PLYMOUTH MEETING, Pa.,
March 12, 2019 /PRNewswire/
-- Inovio Pharmaceuticals, Inc. (NASDAQ:INO), a late-stage
biotechnology company focused on the development and
commercialization of DNA immunotherapies targeted against cancers
and infectious diseases, today reported financial results for the
fourth quarter and year ended December 31,
2018. Inovio's management will host a live conference
call and webcast at 4:30 p.m. Eastern
Time today to discuss financial results and provide a
general business update.
Inovio Highlights
- MEDI0457 (formerly INO-3112, licensed to
AstraZeneca)
Between October
2018 and January 2019, Inovio
announced two patients with human papilloma virus (HPV)-related
head and neck cancer that were treated with INO-3112 (now called
MEDI0457) in a Phase 1 trial achieved a sustained complete response
(full remission) following subsequent treatment with a PD-1
checkpoint inhibitor. Both patients who achieved full cancer
remission were treated with four doses of synthetic DNA vaccine as
part of a Phase 1 monotherapy trial of 22 patients with HPV-related
head and neck squamous cell carcinoma in which 91% of patients
(20/22) showed T cell activity in the blood or tissue. The
administration of synthetic DNA vaccine in the trial generated
robust HPV16/18 specific CD8+ T cell responses in peripheral blood
and increased CD8+ T cell infiltration in resected tumor tissue
samples. Complete response in 2 out of 4 (50%) progressors is
encouraging, as to Inovio's knowledge, the best complete response
rate by PD-1 inhibitors as a monotherapy in metastatic head and
neck cancer is approximately 4% (8/192 with
KEYTRUDA® alone and 6/240 with
OPDIVO® alone).
Additionally, in December 2018,
Inovio announced a second Phase 2 study in collaboration with
AstraZeneca and the MD Anderson Cancer Center to evaluate MEDI0457
in combination with durvalumab targeting a broad array of cancers
associated with HPV. The treatment of the first patient with
cervical cancer in this trial resulted in a milestone payment from
AstraZeneca to Inovio.
- VGX-3100 – HPV-related Pre-cancers
VGX-3100, which is
a sibling product candidate to MEDI0457, continues to be evaluated
in the double-blind global Phase 3 study for the treatment of
cervical dysplasia (CIN). The enrollment for primary study,
REVEAL 1, is nearing completion; while the confirmatory study,
REVEAL 2, is now open and recruiting. The company maintains
the target objective on a BLA submission for VGX-3100 in 2021.
In addition to VGX-3100 for the treatment of CIN, the company
anticipates interim efficacy later this year from our 2 separate
Phase 2 studies that are evaluating the efficacy of VGX-3100 in
patients with precancerous lesions of the vulva, or vulvar
dysplasia, as well as for anal dysplasia.
- INO-5401 – Cancer Combination Trials
Inovio's Phase
1/2 immuno-oncology trial evaluating INO-5401 plus INO-9012, in
combination with Regeneron Pharmaceuticals' cemiplimab (REGN2810)
in patients with newly diagnosed glioblastoma currently has 20
sites open within the United
States with the enrollment of 52 patients nearly
completed. In Inovio's other Phase 1/2a study of INO-5401
plus INO-9012, in combination with Genentech/Roche's atezolizumab,
for the treatment of advanced or metastatic bladder cancer, the
company recently opened sites in Europe to further accelerate enrollment along
with its 13 active sites in the United States. The company
expects interim efficacy results from both programs in 2019.
- Infectious Diseases
-
- Inovio and its partner GeneOne Life Science, with a full
funding from the International Vaccine Institute, are conducting a
Phase 1/2a MERS vaccine study in South
Korea, with data report expected in 2019. Inovio also
plans to initiate a Phase 2 MERS vaccine field trial in the
Middle East with full CEPI funding
in 2H 2019.
- Inovio received IND approval for another CEPI funded vaccine
for combatting Lassa fever, which will advance into the first human
trial in the second quarter.
- All patient samples have been collected for Inovio's Zika
vaccine trial in Puerto Rico.
