Unicycive Therapeutics Inc (UNCY) News

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. 

Nice day of gains so far on light volume….needs to keep climbing slowly and establish new higher levels in anticipation of future approval hopefully in a few months ….then explode like PROK

Stumble ..cant find confirmation of the extra O2 molecule but
OLC: Utilizes proprietary nanoparticle technology to enhance phosphate-binding efficiency.
Good chance at least that their back up manufacturer imports the API and does final assembly using proprietary nanoparticle technology here in the US ...or if in Ireland etc, final assembly could be transferred here
JMO
Kiwi

As much as some of us might bemoan the fact, the world is different today than it was 75 years ago.  Just as the world 75 years ago was different from the world 150 years ago. 
Tariffs won't bring back my grandfather nor will they bring back America of the 50's. 
SMH

Stumble its usually the generics that are made overseas.
Brand drugs like OLC sometimes start out being made in places like Puerto Rico ...so would be considered US .
So this Trumps Pharma tariff may actual help OLC price wise ...as the generics like Fosrenol and Renvela that OLC will compete with are almost certainly made ex US ( India , maybe Costa Rico etc )

Well to correct myself
India and China: These countries dominate API production for both brand and generic phosphate binders due to established supply chains and cost advantages. India supplies a large portion of generics to the US market.
US and Europe: Some brand-name binders, especially biologics or complex formulations, may have final assembly in the US or Europe, but even these often rely on imported APIs.
Regulatory Oversight: The FDA inspects foreign facilities, but concerns persist about quality control in some overseas plants, particularly in China.

Maybe their back up manufacturer imports the API and does the final assembly in the US ?
I believe OLC is a complex formulation ...extra O2 molecule added to reduce side effects like nausea


Kiwi

Hello "Sure hope OLC is made in the USA". IMO. I seriously doubt it will be made in USA, but this 200% tariff situation is very fluid right now, and I don't think the market as a whole is pricing that 200% to become a reality any time soon.It looks like the Administration (Presidential office) is just throwing things on the wall to see what is going to stick.

I think I've been in that just after I found UNCY - Take a look at ICU I picked that up about a week ago at .34 avg I like the story of NICU babies using the product and from what I read these babies grow out of their diabetes at a rate of 78% I think I read. Gotta be a winner down the road as adoption increases, I don't understand how it hooks into the dialysis machine but it does.

Sure hope OLC is made in the USA

President Donald Trump suggested Tuesday his administration intends to impose a 200% tariff rate on pharmaceutical imports into the U.S., which would take effect in a year, a major fee that could affect some $200 billion in imports and raise prices on Americans’ medications if it takes effect.

OT. re PROK
The study protocol was amended in 1H 2024 to focus on a subset of patients with stage 4 CKD (eGFR 20-30ml min/1.73m2) and late stage 3b CKD (eGFR 30-35ml min/1.73m2) with accompanying albuminuria (urine albumin-to-creatinine ratio, or UACR less than 5,000 mg/g for patients with eGFR 20-30ml min/1.73m2 and 300-5,000 mg/g for patients with eGFR 30-35ml min/1.73m2).
The total planned enrollment is approximately 685 subjects

So very high risk patients and P 3 underway in the US. This new data will accelerate enrollment

Kiwi

Ernie ...are you in PROK ?

Kiwi

Wow ...why didn't you tell me about it yesterday ..:--)
From a Quick Look ....looks like they are focusing on those with eGFR ( kidney function ) down to dangerously low levels .
At an eGFR of around 20 my wife is thinking how to psychologically prep her patient for eventual dialysis .
Being able to halt the decline at that critical level would be huge for these patients .
They still have to do a P 3 trial and it would probably be a large international trial over several yrs ...
Thx
I'll do some more DD
Kiwi

Maybe. Herr Gupta has a lot of 'splainin' to do.

maybe monday or tuesday next week? After H.C. Wainwright 4th Annual Kidney Virtual Conference on Monday, July 14, 2025

Did you see PROK?

