Rezolute Inc (RZLT) Quote

“Coming on the heels of our recent announcement of FDA clearance of a separate Phase 3 study in tumor-associated HI, we are in the unique and fortunate position to be advancing ersodetug in two Phase 3 rare disease programs in the U.S. and globally.”

Good day on 4 X vol

Kiwi

FDA Lifts Partial Clinical Holds on RZ358 for the Treatment of Congenital Hyperinsulinism and Authorizes U.S. Inclusion in Ongoing Phase 3 Study

RZLT under $5

Notice a poster on ST posted a story about Guggenheim on 8/27 initiated with a buy and an $11 target. I will just copy and paste since I can't access the link directly myself:

$RZLT one to watch today on the good Guggenheim note and 11 target--Rezolute initiated with a Buy at Guggenheim on potential in CHI 06:21 RZLT As previously reported, Guggenheim initiated coverage of Rezolute with a Buy rating and $11 price target. The firm's view is based on expectations for a resolution of the partial clinical hold imposed by the FDA on RZ358 for the treatment of congenital hyperinsulinism, or CHI, coming in the second half, stating that regulatory alignment on the sunRIZE Phase 3 trial could open up the trial to the commercially relevant population in the U.S. and re-rate the stock by 100%. Conversations with CHI experts and the firm's analysis of Phase 2 data drives the firm's "sanguine thesis on a positive readout" from the sunRIZE trial, which would position RZ358 as a $1B global product for infants and children diagnosed with CHI, the analyst tells investors.

Read more at:
thefly.com:443/landingPageN...

As filed with the Securities and Exchange Commission on August 5, 2024
Registration No. 333- ? SECURITIES AND EXCHANGE COMMISSION
UNITED STATES
Washington, D.C. 20549
FORM S-3 REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
REZOLUTE, INC.
(Exact Name of Registrant as Specified in Its Charter) ? (State or Other Jurisdiction of
Incorporation or Organization)?
27-3440894
(I.R.S. Employer Identification No.)
275 Shoreline Drive, Suite 500
Redwood City, CA 94065
(650) 206-4507
(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices) ?
Nevan Elam
Chief Executive Officer 275 Shoreline Drive, Suite 500 Redwood City, CA 94065
Telephone: (650) 206-4507
(Name, Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent for Service) ? Copies to:
Anthony W. Epps Dorsey & Whitney LLP 1400 Wewatta St #400 Denver, CO 80202 (303) 629-3400
Approximate date of commencement of proposed sale to the public: From time to time after the effective date of this registration statement. If the only securities being registered on this Form are being offered pursuant to dividend or interest reinvestment plans, please check the
following box. ?
If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, other than securities offered only in connection with dividend or interest reinvestment plans, please check the following box. ?
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ?
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ?
If this Form is a registration statement pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become effective upon filing with the Commission pursuant to Rule 462(e) under the Securities Act, check the following box. ?
If this Form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.D. filed to register additional securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, check the following box. ?
Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act:
Large accelerated filer ? Smaller reporting company ? Accelerated Filer ? Emerging growth company ? Non-accelerated filer ?
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ?
The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, or until this registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to Section 8(a), may determine.

