Item 9A. Controls and Procedures
Item 9A. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
We maintain “disclosure controls and procedures” as such term is defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act, that are designed to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms, and such information is accumulated and communicated to our management, including the individual that serves as both our chief executive officer and principal financial officer, to allow timely decisions regarding required disclosure.
As of the end of the period covered by this Annual Report, we carried out an evaluation, under the supervision and with the participation of senior management, including our chief executive officer (our principal executive and financial officer), of the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Exchange Act Rules 13a-15(b) and 15d-15(b). Based upon this evaluation, our chief executive officer concluded that our disclosure controls and procedures as of the end of the period covered by this Annual Report were not effective at the reasonable assurance level.
Management’s Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Our internal control over financial reporting has been designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with US GAAP.
Our internal control over financial reporting includes policies and procedures that pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect transactions and dispositions of our assets; provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with US GAAP, and that receipts and expenditures are being made only in accordance with authorization of our management and directors; and provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on our financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Our management assessed the effectiveness of our internal control over financial reporting as of June 30, 2022. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in 2013 Internal Control—Integrated Framework. Based on that assessment under those criteria, our management has determined that, as of June 30, 2022, our internal control over financial reporting was not effective due to a material weakness in the system of internal control that related to an inadequate segregation of duties. A material weakness is a deficiency, or combination of deficiencies, that creates a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected in a timely manner.
The material weakness identified by management is that due to our limited number of employees, we have not adequately segregated certain duties to prevent employees from overriding the internal control system. During our fiscal years ended June 30, 2022 and 2021, we have hired additional personnel which enabled us to better segregate many functions, and we recently implemented more robust accounting software that is expected to result in stronger controls. While we believe these are important steps in our ongoing remediation efforts, we concluded that this material weakness had not been
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remediated as of June 30, 2022. We cannot provide assurance that the actions taken to date or other measures will eventually result in the elimination of the material weakness related to the segregation of duties.
Changes in Internal Control over Financial Reporting
Prior to the fiscal year ended June 30, 2022, we had identified a material weakness whereby we had ineffective treasury controls over authorized share limits such that an inadequate number of shares is authorized to ensure that all securities and contracts to issue common shares may be exercised, converted or exchanged. During the fiscal year ended June 30, 2022, we successfully remediated this material weakness. There were no other changes in our internal control over financial reporting during the fiscal quarter ended June 30, 2022, that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. There were no other changes in our internal control over financial reporting during the fiscal quarter ended June 30, 2022, that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Attestation Report of Independent Registered Public Accounting Firm
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to include an attestation report of our registered public accounting firm regarding internal control over financial reporting.
Item 9B. Other Information.
Not applicable.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
None.
PART III
Item 10. Directors, Executive Officers and Corporate Governance.
The following table sets forth certain information as of June 30, 2022 with respect to our directors, executive officers and key employees. The term for each director expires at our next annual meeting or until his or her successor is appointed.
Name
Age
Position
Date Appointed
Nevan Charles Elam
54
Acting Chairman of the Board of Directors and Chief Executive Officer
January 31, 2013
Young-Jin Kim
65
Director
February 10, 2019
Gil Labrucherie
51
Director
November 20, 2019
Philippe Fauchet
64
Director
September 10, 2020
Nerissa Kreher, M.D.
49
Director
March 2, 2021
Wladimir Hogenhuis, M.D.
57
Director
March 2, 2021
Brian Roberts, M.D.
47
Chief Medical Officer
October 23, 2020
Set forth below is biographical information with respect to each of the aforementioned individuals.
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Nevan Charles Elam. Mr. Elam has served as our Chief Executive Officer since January 2013 and also currently serves as our principal financial officer. Mr. Elam is also serving as our Acting Chairman of the Board since May 2022. Prior to Mr. Elam’s service with Rezolute, he has served various leadership roles throughout his career including as Chief Executive Officer of a European medical device company, co- founder and Chief Financial Officer of a software company, as well as a Senior Vice President at Nektar Therapeutics. Earlier in his career, Mr. Elam was a corporate partner in the law firm of Wilson Sonsini Goodrich & Rosati. He serves as Director of Savara, Inc. Mr. Elam received his Juris Doctorate from Harvard Law School and a Bachelor of Arts from Howard University. We believe that Mr. Elam’s experience advising pharmaceutical companies of their unique legal and regulatory obligations qualifies him to serve on the Board.
Young-Jin Kim. Mr. Kim serves as a member of our Board and served as Chairman of the Board until May 2022. Mr. Kim is Chairman and Chief Executive Officer Handok Inc. (“Handok”), one of the leading pharmaceutical companies in the Republic of Korea. Since May 2022, Mr. Kim has also served as chairman of the Board of Directors of Genexine Inc. Mr. Kim joined Handok in 1984 and spent two years between 1984 and 1986 working at Hoechst AG in Frankfurt, Germany. Between 1991 and 2005, he served as CEO of Roussel Korea, Hoechst Marion Roussel Korea and Aventis Pharma Korea and also appointed as the Country Manager of Hoechst AG and Aventis in Korea between 1996 and 2005. In 1996, he was appointed as CEO of Handok. Mr. Kim has been serving as President of Handok Jeseok Foundation since 2014. He has also been serving as President of KDG (Korean-German Society) since 2010. Mr. Kim received an MBA at the Kelley School of Business at Indiana University in 1984 and received the award of Distinguished Alumni Fellows from Indiana University. Mr. Kim completed Advanced Management Program at the Harvard Business School in 1996. We believe Mr. Kim’s experience working with pharmaceutical companies qualifies him to serve on the Board.
Gil Labrucherie. Mr. Labrucherie serves as a member of our Board. Mr. Labrucherie brings more than 20 years of senior leadership experience in finance, legal and corporate development to the Board. He currently serves as Chief Financial Officer at ACELYRIN, Inc, a late-stage clinical biopharma company with an initial focus in immunology. Previously he served as Chief Financial Officer of Nektar Therapeutics, a publicly traded development stage biopharmaceutical company, from 2016 to June 2022, and also has held the position of Chief Operating Officer since 2019. Prior to serving as Chief Operating Officer and Chief Financial Officer of Nektar, he was Senior Vice President, General Counsel and Secretary of Nektar from 2007 to 2016. Earlier in his career, Mr. Labrucherie was an executive at different organizations where he was responsible for global corporate alliance and mergers and acquisitions. Mr. Labrucherie began his career as an associate in the corporate practice of the law firm of Wilson Sonsini Goodrich & Rosati. Mr. Labrucherie received his J.D. from University of California Boalt Hall School of Law, where he was a member of the California Law Review and Order of the Coif, and received his B.A. with highest honors from the University of California, Davis. Mr. Labrucherie is a member of the State Bar of California and is a Certified Management Accountant. We believe Mr. Labrucherie’s experience as the Chief Operating Officer and Chief Financial Officer of a public biotechnology company and his management background as an executive in different organizations qualify him to serve on the Board.
