Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today reported financial
results for the quarter ended September 30, 2015.
Total revenue was $24.2 million and $34.6
million for the three and nine months ended September 30, 2015,
compared to $1.8 million and $8.0 million for the same periods in
2014.
Total operating expenses were $20.5 million and
$54.4 million for the three and nine months ended September 30,
2015, compared to $10.2 million and $36.5 million for the same
periods in 2014.
The net income (loss) attributable to common
stockholders for the three and nine months ended September 30,
2015, was $5.6 million, or $0.08 per share, and $(11.2 million), or
$(0.17) per share, compared to $(7.2 million), or $(0.12) per
share, and $(28.7 million), or $(0.49) per share, for the same
periods in 2014.
Revenue
The increase in revenue for the comparable
periods was primarily due to development payments from our DARPA
Ebola grant as well as $15.0 million of revenue recognized in the
third quarter 2015 from the up-front payment received from our
partnership agreement with MedImmune. Accounting recognition of the
remainder of the $27.5 million upfront payment has been deferred
and will be triggered by future events. The net income achieved
during the third quarter was attributable to the increase in
revenue and may not be reflective of future quarters.
Operating Expenses
Research and development expenses for the three
and nine months ended September 30, 2015, were $16.1 million and
$42.2 million, compared to $7.0 million and $24.9 million for the
same periods in 2014. The increase for the three and nine month
periods was primarily related to increased investment in our
product development programs. General and administrative expenses
for the three and nine months ended September 30, 2015, were $4.4
million and $13.2 million versus $3.2 million and $11.6 million for
the same periods in 2014.
Capital Resources
As of September 30, 2015, cash and short-term
investments were $170.8 million compared with $93.6 million as of
December 31, 2014. At quarter end the company had 72.2 million
shares outstanding and 78.9 million fully diluted.
Inovio’s balance sheet and statement of
operations are provided below. Form 10-Q providing the complete
2015 third quarter financial report can be found at:
http://ir.inovio.com/secfilings.
Corporate Update
Corporate Development On August
7, 2015, Inovio entered into a strategic cancer vaccine
collaboration and license agreement with MedImmune, the global
biologics research and development arm of AstraZeneca. MedImmune
acquired exclusive rights to Inovio’s INO-3112 immunotherapy, which
targets cancers caused by human papillomavirus (HPV) types 16 and
18. MedImmune intends to study INO-3112 in combination with
selected immunotherapy molecules within its pipeline in HPV-driven
cancers. Emerging evidence suggests that the benefits from
immuno-oncology molecules, such as those in MedImmune’s portfolio,
can be enhanced when they are used in combination with cancer
vaccines that generate tumor-specific T-cells.
MedImmune paid Inovio $27.5 million in the third
quarter and will make potential future payments totaling up to $700
million upon reaching development and commercial milestones.
MedImmune will fund all development costs. Inovio is entitled to
receive up to double-digit tiered royalties on INO-3112 product
sales.
Inovio and MedImmune will also develop two
additional DNA-based cancer vaccine products not included in
Inovio's current product pipeline, which MedImmune will have the
exclusive rights to develop and commercialize. Inovio will be
eligible to receive development, regulatory and commercialization
milestone payments and royalties on net sales for these cancer
vaccines.
This is the second major pharmaceutical
partnership for Inovio’s DNA-based immunotherapy technology, adding
to its existing license agreement with Roche for the INO-1800
hepatitis B immunotherapy.
Inovio initiated a partnership with the European
Organization for Research and Treatment of Cancer to evaluate
INO-3112 in combination with traditional chemo-radiotherapy for the
treatment of patients with locally advanced stage cervical cancer.
The primary endpoint of this phase II study is to evaluate
progression free survival at 18 months. It is expected to begin in
2016 and will be part of MedImmune’s development plans.
Inovio and collaborators are advancing multiple
treatment and prevention approaches against Ebola. Inovio received
an initial $20 million award from the Defense Advanced Research
Projects Agency (DARPA). In September, DARPA awarded Inovio an
additional $25 million for the successful completion of
pre-clinical and clinical development milestones. This funding
supports the development of a DNA-based vaccine, a therapeutic
DNA-based monoclonal antibody treatment (dMAb™), and a conventional
monoclonal antibody treatment. Inovio has completed enrollment of
75 healthy subjects in a phase I study of the Ebola DNA
vaccine.
Clinical Development
Inovio’s manuscript detailing the broad study
findings of its phase II study of VGX-3100 in patients with
high-grade cervical dysplasia (CIN 2/3) was published in The
Lancet, a top peer-reviewed medical journal. This publication
describes that VGX-3100, a first-in-class product for treating high
grade cervical neoplasia associated with HPV, is the first therapy
to demonstrate that activated killer T cells induced in the body
have the power to clear neoplastic lesions as well as the virus
which caused the disease. These findings provide proof of principle
not only for this disease indication but for the broad utility of
Inovio’s technology across cancers and infectious diseases.
