Medicus Pharma Ltd. to Present at Biotech Showcase 2026 as SkinJect Phase 2 Clinical Data Approaches Readout and Partnering Readiness Accelerates

Rhea-AI Summary

Medicus Pharma (NASDAQ: MDCX) will present at Biotech Showcase 2026 on Jan 13, 2026 at 10:00 a.m. PT, discussing Phase 2 catalysts, partnering readiness, and regulatory strategy for SkinJect™ and recent portfolio additions.

Key facts: completed enrollment of 90 patients in SKNJCT-003, topline Phase 2 results expected in Q1 2026, FDA Type C feedback supporting a 505(b)(2) pathway, CNPV application submitted in Nov 2025, acquisition of Antev (Teverelix) and a non-binding LOI with Reliant AI.

Positive

• SKNJCT-003 enrollment completed: 90 patients
• Topline Phase 2 results expected in Q1 2026
• FDA Type C feedback supports 505(b)(2) regulatory pathway
• Acquisition of Antev adds Teverelix program
• Applied for CNPV in Nov 2025 to accelerate review

Negative

• Teverelix Phase 2a secondary endpoint fell to 82.5% by Day 42
• SKNJCT-003 interim findings are preliminary and may not correlate
• Reliant AI LOI and HelixNano MoU are non-binding

Key Figures

SKNJCT-003 enrollment 90 patients Phase 2 proof-of-concept BCC study in the U.S.

Clinical clearance rate >60% Exploratory interim analysis in SKNJCT-003

Phase 1 complete responses 6 participants SKNJCT-001 histologic complete responses

SKNJCT-004 sample size 36 subjects UAE Phase 2 BCC study across multiple sites

Teverelix Phase 1 size 48 volunteers Phase 1 trial in healthy male volunteers

Teverelix Phase 2a size 50 patients Advanced prostate cancer Phase 2a study

Castration suppression rate 97.5% Primary endpoint in Teverelix Phase 2a APC study

Day 42 suppression probability 82.5% Secondary endpoint in Teverelix Phase 2a APC study

Market Reality Check

$1.55 Last Close

Volume Volume 175,607 is at 0.46x the 20-day average of 377,729, indicating subdued trading versus recent norms. low

Technical Shares at $1.60 are trading below the 200-day MA of $2.88 and remain far under the $8.94 52-week high.

Peers on Argus 1 Up

Key biotech peers show mixed but mostly positive moves, with names like IXHL up 8% and SCLX up 7.47%, suggesting today’s setup for MDCX is more stock-specific than a broad sector swing.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 22	AI collaboration, clinical	Positive	-7.7%	Non-binding LOI with Reliant AI plus SkinJect and Antev clinical progress.
Dec 15	Phase 2 enrollment	Positive	-3.2%	Completion of 90-patient SKNJCT-003 enrollment and Q1 2026 topline timing.
Dec 05	Warrant inducement	Positive	+3.5%	Warrant exercise at $1.92 for $5.1M gross proceeds and new C/D warrants.
Dec 01	Management, pipeline	Positive	-10.2%	CFO appointment plus SkinJect Phase 2 progress and Antev acquisition recap.
Nov 24	Oncology pipeline	Positive	-7.0%	Updates on Teverelix prostate program and SkinJect trials and access plans.

Pattern Detected

Recent positive operational and clinical updates have often coincided with negative next-day price reactions, indicating a pattern of downside divergence on good news.

Recent Company History

Over the last several months, Medicus has focused on advancing SkinJect and Teverelix while strengthening its capital structure and leadership. Key steps included U.S. and UAE Phase 2 progress for SkinJect, U.K. regulatory approvals, and acquisition of Antev in August 2025. A $5.1M warrant inducement and multiple insider option grants also featured. Clinical‑trial tagged news, such as completion of 90-patient enrollment, previously met with modest to negative price moves, providing context for how markets have reacted to development milestones ahead of this new Phase 2–focused update.

Market Pulse Summary

This announcement highlights Medicus entering 2026 with multiple Phase 2 catalysts, notably SkinJect, which has completed enrollment of 90 patients in SKNJCT-003 and is approaching topline data. It also underscores Teverelix’s existing Phase 1 and 2a results and planned Phase 2b work. Historically, clinical‑trial news for the company has led to varied price reactions, so investors may focus on the upcoming Phase 2 readouts, regulatory interactions, and partnering progress to gauge future impact.

Key Terms

dissolvable microneedle array medical

"its novel, proprietary doxorubicin containing dissolvable microneedle array (D-MNA) platform"

A dissolvable microneedle array is a patch covered in tiny, painless needles made from a material that dissolves into the skin to release a drug or vaccine. For investors, it matters because this delivery method can reduce costs and logistical hurdles (less need for cold storage and sharps disposal), improve patient comfort and uptake, and open new manufacturing and regulatory pathways that can affect a product’s commercial potential.

