- Reported preliminary data from Phase 2 basket study of
DPX-Survivac in multiple solid tumors at the ESMO annual meeting,
showing treatment was well-tolerated and showed signs of clinical
activity
- Entered into research collaboration with The Wistar Institute,
leveraging DPX technology to develop targeted T cell therapy
against BRAF mutation
- Multiple near-term readouts from Phase 2 studies of
DPX-Survivac, including updated data from SPiReL in
recurrent/refractory DLBCL to be presented at ASH 2019 on
December 8, 2019 and topline interim results from DeCidE1 in
advanced ovarian cancer expected during Q1 2020
- Management to host conference call and webcast this morning
at 8:00 am ET
IMV Inc. (TSX: IMV; NASDAQ: IMV), a clinical-stage
biopharmaceutical company pioneering a novel class of
immunotherapies, today announced its financial and operational
results for the third quarter ended September 30, 2019.
“In the third quarter and more recently, we have continued to
advance our pipeline forward. In particular, we were pleased to
report preliminary data at ESMO that highlighted DPX-Survivac’s
potential to treat numerous solid tumors beyond our lead
indications. Additionally, we launched a collaboration with The
Wistar Institute, which applies our DPX-based targeted T cell
therapy to the common BRAF mutation – another prevalent target
across a range of tumor types,” said Frederic Ors, President and
Chief Executive Officer of IMV. “Importantly, these recent
achievements reinforce our belief in the breadth of our platform
and its ability to produce cancer-targeted T cells that elicit a
more rapid, robust and sustained immune response. Looking ahead, we
await key readouts from DPX-Survivac, including updated data from
the Phase 2 study in r/r DLBCL at ASH on December 8, 2019 and
topline interim data from our Phase 1b/2 study in advanced ovarian
cancer during the first quarter of next year. As we close in on
proof-of-concept in these indications of high unmet medical need,
we continue to believe both represent fast-to-market opportunities
and are therefore preparing to launch potential pivotal studies in
2020.”
DPX-Survivac Clinical Program
Updates
Phase 1b/2 DeCidE1 Study in Advanced Recurrent Ovarian
Cancer
DeCidE1, the Company’s Phase 1b/2 open-label study evaluating
the safety and efficacy of DPX-Survivac and intermittent low-dose
cyclophosphamide (CPA), with and without Epacadostat, in advanced
recurrent ovarian cancer, is ongoing without Epacadostat.
Enrollment is complete in this study and the Company intends to
report topline interim data during Q1 2020.
Phase 2 SPiReL Study in Recurrent/Refractory Diffuse Large
B-Cell Lymphoma (DLBCL)
SPiReL, an investigator-sponsored Phase 2 study evaluating
DPX-Survivac and ildCPA in combination with Keytruda®
(pembrolizumab) in recurrent/refractory DLBCL is ongoing.
Neil Berinstein, M.D. FRCPC, ABIM, Hematologist at the
Sunnybrook Health Science Centre will deliver a poster presentation
at the American Society of Hematology (ASH) Annual Meeting on
December 8, 2019, including updated data from the study.
As of November 7, 2019, 17 patients have been enrolled across
five different clinical sites in Canada. The non-randomized, open
label study is expected to enroll 25 evaluable participants in
Canada. Additional patients are being screened and topline data are
expected from this study in the first half of 2020.
Phase 2 Basket Trial in Multiple Advanced and Metastatic
Solid Tumors
In September 2019, at the European Society for Medical Oncology
(ESMO) 2019 Congress in Barcelona, Spain, IMV presented preliminary
results from its ongoing Phase 2 basket trial, evaluating
DPX-Survivac and intermittent low-dose CPA in combination with
pembrolizumab in patients with advanced and metastatic solid
tumors.
As of the data cut-off, 23 patients had been treated across all
five patient cohorts with bladder, hepatocellular carcinoma
(liver), ovarian, and non-small cell lung (NSCLC) cancers, as well
as tumors shown to be positive for the microsatellite instability
high (MSI-H) biomarker. Preliminary results from the first on-study
scan showed signs of clinical activity with tumor regressions
observed in patients with ovarian, non-small cell lung and bladder
cancers, including two partial responses, and a consistent safety
profile including no grade 3-4 immune-related adverse events. The
preliminary data are available here.
