Item 9A. Controls and Procedures
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
The term “disclosure controls and procedures” means our controls and other procedures that are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Securities Exchange Act of 1934, as amended, or the Exchange Act, is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive officer and principal financial officer, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
We carried out an evaluation, under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rules 13a – 15(e) and 15d – 15(e)). Based upon that evaluation, our principal executive officer and principal financial officer concluded that, as of the end of the period covered in this report, our disclosure controls and procedures were effective to ensure that information required to be disclosed in reports filed under the Exchange Act is recorded, processed, summarized and reported within the required time periods and is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.
Our principal executive officer and principal financial officer do not expect that our disclosure controls or internal controls will prevent all error and all fraud. Although our disclosure controls and procedures were designed to provide reasonable assurance of achieving their objectives, a control system, no matter how well conceived and operated, can provide only reasonable, but not absolute assurance that the objectives of the system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented if there exists in an individual a desire to do so. There can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.
Management’s Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rules 13a-15(f) and 15d-15(f). Under the supervision and with the participation of our Chief Executive Officer and Chief Financial Officer, our management conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on that evaluation, our management concluded that our internal control over financial reporting was effective as of December 31, 2022.
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Attestation Report of the Independent Registered Public Accounting Firm
This report does not include an attestation report of our independent registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by our independent registered public accounting firm pursuant to Section 989G of the Dodd-Frank Wall Street Reform and Consumer Protection Act, which exempts smaller reporting companies from the auditor attestation requirement.
Changes in Internal Control over Financial Reporting
There has been no change in our internal control over financial reporting (as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the year ended December 31, 2022 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
ITEM 9B. OTHER INFORMATION
None.
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
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PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The information required by item 10 is incorporated herein by reference from the Company’s Proxy Statement, which will be filed with the SEC within 120 days after the end of the Company’s 2022 fiscal year pursuant to Regulation 14A for its 2023 Annual Meeting of Stockholders.
ITEM 11. EXECUTIVE COMPENSATION
The information required by item 11 is incorporated herein by reference from the Company’s Proxy Statement, which will be filed with the SEC within 120 days after the end of the Company’s 2022 fiscal year pursuant to Regulation 14A for its 2023 Annual Meeting of Stockholders.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The information required by item 12 is incorporated herein by reference from the Company’s Proxy Statement, which will be filed with the SEC within 120 days after the end of the Company’s 2022 fiscal year pursuant to Regulation 14A for its 2023 Annual Meeting of Stockholders.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The information required by item 13 is incorporated herein by reference from the Company’s Proxy Statement, which will be filed with the SEC within 120 days after the end of the Company’s 2022 fiscal year pursuant to Regulation 14A for its 2023 Annual Meeting of Stockholders.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The information required by item 14 is incorporated herein by reference from the Company’s Proxy Statement, which will be filed with the SEC within 120 days after the end of the Company’s 2022 fiscal year pursuant to Regulation 14A for its 2023 Annual Meeting of Stockholders.
PART IV
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ITEM 15. EXHIBITS
Exhibit
Number Description Form Exhibit Filing Date
2.1^ Agreement and Plan of Merger, dated as of August 7, 2017, by and among the Registrant, Galena Bermuda Merger Sub, Ltd., Sellas Intermediate Holdings I, Inc., Sellas Intermediate Holdings II, Inc. and SELLAS Life Sciences Group Ltd, as amended (included as Annex A to the proxy statement/prospectus/consent solicitation statement).
8-K 2.1 August 8, 2017
3.1 Composite Amended and Restated Certificate of Incorporation of the Registrant (formerly, Galena Biopharma, Inc.), amended as of December 27, 2017.
10-K 3.1 April 13, 2018
3.2 Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock.
8-K 3.1 March 12, 2018
3.3 Certificate of Amendment to the Amended and Restated Certificate of Incorporation of the Registrant.
8-K 3.1 November 6, 2019
3.4 Amended and Restated By-Laws of the Registrant.
8-K 3.3 January 5, 2018
4.1 Form of Common Stock Certificate.
10-K 4.1 April 13, 2018
4.2 Form of Contingent Value Rights Agreement among the Registrant (formerly RXi Pharmaceuticals Corporation), Computershare Trust Company, N.A., Computershare Inc., and Robert E Kennedy, dated April 13, 2011.
8-K 10.1 April 14, 2011
4.3 First Amendment to Contingent Value Rights Agreement among the Registrant (formerly RXi Pharmaceuticals Corporation), Computershare Trust Company, N.A., Computershare Inc., and Robert E Kennedy, dated February 15, 2012.
