- Achieved significant progress with lead product candidate,
INO-3107
- Received Breakthrough Therapy designation from U.S. Food and
Drug Administration (FDA) as a potential treatment for Recurrent
Respiratory Papillomatosis (RRP)
- Received FDA feedback that data from completed Phase 1/2
trial could be used to submit a Biological License Application
(BLA) under Accelerated Approval program
- Accelerating commercialization strategy in preparation for
an earlier launch, should regulatory approval be achieved
- If approved, INO-3107 could revolutionize treatment options
for patients with RRP, a debilitating rare disease caused by
human papillomavirus (HPV)
- Could be first DNA medicine available in United States and first commercial product
for INOVIO
- Continued to advance corporate strategy to align resources
with focus on INO-3107 and late-stage clinical candidates closest
to market, with greatest opportunity to deliver on the promise of
DNA medicines for patients
- $167.5 million in cash, cash
equivalents and short-term investments as of September 30, 2023
- Investor call today at 4:30 PM
ET
PLYMOUTH
MEETING, Pa., Nov. 9, 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 its financial
results and operational highlights for the third quarter ended
September 30, 2023.
"The past quarter has seen significant progress for our lead
candidate, INO-3107, for the treatment of Recurrent Respiratory
Papillomatosis, or RRP," said INOVIO's President and Chief
Executive Officer, Dr. Jacqueline
Shea. "Following Breakthrough Therapy designation from the
FDA in September and subsequent feedback that we no longer need to
complete a Phase 3 trial prior to submitting a BLA under the
accelerated approval program, our team is laser-focused on next
steps. These steps include holding an Initial Comprehensive
Multidisciplinary Breakthrough Therapy Meeting with the FDA in the
near future to confirm alignment on our accelerated development
plans and to clarify timing associated with potentially making
INO-3107 available to patients suffering from this devastating
disease."
Shea continued: "The progress we have achieved with INO-3107
exemplifies the strategy we have been implementing over the past
year, as we have focused on advancing late-stage candidates and
driving toward near, mid- and long-term milestones for our
pipeline. In the past 18 months, we have reshaped our company,
reduced our operating spend and reprioritized our pipeline with
INO-3107 as our lead candidate. I am more confident than ever that
our experienced team is prepared to deliver on the next critical
steps of development and on the promise of DNA medicine for
patients."
INOVIO's Chief Commercial Officer, Mark
Twyman, stated: "Now that we are moving toward a BLA
submission on an accelerated timeline, we are advancing our
commercialization strategy expeditiously. We are implementing all
aspects of our plan, including strategies for distribution, payor,
specialty pharmacy and field force design, with the goal of being
ready to launch rapidly if we receive approval. We are also
continuing to deepen our understanding of the RRP market and
applying what we have learned from our discussions with healthcare
providers and RRP patients. Delivering on this opportunity now is
incredibly important for patients suffering from RRP as INO-3107
represents a significant improvement in therapeutic options over
the current standard of care."
Regulatory Status of INO-3107
The FDA granted
Breakthrough Therapy designation to INOVIO's lead candidate based
on clinical evidence indicating INO-3107 may demonstrate
substantial improvement over existing therapies for RRP.
Breakthrough Therapy designation was created by the FDA to help
expedite the development and review of drug candidates that are
intended to treat a serious or life-threatening condition and for
which preliminary clinical evidence indicates that the drug may
demonstrate substantial improvement over available therapy on a
clinically significant endpoint(s).
INOVIO also received feedback from the FDA that data from its
completed Phase 1/2 trial of INO-3107 could support INOVIO's
submission of a BLA for review under the FDA's accelerated approval
program. The FDA advised that completion of a Phase 3 trial would
not be required to support this submission. INOVIO will be required
to initiate a confirmatory trial prior to BLA submission for
accelerated approval and satisfy all other FDA filing requirements.
Subsequent to this feedback, INOVIO has been focused on preparing
to file its BLA under the accelerated approval program. The company
anticipates additional meetings with the FDA to finalize next
steps, including an Initial Comprehensive Multidisciplinary
Breakthrough Therapy Meeting, or Type B meeting, which it has
requested to be held in the fourth quarter of 2023. INOVIO plans to
pursue other benefits offered by Breakthrough Therapy designation
to quickly resolve any future questions, as well as take advantage
of the opportunity to submit under the FDA's Rolling Review program
and request a Priority Review once the BLA is fully submitted.
