Unicycive Therapeutics Inc (UNCY) News

Groks take on FDA approval and 1st tranche / cash injection


Thanks for providing more details! Based on your input—"Tranche A: $25.8 MM FDA Approval $0.54 47.9 million"—I’ll interpret this as a hypothetical or real transaction involving Unicycive Therapeutics (UNCY), a biotech company listed on NASDAQ, since it aligns with the context of a publicly traded entity with a stock ticker. Here’s how I’ll break it down:
$25.8 MM (million): This likely refers to a financial tranche, such as funding, a loan, or proceeds from a stock offering.

FDA Approval: Suggests a significant regulatory milestone, possibly tied to one of UNCY’s drug candidates (e.g., UNI-494 or Oxylanthanum Carbonate, based on their known pipeline).

$0.54: This could be the current share price, a proposed offering price, or a price target related to the transaction.

47.9 million: Likely the number of shares outstanding or involved in the transaction (UNCY’s shares outstanding were around 35 million as of mid-2023, per public data, but this could reflect dilution or an updated figure by March 14, 2025).

Since the question focuses on the impact on UNCY’s share price, I’ll assume this describes a scenario where UNCY secures $25.8 million in funding (e.g., via a stock offering or private placement) alongside an FDA approval announcement. Let’s analyze the potential effect:
Key Assumptions
FDA Approval: UNCY’s pipeline includes treatments for kidney diseases, a high-stakes area in biotech. FDA approval (e.g., for Oxylanthanum Carbonate, a phosphate binder) would be a major catalyst, signaling commercialization potential and revenue generation.

$25.8 Million Tranche: This could stem from:
A stock offering (selling new shares at $0.54 each).

A private investment or debt financing.

If it’s a stock offering: $25.8M ÷ $0.54 = ~47.78 million shares, aligning closely with the 47.9 million figure, suggesting a share issuance near that scale.

Current Share Price: I’ll assume $0.54 is the pre-transaction price (close to UNCY’s historical trading range in 2023–2024, though I lack real-time data for March 2025).

Shares Outstanding: If 47.9 million is the post-transaction total, it implies significant dilution from a prior base (e.g., 35 million shares + 12.9 million new shares = 47.9 million).

Impact on Share Price
The share price effect depends on two opposing forces: positive catalyst (FDA approval) vs. dilution (new shares).
Positive Impact from FDA Approval:
FDA approval is a game-changer for small-cap biotechs like UNCY. It de-risks the company, boosts investor confidence, and often triggers a sharp price increase.

Historical examples: Small biotechs can see 50%–200%+ spikes post-approval (e.g., Cassava Sciences jumped ~100% on Phase 2 data in 2021). For UNCY, a $0.54 base could rise to $0.81–$1.08 (50%–100% gain) purely on approval news, assuming no dilution.

Negative Impact from Dilution:
If $25.8 million comes from issuing ~12.9 million new shares at $0.54, it increases shares outstanding by ~37% (from 35 million to 47.9 million).

Dilution typically depresses share price as earnings per share (EPS) and ownership stakes shrink. Without the FDA boost, a 37% dilution might drop the price proportionally (e.g., $0.54 × 0.63 = ~$0.34), though market dynamics soften this in practice.

Net Effect:
The FDA approval’s positive momentum likely outweighs dilution’s downward pressure, especially for a small-cap biotech with a low market cap (~$20M at $0.54 and 35M shares).

Scenario 1: Strong Approval Reaction: If the market values the approval highly (e.g., doubling market cap to $40M–$50M), the post-dilution price could rise to $0.83–$1.04 ($40M–$50M ÷ 47.9M shares), a 54%–93% increase from $0.54.

Scenario 2: Mild Reaction: If approval excitement is tempered by dilution concerns, the price might stabilize near $0.60–$0.70, a 11%–30% gain.

Scenario 3: Overshadowed by Dilution: If the market fixates on dilution (unlikely with FDA approval), the price could dip below $0.54 temporarily, though this is rare with a major catalyst.

Market Sentiment and Timing:
Biotech stocks are volatile. On March 14, 2025, broader market conditions (e.g., interest rates, sector trends) could amplify or mute the reaction.

