UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DCWashington, D.C. 20549

FormForm 10-K/A

(Amendment No. 1)

(Mark One)

For the fiscal year ended December 31, 20162018

OR

For the transition period from    to    

Commission filenumber 001-36620

Tokai Pharmaceuticals, Inc.NOVUS THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

(617) 225-4305(949) 238-8090

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Securities registered pursuant to Section 12(g) of the Act:

None.

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.    Yes  ☐        No  ☒

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.    Yes  ☐        No  ☒

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  ☒        No  ☐

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 ofRegulationS-T during during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  ☒        No  ☐

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 ofRegulationS-K is is not contained herein, and will not be contained, to the best of the registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of thisForm 10-K or or any amendment tothisForm 10-K. ☒

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, anon-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 RuleRule 12b-2 of the Exchange Act.

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 13(a) of the Exchange Act. ☒

Indicate by check mark whether the registrant is a shell company (as defined inRule 12b-2 of of the Exchange Act).    Yes  ☐        No  ☒

As of June 30, 2016,29, 2018, the last business day of the registrant’s most recently completed second fiscal quarter, the aggregate market value of the registrant’s common stock heldbynon-affiliates was was $53,968,136,$47,021,457, based on the last reported sale price of such stock on the NASDAQNasdaq Global Market as of such date.

As of March 31, 2017,22, 2019, the registrant had 22,641,6519,434,243 shares of Common Stock, $0.001 par value per share, outstanding.

DOCUMENTS INCORPORATED BY REFERENCE

None.

Table of Contents

EXPLANATORY NOTE

The purpose of this amendment, (the “Amendment”), is to include the information required by Items 10 through 14 of Part III ofForm10-K, which was omitted from Tokai Pharmaceuticals,Novus Therapeutics, Inc.’s Annual Report onForm10-K for the fiscal year ended December 31, 2016,2018, (the “Annual Report”), as originally filed with the Securities and Exchange Commission (the “SEC”), on March 3, 2017,28, 2019, in reliance on General Instruction G(3) toForm10-K, which provides for the incorporation by reference of certain provisions of a registrant’s definitive proxy statement into itsForm10-K.

In accordance withRule12b-15 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), Part III, Items 10 through 14 of the Annual Report are hereby amended and restated in their entirety, and Part IV, Item 15 of the Annual Report is hereby amended and restated in its entirety, withfor the only changes to Part IV, Item 15 being the additionpurpose of adding new certifications by our principal executive officer and principal financial officer filed herewith. Except as otherwise expressly set forth in this Amendment, no portion of the Annual Report filed on March 3, 201728, 2019 is being amended or updated by this Amendment. Accordingly, this Amendment should be read in conjunction with the Annual Report and with our filings with the SEC subsequent to the Annual Report.

Unless we specify otherwise, all references in this Amendment to “we,” “our,” “us,” or “the Company” refer to Tokai Pharmaceuticals,Novus Therapeutics, Inc.

i

INDEX

PART III

Item 10. Directors, Executive Officers and Corporate Governance.

Directors

Our board of directors is divided into three classes, with members of each class holding office for staggered three-year terms. There are currently threetwo Class I directors (Jodie P. Morrison,(Erez Chimovits and Cheryl L. Cohen and Joseph A. Yanchik, III)Cohen), whose terms expire at the 20182021 annual meeting of stockholders; onetwo Class II director (Daviddirectors (Keith A. Kessler)Katkin and John S. McBride), whose term expiresterms expire at the 2019 annual meeting of stockholders; and two Class III directors (Seth L. Harrison(Gregory J. Flesher and Stephen Buckley Jr.)Gary A. Lyons), whose terms expire at the 20172020 annual meeting of stockholders (in all cases subject to the election and qualification of their successors or to their earlier death, resignation or removal). Dr. Harrison was elected asAs described in the biographical information below, a director pursuant to a stockholders agreement that we entered into withnumber of the holdersmembers of our preferred stock that terminated uponboard of directors were associated with Otic Pharma, Ltd. (“Otic”) prior to the closingcombination of our initial public offering.Tokai Pharmaceuticals, Inc. (“Tokai”) and Otic in May 2017 (the “Otic Transaction”).

Set forth below are the ages of the directors as March 31, 2017, the positions held in our companynames and othercertain information for each memberdirector, as of the board.May 15, 2019. The information presented includes each director’s principal occupation and business experience for the past five years, and the names of other public companies of which he or she has served as a director during the past five years. The information presented below regarding the specific experience, qualifications, attributes and skills of each director led our nominating and corporate governance committee and our board of directors to conclude that he or she should serve as a director. There are no family relationships among any of our directors nominees for director, or executive officers.

Class I Directors

Jodie P. MorrisonErez Chimovits, M.Sc., MBAhas served as our President and Chief Executive Officer and as a member of our board of directors since March 2013. From December 2006 until March 2013, Ms. Morrison held otherMay 2017. Mr. Chimovits is a Senior Managing Director with OrbiMed, a healthcare investment firm where he has been employed since 2010. He has more than fourteen years of operational experience, including ten years of senior positions with us, including Chief Operating Officer, Head of Clinical Affairs and Program Operations and Vice President of Clinical Affairs and Program Operations.managerial experience in public companies. Prior to joining our company, Ms. Morrison servedOrbiMed, he was the Chief Executive Officer of NasVax Ltd. NasVax acquired Protea Vaccine Technologies Ltd. and struck key agreements with GlaxoSmithKline and Novartis. Previously, Mr. Chimovits spent more than seven years with Compugen, as Director of Clinical Operations and Medical Affairs at Dyax Corporation, or Dyax. Prior to joining Dyax, Ms. Morrison held clinical management positions at both Curis,President, Compugen USA Inc. and Executive Vice President, Commercial Operations. While at Diacrin, Inc. Ms. MorrisonCompugen, he had profit and loss responsibility for more than 100 people and led multiple transactions with companies including Johnson &Johnson, Novartis, Teva, Abbott, Medarex and others. He currently serves on the board of directors of Keryx Biopharmaceuticals,LogicBio Therapeutics, Inc., a publicly tradedgenome editing company. Ms. Morrison received aB.A.Mr. Chimovits earned his M.B.A., M.Sc. in neuroscienceMicrobiology and his B.Sc. from

Mount Holyoke College, her clinical research certification from the Boston University School of Medicine and her business training through the Greater Boston Executive Program at the MIT Sloan School of Management. Tel Aviv University. We believe Ms. MorrisonMr. Chimovits is qualified to serve on our board of directors due to her service as our Presidenthis vast operational and Chief Executive Officer, her yearsmanagerial experience in the biopharmaceutical industry, much of service as our Chief Operating Officer and her extensive knowledge of our company and industry.which took place in public companies.

