Inovio Pharmaceuticals, Inc. (NASDAQ:INO), a late-stage
biotechnology company focused on the discovery, development, and
commercialization of DNA immunotherapies targeted against cancers
and infectious diseases, today reported financial results for the
first quarter ended March 31, 2018, along with a general
business update.
Inovio Highlights
- VGX-3100. A total of 60 sites globally are
open and recruiting for REVEAL 1 (Phase 3 clinical trial for
treating cervical dysplasia (CIN) caused by human papillomavirus
(HPV)); recruiting patients in Phase 2 study for treating vulvar
dysplasia (VIN) and associated diseases.
- MEDI0457 in combination with durvalumab
advanced to the Phase 2 efficacy stage of the trial, triggering a
milestone payment to Inovio. MedImmune is evaluating MEDI0457 in
combination with durvalumab, its PD-L1 checkpoint inhibitor, in
patients with recurrent/metastatic HPV-associated HNSCC in a
clinical trial with an estimated total enrollment of 50
patients.
- INO-5401. Opening sites for Phase 1/2a study
to evaluate the safety, immunogenicity and preliminary clinical
efficacy of INO-5401 and INO-9012 in combination with
Roche/Genentech’s atezolizumab in participants with locally
advanced unresectable or metastatic/recurrent urothelial carcinoma
(UCa); opening sites for Phase 1/2 study to evaluate safety,
immunogenicity and preliminary efficacy of INO-5401 and INO-9012 in
combination with Regeneron’s cemiplimab in participants with
newly-diagnosed glioblastoma (GBM).
- INO-1800. Inovio’s treatment for hepatitis B
infection is being evaluated in a Phase 1 clinical study in which
it has generated virus-specific T cells with a favorable safety
profile to date. Inovio continues its partnering discussions and
plans to report additional data from this trial at upcoming
scientific conferences and in a publication in 2018.
- Executed collaboration and partnering agreement with
ApolloBio. Inovio received an upfront payment of $23
million (approximately $19.4 million after payment of required
taxes) from ApolloBio, which gained the rights to develop,
manufacture and commercialize VGX-3100 to treat precancers caused
by HPV, within Greater China.
- Entered into a clinical collaboration agreement with
the Parker Institute for Cancer Immunotherapy. The
agreement provides that Inovio and the Parker
Institute will undertake clinical evaluation of novel
combination regimens within the field of immuno-oncology. Under the
agreement, the Parker Institute will have responsibility
for funding and clinical study execution, working in collaboration
with its established network. Inovio will provide financial
contributions if Inovio's product(s) studied under the
collaboration reaches the initiation of a Phase 3 study.
- Established partnership with CEPI (in April).
Inovio will develop vaccine candidates against Lassa fever and
Middle East Respiratory Syndrome (MERS). The Coalition for Epidemic
Preparedness Innovations (CEPI) will directly fund up to $56
million to support Inovio’s pre-clinical and clinical advancement
through Phase 2 of INO-4500, its Lassa fever vaccine, and INO-4700,
its MERS vaccine, over a five-year period.
- GENEOS Therapeutics, Inc. Our wholly-owned
subsidiary, GENEOS Therapeutics, Inc., which is developing
neoantigen-based personalized cancer therapies, plans to raise
capital in 2018 to fund the development of its programs.
- Cash Position. As of March 31, 2018, cash and
cash equivalents and short-term investments were $112.8 million
compared to $127.4 million as of December 31, 2017.
Dr. J. Joseph Kim, Inovio’s President & CEO
said, “During the first quarter of 2018, Inovio has made
significant progress in its clinical trials, while continuing to
secure corporate partnerships and obtain significant non-dilutive
funding. These accomplishments further validate our proprietary
ASPIRE™ technology targeting cancer and emerging infectious
diseases in addition to positioning us as a global leader for
treating a wide spectrum of HPV-related diseases. We look forward
to building on our treatment capabilities, while continuing to
expand on our partnering successes from the first
quarter.”
First Quarter 2018 Financial
Results
Total revenue was $1.5 million for the three
months ended March 31, 2018, compared to $10.4 million for the same
period in 2017. Total operating expenses were $34.3 million
compared to $32.3 million for the same period in 2017.
As a result of the adoption of Accounting
Standards Update No. 2014-09, Revenue from Contracts with
Customers, beginning on January 1, 2018, all contributions received
from current grant agreements have been recorded as a
contra-expense as opposed to revenue on the consolidated statement
of operations. For the three months ended March 31, 2018, $2.2
million was recorded as contra-research and development expense
which would have been classified as grant revenue in the prior
year. Had this change in presentation not occurred, total revenue
would have been $3.7 million for the three months ended March 31,
2018, compared to $10.4 million for the same period in 2017. Total
operating expenses would have been $36.5 million compared to $32.3
million for the prior year period.
Inovio’s net loss for the quarter ended March
31, 2018 was $32.4 million, or $0.36 per basic and diluted share,
compared to $23.1 million, or $0.31 per basic and diluted share,
for the quarter ended March 31, 2017.
