PLYMOUTH MEETING, Pa.,
Aug. 9, 2021 /PRNewswire/ -- INOVIO
(NASDAQ:INO), a biotechnology company focused on rapidly bringing
to market precisely designed DNA medicines to treat and protect
people from infectious diseases, cancer, and HPV-associated
diseases, today reported financial results for the quarter ended
June 30, 2021. INOVIO's management
will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss financial
results and provide a general business update. The business update
includes INOVIO's COVID-19 vaccine development efforts that address
both current and future variants of concern ("VOC"), accompanied
with recent developments associated with INOVIO's various
therapeutic programs relating to its DNA medicines platform. The
live webcast and replay may be accessed by visiting INOVIO's
website at
http://ir.inovio.com/events-and-presentations/default.aspx.
Dr. J. Joseph Kim, President and
CEO of INOVIO, said, "With COVID-19 rates surging again globally
and an increasing number of breakthrough infections, INOVIO
recognizes the need for additional safe and effective first-line
vaccines, particularly those which could offer potential boosting
capabilities, to combat the spread of the virus and emerging
variants, including the rapidly spreading delta variant. INO-4800's
ability to generate CD8 T cells are important to mitigating against
variants of concern, including the delta variant. Findings from a
study using clinical samples showed that INO-4800 maintained a
robust T cell level against the delta variant when compared to
T-cell responses from the original wildtype strain. These findings
further complement our previously published Phase 1 and 2
trial data for INO-4800. As a reminder, the key advantages of
INOVIO's DNA medicines platform include the ability to generate a
balanced immune response that includes engagement of both T cells
and B cells, coupled with a favorable transport, thermostability,
and tolerability profile. These advantages continue to be integral
to our ongoing discussions with countries expected to participate
in the global INNOVATE Phase 3 trial for INO-4800, some of which
are also considering INO-4800 for both clinical trials and the
eventual emergency use authorization (EUA)."
Dr. Kim continued, "In parallel with our global INNOVATE Phase 3
trial, we continue to prepare INOVIO's next-generation, pan-COVID
vaccine candidate, INO-4802, in a Phase 1/2 trial entitled IMPACT
(INOVIO INO-4802 Multi-variant
Pan-COVID-19 Vaccine Trial), where the goal is
to induce cross-reactive immune responses against current and
emerging viral variants as either a first-line vaccine, or as a
boost."
INOVIO Key Updates & Second Quarter 2021
Highlights
Key Updates
- INOVIO expanded its partnership with Advaccine
Biopharmaceuticals Suzhou Co., Ltd. ("Advaccine") to jointly
conduct the global Phase 3 segment of the ongoing Phase 2/3 trial
called INNOVATE (INOVIO INO-4800 Vaccine
Trial for Efficacy) in multiple countries.
- Subsequent to the quarter end, INOVIO and Advaccine received
regulatory allowance to conduct two clinical trials in China investigating heterologous boosting with
INO-4800 through partner and trial-sponsor Advaccine, together with
Sinovac Biotechnology ("Sinovac"). The studies will evaluate the
safety and efficacy of heterologous prime-boost sequential
immunizations using INO-4800 and CoronaVac®, an
inactivated virus COVID-19 vaccine developed by Sinovac and
validated by the World Health Organization (WHO) for emergency
use.
- INO-4800 vaccination maintained a similar level of T cell
responses against the delta variant when compared to the T cell
responses to the original wildtype strain and showed a similar
level of reduced neutralizing antibody activity against the delta
variant by the mRNA vaccines. These findings build on previously
published results showing that INO-4800 provided broad,
cross-reactive immune responses in humans against alpha, beta and
gamma VOC.
- INOVIO published pre-clinical data as a pre-print for INO-4802
demonstrating cross-reactive immune responses against current and
emerging viral variants that shows the potential INOVIO's
next-generation, pan-COVID-19 vaccine candidate, as either a
first-line vaccine or potentially as a booster for individuals
previously immunized with various wildtype-matched vaccines.
INO-4802 induced potent neutralizing antibodies, T cell responses,
and protection in a pre-clinical model against the original
wildtype strain as well as against the alpha, beta, gamma and, in
subsequent research, the delta variant.
- Subsequent to the quarter end, INOVIO dosed the first subject
in its Phase 2 clinical trial for INO-4700, its DNA vaccine
candidate for Middle East Respiratory Syndrome ("MERS"), a disease
in the coronavirus family for which there are no approved vaccines.
