Medicus Pharma Ltd.

Medicus Pharma Ltd. announced that the U.S. Food and Drug Administration (FDA) has issued a "Study May Proceed" letter for its Investigational New Drug (IND) application for SKNJCT-005. This authorization allows the company to initiate a registrational Phase 2b clinical study evaluating SkinJect® (D-MNA) 200 mcg in patients with Gorlin Syndrome presenting with multiple basal cell carcinomas. The FDA's recommendations are expected to strengthen the study's scientific rigor and support long-term evaluation of treatment durability, positioning SkinJect® for a robust data package toward a potential NDA submission.

Medicus Pharma Ltd. announced its participation in the 2026 Bio International Conference, where Chief Medical Officer Dr. Faisal Mehmud will present updates on the company's clinical, regulatory, and strategic advancements. The presentation will highlight positive Phase 2 results for SkinJect® in basal cell carcinoma, ongoing FDA interactions, and regulatory initiatives for Gorlin Syndrome. Additionally, updates on Teverelix® will include progress in advanced prostate cancer, acute urinary retention relapse, and the newly initiated PRECISION-E2 Phase 2a study for endometriosis.

Medicus Pharma Ltd. announced the submission of a Rare Pediatric Disease Designation (RPDD) request to the U.S. FDA for SkinJect®, its investigational doxorubicin-containing microneedle array patch, for treating basal cell carcinoma in patients with Gorlin Syndrome. This follows a previous Orphan Drug Designation application and positive Phase 2 study results showing 64% clinical clearance and 55% complete response. If granted, RPDD could lead to a Priority Review Voucher, potentially accelerating FDA review, and Orphan Drug Designation could provide seven years of market exclusivity, addressing a significant unmet medical need for this rare disease.

Medicus Pharma Ltd. announced the submission of an Investigational New Drug (IND) application to the Department of Health, Abu Dhabi, for PRECISION-E2, a Phase 2a genomics-enabled clinical trial. This study will evaluate Teverelix® in approximately 84 women with symptomatic endometriosis in the United Arab Emirates, leveraging the Emirati Genome Program. The trial aims to develop a personalized treatment model for endometriosis by combining clinical, hormonal, pharmacokinetic, and genomic data, potentially transforming the management of estrogen-driven diseases.

Medicus Pharma Ltd. held its 2026 Annual General and Special Meeting of Shareholders on June 3, 2026. Shareholders ratified the appointment of KPMG LLP as the independent registered public accounting firm for the 2026 fiscal year. All nine directors nominated by the Board were elected to serve one-year terms. Additionally, shareholders approved a special resolution authorizing the Board to effect a common share consolidation at a ratio up to 50-to-1, if deemed necessary or desirable.

Medicus Pharma Ltd. announced it has entered into a definitive financing agreement with an institutional investor for an up to $22 million structured financing facility. This financing is expected to boost the company's pro forma cash position to approximately $30 million, providing a projected operating cash runway of over twenty-four months. The company will receive $12 million immediately, with an additional $10 million released upon achieving specified milestones, and intends to use the proceeds to advance clinical development programs, pursue strategic initiatives, and repay existing debt.

Medicus Pharma Ltd. entered into a note purchase agreement with Streeterville Capital, LLC, securing $22.86 million in financing. This involved issuing a Secured Promissory Note A-1 for $12,864,225 and a Secured Promissory Note B for $10,000,000. The company received $12 million upfront for the A-1 Note, while $10 million for the B Note was deposited into a subsidiary's account. Proceeds will be used for clinical development programs, strategic business development, general corporate purposes, and to repay approximately $2.5 million of existing debt.

Medicus Pharma Ltd. reported its financial results for the first quarter ended March 31, 2026, with a net loss of $9.0 million, an increase from $5.1 million in Q1 2025, and higher operating expenses. Concurrently, the company provided a corporate update highlighting significant progress in its clinical development programs. SkinJect® Doxorubicin Microneedle Array demonstrated positive Phase 2 data for nodular basal cell carcinoma, including dose response and registrational grade clearance rates. Teverelix® received FDA clearance to initiate a Phase 2b dose optimization study in advanced prostate cancer and an optimized Phase 2 protocol submission for acute urinary retention recurrence prevention. The company also strengthened its balance sheet by securing $10 million in financing and expanding its ATM facility to $50 million.

Medicus Pharma Ltd. reported a net loss of $(9.04) million for Q1 2026, a significant increase from $(5.10) million in Q1 2025. The company's cash and cash equivalents decreased to $6.37 million from $8.71 million at year-end 2025. Management expressed substantial doubt about the company's ability to continue as a going concern, despite raising $6.83 million from financing activities, including common share issuances under SEPA and ATM programs.

Medicus Pharma Ltd. announced positive dose response results from an expanded dataset analysis of its Phase 2 SKNJCT-003 study for Doxorubicin Microneedle Array (D-MNA) in treating nodular basal cell carcinoma (BCC). The study demonstrated progressive and dose-dependent improvement, with the 200µg D-MNA cohort showing 64% clinical clearance and 55% histological clearance at Day 57, significantly outperforming the device-only control. The D-MNA also exhibited a favorable safety and tolerability profile, reinforcing its therapeutic potential and supporting future registrational discussions with the FDA.