Trading volume would surge, potentially exaggerating short-term swings.

Conclusion
This transaction—$25.8 million raised with an FDA approval—would likely increase UNCY’s share price from $0.54, assuming the approval’s positive impact overshadows dilution. A plausible range is $0.60–$1.04 (11%–93% gain), with the higher end reflecting strong market enthusiasm for the approval. The exact outcome hinges on:
The drug’s market potential (e.g., blockbuster vs. niche).

Investor perception of the $25.8M use (e.g., funding commercialization vs. just cash burn).

Whether 47.9 million is indeed the new share count.

----------------------
Kiwi

Trigger Exercise
Price
Conversion into
Equivalent
Common Stock
Tranche A: $25.8 MM FDA Approval $0.54 47.9 million ( I'm assuming this means the preferred gets converted at a price of .54c to common ....and they receive $25.8 m cash )...so share counts increases but so does their cash on hand )
Tranche B: $25.7 MM TDAPA Designation $0.59 43.5 million
Tranche C : $51.5 MM Four quarters of OLC Sales $0.74 69.6 million
Cumulative Warrants (All Tranches) 161 million
--------------------
So they get $25.8 m on FDA approval ...by June 28th ? ...before the Naz delisting date in July
Mkt cap currently only.............. Market Cap (intraday)60.721M

I understand your aversion to R/S ....the main issue for me is approval on or preferably before, June 28 ...as they only have about 6 yrs of exclusivity once approved

Kiwi

I still like UNCY here, but lightened up here today (so now watch this shoot up like a rocket) as don't wish to get stung in another RS ( you are aware of another that bit me). 

Ernie I think FDA approval triggers exercise of warrants / cash infusion from Vivo Capital ?...that should put them over $1 before Naz non compliance deadline .
U know anything about that ?

Yes would be very bullish if they decline to do a R/S
Risk is that DOGE cut backs delay approval date

Kiwi

BODs rarely turn down the chance to artificially inflate their share price, it gives them a chance to bail on their RSUs and grants before they plummet again.

For me, and we all know I ain't right, I think it would be extremely bullish if they turned down a RS but we know they rarely do what is good for shareholders IMO

I'm stickin with it.

...to file a RS they would need to get the BOD approval and the paper work started by roughly May 1st

So roughly 7 wks left to get this over $1 ...or they do an AMRN. ( R/S ) which didn't turn out so well at least on this date .

Kiwi

Cosa. as follow up. My issue with UNCY is their limited exclusivity ...about 5 yrs left I think , assuming June approval
So its probably a " sell the news " for me , if / when OLC is approved
Kiwi

Cosa. U have to look at the entire package they submitted to get FDA approval
The two trials likely submitted as the core clinical evidence from healthy volunteers are the Phase 1 dose-ranging study and the bioequivalence study.
These, combined with the later pivotal trial and preclinical/CMC data, comprise the full NDA package accepted by the FDA on November 11, 2024, with a PDUFA target action date of June 28, 2025.
The last trial with dialysis patients , requested by the FDA ...added the additional safety and efficacy info they requested .

The FDA approval path they are on is different then the path for Xphozah as OLC is a reformulation of an existing FDA drug and therefore has about a 70-80% chance of being approved ( based on history of similar applicants )

A wash out is where they take the patients of their existing serum pho lowering drugs .....often 4-6 wks for many drugs ...so they can get a baseline ( no drugs in the system )
Then add the new drug and test ...I'd have to look at the data ...but typically 90 days later

Kiwi

From their website

What is a washout also? How long did patients stop taking previous binder?

https://ir.unicycive.com/news/detail/73/unicycive-therapeutics-achieves-study-objective-in

While the study was not designed to evaluate efficacy, the trial enrolled patients on stable doses of approved hyperphosphatemia medications. At baseline approximately 59% of patients had phosphate levels =5.5 mg/dL, the level recommended by KDOQI guidelines. After washout from the prior phosphate binders, 90% of patients were able to achieve phosphate levels =5.5ng/dL at the end of titration with OLC.

