PLYMOUTH MEETING, Pa.,
Aug. 8, 2019 /PRNewswire/
-- Inovio Pharmaceuticals, Inc. (NASDAQ: INO), an innovative
biotechnology company focused on the discovery, development and
commercialization of synthetic DNA technology targeted against
cancers and infectious diseases, today reported financial results
for the second quarter ended June 30,
2019. 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
- VGX-3100/HPV-Related Diseases
Inovio completed enrollment of 198
participants for its primary Phase 3 registration trial (REVEAL 1)
of VGX-3100 for the treatment of high-grade cervical dysplasia
(cervical HSIL) caused by human papillomavirus (HPV). Inovio
is currently enrolling its confirmatory Phase 3 trial (REVEAL
2).
VGX-3100 was granted an Advanced
Therapy Medicinal Product Certificate for quality and non-clinical
data by the European Medicines Agency (EMA), which confirms that
Inovio's chemistry, manufacturing and controls (CMC) data and
nonclinical results available to date overall comply with the
scientific and technical standards for evaluating an EU Marketing
Authorization.
Inovio and QIAGEN announced a
collaboration to co-develop a liquid biopsy-based companion
diagnostic to identify patients who could benefit from
VGX-3100.
Inovio completed enrollment for
its Phase 2 trial of VGX-3100 for the treatment of high-grade
vulvar dysplasia (vulvar HSIL) in July. Inovio intends to report
interim clinical data from this study, along with interim results
from the Phase 2 study for high-grade anal dysplasia (anal HSIL),
before the year end.
In July, Inovio executed a
strategic refinement to focus on the commercial development of its
late-stage HPV assets, which includes VGX-3100, and reallocate
capital to develop fast-to-market product candidates, such as
INO-3107 (previously called INO-3106) to treat RRP (recurrent
respiratory papillomatosis). RRP is a rare, orphan disease caused
by HPV 6 and 11 infections, for which clinical benefit was recently
demonstrated in a pilot study. Inovio plans to initiate the next
clinical trial of INO-3107 within the next 12 months.
- Cancer Combination Trials
Inovio received a third Phase 2
milestone payment from AstraZeneca for MEDI0457 in combination with
durvalumab for dosing patients in the third HPV-related cancer
indication; two previous milestone payments resulted from
initiating Phase 2 combination trials targeting head and neck and
cervical cancers. AstraZeneca continues to expand and evaluate
MEDI0457 in three different Phase 2 trials that target HPV caused
cancers. Subsequent to the quarter, AstraZeneca completed planned
enrollment of its Phase 2 study in head and neck cancer
(ClinicalTrials.gov Identifier: NCT03162224).
Inovio completed enrollment of its
Phase 1/2 immuno-oncology trial in 52 patients with newly diagnosed
glioblastoma three months ahead of schedule. Interim results
evaluating safety, immunological impact, progression-free survival
and overall survival from this study are expected by the end of
2019.
As part of the strategic
organizational restructuring announcement in July, Inovio
discontinued its Phase 1/2 clinical trial of INO-5401 in patients
with advanced bladder cancer. The decision to discontinue the trial
was made because of the recognition that several new therapeutic
alternatives have been approved, or are likely to be approved, for
study patients since the trial's design and inception, and because
of the high expense of the trial.
INO-5151, Inovio's prostate cancer
immunotherapy, will be combined with an immune modulator (CDX-301,
FLT3 ligand, a dendritic cell mobilizer) and a PD-1 checkpoint
inhibitor (nivolumab) targeting metastatic castration-resistant
prostate cancer in a Parker Institute for Cancer Immunotherapy
(PICI) sponsored platform study. As part of Inovio's clinical
collaboration agreement with PICI and in collaboration with the
Cancer Research Institute, INO-5151 is one arm (Cohort C) of this
broad PICI-supported study which is a multi-arm, multi-stage
platform design (PORTER Study: ClinicalTrials.gov Identifier:
NCT03835533).
- DNA-encoded Bi-specific T Cell Engagers (dBTEs)
Preclinical data results for
Inovio's transformative dBTE technology were published
in JCI Insight. The current bi-specific T cell engager
product has only a few hours of half-life and requires several
weeks of continuous intravenous infusion. Inovio developed a
novel dBTE targeting the HER2 molecule which was tested
successfully in therapeutic models for the treatment of ovarian and
breast cancers. A single injection of the HER2 dBTE candidate
produced bi-specific antibodies that lasted for several weeks and
effectively killed HER2-expressing tumor cells resulting in a
near-complete tumor clearance. Inovio plans to rapidly advance its
dBTE technology.
