IMV Inc. Announces Q2 2018 Financial Results
- Initiated Trading of Common Shares on Nasdaq; Finalized Corporate Name Change
- Presented New Positive Data at ASCO on the DECIDE1 trial in Ovarian Cancer
- Advanced Ongoing Clinical Programs with Merck and Incyte
“During the second quarter of 2018, we attained milestones advancing IMV’s ability to deliver novel immuno-oncology therapeutics,” stated
“Based on our current financial position and operational strategy, we look forward to delivering on several anticipated milestones over the next four quarters, including:
- Expansion of our clinical program with a new phase 2 basket trial;
- Topline data from the higher dosing cohort in our clinical trial with Incyte;
- Preliminary and topline data from our triple combination phase 2 trial with Merck in diffuse large B-cell lymphoma (DLBCL); and
- Preliminary and topline data from our second triple combination phase 2 trial with Merck in ovarian cancer.”
IMV will host a conference call and webcast today at 8 a.m. ET. The dial-in number for the conference call is (844) 461-9932 (
Clinical Program Highlights – DPX-Survivac
- New positive data highlighted in an oral presentation at the 2018 ASCO meeting from the DECIDE1 (DPX-Survivac with low dose cyclophosphamide and Epacadostat) phase 1b/2 clinical trial in ovarian cancer with Incyte showed 7 tumor regressions, including 4 partial responses (PR, defined as ≥30% decrease in tumor lesion size) in the first 18 evaluable patients.
- Mechanism of action (MOA) analysis from the ASCO data showed that DPX-Survivac generated survivin-specific T cell responses in 100% (10/10) of evaluated patients; there was an increase in T cell infiltration post treatment in 37% (3/8) analyzable tumor biopsies; and 2 of the 3 patients with T cell infiltration showed PRs with significant and durable tumor regressions lasting more than one year.
- Expansion of the ongoing clinical collaboration with Incyte Corporation by adding a phase 2 cohort. This new portion of the program will evaluate DPX-Survivac and low dose cyclophosphamide with, or without, epacadostat in patients with advanced recurrent ovarian cancer. 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.
Operational Highlights of Q2 2018:
- Nasdaq listing and share consolidation: IMV’s common shares commenced trading on the
Nasdaq Stock Market LLCon June 1, 2018. In connection with the listing, a consolidation of its outstanding common shares took place on the basis of one new common share for every 3.2 outstanding common shares on May 2, 1018.
- Corporate name change: Because the underlying mechanism of action of DPX-based therapies represents a new class of immunotherapies and is not consistent with vaccines, the Corporation’s leadership decided to change the name from Immunovaccine to IMV to better reflect the true potential of its therapeutic candidates. The shareholders of the Corporation overwhelmingly voted in favour of this change at their last meeting.
- Addition of
Julia P. Gregoryto the Corporation’s Board of Directors: Ms. Gregoryis a seasoned biotechnology executive most recently serving as Chief Executive Officer and Board Member of ContraFect Corporation. She previously served as the Chief Executive Officer and Board Member of the immuno-oncology company Five Prime Therapeutics.
- Cash position: As of
June 30, 2018, cash and cash equivalents and short-term investments were $25 millioncompared to $15 millionas of December 31, 2017.
Overview of Q2 2018 Financial Results
The net loss and comprehensive loss of
Research and development expenses increased by
General and administrative expenses increased by
Business development and investor relations expenses increased by
The Corporation's unaudited interim condensed consolidated results of operations, financial condition and cash flows for the three and six-months period ended
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 immunotherapies based on the Corporation’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.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. 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.
Contacts for IMV:
T: (312) 961-2502 E: firstname.lastname@example.org
Pierre Labbé, Chief Financial Officer
T: (902) 492-1819 E: email@example.com
O: (415) 513-1284
T: (415) 515-4572 E: firstname.lastname@example.org
Unaudited Interim Condensed Consolidated Statements of Loss and Comprehensive Loss
|(In thousands of Canadian dollars, except shares and per share amounts)|
|Research and development||2,605||1,259||4,487||2,269|
|General and administrative||2,046||859||2,968||1,889|
|Business development and investor relations||594||454||962||725|
|Total operating expenses||5,825||2,642||8,489||5,045|
|Net loss and comprehensive loss||(5,196||)||(2,606||)||(8,263||)||(4,975||)|
|Basic and diluted loss per share||(0.12||)||(0.07||)||(0.19||)||(0.13||)|
|Weighted-average shares outstanding||43,001,620||37,657,361||42,539,304||37,310,192|
|Unaudited Interim Condensed Consolidated Statements of Financial Position|
|(Expressed in thousands of Canadian dollars except for per share amounts)|
|Cash and cash equivalents||$||25,148||$||14,909|
|Investment tax credits receivable||523||461|
|Total current assets||28,322||16,469|
|Property and equipment||2,225||563|
|Liabilities and Equity|
|Accounts payable and accrued liabilities||$||4,248||$||2,760|
|Amounts due to directors||22||21|
|Current portion of long-term debt||62||61|
|Current portion of lease obligations||31||--|
|Total current liabilities||4,363||2,842|
|Long-term portion of lease obligation||1,355||--|
|Deferred share units||1,292||1,371|
|Total liabilities and equity||$||30,547||$||17,032|
Source: IMV Inc.