Rezolute Inc (RZLT)

Was looking at something else and came across this.  I found that options for RZLT have what seem to be very high implied volatility. Especially when I compare them to say options for UNCY.  Both companies are hoping for positive decisions from the FDA in the near future.  Unless I am not seeing it clearly. 

Stock moved up slightly in the am and then down slightly in pm and ended basically unchanged. However, volume was high at about 6.5 million shares. I know a number of other stocks who were being included into some of the Russell indexes had high volume on Friday. Anyone know if RZLT volume was related to anything like that? I assume we should have some trial developments before the end of the year, hopefully 3Q.

Kiwi I wonder if that note was written when the stock was at $4.  Because the $11 target and 175% upside doesn’t match if written with stock at $5. 

Guggenheim analyst Debjit Chattopadhyay raised the firm's price target on Rezolute to $11 from $6 and keeps a Buy rating on the shares, which the analyst is also naming as a "Best Idea (again)," given what the firm sees as the high probability of a positive tumor-induced hypoglycemia readout over the next six months and a potential 175% upside from current levels.
------------
Kiwi

Another good day for the stock. Would love to see double digits again.

Still here, seems I'm always the last one out because lil guppy is a piggy piggy.

It is certainly looking up from where it was looking forward to seeing double digits again.

Just checking in to see if you're still here .
Co should announce full enrollment in the UpLift tumor trial within 30 days ...my guess ...if anyone was paying attention recently at the conference .
Maybe price action is anticipating that .

Kiwi

Yep. Definitely better to be up after the presentation rather than down.  GLTA. 

Well up 10% as I type ..following Saturdays presentation ...U feeling better now ?
That is a huge convention ...easy to get lost in the crowd .
JMO
Kiwi

Well, they are definitely not bidding up the stock price in advance of the presentation this weekend - at least not yet. Only a day and a half to go though. Chart looks ripe for a rebound upwards.

I actually have more faith in this one paying off more than some others. Just needs good verifiable trial results IMO

When that happens I do not know

That oral presentation on the 13th can't come fast enough. Stock has been drifting down for almost a week. I actually added some to my brokerage (dividend only) account a few minutes ago, so it had better jump the shark.

Interesting stuff I know nothing about. THANKS

Ernie ..this is a for poster presentation for upLift ( Tumor ) patients . How I think these work is that Gopal Saha will be standing in front of the poster for 1.1/2 hrs on Sat to answer questions etc .
The poster is up for the entire conference .
They will definitely be using this poster presentation to try and recruit more patients for the upLift trial .

Some times these posters are featured on a grand rounds type walk where MD's as a group go from one poster presentation to another ....to catch up on " action now " type posters .
They usually select maybe up to 10 poster presentations for this more focused attention
Wife used to go to these for her Nephrology dept ...I went along once .

Kiwi

The Case Series is 1 1/2 hours so it must be a deep dive into everything they have - let's hope it is well received to bring much needed interest to Rezolute.

Presenting at a conference June 13th -16th ..hopefully that will help drive enrollment in the upLift trial

Presentation Title: Ersodetug (RZ358) in Congenital Hyperinsulinism: Top-Line Results from a Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study (sunRIZE)
Format: Oral presentation
Presenter: Huseyin Demirbilek, M.D.
Poster Number: SAT-10-06
Session Date and Time: Saturday, June 13, 2026, from 2:30 - 2:45 p.m. CDT
Session Title: Pediatric and Adolescent Endocrinology: Diabetes and Insulin

Presentation Title: A Case Series on the Compassionate Use of Ersodetug, an Insulin Receptor Modulating Antibody, in Patients with Refractory Hypoglycemia Due to Malignant Insulin-Secreting Tumors
Format: Poster presentation
Presenter: Gopal Saha, M.B.B.S.
Poster Number: SAT-087
Session Date and Time: Saturday, June 13, 2026, from 12:15 - 1:45 p.m. CDT
Session Title: Neuroendocrinology and Pituitary: Neuroendocrine Tumors I

--------------------
Kiwi

Well, one thing for sure, this morning in premarket it is breaking out of its tight range. Looking back, last year in June it touched just under $4 and then by November it hit $11. That was all before the pediatric data came out. So it is possible that we could have a similar run up. And as you mention, if there is any interest in someone acquiring them then that would add more fuel.

Hi RMB ...well next is who might buy them
Zealand Pharmaceutical already works in the congenital hyperinsulinism space so they know the patient population and specialist centers really well .
Novartis is big in neuroendocrine tumor expertise and may want ersodetug for those patients and license out the pediatric portion .
There are a lot of co"s with overlapping expertise in the space .

