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): October 4, 2018

 Akcea Therapeutics, Inc.
(Exact name of registrant as specified in its charter)

Delaware
001-38137
47-2608175
(State or other jurisdiction of incorporation)
(Commission File Number)
(IRS Employer Identification No.)

22 Boston Wharf Road
9th Floor
Boston, Massachusetts
 
02210
(Address of principal executive offices)
 
(Zip Code)

Registrant’s telephone number, including area code: (617) 207-0202



Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations 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 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.

On October 4, 2018, Stanley T. Crooke, M.D, Ph.D. resigned his position as a member of the Akcea Therapeutics, Inc. (the “Company”) Board of Directors (“Board”). Dr. Crooke has served on the Board since January 2015.

On October 5, 2018, the Board accepted Dr. Crooke’s resignation and appointed Damien McDevitt, Ph.D. to fill Dr. Crooke’s vacancy on the Board, effective immediately.

Dr. McDevitt is Chief Business Officer of Ionis Pharmaceuticals, Inc. He is a member of Ionis’ executive leadership team, responsible for leading Ionis’ corporate development activities, including corporate communications, business development, patient advocacy, competitive intelligence and alliance management. Dr. McDevitt joined Ionis in June 2018. Previously, Dr. McDevitt was senior vice president, corporate development at ACADIA Pharmaceuticals. Prior to ACADIA, he was at GSK for more than two decades, where he was instrumental in over 70 global business development transactions involving multiple therapeutic areas, including severe and rare and neuromuscular diseases, among others. He served in various roles with increasing responsibility including vice president, head of business development for R&D Extended Therapy areas, head of Worldwide Business Development Asia and head of GSK’s R&D West Coast Innovation Center.

There are no arrangements or understandings between Dr. McDevitt and any other persons pursuant to which Dr. McDevitt was appointed as a director of the Company.

Dr. McDevitt will enter into the Company’s standard form of indemnity agreement, the form of which has been filed as Exhibit 10.1 to the Company’s registration statement on Form S-1 filed with the Securities and Exchange Commission on April 10, 2017.

A copy of the press release announcing Dr. Crooke’s resignation and the appointment of Dr. McDevitt to the Board is attached as Exhibit 99.1 to this Current Report on Form 8-K.

Item 9.01.
Financial Statements and Exhibits.

(d)
Exhibits.

 
99.1
Press Release dated October 8, 2018.


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.

 
AKCEA THERAPEUTICS, INC.
       
Date: October 9, 2018
By:
/s/ Paula Soteropoulos
 

Paula Soteropoulos


Chief Executive Officer


INDEX TO EXHIBITS

Press Release dated October 8, 2018.




Exhibit 99.1


Akcea Announces Changes to Board of Directors

Dr. Damien McDevitt replaces Dr. Stanley Crooke on Akcea Board of Directors

The change enhances focus on global approval and commercialization of TEGSEDI™ (inotersen)

BOSTON, Mass October 8, 2018 – Akcea Therapeutics, Inc. (NASDAQ: AKCA), an affiliate of Ionis Pharmaceuticals, Inc. today announced that Damien McDevitt, Ph.D. Chief Business Officer of Ionis Pharmaceuticals, is joining the Akcea Board of Directors to replace Ionis Founder, Chairman and CEO Stanley T. Crooke, M.D., Ph.D. who has resigned from Akcea’s Board of Directors.

“We thank Stan for his leadership in founding Akcea and leading it to this key point in our maturation. His impact on Akcea has been immeasurable. Though he is leaving our board, we know he will remain keenly interested in the company’s progress as Ionis is our most important partner and our largest shareholder. We will continue to benefit from his insights as we advance in our mission to bring transformative medicines to patients with unmet medical needs,” said Paula Soteropoulos, CEO of Akcea.

“With the global approval and launch of TEGSEDI™ (inotersen), Akcea is entering a new phase – the one for which the company was created – commercializing drugs. I believe Damien’s business and corporate development expertise and strategic vision will add tremendous value to Akcea and to the board,” said Dr. Crooke.  “I am proud to have founded Akcea and for the progress they have made bringing TEGSEDI to patients globally and advancing the rest of their exciting pipeline of antisense drugs.”

Soteropoulos added, “We’re excited to welcome Damien to the Akcea board at this pivotal time. His deep understanding of the dynamics shaping our business make him an invaluable addition.”

As Ionis’ CBO, Dr. McDevitt is responsible for leading Ionis’ corporate development activities, including business development, competitive intelligence, alliance management investor relations and corporate communications. He joined Ionis in June 2018, after serving as senior vice president of corporate development at ACADIA Pharmaceuticals. Prior to that, Damien spent more than two decades at GSK in a variety of global and strategic business roles where he was instrumental in delivering more than 70 transactions, building experience supporting the commercial business, and he helped drive the strategic expansion of GSK in the US west coast and Asia.

“I am honored to accept this appointment to Akcea’s board and look forward to working closely with Paula, her team and the rest of the board to execute on the company’s strategies for delivering breakthrough therapies to patients around the world who depend on Akcea and Ionis,” said Dr. McDevitt.


Exhibit 99.1

ABOUT AKCEA THERAPEUTICS
Akcea Therapeutics, Inc., an affiliate of Ionis Pharmaceuticals, Inc. (NASDAQ:IONS), is a biopharmaceutical company focused on developing and commercializing drugs to treat patients with serious and rare diseases. Akcea is advancing a mature pipeline of six novel drugs, including TEGSEDI™ (inotersen), WAYLIVRA™ (volanesorsen), AKCEA-APO(a)-LRx, AKCEA-ANGPTL3-LRx, AKCEA-APOCIII-LRx, and AKCEA-TTR-LRx, all with the potential to treat multiple diseases. All six drugs were discovered by and are being co-developed with Ionis, a leader in antisense therapeutics, and are based on Ionis’ proprietary antisense technology. TEGSEDI is approved in the U.S., E.U. and Canada. WAYLIVRA is under regulatory review for the treatment of familial chylomicronemia syndrome, or FCS, and is currently in Phase 3 clinical development for the treatment of people with familial partial lipodystrophy, or FPL. Akcea is building the infrastructure to commercialize its drugs globally. Akcea is a global company headquartered in Boston, Massachusetts. Additional information about Akcea is available at www.akceatx.com.

FORWARD-LOOKING STATEMENT
This press release includes forward-looking statements regarding the business of Akcea Therapeutics, Inc. Any statement describing Akcea’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. Akcea’s forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Akcea’s forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Akcea. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Akcea’s programs are described in additional detail in Akcea’s annual report on Form 10-K for the year ended December 31, 2017, and most recent Form 10-Q quarterly filing, which are on file with the SEC. Copies of this and other documents are available from the Company.

In this press release, unless the context requires otherwise, “Ionis,” “Akcea,” “Company,” “Companies,” “we,” “our,” and “us” refers to Ionis Pharmaceuticals and/or Akcea Therapeutics.

Ionis Pharmaceuticals™ is a trademark of Ionis Pharmaceuticals, Inc. Akcea Therapeutics™, TEGSEDI™, WAYLIVRA™ are trademarks of Akcea Therapeutics, Inc.

Akcea Media and Investor Contact:
Kathleen Gallagher
Vice President of Communications and Investor Relations
617-207-8509
kgallagher@akceatx.com