The study, which is sponsored by INOVIO and funded by the Coalition
for Epidemic Preparedness Innovations ("CEPI"), is evaluating the
safety, tolerability and immunogenicity of INO-4700 in
approximately 500 healthy adult volunteers in Jordan and Lebanon.
- In 2Q 2021, the University of
Pennsylvania enrolled its first patient in a Phase
1b investigator-sponsored trial of
INOVIO's DNA vaccine candidate INO-5401 alone or INO-5401 in
combination with INO-9012 delivered with INOVIO's
CELLECTRA® smart device, in adult cancer and non-cancer
patients with BRCA1 or BRCA2 mutations.
INOVIO Second Quarter 2021 Program Updates
DNA Vaccine Candidates
INO-4800: INNOVATE Phase 3 Trial
INOVIO expanded its partnership with Advaccine to jointly
conduct a global Phase 3 trial for INO-4800. Under the terms of the
collaboration, INOVIO and Advaccine intend to share equally,
subject to specified limitations and conditions, the total cost of
the planned global Phase 3 trial, which is estimated to be
approximately $100 million. This is
an extension of an existing relationship between the two companies,
including an exclusive agreement announced in January 2021 under which Advaccine has the
exclusive rights to develop, manufacture and commercialize INO-4800
within Greater China, inclusive of
mainland China, Hong Kong, Macao and Taiwan. Under the expanded partnership,
Advaccine obtained rights to additional Asian countries outside of
Greater China. The companies
intend to evaluate the safety and efficacy of INO-4800 in a
two-dose regimen (2.0 mg), administered one month apart, in a
two-to-one randomization in healthy men and non-pregnant women 18
years and older across several countries, with a focus on
Latin America, Asia and Africa. The 2.0 mg dose was selected from the
Phase 2 segment, where INO-4800 was shown to be generally
well-tolerated and immunogenic across all adult age groups. In
particular, the geometric mean fold rise of binding and
neutralizing antibody levels was statistically significant and
greater in the 2.0 mg dose group versus the 1.0 mg dose group.
Notably, the T cell immune responses measured by the ELISpot assay
were also higher in the 2.0 mg dose group as compared to the 1.0 mg
dose group. The primary endpoint of the Phase 3 segment will be
virologically confirmed COVID-19 cases, and INOVIO anticipates the
first regulatory approval next month.
During the second quarter of 2021, INOVIO released as a
pre-print results from a study using clinical samples showing that
INO-4800 provided broad cross-reactive immune responses in humans
against VOC. The study showed the T cell responses induced by
INO-4800 vaccination were fully maintained against the alpha, beta,
and gamma variants when compared to the T cell responses to the
original wildtype strain. Despite recent reports showing a
reduction in neutralizing activity against the gamma variant by the
mRNA or viral vector vaccines, INO-4800 generated robust
neutralizing antibodies at levels against the gamma variant that
were comparable to those observed against the wildtype strain.
Taken together with the data showing the maintenance of T cell
activity, the results reported in this study provide a
comprehensive overview of cross-reactive cellular and humoral
immune responses against SARS-CoV-2 variants for INO-4800
vaccinated individuals, showing the potential of INO-4800 to combat
emerging as well as future variants of concern. The study,
entitled, "INO-4800 DNA Vaccine Induces T Cell Activity and
Neutralizing Antibodies Against Global SARS-CoV-2 Variants," is
available via pre-print in bioRxiv.
Subsequent to this published work, INO-4800 vaccination was also
found to maintain a similar level of T cell responses against the
delta variant when compared to the T cell responses to the original
wildtype strain, while it showed a similar level of reduced
neutralizing antibody activity against the delta variant by the
mRNA vaccines.
INOVIO continues to evaluate and assess the impact the new
circulating strains of SARS-CoV-2 have on the immune profile
elicited by INO-4800, as well as assessing boosting capabilities of
INO-4800.
INO-4800: Heterologous Prime-Boost Trials
This morning, INOVIO announced the regulatory allowance in
China to conduct two clinical
trials investigating heterologous boosting with INO-4800 through
its partner and trial-sponsor Advaccine, together with Sinovac. The
trials will evaluate the safety and efficacy of heterologous
prime-boost sequential immunizations using INO-4800 and
CoronaVac®, an inactivated virus COVID-19 vaccine
developed by Sinovac and validated by the WHO for emergency use.