Anyway ...first thing is to get upLift fully enrolled and hopefully excellent data by EOY .
If they can ramp up enrollment ...maybe data late Q3 into Q4 .
Each patient is only in the trial for 8 wks ...then allow 3-4 wks for data cleaning , checking etc etc ....so within 3 mths after last patient enrolled , we should have the full trial results

Kiwi

Thanks Kiwi. Those targets seem ridiculously low. I guess we shall see.

$RZLT
- RZLT Price Target Alert 600 Issued by BTIG

2026-06-02 17:15:05 ET from BTIG issued a price target of $6.00 for RZLT on 2026-06-02 19:54:30. The adjusted price target was set to $6.00.

And to $5 at Wainwright
-----------
FWIW
Kiwi

$RZLT
- RZLT Price Target Alert 1400 Issued by Maxim Group

2026-06-02 17:15:03 ET from Maxim Group issued a price target of $14.00 for RZLT on 2026-06-02 18:58:51. The adjusted price target was set to $14.00.
---------------------
FWIW
Kiwi

Well IMHO theres no need for them to raise cash at this time unless they were thinking of a new pediatric trial .
What we as investors want is for them to ramp enrollment ...only another 8 ...get this interim update out to all recruiting sites and push recruitment .
Get the final data ...hopefully as good as we have seen so far ...and apply for approval in this adult population and the pediatric population already in the extension trial ...plus the most difficult other pediatric cases.

Get this amount of pediatric approval ...without another trial ....based on the Adult tumor trial .

So my guess is that if they don't raise capital at this time ....market will see that as a plus
Just my guess
Kiwi

Thanks Kiwi.  On a side note I believe the first dirty movie I ever saw was called Quiet Days in Clichy IFRC. As far as raising cash I can’t see how it would be a long term negative. 

Actively Recruiting Sites
The majority of listed locations are currently active "Investigative Sites," including:United States: Chicago (IL), Boston (MA), Rochester (MN), New York (NY), Canton (OH), and Portland (OR)

.United Kingdom:
London (NW3 2QG) and Manchester (M20 4BX).

International:
Clichy (France), Rotterdam (Netherlands), and Basel (Switzerland)

.Not Yet Recruiting Sites
Specific locations designated as Not yet recruiting include:Bethesda, Maryland, USAHouston, Texas, USA

Kiwi

Well the way this closed looks as tho market expects a raise . They are now recruiting internationally at hospitals treating these patients .
I'm sure they are contacting all those centers with the interim data , emphasizing that its an open label trial ( no placebo so you know patient gets the drug ) and really pushing to enroll the remaining 8 patients needed for this P 3 trial

JMO
Kiwi

I said nothing about another Pedi trial - You are using logic I feed on fear, but only guppy bites not a whale attack.

I always stay in it to win it but the carnage from an offering, needed or not, is what I look for when bidding tickers.

It's just a game I love playing

Nemo

And what would they use the $ for .
This UpLift trial is a P 3 trial and they only need to qualify another 8 patients ...which should be a lot easier now with this interim data .
Stock would probably tank if they wanted to do another pediatric trial .
They will probably use the UpLift data to convince the FDA that their drug works ...and that the FDA should approve it for those in the current pediatric extension group ...as well as the highest risk pediatric patients .

So what can I say ...hope cheapie's aren't made available :--)

Kiwi

A raise would be welcomed as it would present a cheaper add before it really takes off. Remember this was trading at like $11 before the pediatric trial "failed" due to things beyond the company's control.

Yeah, I'm up for an offering so I can grab some cheapies on the offering beatdown. I'm only up 170% and expect much more.

Nemo

Rezolute, Inc. (RZLT) had $120.3 million in cash, cash equivalents, and investments in marketable securities as of March 31, 2026.

The only trial they have running is the UpLift trial ...max 16 patients ...plus their pediatric extension program
Maybe they ramp up spend to complete enrollment of the UpLift trial which would be welcomed ...but hard to justify a raise when their current loss is only about $14 m a Qt

But its a truism ...Biotechs love to raise $ on any positive news .

Kiwi

Not necessarily negative but if there is a raise it will be at a discount to current prices. Biotech CEOs love to raise money. Let's see if there is one.

How negative do you think that would be for the sp considering they seem to be firing on all cylinders and money would be used to bring drug to market?

I would not be shocked to see a share offering on this stock rise here.

Normal days vol in first 2 hrs ...the sound of a thundering herd charging in

Kiwi

Heavy positive vol ...guess markets paying attention .

