Unicycive Therapeutics Inc (UNCY) Share Price

RMB. its not really clear to me how much they actually own .
Reading the filing
Octagon Capital advisors reports 8.5 m shares
Octagon Investments reports 5.5m shares
Octagon private opportunity reports 3 m shares
Ting Jia reports 8.5 m shares

That totals roughly 24.5 m shares .....over 1/4 of all outstanding shares !!!

Looks like they have organized their buys so as not to trigger the 10% ownership rule for any one entity ( which increases SEC compliance regs )

Not an expert in this field so anyone more knowledgable in the area ...please correct .

Kiwi

Here are the "players " https://octagoninvestments.com. ( some serious brain power )

UNCY. total shares outstanding = 94m
Octagon now owns 8.6 m shares
Vivo owns 3.47m
Logos owns 3.47 m
Nantahala owns 2.8 m

Vivo and Nantahala are well known in the biotech hedge fund area.


Kiwi

It was a 13D filing

Schedule 13D is an important SEC filing that provides transparency about significant ownership stakes in public companies. Here are the key points about Schedule 13D filings:
Filing Requirements
Schedule 13D must be filed within 5 business days by any person or group that acquires beneficial ownership of more than 5% of a voting class of a public company's equity securities16. The filing deadline was recently shortened from 10 calendar days to 5 business days, effective February 5, 20243.
Purpose and Contents
The purpose of Schedule 13D is to disclose large shareholders and their intentions. It consists of seven main sections:
Security and Issuer
Identity and Background
Source and Amount of Funds
Purpose of Transaction
Interest in Securities of the Issuer
Contracts, Arrangements, Understandings or Relationships
Materials to Be Filed as Exhibits
The "Purpose of Transaction" section is particularly important, as it reveals why the filer acquired the shares (e.g. investment, takeover attempt, etc.)12.
Amendments
Filers must promptly update their Schedule 13D to reflect any material changes, including acquisitions or dispositions of 1% or more of the securities1. The new rules set a 2 business day deadline for filing amendments after a material change occurs3.
Significance
Schedule 13D filings can signal potential takeovers, activist campaigns, or other significant events that may impact a company's control or direction12. They provide valuable information to the investing public about major shareholders and their intentions.
Alternative Filing
In some cases, certain investors may be eligible to file the simpler Schedule 13G instead of 13D. This includes qualified institutional investors and passive investors who have no intention of changing or influencing control of the issuer23.
By requiring timely disclosure of large ownership stakes, Schedule 13D filings play an important role in maintaining transparency in the public markets.


Definitely a good sign. This hedge fund is betting UNCY's NDA application will be accepted ...decision by Nov 3 ....and ultimately approved ...around 9-10 mths after acceptance
Kiwi
PS watch VERA in Kidney wk ...Oct 24th
EWTX ...new high following European conference presentations

Thanks Kiwi. From what I can gather from the docs, some purchases were made on Sept. 30.

Octagon discloses 9.1 % position https://archive.fast-edgar.com/20241011/ATB2R22CIC22T9ZZ282C2ZZZ9BV3H2Y2Z262/

OCTAGON CAPITAL ADVISORS LP REPORTS 9.1% PASSIVE STAKE IN UNICYCIVE THERAPEUTICS INC AS OF SEPT 30

Kiwi

Wainwright is assuming best case scenario in all areas ...something they are known for :--)

Kiwi

Does that imply that Wainwright is assuming either CMS loses or the Kidney Act passes?

Yep. agree ,,,FDA decision due before Nov 3rd I think .
Theres also this for what its worth ( which is often not much )
HC Wainwright & Co. Reiterates Buy on Unicycive Therapeutics, Maintains $2.5 Price Target
BENZINGA - 2:41 PM ET 10/9/2024

Kiwi

So Phase 1 494 results didn't move this at all. Does everyone agree that the next catalyst is press release of FDA NDA acceptance?

So Phase 1 494 results didn't move this at all. Does everyone agree that the next catalyst is press release of FDA NDA acceptance?

Likely reason for sell off....UNCY related
...CMS likely to prevail


Richard Cantillon
@cantilloncap
·
36m
My best guess is CMS wins and Court declines motion for prelim. injunction & sets a new schedule for MSJs. A better bet is HR5074 but I think we need 50 co-sponsors to really feel comfortable here. $ARDX

Kiwi

$UNCY Dip opportunity DD - https://www.barchart.com/stocks/quotes/UNCY/cheat-sheet

Transcript of a Nephrology video recently repeated discussing OLC
Another company called Unicycive has developed lanthanum dioxycarbonate.
And this is a pill, but it's much more potent and doesn't need to be chewed up to be activated.
It's kind of microparticles.
And at least in preliminary studies, it looks like it's probably about 40% more potent than our most potent binder right now, which is Velphoro (sucroferric oxyhydroxide, Fresenius Medical Care North America).
And conceivably, this would lead to 70% to 80% of patients could literally take just one pill with each meal and have adequate phosphorus control, at least less than 5.5 mg/dL.
And that's kind of exciting. I think we need more potent phosphate binders.

