Medicus Pharma Ltd. Announces Amendment to LifeArc License Improving Teverelix® Long-Term Economic and Development Profile

Rhea-AI Summary

Medicus Pharma (NASDAQ: MDCX) amended its LifeArc license for Teverelix, reducing the royalty rate from ~4% to 2% while preserving exclusive worldwide rights, sublicensing ability, IP ownership of Medicus-developed improvements, and operational control.

The release cites a ~$6 billion potential combined market for AURr and high cardiovascular‑risk prostate cancer. Parallel updates: SkinJect Phase 2 enrollment completed with 90 patients and topline data expected in Q1 2026, with an end-of-Phase 2 FDA meeting planned in H1 2026.

Positive

• Royalty rate reduced from ~4% to 2%
• Exclusive worldwide rights and sublicensing preserved
• Teverelix addresses a ~$6 billion target market
• SkinJect Phase 2 enrollment completed: 90 patients
• Topline SKNJCT-003 results expected in Q1 2026

Negative

• Phase 2a secondary endpoint not met: probability fell to 82.5% by Day 42
• Phase 2b APC study size is small: 40 patients

News Market Reaction

+0.75%

4 alerts

+0.75% News Effect

+2.4% Peak Tracked

+$249K Valuation Impact

$33M Market Cap

0.1x Rel. Volume

On the day this news was published, MDCX gained 0.75%, reflecting a mild positive market reaction. Argus tracked a peak move of +2.4% during that session. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $249K to the company's valuation, bringing the market cap to $33M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Teverelix royalty rate: 2% Prior royalty rate: ~4% Teverelix/SkinJect market: ~US$6 billion +5 more

8 metrics

Teverelix royalty rate 2% Reduced from ~4% on worldwide net sales under amended LifeArc license

Prior royalty rate ~4% Original royalty rate on worldwide net sales of Teverelix

Teverelix/SkinJect market ~US$6 billion Potential combined market opportunity cited for target indications

SkinJect Phase 2 enrollment 90 patients SKNJCT-003 Phase 2 study across nine U.S. sites

SkinJect interim clearance >60% clinical clearance Exploratory interim analysis in SKNJCT-003 after >50% randomization

Teverelix Phase 1 size 48 healthy male volunteers Completed Phase 1 trial in September 2020

Teverelix APC Phase 2a size 50 patients Phase 2a study in advanced prostate cancer

Teverelix castration response 97.5% vs 82.5% Probability of castration-level suppression initially vs Day 42 in Phase 2a

Market Reality Check

Price: $1.34 Vol: Volume 206,384 is below t...

normal vol

$1.34 Last Close

Volume Volume 206,384 is below the 20-day average of 275,948, suggesting muted pre-news positioning. normal

Technical Shares at $1.33 were trading below the $2.77 200-day moving average, reflecting a weak longer-term trend.

Peers on Argus

Momentum scanner flagged only one peer, RMTI, moving down without news, while MD...

1 Down

Momentum scanner flagged only one peer, RMTI, moving down without news, while MDCX was flagged as up, pointing to stock-specific dynamics rather than a coordinated sector move.

Historical Context

5 past events · Latest: Jan 20 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 20	Corporate milestone	Positive	-1.4%	Nasdaq anniversary bell and multiple Phase 2 and partnering milestones.
Jan 12	Clinical data update	Positive	-5.8%	Teverelix Phase 1 women’s data with hormone suppression and safety profile.
Jan 05	Conference presentation	Positive	+0.0%	Biotech Showcase presentation and SkinJect Phase 2 catalyst timeline.
Dec 22	AI collaboration	Positive	-7.7%	Non-binding LOI with Reliant AI for clinical data analytics platform.
Dec 15	Clinical enrollment	Positive	-3.2%	Completion of 90-patient Phase 2 SKNJCT-003 enrollment with prior positive signals.

Pattern Detected

Recent ostensibly positive clinical and partnering updates have often been followed by flat to negative 24-hour price reactions.

Recent Company History

Over the last five news events since Dec 15, 2025, Medicus highlighted steady clinical and partnering progress: completion of 90-patient Phase 2 enrollment for SkinJect (SKNJCT-003), UK expansion, interim efficacy signals, AI and partnering initiatives, and the Antev/Teverelix acquisition. Despite this, 24-hour reactions were negative or flat after each release. Today’s amendment improving Teverelix economics and reinforcing global rights fits the ongoing theme of de-risking and partnering preparation across both SkinJect and Teverelix programs.

Market Pulse Summary

This announcement improves Teverelix’s long-term economics by reducing royalties to 2% while keeping...

