- Increased Cash Runway into Third Quarter 2024 with Cost-Savings
and Corporate Restructuring Efforts
- Strengthened Executive Team with Appointment of Dr.
Michael Sumner as Chief Medical
Officer
- Announced Positive Data from a Phase 1/2 Trial with INO-5401 to
treat Glioblastoma (GBM) at the American Society of Clinical
Oncology (ASCO) Annual Meeting
- Will hold investor call today at 4:30 PM
EDT
PLYMOUTH
MEETING, Pa., Aug. 9, 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 and six months ended June 30, 2022. INOVIO's management will host a
live conference call and webcast at 4:30
p.m. Eastern Daylight Time (EDT) today to discuss financial
results and provide a general business update for the second
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, President
and Chief Executive Officer, said: "During the second quarter, we
focused on reshaping our organizational structure to help us
achieve our product development goals. These efforts included
strengthening our executive and R&D teams by appointing Dr.
Michael Sumner as our Chief Medical
Officer and extending our cash runway into the third quarter of
2024 through cost-savings measures and a corporate restructuring
effort."
Dr. Shea continued: "During the quarter we also focused on
advancing our strategies for those programs that have the greatest
potential to deliver DNA medicine technology to the market. Those
programs include our heterologous booster program for our COVID-19
vaccine candidate, INO-4800, as well as our HPV-associated
programs. We were also encouraged by positive Phase 1/2 data
presented at ASCO involving INO-5401, when used in combination with
PD-1 inhibitor, Libtayo®, against glioblastoma. With
several additional pipeline milestones expected over the next
several months, I look forward to sharing our progress in advancing
our DNA medicines towards commercialization in the second half of
2022."
Second Quarter 2022 Corporate Updates
Extended Cash Runway into Third Quarter 2024 –
INOVIO announced a corporate reorganization designed to extend its
cash runway and support the Company's focus on key clinical
programs with the goal of driving long-term growth. The
reorganization, which included an 18% workforce reduction in
full-time employees and an 86% reduction in contractors, along with
other cost-saving measures, is expected to reduce operating
expenses by approximately 30% over the next 18 months and extend
INOVIO's cash runway into the third quarter of 2024. These
projections do not include any funds that may or may not be raised
during the time period through the Company's existing at-the-market
program or other fundraising mechanisms. INOVIO expects a one-time
restructuring charge of approximately $1.6
million in the third quarter of 2022 related to the
headcount reduction.
Strengthened Executive and R&D Teams – INOVIO
announced the appointment of Dr. Michael Sumner, MB BS, MBA, as
Chief Medical Officer. Dr. Sumner brings more than 25 years of
extensive pharmaceutical, medical and clinical experience driving
numerous late-stage product approvals and supporting successful
commercial products on a global basis across multiple therapeutic
areas. Dr. Sumner now oversees INOVIO's entire clinical-stage
pipeline of DNA medicines, as well as global clinical development,
clinical operations and biostatistics efforts, and regulatory
affairs, pharmacovigilance and medical affairs.
Presented Positive Clinical Data for INO-5401 at ASCO –
INOVIO announced additional results from a Phase 1/2 trial
involving INO-5401 and INO-9012 at the 2022 American Society of
Clinical Oncology (ASCO) Annual Meeting held in June. In the trial,
INO-5401 + INO-9012 was observed to have favorable tolerability and
immunogenicity results when administered with Libtayo®
and RT/TMZ (radiation and temozolomide) to newly diagnosed GBM
patients. Notably, INO-5401 + INO-9012 elicited antigen-specific T
cells that may infiltrate GBM tumors.
Second Quarter 2022 Financial Results
INOVIO reported total revenue was $784,000 for the three months ended June 30, 2022, compared to $273,000 for the same period in 2021. The
increase in revenue resulted from the delivery of INOVIO's
proprietary smart devices related to its contract with the U.S.
Department of Defense. Total operating expenses for the three
months ended June 30, 2022, were
$104.9 million compared to
$83.5 million for the same period in
2021.
INOVIO's net loss for the three months ended June 30, 2022, was $108.5
million, or $0.46 per basic
and diluted share, compared to net loss of $82.1 million, or $0.39 per basic and diluted share, for the
quarter ended June 30, 2021.
Operating Expenses
Research and development (R&D) expenses for the three months
ended June 30, 2022, were
$56.5 million compared to
$70.8 million for the same period in
2021. The decrease in R&D expenses was primarily due to
$21.9 million in lower expenses
related to the acquisition and installation of manufacturing
equipment for INO-4800 during 2021 were non-recurring, and
$7.0 million in lower engineering
services and expensed equipment related to our CELLECTRA® 3PSP
device array automation project. These decreases were partially
offset by an $8.3 million increase in
drug manufacturing costs related to our COVID-19 variant studies
and a Defense Advanced Research Projects Agency COVID-19 dMAb
grant, as well as $6.9 million lower
contra-research and development expense recorded from grant
agreements, among other variances.