Revenue
The decrease in comparable revenue and grant
agreement recognition for the first quarter 2018 compared to 2017
was primarily due to the prior year revenue recognized from the
termination payment received from Roche during the first quarter of
2017 of $4.0 million. The decrease was also due to a decrease in
grant funding recognized from our Defense Advanced Research
Projects Agency (DARPA) Ebola grant of $4.7 million, partially
offset by an increase in grant funding recognized from our Zika
virus sub-grant of $1.2 million.
Operating Expenses
Research and development (R&D) expenses for
the three months ended March 31, 2018 were $24.6 million compared
to $24.5 million for the same period in 2017. The increase in
R&D expenses was primarily related to our VGX-3100 clinical
trials, activities under our collaboration with MedImmune and an
increase in employee headcount to support our clinical trial
activities and partnerships. These increases were offset by the
$2.2 million contra-research and development expense recorded from
grant agreements as discussed above, as well as a decrease in
expenses related to the DARPA Ebola grant as it nears
completion.
General and administrative (G&A) expenses
were $9.7 million for the three months ended March 31, 2018 versus
$7.8 million for the same period in 2017. The increase in G&A
expenses was primarily related to the Chinese taxes and advisory
fees incurred in connection with the ApolloBio upfront payment we
received, offset by a decrease in non-cash stock based
compensation.
Capital Resources
As of March 31, 2018, cash and cash equivalents
and short-term investments were $112.8 million compared to $127.4
million as of December 31, 2017. As of March 31, 2018, the Company
had 90.7 million common shares outstanding and 102.3 million common
shares outstanding on a fully diluted basis, after giving effect to
outstanding options, warrants, restricted stock units and
convertible preferred stock.
Inovio’s balance sheet and statement of
operations are provided below. Form 10-Q providing the complete
2018 first quarter financial report can be found at:
http://ir.inovio.com/investors/financial-reports/default.aspx.
Conference Call / Webcast
Information
Inovio’s management will host a live conference
call and webcast at 4:30 p.m. Eastern Time today to discuss
Inovio’s financial results and provide a general business
update.
The live webcast and a replay may be accessed by
visiting the Company's website at
http://ir.inovio.com/investors/events/default.aspx. Please connect
to the Company's website at least 15 minutes prior to the live
webcast to ensure adequate time for any software download that may
be needed to access the webcast. Telephone replay will be available
approximately two hours after the call at 877-481-4010 (domestic)
or 919-882-2331 (international) using replay ID 29009.
About Inovio Pharmaceuticals,
Inc.
Inovio is a late-stage biotechnology company
focused on the discovery, development, and commercialization of DNA
immunotherapies that transform the treatment of cancer and
infectious diseases. The ASPIRE (Antigen Specific Immune Responses)
technology platform is designed to activate an individual’s immune
system to generate a robust, targeted T cell and antibody response
against targeted diseases. We are the only
immunotherapy company that has reported generating T cells
entirely in vivo in high quantity that are fully functional
and whose killing capacity correlates with relevant clinical
outcomes with a favorable safety profile. Inovio’s most advanced
clinical program, VGX-3100, is in Phase 3 for the treatment of
HPV-related cervical precancer. Also in development are Phase 2
immuno-oncology programs targeting head and neck cancer, bladder
cancer, and glioblastoma, as well as platform development programs
in hepatitis B, Zika, Ebola, MERS, and HIV. Partners and
collaborators include MedImmune, Regeneron, Roche/Genentech,
ApolloBio Corporation, The Wistar Institute, University of
Pennsylvania, the Parker Institute for Cancer Immunotherapy, DARPA,
GeneOne Life Science, Plumbline Life Sciences, Drexel University,
NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S.
Military HIV Research Program, and Laval University. For more
information, visit www.inovio.com.
