Beyond the Scalpel: Microneedle Patch Shows Promise for Skin Cancer

PHILADELPHIA, PA – March 09, 2026 – A novel microneedle patch may soon offer a non-surgical alternative for treating the world's most common cancer. Medicus Pharma (NASDAQ: MDCX) today detailed encouraging results from a Phase 2 study of its SkinJect™ system, which demonstrated that nearly three-quarters of basal cell carcinoma lesions treated with its highest dose vanished completely from sight.

A New Front in the Fight Against Skin Cancer

The data, from the SKNJCT-003 clinical trial, represents a significant step forward in the quest for less invasive cancer treatments. In the cohort receiving a 200-microgram dose of a chemotherapeutic agent delivered via the dissolvable microneedle patch, 73% of patients achieved "clinical clearance"—the visual disappearance of their skin tumor—by day 57.

This clinical outcome is a key metric, suggesting that a majority of patients could potentially avoid or delay immediate surgical intervention, the current standard of care. The study also measured "histological clearance," the complete absence of cancer cells under a microscope following a biopsy. In the same high-dose group, 40% of patients achieved this more stringent endpoint.

"We believe the SKNJCT-003 dataset reinforces the premise of SkinJect as a potential new treatment modality for basal cell carcinoma," said Dr. Raza Bokhari, Executive Chairman and CEO of Medicus, in a statement. "The 73% clinical clearance observed in the 200-µg treatment cohort suggests that approximately three out of four treated lesions may achieve visual tumor clearance, potentially allowing many patients to avoid immediate surgical intervention.”

The results gain further significance when compared to the study's active placebo arm. In this group, patients received a microneedle patch without the active drug. While they still saw a 38% rate of clinical clearance, the clear separation between this group and the 73% rate in the drug-treated group provides strong evidence that the combination of the device and the therapeutic agent is key to its efficacy.

The Science of the 'Active' Needle

One of the most fascinating aspects of the SkinJect™ technology is the inherent biological activity of the microneedle patch itself. The study's design intentionally included an "active placebo" to measure this effect, which has become an increasingly recognized phenomenon in device-drug combination trials.

When the tiny, dissolvable needles penetrate the tumor, they create micro-injuries that trigger a cascade of natural responses. According to the company, this includes the mechanical disruption of the tumor's structure, the activation of the body's wound-healing pathways, and the stimulation of localized immune signaling. Basal cell carcinoma is known to be a highly immunogenic tumor, meaning it is often recognized and attacked by the immune system. The microneedles appear to amplify this natural defense mechanism, contributing to tumor regression even without a drug.

The 38% clinical clearance seen in the placebo arm validates this device-mediated effect. However, the near-doubling of that response rate to 73% in the drug-loaded cohort demonstrates the powerful synergistic effect of adding a targeted chemotherapeutic agent, doxorubicin, directly into the tumor. This two-pronged attack—disrupting the tumor physically while delivering a cancer-killing drug—is central to Medicus's strategy for securing regulatory approval.

The company plans to use this data in an upcoming End-of-Phase-2 meeting with the U.S. Food and Drug Administration (FDA). The data supports a potential 505(b)(2) regulatory pathway, which can streamline development by leveraging existing knowledge about a drug's components.

A Beacon of Hope for High-Risk Patients

For millions diagnosed with basal cell carcinoma each year, the primary treatment is surgery, most notably Mohs micrographic surgery. While highly effective, Mohs is an invasive procedure that can be costly, time-consuming, and result in significant scarring, particularly for tumors on the face and neck. A simple, minimally invasive patch applied in a dermatologist's office could transform the patient experience.

The potential impact is even more profound for individuals with Gorlin Syndrome, a rare genetic condition that causes patients to develop dozens, or even hundreds, of basal cell carcinomas over their lifetime. For these patients, the cumulative burden of repeated surgeries can be physically and emotionally devastating, leading to significant disfigurement.

Recognizing this unmet need, Medicus has already forged a strategic collaboration with the Gorlin Syndrome Alliance (GSA). The partnership aims to establish an Expanded Access Program with the FDA, which would allow patients with the most severe cases—those with multiple, recurrent, or inoperable tumors—to receive SkinJect™ under physician supervision even before it gains full market approval. This initiative not only offers early hope to a vulnerable population but will also provide valuable real-world data on the treatment's safety and tolerability.

A Strategic Play in a Challenging Market

The positive clinical data serves as the centerpiece of Medicus Pharma's corporate strategy: advance promising assets through mid-stage clinical trials to "de-risk" them, making them attractive targets for licensing or acquisition by larger pharmaceutical companies. With these "decision-grade" results in hand, the company believes it is in a strong position to accelerate discussions with potential partners in the dermatology and oncology sectors.

This clinical milestone, however, comes at a time of significant pressure for the company in the financial markets. Despite the promising science, Medicus's stock (MDCX) has struggled, trading near its 52-week low. This reflects a broader trend where clinical-stage biotech companies, which often burn through cash for years before generating revenue, face intense scrutiny from investors.

While the company reported holding more cash than debt, a positive sign of stability, analysts note its ongoing cash burn and lack of profitability. Yet, this high-risk profile is paired with high-reward potential. Some analysts have set price targets significantly above the current stock price, betting that a successful partnership or regulatory progress for SkinJect™ could unlock substantial value.

The SKNJCT-003 study, which completed enrollment of 90 patients in the U.S. in late 2025 and has since expanded to the United Kingdom, is part of a broader global development program. As Medicus prepares for its crucial meeting with the FDA, the company is also advancing other assets, including Teverelix for prostate cancer, underscoring its strategy of building a diversified pipeline to attract the major partners needed to bring these innovations to patients.

The journey from a promising Phase 2 trial to a widely available treatment is long and fraught with challenges, but for the millions affected by basal cell carcinoma, the prospect of a simple patch replacing the surgeon's scalpel is a powerful step forward.