UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): June 4, 2017

 

 

Novan, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

 

 

 

 

 

 

 

 

Delaware

 

001-37880

 

20-4427682

 

 

(State or other jurisdiction of

incorporation or organization)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

4105 Hopson Road, Morrisville, North Carolina 27560

(Address of principal executive offices) (Zip Code)

(919) 485-8080

(Registrant’s telephone number, include area code)

N/A

(Former Name or Former Address, if Changed Since Last Report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company

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.

 


 

 

 

Item 5.02.

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

Effective June 4, 2017, Nathan Stasko, formerly the President and Chief Executive Officer of Novan, Inc. (the “Company”) has transitioned to the role of President and Chief Scientific Officer of the Company, and G. Kelly Martin, currently serving on the Company’s Board of Directors (the “Board”), has been appointed to serve as the Company’s Chief Executive Officer on an interim basis. Additional information about Mr. Martin can be found in the Company’s definitive proxy statement, filed with the Securities and Exchange Commission on April 17, 2017. Effective with this transition, Mr. Martin has stepped down from the Compensation Committee of the Board.

 

In connection with the transition, the Company and Dr. Stasko have entered into an amendment (the “Amendment”) to the Amended and Restated Employment Agreement, dated April 13, 2016, between the Company and Dr. Stasko (the “Agreement”). The Amendment provides that Dr. Stasko will receive a base salary equal to his current base salary of $400,000 and, subject to approval of the Board, a grant of options to purchase up to 80,000 shares of the Company’s common stock, which shares will vest in accordance with performance terms to be established by Board. The establishment of performance criteria and the grant will be completed by June 30, 2017. Following the appointment of a Chief Executive Officer of the Company (subsequent to Mr. Martin’s appointment as Chief Executive Officer on an interim basis) and upon request of the Board, Dr. Stasko has agreed to resign from his positions as either President or as a director of the Company, or both, as requested. Upon termination without cause or for good reason, Dr. Stasko, in addition to the other items outlined in the Agreement, will receive (i) vesting of any time-based options that would have vested during the calendar year but for the termination, provided that they are exercised within 90 days of the termination date and (ii) payment of any bonus earned from a prior calendar year but not yet paid, to be paid in a lump sum, less applicable withholdings. Dr. Stasko has agreed that the changes in position and duties addressed in the Amendment, including future resignation as president or a director will not trigger “Good Reason” under the Agreement.

The foregoing description of the Amendment does not purport to be complete and is qualified in its entirety by reference to the full text of the Amendment, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

Item 7.01.

Regulation FD Disclosure.

 

 

On June 5, 2017, the Company announced certain changes to its executive leadership structure. The full text of this press release is furnished herewith as Exhibit 99.1 to this Current Report and incorporated herein by reference.

 

The information in this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section. Furthermore, the information in this report shall not be deemed incorporated by reference into the filings of the Company under the Securities Act of 1933, as amended.

 

Item 9.01.

Financial Statements and Exhibits.

 

 

(d)

Exhibits

 

See the Exhibit Index which follows the signature page of this Current Report on Form 8-K, which is incorporated herein by reference.

 

 

 


 

 

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 hereunto duly authorized.

 

 

 

 

 

 

 

 

 

 

 

 

Novan, Inc.

 

 

 

 

Date: June 5, 2017

 

 

 

By:

 

/s/ G. Kelly Martin

 

 

 

 

 

 

 

 

 

 

 

 

 

G. Kelly Martin

 

 

 

 

 

 

Interim Chief Executive Officer

 


 

 

EXHIBIT INDEX

 

 

 

 

Exhibit No.

 

Description

 

 

10.1

 

First Amendment, dated June 4, 2017, to Amended and Restated Employment Agreement, dated April 13, 2016, between the Company and Nathan Stasko.

99.1

 

Press Release dated June 5, 2017.

 

 

Exhibit 10.1

FIRST AMENDMENT TO

amended and restated employment agreement

This First Amendment to the Amended and Restated Employment Agreement (“Amendment”) is effective as of June 4, 2017, and made and entered into by and among Novan, Inc., a Delaware corporation with its principal place of business in Durham County, North Carolina (the “Company”) and Nathan Stasko (“Employee”). Throughout the remainder of this Agreement, the Company and Employee may be collectively referred to as the “Parties”.