I need to chk their cash on hand . The UpLift trial is enrolling slower than I expected ...but I'm an impatient type anyway .
Hopefully this interim data speeds up completing enrollment in this trial.

Kiwi

I used the wrong terminology but he will be counted as a non-responder, so not having met primary endpoint:
“  so the participant is being counted as a non-responder for purposes of assessing the primary endpoint.”

I don't think they were counted as a negative, I think they were just explaining that they stopped treatment, went home and then Hospice where they expired.

They have a new 8th enrolled already, they seem to be on the ball IMO

Thx Ernie
"These results reveal the clinically impactful hypoglycemia-correcting activity of ersodetug in an unbiased GIR assessment in patients with HI caused by varying tumor types.

This further highlights the aberrant outcome from the recently completed randomized, placebo-controlled, Phase 3 sunRIZE study in pediatric congenital HI, where we believe that self-monitored glycemic measures were confounded by divergent caretaker behaviors stemming from functional unblinding to treatment status by real-time glucose monitoring.

Importantly, these findings continue to support the potential for ersodetug to be a universal treatment option for patients with serious and refractory hypoglycemia caused by congenital and a variety of acquired forms of hyperinsulinism, including tumor HI and following bariatric and non-bariatric gastrointestinal surgeries.

Hopefully these interim results will speed up enrollment in this trial

Kiwi

Thanks for posting Ernie. Some obviously knew about this yesterday hence the uptick. I don’t fully understand why that patient who died is being counted as a negative but I am still asleep.  

Rezolute Announces Positive Interim Data for its Phase 3 upLIFT Study of Ersodetug in Tumor Hyperinsulinism


Study now 50% enrolled

6 of 8 participants have already met the responder criterion for the study’s primary endpoint

Topline results for the fully enrolled open-label study are expected in the second half of 2026

REDWOOD CITY, Calif., June 2, 2026 – Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage ultra-rare disease company focused on treating refractory hypoglycemia caused by a congenital or any acquired form of hyperinsulinism (HI), today provided an interim update on its ongoing open-label Phase 3 study (upLIFT) of ersodetug in tumor HI.

With 8 participants enrolled in upLIFT to date, comprising both insulinoma and non-islet cell tumor hypoglycemia, the Company is midway through enrollment of the planned study sample size of 16 participants.

Of the 8 participants enrolled, 6 have already met the responder criterion for the study’s primary endpoint, which is the number of participants achieving at least a 50 percent reduction from baseline in intravenous glucose requirements (glucose infusion rate; GIR) within the 8-week pivotal treatment phase. Each of these 6 participants also achieved a complete discontinuation of intravenous glucose requirements with the administration of ersodetug.

One of the 8 enrolled participants withdrew study consent and discontinued ersodetug and all other non-palliative therapies prior to completion of the pivotal treatment phase. This patient had Stage 4 metastatic colon cancer and a poor Eastern Cooperative Oncology Group performance status (ECOG 4). The participant elected to be discharged from the hospital to receive hospice care at home, where they died one week later due to cancer progression. The reduction and eventual discontinuation of intravenous glucose were undertaken in the setting of hospice transition, so the participant is being counted as a non-responder for purposes of assessing the primary endpoint.

The 8th participant was recently enrolled and is still dosing in the pivotal phase of the study. All participants that have completed the 8-week pivotal treatment period have elected to continue into the open-label extension, with a cumulative treatment duration of up to 6 months. Ersodetug has been well-tolerated in the pivotal and extension phases of the study, with no drug-related adverse events or other safety findings reported to date.

“We are very excited by the interim observations from the upLIFT study as they largely mirror what we previously observed and reported from an initial case series of patients from our expanded access program for compassionate use,” said Dr. Brian Roberts, Chief Medical Officer of Rezolute. “These results reveal the clinically impactful hypoglycemia-correcting activity of ersodetug in an unbiased GIR assessment in patients with HI caused by varying tumor types. This further highlights the aberrant outcome from the recently completed randomized, placebo-controlled, Phase 3 sunRIZE study in pediatric congenital HI, where we believe that self-monitored glycemic measures were confounded by divergent caretaker behaviors stemming from functional unblinding to treatment status by real-time glucose monitoring. Importantly, these findings continue to support the potential for ersodetug to be a universal treatment option for patients with serious and refractory hypoglycemia caused by congenital and a variety of acquired forms of hyperinsulinism, including tumor HI and following bariatric and non-bariatric gastrointestinal surgeries. We look forward to announcing topline results of the fully enrolled upLIFT study in tumor HI in the second half of 2026, as well as continuing our engagement with FDA to determine the path forward for the congenital HI indication.”

