Inovio Pharmaceuticals Reports 2016 First Quarter Financial Results
May 09 2016 - 7:50AM
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today reported financial
results for the quarter ended March 31, 2016.
Total revenue was $8.1 million for the three
months ended March 31, 2016, compared to $5.2 million for the same
period in 2015. Total operating expenses were $23.6 million
compared to $13.5 million.
The net loss attributable to common stockholders
for the quarter ended March 31, 2016, was $8.0 million, or $0.11
per share, compared to $10.6 million, or $0.17 per share, for the
quarter ended March 31, 2015.
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 for Q1 2016
were $18.2 million compared to $9.4 million for Q1 2015. The
increase in R&D expenses was generally related to increased
investment in all our product development programs. General and
administrative expenses were $5.4 million for Q1 2016 versus $4.1
million for Q1 2015.
Capital Resources
As of March 31, 2016, cash and cash equivalents
and short-term investments were $146.8 million compared with $163.0
million as of December 31, 2015. At quarter end the company
had 72.3 million shares outstanding and 80.7 million fully
diluted.
Inovio’s balance sheet and statement of
operations are provided below. Form 10-Q providing the complete
2016 first quarter financial report can be found at:
http://ir.inovio.com/secfilings.
Corporate Update
Clinical Development
- Subsequent to the quarter, Inovio held constructive meetings
with both FDA (end of phase II) and European Medicines Agency (EMA)
providing an affirmative path forward toward an indication
for VGX-3100 to treat HPV-16/18-related high grade cervical
dysplasia that is consistent with our previously reported
expectations to start a pivotal phase III registration study in
2016.
- Interim data from the fully enrolled phase I study of INO-4212
Ebola vaccine in 75 healthy subjects showed it was safe, tolerable,
and generated strong T cell and antibody responses.
- Inovio and GeneOne Life Science Inc. began recruitment of
the collaborative study of GLS-5300 MERS (Middle East Respiratory
Syndrome) vaccine with Walter Reed Army Institute of
Research.
Corporate Development
- Subsequent to the quarter, 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.
- Received $500,000 grant from the U.S. Army’s Small
Business Innovation Research program to advance Inovio’s next
generation delivery device capable of administering vaccines via
skin-surface, needle-free electroporation delivery.
- Signed collaborative research agreements with the Wistar
Institute for therapeutic and preventive DNA-based
immunotherapy applications and products for cancers and infectious
diseases developed by David B. Weiner, Ph.D., and his Wistar
laboratory. Inovio will have the exclusive right to in-license new
intellectual property developed in this collaboration.
- VGX-3100 HPV cervical dysplasia immunotherapy recognized as
"Best Therapeutic Vaccine" by World Vaccine Congress for fourth
consecutive year.
Preclinical Development
- The Journal of Infectious Diseases published the paper,
“Rapid and long-term immunity elicited by DNA encoded antibody
prophylaxis and DNA vaccination against Chikungunya virus,”
highlighting Inovio’s DNA-based monoclonal antibody
technology.
- Preclinical testing of Zika virus synthetic vaccine induced
robust and durable immune responses. The first clinical study of
Inovio’s Zika vaccine is on track to start in 2016.
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, Roche, The Wistar Institute, 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 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 March 31, 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 |
|
|
|
|
|
March 31, 2016 |
|
December 31, 2015 |
|
(Unaudited) |
|
|
ASSETS |
|
|
|
Current
assets: |
|
|
|
Cash and cash
equivalents |
$ |
41,624,045 |
|
|
$ |
57,632,693 |
|
Short-term
investments |
105,163,382 |
|
|
105,357,277 |
|
Accounts receivable |
11,152,759 |
|
|
