As filed with the Securities and Exchange Commission
on October 28, 2022
Registration No.
333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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)
Nevada |
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27-3440894 |
(State or Other Jurisdiction of |
|
(I.R.S. Employer |
Incorporation or Organization) |
|
Identification No.) |
201
Redwood Shores Parkway, Suite 315
Redwood City, CA 94065
(650) 206-4507
(Address, Including
Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)
Nevan Charles Elam
Chief Executive Officer
201
Redwood Shores Parkway, Suite 315
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
Joshua B. Erekson
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. x
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 x |
Accelerated Filer ¨ |
Emerging growth company ¨ |
Non-accelerated filer x |
|
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.
The information in this prospectus is not complete and
may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is
effective. This prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any state
where such offer or sale is not permitted.
SUBJECT TO COMPLETION, DATED OCTOBER
28, 2022
PROSPECTUS
3,244,736 Shares of Common Stock
This prospectus relates to the resale of 3,244,736
shares of common stock, par value $0.001 per share (“Common Stock”) of Rezolute, Inc. (the “Company”) by
Handok, Inc. (“Handok”), Young-Jin Kim and SoHyun Kwon (the “Selling Stockholders”). The Common Stock was
issued to the Selling Stockholders pursuant to a private placement agreement dated May 1, 2022 between the Company and Jefferies
LLC, as agent, and securities purchase agreements dated May 4, 2022, which were amended and restated on July 22 and 26, 2022.
We will not receive any proceeds from the sale of any shares of Common Stock by the Selling Stockholders pursuant to this prospectus.
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 October 24, 2022, the last reported sale price for our Common Stock was $1.85 per
share.
Investing in our securities involves risks.
You should carefully review the risks and uncertainties described under the heading “Risk Factors” beginning on page 8
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 , 2022
ABOUT THIS PROSPECTUS
You should rely only on the information contained
in this prospectus or in any related free writing prospectus filed by us with the Securities and Exchange Commission (“SEC”).
We and the Selling Stockholders have not authorized anyone to provide you with any information or to make any representation not contained
in this prospectus. We and the Selling Stockholders do not take any responsibility for, and can provide no assurance as to the reliability
of, any information that others may provide to you. This prospectus is not an offer to sell or an offer to buy securities in any jurisdiction
where offers and sales are not permitted. The information in this prospectus is accurate only as of its date, regardless of the time of
delivery of this prospectus or any sale of securities. You should also read and consider the information in the documents to which we
have referred you under the caption “Where You Can Find More Information” in the prospectus.
Neither we nor the Selling Stockholders have done
anything that would permit a public offering of the securities or possession or distribution of this prospectus in any jurisdiction where
action for that purpose is required, other than in the United States. Persons outside the United States who come into possession of this
prospectus must inform themselves about, and observe any restrictions relating to, the offering of the securities and the distribution
of this prospectus outside of the United States.
This prospectus contains summaries of certain
provisions contained in some of the documents described herein, but reference is made to the actual documents for complete information.
All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein have
been filed, will be filed or will be incorporated by reference as exhibits to the registration statement of which this prospectus is a
part, and you may obtain copies of those documents as described below under the section titled “Where You Can Find Additional Information.”
We urge you to read carefully this prospectus,
as supplemented and amended, before deciding whether to invest in any of the Common Stock being offered.
Unless the context indicates otherwise, as used
in this prospectus, the terms “the Company,” “Rezolute,” “we,” “us,” “our,”
and “our business” refer to Rezolute, Inc. and its subsidiaries.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus, and the documents incorporated
by reference herein, contain certain “forward-looking statements” within the meaning of Section 27A of the Securities
Act of 1933 (the “Securities Act”), Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”) and the Private Securities Litigation Reform Act of 1995, and are based on management’s current expectations. These
forward-looking statements can be identified by the use of forward-looking terminology, including, but not limited to, “believes,”
“may,” “will,” “would,” “should,” “expect,” “anticipate,” “seek,”
“see,” “confidence,” “trends,” “intend,” “estimate,” “on track,”
“are positioned to,” “on course,” “opportunity,” “continue,” “project,” “guidance,”
“target,” “forecast,” “anticipated,” “plan,” “potential” and the negative
of these terms or comparable terms.
Various factors could adversely affect our operations,
business or financial results in the future and cause our actual results to differ materially from those contained in the forward-looking
statements, including those factors discussed under “Risk Factors” and “Management’s Discussion and Analysis of
Financial Condition and Results of Operations,” or otherwise discussed in our Annual Report on Form 10-K for the fiscal year
ended June 30, 2022 (the “2022 Form 10-K”), , and in our other filings made from time to time with the SEC after
the date of this prospectus.
For additional information about factors that
could cause actual results to differ materially from those described in the forward-looking statements, please see the documents that
we have filed with the SEC, including our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K
and other documents and reports filed from time to time with the SEC.
All subsequent forward-looking statements attributable
to us or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred
to in this section. We are not under any obligation to, and expressly disclaim any obligation to, update or alter any forward-looking
statements whether as a result of such changes, new information, subsequent events or otherwise.
THE COMPANY
We are a clinical-stage biopharmaceutical company
developing transformative therapies for metabolic diseases related to chronic glucose imbalance.
Our Pipeline
RZ358
Our lead clinical asset,
RZ358, is a potential treatment for congenital hyperinsulinism (“HI”), an ultra-rare pediatric genetic disorder characterized
by excessive production of insulin by the pancreas. If untreated, the elevated insulin levels in patients suffering with congenital HI
can induce extreme hypoglycemia (low blood sugar) events, increasing the risk of neurological and developmental complications, including
persistent feeding problems, learning disabilities, recurrent seizures, brain damage or even death. There are no FDA approved therapies
for all forms of congenital HI and the current standard of care treatments are suboptimal. The current treatments used by physicians include
glucagon, diazoxide, somatostatin analogues and pancreatectomy.
