- Announced additional positive data from Phase 1/2 trial for
INO-3107 in recurrent respiratory papillomatosis patients
-
- Second cohort of trial showed 10 of the 11 (91%) patients saw a
reduction in surgical interventions in the year following initial
treatment
- New combined safety and immunological data showing tolerability
and durable immune response presented at ABEA/COSM
- Announced positive data from Phase 1b trial with INO-4201 as an Ebola booster for
ERVEBO®
-
- INO-4201 was well-tolerated and boosted humoral responses in 36
of 36 (100%) treated participants
- New safety and immunological data indicating potential to
extend protection against Ebola presented at ECCMID
- Announced topline results for REVEAL2, the second Phase 3 trial
for VGX-3100 as a treatment for cervical high-grade squamous
intraepithelial lesions
-
- Analysis of clinical characteristics of biomarker population is
ongoing; findings to be shared in third quarter 2023
- Trial results achieved statistical significance in
all-participants population
- Trial results did not meet primary endpoint in
biomarker-selected population
- Enhanced product development team with appointment of Dr.
Cheryl Elder as Senior Vice
President, Regulatory Affairs
- Ended the first quarter 2023 with $223.8
million in cash, cash equivalents and short-term
investments
- Company maintains cash runway projection into first quarter
2025
- Management will host conference call today at 4:30 p.m. EDT
PLYMOUTH
MEETING, Pa., May 10, 2023
/PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company
focused on developing and commercializing DNA medicines
to help treat and protect people from HPV-related diseases,
cancer, and infectious diseases, today announced financial results
and operational highlights for the first quarter of 2023. INOVIO's
management will host its quarterly conference call and webcast
today at 4:30 p.m. EDT. The live
webcast and replay may be accessed by visiting INOVIO's website at
http://ir.inovio.com/events-and-presentations/default.aspx.
"In the first quarter of 2023 we made solid progress with
several key pipeline candidates, including important headway in our
development plans for INO-3107, our DNA medicine candidate for the
treatment of RRP," said INOVIO's President and Chief Executive
Officer, Dr. Jacqueline Shea. "From
our ongoing discussions, we believe we are in alignment with the
FDA on several critical design elements for our planned Phase 3
program for INO-3107, as we continue to work through a number of
their questions. Additionally, we were also encouraged to receive a
positive opinion from the European Committee for Orphan Medicinal
Products on our application for orphan drug designation for
INO-3107. The final determination is now with the European
Commission, which will decide on our application this month. We
believe the committee's opinion is another step in the right
direction for the development of this candidate on a global
basis."
Dr. Shea continued: "Since our last quarterly report, INOVIO has
presented at several scientific and medical conferences, including
presentations by lead investigators from our RRP and Ebola booster
studies sharing important new immunological and safety data that
shows the immense potential and versatility of our
candidates. At the same time, we continued our focus on
operational excellence, taking steps to build upon the strong team
we have in place by the hiring of Dr. Cheryl Elder as Senior Vice President of
Regulatory Affairs. Cheryl's considerable regulatory expertise and
track record of successfully bringing products through licensure
will help us implement efficient regulatory strategies as we work
to advance our promising candidates through development and the
regulatory approval process."
Organizational and Clinical Highlights
INO-3107 – Recurrent Respiratory Papillomatosis (RRP)
- During the quarter, INOVIO announced data from the second
cohort of its Phase 1/2 clinical trial (NCT:04398433) that was
statistically significant and showed 10 of the 11 (91%) patients
saw a reduction in surgical interventions in the year following
initial treatment, with measurement beginning at Day 0, the start
of trial therapy. Of these 10 patients, four did not require
surgery. There was a statistically significant median decrease of
three surgical interventions when comparing the year following
treatment to the year prior. In the year prior to treatment, the
number of surgical interventions for these 11 patients ranged
between 2 and 8, and the median was 5. INO-3107 was well-tolerated
and immunogenic among patients in the second cohort. The safety and
efficacy results for the second cohort were consistent with results
announced for the first cohort in October
2022.
