IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immunotherapy
company, today released its financial and operational results for
the first quarter ended March 31, 2019.
“The DPX-Survivac program continues to be a major value-driver
for IMV, with its unique mechanism of action providing significant
clinical differentiation and, potentially, a much-needed innovation
for hard-to-treat cancers,” said Frederic Ors, IMV's Chief
Executive Officer. “Highlights of our overall progress this quarter
include:
- Reported promising initial data from
the phase 2 cohort of the DeCidE1 clinical study, which underscores
the potential of DPX-Survivac as a monotherapy;
- Awarded a grant with le Centre de
Recherche du CHU de Québec-Université Laval to develop a
first-in-class dual target T cell therapy in bladder cancer;
and
- Completed a C$29.46 million financing
with Wells Fargo acting as lead underwriter that provided the
Company with increased financial flexibility."
DPX-Survivac Clinical Program
Updates:
Phase 2 Cohort of the DeCidE1 Clinical Study in Ovarian
Cancer
IMV provided a clinical update in March indicating that six
patients receiving DPX-Survivac monotherapy with intermittent
low-dose cyclophosphamide (mCPA) had reached the first CT scan
assessment. Key related findings were as follows:
- 83% of the participants (5 of 6) showed
stable disease (SD), including two tumor regressions; and
- 80% (4 of 5) of those with stable
disease were subjects with a lower baseline tumor burden (BTB) of
less than 5 centimeters, which also included the two tumor
regressions.
In earlier stages of this trial, durable clinical responses
occurred after 140 days, and at the date of this latest update,
they had lasted for 20 months or more. The amended phase 2 cohort
of the DeCidE1 trial focuses on patients with low BTB (less than 5
centimeters). The Corporation is targeting enrollment of at least
16 additional patients at sites in the U.S. and Canada.
IMV will present additional data on DeCidE1 at the 2019 American
Society of Clinical Oncology (ASCO) annual meeting.
Phase 2 Study in Combination with KEYTRUDA® in
Relapsed/Refractory DLBCL (SPiReL)
As of April 5, 2019, investigators had enrolled ten patients in
four different clinical sites in Canada. Additional patients are
being screened and IMV expects to report updated clinical data at
the bi-annual International Conference on Malignant
Lymphoma, which will be held in Lugano
Switzerland in June 2019.
Phase 2 Basket Trial in Combination with KEYTRUDA® in
Multiple Solid Tumors
Screening and enrollment of patients is ongoing at multiple
clinical sites across the U.S. and Canada for 5 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.
The first patients have been treated in the ovarian, NSCLC and
MSI-H cohorts and IMV expects to report preliminary clinical
results on several of the solid tumor indications before the end of
2019.
The Corporation expects to reach the following milestones
between now and the first half of 2020:
Milestones Key dates Phase 2
monotherapy clinical results in Ovarian – ASCO June
2019 Phase 2 clinical results with Merck Keytruda in DLBCL – ICML
June 2019 Preliminary clinical results Basket trial
in 5 indications H2 2019 Topline monotherapy clinical
results in Ovarian H2 2019 Top line clinical results
for Basket trial H1 2020
“We are pleased at the steady progress we’ve made this far in
2019, and look forward to leveraging our technology to improve
immunotherapy treatment options, particularly in underserved
cancers,” continued Mr. Ors. “We are grateful for the continued
support of our shareholders and partners and look forward to a very
productive remainder of 2019.”
Q1 2019 Operational
Highlights
Completion of an underwritten public offering: IMV
completed, in early March 2019 an underwritten public offering of
5,404,855 common shares at a price to the public of
C$5.45 per common share, for aggregate gross of
approximately C$29.46 million, before deducting the
underwriting commissions and estimated Offering expenses. Wells
Fargo Securities and Raymond James acted as joint
book-running managers for the Offering. B. Riley FBR acted as
co-manager.
The Corporation intends to use the net proceeds of the Offering
to accelerate the development of DPX-Survivac in combination with
Keytruda as part of the basket trial in select advanced or
recurrent solid tumors in bladder, liver (hepatocellular
carcinoma), ovarian or non-small-cell lung cancers, as well as
tumors shown to be positive for the microsatellite instability high
biomarker and for general corporate purposes.
