Rezolute Inc (RZLT) 옵션

Well theres a certain risk off ....on anything speculative ...thats tracking the general market .
Compare the movement today with the changes in the S&P .
IMHO it's very unlikely the trial gets stopped for futility ....probably 50% chance they need / or want ...to add more patients to increase the statistical power .
CEO , CFO and a board member have all been making open market buys ....so they must feel pretty confident on eventually getting a drug approved.

UNCY is green even tho Dow is down over 1,000 pts ...!

Kiwi

I guess from the looks of the stock price, the market is pricing in option 1 or 3.  1 is bad but 3 means they have to churn through more cash. 

RMB ... Direction of RZLT near term ultimately depends on this interim readout
An interim analysis of the primary study endpoint (change in hypoglycemia events) is planned for this quarter, with results and study update to be announced early in the second quarter.
Three possible outcomes from the analysis include: (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.

Obviously high risk so risk only what you are comfortable with .
Insiders have been buying recently ...lets hope that means something
Kiwi

And, there are other people (Trump supporters) like Ben Shapiro and Ackman, and Druckenmiller calling out this stupidity. So far on the MAGA websites I check the commenters immediately trash anyone coming out bashing the Pres. Of course many of these don't have much on the line.

I guess I am always a day late. Bought stuff first thing Monday morning and felt good about the turn around that day. I thought today would be an up day and sure enough it started that way. My plan was to sell those Monday morning purchases on the start of Wednesday trading but obviously that should have been today. Unfortunately, I had to go to the Eye Doctor for an appointment and by the time I was out - and could see - the market had turned. My thought was to repurchase a testing of Monday lows, but even though I was thinking of buying the down opening tomorrow, I worry that if Monday's lows are taken out that things could go quite lower. For instance if you look at say, META, on a 2 year chart, it can still go quite a bit lower. Thought around 480 would be a good buy but if that doesn't hold it could be a long way down. Looking also to maybe get some CDs. I have some maturing in the next few months and although inflation will not be in check, I worry that between the economic slowdown and the market meltdown, the FED may be forced to drop rates sooner than later. When you are retired if interest rates drop in half, it can make a huge dent in one's income.

Everything including RZLT backed off today. But hopefully, RZLT doesn't have much more downside and we wait it out.

RMB. whats interesting to me is that Musk is trashing Navarro ...calling him "dumber than a sack of bricks ...and thats an insult to bricks. "
Writing this as we await the extra 50% tariff due to go into effect against China ...and our Defense guy said to be sending battle ships to the Panama Canal to " protect our interests "
Interesting times
Kiwi

I know that although insiders buy because they think the shares are undervalued, they can sometimes be wrong.  But today I was busy reshuffling my portfolio and had some extra cash left over so bought some more RZLT.  
Of course the worst may not yet be over but a number of MAGATs have bashed the tariffs (Musk, Shapiro) and Congress is talking (they are good at that) about trying to stop it.  As a matter of fact I read today where the U.S. Chamber of Commerce is contemplating taking the Administration to court.  We shall see. 

As far as AMRN goes, I was all set to dump a bunch today and throw that onto some beaten down techs, but they announced that they have given a board seat to Torok - the hedge fund guy who blasted them in a public letter a few weeks ago. My first gut reaction was that they brought him in to drown him out in the board room and get him to no longer utter his grievances in public. But JRoon on their iHub board thinks it may mean that management does have some plan going forward and brought him into the inner circle. We shall say. That made me hold off selling my shares today. That plus the fact that the premarket was so thin it was difficult to make a trade, and then I saw the news story.

RMB. it was for DME. ( diabetic eye disease ). I added this am ...Bitten by FOMO following all the insider buys :--)

Kiwi

I got involved here last year when I heard the CEO at a presentation. He impressed me.  A little disappointed so far because they were supposed to offload one drug to an acquirer (forget the drug number designation) but it hasn't happened.  That sale would help any cash concerns.  Good luck to us all

Hello.
Just dipped into RZLT this morning. Bought 600 shares at between $2.72 to $2,87) average $2.78. Will wait for year end results prior to investing more if warranted & company has positive results in their Phase 4 trial. I like that fact that they basically have no debt. Worry about their cash burn though.

According to Dew Diligence ( Biotech Values board ) ... PDUFA dates less affected
FDA reviews cannot be delayed much, if at all, without breaching the minimum performance metrics inherent in Congress’ PDUFA funding for these reviews.

