PLYMOUTH MEETING, Pa.,
May 9, 2019 /PRNewswire/
-- Inovio Pharmaceuticals, Inc. (NASDAQ: INO), an innovative
biotechnology company focused on the discovery, development and
commercialization of its synthetic nucleic technology targeted
against cancers and infectious diseases, today reported financial
results for the first quarter ended March
31, 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/INO-3106; HPV-related Pre-cancers
Inovio's
Phase 3 trials for VGX-3100, REVEAL 1 and REVEAL 2, are both up and
running and are executing on track. REVEAL 2 began recruitment in
March while REVEAL 1 is anticipated to be fully enrolled with 198
patients by mid-2019. Additionally, Inovio expects interim data
from its two Phase 2 trials with VGX-3100 in patients with vulvar
and anal dysplasia later this year.
Inovio recently announced that VGX-3100 has been granted an
Advanced Therapy Medicinal Product certificate by the European
Medicines Agency's (EMA) Committee for Advanced Therapies following
an extensive evaluation of its chemistry, manufacturing and
controls (CMC) data and nonclinical results. Since the inception of
the program in 2009, only 11 ATMP Certifications have been awarded
by the EMA. This certificate is an important developmental
milestone for VGX-3100 as it will facilitate the preparation,
filing, and review of a future European market application for
VGX-3100.
In April, VGX-3100 was selected at the World Vaccine Congress as
the 2019 "Best Therapeutic Vaccine."
Extending its portfolio into additional HPV-related diseases,
Inovio announced its novel therapy, INO-3106, against the human
papilloma virus type 6 (HPV 6) demonstrated clinical efficacy in a
pilot clinical study of two patients with recurrent respiratory
papillomatosis (RRP), a rare orphan disease. Results presented at
the American Association for Cancer Research (AACR) demonstrated
that following both patient's last dose of INO-3106, the patients
have been surgery-free, due to lack of tumor recurrence. One
patient has not needed surgery for over two years; the other has
been surgery-free for over one year. A complete study report is
being prepared for publication in a medical journal, and Inovio
plans to further develop INO-3106 as a novel, non-invasive
immunotherapy for the treatment of RRP, for both adult and
pediatric populations.
- MEDI0457 (VGX-3100 + IL-12; licensed to
AstraZeneca)
Inovio achieved a third cancer indication
milestone under its collaboration with AstraZeneca, triggered by
AstraZeneca dosing a patient in a Phase 2 combination trial
evaluating MEDI0457 (formerly called INO-3112) in combination with
durvalumab, an anti-PD-L1 immune checkpoint inhibitor, targeting
cervical, anal, penile, and vulvar cancers associated with human
papilloma virus (HPV). AstraZeneca continues to evaluate
MEDI0457 in combination with durvalumab in multiple Phase 2 trials
in patients with HPV-related cancers.
In January, Inovio announced that two patients with HPV-related
head and neck cancer, who were treated with MEDI0457 in a Phase 1
trial, achieved a sustained complete response (full remission)
following subsequent treatment with a PD-1 checkpoint
inhibitor.
- INO-5401 – Cancer Combination Trials
Inovio completed
enrollment of its Phase 1/2 immuno-oncology trial in patients with
newly diagnosed glioblastoma (GBM). The enrollment of 52 patients
was achieved three months ahead of schedule. The trial is designed
to evaluate Inovio's INO-5401 T cell activating immunotherapy
encoding multiple antigens expressed by GBM and INO-9012, an immune
activator encoding IL-12, in combination with cemiplimab-rwlc (also
known as Libtayo® or REGN2810), a PD-1 inhibitor
developed by Regeneron Pharmaceuticals in collaboration with
Sanofi. Interim results evaluating safety, immunological impact,
progression-free survival and overall survival from this study are
expected before the end of this year.