- Following quarter end, data from the entire study, including
new combined safety and immunology data not previously announced,
were presented by lead investigator Dr. Ted
Mau at the scientific program of the American
Broncho-Esophagological Association (ABEA) at the Combined
Otolaryngology Spring Meetings (COSM) in Boston, Massachusetts. The presentation
highlighted the safety profile of INO-3107, which continued to be
well-tolerated and elicited mostly low-grade (Grade 1)
treatment-emergent adverse effects (TEAEs) such as injection site
pain and fatigue. There were no high-grade TEAEs deemed related to
treatment and no TEAEs leading to treatment discontinuation. The
new data also showed that INO-3107 provoked a strong immune
response, inducing activated CD4 T cells and activated CD8 T cells
with lytic potential. T-cell responses were also observed at Week
52, indicating a persistent cellular memory response. Additional
analyses are ongoing to determine a possible relationship between
specific CD4 and CD8 phenotypes and clinical outcomes. The new data
also included a marked improvement after treatment in the RRP
staging assessment score. We believe these encouraging data
indicate that INO-3107 could provide clinical benefit to adults
with RRP.
- Following quarter end, INOVIO announced that the European
Committee for Orphan Medicinal Products issued a positive opinion
on INOVIO's application for orphan drug designation for INO-3107,
with the final decision from the European Commission expected in
late May.
INO-4201 – Ebola Booster for ERVEBO
- During the quarter, INOVIO announced positive results from a
Phase 1b trial with INO-4201 as a
potential Ebola booster for ERVEBO (NCT04906629) showing INO-4201
was well-tolerated and boosted humoral responses in 36 of 36 (100%)
of treated participants.
- Following quarter end, lead investigator Dr. Angela Huttner presented new safety and
immunology data from the trial at the 33rd European Congress of
Clinical Microbiology and Infectious Diseases (ECCMID) in April.
The new data showed that a single-dose of INO-4201 followed by
electroporation was well-tolerated and immunogenic compared to
placebo in a cohort of healthy volunteers primed with ERVEBO up to
5 to 7 years previously. Binding antibody titers rose significantly
after boost for each time point measured, peaking at week 2 in all
treated participants. Mean neutralizing antibody titers also rose
and remained high and constant until the end of the 24-week trial
period. There was also a noteworthy engagement of T cells,
including increased production of IFNγ, IL2, and/or TNFα from
EBOV-specific CD4+ and CD8+ T cells. The additional data indicated
that a booster dose of INO-4201 has the potential to restore the
levels of antibodies needed to extend protection against Ebola and
thus could be an important tool in future Ebola outbreaks.
VGX-3100 – High-Grade Squamous Intraepithelial Lesions
(HSIL)
- During the quarter, INOVIO shared topline results from REVEAL2,
the second Phase 3 trial for VGX-3100 as a treatment for cervical
HSIL indicating that the trial results did not meet the primary
endpoint in the biomarker-selected population, but the trial did
achieve statistical significance in the all-participants
population.
- INOVIO has continued to analyze the clinical characteristics of
the biomarker positive population that may have had an impact on
response to treatment, such as stage of disease, infection with
other HPV types, clinical site location, age, and smoking status.
Additionally, INOVIO is working to better understand why some
patients who exhibited a clinical response were not positive for
the biomarker. INOVIO expects to share findings from its ongoing
biomarker analysis in the third quarter.
- In the all-participants population of REVEAL2, VGX-3100 showed
an ability to clear HPV infection, with viral clearance of 37.3% in
the treated group versus 8.7% in the placebo group. INOVIO
continues to evaluate how this data further informs its extensive
body of evidence regarding the potential of DNA medicines to treat
HPV-related diseases, including anal HSIL, which can be a precursor
to anal cancer. INOVIO continues to discuss next steps for
developing VGX-3100 for anal HSIL with key opinion leaders and
regulators.
- Discussions with partner ApolloBio to support continued
development of VGX-3100 in China
are underway.
Strengthened Product Development Team
- Dr. Cheryl Elder joined INOVIO
as Senior Vice President of Regulatory Affairs, adding additional
leadership and expertise to an already strong product development
team. With over 30 years of experience leading cross-functional
teams in drug development in multiple therapeutic areas, Dr. Elder
has a successful track record of driving regulatory strategies
within both small and multinational biotechnology companies,
including Hoffman La Roche and, most recently, Novartis
Pharmaceuticals. She will be responsible for developing INOVIO's
regulatory strategy and will lead company interaction with
regulatory authorities globally.
Data Presentations & Publications
During and following the quarter, INOVIO presented, published,
or submitted data from several of its clinical programs:
- Glioblastoma Drug Development Summit (March): Dr. Jeffrey Skolnik, INOVIO's Senior Vice President,
Clinical Development, presented data on INO-5401 (glioblastoma
therapeutic candidate).