TABLE OF CONTENTS
PROSPECTUS
SUBJECT TO COMPLETION, DATED AUGUST 5, 2024
Up to 4,500,000 Shares of Common Stock and
This prospectus relates to the resale of 4,500,000 shares of Common Stock, par value $0.001 per share (“Common Stock”) of Rezolute, Inc. by certain selling stockholders named herein (the “Selling Stockholders”) consisting of, (i) 1,500,000 shares of Common Stock, (ii) 610,404 shares of Common Stock and (iii) 2,389,596 shares of Common Stock issuable upon the exercise of pre-funded warrants (the “Warrants”) of the Company.
The Warrants were issued pursuant to the securities exchange agreement dated March 8, 2024 between the Company and certain Selling Stockholders. The Warrants have an exercise price of $0.001 per share. We may receive proceeds from the exercise of the Warrants if the Warrants are exercised on a cash basis. 610,404 shares of Common Stock covered by this prospectus were issued a certain Selling Stockholder upon the partial exercise of the Warrants.
Certain shares of the Common Stock was issued pursuant to the securities purchase agreement dated June 25, 2024 and July 5, 2024, respectively, between the Company and certain Selling Stockholders. We will not receive any proceeds from the sale of any shares of Common Stock by the Selling Stockholders pursuant to this prospectus.
Our registration of the securities covered by this prospectus does not mean that the Selling Stockholders will offer or sell any of the shares of Common Stock. The Selling Stockholders may sell the shares of Common Stock offered by this prospectus from time to time on terms to be determined at the time of sale through ordinary brokerage transactions or through any other means described in this prospectus under the caption “Plan of Distribution.” The shares of Common Stock may be sold at fixed prices, at market prices prevailing at the time of sale, at prices related to prevailing market prices or at negotiated prices.
Our Common Stock is listed on The Nasdaq Capital Market under the symbol “RZLT”. On July 26, 2024, the last reported sale price for our Common Stock was $4.68 per share. Each prospectus supplement to this prospectus will indicate if the securities offered thereby will be listed on any securities exchange.
Investing in our securities involves risks. You should carefully review the risks and uncertainties described under the heading “Risk Factors” beginning on page 11 of this prospectus, any applicable prospectus supplement or any related free writing prospectus, and in any documents incorporated by reference herein or therein before investing in our securities.
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION NOR HAS
THE SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES
COMMISSION PASSED UPON THE ACCURACY OR ADEQUACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
The date of this prospectus is , 2024
The information in this prospectus is not complete and may be changed. We may not sell these securities

REZOLUTE ANNOUNCES FDA CLEARANCE OF IND APPLICATION FOR PHASE 3 REGISTRATIONAL STUDY OF RZ358 FOR TREATMENT OF HYPOGLYCEMIA DUE TO TUMOR HYPERINSULINISM

August 05, 2024 7:30am EDT Download as PDF
Second rare disease program with RZ358 in Phase 3 development

Follows successful treatment of multiple patients with tumor hyperinsulinism
under the Company’s Expanded Access Program

REDWOOD CITY, Calif., Aug. 05, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage biopharmaceutical company committed to developing novel, transformative therapies for serious rare diseases, today announced that it received U.S. Food and Drug Administration (FDA) clearance for its Investigational New Drug (IND) application for RZ358 (ersodetug) to treat hypoglycemia in patients with tumor hyperinsulinism (HI). The Company is initiating start-up activities for the study which will be primarily conducted in the U.S. and patient enrollment is planned to commence in the first half of 2025. Ersodetug is also being studied in an ongoing global, pivotal, Phase 3 clinical trial in patients with congenital HI. Topline data from that study is expected in mid-2025.

“Hypoglycemia associated with tumor HI requires treatment to prevent serious adverse outcomes and to improve patients’ daily function and quality of life, including enabling them to receive tumor directed therapies,” said Brian Roberts, M.D., Chief Medical Officer at Rezolute. “We are encouraged by the substantial real-world benefit we’ve witnessed in tumor HI patients who have previously received ersodetug in our Expanded Access Program, coupled with the safety and efficacy demonstrated in clinical studies in patients with congenital HI, a similar condition. We believe that the clearance of our IND for this Phase 3 study reflects FDA’s recognition of the potential for ersodetug to address this serious unmet need and we are excited to be moving one step closer to a potential universal treatment for hypoglycemia caused by all forms of HI.”

The Phase 3 registrational study is a double-blind, randomized, placebo-controlled trial of 24 participants who have inadequately controlled hypoglycemia because of tumor HI. Eligible participants will be randomized in 1:1 fashion (12 per treatment arm) to receive ersodetug 9 mg/kg per week or matched placebo, as an add-on to standard of care. Up to 24 additional participants may be enrolled into an open-label arm, in participants whose hypoglycemia is being managed by IV glucose in a hospital setting. Following a 6-week pivotal treatment period, all participants may receive ersodetug in open-label extension. The primary endpoint is the change in Level 2 (moderate) and Level 3 (severe) hypoglycemia events by self-monitored blood glucose. Additional endpoints include overall hypoglycemia events, time in hypoglycemia by continuous glucose monitor, patient reported quality of life, hospitalizations, and change in glucose requirements (for open-label hospitalized participants).

