Talphera Inc (TLPH) Options

Thanks. Sailed around hurricane John a couple of days ago and now weather is great. Tomorrow canal.

Re TLPH ...my guess is market's concerned theres no update on trial enrollment so theres a risk Co will need to raise more $ .
Sold most of my position some time ago as noted in a previous post .
How's the weather where ever U are ?

Kiwi

Thx ...Yes probably no action till EOY .
I may copy and paste to the ARDX and UNCY boards
Safe travels
Kiwi

Saw this but it is a few days old:

“(Bloomberg Intelligence) - Ardelyx, Akebia Therapeutics and other makers of oral-only, end-stage renal disease (ESRD) drugs will likely see Congress pass legislation during the lame duck session
that blocks an administrative proposal to move the therapies out of the Medicare Part D program. Some lawmakers have expressed concerns with the regulatory decision, and a delay won't impact federal finances. Passing the bill would remove some near-term uncertainty around utilization and
pricing for newer drugs. (09/04/24)
1. Lawmakers Ramp Up Scrutiny of Regulatory Change Ramped-up congressional oversight of Medicare's implementation effort to incorporate oral-only drugs into the ESRD payment bundle should generate enough headline noise to keep the issue front-and-center for action during the lame-duck session. Lawmakers continue to raise concerns about the regulatory change, and have requested information from the Biden administration on the implementation process. But with only a handful of legislative weeks scheduled in September, major policy changes won't make it to the president's desk before Congress adjourns for election
campaigns. The policy change will likely be folded into a broad-based year-end omnibus bill with other member
priorities such as PBM regulation changes and legislation curtailing biotech research with China.
(09/04/24)”

Thanks Kiwi. I unfortunately have been running around today and just got home and am now going back out to cut the grass. Will listen if I can find a replay.

Going on a Panama Canal cruise in a couple days and of course the stuff always hits the fan when I leave.

RMB. I listened to TLPH's presentation and my take was
1) This trial is going to take a lot longer to complete than I anticipated .
2) Even when approved their drug will be included in the dialysis bundle since its used during the actual dialysis process ...so it may be a hard sell as CMS caps each dialysis payment and dialysis co's get to keep the difference between what its costs to dialyze some one .....and what CMS pays .

I lowered my position and are now more interested in VERA, UNCY and ARDX in the CKD space .
Good luck
Kiwi

Re Defencath ...Central venous catheters (CVCs) are often used as the first-line vascular access for incident hemodialysis patients, especially in acute or emergency situations that are more common in hospital settings.
I was at a patient Xmas party once ( favor to wife ) ...hospital dialysis unit ...Patient with an exposed central venous cath sat down at my table and asked me why he was " stroking out ".
He thought I was an MD ...quite an experience .
Don't see it being used much in regular dialysis ( non hospital ) units ...JMO

I'm not much of a believer in the retire with solely dividends view pt.
I have had fairly large positions ( for me ) in MSFT , AMZN for decades ....and have been buying BRK-B lately ...so more growth orientated

Biotechs are an interesting side spec ....hopefully we will see updates on TLPH's trial and UNCY's NDA filing soon .
My wife is interested in IgAN ...big issue for some of her patients .
VERA to report key data in Q4

Just have to be patient with biotech ...wait for the data

Good luck
Kiwi

You are correct about Defencath has it has a limited target population. I am there as they are about to sign up a couple more dialysis providers and technically the stock looks strong and I plan to be out in the near future - upon positive news.

I have been slowly over the last number of years funneling proceeds from bio/spec sales into mid/large cap div payers. 2025 will require me to start RMDs in my tax sheltered account. My taxable brokerage account is already completely in dividend stocks save for AMRN. With interest rates dropping in the coming year my savings accounts will be bringing me much less interest income at a time that I moved to a more expensive area to live - what was I thinking?

OMG. you're running a mini biotech fund ....why didn't U mention AMRN ...:--)
If U don't mind I'll do a mini critique some time
Re CRMD ...and their cath loc . I had briefly discussed cath infections with my smarter half some time ago.. She sees 1-2 cases a mth
Rate of infection
The event rate per 1000 catheter-days was:
0.13 for DefenCath
0.46 for heparin
It's only used in central venous lines. correct ? . Most access in dialysis clinics are thru fistula's in the arm .
Are they included in the dialysis bundle ??...which is supposed to cover all things dialysis .

