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Medicenna Reports Third Quarter Fiscal 2023 Financial Results and Operational Highlights
TORONTO and HOUSTON, Feb. 07, 2023 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. (“Medicenna” or “the Company”) (NASDAQ: MDNA TSX: MDNA), a clinical stage immunotherapy company, today announced its financial results and operational highlights for the quarter ended December 31, 2022, and that the Phase 1/2 ABILITY study of MDNA11 has advanced to a sixth dose escalation cohort. All dollar amounts are in Canadian currency unless otherwise noted. “Encouraged with MDNA11’s tolerability profile in end-stage cancer patients together with its enduring trend demonstrating dose-dependent expansion of lymphocytes, we are pleased to advance the ABILITY study to the sixth dose escalation cohort,” said Dr. Fahar Merchant, President and CEO of Medicenna. “MDNA11 has thus far functioned as intended, by displaying durable tumor control with better tolerability upon repeat dosing, showing dose-dependent increase in exposure without immunogenicity, and boosting anti-cancer immune cell expansion without pro-tumoral immune suppression. With these attributes together with early signs of anti-tumor activity, we hope to bolster MDNA11’s efficacy in a select group of less advanced cancer patients at the optimum dose in ABILITY’s upcoming Phase 2 monotherapy dose expansion cohort.” Program highlights for the quarter ended December 31, 2022, along with recent developments include: MDNA11: IL-2 Superkine Program In November 2022, Medicenna presented safety, pharmacokinetic (PK), and PD data from the first four (low and mid) dose escalation cohorts of the ABILITY study at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting. Safety data indicated that MDNA11 was well tolerated with no dose limiting toxicities observed. PK data showed dose-dependent increases in exposure that were sustained with repeat dosing, suggesting there is no clinically meaningful anti-drug-antibody response to MDNA11. PD data showed dose-dependent stimulation of anti-cancer immunity, with MDNA11 preferentially stimulating the proliferation and expansion of anti-cancer CD8+ T and NK cells but not Tregs (associated with pro-tumor immune pathways) or eosinophils (associated with vascular leak syndrome, a known side effect of the only approved IL-2 therapy). The results presented at the SITC meeting provide mechanistic support for previously reported anti-tumor activity data demonstrating MDNA11’s single-agent potential in advanced solid tumors unresponsive to established treatments. These data show that five of fourteen (36%) evaluable patients in the ABILITY study’s first four dose escalation cohorts achieved tumor control (partial response or stable disease), including one fourth-line metastatic pancreatic cancer patient who achieved a confirmed partial response. In December 2022, previously reported data from the Phase 1/2 ABILITY study of MDNA11 were featured in an oral presentation at the 2022 Immunotherapy Bridge Conference. The presentation, titled “Early Results of an IL-2 Superkine (MDNA11) from the Phase 1/2 ABILITY Study in Advanced Solid Tumors” was delivered by Arash Yavari, M.B.B.S., DPhil., M.R.C.P., Principal Investigator at the Radcliffe Department of Medicine, University of Oxford and Principal Clinical Advisor to Medicenna. Bizaxofusp (formerly MDNA55): Empowered IL-4 Superkine Program Intellectual Property Expected Upcoming Milestones Initial PK/PD data from the ABILITY study’s fifth dose escalation cohort and updated anti-tumor activity data from the first four dose escalation cohorts are expected in calendar Q1 2023. Early anti-tumor activity data from the ABILITY study’s sixth dose escalation cohort and single agent expansion phase (Phase 2) are expected in calendar Q3 2023. Early anti-tumor activity data from the ABILITY study’s combination arm are expected in calendar Q4 2023. Financial Results Medicenna had cash and cash equivalents of $36.2 million at December 31, 2022. These funds are expected to provide the Company with sufficient capital to execute its current planned expenditures through the completion of the ABILITY study and through calendar Q2 2024 based on its current plans and projections. Net loss for the quarter ended December 31, 2022, was $1.1 million, or ($0.02) per share, compared to a net loss of $4.8 million or ($0.09) per share for the quarter ended December 31, 2021. The decrease in net loss for the quarter ended December 31, 2022, compared with the quarter ended December 31, 2021, was primarily a result of a non-cash gain of $3.7 million related to the change in valuation of a non-cash warrant liability associated with the August 2022 financing. Research and development expenses of $2.9 million were incurred during the quarter ended December 31, 2022, compared with $2.9 million incurred in the quarter ended December 31, 2021. Research and development expenses were consistent quarter over quarter. General and administrative expenses of $2.0 million were incurred during the quarter ended December 31, 2022, compared with $2.0 million during the quarter ended December 31, 2021. General and administrative expenses were consistent quarter over quarter. Medicenna’s condensed consolidated interim financial statements for the quarter ended December 31, 2022 and the related management’s discussion and analysis (MD&A) will be available on SEDAR at www.sedar.com and EDGAR at www.sec.gov. Conference Call and Webcast About Medicenna Forward Looking Statements The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date hereof and except as required by law, we do not intend and do not assume any obligation to update or revise publicly any of the included forward-looking statements. Further Information For further information about the Company please contact: Elizabeth Williams, Chief Financial Officer, 416-648-5555, [email protected] Investor Contact For more investor information, please contact: Dan Ferry, Managing Director, LifeSci Advisors, 617-430-7576, [email protected] |