Grant awarded by CQDM to IMV to develop first-in-class dual
target T cell therapy: In March, a grant was awarded by
CQDM to develop a first-in-class dual target T Cell therapy in
bladder cancer based on IMV’s DPX technology to IMV and Centre de
Recherche du CHU de Québec-Université Laval.
The work will target immunogenic peptides from the MAGE protein
family member A9 (MAGE-A9) as identified by a team from Centre de
Recherche du CHU de Québec-Université Laval. This protein is
frequently expressed in various human cancers including bladder,
lung, and kidney. These peptides will be combined with
selected immunogenic peptides from the survivin protein composing
the DPX-Survivac T cell drug candidate.
Overview of Q1 2019 Financial Results
The net loss and comprehensive loss of $5,943,000 ($0.13 per
share) for the three-month period ended March 31, 2019, was
$2,876,000 higher than the net loss and comprehensive loss for
three-month period ended March 31, 2018. This relates mainly to a
$2,131,000 increase in research and development (R&D) expenses,
a $670,000 increase in general and administrative expenses and a
$71,000 increase in government assistance in the three-month period
ended March 31, 2019.
At March 31, 2019, the Corporation had cash and cash equivalents
of $34,207,000 and working capital of $33,893,000, compared with
$14,895,000 and $12,247,000, respectively at December 31, 2018. For
the three-month period ended March 31, 2019, IMV's cash burn rate
(defined as net loss for adjusted for non-cash transactions
including amortization, depreciation, accretion of long-term debt
and stock-based compensation) was approximately $5.2 million. Based
on the current business plan, the Corporation forecasts the
quarterly cash burn rate to be between $5 million and $6 million
for 2019.
As of May 9, 2019, the number of issued and outstanding common
shares was 50,597,306. A total of 2,030,471 stock options,
warrants, and deferred share units were outstanding on May 9,
2019.
The Corporation's unaudited interim condensed consolidated
results of operations, financial condition and cash flows for the
three months ended March 31, 2019 and the related management's
discussion and analysis (MD&A) are available on SEDAR at
www.sedar.com.
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-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
March 31
2019
$
2018
$
Revenue Subcontract revenue 8 27 Interest Income 74 69 Total
revenue 82 96
Expenses Research and development 4,013 1,882
General and administrative 1,960 1,290 Government assistance (346)
(275) Accreted interest 398 266 Total operating expenses 6,025
3,163
Net loss and comprehensive loss (5,943) (3,037)
Basic and diluted loss per share (0.13) (0.07)
Weighted-average shares outstanding 46,712,436 41,594,865
IMV INC.Unaudited Interim Condensed
Consolidated Statements of Financial Position(Expressed in
thousands of Canadian dollars except for per share amounts)
March 31, December 31, 2019 2018
Assets Current
assets Cash and cash equivalents $ 34,207 $ 14,895 Accounts
receivable 878 1,337 Prepaid expenses 2,974 2,699 Investment tax
credits receivable 1,456 1,111 Total current assets 39,515 20,042
Property and equipment 2,880 2,883 Total assets $ 42,395 $ 22,925
Liabilities and Equity
Current liabilities Accounts payable and accrued liabilities $
5,383 $ 7,575 Amounts due to directors 63 49 Current portion of
long-term debt 84 81 Current portion of lease obligations 92 90
Total current liabilities 5,622 7,795 Lease obligation 1,285 1,308
Deferred share units 1,232 1,436 Long-term debt 8,444 8,069 Total
liabilities 16,583 18,608 Equity 25,812 4,317 Total liabilities and
equity $ 42,395 $ 22,925
Source: IMV Inc.
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INVESTOR RELATIONS:
Marc Jasmin, Senior Director, Investor Relations and
CommunicationsO: (902) 492-1819 ext : 1042M: (514) 917-9481 E:
mjasmin@imv-inc.com
MEDIA:Andrea Cohen, Sam Brown Inc.O: (917)
209-7163 E: andreacohen@sambrown.com
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