PLYMOUTH MEETING, Pa.,
Nov. 12, 2019 /PRNewswire/
-- Inovio Pharmaceuticals, Inc. (NASDAQ: INO), an innovative
biotechnology company focused on the discovery, development, and
commercialization of synthetic DNA products for treating
cancers and infectious diseases, today reported financial results
for the third quarter ended September 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/MEDI0457/INO-3107/HPV-Related Diseases
REVEAL 1 Phase 3 trial of VGX-3100
for HPV-related high-grade cervical dysplasia, which completed
enrollment of 198 patients in the second quarter of 2019, is on
schedule to read out top-line efficacy data by the fourth quarter
of 2020. Enrollment for the second Phase 3 trial for this program,
REVEAL 2, remains on track, with expanded sites both within
the United States and globally,
including new sites recently opened in Argentina, Lithuania, and Spain.
Inovio completed enrollment of 33
patients for its Phase 2 trial of VGX-3100 for HPV-related
high-grade vulvar dysplasia (vulvar HSIL).
In addition, the company completed
enrollment in its open-label, 24 patient, Phase 2 trial of VGX-3100
in patients with HPV-related high-grade anal dysplasia (anal
HSIL).
Inovio plans to present interim
results for both vulvar HSIL and anal HSIL clinical trials at a
medical conference in the first quarter of 2020.
In a global partnership with
AstraZeneca, MEDI0457 (formerly INO-3112) in combination with
durvalumab, an anti-PD-L1 checkpoint inhibitor, continues to be
evaluated in multiple Phase 2 studies in patients with HPV-related
head and neck, cervical, anal, penile, and vulvar cancers. Inovio
is eligible to receive future milestone payments and double-digit
tiered royalties on MEDI0457 product sales.
Inovio continues to prepare to
initiate a pivotal clinical trial of INO-3107 for HPV-caused
recurrent respiratory papillomatosis (RRP), which we plan to
advance as a rare, orphan product, within the first half of
2020.
- INO-5401/Glioblastoma Multiforme (GBM) Phase 2
Trial
Inovio reported positive interim
data from its ongoing Phase 2 trial of newly diagnosed glioblastoma
multiforme (GBM), which combines Inovio's INO-5401, a T
cell-activating immunotherapy encoding for three tumor-specific
antigens (hTERT, WT1, and PSMA), and INO-9012, an immune activator
encoding IL-12, in combination with Libtayo®, a PD-1
blocking antibody produced by Regeneron Pharmaceuticals in
collaboration with Sanofi.
Key interim data from the
52-patient clinical trial showed that 80% (16 of 20) of MGMT gene
promoter methylated patients and 75% (24 of 32) of unmethylated
patients were progression-free at six months (PFS6) measured from
the time of their first dose, substantially exceeding historical
standard-of-care data (approximately 60% of MGMT promoter
methylated patients and 40% of unmethylated patients historically
were progression-free at six months). The data was presented at the
Society for Immunotherapy of Cancer (SITC) 2019 Annual Meeting.
Inovio will report 12- and 18-month overall survival data next
year.
- INO-5151/Prostate Cancer Combination Trial
INO-5151 was featured in a
trial-in-progress poster at SITC 2019. INO-5151, which is a
combined formulation of INO-5150 (with SynCon® antigens
encoding for PSA and PSMA) and INO-9012, is being tested in one arm
(Cohort C) of this exploratory platform study along with nivolumab,
a PD-1 inhibitor (Bristol-Myers Squibb), and CDX-301 (Celldex).
This study is being conducted and funded by the Parker Institute
for Cancer Immunotherapy (PICI) and the Cancer Research Institute
(CRI), as part of Inovio's previously established clinical
collaboration agreement (ClinicalTrials.gov Identifier:
NCT03835533).
- DNA-encoded monoclonal antibodies
(dMAb®)/DNA-encoded Bi-specific T Cell Engagers
(dBTE)
Inovio and its collaborator, The
Wistar Institute, received a $4.6
million grant from the National Institutes of Health (NIH)
in support of innovative research of antimicrobial resistance (AMR)
and continued development of Inovio's DNA-encoded monoclonal
antibodies (dMAb®) platform.
Using direct local delivery into
the body by the CELLECTRA® platform, the synthetic
genetic codes provided by the dMAbs instruct the body's cells to
become a customized patient-specific factory that manufactures its
own therapeutic antibody products, enabling a major leap in
antibody technology. Traditional monoclonal antibodies represent
the largest segment of pharmaceutical markets today, accounting for
more than $100 billion in
pharmaceutical sales each year, with treatments spanning cancer,
infectious diseases, inflammation, and cardiovascular diseases.