Cheryl L. Cohen has served as a member of our board of directors since April 2015 and as a member ofcurrently serves on our audit committee, compensation committee, since September 2015.and nominating and corporate governance committee. Ms. Cohen currently serves as President of CLC Consulting, a pharmaceutical and biotechnology consulting firm specializing in new productstart-up and commercialization. From September 2011 until July 2014, Ms. Cohen served as Chief Commercial Officer of Medivation, Inc. Ms. Cohen currently serves as president of CLC Consulting,, a pharmaceutical and biotechnology consulting firm specializing in new productstart-up and commercialization, where she also served as president from September 2008 until September 2011.publicly traded biopharmaceutical company. From November 2007 to September 2008, she served as the vice president,Vice President, strategic commercial group, of Health Care Systems, Inc., a Johnson & Johnson company, and from October 1998 to November 2007, she worked at Janssen Biotech, Inc. (formerly Centocor Biotech, Inc.), a Johnson & Johnson company, in a variety of senior sales roles including vice president,Vice President, rheumatology franchise. Ms. Cohen began her career at Solvay Pharmaceuticals in a variety of sales positions. Ms. Cohen currently serves on the boardsboard of directors of Protein Sciences Corp., a private company, and Vital Therapies, Inc., a publicly-tradedbiotherapeutic company. Ms. Cohen received her B.A. from Saint Joseph College. We believe Ms. Cohen is qualified to serve on our board of directors due to her expertise in oncologydrug development and new drug commercialization.

Class II Directors

JosephKeith A. Yanchik, IIIKatkin is one of our foundershas been a member and has served as a memberthe Chair of our board of directors since August 2005May 2017 and currently serves on our audit committee and nominating and corporate governance committee. Mr. Katkin joined Otic as the Chairman of its board of directors in November 2015. Mr. Katkin currently serves as the Chief Executive Officer and a member of our audit committee since January 2012.the board of directors of Urovant Sciences Ltd,, a public biopharmaceutical company focused on developing novel therapies for urologic conditions. Mr. Yanchik served as our Chief Executive Officer from June 2005 until March 2008. Mr. Yanchik hasKatkin served as the President and Chief Executive Officer of Avanir Pharmaceuticals from 2007 through the company’s acquisition by Otsuka Pharmaceutical Co. Ltd. in 2015. Avanir Pharmaceuticals focused on the development, acquisition, and commercialization of therapeutic products for the treatment of central nervous system disorders. Prior to serving as a director, of Aileron Therapeutics, Inc., or Aileron, since January 2006.President and Chief Executive Officer, Mr. Yanchik previously served as Venture Partner at Apple Tree Partners, or Apple Tree, a life sciences investment firm, from June 2005 until September 2006,Katkin was the Senior Vice President of Corporate DevelopmentSales and Marketing at Mendel Biotechnology, Inc., and founder and Chief Business Officer of Poetic Genetics, Inc.Avanir. Prior to that,joining Avanir, Mr. Yanchik specializedKatkin served as the Vice President, Commercial Development for Peninsula Pharmaceuticals, playing a key role in corporatethe concurrent initial public offering and securities lawultimate sale of the company to Johnson and Johnson. Additionally, Mr. Katkin’s employment experience includes leadership roles at Cahill Gordon & ReindelInterMune, Amgen and Venture Law Group.Abbott Laboratories. Mr. Yanchik received a B.B.A. from Loyola CollegeKatkin currently serves on the board of directors of Syndax Pharmaceuticals, Inc. and a J.D.Rigel Pharmaceuticals, Inc. Mr. Katkin has an M.B.A. from the Villanova UniversityAnderson School of Law.at UCLA and earned his B.S. in Business and Accounting from Indiana University. Mr. Katkin became a licensed certified public accountant in 1995. We believe Mr. YanchikKatkin is qualified to serve on our board of directors due to his extensive business, legalyears of experience in and investment experience, hisextensive knowledge of our company and his experience as a chief executive officer of a life sciences company.the industry.

Class II DirectorJohn S. McBride

David A. Kessler, M.D.has served asbeen a member of our board of directors since March 2009, as a member of our compensation committee since September 2014 and as a member of our nominating and corporate governance committee since September 2014. Dr. Kessler became chair of our nominating and corporate governance committee in December 2015. Dr. Kessler hasMay 2017. Mr. McBride served as Professor of Pediatrics and Epidemiologyand Biostatistics at the University of California, San Francisco, or UCSF, School of Medicine since 2003. Dr. Kessler served as the Dean of the School of Medicine and the Vice Chancellor for Medical Affairs at UCSF from 2003 until 2007 and Dean of the Yale University School of Medicine from 1997 until 2003. Dr. Kessler served as Commissioner of the FDA from November 1990 until March 1997. He currently serves as a senior advisor to TPG Capital. Dr. Kessler was elected a member of the Institute of Medicine in 1993. Currently, Dr. Kessler serves on the board of directors of the following private companies: Immucor, Inc. and ASOthera Pharmaceuticals, Inc., or ASOthera. He previously served on the board of directors of Aptalis Pharma Inc. Dr. Kessler received a B.A. from Amherst College, a J.D. from The University of Chicago Law School and an M.D. from Harvard Medical School. In addition, Dr. Kessler received an Advanced Professional Certificate from the New York University Graduate School of Business Administration. We believe Dr. Kessler is qualified to serve on our board of directors due to his extensive healthcare and regulatory experience.

Class III Directors

Seth L. Harrison, M.D. is one of our founders and has served as a member of our board of directors since April 2005, including as chair of our board of directors since August 2005, and as a member of our compensation committee since January 2012. In September 1999, Dr. Harrison founded Apple Tree and since that time has served

as Apple Tree’s Managing Partner. In addition, Dr. Harrison previously served as our Chief Executive Officer from August 2008 until September 2011. Currently, Dr. Harrison serves as a member of the boards of directors of the following private companies, ASOthera, Cure Forward Corp. and Syntimmune, Inc., and as chair of the board of directors of Braeburn Pharmaceuticals, Inc. From November 2004 to August 2016, prior to HeartWare International’s acquisition by Medtronic, Dr. Harrison served as a member of the board of directors of HeartWare, a publicly-traded company. From 2002 until 2010, Dr. Harrison served as a member of the board of directors of the International Partnership for Microbicides, a Rockefeller Foundation/Gates Foundation sponsored public-private partnership engaged in the development ofanti-HIV microbicides. Dr. Harrison received an A.B. from Princeton University and an M.D. and M.B.A. from Columbia University, and completed a surgery internship at the Presbyterian Hospital in the City of New York. We believe Dr. Harrison is qualified to serve on our board of directors due to his strong medical and venture capital background, his extensive experience with development-stage companies such as ours and his service on the boards of directors of a range of public and private companies.

Stephen Buckley, Jr.has served as a member of our board of directors and as chair of our audit committee since January 2015 and has served on our nominating and corporate governance committee since December 2015. Mr. Buckley spent 25 years as a partner of Ernst & Young LLP, where he led assurance and advisory teams serving public and private companies in life sciences and other technologies. Mr. Buckley led Ernst & Young’s Life Sciences Industry Practice of New England from 1991 to 2006, and was Director of its New England Entrepreneurial Services Group from 1991 to 2001. He was previously a partner in the Boston, Massachusetts office of Arthur Young until its merger into Ernst & Young in 1989. Mr. Buckley is a member of the American Institute of CPAs. Mr. Buckley serves on the board of directors of Enanta Pharmaceuticals, Inc., a publicly-traded company. Mr. Buckley received an A.B. from Bowdoin College and a Master of Science in Accounting from Northeastern University. We believe Mr. Buckley is qualified to serve on our board of directors due to his extensive experience evaluating financial statements and financial reporting procedures.

