PLYMOUTH MEETING, Pa.,
March 1, 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 December 31, 2020.
INOVIO's management will host a live conference call and webcast at
4:30 p.m. Eastern Standard Time today
to discuss financial results and provide a general business update,
including: top-line efficacy data from REVEAL 1, a Phase 3 clinical
trial of VGX-3100; a progress update for the company's INNOVATE
Phase 2/3 COVID-19 vaccine clinical trial and its development
strategy regarding the new COVID-19 vaccine addressing the current
and future COVID variants of concern (VOC); and a general update on
its DNA medicines platform. The live webcast and a replay may be
accessed by visiting INOVIO's website at
http://ir.inovio.com/events-and-presentations/default.aspx.
INOVIO Fourth Quarter and Year-End 2020 Highlights
- On March 1, 2021, INOVIO
announced that it met primary and secondary efficacy endpoints
among all evaluable subjects for the REVEAL 1 (Randomized
Evaluation of VGX-3100 and
Electroporation for the treatment of Cervical HSIL)
trial. This trial is one of two ongoing pivotal, randomized,
double-blind, multi-center, placebo-controlled, Phase 3 trials
evaluating the safety, tolerability and efficacy of VGX-3100 to
treat HPV-16/18-associated cervical high-grade squamous
intraepithelial lesions (HSIL) using the company's proprietary
CELLECTRA® 5PSP device.
- In first quarter 2021, INOVIO completed enrollment of 400
subjects in the Phase 2 segment of the INNOVATE (INOVIO
INO-4800 Vaccine Trial for Efficacy)
Phase 2/3 clinical trial.
- INOVIO is addressing the new COVID variants through evaluating
the impact of newly circulating strains of the SARS-CoV-2 virus on
the immune profile of the INO-4800 vaccine and developing
next-generation, pan-COVID vaccine candidates whose design could
potentially provide better protection against the known and
currently unknown SARS-CoV-2 variants.
- In December, Phase 1 peer-reviewed clinical data from the first
cohort of 40 participants administered with INO-4800 was published
in The Lancet's EClinicalMedicine.
- In November, INOVIO presented overall survival at 18 months
(OS18) data from its novel combination trial of INO-5401 and
INO-9012 in combination with PD-1 inhibitor Libtayo® at
the Society for Neuro-Oncology (SNO) 2020 Annual Meeting. Median
overall survival among the unmethylated Glioblastoma
Multiforme (GBM) patients in the trial was 17.9 months, which
compares favorably to historical controls.
Dr. J. Joseph Kim, INOVIO's
President and CEO, said, "We have had a productive fourth quarter
across our DNA medicines platform, including significant
developments within both our HPV and oncology programs. We
presented encouraging clinical efficacy results in a landmark
combination trial for INO-5401 in GBM at the SNO 2020 Annual
Meeting last November. Most importantly, we announced that our
REVEAL 1 Phase 3 clinical trial for VGX-3100 met primary and
secondary endpoints among all evaluable subjects. We are truly
proud to advance VGX-3100 as the first DNA medicine to reach this
important milestone."
"INOVIO recognizes and applauds the incredible work to address
the global COVID-19 pandemic across the industry, while also
acknowledging the need for continued collaboration and coordination
in vaccine development, manufacturing, and distribution. I am also
extremely proud of the dedication and efforts of our INOVIO team in
contributing to this global endeavor, grateful for the continued
support of our partners, and thankful for all Phase 2 participants
in our INNOVATE clinical trial for their help in the ongoing fight
against the pandemic. We look forward to successfully completing
our Phase 2 segment in the second quarter and seeking to advance to
the Phase 3 portion of the trial."
INOVIO Fourth Quarter 2020 Program Updates
DNA Immunotherapies: HPV-associated Diseases and
Immuno-Oncology
HPV-related Diseases
VGX-3100: Cervical, Vulvar, and Anal HSIL
INOVIO announced today that it met primary and secondary
endpoints among all evaluable subjects for the REVEAL 1 trial. The
trial protocol-defined modified intention to treat (mITT)
population (N=193) includes all subjects with endpoint data. For
the primary endpoint of histopathological regression of HSIL
combined with virologic clearance of HPV-16 and/or HPV-18 at week
36, the percentage of responders was 23.7% (31/131) in the
treatment group, versus 11.3% (7/62) in the placebo group (p=0.022;
12.4% difference in percentage, 95%CI: 0.4,22.5), thus achieving
statistical significance. All secondary efficacy endpoints were
achieved in the mITT population. These endpoints were: a)
regression of cervical HSIL to normal tissue combined with HPV16/18
viral clearance, b) regression of cervical HSIL alone, c)
regression of cervical HSIL to normal tissue, and d) HPV 16/18
viral clearance alone.
The trial protocol-defined intention to treat (ITT) population
(N=201) includes all randomized subjects regardless of availability
of endpoint data and defines those without endpoint data as
non-responders. There were eight such subjects (seven in the
treatment group, one in the placebo group). Including subjects with
missing endpoint data, the percentage of subjects meeting the
primary endpoint was 22.5% (31/138) in the treatment group, versus
11.1% (7/63) in the placebo group (p=0.029; 11.4% difference in
percentage, 95%CI: -0.4,21.2), which was not statistically
significant. All secondary endpoints were achieved in the ITT
population except for regression of cervical HSIL alone (12.8%
difference in percentage, 95%CI: -0.6,24.5). The reasons for
missing endpoint data were: one subject was randomized but was
never dosed, one withdrawal due to pregnancy, one withdrawal due to
administration error, one withdrawal due to post-administration
pain, one loss of follow-up due to COVID19-related travel
restrictions, and three losses to follow-up due to undetermined
reasons. A per-protocol analysis will also be performed upon trial
completion.
There were no treatment-related serious adverse events and most
adverse events were self-resolving and were considered to be mild
to moderate, consistent with earlier clinical trials.
REVEAL 1 and REVEAL 2 are designed to assess and confirm the
safety, tolerability, immunogenicity, and efficacy of VGX-3100.
INOVIO will continue to follow subjects in REVEAL 1 for safety and
durability of response for 18 months following the last
administration and REVEAL 2 is currently enrolling subjects. INOVIO
expects to present REVEAL 1 findings at a scientific meeting this
year.
In December 2020, the company
reported positive Phase 2 efficacy results demonstrating that
VGX-3100 showed resolution of HPV-16/18-associated precancerous
anal HSIL in 50% (11 of 22) of subjects six months following the
start of treatment. The open-label, single-arm trial also showed
VGX-3100 to be well-tolerated in treating men and women with
HPV-16-/18-associated anal HSIL.
In January 2021, the company also
reported positive efficacy results from an open-label Phase 2 trial
of VGX-3100 to treat HPV-16 and HPV-18-associated vulvar HSIL. A
25% or more reduction in HPV-16/18-associated vulvar HSIL was
observed for 63% of trial participants (12 of 19) treated with
VGX-3100 at six months post-treatment. Three out of the 20
participants with histology data (15%) resolved their vulvar HSIL
and had no HPV-16/18 virus detectable in the healed area. By
comparison, the spontaneous resolution of vulvar HSIL caused by
HPV-16/18 is estimated to be 2%. The trial also showed VGX-3100 to
be well-tolerated.
INOVIO will continue to evaluate expansion of indications for
vulvar and anal dysplasia.
INO-3107: Recurrent Respiratory Papillomatosis (RRP)
In November, INOVIO dosed its first subject with DNA medicine
INO-3107 in a Phase 1/2 clinical trial for the treatment of RRP.
The trial, called RRP-001, is a clinical trial investigating the
efficacy, safety, tolerability and immunogenicity of INOVIO's novel
HPV-6/HPV-11 therapy in subjects with RRP, designed to eradicate
both the cause, and sequelae, of infection of the airway with HPV
in subjects who have required at least two surgical interventions
per year for the past three years for the removal of associated
papilloma(s). For this study, adult subjects will first undergo
surgical removal of their papilloma(s) and then receive four doses
of INO-3107, once every three weeks. The primary efficacy endpoint
is a doubling or more in the time between surgical interventions
following the first dose of INO-3107 relative to the frequency
prior to study therapy. The study is currently open in the United States and is listed on
ClinicalTrials.Gov (NCT04398433).
Immuno-oncology
INO-5401: Newly Diagnosed GBM
At the SNO 2020 Annual Meeting last November, INOVIO presented
data from the company's novel combination trial of DNA medicines
INO-5401 and INO-9012 in combination with PD-1 inhibitor
Libtayo® (cemiplimab) in the treatment of newly
diagnosed GBM. In the MGMT promoter unmethylated cohort, which is
the more difficult to treat group, 19/22 (86%) subjects had an
IFN-gamma T cell response that increased over baseline to one or
more of the antigens encoded by INO-5401. In the MGMT promoter
methylated cohort, 16/17 (94%) subjects had an IFN-gamma response
that increased over baseline to one or more of the antigens encoded
by INO-5401. The novel combination of INO-5401 + INO-9012 continues
to demonstrate a well-tolerated safety profile when given not only
with radiation and chemotherapy, but also with PD-1 blockade by
Libtayo®, which is being jointly developed by Regeneron
and Sanofi. Additional data will be provided in the coming months,
including correlative immunology and tissue data, as well as
additional patient survival data.
