Rezolute Inc (RZLT) Share Price

An IA of the study primary hypoglycemia endpoint is being conducted following the accumulation of sufficient patient data and is designed to optimize the study sample size and statistical confidence in the final analysis outcomes. . my emphasis
The IA will be conducted at the end of this quarter and the Company plans to announce the conclusions of the DMC early in the second quarter of 2025 while also providing additional overall study updates.
There are three possible outcomes from the analysis: (i) futility and the study should be stopped, (ii) continue the study as is or (iii) continue the study as is but increase the sample size by 33% (18 additional patients) to enhance statistical confidence in the final outcome.

IMHO it's not unusual to optimize a trial after the DMC collects some actual data . It increases confidence in the final result .


Interim analysis conducted by a Data Monitoring Committee (DMC) can provide significant benefits for optimizing the power of a clinical trial. This practice has become increasingly common, especially in large, long-duration, and multi-center studies.
Benefits of DMC Interim Analysis for Trial Power Optimization
Enhanced Statistical Power
Interim analysis allows for the assessment of a trial's statistical power while it is still ongoing. This enables researchers to make informed decisions about potential adjustments to the study design, such as sample size modifications, to ensure adequate power for detecting clinically meaningful effects3.
Adaptive Design Opportunities
DMCs can facilitate adaptive trial designs, where interim analyses are used to guide decisions about continuing, modifying, or stopping a trial. For example, in a recent adaptive design study, the DMC conducted two planned interim data reviews:
At 12 weeks, they assessed the effect on the primary outcome measure.
At 24 weeks, they evaluated whether the trial had adequate power to achieve a statistically significant effect on the primary endpoint3.
Based on these analyses, the DMC could recommend stopping for futility, increasing the trial size, or continuing as planned.
Resource Optimization
By allowing for early stopping due to futility or overwhelming efficacy, interim analyses can help conserve resources and prevent unnecessary continuation of trials that are unlikely to yield meaningful results4.
Ethical Considerations
Interim analyses can enhance the ethical conduct of trials by ensuring that participants are not exposed to ineffective or potentially harmful treatments for longer than necessary1.
Prevalence of DMC Interim Analyses for Power Optimization
The use of DMCs for interim analyses, including power optimization, has become increasingly common in clinical trials:
Regulatory Recommendations: Both the FDA and EMA strongly recommend the use of DMCs for certain types of clinical trials, particularly those that are large, long-term, and involve serious health outcomes7.
Increasing Adoption: The use of DMCs has evolved and increased since their introduction in 1967. They are now used across various therapeutic areas and trial phases5.
Industry Standard: DMCs are considered standard practice for many randomized trials, especially those utilizing important clinical endpoints such as survival or disease progression8.
Expanding Applications: While initially focused on safety monitoring, DMCs are now commonly involved in effectiveness analyses and other interim evaluations that can impact trial power4.

Kiwi

THx but Laurent on the AMRN board knows far more .
Many dont know this but R-IT could have been stopped at the first Interim
In the REDUCE-IT trial, the first interim analysis showed significant results for both the primary and key secondary endpoints.
For the primary endpoint, which was a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, or unstable angina requiring hospitalization, the P value at the first interim analysis was 0.000051. This analysis was conducted at approximately 60% of events, with a median follow-up of 2.9 years and 953 first events1.
For the key secondary endpoint, which was a composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke, the P value at the first interim analysis was also 0.000051.
These highly significant P values at the first interim analysis demonstrated the strong efficacy of icosapent ethyl in reducing cardiovascular events among the study population. The consistency of these results across both primary and secondary endpoints, as well as their persistence through subsequent analyses, underscored the robustness of the treatment effect observed in the REDUCE-IT trial1.


They probably hit a P value of .01 ( one chance in 100 that results due to chance ) around 2 yrs into that trial ......

With RZLT .. they appear to have enough cash to run into / thru 2026 ...if they need to add more to the trial.
Having come this far they will want to be absolutely certain the trial is powered properly
JMO
Kiwi

I meant to add: notice how the stock lately, after a drop (usually in ghe am) seems to bounce back.  

Kiwi, I think your "limited understanding" is a gross underestimating of your cognitive skills when it comes to dissecting clinical trial data.  I took the info today the same way.  