- World Vaccines Congress (April): Dr. Michael Sumner, INOVIO's Chief Medical Officer,
presented data on INO-3107 (RRP product candidate) and INO-4201
(Ebola vaccine booster candidate).
- 33rd European Congress of Clinical Microbiology and
Infectious Diseases (April): Dr. Angela
Huttner, Infectious Disease Consultant, Geneva University
Hospitals, and lead investigator for the trial, presented data on
INO-4201 (Ebola vaccine booster candidate).
- The Laryngoscope (April): Paper entitled "Interim
Results of a Phase 1/2 Open-Label Study of INO-3107 for HPV-6
and/or HPV-11–Associated RRP" accepted for publication in this
peer-reviewed journal focused on advances in the diagnosis and
treatment of head and neck disorders.
- American Broncho-Esophagological Association Meeting (May): Dr.
Ted Mau, lead investigator and
laryngologist at University of Texas
Southwestern Medical Center, presented data on INO-3107 (RRP
therapeutic candidate).
INOVIO plans to continue to submit papers and abstracts related
to its research for publication and presentation as data becomes
available to various journals and medical conferences. Further
details will be shared upon acceptance for publication.
First Quarter 2023 Financial Results
- INOVIO reported total revenue of $115,000 for the three months ended March 31, 2023, compared to $199,000 for the same period in 2022. Total
operating expenses were $44.1 million
compared to $71.9 million for the
same period in 2022.
- INOVIO's net loss for the quarter ended March 31, 2023 was $40.6
million, or $0.16 per basic
and diluted share, compared to net loss of $79.1 million, or $0.36 per basic and diluted share, for the
quarter ended March 31, 2022.
Operating Expenses
- Research and development (R&D) expenses for the three
months ended March 31, 2023, were
$30.2 million compared to
$56.0 million for the same period in
2022. The decrease in R&D expenses was primarily the result of
lower drug manufacturing, clinical trial expenses and outside
services related to INO-4800, and lower expensed inventory and
outside services related to our CELLECTRA® 3PSP device and array
automation project, among other variances.
- General and administrative (G&A) expenses were $13.9 million for the three months ended
March 31, 2023, compared to
$16.0 million for the same period in
2022. The decrease in G&A expenses was primarily related to a
decrease in non-cash stock-based compensation, insurance and other
outside services expenses, offset by higher legal expenses, among
other variances.
Capital Resources
- As of March 31, 2023, cash and
cash equivalents and short-term investments were $223.8 million compared to $253.0 million as of December 31, 2022. As of March 31, 2023, the Company had 262.7 million
common shares outstanding and 283.2 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, 2023, which can be accessed at:
http://ir.inovio.com/financials/default.aspx.
Cash Guidance
- INOVIO continues to expect its cash runway to extend into the
first quarter of 2025. This projection includes a cash burn
estimate of approximately $33 million
for the second quarter 2023 and its ongoing expectation that cash
burn will decrease incrementally from there into the first quarter
of 2025. These projections do not include any funds that may be
raised through the Company's existing at-the-market program or
other capital-raising activities.
Conference Call / Webcast Information
INOVIO's management will host its quarterly conference call and
webcast at 4:30 p.m. ET today. A
replay of the conference call will be available following the
conclusion of the call. 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 treat and protect people from
HPV-related diseases, cancer, and infectious diseases. INOVIO's DNA
medicines in development are delivered using its investigational
proprietary smart device, CELLECTRA®, to produce immune
responses against targeted pathogens and cancers. For more
information, visit www.inovio.com.
