PLYMOUTH MEETING, Pa.,
March 12, 2020 /PRNewswire/
-- INOVIO Pharmaceuticals, Inc. (NASDAQ: INO), a biotechnology
company focused on rapidly bringing to market precisely designed
DNA medicines to treat, cure, and protect people from diseases
associated with HPV, cancer, and infectious diseases, today
reported financial results for the fourth quarter and year ended
December 31, 2019. 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.
INOVIO Highlights
VGX-3100: Cervical, vulvar, and anal HSIL
REVEAL 2 Phase 3 clinical trial evaluating VGX-3100 for
treatment of HPV-related cervical high-grade squamous
intraepithelial lesions (HSIL) has a total of 43 sites opened
globally for recruitment, which includes newly opened sites in
Brazil and South Africa, along with four new U.S.-based
sites. Top-line efficacy data from REVEAL 1 Phase 3 clinical trial
is expected to be reported by the fourth quarter of 2020.
INOVIO is also evaluating VGX-3100 in two Phase 2 trials for the
treatment of vulvar HSIL and anal HSIL. Preliminary efficacy and
safety data are planned to be presented later this month at The
American Society for Colposcopy and Cervical Pathology (ASCCP) 2020
Scientific Meeting on Anogenital & HPV-Related Diseases.
INO-3107: Recurrent respiratory papillomatosis (RRP)
In February 2020, INOVIO announced
that the U.S. Food and Drug Administration (FDA) accepted its
Investigational New Drug (IND) application to evaluate INO-3107 in
a Phase 1/2 trial for treatment of recurrent respiratory
papillomatosis (RRP). The Phase 1/2 trial is expected to enroll
approximately 63 subjects in the United
States and will evaluate the efficacy, safety, tolerability,
and immunogenicity of INO-3107 in subjects with HPV 6 and/or
11-associated RRP who have required at least two surgical
interventions per year for the past three years for the removal of
associated papilloma(s). As RRP is a rare, orphan disease, INOVIO
plans to work with the FDA's Office of Orphan Products Development
(OOPD) in an effort to attain Orphan Disease designation for
INO-3107.
INOVIO and its collaborators published data from a pilot,
compassionate use clinical trial for the treatment of RRP in the
scientific journal Vaccines (MDPI). The article, entitled
"Immune Therapy Targeting E6/E7 Oncogenes of Human Papillomavirus
Type 6 (HPV-6) Reduces or Eliminates the Need for Surgical
Intervention in the Treatment of HPV-6 Associated Recurrent
Respiratory Papillomatosis," detailed the clinical efficacy
observed in the pilot study of two patients with RRP.
INO-4800: COVID-19
In January 2020, INOVIO was
awarded a grant of up to $9 million
from the Coalition for Epidemic Preparedness Innovations (CEPI) to
develop a vaccine against COVID-19, the disease caused by the novel
coronavirus. This initial CEPI funding is anticipated to support
INOVIO's preclinical and clinical development through a Phase 1
clinical trial of INO-4800, INOVIO's COVID-19 vaccine candidate, in
the United States.
Subsequent to the grant from CEPI, INOVIO announced a
collaboration agreement with Beijing Advaccine Biotechnology Co. to
advance the development of INO-4800 in China. The goal of this collaboration is to
leverage Beijing Advaccine's expertise to run a Phase 1 trial in
China in parallel with INOVIO's
ongoing clinical development efforts in the United States.
In March 2020, INOVIO received a
new $5 million grant from the Bill
and Melinda Gates Foundation anticipated to fund accelerated
testing and scale up of INOVIO's CELLECTRA® 3PSP proprietary smart
device for the intradermal delivery of INO-4800, in order to
support large scale manufacturing of INO-4800 doses by end of
2020.
INO-5401: Newly diagnosed glioblastoma multiforme
(GBM)
In November 2019, INOVIO reported
positive interim data for INO-5401 from its ongoing Phase 2 trial
in patients with newly diagnosed glioblastoma multiforme (GBM) at
the Society for Immunotherapy of Cancer (SITC) 2019 Annual Meeting.
The Phase 2 trial is evaluating INO-5401, a T cell-activating
immunotherapy candidate encoding for three tumor-specific antigens
(hTERT, WT1, and PSMA), and INO-9012, an immune activator encoding
IL-12, in combination with Libtayo®, a PD-1 blocking
antibody produced by Regeneron Pharmaceuticals in collaboration
with Sanofi.