With its synthetic design and in-patient production, dMAb products
represent a disruptive and innovative entrant to this important
class of pharmaceuticals. Collectively, dMAb and dBTE offer the
opportunity to provide improved yet cost-effective therapeutic
options across cancer and infectious diseases.
Earlier this year, Inovio advanced
its first dMAb candidate INO-A002 (for preventing or treating Zika
virus infection) to a Phase 1 dose-escalation trial to assess
safety and tolerability and expression of dMAb-produced antibodies
with full funding from the Bill & Melinda Gates Foundation.
As of September 30, 2019, cash and cash equivalents and
short-term investments were $93.8
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. Net
proceeds from the offering were approximately $14.5 million after deducting offering expenses
payable by Inovio.
In July, Inovio implemented a
strategic cost-reduction plan (including a 28% staff reduction and
cessation of several R&D and clinical programs), which resulted
in an approximately 25% reduction in annual burn. The reallocation
of resources focuses the company's commercialization efforts for
its lead asset, VGX-3100, while also developing high-value,
fast-to-market product candidates, such as INO-3107 to treat RRP
and INO-5401 for GBM.
Dr. J. Joseph Kim, Inovio's
President & CEO, said, "Our recently presented INO-5401 data
demonstrated promising efficacy results, in terms of
progression-free survival rates, against a very difficult to treat
cancer in GBM and highlighted the potential of our immunotherapies
utilizing tumor-associated antigens in cancer treatments. Looking
ahead, the next 12 months should be a transformational period for
Inovio, as we expect to have data readouts from multiple Phase 3
and Phase 2 programs. With our sharpened focus on advancing and
commercializing products for HPV-related diseases and
fast-to-market opportunities, the company is uniquely positioned to
bring multiple products to the market."
Dr. Kim further stated, "We continue to advance our HPV
treatment capabilities, where we will have efficacy results from
our Phase 3 VGX-3100 REVEAL 1 trial and Phase 2 VIN/AIN programs
next year. Additionally, we plan to initiate a pivotal clinical
trial of INO-3107 for HPV-caused RRP, which we expect to move
forward rapidly as a rare, orphan product. In cancer, you can
expect overall survival data from our INO-5401 cancer combination
trial with Regeneron for GBM, building upon the promising PFS6
data. Finally, the fully enrolled head and neck cancer Phase 2
trial sponsored by our partner AstraZeneca, combining MEDI0457 with
AstraZeneca's checkpoint inhibitor should be completed by the third
quarter. Collectively, these anticipated data readouts in 2020 all
point to great promise for Inovio's product pipeline, and further
solidify Inovio as the leader in synthetic DNA immunotherapy."
Third Quarter 2019 Financial Results
Inovio's total revenue was $867,000 for the three months ended September 30, 2019, compared to $2.0 million for the same period in 2018.
Inovio's total operating expenses were $24.8
million for the three months ended September 30, 2019, compared to $28.6 million for the same period in 2018.
Inovio's net loss for the quarter ended September 30, 2019 was $23.1 million, or $0.23 per basic and $0.25 per diluted share, compared to $25.0 million, or $0.27 per basic and diluted share, for the same
period in 2018.
Revenue
The year-over-year decrease in revenue under collaborative
research and development arrangements was primarily due to a
decrease in reimbursed drug manufacturing activities related to our
partnership with AstraZeneca.
Operating Expenses
R&D expenses were $19.1
million for the three months ended September 30, 2019, as compared to $21.9 million for the same period in 2018. The
decrease in R&D expenses was primarily related to decreases in
employee compensation expense, drug manufacturing expense related
to our partnership with AstraZeneca and engineering and lab
supplies, among other variances. These decreases were offset by a
personnel-related restructuring charge in connection with the
one-time employee termination costs incurred during the third
quarter of 2019.
Contributions received from current grant agreements and
recorded as contra-R&D expense were $2.8
million for the three months ended September 30, 2019, compared to $2.6 million for the same period in 2018.
General and administrative (G&A) expenses were $5.7 million for the three months ended
September 30, 2019, versus
$6.8 million for the same period in
2018. The decrease in G&A expenses was primarily related to
decreases in employee compensation, allocated depreciation expense,
and legal expenses, among other variances.
Capital Resources
As of September 30, 2019, cash and
cash equivalents and short-term investments were $93.8 million compared to $81.2 million as of December 31, 2018. As of September 30, 2019, Inovio had 99.0 million
common shares outstanding and 129.5 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 debt.
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
September 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 10136605.
