IMV Inc. Announces Fourth Quarter and Full Year 2021 Financial and Operational Results
IMV announced significant developments regarding its clinical trials and financial results. The first patient was dosed in the VITALIZE Phase 2B trial for relapsed/refractory DLBCL, with early data from this trial anticipated in summer 2022. The company reported a cash position of $38.6 million, sufficient to fund operations into Q2 2023, despite increased operational costs of $39 million. Notably, the company aims to register MVP-S based on positive clinical data across multiple cancers. Upcoming milestones include presentations at AACR in April and the initiation of the AVALON ovarian cancer trial.
- First patient dosed in VITALIZE Phase 2B trial for r/r DLBCL.
- Cash runway extended into Q2 2023, with $38.6 million available.
- Positive topline data from the metastatic bladder cohort expected to be presented at AACR.
- Net loss increased to $36.7 million for FY 2021, up $10.5 million from 2020.
- R&D expenses rose to $23 million from $19.9 million, indicating increased operational costs.
- First patient dosed in VITALIZE Phase 2B trial in relapsed/refractory DLBCL
- Metastatic bladder cancer cohort data from Phase 2 basket trial to be presented at late-breaking symposium at AACR
- Phase 2B Avalon trial in advanced ovarian cancer to start in second half 2022
- Cash runway extended into second quarter 2023
“2022 is off to a promising start, following the accomplishments across our pipeline in 2021,” said
“A top priority for the year ahead is to move MVP-S forward on the path toward registration based on the strength of the data observed across several indications to date. In parallel, we continue to look for opportunities to leverage our DPX® delivery platform through business development activities,” continued
Clinical Programs with Maveropepimut-S (MVP-S)
VITALIZE Phase 2B Study in Relapsed/Refractory DLBCL ("r/r DLBCL")
In
IMV aims to further validate the strong therapeutic potential previously seen in PD-L1 positive patients who were administered a combination regimen of pembrolizumab, MVP-S and cyclophosphamide (CPA) in its SPiReL Phase 2 study. Eleven clinical sites are now activated in the US and
Phase 2 Basket Trial in Multiple Advanced Metastatic Solid Tumors
In
Data observed in this cohort of the trial will be presented at a late-breaking oral symposium at the
Presentation Number: CT035
Session Date and Time:
AVALON Phase 2B Trial in Platinum-Resistant Ovarian Cancer.
The Company is preparing to initiate AVALON, 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 evaluate the data observed in our Phase 2 DeCidE trial. The AVALON design was informed by results from the DeCidE study, completed in 2021. Among patients with advanced and recurrent ovarian cancer receiving MVP-S and intermittent, low-dose CPA, nearly half survived to 2 years. Treatment-related adverse events (AEs) were mostly Grade 1 and Grade 2 and tolerable. Translational analyses from DeCidE (presented at the SITC annual meeting and ESMO-IO congress in 2021) implicated roles for both T and B cells in the sustained, anti-tumor immune response induced by MVP-S. Site selection and activation are ongoing, and the first patient is expected to be dosed in H2 2022.
Phase 1B Trial in HR+/HER2- Breast Cancer
In
Clinical Programs 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. Preliminary data are expected by the end of 2022.
Research and Development
IMV hosted a “Research and Development Day” for the investment community via webcast on
Selected Upcoming Milestones
Maveropepimut-S (MVP-S):
-
April 2022 : Present detailed top line data on the bladder cancer cohort from the basket trial at a late-breaking oral presentation at the annual AACR meeting. - Summer 2022: Provide clinical update on the open-label Phase 2B VITALIZE r/r DLBCL trial.
- H2 2022: Initiate enrollment in AVALON open-label Phase 2B Avalon platinum-resistant ovarian cancer trial.
-
December 2022 : Present first clinical and translational results update for the investigator-initiated breast cancer trial. - Q4 2022: Present preliminary Phase 1 data from the MVP-S and DPX-SurMAGE in non-muscle invasive bladder cancer (NMIBC).
