Rezolute Inc. (RZLT)

[Whalatane]

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

[Whalatane]

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

[tbonaces80]

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

[Whalatane]

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

[tbonaces80]

Went parabolic. I lighten in the rip

[Whalatane]

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

[rosemountbomber]

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.

[Whalatane]

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

[Whalatane]

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

[rosemountbomber]

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.

[TrendTrade2016]

WEEKLY BREAK OUT BIO UNDERWAY!

[Whalatane]

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

Kiwi

[tbonaces80]

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

[tbonaces80]

Basing

[Whalatane]

RMB. OT. I expect UNCY data this wk
Kiwi

[rosemountbomber]

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

[Monksdream]

RZLT still making higher highs

[rosemountbomber]

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

[glenn1919]

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

[Whalatane]

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

[BadCuda]

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 ??

[tbonaces80]

Chart showing low volume consolidation in the daily. Loooking giod

[tbonaces80]

Bought tier 3 at $4.

[rosemountbomber]

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.

[tbonaces80]

Who saw the print of 700k

[rosemountbomber]

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

[tbonaces80]

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

[tbonaces80]

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

[Whalatane]

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

[rosemountbomber]

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.

[Whalatane]

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

[rosemountbomber]

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

[Whalatane]

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

Kiwi

[tbonaces80]

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

[Whalatane]

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

Kiwi

[glenn1919]

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

[BadCuda]

On fire today with the volume again , those 8 million shares sold after hours up to 5.20ish are not just stupid money . They know the valuation on this is much higher , they coordinated a share exchange in the open market IMO - not often seen . Don’t care much about the particulars of the company but the product will sell , how much is it worth when it starts selling is what will determine the share price ..( if they don’t get bought first ) .Institutional investors control this thing for the most part , let’s see how high they take it . If we break out Tuesday then 5.25 is not out of the question by end of week .

[Whalatane]

Co says to expect 6-12 mths to see improvement .
There are risks with anti VEGF shots ...and long term compliance is not that great

Anti-VEGF (anti-vascular endothelial growth factor) injections into the eye are commonly used to treat various retinal diseases like age-related macular degeneration, diabetic retinopathy, and retinal vein occlusions. While generally safe and effective, these injections can lead to certain complications:
Ocular Complications
Intraocular Inflammation/Endophthalmitis: There is a small risk of developing intraocular inflammation or endophthalmitis (severe intraocular bacterial infection) after the injection procedure.
Retinal Detachment/Tears: Intravitreal injections carry a risk of causing retinal tears or detachments, though the incidence is low.
Intraocular Hemorrhage: Subconjunctival hemorrhage can occur in around 10% of injections. Rare cases of massive subretinal or choroidal hemorrhages have also been reported.
Increased Intraocular Pressure (IOP): Studies show a significant portion (3.5-11%) of patients experience sustained IOP elevation after repeated anti-VEGF injections, potentially due to outflow obstruction or trabecular meshwork damage.
Silicone Oil Droplets: Silicone oil microdroplets can dislodge from the syringes used and accumulate in the vitreous, causing floaters and visual disturbances.
Systemic Complications
Thromboembolic Events: Though not conclusively proven, there are concerns that suppression of systemic VEGF levels by the injected anti-VEGF drugs could increase the risk of arterial thrombotic events like stroke or myocardial infarction.
Hypertension: Systemically administered anti-VEGF drugs are known to raise blood pressure by reducing vascular permeability. This risk with intravitreal injections is unclear.
While the overall safety profile is good, close monitoring for potential complications, especially IOP elevation, is recommended for patients receiving repeated anti-VEGF injections.

I think theres concern re repeat injections over time

Kiwi

[rosemountbomber]

Impressive. No question this investment is confusing. That plus the fact that there were no visual improvements in the subjects, whereas there is improvement fairly rapidly with anti-vegf shots.

