- Announces prioritization of heterologous booster strategy for
COVID-19 vaccine candidate INO-4800 and discontinuation of Phase 3
INNOVATE trial to optimize potential impact on global public
health
- Reports, with partner Advaccine, positive T cell immune
response data with INO-4800 as a heterologous booster to an
inactivated COVID-19 vaccine
- Announces change in plans for VGX-3100 following input from FDA
on need for additional trials for a marketing application for the
treatment of HPV-associated cervical high-grade squamous
intraepithelial lesions
- Announces appointment of Jacqueline
Shea, Ph.D. as CEO
- Will hold investor call today at 4:30 PM
EDT
PLYMOUTH MEETING, Pa.,
May 10, 2022 /PRNewswire/ -- INOVIO
(NASDAQ: INO), a biotechnology company focused on developing and
commercializing DNA medicines to help protect people from
infectious diseases and treat people with cancer and HPV-associated
diseases, today reported financial results for the quarter ended
March 31, 2022 and announced recent
program and corporate developments. INOVIO's management will host a
live conference call and webcast at 4:30
p.m. Eastern Time today to discuss financial results and
provide a general business update. The live webcast and replay may
be accessed by visiting INOVIO's website at
http://ir.inovio.com/events-and-presentations/default.aspx.
In a separate press release, the Company announced the
appointment of Jacqueline Shea,
Ph.D., as President and Chief Executive Officer (CEO). Dr. Shea,
INOVIO's former Chief Operating Officer, succeeds Dr. J.
Joseph Kim in these roles.
"We believe in the potential of our DNA medicines and vaccines
to combat infectious diseases, cancer and HPV-associated diseases,"
said Dr. Jacqueline Shea, President
and CEO of INOVIO. "To achieve these goals, INOVIO must
strategically prioritize our resources to capitalize on its
demonstrated ability to generate functional T-cell and antibody
immune responses, lack of anti-vector response, tolerability for
re-administration and favorable temperature stability for
transport, storage and distribution."
First Quarter Program Updates
COVID-19: INNOVATE
INOVIO has decided to prioritize its COVID-19 efforts to advance
its heterologous booster strategy. In so doing, the company will
discontinue its Phase 3 INNOVATE trial. This decision reflects
emerging global data that indicate a lower incidence of severe
COVID-19 cases1, which would necessitate an increase in
trial size and costs for INNOVATE. In contrast, the heterologous
booster market offers greater opportunities as the world prepares
to enter the endemic phase of COVID-19.
COVID-19: Heterologous Booster – Preliminary Data
With its partner, Advaccine, INOVIO reported positive T cell
immune response data with INO-4800 as a heterologous booster to an
inactivated COVID-19 vaccine. This data came from a heterologous
booster clinical trial conducted by Advaccine that assessed the
immune responses following a primary series of two doses of an
inactivated COVID-19 vaccine followed by a booster with INO-4800
after 3 or 6 months. Interim immunogenicity data showed that
using INO-4800 as a booster after 6 months resulted in a 6.3-fold
increase in T cell immune response. In a separate Advaccine study
where a third dose of an inactivated COVID-19 vaccine was assessed,
the cellular response increased by 1.7-fold. The highest booster
effect of INO-4800 was observed with a 2 mg dose of INO-4800
delivered 6 months after a primary series with an inactivated
vaccine.
Following INO-4800 vaccination, the preservation of
cross-reactive T cell responses remains a consistent observation
against multiple SARS-CoV-2 variants of concern, including Omicron,
without a significant loss in response magnitude. T cells that can
recognize SARS-CoV-2 may play a role in reducing disease severity.
Therefore, INO-4800 has the potential to play an important role in
reducing incidence of severe COVID-19 cases, which could reduce
hospitalizations as the virus continues to mutate and new variants
arise.
INOVIO is continuing discussions with regulators in select
countries regarding potential regulatory pathways for licensure.