Ersodetug is a fully human monoclonal antibody that binds to an allosteric site on the insulin receptor at target tissues such as liver, fat and muscle. Ersodetug counteracts excess insulin receptor activation caused by insulin and related hormones thereby correcting hypoglycemia. Ersodetug has the potential to be universally effective at treating hypoglycemia caused by any form of HI, including congenital or acquired forms.

About Tumor Hyperinsulinism (HI)

Tumor 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 excessive activation of the insulin receptor. Insulinomas are the most common type of ICT and may 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 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 preclinical studies have shown that ersodetug can similarly blunt IGF-2 and insulin-mediated insulin-receptor signaling.

About Rezolute, Inc.

Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by HI. The Company’s antibody therapy, ersodetug, is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital HI and tumor HI.

Saw this posted on ST:

“BTIG initiated coverage of Rezolute with a Buy rating and $13 price target. The analyst sees an "attractive disconnect" between the company's three shots on goal and where the shares currently trade. Efforts to address an FDA-implemented partial clinical hold on the ongoing Phase 3 study of RZ358 in congenital hyperinsulinism are underway, with new safety data and renewed determination, the analyst tells investors in a research note.

The firm thinks there is a good chance the FDA capitulates, which could allow pediatric enrollment in the US if the partial hold is lifted by September, and more importantly, signal that RZ358's eventual label could include pediatric patients. BTIG says RZ358 is the only therapeutic it is aware of that is being developed for all forms of hyperinsulinism.”

Re UNCY lot of vol so I think some of the original investors are selling into any PPS increase. A major catalyst will be passage of the Kidney Patient Act ...assuming it pass's later this yr. Co does need to get PPS over $1 for 10 days to avoid Naz delisting or reverse split .
TLPH ...really need an update on their trial ...have they enrolled first patient etc or not as risk of a capital raise increases with delay of the trial .
RZLT ...just got to go with what works .....we are operating in a semi fog anyway ...while never know all the positives and negatives affecting PPS performance .
Enjoy the weekend
Kiwi

Yep. A very good few days, albeit on not very heavy volume. I’m fine with that. Weakness in UNCY and TLPH being offset by strength in RZLT in my portfolio. That gives time for the other two stocks to wake up. Have a good weekend.

RMB. U have to be impressed with the action in this stock . Sold off on the capital raise and once that was digested ...PPS resumed its upwards climb
Kiwi

Yes interesting about the dose responses. Finding the optimal risk / benefit dose . Take Vascepa for instance ...I think above 6 gms a day bleeding risk really ramps up ...optimal lowest risk for max benefit is 4 gms .
So I have to wonder if its causing some harm at 400 mg dose that negates any benefit
Kiwi

Thanks Kiwi. I don't see anything real negative there. One thing that stands out is that the 400mg dosage did do anywhere as well in reducing CST as the 200 mg or even the 50 mg doses. They do offer an explanation for that, claiming that "the maximal response at 200 mg likely explained by drug saturation of plasma kallikrein activity". That is definitely a possibility, but I would think that is such a case, that the 400 mg (which by that theory would be in excess of what saturation could be achieved) one would think should do approximately as well as the 200 mg, yet it did measurably worse. So not sure about that.

http://archive.fast-edgar.com/20240628/ADB2K22C8Z22H2ZU22ZG2WZZMTBIR2Y2Z266

Apparently more details re their DME trial ...just wondering how it compares with their original data release
Guess its the Appendix ...page 16 onwards ?...Additional Data

Kiwi

Nope what was it?

Did you notice what was updated in the RZ 402 ..DME trial data today ...8k out ?
Kiwi

In addition, the Company has entered into an agreement for a concurrent private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”), of 1,500,000 shares of its common stock, at a sale price of $4.00 per share.

$6m Private placement at $4 a share ?

Kiwi

Looks like our little RZLT is finding a little spring in its step today.

OCUL's implants look to replace Eylea injections ...chk out latest KOL presentation . RZLT 's oral DME is likely to slow decline but not correct it ..if they go ahead and pursue it ....just my take . I have positions in both Co's .