Inovio's partner GeneOne is analyzing all samples blindly and
will report safety, immune responses and infection rate data from
this study in 2019.
- Inovio expects to have clinical data from several Phase 1
vaccine programs published multiple publications in 2019: Ebola
vaccine; MERS vaccine; HIV; and ZIka vaccine study in Puerto Rico.
- DNA-Encoded Monoclonal Antibody (dMAb™)
In
February 2019, the company dosed the
first subject in the first-ever human study of Inovio's DNA-encoded
monoclonal antibody (dMAb™) technology evaluating the dMAb's
(INO-A002) ability to prevent or treat Zika virus infection.
This study is being fully funded by The Bill and Melinda Gates
Foundation. While the trial's focus is on evaluating the dMAb
for Zika infection, the clinical results are intended to help
advance Inovio's dMAb programs in infectious diseases and
cancer.
- Geneos Therapeutics, Inc.
In February 2019, Inovio's subsidiary Geneos,
secured a Series A financing round with potential proceeds of up
$10.5 million. This funding has
launched Geneos' operations as a standalone entity to develop the
next generation of neoantigen-targeting cancer immunotherapies.
Geneos has an exclusive license to Inovio's DNA-based
immunotherapy platform for personalized cancer immunotherapy;
Inovio will continue to develop and potentially commercialize all
global population-based (non-personalized) cancer immunotherapies
and infectious disease vaccines based on its proprietary
SynCon® design.
- Cash Position
As of December
31, 2018, cash and cash equivalents and short-term
investments were $81.2 million
compared to $85.5 million as of
September 30, 2018. In February
and March 2019, the Company completed
a private placement of $78.5 million
aggregate principal amount of 6.50% convertible senior notes due
2024, or the Notes. The Notes were sold in a private offering
to qualified institutional buyers pursuant to Rule 144A under the
Securities Act of 1933, as amended. Net proceeds from the
offering were approximately $75.8
million, after deducting the initial purchasers' discount
and estimated offering expenses payable by the Company.
Dr. J. Joseph Kim, Inovio's
President & CEO said, "Our Phase 3 program for VGX-3100 is
advancing with REVEAL 1 nearing complete enrollment and the opening
of sites for REVEAL 2. Moreover, Inovio continues to generate
impressive efficacy data for HPV-related head and neck cancers,
further validating our objective to be the global leader in
treating HPV-related diseases. The announcement of the second
patient achieving full cancer remission in January provides
additional corroboration for Inovio's overall cancer combination
strategy using a T cell activator combined with a checkpoint
inhibitor against an array of cancers with big pharma partners
providing various checkpoint inhibitors. With interim
efficacy data expected later this year from our INO-5401 programs,
we believe Inovio is well-positioned to continue to build upon its
synthetic DNA immunotherapy approach, while continuing to leverage
our current partnerships and seeking to form new
ones."
Fourth Quarter 2018 Financial Results
Total revenue was $2.5 million and
$30.5 million for the quarter and
year ended December 31, 2018,
respectively, compared to $8.8
million and $42.2 million for
the same periods in 2017. Total operating expenses were
$32.0 million and $124.6 million for the quarter and year ended
December 31, 2018, respectively,
compared to $31.7 million and
$125.9 million for the same periods
in 2017, respectively.
As a result of the adoption of Accounting Standards Update No.
2014-09, Revenue from Contracts with Customers, beginning on
January 1, 2018, all contributions
received from current grant agreements have been recorded as a
contra-expense as opposed to revenue on the consolidated statement
of operations. For the quarter and year ended December 31, 2018, $2.8
million and $9.5 million,
respectively, was recorded as contra-research and development
expense, which would have been classified as grant revenue in the
prior year. Had this change in presentation not occurred,
total revenue would have been $5.3
million and $40.0 million for
the quarter and year ended December 31,
2018, respectively, compared to $8.8
million and $42.2 million for
the same periods in 2017. Total operating expenses would have
been $34.8 million and $134.1 million for the quarter and year ended
December 31, 2018, respectively,
compared to $31.7 million and
$125.9 million for the same periods
in 2017.