The Company believes the increased global awareness about the
importance of T cell immune responses and durability of protection
for effective booster vaccines correspond well with INO-4800's key
strength – its ability to generate CD8+ T cell responses
against SARS-CoV-2.
INOVIO is planning to expand its partnership with Advaccine
beyond INO-4800 to include heterologous boosters and vaccine
candidates covering future variants. The expanded partnership will
allow both companies to share data, leverage Advaccine's multiple
manufacturing sites in China, and
access opportunities globally.
VGX-3100: HPV-associated Cervical High-Grade Squamous
Intraepithelial Lesions (HSIL)
Based on feedback from the U.S. Food and Drug Administration
(FDA), INOVIO has changed its development plans for VGX-3100 for
HPV-16/18-associated cervical HSIL to a biomarker-selected
population. In a recent preliminary letter, the FDA advised INOVIO
that the REVEAL2 Phase 3 study would not be sufficient to support
approval of a potential marketing application for VGX-3100 in that
population. The FDA recommended that using REVEAL2 as an
exploratory study to evaluate a biomarker-selected population and
then conducting one or two additional well-controlled trials in the
biomarker-positive population would be more likely to provide
sufficient evidence to support approval of a marketing
application.
To better assess potential efficacy in a biomarker-selected
population, the Company plans to amend the fully enrolled
REVEAL2 trial to revise the primary analysis population from the
all-comers population to the biomarker-positive population. Both
the biomarker-positive population and the all-comers population
will be analyzed.
INOVIO will continue its REVEAL2 trial to completion and assess
the path forward for the VGX-3100 program following analysis of the
REVEAL2 results. Given the likelihood for at least one additional
trial, INOVIO no longer expects to submit a BLA in 2023 for
VGX-3100.
INO-3107: Recurrent Respiratory Papillomatosis (RRP)
INOVIO completed enrollment of 32 participants in the
open-label, multicenter Phase 1/2 trial to evaluate the efficacy,
safety, tolerability, and immunogenicity of INO-3107 in
participants with HPV-6/11-associated RRP who have required at
least two interventions in the past year for the removal of
associated papilloma(s). For this study, adult participants will
first undergo removal of their papilloma(s) and will subsequently
receive four doses of INO-3107, one every three weeks. The efficacy
endpoint will be a reduction in the frequency of therapeutic
interventions following the first dose of INO-3107 relative to the
frequency prior to study therapy.
INOVIO expects preliminary efficacy, safety and immunogenicity
data from a portion of participants from this Phase 1/2 trial in
the second half of this year. The Company will share additional
clinical development plans after analysis of the data.
INO-5401: Newly Diagnosed Glioblastoma Multiforme
(GBM)
INOVIO's abstract providing follow-up Phase 1/2 overall
survival, safety and immunogenicity data from the Company's novel
combination trial of DNA medicines INO-5401 and INO-9012 in
combination with Regeneron's PD-1 inhibitor Libtayo® (cemiplimab)
in the treatment of newly diagnosed GBM has been selected for oral
presentation as part of an Oral Abstract Session at the 2022
American Society of Clinical Oncology (ASCO) Annual Meeting under
the title "Intramuscular (IM)
INO-5401 + INO-9012 with electroporation (EP) in combination
with cemiplimab (REGN2810) in newly diagnosed glioblastoma".
The complete text of the abstract will be posted on the website,
meetings.asco.org, on May 26, 2022 at
5:00 PM EDT. The 2022 ASCO Annual
Meeting will take place on June 3-7,
2022 at the McCormick Place Convention Center in
Chicago, Illinois.
First Quarter 2022 Financial Results
INOVIO reported total revenue was $199,000 for the three months ended March 31, 2022, compared to $371,000 for the same period in 2021. Total
operating expenses were $71.9 million
compared to $52.9 million for the
same period in 2021.
INOVIO's net loss for the quarter ended March 31, 2022, was $79.1
million, or $0.36 per basic
and diluted share, compared to net loss of $54.4 million, or $0.27 per basic and diluted share, for the
quarter ended March 31, 2021.