Above is just quick thoughts on a Fri eve and may be totally incorrect

I usually don't hold a Co once a drug is approved ....Launch usually longer and harder then most expect and -ve surprises seem inevitable ...AMRN case in pt.
Currently in UNCY and ARDX as I expect the Kidney Patient Act to pass
Also in EWTX, VERA, RZLT, OCUL,TLPH , FULC, RNA , KYMR ...and of course AMRN . Why AMRN ...to remind myself to always sell on FDA approval. ..:--)

Kiwi

You are right that some of these small bios are taxing our patience or at least make it frustrating to hold. I have invested in a group of them for the potential they hold and will look at them as a group insofar as what return I will be getting on the investment.

ALLO, ARDX, EYEN, TLPH, RZLT, UNCY. I do have other small bios but I consider them separate since they have approved products already selling in the marketplace. AXSM, CRSP, AUPH, BCRX, CRMD.

Hopefully stock will stay above $1 for 10 days and cure its delisting notice
To regain compliance, the stock must trade at or above $1 for a minimum of 10 consecutive business days

Co will have to renegotiate the timing of a progress payment ....originally a payment was to be made if their pivotal trial was fully enrolled by Sept 30 th ...looks unlikely altho not impossible

Kiwi

Another Co besides UNCY thats difficult to be patient with .
The pivotal clinical trial for TLPH has been painfully slow to enroll ...while they burn thru their cash on hand

Kiwi

I listened to their CC. Multiple sites have now been signed up and are screening patients .
No one has completed the trial yet ...so total completion is pushed off till end of year ( my guess )
Have $14m in cash and will burn thru much of that running this trial ...so renegotiating mile stone payment with Nantahala will be key in Sept . Nantahala now has some one on the BOD.
New CMO ? is a Nephrologist and may be able to expedite the clinical trial site set ups / enrollment faster

Kiwi

ER on Aug 14th ...need an update on their trial ...if its enrolling and when they expect results ...and if they need more cash

Kiwi

Copy from a friend asking what's up with TLPH ..my response
TLPH. New mission … to get a drug used in Korea and Japan approved in the US
From memory- heparin is used in dialysis to prevent clotting … it has a fairly long half life
The problem is those admitted to the ICU after surgery or from a serious accident and need dialysis …. Need something that prevents clotting but only for a short time … as these patients often have high bleeding risk
That’s what TLPH’s drug does …. Reduces clotting for a short time
FDA requires a US trial before approval
Problem … since Covid a lot of the hospital staff that set up these trials have retired
So it’s been slow to get this pivotal trial going But looks like it may finally be underway


So either that or more funding
JMO
Kiwi

RMB / Molee ..they probably have made progress enrolling patients in their trial . I'll look for an update on clinical trials .gov .
P3 results still due this yr
Kiwi

That's why day trading is like a casino . House has the advantage ....

Yet , we continue to come back , hopeful that we can win a few shekels here and there .

Possible. Volume already 3 times avg 3mo volume. Why are we always last to know?

Something ???

No update on trial enrollment ...or even if first patient has been enrolled ???

Just picked up a few more shares, with understanding that this may take longer than originally expected.

AH gains not showing up as much in next day trading
Kiwi

Got tied up all day and had no chance.

RMB. did U add ...trading up a lot after hrs today ...at least on this board

Kiwi

Trading up 15% after hrs !!! Lets see what tomorrow brings
Kiwi

From May 13th CC
. As a result of the initial delays, we expect that our previous guidance of having top-line data available by September 30 will be revised. Once patients begin enrolling, we plan to provide an updated expected study completion date.

Will need update on trial before I add more . If top line data is pushed back to EOY ...they will almost certainly raise $

Kiwi
PS. I hope UNCY doesn't do a MITIGATE ...ie never release the data :--(

Definitely could be worse. Might look at adding as well.

Q1 ER Considering the Company’s current cash resources and its current and expected levels of operating expenses for the next twelve months, management expects to need additional capital to fund its planned operations prior to the 12-month anniversary of the date

We need an update on trial progress

From a March post

Sites have been slow to be approved due to administrative back log at the academic hospitals that will run this short trial ....but some should be up and running 4/1 onwards .
Short trial ...patients are only on drug for max 72 hrs , DMS safety signal at 32 patients , results expected Q3

So my guess is trial results pushed back and they need more $

Kiwi

They need $ ...see post to RMB ...just my guess
Kiwi

Ceo was buying 10,000 shares last week ...open market purchases .
http://archive.fast-edgar.com/20240614/AQLHSQ2CKC22VZZX222H2ZZZBBT5Z2X2Z262/
Co may be about to do a RZLT ...raise $ and dilute current investors despite saying they have enough $ to complete trial .

