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 6, 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.

(b) Termination of Dr. Mark Bagarazzi as Chief Medical Officer

On March 6, 2019, Inovio Pharmaceuticals, Inc. (the “Company”) notified its Chief Medical Officer, Dr. Mark Bagarazzi, that his employment with the Company would be terminated, effective as of April 5, 2019. Upon such notice, his service as an executive officer of the Company ceased immediately. In connection with this termination, the Company has proposed to enter into a separation agreement with Dr. Bagarazzi, which Dr. Bagarazzi may consider for a period required by law. If executed, the material terms of the separation agreement will be described as required in the Company’s filings with the Securities and Exchange Commission, and the separation agreement would be filed as an exhibit to the Company’s quarterly report on Form 10-Q for the quarter ending March 31, 2019.

The Company also expects to enter into a consulting agreement with Dr. Bagarazzi pursuant to which he would provide consulting services to the Company for a specified period of time following the termination of his employment.

(c) Appointment of Jacqueline E. Shea, Ph.D., as Chief Operating Officer

On March 8, 2019, the Company appointed Jacqueline E. Shea, Ph.D., as its new Chief Operating Officer. Dr. Shea replaces the Company’s former Chief Operating Officer Dr. Niranjan Sardesai, who now serves as Chief Executive Officer of Geneos Therapeutics, Inovio’s majority-owned subsidiary. Dr. Shea will begin service as the Company’s principal operating officer on March 25, 2019.

Prior to joining the Company, Dr. Shea, age 53, served as chief executive officer of Aeras, a nonprofit organization developing tuberculosis vaccines, from August 2015 to December 2018, and as its chief operating officer from April 2014 to August 2015. Dr. Shea previously served as Vice President of Business Development, Europe for Emergent BioSolutions Inc. from May 2013 to March 2014.

There are no arrangements or understandings between Dr. Shea and any other person pursuant to which she was selected as an officer of the Company, and there is no family relationship between Dr. Shea and any of the Company’s other directors or executive officers.

The Company has entered into an employment agreement with Dr. Shea that provides for an annual base compensation of $400,000, a one-time signing bonus of $35,000 and an annual bonus of up to 40% of her base salary. In addition, upon commencing employment with the Company, she will be granted an option to purchase 200,000 shares of common stock and will also be granted 50,000 restricted stock units. The options will vest over a period of three years, with one-quarter of the shares vesting on the date of grant and one-quarter of the shares vesting on each of the first, second and third anniversaries of the grant date. 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. Vesting in each case is subject to Dr. Shea’s continued service as an officer of the Company on each vesting date.

The terms of Dr. Shea’s employment also provide for certain severance benefits. If Dr. Shea is terminated other than on account of death, total disability or for Cause (as defined in her employment agreement), or if Dr. Shea terminates her employment for Good Reason (as defined in her employment agreement), she will be entitled to any unpaid portion of her base salary computed on a pro-rata basis through the date of termination, any unreimbursed expenses, all other accrued but unpaid rights, a severance payment in the amount of 12 months of base salary and COBRA payments for 12 months following termination.

Item 7.01 Regulation FD Disclosure.

On March 12, 2019, the Company issued a press release announcing an executive-level reorganization, including the appointment of Dr. Shea and the termination of Dr. Bagarazzi. 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 12, 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 12, 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 Chief Operating Officer;

Announces Strategic Management Changes

PLYMOUTH MEETING, PA – March 12, 2019 – Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today the appointment of Jacqueline E. Shea, PhD, as Inovio’s Chief Operating Officer (COO) and Executive Vice President. Dr.  Shea is an experienced life sciences senior executive with an extensive track record of leadership, strategy development, operational management, product development and international corporate development achievements. She most recently served as CEO and COO of Aeras, the leading not-for-profit organization dedicated to developing new tuberculosis vaccines. At Inovio, Dr. Shea will be responsible for Inovio’s manufacturing, commercial, business development, and alliance management operations as well as serving as a key member of the executive team along with CFO and CSO in formulating and implementing overall corporate strategy. Dr. Shea replaces Dr.  Niranjan Y. Sardesai who now serves as Chief Executive Officer of Geneos Therapeutics, a spin-out of Inovio developing personalized cancer treatments.

Across the board, Inovio has taken steps to streamline its management responsibilities to better align comprehensive development strategy from discovery to commercialization. Effective immediately, Inovio’s global clinical and R&D functions will report to Dr. Laurent Humeau, Inovio’s Chief Scientific Officer and Executive Vice President.

As a part of this realignment, Dr. Mark Bagarazzi, formerly Chief Medical Officer, has left the company. In place of the Chief Medical Officer position, Inovio’s newly formed Medical Council will oversee all clinical studies and medical-related reporting and monitoring activities and will report to Dr.  Humeau. Inovio’s Medical Council comprises three of Inovio’s current Vice Presidents of Clinical Development: Prakash Bhuyan, MD (HPV program); Jeffrey Skolnik, MD, (cancer); and Scott White, MD (infectious diseases).

Dr. J. Joseph Kim, Inovio’s President and CEO, said, “This strategic reorganization will improve execution of current clinical programs and provide the management alignment to seamlessly connect new product research to commercial product candidates. Drs. Shea and Humeau are accomplished industry executives who have demonstrated their leadership qualities and delivered commercial results. In addition, the three physicians who make up our Medical Council have deep expertise in the global clinical development of Inovio’s major therapeutic areas of cancer, infectious disease and our lead program devoted to HPV diseases.”

Dr. Shea said, “I am excited by Inovio’s proven development platform and clinical pipeline and its potential to address major diseases across cancer and infection. In addition to the vaccines and immunotherapies that are in the clinic, I see the tremendous potential for the dMAb programs to drive significant value for the company and am delighted to join the leadership team developing Inovio’s portfolio of products.”

Prior to her role at Aeras, Dr. Shea held top management positions at two biotechnology companies: Emergent Product Development UK (part of Emergent BioSolutions) and Microscience Ltd; and was general manager of The Oxford-Emergent Tuberculosis Consortium, a global health joint venture formed between Oxford University and Emergent BioSolutions. She started her career as a post-doctoral researcher at Imperial College, London, where she contributed to the development of signature-tagged

mutagenesis which received a Prix Galien commendation for excellence in innovative research. She received her PhD from the National Institute for Medical Research and a BSc in Applied Biology with First Class  Honors from University of Bath.

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, U.S. Military HIV Research Program, 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 Dr. Shea’s responsibilities, the role of our newly formed Medical Council and anticipated benefits of our strategic reorganization. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including our ability to successfully implement the strategic reorganization and effectively integrate and transition changes in management, our ongoing business needs and other factors set forth in our Quarterly Report on Form 10-Q for the quarter ended September 30, 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.