Rezolute Inc (RZLT) Quote

That article says that it’s just eyelea sales , if RZLT replaces that therapy or even gains some market share . This will go , guess we gotta wait and see who they’re going to partner with to fill this out . Our FDA is holding us up from moving forward , once they get approval - who knows where it goes

Sure but as a competitor it wouldn’t all sales from Eyelea but only a portion.

RZ402 would compete with Regeneron's Eylea, originally approved in 2011 for treating wet age-related macular degeneration. Developed with Bayer, Eylea has been highly successful, with its original and recently approved higher-dose versions earning $5.89 billion in net sales in 2023.
Valuation of products competition-
If sales of RZ402 equal eyelea sales that’s 147.5/share valuation…. Crazy for a small cap
Handok Inc keeps buying shares the company as well as their officers.

Re RZ358 for cancer patients with hypoglycemia
The Company recently reported on its successful interaction with the U.S. Food and Drug Administration (FDA) in January 2024 regarding the potential to initiate a single registrational study in patients with hypoglycemia due to tumor HI.
The Company will continue to evaluate the feasibility of a development program in this indication, with the possibility of including both ICTH and NICTH patients. The inclusion of NICTH patients in a potential addressable market for RZ358 in tumor HI would more than double the population.

So only 1 trial needed . Probably fairly small ( max 100 patients ) ...currently 1500 each yr with ICTH and another 2,000 with NICTH ( I think ) ...in the US
High unmet need

Kiwi

No question that that could be a possibility and no dilution.

Well the RZ358 trial is funded thru data readout out mid 2025 . Did U notice he referred to Real World data from the expanded access for those in the P 2 RZ358 trial.
So maybe sell the DME asset and use those funds for the RZ 358 in cancer patients trial ...no shareholder dilution

Kiwi

Well it definitely sounded like they will sell the DME drug with no intention for rolling it out themselves, so that will bring some cash.

But a capital raise is not always bad. If the market feels that the cash raise will yield something far greater with a promising study.

As follow up on the potential trial in cancer patients . I think they need a capital raise or sell the DME indication to fund this .
JMO
Kiwi

Yes I liked the presentation also. Key driver of PPS ( besides DME deal ) will be the FDA lifting their partial hold on their P3 RZ358 program This will allow some US patients to be enrolled in the trial ...read out mid 2025 ...and make it easier for US approval assuming trial succeeds .

RZ358 for cancer patients with hyperglycemia looks interesting also ...sounds as tho they will proceed with that .
RZ358 P2 patients are apparently still on the drug under expanded use and now they have 2 yrs of data on them .

RZ402 ...their DME drug. His comments ...Exciting data , more detail at conferences , lots of interest ( from BP ) that they will explore or are exploring .

General notes ...patent protection to 2035 , 2036 and cash out to Q3 2025 ( so expect a capital raise at some pt unless they sell the DME indication for huge $ )

Kiwi
PS. chk the vol in UNCY ...huge churn , PPS going no where as I type

Says a lot of interest in DME drug already. Buying back what I sold at end of day yesterday.

Elam a good speaker and instills confidence for sure.

RZLT bio beast!

Recent insider purchases

KIM YOUNG-JIN
Director
Purchase Mar 7, 2024 6,058,070
LABRUCHERIE GILBERT M JR
Director
Purchase May 4, 2022 99,673
ROBERTS BRIAN KENNETH
Officer
Purchase May 23, 2024 61,128

Kiwi

Ha. sometimes the decision to sell is harder than the decision to buy .
Congrats on your R-IT sale
Kiwi

I may be tied up at 10:00 am Pac time tomorrow so may have to see if I can access a recording later to see what the founder has to say.

As far as taking some profits, I learned my lesson after V label expansion decision by FDA (believe it or not I did take some profits at the time R-I topline results were released) so that is part of my habits now.

Biggest problem are those stocks that never afford me the opportunity HA!

Well different situations . UNCY is a binary event ....clinical trial results due any day now .
RZLT ...when stocks go parabolic they can be subject to aggressive profit taking .
What is driving the PPS increase in RZLT ? Two hedge funds control 66 % of the stock and insiders control 20% I think ...so if 86% of the stock holders refuse to sell ...are they in effect creating a type of short squeeze. ?

The obvious speculation ( to me at least ) is that Big Pharma is interested in RZ402 ...their DME drug .
To have an oral medication that can delay the need for eye injections for diabetics ( I think roughly 80% of diabetics eventually develop DME...altho would need to chk )
My wild guess is that if the interest is there ...RZLT could probably sell the rights to RZ402 for around $100m . BP would spend at least another $100m getting it thru the trials and eventually approved ....but then for a cost of $200m plus you have a drug that could be used by millions of diabetics worldwide.

I was buying RZLT back in Feb for around $1.60 ...largely because Vivo and Nantahala were backing them and I think some on their scientific advisory board are widely respected .
Its done far better than I expected .
Congrats on your trade
Kiwi

Most of the day I kept thinking that if I was hanging on to UNCY that I should do the same with RZLT. Well, I just couldn't resist the entire day. Took some profits at 5.79 almost right at the closing bell.

REDWOOD CITY, Calif., May 30, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced that Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute, will participate in a fireside chat during the Jefferies Global Healthcare Conference on Thursday, June 6, 2024, at 1:00 p.m. ET in New York City.


