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
third quarter ended September 30, 2018. 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.
Inovio Highlights
- VGX-3100 –
HPV-related PrecancersPhase 3 trial enrollment
remains ongoing and on track for REVEAL 1, with REVEAL 2 expected
to begin in early 2019. To date, REVEAL 1 has opened sites across
19 countries, actively recruiting patients. Recruitment for Phase 2
studies in vulvar dysplasia and anal dysplasia is also underway. In
August, Inovio entered into a partnership with the AIDS Malignancy
Consortium to evaluate VGX-3100 in a multi-site Phase 2 study in
HIV-positive adult men and women. Interim efficacy data from all
these Phase 2 studies are expected in 2019.
- MEDI0457 (formerly
INO-3112, licensed to MedImmune)The October issue of
Clinical Cancer Research detailed results of a patient with head
and neck cancer treated with MEDI0457 who achieved a sustained
complete response (full remission) following subsequent treatment
with a PD-1 checkpoint inhibitor. In the Inovio-sponsored study of
22 patients with head and neck squamous cell carcinoma, 91% of
patients (20/22) showed T cell activity in the blood or tissue.
MEDI0457 is currently in a Phase 2 study to evaluate the anti-tumor
activity of MEDI0457 in combination with durvalumab in patients
with recurrent/metastatic HPV 16- or 18- associated head and neck
cancer. MedImmune is also expected to begin another Phase 2 study
in the fourth quarter to evaluate the anti-tumor activity of
MEDI0457 in combination with durvalumab in patients with
recurrent/metastatic HPV 16- or 18- associated cancers (other than
head and neck). The commencement of this study will trigger a
milestone payment to Inovio under the terms of the parties’
collaboration agreement.
- INO-5150 – Prostate
cancerPresented prostate cancer data from Inovio’s Phase 1
study at the ESMO 2018 conference in which a slowing of
Prostate-Specific Antigen Doubling Time (PSADT) was observed in men
with prostate cancer, with 86% of patients remaining
progression-free at week 72.
- INO-5401 –
Cancer Combination TrialsEnrollment is going as
planned and is on target to report interim Phase 2 data for both
glioblastoma (GBM) and bladder cancer in 2019. In both trials
INO-5401 is combined with a checkpoint inhibitor – for GBM with
Regeneron (PD-1); for bladder cancer with Genentech (PD-L1).
- PENNVAX®-GP –
HIVIn August, first patient was dosed with
PENNVAX®-GP in a randomized clinical trial that
will evaluate its ability to drive remission of HIV infection.
Enrollment remains on track. The trial is part of a previously
reported multi-year $6.95 million grant from the NIH’s National
Institute of Allergy and Infectious Diseases to develop a single or
combination therapy using Inovio’s PENNVAX®-GP
with the goal of attaining long-term HIV remission. Inovio
anticipates interim results in 2019.
- INO-4700 (GLS-5300) –
MERSFirst patient was dosed with vaccine to prevent
infection from the deadly MERS virus (Middle East Respiratory
Syndrome) in a Phase 1/2a study to evaluate INO-4700 (or GLS-5300).
The trial is ongoing in South Korea, sponsored by Inovio’s Korean
development partner GeneOne Life Science (KSE: 011000) with full
funding from the International Vaccine Institute. Inovio
anticipates interim results in 2019.
- DNA-Encoded Monoclonal
Antibody (dMAb™)In October, Inovio received the first two
U.S. patents for its DNA-encoded monoclonal antibody technology
(dMAb™) from the USPTO and was awarded a $2.2 million grant from
the Bill & Melinda Gates Foundation to advance its dMAb
platform and new clinical delivery devices. In addition, Inovio
announced an important milestone in the field of dMAb
immunotherapies where Inovio was the first to report evidence on
the use of dMAb technology to develop novel monoclonal
antibody-based therapies targeting checkpoint inhibitors.
- Cash PositionAs of
September 30, 2018, cash and cash equivalents and short-term
investments were $85.5 million compared to $95.6 million as of June
30, 2018.
Dr. J. Joseph Kim, Inovio’s President & CEO
said, “Utilizing ample resources, Inovio is making significant
advancements on many fronts. The Phase 3 REVEAL 1 study for our
lead VGX-3100 program is on track to fully enroll in 2019 and our
three separate immuno-oncology, checkpoint combination Phase 2
trials, being executed with top partners and collaborators,
MedImmune, Genentech, and Regeneron, are also advancing well. In
fact, we saw a potential preview of what could come from the
ongoing cancer efficacy studies in a new publication in Clinical
Cancer Research which showcased the first complete responder from
our Phase 1 MEDI0457 head & neck cancer trial. Also progressing
well are our externally funded vaccine programs including the
CEPI-funded Lassa vaccine program as well as IVI-funded MERS and
GeneOne-funded Zika vaccine trials. Overall, these clinical trial
advancements ensure that we will have multiple, meaningful data
catalysts in the coming months.”
