PLYMOUTH MEETING, Pa.,
Aug. 10, 2020 /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 and cancer, today reported
financial results for the quarter ended June
30, 2020. 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, including near-term expectations for its
COVID-19 DNA vaccine development program and a mid-year clinical
program update for its DNA medicines portfolio.
Dr. J. Joseph Kim, INOVIO's
President and Chief Executive Officer, said, "The second quarter
further demonstrated the versatility and potential of INOVIO's DNA
medicines platform to meet urgent global health needs. In addition
to advancing our DNA vaccine INO-4800 to combat the ongoing
COVID-19 pandemic, INOVIO presented encouraging results for one of
the most devastating and difficult-to-treat cancers, GBM. We
believe our DNA medicines are ideally suited to safely drive robust
immune responses across infectious diseases and cancer, and we look
forward to publishing our latest INO-4800 data, starting our Phase
2/3 COVID-19 clinical study in the U.S. in September, and expanding
the manufacturing capacity to produce at least 100 million doses of
INO-4800 in 2021 via our growing global coalition of partners and
funders."
INOVIO Second Quarter Program Updates
DNA Vaccines for COVID-19 and MERS
INO-4800: COVID-19
INOVIO reported positive interim clinical data from the first
two cohorts in its Phase 1 clinical trial in the U.S.
Specifically:
- The trial enrolled 40 healthy adult volunteers 18 to 50 years
of age at two U.S. sites.
- The participants were enrolled into 1.0 mg and 2.0 mg dose
cohorts; each participant received two doses of INO-4800 four weeks
apart, administered by intradermal injection using INOVIO's
CELLECTRA® 2000 device.
- INOVIO has submitted the full clinical data to a peer-reviewed
medical journal.
- INO-4800 was generally safe and well-tolerated in all
participants in both cohorts through week 8: there were no reported
serious adverse events (SAEs) and 6 reported mild (all Grade 1 in
severity), transient adverse events related to vaccine dose.
- 100% (38 out of 38) of trial participants demonstrated overall
immunological responses based on binding and neutralizing antibody
responses and T cell immune responses.
- 95% of vaccinated participants had overall seroconversion
(defined as those participants who respond with neutralization
and/or binding antibodies) after 2 vaccine doses.
- Nearly 90% of vaccinated participants generated strong T cell
responses, including CD8+ killer T cell responses. T
cell responses were higher in magnitude than convalescent samples
tested and were similar or greater responses to those previously
reported for other vaccine candidates.
- The Phase 1 trial was also recently expanded with 80 additional
participants age 18 and up, with no upper age limit, and with the
inclusion of a low-dose arm. The study extension was fully enrolled
by mid-July.
INOVIO has received significant funding from government and
private sources in 1H 2020 to support vaccine development and
manufacturing scale-up. Funders include:
- The Department of Defense (DoD), which awarded INOVIO
$71 million to support the
large-scale manufacture of the company's proprietary
CELLECTRA® 3PSP smart device and the procurement of
CELLECTRA 2000 devices that are used to deliver INO-4800
intradermally. The DoD also awarded Ology Bioservices $11.9 million to work with INOVIO to manufacture
INO-4800 DNA plasmids.
- The Coalition for Epidemic Preparedness Innovations (CEPI),
which awarded INOVIO a total of $17.2
million in funding to date to support the Phase 1 clinical
trial of INO-4800 in the U.S. and a Phase 1/2 clinical trial in
South Korea as well as a
$5 million grant to support CELLECTRA
3PSP smart device development.
- The Bill & Melinda Gates Foundation, which provided INOVIO
a $5 million grant to accelerate
testing and production scale-up of CELLECTRA 3PSP.
INOVIO and the International Vaccine Institute in partnership
with Seoul National University Hospital
has initiated a Phase 1/2 clinical trial of INO-4800 in
South Korea. This is the first
COVID-19 vaccine clinical study approved in South Korea and is funded by CEPI through
INOVIO and supported by the Korea Center for Disease Control and
Prevention (KCDC)/Korea National Institute of Health (KNIH). The
two-stage trial will assess the safety, tolerability, and
immunogenicity of INO-4800 in 40 healthy adults aged 19-50 years in
the Phase 1 portion, and will further expand to enroll an
additional 120 people aged 19-64 years in the Phase 2 portion.