Results of the trial were reported in the
article entitled, "Safety, efficacy, and immunogenicity of
VGX-3100, a therapeutic synthetic DNA vaccine targeting human
papillomavirus 16 and 18 E6 and E7 proteins for cervical
intraepithelial neoplasia 2/3: a randomized, double-blind,
placebo-controlled phase 2b trial."
Inovio continues to make preparations to launch
a phase III registration study of VGX-3100 in 2016. Necessary steps
include scaling to commercial-level production of its immunotherapy
product and delivery devices. The company expects its
end-of-phase-II meeting with the FDA, which will review Inovio’s
phase II data and proposed phase III clinical trial design, to take
place in early 2016.
Inovio launched a phase I study of INO-5150, its
SynCon® immunotherapy targeting prostate-specific membrane antigen
and prostate-specific antigen, in men with biochemically relapsed
prostate cancer. This study is evaluating the safety, tolerability,
and immunogenicity of INO-5150 alone or in combination with
Inovio’s DNA-based IL-12 immune activator. The company expects to
report interim data from this study in 2016.
The first patient was dosed in Inovio’s phase I
trial to evaluate safety and tolerability of PENNVAX®-GP, the
company’s "universal" DNA vaccine for HIV. The trial will measure
immune responses following administration of the vaccine in four
groups of healthy subjects receiving the vaccine with and without
an immune activator (DNA IL-12) and delivered into muscle or skin
using Inovio's CELLECTRA® delivery technology. This 94-patient
study is being conducted by the HIV Vaccines Trial Network (HVTN)
and funded by the National Institute of Allergy and Infectious
Diseases (NIAID).
Inovio’s partner for its DNA vaccine for Middle
East Respiratory Syndrome (MERS), GeneOne Life Science Inc., filed
an Investigational New Drug Application (IND) for GLS-5300 with the
United States Food and Drug Administration in October and intends
to launch a clinical trial in healthy volunteers by the year
end.
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 is 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,
Roche, University of Pennsylvania, DARPA, GeneOne Life Science,
Drexel University, NIH, HIV Vaccines Trial Network, National Cancer
Institute, U.S. Military HIV Research Program, and University of
Manitoba. 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 immune therapy and vaccine
products, our ability to advance our portfolio of immune-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, 2014,
our Form 10-Q for the quarter ended September 30, 2015, 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 |
|
|
|
|
|
September 30, 2015 |
|
December 31, 2014 |
|
(Unaudited) |
|
|
ASSETS |
|
|
|
Current
assets: |
|
|
|
Cash and cash
equivalents |
$ |
85,468,796 |
|
|
$ |
40,543,982 |
|
Short-term
investments |
85,313,556 |
|
|
53,075,974 |
|
Accounts receivable |
10,965,273 |
|
|
2,804,207 |
|
Prepaid expenses and other
current assets |
1,348,890 |
|
|
797,973 |
|
Prepaid expenses and other
current assets from affiliated entity |
634,326 |
|
|
1,382,375 |
|
Deferred tax asset |
342,573 |
|
|
342,573 |
|
Total current
assets |
184,073,414 |
|
|
98,947,084 |
|
Fixed assets, net |
6,458,900 |
|
|
4,583,204 |
|
Investments in affiliated
entities |
25,321,361 |
|
|
12,340,811 |
|
Intangible assets,
net |
4,118,010 |
|
|
4,776,059 |
|
Goodwill |
10,113,371 |
|
|
10,113,371 |
|
Common stock warrants |
88,900 |
|
|
550,000 |
|
Other assets |
597,570 |
|
|
474,568 |
|
Total
assets |
$ |
230,771,526 |
|
|
$ |
131,785,097 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable and
accrued expenses |
$ |
10,519,408 |
|
|
$ |
6,383,170 |
|
Accounts payable and
accrued expenses due to affiliated entity |
2,813,019 |
|
|
28,407 |
|
Accrued clinical trial
expenses |
2,942,444 |
|
|
2,007,432 |
|
Common stock warrants |
1,093,752 |