Philippe Fauchet. Mr. Fauchet serves as a member of our Board. Mr. Fauchet has spent more than 35 years in the pharmaceutical industry, most recently as the Chairman of GlaxoSmithKline K.K. from April 2017 to February 2019. Mr. Fauchet joined GlaxoSmithKline K.K. as President & Representative Director in 2010. Previously, he served as Senior Vice President, Corporate Business Development Head of Sanofi-Aventis Group and a member of the Management Committee. Mr. Fauchet is an independent director on the board of JCR Pharmaceutical (4502.T) as well as a director of unlisted Japanese biotech companies. Mr. Fauchet is a graduate of Hautes Etudes Commerciales in France and received a Bachelor of Law at Paris X University. He is an Honorary Officer of the Order of the British Empire (O.B.E.). We believe Mr. Fauchet’s experience in the pharmaceutical industry qualifies him to serve on the Board.
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Nerissa Kreher, M.D., M.S., MBA. Dr. Kreher serves as a member of our Board. She has served as Chief Medical Officer of Entrada Therapeutics, Inc. since December 2020. From February 2019 to October 2020, Dr. Kreher served as Chief Medical Officer at Tiburio Therapeutics, Inc., where she was responsible for clinical development, clinical operations, regulatory and patient advocacy. From October 2016 to December 2018, Dr. Kreher served as Chief Medical Officer at Avrobio, Inc., where she oversaw clinical and regulatory development strategy for the Company’s rare disease, ex vivo lentiviral gene therapy pipeline programs. From March 2015 to July 2016, Dr. Kreher served as Global Head (VP) of Clinical and Medical Affairs of Zafgen, Inc., where she was a strategic leader of a cross-functional team charged with creation of global development strategy for beloranib. Dr. Kreher is a board-certified pediatric endocrinologist and holds multiple degrees including her B.S. in biology from University of North Carolina at Chapel Hill, M.D. from East Carolina University, an M.S. in clinical research from Indiana University-Purdue University Indianapolis, and an MBA from Northeastern University Graduate School of Business Administration. We believe Dr. Kreher’s experience in the pharmaceutical industry and her service as an executive and Chief Medical Officer of a range of private and publicly held companies qualify her to serve on the Board.
Wladimir Hogenhuis, M.D., MBA. Dr. Hogenhuis serves as a member of our Board. He is currently the Chief Executive Officer of Chimera Bioengineering, where he also serves on the Board of Directors. He previously served as Chief Operating Officer of Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) with responsibilities for global commercial operations, business development, and manufacturing of medicines for patients with rare diseases. Before that, Dr. Hogenhuis served as Senior Vice President and Global Franchise Head, Specialty Pharmaceuticals of GlaxoSmithKline Plc. (LSE/NYSE: GSK), from December 2012 to September 2018. From 1994 to 2012, he served in leadership positions at Merck in the US, China, and Europe, where he was responsible for managing the P&L of specialty and cardiovascular care medicines. He also served as a National Institutes of Health Fellow in Medical Decision Making at New England Medical Centre in Boston, and as a Naval Lieutenant Surgeon in the Royal Dutch Navy. Dr. Hogenhuis currently serves on the board of GATT Technologies B.V., a private company in the Netherlands developing novel surgical hemostats and sealants. He previously served as a member of the Board of Directors of Vision 2020, a global initiative for the elimination of avoidable blindness, a joint program of the World Health Organization and the International Agency for the Prevention of Blindness. Dr. Hogenhuis received his M.D. Cum Laude from the University of Leiden in the Netherlands and received an M.B.A. from the Wharton School of Business at The University of Pennsylvania, Philadelphia. We believe Dr. Hogenhuis’s experience in the pharmaceutical industry and his service on the board of directors of a range of private companies qualify him to serve on the Board.
Brian Roberts, M.D . Dr. Roberts has served as our Chief Medical Officer since June 2022. Prior to serving as Chief Medical Officer, he served as our Senior Vice President and Head of Clinical Development, from October 2020 to June 2022, and as our Vice President of Clinical Development from April 2017 to October 2020. Prior to joining us, Dr. Roberts served as Senior Director at Fibrogen, Inc. from 2012 to April 2017, where he directed clinical development and helped successfully launch and execute the global Phase 3 program and pharmaceutical partnership for a novel oral therapy for anemia associated with kidney disease, concluding the largest Phase 3 program ever conducted in CKD anemia, and resulting in global NDA filings. From 2007 until 2012 Dr. Roberts held clinical development positions of increasing responsibility at Metabolex, Inc. Dr. Roberts received his B.S. in biochemistry from the University of California, San Diego and his M.D. Magna Cum Laude from Georgetown University.
Family Relationships
There are no family relationships between any of our directors and executive officers.
Legal Proceedings
During the past ten years, none of our directors, executive officers, promoters, control persons, or nominees has been:
● the subject of any bankruptcy petition filed by or against any business of which such person was a general partner or executive officer either at the time of the bankruptcy or within two years prior to that time;
● convicted in a criminal proceeding or is subject to a pending criminal proceeding (excluding traffic violations and other minor offenses);
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● subject to any order, judgment, or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction or any Federal or State authority, permanently or temporarily enjoining, barring, suspending or otherwise limiting his involvement in any type of business, securities or banking activities;
● found by a court of competent jurisdiction (in a civil action), the Commission or the Commodity Futures Trading Commission to have violated a federal or state securities or commodities law;
● the subject of, or a party to, any Federal or State judicial or administrative order, judgment, decree, or finding, not subsequently reversed, suspended or vacated, relating to an alleged violation of (a) any Federal or State securities or commodities law or regulation; (b) any law or regulation respecting financial institutions or insurance companies including, but not limited to, a temporary or permanent injunction, order of disgorgement or restitution, civil money penalty or temporary or permanent cease-and-desist order, or removal or prohibition order; or (c) any law or regulation prohibiting mail or wire fraud or fraud in connection with any business entity; or
● the subject of, or a party to, any sanction or order, not subsequently reversed, suspended or vacated, of any self-regulatory organization (as defined in Section 3(a)(26) of the Exchange Act (15 U.S.C. 78c(a)(26))), any registered entity (as defined in Section 1(a)(29) of the Commodity Exchange Act (7 U.S.C. 1(a)(29))), or any equivalent exchange, association, entity or organization that has disciplinary authority over its members or persons associated with a member.
Code of Ethics
We have adopted a Code of Business Conduct and Ethics that is applicable to all of our employees, officers and directors. The code is available on our web site, www.rezolutebio.com , under the “Investors” tab. We intend to disclose future amendments to, or waivers from, certain provisions of our code of ethics, if any, on the above website within four business days following the date of such amendment or waiver.
