TSXV:MDCX
READ THE FULL V.MDCX RESEARCH REPORT
First Patient Randomized for Medicus Pharma’s Phase 2 Clinical Study (SKNJCT-003)
On August 27, 2024, Medicus Pharma (TSXV:MDCX) announced that the first patient (of up to 60 subjects) has been randomized in the Phase 2 clinical trial (SKNJCT-003) for the treatment of nodular BCC (Basal Cell Carcinoma). This milestone indicates the culmination of the enrollment period for the first patient in this trial, which includes 1) the process of pre-screening of the potential candidate that meets the inclusion criteria, 2) the receipt of informed consent, 3) successfully undergoing a series of evaluations and diagnostic tests at in-person visit(s) with the research team, 4) completing the collection of baseline data to serve as a reference point for accessing changes in the subject’s health, and finally 4) the patient being informed that he/she has been enrolled and randomized, though in this particular case with the clinical trial being randomized and double-blind, the patient will not be informed into which arm he/she has been randomized.
The SKNJCT-003 protocol is a randomized, double-blinded, placebo-controlled clinical study with up to 60 patients with nodular BCC of the skin being enrolled across 6 trial sites in the U.S. The efficacy of two dose levels (100μg and 200μg of doxorubicin hydrochloride) will be evaluated compared to the placebo control group (three groups in total). The participants will be randomly and equally placed in one of three groups: the placebo-controlled group, a low-dose group (100μg) and a high-dose group (200μg). The SKNJCT-003 protocol follows the FDA guidelines for fast-tracking the approval process with its AI-powered protocol supported by confocal microscopy.
EXECUTIVE SUMMARY
➢ Medicus Pharma Ltd. is a holding company specializing in the acquisition life-science / biotechnology companies that are advancing novel therapies through clinical trials toward commercialization.
➢ Medicus Pharma completed its first acquisition, SkinJect, Inc., in September 2023. SkinJect holds an exclusive license to a Dissolvable Microneedle Array drug delivery system for basal cell carcinoma (BCC)
â–ª In the last NINE (9) months, Medicus has significantly accelerated the regulatory process for the SkinJect transdermal patch for the treatment of BCC.
1) In the first week of January 2024, the protocol for a Phase 2 clinical study was submitted to the FDA for review.
2) In mid-February 2024, Medicus published an abbreviated clinical study report on the SKNJCT-001 Phase 1 safety and tolerability study, which concluded in May 2021.
3) On March 21, 2024, Medicus Pharma received clinical non-hold comments from the FDA, which requested additional data to support the protocol’s dosing arms and specifically the data related to dose-limiting toxicities.
4) On July 15, 2024, Medicus Pharma announced that a full package of information was submitted to the FDA to support the approval to conduct the Phase 2 clinical trial (SKNJCT-003).
5) On August 27, 2024, Medicus Pharma announced that the first patient in the Phase 2 (SKNJCT-003) clinical trial has been randomized.
➢ Through Private Placements of Convertible Notes and Common Shares between May and July 2024, along with the subsequent conversion of the Convertible Notes to Common Shares, Medicus raised over US$10 million to help fund research & development programs, along with bolstering working capital. As a result, shares outstanding increased 34.3% to 21,693,560 shares.
➢ Company representatives are attending conferences to advance the awareness of the Medicus Pharma’s novel non-invasive therapeutic treatment for BCC skin cancer.
â–ª UAE Healthcare and Life Sciences Mission (5/13-17/2024) in Dubai
â–ª NIDI Skin Spring Symposium (5/24-25/2024) in New York City
â–ª BIO International Convention (June 5, 2024) in San Diego
➢ The company was listed on the TSX Venture Exchange, and began trading on October 11, 2023. Subsequently, the company’s common shares were listed on the Frankfurt Stock Exchange under the ticker symbol N46.
➢ On January 25, 2024, Medicus Pharma filed a short-form shelf prospectus allowing the company to offer (from time to time) up to US$50,000,000 in securities (common shares, preferred shares, warrants, debt, Units etc.) in Canada over a period of 25 months.
➢ On May 29, 2024, Medicus Pharma filed Form F-1 (registration statement) with the SEC relating to its proposed IPO in the United States.
➢ Medicus Pharma presents the opportunity to participate in the development of relatively advanced novel therapies that already have completed a clinical trial.
Valuation
Utilizing a financial model based on DCF methodology, which forecasts out to 2031 and uses a 10% discount rate (based on CAPM), and a terminal P/S multiple of 3.09 (based on Specialty Drug Manufacturers that focus on developing and commercializing novel therapeutics for unmet healthcare needs), the indicated value of MDCX.V is CDN$5.30 per share.
SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR.Â
DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives quarterly payments totaling a maximum fee of up to $40,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE.