General and administrative (G&A) expenses were $48.5 million for the three months ended
June 30, 2022, versus $12.7 million for the same period in 2021. The
significant increase in G&A expenses in the 2022 second quarter
was primarily due to a $14.0 million
non-cash expense related to the proposed settlement of INOVIO's
previously disclosed securities class action litigation, including
the proposed issuance of INOVIO common stock as part of the
settlement, and other related litigation costs, as well as
$6.9 million in one-time severance
expenses related to the separation of INOVIO's former president and
chief executive officer, among other variances. The proposed
settlement still requires court approval, but has been agreed to,
in principle.
Capital Resources
As of June 30, 2022, cash and cash
equivalents and short-term investments were $348.1 million compared to $401.3 million as of December 31, 2021. As of June 30, 2022, INOVIO had 247.5 million shares of
common stock outstanding and 267.8 million shares of common stock
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 June 30, 2022, which can be accessed at:
http://ir.inovio.com/financials/default.aspx.
Financial Guidance
INOVIO's projections to extend its cash runway into the third
quarter 2024 include its cash burn estimate of approximately
$73 million for the third quarter
2022, and its expectation that cash burn will decrease
incrementally from there into the third quarter of 2024.
Conference Call / Webcast Information
INOVIO's management will host a live conference call and webcast
at 4:30 p.m. EDT 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 INO-4800
INO-4800 is INOVIO's clinical-stage DNA vaccine candidate
targeting the spike protein of the SARS-CoV-2 virus. INOVIO has
conducted clinical trials with INO-4800 as a primary vaccine
candidate that demonstrated it was well tolerated and generated an
immune response consisting of both a humoral response (including
neutralizing antibodies) as well as cellular responses (generation
of both CD4+ and CD8+ T cells). In 2022,
INOVIO began developing a strategy to explore the use of INO-4800
as a heterologous booster vaccine.
About VGX-3100
VGX-3100 is INOVIO's clinical-stage DNA medicine product
candidate being developed as a potential treatment for several
diseases associated with the human papillomavirus (HPV). It is
designed to elicit T cell immune responses against the E6 and E7
proteins of HPV types 16 and 18, which are known to be associated
with different pre-cancerous conditions and cancer. INOVIO has
conducted several clinical trials with VGX-3100 targeting cervical,
anal, and vulvar high-grade squamous intraepithelial lesions
(HSIL), which are precursors to cancer.
About INO-5401
INO-5401 is INOVIO's clinical-stage DNA medicine product
candidate being developed as a potential treatment for glioblastoma
(GBM), a rapidly growing and aggressive tumor of the brain and
spine. INO-5401 is designed to enhance T cell immune responses
against three known tumor-associated antigens commonly expressed in
a variety of cancers: human telomerase (hTERT), Wilms tumor gene-1
(WT1), and prostate-specific membrane antigen (PSMA). GBM is an
almost universally fatal disease with treatment essentially
unchanged for the last decade.
About CELLECTRA® Delivery Technology
INOVIO's DNA medicines are delivered into cells of the body
using its investigational proprietary CELLECTRA smart device,
either intramuscularly (IM) or intradermally (ID). CELLECTRA
devices use brief (millisecond-long) electrical pulses to
reversibly create small pores in the cell membrane, enhancing
intracellular uptake of DNA medicines by more than a thousand-fold
compared to the injection of a DNA medicine without this delivery
enhancement technique.
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. Our
DNA medicines are delivered using our proprietary smart device to
produce immune responses against targeted pathogens and cancers.
For more information, visit www.inovio.com.
