IMV Inc. (Nasdaq:IMV) (TSX:IMV), a clinical stage
immuno-oncology corporation, today released its financial and
operational results for the three- and six-month period ended June
30, 2018.
“During the second quarter of 2018, we attained
milestones advancing IMV’s ability to deliver novel immuno-oncology
therapeutics,” stated Frederic Ors, IMV Chief Executive Officer.
“We listed our common shares on Nasdaq and adopted a new company
name. In addition, we reported clinical data for the first time at
the 2018 American Society for Clinical Oncology (ASCO) meeting.
These data highlighted the strong efficacy signals of DPX-Survivac
and provided a clinical demonstration of the ability of
DPX-Survivac to trigger the production of T cells that can
infiltrate tumors and induce tumor regression in hard-to-treat
cancers.
“Based on our current financial position and
operational strategy, we look forward to delivering on several
anticipated milestones over the next four quarters, including:
- Expansion of our clinical program with a new phase 2 basket
trial;
- Topline data from the higher dosing cohort in our clinical
trial with Incyte;
- Preliminary and topline data from our triple combination phase
2 trial with Merck in diffuse large B-cell lymphoma (DLBCL);
and
- Preliminary and topline data from our second triple combination
phase 2 trial with Merck in ovarian cancer.”
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: 6583235. Those interested
can access the live audio webcast at this link:
https://edge.media-server.com/m6/p/xt8xgtjx. The webcast will be
recorded and available on the IMV website for 30 days following the
call.
Clinical Program Highlights –
DPX-Survivac
Ovarian Cancer
- New positive data highlighted in an oral presentation at the
2018 ASCO meeting from the DECIDE1 (DPX-Survivac with low dose
cyclophosphamide and Epacadostat) phase 1b/2 clinical trial in
ovarian cancer with Incyte showed 7 tumor regressions, including 4
partial responses (PR, defined as ≥30% decrease in tumor lesion
size) in the first 18 evaluable patients.
- Mechanism of action (MOA) analysis from the ASCO data showed
that DPX-Survivac generated survivin-specific T cell responses in
100% (10/10) of evaluated patients; there was an increase in T cell
infiltration post treatment in 37% (3/8) analyzable tumor biopsies;
and 2 of the 3 patients with T cell infiltration showed PRs with
significant and durable tumor regressions lasting more than one
year.
- Expansion of the ongoing clinical collaboration with Incyte
Corporation by adding a phase 2 cohort. This new portion of the
program will evaluate DPX-Survivac and low dose cyclophosphamide
with, or without, epacadostat in patients with advanced recurrent
ovarian cancer. In accordance with regulatory guidelines for
combination trials, the goal of this portion of the program is to
evaluate the clinical contribution of each investigational drug in
the combination regimen.
Operational Highlights of Q2 2018:
- Nasdaq listing and share
consolidation: IMV’s common shares commenced trading on
the Nasdaq Stock Market LLC on June 1, 2018. In connection with the
listing, a consolidation of its outstanding common shares took
place on the basis of one new common share for every 3.2
outstanding common shares on May 2, 1018.
- Corporate name change: Because the underlying
mechanism of action of DPX-based therapies represents a new class
of immunotherapies and is not consistent with vaccines, the
Corporation’s leadership decided to change the name from
Immunovaccine to IMV to better reflect the true potential of its
therapeutic candidates. The shareholders of the Corporation
overwhelmingly voted in favour of this change at their last
meeting.
- Addition of Julia P. Gregory
to the Corporation’s Board of Directors: Ms.
Gregory is a seasoned biotechnology executive most recently serving
as Chief Executive Officer and Board Member of ContraFect
Corporation. She previously served as the Chief Executive Officer
and Board Member of the immuno-oncology company Five Prime
Therapeutics.
- Cash position: As of June 30, 2018, cash and
cash equivalents and short-term investments were $25 million
compared to $15 million as of December 31, 2017.
Overview of Q2 2018 Financial Results
The net loss and comprehensive loss of
$5,196,000 ($0.12 per share) and $8,263,000 ($0.19 per share) for
the three and six-month periods ended June 30, 2018 were
$2,590,000 and $3,588,000 higher than the net loss and
comprehensive loss for the three and six-month periods ended June
30, 2017.
Research and development expenses increased by
$1,346,000 and $2,218,000 for the three and six-month periods ended
June 30, 2018, respectively compared to 2017. These increases
are mainly due to the two new phase 2 clinical trials collaboration
with Merck in ovarian cancer and DLBCL started in 2018 and also
costs related to the preparation of the upcoming basket trial.
General and administrative expenses increased by
$1,187,000 and $1,079,000 for the three and six-month periods ended
June 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 and listing fees) that
are non-recurring expenses, the filing of a shelf prospectus and an
increase in patent fees.
Business development and investor relations
expenses increased by $140,000 and $237,000 for the three and
six-month periods ended June 30, 2018, respectively compared to
2017. These increases are almost entirely due to the hiring of a
Senior Vice President, Business Development in January 2018.
