- Announced positive interim data for INO-3107 as a potential
first-in-class treatment for Recurrent Respiratory
Papillomatosis
- Advanced strategy to focus on developing candidates that have
the greatest opportunity for near-term success
- Updates prior financial guidance and extends cash runway into
first quarter of 2025
- Company will hold investor call today at 4:30 PM ET
PLYMOUTH
MEETING, Pa., Nov. 8, 2022
/PRNewswire/ -- INOVIO (NASDAQ: INO), a biotechnology company
focused on developing and commercializing DNA medicines to help
treat and prevent infectious diseases, cancer, and diseases
associated with HPV, today reported financial results for the
quarter and nine months ended September 30,
2022. 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 for the third quarter. The live webcast and replay may be
accessed by visiting INOVIO's website at
http://ir.inovio.com/events-and-presentations/default.aspx.
Dr. Jacqueline Shea, INOVIO's
President and Chief Executive Officer, said, "INOVIO continues to
implement its strategy of delivering the potential of DNA medicines
to patients, focusing its resources on those candidates that have
the greatest opportunity for near-term success. In the third
quarter, INOVIO announced positive Phase 1/2 data for INO-3107, a
promising DNA medicine candidate as a potential treatment for
recurrent respiratory papillomatosis. These results are exciting to
us because they build upon our ongoing work indicating that DNA
medicines have the potential to treat HPV-associated diseases. We
are also encouraged by other candidates in our pipeline, such as
INO-5401, which has also shown positive results this year as a
potential treatment for glioblastoma. We look forward to continuing
to advance these programs as well as other pipeline programs for
which we continue to anticipate data announcements in the coming
months."
Dr. Shea continued: "In the third quarter, we also continued our
efforts to create a more focused company rooted in operational
excellence and optimized capital and resource allocation. Our
decision to discontinue our internally funded development of
INO-4800 as a heterologous COVID-19 booster is in line with this
strategy and we will deploy cost savings from this effort to the
development of other promising candidates. We will also leverage
the strengths and capabilities developed by our COVID-19 program
across our portfolio, where appropriate, such as our new
intradermal 3PSP investigational delivery device."
Recent Corporate Highlights
Positive Phase 1/2 Trial Results INO-3107 – In the
third quarter, INOVIO announced positive interim Phase 1/2 results
for INO-3107 in participants with recurrent respiratory
papillomatosis (RRP). In the open-label, multicenter trial
(NCT:04398433), INO-3107 demonstrated statistical
significance based on the clinical endpoint of a reduction in
the number of RRP surgical interventions in the year following
administration of INO-3107 compared with the year prior to
treatment, in an initial cohort of 21 participants. In the trial,
there was a median decrease of three (3) surgical interventions.
(95% confidence interval 1, 3). In addition, 16 of 21 (76%)
participants in the trial experienced a decrease in the number of
surgical interventions in the year following administration of
INO-3107 relative to the number of surgeries in the year prior to
the trial. Of those 16 participants, six (29%) required no surgical
intervention during the 52-week trial period.
In the trial, treatment with INO-3107 induced cellular responses
against both HPV 6 and HPV 11, inducing both CD4 and CD8 T cells.
T-cell responses were still observed at Week 52, indicating a
persistent cellular memory response.
INO-3107 demonstrated a favorable safety and tolerability
profile in the trial. Results from the second cohort of 11
participants are expected in the first half of 2023.
Internally Funded Development of INO-4800 Heterologous Boost
Trials Discontinued – In October, INOVIO announced that
following a comprehensive review of its portfolio, market
conditions, and global demand for COVID-19 vaccines, it had
discontinued internally-funded efforts to develop INO-4800 as a
COVID-19 heterologous booster vaccine. INOVIO's efforts towards the
global COVID-19 pandemic response will continue through its
participation in the Solidarity Trial Vaccines (STV) sponsored by
the World Health Organization (WHO) and its preclinical work on a
pan-COVID vaccine candidate. In addition, INOVIO's partner
Advaccine will continue to develop INO-4800 as a heterologous
booster vaccine using its own resources. Future updates related to
this trial will be provided by Advaccine.
