0001193125-23-019738.txt : 20230131 0001193125-23-019738.hdr.sgml : 20230131 20230131081201 ACCESSION NUMBER: 0001193125-23-019738 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20230118 ITEM INFORMATION: Cost Associated with Exit or Disposal Activities ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20230131 DATE AS OF CHANGE: 20230131 FILER: COMPANY DATA: COMPANY CONFORMED NAME: INOVIO PHARMACEUTICALS, INC. CENTRAL INDEX KEY: 0001055726 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 330969592 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-14888 FILM NUMBER: 23570285 BUSINESS ADDRESS: STREET 1: 6769 MESA RIDGE RD. CITY: SAN DIEGO STATE: CA ZIP: 92121 BUSINESS PHONE: 8584103134 MAIL ADDRESS: STREET 1: 6769 MESA RIDGE RD. CITY: SAN DIEGO STATE: CA ZIP: 92121 FORMER COMPANY: FORMER CONFORMED NAME: INOVIO BIOMEDICAL CORP DATE OF NAME CHANGE: 20050404 FORMER COMPANY: FORMER CONFORMED NAME: GENETRONICS BIOMEDICAL CORP DATE OF NAME CHANGE: 20011116 FORMER COMPANY: FORMER CONFORMED NAME: GENETRONICS BIOMEDICAL LTD DATE OF NAME CHANGE: 19980213 8-K 1 d295438d8k.htm 8-K 8-K
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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): January 18, 2023

 

 

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))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading
Symbol(s)

 

Name of each exchange
on which registered

Common Stock, $0.001 par value   INO   The Nasdaq Stock Market LLC

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 2.05

Costs Associated with Exit or Disposal Activities.

On January 31, 2023, Inovio Pharmaceuticals, Inc. (the “Company”) committed to and communicated a corporate reorganization plan, including a reduction in force (the “Reduction”). The purpose of the Reduction is to decrease expenses and maintain a streamlined organization to support key clinical programs that are expected to drive long-term growth. As part of the Reduction, the Company has reduced its overall headcount by approximately 24 employees, which represents 11% of its full-time employees. Along with other planned cost-saving measures, the Reduction is expected to provide annual savings of approximately $4.3 million. The Company expects to incur a one-time pre-tax charge of approximately $1.1 million in the first quarter of 2023 related to the Reduction, consisting primarily of one-time severance payments upon termination, continued benefits for a specific period of time, and outplacement services. The Company expects such costs to be the only direct expense of the Reduction. The Company expects all charges associated with the Reduction to be incurred during the quarter ending March 31, 2023, with related cash payments expected to be paid out in the first half of 2023.

 

Item 7.01

Regulation FD Disclosure.

On January 31, 2023, the Company issued a press release related to the Reduction and other matters, which is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information provided in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such filing.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements in this Current Report on Form 8-K contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding our business, including our plans to develop and commercialize DNA medicines, our expectations regarding our research and development programs, the availability and timing of data from clinical trials and expectations about the upfront costs and long-term cost reductions associated with our corporate reorganization. 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, product development programs and commercialization activities and outcomes, 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 medicines, our ability to support our pipeline of DNA medicine 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 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, 2021, our Quarterly Report on Form 10-Q for the quarter ended September 30, 2022 and other filings we make from time to time with the Securities and Exchange Commission. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured, or commercialized, that the results of clinical trials will be supportive of regulatory approvals required to market 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.


Item 8.01

Other Events.

On January 18, 2023, the United States District Court for the Eastern District of Pennsylvania (the “Court”) entered an order (the “Order”) granting final approval of the settlement, as set forth in a stipulation of settlement (the “Settlement”), of the consolidated securities class action captioned McDermid. v. Inovio Pharmaceuticals, Inc. et al., No. 2:20-cv-01402-GJP (E.D. Pa.) (the “Class Action”).

The Settlement was subject to final approval by the Court and, upon entry of the Order by the Court on January 18, 2023, became fully and finally approved. The Order provides for the full and final settlement of the Class Action and all related claims according to the terms of the Settlement.

Pursuant to the terms of the Settlement, the Company will pay an award of $44.0 million, consisting of $30.0 million in cash and $14.0 million in shares of the Company’s common stock, par value $0.001 per share (the “Common Stock”). Each individual class member’s recovery will depend on when they purchased their Common Stock, how much they paid for their Common Stock, and how many shares the individual purchased.

The Company previously disclosed the terms of the proposed Settlement, including the planned share issuance, in its Quarterly Report on Form 10-Q for the quarter ended September 30, 2022. The Company’s insurance carriers have paid the cash component of the Settlement, which amounts were being held in escrow.

