IMV Inc. (TSX:IMV) (OTCQX:IMMVD), a clinical stage immuno-oncology
corporation, today released its financial and operational results
for the first quarter ended March 31, 2018.
“In continuing to deliver value to our
shareholders and partners, IMV has made remarkable progress this
quarter in validating our potential in immuno-oncology. Since the
beginning of 2018, we have expanded our clinical collaboration with
Incyte; observed the dosing of first patients in both Phase 2
combination trials evaluating DPX-Survivac with Merck’s checkpoint
inhibitor, pembrolizumab; and, completed a $14.375 million
financing that provides funds for the Corporation through Q4 of
2019, which is beyond our major upcoming clinical milestones," said
Frederic Ors, IMV's Chief Executive Officer. “These achievements
have significantly advanced our programs, and together with our
anticipated milestones – including our oral presentation at this
year’s ASCO conference as well as early data read-outs from our
Phase 2 combination trials with Merck, we look forward to further
advancing DPX-Survivac in the immunotherapy clinical landscape.
“These achievements have come at a critical time
in our Company’s history,” continued Mr. Ors. “We are now in a new
phase of anticipated growth, announcing plans to list IMV common
shares on the Nasdaq exchange, as well as changing the Company’s
name from Immunovaccine to IMV, to better reflect the technologies
we are advancing.”
Clinical program updates
include:
DPX-Survivac
- Phase 1b clinical trial in ovarian cancer with IncyteShortly
following the end of the quarter, IMV announced an agreement with
Incyte Corporation to expand the companies’ clinical trial
collaboration, adding a Phase 2 component to the ongoing
combination study. The Phase 2 arm will evaluate DPX-Survivac and
low-dose cyclophosphamide with, and without, Incyte’s epacadostat
in advanced ovarian cancer patients. 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.
- Phase 2 clinical trial in Diffuse Large B Cell Lymphoma (DLBCL)
with MerckOn March 28, 2018, the Corporation announced that the
first patient was treated in the Phase 2 study combining
DPX-Survivac, low-dose cyclophosphamide, and Merck’s checkpoint
inhibitor, pembrolizumab, in patients with persistent or
recurrent/refractory DLBCL.
- Phase 2 clinical trial in ovarian cancer with MerckDuring the
first quarter, clinicians treated the first patient in the
investigator-sponsored Phase 2 clinical trial evaluating
DPX-Survivac, in combination with Merck’s checkpoint inhibitor,
pembrolizumab, in patients with recurrent, platinum-resistant
ovarian cancer.
Q1 2018 operational highlights
include:
- Potential Nasdaq listing: In May 2018, IMV
announced that it has applied to list its common shares on the
Nasdaq Stock Market LLC. In connection with the planned U.S.
listing, and as previously authorized by its shareholders at more
than 99%, the Corporation has implemented a consolidation of its
outstanding common shares that was done on the basis of one new
common share for every 3.2 outstanding common shares at the date of
the consolidation, and changed the Corporation’s name from
Immunovaccine Inc. to IMV Inc. The Company currently
anticipates that, subject to the receipt of all required approvals,
its common shares would begin trading on the Nasdaq before the end
of Q2 2018.
- Completion of a bought deal public offering:
In February 2018, IMV completed a bought deal public offering of
common shares of the Corporation, including the exercise of the
overallotment option-in-full. An aggregate of 7,187,500 common
shares pre-consolidation (2,246,094 post-consolidation) were issued
at a price of $2.00 per common share pre-consolidation ($6.40
post-consolidation). IMV raised $14.375 million in gross
proceeds.
- Expanding the management team: The Corporation
named Joseph Sullivan to the newly created role of Senior Vice
President, Business Development, in February 2018. Mr. Sullivan
brings over 25 years of global pharmaceutical and vaccine
experience with Merck & Co. Inc. to his new position at
IMV.
Anticipated upcoming clinical milestones
for the Corporation’s lead product DPX-Survivac
include:
• Phase 1b clinical trial in ovarian cancer with
Incyte
- Oral presentation at the 2018 American Society of Clinical
Oncology (ASCO) annual meeting on June 3, 2018
- Top line clinical results with the 300mg dose of Incyte’s
epacadostat at the ASCO meeting
- Update on the 300mg dose of epacadostat clinical results in Q3
2018
• Phase 2 clinical trial in ovarian cancer with Merck
- Preliminary clinical results around mid-year 2018
- Top line clinical results expected at the end of 2018 or
beginning of 2019
• Phase 2 clinical trial in DLBCL with Merck
- Preliminary clinical results expected around mid-year
- Top line clinical results expected at the end of 2018 or
beginning of 2019
“We are celebrating the great progress we have
recently made, and we anticipate tremendous opportunities that will
continue to improve immunotherapy treatment options, particularly
in underserved cancers,” continued Mr. Ors. “We are grateful for
the continued support of our partners, Incyte and Merck, as well as
our shareholders and investors, and look forward to another
productive quarter.”
Overview of Q1 2018 Financial Results
The net loss and comprehensive loss of
$3,067,000 ($0.7 per share) for the three-month period ended March
31, 2018, was $898,000 higher than the net loss and comprehensive
loss for three-month period ended March 31, 2017. This relates
mainly to a $873,000 increase in research and development (R&D)
expenses, a $89,000 increase in business development and investor
relations expenses – partly offset by a $111,000 decrease in
general and administrative expenses and a $98,000 increase in
government assistance in the three-month period ended March 31,
2018.
At March 31, 2018, the Corporation had cash and
cash equivalents of $24,019,000 and working capital of $24,057,000,
compared with $14,909,000 and $13,627,000, respectively at December
31, 2017. For the three-month period ended March 31, 2018, 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
$2.7-million. Based on the current business plan, the Corporation
forecasts the cash burn rate to be between $12-million and
$14-million for 2018.
As of May 14, 2018, the number of issued and
outstanding common shares was 42,960,767. A total of
3,972,700 stock options, warrants, and deferred share units were
outstanding on May 14, 2018.
The Corporation's unaudited interim condensed
consolidated results of operations, financial condition and cash
flows for the three months ended March 31, 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 Company’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.imvaccine.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 (TSX:IMV)
Historical Stock Chart
From Jun 2024 to Jul 2024
IMV (TSX:IMV)
Historical Stock Chart
From Jul 2023 to Jul 2024