Analysis

This announcement improves Teverelix’s long-term economics by reducing royalties to 2% while keeping global rights and IP control intact, and it reiterates upcoming SkinJect Phase 2 data from 90 enrolled patients. Together with prior Teverelix Phase 1/2a results and FDA feedback on later-stage designs, the news highlights a strategy focused on de-risking assets for partnerships. Investors may watch royalty-bearing deal terms, Phase 2 readouts, and regulatory interactions as key validation points.

Key Terms

gnrh antagonist, acute urinary retention, phase 2, end-of-phase 2, +4 more

8 terms

gnrh antagonist medical

"Teverelix, an investigational next generation long-acting GnRH antagonist."

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

"first in class market product for Acute Urinary Retention Relapse prevention (AURr)"

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 2 medical

"advance select programs through Phase 2 proof-of-concept and pursue licensing"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

end-of-phase 2 regulatory

"End-of-Phase 2 Food and Drug Administration (“FDA”) meeting planned"

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 program regulatory

"pursue the Expanded Access IND Program with the FDA to allow patients"

An expanded access IND program is a regulatory pathway that lets patients get a not-yet-approved drug or therapy outside of clinical trials when no satisfactory alternatives exist, under a company’s investigational new drug (IND) application. It matters to investors because providing early access can demonstrate real-world demand and generate safety or usage information that may influence approval prospects and future sales, but it can also add cost, liability and regulatory scrutiny for the developer.

investigational medicinal product dossier regulatory

"review of the Investigational Medicinal Product Dossier (IMPD) and protocol."

A investigational medicinal product dossier is a comprehensive document that compiles everything regulators need to know about a drug being tested in people: what it is made of, how it is made and controlled, results from lab and animal studies, and plans for human trials. For investors, it is a key milestone because a thorough, well-organized dossier increases the chance regulators will allow clinical testing, reducing development risk and signaling progress toward potential value-creating approvals.

good clinical practice regulatory

"confirming compliance with UK Good Clinical Practice and National Health Service"

Good clinical practice is a global set of ethical and scientific rules for designing, conducting, recording, and reporting clinical trials so that participant safety is protected and results are reliable. For investors, adherence to these rules is like following a strict recipe and inspection checklist: it reduces the risk that trial data will be rejected by regulators, delays approval, or causes costly rework, and therefore affects a company’s timeline, costs, and credibility.

basal cell carcinoma medical

"treatment of basal cell carcinoma (BCC) of the skin."

A type of skin cancer that starts in the cells at the bottom layer of the skin and usually grows slowly and stays local rather than spreading to other organs. It matters to investors because its high frequency and generally surgical treatment drive steady demand for diagnostics, procedures, topical or surgical products, and follow‑on therapies, while new drugs, devices or regulatory approvals can shift market value and reimbursement dynamics. Think of it as a common maintenance issue whose repair options and costs influence healthcare spending and related businesses.

AI-generated analysis. Not financial advice.

Amendment reduces and simplifies royalty structure on Teverelix^® from ~4% to 2% while preserving global rights and IP control

The Company is developing Teverelix^® as a first in class market product for Acute Urinary Retention Relapse prevention (AURr) and best in class for prostate cancer patients with high CV risk collectively representing ~US$6 billion in potential market opportunity

PHILADELPHIA, Jan. 22, 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 its subsidiary, Antev Ltd., has entered into Amendment No. 3 to its license agreement with LifeArc relating to Teverelix, an investigational next generation long-acting GnRH antagonist.

Under the amended agreement, the royalty rate payable on worldwide net sales of Teverelix has been reduced from ~4% to 2%, with the royalty term clarified on a country-by-country basis in line with standard industry practice. The amendment does not alter the scope of the license, the underlying intellectual property, or the respective development responsibilities of the parties, and all other terms of the original agreement remain in full force and effect.

“This amendment substantially improves the long-term economic profile of Teverelix while preserving the strength and integrity of the underlying license,” stated Dr. Raza Bokhari, Medicus Exec. Chairman & CEO, “we believe the reduced royalty burden enhances Teverelix’s attractiveness for future partnering, especially for late-stage development and commercialization.”

The original license grants exclusive, worldwide rights to develop, manufacture, and commercialize Teverelix across all major global markets, with full rights to grant sublicenses, including through multiple tiers, supporting flexible global partnering strategies. Medicus maintains full operational control over development, manufacturing, and commercialization activities, enabling efficient execution and streamlined decision-making.