Third Quarter 2022 Financial Results
As of September 30, 2022, cash and cash equivalents and
short-term investments were $281.9
million compared to $401.3
million as of December 31, 2021. As of
September 30, 2022, INOVIO had 249.5 million common shares
outstanding and 268.7 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 reported total revenue of $9.2
million for the three months ended, September 30, 2022, compared to $292,000 for the same period in 2021. The
increase in revenue resulted from the fulfillment of obligations
under its contract with the U.S. Department of Defense. Total
operating expenses were $44.9 million
compared to $60.2 million for the
same period in 2021.
INOVIO's net loss for the quarter ended September 30, 2022,
was $37.8 million, or $0.15 per basic and diluted share, compared to
net loss of $60.2 million, or
$0.29 per basic and diluted share,
for the quarter ended September 30, 2021.
Operating Expenses
Research and development (R&D) expenses for the three months
ended September 30, 2022, were
$33.1 million compared to
$47.1 million for the same period in
2021. The decrease in R&D expenses was primarily related to
lower drug manufacturing, outside services and clinical study
expenses related to INO-4800 and VGX-3100, and lower engineering
services and expensed equipment related to our
CELLECTRA® 3PSP device array automation project. These
decreases were offset by $8.2 million
lower contra-research and development expenses recorded from grant
agreements, among other variances.
General and administrative (G&A) expenses were $11.8 million for the three months ended
September 30, 2022, versus
$13.2 million for the same period in
2021. The decrease in G&A expenses was primarily related to a
decrease in employee and consultant non-cash stock-based
compensation, among other variances.
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, 2022,
which can be accessed at:
http://ir.inovio.com/financials/default.aspx.
Financial Guidance
INOVIO is updating its prior guidance and now expects
its cash runway to extend into the first quarter of 2025. This
projection includes its cash burn estimate of approximately
$45 million for the fourth quarter of
2022 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 a live conference call and webcast
at 4:30 p.m. ET 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 treat and protect people from
infectious diseases, cancer, and diseases associated with HPV.
INOVIO's DNA medicines in development are delivered using its
investigational proprietary smart device to produce immune
responses against targeted pathogens and cancers.
For more information, visit www.inovio.com.
About CELLECTRA® Delivery Technology
INOVIO's DNA medicines are delivered into cells either
intramuscularly (IM) or intradermally (ID) using its
investigational proprietary CELLECTRA smart devices. CELLECTRA
devices use brief (millisecond-long) electrical pulses to
reversibly create tiny pores in the cell membrane, which enhance
cellular uptake of DNA medicines. In 2022, with the support of the
U.S. Department of Defense, INOVIO developed its next-generation ID
delivery device, 3PSP, and an automated high throughput array
manufacturing process.
Contacts
Investors & Media:
Gene
Kim, (267) 589-9471, gene.kim@inovio.com
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 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, 2021, our
Quarterly Report on Form 10-Q for the quarter ended September 30, 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 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.