In addition, INOVIO is collaborating with Advaccine to advance
the development of INO-4800 in China. INOVIO will leverage Advaccine's
expertise and has initiated a Phase 1 trial in China in parallel with INOVIO's clinical
development efforts in the U.S. and South
Korea. In July, regulatory authorities in China approved the clinical testing of
INO-4800 by Advaccine in China.
Preclinical study data of INO-4800 was published May 20 in the peer-reviewed journal Nature
Communications in a manuscript titled, "Immunogenicity of a DNA
vaccine candidate for COVID-19" by INOVIO scientists and
collaborators from The Wistar Institute, the University of Texas, Public Health England,
Fudan University, and Advaccine. The
studies demonstrated that vaccination with INO-4800 generated
robust binding and neutralizing antibody as well as T cell
responses in mice and guinea pigs.
Animal challenge data submitted to a peer-reviewed journal
support and expand upon these preclinical findings. Specifically,
INO-4800 reduced viral load in both the nasal passages and lower
lungs in five macaques that received two doses of INO-4800 four
weeks apart and then were challenged with live virus at week 17.
Compared to five macaques that received placebo, the
INO-4800-treated subjects had protective neutralizing antibodies
and T cells in blood samples more than four months after
inoculation. The antibody levels in primates were similar to and in
some instances greater than those seen in human patients who have
recovered from COVID-19. All other previously reported NHP vaccine
protection studies actually challenged the animals at the time near
their peak immune responses (1-4 weeks from their last
vaccination). INOVIO's study demonstrates that INO-4800 could
provide protection in a more real-world setting, where
vaccine-generated memory immune responses protected NHPs for more
than 3 months (13 weeks) from the last vaccination. This is the
first time vaccine protection in non-human primates was reported
from memory immune responses. INO-4800 vaccination in the NHPs also
generated antibodies that neutralized both the earlier strain of
virus as well as the mutant variant (D614G) that has emerged with
greater infectivity, and now accounts for >80% of newly
circulating virus.
No adverse events or antibody dependent enhancement (ADEs) were
reported. Safety is paramount when assessing the viability of a
vaccine for mass immunizations. These findings bolster the safety
profile INOVIO has seen in over 7,000 administrations of its DNA
medicines with its CELLECTRA delivery devices. These results
support the robust immune ability of INO-4800 to induce both
antibody and T cell responses, which are believed to be important
for providing durable protection against COVID-19 disease.
INO-4700: MERS
Positive interim data were presented at the American Society of
Gene & Cell Therapy (ASGCT) Conference (May 12-15, 2020) from a Phase 1/2a trial of DNA
vaccine INO-4700 (GLS-5300) for the coronavirus MERS-CoV that
causes MERS (Middle East Respiratory Syndrome). Vaccine recipients
demonstrated strong antibody and T cell immune responses, showing
100% binding and 92% neutralizing antibody responses, after two or
three doses with 0.6 mg of INO-4700, which was delivered
intradermally via the CELLECTRA smart device. The vaccination
regimen was well-tolerated with no vaccine-associated SAEs
reported. With previously announced CEPI funding of $56 million, INOVIO is preparing for a Phase 2
clinical trial to begin in the Middle
East later this year.
DNA Immunotherapies: Immuno-oncology and HPV-related
Diseases
Immuno-oncology
INO-5401: Newly Diagnosed Glioblastoma Multiforme
(GBM)
In a Phase 1/2 clinical trial, 85% (44 out of 52) of patients
newly diagnosed with the deadly brain cancer glioblastoma
multiforme (GBM) who received INO-5401 in combination with INO-9012
(IL-12) and PD-1 inhibitor Libtayo® (cemiplimab) were
alive for at least 12 months (overall survival at 12 months)
following treatment. These data were featured at an oral poster
presentation at the ASCO 2020 Virtual Scientific Program.
GBM is the most common and aggressive type of brain cancer.
