Item 8.01. Other Events.
On June 3, 2020, Inovio Pharmaceuticals, Inc. (the Company) filed a complaint in the Court of Common Pleas of Montgomery County,
Pennsylvania seeking, among other requests for emergency relief, to compel VGXI, Inc. and GeneOne Life Science, Inc. (together, VGXI) to facilitate the transfer of manufacturing methods, using VGXIs technology, under
the parties existing supply agreement (the Supply Agreement). The technology transfer, which the Company has requested as permitted under the Supply Agreement, will allow for the large-scale manufacture of the
Companys product candidate INO-4800, a new vaccine candidate against the disease, known as COVID-19, caused by the outbreak strain of the coronavirus SARS-CoV-2. The Company believes that widespread availability of its potential COVID-19 vaccine, which can only be achieved through
accelerated large-scale manufacture following clinical trials and regulatory approval, is essential to combat the ongoing global coronavirus pandemic.
As
described in the Companys Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission on March 12, 2020, the Company and VGXI entered
into the Supply Agreement in 2008. Under the Supply Agreement, VGXI produces and supplies the DNA plasmids for the Companys research and early clinical trials for its product candidates. There are no purchase commitments by the Company under
the Supply Agreement; rather, terms of purchase are determined on an individual purchase order basis. Under the Supply Agreement, the Company has agreed to treat VGXI as its most favored supplier for DNA plasmids, and VGXI has agreed to treat the
Company as its most favored customer.
In January 2020, the Company began preclinical studies of INO-4800 in an
effort to develop a potential vaccine for an urgent public health need. In April 2020, the Company received approval from the U.S. Food and Drug Administration (the FDA) to begin a Phase 1 clinical trial of INO-4800. If the initial safety and immunogenicity data from the Phase 1 trial are acceptable, the Company plans to advance the development of INO-4800 into later-stage
efficacy trials in the second half of 2020, subject to further regulatory guidance from the FDA. The Company has a goal of producing one million doses of INO-4800 by the end of 2020, with its existing capacity
and contract resources, for further clinical trials or emergency use.
VGXI informed the Company that it did not have the capacity to manufacture the
Companys full order of DNA plasmids on the requested timeline, nor would it be able to manufacture plasmids for the commercial sale of INO-4800, if it were to be approved for sale. The Company began
discussions with other third-party contract manufacturers, as permitted by the Supply Agreement. As previously announced, in March and April 2020, the Company engaged Ology Bioservices Inc. and Richter-Helm BioLogics GmbH & Co. KG to
support large-scale manufacturing of INO-4800. Richter-Helm BioLogics has manufactured the Companys DNA medicine candidate VGX-3100, currently in Phase 3 trials as
a potential treatment for precancerous cervical dysplasia, since 2015 using a process technology that was transferred by VGXI at that time. The Company intends to engage additional contract manufacturers for the production of INO-4800.
Following notification of VGXIs insufficient capacity, the Company requested that VGXI provide the
necessary technology transfer materials in order to allow its engaged contract manufacturers to proceed with the manufacture of INO-4800, as required by the Supply Agreement. In May 2020, following further
discussions between the parties, VGXI notified the Company of its refusal to undertake the Companys request, leading the Company to initiate legal proceedings as an emergency action to compel the technology transfer required of VGXI by the
Supply Agreement for the planned large-scale manufacture of the Companys COVID-19 vaccine candidate.
Forward-Looking Statements
This report contains certain
forward-looking statements relating to the Companys business that involve a number of risks and uncertainties, including statements related to expected development and manufacturing of its vaccine candidate
INO-4800. These statements may be identified by introductory words such as may, expects, plan, believe, will, achieve,
anticipate, would, should, subject to or words of similar meaning, or by the fact that they do not relate strictly to historical or current facts. For such statements, the Company claims the protection
of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including, but not limited to, the risk that the Company may not be able to
procure the necessary contract manufacturing capacity in order to sufficiently produce INO-4800 on the planned timeline, as well as other factors discussed in the Risk Factors section of the
Companys most recently filed Annual Report on Form 10-K or Quarterly Report on Form 10-Q, as well as other filings that the Company makes with the SEC from time to
time. There can be no assurance that any of the forward-looking information provided herein will be proven accurate.