Otic Transaction

On December 21, 2016, we entered into a Share Purchase Agreement, or Share Purchase Agreement, with Otic Pharma, Ltd., a private limited company organized under the laws of the State of Israel, or Otic, and the shareholders of Otic named therein, or the Selling Shareholders, pursuant to which, among other things, subject to the satisfaction or waiver of the conditions set forth in the Share Purchase Agreement, each Selling Shareholder agreed to sell to us, and we agreed to purchase from each Selling Shareholder, all of the ordinary and preferred shares of Otic, owned by such Selling Shareholder. We refer to our acquisition of all the outstanding equity of Otic as the Otic Transaction. We amended and restated the Share Purchase Agreement on March 2, 2017 to update the allocation of shares of our common stock among the Selling Shareholders, to update the manner in which Otic options and warrants are converted and to extend to May 31, 2017, the date after which we or Otic may terminate the Share Purchase Agreement.

Under the Share Purchase Agreement, effective upon the closing of the Otic Transaction, four members of our existing board of directors, Stephen Buckley, Jr., Seth L. Harrison, David A Kessler and Joseph A. Yanchik, III, will resign as directors. Following the closing of the Otic Transaction, our board of directors which will initially be fixed at seven members, will consist of (i) three members designated by Tokai, namely Cheryl L. Cohen, John S. McBride and Jodie P. Morrison and (ii) four members designated by Otic, namely Keith A. Katkin as Chairman, Gregory J. Flesher, Gary A. Lyons, and Erez Chimovits. Pursuant to the terms of the Share Purchase Agreement, it is anticipated that these directors will be appointed to the three staggered director classes of the combined company’s board of directors as follows:

Executive Officers

Set forth below is the name of our only executive officer who is not also a director, his age as of March 31, 2017, the positions he holds in our company, his principal occupation and his business experience for the past five years.

John S. McBride. Mr. McBride has served as ourTokai’s Chief Operating Officer sincefrom February 2014 to May 2017 and as ourTokai’s Chief Financial Officer sincefrom September 2016.2016 to May 2017. He previously served as ourTokai’s interim Chief Financial Officer from April 2014 until September 2014. Prior to joining our company,Tokai, Mr. McBride founded and served as President of Alliance Life Science Advisors, Inc., a consulting firm focused on assisting life science companies with strategic planning, business development and financing projects, where Mr. McBride was active from March 2012 until February 2014.2014 and became active again beginning in June 2017. Prior to founding Alliance Life Science Advisors, Inc., Mr. McBride was an independent consultant from January 2009 until March 2012. In addition, Mr. McBride previously served as Executive Vice President and Chief Operating Officer of Gloucester Pharmaceuticals, Inc., Global Head of Oncology Licensing at Pharmacia Corporation, Executive Vice President, Business Operations and Chief Financial Officer at CytoTherapeutics, Inc., Vice President, Business Development and Treasurer at Phytera, Inc., Vice President, Commercial Development at Sparta Pharmaceuticals, Inc. and Vice President, Business Development at U.S. Bioscience, Inc. Currently,Inc.. We believe Mr. McBride serves as chairman of theis qualified to serve on our board of directors due to his extensive knowledge of Intezyne,the Company and our industry.

Class III Directors

Gregory J. Flesherhas been a member of our board of directors and the Company’s Chief Executive Officer since May 2017. Mr. Flesher was appointed Chief Executive Officer of Otic in July 2015. Mr. Flesher has over 20 years of pharmaceutical industry experience. Prior to joining Otic, Mr. Flesher held positions as Senior Vice President and Chief Business Officer, Vice President of Business Development, and Senior Director of Commercial Strategy at Avanir Pharmaceuticals, Inc. From August 2008 until June 2013,from 2006 to 2015. Mr. McBride servedFlesher also held positions as Director of Hepatology Sales and Director of Pulmonary Marketing from 2002 to 2006 at InterMune, Inc., as well commercial roles in both the Oncology and Nephrology business units at Amgen, Inc. from 1999 to 2002. Mr. Flesher began his industry career at Eli Lilly and Company where he held positions in both clinical development and global marketing from 1995 to 1998. During his industry tenure, Mr. Flesher has participated in several drug development programs resulting in multiple product approvals and successful launches in the U.S. and Europe. Mr. Flesher earned his Bachelor of Science in Biology from Purdue University and studied Biochemistry and Molecular Biology at Indiana University School of Medicine. We believe Mr. Flesher is qualified to serve on our board of directors due to his tenure in the industry, which includes a number of senior leadership roles at other biopharmaceutical companies.

Gary A. Lyonshas been a member of our board of directors since May 2017 and currently serves on our audit committee and compensation committee. Mr. Lyons has more than 35 years of industry experience. Mr. Lyons is currently a member of the board of directors of Niiki PharmaNeurocrine Biosciences, Inc., a position he has held since 1993. Mr. McBride receivedLyons joined Neurocrine in 1993 as Chief Executive Officer until 2008. Mr. Lyons also serves on the board of directors of Vical, Inc., and is the Chairman of the board of directors for Rigel Pharmaceuticals and Retrophin Inc. He previously served on the board of directors of PDL BioPharma, Inc. and Facet Biotech Corporation following Facet’sspin-off from PDL, until Facet’s acquisition by Abbott Laboratories in April 2010. Mr. Lyons also previously served on the board of directors of NeurogesX, Inc. and KaloBios Pharmaceuticals, Inc., each a biopharmaceutical company. From 1983 to 1993, he held a number of management positions at Genentech, including Vice President of Business Development and Vice President of Sales, and also served as a member of Genentech’s Executive Committee. Mr. Lyons was responsible for international licensing, acquisitions and partnering for Genentech’s Corporate Venture Program and had operating responsibility for two subsidiaries, Genentech Canada, Inc. and Genentech Limited (Japan). He holds a B.S. in biochemistry and an M.S. in chemical engineeringMarine Biology from the University of WisconsinNew Hampshire and an M.B.A. from the WhartonNorthwestern University’s J.L. Kellogg Graduate School University of Pennsylvania.

Immediately following the completionManagement. We believe Mr. Lyons is qualified to serve on our board of directors due to his depth of knowledge of the Otic Transaction,industry and his many years of experience serving on the board of directors of biopharmaceutical companies.