RZ358, is an intravenously
administered human monoclonal antibody that binds to a unique site (allosteric) on the insulin receptor in insulin target tissues, such
as in the liver, fat, and muscle. The antibody modifies insulin’s binding and signaling to maintain glucose levels in a normal range
which counteracts the effects of elevated insulin in the body. RZ358 shows dose dependent pharmacokinetics with a half- life greater than
two weeks which has the potential for semi-monthly dosing. Therefore, we believe that RZ358 is ideally suited as a potential therapy for
conditions characterized by excessive insulin levels, and it is being developed to treat hyperinsulinism and low blood sugar. As RZ358
acts downstream from the beta cells, it has the potential to be universally effective at treating congenital HI caused by any of the underlying
genetic defects.
A summary of the completed
clinical studies for RZ358 is as follows.
A Phase 1 pharmacokinetic
(“PK”) study of single intravenous doses of RZ358 at 0.1 to 9 mg/kg in healthy volunteers revealed dose-dependent pharmacokinetics
with a half-life of 15 days, supporting the biweekly dosing approach. In healthy volunteers, RZ358 prevented hypoglycemia induced by insulin
administration, without producing hyperglycemia. This effect showed a PK-pharmacodynamic (dose—response) correlation, with the hypoglycemia
blunting effects of RZ358 lasting for two weeks.
The clinical proof-of-concept
of RZ358 in congenital HI was evaluated in a Phase 2a study in a total of 14 patients with congenital HI. The study investigated the PK,
pharmacodynamics (“PD”), safety and preliminary efficacy of RZ358. RZ358 was well-tolerated in adult and pediatric patients
with congenital HI who received single intravenous doses in the Phase 2a study and the PK results from the Phase 2a studies were consistent
with those in healthy volunteers. There was a durable normalization of blood sugar in patients with hypoglycemia, with an approximate
50% improvement and near normalization of glucose control, which was sustained for more than two weeks after dosing. RZ358 did not increase
blood sugar levels in patients with normal blood sugar levels at baseline.
In calendar year 2022
we completed the RZ358-606 Phase 2b global clinical study for RZ358 (“RIZE”). The RIZE study was conducted in a repeat-dose
fashion to evaluate the safety, pharmacokinetics, dose-exposure response relationship and to assess the glycemic efficacy across a range
of continuous glucose monitoring (“CGM”) and blood glucose monitoring-based principle glycemic endpoints to inform Phase 3.
In the study, eligible patients received RZ358 in open-label fashion in one of 4, sequentially conducted dosing cohorts of up to 8 participants
per cohort. RZ358 was administered as a 30 minute intravenous infusion every other week for eight weeks. The first three cohorts were
fixed dosing levels of RZ358 and the fourth cohort was designed to explore whether there were any advantages of a fixed titration approach.
The RIZE study enrolled
23 patients and was primarily in a young pediatric population, average ~6.5 years of age, and in a diverse group of patients across gender
and genetic cause of congenital HIs. A key entry criterion was for patients to have continued hypoglycemia despite available therapies,
to be eligible for enrollment. We observed that patients enrolled on stable background therapies had clinically significant, and in many
cases, substantial residual hypoglycemia as well as some hyperglycemia (> 180 mg/dL) at baseline.
Results from the RIZE
study showed that target and expected RZ358 concentrations were achieved and dose-exposure dependent responses were also observed. RZ358
was generally safe and well-tolerated and there were no adverse drug reactions, adverse events leading to study discontinuations, or dose-limiting
toxicities. Importantly, RZ358 demonstrated a ~50% improvement in hypoglycemia across all doses and cohorts and a ~75% improvement in
hypoglycemia at the 6 mg/kg and 9 mg/kg cohorts. Time in range by CGM improved 8% across all doses, 16% at the top dose, and more significantly
(>25%) in patients without baseline hyperglycemia on SOC.
In calendar year 2022,
we reported positive topline results from the RIZE study which were presented at the Pediatric Endocrine Society Meeting on May 1,
2022. We believe that the positive results from the RIZE study will be Phase 3 enabling and accordingly we have initiated interactions
with regulatory authorities in the US and Europe. Our objective is to complete the regulatory dialogue prior to the end of the first quarter
of calendar year 2023, which would facilitate initiation of a Phase 3 study in the first half of calendar year 2023.
RZ402
Our second clinical asset,
RZ402, is an oral plasma kallikrein inhibitor (“PKI”) being developed as a potential therapy for the chronic treatment of
diabetic macular edema (“DME”). DME is a vascular complication of diabetes and a leading cause of blindness in the US and
elsewhere. Chronic exposure to high blood sugar levels can lead to inflammation, cell damage, and the breakdown of blood vessel walls.
Specifically, in DME, blood vessels behind the back of the eye become porous and permeable leading to the unwanted infiltration of fluid
into the macula. This fluid leakage creates distorted vision, and if left untreated, blindness.
Currently available treatments
for DME include anti-vascular growth factor (anti-VEGF) injections into the eye or laser surgery. RZ402 is designed to be a once daily
oral therapy for the treatment of DME and unlike the anti-VEGF therapies, RZ402 targets the Kallikrein-Kinin System to address inflammation
and vascular leakage. We believe that systemic exposure through oral delivery is critical to target the microvasculature behind the back
of the eye. Further, as an oral therapy, RZ402 has the potential to substantially change the therapeutic paradigm for patients suffering
with DME by providing a convenient, self-administered treatment option to encourage earlier initiation of therapy, adherence to prescribed
treatment guidelines, and improved overall outcomes.
In our modeling of RZ402
low nanomolar potency was exhibited in rodent DME models.