Contacts
Investors & Media:
Gene Kim, (267) 589-9471,
gene.kim@inovio.com
Thomas Hong, (267) 440-4298,
thomas.hong@inovio.com
Forward-Looking Statement
This press release contains certain forward-looking statements
relating to our business, including our plans to develop and
commercialize DNA medicines, 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,
expectations about the upfront costs and long-term cost reductions
associated with our corporate reorganization and the anticipated
extension of the company's cash runway. 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 June 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
|
|
|
|
|
|
June 30,
2022
|
|
December 31,
2021
|
|
(Unaudited)
|
|
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$ 41,101,858
|
|
$
71,143,778
|
Short-term
investments
|
307,023,457
|
|
330,170,940
|
Accounts
receivable
|
4,482,639
|
|
5,466,850
|
Accounts receivable
from affiliated entities
|
6,888,895
|
|
2,565,194
|
Prepaid expenses and
other current assets
|
56,255,326
|
|
38,836,991
|
Prepaid expenses and
other current assets from affiliated entities
|
433,259
|
|
261,192
|
Total current
assets
|
416,185,434
|
|
448,444,945
|
Fixed assets,
net
|
16,213,436
|
|
17,453,206
|
Investment in
affiliated entity
|
2,435,053
|
|
3,906,796
|
Intangible assets,
net
|
2,369,028
|
|
2,626,355
|
Goodwill
|
10,513,371
|
|
10,513,371
|
Operating lease
right-of-use assets
|
10,912,525
|
|
11,571,026
|
Other assets
|
770,144
|
|
1,425,794
|
Total
assets
|
$
459,398,991
|
|
$
495,941,493
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued expenses
|
$
105,015,337
|
|
$
47,644,530
|
Accounts payable and
accrued expenses due to affiliated entities
|
1,338,692
|
|
548,032
|
Accrued clinical trial
expenses
|
10,122,869
|
|
10,326,266
|
Deferred
revenue
|
8,982,619
|
|
21,628
|
Operating lease
liability
|
2,737,631
|
|
2,603,956
|
Grant funding
liability
|
2,712,905
|
|
4,559,721
|
Grant funding liability
from affiliated entity
|
154,000
|
|
37,500
|
Total current
liabilities
|
131,064,053
|
|
65,741,633
|
Deferred revenue, net
of current portion
|
56,935
|
|
64,361
|
Convertible senior
notes
|
16,521,352
|
|
14,959,647
|
Operating lease
liability, net of current portion
|
14,053,493
|
|
15,459,559
|
Deferred tax
liabilities
|
32,046
|
|
32,046
|
Other
liabilities
|
—
|
|
14,826
|
Total
liabilities
|
161,727,879
|
|
96,272,072
|
Stockholders'
equity:
|
|
|
|
Preferred
stock
|
—
|
|
—
|
Common stock
|
247,503
|
|
217,382
|
Additional paid-in
capital
|
1,693,674,022
|
|
1,609,589,797
|
Accumulated
deficit
|
(1,395,600,749)
|
|
(1,209,855,522)
|
Accumulated other
comprehensive loss
|
(649,664)
|
|
(282,236)
|
Total Inovio
Pharmaceuticals, Inc. stockholders' equity
|
297,671,112
|
|
399,669,421
|
Total liabilities
and stockholders' equity
|
$
459,398,991
|
|
$
495,941,493
|
INOVIO
Pharmaceuticals, Inc.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
Revenues:
|
|
|
|
|
|
|
|
Revenue under
collaborative research and development arrangements
|
$
36,839
|
|
$
82,923
|
|
$
102,734
|
|
$
122,538
|
Revenue under
collaborative research and development arrangements
with affiliated entities
|
6,214
|
|
74,787
|
|
15,056
|
|
124,736
|
Other
revenue
|
741,342
|
|
115,114
|
|
865,679
|
|
396,671
|
Total
revenues
|
784,395
|
|
272,824
|
|
983,469
|
|
643,945
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
56,464,885
|
|
70,808,418
|
|
112,443,496
|
|
109,852,836
|
General and
administrative
|
48,456,836
|
|
12,666,341
|
|
64,410,294
|
|
26,547,535
|
Total operating
expenses
|
104,921,721
|
|
83,474,759
|
|
176,853,790
|
|
136,400,371
|
Loss from
operations
|
(104,137,326)
|
|
(83,201,935)
|
|
(175,870,321)
|
|
(135,756,426)
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest
income
|
857,667
|
|
928,111
|
|
1,527,481
|
|
1,697,347
|
Interest
expense
|
(313,488)
|
|
(466,726)
|
|
(626,976)
|
|
(979,760)
|
(Loss) gain on
investment in affiliated entities
|
(934,015)
|
|
278,818
|
|
(1,471,743)
|
|
(551,657)
|
Net unrealized (loss)
gain on available-for-sale equity securities
|
(3,967,101)
|
|
136,493
|
|
(8,807,742)
|
|
(711,465)
|
Other (expense) income,
net
|
(3,048)
|
|
185,281
|
|
(156,516)
|
|
194,259
|
Net loss before
share in net loss of Geneos
|
(108,497,311)
|
|
(82,139,958)
|
|
(185,405,817)
|
|
(136,107,702)
|
Share in net loss of
Geneos
|
—
|
|
—
|
|
(2,165,213)
|
|
(434,387)
|
Net
loss
|
$
(108,497,311)
|
|
$
(82,139,958)
|
|
$
(187,571,030)
|
|
$
(136,542,089)
|
Net loss per
share
|
|
|
|
|
|
|
|
Basic and diluted
|
$
(0.46)
|
|
$
(0.39)
|
|
$
(0.83)
|
|
$
(0.66)
|
Weighted average
number of common shares outstanding
|
|
|
|
|
|
|
|
Basic and diluted
|
235,278,276
|
|
209,561,064
|
|
227,154,616
|
|
206,007,497
|
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SOURCE INOVIO Pharmaceuticals, Inc.