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 |
|
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); |
| |
● |
a discussion of any additional
material federal income tax consequences applicable to an
investment in such class or series of preferred stock; |
| |
● |
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; |
| |
● |
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; |
| |
● |
any voting rights of such class or
series of preferred stock; and |
| |
● |
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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