TSXV:MDCX
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EXECUTIVE SUMMARY
➢ Medicus Pharma Ltd. (TSXV:MDCX) 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)
• In the last six 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 II 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) Management intends to make a full submission to the FDA in second quarter of 2024, which will not only provide the information requested by the FDA, but also include CMC stability, which should further accelerate the timeline for the Phase II clinical trial.
➢ 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.
➢ Medicus Pharma presents the opportunity to participate in the development of relatively advanced novel therapies that already have completed a clinical trial.
RECENT DEVELOPMENTS
On March 21, 2024, Medicus Pharma received clinical non-hold comments from the FDA, which included two requests:
1) the data from the Phase I clinical study (SKNJCT-001) in order to support the dosing of 100μg and 200μg of doxorubicin hydrochloride in the microneedle array and
2) an updated investigator brochure that includes information from the SKNJCT-001 and SKNJCT-002 clinical studies, along with data at each dose level was specifically requested concerning any adverse events that would relate to any dose-limiting toxicities.
In mid-February 2024, the company published an abbreviated clinical study report for the Phase I safety and tolerability study (SKNJCT-001 aka NCT03646188), which studied 13 participants across five dose levels (25 ug, 50 ug, 100 ug, 200 ug and placebo). The micro-array needles containing doxorubicin (D-MNA) was found to be safe and well-tolerated across all dose levels. There were not any dose-limiting toxicities (DLTs) or serious adverse events (SAE). Two (2) participants reported pain at the application site, which were classified as Other Adverse Events. The maximum tolerated dose was at 200 ug, the highest dose which was administered in the study to one (1) participant.
The study also described the efficacy of D-MNA with six participants, all with nodular BCC, experiencing complete responses (disappearance of BCC at the last study visit). The application of the microneedle array on the other seven (7) patients did not adequately penetrate the skin, and therefore, only mild dissolution was achieved.
The clinical study report is available at: https://clinicaltrials.gov/study/NCT03646188?tab=results.
On January 25, 2024, Medicus Pharma filed a short-form shelf prospectus in Canada which allows the company to offer (from time to time) up to US$50,000,000 in securities (common shares, preferred shares, warrants, debt, Units etc.) over a 25-month period. The filing of a shelf prospectus is a common method to raise capital for public companies from large-cap to micro-cap in order to maintain financial flexibility.
On January 3, 2024, Medicus Pharma announced that the company had submitted its Phase II IND clinical protocol to the U.S. FDA for the non-invasive treatment of BCC of the skin. The proposed protocol (SKNJCT-003) is a randomized, double-blinded, placebo-controlled clinical study. Up to 60 patients with nodular BCC of the skin will be enrolled, and the efficacy of two dose levels (100μg and 200μg of doxorubicin hydrochloride) will be evaluated compared to the placebo control group. 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).
UPCOMING PHASE II CLINICAL TRIAL of SkinJect PATCH
In its effort to fast track the clinical development program for the SkinJect D-MNA patch, in the first week of January 2024, Medicus Pharma submitted a clinical protocol (SKNJCT-003) to the FDA for a Phase II clinical trial on its non-invasive treatment of nodular BCC of the skin. The proposed protocol is a randomized, double-blinded, placebo-controlled clinical study. Up to 60 patients with nodular BCC of the skin are planned to be enrolled, and 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.
The FDA commented on protocol around March 20th, with requests for additional data to support the protocol’s dosing arms and specifically the data related to dose-limiting toxicities. These non-hold comments did not contain any clinical comments (such as suggested revisions or amendments related to the proposed protocol). Nor did the comments include a deadline.
In order to maintain the new, higher level of momentum in the regulatory process, management decided to submit a full submission, which will not only provide the information/data requested by the FDA, but also contain stability data concerning CMC (Chemistry, Manufacturing and Controls) of the product that is being manufactured for the Phase II trial. Once the stability becomes available, probably in the early part of 2Q 2024, management intends to make this full submission to the FDA, with a target date sometime during the second quarter of 2024.
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 2.65 (based on Specialty Drug Manufacturers that focus on developing and commercializing novel therapeutics for unmet healthcare needs), the indicated value of MDCX is CDN$5.90 per share.
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