About upLIFT
The Phase 3 registrational study is a single-arm, open-label, pivotal trial in approximately 16 participants with insulinoma or non-islet cell tumors who have uncontrolled hypoglycemia caused by tumor hyperinsulinism (HI). Eligible participants requiring continuous intravenous (IV) glucose will receive ersodetug 9 mg/kg per week for 8 weeks, as an add-on to standard of care. Following this 8-week pivotal treatment period, all participants may receive ersodetug in long-term extension. The primary endpoint is the proportion of participants achieving at least a 50 percent reduction from baseline in IV glucose requirements (glucose infusion rate; GIR). Additional endpoints include the number of participants and time to discontinuation of GIR, time to discharge from the hospital, extent of hypoglycemia events and hypoglycemia time in the outpatient setting by self-monitored blood glucose and continuous glucose monitor, respectively, and patient reported quality of life.

About Tumor Hyperinsulinism
Tumor hyperinsulinism (HI) is a rare disease that may be caused by two distinct types of tumors: islet cell tumors (ICTs) and non-islet cell tumors (NICTs), both of which lead to hypoglycemia as a result of over-activation of the insulin receptor. Insulinomas are the most common type of ICT and cause hypoglycemia by stimulating the over production of insulin. A variety of different NICTs, particularly hepatocellular carcinoma, can cause hypoglycemia by producing and secreting insulin-like paraneoplastic substances such as variants of IGF-2 that bind to and activate the insulin receptor. With high morbidity and mortality rates within tumor HI, there remains a significant unmet need for new therapies directed at hypoglycemia treatment. Ersodetug has shown real-world benefit in patients with insulinoma and NICTs

Sort of breaking out of its most recent trading range so hopefully something is about to break positively for us here.

UpnDownisBack
@UpnDownisBack
·
May 30
$RZLT
…Pipeline Snapshot (as of late May 2026)Congenital Hyperinsulinism (CHI): Ultra-rare pediatric disorder.
Phase 3 sunRIZE (double-blind, placebo-controlled): Topline Dec 2025 missed primary (SMBG hypoglycemia events) and key secondary due to ~40% placebo response and SMBG limitations in this population. Top dose (10 mg/kg) showed ~45% reduction vs. placebo (non-significant).
However, expanded CGM analyses (oral presentation at Pediatric Endocrine Society PES 2026, early May): Nominally statistically significant, clinically meaningful wins vs. placebo across FAS/PPS: Hypoglycemia time: >50% (FAS) to 60–80% (PPS) reductions.
Hypoglycemia events: ~50–80% reductions.
Time in normoglycemia (70–180 mg/dL): +25–50%.
Average BG: +10–15 mg/dL (~10–15%).
Open-label extension (OLE): Near-100% retention; many patients reduced/discontinued background SOC with sustained benefit. Safety acceptable (some hypersensitivity).
FDA Type B meeting (March 2026): Agency acknowledged study challenges in heterogeneous population and SMBG issues; encouraged full dataset submission. Company preparing; program update expected H2 2026.

Tumor Hyperinsulinism (tumor HI / insulinoma etc.): Parallel opportunity.
Phase 3 upLIFT: Single-arm, open-label (~16 patients, hospitalized); enrollment ongoing; topline H2 2026 (GIR reduction endpoint—objective in controlled setting).
Expanded Access Program (EAP) data (Jan 2026, initial 9 pts): 75% of those on IV dextrose/TPN fully discontinued support—highly encouraging signal.

Financials & Capital (Q3 FY2026 ended Mar 31, reported May 12)Cash, cash equivalents & marketable securities: $120.3M (vs. $167.9M at FYE June 30, 2025). Solid runway into key 2H 2026 readouts/catalysts with current burn.
R&D: $11.4M (? from $15.3M YoY—lower manufacturing/trial spend).
G&A: $6.0M (? from $4.7M—stock comp).
Net loss: $16.2M (~$0.16 EPS; beat consensus by ~$0.02).
Shares outstanding: ~104–105M; market cap ~$318M at $3.30.

Market & ValuationRecent close (May 29, 2026): $3.30 (+0.9%); intraday range recently 3.22–3.46.
52-week: $1.07 – $11.46 (post-sunRIZE miss crash + partial CGM/FDA recovery).
TTM EPS: –$0.81; unprofitable as expected.
Analysts (6–11 covering): Consensus leans Buy / Moderate Buy (some “Hold” post-miss). Average 12-mo PT $5.88–$8.75 (range $2–$20); recent Maxim raise to $10 (from $4) on May 14. Significant implied upside (80–165%+).