Board Structure

Our corporate governance guidelines provide that the nominating and corporate governance committee shall periodically assess the board of directors’ leadership structure, including whether the offices of Chief Executive Officer and Chair of the board of directors should be separate. Our guidelines provide the board of directors with flexibility to determine whether the two roles should be combined or separated based upon our needs and the board of directors’ assessment of its leadership from time to time. We currently separate the roles of Chief Executive Officer and Chair of the board of directors. Our Chief Executive Officer is responsible for setting the strategic direction for our company and theday-to-day leadership and performance of our company, while our Chair of the board of directors presides over meetings of the board of directors, including executive sessions of the board of directors, and performs oversight responsibilities. Because we have an independent Chair, the board of directors has not appointed a separate lead independent director. Our board of directors has three standing committees that currently consist of, and are chaired by, independent directors. Our board of directors delegates substantial responsibilities to the committees, which then report their activities and actions back to the full board of directors. We believe that the independent committees of our board of directors and their chairpersons promote effective independent governance. We believe this structure represents an appropriate allocation of roles and responsibilities for our company at this time because it strikes an effective balance between management and independent leadership participation in our board of directors proceedings.

Executive Officers

Certain information regarding our executive management teamofficers who are not directors, as of May 15, 2019, is expected to be composed of the current executive team of Otic: Gregory J. Flesher, serving as President and Chief Executive Officer; Christine G. Ocampo, serving as Chief Financial and Compliance Officer; and Dr. set forth below.

Catherine C. Turkel, servingPharmD, MBA, PhD. has served as our Chief Development Officer.Officer since November 2015 and has served as our President since November 2017. She is responsible for leading Novus’ preclinical, clinical, regulatory, quality assurance and CMC functions globally. Dr. Turkel has more than 30 years of combined clinical practice and drug development experience. Dr. Turkel has successfully led global development project teams resulting in multiple registrations of new drug treatments around the world. Prior to Novus, Dr. Turkel held several R&D leadership positions at Allergan, Inc., including Vice President of Clinical Development for Neurology, Urology, and Pain, Vice President of Global Medical Affairs, and other positions between 1998 and 2015. Prior to Allergan, Dr. Turkel was Director of Drug Development, Regulatory Affairs and Data Management at Cypros Pharmaceuticals from 1995 to 1998. Dr. Turkel industry tenure also includes past positions at IVAC Corporation, California Clinical Trials, and Siemens Infusion Systems as well as many years as a hospital based critical care pharmacist. Dr. Turkel holds a Doctor of Pharmacy from the University of the Pacific, an MBA from the University of California, Irvine, and a Doctor of Philosophy in Business from Capella University.

Jon S. Kuwahara, CPA has served as our Senior Vice President of Finance and Administration since July 2017. He has over 25 years of finance and operations experience, primarily within the pharmaceutical industry. In his previous roles, Mr. Kuwahara directed all aspects of finance and accounting operations, including financial reporting, internal controls, treasury management, and budgeting. Prior to joining the Company, from June 2016 to June 2017, Mr. Kuwahara served as Vice President of Finance at Espero Pharmaceuticals, a private pharmaceutical company focused on the development and commercialization of cardiovascular products. Prior to Espero, from November 2014 to June 2016, Mr. Kuwahara served in multiple roles, most recently as Corporate Controller, at Avanir Pharmaceuticals. Prior to Avanir, from October 2010 to October 2014, Mr. Kuwahara served as Assistant Corporate Controller at Questcor Pharmaceuticals, a public specialty pharmaceutical company (acquired by Mallinckrodt Pharmaceuticals). Since December 2015, Mr. Kuwahara has served as a member of the Board of Directors, and Chairman of the Audit Committee, for Emmaus Life Sciences, Inc., a biopharmaceutical company focused on rare and orphan diseases. Mr. Kuwahara holds a B.B.A. with emphasis in accounting from the University of Hawaii and is a certified public accountant in California and Hawaii.

Code of Business Conduct and Ethics

We have adopted a written code of business conduct and ethics that applies to our directors, officers and employees, including our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions. A copy of the code is available on the Corporate Governance section of our website, which is located at http://ir.novustherapeutics.com/corporate-governance/governance-overview. We intend to disclose on our website any amendments to, or waivers from, the code of business conduct and ethics that are required to be disclosed pursuant to the disclosure requirements of Item 5.05 of Form8-K.

Corporate Governance Matters

Our board of directors believes that good corporate governance is important to ensure that our company is managed for the long-term benefit of stockholders. This section describes key corporate governance policies and practices that our board of directors has adopted. Complete copies of our corporate governance guidelines, committee charters and code of conduct are available on the Corporate Governance section of our website, which is located at http://ir.novustherapeutics.com/corporate-governance/governance-overview. Alternatively, you can request a copy of any of these documents by writing us at Novus Therapeutics, Inc., 19900 MacArthur Boulevard, Suite 550, Irvine, California 92612, Attention: Investor Relations.

Audit Committee

We have established an audit committee, which operates under a charter approved by our board of directors. The members of our audit committee are Cheryl L. Cohen, Keith A. Katkin and Gary A. Lyons. Mr. Lyons chairs the audit committee. Our board of directors has determined that Keith A. Katkin and Gary A. Lyons each qualifies as an “audit committee financial expert” within the meaning of applicable SEC rules. Each member of audit committee satisfies the independence standards for audit committees established by the SEC and the Nasdaq Listing Rules, including the independence requirements contemplated byRule 10A-3 under the Exchange Act. The audit committee held four meetings during fiscal 2018.

Section 16(a) Beneficial Ownership Reporting Compliance

Section 16(a) of the Exchange Act requires our directors and officers and holders of more than 10% of our common stock to file with the SEC initial reports of ownership of our common stock and other equity securities on a Form 3 and reports of changes in such ownership on a Form 4 or Form 5. Directors and officers and holders of 10% of our common stock are required by SEC regulations to furnish us with copies of all Section 16(a) forms they file. To our knowledge, based solely on a review of our records and representations made by our directors and officers regarding their filing obligations, all Section 16(a) filing requirements were satisfied with respect to fiscal 2016.2018.

Item 11. Executive Compensation.

Executive Compensation

This section discusses the material elements of our executive compensation policies for our “named executive officers” and the most important factors relevant to an analysis of these policies. For 2016,2018, our “named executive officers” are Jodie P. Morrison,include Gregory J. Flesher, our President and Chief Executive Officer, and our two other most highly compensated executive officers who served during the year ended December 31, 2016, John2018, Catherine C. Turkel, our President, and Jon S. McBride,Kuwahara, our Chief Operating OfficerSenior Vice President of Finance and Chief Financial Officer, and Lee H. Kalowski, our former Chief Financial Officer.Administration. In addition, this section provides qualitative information regarding the manner and context in which compensation is awarded to and earned by our named executive officers and is intended to place in perspective the data presented in the following tables and the corresponding narrative.

Summary Compensation Table

The following table sets forth information regarding compensation earned by our named executive officers during the years ended December 31, 20162018 and 2015.2017.

In fiscal 2018, our compensation committee generally consultsconsulted with external advisors for annual review of compensation, in fiscal 2016, our compensation committee did not consult with an independent compensation consultant.Radford to advise on executive compensation.

