SAN DIEGO--(BUSINESS WIRE)--Inovio Biomedical Corporation (NYSE AMEX: INO) (“Inovio”) today reported
financial results for the three and nine months ended September 30, 2009.
“Development of a novel DNA SynCon tetravalent
dengue vaccine that elicits immune responses against four serotypes.”
Total revenue was $3.6 million and $6.5 million for the three and nine
months ended September 30, 2009, respectively, compared to $455,000 and
$1.8 million for the three and nine months ended September 30, 2008,
respectively.
Total operating expenses for the three and nine months ended September
30, 2009, were $7.2 million and $16.7 million, respectively, as compared
to $3.2 million and $12.0 million, respectively, for the three and nine
months ended September 30, 2008.
The net loss attributable to common stockholders for the three and nine
months ended September 30, 2009, was $2.9 million, or $0.03 per share
and $17.1 million, or $0.26 per share, respectively, as compared with a
net loss attributable to common stockholders of $2.3 million, or $0.05
per share and $9.4 million, or $0.21 per share, respectively, for the
three and nine months ended September 30, 2008.
Revenue
Revenue from license fees and milestone payments was $2.1 million and
$4.6 million for the three and nine months ended September 30, 2009,
respectively, compared to $215,000 and $612,000 for the three and nine
months ended September 30, 2008. The increase in revenue under license
fees and milestone payments was mainly due to the acceleration of
deferred revenues recognized as a result of the cancellation of the
Wyeth collaboration and licensing agreement in July 2009.
During the three and nine months ended September 30, 2009, we recorded
revenue under collaborative research and development arrangements of
$33,000 and $120,000, respectively, compared to $240,000 and $1.2
million in the same periods of 2008. This decrease in revenue was
primarily due to a decrease in collaborative research billings to Merck
and Wyeth. Revenues from collaborative research and development
arrangements are expected to continue to decline, as Wyeth terminated
its collaboration and licensing agreement as of July 2009 and, under our
research and collaboration agreement with Merck, we have provided the
majority of the required device development for use in their clinical
trials and believe that development activities will be limited until
trial results are obtained.
During the three and nine months ended September 30, 2009, Inovio
recorded grant and miscellaneous revenue of $1.5 million and $1.8
million, respectively, compared to no grant revenue in the respective
periods of 2008. This increase was primarily due to revenue from VGX’s
contracts with the National Institute of Allergy and Infectious Diseases
(“NIAID”) and PATH Malaria Vaccine Initiative (“MVI”) of $1.4 million
and $55,000, respectively, since June 1, 2009, and the Department of
Defense (“U.S. Army”) grant in the amounts of $113,000 and $293,000 for
the three and nine months ended September 30, 2009.
Details of these contracts are:
-
The NIAID contract is for five years with two one-year options (period
of performance is September 30, 2008 — September 29, 2015). The value
over the five years is $21.3 million with option years six and seven
valued at $1.2 million and $1.1 million, respectively, for a total
potential value of $23.6 million. The contract will fund research and
development for HIV DNA-based vaccines delivered via our proprietary
electroporation system.
-
The U.S. Army grant has a total value of $933,000, will fund research
and development of DNA-based vaccines delivered via our proprietary
electroporation system, and will run through May 2010. This project is
focused on identifying DNA vaccine candidates with the potential to
provide rapid, robust immunity to protect against bio-warfare and
bio-terror attacks.
-
MVI is an international nonprofit organization established through a
grant from the Bill & Melinda Gates Foundation. Inovio’s research
program and agreement with MVI is evaluating Inovio’s SynCon™ DNA
vaccine development platform to target antigens from malaria-causing Plasmodium
species and deliver them intradermally using the CELLECTRA®
electroporation device. The agreement with MVI is for $685,000 and
will run through February 2010.
Operating Expenses
Research and development expenses for the three and nine months ended
September 30, 2009, were $3.4 million and $5.6 million, respectively,
compared to $1.3 million and $4.6 million for the respective periods in
September 30, 2008. The increase in these expenses for the three and
nine months was primarily due to higher costs related to work performed
for the NIAID contract.
General and administrative expenses, including business development
expenses and amortization of intangible assets, for the three and nine
months ended September 30, 2009, were $3.8 million and $11.1 million,
compared to $1.9 million and $7.4 million for the respective periods
ended September 30, 2008. The increase in these expenses was primarily
due to extraordinary legal and related fees associated with the merger
and other corporate matters. We expect these legal fees to decrease in
future quarters. Upon closing of Merger, the Company also incurred costs
that would have not been incurred in the comparable period in 2008, such
as Merger-related compensation to key employees, higher amortization
expense as a result of the intangible assets that were acquired from
VGX, and higher employee stock-based compensation due to the accelerated
vesting of all Inovio stock options. The increase was also attributed to
higher accounting, audit and valuation fees incurred related to the
Merger and the combined company.