WHEREAS, the Company and Employee entered into the Amended and Restated Employment Agreement (the “Employment Agreement”), effective April 13, 2016, under which Employee is currently serving as the Company’s President and Chief Executive Officer;

WHEREAS, Employee is subject to the terms of the Confidentiality and Assignment of Inventions Agreement, executed by Employee on October 9, 2009, and the Amended and Restated Noncompetition Agreement, executed by Employee on May 11, 2016 (collectively the “Restrictive Covenants Agreements”).

WHEREAS, Employee and the Company have agreed that Employee will assume the position of Chief Scientific Officer, while retaining the position of President, but will immediately relinquish the position of Chief Executive Officer (“CEO”); and

WHEREAS, Employee has also agreed that after a new CEO is hired, subsequent to the interim CEO appointment made contemporaneously herewith, and upon the request of the Board of Directors, he will resign from his position as President and/or as a director of the Company;

WHEREAS, the Company and Employee wish to amend the Employment Agreement to provide this change.

NOW, THEREFORE, the Company and Employee, intending to be legally bound, and for good and valuable consideration, hereby agree to the following:

1. EMPLOYMENT.   Section 1 of the Employment Agreement is hereby amended by deleting the first sentence of Section 1 in its entirety and replacing it with the following:

“The Company hereby agrees to continue to employ Employee, and Employee hereby accepts such continued employment.  Employee shall serve as the Company’s President and Chief Scientific Officer upon the terms and conditions hereinafter set forth; provided, however , that Employee agrees that on or following the date on which the Company hires a new Chief Executive Officer (“CEO”), subsequent to the interim CEO appointment made contemporaneously herewith, and upon the request of the Board of Directors, Employee will immediately resign from the position of President.”

2. DUTIES; EXCLUSIVE SERVICE .  Section 2 of the Employment Agreement is hereby amended by deleting the first two (2) sentences in their entirety, and replacing them with the following:

 


 

 

“During the Term, Employee shall faithfully discharge his responsibilities and perform all duties prescribed to him by the Chief Executive Officer or the Board of Directors of the Company (the “ Board ”), or other appropriate parties within the Company.”

3. COMPENSATION – Base Salary .  Section 3(a) of the Employment Agreement is hereby amended by deleting the amount of Base Salary specified therein and replacing it with the following:  “Four Hundred Thousand Dollars ($400,000.00)”.

4. Compensaton upon Separation without “Cause” or for “Good REason .”   Section 6(b) of the Employment Agreement is hereby amended by adding new subsections (iii) and (iv) as follows:

“(iii) Vesting of any time-based options Employee has to purchase the Company’s common stock that would have vested during the calendar year in which Employee’s employment is terminated but for Employee’s termination, such options requiring exercise within ninety (90) days of the Separation Date and pursuant to the other terms and conditions of the applicable Company incentive award plan and individual award agreement; and

(iv) payment of any bonus earned for a prior calendar year but not yet paid, with such bonus to be paid in lump sum, less applicable withholdings, when such bonuses are paid to other executives, with such bonuses to be paid no later than two-and-a-half months after the end of such calendar year.”

5. Resignations .  As of the Effective Date, set forth in Section 11 of this Amendment, Employee hereby resigns as Chief Executive Officer.   Employee also agrees that on or following the date on which the Company hires a new CEO, subsequent to the interim CEO appointment made contemporaneously herewith, and upon the request of the Board of Directors, Employee will immediately resign as President of the Company.  

6. CONSENT TO EMPLOYMENT CHANGES .  Employee hereby consents to the changes in his title, position, authority and duties (the “Changes”) provided for in this Amendment, including but not limited to the immediate relinquishment of the position of CEO and the future relinquishment of the position of President and, therefore, Employee acknowledges and agrees that such Changes do not constitute grounds for “Good Reason” under, or a material breach of, the Employment Agreement, within the meaning of Section 6(a)(v) of the Employment Agreement. Notwithstanding any other provision of this Amendment, Employee’s consent to the Changes as provided in this Section 6 will not apply to any other changes or events not provided for in this Amendment that may constitute “Good Reason” under Section 6(a)(v) of his Employment Agreement.

7. Board of Directors .  Employee also agrees that on or following the date on which the Company hires a new CEO, subsequent to the interim CEO appointment made contemporaneously herewith, and upon the request of the Board of Directors, Employee will immediately resign as a director on the Board.  Employee further agrees that such request to resign or such resignation as a director shall not constitute grounds for Good Reason under, or a material breach of, the Employment Agreement, within the meaning of Section 6(a)(v) of the Employment Agreement.