This press release contains certain
forward-looking statements relating to our business, including our
plans to develop electroporation-based drug and gene delivery
technologies and DNA vaccines, our expectations regarding our
research and development programs, including the planned initiation
and conduct of clinical trials and the availability and timing of
data from those trials, our plans and expectations regarding
partnerships and the plans of GENEOS Therapeutics, Inc. to raise
capital. 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 and
product development programs, 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 vaccines, our ability to support
our pipeline of SynCon® active immunotherapy and vaccine 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 our 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, 2017, our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2018
and other regulatory filings we make from time to time. There can
be no assurance that any product candidate in our pipeline will be
successfully developed, manufactured or commercialized, that final
results of clinical trials will be supportive of regulatory
approvals required to market licensed 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, 2018 |
|
December 31, 2017 |
|
(Unaudited) |
|
|
ASSETS |
|
|
|
Current
assets: |
|
|
|
Cash and cash
equivalents |
$ |
37,508,863 |
|
|
$ |
23,786,579 |
|
Short-term
investments |
75,259,889 |
|
|
103,638,844 |
|
Accounts
receivable |
5,147,851 |
|
|
6,003,205 |
|
Accounts receivable
from affiliated entities |
2,242,569 |
|
|
486,619 |
|
Prepaid expenses and
other current assets |
2,002,015 |
|
|
2,600,906 |
|
Prepaid expenses and
other current assets from affiliated entities |
1,674,981 |
|
|
1,846,007 |
|
Total current
assets |
123,836,168 |
|
|
138,362,160 |
|
Fixed assets, net |
17,486,103 |
|
|
18,320,176 |
|
Investment in
affiliated entity – GeneOne |
10,467,711 |
|
|
9,069,401 |
|
Investment in
affiliated entity – PLS |
3,307,192 |
|
|
2,325,079 |
|
Intangible assets,
net |
5,605,667 |
|
|
6,009,729 |
|
Goodwill |
10,513,371 |
|
|
10,513,371 |
|
Other assets |
2,448,628 |
|
|
2,639,354 |
|
Total
assets |
$ |
173,664,840 |
|
|
$ |
187,239,270 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable and
accrued expenses |
$ |
15,825,207 |
|
|
$ |
23,278,798 |
|
Accounts payable and
accrued expenses due to affiliated entities |
1,298,741 |
|
|
926,943 |
|
Accrued clinical trial
expenses |
8,428,881 |
|
|
8,611,892 |
|
Common stock
warrants |
488,636 |
|
|
360,795 |
|
Deferred revenue |
24,088,288 |
|
|
1,175,353 |
|
Deferred revenue from
affiliated entities |
56,167 |
|
|
174,110 |
|
Deferred rent |
928,098 |
|
|
877,535 |
|
Other liabilities |
261,325 |
|
|
— |
|
Total current
liabilities |
51,375,343 |
|
|
35,405,426 |
|
Deferred revenue, net
of current portion |
203,322 |
|
|
215,853 |
|
Deferred rent, net of
current portion |
8,966,846 |
|
|
9,104,416 |
|
Deferred tax
liabilities |
24,766 |
|
|
24,766 |
|
Total
liabilities |
60,570,277 |
|
|
44,750,461 |
|
Stockholders’
equity: |
|
|
|
Preferred stock |
— |
|
|
— |
|
Common stock |
90,705 |
|
|
90,358 |
|
Additional paid-in
capital |
668,844,504 |
|
|
665,775,504 |
|
Accumulated
deficit |
(555,475,779 |
) |
|
(523,356,317 |
) |
Accumulated other
comprehensive loss |
(461,136 |
) |
|
(117,005 |
) |
Total Inovio
Pharmaceuticals, Inc. stockholders’ equity |
112,998,294 |
|
|
142,392,540 |
|
Non-controlling
interest |
96,269 |
|
|
96,269 |
|
Total stockholders’
equity |
113,094,563 |
|
|
142,488,809 |
|
Total
liabilities and stockholders’ equity |
$ |
173,664,840 |
|
|
$ |
187,239,270 |
|
|
Inovio Pharmaceuticals,
Inc.CONSOLIDATED STATEMENTS OF
OPERATIONS
|
|
|
Three Months EndedMarch 31, |
|
2018 |
|
2017 |
Revenues: |
|
|
|
Revenue under
collaborative research and development arrangements |
$ |
1,289,046 |
|
|
$ |
4,288,586 |
|
Revenue under
collaborative research and development arrangements with affiliated
entities |
|
148,008 |
|
|
|
233,330 |
|
Grants and
miscellaneous revenue |
|
92,590 |
|
|
|
5,240,233 |
|
Grants and
miscellaneous revenue from affiliated entity |
|
— |
|
|
|
614,036 |
|
Total
revenues |
|
1,529,644 |
|
|
|
10,376,185 |
|
Operating
expenses: |
|
|
|
Research and
development |
|
24,577,751 |
|
|
|
24,542,504 |
|
General and
administrative |
|
9,698,015 |
|
|
|
7,767,589 |
|
Total operating
expenses |
|
34,275,766 |
|
|
|
32,310,093 |
|
Loss from
operations |
|
(32,746,122 |
) |
|
|
(21,933,908 |
) |
Other income
(expense): |
|
|
|
Interest and other
income, net |
|
312,523 |
|
|
|
340,341 |
|
Change in fair value of
common stock warrants |
|
(127,841 |
) |
|
|
116,477 |
|
Gain (loss) on
investment in affiliated entities |
|
2,380,423 |
|
|
|
(1,608,817 |
) |
Net loss before
provision for income taxes |
|
(30,181,017 |
) |
|
|
(23,085,907 |
) |
Provision for income
taxes |
|
(2,169,811 |
) |
|
|
— |
|
Net
loss |
$ |
(32,350,828 |
) |
|
$ |
(23,085,907 |
) |
Net loss per
share |
|
|
|
Basic |
$ |
(0.36 |
) |
|
$ |
(0.31 |
) |
Diluted |
$ |
(0.36 |
) |
|
$ |
(0.31 |
) |
Weighted
average number of common shares outstanding |
|
|
|
Basic |
|
90,451,791 |
|
|
|
74,152,609 |
|
Diluted |
|
90,451,791 |
|
|
|
74,300,884 |
|
|
CONTACTS:Investors:
Ben Matone,
Inovio, 484-362-0076, ben.matone@inovio.comMedia:
Jeff Richardson, Inovio, 267-440-4211, jrichardson@inovio.com
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