10-K 10.2 March 28, 2012
4.4 Warrant issued to EQC Private Markets SAC Fund Ltd – EQC Biotech Sely I Fund.
8-K 10.5 January 5, 2018
4.5 Warrant Agreement including form of accompanying Common Warrant as Exhibit B thereto, dated as of July 16, 2018, among the Registrant, Computershare, Inc., and Computershare Trust Company N.A.
8-K 10.1 July 18, 2018
4.6 Amendment to Warrant Agreement including form of accompanying Common Warrant as Exhibit B thereto, dated as of July 16, 2018, among the Registrant, Computershare, Inc., and Computershare Trust Company N.A.
8-K 10.2 July 9, 2019
4.7 Form of Warrant issued in exchange of Series A Preferred Stock in connection with July 2018 public offering.
8-K 10.3 July 18, 2018
4.8 Form of New Warrant issued in connection with Warrant Exercise Agreement dated March 6, 2019.
8-K 4.1 March 6, 2019
4.9 Warrant Agreement, including form of accompanying Common Warrant as Exhibit B thereto, dated as of June 18, 2019, among the Registrant, Computershare Inc., and Computershare Trust Company N.A.
8-K 10.1 June 18, 2019
4.10 Form of Pre-Funded Warrant in connection with June 2019 public offering.
8-K 10.2 June 18, 2019
4.11 Form of Warrant in connection with January Registered Direct 2020.
8-K 4.1 January 10, 2020
4.12 Form of Pre-Funded Warrant in connection with January registered Direct 2020 Offering.
8-K 4.2 January 10, 2020
4.13 Form of Warrant in connection with July 2020 Private Placement.
8-K 4.1 August 4, 2020
4.14 Form of Warrant issued pursuant to that certain Securities Purchase Agreement dated March 7, 2018 by and between the Registrant and certain investors.
8-K 4.1 March 12, 2018
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Exhibit
Number Description Form Exhibit Filing Date
4.15 Form of Warrant
8-K 4.1 April 1, 2022
4.16 Description of Securities.
10-K 4.41 March 13, 2020
9.1 Securities Purchase Agreement dated March 7, 2018 by and between the Registrant and certain investors.
8-K 10.1 March 12, 2018
10.1* SELLAS Life Sciences Group, Ltd Stock Incentive Plan #1.
S-4/A 10.61 October 30, 2017
10.2* Form of Restricted Stock Unit Grant and Agreement under SELLAS Life Sciences Group Ltd Stock Incentive Plan #1.
S-4/A 10.63 October 30, 2017
10.3* 2017 Equity Incentive Plan of the Registrant.
8-K 10.10 January 5, 2018
10.4* 2017 Employee Stock Purchase Plan of the Registrant.
8-K 10.11 January 5, 2018
10.5* Form of Stock Option Grant Notice and Option Agreement under the 2017 Equity Incentive Plan.
8-K 10.2 March 19, 2018
10.6* Form of Restricted Stock Unit Grant and Agreement under the 2017 Equity Incentive Plan.
10-K 10.9 April 13, 2018
10.7* Employment Agreement, effective July 1, 2019, by and between the Registrant and Angelos Stergiou.
10-Q 10.3 May 14, 2020
10.8* Letter Employment Agreement, dated March 14, 2018, by and between the Registrant and Barbara Wood.
8-K 10.1 March 19, 2018
10.9* Employment Agreement, effective as of January 11, 2018, by and between the Registrant and John Burns.
8-K 10.1 January 18, 2018
10.10* Change in Control Severance Agreement, dated December 14, 2021, by and between the Registrant and Dragan Cicic, M.D.
8-K 10.1 December 16, 2021
10.11+ Patent and Technology License Agreement, dated September 11, 2006, by and among the Board of Regents of the University of Texas System, the University of Texas M.D. Anderson Cancer Center, the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., and Apthera, Inc. (formerly Advanced Peptide Therapeutics, Inc.).
10-Q 10.1 August 15, 2011
10.12 Amendment No. 1 to Patent and Technology License Agreement, dated December 21, 2007, by and among the Board of Regents of the University of Texas System, the University of Texas M.D. Anderson Cancer Center, the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., and Apthera, Inc. (formerly Advanced Peptide Therapeutics, Inc.).
