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Rezolute Inc

Rezolute Inc (RZLT)

4.66
-0.02
(-0.43%)
At close: July 26 4:00PM
4.66
0.02
( 0.43% )
After Hours: 6:15PM

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RZLT News

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RZLT Discussion

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rosemountbomber rosemountbomber 1 week ago
Saw this posted on ST:

“BTIG initiated coverage of Rezolute with a Buy rating and $13 price target. The analyst sees an "attractive disconnect" between the company's three shots on goal and where the shares currently trade. Efforts to address an FDA-implemented partial clinical hold on the ongoing Phase 3 study of RZ358 in congenital hyperinsulinism are underway, with new safety data and renewed determination, the analyst tells investors in a research note.

The firm thinks there is a good chance the FDA capitulates, which could allow pediatric enrollment in the US if the partial hold is lifted by September, and more importantly, signal that RZ358's eventual label could include pediatric patients. BTIG says RZ358 is the only therapeutic it is aware of that is being developed for all forms of hyperinsulinism.”
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Whalatane Whalatane 2 weeks ago
Re UNCY lot of vol so I think some of the original investors are selling into any PPS increase. A major catalyst will be passage of the Kidney Patient Act ...assuming it pass's later this yr. Co does need to get PPS over $1 for 10 days to avoid Naz delisting or reverse split .
TLPH ...really need an update on their trial ...have they enrolled first patient etc or not as risk of a capital raise increases with delay of the trial .
RZLT ...just got to go with what works .....we are operating in a semi fog anyway ...while never know all the positives and negatives affecting PPS performance .
Enjoy the weekend
Kiwi
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rosemountbomber rosemountbomber 2 weeks ago
Yep. A very good few days, albeit on not very heavy volume. I’m fine with that. Weakness in UNCY and TLPH being offset by strength in RZLT in my portfolio. That gives time for the other two stocks to wake up. Have a good weekend.
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Whalatane Whalatane 2 weeks ago
RMB. U have to be impressed with the action in this stock . Sold off on the capital raise and once that was digested ...PPS resumed its upwards climb
Kiwi
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Whalatane Whalatane 4 weeks ago
Yes interesting about the dose responses. Finding the optimal risk / benefit dose . Take Vascepa for instance ...I think above 6 gms a day bleeding risk really ramps up ...optimal lowest risk for max benefit is 4 gms .
So I have to wonder if its causing some harm at 400 mg dose that negates any benefit
Kiwi
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rosemountbomber rosemountbomber 4 weeks ago
Thanks Kiwi. I don't see anything real negative there. One thing that stands out is that the 400mg dosage did do anywhere as well in reducing CST as the 200 mg or even the 50 mg doses. They do offer an explanation for that, claiming that "the maximal response at 200 mg likely explained by drug saturation of plasma kallikrein activity". That is definitely a possibility, but I would think that is such a case, that the 400 mg (which by that theory would be in excess of what saturation could be achieved) one would think should do approximately as well as the 200 mg, yet it did measurably worse. So not sure about that.
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Whalatane Whalatane 4 weeks ago
http://archive.fast-edgar.com/20240628/ADB2K22C8Z22H2ZU22ZG2WZZMTBIR2Y2Z266

Apparently more details re their DME trial ...just wondering how it compares with their original data release
Guess its the Appendix ...page 16 onwards ?...Additional Data

Kiwi
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rosemountbomber rosemountbomber 4 weeks ago
Nope what was it?
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Whalatane Whalatane 4 weeks ago
Did you notice what was updated in the RZ 402 ..DME trial data today ...8k out ?
Kiwi
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Whalatane Whalatane 4 weeks ago
In addition, the Company has entered into an agreement for a concurrent private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”), of 1,500,000 shares of its common stock, at a sale price of $4.00 per share.

$6m Private placement at $4 a share ?

Kiwi
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rosemountbomber rosemountbomber 1 month ago
Looks like our little RZLT is finding a little spring in its step today.
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Whalatane Whalatane 1 month ago
OCUL's implants look to replace Eylea injections ...chk out latest KOL presentation . RZLT 's oral DME is likely to slow decline but not correct it ..if they go ahead and pursue it ....just my take . I have positions in both Co's .