Kiwi

Pretty dire description of what transpired with all the firings. All descimated:
https://www.yahoo.com/news/fda-ve-known-finished-former-190329689.html

Laid off.  Big difference 😞

Read on another board (AVXL) that almost all that were working on Alzheimers at FDA were laid.  Not sure of the veracity of that statement.  Very disturbing to see this state of ignorance take control of this country in the year of 2025.  Going backward. 

A director also buying Wladimir Hogenhuis, serving as a Director for Rezolute, has purchased 6,758 Common Shares at a price of $2.92 per share, totaling $19,733. Following this transaction, Hogenhuis directly owns 84,025 Commo

So in the last wk or so ...Ceo , Cfo and a director ...all making open market buys !!

Kiwi

And don't think that the workers that are left behind are going to work extra hard to makeup fir the shortfall in manpower.  This new group in DC are not serious people in the sense of being knowledgeable and interest in doing the correct thing.  Only their ideology counts.  

WASHINGTON, April 1 (Reuters) - The Trump administration began mass layoffs of 10,000 staffers at U.S. health agencies on Tuesday, according to multiple sources familiar with the situation, with security guards barring entry to some employees just hours after they received dismissal notices.
The cuts, which affect several high-profile agencies under the Department of Health and Human Services, including the FDA, CDC and the National Institutes of Health, are part of a broad plan by President Donald Trump and billionaire ally Elon Musk to shrink the federal government and slash spending.
-----------------
Any delay in approval = more cash spend

Kiwi

Reported layoff's in the drug approval dept at DHS ...may delay drug approvals ...cause Co's to burn more cash
JFK jr at work
Kiwi

I followed those guys by adding some myself this morning.  Problem was that I did not have that much free cash and also didn't want to sell anything else since this last week or two have really depressed prices.  So small purchases. 

Both Cfo and Ceo buying stock in open market in last wk of March

Kiwi

Open market purchase by Ceo

1. Name and Address of Reporting Person*
Elam Nevan C
(Last) (First) (Middle)
C/O REZOLUTE, INC.
275 SHORELINE DRIVE, SUITE 500
(Street)
REDWOOD CITY CA 94065
Code V Amount (A) or (D) Price
Common Shares 03/27/2025 P 12,302 A $2.845(1) 224,119 D

( 12,302 shares acquired at average cost of $2.845 - now owns 224,119 share direct )

Explanation of Responses:
1. The purchase price reported above is a weighted average price. These shares were purchased in multiple transactions at prices ranging from $2.83 to $2.87, inclusive. The reporting person undertakes to provide to Rezolute, Inc.,, any security holder of Rezolute, Inc., or the staff of the Securities and Exchange Commission, upon request, full information regarding the number of shares purchased at each separate price within the ranges set forth in this footnote.

Kiwi

CFO buying again https://ir.stockpr.com/rezolutebio/sec-filings-email/content/0000912282-25-000339/form4.html

Kiwi

Thanks for your thoughts on this.  So it would extend the time frame for readout and cost more money.  Wish thry could sell their other asset. 

An interim analysis of the primary study endpoint (change in hypoglycemia events) is planned for this quarter, with results and study update to be announced early in the second quarter.
Three possible outcomes from the analysis include: (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.


So my guess is that the trial won't be stopped for futility and that the recent stock decline is pricing in the risk that they will need to increase the sample size ....ie increase the power of the trial ...to enhance statistical confidence .
So hopefully they have lined up an additional 18 patients all set to go ..assuming this is the guidance they get
This is a 6 mth trial ..so results pushed into 2026 if they need to add patients

Eric Harris just got options for 60,000 shares that vest over 36 mths I think . He's the new commercialization guy

Kiwi

Good luck to both of us. 

Rezolute, Inc. (Nasdaq: RZLT), a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs, announced the appointment of Erik Harris to its Board of Directors, effective immediately.
Mr. Harris, who currently serves as Chief Commercial Officer and Executive Vice President at Ultragenyx, brings more than 20 years of biopharmaceutical expertise to Rezolute.