While the update today raised the possibility of the results being pushed out to 2026 ....ensuring that the trial is powered properly ( enough patients in the trial ) to generate statistically significant results ...is critical .
It reminds me a little of the Reduce It trial .
That trial was statistically significant at the the first interim analysis , even more so at the second interim ( and definitely could have been stopped there )...but they continued to the end to have overwhelming stat sig .
RZLT does not want a trial barely stat sig ...say a P value of .03 or .04 . A P value of .04 I believe indicates a 1 in 25 risk that the results were due to chance .
They will aim for a P value of .01 ....ie only a 1 in 100 risk that results are due to chance .
JMO...based on my limited understanding of Stat Sig ,powering trials etc .
I added on todays sell off
Kiwi

I tend to avoid trading . The P 3 results for RZ358 will be out mid 2025 so I'll hold for those .
Meantime
REDWOOD CITY, Calif., Jan. 31, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs, today announced that management will participate in the Guggenheim SMID Cap Biotech Conference, taking place February 5-6, 2025, in New York City.

Management will be participating in one-on-one investor meetings throughout the conference. Investors interested in scheduling a meeting with the Rezolute management team should contact their Guggenheim representative.

I'm sure they'll use this opportunity to try and sell RZ 402

Kiwi

Nice 3 day run , not sure why we haven't heard anything , Still wondering how 3 million shares went thru last Thursday and the price didn't move? no press release or info on the trade makes me worry , Hopefully there's news coming . Looks like someone jumped in early (inside info) before news hits , or it could be MM pump for their future short. should I say current short , which increased again by 140000 plus the 40k from Dec .11.3% increase - what do they know - maybe that why the price is going up on low volume now . I'm flipping it so that's my 2 cents been selling some today between 5.15-5.20, might pop tomorrow morning and I'll sell some more . Don't think Feb 11 quartly report is gonna be any thing at all , what's there to report. I may be wrong but that's my read , if the stock continues to bounce between 5.50-4.25 I will continue - hopefully they partner with another pharma to roll out RZ402 and this sucker takes off . But until then we watch and try to make money flipping . I usually trade some above the 7 dma when the Williams indicator is -20 or better on a 9 month chart (if your a chartist) volume doesn't seem to mater these days , Macd is a tight but in the positive barely . Looks like a bear trap to me but we'll see . 

I tend to think its a fund like Vivo Capital , starting or expanding their stake in the Co
Vivo Capital's holding represents approximately 33.23% of their portfolio value in Rezolute, with a total value of $13,401,002 as of the reported date7.
Rezolute's total shares outstanding as of June 30, 2024, were 51,465,0002. However, more recent data from January 2025 indicates that the shares outstanding have increased to 57.94 million5.
Vivo Capital is listed among the top institutional shareholders of Rezolute, along with other notable investors such as Federated Hermes, Inc. and Nantahala Capital Management, LLC36.

They or Nantahala may have raised their stake to just under the 10% ownership level that triggers SEC requirements for more frequent reporting
JMO
Kiwi

Hopefully we see an email after hours about a big buy in from another pharmaceutical/invesment company other wise we might be in for a dip if someone started a new short position . Hoping it's a new buy in , if anyone able to see new short position taken today let us know I only see them every 15 days 

3.5 million share buy just went thru , I little suspicious but watching closely 

As you probably know ...CFO has been making several open market share purchases ...usually a good sign .
Per SEC..... he has to hold at least 6 mths before he can trades these.
Great video ...thx
Kiwi

Great video sent out by the company tonight , they've had people on this drug for 2.5 years successfully. Incredible that they know it already works , just gotta finish jumping thru US hoops and we'll see it roll out . Test results be in by this June , if it models the international results , we're good to go . MM's shorting this sucker every chance they get, another 40k on 12/31/24  - on top of the million they shorted at 1.10 , I'll be selling when we short squeeze their asses .Buy back on the dips , watching my charts closely. 

