients perspective , the ideal combo is Xphozah in the am ( lowers serum pho and reduces constipation - common complaint from those on these pho binders )........ and OLC with lunch and dinner ( smaller daily dose so lowers risk of nausea ).
This has lead some to speculate that ARDX should buy UNCY

CRL's are confidential communications and unlikely UNCY would publish in full .

Next catalyst IMHO ...weither its a Class 1 or Class 2 re submission

Kiwi

Plus, Kiwi would be knowledgeable about this, but I worry with amount of time that ARDX comes to some agreement with Medicare which impacts our ultimate sales growth.  

I agree with your timeline and don't intend to pull the plug. I had high hopes or dreams there might be an expeditious path. I based that on the tenor of the company's two announcements regarding the GMP compliance and CRL. I read them over and over again and came away believing this wasn't going to drag on for an eternity. I also had hopes this was a new and improved FDA, that they wouldn't be standing in the way of drugs being approved. Let's all pray for a Class # 1 filing.

Better not take that long just another year taken away from there olc patent protection

Well count me in.  Not thrilled that this may take 12 to 18 months to get squared away but nothing wrong with the drug or efficacy (we haven't seen the CRL mind you).  

Well Stumble its at least you and I till the end ...at least till FDA approval .
My guess is that if it's a Class 2 re submission .... stock will retest ( at least ) recent lows ..at which time I'll add
What should've been a $15 - $20 stock now ...is instead at $4-$5 stock ...all because of a cGMP issue that may take a year to resolve.
Oy vey
Kiwi

Been buying since march 2024 I can wait

That was my point. This looks likely.

I'm waiting to see if its a Class 1 or Class 2 resubmission .
Class 1 and stock will rally
Class 2 and stock may tank
JMO
Kiwi

Risk is the stock will tank if they need to do Class 2 resubmission ...then you're looking at early / mid 2026 for approval .
Sorry ...just telling it like I see it
Kiwi

Kiwi….I’m with you …adding as it goes down….just picked up some more today ….🤞💰

Gupta has already referenced finding a new backup mfgr , so I'd assume class 2.
What do you think? Hopefully someone will put his feet to the fire when he gives his talks next week.

Well after some more DD on cGMP issues ..via ChatGPT
Fast turnaround in 3-6 mths assuming no re inspection is required and the Co can submit a Class 1 resubmission ( minor changes ) and the FDA assigns a 2 mth review clock.
A Class 2 resubmission is reviewed in 6 mths .
If a re inspection of a manufacturing site is required ...add an additional 3-9 mths
Ugh

So here's hoping for a Class 1 resubmission
Examples of Class 1 resubmissions
Corrected batch records
Minor manufacturing issues that dont need re inspection

Class 2 is switching manufacturing facilities etc

So we wait for the Co to tell us .
Will this be a Class 1 or Class 2 re submission ?


Kiwi

Re If we're still waiting for our drug to be approved in October I'll be pulling the plug on investing in the biotech sector.

UNCY received their CRL on June 30th .
Assuming they requested their Type A meeting in the following week ...ie by July 4th .
FDA typically acknowledges the request within 14 calendar days.
Then the FDA usually sets the meeting within 30 calendar days of the original request ...ie by August 4th .

If we allow UNCY 90 days to respond to the specifics of the Type A meeting and for the FDA to be able to inspect and approve the back up manufacturer or original manufacturer ...we're at around Nov 2nd .

So I'd hate to see you " pull the plug " in October and OLC being approved in Nov. .
Maybe we retest the recent lows as investors lose patience .
I'll add under $5 ...preferably on a retest of the recent low .

JMO ...I could be totally wrong on this . It may take longer to get FDA approval . But buying in when others have " pulled the plug " on a drug that IMHO will eventually be approved... seems a low risk bet on a positive ROI

Kiwi

OT-VKTX - Thanks, didn't know there was a shorter term potential catalyst. They started ph3 in June which will last 78 weeks I believe. I'm a little cautious here because I saw what happened in RVNC, an analogous space and who similarly had a superior product - but not the management to get 'er done.

Fred they're going to be releasing their Phase 2 data for VK2735 very soon. The 13 week study completed enrollment in late March. They're always quick to release the data and conclusions. Hopefully they maintain best in class, it's become a crowded field. Here again the insurance coverage may be non-existent so it'll become a volume play...sound familiar AMRN holders?

OT - VKTX is showing signs of life but I think it's probably just reflecting the macro trend at the moment. Lots of biotech has moved higher in recent days.

The reason the market didn't react is because this is just theatrics. In the end you might see 5-10% tariffs here there and everywhere. That will be hailed as total victory. Remember 90 deals in 90 days? We're at a couple quasi deals and slowly counting. My real concern is the self inflicted workforce shortage at the FDA. If we're still waiting for our drug to be approved in October I'll be pulling the plug on investing in the biotech sector. Also on publishing the CRL I've never seen that done before. No company can risk upstaging the FDA. Imagine if the compliance issue(s) are bogus nonsense. Which wouldn't surprise me.

Fred, you in VKTX as well?   Bouncing around the bottom for a while but seems to be waking up the last couple of days.