- DNA-Encoded Bi-specific T Cell Engagers
(dBTEs)
Inovio presented pre-clinical results at a major
cancer conference (AACR) on the company's novel DNA-encoded
Bi-specific T Cell Engagers (dBTE) technology. Inovio, with its
collaborators at The Wistar Institute, developed a novel dBTE
targeting the HER2 molecule which was tested in therapeutic models
for the treatment of ovarian and breast cancers. Importantly, just
a single dose of Inovio's HER2 dBTE resulted in high levels of
corresponding BiTE in mice for four months, far exceeding what is
typically displayed with conventional BiTE's short half-life of
only a few hours. The HER2 dBTE effectively killed HER2-expressing
tumor cells resulting in a near-complete tumor clearance. Also
presented was Inovio's CD19 dBTE which can kill B cell cancers by
targeting B cell specific marker CD19.
These results were subsequently published in a JCI
Insight journal article entitled, "DNA-encoded bi-specific
T cell engagers and antibodies present long-term antitumor
activity."
- DNA-Encoded Monoclonal Antibody (dMAb™)
In February,
the company dosed a subject in the first-ever human study of
Inovio's DNA-encoded monoclonal antibody (dMAb™) technology
evaluating the ability of our technology to express Zika
virus-specific mAbs. 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 and dBTE programs in
infectious diseases and cancer.
- Infectious Diseases
Phase 1 data for INO-4201, the
company's Ebola vaccine, was published in The Journal of
Infectious Diseases, further supporting the advancement of the
intradermal delivery platform for vaccines. Significantly, the
study demonstrated that intradermal (skin) administration with
Inovio's CELLECTRA® efficacy enhancing device
resulted in 100% of evaluable subjects generating antigen-specific
antibody responses that persisted for more than one year in most
subjects and generated robust T cell responses. The published data
further validates the safety, potency, and product stability
advantages of Inovio's immunotherapy platform.
- Geneos Therapeutics, Inc.
In February, Inovio's
personalized cancer vaccine subsidiary Geneos, secured a Series A
financing round with potential proceeds of up to $10.5 million. With this funding, Geneos is fully
operational as a standalone entity in its efforts to develop the
next generation of neoantigen-targeting cancer immunotherapies.
Geneos has an exclusive license to Inovio's immunotherapy platform
in the area of personalized cancer immunotherapy; Inovio holds
majority equity position in Geneos and continue to develop and
commercialize all global population-based (non-personalized) cancer
immunotherapies based on its proprietary SynCon® design.
Geneos is now focused on initiating its first clinical study in
2019.
- Management and Board Updates
During the first
quarter, Inovio announced the appointment of Jacqueline E. Shea, PhD, as Inovio's Chief
Operating Officer (COO) and Executive Vice President. Dr. Shea will
be responsible for Inovio's manufacturing, commercial, business
development, and alliance management operations as well as serving
as a key member of the executive team along with the CFO and CSO in
formulating and implementing overall corporate strategy.
Also in the first quarter, the Company announced that
Mr. Simon X. Benito, former Merck Vaccines executive, was
appointed Chairman of Inovio's Board of Directors. In addition, the
Company appointed Ms. Lota Zoth, former CFO of MedImmune, and
Dr. Ann C. Miller, former commercial
executive with Merck, Amgen, Eisai and Sanofi, to its Board of
Directors.
- Cash Position
As of March 31,
2019, cash and cash equivalents and short-term investments
were $128.0 million compared to
$81.2 million as of December 31, 2018. In the first quarter 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 $75.7 million, after deducting the initial
purchasers' discount and offering expenses payable by the
Company.
Dr. J. Joseph Kim, Inovio's
President & CEO said, "The last several months have been
extremely productive for Inovio by validating the company's
versatile technology platform. We ended the first quarter by
featuring positive data from our Phase 1 Ebola study in a
prestigious publication. Inovio further highlighted its
capabilities in treating HPV-associated disease after presenting
positive data from patients diagnosed with RRP, where we
demonstrated a clinical benefit for these patients. Additionally,
we initiated the first ever clinical study for our dMAb platform
during the first quarter and unveiled an exciting new component
within our platform involving our novel dBTE technology, which
we're working towards rapidly advancing the first product into
clinical testing. Inovio enters the second quarter well-financed
following the February raise, placing us in a prime position to
continue to deliver on our game-changing clinical programs."
