UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 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): March 21, 2019

 

 

Inovio Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-14888   33-0969592

(State or other jurisdiction of

incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

660 W. Germantown Pike, Suite 110

Plymouth Meeting, PA 19462

(Address of principal executive offices, including zip code)

(267) 440-4200

(Registrant’s telephone number, including 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 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 Principal Officers; Election of Directors; Appointment of Principal Officers.

On March 21, 2019, the Board of Directors (the “Board”) of Inovio Pharmaceuticals, Inc. (the “Company”) appointed Ann C. Miller, M.D. to serve as a director of the Company. Dr. Miller’s term will continue until the Company’s 2019 Annual Meeting of Stockholders. There is no arrangement or understanding between Dr. Miller and any other person pursuant to which she was selected as a director of the Company, and there is no family relationship between Dr. Miller and any of the Company’s other directors or executive officers. The Company is not aware of any transaction involving Dr. Miller requiring disclosure under Item 404(a) of Regulation S-K. Additional information regarding Dr. Miller is set forth below:

Ann C. Miller, M.D., age 62, joined the Board in March 2019. Dr. Miller worked at Sanofi S.A. from 2012 until her retirement in September 2018, serving as Vice President of Marketing and Vice President of Global Marketing, Oncology Division. From 2009 to 2011, Dr. Miller served as Senior Vice President of Pharmaceutical Services at Eisai Co., Ltd., leading its Primary Care and Specialty Business unit. Dr. Miller previously served in management roles in global marketing at Amgen Inc. and in positions of increasing responsibility at Merck & Co., Inc. over a period of 16 years. Dr. Miller received an M.D. from the Duke University School of Medicine and a B.A. in chemistry with honors from Duke University. She is a member of the Duke University Medical Alumni Council.

Dr. Miller will be compensated in accordance with the Company’s non-employee director compensation policy. She will receive an annual cash retainer of $45,000 for serving on the Board. In addition, Dr. Miller received initial equity awards under and pursuant to the Company’s 2016 Omnibus Incentive Plan upon her appointment as of March 21, 2019, the date of grant. As a newly elected director, Dr. Miller was awarded 12,821 restricted stock units and a stock option to purchase 20,000 shares of the Company’s common stock at an exercise price of $3.72, the closing price of the Company’s common stock on the date of grant. The restricted stock units will vest over a period of three years, with one-third of the shares vesting on each of the first, second and third anniversaries of the grant date, subject to Dr. Miller’s continued service as a director of the Company as of each vesting date. With respect to the shares of common stock underlying the stock option grant, one-quarter of the shares vested as of the grant date, with the remainder vesting in three equal annual installments on the first, second and third anniversaries of the grant date, subject to Dr. Miller’s continued service as a director of the Company as of each vesting date. Dr. Miller will be eligible to receive additional annual equity awards on each date of the Company’s annual meeting of stockholders in accordance with the non-employee director compensation policy.

 

Item 7.01

Regulation FD Disclosure.

On March 25, 2019, the Company issued a press release announcing the appointment of Dr. Miller to the Board. A copy of this press release is furnished herewith as Exhibit 99.1 to this Current Report. The information contained in the press release furnished as Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and is not incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in any such filing.

 

Item 9.01

Financial Statements and Exhibits.

 

Exhibit
No. 		  

Exhibit Description

99.1   

Press Release, dated March 25, 2019.

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.

 

 

INOVIO PHARMACEUTICALS, INC.

