TORONTO and HOUSTON, Feb. 13, 2020 /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 nine months ended December 31, 2019. The Company's fiscal Q3 2020 interim financial statements and MD&A will be available on SEDAR.

"We have achieved a number of exciting and important milestones this quarter, both in the ongoing development of MDNA55 and MDNA19 and in further strengthening our financial position as we swiftly advance towards the important End of Phase 2 meeting with the FDA this spring," said Dr. Fahar Merchant, President and CEO, Medicenna Therapeutics. "We've documented exceptional survival advantage rates with MDNA55 in patients with the most difficult to treat form of brain cancer when compared to today's commonly used treatments, and will have key non-human primate data for MDNA19 this quarter as we accelerate development of our second important asset. Recent acquisitions in the space are further evidence that Medicenna is ideally positioned in a market that is growing in both opportunity and value, as major pharmaceutical companies recognize the necessity of novel IL2 assets like MDNA19 to support their cancer portfolio."

The following are the achievements and highlights for the quarter ending December 31, 2019, through to the date hereof:

  • On January 13, 2020, Medicenna announced results from a retrospective study of subjects with recurrent glioblastoma ("rGBM") receiving standard therapies who matched eligibility requirements of subjects enrolled in the MDNA55-05 clinical trial (Synthetic Control Arm, or SCA), and compared their survival versus subjects treated with MDNA55 in the Phase 2b rGBM clinical trial. The SCA comprised of 81 rGBM patients receiving standard therapies, including Avastin, Lomustine and Temozolomide, with similar baseline features as patients treated in the MDNA55 trial (including age, tumor size, ineligibility for surgery, lack of IDH mutations, IL4R expression and other parameters known to affect survival). A 150% survival advantage was seen in patients who received MDNA55, when comparing IL4R High groups across the two populations.
  • On January 8, 2020, Medicenna announced receipt of $1.3 million in proceeds from the exercise of previously issued warrants. Of this amount, $985,443 was received as of December 31, 2019.
  • On December 12, 2019, Medicenna President and CEO Dr. Fahar Merchant presented subgroup analysis data from the first 40 patients treated with MDNA55 in a Phase 2b clinical trial for patients with rGBM at the Inaugural Glioblastoma Drug Development Annual Summit.
  • On November 25, 2019, Medicenna announced the presentation of updated clinical results from its Phase 2b trial of MDNA55 at the 24th Society for Neuro-Oncology ("SNO") annual meeting. The presentation was delivered by Dr. John Sampson and discussed updated efficacy results from the Phase 2b clinical trial of MDNA55 in rGBM patients using the IL4R as an immunotherapy target.
  • On November 21, 2019, Medicenna announced positive new results on drug distribution from the completed Phase 2b clinical trial of MDNA55. The results showed that implementing new advances in Convection Enhanced Delivery ("CED") allows the drug to bypass the blood-brain barrier and deliver high concentrations of MDNA55 directly to the tumor and the at-risk area immediately surrounding it, without exposure to the rest of the body. This approach, along with the ability to continuously monitor distribution using real-time imaging allows Medicenna to dramatically improve drug delivery and maximize tumor coverage.
  • On October 17, 2019, Medicenna completed an oversubscribed 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.

Financial Results

Medicenna had a cash balance of $6,974,004 at December 31, 2019 and subsequent to the quarter end has received $856,100 in proceeds from warrant exercises. 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 December 31, 2019, Medicenna reported a net loss of $2,389,463 or $0.07 per share compared to a loss of $1,723,081 or $0.07 per share for the three months ended December 31, 2018.  The increase in net loss in the current year period was primarily a result of a lower amount of costs reimbursed under the CPRIT grant in the current year period ($nil) compared with the prior year period ($1,033,072).

The press release, the financial statements and the management's discussion and analysis for the quarter ended December 31, 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 we have achieved a number of exciting and important milestones this quarter, that the End of Phase 2 meeting with the FDA will be this spring, that we will have key primate data for MDNA19 this quarter that recent acquisitions in the space are further evidence that Medicenna is ideally positioned in a market that is growing in both opportunity and value, that major pharmaceutical companies recognize the necessity of novel IL2 assets like MDNA19 to support their cancer portfolio, 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.

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