505(b)(2) regulatory

"supporting the potential use of the 505(b)(2) regulatory pathway for SkinJect™"

A 505(b)(2) is an FDA drug approval pathway that lets a company win approval by relying partly on existing studies or published data instead of doing all new clinical trials. Think of it like building a renovated house using the original foundation: it can be faster and less costly than a full new-drug route, reducing development risk and expense. Investors care because it can speed market entry, lower capital needs, and offer opportunities for exclusivity or competitive advantage.

end-of-phase 2 regulatory

"to pursue an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration"

End-of-phase 2 is the development milestone when a drug or medical treatment completes its mid-stage human testing and the sponsor and regulators review the results to decide whether and how to proceed to larger late-stage trials. It matters to investors because this review signals whether the product showed enough benefit and acceptable safety to justify expensive Phase 3 studies, much like passing a major exam before committing to the final, costly year of a degree, and can materially affect a company’s value and funding needs.

expanded access ind regulatory

"pursuing an Expanded Access IND program to provide Gorlin Syndrome patients"

An expanded access IND is a regulatory permission that allows patients to receive an experimental drug or therapy outside of formal clinical trials when no approved options exist. For investors, it means a company can legally supply its investigational treatment to seriously ill patients under supervision — like a limited release of a prototype — which can reveal early real‑world use, influence perceived demand, produce safety data, and introduce costs or reputational risk before full approval.

gonadotrophin-releasing hormone medical

"Teverelix trifluoroacetate, a long-acting gonadotrophin-releasing hormone (GnRH) antagonist"

Gonadotrophin-releasing hormone is a small signaling hormone produced by the brain that tells the body when to make sex hormones like estrogen and testosterone, acting like a traffic light that starts or stops reproductive hormone production. Investors watch it because medicines that mimic or block this signal are used to treat fertility issues, hormone-sensitive cancers, and other conditions; regulatory approvals, patent news, or clinical trial results for such drugs can materially affect company value.

gnrh antagonist medical

"a next generation GnRH antagonist targeting advanced prostate cancer patients"

A GnRH antagonist is a type of medicine that blocks the body’s chemical switch that tells the ovaries or testes to make sex hormones like estrogen or testosterone. Like turning off a faucet that controls hormone flow, this immediate block lowers hormone levels and is used in conditions such as hormone-driven cancers and fertility treatments. Investors follow GnRH antagonists for their potential market size, regulatory approvals, and how they fit into a drug maker’s pipeline and revenue outlook.

acute urinary retention medical

"patients with acute urinary retention relapse (AURr) episodes due to enlarged prostate"

A sudden inability to pass urine that creates severe discomfort and often requires immediate medical help, like inserting a tube to drain the bladder. Investors care because it drives urgent healthcare visits, short-term hospital procedures and demand for drugs, devices or diagnostic services, so changes in incidence, new treatments, or regulatory approvals can affect revenue, clinical trial opportunities and healthcare costs in related markets.

phase 2b medical

"In December 2023, FDA approved the Phase 2b study design in advanced prostate cancer"

Phase 2b is a stage in the development of a new medicine or treatment where researchers test its effectiveness and safety in a larger group of people. This step helps determine whether the treatment works well enough to move forward and if it has manageable side effects, which is important for investors because successful results can lead to potential approval and market opportunity.

AI-generated analysis. Not financial advice.

The Company enters 2026 with Multiple Phase 2 Catalysts collectively representing ~$8 billion in potential market opportunities, an AI-enabled development strategy, and regulatory optionality

PHILADELPHIA, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a precision guided 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 Biotech Showcase 2026, taking place January 12–14, 2026, in San Francisco.

Dr. Raza Bokhari, Executive Chairman & CEO of Medicus will deliver a company presentation as Medicus enters 2026 with multiple Phase 2 Catalysts across clinical, regulatory, and pipeline expansion programs.

Biotech Showcase Presentation Details

Presentation Date:	Tuesday, January 13, 2026
Time:	10:00 a.m. Pacific time
Location:	Yosemite A (Ballroom Level), Hilton San Francisco – Union Square

The presentation will be webcast live and can be accessed here or from the company's website. The webcast will be archived and available for replay after the presentation.

Dr. Bokhari and Medicus executives will be available for one-on-one meetings with institutional investors and prospective partners registered for the conference through the partneringONE portal of the event.

