Inovio Pharmaceuticals, Inc. (Nasdaq:INO) today reported financial
results for the quarter ended March 31, 2015.
Total revenue was $5.2 million for the three months ended March
31, 2015, compared to $2.4 million for the same period in 2014.
Total operating expenses were $13.5 million compared to $12.4
million.
The net loss attributable to common stockholders for the quarter
ended March 31, 2015, was $10.6 million, or $0.17 per share,
compared to $10.8 million, or $0.20 per share, for the quarter
ended March 31, 2014.
Revenue
The increase in revenue was primarily due to payments received
from Roche under our partnership agreement established in September
2013.
Operating Expenses
Research and development expenses for Q1 2015 were $9.4 million
compared to $8.2 million for Q1 2014. The increase in R&D
expenses was generally related to increased investment in all our
product development programs. General and administrative expenses
were $4.1 million for Q1 2015 versus $4.1 million for Q1 2014.
Capital Resources
As of March 31, 2015 cash and cash equivalents and short-term
investments were $81.0 million compared with $93.6 million as of
December 31, 2014. At quarter end the company had 60.7 million
shares outstanding and 67.8 million fully diluted.
On May 5, 2015, the Company closed an underwritten public
offering of 10,925,000 shares of the Company's common stock,
including 1,425,000 shares of common stock issued pursuant to the
underwriter's exercise of its option, at the public offering price
of $8.00 per share. The gross proceeds of this offering
were $87.4 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 $82.1 million.
We intend to use the net proceeds received from the sale of our
common stock for general corporate purposes, including clinical
trial expenses, research and development expenses, general and
administrative expenses, manufacturing expenses and potential
acquisitions of companies and technologies that complement our
business.
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,
including the cost of its planned phase III clinical trial of
VGX-3100, through the end of 2018.
Inovio's balance sheet and statement of operations are provided
below. Form 10-Q providing the complete 2015 first quarter
financial report can be found at:
http://ir.inovio.com/secfilings.
Corporate Update
Clinical Development
Detailed study findings from our phase II study of VGX-3100 in
patients with high-grade cervical dysplasia have been submitted in
a manuscript for peer review with the goal of publication in a
medical journal. In this study we achieved our primary and
secondary endpoints, with statistical significance in regressing
high grade cervical dysplasia from CIN2/3 to CIN1 or no disease and
clearing HPV. Robust and durable T-cell activity was detected in
subjects who received VGX-3100 compared to those who received
placebo. There were no serious adverse events.
We are preparing to launch a phase III registration study of
VGX-3100 in early 2016. Necessary steps include scaling up
commercial-level production of our immunotherapy product and
delivery devices, and completing an end-of-phase-II meeting with
the FDA.
As part of our expanding franchise targeting all HPV-associated
precancers and cancers, we reported preliminary data from our first
cancer study, a head & neck cancer trial, showing that INO-3112
(VGX-3100 plus Inovio's IL-12 based immune activator) generated
strong CD8+ T cell responses in 3 of 4 patients.
We received regulatory approval to initiate a phase I study of
our prostate cancer DNA immunotherapy, INO-5150, targeting
prostate-specific membrane antigen and prostate-specific antigen.
We intend to begin enrolling patients in 2Q 2015.
We initiated with our partner Roche a phase I trial for our
hepatitis B immunotherapy, INO-1800. This randomized, open-label,
active-controlled, dose escalation study is evaluating the safety,
tolerability, and immunogenicity of Inovio's hepatitis B
immunotherapy alone or in combination with Inovio's IL-12-based
immune activator.
With collaborators under a DARPA-funded project (see Corporate
Development below), we expect to start a phase I study of our Ebola
immunotherapy, INO-4212, in 2Q 2015. Inovio published data in 2013
showing 100% protection of animals immunized with our Ebola DNA
immunotherapy.