Key interim data from the 52-patient clinical trial showed that
80% (16 of 20) of MGMT gene promoter methylated patients and 75%
(24 of 32) of unmethylated patients were progression-free at six
months measured from the time of their first dose, substantially
exceeding historical standard-of-care data (approximately 60% of
MGMT promoter methylated patients and 40% of unmethylated patients
historically were progression-free at six months). INOVIO expects
to report 12-month overall survival data in June 2020, followed by 18-month overall survival
data in the fourth quarter of 2020.
Dr. J. Joseph Kim, INOVIO's
President & CEO, said, "The company remains well-positioned for
2020 to be a transformational year for INOVIO. Following our very
encouraging, albeit early, positive data for INO-5401 in our GBM
study, we look forward to presenting 12-month overall survival data
next quarter. We also continue to expand our capabilities in
treating HPV-associated diseases, with IND acceptance from the FDA
for a Phase 2 trial evaluating INO-3107 for the rare, orphan
disease RRP. We also look forward to sharing interim efficacy and
safety data from our Phase 2 study in HPV-associated vulvar HSIL
and anal HSIL at ASCCP later this month."
"The evolving situation following the outbreak of COVID-19 has
allowed us to further showcase INOVIO's technology capabilities and
versatility in fighting emerging infectious diseases. We are very
grateful for both the financial and moral support from CEPI to take
steps toward tackling this global pandemic. Our DNA medicine
platform has been selected among a small group of important vaccine
technologies for rapidly impacting emerging infectious diseases
outbreaks such as COVID-19, having already advanced INO-4700, our
vaccine candidate against MERS-CoV, another coronavirus, to a Phase
1/2a clinical trial. We look forward to sharing more on INO-4800's
development along with our broader pipeline initiatives and
achievements in the future."
Fourth Quarter 2019 Financial Results
Total revenue was $279,000 and
$4.1 million for the quarter and year
ended December 31, 2019,
respectively, compared to $2.5
million and $30.5 million for
the same periods in 2018, respectively. Total operating expenses
were $30.7 million and $115.2 million for the quarter and year ended
December 31, 2019, respectively,
compared to $32.0 million and
$124.6 million for the same periods
in 2018, respectively.
INOVIO's net loss for the quarter and year ended December 31, 2019 was $37.7 million, or $0.38 per basic and diluted share, and
$119.4 million, or $1.21 per basic and diluted share, respectively,
as compared to $33.0 million, or
$0.34 per basic and diluted share,
and $97.0 million, or $1.05 per basic and diluted share, for the same
periods in 2018, respectively.
Revenue
The year-over-year decrease in revenue under collaborative
research and development (R&D) arrangements was primarily due
to the recognition of a one-time upfront payment of $23.0 million form ApolloBio during the second
quarter of 2018.
Operating Expenses
R&D expenses for the quarter and year ended December 31, 2019 were $22.0 million and $88.0
million, respectively, compared to $26.4 million and $95.3
million for the same periods in 2018, respectively. The
year-over-year decrease in R&D expenses was primarily due to
decreases in employee compensation expense and drug manufacturing
expense related to our partnership with AstraZeneca, among other
variances. These decreases were offset by an increase in expenses
related to clinical trials and a personnel-related restructuring
charge in connection with the one-time employee termination costs
incurred during the third quarter of 2019.
General and administrative expenses were $8.7 million and $27.2
million, respectively, for the quarter and year ended
December 31, 2019 versus $5.6 million and $29.3
million, respectively, for the same periods in 2018.
Capital Resources
As of December 31, 2019, cash and
cash equivalents and short-term investments were $89.5 million compared to $93.8 million as of September 30, 2019. As of December 31, 2019, the Company had 101.4 million
common shares outstanding and 132.1 million common shares
outstanding on a fully diluted basis, after giving effect to
outstanding options, restricted stock units and convertible
preferred stock.
During the year ended December 31,
2019, the Company sold 3,340,678 shares of common stock
under its "at-the-market" (ATM) common stock sales agreement for
aggregate net proceeds of $9.1
million.
From January 1, 2020 through
March 11, 2020, the Company sold
43,148,952 shares of common stock under its ATM agreement for net
proceeds of $208.2 million. The sales
were made at a weighted average price of $4.92 per share. As of March 11, 2020, there is no remaining capacity
under the ATM agreement.
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,
2019, 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 10139836.
About INOVIO Pharmaceuticals, Inc.
INOVIO is a biotechnology company focused on rapidly bringing to
market precisely designed DNA medicines to treat, cure, and protect
people from diseases associated with HPV, cancer, and infectious
diseases. 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 immune response to destroy and clear high-risk HPV 16 and
18, which are responsible for 70% of cervical cancer, 90% of anal
cancer and 69% of vulvar cancer. In addition to HPV, INOVIO's
optimized plasmid design and delivery technology have been
demonstrated to consistently activate robust and fully functional T
cell and antibody responses against targeted cancers and pathogens.
