Inovio Pharmaceuticals Reports 2016 Second Quarter Financial Results
August 08 2016 - 8:00AM
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today reported financial
results for the quarter ended June 30, 2016. The following
financial results provide a year-over-year comparison of the second
quarter in 2016 and 2015. Total revenue was $6.2 million compared
to $5.3 million. Total operating expenses were $24.4 million
compared to $20.4 million. The net loss attributable to common
stockholders was $18.7 million, or $0.26 per share, compared to
$6.2 million, or $0.09 per share.
Revenue
The increase in revenue was primarily due to an
increase in development payments from our DARPA Ebola grant.
Operating Expenses
Research and development expenses were $19.6
million compared to $16.7 million. The increase was primarily
related to increased investment in our product development
programs. General and administrative expenses were $5.8 million
compared to $4.7 million.
Capital Resources
As of June 30, 2016, cash and cash equivalents
and short-term investments were $134.5 million compared with $163.0
million as of December 31, 2015. There were 73.5 million
shares outstanding and 81.2 million fully diluted.
The Company sold 119,400 shares of common stock
at an average price of $11.12 per share, for net proceeds of $1.3
million, under the ATM common stock sales agreement implemented
during the period.
Inovio’s balance sheet and statement of
operations are provided below. Form 10-Q providing the complete
2016 second quarter financial report can be found at:
http://ir.inovio.com/secfilings.
Corporate Update
Clinical Development
- The FDA and European Medicines Agency provided an affirmative
path toward an indication for VGX-3100 to treat HPV-16/18-related
high grade cervical dysplasia in a pivotal phase III registration
study. We completed major commercial device design and
manufacturing process development efforts, and are in the final
stage of testing. Completion of this extensive work will
enable us to then submit our final package to the FDA in order to
start the phase III in 4Q 2016.
- Received approval from the FDA to initiate a phase I human
trial to evaluate Inovio’s Zika DNA vaccine (GLS-5700). This phase
I, open-label, dose-ranging study with 40 healthy subjects is
evaluating the safety, tolerability and immunogenicity of GLS-5700.
Subsequent to the quarter Inovio announced the dosing of the first
subject in this study. We expect to report interim immune response
and safety data in 4Q 2016.
- Inovio will continue to develop its hepatitis B DNA
immunotherapy (INO-1800) independently following Roche’s notice
that it will discontinue its collaboration with Inovio and its
development of INO-1800. INO-1800 was licensed
to Roche from Inovio in 2013. All
of Roche's rights to INO-1800, including the right to
license the product to other parties, will be returned. Inovio will
continue to advance its current phase I study of INO-1800, which is
enrolling as planned in 30 clinical sites in the U.S.
and Asia-Pacific regions. Inovio anticipates completing
enrollment in the first half of 2017 and expects results in the
second half of 2017.The study has completed interim safety reviews
with a favorable safety profile to date. Immunology analyses are
planned after completion of enrollment.
- Partnered with the National Cancer Institute and Mayo Clinic to
initiate a phase I trial of our immunotherapy for hepatitis C
(INO-8000). The dose escalation study will enroll patients in the
early stages of chronic HCV infection to determine the therapy’s
ability to decrease and potentially eliminate HCV viral load,
measure HCV specific immune responses and durability of these
immune responses, and evaluate safety and tolerability.
- Completed enrollment of 94 subjects in the phase I study of our
PENNVAX®-GP HIV immunotherapy. After completing extensive
immunogenicity analyses, we expect to report data in 1H 2017.
- Completed enrollment of 22 subjects in the phase I study of our
HPV-driven cancer immunotherapy, INO-3112, in head & neck
cancer patients. We expect to report additional immune response and
safety data in 4Q 2016.
- Completed enrollment of 62 subjects in the phase I study of our
INO-5150 prostate cancer immunotherapy. We expect to report interim
immune response and safety data in 4Q 2016.
- Completed enrollment of 75 subjects in the phase I study of our
GLS-5300 MERS vaccine. We expect to report interim immune
response and safety data in 4Q 2016.
Corporate Development
- Inovio completed the acquisition of all of Bioject Medical
Technologies Inc.’s assets, including pioneering needle-free jet
injection technology, devices, and intellectual property, for $5.5
million in cash and stock.
- Inovio’s DNA-based monoclonal antibody technology will be
deployed to develop new immunotherapy approaches to treat HIV. This
work will be funded by a $23 million grant, called
BEAT-HIV: Delaney Collaboratory to Cure HIV-1 Infection by
Combination Immunotherapy, from the National Institutes of
Health to The Wistar Institute, an Inovio collaborator,
and more than 30 of the nation's leading HIV investigators.
