Inovio Pharmaceuticals, Inc. (NASDAQ:INO), a late-stage
biotechnology company focused on the development and
commercialization of DNA immunotherapies targeted against cancers
and infectious diseases, today reported financial results for the
second quarter ended June 30, 2018, along with a general
business update. 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.
Inovio Highlights
- VGX-3100 -
HPV-related PrecancersREVEAL 1 Phase 3 trial
enrollment on track. Opened a total of 70 sites across 16 countries
and are actively recruiting for REVEAL 1, Inovio’s Phase 3 clinical
trial for treating cervical dysplasia (CIN) caused by the human
papillomavirus (HPV); the company anticipates opening approximately
90 sites globally by the end of August 2018. Also commenced during
the quarter a Phase 2 clinical trial in its third indication
to evaluate the efficacy of VGX-3100 in approximately 24 patients,
adult men and women, with HPV-related anal dysplasia. This
expansion increases the overall commercial value potential of our
lead product, VGX-3100.
- INO-5401 -
CancerDosed first patient in June as part of its
Phase 1/2 immuno-oncology trial in patients with newly diagnosed
glioblastoma (GBM); open-label, multi-center trial evaluating
INO-5401 and INO-9012 in combination with cemiplimab in 50 newly
diagnosed GBM patients with primary endpoint of safety and
tolerability; the study will also evaluate immunological impact,
progression-free survival and overall survival
(see www.clinicaltrials.gov, identifier NCT03491683).
- INO-5150 -
CancerPresented prostate cancer data at ASCO 2018 where
analyses showed clinically meaningful PSA stabilization
post-administration of INO-5150 in patients with no documented
disease progression during the study; of the 61 evaluable patients,
77% (47/61) demonstrated T cell immunogenicity; additional
immunology data past week 27 is expected to be presented at a major
oncology conference in the third quarter of 2018.
- PENNVAX®-GP -
HIVPresented data in May from a Phase 1 clinical trial in
which Inovio’s HIV vaccine maintained durable and robust immune
responses at month 12, a full 6 months after the last dose; 96% (26
of 27) of participants receiving PENNVAX-GP and IL-12 via IM
delivery demonstrated a CD4+ T cell response, while the same
percentage (96%, 27 of 28) of participants receiving the vaccine
formulation via ID delivery also displayed anti-HIV CD4+ T cell
responses; this data was presented at the 2018 HVTN Full Group
Meeting in May.
- INO-4700 (GLS-5300) -
MERSReported positive Phase 1 results of Inovio’s
collaborative vaccine study with INO-4700 (GLS-5300) against the
MERS virus (Middle East Respiratory Syndrome); results showed that
the vaccine was well-tolerated and approximately 95% of treated
patients achieved overall high levels of antibody responses and
approximately 90% of subjects also generated robust T cell
responses. The new data was presented in June at the WHO-IVI
Joint Symposium for MERS-CoV Vaccine Development.
- Established partnership
with CEPISigned a partnership agreement with the Coalition
for Epidemic Preparedness Innovations (CEPI) under which 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. Additional revenue is possible with vaccine stockpile
post-Phase 2 testing.
- Recognized revenue from
ApolloBio PartnershipReceived an upfront payment of $23
million (approximately $19.4 million after payment of required
taxes) in March 2018 from ApolloBio, which gained the rights to
develop, manufacture and commercialize VGX-3100 to treat precancers
caused by HPV, within Greater China. This amount was recognized in
Inovio’s reported revenue for the second quarter of 2018.
- Cash PositionAs of
June 30, 2018, cash and cash equivalents and short-term investments
were $95.6 million compared to $112.8 million as of March 31,
2018.
Dr. J. Joseph Kim, Inovio’s President & CEO
said, “The second quarter included important strategic
accomplishments for Inovio, while also providing shareholders with
much to look forward to over the next 12 months. From presenting
expanded data from our HIV developmental vaccine, PENNVAX®-GP, to
dosing our first patient with INO-5401 in our GBM trial, Inovio
continues to showcase the versatility of our technology in both
immunotherapy and infectious diseases. We continue to work
diligently with our newly established partners ApolloBio, CEPI and
the Parker Institute, while maintaining focus on opening sites and
enrolling patients globally for our lead asset, VGX-3100, for
treating patients with cervical dysplasia as well as capturing the
overall commercial value potential of VGX-3100 through the
expansion of our immunotherapeutic solution capabilities in
HPV-related vulvar and anal precancers.”
Second Quarter 2018 Financial
Results
Total revenue was $24.4 million for the three months ended June
30, 2018, compared to $20.4 million for the same period in 2017.