Kiwi

Vivo Capital and Nantahala already own 2/3rds of the outstanding shares
Nantahala Capital Management, LLC 3.02M Mar 31, 2024 35.91% 16,958,733
Vivo Capital, LLC 2.8M Mar 31. 2023 33.23% 15,695,119

Fireside chat tomorrow
Good luck
Kiwi

Has the potential to really go if funds are buying. Let’s see and gl

Heavy vol ..wonder if hedge funds are adding ?
Kiwi

Went parabolic. I lighten in the rip

Going vertical as I type ..up 20% ..so I lightened up some .
Simple risk mgt
Huge winner for me YTD
Kiwi

With this great runup I am debating lightening up before the CEO speaks tomorrow. But you didn’t think that tomorrow would be a sell the news event.

RMB. Well so far this has been the stock of the year for me . Buying in Feb , then selling 50% once it doubled to recover my initial investment ...now just letting the rest ride to see where this Co takes us.
Any 20% drop will make me reconsider my sizing ...portfolio risk mgt.

Before the DME data this Co had a market cap close to $100m . The DME data alone would now seem to justify a BP paying at least that just for RZ402 .
JMO
Kiwi

RMB. I don't see it as a sell the news event . Hopefully there will be some discussion on their DME drug RZ402 and if they have received any BP interest.
Some times the Ceo can say something like " We've received interest " etc without legally having to file an SEC required PR.
Or " yes we are in talks but can't comment any further " or a watered down version of such

Kiwi

Kiwi so the “presentation” is a fireside chat so I assume new info is typically not released that way. Wonder, however, if there can still be a sell the news action.

I guess it depends on the outlook given.

WEEKLY BREAK OUT BIO UNDERWAY!

RZLT Rezolute initiated with a Buy at Craig Hallum; tgt $14

Kiwi

Agree. Gluck. Chart looks healthy on daily. Parabolic gets squashed. The is is a triple in volume. Gluck longs

Basing

RMB. OT. I expect UNCY data this wk
Kiwi

Looks like (hopefully) low volume consolidation and preparing for next leg up.

RZLT still making higher highs

Thanks for posting. Clearly above the 50 day ma but still below 200 day but should be attacking that soon.

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

BC. RZ402 may DELAY the need for eye injections ...and that in my wild guess is worth $100m to a BP willing to finance and run the large trials the FDA will want before approval ....IF the trials succeed.
Kiwi

28 million people worldwide (7.7 million US) suffer from DME , that’s the market size . How does that translate into sales and if we license this technology, how much is that worth . Any reasonable estimate accepted , that’s how we’ll get a better price per share estimate . How much is not losing your sight worth ??

Chart showing low volume consolidation in the daily. Loooking giod

Bought tier 3 at $4.

A very slow bleed these last 2 hours from the highs of the day on virtually no volume. Virtually all the volume coming before that.

Who saw the print of 700k

Well right now we are sitting on double average volume at only half a day. Maybe a big afternoon push.

Let’s get some volume on a breakout. Daily chart looks poised to do that

Nice action today with a bit of headwind. Let’s see how futures run in am. We could see a nice gap if futures rip. $4.28-4.45 then up to mid $5’s. Gluck

RMB. my take is this .
1) Its always a positive when the CMO and CFO make open market buys . CMO obviously likes the medical implications and CFO sees the value that a larger Co might see in the DME data
2) Market was initially disappointed that there was no signal in improvement of BCVA ( visual Acuity )
. Co ...especially their Stanford KOL argued the trial was to short to see that but the necessary signs ...improvement in CST ( reduced retinal thickening ) were seen and eventually improvement in BCVA would follow ( 6-12 mths later ) .
3) Co does not have the funds to run a large 12 mth trial ....so the spec is whether or not a BP might buy rights to their DME drug or partner in its development. .
CFO is betting that a larger Co will make an offer for the drug / DME indication .
4) The potential in the DME drug is that it is expected to slow loss of vision delaying the need for the Eyelea eye injections ( usually every 2 mths )

Stock will probably be volatile
JMO
No investment advice etc etc
FYI. AMRN mgt says UK decision on buyback this Qt . UK law states Co must make decision public within 8 days of receiving decision ( IIRC )

Kiwi

Kiwi, so correct me if I am wrong on this but here is how I am thinking about this. These insider purchases are not based on any non-disclosed information, but rather their better understanding of the data that was recently released. The market sold the stock off on the data release but these insiders possibly understand the data better and know what it means for the future - right? By the way added more early this morning at 3.70

I guess where I am a little confused is whether this move is a little early (or what may be moving the stock). What I mean is if they need to do a 12 month study to show improvement in vision then wonder if this rally will fade. It seems really strong on even very weak market days.

RMB

EXPERT CALL TODAY AT SLINGSHOT
May 29, 2024
LISTEN LIVE OR ACCESS TRANSCRIPT & RECORDING
Get an Expert's View Today:
RZLT: Delving into the topline results from the Phase 2 clinical study of RZ402 in patients with Diabetic Macular Edema (DME)


Kiwi

Well Kiwi all this insider buying is gonna make me have to add back what I lightened, at unfortunately a slightly higher price.

CMO also buying https://ih.advfn.com/stock-market/NASDAQ/rezolute-RZLT/stock-news/93936221/form-4-statement-of-changes-in-beneficial-owners

Kiwi

Holding 15 large till $12-15. Load em up boys and gals.