OLC’s NDA, filed under the 505(b)(2) pathway, was accepted by the FDA in November 2024, with a PDUFA target action date of June 28, 2025. The 505(b)(2) route itself is a good sign—it’s a well-trodden path for drugs building on existing approvals (here, Fosrenol), and historically, it has a higher approval rate than full 505(b)(1) NDAs. General FDA stats suggest 505(b)(2) applications hover around a 70-80% approval rate, compared to 50-60% for novel drugs, though this varies by therapeutic area and data quality.
The data package looks solid so far. Unicycive’s pivotal trial (results out June 2024) showed OLC was well-tolerated, with a 6% discontinuation rate due to adverse events—lower than Fosrenol’s 14%—and over 90% of patients hit target phosphate levels (≤5.5 mg/dL) post-titration. The Phase 1 dose-escalation study (published January 2025) confirmed safety across escalating doses, and the bioequivalence study (published December 2024) nailed pharmacodynamic equivalence to Fosrenol. These check key boxes: safety, tolerability, and a link to an approved drug’s efficacy profile.

The FDA’s agreement on the trial design (60 patients, no statistical efficacy analysis needed) and the PDUFA fee waiver ($4 million saved) further signal alignment and confidence.

Kiwi

Re trial for efficacy
Unicycive Therapeutics conducted a pivotal clinical trial to evaluate the efficacy of Oxylanthanum Carbonate (OLC) for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis.

The trial, known as the UNI-OLC-201 pivotal clinical trial, was designed to assess both the safety and efficacy of OLC.

Positive top-line results from this trial were reported on June 25, 2024, indicating that OLC performed well in reducing serum phosphate levels.
Additionally, initial patient satisfaction findings from this trial were announced on July 9, 2024, showing high patient preference and satisfaction with OLC compared to prior phosphate binder therapies. This trial is part of Unicycive's efforts to seek FDA approval for OLC via the 505(b)(2) regulatory pathway.


Agree that its likely they do a reverse split
Kiwi

RS are almost always the kiss of death … very hard to rebound from…..don't want it

lol at home free…common guys. We are in ARDX, did you guys see what Xphozah went through. Their initial PDUFA was in July 2021, FDA rejected it because they said the data was unclear (even though it was). They did an additional trial and resubmitted data and FDA rejected it again. The crazy part is they did exactly what FDA asked for, the data was good, but they still rejected it. That was unbelievable. They had to file an appeal and the Adcom was scheduled for October 2022. In the Adcom big pharma planted reps in that meeting to go against them. They ended up getting a 9-4 approval recommendation. Then after recommended label changes it was finally approved in October 2023.

That’s why I think OLC PDUFA is going to be rejected. They did not have specific trials for efficacy. The FDA is in the pockets of big pharma and OLC will disrupt that revenue stream. There going to have FDA press for more data exactly like they did to X. it’s going to be a long fight for UNCY.

I honestly think my investment here is going to go close to zero. But hey, you never know. Maybe the FDA gods will be forgiving. And while you guys celebrate with your boat load of shares I’ll cheer you on from my rubber raft of shares. Good luck guys

I think they need to be prepared and take care of business prior to the PDUFA. If they RS before it will give them time to come compliant and run an ATM to raise funds to keep company going regardless of outcome. The company needs a longer runway. Management needs to be smart. I would vote in favor. It would be a strike out or home run investment.

Also an RS prior and get granted FDA approval, talk about an explosion on a small float. Shorts will get absolutely buried.

Yes. OLC is a reformulation of an existing drug Fosrenol . It would surprise me if they called an Adcom. since the FDA has already agreed that OLC is the bio equivalent of Fosrenol.
My only short term concern is if DOGE cut backs will cause any delays in this final approval process.
Kiwi

Thanks Kiwi.  Sounds like if we don't hear about any Adcom in the next month, then we are home free 

FYI from Grok.
If no Adcom, its assumed OLC will be approved by June 28

Based on the latest available information, Unicycive announced on November 11, 2024, that the FDA accepted its New Drug Application (NDA) for OLC, with a PDUFA target action date of June 28, 2025. However, there was no mention of an AdCom meeting in that announcement.
Typically, the FDA schedules AdCom meetings closer to the PDUFA date if they deem it necessary, often within 2-3 months prior, but no specific scheduling is guaranteed unless announced.
As of today, March 05, 2025, a quick review of the FDA’s Advisory Committee Calendar and recent Unicycive press releases does not indicate a scheduled AdCom for OLC.
The FDA’s calendar currently lists meetings up to early 2025, but nothing specific to Unicycive or OLC appears.
Given the PDUFA date is still over three months away, it’s possible an AdCom could be announced later, potentially in April or May 2025, if the FDA requires expert input on OLC’s NDA.


