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RMB
EXPERT CALL TODAY AT SLINGSHOT
May 29, 2024
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RZLT: Delving into the topline results from the Phase 2 clinical study of RZ402 in patients with Diabetic Macular Edema (DME)
Well Kiwi all this insider buying is gonna make me have to add back what I lightened, at unfortunately a slightly higher price.
Holding 15 large till $12-15. Load em up boys and gals.
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
RZLT...........................https://stockcharts.com/h-sc/ui?s=RZLT&p=W&b=5&g=0&id=p86431144783
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 .
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.
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.
Here's the advisor that thinks the DME results are a big deal
https://med.stanford.edu/profiles/QUAN%20DONG%20NGUYEN
Kiwi
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
“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.
8K just out. note
Sub-analysis by DME severity (CST =400 microns) indicates an improvement of approximately 75 microns at the 200 mg dose
Sub-analysis by DME severity (CST =400 microns) indicates an improvement of approximately 75 microns at the 200 mg dose
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.
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
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
Strong on a down day on NAZ. hope people bought premarket
Thanks for posting.
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.
Now is a great time , hehehe
I got back in a little early but it’s all gambling , good product , good investors and solid company . What’s a drug like this gonna do to the market , what’s its potential market size ? Not sure but it’ll help with valuation to predict target price .
RMB. In the CC the Co thought the difference between the 400 mg and 200 mg dose was that there were more with advanced DME in the 200 mg dose .
So those with limited DME ...more of them in the 400 mg cohort ...saw limited benefit as not a lot to improve on.
So the challenge is to recruit those with moderate DME who aren't yet taking the eye injections
Kiwi
EOT was the data they stopped taking the drug . Then there was a 2 wk follow up to see if there was any lingering benefit ....which they recorded for the 200 mg dose .
The problem is that they say there was probably full cell penetration at the 200 mg dose so there was no benefit from a larger dose ...however ...if there was full cell penetration at the 200 dose ...and the 400 dose ...those graphs should be the same or close .
But they aren't
Kiwi
Thanks Kiwi. I am a little confused. I assume EOT means end of trial but it seems there is data (or some kind of extrapolation or estimation) past that. Also, not sure if they are surprised that the 400mg dosage results not what it was expected to be.
4th option is to run a larger P2b trial for 6 mths with DME patients confirmed in decline .
Aim would be to see at what pt BCVA ( visual acuity ) improved .
Co maintains 3 mths is to short a time to see improvement in these patients ...but 6 mths on treatment should do it.
Benefit from the injections kicks in fairly fast
anti-VEGF agents like ranibizumab and aflibercept can lead to rapid and significant visual acuity gains in patients with DME, with responses largely established by 3 months of treatmen
RMB. some skepticism over the results ...expressed on Twitter ( X )
$RZLT
https://x.com/BiotechElmo/status/1793035993991266771/photo/1
Kiwi
One would think that “monumental” data would garner some interest in at least a partner. Of course the doc may have used that term with his company hat on rather than a pure scientist but who knows
RZLT.
Cash, cash equivalents and investments in marketable securities were $81.6 million as of March 31, 2024,
Huge volume - which is usually at peaks and change of direction. Hopefully, though a lot of volume is coming in after the price drop but I don’t know.
At the 50 day and rsi beyond belief. Tripling down here.
RMB ..re those comments ...which is why I'm stunned by the markets reaction ...which apparently is " sell the news " on steroids
Kiwi
I am guessing that these past two months there has been constant upward pressure on the stock (causing me to not be able to get in) and so everyone got long prior to data release. Profit taking snowballing but have to see when dust settles.
How do you like the comment the results:
““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. “
Good luck to you. The seller will lift.
Good luck . I didn't expect this sell off. Co is going to sell or partner for the DME indication and market is saying the data may not be good enough to attract BP interest.
Here we have the first oral drug that may delay the need for eye injections in treating DME ....and the stock tanks !!!!!
Kiwi
Just dipped my toes in here at 2.88.
RZLT CC. key pts
1) Co is unlikely to advance drug themselves ( so probably no capital raise after this :--). Mgt says to big a market to take on by themselves .
2( They would expect to see BCVA improvement by 6 mths ...theres a lag response to reducing retinal thickness .
3) Retinal specialists say multiple eye disease indications may benefit from this drug RZ402 ...far larger / longer trials with 3 mth , 6 mth and 12 mth data warranted . They want to start RZ402 early to delay need for eye injections and then later use with the injections if needed. Many ways to use the drug ...standalone and in combination.
Kiwi
This is the first safe oral therapy that I'm aware of that reduces retinal thickening and is likely to at least enable these patients to retain their visual clarity if treatment is started early enough.
Without a drug like this , patients require injections into their eye usually every 3 mths.
The problem with selling a Co like this ...with a drug that appears to be a major advance in therapy ...is trying to time when to get back in .
Kiwi
“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.
These data are very encouraging and are supportive of the potential for a new first-line, non-invasive treatment for DME.”
HC Wainwright & Co. analyst Douglas Tsao reiterates Rezolute (RZLT.NaE) with a Buy and maintains $14 price target.
RMB. P2 DME data due this month ( May ) . Long shot but theres some leading edge eye disease KOL's involved with this trial
Kiwi
Diabetic Macular Edema (DME)
Completed patient dosing for Phase 2 U.S., multi-center clinical study in 94 participants with DME who are naïve to or have received limited anti-VEGF injections.
Primary endpoints include (i) stabilization of disease and/or change in study eye macular central subfield thickness, as measured by Spectral Domain Ocular Coherence Tomography, (ii) change in study eye visual acuity as measured by the early treatment diabetic retinopathy scale, (iii) the repeat dose pharmacokinetics of RZ402 in patients with DME, and (iv) the safety and tolerability of RZ402.
Topline results expected in May 2024.
We have also completed dosing of patients with diabetic macular edema for our Phase 2 multi-center clinical study of RZ402 and we expect to announce topline results from that study this month,”
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