Inovio dosed its first patients in
its Phase 1 clinical study evaluating safety, tolerability and
immune responses to INO-4500 in patients with Lassa fever. INO-4500
is the world's first Lassa fever virus vaccine candidate. The
INO-4500 program is fully funded through a global partnership with
the Coalition for Epidemic Preparedness Innovations (CEPI).
In July, positive clinical trial
results from the world's first clinical testing of a vaccine
against the Middle East Respiratory Syndrome Coronavirus (MERS)
were published in The Lancet Infectious Diseases. Inovio's
MERS DNA vaccine INO-4700 was well-tolerated and 94% of patients
demonstrated overall high levels of antibody responses, while 88%
of study participants demonstrated broad-based T cell responses. A
Phase 2 field trial is being planned in the Middle East through the partnership with
CEPI.
As of June
30, 2019, cash and cash equivalents and short-term
investments were $106.0 million
compared to $81.2 million as of
December 31, 2018.
In August, Inovio closed a private
placement of 1.0% convertible bonds due 2024 with an aggregate
principal amount of 18 billion Korean
Won (KRW) (approximately USD $15.0
million based on the exchange rate on the date of issuance)
issued to a group of institutional investors led by Korea
Investment Partners (KIP), a global venture capital and private
equity firm. These bonds are convertible into Inovio's Korean
Depositary Receipts (KDRs) assuming Inovio has completed a
secondary listing of its securities on the KOSDAQ Market of the
Korea Exchange in the form of KDRs, or otherwise shares of common
stock if KDRs are not listed at the time of conversion.
Dr. J. Joseph Kim, Inovio's
President & CEO said, "Inovio is well-positioned to advance its
later-stage HPV programs while devoting more resources to develop
fast-to-market product candidates. Through its recent strategic
organizational restructuring the company has sharpened its focus to
create a more efficient organization with greater financial
flexibility and a longer runway. We continue to make excellent
progress on expanding our treatment capabilities within the areas
of HPV related diseases and we're excited that before year-end we
plan to have interim data from our Phase 2 studies involving
VGX-3100 targeting vulvar HSIL and anal HSIL, and plan to initiate
the next clinical trial of INO-3107 targeting RRP within 12
months."
Second Quarter 2019 Financial Results
Total revenue was $136,000 for the
three months ended June 30, 2019,
compared to $24.4 million for the
same period in 2018. Total operating expenses were $28.3 million for the three months ended
June 30, 2019, compared to
$29.7 million for the same period in
2018.
Inovio's net loss for the quarter ended June 30, 2019 was $29.4
million, or $0.30 per basic
and diluted share, compared to $6.6
million, or $0.07 per basic
and $0.08 per diluted share, for the
quarter ended June 30, 2018.
Revenue
The year over year decrease in revenue under collaborative
research and development arrangements was primarily due to the
recognition of the gross up-front payment from ApolloBio of
$23.0 million during the second
quarter of 2018 (approximately $19.4
million was received after payment of required taxes).
Operating Expenses
Research and development (R&D) expenses were $22.5 million for the three months ended
June 30, 2019 and June 30, 2018.
Contributions received from current grant agreements and
recorded as contra-research and development expense were
$2.6 million for the three months
ended June 30, 2019 compared to
$1.9 million for the same period in
2018.
General and administrative (G&A) expenses were $5.9 million for the three months ended
June 30, 2019 versus $7.2 million for the same period in 2018. The
decrease in G&A expenses was primarily related to the foreign
non-income taxes and advisory fees incurred in connection with the
ApolloBio upfront payment Inovio received in 2018.
Capital Resources
As of June 30, 2019, cash and cash
equivalents and short-term investments were $106.0 million compared to $81.2 million as of December 31, 2018. As of June 30, 2019, Inovio had 98.6 million common
shares outstanding and 125.5 million common shares outstanding on a
fully diluted basis, after giving effect to the exercise, vesting
and conversion, as applicable, of its outstanding options,
restricted stock units, convertible preferred stock and convertible
notes.
Inovio's condensed consolidated balance sheet and statement of
operations are provided below. Additional information is included
in Inovio's quarterly report on Form 10-Q for the quarter ended
June 30, 2019, which can be accessed
at:
http://ir.inovio.com/investors/financial-reports/default.aspx.
Conference Call / Webcast Information
Inovio's management will host a live conference call and webcast
at 4:30 p.m. Eastern Time today to
discuss Inovio's financial results and provide a general business
update.
The live webcast and a replay may be accessed by visiting
Inovio's website at
http://ir.inovio.com/investors/events/default.aspx. Telephone
replay will be available approximately one hour after the call at
877-344-7529 (US toll free) or 412-317-0088 (international toll)
using replay access code 10133668.
About Inovio Pharmaceuticals, Inc.
Inovio is an innovative biotechnology company focused on the
discovery, development, and commercialization of its synthetic DNA
technology targeted against cancers and infectious diseases.