Operating Expenses
Research and development (R&D) expenses for the three months
ended March 31, 2022, were
$56.0 million compared to
$39.0 million for the same period in
2021. The increase in R&D expenses was primarily related to
higher drug manufacturing and clinical trial expenses related to
INO-4800 and higher employee compensation. The increase was also
due to $6.3 million lower
contra-research and development expense recorded from grant
agreements. These increases were offset by lower engineering
services and expensed equipment related to our
CELLECTRA® 3PSP device array automation project, among
other variances.
General and administrative (G&A) expenses were $16.0 million for the three months ended
March 31, 2022, versus $13.9 million for the same period in 2021. The
increase in G&A expenses was primarily related to an increase
in employee compensation and insurance expenses, among other
variances.
Capital Resources
As of March 31, 2022, cash and
cash equivalents and short-term investments were $360.4 million compared to $401.3 million as of December 31, 2021. As of March 31, 2022, the Company had 226.5 million
common shares outstanding and 247.8 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, 2022, 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 Daylight Time
today to discuss INOVIO's financial results and provide a general
business update. The live webcast and replay may be accessed by
visiting INOVIO's website at
http://ir.inovio.com/events-and-presentations/default.aspx.
About INOVIO
INOVIO is a biotechnology company focused on developing and
commercializing DNA medicines to help protect people from
infectious diseases and help treat people with cancer and
HPV-associated diseases. Our DNA medicines are delivered using our
proprietary smart device to produce a robust and tolerable immune
response against targeted pathogens and cancers.
Partners and collaborators include Advaccine, ApolloBio
Corporation, AstraZeneca, The Bill & Melinda Gates Foundation,
Coalition for Epidemic Preparedness Innovations, Defense Advanced
Research Projects Agency/Joint Program Executive Office for
Chemical, Biological, Radiological and Nuclear Defense/Department
of Defense, HIV Vaccines Trial Network, International Vaccine
Institute, Kaneka Eurogentec, Medical CBRN Defense Consortium,
National Cancer Institute, National Institutes of Health, National
Institute of Allergy and Infectious Diseases, Ology Bioservices,
the Parker Institute for Cancer Immunotherapy, Plumbline Life
Sciences, Regeneron, Richter-Helm BioLogics, Thermo Fisher
Scientific, University of Pennsylvania,
Walter Reed Army Institute of Research, and The Wistar Institute.
For more information, visit www.inovio.com.
CONTACTS:
Media: Jeff
Richardson, 267-440-4211, jeff.richardson@inovio.com
Investors: Ben Matone, 484-362-0076,
ben.matone@inovio.com
References:
1. Institute for Health Metrics Evaluation. Used with
permission. All rights reserved.
* * * *
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, our planned
heterologous booster strategy, our ability to obtain regulatory
approval for our product candidates, and our plans to expand our
collaboration with Advaccine.. 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, 2021, our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, 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,
2022
|
|
December 31,
2021
|
|
|
|
ASSETS
|
|
|
Current
assets:
|
|
|
Cash and cash
equivalents
|
$
59,009,491
|
|
$
71,143,778
|
Short-term
investments
|
301,384,357
|
|
330,170,940
|
Accounts
