Rezolute Inc. (RZLT)

[Whalatane]

Another huge vol day to the upside ( at least so far today ) , so congrats on accumulating .
The p2 DME trial has ended about now ...so its now down to data checking and publishing the data .
I have no idea if the recent increase in PPS is a data leak , accumulation for a buy out or simply due to speculative positioning .
Guess we will know in " the fullness of time "
Kiwi

[kindo]

I’m following and accumulating!

[Whalatane]

RMB. P2 DME . data due late next month ( my guess )
https://www.rezolutebio.com/for-patients/living-with-dme/

P1b results of same drug
https://ir.rezolutebio.com/news-events/press-releases/detail/295/rezolute-announces-positive-study-results-for-rz402-an

Kiwi

[Whalatane]

RZLT. P2 DME trial ending approximately next week ...now data chk / cleaning etc ...results probably late next month .
Anyone else following this ?
https://ir.rezolutebio.com/news-events/press-releases/detail/322/rezolute-completes-enrollment-of-its-phase-2-study-in

Kiwi

[glenn1919]

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

[BadCuda]

RSI 74 , Williams % -8 , looks ready to blow 3.75+ IMO price 2.60

[Whalatane]

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

[kindo]

Time to buy more!

[glenn1919]

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

[Whalatane]

DME P2 results due Q2
https://www.rezolutebio.com/for-patients/living-with-dme/

Kiwi

[glenn1919]

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

[Whalatane]

CFO was granted 275,000 options a $0 on 1/23/24 that start vesting in Jan 25
That wasnt enough for him
So far he has bt on the open market ....another 159,000 shares for himself and his kids.
139,000 of those since 2/16

Kiwi

[Whalatane]

3/19. CFO open mkt purchase of 20,000 shares
3/19 CMO open mkt purchase of 10,000 shares

Kiwi

[Monksdream]

RZLT under $2

[Whalatane]

This is a new position for Nantahala Capital ....4,118,164 shares

Kiwi

[Whalatane]

March 11 (Reuters) - Rezolute Inc ( RZLT ):
* NANTAHALA CAPITAL MANAGEMENT LLC REPORTS 9.9% PASSIVE STAKE IN REZOLUTE INC AS OF AS OF FEB 29 - SEC FILING Source text for Eikon: Further company coverage:

Kiwi

[glenn1919]

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

[Whalatane]

RMB ...comparing RZLT and EYEN ...a quick Look.
Last earnings report EYEN had $21m cash and were losing $7.3 m a qt ....so you know a huge capital raise is coming if they hope to manufacture and sell their device
RZLT has $96m in cash and are losing $14m a qt ...so their cash on hand will last them well into 2025 ...altho they will probably raise $ on a good DME trial read out ...late May I think .
I'm biased to Bay Area biotechs as I've met people working at some of them and hedge fund managers that invest in them .
They are usually connected to leading edge KOL's at places like Stanford and UCSF and often have them on their advisory boards , even BOD's.
Chk TNYA for instance ( which I also own ...early days )
Good luck
Kiwi

[rosemountbomber]

Kiwi, RZLT not giving me a break to buy in as it keeps marching north. I do have to tell you about a drug approval that I did handle correctly (of course you remember Amarin's label expansion). I was in EYEN and they received approval of their drug candidate Monday night. The stock was not behaving as it should have that day and when the approval came in the after market, it did not move at all. I dumped in the after hours market immediately when I saw that. I had intentions of selling on the pop, but there was no pop and the following days it has dropped. Of course it did have a rise during the month prior. Glad to get out.

[BadCuda]

Shorts covering ,19.25% change since 2/15/24

[Whalatane]

GD. Well it will be a big deal if they see clinical benefit in DME . I'm also in OCUL ..drug eluting inserts , and you're in EYPT ...injections ( but longer duration between shots ? )
If U have time take a look at UNCY. My wife rounds dialysis clinics ( also did CKD research at Yale ). None of her patients are at goal for serum phosphorous.....and none can afford the copay for the new serum phosphorous lower drug ...Xphanozh ? ...unless co ( ARDX ) pays down their copay ( currently $1,000 a mth ) .
The clinical data for OLC ( UNCY ) looks impressive . Co has also just been granted Orphan Drug designation .
However Co has limited cash and looks to need a capital raise to complete their current pivotal trial .
So if you have time , take a look ...let me know if you see any red flags I'm blind to .