Biogen $BIIB CEO confirms he’s shopping for biotechs: ‘We will be doing deals’

JPM conference
Kiwi

Well there is the patent cliff and BP is looking for new assets ...RZLT unlikely launch their drug themselves


Biogen proposes to buy remaining stake in Sage in $442 million deal

Kiwi

Well as much as I like RZLT I'm wondering why that dont appear to be attending / presenting at the JPM healthcare conference next week .
The conference is only about a 40 min drive from their HQ ....and they need to raise some cash selling their DME drug .
If they dont sell their DME drug theres a risk they'll raise capital before the pivotal trial top line data release ...due I think second half 2025 .
They are also starting to enroll for their tumor trial this Qt ...so cash burn

Kiwi

Yes I think its very likely the Ceo will eventually sell the entire Co .
I dont see them launching their drug alone .
Kiwi

Thanks Kiwi.  I know that the CEO has mentioned selling off or partnering RZ402 (DME) drug, but do you think his intentions would be to sell the entire company?

Also. RZ358 has been granted a priority medicines (PRIME) designation by the European Medicines Agency (EMA) and an Innovation Passport designation by the U.K. Innovative Licensing and Access Pathway (ILAP) Steering Group for the treatment of cHI.
RZ358 also received orphan drug and pediatric rare disease designation in the U.S., and orphan drug designation in the European Union for the treatment of insulinoma, the primary cause of islet cell tumor hypoglycemia (ICTH).
Under the Company’s Expanded Access Program, multiple individuals with ICTH have been successfully treated with RZ358 resulting in substantial hypoglycemia improvement, discontinuation of intravenous dextrose, and hospital discharge.

Ceo in his earlier M&A days worked on the sale of NEXT for Steve Jobs ...before moving into Biotech

Kiwi

Thx Jan 7 (Reuters) - Rezolute Inc ( RZLT ):

* REZOLUTE INC ( RZLT ): TOPLINE SUNRIZE DATA EXPECTED SECOND HALF OF THIS YEAR Source text: Further company coverage:

Kiwi

Rezolute (Nasdaq: RZLT), a late-stage biopharmaceutical company, announced that the FDA granted Breakthrough Therapy Designation to ersodetug (RZ358) for treating hypoglycemia due to congenital hyperinsulinism (HI). This designation, aimed at expediting the development of treatments for serious conditions, is based on Phase 2b (RIZE) study results showing significant hypoglycemia improvement of 75% or better without clinically significant hyperglycemia.

CEO Nevan Charles Elam highlighted 2024 as a transformative year with key clinical milestones. The company plans to finish recruitment for the sunRIZE study and announce topline results in the second half of the year. Additionally, Phase 3 study for tumor HI is set to commence.

Key highlights from 2024:

FDA lifted partial clinical holds on the Phase 3 sunRIZE study, enabling U.S. site inclusion.
Received Innovation Passport Designation from the U.K. for congenital HI treatment.
Preclinical validation for treating hypoglycemia due to non-islet cell tumors (NICTs).
FDA clearance for a Phase 3 study for tumor HI, with topline results expected in 2026.
Received Orphan Drug Designation for tumor HI.
Raised $73 million in June to support clinical programs and operational goals into Q2 2026.

Good little (a little longer than little) article outlining prospects for RZLT. Seems promising:

https://biotenic.substack.com/p/rzlt-long-ph3-sunrize-data-2h-2025?r=5xh7t

CFO buying again ...3rd purchase this mth

http://archive.fast-edgar.com/20241218/AP2ZRQ22E222HZM2222B2ZO2NADDZ222BO62/

12/18. ....10,000 shares , 12/12 ....9,000 shares ,......12/9. 10,549 shares

Kiwi

CFO open market purchases ...ie these were not RSU, options vesting etc ...he had to put up the cash for these buys ....might have been thru an LLC

12/9 10,549 shares at $5.04 = $53,166
12/12 9,000 shares at $4.60 = $ 41,400
-----------------
$ 94,566

So he is not buying in anticipation of some immediate good news as that could be seen as insider trading . He probably anticipates a good read out from their RZ358 trial with top line results mid 2025 ( that trial is fully enrolled ) . He probably can't make purchases ( or sales ) close to the read out .

Kiwi

Looks like instead of working he was sitting watching the stock price all day and then jumped in to buy when it dropped to 4.60. I'll stick with his lead. 

CFO keeps buying http://archive.fast-edgar.com/20241212/AP2HRG22E222HZU2222B2ZO2NA7DZ222B262/

I'll assume he's also good at accounting :--)

Second purchase this week isn't it ?

