UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
CURRENT REPORT
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Item 2.05 | Costs Associated with Exit or Disposal Activities |
On July 18, 2022, 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, extend cash runway, 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 55 employees, which represents 18% of its full-time employees. The Company has also terminated agreements with approximately 86% of its contractors. Along with other planned cost-saving measures, the Reduction is expected to reduce operating expenses by approximately 30% over the next 18 months and extend the Company’s cash runway into the third quarter of 2024. These projections do not include any funds that may or may not be raised during the time period through the Company’s existing ATM or other fundraising mechanisms. The Company expects to incur a one-time pre-tax charge of approximately $1.6 million in the third quarter of 2022 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 September 30, 2022, with related cash payments expected to be substantially paid out by September 30, 2022.
Item 7.01 | Regulation FD Disclosure. |
On July 19, 2022, 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, including the planned initiation and conduct of pre-clinical studies and clinical trials and the availability and timing of data from those studies and trials, expectations about the upfront costs and long-term cost reductions associated with our corporate reorganization and the anticipated extension of the company’s cash runway. 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 March 31, 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 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
Exhibit Number |
||
99.1 | Press Release, dated July 19, 2022, “INOVIO Announces Corporate Reorganization to Reduce Operational Expenses and Focus on Opportunities to Bring the Promise of DNA Medicines to Patients” | |
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: July 19, 2022 | By: | /s/ Peter Kies | ||||
Peter Kies | ||||||
Chief Financial Officer |
Exhibit 99.1
INOVIO Announces Corporate Reorganization to Reduce Operational Expenses and Focus on Opportunities to Bring the Promise of DNA Medicines to Patients
| Changes expected to reduce operational expenses and extend the companys cash runway into third quarter of 2024 |
| Improving cost structure will allow company to focus on strategic priorities, including heterologous boost strategy for COVID-19 vaccine candidate and HPV programs |
PLYMOUTH MEETING, PA, July 19, 2022 INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help protect people from infectious diseases and treat people with cancer and HPV-associated diseases, announced that it has implemented a corporate reorganization designed to extend its cash runway and to focus on key clinical programs with the goal to drive long-term growth.
The reorganization, which includes an 18% workforce reduction in full-time employees and 86% reduction in contractors, along with other cost-saving measures, is expected to reduce operating expenses by approximately 30% over the next 18 months and will extend the Companys cash runway into the third quarter of 2024. These projections do not include any funds that may or may not be raised during the time period through the Companys existing ATM or other fundraising mechanisms. INOVIO expects a one-time restructuring charge of approximately $1.6 million in the third quarter of 2022.
The organizational adjustments weve announced today underpin our strategy to realize the promise of DNA medicines and better position INOVIO for future growth, said Dr. Jacqueline Shea, Chief Executive Officer. By driving operational efficiencies throughout our organization, we are focused on advancing our lead pipeline candidates toward commercialization and optimizing our chances of success.
INOVIOs lead programs include its heterologous boost strategy for its COVID-19 vaccine candidate, INO-4800, and its HPV-targeted programs. INOVIO expects to have data readouts from key studies that will further inform the strategic development of these leading DNA medicine assets later this year.
Dr. Shea continued: While we focus on near-term catalysts, we are also dedicated to improving our prioritization processes in developing our entire R&D pipeline to maximize our ability to deliver innovative products to patients around the globe over the longer term.
INOVIOs DNA technology pipeline includes a number of other clinical-stage product candidates focused on infectious diseases and immuno-oncology. This reorganization is aligned with the previously announced strategic changes for the INO-4800 development program to focus on the heterologous boost indication, as well as the development path and timeline for VGX-3100, a product candidate for treating HPV-associated cervical high-grade squamous intraepithelial lesions (HSIL).
About INOVIO
INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to potentially treat and protect people from infectious diseases, cancer, and diseases associated with HPV. Our DNA medicines are delivered using our proprietary smart device to produce immune responses against targeted pathogens and cancers.
Partners and collaborators include Advaccine, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations, Defense Advanced Research Projects Agency/Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense/Department of Defense, HIV Vaccines Trial Network, International Vaccine Institute, Kaneka Eurogentec, Medical CBRN Defense Consortium, National Cancer Institute, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Ology Bioservices, the Parker Institute for Cancer Immunotherapy, Plumbline Life Sciences, Regeneron, Richter-Helm BioLogics, Thermo Fisher Scientific, University of Pennsylvania, Walter Reed Army Institute of Research, and The Wistar Institute. For more information, visit www.inovio.com.
Contacts
Investors & Media:
Gene Kim, (267) 589-9471, gene.kim@inovio.com
Thomas Hong, (267) 440-4298, thomas.hong@inovio.com
Forward Looking Statements
This press release contains certain forward-looking statements relating to our business, including our plans to develop and commercialize DNA medicines, our expectations regarding our research and development programs, including the planned initiation and conduct of pre-clinical studies and clinical trials and the availability and timing of data from those studies and trials, expectations about the upfront costs and long-term cost reductions associated with our corporate reorganization and the anticipated extension of the companys cash runway. 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 March 31, 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.
Document and Entity Information |
Jul. 18, 2022 |
---|---|
Cover [Abstract] | |
Amendment Flag | false |
Entity Central Index Key | 0001055726 |
Document Type | 8-K |
Document Period End Date | Jul. 18, 2022 |
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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