China's Center for Drug Evaluation
of the National Medical Products Administration has allowed two
Advaccine-sponsored open-label, positive-control trials to evaluate
the safety, tolerability and immunogenicity of mixed boosted
regimens. Both studies, which will be conducted in China, are anticipated to begin this fall and
will involve healthy adult subjects 18 years of age or older.
INOVIO, Advaccine, and Sinovac have completed cross prime-boost
pre-clinical animal tests using INO-4800 and CoronaVac®,
demonstrating that the prime-boost strategy can stimulate
high-level of antigen specific binding antibodies, neutralizing
antibodies by both live-virus neutralization assay and hACE2
receptor blocking assay, and antigen-specific T cell immune
response.
IMPACT (INOVIO INO-4802 Multi-variant
Pan-COVID-19 Vaccine Trial):
In parallel with INO-4800, INOVIO is also developing a second
generation, pan-COVID vaccine candidate, INO-4802, which is
designed to protect against current and future VOC. INO-4802 could
potentially offer boosting capabilities in addition to an initial
vaccination regimen with INO-4800 and/or other first-generation
vaccines, including both adenovirus and
mRNA-based platforms.
In 2Q and then updated subsequent to the quarter, INOVIO
released a manuscript as a preprint in bioRxiv
entitled, "Design and Immunogenicity of a Pan-SARS-CoV-2 Synthetic
DNA Vaccine," which demonstrated cross-reactive immune responses
against current and emerging viral variants using INOVIO's
next-generation pan-COVID-19 vaccine candidate, INO-4802, as either
a first-line vaccine, or potentially as a booster for individuals
previously immunized with various wildtype-matched vaccines.
Specifically, INO-4802 generated potent neutralizing antibodies, T
cell responses, and protection in a preclinical model against the
original wildtype strain as well as against the alpha, beta, gamma
and delta variants.
Infectious Diseases: Middle East Respiratory Syndrome ("MERS")
and Lassa Fever
INOVIO dosed the first subject in its Phase 2 clinical trial for
INO-4700, its DNA vaccine candidate for MERS. MERS, which currently
has no approved vaccine, is a coronavirus that is about 100 times
deadlier than COVID-19 and fatal to approximately 34% of those
infected.
The Phase 2 trial is being conducted at sites in Jordan and Lebanon, where MERS cases have been reported.
The randomized, double-blinded, placebo-controlled, multi-center
trial, which is sponsored by INOVIO and funded by CEPI, evaluates
the safety, tolerability and immunogenicity of INO-4700
administered using INOVIO's CELLECTRA® smart device
in approximately 500 healthy adult volunteers.
INOVIO's pursuit of a MERS vaccine is funded by a previously
announced $56 million grant from
CEPI, under which INOVIO will develop vaccine candidates through
Phase 2 against MERS and Lassa fever. INOVIO and CEPI plan to
pursue a stockpile of MERS vaccines available for emergency use as
soon as possible following Phase 2 testing.
Subsequent to the quarter end, CEPI announced in July 2021 that it is providing $10.3 million in funding to partners in
Benin, Guinea, Liberia, and Sierra
Leone to participate in the epidemiological research program
entitled Enable, which will enroll up to 23,000
participants, including in Nigeria, which began collecting participant
data in December 2020. The
Enable study aims to better understand the rate, location,
and spread of Lassa virus across the region. CEPI has supported the
development of six Lassa vaccine candidates, including INOVIO's
INO-4500. INO-4500 is the first Lassa vaccine candidate to enter
Phase 1 trial in the U.S., and in the first quarter INOVIO dosed
the first subject in a Phase 1b
clinical trial for INO-4500 in Africa. It remains INOVIO's and CEPI's goal to
making INO-4500 available for possible emergency use as a stockpile
product after successful completion of the Phase 2 trial.
HPV-related Diseases
VGX-3100: Cervical, Vulvar, and Anal HSIL
REVEAL 1 / REVEAL 2 (Cervical HSIL)
INOVIO continues to follow subjects in REVEAL 1
(Randomized Evaluation of VGX-3100 and
Electroporation for the treatment of Cervical HSIL),
a Phase 3 pivotal trial evaluating VGX-3100 for the treatment of
cervical high-grade squamous intraepithelial lesions caused by
HPV-16 and/or HPV-18, for safety and durability of response for 18
months following the last administration. INOVIO expects to present
its findings at a scientific meeting later this
year and anticipates full subject-level unblinding for
REVEAL 1 in the second half of 2021, which is expected to
facilitate better analysis of individual, patient-level data.
