Medicus Pharma Ltd. (NASDAQ:MDCX): Novel Treatment For Basal Cell Carcinoma Could Upend The $15 Billion Market

Skin cancer is the most common form of cancer in the United States, with more than 9,500 cases getting diagnosed every day. In fact, more people are diagnosed with skin cancer each year in the U.S. than all other cancers combined.

The most common form of skin cancer is basal cell carcinoma (BCC), which accounts for over 5 million cases of all skin cancers diagnosed in the U.S. each year. Currently, the standard treatment for most BCC patients is surgery, either standard excision or Mohs micrographic surgery, which has led to a significant unmet medical need for a non-surgical option.

That is why Medicus Pharma Ltd. (NASDAQ:MDCX), a life sciences company focused on accelerating the clinical development programs of novel therapeutic assets, has been attracting investor attention with its revolutionary new treatment that is under development.

A non-invasive novel approach

Medicus, through its wholly owned subsidiary SkinJect Inc., is focused on commercializing a novel, non-invasive treatment for basal cell carcinoma using a patented dissolvable microneedle patch. The patch is thumb-sized, and what makes it particularly unique is its ability to deliver a chemotherapeutic agent (doxorubicin) to kill tumor cells on the skin and induce a memory immune response to prevent cancer recurrence.

Microneedles are promising devices for painless drug delivery, which can improve the biological effect of drugs through adjustable drug release. This novel non-invasive regimen to treat skin cancer, especially BCC, therefore represents a potentially attractive alternative to surgery and current topical therapeutic options.

So far, preliminary trial results have been quite promising.

The company completed a Phase I study for SkinJect in March 2021 for participants with superficial and nodular BCC, which met its primary objective of safety and tolerability. In January 2024, a Phase 2 IND clinical protocol was submitted to the FDA for a randomized, controlled, double-blind, multicenter study that began enrollment in August with 60 patients.

According to Medicus, an interim analysis of the ongoing clinical study reveals that SKNJCT-003 is trending positively, with a proportion of subjects with complete clinical clearance of more than 60%. In April this year, the company announced that the Institutional Review Board (IRB) had approved an increase in the number of patients from 60 to 90, further highlighting the company's progress towards validation.

The company plans to submit the interim analysis to the FDA as part of a package seeking a Type C meeting with the regulator in Q2 2025 with the aim of seeking approval to fast-track the clinical development program. At the same time, the company has said that it will be expanding the phase 2 clinical study into additional sites in the US from the current nine sites as well as two clinical trial sites in Europe.

In addition to that, Medicus has received the study may proceed approval from the UAE Department of Health to commence Phase 2 clinical study (SKNJCT-004) to non-invasively treat BCC. The study is expected to randomize 36 patients in four sites in the UAE.

It's also important to note that the company hasn't limited SkinJect to treating humans only. Last year Medicus received a Minor Use in Major Species Designation (MUMS) for its dissolvable Doxorubin-containing microneedle array (D-MNA) to treat external squamous cell carcinoma (SCC) in horses. MUMS is a designation that is comparable to orphan drug status for human medications.

Earlier this month, the company revealed that it had submitted a comprehensive product development plan to treat external SCC under Investigational New Animal Drug, designed to seek concurrence of the FDA under MUMS designation.

Significant revenue opportunity

As mentioned earlier, the potential addressable market for SkinJect is quite significant. About 40-50% of Americans who live to age 65 will experience BCC or SCC at least once. And while still most prevalent in the older segments of the population, it is becoming ever more frequent in younger individuals.

BCC procedures are projected to grow at 4% per annum, reaching 6 million procedures in 2030, representing a market size in excess of $15 billion annually, and Medicus is well positioned to capture a significant share of this market if SkinJect is approved due to a couple of reasons.

For starters, it is a less painful, less invasive way to treat skin cancer and also lowers the likelihood of recurrence. Secondly, while Mohs surgery costs range between $2,000 and $15,000, the cost of three SkinJect microneedle patches is estimated at $1,000, illustrating the potential for significant cost savings for patients. Furthermore, SkinJect can be administered the same day as a diagnosis, while the average lead time for surgery in the US spans 2-8 months.

Apart from that, the overall incidence of SCC in horses is 2-3%, and recent estimates of the US horse population range from 6.6 to 7.25 million horses. With only a handful of approved oncology drugs in the veterinary market, the company believes that developing a non-invasive treatment for equine SCC represents an untapped and unmet market opportunity potentially in the range of $250 million.

Medicus has continued to show its commitment to unlocking more shareholder value with its recent announcement of a binding letter of intent to acquire Antev Ltd. for $75 million in a share exchange transaction.

Antev is a clinical-stage biotech company developing Teverelix, a next-generation GnRH antagonist, as the first in-market product for cardiovascular high-risk prostate cancer patients and patients with first acute urinary retention (AURr) episodes due to enlarged prostate. Collectively, this represents an additional $6 billion in potential market opportunities for Medicus.

Antev shareholders will receive an aggregate 19% equity stake in Medicus, plus $65 million in additional contingent payments tied to potential future FDA Phase 2 and New Drug Application approvals. The transaction is expected to close before the end of June.

Takeaway

Medicus recently announced the closing of its $7 million public offering, which will be used to fund its Phase 2 proof-of-concept clinical trial, further illustrating investor confidence in the company's progress so far and future prospects. As such, investors searching for a unique opportunity in the cancer treatment space should consider taking a closer look at Medicus before it gains mainstream traction.

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