TORONTO and HOUSTON, TX, June 25, 2019 /CNW/ - Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSX: MDNA, OTCQB: MDNAF), a clinical stage immunotherapy company, today announced its operational and financial results for the year ended March 31, 2019.
"Fiscal 2019 has been a banner year for Medicenna as we continue our strong clinical advancement for both MDNA55 and our Superkine platform. From unmatched disease control and median overall survival rates for MDNA55 to positive early data for MDNA109 and its long acting variants, it is clear that our pipeline is the strongest it has ever been," said Dr. Fahar Merchant, Chairman, President and Chief Executive Officer, Medicenna Therapeutics. "Additionally, we look forward to further value inflection milestones for the balance of this calendar year for both MDNA55 and MDNA109. "
Program updates for the year ended March 31, 2019, along with recent developments, include:
- On June 18, 2019, Dr. Fahar Merchant presented results from the Phase 2b MDNA55 clinical trial at the Inaugural Immuno-Oncology Pharma Congress in Boston, MA. The presentation highlighted a disease control rate of up to 83% overall achieved from the largest tumor size post treatment (nadir). In addition, safety data from the Phase 2b clinical trial show a similar safety profile to previous MDNA55 trials, with no systemic toxicities, no clinically significant laboratory abnormalities and no drug-related deaths.
- On April 30, 2019, Medicenna announced completion of enrolment (N=46) in the MDNA55 Phase 2b clinical study for the treatment of rGBM.
- On February 7, 2019, Dr. John H. Sampson, MD, PhD, (Robert H. and Gloria Wilkins Distinguished Professor and Chair of Neurosurgery at Duke University in Durham, NC) presented new clinical study results on MDNA55. Dr. Sampson outlined that following a single treatment with MDNA55 at the low dose, (a) the IL4R positive group showed a meaningful increase in median overall survival ("mOS") of 15.2 months when compared to 8.5 months in the IL4R negative group, (b) survival rates at 6, 9, and 12 months were 100%, 67% and 55% in the IL4R positive group versus 73%, 40%, and 30%, in the IL4R negative group, (c) irrespective of IL4R expression, mOS was 11.8 months in all patients with an overall survival rate of 89% at 6 months, 59% at 9 months and 46% at 12 months, exceeding landmark mOS and survival rates reported for approved drugs for rGBM.
- On October 22, 2018, the Company presented results and participated in a poster discussion session at the European Society for Medical Oncology congress held in Munich. Based on interim data from patients treated at low doses implemented during the first half of the Phase 2b study of MDNA55, the presentation highlighted the benefits of using of advanced imaging modalities in order to help tumor response evaluation and identify pseudo-progression in some patients which ultimately translates into tumor shrinkage, and potential treatment benefit.
- On November 16, 2018, Medicenna presented an update on intratumoral delivery of MDNA55 using MRI-guided convective delivery at the 23rd Annual Meeting of the Society for Neuro-Oncology.
- On June 20, 2019, Medicenna presented a poster entitled "Engineering a long-acting CD122 biased IL-2 superkine displaying potent anti-tumoral responses". Highlights from the presentation by Dr. Moutih Rafei, PhD, (Associate Professor, Department of Pharmacology and Physiology, Université de Montreal) included that MDNA109-LA demonstrated durable tumor control with strong memory response, blunted treg activity but potent activation of naïve CD8 T cells, absence of CD25 binding and potent effects with minimal dosing.
- On February 6, 2019, Dr. Moutih Rafei, presented new results on MDNA109 and its long acting variants. The presentation outlined that MDNA109 (a) is an engineered IL-2 Superkine exhibiting 1000-fold enhanced affinity toward the CD122 receptor, (b) has best-in-class potency toward cancer killing effector T cells, (c) was not immunogenic in-vivo and (d) potently synergized with anti-PD-1 or anti-CTLA-4 checkpoint inhibitors to eliminate tumors in the majority of tumor-bearing mice.
- On November 9, 2018, Medicenna presented an update on preliminary pre-clinical results on MDNA109 at the 33rd Annual Meeting of the Society for Immunotherapy of Cancer ("SITC") held in Washington, DC.
- On August 28, 2018, Medicenna presented preliminary pre-clinical results on MDNA109 at the Sixth Annual Immuno-Oncology Summit held in Boston, MA. The poster presentation highlighted data comparing efficacy and pharmacokinetics of MDNA109 and long-acting variants of MDNA109 in mouse models.
- On December 21, 2018, the Company completed a public offering and issued 4,000,000 units for gross proceeds of $4,000,000.
- On May 1, 2019, December 5, 2018 and August 10, 2018, Medicenna received amounts of US$757,940, US$1.2 million and US$1.2 million, respectively, from CPRIT for reimbursement of past expenses.
- Subsequent to fiscal year-end, $269,586 has been raised through the exercise of warrants.