Committees of the Board of Directors
The standing committees of our Board of Directors are the Audit Committee, Compensation Committee and Nominating and Corporate Governance Committee.
Audit Committee
The Audit Committee operates under an Audit Committee Charter that is available on our website, www.rezolutebio.com. The functions performed by our Audit Committee consist of selection of the firm of independent registered public accountants to be retained by us subject to stockholder ratification, periodic meetings with our independent registered public accountants to review our accounting policies and internal controls, review the scope and adequacy of the independent registered public accountants’ examination of our annual financial statements, and pre-approval of services rendered by our independent registered public accountants and pre-approval of all related-party transactions.
Mr. Labrucherie serves as the chairman of the audit committee and along with Mr. Fauchet and Dr. Hogenhuis are “independent directors” as defined in Rule 5605(a)(2) of the Nasdaq Listing Rules. In addition, the Board determined that Mr. Gil Labrucherie and Dr. Hogenhuis are qualified as “audit committee financial experts” as such term is used in the rules and regulations of the SEC. Accordingly, the functions of our Audit Committee are now being performed by independent directors that serve as members of our Audit Committee. Our Audit Committee held four meetings during the fiscal year ended June 30, 2022.
For the fiscal year ended June 30, 2022, Mr. Labrucherie, Mr. Fauchet and Dr. Hogenhuis received additional compensation for their service as a member of our Audit Committee as discussed under the caption Non-Employee Director Compensation below.
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Compensation Committee
The Compensation Committee operates under a Compensation Committee Charter that is available on our website, www.rezolutebio.com. Mr. Labrucherie, Mr. Fauchet, Dr. Hogenhuis and Dr. Kreher each serve as members of the Compensation Committee and are each considered an “independent director” as defined in Rule 5605(a)(2) of the Nasdaq Listing Rules. The Compensation Committee is responsible for establishing and administering our compensation arrangements for all executive officers.
The functions performed by our Compensation Committee provided for meetings no less frequently than annually (and more frequently as circumstances dictate) to discuss and determine executive officer and director compensation. The Compensation Committee has not retained the services of any compensation consultants. However, from time to time it utilizes compensation data from companies that the Compensation Committee deems to be competitive with us in connection with its annual review of executive compensation. The Compensation Committee has the power to form and delegate authority to subcommittees when appropriate, provided that such subcommittees are composed entirely of directors who would qualify for membership on the Compensation Committee pursuant to applicable Nasdaq Listing Rules. Our Compensation Committee held seven meetings during the fiscal year ended June 30, 2022.
For the fiscal year ended June 30, 2022, Mr. Labrucherie, Mr. Fauchet, Dr. Hogenhuis and Dr. Kreher received additional compensation for their service as a member of our Compensation Committee as discussed under the caption Non-Employee Director Compensation below.
Nominating and Governance Committee
The Nominating and Governance Committee operates under a Nominating and Governance Committee Charter that is available on our website at www.rezolutebio.com. The Nominating and Governance Committee was established in accordance with the rules and regulations of the SEC Given the overlap between the nominating and corporate governance function with the compensation function, the Company’s independent board members historically have served as the members of the Nominating and Governance Committee through June 30, 2022. Although both the Compensation Committee and the Nominating and Governance Committee had remained separate committees, board membership on both committees counted as one for board compensation purposes. Effective July 1, 2022, the Nominating and Governance Committee was eligible for separate compensation, and members will receive additional compensation for their service as a member of this committee.
Stockholders who wish to recommend nominees for consideration by the Nominating and Governance Committee must submit their nominations in writing to our Acting Chairman of the Board of Directors. Submissions must include sufficient biographical information concerning the recommended individual for the Nominating and Governance Committee to consider, including age, five-year employment history with employer names and a description of the employer’s business, whether such individual can read and comprehend basic financial statements, and other board memberships (if any) held by the recommended individual. The submission must be accompanied by a written consent of the individual to stand for election if nominated by the Nominating and Governance Committee and to serve if elected by stockholders. The Nominating and Governance Committee may consider such stockholder recommendations when it evaluates and recommends nominees to the Board of Directors for submission to the stockholders at each annual meeting.
The Nominating and Governance Committee do not have a specific diversity policy, but consider diversity of race, ethnicity, gender, age, cultural background and professional experiences in evaluating candidates for Board membership. Diversity is important because a variety of points of view contribute to a more effective decision-making process. Our Nominating and Governance Committee held one meeting during the fiscal year ended June 30, 2022.
Scientific Advisory Board
We have established a Scientific Advisory Board (“SAB”). The members of the SAB are Adrian Vella, M.D., Quan Dong Nguyen, M.D., MSc, Robert B. Bhisitkul, M.D., PH.D. and Jerrold Olefsky, M.D .
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Section 16(a) Beneficial Ownership Reporting Compliance
Section 16(a) of the Exchange Act requires our executive officers and directors, and persons who own more than 10% of our common stock, to file reports regarding ownership of, and transactions in, our securities with the SEC and to provide us with copies of those filings. Based solely on our review of the copies of such forms received by us, or written representations from certain reporting persons, we believe that during the fiscal year ended June 30, 2022, all filing requirements applicable to its executive officers, directors and ten percent beneficial owners were complied with except that (i) Form 4 was filed late by Wladimir Hogenhuis for shares of common stock purchased in the October 15, 2021 public offering, (ii) Form 4 was filed late by Young-Jin Kim for stock options granted in June 2022, and (iii) Handok failed to file a Form 4 for shares of common stock purchased during the 2021 RDO.
Item 11. Executive Compensation.
Summary Compensation Table
Our named executive officers consist of all individuals that served as our principal executive officer during the fiscal year ended June 30, 2022, and the next most highly compensated executive officer who was serving as an executive officer as of June 30, 2022. The following table sets forth information concerning the compensation of Mr. Elam and Dr. Roberts, (our “Named Executive Officers”) during the fiscal years ended June 30, 2022 and 2021:
Stock
Fiscal
Option
All Other
Name and Position
Year
Salary
Bonus
Awards
Compensation
Total
Nevan Charles Elam
2022
$
515,000
(1)
$
378,750
(3)
$
6,862,960
(5)
$
24,590
(6)
$
7,781,300
Chief Executive Officer
2021
$
495,682
(1)
$
490,980
(4)
$
3,888,117
(5)
$
21,953
(6)
$
4,896,732
Brian Roberts, M.D.