Date: March 25, 2019   By:   /s/ Peter Kies
    Peter Kies
   

Chief Financial Officer

Exhibit 99.1

 

LOGO

 

 

 

CONTACTS:
Investors:    Ben Matone, Inovio, 484-362-0076, ben.matone@inovio.com
Media:    Jeff Richardson, Inovio, 267-440-4211, jrichardson@inovio.com

Inovio Appoints Global Commercial Leader

to its Board of Directors

PLYMOUTH MEETING, PA – March 25, 2019 – Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today the appointment of Dr. Ann C. Miller to its Board of Directors. Dr. Miller had an outstanding marketing career launching and building blockbuster products for Merck, Amgen, Eisai and Sanofi. While at Sanofi, she led the Sanofi Oncology Global Marketing function including its pipeline, launch, and life cycle management activities. Prior to Sanofi, Dr. Miller served as Senior Vice President at Eisai, including leading the Primary Care and Specialty Business unit with the blockbusters Aricept ® and Aciphex ® and the enterprise-wide service platform for the Oncology and Primary Care businesses. At Amgen, Dr. Miller contributed to building the Global Marketing function; as Executive Director, Global Marketing, Oncology Therapeutic Area she provided commercialization and life cycle management oversight for key products including Neulasta ® and Vectibix ® . During her 16-year career at Merck & Co. she held numerous positions of increasing responsibility including brand lead for such billion-dollar products as Fosamax ® , Mevacor ® , and Zocor ® . Dr. Miller holds MD and BA degrees with honors from Duke University.

Dr. J. Joseph Kim, President and CEO, said, “Dr. Miller’s expertise will help guide us as we transition to a commercial organization. We will benefit from her clinical training and extensive experience developing and executing launch and growth strategies across a wide range of oncology, specialty and primary care portfolios and products.”

Inovio is in late-stage development for several of its product candidates. Inovio’s lead product, VGX-3100, for HPV-caused cervical dysplasia, is advancing in global Phase 3 trials. Inovio is developing its HPV program in Phase 2 trials treating HPV-caused vulvar and anal dysplasia. Inovio’s technology platform is demonstrating its versatility in two Phase 2 oncology combination trials integrating Inovio’s INO-5401 therapy with several checkpoint inhibitors from Genentech/Roche (for bladder cancer,) and Regeneron (for brain cancer (GBM)). MEDI0457 (VGX-3100 + pIL-12, which Inovio licensed to AstraZeneca) is in Phase 2 combination trials with durvalumab targeting head & neck cancer and cervical cancer in addition to a broad array of other cancers associated with the human papilloma virus. Inovio’s infectious disease pipeline is also moving vaccines into late-stage trials for Lassa fever, Ebola, MERS and HIV.

About Inovio Pharmaceuticals, Inc.

Inovio is a late-stage biotechnology company focused on the discovery, development, and commercialization of DNA-based immunotherapies and vaccines that transform the treatment and prevention of cancer and infectious disease. Inovio’s proprietary technology platform applies antigen sequencing and DNA delivery to activate potent immune responses to targeted diseases. The technology functions exclusively in vivo , and has been demonstrated to consistently activate robust and fully functional T cell and antibody responses against targeted cancers and pathogens. Inovio’s most advanced clinical program, VGX-3100, is in Phase 3 for the treatment of HPV-related cervical pre-cancer. Also in development are Phase 2 immuno-oncology programs targeting HPV-related cancers, bladder cancer, and glioblastoma, as well as platform development programs in hepatitis B, Zika, Ebola, MERS, and HIV. Partners and collaborators include AstraZeneca, Regeneron, Roche/Genentech, ApolloBio Corporation, The Wistar Institute, The Bill & Melinda Gates Foundation, the University of Pennsylvania,

Parker Institute for Cancer Immunotherapy, CEPI, DARPA, GeneOne Life Science, Plumbline Life Sciences, NIH, HIV Vaccines Trial Network, National Cancer Institute, Walter Reed Army Institute of Research, Drexel University, and Laval University. For more information, visit www.inovio.com .

* * * *

This press release contains certain forward-looking statements relating to our business, including our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines, our expectations regarding our research and development programs, including the planned initiation and conduct of clinical trials and the availability and timing of data from those trials. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials and product development programs, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA vaccines, our ability to support our pipeline of SynCon ® active immunotherapy and vaccine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or our collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that we and our collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide us with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether we can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2018 and other regulatory filings we make from time to time. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured or commercialized, that final results of clinical trials will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law.