Currently, the median overall survival with standard of care
therapy, which includes radiation and chemotherapy (temozolomide:
TMZ), is approximately 15 to 22 months.
The trial demonstrated that 84.4% percent (27 of 32) of patients
with MGMT promoter unmethylated tumors, and 85% (17 of 20) of
patients with MGMT promoter methylated tumors were alive at 12
months. This promising clinical result is coupled with a robust
immunological response to all three tumor associated antigens in
INO-5401, including human telomerase (hTERT), Wilms Tumor-1 (WT-1)
and prostate specific membrane antigen (PSMA). Activated, cytotoxic
T cells directed towards these cancer antigens commonly expressed
on GBM tumors were detected in all patients tested to date,
supporting the immunogenic potential of INOVIO's DNA medicines.
Importantly, INO-5401 + INO-9012 was safe and well-tolerated when
given not only with radiation and TMZ, but also with PD-1 inhibitor
Libtayo®, which is being jointly developed by Regeneron
and Sanofi.
INOVIO plans to report 18-month overall survival data in Q4 this
year.
HPV-related Diseases
VGX-3100: Cervical, vulvar, and anal Precancerous Dysplasia
or HSIL
The REVEAL 2 Phase 3 clinical trial evaluating DNA medicine
VGX-3100 for treatment of HPV-related precancerous cervical
dysplasia or high-grade squamous intraepithelial lesions (HSIL) has
maintained a total of 43 recruiting sites worldwide. Top-line
efficacy data guidance from the REVEAL 1 Phase 3 clinical trial
remains unchanged and is expected to readout in 4Q 2020.
INOVIO presented positive interim safety and efficacy data from
two separate open-label Phase 2 studies of its lead DNA medicine
candidate VGX-3100 in both HPV-related anal and vulvar HSIL
patients at the annual American Society for Colposcopy and Cervical
Pathology meeting. Full data from the Phase 2 clinical trials for
anal and vulvar dysplasia are expected to readout in 4Q 2020.
INO-3107: Recurrent Respiratory Papillomatosis (RRP)
In July, INO-3107 received Orphan Disease designation by the
FDA. Enrollment recently began in the Phase 1/2 clinical trial to
evaluate the efficacy, safety, tolerability and immunogenicity of
DNA medicine INO-3107 in 63 participants with HPV-6 and/or HPV-11
associated recurrent respiratory papillomatosis (RRP), a rare,
debilitating and potentially life-threatening disease currently
treated by invasive and recurrent surgeries. The trial population
is divided into two cohorts: Cohort A: Participants with diagnoses
of juvenile-onset RRP as defined by age at first diagnosis of RRP
< 12 years. Cohort B: Participants with adult-onset RRP as
defined by age at first diagnosis of RRP ≥ 12 years. A safety
run-in will be performed with up to six participants across cohorts
A and B with a one-week waiting period between each enrolled
participant. For more information on the clinical trial please
visit clinicaltrials.gov (Identifier: NCT04398433).
Second Quarter 2020 Financial Results
Total revenue was $267,000 for the
three months ended June 30, 2020,
compared to $136,000 for the same
period in 2019. Total operating expenses were $33.4 million compared to $28.3 million for the same period in 2019.
INOVIO's net loss for the quarter ended June 30, 2020 was $128.7
million, or $0.83 per basic
and diluted share, compared to $29.4
million, or $0.30 per basic
and diluted share, for the quarter ended June 30, 2019. The increase in net loss for the
quarter was primarily due to the change in fair value of the
derivative liability related to the embedded conversion feature in
our August 2019 Convertible Bonds,
which is revalued at each reporting period. Without this non-cash
derivative liability expense, the Company's net loss for the
quarter would be consistent with the 2nd quarter 2019
and our net loss per share would be $0.20 per share rather than $0.83 per share, which is $0.10 per share less than the loss per share for
the same period in 2019. Subsequent to June
30, 2020, these bonds were converted voluntarily by the bond
holders, into common stock.
