![](/cdn/assets/images/search/clock.png)
We could not find any results for:
Make sure your spelling is correct or try broadening your search.
Share Name | Share Symbol | Market | Type |
---|---|---|---|
IMV Inc | TSX:IMV | Toronto | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 1.12 | 0.60 | 0.70 | 0 | 01:00:00 |
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
Additional Clinical Highlights
R&D Milestones
Operational Highlights:
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
1 Year IMV Chart |
1 Month IMV Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions