PLYMOUTH MEETING, Pa.,
May 10, 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 March 31, 2021.
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,
covering, among other things: the company's recently reported Phase
2 segment trial data and plans for a global Phase 3 segment for
INO-4800's INNOVATE Phase 2/3 clinical trial; an overall update on
the company's COVID-19 vaccine developments to address current and
future variants of concern (VOC) through its INO-4800 and the
pan-COVID INO-4802; and a general update on 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, "As the global community continues to contend
with the COVID-19 pandemic, and as we prepare for endemic
considerations to support the continued fight against variants,
INOVIO remains well-positioned to address the global demand for
COVID-19 vaccines. We recognize that there is an opportunity to
have a meaningful impact in the fight against COVID-19 outside the
U.S. and, are planning for a global Phase 3 trial for INO-4800.
INOVIO is also encouraged by the positive data from the Phase 2
segment of our Phase 2/3 trial of INO-4800, which is being
conducted in the United States.
INO-4800 continues to be safe and well-tolerated and has been
observed to support the body's ability to generate both robust
neutralizing antibodies and T cell responses – which we believe to
be essential in protecting against current and emerging variants of
concern. Equally important, INO-4800 has a favorable
thermostability profile and does not require cold or ultra-cold
chain transport."
Dr. Kim added, "INOVIO continues to be pleased with the progress
across our DNA medicines platform, and our efforts to address not
only infectious disease but also cancer and HPV-associated
diseases, and we look forward to sharing additional updates on GBM
this summer."
INOVIO Key Updates & First Quarter 2021
Highlights
Key Updates
- This morning, INOVIO announced positive preliminary
immunogenicity and safety data from the Phase 2 segment of INNOVATE
(INOVIO INO-4800 Vaccine Trial for
Efficacy), its clinical trial evaluating COVID-19 DNA
vaccine candidate, INO-4800. The Phase 2 data showed the vaccine to
be safe, well-tolerated and immunogenic in all tested age groups.
The Phase 2 results from approximately 400 patients helped
determine INOVIO's selection of a 2.0 mg dose for the global Phase
3 segment of the trial.
- INOVIO met primary and secondary efficacy endpoints among all
evaluable subjects for REVEAL 1 (Randomized
Evaluation of VGX-3100 and Electroporation for
the treatment of Cervical HSIL) trial. REVEAL 2, the
confirmatory Phase 3 trial for VGX-3100, continues to enroll
globally across 48 study sites.
- INOVIO and QIAGEN extended their partnership in late February
with a new master collaboration agreement to include the
co-development of a pre-treatment RNA-based biomarker blood test
designed to identify prospective patients who are most likely to
benefit from the clinical use of VGX-3100.
- In February, INOVIO dosed its first patient in a Phase
1b clinical trial for INO-4500, its
DNA vaccine candidate for Lassa fever, in Ghana. INO-4500 is the first vaccine candidate
for Lassa fever to enter human trials. As part of a 2018
partnership, INOVIO and CEPI are committed to making INO-4500
available for possible emergency use as a stockpile product after
successful completion of the Phase 2 trial.
INOVIO First Quarter 2021 Program Updates
DNA Vaccine Candidates
INO-4800: INNOVATE Phase 2/3 Clinical Trial
The Phase 2 segment of INNOVATE was designed to evaluate the
safety, tolerability and immunogenicity of INO-4800 in a two-dose
regimen (1.0 mg or 2.0 mg) in a three-to-one-randomization to
receive either INO-4800 or placebo for each dose to identify
optimal dose(s) for two age groups (18-50 years and 51 years and
older) for the subsequent Phase 3 efficacy evaluation. The
preliminary Phase 2 results showed that INO-4800 was safe,
well-tolerated and immunogenic in all tested age groups. The trial
was funded by the Department of Defense Joint Program Executive
Office for Chemical, Biological, Radiological and Nuclear Defense,
(JPEO-CBRND) in coordination with the Office of the Assistant
Secretary of Defense for Health Affairs (OASD(HA)) and the Defense
Health Agency. Results from the trial can be found in the paper
entitled "Safety and immunogenicity of INO-4800 DNA vaccine against
SARS-CoV-2: A Preliminary Report of a Randomized, Blinded,
Placebo-controlled, Phase 2 Clinical Trial in Adults at High Risk
of Viral Exposure," has been published as a pre-print in MedRxiv
(https://doi.org/10.1101/2021.05.07.21256652) prior to peer
review.