Additionally, INOVIO is continuing its partnership with QIAGEN
to co-develop an in-vitro diagnostic based on RNA sequencing
technology to guide clinical decision-making for the use of
VGX-3100 in cervical HSIL. INOVIO expects to report QIAGEN's
findings later this year.
REVEAL 2 continues to enroll across 48 sites globally, with
projected total enrollment of approximately 198 adult women with
histologically confirmed cervical HSIL. Participants will be
evaluated for evidence of cervical HSIL on histology as well as
evidence of HPV-16 and/or HPV-18 in cervical samples by
type-specific HPV testing at the Week 36 visit accompanied with a
one-month safety follow-up.
Immuno-oncology
INO-5401
Glioblastoma Multiforme
INOVIO, along with Regeneron, continues to evaluate its findings
from the Phase 1/2 novel combination trial of DNA medicines
INO-5401 and INO-9012 in combination with PD-1 inhibitor
Libtayo® (cemiplimab) – which is being jointly
developed by Regeneron and Sanofi – for the treatment of newly
diagnosed Glioblastoma Multiforme ("GBM"). The companies anticipate
sharing two-year (24 months) overall survival data, including
correlative immunology and tissue data, at an oncology conference
in the fourth quarter of 2021.
Breast Cancer
Separately, the University of
Pennsylvania enrolled its first patient in a Phase
1b investigator-sponsored study of
INO-5401 alone or INO-5401 in combination with INO-9012 delivered
with INOVIO's CELLECTRA® smart device in adult
cancer and non-cancer patients with BRCA1 or BRCA2 mutations. This
study, which is being conducted at the University of Pennsylvania, will enroll
approximately 44 subjects and will test INO-5401, which contains
genes that are active in human cancers (hTERT, PSMA, and WT1) and
are believed to be good targets for the immune system for both
individuals with cancer or at increased risk of getting cancer.
ClinicalTrials.gov identifier: NCT04367675
Manufacturing
Update on Global Manufacturing Consortium
Thermo Fisher, a member of
INOVIO's global manufacturing consortium, announced in July that it
opened a new cGMP plasmid DNA manufacturing facility in
Carlsbad, California with INOVIO
as its first client. The new facility enables Thermo Fisher and its partners to meet
anticipated demand for plasmid DNA and other nucleic-acid based
therapies.
Second Quarter 2021 Financial Results
Total revenue was $273,000 for the
three months ended June 30, 2021,
compared to $267,000 for the same
period in 2020. Total operating expenses were $83.5 million compared to $33.4 million for the same period in 2020.
INOVIO's net loss for the three months ended June 30, 2021
was $82.1 million, or $0.39 per basic and diluted share, compared to
net loss of $128.7 million, or
$0.83 per basic and diluted share,
for the three months ended June 30, 2020.
Operating Expenses
Research and development ("R&D") expenses for the three
months ended June 30, 2021, were
$70.8 million compared to
$22.4 million for the same period in
2020. The increase in R&D expenses was primarily attributable
to manufacturing scale-up activities for INO-4800. These INO-4800
activities included the acquisition and installation of
manufacturing equipment, drug manufacturing, outside services and
clinical study expenses. Other increases included engineering
services and expensed equipment related to our
CELLECTRA® 3PSP device array automation project,
employee and contractor compensation and drug manufacturing
expenses related to our RRP trial. These increases were offset by
an increase in contra-research and development expense recorded
from grant agreements of $8.1
million, among other variances.
General and administrative ("G&A") expenses were
$12.7 million for the three months
ended June 30, 2021, compared to
$11.1 million for the same period in
2020. The increase in G&A expenses was primarily related to an
increase in employee compensation, including non-cash stock-based
compensation, partially offset by lower expenses for work performed
related to corporate marketing and communications, among other
variances.
Capital Resources
As of June 30, 2021, cash and cash equivalents and
short-term investments were $443.7
million compared to $411.6
million as of December 31, 2020. As of June 30,
2021, INOVIO had 210.1 million common shares outstanding and 226.7
million common shares outstanding on a fully diluted basis, after
giving effect to the exercise, vesting and conversion, as
applicable, of its outstanding options, restricted stock units,
convertible preferred stock and convertible debt.
