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Medicenna Therapeutics Corp
Symbol MDNA
Shares Issued 69,637,469
Close 2023-07-27 C$ 0.58
Market Cap C$ 40,389,732
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Medicenna spends $2.8-million on R&D in Q1 2024

2023-07-28 10:35 ET - News Release

Dr. Fahar Merchant reports

MEDICENNA REPORTS FIRST QUARTER FISCAL 2024 FINANCIAL RESULTS AND OPERATIONAL HIGHLIGHTS

Medicenna Therapeutics Corp. has released financial results and corporate highlights for the first quarter ended June 30, 2023, as well as anticipated near-term corporate milestones.

"We are pleased with our start to fiscal 2024 and remain on track to share data readouts for cohorts five and six in addition to updates in lower-dose cohorts. We believe that the clearance by the safety review committee of the 120-microgram-per-kilogram dose administered every two weeks continues to demonstrate the acceptable tolerability profile of MDNA11. Accordingly, we expect to announce, on Aug. 9, the recommended dose for expansion, as well as the indications we plan to pursue in the monotherapy expansion cohort of the phase 2 Ability study following data review by the independent clinical and safety advisers of the company," commented Dr. Fahar Merchant, PhD, president and chief executive officer of Medicenna. "We are encouraged by the safety profile of MDNA11 to date in addition to the prolonged and persistent single-agent activity in heavily pretreated, end-stage cancer patients, even though the purpose of the phase 1 Ability study was to evaluate the safety of MDNA11. We look forward to evaluating MDNA11 in a phase 2 patient population in which the patients are less heavily treated in clinically relevant tumour types and may therefore be more likely to respond to immunotherapy treatments such as MDNA11."

Operational highlights

On April 17, 2023, Medicenna announced new preclinical data characterizing the interleukin 13 (IL-13) superkines, MDNA132 and MDNA213 (an improved version of MDNA132), and a series of IL-13 BiSKITs (bifunctional superkines for immunotherapies), were presented at the American Association for Cancer Research annual meeting, held in Orlando, Fla. The results demonstrated that the IL-13 superkines represent a versatile platform for engineering the next generation of precision immunotherapies for many immune-resistant IL-13Ralpha2-expressing tumours.

On April 25, 2023, the company received an extension notice from Nasdaq granting the company's request for a 180-day extension to regain compliance with the minimum bid requirement. The company has until Oct. 23, 2023, to regain compliance with the minimum bid requirement. The extension notice had no immediate effect on the listing or trading of the common shares on Nasdaq, and the company's operations are not affected by the receipt of the extension notice.

On July 20, 2023, Dr. Merchant, president and CEO of Medicenna, was invited to present and participate in a research roundtable organized by the National Brain Tumor Society. The event, entitled "Use of External Control Data in Brain Tumor Clinical Trials," was held in Washington, D.C.

Expected coming milestones:

  • Initial anti-tumour activity data from Ability's fifth- and sixth-dose escalation cohorts in calendar Q3 2023;
  • Commencement of the Ability study's MDNA11 phase 2 monotherapy arm expected in calendar Q3 2023;
  • Clinical update from the Ability study's MDNA11 phase 2 monotherapy arm expected in calendar Q4 2023;
  • Commencement of the MDNA11 plus pembrolizumab combination arm of the Ability study in calendar Q4 2023.

Financial results

As of June 30, 2023, cash, cash equivalents and marketable securities were $29.6-million, compared with $33.6-million on March 31, 2023.

Net loss for the quarter ended June 30, 2023, was $2.9-million or four cents per share compared with a net loss of $4.2-million or seven cents per share for the quarter ended June 30, 2022. The decrease in net loss for the quarter ended June 30, 2023, compared with the quarter ended June 30, 2022, was primarily a result of a non-cash gain of $1.7-million related to the fair value of the warrant derivative.

Research and development expenses of $2.8-million were incurred during the quarter ended June 30, 2023, compared with $2.4-million incurred in the quarter ended June 30, 2022. The increase in R&D expenses in the current quarter was primarily attributed to increased licensing and patent legal fees and higher clinical costs associated with the MDNA11 Ability study.

General and administrative expenses of $1.6-million were incurred during the quarter ended June 30, 2023, compared with $1.9-million during the quarter ended June 30, 2022. The decrease in G&A expenses in the current quarter is primarily a result of a reduction in directors and officers liability insurance premiums.

About Medicenna Therapeutics Corp.

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. Medicenna's long-acting IL-2 superkine, MDNA11, is a next-generation IL-2 with superior CD122 (IL-2 receptor beta) binding without CD25 (IL-2 receptor alpha) affinity thereby preferentially stimulating cancer-killing effector T cells and NK cells. Medicenna's early-stage BiSKITs program is designed to enhance the ability of superkines to treat immunologically cold tumours. Medicenna's IL-4 empowered superkine, bizaxofusp (formerly MDNA55), has been studied in five clinical trials including a phase 2b trial for recurrent GBM, the most common and uniformly fatal form of brain cancer. Bizaxofusp has obtained fast-track and orphan drug status from the Food and Drug Administration and FDA/European Medicines Agency, respectively.

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