BLUE BELL, Pa.,
May 12, 2014
/PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NYSE MKT:
INO) today reported financial results for the quarter ended
March 31, 2014.
Total revenue was $2.4
million for the three months ended March 31, 2014, compared to $1.5 million for the same period in 2013. Total
operating expenses were $12.4 million
compared to $8.1 million.
The loss from operations prior to other income (expenses)
for the quarter ended March 31, 2014,
was $10.0 million, or $0.05 per share, as compared with $6.6 million, or $0.04 per share for the quarter ended
March 31, 2013.
The net loss attributable to common stockholders for the
quarter ended March 31, 2014, was
$10.8 million, or $0.05 per share as compared with a net loss
attributable to common stockholders of $8.8
million, or $0.06 per share
for the quarter ended March 31,
2013.
The $2.0 million increase in
net loss attributable to common stockholders for the quarter ended
March 31, 2014, compared with the
same period in 2013 resulted primarily from an increase in non-cash
stock-based compensation.
Revenue
The increase in revenue for the three-month period was
primarily due to $1.4 million of
revenue recognized from our agreement with Roche. This revenue from
Roche primarily consisted of development fees paid for work
conducted by Inovio in Q1.
Operating Expenses
Research and development expenses for Q1 2014 were
$8.2 million compared to $5.1 million for Q1 2013. General and
administrative expenses were $4.1
million versus $3.0 million,
respectively.
Capital Resources
As of March 31, 2014, cash
and cash equivalents plus short-term investments were $116.8 million compared with $52.6 million as of December 31,
2013.
On March 4,
2014, the Company closed an underwritten public
offering of 21,810,900 shares of the Company's common
stock, including 2,844,900 shares of common stock
issued pursuant to the underwriter's exercise of its overallotment
option, at a price of $2.90 per
share. The gross proceeds of this offering were approximately
$63.3 million. Net proceeds to the
Company, after deducting the underwriter's discounts and commission
and other estimated offering expenses payable by the Company, were
approximately $59.2
million.
During the three months ended March
31, 2014, warrants and stock options to
purchase 8,030,622 shares of common stock were exercised for total
proceeds to the Company of $10.7
million.
As of March 31, 2014, the
company had 240.1 million shares outstanding and 265.6 million
fully diluted.
Based on management's projections and analysis, the
Company believes that cash, cash equivalents and short-term
investments are sufficient to meet its planned working capital
requirements through the end of 2017.
Inovio's balance sheet and statement of operations is
provided below. Form 10-Q providing the complete 2014 first quarter
financial report can be found at:
http://ir.inovio.com/secfilings.
Corporate Update
Corporate Development
Inovio appointed key individuals to newly created
management roles in R&D, clinical development and clinical
operations, as well as quality assurance. This expansion of the
management team will enhance the Company's ability to manage its
growing clinical and preclinical pipeline, appropriately fulfill
its commitments in its partnership with Roche, and ensure adherence
to the numerous regulatory standards under which the Company
operates.
Inovio was recognized at the World Vaccine Congress with
Vaccine Industry Excellence (ViE) Awards for "Best Therapeutic
Vaccine" for its VGX-3100 HPV immunotherapy, "Best
Licensing Deal" for its $400 million
partnership with Roche for Inovio's prostate cancer and hepatitis B
immunotherapies, and "Best Early Stage Vaccine Biotech" for its
ability to raise funds and build its broad pipeline of DNA-based
immunotherapies and vaccines.
Inovio continues to work toward partnerships with other
large pharmaceutical companies interested in Inovio
SynCon® immunotherapy and vaccine products.
Clinical Development
In Q3 2013 Inovio completed enrollment and treatment of
patients in its double-blinded, placebo-controlled, randomized
phase II clinical study (HPV-003). This study is for VGX-3100, our
SynCon® immunotherapy against HPV-caused pre-cancers and
cancers delivered with our CELLECTRA® electroporation
device. We are approaching the primary endpoint, which is nine
months from the first vaccination, when data will be unblinded and
analyzed. We are on track to report data in mid-2014.
VGX-3100 previously achieved best-in-class T-cell immune
responses that generated a strong killing effect against cells
targeted by this therapeutic vaccine, as published in
Science-Translational Medicine. In this
phase II study we are assessing efficacy, HPV infection status,
immunogenicity, and safety.
With respect to efficacy, we are measuring regression of
disease from late stage cervical pre-cancer (CIN 2/3) to early
stage pre-cancer (CIN 1) or elimination of disease. The study is
80% powered to achieve a 27% greater response rate of vaccinated
subjects achieving this disease regression versus those treated
with placebo plus electroporation. Using 25% as an estimated
response rate for natural regression in the placebo group, we are
aiming for a response rate in vaccinated subjects of 52% or better.
We are also measuring pre- and post-vaccination levels of HPV to
assess the impact of the immunotherapy on this cancer-causing
virus.
Equally important, we will be comprehensively
characterizing immune responses in treated patients. Strong T cell
immune response characteristics from this large controlled study
will help define the potential of Inovio's active immunotherapy
products as stand-alone therapies and their important potential to
be used in combination with complementary technologies such as
immune activators and checkpoint inhibitors to further enhance
potency against cancers and infectious diseases.
