Unicycive Therapeutics Inc (UNCY) 銘柄情報

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

Thanks for posting Kiwi.  Yep seems like they feel Medicare works for them.  Notice the different triggers for the three tranches of commercial funding going forward. 

And, on the map of concentrated prescribers, I see your wife's clinic, right there near SF. 

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

Thx for noting the change in preferred . Its not an area I'm familiar with
Investors typically convert preferred stock to common stock when it becomes financially advantageous to do so. This occurs when the market price of the company's common stock rises above the conversion price12.
The decision to convert is based on several factors:
Stock price appreciation:
If the common stock's market price exceeds the conversion price, preferred shareholders can profit by converting and selling the common shares2.
Potential for higher returns: Converting to common stock allows investors to participate in the company's growth and potentially earn higher returns through capital appreciation3.
Voting rights: Common stockholders typically have voting rights, which preferred stockholders may want to acquire3.

Actually U are correct
Unicycive Therapeutics has multiple series of preferred stock with different conversion prices:
Series A-2 Prime Preferred Stock: $0.49 per share2
Series A-3 Preferred Stock: $0.54 per share2
Series B-1 Convertible Preferred Stock: This series was recently issued in a $50 million private placement at $1,000 per share15. However, the specific conversion price for this series is not explicitly stated in the provided search results.
It's important to note that conversion prices can be subject to adjustments based on various factors outlined in the company's certificate of designation or other governing documents. Additionally, some preferred stock series may have automatic conversion features, such as the Series B-1 Preferred Stock, which is set to automatically convert on the tenth Trading Day following the announcement of Stockholder Approval3.

When the stock hit the recent high, it paid to convert the series A preferred stock to common

Kiwi

Thx Ernie

The Tranche A warrants for an aggregate exercise price of approximately $25 million are exercisable until 21 days following the Company’s announcement of receipt of FDA approval for Renazorb;
So funding already set once they have FDA approval ...ie no need for a capital raise .

The PDUFA date is awfully close to when they face a Naz delisting if PPS is still under $1 for 10 days .
Do you think theres a risk of a reverse split ?

Kiwi

Looks to me that the warrants are milestone warrants tied to extra funding from what I read.

About the Private Placement

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 and (ii) three tranches of warrants that are exercisable for convertible preferred stock as follows:

The Tranche A warrants for an aggregate exercise price of approximately $25 million are exercisable until 21 days following the Company’s announcement of receipt of FDA approval for Renazorb;
The Tranche B warrants for an aggregate exercise price of approximately $25 million are exercisable until 21 days following the Company’s announcement of receipt of TDAPA approval for Renazorb; and
The Tranche C warrants for an aggregate exercise price of approximately $50 million are exercisable until 21 days following public disclosure of four quarters of commercial sales of Renazorb following receipt of TDAPA approval.

I don't know about their warrants. I'm not smart enough to understand that. However, UNCY's December presentation listed 24.6 million preferred shares. The most recent one lists 15.6 million shares. Preferred shareholders must be converting their share into common shares increasing the total on hand. Explains to me why UNCY will be stuck in the 60 cent range for a few months before the PDUFA run up

Do you know anything about the warrants being exercised ? From memory they were exercising warrants ....requires issuing stock when cash is received from the exercise of the warrants ...my limited understanding .
So Co got cash but increased share count ....is this what U are referring to ?

Kiwi

Thanks for your perspective. I did a little digging and compared the company's most recent presentation with their December presentation. There are about 9 million more shares now courtesy of preferred stock conversions. Explains, in my mind anyway, why the stock is rangebound on the lower end

I think the current swings are just determined by how much risk you ( or funds ) want to expose yourself ( themselves ) to in this market .
I can list risks specific to UNCY ...eg ...will they do a reverse split before the PDUFA date . Any delay in PDUFA ( like with SLNO ) and if they are still trading well below $1 ...a reverse split seems inevitable .
Theres a risk they do a reverse split ...and raise funds .

As regards over all market risk . Very hard for market to go higher if the 10 yr note goes over 5% .

Also no presence at JPM even tho ARDX presented there . Maybe they just wanted to save the $ .
No change so far from CMS regarding new Oral pho drugs in the dialysis bundle .

I'm still long ...but investors going " risk off " doesnt surprise me.
JMO
Kiwi

I keep thinking this is dead money until April or May, but it is strange to see this 10% percent drops and recoveries.