Results from our single
ascending dose (“SAD”) Phase 1a Study (“RZ402-101”) were reported in May 2021. RZ402-101 was a first-in-human
single-center, randomized, double-blind, placebo-controlled SAD study in healthy adult volunteers. The study objectives were to characterize
the safety profile and pharmacokinetics of RZ402 administered as single oral doses. The study enrolled 30 individuals in three planned
sequential dose- level cohorts of 25 mg, 100 mg, and 250 mg. Within each ten-subject dose cohort, volunteers were randomized 8:2 to receive
either RZ402 oral solution or matched placebo. After receiving single doses, participants remained in the clinic for seven days for serial
PK and safety assessments, before completing two outpatient follow-up visits at study days 14 and 30. Dose advancement proceeded following
blinded reviews of safety and PK data from the preceding cohort(s).
Single doses of RZ402
resulted in dose-dependent increases in systemic exposure. Plasma concentrations of RZ402 significantly exceeded the 3.5 ng/mL target
concentration that was pharmacologically active in animal models of DME for a 24-hour period after receipt of RZ402. Across the dose and
exposure range, there were no serious adverse events, adverse drug reactions, or discontinuations due to adverse events, and no imbalance
of adverse events between the treatment and placebo control groups. Similarly, regular laboratory, hemodynamic, cardiac, and ophthalmologic
safety examinations were unremarkable.
Following the success
of the SAD study, we undertook a follow-on multiple ascending dose (“MAD”) study (“RZ402-102”). Results from the
MAD Study were reported in February 2022. RZ402-102 was a single center, randomized, double-blind, placebo-controlled, in healthy
adult volunteers. The objectives of the study were to characterize the repeat dose safety profile (including maximum tolerated dose) and
PK of RZ402 administered as daily oral doses for two weeks. The study was conducted in 40 volunteers in sequential ascending dose cohorts
with 10 individuals per cohort. Within each cohort, participants were randomized in an 8:2 ratio to receive either RZ402 as an oral solution
or a placebo. Participants remained in the clinic throughout the two week dosing period for serial PK and safety assessments, before completing
an outpatient follow-up visit at study day 28. Blood biomarkers of target engagement (kallikrein activity) were explored as a systemic
surrogate for DME, using a precedent from studies of kallikrein inhibitors in a systemic vascular leakage syndrome (hereditary angioedema).
Dose advancement proceeded in staggered fashion every three weeks as appropriate, following blinded reviews of data from the preceding
cohort(s).
The MAD study showed
dose-dependent increases in systemic exposures, with repeat-dosing to steady-state resulting in the highest concentrations of RZ402 explored
to date, exceeding 200 ng/mL and 50 ng/mL at peak and 24-hour trough, respectively. Following the precedent established in hereditary
angioedema, steady-state plasma kallikrein activity in human plasma was measured on Day 14 as a biomarker of RZ402 target engagement.
Daily dosing with RZ402 inhibited plasma kallikrein in a dose and concentration-dependent manner (r=0.74; p < 0.001). Given that the
in-vivo EC90 for RZ402 in animal models of DME is ~6 ng/mL, the results at both peak and 24-hour trough substantially exceeded target
concentrations based on a combination of in-vitro and in-vivo profiling. RZ402 was generally safe and well-tolerated, including at higher
doses than previously tested in the SAD study. There were no serious adverse events, adverse drug reactions or identified risks.
We are advancing developmental
activities toward a Phase 2a proof-of-concept study, which we plan to initiate during the fourth quarter of calendar year 2022.
Competition
We face competition from
pharmaceutical and biotechnology companies, academic institutions, governmental agencies, and private research organizations in recruiting
and retaining highly qualified scientific personnel and consultants and in the development and acquisition of technologies.
There are other companies
developing therapies for HI that are potential competitors to RZ358, including Crinetics Pharmaceuticals, Eiger Biopharmaceuticals, Hanmi
Pharmaceuticals, and Zealand Pharma.
There are also companies
developing therapies for DME that are potential competitors to our PKI including Curacle, KalVista, Ocuphire Pharma, Oxurion and Verseon.
Government Regulation
Regulation by governmental
authorities in the US and other countries is a significant factor in the development, manufacture and marketing of pharmaceutical products.
All of our potential products will require regulatory approval by governmental agencies prior to commercialization. In particular, pharmaceutical
therapies are subject to rigorous preclinical testing and clinical trials and other pre-market approval requirements by FDA and regulatory
authorities in foreign countries. Various federal, state and foreign statutes and regulations also govern or influence the manufacturing,
safety, labeling, storage, record keeping and marketing of such products.
We are also subject to
various federal, state, and local laws, regulations and recommendations relating to safe working conditions; laboratory and manufacturing
practices; the experimental use of animals; and the use and disposal of hazardous or potentially hazardous substances, including radioactive
compounds and infectious disease agents, used in connection with our research, development and manufacturing.
Employees
As of September 30, 2022, we had 44 full
time employees, of which 34 employees were engaged in research and development, manufacturing, clinical operations and quality activities
and 10 employees in administrative functions. Of the 44 employees, all were located in the United States. We have a number of employees
who hold Ph.D. degrees and other advanced degrees. None of our employees are covered by a collective bargaining agreement, and we have
experienced no work stoppages nor are we aware of any employment circumstances that are likely to disrupt work at any of our facilities.
As part of our measures to attract and retain personnel, we provide a number of benefits to our full-time employees, including health
insurance, life insurance, retirement plans, paid holiday and vacation time. We believe that we maintain good relations with our employees.
Corporate Information
We were incorporated in Delaware in 2010 and we
re-incorporated in Nevada in June 2021. We maintain an executive office located at 201 Redwood
Shores Parkway, Suite 315, Redwood City, CA 94065 and our phone number is (650) 206-4507. Our website address is www.rezolutebio.com.
The information contained in, or that can be accessed through, our website is not part of, and is not incorporated into this document.