As of November 7, 2019, 13 clinical sites have been activated,
64 patients are screened, and 31 patients have been enrolled. The
study continues to enroll patients towards a total enrollment
target of 184 patients across all five cohorts. The Company expects
to report topline data in the first half of 2020.
Operational Highlights:
Appointment of Joanne Schindler, M.D., D.V.M. as Chief
Medical Officer. Dr. Schindler joined IMV in November 2019 with
over 15 years of experience in the biopharmaceutical industry,
primarily in early-stage oncology drug development. Most recently,
she served as Vice President, Clinical Development and Executive
Medical Director at H3 Biomedicine, where she oversaw clinical
development strategy and execution.
Research collaboration with Meenhard Herlyn, D.V.M., D.Sc.
and The Wistar Institute to develop a targeted T cell therapy
against the BRAF mutation. Under this collaboration, IMV will
optimize the DPX formulation with Wistar-identified peptides
targeting BRAF, one of the most frequently identified
cancer-causing mutations in melanoma and various other cancers,
including non-Hodgkin’s lymphoma, colorectal cancer, thyroid
cancer, and non-small cell lung and ovarian carcinomas. IMV holds
an exclusive option to in-license intellectual property related to
the program.
Upcoming Milestones:
Over the course of upcoming quarters, the Company expects to
deliver the following milestones:
- Updated results from Phase 2 SPiReL trial (DLBCL) at ASH 2019
on December 8, 2019
- Topline results from Phase 1b/2 DeCidE1 trial (ovarian) during
Q1 2020
- Topline results from Phase 2 SPiReL trial (DLBCL) in 1H
2020
- Topline results from Phase 2 basket trial (multiple tumors) of
DPX-Survivac in 1H 2020.
Overview of Q3 2019 Financial
Results (In Canadian dollars)
At September 30, 2019, the Corporation had cash and cash
equivalents of $21.4 million and working capital of $21.2 million,
compared with $14.9 million and $12.2 million, respectively at
December 31, 2018. Management believes that the Corporation’s cash
resources of $21.4 million and its additional potential cash
resources of $2.3 million will be sufficient to fund operations for
the next twelve months.
For the nine-month period ended September 30, 2019, IMV's cash
burn rate (defined as net loss and comprehensive loss adjusted for
charges to operations not involving cash as described in the
statement of cash flows) was $17.4 million. Based on the current
business plan, the Corporation forecasts the quarterly cash burn
rate to be between $5 million and $6 million for the fourth quarter
of 2019.
The net loss and comprehensive loss of $7.9 million ($0.16 per
share) for the three-month period ended September 30, 2019, was
$1.9M higher than the net loss and comprehensive loss for
three-month period ended September 30, 2018. This relates mainly to
an increase in R&D expenses of $1.8M related to the basket
trial and pre-clinical preparation for a phase I trial with
DPX-SurMAGE.
For the nine-month period ended September 30 2019, the net loss
and comprehensive loss of $18.9M ($0.38 per share) was $4.6M higher
than the net loss and comprehensive loss for the nine-month period
ended September 30 2018. This relates mainly to an increase in
R&D expenses of $5.1M related to the basket trial and the
preparation for a phase I trial with DPX-SurMAGE.
As of November 7, 2019, the number of issued and outstanding
common shares was 50,630,875 and a total of 1,932,080 stock
options, warrants, and deferred share units were outstanding.
The Corporation's unaudited interim condensed consolidated
results of operations, financial condition and cash flows for the
three and nine-months ended September 30, 2019 and the related
management's discussion and analysis (MD&A) are available on
SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.
Conference Call and Webcast Information
Management will host conference call and webcast this morning,
November 8, 2019 at 8:00 am ET. Financial analysts are invited to
join the conference call by dialing (844) 461-9932 (U.S. and
Canada) or (636) 812-6632 (international) using the conference ID#
6590953. Other interested parties will be able to access the live
audio webcast at this link:
https://ir.imv-inc.com/events-and-presentations.