Strategic Focus: Phase 2 De-Risking and Partnering

Medicus’ strategy is to advance select programs through Phase 2 proof-of-concept and pursue licensing or strategic partnerships with established pharmaceutical companies that are best positioned to conduct late-stage development and commercialization.

As data matures across its programs, the Company aims to assemble decision-grade clinical, regulatory, and operational data packages aligned with this out-licensing strategy.

SkinJect™ Phase 2 Program: Execution Milestones Achieved

Medicus continues to advance SkinJect™, its novel, proprietary doxorubicin containing dissolvable microneedle array (D-MNA) platform, designed to non-invasively treat basal cell carcinoma (BCC) of the skin.

In December 2025, the Company completed enrollment of 90 patients in its randomized, double-blind, placebo-controlled Phase 2 proof-of-concept study (SKNJCT-003) across nine clinical sites in the United States. The study is designed to evaluate the safety, tolerability, and clinical efficacy of SkinJect™.

The Company expects to report topline decision grade Phase 2 results in the first quarter of 2026 and to pursue an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) in the first half of 2026.

Previously disclosed positively trending interim findings demonstrated greater than 60% clinical clearance in an exploratory analysis conducted after more than 50% of patients of the then-targeted 60 patients in the study had been randomized. The findings of the interim analysis are preliminary and may or may not correlate with the findings of the study once completed.

Regulatory and Geographic Expansion Supports De-Risking Strategy

Medicus has expanded the clinical and regulatory footprint of SkinJect™ to support development and partnering readiness:

• United States: Phase 2 enrollment completed for SKNJCT-003
• United Kingdom: Full regulatory and ethics approvals received from the MHRA, HRA, and WREC to expand SKNJCT-003
• United Arab Emirates: First patient dosed in SKNJCT-004, a Phase 2 study conducted at six sites with Cleveland Clinic Abu Dhabi as principal investigator
  

In September 2025, the FDA provided positive feedback following a Type C meeting, supporting the potential use of the 505(b)(2) regulatory pathway for SkinJect™.

Regulatory Optionality: FDA Commissioner’s National Priority Voucher (CNPV)

In November 2025, Medicus applied to the U.S. Food and Drug Administration (FDA) seeking eligibility for the FDA Commissioner’s National Priority Voucher (CNPV) program for SkinJect™.

If granted, the CNPV could provide Medicus with a voucher intended to accelerate FDA review timelines for a future new drug application, which the Company may utilize as part of a strategic partnering or licensing transaction. There can be no assurance that the application will be approved or that a voucher will be granted.

The Company believes that SkinJect™’s non-invasive approach to treating basal cell carcinoma and its potential public-health impact support consideration under the program. Medicus continues to advance its regulatory strategy in parallel with clinical development and partnering preparation.

AI-Enabled Clinical Development: Reliant AI Engagement

In December 2025, Medicus announced a non-binding letter of intent with Reliant AI Inc., a decision-intelligence company specializing in generative AI for the life sciences, to collaborate on the development of an AI-driven clinical data analytics platform.

Subject to execution of definitive agreements, the platform is expected to support capital-efficient clinical development through data-driven dynamic clinical-site selection, patient stratification, and enrollment forecasting. The initial phase of the collaboration is expected to support an upcoming Teverelix clinical study planned for 2026, with potential expansion into later-stage development programs in collaboration with a strategic partner. There can be no assurance that a definitive agreement will be executed with Reliant AI Inc. or that the proposed collaboration will proceed as contemplated.

Skinject Platform Expansion: Helix Nanotechnologies MoU:

The Company is exploring co-development of thermostable infectious disease vaccines combining HelixNano’s proprietary mRNA technology with Medicus microneedle array delivery platform.

Pipeline Expansion—Acquisition of Antev

With the acquisition of Antev Limited (“Antev”) in August 2025, a UK-based clinical stage biotech company, Medicus added Teverelix, a next generation GnRH antagonist targeting advanced prostate cancer patients with elevated cardiovascular risk and patients with acute urinary retention relapse (AURr) episodes due to enlarged prostate.

Patient Access and Advocacy---Gorlin Syndrome Alliance Collaboration

In collaboration with the Gorlin Syndrome Alliance, Medicus is pursuing an Expanded Access IND program to provide Gorlin Syndrome patients with multiple or inoperable BCCs access to SkinJect™, the Company’s investigational doxorubicin containing microneedle arrays (D-MNA), under physician supervision. The initiative aims to establish a framework for expanded access while generating real-world safety and tolerability data to inform future regulatory filings. It will also more tightly integrate patient community-led insights and data into the design, monitoring, and long-term development of SkinJect™ in this rare disease population.

For further information contact:

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

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

About Medicus Pharma Ltd.