At June 30, 2018, the Corporation had cash and
cash equivalents of $25,148,000 and working capital of $23,959,000,
compared with $14,909,000 and $13,627,000, respectively at December
31, 2017. For the six-month period ended June 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 $7 million. Based on the current
business plan, the Corporation forecasts the cash burn rate to be
between $3.5-million and $4.5-million for each of the last two
quarters of 2018 depending on the timing of certain clinical
expenses.
As of August 8, 2018, the number of issued and
outstanding common shares was 44,893,344 and a total of 2,042,851
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 six-months period ended June 30, 2018 and
the related management's discussion and analysis (MD&A) are
available on SEDAR at www.sedar.com.
About IMVIMV 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
reprogramming 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 conducting three phase 2 studies with Incyte and
Merck assessing DPX-Survivac as a combination therapy in ovarian
cancer and diffuse large B-cell lymphoma. Connect
at www.imv-inc.com.
IMV Forward-Looking StatementsThis 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.
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@imvaccine.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 June 30 |
|
Six-months ended June 30 |
|
2018$ |
|
2017$ |
|
2018$ |
|
2017$ |
Revenue |
|
|
|
|
|
|
|
Subcontract
revenue |
17 |
|
|
-- |
|
|
45 |
|
|
-- |
|
Interest Income |
112 |
|
|
36 |
|
|
181 |
|
|
70 |
|
Total revenue |
129 |
|
|
36 |
|
|
226 |
|
|
70 |
|
Expenses |
|
|
|
|
|
|
|
Research and
development |
2,605 |
|
|
1,259 |
|
|
4,487 |
|
|
2,269 |
|
General and
administrative |
2,046 |
|
|
859 |
|
|
2,968 |
|
|
1,889 |
|
Business development
and investor relations |
594 |
|
|
454 |
|
|
962 |
|
|
725 |
|
Government
assistance |
(189 |
) |
|
(202 |
) |
|
(464 |
) |
|
(378 |
) |
Accreted interest |
269 |
|
|
272 |
|
|
536 |
|
|
540 |
|
Total operating
expenses |
5,825 |
|
|
2,642 |
|
|
8,489 |
|
|
5,045 |
|
Net loss and
comprehensive loss |
(5,196 |
) |
|
(2,606 |
) |
|
(8,263 |
) |
|
(4,975 |
) |
Basic and
diluted loss per share |
(0.12 |
) |
|
(0.07 |
) |
|
(0.19 |
) |
|
(0.13 |
) |
Weighted-average shares
outstanding |
43,001,620 |
|
|
37,657,361 |
|
|
42,539,304 |
|
|
37,310,192 |
|
|
|
|
|
|
|
|
|
IMV INC. |
|
|
|
Unaudited Interim
Condensed Consolidated Statements of Financial Position |
|
|
|
(Expressed in thousands of Canadian dollars except for per share
amounts) |
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
2018 |
|
2017 |
Assets |
|
|
|
|
|
Current assets |
|
|
|
|
|
Cash and cash
equivalents |
$ |
25,148 |
|
|
$ |
14,909 |
|
Accounts
receivable |
|
909 |
|
|
|
261 |
|
Prepaid expenses |
|
1,742 |
|
|
|
838 |
|
Investment tax credits
receivable |
|
523 |
|
|
|
461 |
|
Total current
assets |
|
28,322 |
|
|
|
16,469 |
|
Property and
equipment |
|
2,225 |
|
|
|
563 |
|
Total assets |
$ |
30,547 |
|
|
$ |
17,032 |
|
Liabilities and
Equity |
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
Accounts payable and
accrued liabilities |
$ |
4,248 |
|
|
$ |
2,760 |
|
Amounts due to
directors |
|
22 |
|
|
|
21 |
|
Current portion of
long-term debt |
|
62 |
|
|
|
61 |
|
Current portion of
lease obligations |
|
31 |
|
|
|
-- |
|
Total current
liabilities |
|
4,363 |
|
|
|
2,842 |
|
Long-term portion of
lease obligation |
|
1,355 |
|
|
|
-- |
|
Deferred share
units |
|
1,292 |
|
|
|
1,371 |
|
Long-term debt |
|
6,977 |
|
|
|
6,476 |
|
Total liabilities |
|
13,987 |
|
|
|
10,689 |
|
Equity: |
|
|
|
|
|
Share Capital |
|
89,092 |
|
|
|
70,113 |
|
Contributed
Surplus |
|
5,995 |
|
|
|
6,375 |
|
Warrants |
|
555 |
|
|
|
674 |
|
Deficit |
|
(79,082 |
) |
|
|
(70,819 |
) |
Total equity |
|
16,560 |
|
|
|
6,343 |
|
Total liabilities and
equity |
$ |
30,547 |
|
|
$ |
17,032 |
|
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