Kiwi

Why access to these new serum phosphorous lowering drugs is so important
Patients receiving maintenance dialysis for chronic kidney failure have a high mortality rate, with 5-year survival of less than 50% after dialysis initiation in the US.3

Cardiovascular complications are the leading cause of death, with 40% of deaths attributed to arrhythmia or cardiac arrest.3
Systemic complications of chronic kidney failure include anemia, hypertension, and mineral bone disorders, such as hyperphosphatemia and hyperparathyroidism.

Dialysis treatment–related complications, such as vascular access dysfunction, infections, and hemodynamic instability during dialysis, are common and may cause distressing symptoms, including cramping, post-dialysis fatigue, and poor quality of life.4


Kiwi

FDA is supposed to complete its review of UNCY's drug application by Nov 3 rd
Maxine Waters signs on as a sponsor of the Kidney Patient Act .....designed to ensure better access to new Oral pho drugs ( Xphozah and OLC )
Kiwi

Some time in Nov 2024........PDUFA Date
A key concept associated with PDUFA is the "PDUFA date":
This is the target date by which the FDA aims to complete its review of a new drug or biologics application12.
It is typically set 10 months from the filing date for standard reviews, or 6 months for priority reviews1.
The PDUFA date serves as a good approximation of when a final decision on drug approval can be expected2.


Co maintains they have the cash on hand to run the Co to FDA approval date mid 2025
Kiwi

$UNCY Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. For more information, please visit Unicycive.com and follow us on LinkedIn, X, and YouTube.

Court case involving new oral pho binders ...concerns ARDX but is relevant to UNCY

$ARDX - ***UPDATE***
A large Wall Street bank hosted an investor call with DC legal experts re: ARDELYX, INC. et al v. BECERRA et al

Conclusion - Ardelyx is highly likely to be granted a Preliminary Injunction by Judge Beryl Howell as early as late October '24. This temporary court order prevents the Centers for Medicare & Medicaid Services (CMS) from acting on the challenged policy until the court makes a final decision. A trial would not likely take place until late 2025 and could last months based on the court's calendar and reliance on interpreting the Chevron Doctrine ruling which was recently overturned at the US Supreme Court on June 28, 2024. This case is also highly likely to face appeal and that could push the final ruling well into 2027.

My opinion- This favorable ruling enables both sell-side and buy-side analysts to project Ardelyx's revenues and cash flow through 2026 and likely into the first half of 2027, providing investors with greater confidence in the stock's valuation. Therefore, the stock should grind higher into earnings and beyond

From Frank on X
Kiwi

Sept 25 (Reuters) - Unicycive Therapeutics Inc ( UNCY ):
* UNICYCIVE THERAPEUTICS INC SAYS ON SEPT 24, RECEIVED NOTICE FROM NASDAQ CO REGAINED COMPLIANCE WITH MINIMUM MARKET VALUE REQUIREMENT - SEC FILING Source text for Eikon: Further company coverage:


Still needs PPS over $1 IIRC for full compliance
Kiwi

$UNCY #BreakingNews Unicycive Therapeutics to Participate in a Fireside Chat at the Virtual Lytham Partners Fall 2024 Investor Conference on October 1, 2024 https://finance.yahoo.com/news/unicycive-therapeutics-participate-fireside-chat-110300142.html?soc_src=social-sh&soc_trk=tw&tsrc=twtr

From the ARDX presentation that relates to UNCY

Frank
@justfactstruth
$ARDX -FROM CANTOR CONFERENCE
HR 5074 and S 4510
We have 24 Sponsors / Co-Sponsors and this is truly Bi-Partisan with strong support

It has already passed the House Ways & Means Cmte and the Energy and Commerce Cmte so waiting for a floor vote.

We have many avenues for this to be settled and are hopeful to hear something by the end of the year before patients lose access to this drug
This can happen by Stand Alone HC Bill, Omnibus Bill / Mini or in the CR inclusion

If this legislation pass's ( Kidney Patient Act ). ARDX and UNCY are direct beneficiaries
Kiwi

Kiwi, I upped it to .32 just so you know, I of course would be buying Huuuuuge at .20 but seems to be a dream at this point.

Thanks for checking

.44c after hrs Ernie . Still sticking to your 30/70 chance of PPS under 20c ?

