On May 14, 2026 Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, reported financial results for the three months ended March 31, 2026, and provided a corporate update highlighting continued execution across its SkinJect and Teverelix development programs.
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During the first quarter of 2026, Medicus continued to advance its transition into a diversified clinical-stage biotechnology company with active development programs in dermatologic oncology and urology/oncology, while replenishing its balance sheet through multiple capital market initiatives.
The Company recently reported positive, decision grade, expanded dataset findings from its Phase 2 SKNJCT-003 study evaluating SkinJect Doxorubicin Microneedle Array (D-MNA) for the treatment of nodular basal cell carcinoma (BCC), including evidence of positive dose response and registrational grade clearance rates in the 200-µg treatment cohort.
In parallel, Medicus advanced Teverelix, its next-generation long-acting GnRH antagonist acquired through the acquisition of Antev Limited, with Food and Drug Administration (FDA) clearance to initiate a Phase 2b dose optimization study in advanced prostate cancer and submission of an optimized Phase 2 protocol in acute urinary retention recurrence prevention.
Management Commentary:
"During the first quarter of 2026, Medicus continued to execute on its transformation into a diversified clinical-stage biotechnology company, highlighted by expanded positive Phase 2 SkinJect data, advancement of Teverelix into additional clinical development pathways, and continued expansion of our regulatory and strategic initiatives," stated Dr. Raza Bokhari, Medicus’ Executive Chairman & CEO. "We believe the growing strength of our clinical datasets, combined with expanded financing flexibility and continued development of AI-enabled clinical capabilities, positions the Company to pursue multiple value-driving milestones in dermatologic oncology, prostate cancer, acute urinary retention, and rare disease indications throughout 2026 and beyond."
First Quarter 2026 and Recent Corporate Highlights
SkinJect Platform (Dermatology / Oncology / Rare Disease)
SkinJect, a novel localized immuno-oncology precision product focused on non-melanoma skin diseases, especially basal cell carcinoma (BCC) and Gorlin Syndrome, a rare autosomal dominant disease also called nevoid BCC syndrome, collectively representing a ~$2 billion market opportunity.
In the first quarter 2026, the Company made the following noteworthy advances in the SkinJect program:
Reported positive topline and expanded dataset findings from the Phase 2 SKNJCT-003 clinical study evaluating D-MNA for nodular basal cell carcinoma.
Expanded analysis demonstrated positive dose-response trends and clinically meaningful clearance activity in the 200-µg treatment cohort.
Company believes the dataset supports continued FDA engagement regarding potential registrational development pathways.
Completed enrollment of 90 patients in the U.S.-based Phase 2 SKNJCT-003 study.
Continued expansion activities for the SKNJCT-004 UAE-based clinical study evaluating SkinJect in additional geographic markets.
Submitted an Orphan Drug Designation application to the FDA for SkinJect in Gorlin Syndrome patients.
Continued collaboration with the Gorlin Syndrome Alliance to support compassionate access and expanded access development initiatives.
Teverelix Platform (Prostate + Women’s Health)
Teverelix, a next generation GnRH antagonist, is a first-in-market product for cardiovascular high-risk advanced prostate cancer patients and patients with acute urinary retention relapse (AURr) episodes due to enlarged prostate, collectively representing an ~$6 billion market opportunity.
In the first quarter 2026, the Company made the following noteworthy advances in the Teverelix program:
FDA provided "study may proceed" clearance for the Company’s Phase 2b dose optimization study evaluating Teverelix in advanced prostate cancer.
Submitted optimized Phase 2 protocol to the FDA for prevention of recurrent acute urinary retention in men with benign prostatic hyperplasia.
Presented additional clinical data relating to Teverelix at the American Association of Clinical Endocrinology (AACE) Annual Meeting 2026.
Successfully amended the LifeArc licensing agreement, reducing the royalty rate payable on worldwide net sales from approximately 4% to 2%.
Other Strategic and Corporate Initiatives:
In the first quarter 2026, the Company continued to make progress in other relevant strategic and corporate initiatives, some of which are highlighted below:
Continued development of the Company’s AI-enabled clinical development collaboration with Reliant AI.
Expanded ATM financing capacity from up to approximately $15.3 million to up to $50 million subsequent to quarter end.
Continued evaluation of additional strategic acquisition and partnering opportunities aligned with the Company’s multi-strategy development platform.
Financial Highlights (Q1 2026):
During the first quarter of 2026, the Company continued to replenish its capital position through utilization of its at-the-market ("ATM") facility and Standby Equity Purchase Agreement ("SEPA"), securing approximately $10 million in aggregate gross financing proceeds during the quarter. Subsequent to quarter end, the Company also expanded its ATM facility from up to approximately $15.3 million to up to $50 million.
The Company operates as a clinical-stage enterprise and expects to incur operating losses for the foreseeable future. As disclosed in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, substantial doubt exists regarding the Company’s ability to continue as a going concern without additional financing. However, management believes the Company continues to have access to additional capital resources through public and private equity offerings, debt financings, strategic collaborations, licensing arrangements, and other financing initiatives. Financial results of the Company for the quarter ended March 31, 2026, include:
Cash and cash equivalents: $6.4 million as of March 31, 2026 (vs. $4.0 million as of March 31, 2025)
Operating expenses: $8.6 million (vs. $5.1 million in Q1 2025)
General & administrative: $5.9 million (vs. $3.1 million in Q1 2025)
Research & development: $2.7 million (vs. $2.0 million in Q1 2025)
Net loss: $9.0 million (vs. $5.1 million in Q1 2025)
Loss from operations: $8.6 million (vs. $5.1 million in Q1 2025)
Net loss per share: $0.31 (vs. $0.42 in Q1 2025)
The Company’s complete unaudited financial statements and results of operations for the quarter ended March 31, 2026 are included in its Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 14, 2026.
Expected Upcoming Catalysts in 2026
The Company expects 2026 to remain a catalyst-rich year with multiple anticipated milestones, including:
End-of-Phase 2 FDA meeting (SkinJect) to define registrational pathway
Potential registrational trial design alignment under 505(b)(2) framework
Advancement of Gorlin Syndrome Orphan Drug designation, Registrational grade IND and Pediatrics Rare Disease Voucher Program
Continued evaluation of HelixNano-enabled platform expansion opportunities
Expansion of Teverelix into women’s health (endometriosis) using genomics-enabled clinical strategy
Progression of agentic AI-driven clinical development platform with Reliant AI
Ongoing strategic partnering discussions across both core programs, Skinject and Teverelix
Potential expansion of strategic collaborations and licensing discussions
The Company believes its current financing infrastructure, including the expanded ATM facility and existing capital market access, provides flexibility to support ongoing operations and advancement of its clinical development programs.
(Press release, Skinject, MAY 14, 2026, View Source [SID1234665740])