Talphera Inc. (TLPH)

[rosemountbomber]

Yep, as a matter of fact I added at the beginning of the week

[Whalatane]

Re

All these small bios have crapped out again

Are U still in RZLT ???. Small bio's have their own challenges ...basically getting results they need to advance.... before they run out of cash .
Many will flame out which is why I monitor closely and trim / sell when necessary . Limit loss's but when U find one like RZLT ...be willing to hold as it plays out .

I've been in RZLT since February...so since around $1 ....but sold half when it doubled
Kiwi

[rosemountbomber]

Less than a month ago enrollment looked like it was proceeding. All these small bios have crapped out again

[Whalatane]

Well unfortunately they are having trouble enrolling this trial ...and are burning thru their cash .
I sold most when they couldn't hold over $1 and will keep a small amount just to follow
Kiwi

[Whalatane]

Yep. fantastic . Their 2 immediate concerns where
1) Had they enrolled more in their trial
2) Was Nantahala going to extend their financing .

Looks like both are happening . Co was burning thru their cash and trial had been slow to enroll .
Almost 20X normal Vol ...maybe another fund adding big ...should see a filing in next day or so

If they keep the PPS over $1 for 10 consecutive days they have cured any Naz delisting issue

Kiwi

[rosemountbomber]

Obviously something good. Look at the price and volume.

[rosemountbomber]

Not very authoritative but saw comment posted on ST

[Whalatane]

Thx. where did U get that info . I wasn't able to access the fireside chat
Kiwi

[Whalatane]

Thx. where did U get that info . I wasn't able to access the fireside chat
Kiwi

[rosemountbomber]

5 active sites I see being reported but I unfortunately was not able to listen personally.

[molee]

Bang ... 💲 THAT happened quickly ...

[Whalatane]

TLPH fireside chat tomorrow I think. Let's hope they announce some good trial recruiting numbers .
Kiwi

[rosemountbomber]

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

[Whalatane]

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

[Whalatane]

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

[rosemountbomber]

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)”

[rosemountbomber]

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.

[Whalatane]

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

[Whalatane]

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

[rosemountbomber]

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?

[Whalatane]

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

[rosemountbomber]

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.

[Whalatane]

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

[Whalatane]

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

[Whalatane]

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

[Whalatane]

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

[Whalatane]

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

[Whalatane]

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

[molee]

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 .

[rosemountbomber]

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

[molee]

Something ???

[Whalatane]

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

[rosemountbomber]

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

[Whalatane]

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

[rosemountbomber]

Got tied up all day and had no chance.

[Whalatane]

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

Kiwi

[Whalatane]

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

[Whalatane]

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 :--(

[rosemountbomber]

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

[Whalatane]

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

[Whalatane]

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

[Whalatane]

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

[rosemountbomber]

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

[molee]

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

[Whalatane]

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

Kiwi

[Whalatane]

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

[rosemountbomber]

Good news even if results are pushed out a bit.

[Whalatane]

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

[molee]

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

[Whalatane]

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