7,333,059 |
|
Prepaid expenses and other
current assets |
1,122,707 |
|
|
917,257 |
|
Prepaid expenses and other
current assets from affiliated entity |
1,538,563 |
|
|
610,652 |
|
Total current
assets |
160,601,456 |
|
|
171,850,938 |
|
Fixed assets, net |
8,393,322 |
|
|
7,306,695 |
|
Investment in affiliated
entity- GeneOne |
22,422,255 |
|
|
14,941,277 |
|
Investment in affiliated
entity - PLS |
5,026,917 |
|
|
5,045,915 |
|
Intangible assets,
net |
3,696,318 |
|
|
3,905,860 |
|
Goodwill |
10,113,371 |
|
|
10,113,371 |
|
Other assets |
1,034,753 |
|
|
676,803 |
|
Total
assets |
$ |
211,288,392 |
|
|
$ |
213,840,859 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable and
accrued expenses |
$ |
12,102,303 |
|
|
$ |
13,064,899 |
|
Accounts payable and
accrued expenses due to affiliated entity |
207,233 |
|
|
165,047 |
|
Accrued clinical trial
expenses |
4,150,796 |
|
|
2,600,483 |
|
Common stock warrants |
1,707,387 |
|
|
1,301,138 |
|
Deferred revenue |
14,538,426 |
|
|
13,449,768 |
|
Deferred revenue from
affiliated entity |
376,042 |
|
|
504,442 |
|
Deferred rent |
316,617 |
|
|
380,629 |
|
Total current
liabilities |
33,398,804 |
|
|
31,466,406 |
|
Deferred revenue, net of
current portion |
434,695 |
|
|
103,074 |
|
Deferred revenue from
affiliated entity, net of current portion |
367,944 |
|
|
677,371 |
|
Deferred rent, net of
current portion |
5,693,594 |
|
|
5,485,313 |
|
Deferred tax
liabilities |
175,642 |
|
|
175,642 |
|
Total
liabilities |
40,070,679 |
|
|
37,907,806 |
|
Inovio
Pharmaceuticals, Inc. stockholders’ equity: |
|
|
|
Common stock |
72,268 |
|
|
72,218 |
|
Additional paid-in
capital |
537,131,310 |
|
|
534,004,564 |
|
Accumulated deficit |
(369,140,716 |
) |
|
(361,097,896 |
) |
Accumulated other
comprehensive income |
2,909,023 |
|
|
2,708,339 |
|
Total Inovio
Pharmaceuticals, Inc. stockholders’ equity |
170,971,885 |
|
|
175,687,225 |
|
Non-controlling
interest |
245,828 |
|
|
245,828 |
|
Total stockholders’
equity |
171,217,713 |
|
|
175,933,053 |
|
Total liabilities
and stockholders’ equity |
$ |
211,288,392 |
|
|
$ |
213,840,859 |
|
Inovio
Pharmaceuticals, Inc. |
CONSOLIDATED
STATEMENTS OF OPERATIONS |
(Unaudited) |
|
|
|
Three Months Ended March 31, |
|
2016 |
|
2015 |
Revenues: |
|
|
|
Revenue under
collaborative research and development arrangements |
$ |
1,796,857 |
|
|
$ |
4,245,571 |
|
Revenue under
collaborative research and development arrangements with affiliated
entity |
137,000 |
|
|
112,500 |
|
Grants and miscellaneous
revenue |
6,176,298 |
|
|
808,566 |
|
Total
revenues |
8,110,155 |
|
|
5,166,637 |
|
Operating
expenses: |
|
|
|
Research and
development |
18,189,160 |
|
|
9,426,320 |
|
General and
administrative |
5,371,613 |
|
|
4,107,928 |
|
Total operating
expenses |
23,560,773 |
|
|
13,534,248 |
|
Loss from
operations |
(15,450,618 |
) |
|
(8,367,611 |
) |
Other income
(expense): |
|
|
|
Interest and other income,
net |
333,070 |
|
|
138,276 |
|
Change in fair value of
common stock warrants |
(406,249 |
) |
|
(1,227 |
) |
Gain (loss) on investment
in affiliated entity |
7,480,977 |
|
|
(2,352,309 |
) |
Net
loss |
(8,042,820 |
) |
|
(10,582,871 |
) |
Net loss attributable to
non-controlling interest |
— |
|
|
1,092 |
|
Net loss
attributable to Inovio Pharmaceuticals, Inc. |
$ |
(8,042,820 |
) |
|
$ |
(10,581,779 |
) |
Net loss per
common share attributable to Inovio Pharmaceuticals, Inc.
stockholders: |
|
|
|
Basic |
$ |
(0.11 |
) |
|
$ |
(0.17 |
) |
Diluted |
$ |
(0.11 |
) |
|
$ |
(0.18 |
) |
Weighted
average number of common shares outstanding used in per share
calculations: |
|
|
|
Basic |
72,230,411 |
|
|
60,741,082 |
|
Diluted |
72,230,411 |
|
|
60,913,423 |
|
CONTACTS:
Investors: Bernie Hertel,
Inovio Pharmaceuticals
858-410-3101
bhertel@inovio.com
Media:
Jeff Richardson,
Inovio Pharmaceuticals
267-440-4211
jrichardson@inovio.com
Inovio Pharmaceuticals (NASDAQ:INO)
Historical Stock Chart
From Mar 2024 to Apr 2024
Inovio Pharmaceuticals (NASDAQ:INO)
Historical Stock Chart
From Apr 2023 to Apr 2024