Kiwi

This was the CFO's last buy back in May

Tuesday, May 28, 2024 2:55:20 PM
Post# of 429
CFO buying https://ir.stockpr.com/rezolutebio/sec-filings-email/content/0000912282-24-000460/form4.html

These shares were purchased in multiple transactions at prices ranging from $3.21 to $3.23, inclusive

So it's up almost 50% since that purchase ....and 357 % year to date .
All my biotechs were selling off today ...so called " long dated assets " ...vulnerable to any increase in interest rates .

Top line data for RZ358 is not due till mid 2025 and theres be no update on any interest / possible sale of their DME oral drug RZ 402 which they said they would not develop themselves .

May add more comment later but in brief if the CFO is buying I am also ( RZLT ) and if the CFO leaves the Co for other opportunities , I sell what ever I'm still holding ( AMRN ) .

ARDX / UNCY ... Congress seems unable to act in the best interests of dialysis patients . The dialysis bundle as currently administered clearly discriminates against this , mostly people of color , population . Huge frustration for my wife and others that prescribe to these patients , as they are unable to get the best in class drugs for many of them

Kiwi

Hope the CFO is better at accounting than he appears to be at stock picking.  Actually, most bios getting hit a bit and the volume here is quite low so no biggie.  At least they don't have to depend on Kidney Act passing. 

CFO buying. always a positive sign
https://ir.stockpr.com/rezolutebio/sec-filings-email/content/0000912282-24-000863/form4.html

Kiwi

RZLT, near a 52 week high

Chart looks a reversal today - possibly closing lower than the open - but the volume is anemic so it might not mean anything. Hopefully, it regains strength before the close.

Anyone have a link to the shareholders meeting , I thought they sent me one but I can't find it . TIA 

FDA grants orphan status for RZ358.  

Pretty good writeup about it a month ago.  I know I was drawn to this stock after listening to the CEO sometime this past summer.  Impressed me as quite knowledgeable.  He alluded to them selling the 402 PKI drug so hopefully he is still finding some buyers receptive.  

The only real news I've seen is BVF exiting their position . Hope theres's no problem with their P 3 trial ...or lack of interest in their DME asset
Kiwi

Kind of a disappointing price action today but at least not a very high volume.  

RMB. I reduced my position by 25% today . Been in it since Feb so just lighten'd up ..
I think some funds reduced their holding per todays Sec filings
May add back in later .
Since I post when I buy ...I should also post when I sell

Kiwi

I'm not flipping . Sold half after it doubled and am just holding the rest .
Prefer to " invest " rather then trying to trade
HC Wainwright & Co. Reiterates Buy on Rezolute, Maintains $14 Price Target ...FIWI ...Wedbush same I think
Good luck
Kiwi

If we can close above 6.24 we're gone , sell some in the 7.25 area and wait for pull back . If we partner with eyelea for the RZ402 then it explodes to 20+ , my take anyways . I've been tracking this since 1.09 and it's been trending up since then , holding some flipping a lot . 

Thx for the update
Kiwi

-.28 loss for first quarter 25', better than -.32 they predicted . Everything still on track testing proceeding as scheduled 

Here was the CFO buying big back in February https://content-archive.fast-edgar.com/20240220/AP27R222E222H2S2222A2CO2NABDZ222B262/

Always a good idea to follow CFO buys / sells
JMO
Kiwi

Wedbush Initiates Rezolute at Outperform With $12 Price Target

Kiwi

RZLT 2024 year ended July , should see results by Christmas and news by Feb IMO= great volume 

Thanks Kiwi. I really like RZLT's CEO when I heard him talk. I think I will hang in there as well.

EYPT just came out with some good interim P 2 data on DME ....which may lessen interest in RZLT 's DME drug .
Just an FYI . I still like RZLT .
UNCY and VERA both up about 15% as I type
Kiwi

Yep. and on increased vol. ...stealth accumulation . Co will be adding US patients to its P3 trial early 2025 with results in second half of 2025 .
Kiwi

Slow and steady rise 

Dows down almost 600 pts but RZLT is up about 3 % on above average volume. Co has a mkt cap of only $300m and I think plenty of cash ....My speculation is that they will entertain offers for their DME drug which had great P 2 results . They are unlikely to advance this into P 3 trials themselves as they are focused on Congential HI ( hypoglycemia ) and ramping up US enrollment for that P 3 trial in early 25 ....final results in second half 2025

Kiwi

Up over 7% on triple avg volume but I see no news.

https://www.encodelp.com/coverage-universe/rzlt/

Kiwi