- Phase 2 SPiReL study of DPX-Survivac combination regimen with
Keytruda® in r/r DLBCL successfully reached primary efficacy
endpoint with 64% (7/11) of evaluable patients demonstrating a
clinical response
- Translational and updated clinical response data from Phase 2
DeCidE1 study of DPX-Survivac in advanced ovarian cancer to be
presented by Oliver Dorigo, MD, Ph.D., at the upcoming 2020 ASCO
Virtual Scientific Program
- DPX-COVID-19, a vaccine candidate against COVID-19, on schedule
to complete preclinical studies before the end of May and
progressing towards initiation of Phase 1 study expected this
summer
- Completed CAD $25.1M private placement with new and existing
institutional investors, extending cash runway well into 2021
- Management to host a conference call and webcast today at 8:00
a.m. ET
IMV Inc. (the “Company” or “IMV”) (TSX:IMV; NASDAQ:IMV), a
clinical-stage biopharmaceutical company pioneering a novel class
of cancer immunotherapies and vaccines against infectious diseases,
today announced financial results for the first quarter ended March
31, 2020 and provided an update on its clinical and operational
progress.
“Despite the current pandemic, we have continued to validate our
platform and advance our clinical pipeline targeting various
cancers and other serious diseases, including COVID-19,” said
Frederic Ors, Chief Executive Officer at IMV. “Today, we are
especially pleased to announce that SPiReL, a Phase 2 study of a
DPX-Survivac combination regimen in patients with r/r DLBCL, has
met its primary efficacy endpoint. This represents a significant
milestone for DPX-Survivac, which has so far demonstrated the
ability to shrink both solid and hematological tumors with
long-lasting clinical responses and a differentiated safety
profile. We believe these results in r/r DLBCL, taken together with
emerging data from our DeCidE1 study in advanced ovarian cancer,
support our plan to accelerate development in both of these
indications.”
Mr. Ors continued, “Our recent financing fortifies our corporate
position, with cash to fund operations for more than 12 months and
several milestones anticipated across our portfolio in the interim.
We look forward to presenting translational and updated clinical
response data from DeCidE1 at the ASCO20 Virtual Scientific
Program, and to further updates from each of our Phase 2 studies of
DPX-Survivac later this year. Additionally, we are preparing to
advance a DPX-based vaccine candidate for COVID-19, which is on
track to enter into clinical trials later this summer.”
DPX-Survivac Clinical Program
Updates
Phase 2 SPiReL Study in Recurrent / Refractory Diffuse Large
B-Cell Lymphoma (r/r DLBCL)
SPiReL is an investigator-initiated Phase 2 study evaluating
DPX-Survivac/CPA in combination with Keytruda® (pembrolizumab) in
r/r DLBCL. The study is led by Dr. Neil Berinstein, MD, FFCP©,
ABIM, hematologist-oncologist at the Odette Cancer Centre at
Sunnybrook Health Sciences Centre in Toronto, Ontario.
The study has met its primary efficacy endpoint with 64% (7/11)
of evaluable patients demonstrating a clinical response so far. The
study remains ongoing and the top line data are expected to be
presented at a conference later in 2020.
In December 2019, updated clinical results were reported in a
poster presentation at the American Society of Hematology (ASH)
annual meeting in Orlando, FL. At the time of this presentation, 17
subjects were enrolled in the study, of which nine (9/17) were
evaluable. At that time, three (3/9) complete responses (CR) and
two partial responses (PR) had been observed, with an overall
response rate (ORR) of 59% (5/9).
As of May 7, 2020, 20 patients have been enrolled across five
different clinical sites in Canada.
Phase 2 DeCidE1 Study in Advanced Recurrent Ovarian
Cancer
DeCidE1 is a Phase 2 multicenter, randomized, open-label study
to evaluate the safety and efficacy of DPX-Survivac with
intermittent low dose cyclophosphamide (CPA). This Phase 2 arm
enrolled 22 patients with recurrent, advanced platinum-sensitive
and/or resistant ovarian cancer.
In February, IMV reported interim data from this study,
including:
- 15/19 (79%) evaluable subjects demonstrated disease control,
including 10 tumor regressions (53%);
- 7/19 subjects (37%) achieved clinical benefit with partial
response or stable disease lasting > 6 months; and
- Treatment was well-tolerated with majority of adverse events
being grade 1-2 reactions at the injection site.
At the time of the data cutoff, six (31%) patients remained on
therapy. Five (26%) of these patients were still on treatment at
> 6 months. Additional data are available here.
An abstract has been selected for a poster presentation at the
upcoming American Society of Clinical Oncology (ASCO) Virtual
Scientific Program, which will be held May 29–31, 2020. The poster
presentation by Oliver Dorigo, MD, Ph.D., Associate Professor of
Obstetrics and Gynecology (Oncology), Stanford University Medical
Center, Stanford, CA will provide translational data and an update
on clinical responses and their duration.
