IMV Inc. Announces 2018 Year-end Financial and Operational Results and Provides Updates on Key Clinical Programs
Categorynews North America

IMV Inc. Announces 2018 Year-end Financial and Operational Results and Provides Updates on Key Clinical Programs

March 21, 2019 Off By BusinessWire

DARTMOUTH, Nova Scotia–(BUSINESS WIRE)–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

        • 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

    • 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
    • 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.

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

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