Medicus Pharma Ltd. (Nasdaq: MDCX) is a precision guided 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, 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

In October 2025, the Company announced a strategic collaboration with the Gorlin Syndrome Alliance (GSA) to advance compassionate access to SkinJect™, the Company’s investigational doxorubicin containing microneedle arrays (D-MNA) for patients suffering from Gorlin Syndrome, also known as nevoid basal cell carcinoma syndrome.

Under the collaboration, Medicus and the GSA will jointly pursue the Expanded Access IND Program with the Food and Drug Administration (FDA) to allow patients with multiple, recurrent, or inoperable basal cell carcinomas (BCCs) to access SkinJect™ under physician-supervised treatment protocols. The initiative aims to establish a framework for expanded access while collecting valuable real-world safety and tolerability data to inform future regulatory filings. It will also more tightly integrate patient community-led insights and data into the design, monitoring, and long-term development of SkinJect™ in this rare disease population.

In November 2025, the Company received full regulatory and ethical approvals in the United Kingdom to expand its ongoing Phase 2 clinical study (SKNJCT-003) evaluating Doxorubicin Microneedle Array (D-MNA) to non-invasively treat basal cell carcinoma (BCC) of the skin. The approvals were issued by the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority (HRA) and the Wales Research Ethics Committee (WREC). The MHRA approval followed a comprehensive scientific review of the Investigational Medicinal Product Dossier (IMPD) and protocol. The WREC issued a favorable ethical opinion, and the HRA granted study wide governance approval, confirming compliance with U.K. Good Clinical Practice and National Health Service capacity and capability standards.

In December 2025, the Company announced that it has successfully completed enrolment of ninety (90) patients in the United States for phase 2 clinical study (SKNJCT-003) evaluating D-MNA to non-invasively treat BCC of the skin. The Company expects to release topline results for SKNJCT-003 in the first quarter of 2026 and secure an end of phase 2 (EOP2) meeting with the FDA in the first half of 2026.

In December 2025, Medicus announced a non-binding letter of intent with Reliant AI Inc., a decision-intelligence company specializing in generative AI for the life sciences, to collaborate on the development of an AI-driven clinical data analytics platform. Subject to execution of definitive agreements, the platform is expected to support capital-efficient clinical development through data-driven dynamic clinical-site selection, patient stratification, and enrollment forecasting. The initial phase of the collaboration is expected to support an upcoming Teverelix clinical study planned for 2026, with potential expansion into later-stage development programs in collaboration with a strategic partner.

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, statements regarding the Company’s leadership and prospects, the collaboration with GSA including the potential benefits thereof for GSA, those suffering with Gorlin Syndrome and Medicus (including as it relates to the development of SkinJect™), ability to be approved for the Expanded Access IND Program to enable those suffering with Gorlin Syndrome to access SkinJect™ under physician-supervised treatment protocols, 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, including with respect to the Company’s submission for approval in the FDA Commissioner's National Priority Voucher program, 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 Company’s expectation to release topline results for SKNJCT-003 in the first quarter of 2026 and to secure an EOP2 meeting with the FDA in the first half of 2026, entry into definitive documents with Reliant and the expected terms thereof, engaging in proposed Medicus-sponsored studies currently contemplated in the Reliant non-binding letter of intent and the expected benefits thereof, the expansion of SKNJCT-003 into the United Kingdom and the potential benefits therefrom, the advancement 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.

FAQ

When will Medicus (MDCX) present at Biotech Showcase 2026?

Medicus will present on January 13, 2026 at 10:00 a.m. PT in Yosemite A at the Hilton San Francisco.

When will Medicus (MDCX) release SKNJCT-003 topline Phase 2 results?

The company expects to report topline Phase 2 results for SKNJCT-003 in Q1 2026.

How many patients were enrolled in Medicus’s SKNJCT-003 Phase 2 trial?

Medicus completed enrollment of 90 patients in SKNJCT-003 across nine U.S. sites.

What regulatory pathway did the FDA feedback support for SkinJect (MDCX)?

A Type C meeting provided feedback supporting potential use of the 505(b)(2) regulatory pathway.

What is the status of Medicus’s FDA Commissioner’s National Priority Voucher (CNPV) for SkinJect?

Medicus applied for the CNPV in November 2025; there is no assurance a voucher will be granted.

What material clinical data does Medicus hold for Teverelix after acquiring Antev?

Antev’s Phase 2a showed 97.5% probability of castration-level testosterone suppression but fell to 82.5% by Day 42 for the secondary endpoint.

What are Medicus’s near-term partnering and development plans for SkinJect (MDCX)?

The company aims to use Phase 2 decision-grade data to pursue licensing or strategic partnerships and to seek an EOP2 meeting with FDA in H1 2026.