Item 1.01 Entry into a Material Definitive Agreement.
On June 22, 2020, Inovio Pharmaceuticals, Inc. (the "Company") entered into an
Other Transaction Authority for Prototype Agreement (the "OTA Agreement") with
the U.S. Department of Defense (the "DoD") to fund the Company's efforts in
developing its next-generation intradermal electroportation device, known as
CELLECTRA® 3PSP, and associated arrays to be used for delivery of the Company's
vaccine candidate, INO-4800, as protection against COVID-19. Under the OTA
Agreement, the Company intends to develop the CELLECTRA 3PSP device and arrays
for use in the U.S. military population and the U.S. population as a whole,
subject to approval of the device by the U.S. Food and Drug Administration (the
"FDA"). The OTA Agreement is also expected to support large-scale manufacturing
of the CELLECTRA 3PSP device, as well as large-scale DNA plasmid production for
manufacture and supply of a specified number of doses of INO-4800 in support of
FDA approval of the device. The total amount of funding being made available to
the Company under the OTA Agreement is approximately $54.5 million.
Under the OTA Agreement, the Company has agreed that, for a period of six years,
it will not offer, sell or otherwise provide the production model of the
CELLECTRA 3PSP prototype to any entity at a price lower than that offered to the
DoD. In addition, if the Company develops a commercialized version or derivative
of the production model of the prototype with similar capability and intended
application, but at a lower unit price, the Company will be obligated to make
the DoD aware of the similar product and the technical and price differences
between the products, and no entity will be entitled to receive a lower price
than the DoD for similar purchase quantities of such product.
The DoD may, among other things, suspend or terminate the OTA Agreement if the
Company materially fails to comply with the provisions of the OTA Agreement
after issuance of a cure notice and failure of the Company to cure the defect
within a specified time. The DoD may also terminate the OTA Agreement in its
discretion at any time upon at least 30 days' prior written notice to the
Company.
Additionally, on June 19, 2020, the Company was awarded a fixed-price contract
(the "Procurement Contract") from the DoD for the purchase of the Company's
intradermal CELLECTRA® 2000 device and accessories. The CELLECTRA 2000 devices
will be used to inject INO-4800 in the Company's planned later-stage clinical
trials. The total purchase price under the Procurement Contract is approximately
$16.6 million.
The foregoing description of the material terms of the OTA Agreement and the
Procurement Contract does not purport to be complete and is qualified in its
entirety by reference to such agreements, which will be filed with the
Securities and Exchange Commission as exhibits to the Company's Quarterly Report
on Form 10-Q for the quarter ending June 30, 2020.
Item 7.01 Regulation FD Disclosure.
On June 23, 2020, the Company issued a press release announcing the total
funding of $71 million being made available pursuant to the OTA Agreement and
the Procurement Contract. The funding is being provided by the DoD's Joint
Program Executive Office for Chemical, Biological, Radiological and Nuclear
Defense ("JPEO-CBRND") and JPEO-CBRND's Joint Product Lead CBNRD Enabling
Technologies. A copy of this press release is furnished herewith as Exhibit 99.1
to this 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 8.01 Other Events.
On June 23, 2020, the Company established a new wholly-owned subsidiary, Inovio
Asia LLC, established under the laws of South Korea, through which the Company
intends to advance its corporate development projects and other functions in
South Korea and other Asian countries.
As previously announced, on June 3, 2020, the Company filed a complaint in the
Court of Common Pleas of Montgomery County, Pennsylvania (the "Court") seeking a
preliminary injunction to compel VGXI, Inc. and GeneOne Life Science, Inc.
(together, "VGXI") to facilitate the transfer of manufacturing methods, using
VGXI's technology, under the parties' existing supply agreement. On June 25,
2020, the Court denied the Company's petition for the preliminary injunction.
The Company is exploring its legal options, including a potential immediate
appeal of the Court's decision. In addition, the Company is taking the next
steps, including continuing discussions with third-party manufacturers,
necessary to support the rapid and large-scale manufacturing of INO-4800 to
address the urgent global health need caused by the COVID-19 pandemic.
Forward-Looking Statements
This report contains certain forward-looking statements relating to the
Company's business that involve a number of risks and uncertainties, including
statements related to expected development and manufacturing of its CELLECTRA
3PSP device and its vaccine candidate INO-4800 and planned corporate activities
in Asia. 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
those discussed in the "Risk Factors" section of the Company's 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.
In addition, the forward-looking statements included in this report represent
the Company's views as of the date hereof. The Company anticipates that
subsequent events and developments may cause its views to change. However, while
the Company may elect to update these forward-looking statements at some point
in the future, the company specifically disclaims any obligation to do so,
except as may be required by law. These forward-looking statements should not be
relied upon as representing the Company's views as of any date subsequent to the
date of this report.
Item 9.01 Financial Statements and Exhibits.
Exhibit
No. Exhibit Description
99.1 Press Release, dated June 23, 2020.
--------------------------------------------------------------------------------
© Edgar Online, source Glimpses