- Presented updated data from Phase 2 monotherapy arm of DeCidE1
study at ASCO 2019; DPX-Survivac exhibited durable clinical benefit
with progression-free survival in patients with advanced recurrent
ovarian cancer
- Reported positive new data from Phase 2 SPiReL combination
study of DPX-Survivac in r/r DLBCL, including long-lasting complete
responses
- The 16 additional patients in the expanded monotherapy arm of
the Phase 1b/2 DeCidE1 Clinical Study in Advanced Recurrent Ovarian
Cancer are enrolled
- Additional data expected from three Phase 2 studies of
DPX-Survivac by year-end, including as monotherapy in ovarian
cancer and as combination therapy in r/r DLBCL and multiple other
solid tumor types
- Management to host conference call and webcast tomorrow at 8:00
am ET
IMV Inc. (TSX: IMV; NASDAQ: IMV), a clinical stage immunotherapy
company, today released its financial and operational results for
the second quarter ended June 30, 2019.
“At IMV, we are leveraging DPX, our no-release delivery
technology that enables us to program immune cells in vivo. We
continue to believe this mechanism offers potential to produce a
new class of immunotherapies that elicit a more rapid, robust and
sustained immune response,” said Frederic Ors, IMV's Chief
Executive Officer. “In the second quarter, we reported important
updates from two Phase 2 studies of our lead program, DPX-Survivac,
our T cell-activating immunotherapy harnessing the power of this
approach to target survivin, which is present in more than 20 solid
and hematological tumor types. These results continue to validate
our DPX platform and this novel target, with encouraging signs of
anti-tumor activity contributing to the body of data we have
accumulated to demonstrate DPX-Survivac’s potential in
hard-to-treat cancers, both as a monotherapy and in combination
with other agents. We look forward to providing additional data
from this program by year-end, including top-line results from our
Phase 2 study evaluating DPX-Survivac as a monotherapy in ovarian
cancer and additional results from our Phase 2 r/r DLBCL and basket
trial, evaluating DPX-Survivac in combination with Keytruda in
multiple solid tumor indications.”
DPX-Survivac Clinical Program
Updates:
Phase 1b/2 DeCidE1 Clinical Study in Advanced Recurrent
Ovarian Cancer
In June 2019, IMV presented new data at the 2019 American
Society of Clinical Oncology (ASCO) annual meeting from DeCidE1,
its ongoing Phase 1b/2 study evaluating the safety and efficacy of
DPX-Survivac and intermittent low-dose cyclophosphamide (CPA), with
and without epacadostat, in advanced recurrent ovarian cancer.
These results expand on data previously reported from this study,
which exhibited a durable response. Highlights of the new data from
evaluable patients in the Phase 2 monotherapy arm of the trial
include:
- Five out of seven patients showed signs of treatment benefits,
including reduction of target lesions in two patients;
- Three out of four patients with low tumor burden showed stable
disease, including two with tumour regression at first CT
scan;
- Of the five patients evaluable for T cell responses, all showed
survivin-specific T cell activation in the blood; and
- Treatments were well-tolerated supporting our views of the
favourable safety profile of our approach.
Additionally, longer-term follow-up data from the Phase 1b
portion of the study continued to demonstrate the prolonged
duration of clinical benefits, surpassing two years of
progression-free survival from previous treatments, including
platinum-based chemotherapy.
We have enrolled 16 additional patients in the expanded
monotherapy arm of the DeCidE1 trial. IMV expects to provide the
top-line clinical results from this study before the end of
2019.
Phase 2 SPiReL Study of DPX-Survivac in Combination with
KEYTRUDA® in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
(DLBCL)
In June 2019, IMV reported updated data from SpiRel, its ongoing
investigator-sponsored Phase 2 clinical trial assessing
DPX-Survivac in combination with intermittent low dose
cyclophosphamide and Merck’s checkpoint inhibitor Keytruda, linking
antitumor activity with T cell responses that correlate with
expression of survivin.
At the first "on treatment" interim assessment, five of the
first six patients demonstrated clinical benefit, including four
patients with tumor regressions. Two patients reached a complete
radiological response, one exhibited a partial response and two
reached stable disease while on the study. In addition, the study
continued to demonstrate an acceptable safety profile for the two
therapies in combination.
Based on these data, IMV agreed with the principal investigator
to increase the number of sites recruiting patients from 5 to 9. As
of August 8, 2019, investigators had enrolled 12 patients across
four different clinical sites in Canada. Additional patients are
being screened and IMV expects to give another update on this trial
before the end of 2019 and report top-line clinical data from this
study in the first half of 2020.
Phase 2 Basket Trial of DPX-Survivac in Combination with
KEYTRUDA® in Multiple Solid Tumor Indications
Fifteen patients have been enrolled to date, while screening and
enrollment of patients is ongoing across nine clinical sites in the
U.S. and Canada for five cohorts of patients with bladder, liver
(hepatocellular carcinoma), ovarian, or non-small cell lung (NSCLC)
cancers, as well as tumors shown to be positive for the
microsatellite instability high (MSI-H) biomarker.