2022
$
401,500
(2)
$
121,875
(3)
$
1,847,720
(5)
$
52,053
(7)
$
2,423,148
Chief Medical Officer
2021
$
371,364
(2)
$
171,300
(4)
$
775,203
(5)
$
36,074
(8)
$
1,353,941
(1) Pursuant to the amended and restated employment agreement discussed below, on July 31, 2019, Mr. Elam’s base salary increased to $490,000 with an effective date of June 1, 2019, and subsequently increased to $505,000 on February 15, 2021. On May 25, 2022, Mr. Elam’s base salary was increased to $525,000, with an effective date of January 1, 2022. Mr. Elam also serves as Acting Chairman of our Board of Directors for which no incremental compensation is paid.
(2) Pursuant to the employment agreement discussed below, Dr. Roberts received an annual base salary of $360,000 through February 14, 2021. On February 15, 2021, Dr. Roberts’ base salary increased to $390,000, and subsequently increased to $405,900 on January 1, 2022. On May 25, 2022, Dr. Roberts was appointed by our Board of Directors as our Chief Medical Officer, with a base salary of $450,000 effective June 1, 2022.
(3) On May 25, 2022, the Board of Directors approved bonus payments for calendar year 2021 services in the amounts shown in the table. In June 2022, these cash bonus payments were paid to each executive officer.
(4) On October 7, 2020, in connection with the Company’s financing and up listing, the Board of Directors approved bonus payments to Mr. Elam for approximately $197,000 and Dr. Roberts for approximately $60,000. These bonus payments were paid to each executive officer in October 2020. On February 11, 2021, the Board of Directors approved bonus payments for calendar year 2020 services to Mr. Elam for $294,000 and Dr. Roberts for approximately $104,000. In February 2021, these cash bonus payments were paid to each executive officer.
(5) The aggregate grant date fair value for stock option awards is computed in accordance with ASC 718 set forth by the Financial Accounting Standards Board. A discussion of key assumptions made in the valuation of stock options is presented in Note 8 to our consolidated financial statements, included in Item 8 of this Annual Report. For purposes of this table, the entire fair value of awards with time-based vesting are reflected in the year of grant, whereas under ASC 718 the fair value of such awards is generally recognized over the vesting period in our financial statements.
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(6) Amount includes health, dental, disability and life insurance premiums under our employee benefit plans.
(7) Amount consists of health, dental, disability and life insurance premiums under our employee benefit plans of $36,553, health club fees of $3,300, and matching contributions under our 401(k) Plan of $12,200.
(8) Amount consists of health, dental, disability and life insurance premiums under our employee benefit plans of $21,512, health club fees of $300, and matching contributions under our 401(k) Plan of $14,262.
Narrative Disclosure to Summary Compensation Table
Presented below is summary of key terms of employment agreements with our Named Executive Officers:
Nevan Charles Elam
On June 23, 2015, we entered into an amended and restated employment agreement with Nevan Charles Elam to serve as our Chief Executive Officer. Under the terms of this agreement Mr. Elam is entitled to receive an annual base salary of $450,000 plus a calendar year target bonus up to 60% of his annual base salary based on performance criteria set forth by the Board of Directors. Effective June 1, 2019, the Board of Directors approved an increase in Mr. Elam’s base salary to $490,000. Effective February 15, 2021, the Board of Directors approved an increase in Mr. Elam’s base salary to $505,000. Effective January 1, 2022, the Board of Directors approved an increase in Mr. Elam’s base salary to $525,000. Mr. Elam is eligible to participate in all benefit programs available to our executives and employees, including medical, dental, life and disability insurance plans, and our employee stock option plans. The employment agreement requires Mr. Elam to undertake certain confidentiality, non-competition and non-solicitation obligations. In the event that we terminate Mr. Elam’s employment without “Cause” or if Mr. Elam resigns for “Good Reason”, we are required to pay a severance benefit equal to (i) three times his then current annual base salary, (ii) 150% of his annual Target Bonus, (iii) payment of accrued vacation benefits, and (iv) continuation of certain other benefits such as medical and dental insurance. The aggregate severance benefit is payable over a period of twelve months (the “Elam Severance Period”), and any outstanding stock options that are subject to vesting shall have vesting accelerated with respect to the number of shares that would have vested during the Elam Severance Period as if Mr. Elam had remained employed by us during such period. The terms “Cause” and “Good Reason” are defined in the employment agreement.
Brian Roberts, M.D.
On July 22, 2019, we entered into an employment agreement with Brian Roberts to serve as our Vice President of Clinical Development. Under the terms of this agreement Dr. Roberts is entitled to receive annual base salary of $360,000 plus calendar year target bonus up to 25% of his annual base salary based on performance criteria set forth by the Board of Directors. On October 23, 2020, Dr. Roberts was appointed Senior Vice President, Clinical Development. Effective January 1, 2022, the Board of Directors approved an increase in Dr. Roberts’ salary to $405,900. Effective June 1, 2022, Dr. Roberts was appointed Chief Medical Officer and annual base salary increase was approved to $450,000 with an increase in target bonus to 40% of his annual base salary. The employment agreement requires Mr. Roberts to undertake certain confidentiality, non-competition and non-solicitation obligations. In the event that we terminate Dr. Roberts’ employment without “Cause” or if Dr. Roberts resigns for “Good Reason”, we are required to pay a severance benefit equal to six months’ salary. The aggregate severance benefit is payable over a period of six months (the “Roberts Severance Period”), and any outstanding stock options that are subject to vesting shall have vesting accelerated with respect to the number of shares that would have vested during the Roberts Severance Period as if Dr. Roberts had remained employed by us during such period. The terms “Cause” and “Good Reason” are defined in the employment agreement.
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Outstanding Equity Awards
As of June 30, 2022, there were no restricted stock awards and no stock options that provide for performance vesting conditions held by any of our Named Executive Officers. The following table provides a summary of equity awards outstanding, consisting solely of stock options, for each of our Named Executive Officers as of June 30, 2022:
Number of Securities Underlying
Option
Option
Grant
Unexercised Options
Exercise
Expiration
Name
Date
Exercisable
Unexercisable
Price
Date
Nevan Charles Elam
7/31/19
195,833
4,167
(1)
$
14.50
7/31/29
6/14/21
125,000
250,000
(2)
12.28
6/14/31
6/23/22
—
2,600,000
(4)
3.40
6/23/32
Total for Mr. Elam
320,833
2,854,167
Brian Roberts, M.D.
7/31/19
39,166
834
(1)
$
14.50
7/31/29
6/14/21
37,500
37,500
(3)
12.28
6/14/31
6/23/22
—
700,000
(4)
3.40
6/23/32
Total for Dr. Roberts
76,666
738,334
(1) These stock options vest over a three-year period as follows: 25% of the shares underlying the options became exercisable on the grant date and the remainder of the shares underlying the options became exercisable in equal monthly installments over the remaining 36 months thereafter, subject to the executive’s continued service through each vesting date.
(2) These stock options vest over a three-year period as follows: the shares underlying the options become exercisable in equal monthly installments over 36 months beginning on July 1, 2021, subject to the executive’s continued service through each vesting date.
