Filed by e3 Filing, Computershare 1-800-973-3274 - IMV Inc. - Form 6-K


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of March, 2019

Commission File Number: 001-38480

IMV Inc.
(Name of registrant)

130 Eileen Stubbs Avenue, Suite 19 Dartmouth, Nova Scotia B3B 2C4, Canada

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

[   ] Form 20-F [ X ] Form 40-F

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): [   ]

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): [   ]





SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

  IMV Inc.
 
Date: March 21, 2019 By: /s/ Pierre Labbé
  Name: Pierre Labbé
  Title: Chief Financial Officer

 





Form 6-K Exhibit Index

Exhibit
Number
Document Description
99.1 News Release dated March 21, 2019. Announces 2018 Year-end Financial and Operational Results and Provides Updates on Key Clinical Programs

 



Exhibit 99.1
Exhibit 99.1

Media Release


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

  • 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

Dartmouth, Nova Scotia; March 21, 2019 – 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 Presentation’ 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.

    ###

    SOURCE: IMV Inc.

    Contacts for IMV:

    MEDIA
    Andrea Cohen, Sam Brown Inc.
    O: (917) 209-7163 E: andreacohen@sambrown.com

    INVESTOR RELATIONS
    Marc Jasmin, IMV Senior Director, Investor Relations and Communications

    O: (902) 492-1819 ext: 1042
    M: (514) 917-9481 E: mjasmin@imv-inc.com





    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