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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
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.
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
Nope what was it?
Did you notice what was updated in the RZ 402 ..DME trial data today ...8k out ?
Kiwi
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.
Looks like our little RZLT is finding a little spring in its step today.
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
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.
RMB. good find thx
http://archive.fast-edgar.com/20240614/AP2ZV222E22259V2222D2ZO2PM7AZ222B462/
Ps. missing that weather in Florida ?
Kiwi
Well Kiwi, you asked for it. Here it is. Roberts Brian Kenneth, CMO, bought 7.6K shares TODAY:
https://insiderpeek.com/company/RZLT
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?
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 .
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 .
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
Well chief financial guy might not be interested in stuff like that but he should if he is sinking his money in this
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
Thanks Kiwi. Well, he is obviously aware of the dilution.
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
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
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.
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
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.
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
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.
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
Do we assume that those insiders who purchased were well aware of this?
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
Stopped. Oh well. Would have thought they would have let it rip first. Dummies
Rezolute Announces Proposed Public Offering of Common Stock and Pre-Funded Warrants • GlobeNewswire Inc. • 06/13/2024 08:01:00 PM
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
What is with the dump after hours? Haven't checked the volume.
Adding here. Basing and consolidating
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.
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.
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.
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"AB101 has the potential to be a clearly differentiated product that represents a significant advance in basal insulin delivery," said Nevan Elam, AntriaBio's President and CEO. "AB101 may offer significant advantages over basal insulin products sold by Sanofi-Aventis and Novo Nordisk, which together sell more than $7B annually."
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