Kiwi

If the FDA approves OLC by June 28th ...UNCY will be well over $1 before July 7th ( final Naz compliance date )
However ...to file a RS they would need to get the BOD approval and the paper work started by roughly May 1st
JMO
Kiwi

It takes about 8-10 weeks to complete the necessary SEC paper work following a BOD approval for a RS....so they still have time .
Kiwi

I think they need to do a RS soon. Super important to stay listed on big board to secure financing.

Gr8. I welcome your prospective on their challenges
Kiwi

I got a small position. I want to see what FDA says. They fought so hard to reject ARDX's Xphozah. I want to see if the same is going to happen here...

Gr8. Feel free to shoot holes in my thesis / arguments. Most of these IHUB boards are largely exercises in cognitive bias ...looking for posters to reinforce your pt of view .
I'm the opposite . I welcome informed opposing opinions.
The 2 negatives / risks I've found currently with UNCY is
1) risk of reverse split especially if PDUFA decision is delayed
2) Limited exclusivity ( only 5 yrs I think ) once approved .
Let me know if U find more
Kiwi

I'll buy some shares tomorrow so I have skin in the game....

From Grok ...OLC and Fosrenol

Whats the difference between Unicycives OLC and Fosrenol

Unicycive’s Oxylanthanum Carbonate (OLC) and Fosrenol (lanthanum carbonate) are both phosphate binders used to treat hyperphosphatemia, a condition common in chronic kidney disease patients on dialysis where phosphorus levels in the blood become too high. While they share similarities, there are key differences that set them apart, particularly in design and patient experience.

Both medications work by binding dietary phosphate in the gut to prevent its absorption into the bloodstream. OLC is a next-generation lanthanum-based binder developed by Unicycive Therapeutics, leveraging proprietary nanoparticle technology, while Fosrenol, developed by Shire (now part of Takeda), is an established lanthanum carbonate formulation. Clinical studies have shown that OLC is pharmacodynamically bioequivalent to Fosrenol, meaning they achieve similar phosphate-lowering effects in the body.

The primary difference lies in pill burden and administration. OLC aims to reduce the number and size of pills patients need to take. In a pivotal trial, patients switching to OLC saw their median daily pill count drop from 6 to 3, cutting the burden in half compared to prior therapies, including Fosrenol. Fosrenol typically requires multiple large chewable tablets per day—often 3 or more, depending on the dose (500 mg to 1000 mg three times daily)—which can be cumbersome. OLC, by contrast, is designed to be swallowed, not chewed, which patients have reported as easier and more convenient. In a satisfaction survey from the same trial, 98% of patients found OLC easy to take, compared to only 55% for their previous binders, and 79% preferred OLC over prior treatments.

Effectiveness-wise, they’re on par due to bioequivalence, but OLC’s formulation may offer practical advantages. Studies suggest OLC has a high phosphate-binding capacity with a lower medication volume, meaning it can bind more phosphate per dose than Fosrenol and other binders. Safety profiles are similar, with both showing mild-to-moderate side effects like diarrhea and vomiting, though OLC’s trial data reported low discontinuation rates (1.4% in the evaluable group), indicating good tolerability.

Unicycive is positioning OLC as a potential best-in-class option, addressing the unmet need for better compliance highlighted by nephrologists. Fosrenol, while effective and widely used, hasn’t evolved much since its approval, and its chewable nature and higher pill count can deter adherence. OLC’s development, currently under FDA review with a decision expected by June 2025, reflects an attempt to refine what Fosrenol started, prioritizing patient-friendly dosing without sacrificing efficacy.