Inovio's proprietary technology platform applies antigen sequencing
and delivery to enable in vivo protein expression, which can
activate potent immune responses to targeted diseases. The
technology 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 development for the treatment of
HPV-related cervical pre-cancer. Also in development are Phase 2
immuno-oncology programs targeting HPV-related cancers and
glioblastoma, as well as externally funded platform development
programs in Zika, MERS, Lassa and HIV. Partners and collaborators
include AstraZeneca, Regeneron, Roche/Genentech, ApolloBio
Corporation, GeneOne Life Science, The Bill & Melinda Gates
Foundation, Coalition for Epidemic Preparedness Innovations (CEPI),
Defense Advanced Research Projects Agency, National Institutes of
Health, National Institute of Allergy and Infectious Diseases,
National Cancer Institute, HIV Vaccines Trial Network, Walter Reed
Army Institute of Research, Medical CBRN Defense Consortium (MCDC),
The Wistar Institute, and the University of
Pennsylvania. For more information, visit
www.inovio.com.
This press release contains certain forward-looking
statements relating to our business, including our expectations
related to our strategic organizational restructuring, our plans to
develop electroporation-based drug and gene delivery technologies,
dBTE platforms 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 and the expectation that VGX-3100's Advanced
Therapy Medicinal Product certificate will facilitate the
preparation, filing, and review of a future European market
application. 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 Report on
Form 10-Q for the quarter ended June 30,
2019 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 final
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.
Inovio
Pharmaceuticals, Inc.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
|
June 30,
2019
|
|
December 31,
2018
|
|
(Unaudited)
|
|
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
|
19,735,943
|
|
|
$
|
23,693,633
|
|
Short-term
investments
|
86,235,815
|
|
|
57,538,852
|
|
Accounts
receivable
|
130,230
|
|
|
3,316,361
|
|
Accounts receivable
from affiliated entities
|
996,936
|
|
|
738,583
|
|
Prepaid expenses and
other current assets
|
2,309,362
|
|
|
1,406,590
|
|
Prepaid expenses and
other current assets from affiliated entities
|
1,100,746
|
|
|
1,120,805
|
|
Total current
assets
|
110,509,032
|
|
|
87,814,824
|
|
Fixed assets,
net
|
14,265,951
|
|
|
15,949,014
|
|
Investment in
affiliated entity - GeneOne
|
6,324,766
|
|
|
6,381,926
|
|
Investment in
affiliated entity - PLS
|
2,157,832
|
|
|
3,023,987
|
|
Intangible assets,
net
|
4,227,019
|
|
|
4,760,145
|
|
Goodwill
|
10,513,371
|
|
|
10,513,371
|
|
Operating lease
right-of-use assets
|
14,222,236
|
|
|
—
|
|
Other
assets
|
2,853,089
|
|
|
2,669,998
|
|
Total
assets
|
$
|
165,073,296
|
|
|
$
|
131,113,265
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued expenses
|
$
|
13,388,013
|
|
|
$
|
23,134,733
|
|
Accounts payable and
accrued expenses due to affiliated entities
|
653,568
|
|
|
977,792
|
|
Accrued clinical
trial expenses
|
4,638,397
|
|
|
5,671,764
|
|
Deferred
revenue
|
120,694
|
|
|
223,577
|
|
Deferred revenue from
affiliated entities
|
96,075
|
|
|
33,575
|
|
Deferred
rent
|
—
|
|
|
1,065,387
|
|
Operating lease
liability
|
1,948,716
|
|
|
—
|
|
Deferred grant
funding
|
2,470,657
|
|
|
4,165,848
|
|
Deferred grant
funding from affiliated entities
|
763,208
|
|
|
27,083
|
|
Total current
liabilities
|
24,079,328
|
|
|
35,299,759
|
|
Deferred revenue, net
of current portion
|
116,630
|
|
|
150,793
|
|
Convertible senior
notes
|
62,757,286
|
|
|
—
|
|
Deferred rent, net of