Operating Expenses
Research and development (R&D) expenses for the three months
ended June 30, 2020 were $22.4 million compared to $22.5 million for the same period in 2019. The
decrease in R&D expenses was primarily related to an increase
in contra-research and development expense recorded from grant
agreements, offset by an increase in drug manufacturing expenses
related to our COVID-19 and VGX-3100 clinical trials and an
increase in device inventory and engineering equipment.
General and administrative (G&A) expenses were $11.1 million for the three months ended
June 30, 2020 versus $5.9 million for the same period in 2019. The
increase in G&A expenses was primarily related to an increase
in legal expenses, work performed related to corporate marketing
and communications and higher employee-stock-based compensation
expense.
Capital Resources
As of June 30, 2020, cash and cash
equivalents and short-term investments were $371.7 million compared to $89.5 million as of December 31, 2019. As of June 30, 2020, the Company had 158,756,411 common
shares outstanding and 191,378,948 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.
The end of quarter cash position included net proceeds of
$121.7 million the Company received
by selling 12,041,178 shares of common stock during the three
months ended June 30, 2020 under an
at-the-market (ATM) sales agreement.
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 quarter ended June 30, 2020, which can be accessed at:
http://ir.inovio.com/investors/financial-reports/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/investors/events/default.aspx. Telephone
replay will be available approximately one hour after the call at
877-344-7529 (US toll-free) or 412-317-0088 (international toll)
using replay access code 10146894.
About INOVIO's Global Coalition Advancing INO-4800
INOVIO has assembled a global coalition of collaborators,
partners and funders to rapidly advance the development of
INO-4800. R&D collaborators to date include the Wistar
Institute, the University of
Pennsylvania, the University of
Texas, Fudan University and the Laval
University. INOVIO has partnered with Advaccine and the
International Vaccine Institute to conduct clinical trials of
INO-4800 in China and South Korea, respectively. INOVIO is also
assessing preclinical efficacy of INO-4800 in several animal
challenge models with Public Health England (PHE) and Commonwealth
Scientific and Industrial Research Organization (CSIRO) in
Australia. INOVIO is also working
with a team of contract manufacturers including VGXI, Inc.,
Richter-Helm BioLogics, and Ology Biosciences to produce INO-4800
and seeking additional external funding and partnerships to scale
up the manufacturing capacities to satisfy the urgent global demand
for a safe and effective vaccine. To date, the Coalition for
Epidemic Preparedness Innovations (CEPI), the Bill & Melinda
Gates Foundation, and the U.S. Department of Defense have
contributed significant funding to the advancement and
manufacturing of INO-4800.
About INO-4800
INO-4800 is INOVIO's DNA vaccine candidate intended to protect
against the novel coronavirus SARS-CoV-2, which causes COVID-19.
INOVIO has extensive experience working with coronaviruses and is
the only company with a Phase 2 vaccine for a related coronavirus
that causes Middle East Respiratory Syndrome (MERS).
INO-4800 is the only nucleic-acid based vaccine that is stable
at room temperature for more than a year and does not need to be
frozen in transport of storage, which are important factors when
implementing mass immunizations.
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 MERS
and COVID-19 diseases being developed under grants from the
Coalition for Epidemic Preparedness Innovations (CEPI) and the U.S.
Department of Defense. 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, overcoming 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 ensures
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 2,000 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, currently in Phase 3 trials for precancerous
cervical dysplasia, destroyed and cleared high-risk HPV 16 and 18
in a Phase 2b clinical trial.