Pursuant to the Settlement, the Company will initially issue 7,000,000 shares of Common Stock. Following the expiration of the appeal period or resolution of an appeal if one is filed, the Company will make another contribution of Common Stock to the settlement fund. The number of shares will be calculated based on the average trading price of the Common Stock for the 10 trading days preceding the determination date pursuant to the terms of the Settlement.

The total number of shares of Common Stock to be issued in connection with the Settlement, even if the additional amount is elected to be paid in shares of Common Stock, is expected to constitute less than 5% of the Company’s currently outstanding Common Stock.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit
Number
    
99.1    Press Release, dated January 31, 2023, “INOVIO Announces Strategic Reorganization, Continues Efforts to Focus on Promising DNA Medicine Candidates”
104    Cover Page Interactive Data File (formatted as inline XBRL).


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: January 31, 2023     By:  

/s/ Peter Kies

      Peter Kies
      Chief Financial Officer
EX-99.1 2 d295438dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

INOVIO Announces Strategic Reorganization,

Continues Efforts to Focus on Promising DNA Medicine Candidates

 

   

Cost-saving measures include 11% headcount reduction

 

   

Annual savings expected to be approximately $4.3 million

 

   

Data readouts expected in first quarter of 2023 for key programs including INO-3107 for RRP and VGX-3100 for cervical HSIL

PLYMOUTH MEETING, PA, January 31, 2023 — INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-associated diseases, cancer, and infectious diseases, today announced a strategic reorganization that is intended to deliver on commitments to operational efficiency and better position the company to bring the promise of DNA medicines to patients. The reorganization is expected to provide annual savings of approximately $4.3 million and includes an 11% reduction of full-time employees following the previously announced discontinuation of clinical development programs in late 2022. These and other strategic measures redirect resources needed to advance key programs, including INOVIO’s product candidate INO-3107 for the treatment for Recurrent Respiratory Papillomatosis (RRP).

“Today’s announcement is a reflection of measured efforts INOVIO has undertaken to assess the portfolio and prioritize those programs with the greatest benefit for patients and commercial potential,” said INOVIO’s President and Chief Executive Officer, Dr. Jacqueline Shea. “This decision followed thoughtful consideration and thorough diligence to better position the organization and ultimately realize the potential of DNA medicines. While this is a difficult decision, I want to both recognize and thank my colleagues who were impacted by today’s news for their contributions to INOVIO and their dedication to patients around the world.”

INOVIO expects to incur a one-time restructuring charge of approximately $1.1 million in the first quarter of 2023. More detailed financial guidance will be provided as part of INOVIO’s 2022 fourth quarter and year-end financial results announcement planned for March 2023.

INOVIO’s lead programs include its treatments for HPV-associated diseases, such as INO-3107 for RRP and VGX-3100 for cervical high-grade squamous intraepithelial lesions (HSIL). Data readouts for INOVIO’s Phase 3 REVEAL2 trial for VGX-3100 and the second cohort from the Phase 1/2 trial for INO-3107 are expected to be announced in the first quarter of 2023.


About INOVIO

INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-associated diseases, cancer, and infectious diseases. INOVIO’s DNA medicines in development are delivered using its investigational proprietary smart device, CELLECTRA®, to produce immune responses against targeted pathogens and cancers. For more information, visit www.inovio.com.

Contacts

 

Media:

Jennie Willson (267) 429-8567 jennie.willson@inovio.com

Investors:

Thomas Hong (267) 440-4298 thomas.hong@inovio.com

Forward-Looking Statements

This press release contains certain forward-looking statements relating to our business, our expectations regarding our DNA medicine research and development programs and the commercial potential of our product candidates, the availability and timing of data from clinical trials and expectations about the upfront costs and long-term cost savings associated with headcount reductions and related strategic measures. 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, product development programs and commercialization activities and outcomes, 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 medicines, our ability to support our pipeline of DNA medicine product candidates, 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 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, 2021, our Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, and other filings we make from time to time with the Securities and Exchange Commission. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured, or commercialized, that the results of clinical trials will be supportive of regulatory approvals required to market 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.

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Document and Entity Information
Jan. 18, 2023
Cover [Abstract]  
Amendment Flag false
Entity Central Index Key 0001055726
Document Type 8-K
Document Period End Date Jan. 18, 2023
Entity Registrant Name Inovio Pharmaceuticals, Inc.
Entity Incorporation State Country Code DE
Entity File Number 001-14888
Entity Tax Identification Number 33-0969592
Entity Address, Address Line One 660 W. Germantown Pike
Entity Address, Address Line Two Suite 110
Entity Address, City or Town Plymouth Meeting
Entity Address, State or Province PA
Entity Address, Postal Zip Code 19462
City Area Code (267)
Local Phone Number 440-4200
Written Communications false
Soliciting Material false
Pre Commencement Tender Offer false
Pre Commencement Issuer Tender Offer false
Security 12b Title Common Stock, $0.001 par value
Trading Symbol INO
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
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