- Attained multiple milestones in
DECIDE1/2 clinical program in advanced ovarian cancer
- Achieved initial positive data from
phase 2 clinical trial in DLBCL with Merck
- Initiated a phase 2 basket trial across
five indications under a collaboration with Merck
- Listed on Nasdaq and changed
Corporation name to better reflect inherent value proposition
- Will host conference call tomorrow
morning at 8 a.m. ET
IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage
immuno-oncology corporation, today released its financial and
operational results for year ending December 31, 2018.
“IMV made significant advances in 2018,” said Frederic Ors,
Chief Executive Officer. “Foundational changes, including shifting
the name of the corporation to IMV and listing on Nasdaq, are
enabling us to access to a larger pool of investors and allow us to
better communicate our value proposition globally. However, the
evolution of our clinical program is an even more important
accomplishment: we entered into a collaboration with Merck across
five tumor types; opted, based on DECIDE clinical data, to pursue
DPX-Survivac as a monotherapy in ovarian cancer; and published
studies clearly demarcating the T cell-activating novel mechanism
of action of our DPX platform. With these milestones achieved, we
are looking forward to a strong 2019 in which we will continue to
advance our pipeline, drive value for investors, and support unmet
patient needs.”
IMV will host a conference call and webcast tomorrow 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) using
the conference ID: 9647179. A live audio webcast will be available
through IMV’s website on the ‘Events and Presentations’ page at
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.
Recent Clinical Updates & Expected
Milestones
Phase 1b/2 DPX-Survivac monotherapy and combination trial in
ovarian cancer (DECIDE)
The first 13 patients with advanced recurrent ovarian cancer
have been enrolled in the phase 2 portion of the study. Six
patients were randomized on DPX-Survivac monotherapy and seven were
randomized on the DPX-Survivac/epacadostat combination. The
Corporation is planning to provide an update on the preliminary
clinical data by the end of Q1 2019.
Enrollment of an additional 15 patients in a population with
lower tumor burden is ongoing and the corporation is planning to
provide another clinical update on this cohort in Q2 2019.
Phase 2 Study in Combination with KEYTRUDA® in
Relapsed/Refractory DLBCL (SPIREL)
Seven patients have been enrolled and treated across four
different clinical sites in Canada. Additional patients are being
screened and IMV expects to report updated clinical data in Q2
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 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 dosed in the ovarian and lung cancer
cohorts. IMV expects to report preliminary clinical results on
several of the solid tumor indications before the end of 2019.
2018 Highlights
Clinical Programs - DECIDE1/2 Advanced Ovarian Cancer
Trial
- Updated Phase 1b data shared via an
oral presentation at the 2018 ASCO Meeting and topline data from
the first two Phase 1b dosing cohorts highlighted at the 2018
ESMO-IO Meeting
- Based on these data, IMV opted to
develop DPX-Survivac as a monotherapy in certain ovarian cancer
patients defined by BTB (baseline tumor burden), an indication of
tumour size
- Additional analyses were conducted that
correlated DPX-Survivac’s novel MOA - the level of T cell
infiltration - with clinical response
- Met with the U.S. Food and Drug
Administration (FDA) and submitted an updated DECIDE trial
protocol; in addition, IMV discussed with the FDA the need for
accelerated approvals in advanced ovarian cancer and received
guidance on clinical design considerations for different lines of
therapy and platinum-sensitive and resistant patients
Additional Clinical Highlights
- First clinical data obtained from the
combination of DPX-Survivac and mCPA with Keytruda® (SPIREL Trial),
which came from an investigator-sponsored phase 2 trial in patients
with persistent or recurrent/refractory DLBCL; data from the
combination signaled significant anti-cancer activity in three of
the first four evaluable patients as well as a tolerable safety
profile
- Announced a collaboration with Merck in
a phase 2 basket trial evaluating the safety and efficacy of
DPX-Survivac, low-dose cyclophosphamide, and Keytruda®
(pembrolizumab) in patients with select advanced or recurrent solid
tumors across five different indications: bladder, liver
(hepatocellular carcinoma), ovarian, or non-small cell lung (NSCLC)
cancers as well as tumors with the microsatellite instability high
(MSI-H) biomarker
R&D Milestones
- Research published in the Journal of
Biomedical Science demonstrated the association between IMV’s
proprietary immune-targeted delivery technology and enhanced
efficacy in slowing tumor progression
- New data presented at the 2018 AACR
Meeting highlighted the novel MOA underscoring the Corporation’s T
cell-activating DPX technology and the potential for heightened
anti-cancer activity of combination therapies based on IMV’s
proprietary delivery platform
Operational Highlights:
- Completion of two public
offerings: In February 2018 and in March 2019 for a total of
approximately $43.9 million
- Nasdaq listing and share
consolidation: IMV’s common shares commenced trading on the
Nasdaq Stock Market LLC on June 1, 2018
- Corporate name change: Because
the MOA of DPX-based candidates signals a new class of
immunotherapies that is differentiated from vaccines, IMV
leadership changed the corporation’s name from Immunovaccine to IMV
to better reflect the true potential of its therapeutic
candidates
- Addition of Julia P. Gregory and Dr.
Markus Warmuth to the Corporation’s Board of Directors: Ms.
