PHILADELPHIA, PA — Medicus Pharma Ltd. (Nasdaq: MDCX) reported expanded Phase 2 data for its SkinJect skin cancer therapy and advanced development of its Teverelix prostate cancer program during the first quarter, as the clinical-stage biotechnology company continued raising capital while warning of ongoing going-concern risks.
The company reported positive expanded data from its Phase 2 SKNJCT-003 study evaluating SkinJect Doxorubicin Microneedle Array for nodular basal cell carcinoma, including what management characterized as registrational-grade clearance rates in the highest-dose cohort.
Medicus also disclosed that the U.S. Food and Drug Administration cleared its Phase 2b dose optimization study for Teverelix in advanced prostate cancer and received an updated protocol submission tied to recurrent acute urinary retention associated with enlarged prostate conditions.
“We believe the growing strength of our clinical datasets, combined with expanded financing flexibility, positions the Company to pursue multiple value-driving milestones,” Executive Chairman and Chief Executive Officer Dr. Raza Bokhari stated.
The company completed enrollment of 90 patients in its U.S.-based SkinJect Phase 2 trial and continued expansion of a separate United Arab Emirates-based study evaluating the therapy in additional markets.
Medicus also submitted an Orphan Drug Designation application to the FDA for SkinJect in Gorlin Syndrome, a rare inherited disorder associated with basal cell carcinoma development.
Teverelix, acquired through Medicus’ purchase of Antev Limited, is being developed for advanced prostate cancer and acute urinary retention recurrence prevention.
During the quarter, Medicus amended a licensing agreement with LifeArc, reducing worldwide royalty obligations tied to Teverelix sales from roughly 4% to 2%.
The company also continued development work tied to an AI-enabled clinical collaboration with Reliant AI and indicated it remains open to additional acquisitions and partnership opportunities.
Financially, Medicus raised approximately $10 million during the quarter through its at-the-market equity facility and standby equity purchase agreement. After quarter end, the company expanded its ATM financing capacity to $50 million from approximately $15.3 million.
Despite the financing activity, Medicus disclosed in its quarterly filing that “substantial doubt exists” regarding its ability to continue as a going concern without securing additional capital.
Cash and cash equivalents totaled $6.4 million as of March 31, compared with $4.0 million a year earlier.
Operating expenses increased to $8.6 million from $5.1 million in the prior-year quarter, while net loss widened to $9.0 million from $5.1 million.
Research and development expenses rose to $2.7 million from $2.0 million, while general and administrative costs increased to $5.9 million from $3.1 million.
Net loss per share narrowed to $0.31 from $0.42 in the year-earlier period.
Looking ahead, Medicus expects several potential catalysts in 2026, including an end-of-Phase 2 FDA meeting for SkinJect, possible registrational trial alignment under the FDA’s 505(b)(2) pathway and continued expansion of Teverelix into women’s health indications including endometriosis.
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