Any theories anyone?

Biogen $BIIB CEO confirms he’s shopping for biotechs: ‘We will be doing deals’

Kiwi

Well there is the patent cliff and BP is looking for new assets ...UNCY is unlikely launch their drug themselves


Biogen proposes to buy remaining stake in Sage in $442 million deal

Kiwi

So the risk here is that they raise cash or do a reverse split before the PDUFA date .
JMO
Kiwi

Sounds about right....
hoping to see a buck before June 🤞

PDUFA date is June 28th 2025 ...unless FDA announces a delay ( as recently with SLNO ) .
If the FDFA approves OLC by June 28th ...UNCY will be well over $1 before July 7th ( final Naz compliance date ) . Expect Co to raise $ on FDA approval to fund launch .
Down side risk is any delay by the FDA in approving OLC ......or their decision ( unlikely ) not to .
I dont believe an Adcom has been scheduled ....if no Adcom then very high certainty OLC will be approved
JMO
Kiwi

Item 8.01 Other Events.
On July 9, 2024, Unicycive Therapeutics, Inc. (the “Company”) received written notice (the “Notice”) from the Nasdaq Stock Market, LLC (“Nasdaq”) indicating that the bid price for the Company’s common stock (the “Common Stock”), for the last 30 consecutive business days, had closed below the minimum $1.00 per share and, as a result, the Company was not in compliance with the $1.00 minimum bid price requirement for the continued listing on the Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5550(a)(2).

In accordance with the Nasdaq Listing Rule 5810(c)(3)(A), the Company had a period of 180 calendar days, or until January 6, 2025, to regain compliance with the minimum bid price requirement.

As of January 6, 2025, the Company has not regained compliance with the minimum bid price requirement. On January 7, 2025, Nasdaq notified the Company that it would have an additional 180 calendar days, or until July 7, 2025, to regain compliance.

The Company intends to actively monitor the closing bid price of its Common Stock and may, if appropriate, consider implementing available options to regain compliance with the minimum bid price under the Nasdaq Listing Rules

https://ir.unicycive.com/news/detail/92/unicycive-therapeutics-announces-publication-of-positive

https://ascpt.onlinelibrary.wiley.com/doi/10.1111/cts.70116

Well theres last minute legal action from ARDX
From X Per court order, CMS has until noon on the 29th to respond to injunction request and $ARDX has until noon on the 30th to file a reply. Order signed by judges Katsas and Garcia. Katsas is a Trump appointment. Gacrcia is a Biden appointment.

So there may be a chance for a compromise re new Oral pho drugs and the dialysis bundle .....ie full coverage in TDAPA for 2 yrs and a 5 yr ( instead of 3 ) slide down to competing with generics .
Pure speculation on my part
ARDX might agree to lower the price for Xphozah since its over priced compared to Ibrsela per gm ( its the same drug )

Any deal ARDX makes , helps UNCY
JMO
Kiwi

What is driving UNCY and ARDX higher today?

new 13Gs filed

https://ir.unicycive.com/sec-filings/all-sec-filings

Xphozah is an adjunct therapy. Phosphate binders, ineffective though they may be, are Frontline therapies. Ardelyx was always going to be hurt the most by the KPA not passing in my opinion

Thanks Chevelle, that was good and supportive to the stock, but I am still surprised how well UNCY has held up with the realization that the KPA is probably not passing. Seems to have hurt ARDX much more.

https://ir.unicycive.com/news/detail/91/unicycive-therapeutics-announces-publication-of

RMB. IIRC There are no FDA approved drugs for Delayed Graft function ( a serious risk in kidney transplants )
UNCY completed a successful trial in healthy volunteers . Next step is for agreement with the FDA on the design of a P 2 trial for those undergoing a kidney transplant . Co doesnt have the cash right now to run such a trial so the options are ...sell UNI 494 to a BP or wait till OLC is approved for serum pho lowering and raise cash then ....to promote OLC and run a P2 UNI 494 trial .

Kiwi

Thanks.  Sounds like we are hanging on to this baby. 

Re change in valuation over the last 3 mths . Don't forget UNI-494 . My wife treats a lot of kidney transplant patients and between 30-50% of them experience Acute Kidney injury which can lead to loss of the new kidney ...devastating for the patient


About UNI-494

UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator. Mitochondrial dysfunction plays a critical role in the progression of acute kidney injury and chronic kidney disease. UNI-494 has a novel mechanism of action that restores mitochondrial function and may be beneficial for the treatment of several diseases including kidney disease.

