THE FULL PACKAGE INCLUDES AN UPDATED INVESTIGATOR BROCHURE, CMC (CHEMISTRY, MANUFACTURING AND CONTROLS), STABILITY AND STERILTY DATA

Toronto, Ontario--(Newsfile Corp. - July 15, 2024) - Medicus Pharma Ltd. (TSXV: MDCX) (FSE: N46) ("Medicus" or the "Company") is pleased to announce the submission of an updated and complete Phase 2 Investigational New Drug (IND) clinical protocol (SKNJCT-003) to the United States Food and Drug Administration (FDA) to non-invasively treat basal cell carcinoma (BCC) of the skin using micro-needle arrays containing doxorubicin (D-MNA), developed by its wholly owned portfolio company, Skinject, Inc.

The submission included updates to the clinical protocol, supporting Chemistry, Manufacturing, and Controls (CMC), stability and sterility information, as well as responses to the clinical non-hold comments received from the FDA on March 21st, 2024.

The company provided the safety data requested by the FDA from the Phase 1 safety and tolerability study completed in March 2021 (SKNJCT-001) to support the doses of 100μg and 200μg of D-MNA.

The company also provided an updated investigator brochure featuring safety information from the SKNJCT-001 and SKNJCT-002 clinical trials.

Earlier this year, the Company had submitted a Phase 2 IND clinical protocol (SKNJCT-003) to the FDA to non-invasively treat BCC of the skin using micro-array needles containing doxorubicin (D-MNA). The clinical study, SKNJCT-003, is designed to be a randomized, double-blinded, placebo-controlled (P-MNA), multi-center study enrolling up to 60 subjects presenting with nodular type BCC of the skin. The study will evaluate the efficacy of two dose levels of D-MNA compared to. The participants will be randomized 1:1:1 to one of three groups: a placebo-controlled group receiving P-MNA, a low-dose group receiving 100μg of D-MNA, and a high-dose group receiving 200μg of D-MNA.

The high-dose, 200μg D-MNA, proposed in the study is the maximum dose that was used in Skinject's Phase 1 safety and tolerability study (SKNJCT-001) completed in March 2021.

SKNJCT-001 met its primary objective of safety and tolerability. The investigational product, D-MNA was well-tolerated across all dose levels in all thirteen (13) participants enrolled in the study, with no dose-limiting toxicities (DLTs), or serious adverse events (SAE). Furthermore, there were no systemic effects or clinically significant abnormal findings in laboratory parameters, vital signs, ECGs, and physical examinations. The study also describes the efficacy of the investigational product, D-MNA, with 6 participants experiencing complete responses. The complete response is defined as the disappearance of BCC histologically in the final excision at the end of study visit. The participants profile demonstrating complete responses was diverse, and all participants (6/6) had nodular subtype of BCC.

The updated Phase 2 clinical protocol (SKNJCT-003) includes the addition of artificial intelligence (AI) and confocal microscopy as supplementary endpoints at one of the clinical sites.

"This Phase 2 clinical protocol, in its final form, is a comprehensive design, well positioned to get the nod from the FDA to commence randomizing participants hopefully before the end of this quarter," stated Dr. Raza Bokhari, Executive Chairman & CEO. "We are very excited to incorporate artificial intelligence (AI) powered software and confocal microscopy as supplemental endpoints in one of the clinical site to improve the assessment accuracy of the clinical program and hopefully also eliminate any invasive intervention even at the diagnostic stage, making our treatment regimen completely non-invasive from start to finish."

About Medicus Pharma Ltd:

Medicus Pharma Ltd. (TSXV: MDCX) is a biotech/life sciences company focused on accelerating the clinical development programs of novel and disruptive therapeutics assets.

SkinJect Inc. a wholly owned subsidiary of Medicus Pharma Ltd, is a development stage, life sciences company focused on commercializing novel, non-invasive treatment for basal cell skin cancer using patented dissolvable microneedle patch to deliver chemotherapeutic agent to eradicate tumors cells.

Cautionary Notice on Forward-Looking Statements

Certain information in this news release constitutes "forward-looking information" under applicable securities laws. "Forward-looking information" is defined as disclosure regarding possible events, conditions or financial performance that is based on assumptions about future economic conditions and courses of action and includes, without limitation, statements regarding the submission and advancement of the phase 2 clinical protocol, including improvements thereto and the timing thereof, and approval from the FDA and the timing thereof.. Forward-looking statements are often but not always, identified by the use of such terms as "hope" "may", "might", "will", "will likely result", "would", "should", "estimate", "plan", "project", "forecast", "intend", "expect", "anticipate", "believe", "seek", "continue", "target" or the negative and/or inverse of such terms or other similar expressions.

These statements involve known and unknown risks, uncertainties, and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including those risk factors described in the Company's public filings on SEDAR+, which may impact, among other things, the trading price and liquidity of the Company's common shares. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect our expectations as of the date hereof, and thus are subject to change thereafter. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

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