On January 8, 2023 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, reported its planned 2023 milestones to advance the clinical development of its lead therapeutic, maveropepimut-S (MVP-S) (Press release, IMV, JAN 8, 2023, View Source [SID1234626005]).
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"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 (Free SITC Whitepaper))
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."