INOVIO's balance sheet and statement of operations are provided
below. Additional information is included in INOVIO's quarterly
report on Form 10-Q for the three months ended June 30, 2021,
which can be accessed at:
http://ir.inovio.com/financials/default.aspx.
Conference Call / Webcast Information
INOVIO's management will host a live conference call and webcast
at 4:30 p.m. Eastern Time today to
discuss INOVIO's financial results and provide a general business
update.
The live webcast and a replay may be accessed by visiting
INOVIO's website at
http://ir.inovio.com/events-and-presentations/default.aspx.
About INOVIO's DNA Medicines Platform
INOVIO has 15 DNA medicine clinical programs currently in
development focused on HPV-associated diseases, cancer, and
infectious diseases, including coronaviruses associated with
COVID-19 and MERS. DNA medicines are composed of optimized DNA
plasmids, which are small circles of double-stranded DNA that are
synthesized or reorganized by a computer sequencing technology and
designed to produce a specific immune response in the body.
INOVIO's DNA medicines deliver optimized plasmids directly into
cells intramuscularly or intradermally using INOVIO's proprietary
hand-held smart device called CELLECTRA®. The
CELLECTRA® device uses a brief electrical pulse to
reversibly open small pores in the cell to allow the plasmids to
enter, which is designed to overcome a key limitation of other DNA
and other nucleic acid approaches, such as mRNA. Once inside the
cell, the DNA plasmids enable the cell to produce the targeted
antigen. The antigen is processed naturally in the cell and
triggers the desired T cell and antibody-mediated immune responses.
Administration with the CELLECTRA® device is designed to
ensure that the DNA medicine is efficiently delivered directly into
the body's cells, where it can go to work to drive an immune
response. INOVIO's DNA medicines do not interfere with or change in
any way an individual's own DNA. The advantages of INOVIO's DNA
medicine platform are how fast DNA medicines can be designed and
manufactured; the stability of the products, which do not require
freezing in storage and transport; and the robust immune response,
safety profile, and tolerability that have been observed in
clinical trials.
With more than 3,000 patients receiving INOVIO investigational
DNA medicines in more than 7,000 applications across a range of
clinical trials, INOVIO has a strong track record of rapidly
generating DNA medicine candidates with potential to meet urgent
global health needs.
About INOVIO
INOVIO is a biotechnology company focused on rapidly bringing to
market precisely designed DNA medicines to treat and protect people
from infectious diseases, cancer, and diseases associated with HPV.
INOVIO is the first and only company to have clinically
demonstrated that a DNA medicine can be delivered directly into
cells in the body via a proprietary smart device to produce a
robust and tolerable immune response. Specifically, INOVIO's lead
candidate VGX-3100 met primary and secondary endpoints for all
evaluable subjects in REVEAL 1, in the first of two Phase 3 trials
for precancerous cervical dysplasia, demonstrating ability to
destroy and clear both high-grade cervical lesions and the
underlying high-risk HPV 16 and 18. INOVIO is also evaluating
INO-4800, a DNA vaccine candidate against COVID-19, in a Phase 2
clinical trial in the United
States, as well as Phase 2 trials in China and South
Korea. Partners and collaborators include Advaccine,
ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates
Foundation, Coalition for Epidemic Preparedness Innovations (CEPI),
Defense Advanced Research Projects Agency (DARPA)/Joint Program
Executive Office for Chemical, Biological, Radiological and Nuclear
Defense (JPEO-CBRND)/Department of Defense (DOD), HIV Vaccines
Trial Network, International Vaccine Institute (IVI), Kaneka
Eurogentec, Medical CBRN Defense Consortium (MCDC), National Cancer
Institute, National Institutes of Health, National Institute of
Allergy and Infectious Diseases, Ology Bioservices, the Parker
Institute for Cancer Immunotherapy, Plumbline Life Sciences,
Regeneron, Richter-Helm BioLogics, Thermo Fisher Scientific,
University of Pennsylvania, Walter Reed
Army Institute of Research, and The Wistar Institute. For more
information, visit www.inovio.com.