Findings from the Phase 2 Clinical Trial:
- The Phase 2 segment of the trial enrolled approximately 400
participants, 18 years of age or older, at 16 U.S. sites.
- Participants received either INO-4800 (1.0 mg or 2.0 mg dose)
or placebo at 0 and 4 weeks (randomized 3:3:1:1). Each dose was
administered by intradermal injection followed by electroporation
using INOVIO's CELLECTRA®, its proprietary smart
device.
- Safety endpoints included systemic and local administration
site reactions through 8 weeks post-dose one (or 4 weeks post-dose
2). Immunology endpoints included antigen-specific binding antibody
titers, neutralization titers, and antigen-specific
interferon-gamma (IFN-γ) cellular immune responses after two doses
of the vaccine.
- Vaccine administration was generally safe and well-tolerated.
The majority of adverse events (AEs) were Grade 1 and Grade 2 in
severity and did not appear to increase in frequency with the
second dose. The number of participants experiencing each of the
most common AEs did not differ between the two dosing groups.
- The geometric mean fold rise of binding and neutralizing
antibody levels were statistically significantly greater in the 2.0
mg dose group versus the 1.0 mg dose group.
- The T cell immune responses measured by the ELISpot assay were
also higher in the 2.0 mg dose group compared to the 1.0 mg dose
group.
- ClinicalTrials.gov identifier: NCT04642638
Phase 2 results informed INOVIO's selection of a 2.0 mg dose for
the Phase 3 segment of the trial. Given the increasing availability
of COVID-19 vaccines authorized for emergency use, in April the
Department of Defense Joint Program Executive Office for Chemical,
Biological, Radiological and Nuclear Defense (JPEO-CBRND), in
coordination with the Office of the Assistant Secretary of Defense
for Health Affairs (OASD(HA)) and the Defense Health Agency (DHA),
informed INOVIO that it will discontinue funding for the planned
Phase 3 segment of the INNOVATE trial, while continuing to fund the
completion of the ongoing Phase 2 segment. JPEO informed INOVIO
that: "The decision results from the changing environment of
COVID-19 with the rapid deployment of vaccines. This decision is
not a reflection of the awardee or product, rather a fast-moving
environment associated with the former Operation Warp Speed on
decisions related to future products." The decision by JPEO does
not impact other work that INOVIO does with the U.S. government and
is neither a result of the current FDA partial clinical hold nor a
reflection of the data generated to date for INO-4800.
Recognizing the need to plan for both pandemic and endemic
scenarios, as well as the global demand for safe and effective
vaccines that are also stable at room temperature and do not
require cold-chain or ultra-cold chain transport, INOVIO also
announced in April 2021 that it plans
to proceed with a global Phase 3 clinical trial for INO-4800 and is
working with funders and partners to achieve this plan. The company
plans to initiate the global Phase 3 trial this summer.
INO-4800 and INO-4802: Planning for Existing and Future Variants
of Concern
INOVIO continues to evaluate the impact of existing and
potential new variants of concern for SARS-CoV-2, the virus that
causes COVID-19, as well as assessing boosting capabilities for
INO-4800. The company is assessing the impact that new circulating
strains of the SARS-CoV-2 virus have on the immune profile elicited
by INO-4800.