First Quarter 2019 Financial Results
Total revenue was $2.8 million for
the three months ended March 31,
2019, compared to $1.5 million
for the same period in 2018. Total operating expenses were
$31.4 million compared to
$34.3 million for the same period in
2018.
Inovio's net loss for the quarter ended March 31, 2019 was $29.2
million, or $0.30 per basic
and diluted share, compared to $32.4
million, or $0.36 per basic
and diluted share, for the quarter ended March 31, 2018.
Revenue
The year over year increase in revenue under collaborative
research and development arrangements was primarily due to the
milestone payment recognized in the first quarter 2019 from
AstraZeneca.
Operating Expenses
Research and development (R&D) expenses for the three months
ended March 31, 2019 were
$24.4 million compared to
$24.6 million for the same period in
2018. The decrease in R&D expenses was primarily related to a
sub-license expense of $1.9 million
recorded in 2018 related to the ApolloBio collaboration, partially
offset by an increase of $1.2 million
related to Inovio's VGX-3100 Phase 3 clinical trials, among other
variances.
General and administrative (G&A) expenses were $7.0 million for the three months ended
March 31, 2019 versus $9.7 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 March 31, 2019, cash and
cash equivalents and short-term investments were $128.0 million compared to $81.2 million as of December 31, 2018. As of March 31, 2019, the Company had 97.9 million
common shares outstanding and 125.3 million common shares
outstanding on a fully diluted basis, after giving effect to
outstanding options, restricted stock units, convertible preferred
stock and convertible notes.
In the first quarter 2019, the Company completed a private
placement of $78.5 million aggregate
principal amount of 6.50% convertible senior notes due 2024. Net
proceeds from the offering were approximately $75.7 million.
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
March 31, 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 the
Company'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 10131163.
About Inovio Pharmaceuticals, Inc.
Inovio is an innovative biotechnology company focused on the
discovery, development, and commercialization of its synthetic
nucleic technology targeted against cancers and infectious
diseases. Inovio's proprietary technology platform applies
antigen sequencing and 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, GeneOne Life Science, The Bill & Melinda
Gates Foundation, Coalition for Epidemic Preparedness Innovations,
Parker Institute for Cancer Immunotherapy, 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, 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 plans to develop
electroporation-based drug and gene delivery technologies, dMAB and
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 March 31,
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
|
|
|
|
|
|
March 31,
2019
|
|
December 31,
2018
|
|
(Unaudited)
|
|
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
|
20,779,152
|
|
|
$
|
23,693,633
|
|
Short-term
investments
|
107,216,498
|
|
|
57,538,852
|
|
Accounts
receivable
|
2,783,264
|
|
|
3,316,361
|
|
Accounts receivable
from affiliated entities
|
1,295,737
|
|
|
738,583
|
|
Prepaid expenses and
other current assets
|
1,386,801
|
|
|
1,406,590
|
|
Prepaid expenses and
other current assets from affiliated entities
|
1,441,546
|
|
|
1,120,805
|
|
Total current
assets
|
134,902,998
|
|
|
87,814,824
|
|
Fixed assets,
net
|
15,185,998
|
|
|
15,949,014
|
|
Investment in
affiliated entity - GeneOne
|
6,430,383
|
|
|
6,381,926
|
|
Investment in
