IMV Inc. Announces First Quarter 2022 Financial and Operational Results
IMV Inc. (Nasdaq: IMV) announced positive clinical results for MVP-S in bladder cancer at the AACR annual meeting, showing 2 confirmed complete responses and 3 partial responses among patients previously treated with checkpoint inhibitors. The treatment was well-tolerated, with mostly mild reactions and no severe adverse events. Financial results for Q1 2022 revealed cash of $28.7 million and a net loss of $10.5 million. The company is progressing with its clinical trials and expanding its pipeline, with key milestones expected in 2022 and 2023.
- Positive clinical results for MVP-S in bladder cancer with 5 responses in 17 patients.
- MVP-S combined with pembrolizumab was well tolerated; no severe adverse events reported.
- Michael P. Bailey appointed as Chairman of the Board, bringing 30 years of industry experience.
- Net loss increased to $10.5 million for Q1 2022, up from $7 million in Q1 2021.
- Cash reserves decreased from $38.6 million at year-end 2021 to $28.7 million at Q1 2022.
Positive clinical results in bladder cancer were presented at the AACR annual meeting, including
- 2 confirmed complete responses (CRs) and 3 partial responses (PRs) per RECIST v1.1;
- CRs and PRs were observed in patients previously treated with checkpoint inhibitors;
- Treatment with MVP-S/CPA and pembrolizumab was well-tolerated with mostly grade 1-2 injection site reactions, and no severe adverse events attributed to MVP-S;
New data were presented about DPX-based therapies’ mechanism of action.
- Results from preclinical and clinical studies demonstrate that Natural Killer (NK) cells are also involved in the anti-cancer efficacy of DPX-based therapy.
“A top priority for 2022 is to accelerate MVP-S towards registration trials. The positive clinical data we presented on MVP-S in combination with pembrolizumab in bladder cancer patients at the recent AACR annual meeting support IMV’s prior results in solid and hematologic cancer,” said
Clinical Programs with Maveropepimut-S (MVP-S)
VITALIZE Phase 2B Study in Relapsed/Refractory DLBCL ("r/r DLBCL")
In
AVALON Phase 2B Study in Platinum-Resistant Ovarian Cancer
The Company is preparing to initiate AVALON, a Phase 2B, single arm trial evaluating MVP-S and intermittent low-dose CPA in subjects with platinum-resistant ovarian cancer. The goal of this trial is to further validate the encouraging data observed in our Phase 2 DeCidE trial, which was completed in 2021. The design of the study has been approved by the FDA and
Positive Clinical Results in Bladder Cancer Presented at AACR Annual Meeting
Safety and preliminary efficacy data on a combination of MVP-S with pembrolizumab from the Phase 2 basket study of patients with advanced, metastatic bladder cancer were presented at the
Key findings in this cohort included:
- Treatment with MVP-S/CPA and pembrolizumab was well-tolerated with mostly grade 1-2 injection site reactions, and no severe adverse events attributed to MVP-S;
- Of the 17 treated patients, 5 showed response: 2 confirmed CRs and 3 PRs per RECIST v1.1;
- Complete and partial responses were observed in patients previously treated with checkpoint inhibitors;
- Clinical response was most evident in patients with survivin-specific T cells; and
- One patient is still on treatment after 18 months and remains a complete responder
KOL discussions are ongoing to map out the clinical opportunities for MVP-S in bladder cancer.
Clinical Program with IMV’s Second DPX-based Product Candidate, DPX-SurMAGE
IMV initiated a Phase 1 clinical trial evaluating both MVP-S and DPX-SurMAGE, in patients with non-muscle invasive bladder cancer (NMIBC) in early 2022. The first patient was dosed early
Foundational Science
AACR 2022 Annual Meeting Presentation: NK Cells are involved in Promoting Anti-tumor Responses to DPX-based Immunotherapy
It has been previously shown in clinical trials that MVP-S consistently incites a robust and persistent, survivin-specific immune response and promotes T and B cell infiltration into tumor tissues. At AACR, new data were presented providing the first evidence from preclinical and clinical studies that Natural Killer (NK) cells are also involved in the anti-cancer efficacy of DPX-based therapy.