receivable
|
4,003,680
|
|
5,466,850
|
Accounts receivable
from affiliated entities
|
3,487,116
|
|
2,565,194
|
Prepaid expenses and
other current assets
|
31,946,477
|
|
38,836,991
|
Prepaid expenses and
other current assets from affiliated entities
|
75,772
|
|
261,192
|
Total current
assets
|
399,906,893
|
|
448,444,945
|
Fixed assets,
net
|
16,696,936
|
|
17,453,206
|
Investment in
affiliated entity
|
3,369,068
|
|
3,906,796
|
Intangible assets,
net
|
2,499,585
|
|
2,626,355
|
Goodwill
|
10,513,371
|
|
10,513,371
|
Operating lease
right-of-use assets
|
11,251,440
|
|
11,571,026
|
Other
assets
|
1,273,795
|
|
1,425,794
|
Total
assets
|
$
445,511,088
|
|
$
495,941,493
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
Current
liabilities:
|
|
|
Accounts payable and
accrued expenses
|
$
38,115,396
|
|
$
47,644,530
|
Accounts payable and
accrued expenses due to affiliated entities
|
1,407,386
|
|
548,032
|
Accrued clinical
trial expenses
|
11,827,755
|
|
10,326,266
|
Deferred
revenue
|
15,378
|
|
21,628
|
Operating lease
liability
|
2,672,974
|
|
2,603,956
|
Grant funding
liability
|
5,283,271
|
|
4,559,721
|
Grant funding
liability from affiliated entity
|
37,500
|
|
37,500
|
Total current
liabilities
|
59,359,660
|
|
65,741,633
|
Deferred revenue, net
of current portion
|
60,648
|
|
64,361
|
Convertible senior
notes
|
16,207,864
|
|
14,959,647
|
Operating lease
liability, net of current portion
|
14,765,868
|
|
15,459,559
|
Deferred tax
liabilities
|
32,046
|
|
32,046
|
Other
liabilities
|
—
|
|
14,826
|
Total
liabilities
|
90,426,086
|
|
96,272,072
|
Stockholders'
equity:
|
|
|
Preferred
stock
|
—
|
|
—
|
Common
stock
|
226,509
|
|
217,382
|
Additional paid-in
capital
|
1,642,419,819
|
|
1,609,589,797
|
Accumulated
deficit
|
(1,287,103,438)
|
|
(1,209,855,522)
|
Accumulated other
comprehensive loss
|
(457,888)
|
|
(282,236)
|
Total Inovio
Pharmaceuticals, Inc. stockholders' equity
|
355,085,002
|
|
399,669,421
|
Total liabilities
and stockholders' equity
|
$
445,511,088
|
|
$
495,941,493
|
INOVIO
Pharmaceuticals, Inc.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(Unaudited)
|
|
|
Three Months
Ended March 31,
|
|
2022
|
|
2021
|
|
Revenues:
|
|
|
Revenue under
collaborative research and development arrangements
|
$
65,895
|
|
$
39,615
|
|
Revenue under
collaborative research and development arrangements with
affiliated
entities
|
8,842
|
|
49,949
|
|
Other
revenue
|
124,337
|
|
281,556
|
|
Total
revenues
|
199,074
|
|
371,120
|
|
Operating
expenses:
|
|
|
Research and
development
|
55,978,611
|
|
39,044,418
|
|
General and
administrative
|
15,953,458
|
|
13,881,194
|
|
Total operating
expenses
|
71,932,069
|
|
52,925,612
|
|
Loss from
operations
|
(71,732,995)
|
|
(52,554,492)
|
|
Other income
(expense):
|
|
|
Interest
income
|
669,814
|
|
769,237
|
|
Interest
expense
|
(313,488)
|
|
(513,034)
|
|
Loss on investment in
affiliated entities
|
(537,728)
|
|
(830,475)
|
|
Net unrealized loss
on available-for-sale equity securities
|
(4,840,641)
|
|
(847,958)
|
|
Other income
(expense), net
|
(153,468)
|
|
8,978
|
|
Net
loss
|
(76,908,506)
|
|
(53,967,744)
|
|
Share in net loss of
Geneos
|
(2,165,213)
|
|
(434,387)
|
|
Net
loss
|
$
(79,073,719)
|
|
$
(54,402,131)
|
|
Net loss per share
attributable to Inovio Pharmaceuticals, Inc.
stockholders
|
|
|
Basic and
diluted
|
$
(0.36)
|
|
$
(0.27)
|
|
Weighted average
number of common shares outstanding
|
|
|
Basic and
diluted
|
218,940,693
|
|
202,414,445
|
|
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SOURCE INOVIO Pharmaceuticals, Inc.