Inovio's net loss for the quarter and year ended December 31, 2018 was $33.0 million, or $0.34 per basic and diluted share, and
$97.0 million, or $1.05 per basic and diluted share, respectively,
as compared to $21.5 million, or
$0.24 per basic and diluted share,
and $88.2 million, or $1.08 per basic and $1.09 per diluted share, for the same periods in
2017.
Revenue
The year over year decrease in comparable revenue and grant
agreement recognition was primarily due to $15.4 million in lower revenues recognized under
Inovio's collaborative research and development agreement with
AstraZeneca, as previously deferred revenue was recognized in
June 2017 upon AstraZeneca's
selection of the first cancer research collaboration product
candidate. There was also a decrease in grant funding
recognized from Inovio's DARPA Ebola grant of $8.8 million as well as no revenue recognized in
2018 from Roche compared to $6.1
million for 2017 due to the termination of the agreement in
2017. These decreases were partially offset by the recognition of
the gross up-front payment from ApolloBio of $23.0 million during the year (approximately
$19.4 million after payment of
required taxes), as well as an increase in grant funding from the
CEPI grant of $4.3 million, among
other variances.
Operating Expenses
Research and development (R&D) expenses for the quarter and
year ended December 31, 2018 were
$26.4 million and $95.3 million, respectively, compared to
$24.6 million and $98.6 million for the same periods in 2017.
The year over year decrease in R&D expenses was primarily due
to the $9.5 million contra-research
and development expense recorded from grant agreements as discussed
above, as well as a decrease in expenses related to Inovio's DARPA
Ebola grant. These decreases were offset by an increase in
expenses for drug manufacturing related to Inovio's collaboration
with AstraZeneca, employee headcount to support clinical trials and
partnerships, and expenses related to clinical trials, among other
variances.
General and administrative expenses were $5.6 million and $29.3
million, respectively, for the quarter and year ended
December 31, 2018 versus $8.0 million and $28.3
million, respectively, for the same periods in 2017.
Capital Resources
As of December 31, 2018, cash and
cash equivalents and short-term investments were $81.2 million compared to $85.5 million as of September 30, 2018. As of December 31, 2018, the Company had 97.2 million
common shares outstanding and 107.7 million common shares
outstanding on a fully diluted basis, after giving effect to
outstanding options, restricted stock units and convertible
preferred stock.
During the year ended December 31,
2018, the Company sold 5,669,025 shares of common stock
under its current and prior "at-the-market" (ATM) common stock
sales agreements for aggregate net proceeds of $29.2 million.
During the year ended December 31,
2018, stock options and warrants to purchase an aggregate of
756,853 shares of common stock were exercised for aggregate net
proceeds of $2.4 million.
In February and March 2019, the
Company completed a private placement of $78.5 million aggregate principal amount of 6.50%
convertible senior notes due 2024, or the Notes. The Notes
were sold in a private offering to qualified institutional buyers
pursuant to Rule 144A under the Securities Act of 1933, as
amended. Net proceeds from the offering were approximately
$75.8 million, after deducting the
initial purchasers' discount and estimated offering expenses
payable by the Company.
Inovio's balance sheet and statement of operations are provided
below. Additional information is included in Inovio's annual
report on Form 10-K for the year ended December 31, 2018, which can be accessed at:
http://ir.inovio.com/investors/financial-reports/default.aspx.
About Inovio Pharmaceuticals, Inc.
Inovio is a late-stage biotechnology company focused on the
discovery, development, and commercialization of DNA-based
immunotherapies and vaccines that transform the treatment and
prevention of cancer and infectious disease. Inovio's
proprietary technology platform applies antigen sequencing and DNA
delivery to activate potent immune responses to targeted
diseases. The technology functions exclusively in
vivo, and has been demonstrated to consistently activate robust
and fully functional T cell and antibody responses against targeted
cancers and pathogens. Inovio's most advanced clinical
program, VGX-3100, is in Phase 3 for the treatment of HPV-related
cervical pre-cancer. Also in development are Phase 2
immuno-oncology programs targeting HPV-related cancers, bladder
cancer, and glioblastoma, as well as platform development programs
in hepatitis B, Zika, Ebola, MERS, and HIV. Partners and
collaborators include AstraZeneca, Regeneron, Roche/Genentech,
ApolloBio Corporation, The Wistar Institute, The Bill & Melinda
Gates Foundation, the University of
Pennsylvania, Parker Institute for Cancer Immunotherapy,
CEPI, DARPA, GeneOne Life Science, Plumbline Life Sciences, NIH,
HIV Vaccines Trial Network, National Cancer Institute, Walter Reed
Army Institute of Research, Drexel
University, and Laval University. For more
information, visit www.inovio.com.