Base Salary

For 2016, Ms. Morrison’s2018, Mr. Flesher’s annual base salary was $525,000, Mr. McBride’s$463,500, Dr. Turkel’s annual base salary was $407,804$360,500 and Mr. Kalowski’sKuwahara’s annual base salary was $320,000. Mr. Kalowski ceased his employment with us in August 2016. No adjustments were made to the base salaries for Ms. Morrison or Mr. McBride for 2017.$283,300. We use base salaries to recognize the experience, skills, knowledge and responsibilities required of all our employees, including our named executive officers. None of our named executive officers is currently party to an employment agreement or other agreement or arrangement that provides for automatic or scheduled increases in base salary.

Annual Bonus

Our board of directors may, in its discretion, award bonuses to our named executive officers from time to time. We typically establish

In early 2018, our compensation committee established annual bonus targets based around a setfor each of specifiedMr. Flesher, Dr. Turkel and Mr. Kuwahara of up to 50%, 40%, and 30% of their respective base salaries and corporate performance goals for 2018 and the weighting for each goal. These corporate performance goals included key strategic goals related to drug development, the commencement of certain clinical programs, intellectual property exclusivity activities, and financing and cash management. In March 2019, our compensation committee met to review and consider the level of corporate goals that were achieved for the purposes of making its recommendation to our board of directors regarding the amount of the annual cash bonus earned by our named executive officers for 2018 and conduct an annual performance review to determine the attainment of such goals. Our management may propose bonus awards to thebe paid in 2019. The compensation committee determined that these goals, in the aggregate, had an 82.5% level of the board or the board primarily based on such review process. Ourachievement. The compensation committee recommended, and our board of directors makesapproved, the final determination82.5% level of achievement on the eligibility requirements2018 corporate performance goals and a 2018 annual cash bonus, paid in 2019, of $191,194 for Mr. Flesher, $118,965 for Dr. Turkel, and the amount$70,117 for Mr. Kuwahara.

For 2019, our compensation committee established annual targets for each of such bonus awards. For 2016, Ms. Morrison, Mr. McBrideFlesher, Dr. Turkel and Mr. Kalowski were eligible for performance bonusesKuwahara of up to 50%, 35%40%, and 35%30% of their respective base salaries. We did not award bonusessalaries and corporate performance goals and the weighting for each goal. These corporate performance goals included key strategic goals related to any employees for 2016, including Ms. Morrison, Mr. McBride or Mr. Kalowski.certain clinical program milestones and financing activities.

Equity Incentives

Although we do not have a formal policy with respect to the grant of equity incentive awards to our executive officers or any formal equity ownership guidelines applicable to them, we believe that equity grants provide our executives with a strong link to our long-term performance, create an ownership culture and help to align the interests of our executives and our stockholders. In addition, we believe that equity grants with a time-based vesting feature promote executive retention because this feature incentivizes our executive officers to remain in our employment during the vesting period. Accordingly, our compensation committee and board of directors periodically review the equity incentive compensation of our named executive officers and from time to time may grant equity incentive awards to them in the form of stock options or restricted stock unit awards.

In 2016, we did not make grantsMarch 2018, as part of equity incentiveits annual compensation review, the compensation committee awarded Mr. Flesher an option to purchase 56,500 shares of common stock and 30,700 performance restricted stock units (“RSUs”), Dr. Turkel an option to purchase 24,000 shares of common stock and 20,000 performance RSUs, and Mr. Kuwahara an option to purchase 12,000 shares of common stock and 11,250 performance RSUs. All of these awards are subject to our named executive officers.time-based or performance vesting. For the outstanding equity awards held by our named executed officers see “—Outstanding“Outstanding Equity Awards at Fiscal Year End 2016”2018” below.

Outstanding Equity Awards at Fiscal Year End 20162018

The following table sets forth information regarding outstanding equity awards held by our named executive officers asduring the year ended of December 31, 2016.2018.

Employment Agreements and Potential Payments upon Termination or Change in Control

Jodie P. MorrisonEmployment Agreements

In June 2013, in connection with our appointment of Ms. Morrison as our PresidentMr. Flesher, Dr. Turkel and Chief Executive Officer, we entered intoMr. Kuwahara are each party to an employment agreement with Ms. Morrison. Thethe Company. Each employment agreement establishes Ms. Morrison’s title, her base salary, her eligibility for an annual bonus and her eligibility for benefits made available to employees generally and also provides, for certain benefits upon termination of her employment under specified conditions. Ms. Morrison’s employmentamong other things, that in the event the applicable executive officer is at will. In October 2014, the compensation committee approved amendments to the employment agreement with Ms. Morrison to modify the benefits provided under that agreement upon termination of Ms. Morrison’s employment.

Under the terms of the employment agreement with Ms. Morrison, if Ms. Morrison’s employment is terminated by us without cause or by Ms. Morrison for good reason prior to a change in control, each as defined in her employment agreement, and subject to Ms. Morrison’s execution of a general release of potential claims against us, we have agreed to continue to pay Ms. Morrison her then current base salary for a period ofan involuntary termination within 12 months and to provide medical and dental benefits (to the extent that she was receiving them at the time she ceased to be employed by us) for a period of up to 12 months.

In lieu of receiving the benefits described above in connection with a termination of employment, if Ms. Morrison’s employment is terminated by us without cause or by Ms. Morrison for good reason upon or within one year following a change in control and subjectof the Company, the executive officer is entitled to Ms. Morrison’s executionreceive: (i) acceleration of 100% of such officer’s unvested Company equity-based awards; (ii) a general releaselump sum severance payment equal to a multiple of potential claims against us, we have agreed to continue to pay Ms. Morrison her then-currentthe sum of (x) the annual base salary for a period of 18 months and to provide medical and dental benefits (towhich the extent that sheofficer was receiving them atimmediately prior to the time she ceased to be employedqualifying termination, plus (y) the larger of (1) the officer’s annual target bonus or (2) the annual bonus earned by us)the officer for the year preceding the year of termination; (iii) a period of up to 18 months and to pay her an amountlump sum payment equal to hera pro rata portion of such officer’s target annual bonus amount for the year in which the qualifying termination occurs.

In addition, with respectoccurs, and (iv) continuation of payment by the Company of the full cost of the health insurance benefits provided to each stock optionsuch officer for a specified period. The employment agreement further provides, among other things, that we have granted Ms. Morrison that has not yet vested, we have agreed that if Ms. Morrison is terminated without cause or resigns for good reason in connection with or within one year after a change in control of our company (as defined in the event the applicable stock option agreement), then that stock option will vest in full.

The Otic Transaction constitutes a change in control under the employment agreement and the stock option agreements entered into with Ms. Morrison.

John S. McBride

Mr. McBride’s employment agreement establishes Mr. McBride’s title, his base salary, his eligibility for an annual bonus and his eligibility for benefits made available to employees generally and also provides for certain benefits upon termination of his employment under specified conditions. In October 2014, the compensation committee approved amendments to the employment agreement with Mr. McBride to modify the benefits provided under that agreement upon termination of Ms. Morrison’s employment.