Gregory is a seasoned biotechnology executive, having served as
Chief Executive Officer and of ContraFect Corporation and the
immuno-oncology company Five Prime. Dr. Warmuth brings to the Board
more than 20 years of drug discovery experience with a strong focus
on targeted therapy and immuno-oncology programs
- Expansion of management team:
IMV named Joseph Sullivan as the Corporation’s first Senior
Vice-President, Business Development. Mr. Sullivan brings with him
over 25 years of global pharmaceutical experience with Merck &
Co. Inc. to IMV
- Opening of new facility in
Dartmouth, Nova Scotia: Nearly tripling the functional
workspace, the new premises feature upgraded facilities and
equipment as well as increased laboratory size to support long-term
growth
- Cash position: As of December
31, 2018, cash and cash equivalents and short-term investments were
$14.9 million (excluding the $29.5 million financing completed in
March 2019) compared to $14.9 million as of December 31, 2017
Overview of Year-End 2018 Financial Results
The net loss and comprehensive loss of $21,935,000 ($0.50 per
share) the year ended December 31, 2018 was $9,908,000 higher than
the net loss and comprehensive loss for the year ended December 31,
2017.
Research and development expenses increased by $6,914,000 for
the year ended December 31, 2018, compared to 2017. These increases
are mainly due to higher enrollment in the phase 1b/2 Incyte trial
in ovarian cancer; milestone payments for the phase 2 study in
DLBCL; and expenses related to the initiation of the basket trial.
The increase is also attributable to manufacturing activities to
support the increased clinical activity, which included purchasing
raw materials and contract manufacturing organization costs.
General and administrative expenses increased by $2,039,000 for
the year ended December 31, 2018 compared to 2017. This increase is
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 premiums following the Nasdaq listing,
consulting and professional fees, regulatory fees, the increase of
the rent, lease interest accretion, and utilities related to the
new facility.
Business development and investor relations expenses increased
by $781,000 for the year ended December 31, 2018 compared to 2017.
These increases are mainly explained by the hiring of a Senior Vice
President, Business Development in January 2018 and a Senior
Director of Investor Relations and Communications in November
2018.
At December 31, 2018, the Corporation had cash and cash
equivalents of $14,895,000 (excluding the $29.5 million financing
completed in March 2019) and working capital of $12,247,000,
compared with $14,909,000 and $13,627,000, respectively at December
31, 2017. For the year ended December 31, 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 $18.4 million. IMV expects research and
development expenditures to increase over time due to the
continuing development of product candidates and other clinical,
preclinical, and regulatory activities.
As of March 21, 2019, the number of issued and outstanding
common shares was 50,594,260 and a total of 2,008,057 stock
options, warrants, and deferred share units were outstanding.
The Corporation's audited annual consolidated results of
operations, financial condition and cash flows for the year ended
December 31, 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. is a clinical stage biopharmaceutical corporation
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. In the press release, such forward-looking
statements include, but are not limited to, statements regarding
the FDA potentially granting accelerated regulatory
approval of DPX-Survivac. 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 design and completion of clinical trials
and the receipt and timely 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) Year ended
December 31 2018
$
2017
$
Revenue Subcontract revenue 82 33 Interest Income 401
189 Total revenue 483 222
Expenses Research and development 12,852 5,938 General and
administrative 7,241 5,202 Business development and investor
relations 2,002 1,221 Government assistance (1,062 ) (1,078 )
Accreted interest 1,385 966 Total operating expenses
22,418 12,249
Net loss and comprehensive loss
(21,935 ) (12,027 )
Basic and diluted loss per share (0.50 )
(0.31 ) Weighted-average shares outstanding 43,766,951
38,656,771 IMV INC. Unaudited Interim
Condensed Consolidated Statements of Financial Position (Expressed
in thousands of Canadian dollars except for per share amounts)
December 31, December 31, 2018 2017
Assets Current
assets Cash and cash equivalents $ 14,895 $ 14,909 Accounts
receivable 1,337 261 Prepaid expenses 2,699 838 Investment tax
credits receivable 1,111 461 Total current assets
20,042 16,469 Property and equipment 2,883 563 Total
assets $ 22,925 $ 17,032
Liabilities and
Equity Current liabilities Accounts payable and accrued
liabilities $ 7,575 $ 2,760 Amounts due to directors 49 21 Current
portion of long-term debt 81 61 Current portion of lease
obligations 90 -- Total current liabilities 7,795
2,842 Lease obligation 1,308 -- Deferred share units 1,436 1,371
Long-term debt 8,069 6,476 Total liabilities 18,608
10,689 Equity: Share Capital 90,152 70,113
Contributed Surplus 6,504 6,375 Warrants 415 674 Deficit (92,754 )
(70,819 ) Total equity 4,317 6,343 Total liabilities
and equity $ 22,925 $ 17,032
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190321005717/en/
Contacts for IMV:
MEDIAAndrea Cohen, Sam Brown Inc.O: (917) 209-7163
E: andreacohen@sambrown.com
INVESTOR RELATIONSMarc Jasmin, IMV Senior
Director, Investor Relations and Communications
O: (902) 492-1819 ext: 1042M: (514) 917-9481
E: mjasmin@imv-inc.com
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