There had been some administrative delays starting the trial ...so they may have been burning thru cash on hand getting the trial going .
If trial is delayed ...even worse .

If the only issue is delay in trial starting ( but its on track ) so they needed to raise some $ ....I'll probably add some

Kiwi

Another disaster du jour. we are always last to find out.

What do you suppose THIS drop is all about ???

HC Wainwright & Co. analyst Ed Arce reiterates Talphera ( TLPH ) with a Buy and maintains $6 price target.

Kiwi

Mkt agrees with U . Heavy vol up around 20% as I type.
Recent funding
$18 million in total equity from two existing investors structured as $6 million of equity issued at the first closing, $10 million of committed capital upon the announcement of positive NEPHRO registration trial data, and an additional $2 million commitment if Talphera stock trades above a specified price following that announcement.
Kiwi

Good news even if results are pushed out a bit.

Enrollment delayed
We have finalized clinical trial agreement terms with five large academic institutions and are awaiting these sites to complete their final internal start-up activities before patients are enrolled," stated Vince Angotti, CEO of Talphera. "While the initial site activation has taken longer than expected, based on our ongoing discussions with the principal investigators, they are eager to get started and expect the trial will complete quickly given the primary endpoint is measured at 24 hours. As a result of the initial delays, we expect that our previous guidance of having top-line data available by September 30 will be revised. Once patients begin enrolling, we plan to provide an updated expected study completion date.

Kiwi

Maxim Group analyst Jason McCarthy initiates coverage on Talphera ( TLPH ) with a Buy rating and announces Price Target of $3.

Oh keep the faith

Detailed Description:
Patients in intensive care units with acute kidney injury are often too frail to undergo the rapid fluid shifts that accompany intermittent hemodialysis. Continuous renal replacement therapy (CRRT) allows a more gentle continual dialysis, more similar to regular kidney function. Anticoagulation of the CRRT circuit can reduce clotting of the filter, which can lead to less filter changes and possibly less transfusions. Niyad (nafamostat mesylate), an anticoagulant with an ultra-short half-life of 8 minutes, is approved for use in South Korea and Japan for anticoagulation of the CRRT circuit. For patients who cannot tolerate heparin or who are at a high risk of bleeding, nafamostat may be an optimal anticoagulant to infuse into the CRRT circuit as the short half-life should minimize patient exposure. The primary objective of this study is to measure the anticoagulation efficacy of Niyad in the CRRT circuit versus placebo. Evaluation of the safety of Niyad in patients undergoing CRRT versus placebo will also be performed.
Study Design
Go to sections
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled, Double-blind, Multi-center Study of the Safety and Efficacy of Niyad in Patients Undergoing Continuous Renal Replacement Therapy (CRRT) Who Cannot Tolerate Heparin or Are at a Higher Risk for Bleeding
Estimated Study Start Date : March 2024
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2024


ER MD's needing to dialyze patients ...especially those patients with trauma and bleeding issues ..want FDA approval to use Niyad ...just as the ER MD's are doing in Japan and Korea
Results not to August at earliest . Start of trial was delayed due to administrative issues at the teaching hospitals running this trial
Using Heparin as they do now ...increases the bleeding risk for these patients ..which is why the ER docs want approval to use Niyad
Kiwi

Oh keep the faith

Detailed Description:
Patients in intensive care units with acute kidney injury are often too frail to undergo the rapid fluid shifts that accompany intermittent hemodialysis. Continuous renal replacement therapy (CRRT) allows a more gentle continual dialysis, more similar to regular kidney function. Anticoagulation of the CRRT circuit can reduce clotting of the filter, which can lead to less filter changes and possibly less transfusions. Niyad (nafamostat mesylate), an anticoagulant with an ultra-short half-life of 8 minutes, is approved for use in South Korea and Japan for anticoagulation of the CRRT circuit. For patients who cannot tolerate heparin or who are at a high risk of bleeding, nafamostat may be an optimal anticoagulant to infuse into the CRRT circuit as the short half-life should minimize patient exposure. The primary objective of this study is to measure the anticoagulation efficacy of Niyad in the CRRT circuit versus placebo. Evaluation of the safety of Niyad in patients undergoing CRRT versus placebo will also be performed.
Study Design
Go to sections
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled, Double-blind, Multi-center Study of the Safety and Efficacy of Niyad in Patients Undergoing Continuous Renal Replacement Therapy (CRRT) Who Cannot Tolerate Heparin or Are at a Higher Risk for Bleeding
Estimated Study Start Date : March 2024
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2024


ER MD's needing to dialyze patients ...especially those patients with trauma and bleeding issues ..want FDA approval to use Niyad ...just as the ER MD's are doing in Japan and Korea
Results not to August at earliest
Kiwi

From a comical point of view, sometimes I feel that my diversification only seems to provide a different disaster du jour every day LOL.