Kiwi

$UNCY Trending chart looking good here https://stockcharts.com/sc3/ui/?s=UNCY

$UNCY Dip buy opportunity

.38 c after hrs ...glad you didn't hold your breath waiting for sub .20c. :--)

Kiwi

For what its worth ...which is often not much
Benchmark Reiterates Speculative Buy on Unicycive Therapeutics, Maintains $3 Price Target

Kiwi

Large block just went thru ...was that U wading in Ernie ?

UNCY presenting at a conference / fires side chat .... sept 10th at 10.30am .

By the way ...these guys recent option grants start vesting around the time of expected FDA approval .
No notice yet of an Adcom that I'm aware of ...which is a good thing

Kiwi

30/70 - I'm not holding my breath but still have that bait settling on the bottom - never know when da fishies might take a deep dive.

Cheers

They have completed all the clinical trials required by the FDA and have submitted their NDA
Their cash on hand will last them roughly to the time the FDA will decide on wether to approve OLC or not ...around early mid year 2025

I think the OS tripled in 6 mths as speciality funds like Nathanala exercised warrants . This provided cash to the Co to finish their pivotal trial but required them to increase the share count to cover the exercised warrants
Just my poorly informed opinion on how exercising warrants works ...if you have better info please post.

Yes, exercising stock warrants typically requires the company to issue new shares of stock. Here are the key points about how this works:
When a warrant holder exercises their warrants, the company issues new shares of stock to fulfill the warrant contract.
This issuance of new shares increases the total number of outstanding shares of the company.

The increase in outstanding shares has a dilutive effect on existing shareholders, as it reduces their percentage ownership of the company.
This is different from stock options, where shares are typically transferred from existing stock rather than newly issued.

The company receives the exercise price as payment when warrants are exercised, which can serve as a source of capital for the organization.

The number of new shares to be issued upon exercise is specified in the warrant agreement, along with other key terms like the exercise price and expiration date.
Some warrants may have provisions for cashless exercise, where the number of shares issued is reduced to account for the exercise price, rather than requiring a cash payment.
The issuance of new shares upon warrant exercise is one reason companies must carefully consider the potential dilutive impact when issuing warrants as part of financing or other transactions.

In summary, exercising stock warrants does indeed require the company to issue new shares, which increases the total number of outstanding shares and can have a dilutive effect on existing shareholders.

Kiwi

What phase are they in? How much cash on hand do they have? What is their quarterly burn rate? I'll look up answers to these questions when I have time.

Why did the OS more than triple from 25M to its current 94M in 6 months.
2024-06-30 94,000,000
2024-03-31 35,000,000
2023-12-31 25,000,000
2023-09-30 33,000,000
2023-06-30 15,000,000
2023-03-31 15,000,000
2022-12-31 15,000,000
2022-09-30 15,000,000

Still think its 50/50 for going under 20c ?
Don't let that FOMO bite U in the bum :--)

Kiwi

Heck NO, root against me, I'm just saying where I think it might drop - I think it has a 50 50 chance of a dip down that far.

My thoughts are that if the FDA waives the fees there must be something in the product that probably helps expand the options for the patient group that has limited side effects to improve the patient group targeted.

I'm not a doctor, hell I'm not even versed in pharma development, I just as a thinking human being that if the FDA works with a drug developer WITHOUT FIRST BLEEDING THEM DRY - IT HAS TO BE BULLISH IMO

Am I supposed to be rooting for you ? ( such an American expression ) ...wanting a lower PPS ??

Your pt about a take out is on pt.
The hyperkalemia drugs I invested in ...several years ago ...High serum potassium ( not phosphate ) were both taken out .
Theres also the EU market ...as large as the US market .
AZN is big in the Renal space

Kiwi

Mr Mister ...its often waived for small biotechs with limited funds .....to support innovation .
If they thought it was a futile effort , a waste if their ( FDA ) time , they are less likely to have waived it .
I expect OLC to be approved
The Kidney Patient Act will determine how much it gets prescribed after approval
Kiwi

Why is fee waiving bullish?

Not trying to combative just curious

I need under 20 to get my avg below .45 unless I wanna increase what I what I want to spend.

I think it could get taken out but then again sometimes I under shoot the bottom.