Phase 2 Basket Trial in Multiple Advanced Metastatic Solid
Tumors
The Basket Trial is an open label, multi-center Phase 2 study,
evaluating the safety and efficacy of DPX-Survivac/CPA in
combination with Keytruda® across five cohorts of patients with
bladder cancer, liver cancer (hepatocellular carcinoma), ovarian
cancer (with and without CPA), NSCLC and tumors shown to be
positive for the microsatellite instability high (MSI-H)
biomarker.
As of May 7, 2020, a total of 92 patients out of the planned 184
patients were enrolled across all five indications at 19 clinical
sites in Canada and the US.
The COVID-19 pandemic has impacted data collection and
validation processes and IMV now anticipates reporting updated
results from this study in the second half of 2020.
DPX-COVID-19 Vaccine Program
Update
In early March, IMV announced plans to develop a DPX-based
vaccine candidate for COVID-19 in collaboration with experts in the
field. IMV is on schedule to complete preclinical studies before
the end of May and is on track to initiate a Phase 1 clinical study
for DPX-COVID-19 this summer.
Since this update, IMV has met with Health Canada in preparation
for its clinical trial application (CTA) and is in the process of
finalizing its Phase 1 design. The randomized, placebo-controlled
study will enroll approximately 84 healthy subjects in two age
strata and will assess two different doses of DPX-COVID-19.
IMV has also submitted to relevant authorities’ requests for
grants for its DPX-COVID-19 program.
IMV will provide regular updates on the development of
DPX-COVID-19 and more information can be found on the dedicated
DPX-COVID-19 page on the Company’s website.
Update on Business and Clinical
Operations in the Context of COVID-19 Pandemic
IMV continues to closely monitor the COVID-19 pandemic and adapt
its business operations while prioritizing the health and
well-being of patients, clinical investigators, and personnel. In
accordance with recommendations from health authorities, IMV has
transitioned to a remote working arrangement to protect employees
and the broader community while maintaining business continuity.
All clinical trial sites remain open and active with a heightened
focus on patient safety and data integrity. While the effects of
the pandemic are expected to slow the pace of patient recruitment
due to the diversion of healthcare resources to COVID-19 response
activities, they have not had a material impact on the Company’s
financial condition, liquidity, or longer-term strategic
development plans.
To date, the COVID-19 pandemic has impacted data collection and
validation processes and as outlined above, this has delayed the
planned readout from the Phase 2 basket study of DPX-Survivac/CPA
in combination with Keytruda®. The Company continues to monitor
this situation and will provide regular updates in the future.
Upcoming Milestones
Over the course of upcoming quarters, the Company expects to
deliver the following milestones:
- Initiation of Phase 1 clinical trial for DPX-COVID-19 in the
summer of 2020
- Top line Phase 2 clinical results update in the DLBCL
combination trial in 2020
- Update on the Phase 2 clinical results in the ovarian
monotherapy trial at ASCO 2020
- Updated Phase 2 clinical results for Basket trial in 2H
2020.
Overview of Q1 2020 Financial
Results
Research and development expenses increased by $2,811,000 for
the quarter ended March 31, 2020, compared to Q1 2019. These
increases are mainly due to a spike in enrollment prior to the
onset of the pandemic related to the ongoing basket trial and
non-recurring purchases of GMP grade raw materials and contract
manufacturing for DPX-Survivac. The purchases of GMP grade
materials in 2019 and Q1 2020 covers all the needs of the
Corporation for ongoing DPX-Survivac trials until mid-2021. The
increase in research and development expenses is, to a lesser
extent, also attributable to preclinical development of DPX-SurMAGE
for bladder cancer and personnel costs due to an increase in
headcount.
General and administrative expenses increased by $1,073,000 for
the quarter ended March 31, 2020 compared to Q1 2019. This increase
is mainly due to non-cash DSU compensation caused by share price
fluctuation, foreign exchange loss, and investor relations
activities, including travel costs incurred prior to the start of
the COVID-19 pandemic. The Company expects reduced comparative
volatility in the DSU compensation expense from Q3 2020 onward as a
result of electing to settle all future DSU redemptions in shares
effective August 8, 2019.
The net loss and comprehensive loss of $9,664,000 ($0.19 per
share) the quarter ended March 31, 2020 was $3,721,000 higher than
the net loss and comprehensive loss for the quarter ended March 31,
2019.
At March 31, 2020, the Corporation had cash and cash equivalents
of $7,372,000 and working capital of $4,553,000, compared with
$14,066,000 and $13,199,000, respectively at December 31, 2019.
This does not reflect the proceeds from the CDN $25,100,000 private
placement completed on May 7th, 2020 or utilization of the ATM
Distribution subsequent to the period end date. Based on its
current plan, IMV expects its current cash position will be
sufficient to fund operations for more than 12 months.
For the quarter ended March 31, 2020, 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 $8,646,000. IMV expects the cash burn for the
remainder of 2020 to return to $5-6,000,000 per quarter due to the
impact of COVID-19 and the non-recurring expenditures incurred in
Q1 2020.