(3) These stock options vest over a three-year period as follows: 25% of the shares underlying the options became exercisable on grant date and the remaining shares underlying the options become exercisable in equal monthly installments over the remaining 36 months beginning on July 1, 2021, subject to the executive’s continued service through each vesting date.
(4) These stock vest over a four-year period as follows: 25% of the shares underlying the options become exercisable on the anniversary of the grant date and the remaining shares underlying the options become exercisable in equal monthly installments over the remaining 36 months beginning on July 1, 2023, subject to the executive’s continued service through each vesting date.
Options Exercised
As of June 30, 2022, there were no shares acquired upon the exercise of stock options for any of our Named Executive Officers.
Director Compensation
Effective January 1, 2021, we began using a combination of cash and share-based incentive compensation to attract and retain qualified candidates to serve on our Board of Directors. Additionally, our directors are reimbursed for reasonable
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travel expenses incurred in attending meetings. Presented below is a listing of the individuals that served as directors and the related committee appointments during the fiscal year ended June 30, 2022:
Committee Appointments
Director Name
Audit
Compensation
Nominating
and Governance
Committee Members as of June 30, 2022:
Gil Labrucherie
(1)
X
X
X
Philippe Fauchet
(2)
X
X
X
Wladimir Hogenhuis
(3)
X
X
X
Nerissa Kreher
(4)
X
X
Young-Jin Kim
(5)
(1) Mr. Labrucherie was appointed to serve as a member of our Board of Directors, Compensation Committee, Nominating and Governance Committee, and as chairman of our Audit Committee on November 20, 2019.
(2) Mr. Fauchet was appointed to serve as a member of our Board of Directors, Audit Committee, Nominating and Governance Committee and as a chairman of our Compensation Committee on September 10, 2020.
(3) Dr. Hogenhuis was appointed to serve as a member of our Board of Directors, Audit Committee, Nominating and Governance Committee and Compensation Committee on March 2, 2021.
(4) Dr. Kreher was appointed to serve as a member of our Board of Directors and Compensation Committee Nominating and Governance Committee on March 2, 2021.
(5) Mr. Young-Jin Kim was appointed to serve as our Chairman of the Board of Directors on February 16, 2019. He resigned from this position in May 2022, however, remains a member of our Board of Directors.
Director Compensation Table
Nevan Charles Elam, Acting Chairman of our Board of Directors, effective May 2022, and our Chief Executive Officer, did not receive any additional compensation for serving as a director and has been excluded from this table. Please refer to the “Executive Compensation” section above for a description of Mr. Elam’s compensation. In addition, our director and former Chairman, Young-Jin Kim, has historically not reeved any compensation for his service on the Board. In June 2022, the Board determined to provide Mr. Kim with a one-time grant of stock options in recognition of his contributions as Chairman. The following table provides information related to the compensation of the remaining individuals that served as a member of our Board of Directors during the fiscal year ended June 30, 2022:
Fees Earned
Option
or Paid in
Awards ($)
Name
Cash ($)
(6)
Total ($)
Gil Labrucherie
57,000
(1)
211,168
(7)
268,168
Phillipe Fauchet
57,000
(2)
211,168
(7)
268,168
Wladimir Hogenhuis
54,000
(3)
211,168
(7)
265,168
Nerissa Kreher
47,000
(4)
211,168
(7)
258,168
Young-Jin Kim
—
(5)
105,584
(8)
105,584
(1) Consists of $40,000 for serving as a member of the Board of Directors, $10,000 for serving as Chairman of the Audit Committee and $7,000 for serving as a member of the Compensation Committee.
(2) Consists of $40,000 for serving as a member of the Board of Directors, $10,000 for serving as Chairman of the Compensation Committee and $7,000 for serving as a member of the Audit Committee.
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(3) Consists of $40,000 for serving as a member of the Board of Directors, $7,000 for serving as a member of the Compensation Committee and $7,000 for serving as a member of the Audit Committee.
(4) Consists of compensation for fiscal year ended June 30, 2022 of $40,000 for serving as a member of the Board of Directors and $7,000 for serving as a member of the Compensation Committee.
(5) Mr. Young-Jin Kim served as our Board Chairman until May 2022, for which he did not receive any compensation. Mr. Kim remains a member of our Board of Directors.
(6) The aggregate grant date fair value for stock option awards is computed in accordance with ASC 718 set forth by the Financial Accounting Standards Board. A discussion of key assumptions made in the valuation of stock options is presented in Note 8 to our consolidated financial statements, included in Item 8 of this Annual Report. For purposes of this table, the entire fair value of awards is reflected in the year of grant, whereas under ASC 718 the fair value of such awards is generally recognized over the vesting period in our financial statements.
(7) Consists of the fair value of stock options granted on June 23, 2022 for 80,000 shares exercisable at $3.40 per share for a period of ten years. These stock options vest ratably over 36 months until July 1, 2025 when the entire award will be vested.
(8) Consists of the fair value of stock options granted on June 23, 2022 for 40,000 shares exercisable at $3.40 per share for a period of ten years. These stock options vest ratably over 36 months until July 1, 2025 when the entire award will be vested.
The aggregate number of outstanding options held by our non-employee directors as of June 30, 2022 was as follows:
Shares Underlying
Options outstanding
Vested
Unvested
Gil Labrucherie
8,554
84,446
Philippe Fauchet
5,110
84,890
Wladimir Hogenhuis
3,333
86,667
Nerissa Kreher
3,333
86,667
Young-Jin Kim
—
40,000
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The following table sets forth information with respect to the beneficial ownership of shares of our common stock by (i) each director, (ii) each Named Executive Officer, (iii) all directors and executive officers as a group, and (iv) each person who we know beneficially owns more than 5% of our common stock, in each case as of September 8, 2022 (the “ Determination Date ”), unless otherwise indicated below. Beneficial ownership is determined in accordance with the rules and regulations of the SEC and generally includes voting or investment power with respect to such securities. Under these rules, beneficial ownership includes any shares as to which the individual or entity has sole or shared voting power and investment power and includes any shares that an individual or entity has the right to acquire beneficial ownership of within 60 days after the Determination Date through the exercise of any pre-funded warrant, warrant, stock option, or other right. Shares subject to beneficial ownership through the exercise of pre-funded warrants, stock options and warrants are deemed to be outstanding and beneficially owned for the purpose of computing share and percentage ownership of that person or entity, but are not deemed to be outstanding for the purpose of computing the percentage ownership of any other person or entity. Except as indicated in the footnotes to this table, and as affected by applicable community property laws, all persons listed have sole voting and investment power for all shares shown beneficially owned by them. This information is not necessarily indicative of beneficial ownership for any other purpose.