INO-4800: COVID-19 DNA Vaccine Candidate
Phase 1 Update and Publication
In December 2020, Phase 1 clinical
data from the first cohort of 40 participants for INO-4800 was
published in The Lancet's EClinicalMedicine in a paper,
titled "Safety and immunogenicity of INO-4800 DNA vaccine against
SARS-CoV-2: a preliminary report of an open-label, Phase 1 clinical
trial." The trial found that INO-4800 was immunogenic in all
vaccinated subjects, effectively generating an immune response of
humoral (including neutralizing antibodies) and/or cellular
responses (both CD4 and CD8 T cells). Key findings from the trial
included:
- The 1.0 mg and 2.0 mg dose group both demonstrated
seroconversion in 95% of the subjects, with 78% demonstrating
neutralizing antibodies in the 1.0 mg dose group and 84%
demonstrating neutralizing antibodies in the 2.0 mg dose
group.
- Cellular (T cell) responses were observed against multiple
regions of the spike protein, including the RBD region. 74% had
measurable cellular responses at the 1.0 mg dose group and 100% of
the subjects in the 2.0 mg dose group demonstrated cellular
responses.
- Through week 8, no serious adverse events were reported. Only 6
related Grade 1 adverse events in 5 subjects were observed,
primarily mild injection site reactions (e.g., redness); none of
these increased in frequency with the second administration.
Phase 2 Update
After the quarter, INOVIO completed enrollment of 400 subjects
in the Phase 2 segment of the INNOVATE clinical trial. The U.S.
Department of Defense (DoD) has committed to provide funding for
both the Phase 2 and Phase 3 segments of the INNOVATE clinical
trial, in addition to the $71.1
million of funding previously announced in June 2020 for the large-scale manufacture of the
company's proprietary smart device CELLECTRA® 3PSP,
production of doses and the procurement of CELLECTRA®
2000 devices.
License Agreement for Greater
China with Advaccine
INOVIO also entered into a collaboration and license agreement
for INO-4800 with Advaccine, who will have the exclusive right to
develop, manufacture and commercialize INO-4800 within Greater China, which includes Mainland China,
Hong Kong, Macao, and Taiwan. Advaccine will license its plasmid
manufacturing process for use with INO-4800 and other INOVIO
pipeline product candidates to INOVIO with the right to sublicense
to INOVIO's manufacturing partners. INOVIO received an upfront
payment of $3.0 million and is
eligible to receive up to an aggregate of $108.0 million upon the achievement of specified
development and sales-based milestones for INO-4800 in Greater China. INOVIO is entitled to receive a
royalty equal to a high single-digit percentage of annual net sales
in each region within Greater
China.
INOVIO's Strategy to Address New Variants of Concern (VOC)
INOVIO has been closely monitoring the development and evolution
of SARS-CoV-2 (which causes COVID-19) mutations, with a particular
focus on the UK, South African and Brazilian variants. With
instances of these variants on the rise globally and the UK variant
expected to be the dominant strain in the
United States by March, the emergence and the spread of the
variants have been an area of high priority for INOVIO.
INOVIO is addressing the VOC through a two-pronged approach:
- INOVIO is currently evaluating the impact of newly circulating
strains of the SARS-CoV-2 virus on the immune profile of INO-4800
through an assessment of binding antibodies, neutralizing
antibodies in both live and pseudo assays as well assessing the
impact of the INO-4800-generated T cell responses on these
variants.
- INOVIO is also developing next-generation, pan-COVID vaccine
candidates that could be tailored to the known and potentially
unknown SAR-CoV-2 variants. Our next-generation pan-COVID vaccine
candidates utilize our proprietary SynCon® gene
optimization algorithm to analyze the available sequence data from
all existing circulating variants and create a synthetic SAR-CoV-2
spike protein gene design intended to protect against the known VOC
(notably the UK, SA and Brazilian strains) as well the future
unknown strains.
INOVIO's DNA vaccines are designed to mitigate the risk of the
new viral variants through three main mechanisms:
- Utilizing SynCon®, INOVIO is able to rapidly design
candidates that have the potential to be protective against
multiple newly emerging variants, which could result in a
pan-variant COVID-19 vaccine solution.