About IMV
IMV Inc. is a clinical stage biopharmaceutical company dedicated
to making immunotherapy more effective, more broadly applicable,
and more widely available to people facing cancer and other serious
diseases. IMV is pioneering a new class of immunotherapies based on
the Company’s proprietary drug delivery platform. This patented
technology leverages a novel mechanism of action that enables the
programming of immune cells in vivo, which are aimed at generating
powerful new synthetic therapeutic capabilities. IMV’s lead
candidate, DPX-Survivac, is a T cell-targeted immunotherapy that
combines the utility of the platform with a target: survivin. IMV
is currently assessing DPX-Survivac targeted therapy in advanced
ovarian cancer, and as well as a combination therapy in multiple
clinical studies with Merck. Connect at www.imv-inc.com.
IMV Forward-Looking Statements
This press release contains forward-looking information under
applicable securities law. All information that addresses
activities or developments that we expect to occur in the future is
forward-looking information. Forward-looking statements are based
on the estimates and opinions of management on the date the
statements are made. However, they should not be regarded as a
representation that any of the plans will be achieved. Actual
results may differ materially from those set forth in this press
release due to risks affecting the Corporation, including access to
capital, the successful completion of clinical trials and receipt
of all regulatory approvals. IMV Inc. assumes no responsibility to
update forward-looking statements in this press release except as
required by law. These forward-looking statements involve known and
unknown risks and uncertainties and those risks and uncertainties
include, but are not limited to, our ability to access capital, the
successful and timely completion of clinical trials, the receipt of
all regulatory approvals and other risks detailed from time to time
in our ongoing quarterly filings and annual information form.
Investors are cautioned not to rely on these forward-looking
statements and are encouraged to read IMV’s continuous disclosure
documents, including its current annual information form, as well
as its audited annual consolidated financial statements which are
available on SEDAR at www.sedar.com and on EDGAR at
www.sec.gov/edgar.
IMV INC. Unaudited Interim Condensed
Consolidated Statements of Loss and Comprehensive Loss
(In thousands of Canadian dollars, except
shares and per share amounts)
Three-months ended
Sept 30
Nine-months ended
Sept 30
2019
$
2018
$
2019
$
2018
$
Revenue
Subcontract revenue
13
6
26
49
Interest Income
151
119
405
300
Total revenue
164
125
431
349
Expenses
Research and development
5,652
3,897
13,467
8,384
General and administrative
2,635
2,349
6,778
6,281
Government assistance
(606
)
(404
)
(2,093
)
(838
)
Accreted interest
379
270
1,169
806
Total operating expenses
8,060
6,112
19,321
14,603
Net loss and comprehensive loss
(7,896
)
(5,987
)
(18,890
)
(14,254
)
Basic and diluted loss per
share
(0.16
)
(0.14
)
(0.38
)
(0.33
)
Weighted-average shares outstanding
50,615,488
44,923,009
49,234,232
43,342,664
IMV INC. Unaudited Interim Condensed
Consolidated Statements of Financial Position
(In thousands of Canadian dollars, except
shares and per share amounts)
September 30
December 31
2019
2018
Assets
Current assets
Cash and cash equivalents
$
21,374
$
14,895
Accounts receivable
959
1,337
Prepaid expenses
3,675
2,699
Investment tax credits receivable
1,349
1,111
Total current assets
27,357
20,042
Property and equipment
2,972
2,883
Total assets
$
30,329
$
22,925
Liabilities and Equity
Current liabilities
Accounts payable and accrued
liabilities
$
5,876
$
7,575
Amounts due to directors
62
49
Current portion of long-term debt
87
81
Current portion of lease obligations
99
90
Total current liabilities
6,124
7,795
Lease obligation
1,234
1,308
Deferred share units
–
1,436
Long-term debt
8,327
8,069
Total liabilities
15,685
18,608
Equity
14,644
4,317
Total liabilities and equity
$
30,329
$
22,925
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191108005086/en/
Investor Relations Marc Jasmin, Senior Director,
Investor Relations, IMV O: (902) 492-1819, ext: 1042 M: (514)
617-9481 E: mjasmin@imv-inc.com
Josh Rappaport, Director, Stern IR O: (212) 362-1200 E:
josh.rappaport@sternir.com
Media Mrs. Delphine Davan, Director of Communications,
IMV M: (514) 968-1046 E: ddavan@imv-inc.com
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