Medicus Pharma Ltd. to Present at the Family Office Summit in Dubai, UAE

Rhea-AI Summary

Medicus Pharma (NASDAQ:MDCX) will present at the Family Office Summit in Dubai on October 9, 2025, with CEO Dr. Raza Bokhari speaking on biotech innovation, AI in drug development, and the UAE Genomic project.

Medicus is conducting a Phase 2 study of SKNJCT-003 across 9 US sites, expanded to 90 subjects with >75% randomized after randomization began in August 2024; a March 2025 interim analysis showed >60% clinical clearance but results are preliminary. The company received positive FDA Type C feedback in September 2025 indicating a possible 505(b)(2) pathway for Skinject. Medicus also runs a 36-patient UAE trial (SKNJCT-004) and completed the acquisition of Antev (August 2025), adding Teverelix TFA, a long-acting GnRH antagonist with a six-week dosing interval.

Positive

• Interim SKNJCT-003 result: >60% clinical clearance reported (March 2025)
• FDA Type C feedback (Sept 2025) supports potential 505(b)(2) regulatory pathway
• Trial scale-up: SKNJCT-003 increased to 90 subjects with >75% randomized
• Acquisition completed (Aug 2025): adds Teverelix TFA and late-stage assets

Negative

• Interim SKNJCT-003 findings are preliminary and may not hold at study completion
• SKNJCT-003 remains incomplete despite >75% randomized, maintaining clinical outcome uncertainty

Insights

Clinical and Regulatory Expert

Medicus shows clinical momentum and encouraging regulatory feedback that materially advances Skinject and expands its pipeline.

The company reports a Phase 2 study (SKNJCT-003) that began randomization in August 2024, produced a preliminary interim showing >60% clinical clearance after >50% of the original 60-patient target, and the protocol was expanded to 90 subjects with >75% randomized. The program now includes additional European sites and a parallel SKNJCT-004 study in the UAE across six sites, indicating active patient recruitment and geographic diversification.

The FDA provided positive feedback in a Type C meeting supporting a 505(b)(2) pathway for Skinject, which clarifies a viable regulatory route and can shorten development timelines compared with a full NDA pathway. Key regulatory dependencies include final confirmatory efficacy and safety data from the enlarged Phase 2 cohort and alignment with any FDA chemistry, manufacturing, and controls expectations specific to the dissolvable D-MNA platform.

Watch the completion and readout of the Phase 2 primary endpoint, the final safety dataset, and any FDA follow-up requests; expect these items to crystallize over the next 6–18 months. The interim success and Type C feedback are favorable facts but do not guarantee final outcomes.

Corporate Development and Strategy Expert

Acquisition and investor-facing events broaden the company’s clinical scope and market narrative.

Medicus completed the acquisition of Antev in August 2025, adding Teverelix TFA, a late-stage GnRH antagonist with a six-week dosing profile and cardiovascular-focused positioning. This acquisition diversifies the company beyond dermatology into oncology/urology and may alter clinical and commercialization resource allocation.

The planned presentation at the Family Office Summit in October 2025 offers direct access to high-net-worth and institutional family offices and can support capital formation or strategic partnerships. Near-term monitors include the outcome of the Phase 2 Skinject readout, regulatory interactions following the Type C meeting, early clinical signals from Teverelix trials, and any financing or partnering announcements over the next 6–12 months.

EXECUTIVE CHAIRMAN & CEO OF MEDICUS TO PARTICIPATE IN A PANEL DISCUSSION

The Summit theme "unlocking the $1 Trillion Wealth transfer in Dubai"

PHILADELPHIA, PENNSYLVANIA / ACCESS Newswire / October 7, 2025 / 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, is pleased to announce that it will present at the Family Office Summit in Dubai with the theme of "Unlocking the $1 Trillion Wealth Transfer in Dubai".

Panel Discussion Event Details

Date: October 9, 2025
Time: 11:20-11:50 a.m. local time
Location: Park Hyatt, Dubai

The summit will bring together thought leaders, opinion makers, executives and entrepreneurs from around the world to deliberate on unlocking the wealth transfer in Dubai.

Dr. Raza Bokhari, Medicus's Executive Chairman & CEO, in his presentation, will focus on innovation in biotech/life sciences sector, the role of Artificial intelligence (AI) in drug development as well as the United Arab Emirates (UAE) Genomic project as an untapped differentiator.

Additional information on the Family Office Summit is available on the event website at https://familyofficesummit.ae/dubai/.