current portion
|
—
|
|
|
8,518,207
|
|
Operating lease
liability, net of current portion
|
21,483,568
|
|
|
—
|
|
Deferred tax
liabilities
|
26,649
|
|
|
24,766
|
|
Deferred grant
funding from affiliated entities
|
81,000
|
|
|
—
|
|
Other
liabilities
|
50,762
|
|
|
87,333
|
|
Total
liabilities
|
108,595,223
|
|
|
44,080,858
|
|
Stockholders'
equity:
|
|
|
|
Preferred
stock
|
—
|
|
|
—
|
|
Common
stock
|
98,584
|
|
|
97,226
|
|
Additional paid-in
capital
|
731,819,389
|
|
|
707,794,215
|
|
Accumulated
deficit
|
(679,032,924)
|
|
|
(620,426,436)
|
|
Accumulated other
comprehensive income (loss)
|
731,855
|
|
|
(528,867)
|
|
Total Inovio
Pharmaceuticals, Inc. stockholders' equity
|
53,616,904
|
|
|
86,936,138
|
|
Non-controlling
interest
|
2,861,169
|
|
|
96,269
|
|
Total stockholders'
equity
|
56,478,073
|
|
|
87,032,407
|
|
Total liabilities
and stockholders' equity
|
$
|
165,073,296
|
|
|
$
|
131,113,265
|
|
Inovio
Pharmaceuticals, Inc.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(Unaudited)
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
Revenues:
|
|
|
|
|
|
|
|
|
Revenue under
collaborative research and development arrangements
|
$
|
64,283
|
|
|
$
|
24,385,852
|
|
|
$
|
2,834,995
|
|
|
$
|
25,674,898
|
|
|
Revenue under
collaborative research and development arrangements
with affiliated entities
|
71,390
|
|
|
60,319
|
|
|
126,970
|
|
|
208,327
|
|
|
Miscellaneous
revenue
|
—
|
|
|
2,590
|
|
|
3,614
|
|
|
95,180
|
|
|
Total
revenues
|
135,673
|
|
|
24,448,761
|
|
|
2,965,579
|
|
|
25,978,405
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
22,486,266
|
|
|
22,462,620
|
|
|
46,876,155
|
|
|
47,040,371
|
|
|
General and
administrative
|
5,850,101
|
|
|
7,189,310
|
|
|
12,825,129
|
|
|
16,887,325
|
|
|
Total operating
expenses
|
28,336,367
|
|
|
29,651,930
|
|
|
59,701,284
|
|
|
63,927,696
|
|
|
Loss from
operations
|
(28,200,694)
|
|
|
(5,203,169)
|
|
|
(56,735,705)
|
|
|
(37,949,291)
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Interest
income
|
755,330
|
|
|
518,525
|
|
|
1,380,864
|
|
|
1,083,948
|
|
|
Interest
expense
|
(2,194,783)
|
|
|
—
|
|
|
(2,851,031)
|
|
|
—
|
|
|
Change in fair value
of common stock warrants
|
—
|
|
|
259,971
|
|
|
—
|
|
|
132,130
|
|
|
Gain (loss) on
investment in affiliated entities
|
(173,212)
|
|
|
(2,092,608)
|
|
|
(923,315)
|
|
|
287,815
|
|
|
Other income
(expense), net
|
127,512
|
|
|
(121,844)
|
|
|
91,673
|
|
|
(374,744)
|
|
|
Net loss before
income tax benefit/(provision for income tax)
|
(29,685,847)
|
|
|
(6,639,125)
|
|
|
(59,037,514)
|
|
|
(36,820,142)
|
|
|
Income tax
benefit/(provision for income taxes)
|
106,771
|
|
|
—
|
|
|
169,571
|
|
|
(2,169,811)
|
|
|
Net
loss
|
(29,579,076)
|
|
|
(6,639,125)
|
|
|
(58,867,943)
|
|
|
(38,989,953)
|
|
|
Net loss attributable
to non-controlling interest
|
191,850
|
|
|
—
|
|
|
261,455
|
|
|
—
|
|
|
Net loss
attributable to Inovio Pharmaceuticals, Inc.
|
$
|
(29,387,226)
|
|
|
$
|
(6,639,125)
|
|
|
$
|
(58,606,488)
|
|
|
$
|
(38,989,953)
|
|
|
Net loss per share
attributable to Inovio Pharmaceuticals, Inc.
stockholders
|
|
|
|
|
|
|
|
|
Basic
|
$
|
(0.30)
|
|
|
$
|
(0.07)
|
|
|
$
|
(0.60)
|
|
|
$
|
(0.43)
|
|
|
Diluted
|
$
|
(0.30)
|
|
|
$
|
(0.08)
|
|
|
$
|
(0.60)
|
|
|
$
|
(0.43)
|
|
|
Weighted average
number of common shares outstanding
|
|
|
|
|
|
|
|
|
Basic
|
98,083,896
|
|
|
91,153,776
|
|
|
97,795,910
|
|
|
90,804,722
|
|
|
Diluted
|
98,083,896
|
|
|
91,241,660
|
|
|
97,795,910
|
|
|
90,890,792
|
|
|
CONTACTS:
|
|
Investors:
|
Ben Matone,
484-362-0076, ben.matone@inovio.com
|
Media:
|
Jeff Richardson,
267-440-4211, jrichardson@inovio.com
|
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SOURCE Inovio Pharmaceuticals, Inc.