Corporate Update
Selected Upcoming Milestones
Maveropepimut-S (MVP-S):
- Q3 2022: Early data look for the open label VITALIZE Phase 2 DLBCL trial
- Q3 2022: Initiate enrollment in AVALON Phase 2b trial in platinum-resistant ovarian cancer
- Q4 2022: Early data look for the investigator-initiated breast cancer trial
- H1 2023: Early data look from the AVALON trial in platinum resistant ovarian cancer
DPX-SurMAGE:
-
Q4 2022: Early data look from Phase 1 Non-muscle invasive bladder cancer study in
Canada
OVERVIEW OF FIRST QUARTER 2022 FINANCIAL RESULTS
All dollar amounts noted herein are denominated in
As of
Research and development expenses were
General and administrative expenses were
The net loss and comprehensive loss of
As of
The Company’s unaudited interim condensed consolidated results of operations, financial condition and cash flows for the quarter ended
Conference Call and Webcast Information
Management will host a conference call and webcast today
Other interested parties will be able to access the live audio webcast at this link: https://ir.imv-inc.com/events-and-presentations. The webcast will be recorded and will then be available on the Company’s website for 30 days following the call.
About IMV
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 use such word as “will”, “may”, “potential”, “believe”, “expect”, “continue”, “anticipate” and other similar terminology. 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 potential impact of the VITALIZE study and the anticipated date data from such study and from other ongoing studies of the Company are available, the Company’s ability to advance its development strategy, the potential to expand the Company’s pipeline through business development, the expected dosing timeline for the AVALON Phase 2B trial, the expected timing for data to be available from the Phase I clinical trial evaluating MVP-S and DPX-SurMAGE, the sufficiency of the Company’s cash position, the upcoming milestones discussed in this release, and the prospects for its lead immunotherapy and its other pipeline of immunotherapy candidates. 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 Company, including access to capital, the successful design and completion of clinical trials and the timely receipt of all regulatory approvals to commence, and then continue, clinical studies and trials and the receipt of all regulatory approvals to commercialize its products.
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Consolidated Statements of Loss and Comprehensive Loss |
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(In thousands of |
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|
|
|
|
|
|
|
|
Three Months ended,
|
|||||
|
2022 $ |
|
2021 $ |
|||
Revenue |
|
|
|
|||
Interest Income |
24 |
|
69 |
|||
Total revenue |
24 |
|
69 |
|||
Expenses |
|
|
|
|||
Research and development |
6,631 |
|
4,744 |
|||
General and administrative |
3,990 |
|
3,161 |
|||
Government assistance |
(378) |
|
(1,234) |
|||
Accreted interest and valuation adjustments |
304 |
|
355 |
|||
Total operating expenses |
10,547 |
|
7,026 |
|||
Net loss and comprehensive loss |
(10,523) |
|
(6,957) |
|||
Basic and diluted loss per share |
(0.13) |
|
(0.10) |
|||
Weighted-average shares outstanding |
82,208,052 |
|
67,475,149 |
|
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Consolidated Statements of Financial Position |
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(In thousands of |
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Assets |
|
|
|
|
|
|||||
Current assets |
|
|
|
|
|
|||||
Cash and cash equivalents |
$ |
28,689 |
|
$ |
38,616 |
|||||
Accounts receivable |
|
921 |
|
|
602 |
|||||
Prepaid expenses |
|
5,524 |
|
|
6,037 |
|||||
Investment tax credits receivable |
|
1,527 |
|
|
1,135 |
|||||
Total current assets |
|
36,661 |
|
|
46,390 |
|||||
Property and equipment |
|
4,172 |
|
|
3,731 |
|||||
Total assets |
$ |
40,833 |
|
$ |
50,121 |
|||||
Liabilities and Equity |
|
|
|
|
|
|||||
Current liabilities |
|
|
|
|
|
|||||
Accounts payable, accrued and other liabilities |
$ |
8,815 |
|
$ |
8,607 |
|||||
Current portion of long-term debt |
|
75 |
|
|
73 |
|||||
Current portion of lease obligations |
|
277 |
|
|
265 |
|||||
Warrant liabilities |
|
363 |
|
|
318 |
|||||
Total current liabilities |
|
9,530 |
|
|
9,263 |
|||||
Lease obligation |
|
1,335 |
|
|
1,387 |
|||||
Long-term debt |
|
18,269 |
|
|
17,929 |
|||||
Total liabilities |
|
29,314 |
|
|
28,579 |
|||||
Equity |
|
11,699 |
|
|
21,542 |
|||||
Total liabilities and equity |
$ |
40,833 |
|
$ |
50,121 |
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Investor Relations
O: (902) 492.1819 ext: 2009
E: jbessenger@imv-inc.com
O: (646) 970-4681
M: (917) 734-7387
E: ikoffler@lifesciadvisors.com
Media
O: (902) 492.1819 ext: 1049
E: ddavan@imv-inc.com
M: (603) 479 5267
E: mjoanis@lifescicomms.com
Source:
FAQ
What were the clinical results for MVP-S reported by IMV at the AACR annual meeting?
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Who was appointed Chairman of the Board at IMV and when?