RISK FACTORS
Investing in our securities involves a risk of
loss. Before investing in our securities, you should carefully consider the risk factors described under “Risk Factors” on
the 2022 Form 10-K, in any applicable prospectus supplement and in our future filings with the SEC, including our Annual reports
on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, together with all of the other information
included in this prospectus and any prospectus supplement and the other information incorporated by reference herein and therein. These
risks are not the only ones facing us. Additional risks not currently known to us or that we currently deem immaterial also may impair
or harm our business and financial results. Statements in or portions of a future document incorporated by reference in this prospectus,
including, without limitation, those relating to risk factors, may update and supersede statements in and portions of this prospectus
or such incorporated documents. Please also refer to the section entitled “Special Note Regarding Forward-Looking Statements.”
USE OF PROCEEDS
All of the shares of Common Stock offered by the
Selling Stockholders pursuant to this prospectus will be sold by the Selling Stockholders for their own account. We will not receive any
of the proceeds from these sales.
DESCRIPTION OF TRANSACTIONS WITH THE SELLING
STOCKHOLDERS
On May 1, 2022,
we entered into a placement agency agreement (the “Placement Agency Agreement”) with Jefferies LLC, as placement agent. On
May 4, 2022, we entered into securities purchase agreements (the “SPAs”) with certain purchasers (the “Selling
Stockholders”) relating to a private placement (the “Private Placement”) of equity securities. Since we did not have
a sufficient number of authorized shares of Common Stock available, we agreed to issue to the Selling Stockholders 3,326,157 Class C
Warrants (the “Class C Warrants”) to purchase shares of our Common Stock at a purchase price of $3.799 per Class C
Warrant, with the requirement that we would subsequently seek to obtain stockholder approval for an increase in our authorized shares
of Common Stock. On June 16, 2022, our stockholders approved an increase in our authorized shares of Common Stock from 40.0 million
shares to 100.0 million shares. Accordingly, the parties decided to amend and restate the SPAs to enable the issuance of shares of Common
Stock rather than Class C Warrants.
On July 22, 2022 and July 26, 2022,
we entered into amended and restated SPAs with the Selling Stockholders pursuant to which they agreed to purchase 3,244,736 shares of
Common Stock at a purchase price of $3.80 per share. In July 2022, we received net proceeds from this Private Placement of approximately
$11.6 million, after deducting the placement agent fees and estimated offering expenses payable by us.
DESCRIPTION OF CAPITAL STOCK
General
This prospectus describes the general terms of
our capital stock. For a more detailed description of our capital stock, you should read the applicable provisions of the Nevada Revised
Statutes, or NRS, and our charter and bylaws.
Common Stock
Our amended and restated articles of incorporation
(the “Articles of Incorporation”) provide authority for us to issue up to 100,000,000 shares of Common Stock, par value $0.001
per share. As of October 21, 2022, there were 36,827,567 shares of our Common Stock outstanding. Under Nevada law, stockholders
generally are not personally liable for our debts or obligations solely as a result of their status as stockholders. Our outstanding
shares of Common Stock, including the shares offered by this prospectus are, fully paid and nonassessable.
Holders of our Common Stock are entitled to one
vote per share on all matters submitted to our stockholders for a vote. There are no cumulative voting rights in the election of directors.
Our shares of Common Stock are entitled to receive such dividends as may be declared and paid by our Board of Directors out of funds legally
available therefor and to share ratably in the net assets, if any, of Rezolute upon liquidation. Our stockholders have no preemptive rights
to purchase any shares of our capital stock. Our Articles of Incorporation provides that the Eighth Judicial District Court of Clark County,
Nevada shall be the sole and exclusive forum for (i) any derivative action or proceeding brought on our behalf, (ii) any action
asserting a claim for breach of a fiduciary duty owed by any of our directors, officers, employees or agents to us or our stockholders,
(iii) any action asserting a claim arising pursuant to any provision of the NRS Chapters 78 or 92A, our Articles of incorporation
or our bylaws or (iv) any action asserting a claim governed by the internal affairs doctrine. Notwithstanding this exclusive forum
provision, the exclusive forum provision shall not preclude or contract the scope of exclusive federal or concurrent jurisdiction for
actions brought under the Exchange Act or the Securities Act or the respective rules and regulations promulgated thereunder.
Preferred Stock
Our Articles of Incorporation provides authority
for us to issue up to 400,000 shares of preferred stock, par value $0.001 per share. Our Board of Directors is authorized, without further
stockholder action, to establish various series of preferred stock from time to time and to determine the rights, preferences and privileges
of any unissued series including, among other matters, any dividend rights, dividend rates, conversion rights, voting rights, terms of
redemption, liquidation preferences, sinking fund terms, the number of shares constituting any such series, and the description thereof
and to issue any such shares. As of October 21, 2022, there are no issued and outstanding shares of preferred stock and our Board
of Directors has not designated any series of preferred stock for future issuance.
The rights of the holders of our Common Stock
will be subject to, and may be adversely affected by, the rights of holders of any preferred stock that may be issued in the future. Such
rights may include voting and conversion rights which could adversely affect the holders of the Common Stock. Satisfaction of any dividend
or liquidation preferences of outstanding preferred stock would reduce the amount of funds available, if any, for the payment of dividends
or liquidation amounts on Common Stock.
