BRISTOL, TN, NY / ACCESS Newswire / October 14, 2025 / Most biotech stories collapse on a single product failure. Medicus Pharma Ltd (NASDAQ: MDCX) built three distinct shots at blockbuster markets.

The NASDAQ-listed company is developing Skinject, a dissolvable microneedle array delivering doxorubicin for basal cell carcinoma ^[1]. It acquired Teverelix, a GnRH antagonist designed for prostate cancer patients with cardiovascular risk ^[4]. And it signed a non-binding memorandum of understanding with HelixNano to explore combining its microneedle delivery platform with mRNA vaccine technology ^[4].

Each platform addresses a different therapeutic area, each targets a validated market opportunity, and each helps mitigate the binary risk that defines most biotech portfolios.

The Regulatory Shortcut Investors Shouldn't Overlook

In September 2025, the FDA provided positive feedback in a Type C meeting, confirming that Skinject qualifies for the 505(b)(2) regulatory pathway ^[1]. This pathway allows Medicus to reference existing doxorubicin safety data rather than repeat all foundational studies-potentially reducing costs and shortening development timelines ^[1][6].

The agency also provided guidance on study endpoints, patient selection, and bridging bioavailability studies ^[2]. These details matter: 505(b)(2) approvals typically demonstrate higher success rates and faster review cycles than full NDAs.

Market and Incidence Context

Medicus is targeting a basal cell carcinoma (BCC) treatment market estimated at $3.7 billion in 2025, projected to reach $9.0 billion by 2034, a compound annual growth rate near 10.5 percent ^[1]. The United States alone sees roughly 3.6 million new BCC diagnoses annually ^[1].

Clinical Milestones and Timelines

U.S. Trial (SKNJCT-003): Phase 2 enrollment expanded from 60 to 90 participants. More than 75 percent of patients have been randomized across nine U.S. clinical sites ^[2]. An interim analysis in March 2025 showed over 60 percent clinical clearance in treated patients ^[2]. Medicus expects recruitment completion by Q4 2025 and an End-of-Phase 2 meeting with the FDA in Q1 2026 ^[1].

UAE Trial (SKNJCT-004): A parallel 36-patient study is underway in the United Arab Emirates, including Cleveland Clinic Abu Dhabi and American Hospital Dubai among six participating institutions ^[3].

Microneedle drug-delivery technologies are gaining traction industry-wide, with market forecasts exceeding $4 billion globally by 2030 and North America accounting for roughly 43 percent of revenue share ^[1]. Such systems enable painless, self-administered dosing and higher patient adherence across vaccines, pain management, diabetes, and dermatology.

The Cardiovascular Safety Angle: Teverelix

In August 2025, Medicus completed the acquisition of Antev Limited, securing the Teverelix program ^[4]. Teverelix is a next-generation GnRH antagonist for prostate cancer patients with high cardiovascular risk. GnRH antagonists suppress testosterone immediately-without the initial surge seen in older agonists that may destabilize arterial plaques ^[4].

Multiple meta-analyses indicate that antagonists are associated with approximately 40-50 percent fewer major adverse cardiovascular events (odds ratios in the 0.5-0.6 range) compared with agonists ^[5]. Yet, between 2010 and 2018, only 7.1 percent of prostate-cancer patients received antagonists, while 92.9 percent were treated with agonists ^[5]. That usage gap reflects a substantial opportunity for newer, safer therapies.

Teverelix is formulated as a microcrystalline suspension with a six-week dosing interval, which could improve patient compliance versus monthly regimens ^[4].

Portfolio Strategy as Risk Mitigation

The HelixNano collaboration remains non-binding and exploratory, but it underscores Medicus's intent to pair its microneedle platform with thermostable vaccine technology ^[4].

As of Q2 2025, Medicus reported $9.7 million in cash on hand ^[5]. By distributing risk across three independent programs-dermatology, urology/oncology, and vaccines-the company aims to create diversified paths to value creation. Even one or two program successes could justify its current enterprise valuation-an approach few early-stage biotechs can credibly claim.

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About Medicus Pharma Ltd.
Medicus Pharma Ltd. (NASDAQ: MDCX) is a biotech/life sciences company focused on accelerating the clinical development programs of novel and potentially disruptive therapeutics assets. The Company is actively engaged in multiple countries, spread over three continents.