Well I needed 6 days of Anger Management therapy to get past my CRL funk .
Stock should have been $15-$20 on FDA approval ...but here we are .
Maybe we retest the recent low ...but for those with patience ( which for me is challenging ) ...adding under $5 seems a reasonable bet .
Going to spend some time on FULC ...they have some important data due in next few weeks
Good luck
Kiwi

Overblown reaction to the Gaining compliance PR - We all knew they would regain it. The issue that concerns me is when are they going to come clean with the CRL letter? Publish it so we can see what their problems are. CEO keeping this a secret is BS IMO

I meant 3 business days

The problem here is that this exec team is touted by the CEO as having a great deal of experience in getting through the FDA process.

Heck we might see 5.50 today!

I totally agree with your last comment on the CRL due to manufacturing issue, this was completely avoidable and I do hope they have learned their lesson this time.

Note: In their defense this error is often committed by companies with lack of experience with FDA matter, let's not forget the following:
Unycycive therapeutics was formed august 2016
Went public on Nasdaq in July 2021 4 years ago
Phase 1 trial completed in October 2024

Sure The exchanges with the poster on Biotech Values has convinced me of their funding options
They can access $ thru their ATM as needed in small portions up to $10-$15m .
So the slow bleed down to needed capital raise is probably not going to happen .
Sentiment , including my own , seemed very negative and I try and trade opposite to my emotions
OLC will IMHO eventually be approved .
Its just a matter of being patient ...which can be challenging .

Adding below $5
Not investment advice
Kiwi
PS. isn't it 6 days since my "slow bleed " comment ....probably timed the bottom with my most negative post ....which is why I remind myself to trade opposite to my emotions .
Yes I was really frustrated ( to put it politely ) , that they received a CRL due to a 3rd party manufacturing issue

Kiwi So You said on July 2: "So are we at the " slow bleed , death by a thousand cuts" phase now ?".Now you are adding... Change of heart on the tanking of the stock?
So this is only 3 days after you mentioned the slow bleed. Do you care to elaborate?
Thanks as always.

No I'm not convinced they are actually diluting via the ATM right now ....just that they are able to for at least $10-15M .
So my idea that they would do a capital raise and tank the stock is very unlikely since if they need the $, they can get it via the ATM in small portions over time .

So I've been adding .
Using $ I dont need for at least 6 months .
Hoping I'll be more patient than I was with BTQQF ( my quantum computing stock spec )
Dont look at that 6 mth chart .......dont look now :--)
Here was me back in Jan re BTQQF
Whalatane
Re: EnchantedTitan62 post# 45
Friday, January 03, 2025 8:21:41 PM
Post# of 128
Well buckle up ...Eric Jackson first mentioned this on Fox around Dec 10th I think ...under $1 .
Shorts will be circling ( I'm not one of them )
This Co needs to move their listing to the Naz and their company headquarters to Silicon valley and Stanford talent .


Not investment advice .
May post something later on why I'm adding now .....conference could be a catalyst , current negative sentiment ...including from yours truly etc

Kiwi

On July 7, 2025, the Company received confirmation from the Listing Qualifications Department of Nasdaq that as of July 3, 2025 the Company’s common stock has maintained an average closing share price of at least $1.00 immediately following the Company’s 1:10 reverse stock split that became effective on June 20, 2025 The Company’s shares are no longer considered to be below the minimum bid price requirement of Rule 5550(a)(2), and as a result the Company has regained compliance with the Nasdaq continued listing standard. Nasdaq now considers this matter closed.

Looking for the stock price to go back above $5.50 by month end...

Hopefully yesterday morning was the bottom.  

UNCY formally announces back in NASDAQ compliance as of 7-7-25

Are you convinced that there is dilution (via an ATM) going on right now?

Comment from Dew's board ...Biotech Values
alertmeipp
Re: Whalatane post# 255607
Monday, July 07, 2025 6:21:10 PM
Post# of 255610
UNCY - thanks, it makes sense. I think that’s what analysts are expecting as well

will see if they would provide a more concrete update Monday in the conference.

Share is cheap but every delay means more dilution, probably safer to buy when they have a more concrete timeline even if it means much higher price.


