IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology
corporation, today released its financial and operational results
for the three- and nine-month period ended September 30, 2018.
“DPX-Survivac’s ability to generate novel
targeted anti-cancer T cell responses continues to be a key value
driver for IMV, and we believe it will be a cornerstone for future
immunotherapy combinations,” said Frederic Ors, Chief Executive
Officer of IMV. “From the initial positive data in our lymphoma
trial to our collaboration with Merck on a phase 2 trial in
multiple indications, our clinical program is well positioned to
expand the range of patients who may benefit from novel
immunotherapies, particularly in underserved cancers.”
IMV anticipates continued progress on several
important milestones over the next year, which include:
- Topline data from the higher dosing cohort in the clinical
trial with Incyte;
- Topline data from the triple combination phase 2 trial with
Merck in diffuse large B-cell lymphoma (DLBCL);
- Initial data from the second triple combination phase 2 trial
with Merck in ovarian cancer; and
- Preliminary data from the phase 2 basket trial collaboration
with Merck.
IMV will host a conference call and webcast
today at 8 a.m. ET. The dial-in number for the conference call
is (844) 461-9932 (U.S. and Canada) or (636) 812-6632
(international) with the conference ID: 5779058. The live audio
webcast is available at:
https://edge.media-server.com/m6/p/rrkkk65v. The webcast will
be recorded and available on the IMV website for 30 days following
the call.
Clinical Program Highlights –
DPX-Survivac
Ovarian Cancer
IMV’s DECIDE1 (DPX-Survivac with low dose
cyclophosphamide and Epacadostat) phase 1b/2 clinical trial with
Incyte reached two significant milestones: completion of enrollment
of both phase 1b dosing cohorts and treatment of the first patient
in the phase 2 cohort. The Company expects to announce topline data
from the Phase 1b portion of the trial in the fourth quarter of
2018.
Diffuse large B-cell lymphoma
(DLBCL)
IMV announced the first clinical data from the
combination of DPX-Survivac and mCPA with a checkpoint inhibitor.
The initial data came from the investigator-sponsored phase 2 trial
evaluating DPX-Survivac, low dose cyclophosphamide, and Merck's
Keytruda® (pembrolizumab) in patients with persistent or
recurrent/refractory DLBCL. Significant anti-cancer activity was
seen in three of the first four evaluable patients, along with a
tolerable safety profile.
Merck Collaboration: Phase 2 Basket Trial
IMV announced a collaboration with Merck in a
phase 2 trial that will evaluate the safety and efficacy of
DPX-Survivac in combination with low-dose cyclophosphamide and
Merck's Keytruda (pembrolizumab) in patients with select advanced
or recurrent solid tumors across five different indications (lung
(NSCLC), bladder, liver (HCC), MSI-H and ovarian). In the fourth
quarter of 2018, investigators plan to initiate enrollment of more
than 200 patients at multiple centers across the U.S. and
Canada.
Operational Highlights of Q3 2018:
- Opening of new facility in Dartmouth, Nova
Scotia: The new premises feature upgraded facilities
and equipment as well as increased laboratory size and capacity.
IMV has now nearly tripled its functional workspace to allow for
its expanding business activities in the coming years.
- Cash position: As of September 30, 2018, cash
and cash equivalents and short-term investments were $20.3 million
compared to $15 million as of December 31, 2017.
Overview of Q3 2018 Financial Results
The net loss and comprehensive loss of
$5,987,000 ($0.14 per share) and $14,254,000 ($0.33 per share) for
the three and nine-month periods ended September 30, 2018 were
$3,865,000 and $7,155,000 higher than the net loss and
comprehensive loss for the three and nine-month periods ended
September 30, 2017.
Research and development expenses increased by
$2,556,000 and $4,774,000 for the three and nine-month periods
ended September 30, 2018, respectively compared to 2017.
These increases are mainly due to the two new phase 2 clinical
trials with Merck in ovarian cancer and DLBCL, which started in
2018, and also costs related to the preparation for the upcoming
basket trial.
General and administrative expenses increased by
$981,000 and $2,059,000 for the three and nine-month periods ended
September 30, 2018, respectively compared to 2017. These
increases are mainly due to the various expenses related to the
Nasdaq listing (legal, audit and consulting fees as well as listing
fees) that are non-recurring expenses, the filing of a shelf
prospectus, the increase in insurance premium following the Nasdaq
listing.
Business development and investor relations
expenses increased by $189,000 and $426,000 for the three and
nine-month periods ended September 30, 2018, respectively compared
to 2017. These increases result almost entirely from the hiring of
a Senior Vice President, Business Development, in January 2018.