Kiwi

Hopefully the CMO knows what he is doing. Also I am not that well versed in Ocul's thing but isn't it a drug eluting implant whereas we are still talking an oral from RZLT?

FL weather. I assume you might be referring to the rains and flooding in S. Fl. I was in east central Fl and apparently they have not received any of that. If you mean the weather there in general, in some sense we miss the warmer weather, but at least here in Oregon the weather can be called mild and at least not the brutal winters I was used to growing in Montreal. But there are a number of things I have found to be yearning for.

Better roads (of course that could be consequence of freeze-thaw in NW)
No state estimated tax payments to make
Lower cost of living
Lower property tax
Closer to more cruise options
Some friends and local haunts we used to frequent.

But I am not bitching just being honest.

RMB. good find thx
http://archive.fast-edgar.com/20240614/AP2ZV222E22259V2222D2ZO2PM7AZ222B462/

Ps. missing that weather in Florida ?

Kiwi

Well Kiwi, you asked for it. Here it is. Roberts Brian Kenneth, CMO, bought 7.6K shares TODAY:

https://insiderpeek.com/company/RZLT

Yes, I would like to see the CMO start buying shares. But if I were the CFO, I would have dropped by the CMO's office to get his spin before plopping down cash. Did he do the same?

Re your view . I hope you scare some of the posters into selling their shares cause I’ll be buying at these rock bottom prices .

I'm not intending to scare anyone buying at these levels . I do think a $60m raise was excessive since they had stated they had enough $ to complete their pivotal P3 trial.
The damage to the PPS has been done ...however Co now has roughly $60 m more in cash to pursue other indications ...which I hope won't be their RZ402 DME indication where I think OCUL has a far better candidate

Always a good sign when the CFO buys in the open market ...now let's see if the CMO ( chief medical officer who should know the science ) follows suit .

Kiwi

Re your view . I hope you scare some of the posters into selling their shares cause I’ll be buying at these rock bottom prices .

I'm not intending to scare anyone buying at these levels . I do think a $60m raise was excessive since they had stated they had enough $ to complete their pivotal P3 trial.
The damage to the PPS has been done ...however Co now has roughly $60 m more in cash to pursue other indications ...which I hope won't be their RZ402 DME indication where I think OCUL has a far better candidate

Always a good sign when the CFO buys in the open market ...now let's see if the CMO ( chief medical officer who should know the science ) follows suit .

Kiwi

Only 11.5 million share dilution, that’s awesome , more insiders buying and the company is protected from voting dilemmas . These guys are smart , they did it right and they’re looking to the future . Some of them bought stocks in their kids name , long term foresite - he knows where this is going . I hope you scare some of the posters into selling their shares cause I’ll be buying at these rock bottom prices . Even their partner with dissolving capsule company handok is on board , triple by Christmas IMO . You do want you want, I see what’s happening and I’m surprised and happy what the company did to secure its future . Watch the RZ403 or what over number it is , success with tumors ….. fogetaboutit

Well chief financial guy might not be interested in stuff like that but he should if he is sinking his money in this

Yep ...he facilitated it . Just wondering if he's been following OCUL's DME data which calls into question weither their DME program is worth pursuing
Kiwi

Thanks Kiwi. Well, he is obviously aware of the dilution.

Huge insider buy by CFO in this capital raise
http://archive.fast-edgar.com/20240614/AP2HR222E222H9V2222M2ZO2NA9TZ222B262/


1. The purchase price reported above is a weighted average price. These shares were purchased in multiple transactions at prices ranging from $3.85 to $4.25, inclusive

Kiwi

Massive dilution for a small CO IMHO especially since they said they have funds already to finish their P 3.
The tumor indication is small...they don't need $60 m for that .
Going after the DME indication would require the $60m and given the OCUL data just released ...not a good idea IMHO .
I'm pissed at the size of the raise ......sold some RZLT and added to my OCUL position

Kiwi

60 million:

https://finance.yahoo.com/news/rezolute-announces-pricing-public-offering-033000779.html

Yes, great results, but looking at a stock quote for OCUL they were up very little today and not up at all after hours so possibly not affecting RZLT as much as the dilution.

