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)
July 14, 2015
VITAL THERAPIES, INC.
(Exact name of registrant as specified in its charter)
Delaware | 001-36201 | 56-2358443 | ||
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
15010 Avenue of Science, Suite 200
San Diego, California 92128
(Address of principal executive offices)(Zip Code)
Registrants telephone number, including area code: (858) 673-6840
Not Applicable
(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 (see General Instruction A.2. below):
¨ | 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)) |
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On July 14, 2015, the Board of Directors (the Board) of Vital Therapies, Inc. (the Company) increased the size of the Board by one director, from nine to ten directors, and appointed Cheryl L. Cohen to the Board, effective immediately. Ms. Cohen will serve as a Class III director, with a term expiring at the Companys 2017 annual meeting of stockholders.
Ms. Cohen served as chief commercial officer of Medivation, Inc., a publicly-traded bio-pharmaceutical company, from September 2011 until July 2014. Ms. Cohen currently serves as president of CLC Consulting, a pharmaceutical and biotechnology consulting firm specializing in new product start-up and commercialization, where she also served as president from September 2008 until September 2011. From November 2007 to September 2008, she served as the 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, rheumatology franchise. Ms. Cohen has served on the board of Tokai Pharmaceuticals, Inc., a publicly-traded pharmaceutical company focused on new treatments for prostate cancer, since April 2015, the board of Cytrx Corporation, a publicly-traded bio-pharmaceutical company specializing in oncology, since June 2015, and the board of Protein Sciences Corporation, a privately held bio-pharmaceutical company specializing in vaccine development, since October 2014. Ms. Cohen began her career at Solvay Pharmaceuticals in a variety of sales positions. Ms. Cohen received her B.A. from Saint Joseph College.
In accordance with the Companys outside director compensation policy (the Outside Director Compensation Policy), Ms. Cohen was granted an option on July 14, 2015 to purchase 12,581 shares of the common stock of the Company, at an exercise price of $26.71 per share, the closing sales price of the Companys common stock on the NASDAQ Global Market on the date of grant. The award will vest monthly in 48 equal installments, in each case, subject to Ms. Cohens continued service to the Company. The option is subject to the terms and conditions of the Companys 2014 Equity Incentive Plan and the related stock option agreement. Furthermore, Ms. Cohen is entitled to receive cash compensation (including annual cash retainers and board meeting fees) and additional annual equity awards in accordance with the terms and conditions of the Companys Outside Director Compensation Policy. The Company will also reimburse Ms. Cohen for all expenses associated with attending meetings of the Board. The foregoing summary of the Outside Director Compensation Policy does not purport to be complete and is qualified in its entirety by the full text of the Outside Director Compensation Policy, a copy of which was filed as Exhibit 10.16 to the Companys Quarterly Report on Form 10-Q for the quarter ended March 31, 2015, filed with the Securities and Exchange Commission on May 12, 2015, and is incorporated herein in its entirety by reference.
Ms. Cohen executed the Companys standard form of indemnification agreement, which form has been filed as Exhibit 10.1 to the Companys Amendment No. 2 to Registration Statement on Form S-1 (File No. 333-191711) filed with the Securities and Exchange Commission on November 6, 2013, and is incorporated herein in its entirety by reference.
There is no arrangement or understanding between Ms. Cohen and any other persons pursuant to which Ms. Cohen was selected as a director. In addition, Ms. Cohen is not a party to any transaction, or series of transactions, required to be disclosed pursuant to Item 404(a) of Regulation S-K.
On July 15, 2015, the Company issued a press release announcing Ms. Cohens appointment as a director. The press release is attached hereto as Exhibit 99.1.
Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
Exhibit |
Description | |
99.1 | Press Release dated July 15, 2015. |
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.
VITAL THERAPIES, INC. | ||
By: |
/s/ Michael V. Swanson | |
Michael V. Swanson | ||
Chief Financial Officer |
Date: July 16, 2015
EXHIBIT INDEX
Exhibit |
Description | |
99.1 | Press Release dated July15, 2015. |
Exhibit 99.1
VITAL THERAPIES ANNOUNCES APPOINTMENT OF FORMER MEDIVATION CHIEF COMMERCIAL
OFFICER CHERYL COHEN TO ITS BOARD OF DIRECTORS
SAN DIEGO, July 15, 2015 (GLOBE NEWSWIRE) Vital Therapies, Inc. (Nasdaq: VTL), a biotherapeutic company developing ELAD®, a cell-based therapy targeting the treatment of liver failure, today announced that Cheryl Cohen, the former Chief Commercial Officer of Medivation, Inc., has been appointed to its Board of Directors, effective immediately. With the addition of Ms. Cohen, the Vital Therapies Board of Directors now comprises ten directors, nine of whom are independent.
