Preparing to initiate pivotal Phase 3 trial of
INO-3107 in adult RRP patients in first quarter of 2024; INO-3107
received Orphan Drug Designation from European Commission in second
quarter
Scaling resources and headcount to align with
strategic focus on INO-3107 and late-stage clinical candidates
closest to market and with greatest opportunity to deliver on the
promise of DNA medicines for patients
Following biomarker analysis from REVEAL2,
INOVIO is stopping investment in VGX-3100 for cervical HSIL
for U.S. market; Remains committed to supporting partner
ApolloBio's non-biomarker strategy for Chinese market
$194.9 million
in cash, cash equivalents and short-term investments at quarter
end; Headcount reduction and reallocation of resources expected to
lower future cash burn and extend cash runway into
third quarter of 2025
Investor call today at 4:30 PM EDT
PLYMOUTH
MEETING, Pa., Aug. 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 for the second quarter ended June
30, 2023 and provided a strategic update.
"We continue to make progress with INO-3107, our candidate for
the treatment of recurrent respiratory papillomatosis (RRP).
Following positive results from our Phase 1/2 trial earlier this
year, we are pleased to announce that we are targeting to have the
first patient dosed in a Phase 3 trial in adults in the first
quarter of 2024, moving us one step closer to delivering on the
promise of DNA medicines for patients suffering from this
debilitating disease," said Dr. Jacqueline
Shea, INOVIO's President and Chief Executive Officer. "Based
on our interactions with the U.S. Food and Drug Administration
(FDA) we believe that we have an acceptable trial design. We are
addressing what we believe to be their final questions before we
commence our pivotal Phase 3 trial for patients with RRP."
"As we move forward with our pipeline, we are focused on making
sure our company is scaled for success in light of the challenging
funding environment, particularly for pre-commercial biotech
companies like INOVIO," Dr. Shea continued. "With that in mind, we
made the difficult decision to further reduce our headcount and
operational spending to better align with our strategic
priorities. We believe that with the pipeline reprioritization
announced today, we are well-positioned to execute on our
development plans for INO-3107 while also advancing other promising
candidates, such as INO-3112, INO-5401, VGX-3100 for anal HSIL and
INO-4201. We expect that our existing cash resources will allow us
to achieve important catalysts for these programs. I would like to
extend my deepest gratitude to all of our employees – past and
present – for their efforts on behalf of the company and
contributions to the important progress we're making."
Pipeline Reprioritization and Corporate
Reorganization
INO-3107 – Recurrent Respiratory Papillomatosis (RRP)
- INOVIO has announced today that it is further reprioritizing
its pipeline to focus on its highest potential, closest to market
programs, specifically its late-stage clinical program for INO-3107
as a treatment for RRP. In a Phase 1/2 trial involving RRP
patients, treatment with INO-3107 resulted in a statistically
significant reduction in the number of surgical interventions
required to manage the disease. INOVIO is targeting to commence its
pivotal Phase 3 trial in adult patients with RRP, subject to
clearance by regulators, in the first quarter of 2024.
- On May 5, 2023, data from the
Phase 1/2 trial of INO-3107 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 was well
tolerated by participants in the trial and resulted in 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. Treatment with INO-3107 induced cellular immune
responses against both HPV-6 and HPV-11, with activated CD4 and CD8
T cells, including cytotoxic CD8 T cells thought to be important
for clearance of virally infected cells. Preliminary analysis
indicates a potential correlation between T-cell responses and
reduction of surgeries. T-cell responses were also observed at Week
52, indicating a persistent cellular memory response.
- Also in May 2023, INO-3107 was
granted orphan drug designation by the European Commission (EU) as
a potential treatment for RRP. INO-3107 was granted orphan drug
designation from the FDA in July
2020, making it the first RRP product candidate to receive
designations from both U.S. and EU regulatory bodies.
VGX-3100 – Cervical High-Grade Squamous Intraepithelial
Lesions (HSIL)
- INOVIO has decided to cease all further development of VGX-3100
as a potential treatment for cervical HSIL in the United States. This decision is driven by
a number of factors, including the recent analysis of biomarker
data from REVEAL2 indicating that substantial work would be needed
to refine this novel biomarker before it could be used in any
further Phase 3 trials. Previously, the U.S. FDA indicated that at
least one or more additional well-controlled trials would need to
be conducted in the biomarker-positive population before being
considered for registration. Given these factors, INOVIO has
determined that its resources are best invested in other pipeline
candidates with a faster potential path to market. INOVIO remains
encouraged by the data collected in both of its completed Phase 3
trials for VGX-3100 in cervical HSIL (REVEAL1 and REVEAL2). In
these trials, the data showed that VGX-3100 could clear both virus
and lesions, which INOVIO believes could be supportive evidence for
pursuing regulatory approval in other global markets.