Contacts
Media: Jennie Willson (267)
429-8567 jennie.willson@inovio.com
Investors: Thomas Hong (267)
440-4298 thomas.hong@inovio.com
Forward-Looking Statements
This press release contains certain forward-looking statements
relating to our business, including our plans to develop and
commercialize DNA medicines and our expectations regarding our
research and development programs, including the planned initiation
and conduct of pre-clinical studies and clinical trials and the
availability and timing of data from those studies and trials, and
expectations with respect to our cash resources and expected
operating expenses into the first quarter of 2025. 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 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, 2022, our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, 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 the
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
|
|
|
March 31,
2023
|
|
December 31,
2022
|
|
(Unaudited)
|
|
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
28,238,152
|
|
$ 46,329,359
|
Short-term
investments
|
195,513,005
|
|
206,669,397
|
Accounts
receivable
|
73,304
|
|
1,701,726
|
Accounts receivable
from affiliated entities
|
4,961,802
|
|
10,036,490
|
Prepaid expenses and
other current assets
|
4,914,313
|
|
50,130,481
|
Prepaid expenses and
other current assets from affiliated entities
|
195,853
|
|
375,227
|
Total current
assets
|
233,896,429
|
|
315,242,680
|
Fixed assets,
net
|
6,983,305
|
|
7,727,997
|
Investment in
affiliated entity
|
2,623,781
|
|
2,007,142
|
Intangible assets,
net
|
2,047,778
|
|
2,129,861
|
Goodwill
|
10,513,371
|
|
10,513,371
|
Operating lease
right-of-use assets
|
9,865,543
|
|
10,228,207
|
Other assets
|
652,517
|
|
684,044
|
Total
assets
|
$ 266,582,724
|
|
$
348,533,302
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued expenses
|
$
24,752,171
|
|
$ 79,686,885
|
Accounts payable and
accrued expenses due to affiliated entities
|
1,417,274
|
|
1,220,439
|
Accrued clinical trial
expenses
|
5,795,846
|
|
10,594,073
|
Operating lease
liability
|
2,579,949
|
|
2,803,973
|
Grant funding
liability
|
4,121,989
|
|
2,475,031
|
Grant funding liability
from affiliated entity
|
89,007
|
|
87,673
|
Convertible senior
notes
|
16,394,841
|
|
—
|
Total current
liabilities
|
55,151,077
|
|
96,868,074
|
Convertible senior
notes
|
—
|
|
16,614,840
|
Operating lease
liability, net of current portion
|
12,185,919
|
|
12,655,586
|
Deferred tax
liabilities
|
32,046
|
|
32,046
|
Total
liabilities
|
67,369,042
|
|
126,170,546
|
Stockholders'
equity:
|
|
|
|
Preferred
stock
|
—
|
|
—
|
Common stock
|
262,738
|
|
253,090
|
Additional paid-in
capital
|
1,728,030,842
|
|
1,710,656,191
|
Accumulated
deficit
|
(1,528,497,101)
|
|
(1,487,847,784)
|
Accumulated other
comprehensive loss
|
(582,797)
|
|
(698,741)
|
Total Inovio
Pharmaceuticals, Inc. stockholders' equity
|
199,213,682
|
|
222,362,756
|
Total liabilities
and stockholders' equity
|
$ 266,582,724
|
|
$
348,533,302
|
INOVIO
Pharmaceuticals, Inc.
CONSOLIDATED
STATEMENTS OF OPERATIONS
(Unaudited)
|
|
|
Three Months Ended
March 31,
|
|
2023
|
|
2022
|
|
|
|
|
Revenue from
collaborative arrangements and other contracts
|
$114,943
|
|
$199,074
|
Operating
expenses:
|
|
|
|
Research and
development
|
30,176,511
|
|
55,978,611
|
General and
administrative
|
13,890,610
|
|
15,953,458
|
Total operating
expenses
|
44,067,121
|
|
71,932,069
|
Loss from
operations
|
(43,952,178)
|
|
(71,732,995)
|
Other income
(expense):
|
|
|
|
Interest
income
|
2,207,171
|
|
669,814
|
Interest
expense
|
(313,488)
|
|
(313,488)
|
Gain (loss) on
investment in affiliated entity
|
616,639
|
|
(537,728)
|
Net unrealized gain
(loss) on available-for-sale equity securities
|
3,218,215
|
|
(4,840,641)
|
Other expense,
net
|
(2,425,676)
|
|
(153,468)
|
Net loss before
share in net loss of Geneos
|
(40,649,317)
|
|
(76,908,506)
|
Share in net loss of
Geneos
|
—
|
|
(2,165,213)
|
Net
loss
|
$(40,649,317)
|
|
$(79,073,719)
|
Net loss per
share
|
|
|
|
Basic and diluted
|
$(0.16)
|
|
$(0.36)
|
Weighted average
number of common shares outstanding
|
|
|
|
Basic and diluted
|
258,437,714
|
|
218,940,693
|
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SOURCE INOVIO Pharmaceuticals, Inc.