10-Q 10.2 August 15, 2011
10.13 Amendment No. 2 to Patent and Technology License Agreement, dated September 3, 2008, by and among the Board of Regents of the University of Texas System, the University of Texas M.D. Anderson Cancer Center, the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., and Apthera, Inc. (formerly Advanced Peptide Therapeutics, Inc.).
10-Q 10.3 August 15, 2011
10.14 Amendment No. 3 to Patent and Technology License Agreement, dated July 8, 2009, by and among the Board of Regents of the University of Texas System, the University of Texas M.D. Anderson Cancer Center, the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., and Apthera, Inc. (formerly Advanced Peptide Therapeutics, Inc.).
10-Q 10.4 August 15, 2011
10.15+ Amendment No. 4 to Patent and Technology License Agreement, dated February 11, 2010, by and among the Board of Regents of the University of Texas System, the University of Texas M.D. Anderson Cancer Center, the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., and Apthera, Inc. (formerly Advanced Peptide Therapeutics, Inc.).
10-Q 10.5 August 15, 2011
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Exhibit
Number Description Form Exhibit Filing Date
10.16+ Amendment No. 5 to Patent and Technology License Agreement, dated January 10, 2011, by and among the Board of Regents of the University of Texas System, the University of Texas M.D. Anderson Cancer Center, the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., and Apthera, Inc. (formerly Advanced Peptide Therapeutics, Inc.).
10-Q 10.6 August 15, 2011
10.17 Scientific Advisory Agreement, dated April 13, 2011, between the Registrant (formerly Galena Biopharma, Inc.) and George E. Peoples, Ph.D.
10-Q 10.10 August 15, 2011
10.18+ Exclusive License Agreement, dated as of July 11, 2011, by and among The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., the Registrant (formerly Galena Biopharma, Inc.) and its wholly owned subsidiary, Apthera, Inc.
10-Q 10.12 August 15, 2011
10.19+ Exclusive License Agreement, dated as of September 16, 2011, by and among The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., The Board of Regents of the University of Texas System, The University of Texas M. D. Anderson Cancer Center and the Registrant (formerly Galena Biopharma, Inc.).
8-K 10.1 September 21, 2011
10.20+ License Agreement, effective as of April 30, 2009, by and between Kwangdong Pharmaceutical Co., Ltd. and Apthera, Inc.
10-K 10.45 March 28, 2012
10.21 Amendment No. 1 to License Agreement, dated as of January 13, 2012, by and among Apthera, Inc., Kwangdong Pharmaceutical Co., Ltd., and the Registrant.
10-K 10.46 March 28, 2012
10.22+ License and Supply Agreement, effective December 3, 2012, by and between the Registrant and ABIC Marketing Limited, a subsidiary of Teva Pharmaceuticals.
10-K 10.43 March 12, 2013
10.23+ License and Development Agreement, dated January 13, 2014, by and between the Registrant and Dr. Reddy’s Laboratories, Ltd.
10-K 10.36 March 17, 2014
10.24+ Exclusive License Agreement, dated as of December 20, 2013, between Mills Pharmaceuticals, LLC and BioVascular, Inc.
10-K 10.37 March 17, 2014
10.25 Amendment of the Exclusive License Agreement, dated September 7, 2017, by and between Mills Pharmaceuticals, LLC and BioVascular, Inc.
8-K 10.1 September 11, 2017
10.26+ Amended and Restated Exclusive License Agreement by and between SELLAS Life Sciences Group Ltd and Memorial Sloan Kettering Cancer Center, effective October 11, 2017.
S-4/A 10.65 October 30, 2017
10.27 Form of Indemnity Agreement between the Registrant and each of its directors and executive officers.
8-K 10.8 January 5, 2018
10.28 Form of Warrant Exercise Agreement, dated March 6, 2019.
8-K 10.1 March 6, 2019
10.29* 2019 Equity Incentive Plan.
S-8 99.1 March 13, 2020
10.30* Form of Stock Option Grant Notice and Option Agreement under the 2019 Equity Incentive Plan.
10-K 10.48 March 13, 2020
10.31* Form of Restricted Stock Unit Grant and Agreement under the 2019 Equity Incentive Plan.