- For non-U.S. markets, where the access to and options for
treatment differs, INOVIO believes that VGX-3100 could be a
valuable treatment option for cervical HSIL should current and
future trials continue to show potential efficacy and achieve
regulatory approvals. For the Chinese market, INOVIO's partner
ApolloBio continues to advance the development of VGX-3100 for
cervical HSIL in a Phase 3 trial. This trial is designed to use a
similar protocol to that of REVEAL1 and does not utilize the novel
biomarker used in INOVIO's REVEAL2 trial. INOVIO also continues to
discuss the clinical development of VGX-3100 with potential
partners in other global markets.
Other VGX-3100 Indications and Clinical Pipeline
Candidates
- Pending discussions with regulators, INOVIO plans to
investigate opportunities to advance VGX-3100 as a potential
treatment for anal HSIL, an indication that continues to have
significant unmet need. Results published in the New England
Journal of Medicine in June 2022
from a multi-year study sponsored by the National Cancer Institute,
called the ANCHOR study, showed "for the first time that treating
anal HSIL is effective at reducing the incidence of anal cancer in
a very high-risk group of people – people living with HIV" (NCI
press release, June 15, 2022). INOVIO
has observed that this study produced results that are moving the
medical community away from the historical practice of actively
monitoring anal HSIL and toward a more proactive approach in
treating lesions that can progress to cancer. The challenge for
patients and their healthcare providers in taking a more proactive
approach is that there are few effective options available to treat
anal HSIL. VGX-3100 has the ability to clear HPV-16/18 lesions and
virus, which was not only observed in the cervical HSIL Phase 3
trials, but also in an open-label Phase 2 anal HSIL trial in HIV
negative people. VGX-3100 is currently being investigated in an
ongoing Phase 2 trial in HIV-positive anal HSIL patients being
conducted by the AIDS Malignancy Consortium.
- INOVIO is also working to advance its oncology product
candidates, specifically INO-5401 and INO-3112, which target
glioblastoma (GBM) and HPV-related cancers, respectively, as well
as other candidates in its early-stage clinical pipeline targeting
infectious diseases, in particular the company's Ebola vaccine
candidate, INO-4201. Progress for these candidates has continued in
the areas of manufacturing, regulatory submissions, and partnership
discussions. The next stage of clinical development will most
likely require additional funding or partnerships.
Corporate Restructuring
- As a result of the decision to focus its resources on its
late-stage candidates with the greatest likelihood of success,
including stopping the development of VGX-3100 in cervical HSIL for
the U.S. market, INOVIO has taken steps to further conserve its
capital resources. The company recently announced plans to further
reduce its workforce by 58 employees, or 30%. The company estimates
the cost savings from the headcount reduction will provide annual
savings of approximately $9.9
million, which alongside other reductions in spending would
allow the company to extend its cash runway into the third quarter
of 2025.
Second Quarter 2023 Financial Results
- Cash, Cash Equivalents and Short-term Investments: As of
June 30, 2023, cash, cash equivalents
and short-term investments were $194.9
million compared to $253.0
million as of December 31,
2022.
- Revenues: Total revenues for the three months ended
June 30, 2023 were $226,000, compared to $784,000 for the same period in 2022.
- Research and Development (R&D) Expenses: R&D
expenses for the three months ended June 30,
2023 were $23.7 million
compared to $56.5 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 second quarter were $13.5 million compared to $48.5 million for the same period in 2022. The
decrease in G&A expenses was primarily related to significant
one-time costs in the second quarter of 2022 related to the
settlement of the class action litigation and related legal
expenses, as well as severance expenses incurred in 2022 in
connection with the separation of the company's former president
and chief executive officer, among other variances.
- Total Operating Expenses: Total operating expenses were
$37.3 million compared to
$104.9 million for the same period in
2022.
- Net Loss: INOVIO's net loss for the quarter ended
June 30, 2023 was $35.5 million, or $0.13 per basic and diluted share, compared to
net loss of $108.5 million, or
$0.46 per basic and diluted share,
for the second quarter of 2022.
- Shares Outstanding: As of June
30, 2023, INOVIO had 268.1 million common shares outstanding
and 290.0 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 June 30, 2023, which can be accessed at:
http://ir.inovio.com/financials/default.aspx.
Cash Guidance
INOVIO estimates that the cost savings
announced today will enable it to fund its operations into the
third quarter of 2025. This projection includes a cash burn
estimate of approximately $34.0
million for the third quarter of 2023 and the expectation
that cash burn will decrease incrementally throughout the remainder
of 2023 and 2024. 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
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, the need for third-party funding to
continue certain development programs, expectations with respect to
annual savings from corporate restructuring activities, projected
cash burn for the third quarter of 2023 and reductions in spending
through 2024, and the sufficiency of our cash resources to fund
operations into the third 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 June 30, 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.
