Presenting details on initial response data
from the ongoing VITALIZE DLBCL trial at the Immuno-Oncology 360°
conference on February 10, 2023
Expects preliminary clinical response data from
the AVALON Phase 2b trial in H2 2023
Recently strengthened financial position with
the completion of a $9M financing
Appoints Shabnam Kazmi to its Board of
Directors following the retirement of Julia P. Gregory
IMV Inc. (Nasdaq: IMV; TSX: IMV) (“IMV” or the “Company”), a
clinical-stage biopharmaceutical company developing a portfolio of
immune-educating therapies based on its novel DPX® platform to
treat solid and hematologic cancers, today outlined its planned
2023 milestones to advance the clinical development of its lead
therapeutic, maveropepimut-S (MVP-S).
“We made significant changes at IMV in 2022 to build the proper
foundation for success in 2023. In 2022, we restructured the
organization, enhanced the balance sheet, and clarified the
registration pathway for MVP-S in Ovarian Cancer and DLBCL.” said
Andrew Hall, Chief Executive Officer of IMV. “We also validated and
differentiated the DPX platform as a viable mechanism to enhance
the delivery of therapeutic cancer vaccines.”
On December 15, 2022, the Company announced positive initial
data from the VITALIZE Phase 2B trial evaluating our lead DPX
product, MVP-S, in combination with pembrolizumab in patients with
relapsed, refractory Diffuse Large B Cell Lymphoma (r/r DLBCL).
Complete responses were observed in patients who received at least
three previous lines of treatment, including CAR-T's.
Business Updates and Selected 2023 Milestones
VITALIZE Phase 2B study in patients with r/r DLBCL
- Present details on initial clinical response data at the
Immuno-Oncology 360° conference on February 10, 2023 in New York
City
- Expect to complete enrollment of stage 1 for VITALIZE in H1
2023
AVALON Phase 2B study in patients with platinum-resistant
ovarian cancer
- Expect to complete enrollment of stage 1 (up to 41 patients) by
the end of Q3 2023
- Preliminary clinical response data expected in H2 2023
Foundational Science
- Present translational data from ongoing investigator-led Phase
1 studies evaluating MVP-S as a neoadjuvant in HR+/HER2- breast and
non-muscle invasive bladder cancers
- Present additional mechanism data for the DPX immune delivery
platform at major scientific conferences throughout 2023 (AACR,
SITC)
Preliminary 2022 Financial Results
On December 20, 2022, IMV announced the closing of a registered
direct offering of 3,448,276 common shares (or common share
equivalents) and warrants to purchase up to 3,448,276 common shares
(the “Warrants”) at a price of $2.61, for aggregate gross proceeds
to the Company of approximately $9 million (estimated net proceeds
are $8 million). The accompanying warrants have an exercise price
of $2.50 per share, are exercisable immediately and expire on
December 20, 2027. If the warrants are fully exercised, it would
provide$8.6 million of additional gross proceeds to IMV. Including
the proceeds of this offering and based on preliminary unaudited
financial information, cash and cash equivalents were $21.1 million
of as of December 31, 2022. Based on its current operating plans,
IMV expects its current cash position will be sufficient to fund
operations into the second half of 2023.
Preliminary selected financial information presented in this
release are unaudited, subject to adjustments, and provided as an
approximation in advance of the Company's announcement of its
audited annual financial results expected in March 2023.
Appointment of Shabnam Kazmi to the Board of
Directors
Ms. Kazmi is an experienced CEO and Founder with over 30 years
experience in top-tier global biopharma companies such as
Bristol-Myers Squibb, Sanofi and Otsuka America Pharmaceuticals.
She has deep expertise in oncology, having launched and managed
multiple top tier products across both solid tumors and hematology.
She currently serves as the CEO of Asellus Ventures, a healthcare
advisory and investment firm. She has led multiple global joint
ventures and successfully managed large complex projects across 75
countries with a focus on managing risk and creating asset
value.