Kiwi
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rosemountbomber rosemountbomber 1 month ago
Hopefully the CMO knows what he is doing. Also I am not that well versed in Ocul's thing but isn't it a drug eluting implant whereas we are still talking an oral from RZLT?

FL weather. I assume you might be referring to the rains and flooding in S. Fl. I was in east central Fl and apparently they have not received any of that. If you mean the weather there in general, in some sense we miss the warmer weather, but at least here in Oregon the weather can be called mild and at least not the brutal winters I was used to growing in Montreal. But there are a number of things I have found to be yearning for.

Better roads (of course that could be consequence of freeze-thaw in NW)
No state estimated tax payments to make
Lower cost of living
Lower property tax
Closer to more cruise options
Some friends and local haunts we used to frequent.

But I am not bitching just being honest.
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Whalatane Whalatane 1 month ago
RMB. good find thx
http://archive.fast-edgar.com/20240614/AP2ZV222E22259V2222D2ZO2PM7AZ222B462/

Ps. missing that weather in Florida ?

Kiwi
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rosemountbomber rosemountbomber 1 month ago
Well Kiwi, you asked for it. Here it is. Roberts Brian Kenneth, CMO, bought 7.6K shares TODAY:

https://insiderpeek.com/company/RZLT
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rosemountbomber rosemountbomber 1 month ago
Yes, I would like to see the CMO start buying shares. But if I were the CFO, I would have dropped by the CMO's office to get his spin before plopping down cash. Did he do the same?
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Whalatane Whalatane 1 month ago
Re your view . I hope you scare some of the posters into selling their shares cause I’ll be buying at these rock bottom prices .

I'm not intending to scare anyone buying at these levels . I do think a $60m raise was excessive since they had stated they had enough $ to complete their pivotal P3 trial.
The damage to the PPS has been done ...however Co now has roughly $60 m more in cash to pursue other indications ...which I hope won't be their RZ402 DME indication where I think OCUL has a far better candidate

Always a good sign when the CFO buys in the open market ...now let's see if the CMO ( chief medical officer who should know the science ) follows suit .

Kiwi
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Whalatane Whalatane 1 month ago
Re your view . I hope you scare some of the posters into selling their shares cause I’ll be buying at these rock bottom prices .

I'm not intending to scare anyone buying at these levels . I do think a $60m raise was excessive since they had stated they had enough $ to complete their pivotal P3 trial.
The damage to the PPS has been done ...however Co now has roughly $60 m more in cash to pursue other indications ...which I hope won't be their RZ402 DME indication where I think OCUL has a far better candidate

Always a good sign when the CFO buys in the open market ...now let's see if the CMO ( chief medical officer who should know the science ) follows suit .

Kiwi
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BadCuda BadCuda 1 month ago
Only 11.5 million share dilution, that’s awesome , more insiders buying and the company is protected from voting dilemmas . These guys are smart , they did it right and they’re looking to the future . Some of them bought stocks in their kids name , long term foresite - he knows where this is going . I hope you scare some of the posters into selling their shares cause I’ll be buying at these rock bottom prices . Even their partner with dissolving capsule company handok is on board , triple by Christmas IMO . You do want you want, I see what’s happening and I’m surprised and happy what the company did to secure its future . Watch the RZ403 or what over number it is , success with tumors ….. fogetaboutit
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rosemountbomber rosemountbomber 1 month ago
Well chief financial guy might not be interested in stuff like that but he should if he is sinking his money in this
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Whalatane Whalatane 1 month ago
Yep ...he facilitated it . Just wondering if he's been following OCUL's DME data which calls into question weither their DME program is worth pursuing
Kiwi
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rosemountbomber rosemountbomber 1 month ago
Thanks Kiwi. Well, he is obviously aware of the dilution.
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Whalatane Whalatane 1 month ago
Huge insider buy by CFO in this capital raise
http://archive.fast-edgar.com/20240614/AP2HR222E222H9V2222M2ZO2NA9TZ222B262/


1. The purchase price reported above is a weighted average price. These shares were purchased in multiple transactions at prices ranging from $3.85 to $4.25, inclusive

Kiwi
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Whalatane Whalatane 1 month ago
Massive dilution for a small CO IMHO especially since they said they have funds already to finish their P 3.
The tumor indication is small...they don't need $60 m for that .
Going after the DME indication would require the $60m and given the OCUL data just released ...not a good idea IMHO .
I'm pissed at the size of the raise ......sold some RZLT and added to my OCUL position

Kiwi
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rosemountbomber rosemountbomber 1 month ago
60 million:

https://finance.yahoo.com/news/rezolute-announces-pricing-public-offering-033000779.html
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rosemountbomber rosemountbomber 1 month ago
Yes, great results, but looking at a stock quote for OCUL they were up very little today and not up at all after hours so possibly not affecting RZLT as much as the dilution.