In April, INOVIO published results from a study showing that
INO-4800 provides broad cross-reactive immune responses in humans
against variants of concern. The study showed the T cell responses
induced by INO-4800 vaccination were fully maintained against the
UK, South African and Brazilian variants when compared to the T
cell responses to the original Wuhan strain. The neutralization levels of
INO-4800 against South African and UK variants were reduced to the
levels similar to the previous reports of mRNA or viral vector
vaccines. Furthermore, despite recent reports showing a reduction
in neutralizing activity against the Brazilian variant by the mRNA
or viral vector vaccines, INO-4800 generated robust neutralizing
antibodies at levels against the Brazilian variant that were
comparable to those observed against the Wuhan 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 SARS-CoV-2 variants.
The study, entitled "INO-4800 DNA Vaccine Induces T Cell
Activity and Neutralizing Antibodies Against Global SARS-CoV-2
Variants," has been submitted for peer review and is available
via pre-print in bioRxiv.
In parallel to the late-stage development of INO-4800, the
company is also developing a novel, pan-COVID, second-generation
vaccine candidate, INO-4802, which is designed to protect against
current and potentially future circulating variants. This pan-COVID
vaccine could potentially offer boosting capabilities in addition
to an initial vaccination regimen with INO-4800 and/or other
first-generation vaccines. INOVIO looks forward to sharing
additional information on INO-4802 soon.
DNA Immunotherapies: HPV-associated Diseases and
Immuno-Oncology
HPV-related Diseases
VGX-3100: Cervical, Vulvar, and Anal HSIL
REVEAL 1 / REVEAL 2 (Cervical HSIL)
In the first quarter, INOVIO announced that it met primary and
secondary efficacy endpoints among all evaluable subjects for
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 HSIL caused by
HPV-16 and/or HPV-18 using the company's proprietary
CELLECTRA® 5PSP device. This trial is one of two ongoing
pivotal, randomized, double-blind, multi-center,
placebo-controlled, Phase 3 trials (REVEAL 1 and REVEAL 2) designed
to assess and confirm the safety, tolerability, immunogenicity, and
efficacy of VGX-3100.
INOVIO continues to follow subjects in REVEAL 1 for safety and
durability of response for 18 months following the last
administration and expects to present its findings at a scientific
meeting later this year. The company anticipates subject level
full unblinding for REVEAL 1 in the second half of 2021, which will
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. The biomarker blood test could be used
to identify prospective VGX-3100 patients who would be most likely
to respond to the immunotherapy – an important element of VGX-3100
product and market development. Subject level unblinding for REVEAL
1 will be a key component in enhancing the immune signature of the
biomarker, followed by potential confirmatory biomarker data from
REVEAL 2.
REVEAL 2 continues to enroll across 48 sites globally. The
company continues to assess the impact that the existing pandemic
will have on future enrollment in the REVEAL 2 trial. The company
believes that it will be in a more suitable position at mid-year to
determine if any protocol and/or recruitment adjustments will be
necessary.
REVEAL 1 Results
The trial protocol-defined modified intention to treat (mITT)
population (N=193) included 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 HPV-16
and/or HPV-18 viral clearance, b) regression of cervical HSIL
alone, c) regression of cervical HSIL to normal tissue, and d)
HPV-16 and/or HPV-18 viral clearance alone. 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.
Vulvar and Anal HSIL
In January 2021, INOVIO 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.
The data from the Phase 2 trial of vulvar and anal dysplasia
treatments with VGX-3100 were presented at the 2021 ASCCP Virtual
Conference. INOVIO continues to evaluate best options for Phase 3
clinical trials for vulvar and anal dysplasia pending further
discussions with the FDA.
Immuno-oncology
INO-5401: Newly Diagnosed Glioblastoma Multiforme
(GBM)
INOVIO is currently conducting a 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 – in the treatment of newly
diagnosed GBM, the deadliest and most aggressive form of brain
cancer. 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®.
In late 2020, INOVIO shared encouraging interim OS18 data, which
also demonstrated immunogenicity and tolerability in a majority of
patients. The company anticipates sharing two-year (24 months)
overall survival data, including correlative immunology and tissue
data, later this year.
