IMV Inc. Announces Strategic Update as well as Fourth Quarter and Full Year 2022 Financial and Operational Results
IMV Inc. reported significant updates on its clinical trials and financial position. The company is advancing MVP-S in two global Phase 2B trials for relapsed/refractory DLBCL and platinum-resistant ovarian cancer. Multiple complete clinical responses were observed in the ongoing VITALIZE study, with enrollment expected to finish by Q2 2023. Additionally, IMV completed a $9M financing and retained Stonegate Healthcare Partners to explore strategic alternatives. Financially, IMV had cash and cash equivalents of $21.2M at the end of 2022, with a net loss of $38M for the year.
- Multiple complete clinical responses in the VITALIZE study for r/r DLBCL.
- Expected completion of MVP-S enrollment in VITALIZE by Q2 2023.
- Successful $9M financing to strengthen the company's financial position.
- Net loss of $38M for the year ended December 31, 2022.
- Decreased working capital from $37.1M in 2021 to $18.2M in 2022.
Advanced lead candidate, MVP-S, in two global Phase 2B clinical trials and enhanced the scientific differentiation of the DPX platform
Observed multiple complete clinical responses in relapsed/refractory DLBCL and expect to complete enrollment of stage one in the VITALIZE study in Q2 2023
Accelerated enrollment of stage one in the AVALON study in ovarian cancer expected in Q3 2023
Strengthened financial position with
“The early Phase 2B clinical data for MVP-S is compelling. To see multiple, confirmed complete responses in such a heavily pre-treated lymphoma population as we have seen in the first group of VITALIZE patients with available scans is very encouraging. Patients need improved treatments for cancer, particularly in the refractory setting,” said
Recent Clinical Highlights
VITALIZE Phase 2B Study in Relapsed/Refractory DLBCL ("r/r DLBCL")
The VITALIZE study is designed to further evaluate the favorable clinical outcomes observed in the now completed SPiReL Phase 2a study of MVP-S in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with r/r DLBCL. In the entire SPiReL study, three complete responses and four partial responses were observed, with 6 of these 7 responses observed in patients with PDL1 biomarker positivity.
In
Alongside this announcement, Dr.
Clinical sites are actively recruiting in
AVALON Phase 2B Trial in Platinum-Resistant Ovarian Cancer.
In the third quarter of 2022, IMV initiated the AVALON trial, a phase 2B, single arm trial evaluating MVP-S and intermittent low-dose cyclophosphamide in subjects with platinum-resistant ovarian cancer.
The AVALON trial is a two-stage trial, where the second stage is expressly designed to be registrational. Based on response rates in the 41 patients of stage one in this trial, the Company expects to enroll a total of 110 patients across stage 1 and 2 to have sufficient data to seek accelerated approval from the FDA. Currently 11 out of the 41 patients have been enrolled and acceleration of enrollment continues as additional sites are being opened across
Expected Upcoming Clinical Milestones
- Q2 2023: Stage 1 enrollment complete for the Phase 2B VITALIZE r/r DLBCL trial (30 patients)
- Q3 2023: Stage 1 enrollment complete for the Phase 2B AVALON platinum-resistant ovarian cancer trial (approximately 40 patients)
- Q3 2023: Preliminary Phase 1 data from the MVP-S and DPX-SurMAGE in non-muscle invasive bladder cancer (NMIBC)
2022 Scientific Highlights
In 2022 the Company further validated that the DPX technology mirrors the way the human immune system coordinates an immune response to cancer by trafficking therapeutic targets directly to the lymph nodes via distinct immune cells. These new data were presented at the AACR and SITC annual meetings.
AACR 2022 Annual Meeting Poster Presentation: NK Cells are Involved in Promoting Anti-tumor Responses to DPX-based Immunotherapy
Consistent with the understood mechanism of action, MVP-S consistently incites a robust and persistent, survivin-specific immune response and promotes T and B cell infiltration into tumor tissues. At the 2022 AACR annual meeting, 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.
SITC 2022 Annual Meeting Poster Presentation: DPX-based Immune Education Recruits and Activates Unique Subsets of Antigens Presenting Cells to Drive Immunogenicity of Peptide Antigens
The unique nature of the lipid-in-oil DPX formulation keeps immune educating cargo at the site of injection, ensuring that uptake of the DPX encapsulated cargo is an active process driven by antigen presenting cells (“APCs”) across time. At the 2022 SITC annual meeting, new data was presented highlighting the subset of APCs DPX engages, these APCs are more mature and functional, further validating the uniqueness and differentiation of DPX versus other platform delivery methods.