CONTACTS:
Media: Jeff Richardson,
267-440-4211, jrichardson@inovio.com
Investors: Ben Matone, 484-362-0076,
ben.matone@inovio.com
* * * *
This press release contains certain forward-looking
statements relating to our business, including our plans to develop
DNA medicines, our plans and expectations regarding manufacturing,
our plans regarding development of an in-vitro diagnostic, our
expectations regarding our research and development programs,
including the planned initiation and conduct of preclinical studies
and clinical trials and the availability and timing of data from
those studies and trials, and our ability to successfully
manufacture and produce large quantities of our product candidates
if they receive regulatory approval. 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, the structuring, initiation and outcomes of clinical
trials, product development programs and commercialization
activities and outcomes, our ability to secure sufficient
manufacturing capacity to mass produce our product candidates, 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 medicines,
our ability to support our pipeline of DNA medicine products, 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 us or our collaborators, including alternatives that may be more
efficacious or cost effective than any therapy or treatment that we
and our collaborators hope to develop, issues involving product
liability, issues involving patents and whether they or licenses to
them will provide us 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
we can finance or devote other significant resources that may be
necessary to prosecute, protect or defend them, the level of
corporate expenditures, assessments of our 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, 2020, our
Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 and other filings we make from time
to time with the Securities and Exchange Commission. There can be
no assurance that any product candidate in our pipeline will be
successfully developed, manufactured or commercialized, that final
results of clinical trials will be supportive of regulatory
approvals required to market products, or that any of the
forward-looking information provided herein will be proven
accurate. Forward-looking statements speak only as of the date of
this release, and we undertake no obligation to update or revise
these statements, except as may be required by law.
INOVIO
Pharmaceuticals, Inc.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
|
June
30, 2021
|
|
December
31, 2020
|
|
(Unaudited)
|
|
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
|
58,925,302
|
|
|
$
|
250,728,118
|
|
Short-term
investments
|
384,752,382
|
|
|
160,914,935
|
|
Accounts
receivable
|
13,128,330
|
|
|
18,559,967
|
|
Accounts receivable
from affiliated entities
|
722,941
|
|
|
503,782
|
|
Prepaid expenses and
other current assets
|
84,592,179
|
|
|
40,357,456
|
|
Prepaid expenses and
other current assets from affiliated entities
|
303,491
|
|
|
106,432
|
|
Total current
assets
|
542,424,625
|
|
|
471,170,690
|
|
Fixed assets,
net
|
18,111,288
|
|
|
11,348,144
|
|
Investment in
affiliated entity
|
3,908,709
|
|
|
4,460,366
|
|
Investment in
Geneos
|
—
|
|
|
434,387
|
|
Intangible assets,
net
|
2,879,896
|
|
|
3,146,770
|
|
Goodwill
|
10,513,371
|
|
|
10,513,371
|
|
Operating lease
right-of-use assets
|
12,173,414
|
|
|
12,741,296
|
|
Other
assets
|
1,830,866
|
|
|
25,957,448
|
|
Total
assets
|
$
|
591,842,169
|
|
|
$
|
539,772,472
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued expenses
|
$
|
30,095,578
|
|
|
$
|
21,203,808
|
|
Accounts payable and
accrued expenses due to affiliated entities
|
1,773,846
|
|
|
642,969
|
|
Accrued clinical
trial expenses
|
10,416,164
|
|
|
9,950,345
|
|
Deferred
revenue
|
109,128
|
|
|
46,628
|
|
Operating lease
liability
|
2,463,878
|
|
|
2,329,394
|
|
Grant funding
liability
|