We reported that in a 12-patient phase I study our single-clade
PENNVAX®-B HIV immunotherapy induced in HIV-infected patients CD8+
T cells with functional characteristics similar to those of
long-term non-progressors (rare HIV-infected individuals who,
without treatment, do not progress to further stages of the
disease): "Synthetic consensus HIV-1 DNA induces potent cellular
immune responses and synthesis of granzyme B, perforin in HIV
infected individuals," Molecular Therapy. Building on these data,
we created our global, multi-clade PENNVAX®-GP preventive and
therapeutic HIV DNA immunotherapy candidate with funding via a $25
million NIH contract. We expect the HVTN to initiate a phase I
study of PENNVAX®-GP in 2Q 2015.
Our phase I/IIa studies of INO-3112 in head & neck and
cervical cancers; INO-1400 (hTERT antigen) in breast, lung or
pancreatic cancer patients; and INO-8000, targeting hepatitis C
virus genotypes 1a and 1b, in collaboration with GeneOne Life
Sciences, Inc., are ongoing.
Corporate Development
The initiation of the phase I trial for Inovio's hepatitis B
multi-antigen DNA immunotherapy, INO-1800, triggered a $3 million
milestone payment from Roche, which exclusively licensed this
product in 2013.
The National Institute of Allergy and Infectious Diseases
(NIAID) awarded Inovio and its collaborators (University of
Pennsylvania (primary), Emory University, Duke University,
University of Massachusetts, VGXi, and Waisman Biomanufacturing) a
five-year $16 million Integrated Preclinical/Clinical AIDS Vaccine
Development Program to expand the coverage of Inovio's PENNVAX HIV
vaccine to additional HIV strains and advance new technologies to
further improve vaccination outcomes.
Under an award worth potentially $45 million from the Defense
Advanced Research Projects Agency (DARPA), Inovio (primary) is
collaborating with MedImmune as well as GeneOne Life Sciences and
its manufacturing subsidiary, VGXI, Inc., University of
Pennsylvania, Emory University and Vanderbilt University to advance
multiple treatment and prevention approaches against Ebola. These
approaches include Inovio's therapeutic DNA-based monoclonal
antibody technology, MedImmune's protein-based therapeutic
monoclonal antibodies, and Inovio's DNA-based vaccines. This award
follows on a $12.2 million DARPA grant awarded last September under
which Inovio, MedImmune, and scientists from the University of
Pennsylvania (primary) are collaborating to develop and assess
DNA-based monoclonal antibodies for influenza and antibiotic
resistant bacteria.
For the third consecutive year, Inovio was recognized by
industry peers at the World Vaccine Congress for "Best
Therapeutic Vaccine" for its DNA-based immunotherapy, VGX-3100. In
addition, the laboratory of Dr. David B. Weiner, Chair of
Inovio's Scientific Advisory Board and Professor of
Pathology and Laboratory Medicine at The Perelman School of
Medicine at the University of Pennsylvania, was awarded
"Best Academic Research Team." Through Inovio's license agreement
with the University of Pennsylvania, Dr. Weiner's laboratory is
advancing DNA immunotherapy technology and products that form the
foundation of Inovio's product portfolio.
Inovio continues its corporate development efforts to secure
grants, collaborations, and partnerships to help advance its
SynCon® immunotherapy and vaccine products.
About Inovio Pharmaceuticals, Inc.
Inovio is revolutionizing the fight against cancer and
infectious diseases. Our immunotherapies uniquely activate
best-in-class immune responses to prevent and treat disease, and
have shown clinically significant efficacy 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 Roche,
MedImmune, University of Pennsylvania, DARPA, 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, 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, including INO-5150, and
to commence a phase I clinical trial for INO-5150 in the first half
of 2015, 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 March 31, 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 |
|
|
|
|
March 31, 2015 |
December 31,
2014 |
|
(Unaudited) |
|
ASSETS |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$26,145,723 |
$40,543,982 |
Short-term investments |
54,866,570 |
53,075,974 |
Accounts receivable |
3,299,584 |
2,804,207 |
Prepaid expenses and other current
assets |
657,664 |
797,973 |
Prepaid expenses and other current assets
from affiliated entity |
2,017,465 |
1,382,375 |
Deferred tax asset |
342,573 |
342,573 |
Total current assets |
87,329,579 |
98,947,084 |
Fixed assets, net |
4,946,951 |
4,583,204 |
Investment in affiliated entity |
9,988,502 |
12,340,811 |
Intangible assets, net |
4,552,574 |
4,776,059 |
Goodwill |
10,113,371 |
10,113,371 |
Common stock warrants |
259,000 |
550,000 |
Other assets |
665,220 |
474,568 |
Total assets |
$117,855,197 |
$131,785,097 |
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
Current liabilities: |
|
|
Accounts payable and accrued expenses |
$4,445,074 |
$6,383,170 |
Accounts payable and accrued expenses due to
affiliated entity |
5,000 |
28,407 |
Accrued clinical trial expenses |
1,266,885 |
2,007,432 |
Common stock warrants |
1,732,956 |
2,022,729 |
Deferred revenue |
193,089 |
3,187,223 |
Deferred revenue from affiliated entity |
376,042 |
394,791 |
Deferred rent |
139,842 |
— |
Total current
liabilities |
8,158,888 |
14,023,752 |
Deferred revenue, net of current portion |
329,777 |
173,779 |
Deferred revenue from affiliated entity, net
of current portion |
742,944 |
836,694 |
Deferred rent, net of current portion |
4,693,493 |
4,709,229 |
Deferred tax liabilities |
504,049 |
504,049 |
Total liabilities |
14,429,151 |
20,247,503 |
Inovio Pharmaceuticals, Inc.
stockholders' equity: |
|
|
Common stock |
60,741 |
60,741 |
Additional paid-in capital |
445,739,370 |
443,327,915 |
Accumulated deficit |
(342,492,069) |
(331,910,290) |
Accumulated other comprehensive loss |
(191,522) |
(251,390) |
Total Inovio Pharmaceuticals, Inc.
stockholders' equity |
103,116,520 |
111,226,976 |
Non-controlling interest |
309,526 |
310,618 |
Total stockholders' equity |
103,426,046 |
111,537,594 |
Total liabilities and stockholders'
equity |
$117,855,197 |
$131,785,097 |
Inovio Pharmaceuticals,
Inc. |
CONSOLIDATED STATEMENTS
OF OPERATIONS |
(Unaudited) |
|
|
|
Three Months
Ended March 31, |
|
2015 |
2014 |
Revenues: |
|
|
Revenue under collaborative research and
development arrangements |
$4,245,571 |
$1,435,727 |
Revenue under collaborative research and
development arrangements with affiliated entity |
112,500 |
116,964 |
Grants and miscellaneous revenue |
808,566 |
804,952 |
Total revenues |
5,166,637 |
2,357,643 |
Operating expenses: |
|
|
Research and development |
9,426,320 |
8,225,480 |
General and administrative |
4,107,928 |
4,132,218 |
Total operating
expenses |
13,534,248 |
12,357,698 |
Loss from operations |
(8,367,611) |
(10,000,055) |
Other income (expense): |
|
|
Interest and other income, net |
138,276 |
52,076 |
Change in fair value of common stock
warrants |
(1,227) |
(505,926) |
Loss on investment in affiliated entity |
(2,352,309) |
(376,963) |
Net loss |
(10,582,871) |
(10,830,868) |
Net loss attributable to non-controlling
interest |
1,092 |
9,408 |
Net loss attributable to Inovio
Pharmaceuticals, Inc. |
$(10,581,779) |
$(10,821,460) |
Net loss per common share
attributable to Inovio Pharmaceuticals, Inc.
stockholders: |
|
|
Basic |
$(0.17) |
$(0.20) |
Diluted |
$(0.18) |
$(0.20) |
Weighted average number of common
shares outstanding used in per share calculations: |
|
|
Basic |
60,741,082 |
55,159,002 |
Diluted |
60,913,423 |
55,159,002 |
CONTACT: 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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