Net Loss Attributable to Common Stockholders
The $7.7 million increase in net loss attributable to common
stockholders for the nine months ended September 30, 2009, compared with
the same period in 2008, resulted primarily due to increased operating
expenses, an increase in expense for the revaluation of registered
common stock warrants and the loss due to the change in the fair market
value for our investment in VGX International as of September 30, 2009.
Capital Resources
Inovio ended the third quarter 2009 with cash and cash equivalents of
$32.5 million and working capital of $27.2 million, compared to $14.1
million in cash and cash equivalents and $554,000 working capital as of
December 31, 2008.
The increase in working capital during the nine months ended September
30, 2009, was primarily due to the financing closed on July 31, 2009.
The sale and issuance of 11,111,110 shares of common stock at a purchase
price of $2.70 per share resulted in net proceeds to the company of
approximately $28.4 million. Related warrants to purchase a total of
2,777,776 shares of common stock with an exercise price of $3.50 per
share will be exercisable beginning six months after issuance and will
expire six months from the date they are first exercisable.
The change in working capital is also due to the reclassification of
Auction Rate Securities (“ARS”) and related ARS Rights from long-term
assets to current assets due to the time frame in which they can be
readily convertible to cash and higher account receivables. We believe
our cash and cash equivalents are sufficient to meet our planned working
capital requirements through the second half of 2011.
Effective August 4, 2009, outstanding convertible subordinated
promissory notes were automatically converted into 4,600,681 shares of
Inovio’s common stock. Such shares are subject to a lock-up agreement
which provides that such shares may not be sold for a period of 180 days
following June 1, 2009, the date the Merger closed, provided that such
restriction lapsed with respect to 50% of such shares on the date that
is 90 days from the date the Merger closed.
The number of shares of Common Stock issued and outstanding was
102,128,323 as of November 12, 2009.
Corporate Update
Corporate Development
Inovio announced a research collaboration agreement with the National
Institutes of Health’s Vaccine Research Center (VRC) to develop
influenza vaccines. Under the agreement, the VRC and Inovio will pool
technologies to develop universal influenza vaccines as well as rapidly
advance development of vaccine candidates targeting the emerging
pandemic 2009 H1N1 swine flu strains.
Subsequent to the quarter, Inovio’s board of directors elected David J.
Williams, former chairman and CEO of Sanofi Pasteur, the vaccine
business of Sanofi-Aventis Group, and Keith H. Wells, a senior member of
the Biologics Consulting Group and former director of vaccine
development for The Salk Institute, to the board.
Vaccine Program Accomplishments, Status & Milestones
VGX-3100 Therapeutic Cervical Cancer DNA Vaccine
Inovio
announced on October 5th significant antibody and T-cell
responses from the first of three dose groups being evaluated in this
phase I clinical trial. These results were significant in providing the
first indication of the potential for Inovio’s DNA vaccine platform to
rival levels of immune responses generated by any DNA vaccine
technology. The company currently plans to report interim data relating
to safety and levels of immune responses (immunogenicity) from the
second and third dose groups in the first half of 2010. In addition,
Inovio currently plans to initiate a Phase II trial in late 2010.
VGX-3400 Avian Influenza (H5N1) DNA Vaccine
Our
clinical team is fulfilling information requests from the US Food & Drug
Administration (FDA) relating to our previously-filed investigational
new drug application (IND) and currently plans to initiate a US phase I
clinical trial in Q1 2010. These studies are expected to focus on safety
and immunogenicity.
Universal Influenza DNA Vaccine
Inovio reported
multiple sets of data from its universal influenza vaccine, which was
designed in 2006/2007, indicating its potential to provide broad
cross-strain protection against existing and newly emergent, unknown
seasonal and pandemic-potential influenza strains.
Multiple studies in a pig model showed the potential of Inovio’s
universal DNA vaccines to induce levels of hemagglutination inhibition
(HI) titers against multiple strains of H1N1 influenza, including
currently circulating strains of swine-origin influenza. The titer
levels achieved were above the protection threshold considered to be
protective against influenza infection in 100% of the animals tested.