Key Risks / Bull Case
Risks: Regulatory uncertainty in CHI (reliance on CGM/post-hoc + FDA flexibility—rare disease precedents exist but not guaranteed); tumor HI data still pending; cash burn + potential future dilution; classic biotech volatility; very illiquid small-cap.

The Bull Case: Dual shots on goal. Strong mechanistic/CGM/OLE/EAP data + FDA engagement + orphan unmet need (diazoxide fails ~50% of CHI; surgery risks) could support accelerated/conditional path(s).
Tumor HI potentially faster (smaller, objective endpoint).
Cash covers binary events. If positive FDA update or upLIFT data, re-rating to $8–15+ is plausible.
-------------------

Kiwi

Just a tiny tiny amount - 40% off was just to tempting for a gambler such as myself.

If it goes back up - I win if it goes lower I add

I know absolutely nothing about it - I'm a buy on smackdown and DD later type of player

OT. TLSI Down 40% !
Are U buying it ?

FDA is months behind in their review . Any reason for that ...or fear the Co isn't disclosing the reasons for the delay ??

Kiwi

Found another Nantahala ticker TLSI

OT- Right or wrong I just let my URGN go at 770% - sorry it just had to be done

Bought @ $3.69 in May of 2025

Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by all forms of hyperinsulinism (HI), today announced that management will participate in the following investor conferences:
Event: H.C. Wainwright 4th Annual BioConnect Investor Conference
Date: May 19, 2026

Event: Jefferies Global Healthcare Conference
Date: June 2-4, 2026

Management will be participating in fireside chats and one-on-one investor meetings throughout the conferences. Investors interested in scheduling a meeting with the Rezolute management team should contact their H.C. Wainwright and Jefferies representatives.

About Rezolute, Inc.

Rezolute is a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI). The Company’s antibody therapy, ersodetug, is designed to treat all forms of HI and has been studied in clinical trials and used in real-world cases for the treatment of both congenital and tumor HI. For more information, visit www.rezolutebio.com.

IDK but it all looks good to me.

Summary of Key Additional Data Presented

Average daily percent time in hypoglycemia by CGM: clinically relevant and nominally statistically significant reductions of >50% (Full Analysis Set [FAS]) and ~60-80% (Per Protocol Set [PPS]), compared to placebo across multiple timepoints
Average weekly hypoglycemia events by CGM: clinically relevant and nominally statistically significant reductions of ~50-65% (FAS) and ~50-80% (PPS), compared to placebo across multiple timepoints
Average daily AUC 70 to 180 mg/dL (Exposure to Normoglycemia) by CGM: clinically relevant and nominally statistically significant increases of ~25-50% (FAS and PPS), compared to placebo across multiple timepoints
Average blood glucose (mg/dL) by CGM: clinically relevant and nominally statistically significant increases of ~10-15% (~10-15 mg/dL) in both the FAS and PPS, compared to placebo across multiple timepoints
-----------------------------
Kiwi

“We are pleased to highlight that deeper analyses of the sunRIZE outcomes and ongoing observations from the extension phase of the study consistently indicate evidence of target engagement, drug activity, and the potential for meaningful therapeutic benefit from ersodetug,” said Brian Roberts, M.D., Chief Medical Officer of Rezolute. “These results underscore our confidence in the potential of ersodetug to transform the HI treatment landscape and embolden our mission to achieve alignment with FDA on an acceptable path to approval in this indication, so that we can keep delivering ersodetug to patients and families living with congenital HI.”

The Rezolute (RZLT) oral presentation for its pediatric Phase 3 sunRIZE study is scheduled for Friday, May 1, 2026, from 8:15 a.m. – 9:15 a.m. PT.

The presentation, titled "Top-Line Results From a Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study (sunRIZE)," will be delivered by Diva D. De León-Crutchlow, MD, MSCE. It is part of the Pediatric Endocrine Society (PES) Annual Meeting, which takes place from April 30 to May 3, 2026, in San Francisco, CA.

Key Presentation Details:
Event: Pediatric Endocrine Society (PES) Annual Meeting
Session: Oral Abstracts #1
Topic: Phase 3 sunRIZE study results for ersodetug in congenital hyperinsulinism
Content: The session will include topline results along with pre-specified and post-hoc analyses that the company believes demonstrate target engagement and therapeutic benefit. . my emphasis


Kiwi