INOVIO's most advanced clinical program, VGX-3100, is in Phase 3
development for the treatment of HPV-related cervical pre-cancer.
Also in development are Phase 2 immuno-oncology programs targeting
HPV-related cancers, GBM, and prostate cancer, as well as
externally funded vaccine development programs in Zika, MERS,
Lassa, HIV, and COVID-19. Partners and collaborators include
Advaccine, ApolloBio Corporation, AstraZeneca, The Bill &
Melinda Gates Foundation, Coalition for Epidemic Preparedness
Innovations (CEPI), Defense Advanced Research Projects Agency,
GeneOne Life Science, HIV Vaccines Trial Network, Medical CBRN
Defense Consortium (MCDC), National Cancer Institute, National
Institutes of Health, National Institute of Allergy and Infectious
Diseases, Plumbline Life Sciences, Regeneron, 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.
* * * *
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 clinical trials, and the availability and timing
of data from those trials. 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, 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 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
|
INOVIO
Pharmaceuticals, Inc.
|
|
|
December 31,
|
|
2019
|
|
2018
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
|
22,196,097
|
|
|
$
|
23,693,633
|
|
Short-term
investments
|
67,338,017
|
|
|
57,538,852
|
|
Accounts
receivable
|
700,073
|
|
|
3,316,361
|
|
Accounts receivable
from affiliated entities
|
1,332,044
|
|
|
738,583
|
|
Prepaid expenses and
other current assets
|
1,584,598
|
|
|
1,406,590
|
|
Prepaid expenses and
other current assets from affiliated entities
|
1,050,140
|
|
|
1,120,805
|
|
Total current
assets
|
94,200,969
|
|
|
87,814,824
|
|
Fixed assets,
net
|
12,773,017
|
|
|
15,949,014
|
|
Investments in
affiliated entities
|
6,315,356
|
|
|
9,405,913
|
|
Intangible assets,
net
|
3,693,851
|
|
|
4,760,145
|
|
Goodwill
|
10,513,371
|
|
|
10,513,371
|
|
Operating lease
right-of-use assets
|
13,783,009
|
|
|
—
|
|
Other
assets
|
2,672,024
|
|
|
2,669,998
|
|
Total
assets
|
$
|
143,951,597
|
|
|
$
|
131,113,265
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued expenses
|
$
|
18,237,258
|
|
|
$
|
23,134,733
|
|
Accounts payable and
accrued expenses due to affiliated entities
|
729,729
|
|
|
977,792
|
|
Accrued clinical
trial expenses
|
4,049,727
|
|
|
5,671,764
|
|
Deferred
revenue
|
92,353
|
|
|
223,577
|
|
Deferred revenue from
affiliated entities
|
31,775
|
|
|
33,575
|
|
Deferred
rent
|
—
|
|
|
1,065,387
|
|
Operating lease
liability
|
2,074,842
|
|
|
—
|
|
Grant funding
liability
|
6,065,212
|
|
|
4,165,848
|
|
Grant funding
liability from affiliated entities
|
708,425
|
|
|
27,083
|
|
Total current
liabilities
|
31,989,321
|
|
|
35,299,759
|
|
Deferred revenue, net
of current portion
|
101,567
|
|
|
150,793
|
|
Convertible senior
notes
|
64,180,325
|
|
|
—
|
|
Convertible
bonds
|
12,842,592
|
|
|
—
|
|
Derivative
liability
|
8,819,023
|
|
|
—
|
|
Deferred rent, net of
current portion
|
—
|
|
|
8,518,207
|
|
Operating lease
liability, net of current portion
|
20,409,922
|
|
|
—
|
|
Deferred tax
liabilities
|
32,046
|
|
|
24,766
|
|
Grant funding
liability from affiliated entity, net of current portion
|
135,000
|
|
|
—
|
|
Other
liabilities
|
36,943
|
|
|
87,333
|
|
Total
liabilities
|
138,546,739
|
|
|
44,080,858
|
|
Commitments and
contingencies
|
|
|
|
INOVIO Pharmaceuticals, Inc.