At September 30, 2018, the Corporation had cash
and cash equivalents of $20,300,000 and working capital of
$18,485,000, compared with $14,909,000 and $13,627,000,
respectively at December 31, 2017. For the nine-month period ended
September 30, 2018, IMV's cash burn rate, defined as net loss for
the period adjusted for operations not involving cash (interest on
lease obligation, depreciation, accretion of long-term debt,
stock-based compensation and DSU compensation), was $11.9 million.
Based on the current business plan, the Corporation forecasts the
cash burn rate to be between $4-million and $4.5-million for the
last quarter of 2018, depending on the timing of certain clinical
expenses.
As of November 2, 2018, the number of issued and
outstanding common shares was 44,999,802 and a total of 1,951,842
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 period ended September 30, 2018
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.
About IMV
IMV Inc., formerly Immunovaccine 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-activating immunotherapy
that combines the utility of the platform with a target: survivin.
IMV is currently assessing DPX-Survivac as a combination therapy in
multiple clinical studies with Incyte and 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.
Contacts for IMV:
MEDIA Mike Beyer, Sam Brown
Inc.T: (312) 961-2502 E: mikebeyer@sambrown.com
INVESTOR RELATIONSPierre Labbé, Chief
Financial OfficerT: (902) 492-1819 E: info@imv-inc.com
Patti Bank, Managing Director, Westwicke
PartnersO: (415) 513-1284T: (415) 515-4572 E:
patti.bank@westwicke.com
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 September
30 |
|
|
Nine-months ended September
30 |
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Revenue |
|
|
|
|
|
|
|
Subcontract revenue |
6 |
|
|
-- |
|
|
49 |
|
|
-- |
|
Interest Income |
119 |
|
|
53 |
|
|
300 |
|
|
123 |
|
Total revenue |
125 |
|
|
53 |
|
|
349 |
|
|
123 |
|
Expenses |
|
|
|
|
|
|
|
Research and development |
3,897 |
|
|
1,341 |
|
|
8,384 |
|
|
3,610 |
|
General and administrative |
1,923 |
|
|
942 |
|
|
4,892 |
|
|
2,833 |
|
Business development and investor relations |
426 |
|
|
237 |
|
|
1,389 |
|
|
963 |
|
Government assistance |
(404) |
|
|
(624) |
|
|
(868) |
|
|
(1,003) |
|
Accreted interest |
270 |
|
|
279 |
|
|
806 |
|
|
819 |
|
Total operating expenses |
6,112 |
|
|
2,175 |
|
|
14,603 |
|
|
7,222 |
|
Net loss and comprehensive loss |
(5,987) |
|
|
(2,122) |
|
|
(14,254) |
|
|
(7,099) |
|
Basic and diluted loss per share |
(0.14) |
|
|
(0.05) |
|
|
(0.33) |
|
|
(0.19) |
|
Weighted-average shares outstanding |
43,245,779 |
|
|
39,901,859 |
|
|
43,342,664 |
|
|
38,183,574 |
|
|
|
|
|
|
|
|
|
IMV INC. Unaudited Interim Condensed Consolidated Statements of
Financial Position (Expressed in thousands of Canadian dollars
except for per share amounts)
|
September 30, |
|
December 31, |
|
2018 |
|
2017 |
Assets |
|
|
|
|
|
Current assets |
|
|
|
|
|
Cash and cash
equivalents |
$ |
20,271 |
|
$ |
14,909 |
Accounts
receivable |
|
657 |
|
|
261 |
Prepaid expenses |
|
1,423 |
|
|
838 |
Investment tax credits
receivable |
|
920 |
|
|
461 |
Total current
assets |
|
23,271 |
|
|
16,469 |
Property and
equipment |
|
2,942 |
|
|
563 |
Total assets |
$ |
26,213 |
|
$ |
17,032 |
Liabilities and
Equity |
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
Accounts payable and
accrued liabilities |
$ |
4,564 |
|
$ |
2,760 |
Amounts due to
directors |
|
42 |
|
|
21 |
Current portion of
long-term debt |
|
92 |
|
|
61 |
Current portion of
lease obligations |
|
87 |
|
|
-- |
Total current
liabilities |
|
4,785 |
|
|
2,842 |
Lease obligation |
|
1,332 |
|
|
-- |
Deferred share
units |
|
1,584 |
|
|
1,371 |
Long-term debt |
|
7,402 |
|
|
6,476 |
Total liabilities |
|
15,103 |
|
|
10,689 |
Equity: |
|
|
|
|
|
Share Capital |
|
89,464 |
|
|
70,113 |
Contributed
Surplus |
|
6,164 |
|
|
6,375 |
Warrants |
|
555 |
|
|
674 |
Deficit |
|
(85,073) |
|
|
(70,819) |
Total equity |
|
11,110 |
|
|
6,343 |
Total liabilities and
equity |
$ |
26,213 |
|
$ |
17,032 |
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