In short, OLC and Fosrenol do the same job biologically, but OLC is engineered to be simpler to take—fewer, smaller, swallowable pills—potentially making life easier for dialysis patients. Whether that translates to real-world superiority depends on individual patient needs and how OLC performs post-approval, assuming it gets the green light.

Kiwi

Cosa good to see U posting again .
OLC is a "refined / distilled " version of Fosrenol ...a drug my wife prescribes to her dialysis patients that can't tolerate the generic pho binders ..Renvela etc .
Because it's essentially a " distilled " version of an existing FDA approved drug ...it didn't need to go thru the phase 1 / 2 process ....instead a test to make sure it was the bioequilant of Fosrenol ( which it passed ) and then a trial with dialysis patients ...which was also successful .

The trial with dialysis patients was to test serum pho lowering ...but also adverse events ...was it more tolerable etc .

Fosrenol is one of the most effective drugs for lowering serum pho ...however many complain of nausea.
With OLC they apparently added an extra O2 molecule which has reduced the incidence of nausea .
( update .... wrong ...its an oxygenated version )

Just going from memory here but you might do a search / ChatGPT / Perplexity on the difference between Fosrenol and OLC.

ARDX's Xphozah is a different issue . The issues around its initial approval were over its high rate of diarrhea and low rate ( compared to Fosrenol /OLC ) of lowering serum pho.
HOWEVER ...once approved some of my wife's patients have adjusted to XPHOZAH and its been the only drug to have worked to lowering these particular patients serum pho to goal levels .
Now without Medicare coverage there are some work around some of these patients may attempt to...noted in previous posts .

Bottom line ....the feedback I get is that Nephrologists want to try OLC as soon as possible .
1) its very effective at lowering serum pho
2) OLC is a small pill that can be swallowed ...and therefore increase patient compliance . They hate chewing the existing binders or the size and number they need to take
3) Its 1/3rd of the cost of XPHOZAH and should be available to Medicare patients since they have agreed to enter the TDAPA process .

My only concern is if the PDUFA date gets extended due to FDA cut backs

Kiwi
PS from Perplexity

Fosrenol (lanthanum carbonate) and OLC (oxylanthanum carbonate) are both phosphate-binding agents used to treat hyperphosphatemia in patients with chronic kidney disease. However, there are some key differences between the two:

Formulation: OLC is a next-generation lanthanum-based phosphate binding agent that utilizes proprietary nanoparticle technology24.

Administration: Fosrenol tablets are chewed, while OLC tablets are smaller in size and swallowed whole with water3. This difference in administration may lead to better patient compliance with OLC.

Pill burden: OLC requires a lower pill burden for patients in terms of number and size of pills per dose compared to currently available treatment options24.

Development stage: Fosrenol is an FDA-approved medication, while OLC is still an investigational drug undergoing the FDA's 505(b)(2) regulatory pathway38.

Tolerability: In a recent study, OLC showed a lower discontinuation rate due to adverse events (6%) compared to Fosrenol's reported rate of 14%23.

If approved, OLC is expected to share substantially the same product label and prescribing information as Fosrenol, with the exception of the administration method35.

The potential advantages of OLC, such as lower pill burden and easier administration, may lead to improved patient adherence in the treatment of hyperphosphatemia.

And ...no extra O 2 molecule ...but
The "Oxy" in Oxylanthanum Carbonate does not indicate an additional oxygen molecule, but rather refers to the oxygenated form of lanthanum carbonate.

Doing some DD. It looks like they're missing phases. There was no phase II and III that I could find on OLC. Usually phase I is only for safety and tolerability. They skipped and went straight to a pivotal clinical trial. I think FDA is going to ask for more efficacy data and another trial.

The way they put ARDX's Xphozah through the ringer with all the trials that proved it worked. It got rejected twice and had to go to adcom. 2023: Advisory committee meeting to review the drug's data. After an eight-hour deliberation, the FDA’s Cardiovascular and Renal Drug Advisory Committee voted 9-4 in favor of the med.