* * *
This press release contains certain forward-looking
statements relating to our business, including our plans to develop
electroporation-based drug and gene delivery technologies and DNA
vaccines, our expectations regarding our research and development
programs, including the planned initiation and conduct of clinical
trials and the availability and timing of data from those trials.
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 us or our 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, 2018, our Quarterly Reports on Form
10-Q and other regulatory filings we make from time to time.
There can be no assurance that any product candidate in our
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 we undertake no
obligation to update or revise these statements, except as may be
required by law.
Inovio
Pharmaceuticals, Inc.
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
|
December 31,
|
|
2018
|
|
2017
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
|
23,693,633
|
|
|
$
|
23,786,579
|
|
Short-term
investments
|
57,538,852
|
|
|
103,638,844
|
|
Accounts
receivable
|
3,316,361
|
|
|
6,003,205
|
|
Accounts receivable
from affiliated entities
|
738,583
|
|
|
486,619
|
|
Prepaid expenses and
other current assets
|
1,406,590
|
|
|
2,600,906
|
|
Prepaid expenses and
other current assets from affiliated entities
|
1,120,805
|
|
|
1,846,007
|
|
Total current
assets
|
87,814,824
|
|
|
138,362,160
|
|
Fixed assets,
net
|
15,949,014
|
|
|
18,320,176
|
|
Investment in
affiliated entity - GeneOne
|
6,381,926
|
|
|
9,069,401
|
|
Investment in
affiliated entity - PLS
|
3,023,987
|
|
|
2,325,079
|
|
Intangible assets,
net
|
4,760,145
|
|
|
6,009,729
|
|
Goodwill
|
10,513,371
|
|
|
10,513,371
|
|
Other
assets
|
2,669,998
|
|
|
2,639,354
|
|
Total
assets
|
$
|
131,113,265
|
|
|
$
|
187,239,270
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued expenses
|
$
|
23,134,733
|
|
|
$
|
23,278,798
|
|
Accounts payable and
accrued expenses due to affiliated entities
|
977,792
|
|
|
926,943
|
|
Accrued clinical
trial expenses
|
5,671,764
|
|
|
8,611,892
|
|
Common stock
warrants
|
—
|
|
|
360,795
|
|
Deferred
revenue
|
223,577
|
|
|
1,175,353
|
|
Deferred revenue from
affiliated entities
|
33,575
|
|
|
174,110
|
|
Deferred
rent
|
1,065,387
|
|
|
877,535
|
|
Deferred grant
funding
|
4,165,848
|
|
|
—
|
|
Deferred grant
funding from affiliated entities
|
27,083
|
|
|
—
|
|
Total current
liabilities
|
35,299,759
|
|
|
35,405,426
|
|
Deferred revenue, net
of current portion
|
150,793
|
|
|
215,853
|
|
Deferred rent, net of
current portion
|
8,518,207
|
|
|
9,104,416
|
|
Deferred tax
liabilities
|
24,766
|
|
|
24,766
|
|
Other
liabilities
|
87,333
|
|
|
—
|
|
Total
liabilities
|
44,080,858
|
|
|
44,750,461
|
|
Commitments and
contingencies
|
|
|
|
Inovio
Pharmaceuticals, Inc. stockholders' equity:
|
|
|
|
Preferred stock—par
value $0.001; Authorized shares: 10,000,000, issued and outstanding
shares: 23
