TORONTO and HOUSTON, Nov. 5, 2019 /CNW/ - Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSX: MDNA; OTCQB: MDNAF), a clinical stage immuno-oncology company, today reported financial results for the three and six months ended September 30, 2019. The Company's fiscal Q2 2020 interim financial statements and MD&A will be available on SEDAR.
"This quarter has been an exceptionally productive period for Medicenna as we significantly advance MDNA55 as an innovative treatment paradigm for patients with end-stage recurrent glioblastoma (rGBM). This has been validated by a recent oversubscribed financing providing strong testament by investors that we have widespread market support to build further value with each of our programs," said Dr. Fahar Merchant, President and Chief Executive Officer, Medicenna Therapeutics. "We have the requisite financial resources leading into several key near-term milestones, including additional data from the MDNA55 Phase 2b clinical trial followed by an End of Phase 2 meeting with the US FDA in early 2020 and advancing MDNA19 towards the clinic."
The following are the achievements and highlights for the quarter ending September 30, 2019, through to the date hereof:
- On October 17, 2019, subsequent to the quarter-end, the Company completed a public offering raising total gross proceeds of $6,900,000. The Company issued 5,307,693 units at $1.30, consisting of one common share and one-half common share purchase warrant. Each whole warrant is exercisable at $1.75 until October 17, 2022.
- On September 30, 2019, Medicenna announced the presentation of new pre-clinical data from its IL-2 Superkine program to support the differentiating in vitro and in vivo characteristics of long-acting MDNA109 variants relative to other IL-2 programs.
- On September 26, 2019 Medicenna announced the publication of a peer-reviewed article in the August 2019 edition of Nature Communications providing independent third-party validation of Medicenna's IL-2 Superkine platform, MDNA109.
- On September 25, 2019, Medicenna presented updated efficacy results from the first 33 patients enrolled in the Phase 2b clinical trial (MDNA55-05). MDNA55 is a potent immunotherapy agent as it potently targets the IL-4R which is overexpressed in GBM as well as non-cancerous cells that make up the brain tumor microenvironment ("TME"). The data imply that targeting the TME, particularly in GBM, is critical where almost half of the tumor mass is made up of the TME - a cancer swamp that hides the tumor from the immune system. The TME is emerging as one of the key reasons why glioblastoma is extremely aggressive, and continues to be one of the most difficult cancers to treat. Since MDNA55 can simultaneously kill both the tumor cells and the TME by targeting the IL-4R, the results to date indicate that MDNA55 could emerge as a new treatment for this deadly disease.
- On September 24, 2019, Medicenna announced the appointment of Ms. Karen Dawes to its Board of Directors. Ms. Dawes is an experienced and highly-regarded leader in the life sciences industry with extensive strategic expertise and considerable commercial background.
- On July 31, 2019, Medicenna announced the selection of MDNA19 (formerly, MDNA109-LA1) as its second immuno-oncology clinical candidate for the treatment of cancer. MDNA19 is a best-in-class long-acting IL-2 developed from Medicenna's Superkine platform that has shown unique ability to selectively stimulate cancer killing immune cells without the limitations seen with other long-acting IL-2 programs. Medicenna expects to file an IND for MDNA19 in late 2020.
- On July 9, 2019 Medicenna announced that it had received US$1,915,372 (approximately, CD$2.5M) in non-dilutive funding from CPRIT.
Medicenna had a cash balance of $1,979,727 at September 30, 2019 and on October 17, 2019 completed a public offering raising gross proceeds of $6,900,000. The funds available are sufficient to complete the MDNA55 Phase 2b clinical study and planned End of Phase 2 meeting with the US FDA, continue the development of MDNA19 and finance operations through 2020. In addition, Medicenna has access to another US$1.4 million from the CPRIT grant.
For the three months ended September 30, 2019, Medicenna reported a net loss of $1,904,259 or $0.07 per share compared to a loss of $897,659 or $0.04 per share for the three months ended September 30, 2018. The increase in net loss in the current year period was primarily a result of a lower amount of costs reimbursed under the CPRIT grant in the current year period compared with the prior year period.
The press release, the financial statements and the management's discussion and analysis for the quarter ended September 30, 2019 will be 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, that the current quarter has been exceptionally productive, that MDNA55 has been significantly advanced and that it is an innovative treatment paradigm, that the oversubscribed financing provides strong testament of widespread market support to build further value with each program, that the Company has the requisite financial resources leading in to several key near-term milestones, that the End of Phase 2 meeting with the FDA will occur in early 2020, that Medicenna has access to another US$1.4 million from the CPRIT grant, and statements related to 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 24, 2019 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 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.