The number of shares beneficially owned and the percentage of shares beneficially owned are based on 36,827,567 shares of common stock issued and outstanding as of the Determination Date. Unless otherwise indicated, the address of our
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directors and executive officers is c/o Rezolute, Inc., 201 Redwood Shores Parkway, Suite 315, Redwood City, California 94065.
Beneficial
Percent
Name of Beneficial Owner
Position with Company
Ownership
of Class
Stockholders in excess of 5%
Entities associated with Federated Hermes, Inc.
Stockholder
7,549,032
(1)
19.9
%
Handok, Inc.
Stockholder
5,942,617
(2)
16.1
%
Stonepine Capital, L.P.
Stockholder
3,001,926
(3)
8.2
%
Genexine, Inc.
Stockholder
1,826,019
(4)
5.0
%
Directors and Executive Officers:
Nevan Charles Elam
Chief Executive Officer,
Acting Chairman of the Board of Directors
379,900
(5)
1.0
%
Young-Jin Kim
Director
6,027,119
(6)
16.4
%
Gil Labrucherie
Director
74,821
(7)
*
Philippe Fauchet
Director
17,388
(8)
*
Wladimir Hogenhuis
Director
48,526
(9)
*
Nerissa Kreher
Director
15,833
(10)
*
Brian Roberts
Chief Medical Officer
107,864
(11)
*
Directors and executive officers as a group (7 people)
6,671,451
(12)
17.9
%
(1)
The number of shares includes 6,610,274 shares of common stock held by entities associated with Federated Hermes, Inc., 123,000 shares currently issuable upon the exercise of pre-funded warrants at $0.01 per share and 815,758 shares currently issuable under the exercise of pre-funded warrants at $0.001 per share. The number of shares excludes 400,000 shares currently issuable upon the exercise of warrants at $19.50 per share due to a 14.99% ownership blocker and 2,605,295 shares currently issuable upon the exercise of Class B pre-funded warrants at $0.001 per share that due to a 19.99% ownership blocker. These shares are owned by separate entities which are collectively referred to as the “Funds” which are managed by Federated Equity Management Company of Pennsylvania and subadvised by Federated Global Investment Management Corp., which are wholly owned subsidiaries of FII Holdings, Inc., which is a wholly owned subsidiary of Federated Hermes, Inc. (the “Parent”). All of the Parent’s outstanding voting stock is held in the Voting Shares Irrevocable Trust (the “Trust”) for which Thomas R. Donahue, Rhodora J. Donahue and J. Christopher Donahue act as trustees (collectively referred to as the “Trustees”). The Parent’s subsidiaries have the power to direct the vote and disposition of the securities held by the Funds. Each of the Parent, its subsidiaries, the Trust, and each of the Trustees expressly disclaim beneficial ownership of such securities. The address of the entities associated with Federated Hermes, Inc. is 4000 Ericsson Drive, Warrendale, PA 15086.
(2)
Voting and investment authority over our shares of common stock owned by Handok, Inc. is held by the board of directors of Handok, Inc. The address of stockholder is 132, Teheran-Ro, Gangman Gu, Seoul, Republic of Korea.
(3)
The amount reported as beneficially owned in the table is based solely on a Schedule 13G/A filed with the SEC on February 14, 2022, reporting beneficial ownership as of December 31, 2021, a Schedule 13F-HR filed with the SEC on August 12, 2022, reporting holdings as of June 30, 2022, and this number may have changed subsequent to June 30, 2022. Stonepine Capital Management, LLC, is the General Partner of the partnership and Jon M. Plexico and Timothy P. Lynch are the control persons of the General Partner. Each reporting person disclaims beneficial ownership of except to the extent of that person’s pecuniary interest therein. The address of the filers is 919 NW Bond Street, Suite 20, Bend, Oregon 977003-2767.
(4)
Voting and investment authority over our shares of common stock owned by Genexine, Inc. is held by the board of directors of Genexine, Inc. The address of stockholder is 700 Daewangpangyo-ro, Korea Bio Park, Building B Seongnam-Si, 13488, Republic of Korea.
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(5)
Consists of (i) 2,817 shares of our common stock and (ii) 377,083 shares of our common stock issuable upon exercise of stock options that are exercisable within 60 days of the Determination Date.
(6)
Consists of (i) 78,947 shares of our common stock owned by Mr. Kim and (ii) 5,942,617 shares of our common stock that are owned by Handok, Inc. and (iii) 5,555 shares of our common stock issuable upon exercise of stock options that are exercisable within 60 days of the Determination Date. As Chairman and CEO of Handok, Inc., Mr. Kim has shared investment and voting authority over the shares owned by Handok, Inc.
(7)
Consists of (i) 53,752 shares of our common stock owned by a trust controlled by Mr. Labrucherie and (ii) 21,249 shares of our common stock issuable upon exercise of stock options that are exercisable within 60 days of the Determination Date.
(8)
Consists of (i) 17,388 shares of our common stock issuable upon exercise of stock options that are exercisable within 60 days of the Determination Date.
(9)
Consists of (i) 32,693 shares of our common stock and (ii) 15,833 shares of our common stock issuable upon exercise of stock options that are exercisable within 60 days of the Determination Date.
(10)
Consists of (i) 15,833 shares of our common stock issuable upon exercise of stock options that are exercisable within 60 days of the Determination Date.
(11)
Consists of (i) 22,552 shares of our common stock and (ii) 85,312 shares of our common stock issuable upon exercise of stock options that are exercisable within 60 days of the Determination Date
(12)
Consists of (i) 6,133,198 shares of our common stock that are either owned or beneficially owned by our directors and officers as discussed above and (iii) an aggregate of 538,253 shares of our common stock issuable upon exercise of stock options that are exercisable within 60 days of the Determination Date.
*
Less than 1%.
Equity Compensation Plan Information
The following table displays equity compensation plan information as of June 30, 2022:
Shares to be Issued Upon
Securities
Plan
Exercise of Outstanding Options:
Available
Termination
Number of
Weighted Average
For Future
Date
Shares
Exercise Price
Issuance
Equity compensation plans approved by security holders:
2015 Non-Qualified Stock Option Plan
February 23, 2020
36
$
50.73
—
2016 Non-Qualified Stock Option Plan
October 31, 2021
256
22.77
—
2021 Equity Incentive Plan
March 31, 2031
8,014
4.24
2,686
Equity compensation plans not approved by security holders:
2019 Non Qualified Stock Option Plan
July 31, 2029
200
14.50
—
Total
492
5.24
2,686
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Item 13. Certain Relationships and Related Transactions and Director Independence.