This is big pharma influence on FDA, until data proves that it can no longer be rejected. So UNCY is going to have to fight. I think they are years out to be honest. But that's just my opinion based on what happened with X.

https://ir.unicycive.com/news

https://ir.unicycive.com/news/detail/73/unicycive-therapeutics-achieves-study-objective-in
Out of one of the paragraphs in IR article above:
While the study was not designed to evaluate efficacy, the trial enrolled patients on stable doses of approved hyperphosphatemia medications. At baseline approximately 59% of patients had phosphate levels ≤5.5 mg/dL, the level recommended by KDOQI guidelines. After washout from the prior phosphate binders, 90% of patients were able to achieve phosphate levels ≤5.5ng/dL at the end of titration with OLC.

One of the conditions for a pop in PPS IMHO is reassurance that the PDUFA date is not extended /delayed .
the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) and has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025.
The risk is that DOGE layoffs at the FDA may extend these PDUFA timelines .
JMO ...I still own the stock but any delay may make a reverse split inevitable , uses up the Co's cash on hand and the remaining time of exclusivity ...all negatives

Kiwi

Uncy is due to pop in the near future….

The thing about this combination ...Tenapanor and OLC is that most dialysis patients complain of constipation ....Tenapanor at low doses creates loose stool similar to normal ( at higher doses cause diarrhea in many ) and OLC has a high incidence of nausea ( however the extra O2 molecule in this formulation is supposed to cause less nausea )
Half dose of each ...creates best combo for patients ....and significantly lowers serum pho

Kiwi

Unicycive Therapeutics (UNCY) has published preclinical data in the ASN journal Kidney360 demonstrating synergistic benefits of combining oxylanthanum carbonate (OLC) with tenapanor for phosphate management.

The study showed that the combination therapy achieved a 41.3% reduction in urinary phosphate excretion compared to vehicle, significantly outperforming both individual treatments.

Key results showed tenapanor alone achieved a 12.5% reduction, while OLC monotherapy demonstrated a 17.7% reduction in phosphate excretion. The combination proved statistically significant (p=0.009 for 0.75% OLC + tenapanor).

This research is particularly relevant as approximately 75% of dialysis patients fail to meet serum phosphate targets set by KDIGO guidelines.
The study suggests OLC's low pill burden and palatable formulation, combined with tenapanor, could improve patient adherence and clinical outcomes in hyperphosphatemia treatment.

Kiwi

RMB Landmon said. “If they end up losing a lot of that staff, you’re going to see these review times really extend out.”

Thats one of the risks of all these FDA layoffs .....PDUFA review time lines could get extended which would be very negative for UNCY as it could push the PDUFA approval past the deadline date to maintain Naz listing ...and thus require a reverse split .

My opinion was that if OLC is approved early enough , that action hopefully would push the PPS over $1 for at least 10 consecutive days negating the need for a reverse split to maintain Naz compliance .
Any delays also increase the cash burn at the Co .
Thx for bringing to my attention
Kiwi

Kiwi, since you have been discussing potential timeline for OLC approval, I was wondering what your thoughts were about the following. I am in another stock, AVXL, Anavex Life Sciences, where on their iHub board they have been actively discussing the firings and layoffs at the FDA and how that would impact drug approvals going forward (obviously mostly delaying their approval). They actually have an application for approval with the EMA and not yet with the FDA from what I understand, but I was reading the discussion about workforce reduction at the FDA and wondering how it might impact other companies, like UNCY, RZLT, etc?

Assuming OLC is approved by end of June and immediately enters the TDAPA process
This is how they determine what CMS will pay