UNI-494 is protected by issued patent(s) in the U.S. and Europe and a wide range of patent applications worldwide.
UNI-494 has been granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for the prevention of Delayed Graft Function (DGF) in kidney transplant patients.
UNI-494 has completed a Phase 1 dose-ranging safety study in healthy volunteers.

About Acute Kidney Injury

Acute kidney injury (AKI) is defined as a sudden loss of kidney function that is determined based on increased serum creatinine levels and decreased urine output and is limited to a duration of 7 days. The primary causes of AKI include sepsis, ischemia, hypoxia, and drug-induced nephrotoxicity. Delayed Graft Function is a type of acute kidney injury that occurs in the first week after kidney transplantation. AKI is estimated to occur in 20-200 per million population in the community, 7-18% of patients in the hospital and approximately 50% of patients admitted to the intensive care unit. Importantly AKI is associated with morbidity and mortality; an estimated 2 million people die of AKI worldwide every year whereas survivors of AKI are at increased risk of chronic kidney disease, end stage renal disease.


Kiwi

RMB. Well apparently theres a last minute push to get the Kidney Patient Act attached to some end of year funding bill . Next wk is the last wk of 2024 to act apparently. .
Passage would probably be a big boost to ARDX and UNCY as passage this yr seems a long shot and I think largely priced in .

Re market constantly mis pricing .
A lot a positive developments over the past 3 mths ...chk the history ...plus another hedge fund buying in
Successful UNI-494 trial in Acute Kidney injury
Presentations at Kidney wk including a video interview
Acceptance of NDA
etc

Kiwi

Was thinking the talk of passage of KPA and how it could boost stock prices here and ARDX. If passage of the bill would boost the stock prices, then the corollary is that there must not be much priced in? So, my question is if the KPA does not get enacted before the end of the year, can we assume that these current prices will not crater that much? How can UNCY's valuation be 3 times what it was a couple of months ago. The market constantly mis-prices stocks.

In Hellio Nephrology yesterday

Phosphate binder rule is disease-specific discrimination

Add topic to email alerts
In April, CMS issued guidance for the inclusion of oral-only drugs in the end-stage renal disease bundled payment. The directive included Xphozah as a renal dialysis service.

Xphozah, (tenapanor, Ardelyx) is a first-in-class phosphate absorption inhibitor approved to lower serum phosphorus levels for adults on dialysis. CMS intends to include the agent in the ESRD prospective payment system effective Jan. 1, 2025, but unlike calcimimetics and phosphate binders, tenapanor will have its own transitional drug add-on payment adjustment (TDAPA) and be excluded in the calculation for a permanent add-on payment. Under this guidance, tenapanor will be moved from Medicare Part D to Part B, and Part D pharmacies will no longer be allowed to fill prescriptions to Medicare ESRD beneficiaries.

Premila Bhat, MD, FASN, AHSCP-CHS, and J. Ganesh Bhat, MD, FASN
Tenapanor in phosphate control
Hyperphosphatemia and metabolic bone disease are the most challenging clinical issues facing nephrologists who treat patients on dialysis. Phosphates are ubiquitous in the diet, and normal kidneys excrete most of the phosphates absorbed from the gut. With the decline of kidney function, phosphates accumulate in the blood, leading to secondary hyperparathyroidism and metabolic bone disease.

Since dialysis became a routine procedure for patients with ESRD, traditional management of elevated phosphorus has been through oral drugs that bind phosphates and prevent absorption. Aluminum hydroxide gel and calcium-containing compounds, such as calcium acetate or citrate, were the mainstay for controlling hyperphosphatemia in dialysis. Aluminum toxicity and concerns about calcium burden led to the introduction of other phosphate binders, such as sevelamer carbonate, sevelamer hydrochloride, lanthanum carbonate and iron-based phosphate binders.

Premila Bhat, MD, FASN, AHSCP-CHS
Premila Bhat
J. Ganesh Bhat, MD, FASN
J. Ganesh Bhat
Dietary restriction and dialysis using currently available dialyzer membranes alone are insufficient to maintain phosphate balance; hence, there is a need to bind phosphate in the gut to prevent absorption. Compliance with conventional phosphate binder therapy is difficult and directly attributable to the “pill burden” and need to take the medication with or soon after meals multiple times a day. Gastrointestinal adverse events and intolerance to the binders further complicate the matter.

