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Medicenna Therapeutics Corp.

MDNAF / Other OTC / $2.17

March 26, 2020

 

Business Overview

 

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Medicenna Therapeutics Corp. (the Company) is a clinical-stage immunotherapy company developing highly selective versions of interleukin-2 (IL-2), interleukin-4 (IL-4), and interleukin 13 (IL-13) tunable cytokines (Superkines) and cytokines fused with cell-killing proteins (Empowered Cytokines) for treatment of a broad range of cancers and other human ailments.

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The lead Empowered Cytokine, IL4-EC, MDNA55, is an Empowered IL-4 cytokine that is fused to the catalytic domain of the bacterial pseudomonas exotoxin A (PE). This toxin is active only once it has been internalized by the target cell. The drug is locally administered onto the tumor itself after the tumor has recurred, thereby bypassing the blood-brain barrier and reducing systemic side effects.

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MDNA55 has completed a Phase 2b clinical trial for recurrent brain cancer (rGBM), and it has demonstrated highly promising efficacy vs. approved therapies. There were no detectable levels of MDNA55 in the blood stream, nor any evidence of significant systemic toxicity following treatment. The FDA and the European Medicines Agency have granted MDNA55 Orphan Drug status for treatment of gliomas, as well as Fast Track Designation from the FDA for the treatment of GBM and anaplastic astrocytoma. The pipeline also includes plans to study MDNA55 for metastatic brain cancer, newly diagnosed GBM, and diffuse intrinsic pontine glioma.

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The long-acting Superkine asset, MDNA19, is a next-generation IL-2 for cancer immunotherapies. Non-human primate data has shown superior CD122 binding without CD25 affinity, stimulating cancer-killing cells preferentially compared to competing IL-2 programs. Management expects MDNA19 to be introduced to the clinic in 2021. Approximately C$20,850,000 of the net proceeds from the March 2020 equity offering was earmarked for this program.

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The Company has a pipeline of other candidates in preclinical and discovery phases. These include MDNA57 (solid tumors), MDNA209 (autoimmune diseases), MDNA413 (solid tumors, atopic dermatitis, asthma, and various forms of fibrosis), and MDNA132 (solid tumors).

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The Company licensed technology from Leland Stanford Junior University and the National Institutes of Health (NIH). The Stanford and NIH agreements include low-single-digit royalty rates, modest back-ended development milestone payments, and sub-licensing royalties.

 

 

2020 Focus

 

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Management has updated the MDNA55 clinical data and expects to hold its end of Phase 2 meeting with the FDA in the first half of the year.

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Hold a pre-IND meeting with the FDA for MDNA19 and then complete the IND enabling studies, with a goal of starting a Phase 1 clinical trial in first-half 2021.

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Advance the other preclinical candidates.

 

 

Management and Directors

 

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Fahar Merchant, PhD, is President, CEO, and a co-founder. He has 25+ years of biotech experience and has closed several transactions valued at more than $300 million. Other members of the management team include Elizabeth Williams, CPA, CA (CFO); Rosemina Merchant, MESc (Chief Development Officer); and Martin Bexon, MD (Head of Clinical Development).

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The BoD consists of four non-employee members and Dr. Merchant and Ms. Merchant. The backgrounds of the management and directors are outlined on the Medicenna website and SEDAR filings.

 

 

Financials

 

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Income Statement (9 months through 12/31/19 vs. 12/31/18) (C$)

 

G&A expense: 1,845,873 vs. 1,295,132

R&D expense: 3,734,178 vs. 2,356,683

Operating income (loss): (5,580,051) vs (3,651,815)

Other income (expense): (8,304) vs. (7,142)

Net income (loss): (5,588,356) vs. (3,658,957)

Comprehensive income (loss): (5,512,032) vs. (3,576,497)

Earnings (loss) per basic and diluted common share: (0.19) vs. (0.15)

Weighted average number of common shares outstanding: 30,206,534 vs. 24,723,592

 

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Balance Sheet (12/31/19) (C$)

 

Cash & equivalents: 6,974,004

Other current assets: 264,281

Total current assets: 7,238,285

Intangible assets: 77,475

Total assets: 7,315,780

Current liabilities: 1,993,314

Stockholders equity: 5,322,466

Common shares outstanding: 34,715,796

Warrants exercisable: 7,319,097 at a weighted average exercise price of $1.68

Options outstanding: 4,130,000 at a weighted average exercise price of $1.56

 

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On March 17, 2020, the Company closed a public offering of 11,290,323 shares at a price of C$3.10, generating gross proceeds of approximately C$35 million (C$32.2 million net proceeds). Agents have a 30-day over-allotment option to sell up to an additional 15% of the number of offered shares.

 

On October 17, 2019, the Company completed a public offering of 5,307,693 units at $1.30, each unit consisting of one common share and 1/2 common share purchase warrant exercisable for three years at $1.75 per warrant.

 

 

Valuation Considerations

 

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The target markets are substantial. Brain cancers targeted by MDNA55 alone represent a $2 billion opportunity in the U.S., Europe, and Japan, including $650 million for rGBM, $1.3 billion for metastatic brain cancer, and $50 million for pediatric glioma. MDNA19 is positioned to be a best-in-class IL2 asset ready for the clinic in 2021. Considering recent transactions in the space (THOR: $2.5B acquisition by Sanofi at Phase 1) there is the potential for considerable upside related to this molecule.

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The R&D effort is well focused and has a proven record of advancing the development pipeline. The lead asset is late stage.

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The working capital position is strong, aided by the net proceeds from the March 2020 equity offering. Management expects that its working capital will be sufficient to fund Company operations for approximately three years.

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The impact of COVID-19 is an uncertainty. In addition, the Medicenna website and SEDAR filings detail a number of risk factors, and these are hereby incorporated by reference.

 

 

Contacts

 

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Executive offices: 2 Bloor St. W., 7th Floor, Toronto, Ontario M4W 3E2.

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Investor contact: Elizabeth Williams, CFO; ewilliams@medicenna.com; Phone: 416.648.5555.

 

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TickerBuzz, LLC ("TickerBuzz"), a Florida limited liability company is the author of this Profile. TickerBuzz is not and does not act as a broker-dealer, investment advisor, placement agent, or crowdfunding portal. Furthermore, it does not offer any securities, nor does it provide any investment advice or analysis. The source material for this Profile is the Company presentation materials. Certain information, particularly information relating to future performance and other business matters, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act. TickerBuzz cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties that may change over time and cause actual results to differ materially from the results discussed herein. The forward-looking statements are neither predictions nor guarantees of future events or performance. TickerBuzz has no obligation to update any forward-looking statements after they are made, except as required by applicable law. All of this information is intended for discussion purposes only, is not a solicitation to buy or sell any security, and must not be relied upon for financial, legal, tax, or any other professional advice. This company has not paid TickerBuzz any compensation for publication of this Profile. Analyst: William J. Ritger.

 

 

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Contact: William J. Ritger, writger@gmail.com, 561.891.1903

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