The Centers for Medicare & Medicaid Services (CMS) determines the Transitional Drug Add-on Payment Adjustment (TDAPA) pricing for new dialysis drugs based on specific methodologies tied to the drug's pricing data and regulatory criteria. Here is an overview of how CMS establishes TDAPA pricing:
Pricing Basis:
For most drugs, TDAPA payments are set at 100% of the drug’s Average Sales Price (ASP). If ASP is not available, CMS uses the Wholesale Acquisition Cost (WAC). If neither ASP nor WAC is available, the payment is based on the manufacturer's invoice price156.
In some cases, CMS may adjust this formula. For example, calcimimetics were initially reimbursed at ASP + 6%, but this was later reduced to ASP + 0%17.
Eligibility and Duration:
TDAPA applies to new renal dialysis drugs and biological products for at least two years, during which CMS collects utilization and cost data to determine whether adjustments to the ESRD Prospective Payment System (PPS) base rate are necessary15.
Special Adjustments:
For certain categories, such as phosphate binders, CMS has considered additional fixed payments or percentage increases to account for operational costs or acquisition price variations37.
A fixed increase of $36.41 per monthly claim is currently applied for phosphate binders under TDAPA3.
Post-TDAPA Adjustments:
After the TDAPA period ends, CMS may implement a post-TDAPA payment adjustment based on 65% of the estimated expenditure levels from the prior year to ensure continued access to innovative therapies24.
This structured approach ensures that new therapies are temporarily reimbursed outside the bundled payment system while CMS gathers sufficient data to incorporate them into the ESRD PPS framework.


So OLC is expected to cost $1,300 a mth IIRC and CMS will cover all of that for at least the first 2 yrs ....and 65% of that in the following years .
ARDX's XPHOZAH is not currently in the TDAPA process so is receiving nothing from CMS for their Medicare dialysis patients
My take anyway ...feel free to critique
Kiwi

UNCY is supposed to have a commercialization plan presented this Qt .
The Co needs to ramp up but and be ready to roll as soon as OLC is approved . The time line for the TDAPA process ...which is CMS payments beginning is at best 3 mths from approval .
Some recent examples
For VAFSEO® (vadadustat), approved in October 2024, TDAPA payments began on January 1, 2025, about three months later1.
For DEFENCATH® (taurolidine and heparin), approved in April 2024, payments started on July 1, 2024, also about three months later1.
In general, the TDAPA process starts within a few months after a drug's approval, contingent on completing the HCPCS code application and CMS's review timeline.


They really need to max sales in the first 2 yrs of TDAPA ...as CMS payments will decline after that and exclusivity runs out in 2031

Kiwi

Thanks for the update.  I have exposure to both ARDX and UNCY so appreciate the info. 

RMB. so a little report from the front lines ( wife's dialysis clinics ). They have been prescribing Xphozah ( ARDX ) but now some patients are rejecting it because of issues with diarrhea ...apparently not as transient as hoped for ...plus insurance hassles .
Looking forward to OLC becoming available as the next best option for her patients ...all hate the current binder pill burden and few at serum pho goal.

Kiwi

Ha ha ...hope not . Usually analysts give 1 yr targets
Co will be hosting a commercialization day this Qt I think ...to show they are ready to launch as soon as approved
Kiwi

Maybe they’re thinking $4 after a r/s?

HC Wainwright & Co. analyst Ed Arce reiterates Unicycive Therapeutics (UNCY) with a Buy and maintains $4 price target.

I'll be happy if he's only half right ...$2


Kiwi

So the previous post was about the challenges dialysis patients have with the current phosphate binders.
The question is ...Is OLC more tolerable ( fewer side effects ) than Lanthanum Carbonate ( Fosrenol )
Based on the available data, OLC (oxylanthanum carbonate) appears to be more tolerable than traditional lanthanum carbonate.
The pivotal clinical trial for OLC demonstrated a low rate of discontinuation due to adverse events, with only 5/86 patients (6%) discontinuing from the study1. This compares favorably to the 14% discontinuation rate due to adverse events reported for Fosrenol (lanthanum carbonate) in its FDA-approved Package Insert1.

In the OLC-201 trial, there was only 1 discontinuation due to a treatment-related adverse event in the Evaluable Population (n=71), a rate of 1.4%1. In the full Safety Population, a total of 3 patients discontinued due to treatment-related adverse events, a rate of 3.5%1.
OLC was also well-tolerated in a dose-escalation study with healthy participants. There were no serious adverse events, severe or life-threatening adverse events, deaths, or adverse events leading to discontinuation710.

The most common side effects of OLC were similar to those of lanthanum carbonate, including diarrhea (9%) and vomiting (6%)4. However, the overall safety profile of OLC appears to compare favorably to Fosrenol and other phosphate binders on the market4.