Under the terms of Mr. McBride’s employment agreement, if Mr. McBride’sofficer’s employment is terminated by us withoutthe Company other than for cause, and subject to Mr. McBride’s execution of a general release of potential claims against us, we have agreed to continue to pay Mr. McBride’s then-current base salarydeath or disability or by him or her for a period of six months and to provide medical and dental benefits (to the extent that he was receiving them at the time he ceased to be employed by us) for a period of up to six months.

In lieu of receiving the benefits described abovegood reason (in each case not in connection with a termination of employment, if Mr. McBride’s employment is terminated by us without cause or by Mr. McBride for good reason upon or within one year following a change in control, and subjectcontrol), the officer will receive (i) severance payments for a specified period after the date of termination equal to Mr. McBride’s execution of a general release of potential claims against us, we have agreed to continue to pay Mr. McBride his then-currentthe base salary which the officer was receiving immediately prior to the qualifying termination; and (ii) continuation of payment by the Company of the full cost of the health insurance benefits provided to such officer for a period of 12 months and to provide medical and dental benefits (to the extent that he was receiving them at the time he ceased to be employed by us) for a period of up to 12 months and to pay him an amount equal to his target bonus for the year in which the termination occurs.

In addition, under each stock option agreement that we have entered into with Mr. McBride and has not yet vested, we have agreed that if Mr. McBride is terminated without cause or resigns for good reason in connection with or within one year after a change in control of our company (as defined in the applicable stock option agreement), then that stock option will vest in full.

The Otic Transaction constitutes a change in control under the employment agreement and the stock option agreements entered into with Mr. McBride.

Lee H. Kalowski

Mr. Kalowski’s employment agreement established his title, his base salary, his eligibility for an annual bonus and his eligibility for benefits made available to employees generally and also provides for certain benefits upon termination of his employment under specified conditions. Pursuant to Mr. Kalowski’s employment agreement, in January and April 2015, we paid Mr. Kalowski an aggregate of $30,000 as reimbursement for relocation expenses. Mr. Kalowski’s employment was at will.

In October 2014, the compensation committee of the board of directors approved amendments to the employment agreement with Mr. Kalowski to modify the benefits provided under that agreement upon termination of Mr. Kalowski’s employment. Under the terms of the revised employment agreement with Mr. Kalowski, if Mr. Kalowski’s employment was terminated by us without cause or by Mr. Kalowski for good reason prior to a change in control, each as defined in his employment agreement, and subject to Mr. Kalowski’s execution of a general release of potential claims against us, we agreed to continue to pay Mr. Kalowski his then-current base salary for a period of six months and to provide medical and dental benefits (to the extent that he was receiving them at the time he ceased to be employed by us) for a period of up to six months. Mr. Kalowski received these benefits in connection with his cessation of employment with us on August 31, 2016.

In connection with Mr. Kalowski ceasing employment with us on August 31, 2016, we entered into a consulting agreement with Mr. Kalowski, under which Mr. Kalowski agreed to perform certain consulting and other services through April 30, 2017.

Other Agreements

We have also entered into employee confidentiality, inventions,non-solicitation, andnon-competition agreements with each of our named executive officers. Under the employee confidentiality, inventions,non-solicitation, andnon-competition agreements, each named executive officer has agreed (1) not to compete with us during his or her employment and for a period of one year after the termination of his or her employment, (2) not to solicit our employees during his or her employment and for a period of one year after the termination of his or her employment, (3) to protect our confidential and proprietary information and (4) to assign to us related intellectual property developed during the course of his or her employment.period.

401(k) Retirement Plan

We maintain a 401(k) retirement plan that is intended to beatax-qualified defined defined contribution plan under Section 401(k) of the Internal Revenue Code. In general, all of our employees are eligible to participate, beginning on the first day of the month following commencement of their employment. The 401(k) plan includes a salary deferral arrangement pursuant to which participants may elect to reduce their current compensation by up to the statutorily prescribed limit, equal to $18,000$18,500 in 2016,2018, and have the amount of the reduction contributed to the 401(k) plan. Effective January 1, 2016, we determined to make matching contributions at a rate of 100% of each employee’s contribution up to a maximum matching contribution of 3% ofIn 2018, the employee’s compensation and 50% of each employee’s contribution in excess of 3% up to a maximum of 5% of the employee’s contribution.Company did not match any employee contributions.

Limitation of Liability and Indemnification

As permitted by Delaware law, we have adopted provisions in our certificate of incorporation that limit or eliminate the personal liability of our directors. Our certificate of incorporation limits the liability of directors to the maximum extent permitted by Delaware law. Delaware law provides that directors of a corporation will not be personally liable for monetary damages for breaches of their fiduciary duties as directors, except liability for:

These limitations do not apply to liabilities arising under federal securities laws and do not affect the availability of equitable remedies, including injunctive relief or rescission. If Delaware law is amended to authorize the further elimination or limiting of a director, then the liability of our directors will be eliminated or limited to the fullest extent permitted by Delaware law as so amended.

As permitted by Delaware law, our certificate of incorporation also provides that:

The indemnification provisions contained in our certificate of incorporation are not exclusive. In addition, we have entered into indemnification agreements with each of our directors and executive officers. Each of these indemnification agreements provides, among other things, that we will indemnify such director or executive officer to the fullest extent permitted by law for claims arising in his or her capacity as a director or executive officer, as applicable, provided that he or she acted in good faith and in a manner that he or she reasonably believed to be in, or not opposed to, our best interests and, with respect to any criminal proceeding, had no reasonable cause to believe that his or her conduct was unlawful. Each of these indemnification agreements provides that in the event that we do not assume the defense of a claim against a director or executive officer, as applicable, we are required to advance his or her expenses in connection with his or her defense, provided that he or she undertakes to repay all amounts advanced if it is ultimately determined that he or she is not entitled to be indemnified by us.

We believe that these provisions and agreements are necessary to attract and retain qualified persons as directors and executive officers. Insofar as indemnification for liabilities arising under the Securities Act of 1933, as amended, may be permitted to directors, officers or persons controlling our company pursuant to the foregoing provisions, we understand that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable.

In addition, we maintain standard policies of insurance under which coverage is provided to our directors and officers against losses arising from claims made by reason of breach of duty or other wrongful act, and to us with respect to payments which may be made by us to such directors and officers pursuant to the above indemnification provisions or otherwise as a matter of law.

Director Compensation

Our board of directors has approved a compensation policy for ournon-employee directors that is designed to provide a total compensation package that enables us to attract and retain qualified and experienced individuals to serve as directors and to align our directors’ interests with those of our stockholders. OurFollowing the consummation of the Otic Transaction and the resulting reverse split of our common stock, the compensation committee engaged with its independent compensation consultant to review the Company’s compensation practices for non-employees directors. As a result of this compensation review, the board of directors approved the following compensation fornon-employee directors, are compensated for their services on our boardcommencing as of directors as follows:June 30, 2018:

The stock options granted to ournon-employee directors will have an exercise price equal to the fair market value of our common stock on the date of grant and will expire ten years after the date of grant. The initial stock options granted to our future newly electednon-employee directors will, subjectSubject to the director’s continued service on our board vest with respect toone-thirdof the shares on the first anniversary of the grant date and quarterly thereafter until the third anniversary of the date of grant. The annual stock options granted to ournon-employeedirectors, will, subject to the director’s continued service on our board, vest with respect to 100% of the shares on the first anniversary of the grant date. The initial and annual stock options granted to ournon-employee directors will vest in full with respect toon the shares then underlying such options upon a change in control.first anniversary from the date of grant.