- DNA vaccines generate a balanced immune response, including T
cell responses, which could make them less susceptible to changes
in the genetic sequence of the virus.
- DNA vaccines can be used for multiple boosts without being
impacted by anti-vector immunity or an increase in reactogenicity.
Moreover, pre-clinical studies and clinical trials have shown that
DNA vaccines could also be used safely and efficiently to boost the
initial immune responses generated by multiple other vaccine
platforms.
DNA-encoded monoclonal antibody (dMAb®) for
COVID-19- Innovative monoclonal antibody platform
In December 2020, INOVIO announced
that the company and a team of scientists from The Wistar
Institute, AstraZeneca, the University of
Pennsylvania, and Indiana
University received a $37.6
million grant from DARPA, a research and development agency
of the DoD and the Joint Program Executive Office for Chemical,
Biological, Radiological and Nuclear Defense (JPEO-CBRND), to use
INOVIO's innovative dMAb® technology to develop
anti-SARS-CoV-2-specific dMAbs® which could offer
versatile capabilities to function as both a therapeutic and
preventive treatment for COVID-19. Using our core DNA platform
technology, dMAbs® are constructed by encoding the DNA
sequence for a specific monoclonal antibody in a DNA plasmid. The
plasmids are then directly delivered into cells of the body using
CELLECTRA® delivery devices, enabling these cells to
manufacture the mAbs in vivo, unlike conventional mAb technology
that requires manufacturing outside of the body. INOVIO's
dMAbs® also offer a cost-effective treatment option, are
fast to administer to subjects, can be quickly manufactured and
scaled up compared to traditional recombinant monoclonal
antibody-based therapies, and do not require cold chain transport
or storage. Notably, the overall approach can be applied beyond
COVID-19 for any preventive and therapeutic treatment modalities,
including infectious disease, cancer, or any other disease that can
be treated by recombinant monoclonal antibody-based therapies.
Fourth Quarter and Full Year 2020 Financial Results
Total revenue was $5.6 million and
$7.4 million for the quarter and year
ended December 31, 2020,
respectively, compared to $279,000
and $4.1 million for the same periods
in 2019, respectively. Total operating expenses were $34.9 million and $131.5
million for the quarter and year ended December 31, 2020, respectively, compared to
$30.7 million and $115.2 million for the same periods in 2019.
INOVIO's net loss for the quarter and year ended December 31, 2020 was $24.3 million, or $0.14 per basic and diluted share, and
$166.4 million, or $1.07 per basic and diluted share, respectively,
compared to net loss of $37.7
million, or $0.38 per basic
and diluted share, and $119.4
million, or $1.21 per basic
and diluted share, for the quarter and year ended December 31, 2019, respectively.
Operating Expenses
Research and development (R&D) expenses for the quarter and
year ended December 31, 2020 were
$26.3 million and $94.2 million, respectively, compared to
$22.0 million and $88.0 million, respectively, for the same periods
in 2019. The year-over-year increase in R&D expenses was
primarily related to an increase in drug manufacturing expenses and
outside services related to INO-4800 and other clinical trials, an
increase in engineering services related to our
CELLECTRA® 3PSP device, higher device inventory
expense, an increase in consulting services related to COVID-19,
higher employee stock-based compensation expense due to increased
staff numbers and an increase in patent maintenance and milestone
fees to Wistar. These increases were offset by an increase in
contra-research and development expense recorded from grant
agreements of $33.5 million, among
other variances.
General and administrative (G&A) expenses were $8.6 million and $37.2
million, respectively, for the quarter and year ended
December 31, 2020, versus
$8.7 million and $27.2 million, respectively, for the same periods
in 2019. The year-over-year increase in G&A expenses was
primarily related to an increase in legal expenses and employee and
consultant non-cash stock-based compensation, partially offset by a
gain on foreign exchange among other variances.
Capital Resources
As of December 31, 2020, cash and
cash equivalents and short-term investments were $411.6 million compared to $89.5 million as of December 31, 2019. As of December 31, 2020, the Company had 186.9 million
common shares outstanding and 203.0 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.
On January 25, 2021, the Company
closed an underwritten public offering of 20,355,000 shares of
common stock at a public offering price of $8.50 per share. The net proceeds to the Company,
after deducting the underwriters' discounts and commissions and
other estimated offering expenses, were $162.1 million.