Ms. Kazmi has consistently achieved outstanding financial
results and growth in value for shareholders by managing $1B+
P&Ls, developing innovative strategies, M&A, building
highly talented teams, raising capital, and successfully launching
and commercializing oncology products for the treatment of both
solid tumors and hematology. Her passion for patients and over 20
years of board service has led to multiple awards from cancer
patient groups, and she currently serves as a Board Member of the
Prevent Cancer Foundation.
Ms. Kazmi has a Bachelor’s degree in Economics and Biochemistry
from Smith College and an MBA from Harvard Business School.
Ms. Kazmi’s appointment follows the decision of Ms. Julia P.
Gregory who has served on IMV's Board of Directors since June 2018,
to retire from the Board of Directors. Michael Bailey, Board
Chairman of IMV, commented: “We are exceptionally grateful for
Julia’s service and her significant contributions to IMV over many
years. On behalf of my fellow Board members and IMV’s management
team, I would like to thank Julia for her passion and dedicated
service to the Company.”
About IMV
IMV Inc. is a clinical-stage immuno-oncology company advancing a
portfolio of therapies based on the Company’s immune-educating
platform, DPX®. Through a differentiated mechanism of action, the
DPX platform delivers instruction to the immune system to generate
a specific, robust, and persistent immune response. IMV’s lead
candidate, maveropepimut-S (MVP-S), delivers antigenic peptides
from survivin, a well-recognized cancer antigen commonly
overexpressed in advanced cancers. MVP-S also delivers an innate
immune activator and a universal CD4 T cell helper peptide. These
elements foster maturation of antigen presenting cells as well as
robust activation of CD8 T cell effector and memory function. MVP-S
treatment has been well tolerated and has demonstrated defined
clinical benefit in multiple cancer indications as well as the
activation of a targeted and sustained, survivin-specific
anti-tumor immune response. MVP-S is currently being evaluated in
clinical trials for hematologic and solid cancers, including
Diffuse Large B Cell Lymphoma (DLBCL) as well as ovarian, bladder
and breast cancers. IMV is also developing a second immunotherapy
leveraging the DPX immune delivery platform, DPX-SurMAGE. This
dual-targeted immunotherapy combines antigenic peptides for both
the survivin and MAGE-A9 cancer proteins to elicit immune responses
to these two distinct cancer antigens simultaneously. A Phase 1
clinical trial in bladder cancer, using MVP-S or DPX-SurMAGE, was
initiated in early 2022. For more information, visit
www.imv-inc.com and connect with us on Twitter and LinkedIn.
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 this press
release, such forward-looking statements include, but are not
limited to, statements regarding the potential impact of the
VITALIZE and AVALON studies and the anticipated dates preliminary
and/or detailed results from these Phase 2B trials will be
completed, available and presented; the anticipated dates for the
enrollment in each such study; the possibility that warrants from
the recent financing may be exercised by the holders of such
securities at some point in the future; the anticipated period
through which operations can be sustained with the current cash
available to the Company the Company’s ability to advance its
development strategy, and the prospects for its lead immunotherapy
and its other pipeline of immunotherapy candidates. IMV Inc.
assumes no responsibility to update forward-looking statements in
this press release except as required by law. These forward-looking
statements involve known and unknown risks and uncertainties, and
those risks and uncertainties include, but are not limited to,
those related to the Company’s priorities with MVP-S and its DPX
delivery platform, the potential for its delivery platform and the
anticipated timing of enrollment and results for its clinical trial
programs and studies as other risks detailed from time to time in
our ongoing quarterly filings and annual information form.
Investors are cautioned not to rely on these forward-looking
statements and are encouraged to read IMV’s continuous disclosure
documents, including its current annual information form, as well
as its audited annual consolidated financial statements which are
available on SEDAR at www.sedar.com and on EDGAR at
www.sec.gov/edgar.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230108005029/en/
Investor Relations & Media Delphine Davan
Senior Director, Communications and Investor Relations
IMV Inc.
O: (902) 492.1819 ext: 1049 E: ddavan@imv-inc.com
IMV (NASDAQ:IMV)
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