2022 Operational Highlights
Completion of
Achieved milestone to access remaining
Restructuring: In
New Management Team: At the start of 2022 IMV named
Enhancements to the Board of Directors:
Share Consolidation: In December, IMV completed a 10 for 1 reverse stock split, supported by an
Overview of Full Year 2022 Financial Results
As of
The net loss and comprehensive loss of
Research and development expenses were
General and administrative expenses were
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 registering at this link prior the call to receive individual dial-in information.
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 laws. 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 this press release, such forward-looking statements include, but are not limited to, statements regarding the potential and efficacy of MVP-S, the success of its strategic review process in pursuing a transaction or that any transaction, if pursued, will be completed on attractive terms, the anticipated upcoming milestones and clinical trial outcomes and results with respect to IMV’s product candidates, the timing of enrollment in certain of IMV’s studies, the potential impact of the VITALIZE and AVALON studies and the anticipated date data from such studies will be available; the Company’s ability to advance its development strategy; the prospects for its lead immunotherapy and its other pipeline of immunotherapy candidates; IMV’s intended use of proceeds from its
|
||||
(In thousands of |
||||
|
|
|
|
|
|
|
Years ended |
||
|
||||
|
|
2022 |
|
2021 |
$ |
|
$ |
||
Revenue |
|
|
|
|
Subcontract revenue |
|
- |
|
- |
Interest Income |
|
329 |
|
188 |
Total revenue |
|
329 |
|
188 |
Expenses |
|
|
|
|
Research and development |
|
23,281 |
|
23,080 |
General and administrative |
|
16,986 |
|
16,020 |
Government assistance |
|
(1,775) |
|
(3,230) |
Accreted interest and valuation adjustments |
|
(172) |
|
907 |
Total operating expenses |
|
38,320 |
|
36,777 |
Net loss |
|
(37,991) |
|
(36,589) |
Currency translation adjustment |
|
- |
|
- |
Total comprehensive loss |
|
(37,991) |
|
(36,589) |
Basic and diluted loss per share |
|
(4.55) |
|
(4.93) |
Weighted-average shares outstanding |
|
8,343,455 |
|
7,419,844 |
|
|
|
|
|
|
|||||
Consolidated Statements of Financial Position |
|||||
(In thousands of |
|||||
|
December 31,
|
|
|
||
Assets |
|
|
|||
Current assets |
|
|
|||
Cash and cash equivalents |
$ |
21,223 |
|
$ |
38,616 |
Accounts receivable |
|
727 |
|
|
602 |
Prepaid expenses |
|
4,440 |
|
|
6,037 |
Investment tax credits receivable |
|
1,198 |
|
|
1,135 |
Total current assets |
|
27,588 |
|
|
46,390 |
Property and equipment |
|
3,760 |
|
|
3,731 |
Total assets |
$ |
31,348 |
|
$ |
50,121 |
Liabilities and Equity |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Accounts payable and accrued liabilities |
$ |
9,037 |
|
$ |
8,607 |
Current portion of long-term debt |
|
47 |
|
|
73 |
Current portion of lease obligations |
|
320 |
|
|
265 |
Warrant liabilities |
|
16 |
|
|
318 |
Total current liabilities |
|
9,420 |
|
|
9,263 |
Lease obligation |
|
1,119 |
|
|
1,387 |
Long-term debt |
|
27,411 |
|
|
17,929 |
Total liabilities |
|
37,950 |
|
|
28,579 |
Equity (Deficiency) |
|
(6,602) |
|
|
21,542 |
Total liabilities and equity |
$ |
31,348 |
|
$ |
50,121 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20230316005317/en/
Investor Relations & Media
Senior Director, Communications and Investor Relations
O: (902) 492.1819 ext: 1049
E: ddavan@imv-inc.com
Source:
FAQ
What is the VITALIZE study for IMV (IMV) about?
When is the enrollment expected to complete for the AVALON trial?
What were the financial results for IMV (IMV) in 2022?
Who is exploring strategic alternatives for IMV (IMV)?