Third Quarter 2018 Financial
Results
Total revenue was $2.0 million for the three months ended
September 30, 2018, compared to $2.6 million for the same period in
2017. Total operating expenses were $28.6 million compared to $31.8
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 September 30, 2018, $2.6 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 $4.6
million for the three months ended September 30, 2018, compared to
$2.6 million for the same period in 2017. Total operating expenses
would have been $31.2 million compared to $31.8 million for the
same period in 2017.
Inovio’s net loss for the quarter ended September 30, 2018 was
$25.0 million, or $0.27 per basic and diluted share, compared to
$34.1 million, or $0.39 per basic and $0.40 per diluted share, for
the quarter ended September 30, 2017.
Revenue
The increase in comparable revenue and grant
agreement recognition for the third quarter of 2018 compared to
2017 was primarily due to increases from Inovio’s MedImmune
collaboration and its CEPI grant of $1.5 million and $1.2 million,
respectively. These increases were offset by a decrease in grant
funding recognized from Inovio’s DARPA Ebola grant of $1.2 million,
among other variances.
Operating Expenses
Research and development (R&D) expenses for
the three months ended September 30, 2018 were $21.9 million
compared to $25.5 million for the same period in 2017. The decrease
in R&D expenses was primarily due to the $2.6 million
contra-research and development expense recorded from grant
agreements as discussed above, as well as a decrease of $2.4
million in expenses related to Inovio’s DARPA Ebola grant. These
decreases were slightly offset by an increase of $1.4 million for
drug manufacturing related to Inovio’s collaboration with MedImmune
and an increase of $746,000 related to employee headcount to
support clinical trials and partnerships, among other
variances.
General and administrative (G&A) expenses
were $6.8 million for the three months ended September 30, 2018
versus $6.3 million for the same period in 2017.
Capital Resources
As of September 30, 2018, cash and cash
equivalents and short-term investments were $85.5 million compared
to $95.6 million as of June 30, 2018. As of September 30, 2018, the
Company had 94.5 million common shares outstanding and 105.1
million common shares outstanding on a fully diluted basis, after
giving effect to outstanding options, restricted stock units and
convertible preferred stock.
During the nine months ended September 30, 2018
the Company sold 2,967,480 shares of common stock under its current
and prior ATM common stock sales agreements for aggregate net
proceeds of $14.9 million.
During the nine months ended September 30, 2018,
stock options and warrants to purchase an aggregate of 713,944
shares of common stock were exercised for aggregate net proceeds of
$2.3 million.
Inovio’s balance sheet and statement of
operations are provided below. Form 10-Q for the quarter ended
September 30, 2018 providing the complete 2018 third 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 39603.
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. Inovio’s proprietary platform technology
applies next-generation antigen sequencing and DNA delivery to
activate potent immune responses to targeted diseases. The
technology functions exclusively in vivo, and has been demonstrated
to consistently activate robust and fully functional T cell and
antibody responses against targeted cancers and pathogens. Inovio
is the only immunotherapy company that has reported generating T
cells whose killing capacity correlates with relevant clinical
outcomes. Inovio’s most advanced clinical program, VGX-3100, is in
Phase 3 for the treatment of HPV-related cervical pre-cancer. 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 Bill & Melinda
Gates Foundation, The Wistar Institute, University of Pennsylvania,
Parker Institute for Cancer Immunotherapy, CEPI, 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. 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 September 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.
|
|
|
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Inovio Pharmaceuticals, Inc.CONDENSED
CONSOLIDATED BALANCE SHEETS |
|
|
|
|
|
September 30,
2018 |
|
December 31,
2017 |
|
(Unaudited) |
|
|
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
19,397,822 |
|
|
$ |
23,786,579 |
|
Short-term investments |
66,096,567 |
|
|
103,638,844 |
|
Accounts receivable |
2,831,707 |
|
|
6,003,205 |
|
Accounts receivable from affiliated entities |
1,567,635 |
|
|
486,619 |
|
Prepaid expenses and other current assets |
1,601,859 |
|
|
2,600,906 |
|
Prepaid expenses and other current assets from
affiliated entities |
2,107,194 |
|
|
1,846,007 |
|
Total current assets |
93,602,784 |
|
|
138,362,160 |
|
Fixed assets, net |
16,228,171 |
|
|
18,320,176 |
|
Investment in affiliated entity – GeneOne |
9,501,138 |
|
|
9,069,401 |
|
Investment in affiliated entity – PLS |
3,198,516 |
|
|
2,325,079 |
|
Intangible assets, net |
5,026,708 |
|
|
6,009,729 |
|
Goodwill |
10,513,371 |
|
|
10,513,371 |
|
Other assets |
2,625,659 |
|
|
2,639,354 |
|
Total assets |
$ |
140,696,347 |
|
|
$ |
187,239,270 |
|
LIABILITIES AND STOCKHOLDERS’
EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable and accrued expenses |
$ |
17,324,819 |
|
|
$ |
23,278,798 |
|
Accounts payable and accrued expenses due to
affiliated entities |
690,920 |
|
|
926,943 |
|
Accrued clinical trial expenses |
7,353,055 |
|
|
8,611,892 |
|
Common stock warrants |
— |
|
|
360,795 |
|
Deferred revenue |
192,427 |
|
|
1,175,353 |
|
Deferred revenue from affiliated entities |
68,425 |
|
|
174,110 |
|
Deferred rent |
1,031,370 |
|
|
877,535 |
|
Deferred grant funding |
1,297,416 |
|
|
— |
|
Deferred grant funding from affiliated
entities |
39,583 |
|
|
— |
|
Total current liabilities |
27,998,015 |
|
|
35,405,426 |
|
Deferred revenue, net of current portion |
192,034 |
|
|
215,853 |
|
Deferred rent, net of current portion |
8,672,689 |
|
|
9,104,416 |
|
Deferred tax liabilities |
24,766 |
|
|
24,766 |
|
Other liabilities |
99,669 |
|
|
— |
|
Total liabilities |
36,987,173 |
|
|
44,750,461 |
|
Stockholders’ equity: |
|
|
|
Preferred stock |
— |
|
|
— |
|
Common stock |
94,472 |
|
|
90,358 |
|
Additional paid-in capital |
690,930,769 |
|
|
665,775,504 |
|
Accumulated deficit |
(587,130,576 |
) |
|
(523,356,317 |
) |
Accumulated other comprehensive loss |
(281,760 |
) |
|
(117,005 |
) |
Total Inovio Pharmaceuticals, Inc.