2

 


 

 

8. Options .  Subject to the approval of the Board of Directors and, if necessary, the approval by the Company stockholders of an increase in the number of shares available for issuance under the Company’s 2016 Incentive Award Plan (the “2016 Plan”), the Company will make a grant to Employee under the 2016 Plan of options to purchase up to 80,000 shares of common stock of the Company.  Such award shall be subject to the terms of the 2016 Plan and the Company’s stock option agreement applicable to such award.  The options shall vest in accordance with performance terms to be determined by the Board of Directors, or its designee, with input from Employee, and will have an exercise price per share equal to the fair market value of a share of the Company’s common stock, to be determined in accordance with Section 409A of the Internal Revenue Code.  The performance terms will be established and the grant made no later than June 30, 2017.

 

9. DEFINITIONS .  All terms used in this Amendment shall have the same definitions as used in the Employment Agreement, unless otherwise provided herein.  All references to the “Employment Agreement” shall include all modifications made by this Amendment, unless provided otherwise.

 

10. COUNTERPARTS . This Amendment may be executed in counterparts, each of which shall be an original, with the same effect as if the signatures affixed thereto were on the same instrument.

 

11. EFFECT OF AMENDMENT . This Amendment is effective immediately (the “Effective Date”).  Except as specifically amended herein, the Employment Agreement remains in full force and effect.  In addition, the Restrictive Covenants Agreements will remain in full force and effect, and Employee specifically ratifies and confirms his obligations thereunder.

 

 

[Signature Page Follows.]

 

3

 


 

 

IN WITNESS WHEREOF, the Parties have entered into this Amendment as of the day and year written below.

 

novan, inc.

By:   __/s/ W. Kent Geer___________________

Name:  W. Kent Geer

Title: Board of Directors

Date: June 4 , 2017

 

NATHAN STASKO

By:   __/s/ Nathan Stasko____________________

 

 

 

Exhibit 99.1

Novan Announces Leadership Adjustments and Business Update

 

 

Aligns existing talent and experience with next phase

 

Accelerates broadening the application of the science

 

Intends regulatory follow up with regard to SB204 for acne

 

Resource alignment to near term focus

 

Strengthening the balance sheet an important focus

 

 

MORRISVILLE, N.C., June 5, 2017 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (NASDAQ:NOVN) today announced adjustments to its executive leadership team with immediate effect. These actions will accelerate a repositioning of the business and align talent and experience with the near and intermediate term phase of the Company.

 

The leadership adjustments and alignment of talent are as follows:

 

 

Nate Stasko, the current Chief Executive Officer, will now focus his efforts and considerable scientific talent as “President & Chief Scientific Officer” of Novan.

 

In this role, Nate will help the company deepen its understanding of the possibilities of nitric oxide and its potential therapeutic application across patient needs. Nate will continue to be a central and highly valued member of the Novan team and remain integral to its future.

 

 

Bob Ingram, the current Chairman of the Company’s Board of Directors, will now serve as the non-employee Executive Chairman of the Board. In this role, Bob will devote additional time and effort to Novan.

 

 

Kent Geer will become the Lead Independent Director of the Company and continue in his role as Chairman of the Audit Committee.

 

 

Kelly Martin, currently a Non-Executive Director, will assume the role of Chief Executive Officer of Novan on an interim basis. In this role, Kelly will work closely with Nate and other Novan leaders in order to accelerate progress in positioning the Company in a manner that allows the science to further mature and develop. Extending the business runway and broadening the therapeutic application of the underlying drug technology platform (nitric oxide) are the two primary areas of focus.

 

 

Broadening the application of nitric oxide, the science and potential therapeutic applications:

 

Anti-Inflammatory Applications

 

Data presented at the recent annual meeting for the Society for Investigative Dermatology demonstrated mechanistic evidence for nitric oxide’s potential when administered as a locally applied, topical cream formulation as a treatment for inflammatory skin diseases. Based on this

 


 

pre-clinical data and multiple years of creating increased understandings of nitric oxide , the Company believes that its next area of focus should be on the high impact immunological diseases in dermatology.    Two initial therapeutic areas of focus are psoriasis and atopic dermatitis. Work on a n Investigational New Drug A pplication (IND) for mild - to - moderate psoriasis is currently underway and the company is preparing to execute a phase 2 trial starting in the third quarter . A phase 2 trial in atopic dermatitis is currently in the planning stage.