A prospectus supplement, relating to any offered
class or series of preferred stock, will specify the following terms of such class or series, as applicable:
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the designation of such class or series of our $0.001 par value preferred stock; |
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the number of shares of such class or series of preferred stock offered, the liquidation preference per share and the offering price of such class or series of preferred stock; |
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the dividend rate(s), period(s), and/or payment date(s) or method(s) of calculation thereof applicable to such class or series of preferred stock; |
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whether dividends on such class or series of preferred stock are cumulative or not and, if cumulative, the date from which dividends on such class or series of preferred stock shall accumulate; |
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the provision for a sinking fund, if any, for such class or series of preferred stock; |
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the provision for redemption, if applicable, of such class or series of preferred stock; |
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any listing of such class or series of preferred stock on any securities exchange; |
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the preemptive rights, if any, of such class or series of preferred stock; |
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the terms and conditions, if applicable, upon which shares such class or series of preferred stock will be convertible into shares of our Common Stock or shares of any other class or series of our stock or other securities, including the conversion price (or manner of calculation thereof); |
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a discussion of any additional material federal income tax consequences applicable to an investment in such class or series of preferred stock; |
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the relative ranking and preferences of such class or series of preferred stock as to dividend rights and rights upon liquidation, dissolution or winding up of our affairs; |
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any limitations on issuance of any class or series of stock ranking senior to or on parity with such class or series of preferred stock as to dividend rights and rights upon liquidation, dissolution or winding up of our affairs; |
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any voting rights of such class or series of preferred stock; and |
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any other specific terms, preferences, rights, limitations or restrictions of such class or series of preferred stock. |
Transfer Agent and Registrar
The transfer agent of our Common Stock is Issuer
Direct Corporation. Their address is One Glenwood Avenue, Suite 1001, Raleigh, NC 27306.
SELLING STOCKHOLDERS
We are registering the shares of Common Stock
in order to permit the Selling Stockholders to offer the shares of Common Stock for resale from time to time. Mr. Kim serves as
one of our directors and was previously our chairman until May 2022. Mr. Kim serves as chairman of Handok and Ms. Kwon
serves as Senior Advisor of Handok.
On September 15,
2020, we entered into an exclusive license agreement with Handok (the “Handok License”) for the territory of the Republic
of Korea. The Handok License relates to pharmaceutical products in final dosage form containing the pharmaceutical compounds developed
or to be developed by us, including those related to RZ358 and RZ402. The Handok License is in effect for a period of 20 years after
the first commercial sale of each product and requires (i) milestone payments of $0.5 million upon approval of a New Drug Application
(“NDA”) for each product in the territory, and (ii) we agreed to sell products ordered by Handok at a transfer price
equal to 70% of the net selling price of the products. To date, no milestone payments have been earned by us.
The table below lists the Selling Stockholders
and other information regarding the beneficial ownership of the shares of Common Stock by each of the Selling Stockholders. The second
column lists the number of shares of Common Stock beneficially owned by each Selling Stockholder, based on its ownership of the shares
of Common Stock as of September 30, 2022.
The third column lists the shares of Common Stock
being offered pursuant to this prospectus by Selling Stockholders. The fourth column assumes the sale of all of the shares offered by
the Selling Stockholders pursuant to this prospectus. The Selling Stockholders may sell all, some or none of their shares in this offering.
See "Plan of Distribution."
Name of Selling
Stockholder |
|
Number of
Shares of
Common
Stock
Owned
Prior to
Offering |
|
|
Maximum Number of
Shares of Common
Stock to be Sold
Pursuant to this
Prospectus |
|
|
Number of
Shares of
Common
Stock
Owned
After
Offering
(2) |
|
|
Percentage of Shares
Owned After the Offering
(1)(2) |
|
Handok, Inc. (3) |
|
|
5,942,617 |
|
|
|
3,157,895 |
|
|
|
2,784,722 |
|
|
|
7.6 |
% |
Young-Jin Kim (4) |
|
|
78,497 |
|
|
|
78,947 |
|
|
|
- |
|
|
|
|
* |
SoHyun Kwon |
|
|
7,894 |
|
|
|
7,894 |
|
|
|
- |
|
|
|
|
* |
Total |
|
|
6,029,008 |
|
|
|
3,244,736 |
|
|
|
2,784,722 |
|
|
|
7.6 |
% |
* Represents ownership of less than 1%.
|
1. |
Applicable percentage ownership is based on 36,827,567 shares of our Common Stock outstanding as of October 24, 2022. |
|
|
|
|
2. |
Assumes the sale of all shares of Common Stock offered in this prospectus. |
|
|
|
|
3. |
Voting and investment authority over shares of Common Stock owned by Handok, Inc. is held by the board of directors of Handok, Inc. The address of the stockholder is 132, Teheran-Ro, Gangman Gu, Seoul, Republic of Korea. |
|
|
|
|
4. |
Excludes 2,784,722 shares of our Common Stock that are owned by Handok, Inc. As Chairman and CEO of Handok, Inc., Mr. Kim has shared investment and voting authority over these shares. These shares have been excluded to clarify the number of shares being sold that are held directly by Mr. Kim. The address of Mr. Kim is 132, Teheran-Ro, Gangman Gu, Seoul, Republic of Korea. |
PLAN OF DISTRIBUTION
Each Selling Stockholder of the shares of Common
Stock and any of their pledgees, assignees and successors-in-interest may, from time to time, sell any or all of their securities covered
hereby on the principal Trading Market or any other stock exchange, market or trading facility on which the securities are traded or in
private transactions. These sales may be at fixed or negotiated prices. A Selling Stockholder may use any one or more of the following
methods when selling securities:
|
● |
ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
|
|
|
|
● |
block trades in which the broker-dealer will attempt to sell the securities as agent but may position and resell a portion of the block as principal to facilitate the transaction; |
|
|
|
|
● |
purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
|
|
|
|
● |
an exchange distribution in accordance with the rules of the applicable exchange; |
|
|
|
|
● |
privately negotiated transactions; |
|
|
|
|
● |
settlement of short sales; |
|
|
|
|
● |
in transactions through broker-dealers that agree with the Selling Stockholders to sell a specified number of such securities at a stipulated price per security; |
|
|
|
|
● |
through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise; |
|
|
|
|
● |
a combination of any such methods of sale; or |
|
|
|
|
● |
any other method permitted pursuant to applicable law. |
The Selling Stockholders may also sell securities
under Rule 144 or any other exemption from registration under the Securities Act, if available, rather than under this prospectus.