INOVIO's balance sheet and statement of operations are provided
below. Additional information is included in INOVIO's annual report
on Form 10-K for the year ended December 31,
2020, 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, for which programs are being developed with
funding support from the U.S. Department of Defense and the
Coalition for Epidemic Preparedness Innovations (CEPI). 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 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. INOVIO's lead immunotherapy
candidate, VGX-3100, currently in Phase 3 trials for precancerous
cervical dysplasia, cleared high-risk HPV-16 and/or HPV-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
infectious disease DNA vaccine development programs in
coronaviruses associated with COVID-19 diseases and MERS, Lassa
fever, Ebola, and HIV. 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.
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 and commercialize 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 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 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.
|
CONSOLIDATED
BALANCE SHEETS
|
|
|
December
31,
2020
|
|
December
31,
2019
|
|
|
|
ASSETS
|
|
|
Current
assets:
|
|
|
Cash and cash
equivalents
|
$
|
250,728,118
|
|
|
$
|
22,196,097
|
|
Short-term
investments
|
160,914,935
|
|
|
67,338,017
|
|
Accounts
receivable
|
18,559,967
|
|
|
700,073
|
|
Accounts receivable
from affiliated entities
|
503,782
|
|
|
1,332,044
|
|
Prepaid expenses and
other current assets
|
40,357,456
|
|
|
1,584,598
|
|
Prepaid expenses and
other current assets from affiliated entities
|
106,432
|
|
|
1,050,140
|
|
Total current
assets
|
471,170,690
|
|
|
94,200,969
|
|
Fixed assets,
net
|
11,348,144
|
|
|
12,773,017
|
|
Investment in
affiliated entities
|
4,460,366
|
|
|
6,315,356
|
|
Investment in
Geneos
|
434,387
|
|
|
—
|
|
Intangible assets,
net
|
3,146,770
|
|
|
3,693,851
|
|
Goodwill
|
10,513,371
|
|
|
10,513,371
|
|
Operating lease
right-of-use assets
|
12,741,296
|
|
|
13,783,009
|
|
Other
assets
|
25,957,448
|
|
|
2,672,024
|
|
Total
assets
|
$
|
539,772,472
|
|
|
$
|
143,951,597
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
Current
liabilities:
|
|
|
Accounts payable and
accrued expenses
|
$
|
21,203,808
|
|
|
$
|
18,237,258
|
|
Accounts payable and
accrued expenses due to affiliated entities
|
642,969
|
|
|
729,729
|
|
Accrued clinical
trial expenses
|
9,950,345
|
|
|
4,049,727
|
|
Deferred
revenue
|
46,628
|
|
|
92,353
|
|
Deferred revenue from
affiliated entities
|
—
|
|
|
31,775
|
|
Operating lease
liability
|
2,329,394
|
|
|
2,074,842
|
|
Grant funding
liability
|
7,474,310
|
|
|
6,065,212
|
|
Grant funding
liability from affiliated entities
|
58,500
|
|
|
708,425
|
|
Total current
liabilities
|
41,705,954
|
|
|
31,989,321
|
|
Deferred revenue, net
of current portion
|
79,214
|
|
|
101,567
|
|
Convertible senior
notes
|
14,139,988
|
|
|
64,180,325
|
|
Convertible
bonds
|
4,515,834
|
|
|
12,842,592
|
|
Derivative
liability
|
—
|
|
|
8,819,023
|
|
Operating lease
liability, net of current portion
|
18,063,515
|
|
|
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
|
57,663
|
|
|
36,943
|
|
Total
liabilities
|
78,631,714
|
|
|
138,546,739
|
|
Commitments and
contingencies
|
|
|
|
Inovio
Pharmaceuticals, Inc. stockholders' equity:
|
|
|
Preferred stock—par
value $0.001; Authorized shares: 10,000,000, issued and outstanding
shares: 9 at December 31, 2020 and 23 at December 31,
2019
|
—
|
|
|
—
|
|
Common stock—par
value $0.001; Authorized shares: 600,000,000 at December 31, 2020
and December 31, 2019, issued and outstanding: 186,851,493 at
December 31, 2020 and 101,361,034 at December 31,
2019
|
186,851
|
|
|
101,361
|
|
Additional paid-in
capital
|
1,367,406,869
|
|
|
742,646,785
|
|
Accumulated
deficit
|
(906,196,812)
|
|
|
(739,785,655)
|
|
Accumulated other
comprehensive income (loss)
|
(256,150)
|
|
|
472,608
|
|
Total Inovio
Pharmaceuticals, Inc. stockholders' equity
|
461,140,758
|
|
|
3,435,099
|
|
Non-controlling
interest
|
—
|
|
|
1,969,759
|
|
Total stockholders'
equity
|
461,140,758
|
|
|
5,404,858
|
|
Total liabilities
and stockholders' equity
|
$
|
539,772,472
|
|
|
$
|
143,951,597
|
|
INOVIO
Pharmaceuticals, Inc.