Preclinical Development
- Preclinical testing of our Zika virus synthetic vaccine induced
robust and durable immune responses in mice and in non-human
primates (monkeys).
About Inovio Pharmaceuticals,
Inc.
Inovio is taking immunotherapy to the next level
in the fight against cancer and infectious diseases. We are the
only immunotherapy company that has reported generating T cells in
vivo in high quantity that are fully functional and whose killing
capacity correlates with relevant clinical outcomes with a
favorable safety profile. With an expanding portfolio of immune
therapies, the company is advancing a growing preclinical and
clinical stage product pipeline. Partners and collaborators include
MedImmune, The Wistar Institute, University of Pennsylvania, DARPA,
GeneOne Life Science, Plumbline Life Sciences, Drexel University,
NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S.
Military HIV Research Program, 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 and our capital resources. 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 (including, but not limited to, the fact that
pre-clinical and clinical results referenced in this release may
not be indicative of results achievable in other trials or for
other indications, that the studies or trials may not be successful
or achieve the results desired, including safety and efficacy for
VGX-3100 and INO-3112, that pre-clinical studies and clinical
trials may not commence or be completed in the time periods
anticipated, that results from one study may not necessarily be
reflected or supported by the results of other similar studies and
that results from an animal study may not be indicative of results
achievable in human studies), 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 broad pipeline of SynCon® active immunotherapy and vaccine
products, our ability to advance our portfolio of immuno-oncology
products independently, 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, our ability to enter into
partnerships in conjunction with our research and development
programs, evaluation of potential opportunities, 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 company's 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, 2015,
our Form 10-Q for the quarter ended June 30, 2016, and
other regulatory filings from time to time. There can be no
assurance that any product in Inovio's pipeline will be
successfully developed or manufactured, that final results of
clinical studies 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.
|
Inovio
Pharmaceuticals, Inc. |
CONSOLIDATED
BALANCE SHEETS |
|
|
June 30, 2016 |
|
December 31, 2015 |
|
(Unaudited) |
|
|
ASSETS |
|
|
|
Current
assets: |
|
|
|
Cash and cash
equivalents |
$ |
28,450,373 |
|
|
$ |
57,632,693 |
|
Short-term
investments |
106,082,989 |
|
|
105,357,277 |
|
Accounts receivable |
10,365,950 |
|
|
7,333,059 |
|
Prepaid expenses and other
current assets |
1,188,042 |
|
|
917,257 |
|
Prepaid expenses and other
current assets from affiliated entity |
1,882,257 |
|
|
610,652 |
|
Total current
assets |
147,969,611 |
|
|
171,850,938 |
|
Fixed assets, net |
8,700,628 |
|
|
7,306,695 |
|
Investment in affiliated
entity- GeneOne |
21,716,728 |
|
|
14,941,277 |
|
Investment in affiliated
entity - PLS |
5,309,488 |
|
|
5,045,915 |
|
Intangible assets,
net |
8,449,306 |
|
|
3,905,860 |
|
Goodwill |
10,513,371 |
|
|
10,113,371 |
|
Other assets |
1,326,317 |
|
|
676,803 |
|
Total
assets |
$ |
203,985,449 |
|
|
$ |
213,840,859 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable and
accrued expenses |
$ |
12,707,754 |
|
|
$ |
13,064,899 |
|
Accounts payable and
accrued expenses due to affiliated entity |
600,969 |
|
|
165,047 |
|
Accrued clinical trial
expenses |
5,006,287 |
|
|
2,600,483 |
|
Common stock warrants |