10-K 10.49 March 13, 2020
10.32 Amendment to Warrant to Purchase Common Stock, dated January 2, 2020, between the Registrant and the holders.
8-K 10.1 January 7, 2020
10.33 Form of Placement Agent Agreement.
8-K 1.1 January 10, 2020
10.34 Sublease, dated June 5, 2020, between the Registrant and Riemer & Braunstein LLP.
8-K 10.1 June 11, 2020
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Exhibit
Number Description Form Exhibit Filing Date
10.35 First Amendment to Sublease, dated December 6, 2021, by and between the Registrant and Riemer & Braunstein LLP.
10-K 10.36 March 31, 2022
10.36* 2021 Employee Stock Purchase Plan.
S-8 99.4 August 13, 2021
10.37 Form of Registration Rights Agreement.
8-K 10.2 August 4, 2020
10.38+ Exclusive License Agreement, dated December 7, 2020, among the Registrant, SLSG Limited, LLC and 3D Medicines Inc.
8-K 10.1 January 28, 2021
10.39+ Side Letter Agreement, dated December 5, 2022, by and between the Registrant and 3D Medicines Inc.
10.40 Termination Agreement, dated February 4, 2021, among the Registrant, The Henry M. Jackson Foundation, and the MD Anderson Cancer Center.
10-K 10.50 March 23, 2021
10.41 Sales Agreement, dated as of April 16, 2021, by and between SELLAS Life Sciences Group, Inc. and Cantor Fitzgerald & Co.
S-3 1.2 April 16, 2021
10.42+ License Agreement, dated March 31, 2022, by and between SELLAS Life Sciences Group, Inc. and GenFleet Therapeutics (Shanghai) Inc.
10-Q 10.1 May 12, 2022
14.1 Code of Business Conduct and Ethics.
8-K 14.1 January 5, 2018
21.1 Subsidiaries of the Registrant.
23.1 Consent of Moss Adams LLP, Independent Registered Public Accounting Firm.
24.1 Powers of Attorney (included on signature page hereto).
31.1 Certification of Principal Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities and Exchange Act, as amended.
31.2 Certification of Principal Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities and Exchange Act, as amended.
32.1** Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS*** XBRL Instance Document.
101.SCH*** XBRL Taxonomy Extension Schema.
101.CAL*** XBRL Taxonomy Extension Calculation Linkbase.
101.DEF*** XBRL Taxonomy Extension Definition Linkbase.
101.LAB*** XBRL Taxonomy Extension Label Linkbase.
101.PRE*** XBRL Taxonomy Extension Presentation Linkbase.
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* Indicates management contract or compensatory plans or arrangements.
** The certification attached as Exhibit 32.1 pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, and shall not be deemed “filed” by the Company for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing of the registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
^ The schedules and exhibits to this exhibit have been omitted pursuant to Item 601(b)(2) or 601(b)(10)(iv), as applicable, of Regulation S-K. A copy of any omitted schedule and/or exhibit will be furnished to the SEC upon request.
+ Confidential treatment has been granted with respect to certain portions of this exhibit. Omitted portions have been filed separately with the SEC.
*** In accordance with Rule 406T of Regulation S-T, the Interactive Data Files in Exhibit 101 are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Section 18 of the Exchange Act of 1934, as amended, and otherwise are not subject to liability under these sections.
ITEM 16. FORM 10-K SUMMARY
None.
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SIGNATURES
Pursuant to the requirements 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.
SELLAS Life Sciences Group, Inc.
Date: March 16, 2023 By: /s/ Angelos M. Stergiou
Angelos M. Stergiou, MD, ScD h.c.
President and Chief Executive Officer
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Angelos Stergiou and Barbara A. Wood, and each of them, as his or her true and lawful attorneys-in-fact and agents, each with the full power of substitution, for him or her and in his or her name, place or stead, in any and all capacities, to sign any and all amendments (including post-effective amendments) to this annual report on Form 10-K, and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or their, his or her substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
In accordance with the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant in the capacities and on the dates indicated.
Signature Title Date
/s/ Angelos M. Stergiou President, Chief Executive Officer and Director
(Principal Executive Officer) March 16, 2023
Angelos M. Stergiou, M.D., ScD h.c.
/s/ John T. Burns Senior Vice President, Chief Financial Officer
(Principal Financial and Accounting Officer) March 16, 2023
John T. Burns, CPA
/s/ Jane Wasman Chair of the Board of Directors March 16, 2023
Jane Wasman
/s/ David Scheinberg Director March 16, 2023
David Scheinberg, M.D., PhD.
/s/ Robert Van Nostrand Director March 16, 2023
Robert Van Nostrand
/s/ John Varian Director March 16, 2023
John Varian
/s/ Katherine Kalin Director March 16, 2023
Katherine Kalin
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