The annual cash fee will be payable quarterly in arrears on the last day of each quarter. The amount of each payment will be prorated for any portion of a quarter that a director is not serving on our board.board of directors.

Eachnon-employee director is also entitled to reimbursement for reasonable travel and other expenses incurred in connection with attending meetings of the board of directors and any committee on which he or she serves.

The following table sets forth information regarding compensation earned by ournon-employee directors (including directors no longer serving as of December 31, 2018) during 2016.2018.

Fiscal Year 2018 Director Compensation Table

ITEMItem 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERSSecurity Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

Security Ownership of Certain Beneficial Owners and Management

TheUnless otherwise provided below, the following table presentssets forth information as to theregarding beneficial ownership of our common stock as of JanuaryMarch 31, 2017:2019 by:

Beneficial ownership is determined in accordance with the rules and regulations of the SEC and generally includes voting or investment power with respect to securities. Unless otherwise indicated below, to our knowledge, the persons and entities named in the table have sole voting and sole investment power with respect to all shares beneficially owned, subject to community property laws where applicable.common stock. Shares of our common stock subject to options or restricted stock unit awards that are currently exercisable or will become exercisable within 60 days of Januaryafter March 31, 20172019 are deemed to beconsidered outstanding and to be beneficially owned by the person holding the options or restricted stock units for the purpose of computingcalculating the percentage ownership of that person, but are not treated as outstanding for the purpose of computingcalculating the percentage ownership of any other person.

The percentage Except as otherwise noted, to our knowledge, the persons and entities in this table have sole voting and investing power with respect to all of shares beneficially owned as of January 31, 2017 is based on 22,641,651the shares of our common stock issued andbeneficially owned by them, subject to applicable community property laws. The inclusion herein of any shares as beneficially owned does not constitute an admission of beneficial ownership.

The column entitled “Percentage of Shares Beneficially Owned” is based on a total of 9,447,361 shares of our common stock outstanding as of JanuaryMarch 31, 2017. Unless2019. Except as otherwise indicated,set forth below, the address of each of the individuals and entities named belowbeneficial owner is c/o Tokai Pharmaceuticals,Novus Therapeutics, Inc., 255 State Street, 6th Floor, Boston, Massachusetts 02109.19900 MacArthur Boulevard, Suite 550, Irvine, California 92612. Beneficial ownership representing less than one percent of our outstanding common stock is denoted with an “*.”

Securities Authorized for Issuance Under Equity Compensation Plans

The following table contains information about our equity compensation plans as of December 31, 2016.2018. As of December 31, 2016,2018, we had three equity compensation plans, each of which was approved by our stockholders: our 2007 Stock Incentive Plan or 2007 Plan, our 2014 Stock Incentive Plan or 2014 Plan, and our 2014 Employee Stock Purchase Plan, or 2014 ESPP.

Equity Compensation Plan Information

ITEMItem 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCECertain Relationships and Related Transactions, and Director Independence.

Policies and Procedures for Related Person Transactions

Our board of directors has adopted a written related person transaction policy to set forth policies and procedures for the review and approval or ratification of related person transactions. This policy covers any transaction, arrangement or relationship, or any series of similar transactions, arrangements or relationships, in which we were or are to be a participant, the amount involved exceeds the lesser of $120,000 or one percent of the average of the our total assets at year end for the last two completed fiscal years, and a related person had or will have a direct or indirect material interest, including, without limitation, purchases of goods or services by or from the related person or entities in which the related person has a material interest, indebtedness, guarantees of indebtedness and employment by us of a related person.

Our related person transaction policy contains exceptions for any transaction or interest that is not considered a related person transaction under SEC rules as in effect from time to time. In addition, the policy provides that an interest arising solely from a related person’s position as an executive officer of another entity that is a participant in a transaction with us will not be subject to the policy if each of the following conditions is met:

The policy provides that any related person transaction proposed to be entered into by us must be reported to our chief executive officerChief Executive Officer or chief financial officerChief Financial Officer and will be reviewed and approved by our audit committee in accordance with the terms of the policy, prior to effectiveness or consummation of the transaction whenever practicable. The policy provides that if our chief executive officerChief Executive Officer or chief financial officerChief Financial Officer determines that advance approval of a related person transaction is not practicable under the circumstances, our audit committee will review and, in its discretion, may ratify the related person transaction at the next meeting of the audit committee. The policy also provides that alternatively, our chief executive officerChief Executive Officer or chief financial officerChief Financial Officer may present a related person transaction arising in the time period between meetings of the audit committee to the chair of the audit committee, who will review and may approve the related person transaction, subject to ratification by the audit committee at the next meeting of the audit committee.

In addition, the policy provides that any related person transaction previously approved by the audit committee or otherwise already existing that is ongoing in nature will be reviewed by the audit committee annually to ensure that such related person transaction has been conducted in accordance with the previous approval granted by the audit committee, if any, and that all required disclosures regarding the related person transaction are made.

The policy provides that transactions involving compensation of executive officers will be reviewed and approved by our compensation committee in the manner to be specified in the charter of the compensation committee.

A related person transaction reviewed under this policy will be considered approved or ratified if it is authorized by the audit committee in accordance with the standards set forth in the policy after full disclosure of the related person’s interests in the transaction. As appropriate for the circumstances, the policy provides that the audit committee will review and consider:

The policy provides that the audit committee will review all relevant information available to it about the related person transaction. The policy provides that the audit committee may approve or ratify the related person transaction only if the audit committee determines that, under all of the circumstances, the transaction is in, or is not inconsistent with, our best interests. The policy provides that the audit committee may, in its sole discretion, impose such conditions as it deems appropriate on us or the related person in connection with approval of the related person transaction.

Related Person Transactions

In September 2016, weOn January 31, 2017, the Company entered into a consultingstock purchase agreement or(the “Stock Purchase Agreement”) with certain purchasers named therein (the “Purchasers”), including certain holders of more than 5% of the Apple Tree Consulting Agreement, with Apple Tree Life Sciences, Inc.Company’s capital stock (Pontifax (Israel) III L.P., or Apple Tree, under which Apple Tree agreed to provide consulting, advisoryPontifax (Cayman) III L.P., and related services toPeregrine Ventures Management Ltd.) and for us from time to time. There is no fee for these services except for reimbursement of out of pocket expenses. Affiliates of Apple Tree beneficially own approximately 35%certain current and former officers of the Company (Gregory J. Flesher, Catherine C. Turkel, and Dr. Seth Harrison,Christine Ocampo). Pursuant to the Stock Purchase Agreement, the Purchasers agreed to purchase approximately $4.0 million of the Company’s common stock through the purchase of 400,400 shares of the Company’s common stock at a memberprice of our board$9.99 per share (the “Private Placement”). The Private Placement closed on May 10, 2017.