1,815,343 |
|
|
1,301,138 |
|
Deferred revenue |
14,502,626 |
|
|
13,449,768 |
|
Deferred revenue from
affiliated entity |
469,792 |
|
|
504,442 |
|
Deferred rent |
391,913 |
|
|
380,629 |
|
Total current
liabilities |
35,494,684 |
|
|
31,466,406 |
|
Deferred revenue, net of
current portion |
374,043 |
|
|
103,074 |
|
Deferred revenue from
affiliated entity, net of current portion |
274,194 |
|
|
677,371 |
|
Deferred rent, net of
current portion |
5,576,953 |
|
|
5,485,313 |
|
Deferred tax
liabilities |
175,642 |
|
|
175,642 |
|
Total
liabilities |
41,895,516 |
|
|
37,907,806 |
|
Inovio
Pharmaceuticals, Inc. stockholders’ equity: |
|
|
|
Common stock |
73,483 |
|
|
72,218 |
|
Additional paid-in
capital |
546,251,246 |
|
|
534,004,564 |
|
Accumulated deficit |
(387,845,427 |
) |
|
(361,097,896 |
) |
Accumulated other
comprehensive income |
3,514,362 |
|
|
2,708,339 |
|
Total Inovio
Pharmaceuticals, Inc. stockholders’ equity |
161,993,664 |
|
|
175,687,225 |
|
Non-controlling
interest |
96,269 |
|
|
245,828 |
|
Total stockholders’
equity |
162,089,933 |
|
|
175,933,053 |
|
Total liabilities
and stockholders’ equity |
$ |
203,985,449 |
|
|
$ |
213,840,859 |
|
Inovio
Pharmaceuticals, Inc. |
CONSOLIDATED
STATEMENTS OF OPERATIONS |
(Unaudited) |
|
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
|
2016 |
|
2015 |
|
2016 |
|
2015 |
Revenues: |
|
|
|
|
|
|
|
Revenue under
collaborative research and development arrangements |
$ |
1,889,988 |
|
|
$ |
4,335,236 |
|
|
$ |
3,686,845 |
|
|
$ |
8,580,807 |
|
Revenue under
collaborative research and development arrangements with affiliated
entity |
499,720 |
|
|
166,667 |
|
|
636,720 |
|
|
279,167 |
|
Grants and miscellaneous
revenue |
3,814,083 |
|
|
784,775 |
|
|
9,990,381 |
|
|
1,593,341 |
|
Total
revenues |
6,203,791 |
|
|
5,286,678 |
|
|
14,313,946 |
|
|
10,453,315 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and
development |
19,630,801 |
|
|
16,688,511 |
|
|
37,819,961 |
|
|
26,114,831 |
|
General and
administrative |
5,799,530 |
|
|
4,718,260 |
|
|
11,171,143 |
|
|
8,826,188 |
|
Gain on sale of
assets |
(1,000,000 |
) |
|
(1,000,000 |
) |
|
(1,000,000 |
) |
|
(1,000,000 |
) |
Total operating
expenses |
24,430,331 |
|
|
20,406,771 |
|
|
47,991,104 |
|
|
33,941,019 |
|
Loss from
operations |
(18,226,540 |
) |
|
(15,120,093 |
) |
|
(33,677,158 |
) |
|
(23,487,704 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
Interest and other income,
net |
341,131 |
|
|
146,332 |
|
|
674,201 |
|
|
284,608 |
|
Change in fair value of
common stock warrants, net |
(113,775 |
) |
|
(49,773 |
) |
|
(520,024 |
) |
|
(51,000 |
) |
Gain (loss) on investment
in affiliated entity |
(705,527 |
) |
|
8,861,145 |
|
|
6,775,450 |
|
|
6,508,836 |
|
Net
loss |
(18,704,711 |
) |
|
(6,162,389 |
) |
|
(26,747,531 |
) |
|
(16,745,260 |
) |
Net loss attributable to
non-controlling interest |
— |
|
|
(85,861 |
) |
|
— |
|
|
(84,769 |
) |
Net loss
attributable to Inovio Pharmaceuticals, Inc. |
$ |
(18,704,711 |
) |
|
$ |
(6,248,250 |
) |
|
$ |
(26,747,531 |
) |
|
$ |
(16,830,029 |
) |
Net loss per
common share attributable to Inovio Pharmaceuticals, Inc.
stockholders: |
|
|
|
|
|
|
|
Basic |
$ |
(0.26 |
) |
|
$ |
(0.09 |
) |
|
$ |
(0.37 |
) |
|
$ |
(0.26 |
) |
Diluted |
$ |
(0.26 |
) |
|
$ |
(0.09 |
) |
|
$ |
(0.37 |
) |
|
$ |
(0.27 |
) |
Weighted
average number of common shares outstanding used in per share
calculations: |
|
|
|
|
|
|
|
Basic |
72,957,159 |
|
|
67,655,975 |
|
|
72,591,986 |
|
|
64,198,528 |
|
Diluted |
72,957,159 |
|
|
67,838,738 |
|
|
72,591,986 |
|
|
64,376,523 |
|
CONTACTS:
Investors: Bernie Hertel, Inovio Pharmaceuticals, 858-410-3101, bhertel@inovio.com
Media: Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211, jrichardson@inovio.com
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