Commercialization Plans for INO-3107
INOVIO has
accelerated its commercialization strategy for INO-3107 as a
potential treatment for RRP as a result of the opportunity to file
its BLA under the FDA's accelerated approval program. This includes
implementing its plans for product distribution and logistics,
payor engagement and reimbursement, specialty pharmacy
identification, patient and provider awareness and education,
customer service programs, and other sales and marketing
activities. The company has an experienced commercial team that is
actively engaging external partners and service providers to be
prepared for launch, should INO-3107 receive regulatory
approval.
As part of its commercialization plans, INOVIO is continuing to
deepen its market understanding of RRP as a disease and the
treatment paradigm in the United
States. RRP is a chronic, rare disease caused by HPV-6 and
HPV-11. The current standard of care is surgery, with many patients
facing a lifetime of repeated surgeries as their only option. The
most widely cited U.S. epidemiology data estimated that there were
approximately 14,000 active cases of RRP in the United States. A recent publication cites
that on average, patients with RRP undergo about 4 surgeries per
year.
Based on its ongoing market research, INOVIO believes that
laryngologists are the primary healthcare providers treating
patients suffering from this condition and that they are
comfortable administering drugs and utilizing new tools and
devices. The company estimates that approximately 300 to 400
laryngologists conduct the majority of RRP surgical procedures in
the United States. Key opinion
leaders estimate that approximately one-half of all laryngologists
practice in academic institutions. In recent discussions with
patients, INOVIO believes that RRP patients may prefer to be
treated at these regional academic centers.
About INO-3107
INO-3107 is INOVIO's lead DNA medicine
product candidate and is being developed as a potential treatment
for RRP. INO-3107 is designed to elicit an antigen targeted T cell
response against HPV-6 and HPV-11, the HPV types responsible for
causing RRP, among other HPV-related diseases. These targeted T
cells are designed to seek out and kill HPV-6 and HPV-11 infected
cells, with the aim of potentially preventing or slowing the growth
of new papillomas. In addition to being designated a Breakthrough
Therapy, INO-3107 has also received Orphan Drug designation from
the European Commission and from the FDA.
In a Phase 1/2 clinical trial conducted with INO-3107, 81.3%
(26/32) of patients had a decrease in surgical interventions in the
year after INO-3107 administration compared to the prior year,
including 28.1% (9/32) that required no surgical intervention
during or after the dosing window. Patients in the trial had a
median range of 4 surgeries (2-8) in the year prior to dosing.
After dosing, there was a median decrease of 3 surgical
interventions (95% confidence interval -3, -2). At the outset of
the study (Day 0), patients could have RRP tissue surgically
removed, but any surgery performed after Day 0 during the dosing
window was counted against the efficacy endpoint. Treatment with
INO-3107 generated a strong immune response in the trial, 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. INO-3107 was well
tolerated by participants in the trial, resulting in mostly
low-grade (Grade 1) treatment-emergent adverse effects such as
injection site pain and fatigue.
Advancing INOVIO's Three-Part Strategy to Develop its
Pipeline
Since mid-2022, INOVIO has been advancing a
three-part strategy to deliver on the promise of DNA medicines and
the product candidates in its pipeline. In the near-term, INOVIO is
focused on optimizing the opportunity for INO-3107 as a potential
treatment for RRP patients. In the mid-term, INOVIO is working to
advance eight other clinical-stage candidates targeting a number of
HPV-related diseases, cancers and infectious diseases. For the
longer term, INOVIO is developing next-generation DNA medicine
technology, including DNA encoded monoclonal antibodies (dMAbs)
targeting COVID-19, as well as DNA-launched nanoparticles (dLNPs)
targeting infectious diseases and cancer vaccines that have various
disease targets. INOVIO's commitment to financial discipline and
leveraging strong partnerships are also key components to its
corporate strategy.
Third Quarter 2023 Financial Results
- Cash, Cash Equivalents and Short-term Investments: As of
September 30, 2023, cash, cash
equivalents and short-term investments were $167.5 million compared to $253.0 million as of December 31, 2022.
- Revenues: Total revenues for the three months ended
September 30, 2023 were $388,000, compared to $9.2
million for the same period in 2022. The revenue generated
in the third quarter of 2022 was associated with a Procurement
Contract with the U.S. Department of Defense for INOVIO's devices
and accessories to be used for delivery of its COVID-19 vaccine
candidate, INO-4800, which the company has discontinued.