First Quarter 2021 Financial Results
Total revenue was $371,000 for the
three months ended March 31, 2021,
compared to $1.3 million for the same
period in 2020. Total operating expenses were $52.9 million compared to $26.6 million for the same period in 2020.
INOVIO's net loss for the quarter ended March 31, 2021 was $54.4
million, or $0.27 per basic
and diluted share, compared to net loss of $32.5 million, or $0.26 per basic and diluted share, for the
quarter ended March 31,
2020.
Operating Expenses
Research and development (R&D) expenses for the three months
ended March 31, 2021, were
$39.0 million compared to
$19.1 million for the same period in
2020. The increase in R&D expenses was primarily related to
higher drug manufacturing expenses and outside services related to
INO-4800 and other clinical trials, higher employee and contractor
compensation, including non-cash stock-based compensation, an
increase in engineering services related to our
CELLECTRA® 3PSP device and higher device inventory
expense. These increases were offset by an increase in
contra-research and development expense recorded from grant
agreements of $8.8 million, among
other variances.
General and administrative (G&A) expenses were $13.9 million for the three months ended
March 31, 2021, versus $7.4 million for the same period in 2020. The
increase in G&A expenses was primarily related to an increase
in employee and consultant compensation, including non-cash
stock-based compensation and legal expenses, among other
variances.
Capital Resources
On January 25, 2021, the company
closed an underwritten public offering of 20,355,000 shares of
common stock at a price of $8.50 per
share. The net proceeds to the company, after deducting the
underwriters' discounts and commissions and other offering
expenses, were $162.1 million.
As of March 31, 2021, cash and
cash equivalents and short-term investments were $518.6 million compared to $411.6 million as of December 31, 2020. As of March 31, 2021, the company had 209.3 million
common shares outstanding and 226.5 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 quarter ended March 31, 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, 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. 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 U.S., 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.
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, 2020, our
Quarterly Report on Form 10-Q for the quarter ended March 31, 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
|
|
|
March
31, 2021
|
|
December
31, 2020
|
|
(Unaudited)
|
|
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
|
83,634,176
|
|
|
$
|
250,728,118
|
|
Short-term
investments
|
434,969,528
|
|
|
160,914,935
|
|
Accounts
receivable
|
9,911,922
|
|
|
18,559,967
|
|
Accounts receivable
from affiliated entities
|
346,974
|
|
|
503,782
|
|
Prepaid expenses and
other current assets
|
59,572,236
|
|
|
40,357,456
|
|
Prepaid expenses and
other current assets from affiliated entities
|
—
|
|
|
106,432
|
|
Total current
assets
|
588,434,836
|
|
|
471,170,690
|
|
Fixed assets,
net
|
10,930,312
|
|
|
11,348,144
|
|
Investment in
affiliated entities
|
3,629,891
|
|
|
4,460,366
|
|
Investment in
Geneos
|
—
|
|
|
434,387
|
|
Intangible assets,
net
|
3,010,000
|
|
|
3,146,770
|
|
Goodwill
|
10,513,371
|
|
|
10,513,371
|
|
Operating lease
right-of-use assets
|
12,463,006
|
|
|
12,741,296
|
|
Other