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
|
September
30,
2022
|
|
December 31,
2021
|
|
|
|
ASSETS
|
|
|
Current
assets:
|
|
|
Cash and cash
equivalents
|
$
21,988,239
|
|
$ 71,143,778
|
Short-term
investments
|
259,894,898
|
|
330,170,940
|
Accounts
receivable
|
2,442,866
|
|
5,466,850
|
Accounts receivable
from affiliated entities
|
7,637,820
|
|
2,565,194
|
Prepaid expenses and
other current assets
|
57,970,979
|
|
38,836,991
|
Prepaid expenses and
other current assets from affiliated entities
|
273,211
|
|
261,192
|
Total current
assets
|
350,208,013
|
|
448,444,945
|
Fixed assets,
net
|
15,588,103
|
|
17,453,206
|
Investment in
affiliated entity
|
2,129,992
|
|
3,906,796
|
Intangible assets,
net
|
2,249,444
|
|
2,626,355
|
Goodwill
|
10,513,371
|
|
10,513,371
|
Operating lease
right-of-use assets
|
10,577,077
|
|
11,571,026
|
Other assets
|
701,986
|
|
1,425,794
|
Total
assets
|
$ 391,967,986
|
|
$
495,941,493
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
Current
liabilities:
|
|
|
Accounts payable and
accrued expenses
|
$
74,147,792
|
|
$ 47,644,530
|
Accounts payable and
accrued expenses due to affiliated entities
|
1,633,788
|
|
548,032
|
Accrued clinical trial
expenses
|
13,485,846
|
|
10,326,266
|
Deferred
revenue
|
—
|
|
21,628
|
Operating lease
liability
|
2,820,862
|
|
2,603,956
|
Grant funding
liability
|
2,709,953
|
|
4,559,721
|
Grant funding liability
from affiliated entity
|
116,500
|
|
37,500
|
Total current
liabilities
|
94,914,741
|
|
65,741,633
|
Deferred revenue, net
of current portion
|
—
|
|
64,361
|
Convertible senior
notes
|
16,301,352
|
|
14,959,647
|
Operating lease
liability, net of current portion
|
13,312,383
|
|
15,459,559
|
Deferred tax
liabilities
|
32,046
|
|
32,046
|
Other
liabilities
|
710,348
|
|
14,826
|
Total
liabilities
|
125,270,870
|
|
96,272,072
|
Stockholders'
equity:
|
|
|
Preferred
stock
|
—
|
|
—
|
Common stock
|
249,484
|
|
217,382
|
Additional paid-in
capital
|
1,700,717,489
|
|
1,609,589,797
|
Accumulated
deficit
|
(1,433,384,645)
|
|
(1,209,855,522)
|
Accumulated other
comprehensive loss
|
(885,212)
|
|
(282,236)
|
Total Inovio
Pharmaceuticals, Inc. stockholders' equity
|
266,697,116
|
|
399,669,421
|
Total liabilities
and stockholders' equity
|
$ 391,967,986
|
|
$
495,941,493
|
INOVIO
Pharmaceuticals, Inc.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
|
|
|
Three Months
Ended
September 30,
|
|
Nine Months
Ended
September 30,
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
Revenue from
collaborative arrangements and other contracts
|
$ 9,154,133
|
|
$
291,698
|
|
$
10,137,602
|
|
$
935,643
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
33,087,130
|
|
47,088,669
|
|
145,530,626
|
|
156,941,505
|
General and
administrative
|
11,824,047
|
|
13,156,183
|
|
76,234,341
|
|
39,703,718
|
Total operating
expenses
|
44,911,177
|
|
60,244,852
|
|
221,764,967
|
|
196,645,223
|
Loss from
operations
|
(35,757,044)
|
|
(59,953,154)
|
|
(211,627,365)
|
|
(195,709,580)
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest
income
|
1,365,759
|
|
766,271
|
|
2,893,240
|
|
2,463,618
|
Interest
expense
|
(313,488)
|
|
(476,374)
|
|
(940,464)
|
|
(1,456,134)
|
Loss on investment in
affiliated entities
|
(305,061)
|
|
(21,999)
|
|
(1,776,804)
|
|
(573,656)
|
Net unrealized loss on
available-for-sale equity securities
|
(1,833,284)
|
|
(455,299)
|
|
(10,641,026)
|
|
(1,166,764)
|
Other (expense) income,
net
|
(940,778)
|
|
(28,486)
|
|
(1,097,294)
|
|
165,773
|
Net loss before
share in net loss of Geneos
|
(37,783,896)
|
|
(60,169,041)
|
|
(223,189,713)
|
|
(196,276,743)
|
Share in net loss of
Geneos
|
—
|
|
—
|
|
(2,165,213)
|
|
(434,387)
|
Net
loss
|
$
(37,783,896)
|
|
$
(60,169,041)
|
|
$
(225,354,926)
|
|
$
(196,711,130)
|
Net loss per
share
|
|
|
|
|
|
|
|
Basic and diluted
|
$
(0.15)
|
|
$
(0.29)
|
|
$
(0.96)
|
|
$
(0.95)
|
Weighted average
number of common shares outstanding
|
|
|
|
|
|
|
|
Basic and diluted
|
249,351,023
|
|
210,304,836
|
|
234,634,724
|
|
207,455,684
|
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SOURCE INOVIO Pharmaceuticals, Inc.