As we look ahead to the potential commercialization of the ELAD System, we are thrilled to welcome Cheryl to the Vital Therapies board of directors, said Muneer Satter, Co-Chairman of Vital Therapies. Cheryls long and successful track record of commercializing new therapies, including Medivations recent highly successful launch of Xtandi®, will be of great value to Vital Therapies. We look forward to working closely with Cheryl.
Dr. Terry Winters, Vital Therapies Chief Executive Officer and Co-Chairman added, In the event of successful clinical trial data and ultimate regulatory approval, we intend to commercialize ELAD directly in most major markets of the world without partners. Given Cheryls expertise in launching products, were delighted to have her join the Board.
It is a particularly exciting time to join Vital Therapies as the Company prepares to announce topline results from its first phase 3 trial, VTI-208, said Ms. Cohen. The ELAD System represents a promising potential breakthrough therapy that may have a meaningful impact on survival in liver failure patients. I look forward to working closely with my fellow board members and the management team to advance this technology.
Ms. Cohen served as the Chief Commercial Officer of Medivation, Inc., from September 2011 to July 2014, where she was responsible for the companys U.S. launch of Xtandi (enzalutamide) for metastatic castration-resistant prostate cancer. At Medivation, Ms. Cohen established and led the companys commercial organization and oversaw a successful launch, with the product achieving nearly $400M in U.S. revenues in the first full year of commercialization. Ms. Cohen also worked closely on all Medivation steering committees with its commercial partner, Astellas Pharma Inc., and was involved in life cycle and strategic planning for Xtandi and in the review of new business development opportunities. Ms. Cohen currently serves as president of CLC Consulting, a pharmaceutical and biotechnology consulting firm specializing in new product commercialization. Ms. Cohens previous experience also includes over a decade at Johnson & Johnson, most recently as vice president, strategic commercial group, Health Care Systems, Inc., responsible for the negotiations of Johnson & Johnsons portfolio of products to ensure access and preferred positioning, and as vice president, rheumatology franchise, Centocor, Inc., where she had direct responsibility for the $1+ billion per year Remicade U.S. rheumatoid arthritis business. Ms. Cohen currently serves on the Board of Directors of Tokai Pharmaceuticals, Inc., Protein Sciences Corporation, and CytRx Corporation. She earned her B.A. from Saint Joseph College.
15010 Avenue of Science, San Diego, California, USA 92128
Tel 858.673.6840 ● Fax 858-673-6843
www.vitaltherapies.com
About Vital Therapies, Inc.
Vital Therapies, Inc. is a biotherapeutic company developing a cell-based therapy targeting the treatment of liver failure. The Companys ELAD System is an extracorporeal human allogeneic cellular liver therapy currently in phase 3 clinical trials. Vital Therapies, Inc. is based in San Diego, California. Vital Therapies® and ELAD® are trademarks of Vital Therapies, Inc.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements regarding or implying expectations for the commercialization of the ELAD System, the plan for the commercialization of the ELAD System, the necessity for commercialization expertise within the company, and the timing of the release of topline results from our VTI-208 clinical trial. Forward-looking statements are based on managements current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance and you are cautioned not to place undue reliance on these forward-looking statements. Risks and uncertainties include, but are not limited to, the success or failure of the Companys clinical trials and development programs; whether a single phase 3 clinical trial will be sufficient to support Food and Drug Administration (FDA) approval of a biologics license application (BLA) or whether the FDA will require the Company to conduct additional clinical trials; difficulty obtaining regulatory approval in the United States or Europe, in particular for a combination product and open-label clinical trials; whether the Company begins building any significant commercial infrastructure prior to the fourth quarter of 2016; limited experience in conducting pivotal clinical trials and significant issues regarding the clinical trials, including, but not limited to, the successful opening and the continued participation of clinical sites and their ongoing adherence to protocols, assumptions regarding enrollment rates, timing and availability of subjects meeting inclusion and exclusion criteria, changes to protocols or regulatory requirements, the ability to comply with and meet applicable laws and regulations, and unexpected adverse events or safety issues; and the sufficiency of funding. There can be no assurance that data from any of the Companys clinical trials will be sufficient to support a BLA or an application for marketing in any country or that any such BLA or application will ever be approved. These and other risks regarding our business are described in detail in our Securities and Exchange Commission filings, including in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2015. These forward-looking statements speak only as of the date hereof and the Company disclaims any obligation to update these statements except as may be required by law.
Contact:
Vital Therapies, Inc.
Al Kildani
Vice President, Investor Relations and Business Development
858-673-6840
akildani@vitaltherapies.com
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