assets
|
25,881,934
|
|
|
25,957,448
|
|
Total
assets
|
$
|
654,863,350
|
|
|
$
|
539,772,472
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued expenses
|
$
|
25,974,530
|
|
|
$
|
21,203,808
|
|
Accounts payable and
accrued expenses due to affiliated entities
|
768,261
|
|
|
642,969
|
|
Accrued clinical
trial expenses
|
7,370,869
|
|
|
9,950,345
|
|
Deferred
revenue
|
15,378
|
|
|
46,628
|
|
Deferred revenue from
affiliated entities
|
39,000
|
|
|
—
|
|
Operating lease
liability
|
2,395,928
|
|
|
2,329,394
|
|
Grant funding
liability
|
4,975,484
|
|
|
7,474,310
|
|
Grant funding
liability from affiliated entities
|
—
|
|
|
58,500
|
|
Total current
liabilities
|
41,539,450
|
|
|
41,705,954
|
|
Deferred revenue, net
of current portion
|
75,501
|
|
|
79,214
|
|
Convertible senior
notes
|
14,069,722
|
|
|
14,139,988
|
|
Convertible
bonds
|
—
|
|
|
4,515,834
|
|
Operating lease
liability, net of current portion
|
17,438,841
|
|
|
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
|
73,257,201
|
|
|
78,631,714
|
|
Stockholders'
equity:
|
|
|
|
Preferred
stock
|
—
|
|
|
—
|
|
Common
stock
|
209,333
|
|
|
186,851
|
|
Additional paid-in
capital
|
1,542,261,467
|
|
|
1,367,406,869
|
|
Accumulated
deficit
|
(960,598,943)
|
|
|
(906,196,812)
|
|
Accumulated other
comprehensive loss
|
(265,708)
|
|
|
(256,150)
|
|
Total Inovio
Pharmaceuticals, Inc. stockholders' equity
|
581,606,149
|
|
|
461,140,758
|
|
Total liabilities
and stockholders' equity
|
$
|
654,863,350
|
|
|
$
|
539,772,472
|
|
INOVIO
Pharmaceuticals, Inc.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(Unaudited)
|
|
|
Three Months Ended
March 31,
|
|
2021
|
|
2020
|
Revenues:
|
|
|
|
Revenue under
collaborative research and development arrangements
|
$
|
39,615
|
|
|
$
|
71,500
|
|
Revenue under
collaborative research and development arrangements with affiliated
entities
|
49,949
|
|
|
1,172,126
|
|
Other
revenue
|
281,556
|
|
|
83,648
|
|
Total
revenues
|
371,120
|
|
|
1,327,274
|
|
Operating
expenses:
|
|
|
|
Research and
development
|
39,044,418
|
|
|
19,111,188
|
|
General and
administrative
|
13,881,194
|
|
|
7,448,354
|
|
Total operating
expenses
|
52,925,612
|
|
|
26,559,542
|
|
Loss from
operations
|
(52,554,492)
|
|
|
(25,232,268)
|
|
Other income
(expense):
|
|
|
|
Interest
income
|
769,237
|
|
|
416,569
|
|
Interest
expense
|
(513,034)
|
|
|
(2,803,755)
|
|
Change in fair value
of derivative liability
|
—
|
|
|
(13,221,977)
|
|
Gain (loss) on
investment in affiliated entities
|
(830,475)
|
|
|
13,181,619
|
|
Net unrealized loss
on available-for-sale equity securities
|
(847,958)
|
|
|
(5,050,092)
|
|
Other income
(expense), net
|
8,978
|
|
|
(425,500)
|
|
Net loss before
share in net loss of Geneos
|
(53,967,744)
|
|
|
(33,135,404)
|
|
Share in net loss of
Geneos
|
(434,387)
|
|
|
—
|
|
Net
loss
|
(54,402,131)
|
|
|
(33,135,404)
|
|
Net loss attributable
to non-controlling interest
|
—
|
|
|
594,350
|
|
Net loss
attributable to Inovio Pharmaceuticals, Inc.
|
$
|
(54,402,131)
|
|
|
$
|
(32,541,054)
|
|
Net loss per share
attributable to Inovio Pharmaceuticals, Inc.
stockholders
|
|
|
|
Basic and diluted
|
$
|
(0.27)
|
|
|
$
|
(0.26)
|
|
Weighted average
number of common shares outstanding
|
|
|
|
Basic and diluted
|
202,414,445
|
|
|
124,623,263
|
|
View original
content:http://www.prnewswire.com/news-releases/inovio-reports-first-quarter-2021-financial-results-301287829.html
SOURCE INOVIO Pharmaceuticals, Inc.