High-risk HPV is responsible for 70% of cervical cancer, 91% of
anal cancer, and 69% of vulvar cancer. Also in development are
programs targeting HPV-related cancers and a rare HPV-related
disease, recurrent respiratory papillomatosis (RRP);
non-HPV-related cancers glioblastoma multiforme (GBM) and prostate
cancer; as well as externally funded infectious disease DNA vaccine
development programs in Zika, Lassa fever, Ebola, HIV, and
coronaviruses associated with MERS and COVID-19 diseases. 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), GeneOne Life
Science/VGXI, HIV Vaccines Trial Network, International Vaccine
Institute (IVI), 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, Roche/Genentech, University of Pennsylvania, Walter Reed Army
Institute of Research, and The Wistar Institute. INOVIO also is a
proud recipient of 2020 Women on Boards "W" designation recognizing
companies with more than 20% women on their board of directors. 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 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, 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, 2019, our
Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 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,
2020
|
|
December
31,
2019
|
|
(Unaudited)
|
|
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
|
215,432,713
|
|
|
$
|
22,196,097
|
|
Short-term
investments
|
156,231,102
|
|
|
67,338,017
|
|
Accounts
receivable
|
3,513,159
|
|
|
700,073
|
|
Accounts receivable
from affiliated entities
|
482,373
|
|
|
1,332,044
|
|
Prepaid expenses and
other current assets
|
4,591,966
|
|
|
1,584,598
|
|
Prepaid expenses and
other current assets from affiliated entities
|
1,811,140
|
|
|
1,050,140
|
|
Total current
assets
|
382,062,453
|
|
|
94,200,969
|
|
Fixed assets,
net
|
11,323,531
|
|
|
12,773,017
|
|
Investment in
affiliated entities
|
17,327,569
|
|
|
6,315,356
|
|
Investment in
Geneos
|
2,717,241
|
|
|
—
|
|
Intangible assets,
net
|
3,420,311
|
|
|
3,693,851
|
|
Goodwill
|
10,513,371
|
|
|
10,513,371
|
|
Operating lease
right-of-use assets
|
13,265,144
|
|
|
13,783,009
|
|
Other
assets
|
2,555,782
|
|
|
2,672,024
|
|
Total
assets
|
$
|
443,185,402
|
|
|
$
|
143,951,597
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued expenses
|
$
|
17,216,875
|
|
|
$
|
18,237,258
|
|
Accounts payable and
accrued expenses due to affiliated entities
|
511,953
|
|
|
729,729
|
|
Accrued clinical
trial expenses
|
6,870,450
|
|
|
4,049,727
|
|
Deferred
revenue
|
14,853
|
|
|
92,353
|
|
Deferred revenue from
affiliated entities
|
94,275
|
|
|
31,775
|
|
Operating lease
liability
|
2,200,459
|
|
|
2,074,842
|
|
Grant funding
liability
|
10,330,235
|
|
|
6,065,212
|
|
Grant funding
liability from affiliated entities
|
742,875
|
|
|
708,425
|
|
Total current
liabilities
|
37,981,975
|
|
|
31,989,321
|
|
Deferred revenue, net
of current portion
|
86,641
|
|
|
101,567
|
|
Convertible senior
notes
|
65,844,260
|
|
|
64,180,325
|
|
Convertible
bonds
|
13,718,528
|
|
|
12,842,592
|
|
Derivative
liability
|
119,796,000
|
|
|
8,819,023
|
|
Operating lease
liability, net of current portion
|
19,261,354
|
|
|
20,409,922
|
|
Deferred tax
liabilities
|
32,046
|
|
|
32,046
|
|
Grant funding
liability from affiliated entity, net of current portion
|
37,500
|
|
|
135,000
|
|
Other
liabilities
|
66,629
|
|
|
36,943
|
|
Total
liabilities
|
256,824,933
|
|
|
138,546,739
|
|
Stockholders'
equity:
|
|
|
|
Preferred