Total operating expenses were $29.7 million compared to $30.0
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 June 30, 2018, $1.9 million was recorded as
contra-research and development expense, which amount would have
been classified as grant revenue in the prior year. Had this change
in presentation not occurred, total revenue would have been $26.3
million for the three months ended June 30, 2018, compared to $20.4
million for the same period in 2017. Total operating expenses would
have been $31.6 million compared to $30.0 million for the same
period in 2017.
Inovio’s net loss for the quarter ended June 30, 2018 was $6.6
million, or $0.07 per basic and $0.08 per diluted share, compared
to $9.5 million, or $0.13 per basic and diluted share, for the
quarter ended June 30, 2017.
Revenue
The increase in comparable revenue and grant
agreement recognition for the second quarter of 2018 compared to
2017 was primarily due to the recognition of the gross up-front
payment from ApolloBio of $23.0 million during the period
(approximately $19.4 million after payment of required
taxes). This increase was partially offset by $12.8 million
in lower revenues recognized under Inovio’s collaborative research
and development agreement with MedImmune, as previously deferred
revenue totaling $13.8 million in the aggregate was recognized in
June 2017 upon MedImmune’s selection of the first cancer research
collaboration product candidate. Inovio also had a decrease in
grant funding recognized from its DARPA Ebola grant of $2.2 million
and a decrease in revenue of $2.1 million under its prior
collaboration with Roche, as all remaining deferred revenue was
recognized upon termination of that collaboration agreement in
2017, among other variances.
Operating Expenses
Research and development (R&D) expenses for the three months
ended June 30, 2018 were $22.5 million compared to $23.9 million
for the same period in 2017. The decrease in R&D expenses was
primarily due to the $1.9 million contra-research and development
expense recorded from grant agreements as discussed above, as well
as a decrease of $2.1 million in expenses related to the DARPA
Ebola grant. These decreases were slightly offset by an
increase in employee headcount to support clinical trials and
partnerships and an increase in expenses related to Inovio’s
VGX-3100 clinical trials and its collaboration with MedImmune,
among other variances.
General and administrative (G&A) expenses were $7.2 million
for the three months ended June 30, 2018 versus $6.2 million for
the same period in 2017.
Capital Resources
As of June 30, 2018, cash and cash equivalents
and short-term investments were $95.6 million compared to $112.8
million as of March 31, 2018. As of June 30, 2018, the Company had
91.5 million common shares outstanding and 102.8 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 for the quarter ended June
30, 2018 providing the complete 2018 second 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. Telephone
replay will be available approximately two hours after the call at
877-481-4010 (domestic) or 919-882-2331 (international) using
replay ID 33743.
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 Inovio technology platform is
designed to activate an individual’s immune system to generate a
robust, targeted T cell and antibody response against targeted
diseases. Inovio is 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, National Institute of Allergy and
Infectious Diseases, U.S. Army Medical Research Institute of
Infectious Diseases, NIH, HIV Vaccines Trial Network, U.S. Military
HIV Research Program and CEPI. 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, as well as our plans and expectations
regarding the presentation of data at scientific conferences.
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 June 30, 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. |
CONDENSED CONSOLIDATED BALANCE
SHEETS |
|
|
June 30, 2018 |
|
December 31, 2017 |
|
(Unaudited) |
|
|
ASSETS |
|
|
|
Current
assets: |
|
|
|
Cash and cash
equivalents |
$ |
15,085,643 |
|
|
$ |
23,786,579 |
|
Short-term
investments |
80,509,364 |
|
|
103,638,844 |
|
Accounts
receivable |
1,712,962 |
|
|
6,003,205 |
|
Accounts receivable
from affiliated entities |
960,453 |
|
|
486,619 |
|
Prepaid expenses and
other current assets |
1,785,081 |
|
|
2,600,906 |
|
Prepaid expenses and
other current assets from affiliated entities |