Conference is July 14th 11 am ET at Wainwright ...webcast to follow

Kiwi

My reply
# 255605
Sunday, July 06, 2025 8:41:48 PM
Post# of 255607
Thx for the DD
Re the pill
Renvela ...the most prescribed generic pho binder is usually 2-3 large pills with each meal ....vs 1 small UNCY pill
Renvela is swallowed as is UNCY's OLC

Fosrenol ( another popular binder ) must be chewed with each meal ...1-2 pills depending on dosage

So on approval UNCY's OLC will enter the TDAPA process for 2-3 yrs
During this period Medicare pays the dialysis providers 100% of the average sales price ( ASP ) of OLC plus a small handling fee .
Part B Medicare might have a small copay ...which might apply to all the pho binders . I dont have all the details on that

So imagine you are the average Medicare Dialysis patient .
You are on 10-20 pills a day ...blood pressure meds , Anemia , Statins , Beta blockers and your average of 6 pho binders per day already .

If it's no difference in cost to you ...100% covered by Medicare for 2-3 yrs .....do you want to stay with your average of 6 pho binders a day ..usually large pills to be swallowed or crushed , 2 taken with each meal .

Or switch to one small pill that can be swallowed with each meal and which may have fewer side effects than the current meds.

Pill size does matter to many . I was on the Statin Lipitor ( which is a fairly large pill at max dose ) for years , but switched to Crestor partly because it is a lot smaller pill and I found it easier to take.

Kiwi

Forwarding this discussion from Dew's board re stealth dilution
pp
Re: Whalatane post# 255604
Thursday, July 03, 2025 3:24:09 PM
Post# of 255607
Available probably around 10-15 million now as their market cap fell below the 75mm threshold, as iirc they can only do 1/3 of their market cap max once they fall below 75mm or so.

They will have 100 percent dilution after approval, what’s another 10 15 percent to get them there ;)

will still be nice upside from here IF it gets the approval even they triple their shares

Not sure myself if smaller pill is a big enough difference

Only going by what your hopes are.   

Hope your right I got now 3600 reasons to be happy

Same to you Stumble. AND, if it truly only takes a couple of months for good things to happen, we will truly be Happy.

Happy 4th to all you fellow Uncy shareholders….hoping for much better things to come in the next couple months

So a big capital raise to tank the stock appears unlikely .
Rather a stealth dilution is probably underway
from Dew's board

Thursday, July 03, 2025 12:57:35 PM
Post# of 255604
UNCY Thx . You are correct about the ATM
Set up thru Guggenheim ...total $50m
Total sold up to June 3 rd was 6.36 m shares ( $3.98 M gross proceeds )
So they had as of June 3rd , $46 m available to sell.

So stealth dilution underway ? ...no wonder theres an apparent jump in short interest .
thx for your DD

Kiwi

Uh Oh ..I've been outed to the Twittersphere
I like Kiwi’s comment of $UNCY

JFYI

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=176383958

I think OLC will be quickly adopted in the first 2 yrs after approval
Reasons
1) One small pill with each meal thats SWALLOWED . dialysis patients generally HATE the current pills they have to chew or crush up and eat with each meal
2) The way the new dialysis bundle works means that once in the TDAPA process , which the Co says they will do , OLC will be covered 100% by Medicare
3) The way the new dialysis bundle works is that the serum phosphorous binders ( around 80% of dialysis patients need them )...will now be dispensed in the dialysis clinic by those authorized to prescribe ( like my wife ) .

Kiwi

Some speculation on Grok ...FWIW
An At-The-Market (ATM) offering is a type of public offering where a company can sell newly issued shares directly into the open market at current market prices, typically through a broker or investment bank, without the need for a traditional underwritten offering. This allows companies like Unicycive Therapeutics to raise capital gradually and flexibly.

In the context of the X post by @Arhdan9
, the mention of Unicycive's cash balance of approximately $20.7 million with a cash runway into the second half of 2026 suggests that the company may have utilized or announced an ATM offering to bolster its financial position after a Complete Response Letter (CRL) from the FDA.


Kiwi

Oh the ten days after the rs and staying over a $1 …..I’m sort of slow this morning 😵‍💫