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 GBM, as
well as externally funded platform development programs in Zika,
MERS, Lassa, and HIV. Partners and collaborators include ApolloBio
Corporation, AstraZeneca, The Bill & Melinda Gates Foundation,
Coalition for Epidemic Preparedness Innovations (CEPI), Defense
Advanced Research Projects Agency, GeneOne Life Science, HIV
Vaccines Trial Network, Medical CBRN Defense Consortium (MCDC),
National Cancer Institute, National Institutes of Health, National
Institute of Allergy and Infectious Diseases, Regeneron,
Roche/Genentech, University of
Pennsylvania, Walter Reed Army Institute of Research, and
The Wistar Institute. For more information, visit
www.inovio.com.
* * * *
This press release contains certain forward-looking
statements relating to our business, including our plans to develop
DNA-based immunotherapies, 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 Report on Form
10-Q for the quarter ended September 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
|
|
|
September 30,
2019
|
|
December 31,
2018
|
|
(Unaudited)
|
|
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
|
15,853,236
|
|
|
$
|
23,693,633
|
|
Short-term
investments
|
77,945,753
|
|
|
57,538,852
|
|
Accounts
receivable
|
776,295
|
|
|
3,316,361
|
|
Accounts receivable
from affiliated entities
|
978,544
|
|
|
738,583
|
|
Prepaid expenses and
other current assets
|
1,677,602
|
|
|
1,406,590
|
|
Prepaid expenses and
other current assets from affiliated entities
|
1,581,111
|
|
|
1,120,805
|
|
Total current
assets
|
98,812,541
|
|
|
87,814,824
|
|
Fixed assets,
net
|
13,516,389
|
|
|
15,949,014
|
|
Investment in
affiliated entity - GeneOne
|
5,707,256
|
|
|
6,381,926
|
|
Investment in
affiliated entity - PLS
|
2,289,501
|
|
|
3,023,987
|
|
Intangible assets,
net
|
3,960,457
|
|
|
4,760,145
|
|
Goodwill
|
10,513,371
|
|
|
10,513,371
|
|
Operating lease
right-of-use assets
|
14,002,860
|
|
|
—
|
|
Other
assets
|
2,731,055
|
|
|
2,669,998
|
|
Total
assets
|
$
|
151,533,430
|
|
|
$
|
131,113,265
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued expenses
|
$
|
9,783,964
|
|
|
$
|
23,134,733
|
|
Accounts payable and
accrued expenses due to affiliated entities
|
462,596
|
|
|
977,792
|
|
Accrued clinical
trial expenses
|
4,500,898
|
|
|
5,671,764
|
|
Deferred
revenue
|
106,111
|
|
|
223,577
|
|
Deferred revenue from
affiliated entities
|
64,825
|
|
|
33,575
|
|
Deferred
rent
|
—
|
|
|
1,065,387
|
|
Operating lease
liability
|
2,011,008
|
|
|
—
|
|
Deferred grant
funding
|
1,896,526
|
|
|
4,165,848
|
|
Deferred grant
funding from affiliated entities
|
720,925
|
|
|
27,083
|
|
Total current
liabilities
|
19,546,853
|
|
|
35,299,759
|
|
Deferred revenue, net
of current portion
|
124,105
|
|
|
150,793
|
|
Convertible senior
notes
|
62,119,671
|
|
|
—
|
|
Convertible
bonds
|
7,954,851
|
|
|
—
|
|
Derivative
liability
|
4,503,918
|
|
|
—
|
|
Deferred rent, net of
current portion
|
—
|
|
|
8,518,207
|
|
Operating lease
liability, net of current portion
|
20,953,308
|
|
|
—
|
|
Deferred tax
liabilities
|
26,649
|
|
|
24,766
|
|
Deferred grant
funding from affiliated entities
|
135,000
|
|
|
—
|
|
Other
liabilities
|
50,343
|
|
|
87,333
|
|
Total
liabilities
|
115,414,698
|
|
|
44,080,858
|
|
Stockholders'
equity:
|
|
|
|
Preferred
stock
|
—
|
|
|
—
|
|
Common
stock
|
99,046
|
|
|
97,226
|
|
Additional paid-in
capital
|
735,017,743
|
|
|
707,794,215
|
|
Accumulated
deficit
|
(702,123,617)
|
|
|
(620,426,436)
|
|
Accumulated other
comprehensive income (loss)
|
700,398
|
|
|
(528,867)
|
|
Total Inovio
Pharmaceuticals, Inc. stockholders' equity
|
33,693,570
|
|
|
86,936,138
|
|
Non-controlling
interest
|
2,425,162
|
|
|
96,269
|
|
Total stockholders'
equity
|
36,118,732
|
|
|
87,032,407
|
|
Total liabilities
and stockholders' equity
|
$
|
151,533,430
|
|
|
$
|
131,113,265
|
|
Inovio
Pharmaceuticals, Inc.