The FDA waives NDA (New Drug Application) application fees in several situations:
Small Business Waiver
The FDA offers a one-time fee waiver for small businesses submitting their first human drug application. This is designed to help new companies that may lack the capital to afford application fees, giving them a chance to enter the market. To qualify as a small business, a company must:
Have fewer than 500 employees, including employees of affiliates
Not have a previously approved human drug application introduced into interstate commerce
Orphan Drug Exemption
NDAs for drugs with orphan drug designation are exempt from PDUFA fees, unless the application includes an indication for a non-rare disease or condition. To qualify for this exemption:
The drug must have received orphan drug designation
The applicant must have less than $50 million in gross worldwide revenue during the year preceding the orphan designation request
Public Health Waiver
The FDA may waive or reduce fees to protect public health. This is less commonly granted, especially for companies with over $20 million in working capital.
Barrier to Innovation Waiver
Fees may be waived if they would present a significant barrier to innovation due to limited financial resources. Like the public health waiver, this is granted less frequently, particularly for companies with over $20 million in working capital.
Government Entity Exemption
Applications submitted by state or federal government entities for products not distributed commercially are exempt from fees.
Other Considerations
Waivers are typically granted only for the current year and must be requested annually for future years.
The FDA does not defer fees based on pending waiver requests - fees are expected to be paid while waiver requests are under review.
Waiver requests should be submitted between June 1 and July 1 for the FDA to evaluate them before the due date of program fees.
By offering these waivers and exemptions, the FDA aims to balance the need for funding with supporting innovation, especially for small businesses and developers of treatments for rare diseases.


And you're looking for under 20c to add !!!! can't decide if thats a bullish or bearish post ...:--)

Kiwi

Seems the waiving of the fees is a giant bullish sign for the drug being appoved IMO(which means nothing) to anyone besides myself.
Looks like a textbook sell the news, will be interesting to see how many insiders are selling it down, they are not shy when it comes to selling.

All in all I'm looking for a spot where an add may be safer as it is a new month so another round of insider selling may get this under 20 cents this time.

Molee. My breakeven is 38c . I added on its mini crash down to $23c .
I'm holding as a spec on the Kidney Patient Act passing ...which we may not know if it does or not until the end of the year.

Theres a lot of " hair " on this stock ...no doubt . Mgt seems to have inflated the share count and awarded themselves tons of options .
If the Kidney Act fails and ARDX fails in their legal act against CMS ...then yes this will likely be a wipe out . UNCY will benefit if ARDX prevails in their legal action

On the other hand ...If the Kidney Act pass's , drug is likely to be approved ...and as noted previously ...there is interest among Nephrologists in using OLC


And then the third agent is a phosphate binder of the lanthanum type. So, we already have lanthanum carbonate. It’s a pretty potent drug. [There are] a lot of problems with the GI side effects, and the pills are extremely hard and have to be chewed thoroughly or crushed in order to be effective. Another company called Unicycive has developed lanthanum dioxycarbonate.

And this is a pill, but it's much more potent and doesn't need to be chewed up to be activated. It's kind of microparticles. And at least in preliminary studies, it looks like it's probably about 40% more potent than our most potent binder right now, which is Velphoro (sucroferric oxyhydroxide, Fresenius Medical Care North America).

And conceivably, this would lead to 70% to 80% of patients could literally take just one pill with each meal and have adequate phosphorus control, at least less than 5.5 mg/dL. And that's kind of exciting. I think we need more potent phosphate binders.

Kiwi

I , unfortunately , don't know anything ... Hence me being "invested" here since about $1.00 ...

Well yeah. Did you think they weren't going to submit an NDA ??

Ideally they want OLC approved before they run out of time complying with their Naz listing ....and it's going to be close

Kiwi

. We are also pleased to report that the FDA granted a waiver for the NDA application Prescription Drug User Fee Act (PDUFA) fees which is a significant savings of approximately $4 million.”
I think its very likely that the application will be accepted and approved.
The major catalyst IMHO is passing the Kidney Patient Act to keep the new serum pho drugs ...Xphozah ( ARDX ) and OLC ( UNCY ) out of the dialysis bundle for at least 2 yrs .
Once in the dialysis bundle the financial incentive for at least the private dialysis centers is to push generic pho binders as much as possible as dialysis providers get to keep any money left over below the CMS dialysis payment .......which I think is about $270 per patient each time they are dialyzed.

Median time from NDA submittal to approval is roughly 9 mths ....so mid year 2025 .
By mid yr 2025 UNCY will need to get their PPS over $1 or do a reverse split ( if they want to keep their Naz listing )

Kiwi

I guess whether the FDA accepts it (60 days?), and ultimately approval would mean more to the sp

So ... This NDA was "priced in " ... ???

UNCY....................................https://stockcharts.com/h-sc/ui?s=UNCY&p=W&b=5&g=0&id=p86431144783

Has anyone seen this? It just popped up while I was searching something unrelated.
https://b2idigital.com/unicycive

Buy

Aug 14th CC We remain on track to submit our NDA by the end of this month,

They had to complete the last trial required by the FDA before filing .

We should know within 7-10 days if they have filed .

Kiwi