Corporate Updates
Andrew Hall Appointed as Chief Executive Officer (CEO)
The company’s Board of Directors appointed
Dr.
Overview of Full Year 2021 Financial Results
As of
Research and development expenses were
General and administrative expenses were
The net loss and comprehensive loss of
On
The Company’s audited annual consolidated results of operations, financial condition and cash flows for the year ended
Conference Call and Webcast Information
Management will hold a conference call and webcast on
Financial analysts are invited to join the conference call by dialing 1-844-461-9932 (
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 IMV 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 is available, the Company’s ability to advance its development strategy, as well as 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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Years ended
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2021 $ |
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2020 $ |
||
Revenue |
|
|
|
|
|
|
|
||
Subcontract revenue |
|
|
|
|
- |
|
|
3 |
|
Interest Income |
|
|
|
|
188 |
|
|
222 |
|
Total revenue |
|
|
|
|
188 |
|
|
225 |
|
Expenses |
|
|
|
|
|
|
|
||
Research and development |
|
|
|
|
23,080 |
|
|
19,904 |
|
General and administrative |
|
|
|
|
16,020 |
|
|
11,344 |
|
Government assistance |
|
|
|
|
(3,230 |
) |
|
(4,991 |
) |
Accreted interest and valuation adjustments |
|
|
|
|
907 |
|
|
27 |
|
Total operating expenses |
|
|
|
|
36,777 |
|
|
26,284 |
|
Net loss |
|
|
|
|
(36,589 |
) |
|
(26,059 |
) |
Currency translation adjustment |
|
|
|
|
- |
|
|
2,660 |
|
Total comprehensive loss |
|
|
|
|
(36,589 |
) |
|
23,399 |
|
Basic and diluted loss per share |
|
|
|
|
(0.49 |
) |
|
(0.39 |
) |
Weighted-average shares outstanding |
|
|
|
|
74,198,439 |
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|
60,305,264 |
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Consolidated Statements of Financial Position |
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(In thousands of |
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Assets |
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||||
Current assets |
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|
|
|
||||
Cash and cash equivalents |
$ |
38,616 |
|
$ |
36,268 |
|||
Accounts receivable |
|
602 |
|
|
1,574 |
|||
Prepaid expenses |
|
6,037 |
|
|
4,416 |
|||
Investment tax credits receivable |
|
1,135 |
|
|
1,519 |
|||
Total current assets |
|
46,390 |
|
|
43,777 |
|||
Property and equipment |
|
3,731 |
|
|
2,221 |
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Total assets |
$ |
50,121 |
|
$ |
45,998 |
|||
Liabilities and Equity |
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|
|
|
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|||
Current liabilities |
|
|
|
|
|
|||
Accounts payable and accrued liabilities |
$ |
8,607 |
|
$ |
7,228 |
|||
Current portion of long-term debt |
|
73 |
|
|
856 |
|||
Current portion of lease obligations |
|
265 |
|
|
109 |
|||
Warrant liabilities |
|
318 |
|
|
- |
|||
Total current liabilities |
|
9,263 |
|
|
8,193 |
|||
Lease obligation |
|
1,387 |
|
|
953 |
|||
Long-term debt |
|
17,929 |
|
|
6,050 |
|||
Total liabilities |
|
28,579 |
|
|
15,196 |
|||
Equity |
|
21,542 |
|
|
30,802 |
|||
Total liabilities and equity |
$ |
50,121 |
|
$ |
45,998 |
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View source version on businesswire.com: https://www.businesswire.com/news/home/20220317005270/en/
Investor Relations
O: (902)492.1819
E: jbessenger@imv-inc.com
O: (902) 492-1819 ext: 1042
M: (514) 617-9481 E: mjasmin@imv-inc.com
O: (646) 970-4681
M: (917) 734-7387
E: ikoffler@lifesciadvisors.com
Media
M: (514) 968 1046
E: ddavan@imv-inc.com
M: (603) 479 5267
E: mjoanis@lifescicomms.com
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FAQ
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