Of course where it might affect RZLT is that the OCUL results may be causing potential acquirers to become reticent with RZLT's DME drug.
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Whalatane Whalatane 1 month ago
Chk this out for DME ( RZ402 ). pretty speculator results from OCUL presented today

https://investors.ocutx.com/static-files/9a2366eb-bf3f-45d8-b6f4-8aad4928c536

Page 72 onwards ...reason why we may be down 20% AH

Kiwi
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rosemountbomber rosemountbomber 1 month ago
Actually how that came about was this morning I was thinking of doing some account position rearranging and increasing 2 positions - BCRX and RZLT - 2 where there have been insider purchases in my existing positions. Pulled the trigger to increase BCRX in the morning but held off on RZLT and just thought about it all day. Then when I saw the drop, jumped on it.
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Whalatane Whalatane 1 month ago
You were buying After Hrs ?
We have no idea of the size of the capital raise yet ...or even if they will proceed with one .

A huge positive would be if the stock goes up on them announcing the funding details .

PS. Missing Florida ? Huge rainfall there last couple of days

Kiwi
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rosemountbomber rosemountbomber 1 month ago
That's not what I was hoping you would say LOL. I have seen many times when pr of a dilution happens the stock drops but then over the next few days or weeks comes back. On that premise I picked up more shares after the drop. Guess we will have to see. Some of it is prepaid warrants.
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Whalatane Whalatane 1 month ago
No I don't think so . Co always maintained that had enough $ to see them thru their ongoing P3 trial .

I think this is about RZ 402 ...if they can't sell / partner it for terms they like ...are they going to develop it themselves ?

Kiwi
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rosemountbomber rosemountbomber 1 month ago
Do we assume that those insiders who purchased were well aware of this?
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Whalatane Whalatane 1 month ago
The public offering is subject to market and other conditions, and there can be no assurance as to whether or when the public offering may be completed or as to the actual size or terms of the public offering

We don't know the size of the offering so its hard to estimate degree of dilution .
It may be a negotiating tactic re the sale of RZ402 ...ie if we don't like the terms of the sale or partnership we can raise $ and do it ourselves

Kiwi
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tbonaces80 tbonaces80 1 month ago
Stopped. Oh well. Would have thought they would have let it rip first. Dummies
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Whalatane Whalatane 1 month ago
Rezolute Announces Proposed Public Offering of Common Stock and Pre-Funded Warrants • GlobeNewswire Inc. • 06/13/2024 08:01:00 PM
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Whalatane Whalatane 1 month ago
Well down 16% after hrs on their plan to raise funds .
So either they haven't sold their eye indication RZ402 ? or are raising funds in case they don't and decide to develop themselves .
Or it's a negotiating tactic. They may have a low ball offer and are saying they can do it themselves if needed.
Kiwi
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rosemountbomber rosemountbomber 1 month ago
What is with the dump after hours? Haven't checked the volume.
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tbonaces80 tbonaces80 1 month ago
Adding here. Basing and consolidating
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BadCuda BadCuda 2 months ago
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
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rosemountbomber rosemountbomber 2 months ago
Sure but as a competitor it wouldn’t all sales from Eyelea but only a portion.
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BadCuda BadCuda 2 months ago
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.
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Whalatane Whalatane 2 months ago
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
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rosemountbomber rosemountbomber 2 months ago
No question that that could be a possibility and no dilution.
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Whalatane Whalatane 2 months ago
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
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rosemountbomber rosemountbomber 2 months ago
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.
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Whalatane Whalatane 2 months ago
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
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Whalatane Whalatane 2 months ago
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
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rosemountbomber rosemountbomber 2 months ago
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.
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TrendTrade2016 TrendTrade2016 2 months ago
RZLT bio beast!
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Whalatane Whalatane 2 months ago
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
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