Current Report Filing (8-k)
April 13 2018 - 7:03AM
Edgar (US Regulatory)
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): April 11, 2018
Inovio Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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001-14888
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33-0969592
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(State or other jurisdiction of
incorporation)
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(Commission File Number)
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(IRS Employer
Identification No.)
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660 W. Germantown Pike, Suite 110
Plymouth Meeting, PA 19462
(Address of principal executive offices, including zip code)
(267)
440-4200
(Registrants 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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule
14a-12
under the Exchange Act (17 CFR
240.14a-12)
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Pre-commencement
communications pursuant to Rule
14d-2(b)
under the Exchange Act (17 CFR
240.14d-2(b))
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☐
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Pre-commencement
communications pursuant to Rule
13e-4(c)
under the Exchange Act (17 CFR
240.13e-4(c))
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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. ☐
On April 11, 2018, Inovio Pharmaceuticals, Inc. (the Registrant)
announced that it has entered into agreements with the Coalition for Epidemic Preparedness Innovations, or CEPI, pursuant to which the Registrant intends to develop vaccine candidates against Lassa fever and Middle East Respiratory Syndrome, or
MERS. The goal of the collaboration between the Registrant and CEPI is to unlock research and development potential so that investigational stockpiles will be ready for clinical efficacy trial testing during potential disease outbreaks. The
agreements with CEPI contemplate
pre-clinical
studies, as well as Phase 1 and Phase 2 clinical trials, occurring over the next few years. As part of the arrangement between the parties, CEPI has agreed to fund
up to an aggregate of $56 million of costs over a five-year period for preclinical studies, as well as planned Phase 1 and Phase 2 clinical trials, to be conducted by the Registrant, with funding from CEPI based on the achievement of identified
milestones. The Registrants vaccine candidate for Lassa fever will be known as
INO-4500,
and its vaccine candidate for MERS will be known as
INO-4700.
On April 11, 2018, the Registrant issued a press release announcing the funding agreements with CEPI. A copy of this press release is filed as Exhibit
99.1 to this Current Report on Form
8-K.
Item 9.01
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Financial Statements and Exhibits.
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(d) Exhibits
Forward-Looking Statements
This Current Report contains certain forward-looking statements relating to the agreements entered into between Inovio and CEPI and the funding, anticipated
benefits and clinical trials contemplated under such agreements. 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 and product development programs, 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 vaccines, our ability to support our pipeline of SynCon
®
active immunotherapy and vaccine 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 the company or its collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that the company and its collaborators hope to develop,
issues involving product liability, issues involving patents and whether they or licenses to them will provide the company 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 the company can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of
corporate expenditures, assessments of the companys 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, 2017 and other regulatory filings we make from time to time. There can be no assurance that any product candidate in the Registrants 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 the Registrant undertakes no obligation to update or revise these statements, except as may be required by law.
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.
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INOVIO PHARMACEUTICALS, INC.
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Date: April 11, 2018
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By:
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/s/ Peter Kies
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Peter Kies
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Chief Financial Officer
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Inovio Pharmaceuticals (NASDAQ:INO)
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