at December 31, 2018 and December 31, 2017
|
—
|
|
|
—
|
|
Common stock—par
value $0.001; Authorized shares: 600,000,000 at December 31, 2018
and
December 31, 2017, issued and outstanding: 97,225,810 at
December 31, 2018 and 90,357,644 at
December 31, 2017
|
97,226
|
|
|
90,358
|
|
Additional paid-in
capital
|
707,794,215
|
|
|
665,775,504
|
|
Accumulated
deficit
|
(620,426,436)
|
|
|
(523,356,317)
|
|
Accumulated other
comprehensive loss
|
(528,867)
|
|
|
(117,005)
|
|
Total Inovio
Pharmaceuticals, Inc. stockholders' equity
|
86,936,138
|
|
|
142,392,540
|
|
Non-controlling
interest
|
96,269
|
|
|
96,269
|
|
Total stockholders'
equity
|
87,032,407
|
|
|
142,488,809
|
|
Total liabilities
and stockholders' equity
|
$
|
131,113,265
|
|
|
$
|
187,239,270
|
|
Inovio
Pharmaceuticals, Inc.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
|
|
|
For the Year ended
December 31,
|
|
2018
|
|
2017
|
|
2016
|
Revenues:
|
|
|
|
|
|
Revenue under
collaborative research and development arrangements
|
$
|
29,860,785
|
|
|
$
|
28,407,388
|
|
|
$
|
6,490,747
|
|
Revenue under
collaborative research and development arrangements with
affiliated
entities
|
449,524
|
|
|
765,828
|
|
|
1,400,594
|
|
Grants and
miscellaneous revenue
|
171,588
|
|
|
10,474,539
|
|
|
27,136,457
|
|
Grants and
miscellaneous revenue from affiliated entity
|
—
|
|
|
2,572,331
|
|
|
340,563
|
|
Total
revenues
|
30,481,897
|
|
|
42,220,086
|
|
|
35,368,361
|
|
Operating
expenses:
|
|
|
|
|
|
Research and
development
|
95,257,876
|
|
|
98,572,618
|
|
|
88,712,035
|
|
General and
administrative
|
29,315,159
|
|
|
28,290,369
|
|
|
23,892,263
|
|
Gain on sale of
assets
|
—
|
|
|
(1,000,000)
|
|
|
(1,000,000)
|
|
Total operating
expenses
|
124,573,035
|
|
|
125,862,987
|
|
|
111,604,298
|
|
Loss
from operations
|
(94,091,138)
|
|
|
(83,642,901)
|
|
|
(76,235,937)
|
|
Other income
(expense):
|
|
|
|
|
|
Interest and other
income, net
|
920,891
|
|
|
1,612,974
|
|
|
1,257,257
|
|
Change in fair value
of common stock warrants
|
360,795
|
|
|
806,819
|
|
|
127,554
|
|
Gain (loss) on
investment in affiliated entity
|
(1,988,567)
|
|
|
(6,982,664)
|
|
|
1,110,787
|
|
Net loss before
provision for income tax
|
(94,798,019)
|
|
|
(88,205,772)
|
|
|
(73,740,339)
|
|
Provision for income
taxes
|
(2,169,811)
|
|
|
—
|
|
|
—
|
|
Net
loss
|
(96,967,830)
|
|
|
(88,205,772)
|
|
|
(73,740,339)
|
|
Net loss per
share
|
|
|
|
|
|
Basic
|
$
|
(1.05)
|
|
|
$
|
(1.08)
|
|
|
$
|
(1.01)
|
|
Diluted
|
$
|
(1.05)
|
|
|
$
|
(1.09)
|
|
|
$
|
(1.01)
|
|
Weighted average
number of common shares outstanding
|
|
|
|
|
|
Basic
|
92,539,997
|
|
|
81,777,493
|
|
|
73,214,766
|
|
Diluted
|
92,539,997
|
|
|
81,918,022
|
|
|
73,214,766
|
|
CONTACTS:
|
|
Investors:
|
Ben Matone, Inovio,
484-362-0076, ben.matone@inovio.com
|
Media:
|
Jeff Richardson,
Inovio, 267-440-4211, jrichardson@inovio.com
|
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SOURCE Inovio Pharmaceuticals, Inc.