Medicus Pharma Ltd. Publishes Phase 1 Clinical Study Report Demonstrating Safety & Tolerability in All Participants with Basal Cell Carcinoma

Toronto, Ontario--(Newsfile Corp. - February 15, 2024) - Medicus Pharma Ltd. (TSXV: MDCX) (FSE: N46) ("Medicus" or the "Company") is pleased to announce that it has published the abbreviated clinical study report (CSR) from the SKNJCT-001 Phase 1 safety and tolerability study.

SKNJCT-001 is an open-label, dose-escalation, placebo-controlled trial to evaluate dose limiting toxicity (DLT), maximum tolerated dose (MTD), safety and tolerability of dissolvable microneedle arrays loaded with the chemotherapeutic agent doxorubicin (D-MNA) in participants with basal cell carcinoma (BCC). The study enrolled 13 subjects across five dose levels (25 ug, 50 ug, 100 ug, 200 ug, and placebo).

The study report is available at https://clinicaltrials.gov/study/NCT03646188?tab=results. The associated NCT number for the SKNJCT-001 trial is NCT03646188.

Phase 1 study, SKNJCT-001 met its primary objective of safety and tolerability. The investigational product, D-MNA was found to be safe and well-tolerated across all dose levels in all thirteen (13) participants enrolled in the study, with no dose-limiting toxicities (DLTs), serious adverse events (SAE), or study discontinuations. Furthermore, there were no systemic effects or clinically significant abnormal findings in laboratory parameters, vital signs, ECGs, and physical examinations. The maximum tolerated dose was established at 200 ug.

The CSR also describes the efficacy of the investigational product, D-MNA, with 6 subjects 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 Company, earlier this year, has submitted to the United States Food and Drug Administration (FDA) a Phase 2 Investigational New Drug (IND) clinical protocol (SKINJCT-003) to non-invasively treat BCC using micro-array needles containing doxorubicin (D-MNA). The Company is seeking comments from the FDA to revise and amend the IND and finalize the protocol.

The Company also announced that it has engaged the services of Independent Trading Group ("ITG") and Integral Wealth Securities Limited ("Integral") to provide market-making services with the objective of maintaining a reasonable market and improving the liquidity of the Company's common shares.

Under the ITG agreement, ITG will receive compensation of $6500 per month, payable monthly in advance. The agreement is for an initial term of three months and will renew for additional one-month terms unless terminated. The agreement may be terminated by either party with 30 days' notice. There are no performance factors contained in the agreement and ITG will not receive shares or options as compensation. ITG and the Company are unrelated and unaffiliated entities and at the time of the agreement, neither ITG nor its principals have an interest, directly or indirectly, in the securities of the Company.

Under the Integral agreement, Integral will receive compensation of $6000 per month, payable monthly in advance. The agreement is for an initial term of three month. There are no performance factors contained in the agreement and Integral will not receive shares or options as compensation. Integral and the Company are unrelated and unaffiliated entities and at the time of the agreement, neither Integral nor its principals have an interest, directly or indirectly, in the securities of the Company.

For further information contact:

Carolyn Bonner, President
(610) 636-0184
cbonner@medicuspharma.com

LHA Investor Relations
Tirth T. Patel
212-201-6614
tpatel@lhai.com

About Medicus Pharma Ltd:

Medicus Pharma Ltd. (TSXV: MDCX) is a clinical stage, multi-strategy holding company focused on investing in and accelerating novel life sciences and bio-technology companies through FDA approved clinical trials.

Through our diverse experience and extensive industry network, we are building Medicus into a leading pharmaceutical holding company, committed to delivering better treatment outcomes and alleviate pain and suffering. Utilizing a thesis driven collaborative process, we identify, acquire and advance relatively de-risked clinical stage assets through clinical development and commercialization.

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 and squamous 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 future- oriented financial information with respect to prospective financial performance, financial position or cash flows that is presented as a forecast or a projection. Forward-looking statements are often but not always, identified by the use of such terms as "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.

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