SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of May 2021
Commission File Number: 001-39458
Medicenna Therapeutics Corp.
(Translation of registrant's name into English)
2 Bloor St. W., 7th Floor
Toronto, Ontario M4W 3E2, Canada
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ ] Form 40-F [ X ]
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): [ ]
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): [ ]
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|Medicenna Therapeutics Corp.|
|Date: May 28, 2021||By:||/s/ Elizabeth Williams|
|Name: Elizabeth Williams|
|Title: Chief Financial Officer|
|99.1||Press Release dated May 28, 2021|
Medicenna Reports Fiscal Year 2021 Financial Results and Operational Highlights
-- Management hosting conference call and webcast today at 8:30 AM ET
TORONTO and HOUSTON, May 28, 2021 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. (“Medicenna” or “the Company”) (NASDAQ: MDNA TSX: MDNA), a clinical stage immuno-oncology company, today announced its financial results and operational highlights for the fiscal year ended March 31, 2021. All dollar amounts are expressed in Canadian currency unless otherwise noted.
“The strong momentum we have generated over the past year leaves us poised to achieve key milestones that will lay a solid foundation for expansion of our clinical-stage pipeline,” said Fahar Merchant, PhD, President and CEO of Medicenna. “We have recently added significant talent, expertise, and depth to our management team through the appointments of industry veterans and immuno-oncology experts Kevin Moulder, PhD and Mann Muhsin, MD as our CSO and CMO, respectively. Our ability to recruit such ideal candidates to these positions was due in large part to our innovative preclinical assets and robust clinical data set demonstrating the best-in-class potential of our Superkine platform.” Dr. Merchant continued, “Looking ahead, we will work towards the advancement of MDNA11 into the clinic in calendar Q3 and the selection of a lead candidate from our BiSKITs program by the end of calendar 2021. We are excited for the fiscal year ahead and believe we are well positioned for sustained growth with multiple upcoming catalysts with cash runway into late 2022.”
Program highlights for the year ended March 31, 2021, along with recent developments include:
MDNA11: IL-2 Superkine Program
MDNA55: Recurrent Glioblastoma Program
Bifunctional SuperKine ImmunoTherapies (BiSKITs) Program
Medicenna seeks to achieve the following milestones in the upcoming quarters:
Annual Financial Results
Medicenna had cash, cash equivalents, and marketable securities of $40.4 million at March 31, 2021. These funds provide the Company with sufficient capital to execute its current planned expenditures through late 2022 based on its current plans and projections.
Net loss for the year ended March 31, 2021 was $17.3 million, or $0.35 per share, compared to a loss of $8.2 million, or $0.26 per share for the year ended March 31, 2020. The increase in net loss for the year ended March 31, 2021 compared with the year ended March 31, 2020 was primarily a result of increased research and development expenditures related to the MDNA11 program as well as costs associated with the NASDAQ listing, in particular directors and officers insurance premiums as well as no reimbursement under the grant from the Cancer Prevention and Research Institute of Texas (“CPRIT”) in the current year.
Research and development expenses of $10.9 million were incurred during the year ended March 31, 2021, compared with $5.9 million incurred in the year ended March 31, 2020. The increase in research and development expenses in the current year is primarily attributable to higher CMC costs associated with GMP manufacturing of MDNA11 for the planned Phase 1/2a clinical trial, increased discovery and pre-clinical expenses associated with GLP compliant MDNA11 IND enabling studies as well as discovery work on the BiSKITs platform, increased regulatory costs associated with the EOP2 meeting for MDNA55 as well as the Scientific Advice Meeting for MDNA11 with the MHRA and preparation for the initiation of a Phase 1/2a clinical trial and no reimbursement of expenses with respect to the CPRIT grant in the year ended March 31, 2021, compared with $1.0 million in the year ended March 31, 2020.
General and administrative expenses of $6.5 million were incurred during the year ended March 31, 2021, compared with $2.4 million during the year ended March 31, 2020. The increase in expenditures year over year is primary attributable to increased directors and officers liability insurance premiums due to our NASDAQ listing as well as higher board fees, legal fees and listing expenses in the current year due to activities associated with our NASDAQ listing, filing a shelf prospectus in both Canada and the United States, qualifying our common shares with the Depository Trust Company (DTC) and other corporate initiatives.
Conference Call and Webcast
Medicenna will host a conference call and webcast today at 8:30 AM ET. To access the call, please dial (877) 407-9716 from the United States or (201) 493-6779 internationally, and refer to conference ID: 13719231. To access the live webcast, visit this link to the event. Following the live webcast, an archived version of the call will be available on Medicenna’s website.
Medicenna is a clinical stage immunotherapy company focused on the development of novel, highly selective versions of IL-2, IL-4 and IL-13 Superkines and first in class Empowered Superkines for the treatment of a broad range of cancers. Medicenna's long-acting IL-2 Superkine asset, MDNA11, is a next-generation IL-2 with potentially superior CD122 binding without CD25 affinity and therefore preferentially stimulates cancer killing effector T cells and NK cells when compared to competing IL-2 programs, based on the preclinical studies conducted to date. Medicenna’s early-stage program on Bifunctional SuperKine ImmunoTherapies (BiSKITs) is designed to further enhance the ability of Superkines to treat immunologically “cold” tumors. Medicenna's lead IL4 Empowered Superkine, MDNA55, has completed a Phase 2b clinical trial for rGBM, the most common and uniformly fatal form of brain cancer. MDNA55 has been studied in five clinical trials involving 132 subjects, including 112 adults with rGBM. MDNA55 has obtained Fast-Track and Orphan Drug status from the FDA and FDA/EMA, respectively.
This news release contains forward-looking statements within the meaning of applicable securities laws and relate to the future operations of the Company and other statements that are not historical facts including statements related to the achievement of milestones, the expansion and advancement of its clinical pipeline, the clinical potential and development of its BiSKITs, MDNA11 and MDNA55 programs, and Superkine platform, partnering strategy and activities, cash runway and expected costs and timelines of clinical trials and activities. Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects", "believes" and similar expressions. All statements other than statements of historical fact, included in this release, including the future plans and objectives of the Company, are forward-looking statements that are subject to 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 and Form 40-F of the Company and in other filings made by the Company with the applicable securities regulators from time to time in Canada and the United States.
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. 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.
For further information about the Company please contact:
Elizabeth Williams, Chief Financial Officer, 416-648-5555, firstname.lastname@example.org
For more investor information, please contact:
Dan Ferry, Managing Director, LifeSci Advisors, 617-430-7576, email@example.com