Studies in a mouse model showed the potential of Inovio’s universal DNA
vaccines to provide 100% protection in a lethal challenge study against
an unmatched H1N1 virus that caused the 1918 Spanish flu. In a separate
study, the vaccinated mice recovered from virus infection-induced
morbidity significantly faster compared to the non-immunized control
mice when the mice were challenged with another currently circulating
swine influenza A/H1N1 virus.
A combination of Inovio’s synthetic consensus (SynConTM) H1N1
influenza vaccine candidates achieved protective antibody responses
against the novel pandemic influenza A/H1N1 (2009) in 100% of tested
ferrets. The ferret model is widely considered to be the most
representative of human influenza; achieving in ferrets a level of
antibody titers commonly associated with protection in humans is a
critical milestone in influenza vaccine development.
PENNVAXTM HIV DNA Vaccines
The
company’s partner, HIV Vaccines Trial Network (HVTN), completed
enrollment of 120 subjects in its phase I clinical study of Inovio’s
PENNVAXTM-B preventive HIV vaccine (against HIV clade
B, the prevalent HIV strain in North America and western Europe) without
electroporation. The company currently expects to report results of this
study by year end.
On October 15th, Inovio announced the initiation of a phase I
clinical study of Inovio’s PENNVAX™-B preventive DNA vaccine delivered
using its proprietary electroporation technology. The multi-center study
is being conducted at several HVTN clinical sites under a protocol
designated HVTN-080. The study is enrolling healthy volunteers to assess
safety of and levels of immune responses. The HVTN-080 follow-on study
is sponsored by the National Institute of Allergy and Infectious
Diseases (NIAID), an NIH agency.
In a third trial, initiated in 2009, Inovio’s collaborators at the
University of Pennsylvania began enrolling adult HIV-infected patients
undergoing therapy to assess the use of PENNVAX™-B DNA vaccine without
electroporation in a therapeutic setting.
The company continues to advance its pre-clinical work on PENNVAX™-GP
(against HIV clades A, C, and D, the prevalent strains in Africa and
Asia) as a preventive HIV vaccine. This work is funded by a contract
from the NIH’s National Institute of Allergy and Infectious Diseases
with a total potential value of about $23.5 million.
Other Vaccine Research & Development
Inovio
announced that its SynCon™ dengue virus DNA vaccine induced neutralizing
antibody responses against all four distinct serotypes of dengue viruses
that are transmitted to humans by mosquitoes. Currently there is no
commercially available vaccine or antiviral drug against dengue virus
infections. The results were published in Vaccine, July 3, 2009,
in a paper entitled, “Development of a novel DNA SynCon tetravalent
dengue vaccine that elicits immune responses against four serotypes.” We
believe this accomplishment highlighted the potential of Inovio’s
SynCon™ vaccine design approach to create DNA vaccines with universal
protective capability.
VGX-1027
The company’s small molecule
anti-inflammatory drug for rheumatoid arthritis and diabetes T1
completed a multiple ascending dose study in Q1 2009, marking the end of
the phase 1 trial. Inovio currently plans to seek opportunities to
license the drug to a third party that would continue the drug’s
development.
Partner Programs
PSMA Prostate Cancer DNA Vaccine
New
data generated by the University of Southampton and Institute of
Cancer Research in the U.K. were published in the medical journal, Human
Gene Therapy, July 20, 2009, in a paper entitled, “DNA vaccination
with electroporation induces increased antibody responses in patients
with prostate cancer.”
ChronVac® Hepatitis C Virus DNA Vaccine
Enrollment
has been completed in this phase I proof-of-concept study of Tripep’s
hepatitis C virus vaccine. Inovio currently expects to report additional
interim results before year end.
hTERT Cancer Vaccine
Merck continues to enroll
patients in its phase I clinical study of an hTERT DNA vaccine using
Inovio’s electroporation delivery technology against breast, lung, and
prostate cancers.
About Inovio Biomedical Corporation
Inovio Biomedical is focused on the design, development, and delivery of
a new generation of vaccines, called DNA vaccines, to prevent and treat
cancers and infectious diseases. The company’s SynCon™ technology
enables the design of “universal” vaccines capable of protecting against
multiple – including newly emergent, unknown – strains of pathogens such
as influenza. Inovio’s proprietary electroporation-based DNA vaccine
delivery technology has been shown by initial human data to safely and
significantly increase gene expression and immune responses. Inovio’s
clinical programs include HPV/cervical cancer (therapeutic) and HIV
vaccines. An IND has been filed for an avian influenza vaccine. Inovio
is developing its universal and avian influenza vaccines in
collaboration with scientists from the University of Pennsylvania, the
National Microbiology Laboratory of the Public Health Agency of Canada,
and the NIH’s Vaccine Research Center. Other partners and collaborators
include Merck, Tripep, University of Southampton, National Cancer
Institute, and HIV Vaccines Trial Network. More information is available
at www.inovio.com.