Of course where it might affect RZLT is that the OCUL results may be causing potential acquirers to become reticent with RZLT's DME drug.

Chk this out for DME ( RZ402 ). pretty speculator results from OCUL presented today

https://investors.ocutx.com/static-files/9a2366eb-bf3f-45d8-b6f4-8aad4928c536

Page 72 onwards ...reason why we may be down 20% AH

Kiwi

Actually how that came about was this morning I was thinking of doing some account position rearranging and increasing 2 positions - BCRX and RZLT - 2 where there have been insider purchases in my existing positions. Pulled the trigger to increase BCRX in the morning but held off on RZLT and just thought about it all day. Then when I saw the drop, jumped on it.

You were buying After Hrs ?
We have no idea of the size of the capital raise yet ...or even if they will proceed with one .

A huge positive would be if the stock goes up on them announcing the funding details .

PS. Missing Florida ? Huge rainfall there last couple of days

Kiwi

That's not what I was hoping you would say LOL. I have seen many times when pr of a dilution happens the stock drops but then over the next few days or weeks comes back. On that premise I picked up more shares after the drop. Guess we will have to see. Some of it is prepaid warrants.

No I don't think so . Co always maintained that had enough $ to see them thru their ongoing P3 trial .

I think this is about RZ 402 ...if they can't sell / partner it for terms they like ...are they going to develop it themselves ?

Kiwi

Do we assume that those insiders who purchased were well aware of this?

The public offering is subject to market and other conditions, and there can be no assurance as to whether or when the public offering may be completed or as to the actual size or terms of the public offering

We don't know the size of the offering so its hard to estimate degree of dilution .
It may be a negotiating tactic re the sale of RZ402 ...ie if we don't like the terms of the sale or partnership we can raise $ and do it ourselves

Kiwi

Stopped. Oh well. Would have thought they would have let it rip first. Dummies

Rezolute Announces Proposed Public Offering of Common Stock and Pre-Funded Warrants • GlobeNewswire Inc. • 06/13/2024 08:01:00 PM

Well down 16% after hrs on their plan to raise funds .
So either they haven't sold their eye indication RZ402 ? or are raising funds in case they don't and decide to develop themselves .
Or it's a negotiating tactic. They may have a low ball offer and are saying they can do it themselves if needed.
Kiwi

What is with the dump after hours? Haven't checked the volume.

Adding here. Basing and consolidating

That article says that it’s just eyelea sales , if RZLT replaces that therapy or even gains some market share . This will go , guess we gotta wait and see who they’re going to partner with to fill this out . Our FDA is holding us up from moving forward , once they get approval - who knows where it goes

Sure but as a competitor it wouldn’t all sales from Eyelea but only a portion.

RZ402 would compete with Regeneron's Eylea, originally approved in 2011 for treating wet age-related macular degeneration. Developed with Bayer, Eylea has been highly successful, with its original and recently approved higher-dose versions earning $5.89 billion in net sales in 2023.
Valuation of products competition-
If sales of RZ402 equal eyelea sales that’s 147.5/share valuation…. Crazy for a small cap
Handok Inc keeps buying shares the company as well as their officers.

Re RZ358 for cancer patients with hypoglycemia
The Company recently reported on its successful interaction with the U.S. Food and Drug Administration (FDA) in January 2024 regarding the potential to initiate a single registrational study in patients with hypoglycemia due to tumor HI.
The Company will continue to evaluate the feasibility of a development program in this indication, with the possibility of including both ICTH and NICTH patients. The inclusion of NICTH patients in a potential addressable market for RZ358 in tumor HI would more than double the population.

So only 1 trial needed . Probably fairly small ( max 100 patients ) ...currently 1500 each yr with ICTH and another 2,000 with NICTH ( I think ) ...in the US
High unmet need

Kiwi

No question that that could be a possibility and no dilution.

Well the RZ358 trial is funded thru data readout out mid 2025 . Did U notice he referred to Real World data from the expanded access for those in the P 2 RZ358 trial.
So maybe sell the DME asset and use those funds for the RZ 358 in cancer patients trial ...no shareholder dilution

Kiwi