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 skin cancer using a patented dissolvable microneedle patch to deliver a chemotherapeutic agent to eradicate tumors cells. The Company completed a phase 1 safety & tolerability study (SKNJCT-001) in March of 2021, which met its primary objective of safety and tolerability; the study also describes the efficacy of theinvestigational product D-MNA, with six (6) participants experiencing complete response on histological examination of the resected lesion. The Company is currently conducting a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-003) in the United States and Europe. The Company has also commenced a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-004) in the United Arab Emirates.

In August 2025, the Company announced its entry into a non-binding memorandum of understanding (the "MoU") with Helix Nanotechnologies, Inc. ("HelixNano"), a Boston Based biotech company focused on developing a proprietary advanced mRNA platform, in respect of their shared mutual interest in the development or commercial arrangement contemplated by the MoU. The MoU is non-binding and shall not be construed to obligate either party to proceed with a joint venture or any further development or commercial arrangement, unless and until definitive agreements are executed.

In August 2025, the Company completed the acquisition of Antev, a UK-based late clinical stage biotech company, developing Teverelix, a next generation GnRH antagonist, as a first in market product for cardiovascular high-risk advanced prostate cancer patients and patients with first acute urinary retention relapse (AURr) episodes due to enlarged prostate.

Antev's flagship drug candidate is Teverelix trifluoroacetate (Teverelix TFA), a long-acting gonadotrophin-releasing hormone (GnRH) antagonist. Unlike GnRH agonists, which can cause an initial surge in testosterone levels, Teverelix directly suppresses sex hormone production without this surge, potentially reducing cardiovascular risks. This mechanism is particularly beneficial for patients with existing cardiovascular conditions. Teverelix is formulated as a microcrystalline suspension, allowing for sustained release and a six-week dosing interval, which may improve patient compliance and outcomes.

In September 2020, Antev completed a Phase 1 clinical trial in which Teverelix was shown to be well tolerated with no dose-limiting toxicities and demonstrated rapid testosterone suppression. The study included 48 healthy male volunteers. In February 2023, Antev also completed a Phase 2a study in fifty (50) patients with advanced prostate cancer (APC), where Teverelix achieved the primary endpoint of greater than 90% probability of castration levels of testosterone suppression (97.5%) but the secondary endpoint of maintaining this rate above 90% was not met with the probability dropping to 82.5% by Day 42.

In January 2023, the FDA, reviewed the Phase 1 and Phase 2a data and provided written guidance on Antev's proposed Phase 3 trial design for Teverelix. This milestone supports the Company's clinical plans to develop Teverelix as a treatment for advanced prostate cancer patients with increased cardiovascular risk.

In December 2023, FDA approved the Phase 2b study design in advanced prostate cancer covering 40 patients.

In November 2024, FDA approved the Phase 2b study design in acute urinary retention covering 390 patients.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements, including those regarding future financial performance, business strategy, market expansion, and operational objectives, are based on current expectations and involve risks and uncertainties. Actual results may differ materially from those projected due to various factors including market conditions, competitive dynamics, regulatory changes, and operational challenges.

The company's SEC filings provide detailed risk factors that should inform any investment decision. Market conditions, competitive pressures, and execution challenges could materially impact future performance.

VisionWave operates in a high-growth sector with legitimate technological differentiation. But the gap between market opportunity and captured revenue remains wide.

References

^[1] Towards Healthcare. Basal Cell Carcinoma Treatment Market Sizing. Available at: https://www.towardshealthcare.com/insights/basal-cell-carcinoma-treatment-market-sizing

^[2] Medicus Pharma Ltd. Company filings and press releases regarding SKNJCT-003 Phase 2 trial updates, enrollment expansion, and interim data (March-August 2025).

^[3] Medicus Pharma Ltd. Press releases announcing UAE trial SKNJCT-004, DoH approval, and participating clinical sites (May-September 2025).

^[4] Medicus Pharma Ltd. Press release: Completion of Antev Limited acquisition and HelixNano memorandum of understanding (August 2025).

^[5] Frontiers in Endocrinology. GnRH Antagonist Cardiovascular Safety and Real-World Utilization. Available at: https://www.frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2023.1157857/full; JACC: CardioOncology. Meta-analysis of GnRH Antagonists vs Agonists. Available at: https://www.jacc.org/doi/10.1016/j.jaccao.2023.05.011

^[6] U.S. Food and Drug Administration. Guidance on 505(b)(2) Applications (21 CFR 314.54); ScienceDirect. 505(b)(2) Regulatory Pathway Advantages. Available at: https://www.sciencedirect.com/science/article/abs/pii/S135964461830120X

SOURCE: Medicus Pharma Ltd