Review, Approval or Ratification of Transactions with Related Persons
We have not adopted a policy on related party transactions and rely on our Board to review related party transactions on an ongoing basis to prevent conflicts of interest. Our Board reviews a transaction in light of the affiliations of the director, officer or employee and the affiliations of such person’s immediate family. Transactions are presented to our Board for approval before they are entered into or, if this is not possible, for ratification after the transaction has occurred. If our Board finds that a conflict of interest exists, then it will determine the appropriate remedial action, if any. Our Board approves or ratifies a transaction if it determines that the transaction is consistent with the best interests of the Company.
Director Independence
As the Company is listed on the Nasdaq Capital Market, we have used the definition of “independence” of the Nasdaq Stock Market to determine whether our directors are independent. We have determined that as of June 30, 2022, Mr. Labrucherie, Mr. Fauchet, Dr. Hogenhuis and Dr. Kreher were independent directors as defined by Nasdaq Rule 5605(a)(2), and for purposes of Section 16 of the Exchange Act. Nasdaq Listing Rule 5605(a)(2) provides that an “independent director” is a person other than an officer or employee of the Company or any other individual having a relationship which, in the opinion of our Board, would interfere with the exercise of independent judgment in carrying out the responsibilities of a director.
The Nasdaq listing rules provide that a director cannot be considered independent if:
·
the director is, or at any time during the past three years was, an employee of the Company;
·
the director or a family member of the director accepted any compensation from the Company in excess of $120,000 during any period of twelve consecutive months within the three years preceding the independence determination (subject to certain exclusions, including, among other things, compensation for board or board committee service);
·
a family member of the director is, or at any time during the past three years was, an executive officer of the Company;
·
the director or a family member of the director is a partner in, controlling shareholder of, or an executive officer of an entity to which the Company made, or from which the Company received, payments in the current or any of the past three fiscal years that exceed 5% of the recipient ’ s consolidated gross revenue for that year or $200,000, whichever is greater (subject to certain exclusions);
·
the director or a family member of the director is employed as an executive officer of an entity where, at any time during the past three years, any of the executive officers of the Company served on the compensation committee of such other entity; or
·
the director or a family member of the director is a current partner of the Company ’ s outside auditor, or at any time during the past three years was a partner or employee of the Company ’ s outside auditor, and who worked on the Company ’ s audit.
Presented below is a summary of transactions with related parties for the fiscal years ended June 30, 2022 and 2021:
Licensing Agreement
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
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will 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.
Investors in Registered Direct Offerings
In connection with the 2021 RDO, Handok, an entity affiliated with a member of the Board of Directors, purchased 769,231 shares of our common stock at a purchase price of $6.50 per share, whereby we received gross proceeds of $5.0 million.
In connection with the 2022 RDO, certain officers and directors of the Company purchased 111,840 shares of common stock at $3.80 per share for a total of $0.4 million.
Item 14. Principal Accounting Fees and Services.
Principal Accounting Fees and Services
The aggregate fees billed by Plante & Moran, PLLC for professional services rendered to us for the years ended June 30, 2022 and 2021 are set forth in the table below.
2022
2021
Amount
Percent
Amount
Percent
Audit fees (1)
$
259,000
85
%
$
175,500
82
%
Tax fees
47,225
15
%
38,100
18
%
Total
$
306,225
100
%
$
213,600
100
%
(1)
Audit fees represent amounts billed for professional services rendered for the audit of our annual financial statements, the reviews of the financial statements included in our quarterly reports on Form 10-Q, and reviews of any other SEC filings.
(2)
Tax fees consist of fees billed for professional services for tax compliance, tax planning and tax advice. These services include assistance regarding federal and state tax compliance.
Pre-Approval Policy
Our Audit Committee endeavors to approve in advance all services provided by our independent registered public accounting firm. All services provided by of our independent registered public accounting firm for the fiscal years ended June 30, 2022 and 2021 were pre-approved by the Audit Committee.
PART IV
Item 15. Exhibit and Financial Statement Schedules.
(a)(1) Financial Statements
Reference is made to Item 8 of Part II for the Company’s consolidated financial statements filed as part of this Report.
(a)(2) Financial Statement Schedules
All financial statement schedules are omitted because they are not applicable, or the amounts are immaterial, not required, or the required information is presented in the financial statements and notes thereto included in Item 8 of Part II of this Report.
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(a)(3) Exhibits
Certain of the agreements filed as exhibits to this Report contain representations and warranties by the parties to the agreements that have been made solely for the benefit of the parties to the agreement. These representations and warranties:
● may have been qualified by disclosures that were made to the other parties in connection with the negotiation of the agreements, which disclosures are not necessarily reflected in the agreements;
● may apply standards of materiality that differ from those of a reasonable investor; and
● were made only as of specified dates contained in the agreements and are subject to subsequent developments and changed circumstances.
Accordingly, these representations and warranties may not describe the actual state of affairs as of the date that these representations and warranties were made or at any other time. Investors should not rely on them as statements of fact.
The following exhibits of Rezolute, Inc. are filed or incorporated by reference as part of this Report. For exhibits that are incorporated by reference, we have indicated the document previously filed with the SEC in which the exhibit was included.
Exhibit
No.