[Whalatane]

Here's the advisor that thinks the DME results are a big deal
https://med.stanford.edu/profiles/QUAN%20DONG%20NGUYEN

Kiwi

[Whalatane]

Well the available research certainly doesn't line up with RZLT mgt / advisors view on importance of CSTClinical Significance of CST Reduction

A post-hoc analysis of the Protocol T trial showed that changes in CST accounted for only a small proportion of the total variation in changes in visual acuity with anti-VEGF treatment for DME.
While anti-VEGF therapy led to reductions in CST, the magnitude of vision improvement was not strongly associated with the degree of anatomic CST change.
Factors like baseline hemoglobin A1c levels were more strongly associated with the extent of visual acuity gains than changes in CST.
The presence of intraretinal cystic spaces was associated with greater CST reductions after a meal challenge, but the clinical relevance of these short-term CST fluctuations is unclear.
Overall, the studies indicate that CST is an imperfect surrogate for visual function, and reductions in CST do not reliably predict proportional improvements in visual acuity outcomes for DME patients.
In summary, while anti-VEGF therapies can reduce CST in DME, the clinical significance of these CST reductions in terms of direct visual acuity benefits appears to be limited.
CST changes alone should not be used as a surrogate for predicted vision gains.
Other factors beyond CST appear to play a larger role in determining visual outcomes. lowering

From the original PR

“The results are monumental for the DME community,” said Quan Dong Nguyen, MD, MSc, FAAO, FARVO, FASRS, Professor of Ophthalmology at the Byers Eye Institute, and Professor of Medicine and Professor of Pediatrics at the Stanford University School of Medicine, and a member of Rezolute’s Scientific Advisory Board. “I am impressed by the significant reduction in CST in this study across all three dosages as retinal thickness is the key biomarker to determine whether a therapy may offer a potential benefit to patients.

Kiwi

[Whalatane]

8K just out. note

Sub-analysis by DME severity (CST =400 microns) indicates an improvement of approximately 75 microns at the 200 mg dose

Don't remember that exact detail from their CC .
If you're getting improvement of 75 microns after 12 weeks then I'd think some one / some Co would want to explore that further .
I added ( hey thats what makes a market )

Actually did find it in the original PR

Sub-analysis by DME severity (CST =400 microns) indicates an improvement of approximately 75 microns at the 200 mg dose

Kiwi

[tbonaces80]

Close at $3.72 or higher.

[rosemountbomber]

Kiwi, I have to admit to being a bit confused here. Saw the comment that said that CST was not an endpoint used by the FDA, but checking various clinical studies they usually measure that at least as a secondary endpoint. Again, not sure if this is not a correct analogy, but looking at a Vabysmo study, it appeared that BCVA improved rather rapidly (less than 12 weeks by far), so the idea that here we would see visual improvement if study ran 12 months, I am not so sure about that. Anyway have lightened up here at 3.42.

[Whalatane]

Good positive vol going into a holiday weekend .
Mkt cap on this is only around $130m. . One would think they could sell the DME indication for at least $100m since they are unlikely to pursue themselves.
Yes the drug make take 6-12 mths to reduce retinal thickness ...but given the option of an eye injection every 2-3 mths ...or starting early with a pill to reduce the need for the injection .....I'll go with the pill as long as its safe

They are still working on getting their P3 clinical hold lifted . That will be a real positive when / if it happens

Kiwi

[Whalatane]

Good positive vol going into a holiday weekend .
Mkt cap on this is only around $130m. . One would think they could sell the DME indication for at least $100m since they are unlikely to pursue themselves.
Yes the drug make take 6-12 mths to reduce retinal thickness ...but given the option of an eye injection every 2-3 mths ...or stating early with a pill to reduce the need for the injection .....I'll go with the pill as long as its safe

They are still working on getting their P3 clinical hold lifted . That will be a real positive when / if it happens

Kiwi

[tbonaces80]

Let’s break $3.72. Upto $5.72.

[tbonaces80]

Strong on a down day on NAZ. hope people bought premarket

[rosemountbomber]

Thanks for posting.

[Whalatane]

Fierce Biotech article on DME trial

Roberts said improvements were more pronounced in patients who had a CST of more than 400 µm at baseline. There were more of those patients, who Roberts classed as having more severe CST, in the 200 mg arm than the other cohorts. While Roberts said baseline CST may explain the results, the biotech is continuing to analyze the data and is yet to settle on an answer.

There was no significant improvement in vision in the study but Rezolute attributed that to the length of the trial, rather than a limitation of the drug candidate. The biotech said the CST changes would predict vision benefits in a longer trial.

“Any drug that gets rid of ... the fluid and gets rid of the thickening of the retina is, almost by definition, going to have visual benefits for the patient. I think in a six-month study, a 12-month study, that would give enough time to the clinical trial to demonstrate effects on the visual acuity.”

Rezolute is now evaluating the next steps for the program. Nevan Charles Elam, the biotech’s CEO, said he will “definitely explore all viable options” but it is unlikely the company will advance into late-stage development independently. A larger partner could explore opportunities identified by Rezolute, such as the potential for a lower dose given over a longer period of time to be efficacious.

Kiwi