This press release contains, in addition to historical information,
forward-looking statements. Such statements are based on management’s
current estimates and expectations and are subject to a number of
uncertainties and risks that could cause actual results to differ
materially from those described in the forward-looking
statements. Inovio is providing this information as of the date of this
press release, and expressly disclaims any duty to update information
contained in this press release.
Forward-looking statements in this press release include, without
limitation, express and implied statements relating to Inovio’s
business, plans to develop electroporation-based drug and gene delivery
technologies and DNA vaccines, pre-clinical and clinical studies, financial
results and capital resources. Actual events or results may differ from
the expectations set forth herein as a result of a number of risks,
uncertainties and other factors, including but not limited to: Inovio
has a history of losses; all of Inovio’s potential human products are in
research and development phases; no revenues have been generated from
the sale of any such products, nor are any such revenues expected for at
least the next several years; Inovio’s product candidates will require
significant additional research and development efforts, including
extensive preclinical and clinical testing; uncertainties inherent in
clinical trials and product development programs, including but not
limited to the fact that pre-clinical and clinical results may not be
indicative of results achievable in other trials or for other
indications, that results from one study may not necessarily be
reflected or supported by the results of other similar studies, that
results from an animal study may not be indicative of results achievable
in human studies, that clinical testing is expensive and can take many
years to complete, that the outcome of any clinical trial is uncertain
and failure can occur at any time during the clinical trial process, and
that Inovio’s electroporation technology and DNA vaccines may fail to
show the desired safety and efficacy traits in clinical trials; all
product candidates that Inovio advances to clinical testing will require
regulatory approval prior to commercial use, and will require
significant costs for commercialization; the availability of funding;
the ability to manufacture vaccine candidates; the availability or
potential availability of alternative therapies or treatments for the
conditions targeted by Inovio or its collaborators, including
alternatives that may be more efficacious or cost-effective than any
therapy or treatment that Inovio and its collaborators hope to develop;
whether Inovio’s proprietary rights are enforceable or defensible or
infringe or allegedly infringe on rights of others or can withstand
claims of invalidity; and the impact of government healthcare proposals.
Readers are also referred to Inovio’s Annual Report on Form 10-K for
the year ended December 31, 2008 and its Quarterly Report on Form 10-Q
for the quarter ended September 30, 2009 filed with the Securities and
Exchange Commission which identify important risk factors that could
cause actual results to differ from those contained in the
forward-looking statements.
|
|
|
INOVIO BIOMEDICAL CORPORATION
CONDENSED CONSOLIDATED
BALANCE SHEETS
|
|
|
|
|
|
September 30,
2009
|
|
December 31,
2008
|
|
|
|
(Unaudited)
|
|
|
|
ASSETS
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
32,509,245
|
|
$
|
14,115,281
|
|
|
Short-term investments
|
|
10,420,338
|
|
—
|
|
|
Auction rate security rights
|
|
3,113,515
|
|
—
|
|
|
Accounts receivable
|
|
165,792
|
|
671,187
|
|
|
Accounts receivable from affiliated entity
|
|
1,172,953
|
|
—
|
|
|
Prepaid expenses and other current assets
|
|
464,923
|
|
477,285
|
|
|
Prepaid expenses and other current assets from affiliated entity
|
|
406,000
|
|
—
|
|
|
Inventory purchases from affiliated entity
|
|
177,969
|
|
—
|
|
|
|
|
|
|
|
|
Total current assets
|
|
48,430,735
|
|
15,263,753
|
|
|
|
|
|
|
|
|
Long-term investments
|
|
—
|
|
9,169,471
|
|
|
Auction rate security rights
|
|
—
|
|
4,281,494
|
|
|
Fixed assets, net
|
|
381,968
|
|
353,807
|
|
|
Intangible assets, net