- Research and Development (R&D)
Expenses: R&D expenses for the three months ended
September 30, 2023 were $15.5 million compared to $33.1 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 other COVID-19 studies and lower employee and
consultant compensation, including stock-based compensation, among
other variances.
- General and Administrative (G&A) Expenses: G&A
expenses for the 2023 third quarter were $9.9 million compared to $11.8 million for the same period in 2022.
- Total Operating Expenses: Total operating expenses
were $35.9 million compared to
$44.9 million for the same period in
2022. During the three months ended September 30, 2023, the company recognized a
non-cash goodwill impairment charge of $10.5
million.
- Net Loss: INOVIO's net loss for the quarter ended
September 30, 2023 was $33.9 million, or $0.13 per basic and diluted share, compared to
net loss of $37.8 million, or
$0.15 per basic and diluted share,
for the third quarter of 2022. Excluding the non-cash goodwill
impairment expense, net loss for the quarter ended September 30, 2023 would have been $23.4 million, or $0.09 per basic and diluted share.
- Shares Outstanding: As of September 30, 2023, INOVIO had 269.7 million
common shares outstanding and 290.6 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 September 30, 2023, which can be accessed
at: http://ir.inovio.com/financials/default.aspx.
Cash Guidance
Following feedback from the FDA on the
accelerated approval pathway for INO-3107, INOVIO now estimates its
cash runway to extend into the second quarter of 2025. This
projection includes a cash burn estimate of approximately
$26 million for the fourth quarter of
2023. These cash 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's DNA Medicines Platform
INOVIO's DNA
medicines platform has two innovative components: precisely
designed DNA plasmids, delivered by INOVIO's proprietary
investigational medical device, CELLECTRA®. INOVIO uses proprietary
technology to design its DNA plasmids, which are small circular DNA
molecules that work like software the body's cells can download to
produce specific proteins to target and fight disease. INOVIO's
CELLECTRA® delivery devices help ensure its DNA medicines enter the
body's cells for optimal effect, without chemical adjuvants or
nanoparticles and without the risk of the anti-vector response seen
in viral vector platforms.
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 technology optimizes the design and delivery of
innovative DNA medicines that teach the body to manufacture its own
disease-fighting tools. 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 INOVIO's business,
including its plans to develop and commercialize DNA medicines and
its expectations regarding its research and development programs,
including plans to initiate a confirmatory trial for INO-3107
instead of the previously announced Phase 3 trial, expectations
with respect to INO-3107 if approved, plans for regulatory
submissions, the sufficiency of its cash resources and expected
cash burn for the fourth quarter of 2023. 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, INOVIO's
ability to support its pipeline of DNA medicine products, the
ability of INOVIO's collaborators to attain development and
commercial milestones for products INOVIO licenses and product
sales that will enable INOVIO to receive future payments and
royalties, the adequacy of INOVIO's capital resources, the
availability or potential availability of alternative therapies or
treatments for the conditions targeted by INOVIO or its
collaborators, including alternatives that may be more efficacious
or cost effective than any therapy or treatment that INOVIO and its
collaborators hope to develop, issues involving product liability,
issues involving patents and whether they or licenses to them will
provide INOVIO 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 INOVIO can finance or devote other significant
resources that may be necessary to prosecute, protect or defend
them, the level of corporate expenditures, assessments of INOVIO's
technology by potential corporate or other partners or
collaborators, capital market conditions, the impact of government
healthcare proposals and other factors set forth in INOVIO's Annual
Report on Form 10-K for the year ended December 31, 2022, its Quarterly Report on
Form 10-Q for the quarter ended September
30, 2023, and other filings INOVIO makes from time to time
with the Securities and Exchange Commission. There can be no
assurance that INO-3107 or any other product candidate in INOVIO's
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 INOVIO undertakes no obligation to update
or revise these statements, except as may be required by law.