stockholders’ equity |
103,612,905 |
|
|
142,392,540 |
|
Non-controlling interest |
96,269 |
|
|
96,269 |
|
Total stockholders’ equity |
103,709,174 |
|
|
142,488,809 |
|
Total liabilities and stockholders’
equity |
$ |
140,696,347 |
|
|
$ |
187,239,270 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Inovio Pharmaceuticals,
Inc.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(Unaudited) |
|
|
|
|
|
Three Months Ended September
30, |
|
Nine Months Ended September
30, |
|
2018 |
|
2017 |
|
2018 |
|
2017 |
Revenues: |
|
|
|
|
|
|
|
Revenue under collaborative research and development
arrangements |
$ |
1,813,287 |
|
|
$ |
351,272 |
|
|
$ |
27,488,185 |
|
|
$ |
20,998,174 |
|
Revenue under collaborative research and development arrangements
with affiliated entities |
184,990 |
|
|
129,133 |
|
|
393,317 |
|
|
539,342 |
|
Grants and miscellaneous revenue |
2,591 |
|
|
1,456,216 |
|
|
97,771 |
|
|
9,494,096 |
|
Grants and miscellaneous revenue from affiliated entity |
— |
|
|
707,922 |
|
|
— |
|
|
2,401,240 |
|
Total revenues |
2,000,868 |
|
|
2,644,543 |
|
|
27,979,273 |
|
|
33,432,852 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
21,851,858 |
|
|
25,510,239 |
|
|
68,892,229 |
|
|
73,931,494 |
|
General and administrative |
6,791,693 |
|
|
6,319,775 |
|
|
23,679,018 |
|
|
20,256,470 |
|
Total operating expenses |
28,643,551 |
|
|
31,830,014 |
|
|
92,571,247 |
|
|
94,187,964 |
|
Loss from operations |
(26,642,683 |
) |
|
(29,185,471 |
) |
|
(64,591,974 |
) |
|
(60,755,112 |
) |
Other income (expense): |
|
|
|
|
|
|
|
Interest and other income, net |
380,987 |
|
|
463,346 |
|
|
1,090,191 |
|
|
1,103,708 |
|
Change in fair value of common stock warrants |
228,665 |
|
|
423,296 |
|
|
360,795 |
|
|
227,273 |
|
Gain (loss) on investment in affiliated entities |
1,017,359 |
|
|
(5,835,741 |
) |
|
1,305,174 |
|
|
(7,275,462 |
) |
Net loss before provision for income taxes |
(25,015,672 |
) |
|
(34,134,570 |
) |
|
(61,835,814 |
) |
|
(66,699,593 |
) |
Provision for income taxes |
|
|
— |
|
|
(2,169,811 |
) |
|
— |
|
Net loss |
$ |
(25,015,672 |
) |
|
$ |
(34,134,570 |
) |
|
$ |
(64,005,625 |
) |
|
$ |
(66,699,593 |
) |
Net loss per share |
|
|
|
|
|
|
|
Basic |
$ |
(0.27 |
) |
|
$ |
(0.39 |
) |
|
$ |
(0.70 |
) |
|
$ |
(0.85 |
) |
Diluted |
$ |
(0.27 |
) |
|
$ |
(0.40 |
) |
|
$ |
(0.70 |
) |
|
$ |
(0.85 |
) |
Weighted average number of common shares
outstanding |
|
|
|
|
|
|
|
Basic |
92,423,122 |
|
|
86,952,024 |
|
|
91,350,117 |
|
|
78,894,881 |
|
Diluted |
92,423,122 |
|
|
87,090,683 |
|
|
91,350,117 |
|
|
79,043,480 |
|
|
|
|
|
|
|
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