Kiwi

Bad news short of trial failure priced in ???
Think I'll buy some around here
Dont look at SLNO ...just dont :--)
Kiwi

Big players in RZLT that just scored in SLNO
Holder Shares Date Reported % Out Value
Nantahala Capital Management, LLC 2.86M Dec 31, 2024 33.95% 8,145,248
Vivo Capital, LLC 2.8M Dec 31, 2024 33.23% 7,973,456

Binary event coming re their interim data
Kiwi

The buy by the Director Wladimir Hogenhuis in February....They were mostly options granted that he exercised at 0 cost to him
He paid for these
P 10,000 A $4.7(3) 77,267 D

10,000 shares at an average cost of $4.7 = $47,000

https://www.nasdaq.com/articles/insider-purchase-director-rzlt-buys-10000-shares

Just an FYI
The CFO was repeatedly buying in 2024 ....nothing recently .

Kiwi

I think SEC rules prohibit insider sells within 6 mths of their buys ...insider info reg ....so even if they knew they may have to add patients to the trial , they couldn't sell
I'll chk .
Stock will definitely rip higher if they pass this interim and with no changes required

Under Section 16(b), also known as the "short-swing profit rule," insiders must disgorge (return) any profits made from selling stock within six months of a purchase (or purchasing stock within six months of a sale) if both transactions involve the company's equity securities. This rule applies regardless of whether the insider actually used inside information—it’s a strict liability provision intended to deter short-term speculation.


So not actually prohibited ...just forgo any profits if they do

Kiwi

It sure as heck feels like it. I would like to think that there isn't a leak and somehow this is just a snowball effect from people getting stopped out worried about the interim but not actual knowledge. Notice that the volume has increased that last 3 or 4 sessions. Decided to check insider action and all I see going back to Dec 24 are 3 insider purchases. I huge one from a director in late Feb. Of course if truly blinded even they are not aware of status and they could be wrong in their purchases. But when putting $5 million bucks on the line they must have some confidence.

RZLT is trading like they have failed the interim ...or at least required to add more patients .
As posted previously
There was an interim analysis scheduled for their P 3 trial this Qt with results etc released early in Q2
Interim results will determine if trial is stopped for futility , need to have more patients added to increase power of the trial ...or continue as is .
If continue as is ...topline data Q4 2025
If add more patients ...increased cost and delay on the results .

Stopped out of most of my position .
Stock will definitely rip higher if they pass the interim with flying colors ...so kept small position just in case .

Kiwi

I keep getting stopped out of part of my RZLT position .
Theres certainly nervousness about the interim analysis and if the DMC will require they add more patients to the trial . Decision early in Q2
Kiwi

Agree ..its just how much risk exposure you want to carry going into a binary like event .
I'm also not happy they haven't found a buyer...yet ... for their DME ( eye ) candidate ...they probably spent at least $10m on that trial .
Low vol so probably just nervous nellies like moi.

And yes I did sell before R-IT results ...switched to an strangle / straddle option set up and had to wait till it hit $6 before I was long again .
Man ...the life cycle of those in AMRN from pre R-IT till today ...yikes

Kiwi

Can't argue with the logic expressed but it just could be others like you selling.  Stock price dropped prior to R-I as well. 

There was an interim analysis scheduled for their P 3 trial this Qt with results etc released early in Q2
Interim results will determine if trial is stopped for futility , need to have more patients added to increase power of the trial ...or continue as is .
If continue as is ...topline data Q4 2025
If add more patients ...increased cost and delay on the results .
Dont like how the PPS has been trailing off and I've reduced my position by 1/4

Kiwi

Thx for the update . I'd missed it .
6.3 m shares purchased
. The transaction positions FMR LLC (Trades, Portfolio) with a 10.50% stake in Rezolute Inc,
Kiwi

On February 28, 2025, FMR LLC (Trades, Portfolio) made a strategic move by acquiring 6,360,907 shares in Rezolute Inc at a purchase price of $4.43 per share. This acquisition marks a significant investment in the biopharmaceutical company, reflecting FMR LLC (Trades, Portfolio)'s interest in Rezolute's potential for growth and innovation. The transaction positions FMR LLC (Trades, Portfolio) with a 10.50% stake in Rezolute Inc, highlighting the firm's confidence in the company's future prospects despite its current financial challenges. I'm sure they shorted the stock recently. 

ignore ...wrong co

JMP Securities analyst Jason Butler maintains Rezolute ( RZLT ) with a Market Outperform and raises the price target from $8 to $9.

Kiwi

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