1,787,297 |
|
|
1,846,007 |
|
Total current
assets |
101,840,800 |
|
|
138,362,160 |
|
Fixed assets, net |
16,868,953 |
|
|
18,320,176 |
|
Investment in
affiliated entity - GeneOne |
9,014,490 |
|
|
9,069,401 |
|
Investment in
affiliated entity - PLS |
2,667,805 |
|
|
2,325,079 |
|
Intangible assets,
net |
5,293,271 |
|
|
6,009,729 |
|
Goodwill |
10,513,371 |
|
|
10,513,371 |
|
Other assets |
2,724,376 |
|
|
2,639,354 |
|
Total
assets |
$ |
148,923,066 |
|
|
$ |
187,239,270 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable and
accrued expenses |
$ |
12,609,959 |
|
|
$ |
23,278,798 |
|
Accounts payable and
accrued expenses due to affiliated entities |
600,701 |
|
|
926,943 |
|
Accrued clinical trial
expenses |
10,359,872 |
|
|
8,611,892 |
|
Common stock
warrants |
228,665 |
|
|
360,795 |
|
Deferred revenue |
762,361 |
|
|
1,175,353 |
|
Deferred revenue from
affiliated entities |
55,125 |
|
|
174,110 |
|
Deferred rent |
979,803 |
|
|
877,535 |
|
Deferred grant
funding |
2,620,985 |
|
|
— |
|
Deferred grant funding
from affiliated entities |
188,800 |
|
|
— |
|
Total current
liabilities |
28,406,271 |
|
|
35,405,426 |
|
Deferred revenue, net
of current portion |
175,157 |
|
|
215,853 |
|
Deferred rent, net of
current portion |
8,825,052 |
|
|
9,104,416 |
|
Deferred tax
liabilities |
24,766 |
|
|
24,766 |
|
Total
liabilities |
37,431,246 |
|
|
44,750,461 |
|
Stockholders’
equity: |
|
|
|
Preferred stock |
— |
|
|
— |
|
Common stock |
91,474 |
|
|
90,358 |
|
Additional paid-in
capital |
674,017,367 |
|
|
665,775,504 |
|
Accumulated
deficit |
(562,114,904 |
) |
|
(523,356,317 |
) |
Accumulated other
comprehensive loss |
(598,386 |
) |
|
(117,005 |
) |
Total Inovio
Pharmaceuticals, Inc. stockholders’ equity |
111,395,551 |
|
|
142,392,540 |
|
Non-controlling
interest |
96,269 |
|
|
96,269 |
|
Total stockholders’
equity |
111,491,820 |
|
|
142,488,809 |
|
Total
liabilities and stockholders’ equity |
$ |
148,923,066 |
|
|
$ |
187,239,270 |
|
|
|
|
|
|
|
|
|
Inovio Pharmaceuticals, Inc. |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
(Unaudited) |
|
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
|
2018 |
|
2017 |
|
2018 |
|
2017 |
Revenues: |
|
|
|
|
|
|
|
Revenue under
collaborative research and development arrangements |
$ |
24,385,852 |
|
|
$ |
16,358,316 |
|
|
$ |
25,674,898 |
|
|
$ |
20,646,902 |
|
Revenue under
collaborative research and development arrangements with affiliated
entities |
60,319 |
|
|
176,879 |
|
|
208,327 |
|
|
410,209 |
|
Grants and
miscellaneous revenue |
2,590 |
|
|
2,797,647 |
|
|
95,180 |
|
|
8,037,880 |
|
Grants and
miscellaneous revenue from affiliated entity |
— |
|
|
1,079,282 |
|
|
— |
|
|
1,693,318 |
|
Total
revenues |
24,448,761 |
|
|
20,412,124 |
|
|
25,978,405 |
|
|
30,788,309 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and
development |
22,462,620 |
|
|
23,878,751 |
|
|
47,040,371 |
|
|
48,421,255 |
|
General and
administrative |
7,189,310 |
|
|
6,169,106 |
|
|
16,887,325 |
|
|
13,936,695 |
|
Total operating
expenses |
29,651,930 |
|
|
30,047,857 |
|
|
63,927,696 |
|
|
62,357,950 |
|
Loss from
operations |
(5,203,169 |
) |
|
(9,635,733 |
) |
|
(37,949,291 |
) |
|
(31,569,641 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
Interest and other
income, net |
396,681 |
|
|
300,021 |
|
|
709,204 |
|
|
640,362 |
|
Change in fair value of
common stock warrants |
259,971 |
|
|
(312,500 |
) |
|
132,130 |
|
|
(196,023 |
) |
Gain (loss) on
investment in affiliated entities |
(2,092,608 |
) |
|
169,096 |
|
|
287,815 |
|
|
(1,439,721 |
) |
Net loss before
provision for income taxes |
(6,639,125 |
) |
|
(9,479,116 |
) |
|
(36,820,142 |
) |
|
(32,565,023 |
) |
Provision for income
taxes |
|
|
— |
|
|
(2,169,811 |
) |
|
— |
|
Net
loss |
$ |
(6,639,125 |
) |
|
$ |
(9,479,116 |
) |
|
$ |
(38,989,953 |
) |
|
$ |
(32,565,023 |
) |
Net loss per
share |
|
|
|
|
|
|
|
Basic |
$ |
(0.07 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.43 |
) |
|
$ |
(0.44 |
) |
Diluted |
$ |
(0.08 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.43 |
) |
|
$ |
(0.44 |
) |
Weighted
average number of common shares outstanding |
|
|
|
|
|
|
|
Basic |
91,153,776 |
|
|
75,409,702 |
|
|
90,804,722 |
|
|
74,783,791 |
|
Diluted |
91,241,660 |
|
|
75,409,702 |
|
|
90,890,792 |
|
|
74,783,791 |
|
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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