stockholders' equity:
|
|
|
|
Preferred stock—par
value $0.001; Authorized shares: 10,000,000, issued and outstanding
shares: 23 at December 31, 2019 and December 31,
2018
|
—
|
|
|
—
|
|
Common stock—par
value $0.001; Authorized shares: 600,000,000 at December 31,
2019 and December 31, 2018, issued and outstanding: 101,361,034 at
December 31, 2019 and 97,225,810 at December 31,
2018
|
101,361
|
|
|
97,226
|
|
Additional paid-in
capital
|
742,646,785
|
|
|
707,794,215
|
|
Accumulated
deficit
|
(739,785,655)
|
|
|
(620,426,436)
|
|
Accumulated other
comprehensive income (loss)
|
472,608
|
|
|
(528,867)
|
|
Total
INOVIO Pharmaceuticals, Inc. stockholders'
equity
|
3,435,099
|
|
|
86,936,138
|
|
Non-controlling
interest
|
1,969,759
|
|
|
96,269
|
|
Total stockholders'
equity
|
5,404,858
|
|
|
87,032,407
|
|
Total liabilities
and stockholders' equity
|
$
|
143,951,597
|
|
|
$
|
131,113,265
|
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(Unaudited)
|
|
|
For the Year ended
December 31,
|
|
2019
|
|
2018
|
|
2017
|
Revenues:
|
|
|
|
|
|
Revenue under
collaborative research and development arrangements
|
$
|
3,636,945
|
|
|
$
|
29,860,785
|
|
|
$
|
28,407,388
|
|
Revenue under
collaborative research and development arrangements with affiliated
entities
|
235,649
|
|
|
449,524
|
|
|
765,828
|
|
Grants and
miscellaneous revenue
|
237,536
|
|
|
171,588
|
|
|
10,474,539
|
|
Grants and
miscellaneous revenue from affiliated entity
|
1,800
|
|
|
—
|
|
|
2,572,331
|
|
Total
revenues
|
4,111,930
|
|
|
30,481,897
|
|
|
42,220,086
|
|
Operating
expenses:
|
|
|
|
|
|
Research and
development
|
88,017,319
|
|
|
95,257,876
|
|
|
98,572,618
|
|
General and
administrative
|
27,203,156
|
|
|
29,315,159
|
|
|
28,290,369
|
|
Gain on sale of
assets
|
—
|
|
|
—
|
|
|
(1,000,000)
|
|
Total operating
expenses
|
115,220,475
|
|
|
124,573,035
|
|
|
125,862,987
|
|
Loss from
operations
|
(111,108,545)
|
|
|
(94,091,138)
|
|
|
(83,642,901)
|
|
Other income
(expense):
|
|
|
|
|
|
Interest
income
|
2,605,981
|
|
|
2,264,747
|
|
|
1,836,451
|
|
Interest
expense
|
(7,948,539)
|
|
|
—
|
|
|
(25,933)
|
|
Change in fair value
of common stock warrants
|
—
|
|
|
360,795
|
|
|
806,819
|
|
Change in fair value
of derivative liability
|
(1,763,652)
|
|
|
—
|
|
|
—
|
|
Loss on investment in
affiliated entities
|
(3,090,557)
|
|
|
(1,988,567)
|
|
|
(6,982,664)
|
|
Other income
(expense), net
|
496,200
|
|
|
(1,343,856)
|
|
|
(197,544)
|
|
Net loss before
income tax benefit/(provision for income tax)
|
(120,809,112)
|
|
|
(94,798,019)
|
|
|
(88,205,772)
|
|
Income tax benefit
(provision for income taxes)
|
257,335
|
|
|
(2,169,811)
|
|
|
—
|
|
Net
loss
|
(120,551,777)
|
|
|
(96,967,830)
|
|
|
(88,205,772)
|
|
Net loss attributable
to non-controlling interest
|
1,192,558
|
|
|
—
|
|
|
—
|
|
Net loss
attributable to INOVIO Pharmaceuticals,
Inc.
|
$
|
(119,359,219)
|
|
|
$
|
(96,967,830)
|
|
|
$
|
(88,205,772)
|
|
Net loss
per share attributable to INOVIO Pharmaceuticals,
Inc. stockholders
|
|
|
|
|
|
Basic
|
$
|
(1.21)
|
|
|
$
|
(1.05)
|
|
|
$
|
(1.08)
|
|
Diluted
|
$
|
(1.21)
|
|
|
$
|
(1.05)
|
|
|
$
|
(1.09)
|
|
Weighted average
number of common shares outstanding
|
|
|
|
|
|
Basic
|
98,717,999
|
|
|
92,539,997
|
|
|
81,777,493
|
|
Diluted
|
98,717,999
|
|
|
92,539,997
|
|
|
81,918,022
|
|
CONTACTS:
Investors:
Ben Matone, 484-362-0076,
ben.matone@inovio.com
Media:
Jeff Richardson, 267-440-4211,
jrichardson@inovio.com
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SOURCE INOVIO Pharmaceuticals, Inc.