Kiwi

[GD]

Thanks, Kiwi
Now I am much more conservative in terms of expecting efficacy from
this P2 DME data.

[Whalatane]

RMB. The P2 DME trial is probably a long shot to show clinically relevant improvement . Dew ( biotech values ) was of the opinion that there was a narrow therapeutic window ( which means I think that at high enough dose to see clinically relevant benefit , you'll probably see a lot more side effects .)
I'm hopefully tho because of the involvement of this KOL ...Robert B Bhisikul MD ..UCSF Prof of Ophthalmology and Retinal Specialist .
UCSF are cutting edge ...I was in a Cardiovascular trial their years ago

“We’re in need of new treatments in the clinical care of patients with diabetic eye diseases,” said Robert B. Bhisitkul, M.D., Ph.D., Professor of Ophthalmology and Retinal Specialist at the University of California San Francisco School of Medicine’s Department of Ophthalmology, and member of Rezolute’s Scientific Advisory Board.
“Pioneering research has strongly implicated the kallikrein-kinin system in the development of diabetic retinopathy and macular edema.
A novel plasma kallikrein inhibitor has potential to give patients with diabetic macular edema an alternative therapeutic option.
Oral delivery would provide the possibility of earlier treatment intervention and enable a patient-controlled regimen with advantages in comfort, convenience, and continuous drug levels in the retinal microvasculature.
I look forward to the continued development of RZ402 for patients at risk of losing their sight from DME.”

Current treatment is via an eye injection which is often delayed until sight has significantly deteriorated. A drug eluting insert is in development ( or maybe in use ) .
OCUL ( I have a small position ) also working in the field.

RZLT hopes drug will at least slow progression and may also be a supplement to injections and inserts.

Insider buying recently
Kiwi

[rosemountbomber]

Saw your post about this on another board. I am pi$$ed a bit because I had been trying to buy this from about a couple of weeks ago, but it kept running away from me. I was attempting to liquidate something and pick this up and it became a frustrating experience. Maybe I may have a chance if it retraces a bit?

[Whalatane]

P2 DME trial is fully enrolled with primary completion in April ..results probably in late May
https://www.clinicaltrials.gov/study/NCT05712720?tab=history&a=7

About RZ402
RZ402 is a selective and potent PKI being developed as a potential once-daily oral therapy for the chronic treatment of DME. By inhibiting the activation of kallikrein, RZ402 is designed to block bradykinin production and its resulting effects on vascular leakage and inflammation.

RZ402 has been shown to reduce and prevent retinal vascular leakage in animal models by up to 90%. Results from a Phase 1b multiple ascending dose (MAD) study showed that RZ402 was readily bioavailable with dose-dependent increases in systemic exposures.
RZ402 concentrations substantially exceeded target efficacious concentrations based on a combination of in-vitro and in-vivo pharmacology studies in animals, supporting the potential as a once daily therapy for DME.
RZ402 was generally safe and well-tolerated, including at higher doses than previously tested in the single ascending dose (SAD) study.
There were no serious adverse events, adverse drug reactions, or identified risks.

Kiwi

[glenn1919]

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

[BadCuda]

1.86 , let’s see where she goes -

[glenn1919]

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

[Whalatane]

Feb 22 (Reuters) - Rezolute Inc ( RZLT ):
* REZOLUTE ( RZLT ) -ON FEB 21, GOT LETTER FROM NASDAQ NOTIFYING CO THAT IT HAS REGAINED COMPLIANCE WITH BID PRICE REQUIREMENT FOR CONTINUED LISTING ON NASDAQ Source text for Eikon: Further company coverage:

Kiwi

[GD]

Mid of May, if RZLT follows EYPT steps, very likely, very strong interests in PII
with fast and over enrollments which foretells strong proof of concept data,
we may see $500-600M MC, $13-15 stock, IMO.