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited)
|
|
|
Three Months
Ended
September 30,
|
|
Nine Months
Ended
September 30,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Revenues:
|
|
|
|
|
|
|
|
Revenue under
collaborative research and development arrangements
|
$
|
617,427
|
|
|
$
|
1,813,287
|
|
|
$
|
3,452,422
|
|
|
$
|
27,488,185
|
|
Revenue under
collaborative research and development arrangements with affiliated
entities
|
53,014
|
|
|
184,990
|
|
|
179,984
|
|
|
393,317
|
|
Miscellaneous
revenue
|
196,422
|
|
|
2,591
|
|
|
200,036
|
|
|
97,771
|
|
Total
revenues
|
866,863
|
|
|
2,000,868
|
|
|
3,832,442
|
|
|
27,979,273
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
19,137,209
|
|
|
21,851,858
|
|
|
66,013,364
|
|
|
68,892,229
|
|
General and
administrative
|
5,681,441
|
|
|
6,791,693
|
|
|
18,506,570
|
|
|
23,679,018
|
|
Total operating
expenses
|
24,818,650
|
|
|
28,643,551
|
|
|
84,519,934
|
|
|
92,571,247
|
|
Loss from
operations
|
(23,951,787)
|
|
|
(26,642,683)
|
|
|
(80,687,492)
|
|
|
(64,591,974)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest
income
|
637,438
|
|
|
565,039
|
|
|
2,018,302
|
|
|
1,648,987
|
|
Interest
expense
|
(2,428,671)
|
|
|
—
|
|
|
(5,279,702)
|
|
|
—
|
|
Change in fair value
of common stock warrants
|
—
|
|
|
228,665
|
|
|
—
|
|
|
360,795
|
|
Change in fair value
of derivative liability
|
2,551,453
|
|
|
—
|
|
|
2,551,453
|
|
|
—
|
|
Gain (loss) on
investment in affiliated entities
|
(485,841)
|
|
|
1,017,359
|
|
|
(1,409,156)
|
|
|
1,305,174
|
|
Other income
(expense), net
|
140,956
|
|
|
(184,052)
|
|
|
232,629
|
|
|
(558,796)
|
|
Net loss before
income tax benefit/(provision for income tax)
|
(23,536,452)
|
|
|
(25,015,672)
|
|
|
(82,573,966)
|
|
|
(61,835,814)
|
|
Income tax
benefit/(provision for income taxes)
|
—
|
|
|
—
|
|
|
169,571
|
|
|
(2,169,811)
|
|
Net
loss
|
(23,536,452)
|
|
|
(25,015,672)
|
|
|
(82,404,395)
|
|
|
(64,005,625)
|
|
Net loss attributable
to non-controlling interest
|
445,759
|
|
|
—
|
|
|
707,214
|
|
|
—
|
|
Net loss
attributable to Inovio Pharmaceuticals, Inc.
|
$
|
(23,090,693)
|
|
|
$
|
(25,015,672)
|
|
|
$
|
(81,697,181)
|
|
|
$
|
(64,005,625)
|
|
Net loss per share
attributable to Inovio Pharmaceuticals, Inc.
stockholders
|
|
|
|
|
|
|
|
Basic
|
$
|
(0.23)
|
|
|
$
|
(0.27)
|
|
|
$
|
(0.83)
|
|
|
$
|
(0.70)
|
|
Diluted
|
$
|
(0.25)
|
|
|
$
|
(0.27)
|
|
|
$
|
(0.83)
|
|
|
$
|
(0.70)
|
|
Weighted average
number of common shares outstanding
|
|
|
|
|
|
|
|
Basic
|
99,007,985
|
|
|
92,423,122
|
|
|
98,204,375
|
|
|
91,350,117
|
|
Diluted
|
102,807,056
|
|
|
92,423,122
|
|
|
98,204,375
|
|
|
91,350,117
|
|
CONTACTS:
|
Investors:
|
Ben Matone,
484-362-0076, ben.matone@inovio.com
|
Media:
|
Jeff Richardson,
267-440-4211, jrichardson@inovio.com
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content:http://www.prnewswire.com/news-releases/inovio-pharmaceuticals-reports-2019-third-quarter-financial-results-300956823.html
SOURCE Inovio Pharmaceuticals, Inc.