Many patients on dialysis cannot maintain a serum phosphorus level between 3.5 mg/dL and 5.5 mg/dL even when using medications to manage the condition. The addition of tenapanor as an add-on therapy for patients who have an inadequate response to phosphate binders or intolerance to any dose of phosphate binder would make these goals easier to achieve and prevent complications due to secondary hyperparathyroidism.

Legal action
In July, Ardelyx started legal action arguing that CMS did not have the authority to include oral-only drugs, such as phosphate binders and phosphate absorption inhibitors, in the bundled payment system. From a mechanism-of-action point of view, Ardelyx argued, these drugs should not be labeled as renal dialysis services because the drugs are not administered either orally or parenterally during dialysis treatment, and a parenteral form of phosphate binder or absorption inhibitor is unlikely to be developed.

The judge dismissed the case on Nov. 8. CMS will move the drug from Medicare Part D to Part B as planned on Jan. 1, 2025. Ardelyx has yet to accede to CMS’s request for it to apply for a Healthcare Common Procedure Coding System code and TDAPA status, leaving dialysis providers with no clear pathway to be reimbursed.

CMS stated that moving phosphate binders from Medicare Part D to Part B improves beneficiary access to these medications. Medicare Part D enrollment among patients with ESRD had increased to almost 80% in 2021, and twice as many patients with ESRD qualify for low-income subsidies as those without ESRD. Medicare seeks to improve access to these drugs to all patients with ESRD under Part B, and moving phosphate binders to Part B from Part D would have a negligible impact on access to these drugs. However, this change would burden dialysis providers to procure the drugs be the gatekeeper, keeping an eye on the cost.

Equity in ESRD
ESRD is one of the clearest examples of racial and ethnic disparity in health care in the United States. Black and Latino patients are affected by ESRD four times and 1.3 times more, respectively, than white patients. Furthermore, poverty, as measured by dual eligibility status and low-income subsidies, makes ESRD the poster child for disparity in health care in the country. Since the introduction of the ESRD bundle, CMS has experimented with ineffective ideas, such as TDAPA and transitional add-on payment adjustment for new and innovative equipment and supplies (TPNIES) and mandatory ESRD Treatment Choices model, which have an enormous and often negative impact on the lives of patients with ESRD.

Under the current method used by CMS, innovative drugs and technologies are less attractive to innovators and investors, limiting access of patients with ESRD to the advantage of these drugs and technologies in stark contrast to patients who have cancer or heart disease.

For example, Korsuva (difelikefalin, Cara Therapeutics) is a novel anti-pruritic drug that could have treated severe itching for one of six patients on hemodialysis. After the TDAPA period for the drug ended, CMS adopted a 3-year adjustment that spread the cost of it across all Medicare treatments. To recover the cost of providing the drug to a single patient, a facility would have to treat hundreds of patients who do not require it. No facility has a sufficient patient population to make that equation work. Consequently, only a fraction of patients who would have benefited from the drug are now receiving it, and its future availability remains uncertain.

Under the current bundled payment and drug designation process, CMS has reinforced systematic discrimination against patients with ESRD that the administration has indicated it seeks to end. The current system stifles innovation and puts the financial burden on dialysis providers to bear the full cost of providing these expensive drugs and technologies to patients without adequate reimbursement.

Patients with ESRD are discriminated against with regard to access to novel therapeutics, devices and diagnostics compared with their peers without ESRD. Oncology, cardiology, diabetes and patients with other rare diseases enjoy a rich innovation pipeline due to a reimbursement system that rewards companies for innovating in these therapeutic areas. It is time for Congress and other policymakers to revisit how innovation is sustainably paid for in ESRD to ensure brave patients are not left behind.

For more information:
Premila Bhat, MD, FASN, AHSCP-CHS, is CEO of Tidal Home Dialysis LLC, and a partner at NY Kidney Hypertension Medicine in Ridgewood, New York. She can be reached at pbhat@atlanticdialysis.com.
J. Ganesh Bhat, MD, FASN, is a principal at Atlantic Dialysis Management Services LLC, in College Point, New York. He can be reached at jbhat@atlanticdialysis.com.
Published by:
nephrology news and issues logo
Sources/DisclosuresCollapse
Disclosures: The authors report no relevant financial disclosures.