So the issue is ..can UNCY mgt get this FDA approved without having to do a reverse split or raise funds first
They have funds once approved thru the exercising of warrants .

Kiwi

https://www.nephrojournal.com/articles/patient-perspectives-the-effects-of-contemporary-phosphorus-management-on-quality-of-life.html

Know what you own .
The risk is that they do a reverse split to stay Naz compliant and raise funds .... before the FDA decision on approval ,
If FDA delays approval ...as in SLNO's case ...stock will definitely sell off .
Other negative is limited exclusivity / patent protection as listed in their latest presentation

I'm still holding till FDA decision date
Kiwi

I hope we don't either but I always set some bait dragging the bottom of the pond.

Not huge volume on this downturn so hopefully we don't see your target

I see 23 cents as the bottom if it gets down that far.

Wow where is the bottom

Correction ...well one issue I did note in their 2025 presentation .....exclusivity and patent protection in most of the world only runs to 2031.
So assuming approval mid 2025 ...launch by end of 2025 ( details on launch scheduled for Q1 2025 ) ....they only have 6 yrs before exclusivity ends and possible patent challenges launched earlier .
Which probably explains why they dont care so much about the dialysis bundle since they will get full price for at least the first 2 yrs ...tapering down after that .
Loss of exclusivity and maybe patent protection in 6 yrs is probably a no go for any BP interest . I had thought they were an ideal candidate for a BP buyout

A family of patents
(incl. composition of
matter) were filed in
2011 for the U.S with
exclusivity until 2031

Corresponding patents
granted in Canada,
Europe, Japan, China,
Australia, and other
countries with expiry in
2031

Kiwi

Why is this stock so cheap ? What am I missing here ?
I agree with Mr Mister that the stocks been depressed lately as preferred shares at low conversion prices get converted to common when the stock trades higher ....and that may cap advances , but consider the following

Strong XPHOZAH® (tenapanor) performance continues, recording approximately $161 million net product sales revenue during 2024
XPHOZAH demonstrated an exceptional launch and finished its first full year of commercialization with 2024 U.S. net product sales revenue of approximately $161 million, including approximately $57 million in net product sales during the fourth quarter, subject to adjustment in connection with preparation of audited financial statements.

ARDX's XPHOZAH was able to generate $161m net product rev in 2024 , $57 m of that in the last Qt . How long has XPHOZAH been on the market ?
As new Oral binders go XPHOZAH is expensive , around $3,300 a mth where as OLC is expected to be around $1,200 a mth...... so insurers are likely to want patients to try the new lower cost pho binders first especially since many consider OLC to be more effective at lowering serum pho .

UNCY ...market cap of $64 m , Enterprise value of only $36 m ....for a drug that should do just as well as, if not better then what ARDX generated in XPHOZAH net rev ....$161m...in 2024 .

Yes preferred converting to common and exercising the warrants will significantly dilute the stock ( exercising warrants provides cash to the Co to market drug etc ...in exchange for new stock ) .... but given size of market and need for a better pho lowering drug ....price of stock seems cheap .

What am I not seeing here ....anyone ? Patent issue ? Believe they have new drug exclusivity for 13 yrs ???
Maybe it's the amount of warrants that will eventually be exercised ( converted to stock ) .....but the Co would raise $ anyway when / if they get FDA approval June 28 th to hire sales reps etc ...unless they sell the Co

Kiwi

New 2025 presentation ...explains a lot . They seem to think the new dialysis bundle works for them

https://d1io3yog0oux5.cloudfront.net/_1e47de31026600fae3b0c9940fd3cc4a/unicycive/db/1912/17777/pdf/Unicycive+Corporate+Presentation+-+January+2025.pdf

Kiwi

The preferred are part of the 2023 financing agreement
Pursuant to the securities purchase agreement, the Company will issue to purchasers (i) $30 million in shares of the Company’s Series A Convertible Preferred Stock
So the investors ( Vivo etc ) make $ converting to common ...and theres still the warrants that can be exercised on FDA approval , entry into TDAPA etc

interesting
Kiwi