[Monksdream]

RXLT under $2

[BurgerKing82]

This one looks good....What's the timeframe for a 5X

[Whalatane]

CMO buying
http://archive.fast-edgar.com/20240221/AP22V222E22252T2222D2CO2PM7AU222B262/
His and the CFO's were open market purchases

Kiwi

[Whalatane]

Thx ...the more DD the better ...including informed opposing opinions
Re price targets ...I'm the last person to ask that .
I owned SLNO in the $ 2's . Thought it might triple on good P 3 results . In fact it ran up to $20 ,,,,at which time I sold .
It's now trading at $48 a share !!!!!

You might look at UNCY also . My wife rounds dialysis clinics. None of her patients are at serum phosphorous goals as they hate the current meds
Near term catalyst will be Co announcing pivotal trial is fully enrolled.

VERA is another Co I'm invested in. They appear to have a functional cure for IgAN ( kidney disease ).

All the above are very speculative and are vulnerable to sell off's on any increase in interest rates ...let alone bad data readouts .
Let me know if U look at UNCY

Kiwi

[GD]

Thanks for the DD and reply. From the PR on DEC 13th, the statements are as bullish
as they can be, IMO, assume P2 data is strong positive, what may be the fair price
target in your opinion? Thanks to your mentioning on Biotech value board, I did some
reading last night and like the reward/risk, so I bought in this morning.

[Whalatane]

Well congrats if you are in EYPT . There are some differences between DME and wAMD ...from ChatGPT

Wet AMD is characterized by the growth of abnormal blood vessels, also known as choroidal neovascularization (CNV), which leak fluid and blood into the macula, leading to rapid vision loss if left untreated.
Treatments for wet AMD often involve anti-vascular endothelial growth factor (anti-VEGF) injections or other therapies aimed at stopping the growth of abnormal blood vessels.
DME (Diabetic Macular Edema):
DME is a complication of diabetic retinopathy, which is a condition caused by damage to the blood vessels in the retina due to diabetes.
In DME, the blood vessels in the retina become leaky, leading to fluid accumulation (edema) in the macula.
This accumulation of fluid causes the macula to swell, leading to blurry or distorted vision, and if left untreated, it can cause vision loss.
Treatments for DME often involve anti-VEGF injections, corticosteroid injections, or laser therapy aimed at reducing the leakage of fluid and improving vision.

In summary, while both wet AMD and DME involve fluid accumulation in the macula leading to vision problems, wet AMD is primarily related to abnormal blood vessel growth due to aging, while DME is a complication of diabetic retinopathy resulting from diabetes-related damage to retinal blood vessels.

So the disease process is different ...DME specific to diabetics with the MOA ( method of action ) of RZ402 primarily being anti inflammatory / anti leakage .....not slowing / preventing abnormal growth of blood vessels ( wAMD )

Just my layman's take on this ...Thx for your question as its lead me to more research in the area.

They are hoping RZ402 can be used as an easy treatment for the early stages of DME.

Kiwi

[GD]

Kiwi, We see EYPT has an EYP-1901 P2 for DME, Does RZ402 have potential
for wAMD?

[Whalatane]

CFO buying http://archive.fast-edgar.com/20240220/AP27R222E222H2S2222A2CO2NABDZ222B262/

Kiwi

[Whalatane]

RZ402 is the near term catalyst . P2 data on DME ...with 3 doses 50mg, 200 mg and 400mg .
The 50mg and and 200 mg dose were shown similar to placebo in safety profile. Believe this is the first time using 400 mg dose .
Trial is fully enrolled with 94 patients
12 wk trial followed by 4 wk follow up
Data mid / late Q2 2024.
High risk spec , some talented people in the Co
Kiwi

[sc00pnDump]

Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) eligibility to RZ358 for the treatment of congenital hyperinsulinism (HI).

Read 8k yesterday news

[sc00pnDump]

8k out granted Rz358

[Monksdream]

RZLT new 52 week low

[Monksdream]

RZLT new 52 week low

[Monksdream]

RXLT new 52=week low

[weedtrader420]

RZLT🤑

[Monksdream]

RZLT new 52 week low

[Monksdream]

RZLT under $2

[saigai]

rzlt insider buys
Rezolute Director Gil Labrucherie Buys $199,997.80
Rezolute SVP Brian Kenneth Roberts Buys $79,997.60

[saigai]

great data and then.. the offering.. shoot me

[saigai]

well the numbers are out on sunday.. holding 4k shares...into the news....