Rezolute Inc (RZLT) 銘柄情報

Biogen $BIIB CEO confirms he’s shopping for biotechs: ‘We will be doing deals’

JPM conference
Kiwi

Well there is the patent cliff and BP is looking for new assets ...RZLT unlikely launch their drug themselves


Biogen proposes to buy remaining stake in Sage in $442 million deal

Kiwi

Well as much as I like RZLT I'm wondering why that dont appear to be attending / presenting at the JPM healthcare conference next week .
The conference is only about a 40 min drive from their HQ ....and they need to raise some cash selling their DME drug .
If they dont sell their DME drug theres a risk they'll raise capital before the pivotal trial top line data release ...due I think second half 2025 .
They are also starting to enroll for their tumor trial this Qt ...so cash burn

Kiwi

Yes I think its very likely the Ceo will eventually sell the entire Co .
I dont see them launching their drug alone .
Kiwi

Thanks Kiwi.  I know that the CEO has mentioned selling off or partnering RZ402 (DME) drug, but do you think his intentions would be to sell the entire company?

Also. RZ358 has been granted a priority medicines (PRIME) designation by the European Medicines Agency (EMA) and an Innovation Passport designation by the U.K. Innovative Licensing and Access Pathway (ILAP) Steering Group for the treatment of cHI.
RZ358 also received orphan drug and pediatric rare disease designation in the U.S., and orphan drug designation in the European Union for the treatment of insulinoma, the primary cause of islet cell tumor hypoglycemia (ICTH).
Under the Company’s Expanded Access Program, multiple individuals with ICTH have been successfully treated with RZ358 resulting in substantial hypoglycemia improvement, discontinuation of intravenous dextrose, and hospital discharge.

Ceo in his earlier M&A days worked on the sale of NEXT for Steve Jobs ...before moving into Biotech

Kiwi

Thx Jan 7 (Reuters) - Rezolute Inc ( RZLT ):

* REZOLUTE INC ( RZLT ): TOPLINE SUNRIZE DATA EXPECTED SECOND HALF OF THIS YEAR Source text: Further company coverage:

Kiwi

Rezolute (Nasdaq: RZLT), a late-stage biopharmaceutical company, announced that the FDA granted Breakthrough Therapy Designation to ersodetug (RZ358) for treating hypoglycemia due to congenital hyperinsulinism (HI). This designation, aimed at expediting the development of treatments for serious conditions, is based on Phase 2b (RIZE) study results showing significant hypoglycemia improvement of 75% or better without clinically significant hyperglycemia.

CEO Nevan Charles Elam highlighted 2024 as a transformative year with key clinical milestones. The company plans to finish recruitment for the sunRIZE study and announce topline results in the second half of the year. Additionally, Phase 3 study for tumor HI is set to commence.

Key highlights from 2024:

FDA lifted partial clinical holds on the Phase 3 sunRIZE study, enabling U.S. site inclusion.
Received Innovation Passport Designation from the U.K. for congenital HI treatment.
Preclinical validation for treating hypoglycemia due to non-islet cell tumors (NICTs).
FDA clearance for a Phase 3 study for tumor HI, with topline results expected in 2026.
Received Orphan Drug Designation for tumor HI.
Raised $73 million in June to support clinical programs and operational goals into Q2 2026.

Good little (a little longer than little) article outlining prospects for RZLT. Seems promising:

https://biotenic.substack.com/p/rzlt-long-ph3-sunrize-data-2h-2025?r=5xh7t

CFO buying again ...3rd purchase this mth

http://archive.fast-edgar.com/20241218/AP2ZRQ22E222HZM2222B2ZO2NADDZ222BO62/

12/18. ....10,000 shares , 12/12 ....9,000 shares ,......12/9. 10,549 shares

Kiwi

CFO open market purchases ...ie these were not RSU, options vesting etc ...he had to put up the cash for these buys ....might have been thru an LLC

12/9 10,549 shares at $5.04 = $53,166
12/12 9,000 shares at $4.60 = $ 41,400
-----------------
$ 94,566

So he is not buying in anticipation of some immediate good news as that could be seen as insider trading . He probably anticipates a good read out from their RZ358 trial with top line results mid 2025 ( that trial is fully enrolled ) . He probably can't make purchases ( or sales ) close to the read out .

Kiwi

Looks like instead of working he was sitting watching the stock price all day and then jumped in to buy when it dropped to 4.60. I'll stick with his lead. 

CFO keeps buying http://archive.fast-edgar.com/20241212/AP2HRG22E222HZU2222B2ZO2NA7DZ222B262/

I'll assume he's also good at accounting :--)

Second purchase this week isn't it ?