Annual Financial Results
Net loss for the year ended March 31, 2019 was $4,708,031 or $0.18 per share compared to a loss of $7,465,452 or $0.31 per share for the year ended March 31, 2018. The decrease in net loss in the year ended March 31, 2019 compared with the year ended March 31, 2018 was primarily a result of lower general and administrative expenses due to reduced stock based compensation expenses, lower professional fees and listing costs associated with the TSX graduation and OTC listing in the prior year as well as lower travel, and salary costs resulting from overall cost containment. In addition, research and development expenses were reduced in the current year due to lower consulting and CRO costs related to the MDNA55 Phase 2b clinical trial for which recruitment completed shortly after year end as well as lower discovery costs associated with work completed in the prior year and reduced salary and travel costs resulting from cost containment measures.
Medicenna had cash and cash receivable of $4,815,261 at March 31, 2019. Subsequent to the fiscal year-end, $269,586 was raised through the exercise of warrants. In addition, the Company has funds available of US$2.3 million remaining on the grant from the Cancer Prevention and Research Institute of Texas. The funds available are sufficient to complete the MDNA55 Phase 2b clinical study and planned End of Phase 2 meeting with the US FDA.
Research and development ("R&D") expenses of $3,017,997 were incurred during the year ended March 31, 2019, compared with $5,090,146 incurred in the year ended March 31, 2018. The decrease in the expenses in the year ended March 31, 2019 can be primarily attributed to: lower regulatory costs due to the timing of expenditures and the protocol amendments incurred in the prior year, reduced discovery and pre-clinical expenses due to work ongoing and completed in the prior year related to the development of MDNA57, lower clinical trial costs due to reduced consulting costs, clinical supplies and CRO fees due to nearing the end of the clinical study, reduced salaries and benefits due to lower headcount and overall cost containment measures, lower stock based compensation expense due to the timing of option grants in the current year and a reduction in travel and employee recruitment expenses. These reductions were offset by higher chemistry, manufacturing and controls costs related to MDNA109 program development and higher licensing fees, patent costs, royalties and consulting expenses associated with pipeline review and program prioritization. Expenses incurred that were eligible for reimbursement from the CPRIT grant totaled $5,140,039 in the year ended March 31, 2019 compared with $5,016,479 in the year ended March 31, 2018.
General and administrative expenses of $1,709,286 were incurred during the year ended March 31, 2019, compared with $2,334,684 during the year ended March 31, 2018. The decrease in G&A expenses year over year is attributed primarily to lower stock based compensation costs due to timing of grants as well as a lower value of option grants in the current year, reduced legal, professional and finance expenses in the current year periods due to expenses related to the graduation from the TSXV to TSX as well as the OTC listing incurred in the prior year periods, lower salary and benefit costs due to headcount reductions and reduced travel costs. Expenses incurred that were eligible for reimbursement from the CPRIT grant totaled $506,188 in the year ended March 31, 2019 compared with $671,640 in the year ended March 31, 2018.
Medicenna's audited annual consolidated financial statements for the year ended March 31, 2019 and the related management's discussion and analysis (MD&A) are available on SEDAR at www.sedar.com
About Medicenna Therapeutics Corp.
Medicenna is a clinical stage immunotherapy company focused on oncology and the development and commercialization of novel, highly selective versions of IL-2, IL-4 and IL-13 Superkines and first in class Empowered Cytokines™ (ECs) for the treatment of a broad range of cancers. Supported by a US$14.1M non-dilutive grant from CPRIT (Cancer Prevention and Research Institute of Texas), Medicenna's lead IL4-EC, MDNA55, has completed enrolling patients in a Phase 2b clinical trial for rGBM, the most common and uniformly fatal form of brain cancer, at top-ranked brain cancer centres in the US. MDNA55 has been studied in five clinical trials involving 132 patients, including 112 adults with rGBM. MDNA55 has demonstrated compelling efficacy and has obtained Fast-Track and Orphan Drug status from the FDA and FDA/EMA respectively.
For more information, please visit www.medicenna.com.
This news release contains forward-looking statements relating to the future operations of the Company and other statements that are not historical facts. Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects" and similar expressions. All statements other than statements of historical fact, included in this release, including, without limitation, statements related to the recently completed Phase 2b clinical trial of MDNA55 for the treatment of rGBM including, without limitation, that MDNA55 has unmatched disease control and median overall survival rates, that the early data for MDNA109 and its long acting variants is positive, that our pipeline is the strongest it has ever been, that we will achieve value inflection milestones in the balance of this calendar year for both MDNA55 and MDNA109 and the future plans and objectives of the Company, are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company's expectations include the risks detailed in the annual information form of the Company dated June 26, 2018 and in other filings made by the Company with the applicable securities regulators from time to time.
The reader is cautioned that assumptions used in the preparation of any forward-looking information (including, without limitation, the ability of the Company to fully replicate these interim data results) 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 at the time of preparation, 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 of this news release and the Company will update or revise publicly any of the included forward-looking statements only as expressly required by Canadian securities law.
SOURCE Medicenna Therapeutics Corp.