|
|
13,453,379
|
|
5,850,540
|
|
|
Goodwill
|
|
10,113,371
|
|
3,900,713
|
|
|
Investment in affiliated entity
|
|
17,771,019
|
|
—
|
|
|
Other assets
|
|
287,147
|
|
167,250
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
90,437,619
|
|
$
|
38,987,028
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
Accounts payable and accrued expenses
|
|
$
|
2,641,728
|
|
$
|
1,367,300
|
|
|
Accounts payable due to affiliated entity
|
|
593,668
|
|
—
|
|
|
Accrued clinical trial expenses
|
|
310,506
|
|
399,919
|
|
|
Line of credit
|
|
12,111,660
|
|
12,109,423
|
|
|
Common stock warrants
|
|
4,720,984
|
|
224,582
|
|
|
Deferred revenue
|
|
865,077
|
|
523,544
|
|
|
Deferred rent
|
|
2,687
|
|
84,814
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
21,246,310
|
|
14,709,582
|
|
|
|
|
|
|
|
|
Deferred revenue, net of current portion
|
|
92,385
|
|
4,269,151
|
|
|
Deferred rent, net of current portion
|
|
74,619
|
|
14,898
|
|
|
Deferred tax liabilities
|
|
840,000
|
|
887,250
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
22,253,314
|
|
19,880,881
|
|
|
|
|
|
|
|
|
Inovio Biomedical Corporation Stockholders’ equity:
|
|
|
|
|
|
Common stock
|
|
102,120
|
|
44,022
|
|
|
Additional paid-in capital
|
|
237,221,749
|
|
171,868,914
|
|
|
Accumulated deficit
|
|
(169,878,565
|
)
|
(152,812,948
|
)
|
|
Stockholder note receivable
|
|
(800
|
)
|
—
|
|
|
Accumulated other comprehensive income
|
|
86,921
|
|
6,159
|
|
|
|
|
|
|
|
|
Total Inovio Biomedical Corporation stockholders’ equity
|
|
67,531,425
|
|
19,106,147
|
|
|
|
|
|
|
|
|
Non-controlling interest
|
|
652,880
|
|
—
|
|
|
|
|
|
|
|
|
Total stockholders’ equity
|
|
68,184,305
|
|
19,106,147
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity
|
|
$
|
90,437,619
|
|
$
|
38,987,028
|
|
|
|
|
INOVIO BIOMEDICAL CORPORATION
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(Unaudited)
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
|
2009
|
|
2008
|
|
2009
|
|
2008
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
License fee and milestone payments
|
|
$
|
2,143,239
|
|
|
$
|
214,825
|
|
|
$
|
4,631,711
|
|
|
$
|
611,578
|
|
|
Revenue under collaborative research and development arrangements
|
|
32,885
|
|
|
239,912
|
|
|
120,227
|
|
|
1,159,207
|
|
|
Grant and miscellaneous revenue
|
|
1,470,337
|
|
|
—
|
|
|
1,755,562
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue
|
|
3,646,461
|
|
|
454,737
|
|
|
6,507,500
|
|
|
1,770,785
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
3,412,130
|
|
|
1,274,387
|
|
|
5,557,057
|
|
|
4,551,039
|
|
|
General and administrative
|
|
3,830,703
|
|
|
1,928,928
|
|
|
11,097,617
|
|
|
7,416,613
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
7,242,833
|
|
|
3,203,315
|
|
|
16,654,674
|
|
|
11,967,652
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
(3,596,372
|
)
|
|
(2,748,578
|
)
|
|
(10,147,174
|
)
|
|
(10,196,867
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
Interest (expense)/income, net
|
|
(26,620
|
)
|
|
97,008
|
|
|
(22,903
|
)
|
|
587,128
|
|
|
Other (expense)/income, net
|
|
(2,903,174
|
)
|
|
307,162
|
|
|
(3,108,570
|
)
|
|
219,850
|
|
|
Gain/(loss) from investment in affiliated entity
|
|
3,564,283
|
|
|
—
|
|
|
(3,804,397
|
)
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss from operations
|
|
(2,961,883
|
)
|
|
(2,344,408
|
)
|
|
(17,083,044
|
)
|
|
(9,389,889
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to non-controlling interest
|
|
13,697
|
|
|
—
|
|
|
17,427
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to Inovio Biomedical Corporation
|
|
$
|
(2,948,186
|
)
|
|
$
|
(2,344,408
|
)
|
|
$
|
(17,065,617
|
)
|
|
$
|
(9,389,889
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Loss per common share — basic and diluted:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share attributable to Inovio Biomedical Corporation
stockholders
|
|
$
|
(0.03
|
)
|
|
$
|
(0.05
|
)
|
|
$
|
(0.26
|
)
|
|
$
|
(0.21
|
)
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares
outstanding
— basic and diluted
|
|
93,909,945
|
|
|
43,929,654
|
|
|
65,415,951
|
|
|
43,881,047
|
|
Contacts
Inovio Biomedical
Bernie Hertel, 858-410-3101 (Investors)
or
Richardson
& Associates
Jeff Richardson, 805-491-8313 (Media)