INOVIO
PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED
BALANCE SHEETS
|
|
|
September
30,
2023
|
|
December 31,
2022
|
|
(Unaudited)
|
|
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$18,804,602
|
|
$46,329,359
|
Short-term
investments
|
148,668,866
|
|
206,669,397
|
Accounts
receivable
|
—
|
|
1,701,726
|
Accounts receivable
from affiliated entities
|
2,143,933
|
|
10,036,490
|
Prepaid expenses and
other current assets
|
5,114,873
|
|
50,130,481
|
Prepaid expenses and
other current assets from affiliated entities
|
34,923
|
|
375,227
|
Total current
assets
|
174,767,197
|
|
315,242,680
|
Fixed assets,
net
|
5,632,511
|
|
7,727,997
|
Investment in
affiliated entity
|
2,994,900
|
|
2,007,142
|
Intangible assets,
net
|
—
|
|
2,129,861
|
Goodwill
|
—
|
|
10,513,371
|
Operating lease
right-of-use assets
|
9,097,275
|
|
10,228,207
|
Other assets
|
605,315
|
|
684,044
|
Total
assets
|
$193,097,198
|
|
$348,533,302
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued expenses
|
$15,553,742
|
|
$79,686,885
|
Accounts payable and
accrued expenses due to affiliated entities
|
711,720
|
|
1,220,439
|
Accrued clinical trial
expenses
|
5,011,185
|
|
10,594,073
|
Operating lease
liability
|
2,117,971
|
|
2,803,973
|
Grant funding
liability
|
3,806,161
|
|
2,475,031
|
Grant funding liability
from affiliated entity
|
21,918
|
|
87,673
|
Convertible senior
notes
|
16,488,329
|
|
—
|
Total current
liabilities
|
43,711,026
|
|
96,868,074
|
Convertible senior
notes
|
—
|
|
16,614,840
|
Operating lease
liability, net of current portion
|
11,194,413
|
|
12,655,586
|
Deferred tax
liabilities
|
32,046
|
|
32,046
|
Total
liabilities
|
54,937,485
|
|
126,170,546
|
Stockholders'
equity:
|
|
|
|
Preferred
stock
|
—
|
|
—
|
Common stock
|
269,730
|
|
253,090
|
Additional paid-in
capital
|
1,736,602,555
|
|
1,710,656,191
|
Accumulated
deficit
|
(1,597,961,498)
|
|
(1,487,847,784)
|
Accumulated other
comprehensive loss
|
(751,074)
|
|
(698,741)
|
Total Inovio
Pharmaceuticals, Inc. stockholders' equity
|
138,159,713
|
|
222,362,756
|
Total liabilities
and stockholders' equity
|
$193,097,198
|
|
$348,533,302
|
INOVIO
PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS
OF OPERATIONS (Unaudited)
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
|
|
|
|
|
|
|
Revenue from
collaborative arrangements and other contracts
|
$388,446
|
|
$9,154,133
|
|
$729,359
|
|
$10,137,602
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
15,503,032
|
|
33,087,130
|
|
69,423,513
|
|
145,530,626
|
General and
administrative
|
9,925,055
|
|
11,824,047
|
|
37,338,763
|
|
76,234,341
|
Impairment of
goodwill
|
10,513,371
|
|
—
|
|
10,513,371
|
|
—
|
Total operating
expenses
|
35,941,458
|
|
44,911,177
|
|
117,275,647
|
|
221,764,967
|
Loss from
operations
|
(35,553,012)
|
|
(35,757,044)
|
|
(116,546,288)
|
|
(211,627,365)
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest
income
|
1,938,745
|
|
1,365,759
|
|
6,314,149
|
|
2,893,240
|
Interest
expense
|
(313,488)
|
|
(313,488)
|
|
(940,464)
|
|
(940,464)
|
Gain (loss) on
investment in affiliated entity
|
214,374
|
|
(305,061)
|
|
987,758
|
|
(1,776,804)
|
Net unrealized gain
(loss) on available-for-sale equity securities
|
(219,337)
|
|
(1,833,284)
|
|
3,921,819
|
|
(10,641,026)
|
Other income (expense),
net
|
2,854
|
|
(940,778)
|
|
(3,850,688)
|
|
(1,097,294)
|
Net loss before
share in net loss of Geneos
|
(33,929,864)
|
|
(37,783,896)
|
|
(110,113,714)
|
|
(223,189,713)
|
Share in net loss of
Geneos
|
—
|
|
—
|
|
—
|
|
(2,165,213)
|
Net
loss
|
$(33,929,864)
|
|
$(37,783,896)
|
|
$(110,113,714)
|
|
$(225,354,926)
|
Net loss per
share
|
|
|
|
|
|
|
|
Basic and diluted
|
$(0.13)
|
|
$(0.15)
|
|
$(0.42)
|
|
$(0.96)
|
Weighted average
number of common shares outstanding
|
|
|
|
|
|
|
|
Basic and diluted
|
268,622,753
|
|
249,351,023
|
|
263,842,074
|
|
234,634,724
|
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SOURCE INOVIO Pharmaceuticals, Inc.