Kiwi

This was the CFO's last buy back in May

Tuesday, May 28, 2024 2:55:20 PM
Post# of 429
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

So it's up almost 50% since that purchase ....and 357 % year to date .
All my biotechs were selling off today ...so called " long dated assets " ...vulnerable to any increase in interest rates .

Top line data for RZ358 is not due till mid 2025 and theres be no update on any interest / possible sale of their DME oral drug RZ 402 which they said they would not develop themselves .

May add more comment later but in brief if the CFO is buying I am also ( RZLT ) and if the CFO leaves the Co for other opportunities , I sell what ever I'm still holding ( AMRN ) .

ARDX / UNCY ... Congress seems unable to act in the best interests of dialysis patients . The dialysis bundle as currently administered clearly discriminates against this , mostly people of color , population . Huge frustration for my wife and others that prescribe to these patients , as they are unable to get the best in class drugs for many of them

Kiwi

Hope the CFO is better at accounting than he appears to be at stock picking.  Actually, most bios getting hit a bit and the volume here is quite low so no biggie.  At least they don't have to depend on Kidney Act passing. 

CFO buying. always a positive sign
https://ir.stockpr.com/rezolutebio/sec-filings-email/content/0000912282-24-000863/form4.html

Kiwi

RZLT, near a 52 week high

Chart looks a reversal today - possibly closing lower than the open - but the volume is anemic so it might not mean anything. Hopefully, it regains strength before the close.

Anyone have a link to the shareholders meeting , I thought they sent me one but I can't find it . TIA 

FDA grants orphan status for RZ358.  

Pretty good writeup about it a month ago.  I know I was drawn to this stock after listening to the CEO sometime this past summer.  Impressed me as quite knowledgeable.  He alluded to them selling the 402 PKI drug so hopefully he is still finding some buyers receptive.  

The only real news I've seen is BVF exiting their position . Hope theres's no problem with their P 3 trial ...or lack of interest in their DME asset
Kiwi

Kind of a disappointing price action today but at least not a very high volume.  

RMB. I reduced my position by 25% today . Been in it since Feb so just lighten'd up ..
I think some funds reduced their holding per todays Sec filings
May add back in later .
Since I post when I buy ...I should also post when I sell

Kiwi

I'm not flipping . Sold half after it doubled and am just holding the rest .
Prefer to " invest " rather then trying to trade
HC Wainwright & Co. Reiterates Buy on Rezolute, Maintains $14 Price Target ...FIWI ...Wedbush same I think
Good luck
Kiwi

If we can close above 6.24 we're gone , sell some in the 7.25 area and wait for pull back . If we partner with eyelea for the RZ402 then it explodes to 20+ , my take anyways . I've been tracking this since 1.09 and it's been trending up since then , holding some flipping a lot . 

Thx for the update
Kiwi

-.28 loss for first quarter 25', better than -.32 they predicted . Everything still on track testing proceeding as scheduled 

Here was the CFO buying big back in February https://content-archive.fast-edgar.com/20240220/AP27R222E222H2S2222A2CO2NABDZ222B262/

Always a good idea to follow CFO buys / sells
JMO
Kiwi

Wedbush Initiates Rezolute at Outperform With $12 Price Target

Kiwi

RZLT 2024 year ended July , should see results by Christmas and news by Feb IMO= great volume 

Thanks Kiwi. I really like RZLT's CEO when I heard him talk. I think I will hang in there as well.

EYPT just came out with some good interim P 2 data on DME ....which may lessen interest in RZLT 's DME drug .
Just an FYI . I still like RZLT .
UNCY and VERA both up about 15% as I type
Kiwi

Yep. and on increased vol. ...stealth accumulation . Co will be adding US patients to its P3 trial early 2025 with results in second half of 2025 .
Kiwi

Slow and steady rise 

Dows down almost 600 pts but RZLT is up about 3 % on above average volume. Co has a mkt cap of only $300m and I think plenty of cash ....My speculation is that they will entertain offers for their DME drug which had great P 2 results . They are unlikely to advance this into P 3 trials themselves as they are focused on Congential HI ( hypoglycemia ) and ramping up US enrollment for that P 3 trial in early 25 ....final results in second half 2025

Kiwi

Up over 7% on triple avg volume but I see no news.

https://www.encodelp.com/coverage-universe/rzlt/

Kiwi

https://ir.stockpr.com/rezolutebio/sec-filings-email/content/0000912282-24-000673/form4.html
100k share insider buy

Saw this post on ST:

:$RZLT Opportunity
BTIG raises target price to $15 from $13
Guggenheim raises target price to $15 from $11"

“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