Inovio has been advancing preparatory activities for a
potential phase III study of VGX-3100. In addition,
in Q2 the Company expects to initiate two separate
phase I/IIa studies of VGX-3100 against HPV-caused
cervical cancer and head and neck cancer. Both of these studies
will incorporate an immune activator, DNA-based IL-12, which has
been shown to increase antigen-specific T cell generation relating
to a targeted disease. This combination is designated
INO-3112.
In partnership with Roche, we intend to launch our
prostate cancer immunotherapy (INO-5150) phase I in Q3. Preclinical
results indicated that this therapeutic vaccine induced potent
antibody and T-cell responses in animal models, initial evidence
that our concept for a DNA vaccine comprising a broader set of
antigens delivered with our CELLECTRA® device may
improve the breadth and effectiveness of a prostate cancer
immunotherapy. This launch will trigger the first milestone payment
from Roche.
Inovio expects to start a phase I study for its global,
multi-clade PENNVAX®-GP, its lead preventive and
therapeutic HIV DNA vaccine candidate, in the fourth quarter of
2014. Phase I data from Inovio's PENNVAX®-B preventive
HIV DNA vaccine (targeting only clade B viruses) in non-infected
subjects, published in the Journal of Infectious Diseases,
showed best-in-class T-cell responses. Delivery with our
CELLECTRA® device achieved a seven-fold increase (7% to
52%) in the response rate of subjects with robust CD8+ killer
T-cells compared to delivery without CELLECTRA®.
A paper is being prepared for submission to a peer-reviewed
scientific journal of immune response data from a separate study in
HIV-infected patients.
Inovio also plans to initiate an exploratory human study
for breast, lung and pancreatic cancers in the second half of 2014
for INO-1400, its hTERT DNA immunotherapy. Since hTERT
is over-expressed in 85% of cancers, this antigen has potential as
the basis of a "universal" cancer therapeutic. In an animal study,
INO-1400 generated robust and broad immune responses that were
18-fold higher than the previous best results of a peer's hTERT
therapeutic vaccine, broke the immune system's tolerance to its
self-antigens, induced T-cells with a tumor-killing function, and
increased the rate of survival when delivered with Inovio's
CELLECTRA® device.
Preclinical Development
Inovio continues to expand its cancer immunotherapy
pipeline as its primary product focus. By year end 2014, we aim to
have SynCon® constructs designed for a priority set of
cancer-associated antigens that we believe are the most promising
targets in the battle against cancer. These patented antigen
products will in aggregate encompass a variety of different cancer
types and provide Inovio with a rich cancer product portfolio to be
internally developed or partnered, potentially in combination with
checkpoint inhibitors or other complementary
technologies.
In Q1 we also announced that a new DNA-based cytokine
immune activator, interleukin -33 (IL-33), achieved a more rapid
and complete regression of established tumors in the mouse model
when added to a DNA immunotherapy. In previous studies the HPV 16
DNA immunotherapy alone did prevent tumor growth and delay
progression or cure mice of tumors. Both agents were delivered
using Inovio's CELLECTRA® device. Notably, IL-33
significantly increased the magnitude of vaccine-specific CD8 T
cell responses. The results were published in a paper, "Alarmin
IL-33 acts as potent immunoadjuvant enhancing antigen-specific
cell-mediated immunity and inducing potent anti-tumor immunity,"
in Cancer
Research.
Inovio is developing an expanding portfolio of
patent-protected cytokine and chemokine immune activators to form
combination therapies with its DNA vaccines and immunotherapies
with the goal of achieving the greatest possible efficacy against
targeted diseases.
About Inovio Pharmaceuticals, Inc.