As of May 14, 2020, the number of issued and outstanding common
shares was 60,454,474 and a total of 5,079,375 stock options,
deferred share units and warrants were outstanding.
The Company's unaudited interim condensed consolidated results
of operations, financial condition and cash flows for the quarter
ended March 31, 2020 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.
Conference Call and Webcast Information
Management will host conference call and webcast today, May 15,
2020 at 8:00 a.m. ET. Financial analysts are invited to join the
conference call by dialing (866) 211-3204 (U.S. and Canada) or
(647) 689-6600 (international) using the conference ID# 8081886
Other interested parties will be able to access the live audio
webcast at this link:
https://ir.imv-inc.com/events-and-presentations.
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 cancer immunotherapies
and vaccines against infectious diseases based on the Company’s
proprietary drug delivery platform, DPX. 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. Visit www.imv-inc.com and connect with
us on Twitter and LinkedIn.
Cautionary Language Regarding 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 Company’s progress in developing a DPX-based vaccine candidate
against COVID-19, the Company’s belief that the DPX-based platform
creates the opportunity for production of a COVID-19 vaccine, the
Company’s belief in the potential efficacy of its DPX-based vaccine
against COVID-19, the anticipated timing of the Company’s
preclinical assays, studies and clinical trials related to its
DPX-based vaccine against COVID-19 and the expected impact of
COVID-19 on the Company’s other clinical studies and trials and its
operations generally. Such statements 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 and uncertainties affecting the Company and
its products.
The Company 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, the Company’s ability to develop a DPX-based
vaccine candidate against the COVID-19 through the successful and
timely completion of preclinical assays, studies and clinical
trials, the receipt of all regulatory approvals by the Company to
commence and then continue clinical studies and trials, and, if
successful, the commercialization of its proposed vaccine candidate
related to COVID-19, the Company’s ability to raise sufficient
capital, including potentially through grant awards available in
Canada, to fund such clinical studies and trials and the production
of any COVID-19 vaccine, the ultimate applicability of any
third-party research and studies in related coronavirus and SARS
studies and sequencing, the Company’s ability to enter into
agreements with the proposed lead investigators to assist in the
clinical development on its vaccine candidate related to COVID-19,
the Company’s ability to collaborate with governmental authorities
with respect to such clinical development, the coverage and
applicability of the Company’s intellectual property rights to any
vaccine candidate related to COVID-19, the ability of the Company
to manufacture any vaccine candidate related to COVID-19 rapidly
and at scale, the ability for the Company to accurately assess and
anticipate the impact of COVID-19 on the Company’s other clinical
studies and trials and operations generally and other risks
detailed from time to time in the Company’s ongoing filings and in
its annual information form filed with the Canadian regulatory
authorities on SEDAR as www.sedar.com and with the United States
Securities and Exchange Commission on EDGAR at www.sec.gov/edgar.
Investors are cautioned not to rely on these forward-looking
statements and are encouraged to read the Company’s continuous
disclosure documents which are available on SEDAR and on 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 months ended, March 31,
2020 $
2019 $
Revenue
Subcontract revenue
–
8
Interest Income
68
74
Total revenue
68
82
Expenses
Research and development
6,824
4,013
General and administrative
3,033
1,960
Government assistance
(558)
(346)
Accreted interest
433
398
Total operating expenses
9,732
6,025
Net loss and comprehensive loss
(9,664)
(5,943)
Basic and diluted loss per
share
(0.19)
(0.13)
Weighted-average shares outstanding
50,719,488
46,712,436
IMV INC.
Unaudited Interim Condensed Consolidated
Statements of Financial Position
(In thousands of Canadian dollars, except
shares and per share amounts)
March 31,
December 31,
2020
2019
Assets
Current assets
Cash and cash equivalents
$
7,372
$
14,066
Accounts receivable
653
845
Prepaid expenses
2,676
3,032
Investment tax credits receivable
1,886
1,661
Total current assets
12,587
19,604
Property and equipment
2,742
2,830
Total assets
$
15,329
$
22,434
Liabilities and Equity
Current liabilities
Accounts payable and accrued
liabilities
$
7,525
$
6,157
Amounts due to directors
64
60
Current portion of long-term debt
342
88
Current portion of lease obligations
103
100
Total current liabilities
8,034
6,405
Lease obligation
1,181
1,208
Long-term debt
8,529
8,373
Total liabilities
17,744
15,986
Equity
(2,415)
6,448
Total liabilities and equity
$
15,329
$
22,434
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200515005219/en/
Investor Relations Marc Jasmin, Senior Director,
Investor Relations, IMV O: (902) 492-1819, ext: 1042 M: (514)
617-9481 mjasmin@imv-inc.com
Josh Rappaport, Director, Stern IR O: (212) 362-1200
josh.rappaport@sternir.com
Media Delphine Davan, Director of Communications,
IMV M: (514) 968-1046 ddavan@imv-inc.com
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