stock
|
—
|
|
|
—
|
|
Common
stock
|
158,756
|
|
|
101,361
|
|
Additional paid-in
capital
|
1,087,745,242
|
|
|
742,646,785
|
|
Accumulated
deficit
|
(901,029,768)
|
|
|
(739,785,655)
|
|
Accumulated other
comprehensive income (loss)
|
(610,030)
|
|
|
472,608
|
|
Total Inovio
Pharmaceuticals, Inc. stockholders' equity
|
186,264,200
|
|
|
3,435,099
|
|
Non-controlling
interest
|
96,269
|
|
|
1,969,759
|
|
Total stockholders'
equity
|
186,360,469
|
|
|
5,404,858
|
|
Total liabilities
and stockholders' equity
|
$
|
443,185,402
|
|
|
$
|
143,951,597
|
|
INOVIO
Pharmaceuticals, Inc.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(Unaudited)
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Revenues:
|
|
|
|
|
|
|
|
Revenue under
collaborative research and development arrangements
|
$
|
74,102
|
|
|
$
|
64,283
|
|
|
$
|
145,602
|
|
|
$
|
2,834,995
|
|
Revenue under
collaborative research and development arrangements with affiliated
entities
|
95,146
|
|
|
71,390
|
|
|
1,267,272
|
|
|
126,970
|
|
Miscellaneous
revenue
|
97,939
|
|
|
—
|
|
|
181,587
|
|
|
3,614
|
|
Total
revenues
|
267,187
|
|
|
135,673
|
|
|
1,594,461
|
|
|
2,965,579
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
22,376,575
|
|
|
22,486,266
|
|
|
41,487,763
|
|
|
46,876,155
|
|
General and
administrative
|
11,071,510
|
|
|
5,850,101
|
|
|
18,519,864
|
|
|
12,825,129
|
|
Total operating
expenses
|
33,448,085
|
|
|
28,336,367
|
|
|
60,007,627
|
|
|
59,701,284
|
|
Loss from
operations
|
(33,180,898)
|
|
|
(28,200,694)
|
|
|
(58,413,166)
|
|
|
(56,735,705)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest
income
|
1,067,399
|
|
|
755,330
|
|
|
1,483,968
|
|
|
1,380,864
|
|
Interest
expense
|
(2,846,641)
|
|
|
(2,194,783)
|
|
|
(5,650,396)
|
|
|
(2,851,031)
|
|
Change in fair value
of derivative liability
|
(97,755,000)
|
|
|
—
|
|
|
(110,976,977)
|
|
|
—
|
|
Gain (loss) on
investment in affiliated entities
|
(3,883,176)
|
|
|
(173,212)
|
|
|
9,298,443
|
|
|
(923,315)
|
|
Net unrealized gain
(loss) on available-for-sale equity securities
|
4,358,634
|
|
|
—
|
|
|
(691,458)
|
|
|
—
|
|
Other income
(expense), net
|
(152,102)
|
|
|
127,512
|
|
|
(577,602)
|
|
|
91,673
|
|
Gain on
deconsolidation of Geneos
|
4,121,075
|
|
|
—
|
|
|
4,121,075
|
|
|
—
|
|
Net loss before
income tax benefit and share in net loss of Geneos
|
(128,270,709)
|
|
|
(29,685,847)
|
|
|
(161,406,113)
|
|
|
(59,037,514)
|
|
Income tax
benefit
|
—
|
|
|
106,771
|
|
|
—
|
|
|
169,571
|
|
Share in net loss of
Geneos
|
(901,757)
|
|
|
—
|
|
|
(901,757)
|
|
|
—
|
|
Net
loss
|
(129,172,466)
|
|
|
(29,579,076)
|
|
|
(162,307,870)
|
|
|
(58,867,943)
|
|
Net loss attributable
to non-controlling interest
|
469,407
|
|
|
191,850
|
|
|
1,063,757
|
|
|
261,455
|
|
Net loss
attributable to Inovio Pharmaceuticals, Inc.
|
$
|
(128,703,059)
|
|
|
$
|
(29,387,226)
|
|
|
$
|
(161,244,113)
|
|
|
$
|
(58,606,488)
|
|
Net loss per share
attributable to Inovio Pharmaceuticals, Inc.
stockholders
|
|
|
|
|
|
|
|
Basic and diluted
|
$
|
(0.83)
|
|
|
$
|
(0.30)
|
|
|
$
|
(1.15)
|
|
|
$
|
(0.60)
|
|
Weighted average
number of common shares outstanding
|
|
|
|
|
|
|
|
Basic and diluted
|
155,807,054
|
|
|
98,083,896
|
|
|
140,215,158
|
|
|
97,795,910
|
|
View original
content:http://www.prnewswire.com/news-releases/inovio-reports-second-quarter-2020-financial-results-provides-dna-medicines-clinical-program-mid-year-update-301109361.html
SOURCE INOVIO Pharmaceuticals, Inc.