On May 9, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immunotherapy company, reported its financial and operational results for the first quarter ended March 31, 2019 (Press release, IMV, MAY 9, 2019, View Source [SID1234536094]).
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"The DPX-Survivac program continues to be a major value-driver for IMV, with its unique mechanism of action providing significant clinical differentiation and, potentially, a much-needed innovation for hard-to-treat cancers," said Frederic Ors, IMV’s Chief Executive Officer. "Highlights of our overall progress this quarter include:
Reported promising initial data from the phase 2 cohort of the DeCidE1 clinical study, which underscores the potential of DPX-Survivac as a monotherapy;
Awarded a grant with le Centre de Recherche du CHU de Québec-Université Laval to develop a first-in-class dual target T cell therapy in bladder cancer; and
Completed a C$29.46 million financing with Wells Fargo acting as lead underwriter that provided the Company with increased financial flexibility."
DPX-Survivac Clinical Program Updates:
Phase 2 Cohort of the DeCidE1 Clinical Study in Ovarian Cancer
IMV provided a clinical update in March indicating that six patients receiving DPX-Survivac monotherapy with intermittent low-dose cyclophosphamide (mCPA) had reached the first CT scan assessment. Key related findings were as follows:
83% of the participants (5 of 6) showed stable disease (SD), including two tumor regressions; and
80% (4 of 5) of those with stable disease were subjects with a lower baseline tumor burden (BTB) of less than 5 centimeters, which also included the two tumor regressions.
In earlier stages of this trial, durable clinical responses occurred after 140 days, and at the date of this latest update, they had lasted for 20 months or more. The amended phase 2 cohort of the DeCidE1 trial focuses on patients with low BTB (less than 5 centimeters). The Corporation is targeting enrollment of at least 16 additional patients at sites in the U.S. and Canada.
IMV will present additional data on DeCidE1 at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.
Phase 2 Study in Combination with KEYTRUDA in Relapsed/Refractory DLBCL (SPiReL)
As of April 5, 2019, investigators had enrolled ten patients in four different clinical sites in Canada. Additional patients are being screened and IMV expects to report updated clinical data at the bi-annual International Conference on Malignant Lymphoma, which will be held in Lugano Switzerland in June 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 5 cohorts of 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 treated in the ovarian, NSCLC and MSI-H cohorts and IMV expects to report preliminary clinical results on several of the solid tumor indications before the end of 2019.
The Corporation expects to reach the following milestones between now and the first half of 2020:
Milestones Key dates
Phase 2 monotherapy clinical results in Ovarian – ASCO (Free ASCO Whitepaper) June 2019
Phase 2 clinical results with Merck Keytruda in DLBCL – ICML June 2019
Preliminary clinical results Basket trial in 5 indications H2 2019
Topline monotherapy clinical results in Ovarian H2 2019
Top line clinical results for Basket trial H1 2020
"We are pleased at the steady progress we’ve made this far in 2019, and look forward to leveraging our technology to improve immunotherapy treatment options, particularly in underserved cancers," continued Mr. Ors. "We are grateful for the continued support of our shareholders and partners and look forward to a very productive remainder of 2019."
Q1 2019 Operational Highlights
Completion of an underwritten public offering: IMV completed, in early March 2019 an underwritten public offering of 5,404,855 common shares at a price to the public of C$5.45 per common share, for aggregate gross of approximately C$29.46 million, before deducting the underwriting commissions and estimated Offering expenses. Wells Fargo Securities and Raymond James acted as joint book-running managers for the Offering. B. Riley FBR acted as co-manager.
The Corporation intends to use the net proceeds of the Offering to accelerate the development of DPX-Survivac in combination with Keytruda as part of the basket trial in select advanced or recurrent solid tumors in bladder, liver (hepatocellular carcinoma), ovarian or non-small-cell lung cancers, as well as tumors shown to be positive for the microsatellite instability high biomarker and for general corporate purposes.
Grant awarded by CQDM to IMV to develop first-in-class dual target T cell therapy: In March, a grant was awarded by CQDM to develop a first-in-class dual target T Cell therapy in bladder cancer based on IMV’s DPX technology to IMV and Centre de Recherche du CHU de Québec-Université Laval.
The work will target immunogenic peptides from the MAGE protein family member A9 (MAGE-A9) as identified by a team from Centre de Recherche du CHU de Québec-Université Laval. This protein is frequently expressed in various human cancers including bladder, lung, and kidney. These peptides will be combined with selected immunogenic peptides from the survivin protein composing the DPX-Survivac T cell drug candidate.
Overview of Q1 2019 Financial Results
The net loss and comprehensive loss of $5,943,000 ($0.13 per share) for the three-month period ended March 31, 2019, was $2,876,000 higher than the net loss and comprehensive loss for three-month period ended March 31, 2018. This relates mainly to a $2,131,000 increase in research and development (R&D) expenses, a $670,000 increase in general and administrative expenses and a $71,000 increase in government assistance in the three-month period ended March 31, 2019.
At March 31, 2019, the Corporation had cash and cash equivalents of $34,207,000 and working capital of $33,893,000, compared with $14,895,000 and $12,247,000, respectively at December 31, 2018. For the three-month period ended March 31, 2019, IMV’s cash burn rate (defined as net loss for adjusted for non-cash transactions including amortization, depreciation, accretion of long-term debt and stock-based compensation) was approximately $5.2 million. Based on the current business plan, the Corporation forecasts the quarterly cash burn rate to be between $5 million and $6 million for 2019.
As of May 9, 2019, the number of issued and outstanding common shares was 50,597,306. A total of 2,030,471 stock options, warrants, and deferred share units were outstanding on May 9, 2019.
The Corporation’s unaudited interim condensed consolidated results of operations, financial condition and cash flows for the three months ended March 31, 2019 and the related management’s discussion and analysis (MD&A) are available on SEDAR at www.sedar.com.