6,859,155
|
|
|
7,474,310
|
|
Grant funding
liability from affiliated entities
|
31,250
|
|
|
58,500
|
|
Total current
liabilities
|
51,748,999
|
|
|
41,705,954
|
|
Deferred revenue, net
of current portion
|
71,788
|
|
|
79,214
|
|
Convertible senior
notes
|
14,536,448
|
|
|
14,139,988
|
|
Convertible
bonds
|
—
|
|
|
4,515,834
|
|
Operating lease
liability, net of current portion
|
16,797,476
|
|
|
18,063,515
|
|
Deferred tax
liabilities
|
32,046
|
|
|
32,046
|
|
Grant funding
liability from affiliated entity, net of current portion
|
37,500
|
|
|
37,500
|
|
Other
liabilities
|
64,141
|
|
|
57,663
|
|
Total
liabilities
|
83,288,398
|
|
|
78,631,714
|
|
Stockholders'
equity:
|
|
|
|
Preferred
stock
|
—
|
|
|
—
|
|
Common
stock
|
210,146
|
|
|
186,851
|
|
Additional paid-in
capital
|
1,551,348,435
|
|
|
1,367,406,869
|
|
Accumulated
deficit
|
(1,042,738,901)
|
|
|
(906,196,812)
|
|
Accumulated other
comprehensive loss
|
(265,909)
|
|
|
(256,150)
|
|
Total Inovio
Pharmaceuticals, Inc. stockholders' equity
|
508,553,771
|
|
|
461,140,758
|
|
Total liabilities
and stockholders' equity
|
$
|
591,842,169
|
|
|
$
|
539,772,472
|
|
INOVIO
Pharmaceuticals, Inc.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(Unaudited)
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Revenues:
|
|
|
|
|
|
|
|
Revenue under
collaborative research and development arrangements
|
$
|
82,923
|
|
|
$
|
74,102
|
|
|
$
|
122,538
|
|
|
$
|
145,602
|
|
Revenue under
collaborative research and development arrangements with affiliated
entities
|
74,787
|
|
|
95,146
|
|
|
124,736
|
|
|
1,267,272
|
|
Other
revenue
|
115,114
|
|
|
97,939
|
|
|
396,671
|
|
|
181,587
|
|
Total
revenues
|
272,824
|
|
|
267,187
|
|
|
643,945
|
|
|
1,594,461
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
70,808,418
|
|
|
22,376,575
|
|
|
109,852,836
|
|
|
41,487,763
|
|
General and
administrative
|
12,666,341
|
|
|
11,071,510
|
|
|
26,547,535
|
|
|
18,519,864
|
|
Total operating
expenses
|
83,474,759
|
|
|
33,448,085
|
|
|
136,400,371
|
|
|
60,007,627
|
|
Loss from
operations
|
(83,201,935)
|
|
|
(33,180,898)
|
|
|
(135,756,426)
|
|
|
(58,413,166)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest
income
|
928,111
|
|
|
1,067,399
|
|
|
1,697,347
|
|
|
1,483,968
|
|
Interest
expense
|
(466,726)
|
|
|
(2,846,641)
|
|
|
(979,760)
|
|
|
(5,650,396)
|
|
Change in fair value
of derivative liability
|
—
|
|
|
(97,755,000)
|
|
|
—
|
|
|
(110,976,977)
|
|
Gain (loss) on
investment in affiliated entities
|
278,818
|
|
|
(3,883,176)
|
|
|
(551,657)
|
|
|
9,298,443
|
|
Net unrealized gain
(loss) on available-for-sale equity securities
|
136,493
|
|
|
4,358,634
|
|
|
(711,465)
|
|
|
(691,458)
|
|
Other income
(expense), net
|
185,281
|
|
|
(152,102)
|
|
|
194,259
|
|
|
(577,602)
|
|
Gain on
deconsolidation of Geneos
|
—
|
|
|
4,121,075
|
|
|
—
|
|
|
4,121,075
|
|
Net loss before
share in net loss of Geneos
|
(82,139,958)
|
|
|
(128,270,709)
|
|
|
(136,107,702)
|
|
|
(161,406,113)
|
|
Share in net loss of
Geneos
|
—
|
|
|
(901,757)
|
|
|
(434,387)
|
|
|
(901,757)
|
|
Net
loss
|
(82,139,958)
|
|
|
(129,172,466)
|
|
|
(136,542,089)
|
|
|
(162,307,870)
|
|
Net loss attributable
to non-controlling interest
|
—
|
|
|
469,407
|
|
|
—
|
|
|
1,063,757
|
|
Net loss
attributable to Inovio Pharmaceuticals, Inc.
|
$
|
(82,139,958)
|
|
|
$
|
(128,703,059)
|
|
|
$
|
(136,542,089)
|
|
|
$
|
(161,244,113)
|
|
Net loss per share
attributable to Inovio Pharmaceuticals, Inc.
stockholders
|
|
|
|
|
|
|
|
Basic and diluted
|
$
|
(0.39)
|
|
|
$
|
(0.83)
|
|
|
$
|
(0.66)
|
|
|
$
|
(1.15)
|
|
Weighted average
number of common shares outstanding
|
|
|
|
|
|
|
|
Basic and diluted
|
209,561,064
|
|
|
155,807,054
|
|
|
206,007,497
|
|
|
140,215,158
|
|
View original
content:https://www.prnewswire.com/news-releases/inovio-reports-second-quarter-2021-financial-results-301351440.html
SOURCE INOVIO Pharmaceuticals, Inc.