|
CONSOLIDATED
STATEMENTS OF OPERATIONS
|
(Unaudited)
|
|
|
For the Year ended
December 31,
|
|
2020
|
|
2019
|
|
2018
|
Revenues:
|
|
|
|
|
|
Revenue under
collaborative research and development arrangements
|
$
|
5,170,586
|
|
|
$
|
3,636,945
|
|
|
$
|
29,860,785
|
|
Revenue under
collaborative research and development arrangements from affiliated
entities
|
1,453,730
|
|
|
235,649
|
|
|
449,524
|
|
Other
revenue
|
786,904
|
|
|
237,536
|
|
|
171,588
|
|
Other revenue from
affiliated entities
|
—
|
|
|
1,800
|
|
|
—
|
|
Total
revenues
|
7,411,220
|
|
|
4,111,930
|
|
|
30,481,897
|
|
Operating
expenses:
|
|
|
|
|
|
Research and
development
|
94,245,436
|
|
|
88,017,319
|
|
|
95,257,876
|
|
General and
administrative
|
37,247,828
|
|
|
27,203,156
|
|
|
29,315,159
|
|
Total operating
expenses
|
131,493,264
|
|
|
115,220,475
|
|
|
124,573,035
|
|
Loss from
operations
|
(124,082,044)
|
|
|
(111,108,545)
|
|
|
(94,091,138)
|
|
Other income
(expense):
|
|
|
|
|
|
Interest
income
|
3,311,846
|
|
|
2,605,981
|
|
|
2,264,747
|
|
Interest
expense
|
(8,702,450)
|
|
|
(7,948,539)
|
|
|
—
|
|
Change in fair value
of common stock warrants
|
—
|
|
|
—
|
|
|
360,795
|
|
Change in fair value
of derivative liability
|
(75,670,977)
|
|
|
(1,763,652)
|
|
|
—
|
|
Gain (loss) on
investment in affiliated entities
|
36,556,658
|
|
|
(3,090,557)
|
|
|
(1,988,567)
|
|
Net unrealized gain
on available-for-sale equity securities
|
1,695,497
|
|
|
—
|
|
|
—
|
|
Other income
(expense), net
|
(704,896)
|
|
|
496,200
|
|
|
(1,343,856)
|
|
Gain on
deconsolidation of Geneos
|
4,121,075
|
|
|
—
|
|
|
—
|
|
Loss on
extinguishment of convertible bonds
|
(8,177,043)
|
|
|
—
|
|
|
—
|
|
Gain on
extinguishment of convertible senior notes
|
8,762,030
|
|
|
—
|
|
|
—
|
|
Net loss before
income tax benefit/(provision for income tax)
|
(162,890,304)
|
|
|
(120,809,112)
|
|
|
(94,798,019)
|
|
Income tax
benefit
|
—
|
|
|
257,335
|
|
|
(2,169,811)
|
|
Share in net loss of
Geneos
|
(4,584,610)
|
|
|
—
|
|
|
—
|
|
Net
loss
|
(167,474,914)
|
|
|
(120,551,777)
|
|
|
(96,967,830)
|
|
Net loss attributable
to non-controlling interest
|
1,063,757
|
|
|
1,192,558
|
|
|
—
|
|
Net loss
attributable to Inovio Pharmaceuticals, Inc.
|
$
|
(166,411,157)
|
|
|
$
|
(119,359,219)
|
|
|
$
|
(96,967,830)
|
|
Net loss per share
attributable to Inovio Pharmaceuticals, Inc.
stockholders
|
|
|
|
|
|
Basic and
diluted
|
$
|
(1.07)
|
|
|
$
|
(1.21)
|
|
|
$
|
(1.05)
|
|
Weighted average
number of common shares outstanding
|
|
|
|
|
|
Basic and
diluted
|
155,126,857
|
|
|
98,717,999
|
|
|
92,539,997
|
|
View original
content:http://www.prnewswire.com/news-releases/inovio-reports-fourth-quarter-2020-and-year-end-financial-results-301237781.html
SOURCE INOVIO Pharmaceuticals, Inc.