Patients have been treated in every cohort and IMV expects to
report preliminary clinical results on several of the solid tumor
indications included in this basket trial before the end of
2019.
Operational Highlights:
Modification of $5M loan agreement with the province of Nova
Scotia. Previously, the entire loan was payable on August 9,
2020. Per this modification, the Corporation will now repay the
loan over 60 months starting in January 2021. All the other terms
remain the same. This revised repayment schedule will allow IMV to
focus its cash resources towards developing its clinical
programs.
Upcoming Milestones:
Milestones
Key dates
Preliminary clinical results from basket
trial in 5 indications
H2 2019
Top-line monotherapy clinical results in
ovarian cancer
H2 2019
Clinical results update in the DLBCL
combination trial (investigator-sponsored)
H2 2019
Top-line clinical results in the DLBCL
combination trial (investigator-sponsored)
H1 2020
Top-line clinical results from basket
trial
H1 2020
Overview of Q2 2019 Financial
Results
(In Canadian dollars)
At June 30, 2019, the Corporation had cash and cash equivalents
of $26.9M and working capital of $28.3M, compared with $14.9M and
$12.2M, respectively at December 31, 2018. Management believes that
the Corporation’s cash resources of $26.9M and its additional
potential cash resources of $3.1M will be sufficient to fund
operations up to Q4-2020. For the six-month period ended June 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 $10.4 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 remaining of 2019.
The net loss and comprehensive loss of $5.0M ($0.10 per share)
for the three-month period ended June 30, 2019, was $0.2M lower
than the net loss and comprehensive loss for three-month period
ended June 30, 2018. This relates mainly to a $0.4M decrease in
general and administrative expenses and a $0.9M increase in
government assistance partly compensated by a $1.2M increase in
research and development (R&D) expenses, in the three-month
period ended June 30, 2019.
For the six-month period ended June 30, 2019, the net loss and
comprehensive loss of $11.0M was $2.7M higher than the net loss and
comprehensive loss for six-month period ended June 30, 2018. This
relates mainly to a $3.3M increase in R&D expenses and a $0.2M
increase in general and administrative expenses partly compensated
by $1.0M increase in government assistance in the six-month period
ended June 30, 2019. As of August 8, 2019, the number of issued and
outstanding common shares was 50,612,125 and a total of 1,997,232
stock options, warrants, and deferred share units were outstanding
at that date.
The Corporation's unaudited interim condensed consolidated
results of operations, financial condition and cash flows for the
three and six-months ended June 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
IMV will host a conference call and webcast tomorrow at 8:00 am
ET to discuss these results and provide an update on the
company.
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: 7148568.
Other interested parties will be able to access the live audio
webcast at this link:
https://ir.imv-inc.com/events-and-presentations. The webcast will
be recorded and available on the IMV website for 30 days following
the call.
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 Corporation’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-activating immunotherapy that
combines the utility of the platform with a target: survivin. IMV
is currently assessing DPX-Survivac as a monotherapy in advanced
ovarian cancer, 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-month ended
June 30
Six-month ended
June 30
2019
$
2018
$
2019
$
2018
$
Revenue
Subcontract revenue
6
17
14
45
Interest Income
180
112
254
181
Total revenue
186
129
268
226
Expenses
Research and development
3,803
2,605
7,816
4,487
General and administrative
2,184
2,640
4,144
3,930
Government assistance
(1,142)
(189)
(1,488)
(464)
Accreted interest
392
269
790
536
Total operating expenses
5,232
5,325
11,262
8,489
Net loss and comprehensive loss
(5,051)
(5,196)
(10,994)
(8,263)
Basic and diluted loss per
share
(0.10)
(0.12)
(0.23)
(0.19)
Weighted-average shares outstanding
50,601,866
43,001,620
48,667,904
42,539,304
IMV INC. Unaudited Interim Condensed Consolidated Statements of
Financial Position (In thousands of Canadian
dollars, except shares and per share amounts)
June 30,
December 31,
2019
2018
Assets
Current assets
Cash and cash equivalents
$
26,904
$
14,895
Accounts receivable
1,285
1,337
Prepaid expenses
4,343
2,699
Investment tax credits receivable
1,750
1,111
Total current assets
34,282
20,042
Property and equipment
3,063
2,883
Total assets
$
37,345
$
22,925
Liabilities and Equity
Current liabilities
Accounts payable and accrued
liabilities
$
5,733
$
7,575
Amounts due to directors
63
49
Current portion of long-term debt
86
81
Current portion of lease obligations
95
90
Total current liabilities
5,977
7,795
Lease obligation
1,259
1,308
Deferred share units
1,046
1,436
Long-term debt
7,972
8,069
Total liabilities
16,254
18,608
Equity
21,091
4,317
Total liabilities and equity
$
37,345
$
22,925
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190808005883/en/
INVESTOR RELATIONS: Marc Jasmin, Senior Director,
Investor Relations and Communications O: (902) 492-1819 ext :
1042 M: (514) 917-9481 E: mjasmin@imv-inc.com Josh Rappaport,
Director, Stern IR O: (212) 698-8678 E:
josh.rappaport@sternir.com
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