Under the license framework, all program-specific improvements and enhancements developed by Medicus, and its affiliates are owned by Medicus, supporting continued expansion of the Teverelix intellectual property estate and long-term value creation. Teverelix is supported by a globally issued patent portfolio spanning major pharmaceutical markets.

The amendment reflects the scientific progress and intellectual property expansion achieved by the Antev team, including the generation of additional supporting data and continued strengthening of the Teverelix patent estate, and aligns the parties under a simplified economic framework designed to support efficient, long-term advancement of the program.

LifeArc is a UK-based medical research organization focused on translating high-quality academic and early scientific discoveries into viable medicines by actively partnering with industry to de-risk and advance programs through development. It operates as a sophisticated translational partner, combining scientific expertise, intellectual property creation and licensing capabilities, and long-term partnership governance with a strong patient-impact mission. LifeArc has over £1 billion in assets under management, enabling it to support programs over extended development timelines and reinvest returns from successful partnerships into new medical research initiatives.

Teverelix^®: Differentiated Mechanism with Cardiovascular Relevance

Teverelix trifluoroacetate is a long-acting injectable GnRH antagonist formulated as a microcrystalline suspension. Unlike GnRH agonists, which induce an initial hormonal surge, Teverelix produces immediate receptor antagonism, enabling rapid suppression of LH, FSH, and downstream sex hormones without flare.

This mechanism may be clinically relevant in advanced prostate cancer patients with elevated cardiovascular risk, where emerging evidence suggests persistent FSH exposure may contribute to adverse cardiovascular outcomes. While further clinical validation is required, prior Teverelix studies so far have not demonstrated significant cardiovascular safety signals.

Strategic Focus on Phase 2 De-Risking and Partnering

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

The Company continues to assemble decision-grade clinical and regulatory data packages across its portfolio to support this partnering-focused model.

SkinJect™ Phase 2 Program on Track for Near-Term Data Readout

In parallel, Medicus continues to advance SkinJect™, its proprietary dissolvable microneedle array platform delivering doxorubicin for the non-invasive treatment of basal cell carcinoma (BCC).

• Phase 2 enrollment (SKNJCT-003) completed with 90 patients across nine U.S. sites
• Topline decision-grade data expected in Q1 2026
• End-of-Phase 2 Food and Drug Administration (“FDA”) meeting planned for 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.

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 across three continents.

SkinJect Inc., a wholly owned subsidiary of Medicus Pharma Ltd., is a development-stage life sciences company focused on commercializing a novel, non-invasive treatment for basal cell skin cancer using a patented dissolvable microneedle patch to deliver a chemotherapeutic agent to eradicate tumor cells. The Company completed a Phase 1 study (SKNJCT-001) in March of 2021, which met its primary objective of demonstrating safety and tolerability; the study also describes the efficacy of the investigational product doxorubicin-containing microneedle arrays (D-MNA), with six 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 (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 gonadotrophin-releasing hormone (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.

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 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 U.S. Food and Drug Administration (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, the FDA approved the Phase 2b study design in advanced prostate cancer covering 40 patients.

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

In October 2025, the Company announced a strategic collaboration with the Gorlin Syndrome Alliance (GSA) to advance compassionate access to SkinJect 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 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 D-MNA to non-invasively treat 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 UK Good Clinical Practice and National Health Service capacity and capability standards.

In December 2025, the Company announced that it has successfully completed enrolment of 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 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 industry, 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, high CV risk prostate cancer, women’s health indications like endometriosis, 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

What change did Medicus (MDCX) make to the Teverelix LifeArc license on Jan 22, 2026?

Medicus announced an amendment reducing the Teverelix royalty rate from ~4% to 2% while keeping exclusive global rights and IP control.

How does the royalty cut affect Teverelix’s commercial economics for MDCX shareholders?

The amendment lowers long-term royalty burden to 2%, which the company says improves partner attractiveness for late-stage development and commercialization.

What market opportunity does Teverelix target according to Medicus (MDCX)?

Medicus cites a combined potential market of approximately $6 billion for AURr and high cardiovascular‑risk prostate cancer indications.

What is the timing for SkinJect (MDCX) Phase 2 topline data and regulatory milestones?

SKNJCT-003 completed enrollment with 90 patients; topline results are expected in Q1 2026 and an end-of-Phase 2 FDA meeting is planned in H1 2026.

What notable clinical risk did Medicus disclose about Teverelix’s earlier trials?

In the Phase 2a study, the primary testosterone suppression endpoint met >90% probability initially, but the secondary endpoint was not met, dropping to 82.5% by Day 42.