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
|
June 30,
2023
|
|
December 31,
2022
|
|
(Unaudited)
|
|
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$52,712,543
|
|
$46,329,359
|
Short-term
investments
|
142,212,907
|
|
206,669,397
|
Accounts
receivable
|
5,947
|
|
1,701,726
|
Accounts receivable
from affiliated entities
|
5,110,279
|
|
10,036,490
|
Prepaid expenses and
other current assets
|
3,230,882
|
|
50,130,481
|
Prepaid expenses and
other current assets from affiliated entities
|
11,928
|
|
375,227
|
Total current
assets
|
203,284,486
|
|
315,242,680
|
Fixed assets,
net
|
6,303,949
|
|
7,727,997
|
Investment in
affiliated entity
|
2,780,526
|
|
2,007,142
|
Intangible assets,
net
|
—
|
|
2,129,861
|
Goodwill
|
10,513,371
|
|
10,513,371
|
Operating lease
right-of-use assets
|
9,488,738
|
|
10,228,207
|
Other assets
|
666,890
|
|
684,044
|
Total
assets
|
$233,037,960
|
|
$348,533,302
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued expenses
|
$21,265,150
|
|
$79,686,885
|
Accounts payable and
accrued expenses due to affiliated entities
|
1,686,375
|
|
1,220,439
|
Accrued clinical trial
expenses
|
6,172,382
|
|
10,594,073
|
Operating lease
liability
|
2,351,449
|
|
2,803,973
|
Grant funding
liability
|
3,704,781
|
|
2,475,031
|
Grant funding liability
from affiliated entity
|
43,836
|
|
87,673
|
Convertible senior
notes
|
16,708,329
|
|
—
|
Total current
liabilities
|
51,932,302
|
|
96,868,074
|
Convertible senior
notes
|
—
|
|
16,614,840
|
Operating lease
liability, net of current portion
|
11,702,044
|
|
12,655,586
|
Deferred tax
liabilities
|
32,046
|
|
32,046
|
Total
liabilities
|
63,666,392
|
|
126,170,546
|
Stockholders'
equity:
|
|
|
|
Preferred
stock
|
—
|
|
—
|
Common stock
|
268,072
|
|
253,090
|
Additional paid-in
capital
|
1,733,826,392
|
|
1,710,656,191
|
Accumulated
deficit
|
(1,564,031,634)
|
|
(1,487,847,784)
|
Accumulated other
comprehensive loss
|
(691,262)
|
|
(698,741)
|
Total Inovio
Pharmaceuticals, Inc. stockholders' equity
|
169,371,568
|
|
222,362,756
|
Total liabilities
and stockholders' equity
|
$233,037,960
|
|
$348,533,302
|
INOVIO
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
|
|
|
|
|
|
|
Revenue from
collaborative arrangements and other contracts
|
$225,971
|
|
$784,395
|
|
$340,914
|
|
$983,469
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
23,743,970
|
|
56,464,885
|
|
53,920,481
|
|
112,443,496
|
General and
administrative
|
13,523,098
|
|
48,456,836
|
|
27,413,708
|
|
64,410,294
|
Total operating
expenses
|
37,267,068
|
|
104,921,721
|
|
81,334,189
|
|
176,853,790
|
Loss from
operations
|
(37,041,097)
|
|
(104,137,326)
|
|
(80,993,275)
|
|
(175,870,321)
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest
income
|
2,168,233
|
|
857,667
|
|
4,375,404
|
|
1,527,481
|
Interest
expense
|
(313,488)
|
|
(313,488)
|
|
(626,976)
|
|
(626,976)
|
Gain (loss) on
investment in affiliated entity
|
156,745
|
|
(934,015)
|
|
773,384
|
|
(1,471,743)
|
Net unrealized gain
(loss) on available-for-sale equity securities
|
922,941
|
|
(3,967,101)
|
|
4,141,156
|
|
(8,807,742)
|
Other expense,
net
|
(1,427,867)
|
|
(3,048)
|
|
(3,853,543)
|
|
(156,516)
|
Net loss before
share in net loss of Geneos
|
(35,534,533)
|
|
(108,497,311)
|
|
(76,183,850)
|
|
(185,405,817)
|
Share in net loss of
Geneos
|
—
|
|
—
|
|
—
|
|
(2,165,213)
|
Net
loss
|
$(35,534,533)
|
|
$(108,497,311)
|
|
$(76,183,850)
|
|
$(187,571,030)
|
Net loss per
share
|
|
|
|
|
|
|
|
Basic and diluted
|
$(0.13)
|
|
$(0.46)
|
|
$(0.29)
|
|
$(0.83)
|
Weighted average
number of common shares outstanding
|
|
|
|
|
|
|
|
Basic and diluted
|
264,353,833
|
|
235,278,276
|
|
261,412,116
|
|
227,154,616
|
View original
content:https://www.prnewswire.com/news-releases/inovio-announces-second-quarter-2023-financial-results-and-provides-strategic-update-301897181.html
SOURCE INOVIO Pharmaceuticals, Inc.