Broker-dealers engaged by the Selling Stockholders
may arrange for other brokers-dealers to participate in sales. Broker-dealers may receive commissions or discounts from the Selling Stockholders
(or, if any broker-dealer acts as agent for the purchaser of our Common Stock, from the purchaser) in amounts to be negotiated, but, except
as set forth in a supplement to this prospectus, in the case of an agency transaction not in excess of a customary brokerage commission
in compliance with Financial Industry Regulatory Authority, or FINRA, Rule 5110; and in the case of a principal transaction a markup
or markdown in compliance with FINRA Rule 2121.
In connection with the sale of the securities
or interests therein, the Selling Stockholders may enter into hedging transactions with broker-dealers or other financial institutions,
which may in turn engage in short sales of the securities in the course of hedging the positions they assume. The Selling Stockholders
may also sell securities short and deliver these securities to close out their short positions, or loan or pledge the securities to broker-dealers
that in turn may sell these securities. The Selling Stockholders may also enter into option or other transactions with broker-dealers
or other financial institutions or create one or more derivative securities which require the delivery to such broker-dealer or other
financial institution of securities offered by this prospectus, which securities such broker-dealer or other financial institution may
resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).
The Selling Stockholders and any broker-dealers
or agents that are involved in selling the securities may be deemed to be “underwriters” within the meaning of the Securities
Act in connection with such sales. In such event, any commissions received by such broker-dealers or agents and any profit on the resale
of the securities purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act. Each Selling Stockholder
has informed us that it does not have any written or oral agreement or understanding, directly or indirectly, with any person to distribute
the securities.
We are required to pay certain fees and expenses
incurred by us incident to the registration of the securities. We have agreed to indemnify the Selling Stockholders against certain losses,
claims, damages and liabilities, including liabilities under the Securities Act.
We agreed to keep this prospectus effective until
the date that all shares of Common Stock covered by this prospectus (i) have been sold, thereunder or pursuant to Rule 144,
or (ii) may be sold without volume or manner-of-sale restrictions pursuant to Rule 144 and without the requirement us to be
in compliance with the current public information requirement under Rule 144, as determined by counsel for us pursuant to a written
opinion letter to such effect, addressed and acceptable to the Transfer Agent and the affected holders We shall telephonically request
effectiveness of a Registration Statement as of 5:00 p.m. (New York City time) on a Trading Day. The resale securities will be sold
only through registered or licensed brokers or dealers if required under applicable state securities laws. In addition, in certain states,
the resale securities covered hereby may not be sold unless they have been registered or qualified for sale in the applicable state or
an exemption from the registration or qualification requirement is available and is complied with.
Under applicable rules and regulations under
the Exchange Act, any person engaged in the distribution of the resale securities may not simultaneously engage in market making activities
with respect to the Common Stock for the applicable restricted period, as defined in Regulation M, prior to the commencement of the distribution.
In addition, the Selling Stockholders will be subject to applicable provisions of the Exchange Act and the rules and regulations
thereunder, including Regulation M, which may limit the timing of purchases and sales of the Common Stock by the Selling Stockholders
or any other person. We will make copies of this prospectus available to the Selling Stockholders and have informed them of the need to
deliver a copy of this prospectus to each purchaser at or prior to the time of the sale (including by compliance with Rule 172 under
the Securities Act).
At the time a particular offer of securities is
made, if required, a prospectus supplement will be distributed that will set forth the number of securities being offered and the terms
of the offering, including the name of any underwriter, dealer or agent, the purchase price paid by any underwriter, any discount, commission
and other item constituting compensation, any discount, commission or concession allowed or reallowed or paid to any dealer, and the proposed
selling price to the public.
LEGAL MATTERS
Certain legal matters in connection with the offered
securities will be passed upon for us by Dorsey & Whitney LLP, Denver, Colorado. Any underwriters or agents will be represented
by their own legal counsel, who will be identified in the applicable prospectus supplement.
EXPERTS
Plante & Moran, PLLC, an independent
registered public accounting firm, has audited our consolidated financial statements for the years ended June 30, 2022 and 2021 included
in our 2022 Form 10-K, which are incorporated by reference in this prospectus and elsewhere in the registration statement. Our consolidated
financial statements are incorporated by reference in reliance on Plante & Moran, PLLC’s report, given their authority
as experts in accounting and auditing.
WHERE YOU CAN FIND ADDITIONAL INFORMATION
We file annual, quarterly and current reports,
proxy statements and other information with the SEC. The SEC maintains an Internet website at http://www.sec.gov that contains
reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC. Our reports
on Forms 10-K, 10-Q and 8-K, and amendments to those reports, are also available for download, free of charge, as soon as reasonably practicable
after these reports are filed with, or furnished to, the SEC, at our website at www.rezolutebio.com. Information contained on or
accessible through our website is not a part of this prospectus supplement, and the inclusion of our website address in this prospectus
supplement is an inactive textual reference only.
As permitted by SEC rules, this prospectus does
not contain all of the information we have included in the registration statement and the accompanying exhibits and schedules we file
with the SEC. You may refer to the registration statement, exhibits and schedules for more information about us and the securities. The
registration statement, exhibits and schedules are available through the SEC’s website or at its public reference room.
INCORPORATION BY REFERENCE
In this prospectus, we “incorporate by reference”
certain information that we file with the SEC, which means that we can disclose important information to you by referring you to that
information. The information we incorporate by reference is an important part of this prospectus, and later information that we file with
the SEC will automatically update and supersede this information. The following documents or information have been filed by us with the
SEC and are incorporated by reference into this prospectus (other than, in each case, documents or information that are or are deemed
to have been furnished rather than filed in accordance with SEC rules, including disclosure furnished under Items 2.02 or 7.01 of Form 8-K):
All documents and reports that we file with the
SEC (other than, in each case, documents or information that are or are deemed to have been furnished rather than filed in accordance
with SEC rules) under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act of 1934 from the date of this prospectus until the completion
of the offering under this prospectus shall be deemed to be incorporated by reference into this prospectus. Unless specifically stated
to the contrary, none of the information we disclose under Items 2.02 or 7.01 of any Current Report on Form 8-K that we may from
time to time furnish to the SEC will be incorporated by reference into, or otherwise included in, this prospectus. The information contained
on or accessible through any websites, including our website, is not and shall not be deemed to be incorporated by reference into this
prospectus.