 

With regard to SB204 for the treatment of acne, the Company intends to schedule a follow up meeting with the FDA in the third quarter of 2017. During that meeting, the Company will seek clarity with regards to a path forward for this asset from both a clinical and regulatory perspective. Additionally, the Company is completing its long-term safety study, its two year carcinogenicity study and other safety studies in support of SB204 for potential marketing approvals in the US and Japan, where Sato Pharmaceutical Co., Ltd has licensed the product.

 

The Company continues to believe that SB204 for the treatment of acne is a viable drug candidate and will assess the path forward following the upcoming FDA meeting.

 

Anti-Viral Applications

 

The Company recently announced statistically significant results from its SB206  Phase II dose-ranging clinical study for genital warts – caused by the human papillomavirus (HPV).  An end of Phase II meeting with the FDA is planned for the end of the second quarter and will provide further clarity on the path forward for this indication as well as other possible anti-viral indications which the company believes are appropriate.

 

Anti – Fungal Applications

 

The Company has recently generated positive data from SB208 in a phase II dose ranging study for the treatment of superficial cutaneous fungal infections of the skin and nails. Possible therapeutic applications include tinea pedis as well as onychomycosis. Regulatory follow up and further market and competitive analysis will provide additional clarity as to possible paths forward.

 

 

Resource Alignment to Enable Near Term Focus:

 

Given our near term business focus on executing less resource intensive phase 2 trials in psoriasis and atopic dermatitis, and the need to be disciplined with regard to cash utilization, the Company has reduced its overall headcount by approximately 20%. This action will accomplish three things: reduce near term operating costs and preserve cash on our balance sheet, enable refined focus around key projects, and align necessary skills to near term tasks and activities. The Company will continue to evaluate the component parts of the business and adjust resources up or down as needed. Novan continues to believe that the Company’s cash on hand is sufficient to fund operations at least through the end of 2017.

 

 

 


 

 

Balance sheet focus and sequence:

 

To be exceedingly clear, the Company will require additional capital in order to proceed on broadening the potential application of the science (nitric oxide) and the underlying technology, and specifically to initiate and complete the planned phase 2 trials in both psoriasis and atopic dermatitis. Additional regulatory clarity surrounding SB204 for acne, as well as both SB206 and SB208, will provide important financial and strategic options as to how the Company strengthens its balance sheet and actively manages other financial considerations.

 

Creating a longer term “runway” for the overall Novan business remains a central imperative for the executive management team and the Board of Directors.

About Novan

 

Novan, Inc. is a late-stage pharmaceutical company focused on redefining the standard of care in dermatology through the development and commercialization of innovative therapies using the Company’s nitric oxide-releasing platform. Nitric oxide plays a vital role in the natural immune system response against microbial pathogens and is a critical regulator of inflammation. Our ability to harness nitric oxide and its multiple mechanisms of action has enabled us to create a platform with the potential to generate differentiated, first-in-class product candidates. We are advancing programs in five dermatological conditions with significant unmet medical need. We believe that our ability to conveniently deploy nitric oxide on demand in topical formulations allows us the potential to significantly improve patient outcomes in a variety of skin diseases and positions us to be a commercially successful leader in the dermatology market.

 

Forward-Looking Statements

 

This press release contains forward-looking statements including, but not limited to, statements related to pharmaceutical development of nitric oxide-releasing product candidates, our potential financing opportunities and partners, as well as our expected uses of cash and cost-savings initiatives, and the future prospects of our business, including management succession, operating activities and our product candidates. Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from our expectations, including, but not limited to, uncertainties and risks in the clinical development process, including, among others, length, expense, ability to enroll patients, reliance on third parties, and that results of earlier research and preclinical or clinical trials may not be predictive of results, conclusions or interpretations of later research or trials; the lengthy and unpredictable nature of the U.S. Food and Drug Administration’s drug approval process; whether we will be able to enter into strategic arrangements or obtain adequate funding to support our operations and initiatives on acceptable terms, or at all; our ability to implement and realize anticipated benefits from any adjustments to our business, including headcount reductions and other cost-saving measures; our ability to modify, streamline or reposition our manufacturing infrastructure and associated   capabilities on financial and operational terms that are acceptable; the ability to attract and retain senior management and key employees and other risks and uncertainties described in our annual report filed with the Securities and Exchange Commission, or SEC, on

 


 

Form 10-K for the twelve months ended Dec. 31, 2016, and in any subsequent filings with the SEC. These forward-looking statements speak only as of the date of this press release, and Novan disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law.