Kiwi

There was an article yesterday in Helio penned by 2 Nephrologists explaining how the current CMS dialysis bundle system for dialysis patients ....stifles new innovation , punishes Co's that develop new drugs for CKD patients ...especially dialysis patients ...and discriminates because most on dialysis are people of color .
They pt out that the Cardiology community by contrast has far better access to new drugs than the CKD dialysis community .
They say the whole CMS TDAPA program for dialysis patients needs to be changed .

Kiwi

I see that UNCY has come alive today but trying to figure out why.  Any news on Kidney Act?

It's Alive ....:--)
Kiwi

Yep. The market is probably pricing in a high chance of failing to pass the Kidney Patient Act this yr . Eventually I think the ARDX issue will be resolved like Amgens introduction of Repatha
At first they wanted $14,000 a yr ....few scripts were accepted for coverage
2 yrs later they dropped the price to around $6,000 a yr in exchange for wide coverage ...now its widely used ..I'm on it
Kiwi

Kiwi, I understand the reasoning as to why ARDX would have the most immediate benefit if the KA passes.  But I would assume by the same logic that if the KA fails to be passed that UNCY would drop less than ARDX?

3 new co sponsors ( 1 is Republican ) for the Kidney Patient Act . Total of 43 cosponsors now . An informed opinion I'd read on these bills is that you need at least 50 co sponsors to tilt the scales towards passing the Act
Still about a week and a half before they shut down for the yr

ARDX will see the most immediate benefit if this pass's ...but UNCY should benefit also and maybe push the PPS over $1
JMO
Kiwi

Hope so I’ve been accumulating UNCY the last few months …..got a decent position and still adding here and there

Yep ..it applies to Medicare patients on dialysis . ARDX did not apply to the TDAPA process which determines pricing because CMS wants Xphozah in the dialysis bundle which would mean in about 5 yrs Xphozah would have to compete with generic pricing .
Their view is ...why spend the time and $ running trials etc if CMS mandates the new drug to generic pricing in 5 yrs . It's rare for a Co to even breakeven in the first 2 yrs of launch .
On the other side ...ARDX over charges for X relative to Ibserla ( as explained previously ) so CMS is basically saying FU to ARDX
Meanwhile Medicare dialysis patients look to be the loser at least near term as their scripts may not be renewed .

UNCY is also a big winner if a deal is worked out favorable to ARDX.... as it will apply to all new oral pho binders

Kiwi

Xphozah is shown to still be available by ardelyx but the company has not chosen to file a specific payment program under Medicare …that will restrict patients access to the drug…unless of course legislation changes that

I think what might be firming up the price this week are the two conferences. One today and one Thursday. Depending how high the stock price gets to and what action/inaction on Kidney Act in the Senate, I may look to book some profits. Not a bunch but at some maybe.

it's good for me!

I got my average down enough for a healthy profit if it hits $1. I was just being greedy I suppose.

Shame about Xphozah. Sounds like it needs a miracle to thrive in 2025

it's good for me!

I got my average down enough for a healthy profit if it hits $1. I was just being greedy I suppose.

Shame about Xphozah. Sounds like it needs a miracle to thrive in 2025

Is that good or bad for U ? I thought you were hoping for a pull back to 50c... to load up ?
You were right about the pull back after the NDA was accepted ....definitely a good buying op . .
The sh#t is about to hit the fan on Xphozah ( ARDX ) . My wife wrote 2 scripts for it today . Both were rejected on the basis the drug will no longer be available ( as it currently stands ) Jan 1.
The patients on it and the Nephrologists prescribing it ..... are pissed off to say the least .
Kiwi

Is that good or bad for U ? I thought you were hoping for a pull back to 50c... to load up ?
You were right about the pull back after the NDA was accepted ....definitely a good buying op . .
The sh#t is about to hit the fan on Xphozah ( ARDX ) . My wife wrote 2 scripts for it today . Both were rejected on the basis the drug will no longer be available ( as it currently stands ) Jan 1.
The patients on it and the Nephrologists prescribing it ..... are pissed to say the least .
Kiwi

This may get back to a $1 pretty soon.

So on a quiet holiday half day, UNCY will do more than average volume. Definitely looks like this will work out. (Of course after I say that I hope I don't jinx it). Those senators need to move their butts and get it done.

Right back at ya.  Man I must be really declining not spelling there correctly.  

Thx for the info
Happy Turkey day
Kiwi