You may request a copy of these filings, other
than an exhibit to these filings unless we have specifically included or incorporated that exhibit by reference into the filing, at no
cost, by writing or telephoning us at the following address:
Rezolute, Inc.
201
Redwood Shores Parkway, Suite 315
Redwood City, CA 94065
(650) 206-4507
Any statement contained in a document incorporated
or deemed to be incorporated by reference into this prospectus will be deemed to be modified or superseded for purposes of this prospectus
to the extent that a statement contained in this prospectus, any prospectus supplement, or any other subsequently filed document that
is deemed to be incorporated by reference into this prospectus modifies or supersedes the statement. Any statement so modified or superseded
will not be deemed, except as so modified or superseded, to constitute a part of this prospectus.
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The following table sets forth expenses payable
by us in connection with the issuance and distribution of the securities being registered pursuant to this registration statement.
SEC registration fee |
|
$ |
691 |
|
Legal fees and expenses |
|
|
10,000 |
|
Accounting fees and expenses |
|
|
7,000 |
|
Miscellaneous |
|
|
3,000 |
|
Total |
|
$ |
20,691 |
|
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS
Our officers and directors are indemnified against
certain liabilities under Nevada law, our Articles of Incorporation, and our amended and restated bylaws,. Articles of Incorporation require
us to indemnify our directors and officers to the fullest extent permitted by the laws of the State of Nevada in effect from time to time.
Pursuant to Articles of Incorporation and our
amended and restated bylaws, each person who was or is made a party or is threatened to be made a party to or is otherwise involved in
any action, suit or proceeding, by reason of the fact that such person is or was one of our directors or officers of or is or was serving
at our request as a director, officer, or trustee of another enterprise, (hereinafter an “Indemnitee”), whether the basis
of such proceeding is alleged action in an official capacity as a director, officer or trustee or in any other capacity while serving
as a director, officer or trustee, shall be indemnified and held harmless by us to the fullest extent permitted by the Nevada Revised
Statutes, as the same exists or may hereafter be amended, against all expense, liability and loss (including attorneys’ fees, judgments,
fines, ERISA excise taxes or penalties and amounts paid in settlement) reasonably incurred or suffered by such Indemnitee in connection
therewith; provided, however, that, except as otherwise provided in our amended and restated articles of incorporation, we shall not be
required to indemnify or advance expenses to any such Indemnitee in connection with a proceeding initiated by such Indemnitee unless such
proceeding was authorized by our Board of Directors. However, Nevada Revised Statutes 78.138 currently provides that, except as otherwise
provided in the Nevada Revised Statutes, a director or officer shall not be individually liable to us or our stockholders or creditors
for any damages as a result of any act or failure to act in his or her capacity as a director or officer unless it is proven that (i) the
presumption established by Nevada Revised Statutes 78.138(3) has been rebutted, (ii) the director’s or officer’s
acts or omissions constituted a breach of his or her fiduciary duties as a director or officer, and (iii) such breach involved intentional
misconduct, fraud or a knowing violation of the law.
In addition, an Indemnitee shall also have the
right to be paid by us for the expenses (including attorney’s fees) incurred in defending any such proceeding in advance of its
final disposition; provided, however, that, if Nevada Revised Statutes requires, an advancement of expenses incurred by an Indemnitee
in his capacity as a director or officer shall be made only upon delivery to us of an undertaking, by or on behalf of such Indemnitee,
to repay all amounts so advanced if it shall ultimately be determined by final judicial decision from which there is no further right
to appeal that such Indemnitee is not entitled to be indemnified for such expenses.
No director shall be personally liable to us or
our stockholders for any monetary damages for breaches of fiduciary duty as a director; provided that this provision shall not eliminate
or limit the liability of a director, to the extent that such liability is imposed by applicable law, (i) for any breach of the director’s
duty of loyalty to us or our stockholders; (ii) for acts or omissions not in good faith or which involve intentional misconduct or
a knowing violation of law; (iii) under Section 174 or successor provisions of the Nevada Revised Statutes; or (iv) for
any transaction from which the director derived a personal benefit. No amendment to or repeal of this provision shall apply to or have
any effect on the liability or alleged liability of any director for or with respect to any acts or omissions of such director occurring
prior to such amendment or repeal. If the Nevada Revised Statutes is amended to authorize corporate action further eliminating or limiting
the personal liability of directors, then the liability of our directors shall be eliminated or limited to the fullest extent permitted
by Nevada Revised Statues, as so amended.
Section 78.7502 of the Nevada Revised Statutes
permits a corporation to indemnify, pursuant to that statutory provision, a present or former director, officer, employee or agent of
the corporation, or of another entity or enterprise for which such person is or was serving in such capacity at the request of the corporation,
who was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding, except an
action by or in the right of the corporation, against expenses, including attorneys’ fees, judgments, fines and amounts paid in
settlement actually and reasonably incurred in connection therewith, arising by reason of such person’s service in such capacity
if such person (i) is not liable pursuant to Section 78.138 of the Nevada Revised Statutes, or (ii) acted in good faith
and in a manner which he or she reasonably believed to be in or not opposed to the best interests of the corporation and, with respect
to a criminal action or proceeding, had no reasonable cause to believe his or her conduct was unlawful. In the case of actions brought
by or in the right of the corporation, however, no indemnification pursuant to Section 78.7502 of the Nevada Revised Statutes may
be made for any claim, issue or matter as to which such person has been adjudged by a court of competent jurisdiction, after exhaustion
of all appeals therefrom, to be liable to the corporation or for amounts paid in settlement to the corporation, unless and only to the
extent that the court in which the action or suit was brought or other court of competent jurisdiction determines upon application that
in view of all the circumstances of the case, such person is fairly and reasonably entitled to indemnity for such expenses as the court
deems proper.