The benefits of diversification
I have positions in UNCY , RZLT ( sold half recently up 100% ) and TLPH ...plus a little AMRN cos I'm an idiot and take their drug Vascepa
So the gain in TLPH today outweighs the loss in RZLT and UNCY .
Now if I could just get all 3 heading higher ...:--)
Kiwi

I see that. Here is hoping for good news down the road

Well they may have finally got their pivotal trial underway ( was delayed due to hospital site admin delays ) ...stock up on heavy vol
Kiwi

RMB. very low vol so wouldn't take much to drop the PPS if someone unloaded 20,000 shares at once , .simply because of general risk off ....nothing TLPH specific.
There is a lot to be on edge for right now . Inflation coming in hotter than expected , interest rate cuts delayed ( or eliminated ) for 24. How is Iran going to retaliate against Israel and will this cause a spike over $100 in oil. .
Market over all has run a lot the past 6 mths so some are simply reducing their exposure .
Market was broadening out, but after the CPI reading , small caps in particular sold off .

Note. as example I reduced my position in RZLT before the CPI report
Up close to 80% since my initial purchase. Reduced my position somewhat going into the CPI report tomorrow as a bad report will mean a sell off in spec biotechs as well as small caps .
Simple risk mgt.
Kiwi

Don’t see any news —- anyone know the reason for this morning’s drop?

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

RMB. sorry been doing some minor retrofitting in the house ...remind me to never do that again ..always costs more and takes longer then I planned for ..---)
Re TLPH .....This Co is very unlikely to sell this product . They will sell to a large Pharma in the Renal space.
This is a specialty drug / treatment simply trying to get FDA approval on a drug used for decades in Japan and Korea .
It's a niche drug that ICU MD's needing to dialyze patients ...especially those with trauma or bleeding risk.

Keep an eye on UNCY
Their pivotal trial is fully enrolled . Most have probably already completed .
Its Open Label ...so they know how the patients are doing re tolerability

Brief Summary: The goal of this clinical study is to test the tolerability of oxylanthanum carbonate (OLC) in patients with chronic kidney disease on hemodialysis and have hyperphosphatemia (too much phosphorus in their blood). The main question it aims to answer is whether patients taking OLC for hyperphosphatemia are able to tolerate the drug.
Participants will continue with their scheduled dialysis treatments and replace their current phosphate binder drug with OLC.

Detailed Description: This is a 17-week study consisting of 4 parts. In Part 1, patients are screened for eligibility. In Part 2 patients undergo approximately 3-weeks of washout from previous phosphate binder therapy. Part 3 of the study is up to 6-week titration period where patients are treated with OLC starting at a dose level of 1500 mg/day. At the end of 2 weeks, the dose will be adjusted based on serum phosphate level, up to a maximum dose of 3000 mg/day. Part 4 of the study is a 4-week Maintenance Period with patients treated for 4 weeks on the clinically effective dose of oxylanthanum carbonate (OLC) identified in the Titration Period. Patients will return to the clinic for the End-of-Study Visit on the last day of the 4-week Maintenance Period before restarting their prescribed phosphate binder therapy. The primary endpoint will be to evaluate the tolerability of OLC (as assessed by rate of discontinuations due to treatment-related adverse events) and the secondary endpoints are the evaluation of the safety of clinically effective doses of OLC and evaluate the pharmacokinetics of OLC. Once weekly, at one of the patient's scheduled dialysis appointments and at the End-of-Study Visit, the tolerability will be assessed. After the End-of-Study Visit, patients will reinitiate standard therapy. Toxicity will be assessed during the study based on the severity grade (mild, moderate, or severe) as assessed by the Investigator.
Open or close this module Conditions
Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
Keywords: CKD, ESRD
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 90 [Anticipated]

Kiwi

Thanks Kiwi for pointing me here. I didn't recognize the symbol but then found out there was a name change from AcelRx, which I had looked at in the distant past. Will check this out here.

Notice right off the bat that there has been some net insider buying, not a whole lot, but still some. And, of course you mentioned Nantahala. Also I noticed they streamlined their board, reducing from 10 to 7 members. And, they mention keeping their M&A expertise with the company so they may be looking for some bigger group to swoop them up eventually.

Its random risk off in a down market . This Co will live or die on a successful trial before their money runs out.
JMO
Kiwi

$TLPH under a buck . Looks like "distribution" to me .