Medicus is currently conducting a Phase 2 clinical study for SKNJCT-003 in nine (9) clinical sites across the United States which commenced randomizing patients in August 2024. SKNJCT-003 is a double blinded, placebo controlled triple arm proof of concept Phase 2 clinical study, designed to non-invasively treat basal cell carcinoma (BCC) of the skin using novel, patent protected, dissolvable Doxorubicin-containing microneedle arrays (D-MNA). In March 2025, the Company announced a positively trending interim analysis for SKNJCT-003 demonstrating more than 60% clinical clearance. The interim analysis was conducted after more than 50% of the then-targeted 60 patients in the study were randomized. The findings of the interim analysis are preliminary and may or may not correlate with the findings of the study once completed.In April 2025, the investigational review board approved to increase the number of participants in SKNJCT-003 to ninety (90) subjects. The Company is expanding its trial sites in Europe and has randomized more than 75% of the ninety (90) participants expected to be randomized in the study. In September 2025, the company received positive feedback from the Food and Drug Administration (FDA) regarding its Type C meeting supporting the development of Skinject, indicating that the company may follow 505(b)(2) regulatory pathway to non-invasively treat BCC using dissolvable D-MNA.

The Company also has a clinical study (SKNJCT-004) currently underway in the United Arab Emirates (UAE). The study is expected to randomize thirty-six (36) patients in six (6) sites in the UAE. Cleveland Clinic Abu Dhabi (CCAD) is the principal investigator, along with Sheikh Shakbout Medical City (SSMC), Burjeel Medical City (BMC), Rashid Hospital (RH), Clemenceau Medical Center (CMC) and American Hospital of Dubai (AHD). Insights Research Organization and Solutions (IROS), a UAE-based contract research organization, is coordinating the clinical study for the Company. IROS is a M42 portfolio company.

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.

For further information contact:

Carolyn Bonner, President and Acting Chief Financial Officer
(610) 636-0184
cbonner@medicuspharma.com

Anna Baran-Djokovic, SVP Investor Relations
(305) 615-9162
adjokovic@medicspharma.com

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 the investigational 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.

Cautionary Notice on Forward-Looking Statements

Certain information in this news release constitutes "forward-looking information" under applicable securities laws. "Forward-looking information" is defined as disclosure regarding possible events, conditions or financial performance that is based on assumptions about future economic conditions and courses of action and includes, without limitation, the development of Teverelix and expectations concerning, and future outcomes relating to, the development, advancement and commercialization of Teverelix for AURr and high CV risk prostate cancer, and the potential market opportunities related thereto, the MOU, including the potential signing of definitive agreements between Medicus and HelixNano and the development of thermostable infectious diseases vaccines by combining HelixNano's proprietary mRNA vaccine platform with Medicus's proprietary microneedle array (MNA) delivery platform, the Company's aim to fast-track the clinical development program and convert the SKNJCT-003 exploratory clinical trial into a pivotal clinical trial, and approval from the FDA and the timing thereof, plans and expectations concerning, and future outcomes relating to, the development, advancement and commercialization of SkinJect through SKNJCT-003 and SKNJCT-004, and the potential market opportunities related thereto, the commencement of the SKNJCT-004 study and the potential results of and benefits of such study. Forward-looking statements are often but not always, identified by the use of such terms as "may", "on track", "aim", "might", "will", "will likely result", "could," "designed," "would", "should", "estimate", "plan", "project", "forecast", "intend", "expect", "anticipate", "believe", "seek", "continue", "target", "potential" or the negative and/or inverse of such terms or other similar expressions. These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including those risk factors described in the Company's annual report on form 10-K for the year ended December 31, 2024 (the "Annual Report"), and in the Company's other public filings on EDGAR and SEDAR+, which may impact, among other things, the trading price and liquidity of the Company's common shares. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect our expectations as of the date hereof and thus are subject to change thereafter. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Readers are further cautioned not to place undue reliance on forward-looking statements as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.

SOURCE: Medicus Pharma Ltd

View the original press release on ACCESS Newswire

FAQ

When and where will Medicus Pharma (MDCX) present at the Family Office Summit?

Medicus will present on October 9, 2025 at Park Hyatt Dubai, panel time 11:20–11:50 a.m.

What did Medicus report about SKNJCT-003 interim results and timing?

A March 2025 interim analysis showed more than 60% clinical clearance; randomization began in August 2024 and the trial was expanded to 90 subjects.

What regulatory feedback did Medicus receive from the FDA about Skinject (MDCX)?

In September 2025, Medicus received positive Type C meeting feedback indicating it may pursue a 505(b)(2) pathway for Skinject development.

How does the Antev acquisition affect Medicus' pipeline and product profile?

The August 2025 acquisition adds Antev's late-stage candidate Teverelix TFA, a long-acting GnRH antagonist with a six-week dosing interval.

What is the status of Medicus' clinical program in the UAE (SKNJCT-004)?

SKNJCT-004 is underway in the UAE, expected to randomize 36 patients across 6 sites with Cleveland Clinic Abu Dhabi as principal investigator.

Do the March 2025 interim SKNJCT-003 results guarantee final study success for MDCX?

No; the company said the interim findings are preliminary and may or may not correlate with final study outcomes.