Any discretionary indemnification pursuant to
Section 78.7502 of the Nevada Revised Statutes, unless ordered by a court or advanced to a director or officer by the corporation
in accordance with the Nevada Revised Statutes, may be made by a corporation only as authorized in each specific case upon a determination
that indemnification of the director, officer, employee or agent is proper in the circumstances. Such determination must be made (1) by
the stockholders, (2) by the board of directors by majority vote of a quorum consisting of directors who were not parties to the
action, suit or proceeding, (3) if a majority vote of a quorum consisting of directors who were not parties to the action, suit or
proceeding so orders, by independent legal counsel in a written opinion, or (4) if a quorum consisting of directors who were not
parties to the action, suit or proceeding cannot be obtained, by independent legal counsel in a written opinion.
Section 78.751 of the Nevada Revised Statutes
further provides that indemnification pursuant to Section 78.7502 of the Nevada Revised Statutes does not exclude any other rights
to which a person seeking indemnification or advancement of expenses may be entitled under our amended and restated articles of incorporation,
as amended, or any bylaw, agreement, vote of stockholders or disinterested directors or otherwise, for either an action in the person’s
official capacity or an action in another capacity while holding office, except that indemnification, unless ordered by a court pursuant
to Section 78.7502 of the Nevada Revised Statutes or for the advancement of expenses, may not be made to or on behalf of any director
or officer finally adjudged by a court of competent jurisdiction, after exhaustion of any appeals, to be liable for intentional misconduct,
fraud or a knowing violation of law, and such misconduct, fraud or violation was material to the cause of action.
As permitted by the Nevada Revised Statutes, we
have entered into indemnity agreements with each of our directors and executive officers. These agreements, among other things, require
us to indemnify each director and officer to the fullest extent permitted by law and advance expenses to each indemnitee in connection
with any proceeding in which indemnification is available.
We have an insurance policy covering our officers
and directors with respect to certain liabilities, including liabilities arising under the Securities Act, or otherwise.
See also the undertakings set out in response
to Item 17 herein.
ITEM 16. EXHIBITS
EXHIBITS
ITEM 17. UNDERTAKINGS
(a) |
The undersigned registrant hereby undertakes: |
|
(1) |
To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement: |
|
(i) |
To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933; |
|
(ii) |
To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and |
|
(iii) |
To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement; |
provided, however, that paragraphs
(a)(1)(i), (a)(1)(ii) and (a)(1)(iii) of this section do not apply if the information required to be included in a post-effective
amendment by those paragraphs is contained in reports filed with or furnished to the Commission by the registrant pursuant to Section 13
or Section 15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in the registration statement, or
is contained in a form of prospectus filed pursuant to Rule 424(b) that is part of the registration statement.
|
(2) |
That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
|
(3) |
To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering. |
|
(4) |
That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser: |
|
(i) |
Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and |
|
(ii) |
Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii) or (x) for the purpose of providing the information required by Section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date. |
|
(5) |
That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution of the securities of the undersigned registrant pursuant to the registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser: |
|
(i) |
Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424; |
|
(ii) |
Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant; |
|
(iii) |
The portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and |
|
(iv) |
Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser. |
|
(b) |
That, for purposes of determining any liability under the Securities Act of 1933, each filing of the registrant’s annual report pursuant to Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
|
(c) |
Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act of 1933 and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act of 1933 and will be governed by the final adjudication of such issue. |
SIGNATURES
Pursuant to the requirements of the Securities
Act of 1933, the registrant has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly
authorized in the City of Redwood City, State of California, on October 28, 2022.
|
|
REZOLUTE, INC. |
|
|
|
By: |
/s/ Nevan Charles Elam |
|
|
Nevan Charles Elam
Chief Executive Officer
(Principal Executive and Financial Officer) |
Each person whose signature appears below constitutes and appoints
Nevan Elam his attorney-in-fact and agent, with the full power of substitution and resubstitution and full power to act without the other,
for them in any and all capacities, to sign any and all amendments, including post-effective amendments, and any registration statement
relating to the same offering as this registration that is to be effective upon filing pursuant to Rule 462(b) under the Securities
Act of 1933, as amended, to this registration statement, and to file the same, with exhibits thereto and other documents in connection
therewith, with the Securities and Exchange Commission, hereby ratifying and confirming all that said attorneys-in-fact, or their substitute
or substitutes, may do or cause to be done by virtue hereof. Pursuant to the requirements of the Securities Act of 1933, as amended, this
registration statement has been signed by the following persons in the capacities and on the dates indicated.
Signature |
|
Title |
|
Date |
|
|
|
|
|
/s/ Nevan Charles Elam |
|
Chief Executive Officer and Acting Chairman of the Board |
|
October 28, 2022 |
Nevan Charles Elam |
|
(Principal Executive and Financial Officer) |
|
|
|
|
|
|
|
/s/ Young-Jin Kim |
|
Director |
|
October 28, 2022 |
Young-Jin Kim |
|
|
|
|
|
|
/s/ Nerissa Kreher |
|
Director |
|
October 28, 2022 |
Nerissa Kreher |
|
|
|
|
|
|
|
|
|
/s/ Gil Labrucherie |
|
Director |
|
October 28, 2022 |
Gil Labrucherie |
|
|
|
|
|
|
|
|
|
/s/ Philippe Fauchet |
|
Director |
|
October 28, 2022 |
Philippe Fauchet |
|
|
|
|
|
|
|
|
|
/s/ Wladimir Hogenhuis |
|
Director |
|
October 28, 2022 |
Wladimir Hogenhuis |
|
|
|
|
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