affiliated entity - PLS
|
2,225,427
|
|
|
3,023,987
|
|
Intangible assets,
net
|
4,493,582
|
|
|
4,760,145
|
|
Goodwill
|
10,513,371
|
|
|
10,513,371
|
|
Operating lease
right-of-use assets
|
14,432,479
|
|
|
—
|
|
Other
assets
|
2,981,270
|
|
|
2,669,998
|
|
Total
assets
|
$
|
191,165,508
|
|
|
$
|
131,113,265
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued expenses
|
$
|
15,644,783
|
|
|
$
|
23,134,733
|
|
Accounts payable and
accrued expenses due to affiliated entities
|
1,315,610
|
|
|
977,792
|
|
Accrued clinical
trial expenses
|
7,159,243
|
|
|
5,671,764
|
|
Deferred
revenue
|
110,694
|
|
|
223,577
|
|
Deferred revenue from
affiliated entities
|
2,325
|
|
|
33,575
|
|
Deferred
rent
|
—
|
|
|
1,065,387
|
|
Operating lease
liability
|
1,888,804
|
|
|
—
|
|
Deferred grant
funding
|
1,279,005
|
|
|
4,165,848
|
|
Deferred grant
funding from affiliated entities
|
14,583
|
|
|
27,083
|
|
Total current
liabilities
|
27,415,047
|
|
|
35,299,759
|
|
Deferred revenue, net
of current portion
|
141,803
|
|
|
150,793
|
|
Convertible senior
notes
|
60,562,503
|
|
|
—
|
|
Deferred rent, net of
current portion
|
—
|
|
|
8,518,207
|
|
Operating lease
liability, net of current portion
|
21,990,881
|
|
|
—
|
|
Deferred tax
liabilities
|
24,766
|
|
|
24,766
|
|
Other
liabilities
|
64,257
|
|
|
87,333
|
|
Total
liabilities
|
110,199,257
|
|
|
44,080,858
|
|
Stockholders'
equity:
|
|
|
|
Preferred
stock
|
—
|
|
|
—
|
|
Common
stock
|
97,934
|
|
|
97,226
|
|
Additional paid-in
capital
|
727,166,934
|
|
|
707,794,215
|
|
Accumulated
deficit
|
(649,645,698)
|
|
|
(620,426,436)
|
|
Accumulated other
comprehensive income (loss)
|
290,310
|
|
|
(528,867)
|
|
Total Inovio
Pharmaceuticals, Inc. stockholders' equity
|
77,909,480
|
|
|
86,936,138
|
|
Non-controlling
interest
|
3,056,771
|
|
|
96,269
|
|
Total stockholders'
equity
|
80,966,251
|
|
|
87,032,407
|
|
Total liabilities
and stockholders' equity
|
$
|
191,165,508
|
|
|
$
|
131,113,265
|
|
Inovio
Pharmaceuticals, Inc.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(Unaudited)
|
|
|
|
Three Months
Ended
March
31,
|
|
2019
|
|
2018
|
Revenues:
|
|
|
|
Revenue under
collaborative research and development arrangements
|
$
|
2,770,712
|
|
|
$
|
1,289,046
|
|
Revenue under
collaborative research and development arrangements with affiliated
entities
|
55,579
|
|
|
148,008
|
|
Miscellaneous
revenue
|
3,614
|
|
|
92,590
|
|
Total
revenues
|
2,829,905
|
|
|
1,529,644
|
|
Operating
expenses:
|
|
|
|
Research and
development
|
24,389,888
|
|
|
24,577,751
|
|
General and
administrative
|
6,975,029
|
|
|
9,698,015
|
|
Total operating
expenses
|
31,364,917
|
|
|
34,275,766
|
|
Loss from
operations
|
(28,535,012)
|
|
|
(32,746,122)
|
|
Other income
(expense):
|
|
|
|
Interest and other
income (expense), net
|
(66,552)
|
|
|
312,523
|
|
Change in fair value
of common stock warrants
|
—
|
|
|
(127,841)
|
|
Gain (loss) on
investment in affiliated entities
|
(750,103)
|
|
|
2,380,423
|
|
Net loss before
income tax benefit/(provision for income tax)
|
(29,351,667)
|
|
|
(30,181,017)
|
|
Income tax
benefit/(provision for income taxes)
|
62,800
|
|
|
(2,169,811)
|
|
Net
loss
|
(29,288,867)
|
|
|
(32,350,828)
|
|
Net loss attributable
to non-controlling interest
|
69,605
|
|
|
—
|
|
Net loss
attributable to Inovio Pharmaceuticals, Inc.
|
$
|
(29,219,262)
|
|
|
$
|
(32,350,828)
|
|
Net loss per share
attributable to Inovio Pharmaceuticals, Inc.
stockholders
|
|
|
|
Basic and diluted
|
$
|
(0.30)
|
|
|
$
|
(0.36)
|
|
Weighted average
number of common shares outstanding
|
|
|
|
Basic and diluted
|
97,494,968
|
|
|
90,451,791
|
|
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.