As previously disclosed, as part of directors, is a principal of Apple Tree.the Otic Transaction, the Company entered into various arrangements with current and former officers and directors. For more information regarding these arrangements and the Private Placement, see the disclosures in the Definitive Proxy Statement on Schedule 14A filed by the Company on April 7, 2017.

Other than the Apple Tree Consulting AgreementPrivate Placement, the Otic Transaction, and the compensation arrangements for our named executive officers and directors, which are described elsewhere in the “Executive Compensation” and “DirectorDirector Compensation” sections of this Amendment,proxy statement, we have not been a party to any transaction since January 1, 20162017 in which the amounts involved exceeded or will exceed the lesser of $120,000 or one percent of the average of our total assets at year end for the last two years, and any of our directors, executive officers nominees for director or holders of more than 5% of our capital stock, or any member of the immediate family of, or person sharing the household with, the foregoing persons, had or will have a direct or indirect material interest.

Board Determination of Independence

Rule 5605 of the NASDAQNasdaq Listing Rules requires a majority of a listed company’s board of directors to be comprised of independent directors within one year of listing. In addition, the NASDAQNasdaq Listing Rules require that, subject to specified exceptions, each member of a listed company’s audit, compensation and nominating and corporate governance committees be independent under the Securities Exchange Act of 1934, as amended, or the Exchange Act. Audit committee members must also satisfy the independence criteria set forth in Rule10A-3 under the Exchange Act, and compensation committee members must also satisfy the independence criteria set forth in Rule10C-1 under the Exchange Act. Under Rule 5605(a)(2) of the NASDAQNasdaq Listing Rules, a director will only qualify as an “independent director” if, in the opinion of our board of directors, that person does not have a relationship that would interfere with the exercise of independent judgment in carrying out the responsibilities of a director. In order to be considered independent for purposes of Rule10A-3, a member of an audit committee of a listed company may not, other than in his or her capacity as a member of the audit committee, the board of directors, or any other board committee, accept, directly or indirectly, any consulting, advisory, or other compensatory fee from the listed company or any of its subsidiaries or otherwise be an affiliated person of the listed company or any of its subsidiaries. In order to be considered independent for purposes of Rule10C-1, the board must consider, for each member of a compensation committee of a listed company, all factors specifically relevant to determining whether a director has a relationship to such company which is material to that director’s ability to be independent from management in connection with the duties of a compensation committee member, including, but not limited to: (1) the source of compensation of the director, including any consulting advisory or other compensatory fee paid by such company to the director; and (2) whether the director is affiliated with the company or any of its subsidiaries or affiliates.

Our board of directors undertook a review of the composition of our board of directors and its committees and the independence of each director. In 2016, basedBased upon information requested from and provided by each

director concerning his or her background, employment and affiliations, including family relationships, our board of directors has determined that each of the directors who currently serves (or during 2018 served) on our directors,board, with the exceptionexceptions of Gregory J. Flesher, John S. McBride and Jodie P. Morrison, wasis an “independent director” as defined under Rule 5605(a)(2) of the NASDAQNasdaq Listing Rules. Ms. MorrisonRules (or was independent during the time of service on our board). Mr. Flesher is not an independent director under Rule 5605(a)(2) because shehe is our Chief Executive Officer. Mr. McBride is not an “independent director” as defined under Rule 5605(a)(2) because he was our Chief Operating Officer until May 2017. Ms. Morrison was not an “independent director” as defined under Rule 5605(a)(2) because she was the President and Chief Executive Officer. Officer of Tokai until May 2017.

Our board of directors also determined that Stephen Buckley, Jr., Cheryl L. Cohen, Keith A. Katkin and JosephGary A. Yanchik, III,Lyons, who were members ofcurrently serve on our audit committee, during 2016, Cheryl L. Cohen, Seth L. Harrison and David A. Kessler, who were members of our compensation committee during 2016 and David A. Kessler and Stephen Buckley, Jr., who were members of our nominating and corporate governance committee during 2016, satisfy the independence standards for suchaudit committees established by the SEC and the NASDAQNasdaq Listing Rules, as applicable, including in the case of all members of the audit committee, the independence requirements contemplated byRule10A-3 under the Exchange ActAct. In addition, our board of directors determined that Cheryl L. Cohen and inGary A. Lyons, who currently serve on our compensation committee, satisfy the case of all members ofindependence standards for compensation committees established by the compensation committee,SEC and the Nasdaq Listing Rules, including the independence requirements contemplated byRule10C-1 under the Exchange Act. In making such determinations, our board of directors considered the relationships that each suchnon-employee director has with our company and all other facts and circumstances our board of directors deemed relevant in determining independence, including the beneficial ownership of our capital stock by eachnon-employee director.

ITEM 14.

PRINCIPAL ACCOUNTANT FEES AND SERVICES

Item 14. Principal Accounting Fees and Services.

Dismissal of PricewaterhouseCoopers

As previously disclosed in our Current Report onForm 8-K filed on May 15, 2017, PricewaterhouseCoopers LLP(“PwC”), an independent registered public accounting firm, served as our independent auditors until May 10, 2017 when our audit committee dismissed PwC in connection with the closing of the Otic Transaction and the appointment of EY.

During the interim period through May 10, 2017, there were no disagreements (as that term is defined in Item 304(a)(1)(iv) of RegulationS-K and related instructions) between us and PwC on any matter of accounting principles or practices, financial statement disclosure or auditing scope or procedures which disagreements, if not resolved to the satisfaction of PwC would have caused PwC to make reference thereto in their reports on the financial statements.

As disclosed in our Current Report onForm 8-K filed May 15, 2017, we provided PwC with a copy of the disclosures it made in theForm 8-K (which are repeated above) and requested that PwC furnish us with a letter addressed to the Securities and Exchange Commission stating whether it agrees with the statements contained herein. A copy of PwC’s letter, dated May 12, 2017, was filed as Exhibit 16.1 to our Current Report onForm 8-K filed on May 15, 2017.

During the interim period through May 10, 2017, neither we, nor anyone acting on its behalf, consulted with EY regarding: (i) the application of accounting principles to a specified transaction, either completed or proposed, or the type of audit opinion that may be rendered on our financial statements, and EY did not provide either a written report or oral advice to the Company that was an important factor considered by us in reaching a decision as to the accounting, auditing or financial reporting issue, or (ii) any matter that was either the subject of a disagreement (as defined in Item 304(a)(1)(iv) ofRegulation S-K and the related instructions) or a reportable event (as described in Item 304(a)(1)(v) ofRegulation S-K).

Audit Fees and Services

EY was our independent registered public accounting firm for the years ended December 31, 20162018 and December 31, 2015.2017. The following table summarizes the fees of PricewaterhouseCoopers LLPEY billed to us for each of the last two fiscal years. All of such services and fees werepre-approved by our audit committee in accordance with the“Pre-Approval Policies and Procedures” described below.