|
|
2,022,729 |
|
Deferred revenue |
188,415 |
|
|
3,187,223 |
|
Deferred revenue from
affiliated entity |
523,192 |
|
|
394,791 |
|
Deferred rent |
197,642 |
|
|
— |
|
Total current
liabilities |
18,277,872 |
|
|
14,023,752 |
|
Deferred revenue, net of
current portion |
12,798,493 |
|
|
173,779 |
|
Deferred revenue from
affiliated entity, net of current portion |
798,532 |
|
|
836,694 |
|
Deferred rent, net of
current portion |
5,007,000 |
|
|
4,709,229 |
|
Deferred tax
liabilities |
504,049 |
|
|
504,049 |
|
Total
liabilities |
37,385,946 |
|
|
20,247,503 |
|
Inovio
Pharmaceuticals, Inc. stockholders’ equity: |
|
|
|
Common stock |
72,181 |
|
|
60,741 |
|
Additional paid-in
capital |
532,559,242 |
|
|
443,327,915 |
|
Accumulated deficit |
(343,145,851 |
) |
|
(331,910,290 |
) |
Accumulated other
comprehensive income (loss) |
3,654,180 |
|
|
(251,390 |
) |
Total Inovio
Pharmaceuticals, Inc. stockholders’ equity |
193,139,752 |
|
|
111,226,976 |
|
Non-controlling
interest |
245,828 |
|
|
310,618 |
|
Total stockholders’
equity |
193,385,580 |
|
|
111,537,594 |
|
Total liabilities
and stockholders’ equity |
$ |
230,771,526 |
|
|
$ |
131,785,097 |
|
Inovio Pharmaceuticals, Inc. |
CONSOLIDATED STATEMENTS OF
OPERATIONS |
(Unaudited) |
|
|
|
|
|
Three Months Ended September
30, |
|
Nine Months Ended September
30, |
|
2015 |
|
2014 |
|
2015 |
|
2014 |
Revenues: |
|
|
|
|
|
|
|
Revenue under
collaborative research and development arrangements |
$ |
16,475,083 |
|
|
$ |
1,114,952 |
|
|
$ |
25,055,890 |
|
|
$ |
5,658,460 |
|
Revenue under
collaborative research and development arrangements with affiliated
entity |
125,000 |
|
|
112,500 |
|
|
404,167 |
|
|
366,964 |
|
Grants and miscellaneous
revenue |
7,583,151 |
|
|
612,901 |
|
|
9,176,492 |
|
|
1,974,234 |
|
Total
revenues |
24,183,234 |
|
|
1,840,353 |
|
|
34,636,549 |
|
|
7,999,658 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and
development |
16,075,201 |
|
|
7,017,805 |
|
|
42,190,032 |
|
|
24,850,566 |
|
General and
administrative |
4,377,616 |
|
|
3,153,714 |
|
|
13,203,804 |
|
|
11,633,259 |
|
Gain on sale of
assets |
— |
|
|
— |
|
|
(1,000,000 |
) |
|
— |
|
Total operating
expenses |
20,452,817 |
|
|
10,171,519 |
|
|
54,393,836 |
|
|
36,483,825 |
|
Income (Loss) from
operations |
3,730,417 |
|
|
(8,331,166 |
) |
|
(19,757,287 |
) |
|
(28,484,167 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
Interest and other income,
net |
214,982 |
|
|
97,174 |
|
|
499,590 |
|
|
218,249 |
|
Change in fair value of
common stock warrants |
518,877 |
|
|
(113,980 |
) |
|
467,877 |
|
|
204,484 |
|
Gain (loss) on investment
in affiliated entity |
(659,054 |
) |
|
1,168,911 |
|
|
5,849,782 |
|
|
(666,212 |
) |
Net income (loss)
before income tax benefit |
3,805,222 |
|
|
(7,179,061 |
) |
|
(12,940,038 |
) |
|
(28,727,646 |
) |
Income tax benefit |
1,789,246 |
|
|
— |
|
|
1,789,246 |
|
|
— |
|
Net income
(loss) |
5,594,468 |
|
|
(7,179,061 |
) |
|
(11,150,792 |
) |
|
(28,727,646 |
) |
Net (income) loss
attributable to non-controlling interest |
— |
|
|
1,486 |
|
|
(84,769 |
) |
|
17,337 |
|
Net income (loss)
attributable to Inovio Pharmaceuticals, Inc. |
$ |
5,594,468 |
|
|
$ |
(7,177,575 |
) |
|
$ |
(11,235,561 |
) |
|
$ |
(28,710,309 |
) |
Net income
(loss) per common share attributable to Inovio Pharmaceuticals,
Inc. stockholders: |
|
|
|
|
|
|
|
Basic |
$ |
0.08 |
|
|
$ |
(0.12 |
) |
|
$ |
(0.17 |
) |
|
$ |
(0.49 |
) |
Diluted |
$ |
0.07 |
|
|
$ |
(0.12 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.52 |
) |
Weighted
average number of common shares outstanding used in per share
calculations: |
|
|
|
|
|
|
|
Basic |
72,029,644 |
|
|
60,392,911 |
|
|
66,846,481 |
|
|
58,625,740 |
|
Diluted |
73,961,237 |
|
|
60,602,831 |
|
|
67,018,961 |
|
|
58,936,414 |
|
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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