Inovio is revolutionizing vaccines to prevent and treat
today's cancers and challenging infectious diseases. Its
SynCon® vaccines, in
combination with its proprietary electroporation delivery, are
generating best-in-class immune responses, with therapeutic T-cell
responses exceeding other technologies in terms of magnitude,
breadth, and response rate. Human data to date have shown a
favorable safety profile. Inovio's lead vaccine, a therapeutic
against HPV-caused pre-cancers and cancers, is in phase II. Other
phase I and preclinical programs target prostate, breast, and lung
cancers as well as HIV, influenza, malaria and hepatitis. Partners
and collaborators include Roche, the University of Pennsylvania, NIH, HIV Vaccines Trial
Network, National Cancer Institute, U.S. Military HIV Research
Program, University of Southampton, US Dept. of Homeland Security,
University of Manitoba and PATH Malaria
Vaccine Initiative. More information is available at
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 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, 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, 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, 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, 2013, our Form 10-Q for the quarter
ended March 31, 2014, 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.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
|
|
|
|
|
|
March 31,
2014
|
|
December 31,
2013
|
ASSETS
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
Cash and cash equivalents
|
$
|
98,770,907
|
|
|
$
|
33,719,796
|
|
Short-term investments
|
18,011,492
|
|
|
18,905,608
|
|
Accounts receivable
|
2,699,570
|
|
|
3,301,563
|
|
Accounts receivable from affiliated
entity
|
18,652
|
|
|
—
|
|
Prepaid expenses and other current
assets
|
464,093
|
|
|
637,433
|
|
Prepaid expenses and other current assets from
affiliated entity
|
1,657,734
|
|
|
2,057,350
|
|
Deferred tax asset
|
61,839
|
|
|
61,839
|
|
Total current assets
|
121,684,287
|
|
|
58,683,589
|
|
Restricted cash
|
100,849
|
|
|
100,762
|
|
Fixed assets, net
|
3,021,222
|
|
|
2,886,545
|
|
Investment in affiliated entity
|
9,287,624
|
|
|
9,664,587
|
|
Intangible assets, net
|
5,478,966
|
|
|
5,718,778
|
|
Goodwill
|
10,113,371
|
|
|
10,113,371
|
|
Common stock warrants
|
1,410,000
|
|
|
717,500
|
|
Other assets
|
561,326
|
|
|
402,075
|
|
Total assets
|
$
|
151,657,645
|
|
|
$
|
88,287,207
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
Accounts payable and accrued
expenses
|
$
|
5,250,417
|
|
|
$
|
5,444,508
|
|
Accounts payable and accrued expenses due to
affiliated entity
|
779,500
|
|
|
522,255
|
|
Accrued clinical trial expenses
|
1,735,148
|
|
|
1,446,180
|
|
Common stock warrants
|
6,045,903
|
|
|
19,540,583
|
|
Deferred revenue
|
1,454,065
|
|
|
1,624,388
|
|
Deferred revenue from affiliated
entity
|
376,041
|
|
|
388,542
|
|
Total current liabilities
|
15,641,074
|
|
|
28,966,456
|
|
Deferred revenue, net of current
portion
|
2,315,158
|
|
|
1,997,333
|
|
Deferred revenue from affiliated entity, net of
current portion
|
1,117,944
|
|
|
1,211,694
|
|
Deferred rent
|
3,207,784
|
|
|
3,013,263
|
|
Deferred tax liabilities
|
195,778
|
|
|
195,778
|
|
Total liabilities
|
22,477,738
|
|
|
35,384,524
|
|
Inovio Pharmaceuticals, Inc. stockholders'
equity:
|
|
|
|
|
|
Common stock
|
240,147
|
|
|
210,305
|
|
Additional paid-in capital
|
435,183,356
|
|
|
348,109,661
|
|
Accumulated deficit
|
(306,610,037)
|
|
|
(295,788,577)
|
|
Accumulated other comprehensive income
(loss)
|
(71,810)
|
|
|
(76,365)
|
|
Total Inovio Pharmaceuticals, Inc. stockholders'
equity
|
128,741,656
|
|
|
52,455,024
|
|
Non-controlling interest
|
438,251
|
|
|
447,659
|
|
Total stockholders' equity
|
129,179,907
|
|
|
52,902,683
|
|
Total liabilities and stockholders'
equity
|
$
|
151,657,645
|
|
|
$
|
88,287,207
|
|
INOVIO PHARMACEUTICALS, INC
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
(Unaudited)
|
|
|
|
Three Months Ended
March
31,
|
|
2014
|
|
2013
|
Revenues:
|
|
|
|
|
|
Revenue under collaborative research and development
arrangements
|
$
|
1,435,727
|
|
|
$
|
14,259
|
|
Revenue under collaborative research and development
arrangements with affiliated entity
|
116,964
|
|
|
106,250
|
|
Grants and miscellaneous revenue
|
804,952
|
|
|
1,334,716
|
|
Total revenues
|
2,357,643
|
|
|
1,455,225
|
|
Operating expenses:
|
|
|
|
|
|
Research and development
|
8,225,480
|
|
|
5,115,112
|
|
General and administrative
|
4,132,218
|
|
|
2,974,153
|
|
Total operating expenses
|
12,357,698
|
|
|
8,089,265
|
|
Loss from operations
|
(10,000,055)
|
|
|
(6,634,040)
|
|
Other income (expense):
|
|
|
|
|
|
Interest and other income, net
|
52,076
|
|
|
39,460
|
|
Change in fair value of common stock
warrants
|
(505,926)
|
|
|
(1,427,616)
|
|
Loss on investment in affiliated
entity
|
(376,963)
|
|
|
(836,084)
|
|
Net loss
|
(10,830,868)
|
|
|
(8,858,280)
|
|
Net loss attributable to non-controlling
interest
|
9,408
|
|
|
14,160
|
|
Net loss attributable to Inovio Pharmaceuticals,
Inc.
|
$
|
(10,821,460)
|
|
|
$
|
(8,844,120)
|
|
Loss per common share—basic and
diluted:
|
|
|
|
|
|
Net loss per share attributable to Inovio
Pharmaceuticals, Inc. stockholders
|
$
|
(0.05)
|
|
|
$
|
(0.06)
|
|
Weighted average number of common shares
outstanding—basic and diluted
|
220,636,004
|
|
|
156,155,532
|
|
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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SOURCE Inovio Pharmaceuticals, Inc.