Description
1.1
Underwriting Agreement, dated as of May 1, 2022, by and between the Company and Jefferies LLC (incorporated by reference to Exhibit 1.1 of the Company’s Form 8-K filing on May 4, 2022)
1.2
Underwriting Agreement, dated as of October 12, 2021, by and between the Company and Oppenheimer & Co., Inc. (incorporated by reference to Exhibit 1.1 of the Company's Form 8-K filing on October 13, 2021)
2.1
Agreement and Plan of Merger dated as of June 18, 2021, by and between Rezolute, Inc. and Rezolute Nevada Merger Corporation (incorporated by reference to Exhibit 2.1 of the Company’s Form 8-K filing on June 21, 2021)
3.1
Delaware Certificate of Merger, effective as of June 18, 2021 (incorporated by reference to Exhibit 3.1 of the Company’s Form 8-K filing on June 21, 2021)
3.2
Nevada Articles of Merger, effective as of June 18, 2021 (incorporated by reference to Exhibit 3.3 of the Company’s Form 8-K filing on June 21, 2021)
3.3
Amended and Restated Articles of Incorporation of Rezolute Nevada Merger Corporation (incorporated by reference to Exhibit 3.3 of the Company’s Form 8-K filing on June 21, 2021)
3.4
Certificate of Amendment, as filed with the Secretary of State of the State of Nevada on June 16, 2022 (incorporated by reference to Exhibit 3.1 of the Company’s Form 8-K filing on June 17, 2022)
3.5
Amended and Restated Bylaws of Rezolute Nevada Merger Corporation ( incorporated by reference to Exhibit 3.4 of the Company’s Form 10-K filing on September 15, 2021 )
4.1
Form of Financing Warrant (incorporated by reference to Exhibit 4.1 of the Company's Form 8-K filing on April 3, 2018 )
4.2
Form of Common Stock Purchase Warrant by and between the Company and the Investor identified therein ( incorporated by reference to Exhibit 4.1 the Company’s 8-K filing on October 13, 2020 )
4.3
Form of Pre-Funded Warrant to Purchase Common Stock ( Incorporated by reference to Exhibit 4.1 of the Company’s 8-K filing on October 13, 2021 )
4.4
Form of Class A Pre-Funded Warrant ( incorporated by reference to Exhibit 4.1 of the Company’s 8-K filing on May 4, 2022 )
4.5
Form of Class B Pre-Funded Warrant ( incorporated by reference to Exhibit 4.2 of the Company’s 8-K filing on May 4, 2022 )
10.1
Second Amended and Restated Employment Agreement with Nevan Elam, dated February 23, 2015 (incorporated by reference to Exhibit 10.2 of the Company’s Form 8-K filing on February 24, 2015)
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10.2
AntriaBio, Inc. 2014 Stock and Incentive Plan (incorporated by reference to Appendix B to the Company’s Definitive Information Statement on Schedule 14C filed on April 10, 2014)
10.3
AntriaBio, Inc. 2015 Non Qualified Stock Option Plan (incorporated by reference to Exhibit 10.5 of the Company’s Form 8-K filing on February 24, 2015)
10.4
AntriaBio, Inc. 2016 Non Qualified Stock Option Plan (incorporated by reference to Exhibit 10.2 of the Company’s Form 8-K filing on November 4, 2016)
10.5
AntriaBio, Inc. 2016 Non Qualified Stock Option Plan, as Amended (incorporated by reference to Exhibit 10.25 of the Company’s Form 10-K on September 21, 2017)
10.6
2019 Non Qualified Stock Option Plan (incorporated by reference to Exhibit 10.3 of the Company’s Form 8-K filing on August 6, 2019)
10.7
Rezolute, Inc. 2021 Equity Incentive Plan (incorporated by reference to Exhibit 4.2 of the Registration Statement on Form S-8 filed on July 28, 2021)
10.8
Development and License Agreement with ActiveSite Pharmaceuticals, Inc. (incorporated by reference to Exhibit 10.1 of the Company’s Form 8-K filing on August 7, 2017)
10.9
License Agreement with XOMA (US) LLC (incorporated by reference to Exhibit 10.1 of the Company’s 10-Q filing on February 14, 2018)
10.10
Amendment No. 2 to the Stock Purchase Agreement with XOMA (US) LLC (incorporated by reference to Exhibit 10.1 of the Company's Form 10-Q filing on February 14, 2019)
10.11
Amendment No. 2 to the License Agreement with XOMA (US) LLC (incorporated by reference to Exhibit 10.2 of the Company's Form 10-Q filing on February 14, 2019)
10.12
First Amendment to the 2016 Non-Qualified Stock Option Plan (incorporated by reference to Exhibit C to the Company’s Schedule 14A definitive proxy statement filing on April 5, 2019)
10.13
Master Services Agreement with Genexine, Inc. and Handok, Inc., effective as of July 1, 2019 (incorporated by reference to Exhibit 10.1 of the Company’s Form 10-Q filing on November 14, 2019)
10.14
Amendment No. 3 to the License Agreement with XOMA (US) LLC (incorporated by reference to Exhibit 10.1 of the Company’s Form 10-Q filing on May 14, 2020)
10.15
License Agreement with Handok, Inc. entered into on September 15, 2020 (incorporated by reference to Exhibit 10.21 of the Company’s Form 10-K filing on October 13, 2020)
10.16
Registration Rights Agreement, dated as of October 8, 2020, by and between Rezolute, Inc., and the Investors identified therein ( incorporated by reference to Exhibit 10.2 of the Company’s Form 8-K filing on October 13, 2020 )
10.17
Loan and Security Agreement, dated as of April 14, 2021 by and among Rezolute, Inc., SLR Investment Corp, as collateral agent and lender, and the other lenders named therein (incorporated by reference to Exhibit 10.1 of the Company’s Form 10-Q filing on May 17, 2021)
10.18
Exit Fee Agreement, dated as of April 14, 2021 by and among Rezolute, Inc., SLR Investment Corp, as collateral agent and lender, and the other lenders named therein (incorporated by reference to Exhibit 10.2 of the Company’s Form 10-Q filing on May 17, 2021)
10.19
Form of Subscription Agreement, dated October 12, 2021 (incorporated by reference to Exhibit 10.1 of the Company’s Form 8-K filing on October 13, 2021)
10.20
Registration Rights Agreement, dated as of May 4, 2022, by and between Rezolute, Inc., and the purchasers identified therein ( incorporated by reference to Exhibit 10.1 of the Company’s Form 8-K filing on May 4, 2022 )
10.21
Placement Agency Agreement, dated as of May 1, 2022, by and between the Company and Jefferies LLC ( incorporated by reference to Exhibit 10.2 of the Company’s Form 8-K filing on May 4, 2022 )
10.22
Form of Amended and Restated Securities Purchase Agreement, dated as of July 22, 2022*
10.23
Amended and Restated Rezolute, Inc. 2021 Equity Incentive Plan*
21.1
Listing of Subsidiaries *
23.1
Consent of Plante & Moran, PLLC*
31.1
Certifications of Chief Executive Officer and Principal Financial Officer as adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*
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32.1
Certifications of Chief Executive Officer and Principal Financial Officer as adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*
101.INS
Inline XBRL Instance Document*
101.SCH
Inline XBRL Taxonomy Extension Schema*
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase*
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase*
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase*
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase*
104
Cover Page Interactive Data File, formatted in Inline XBRL (included as Exhibit 101)
* Filed herewith.
In accordance with SEC Release 33-8238, Exhibit 32.1 is being furnished and not filed.
Item 16. Form 10-K Summary.
Not applicable
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
REZOLUTE, INC.
Date: September 15, 2022
By:
/s/ Nevan Charles Elam
Nevan Charles Elam
Acting Chairman of the Board of Directors and Chief Executive Officer
(Principal Executive and Financial Officer)
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.
Date: September 15, 2022
By:
/s/ Nevan Charles Elam
Nevan Charles Elam
Acting Chairman of the Board of Directors and Chief Executive Officer (Principal Executive and Financial Officer)
Date: September 15, 2022
By:
/s/ Young-Jin Kim
Young-Jin Kim
Director
Date: September 15, 2022
By:
/s/ Gil Labrucherie
Gil Labrucherie
Director
Date: September 15, 2022
By:
/s/ Philippe Fauchet
Philippe Fauchet
Director
Date: September 15, 2022
By:
/s/ Nerissa Kreher
Nerissa Kreher
Director
Date: September 15, 2022
By:
/s/ Wladimir Hogenhuis
Wladimir Hogenhuis
Director
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