Medicus Pharma Business Update Call to Highlight 80% Overall Response Rate (ORR) in Phase 2 SkinJect Study and Agentic AI-enabled Drug Development Plan

Rhea-AI Summary

Medicus Pharma (NASDAQ: MDCX) will host a business update on March 26, 2026, highlighting Phase 2 SkinJect data and AI plans. The 200µg cohort showed an 80% overall response rate (ORR) at Day 57, with 73% clinical clearance and 40% histological complete response.

The company plans an End-of-Phase 2 FDA discussion, is advancing an agentic AI clinical platform, and reported $8.7 million in cash at year-end 2025 after raising ~$31.9 million in 2025.

Positive

• 80% ORR in 200µg cohort at Day 57
• 73% clinical (visual) clearance at Day 57
• 40% histological complete response (CR) at Day 57
• $31.9M capital raised during 2025

Negative

• Only $8.7M cash and cash equivalents at year-end 2025
• Phase 2 is exploratory pending End-of-Phase 2 FDA alignment

Market Reaction – MDCX

-8.50% $0.45

15m delay 4 alerts

-8.50% Since News

-5.2% Trough Tracked

$0.45 Last Price

$0.42 $0.51 Day Range

-$1M Valuation Impact

$11M Market Cap

0.3x Rel. Volume

Following this news, MDCX has declined 8.50%, reflecting a notable negative market reaction. Argus tracked a trough of -5.2% from its starting point during tracking. Our momentum scanner has triggered 4 alerts so far, indicating moderate trading interest and price volatility. The stock is currently trading at $0.45. This price movement has removed approximately $1M from the company's valuation.

Data tracked by StockTitan Argus (15 min delayed). Upgrade to Silver for real-time data.

Key Figures

Overall Response Rate: 80% ORR Clinical clearance: 73% clearance Histological CR: 40% complete response +5 more

8 metrics

Overall Response Rate 80% ORR 200µg SkinJect cohort at Day 57 (Phase 2 SKNJCT-003)

Clinical clearance 73% clearance 200µg SkinJect cohort at Day 57 (visual)

Histological CR 40% complete response 200µg SkinJect cohort at Day 57

Cohort size 15 patients 200µg D-MNA cohort in SKNJCT-003

Capital raised $31.9 million Capital raised during 2025

Year-end cash $8.7 million Cash and cash equivalents at year-end 2025

SkinJect market ~$2 billion Estimated market opportunity for SkinJect-related indications

Teverelix market ~$6 billion Estimated market opportunity for Teverelix indications

Market Reality Check

Price: $0.4939 Vol: Volume 1,045,494 is about...

low vol

$0.4939 Last Close

Volume Volume 1,045,494 is about 0.1x the 20-day average of 10,746,329, indicating subdued trading ahead of the update call. low

Technical Shares at $0.4939 are trading below the $2.00 200-day moving average and remain 94.48% under the 52-week high of $8.94.

Peers on Argus

Scanner data flags the stock moving separately from peers: one momentum peer is ...

1 Up 1 Down

Scanner data flags the stock moving separately from peers: one momentum peer is up while another is down, and other high-affinity peers show mixed single-day changes between about -2% and +15%, pointing to a stock-specific narrative.

Previous Clinical trial,AI Reports

1 past event · Latest: Dec 22 (Positive)

Same Type Pattern 1 events

Date	Event	Sentiment	Move	Catalyst
Dec 22	AI platform engagement	Positive	-7.7%	Non-binding LOI with Reliant AI for data-driven clinical development.

Pattern Detected

For AI-linked clinical development news, the prior tagged event showed a negative price reaction despite constructive operational updates.

Recent Company History

Recent news flow has centered on SkinJect’s Phase 2 results and the AI-enabled development strategy. Multiple March 2026 releases highlighted 73% clinical clearance and 40% histological clearance in the 200µg cohort, alongside plans for an End-of-Phase 2 FDA meeting and partnering discussions. The current announcement adds an 80% ORR at Day 57 plus a broader agentic AI vision, extending the earlier narrative of decision-grade data, regulatory engagement, and capital-efficient trial execution.

Historical Comparison

-7.7% avg move · Historically, MDCX’s only prior ‘clinical trial,AI’ update on Dec 22, 2025 saw a -7.69% move despite...

clinical trial,AI

-7.7%

Average Historical Move clinical trial,AI

Historically, MDCX’s only prior ‘clinical trial,AI’ update on Dec 22, 2025 saw a -7.69% move despite constructive AI and SkinJect progress. Today’s combined SkinJect ORR and agentic AI plan extends that theme, with the earlier reaction suggesting investors have previously discounted similar strategy updates.

The company has progressed from a Reliant AI LOI supporting Teverelix trials and SkinJect enrollment milestones to presenting detailed Phase 2 SkinJect efficacy metrics plus a broader agentic AI-enabled clinical development roadmap.

Market Pulse Summary

The stock is down -8.5% following this news. A negative reaction despite the 80% ORR and 73% clearan...

Analysis

The stock is down -8.5% following this news. A negative reaction despite the 80% ORR and 73% clearance at Day 57 would fit a pattern where prior AI-linked clinical updates drew selling even on constructive news. The stock already traded well below its 200-day moving average and far under the 52-week high, so concerns about future capital needs, trial design complexity, and regulatory milestones could have outweighed the incremental efficacy details and AI-development narrative in the short term.

Key Terms

overall response rate, orr, partial response, microneedle, +3 more

7 terms

overall response rate medical

"highlight 80% Overall Response Rate (ORR) in the 200µg cohort at Day 57"

Overall response rate is the percentage of patients in a clinical study whose measurable disease shrinks or disappears after receiving a treatment. Investors watch it like a product’s “hit rate” because higher response rates can signal a drug’s effectiveness, boost chances of regulatory approval and market demand, and affect a company’s future revenue prospects, similar to how a higher batting average suggests a more reliable player.

orr medical

"including an overall response rate (ORR) of 80% in the 200µg cohort"

Objective Response Rate (ORR) is the percentage of patients in a clinical trial whose tumors shrink or disappear by a predefined amount after treatment. For investors, ORR is a quick, measurable signal of a therapy’s effectiveness—like early sales numbers for a new product—and strong ORR data can boost a drug’s commercial prospects and company valuation, while weak ORR can temper expectations.

partial response medical

"representing partial response (PR) and over-all response rate (ORR) for each cohort"

A partial response is a clinical outcome where a treatment produces a clear, measurable improvement in a disease — for example a substantial shrinkage of a tumor or reduction in symptom measures — but does not eliminate the disease entirely. For investors it signals meaningful efficacy that can support regulatory progress, further trials, or commercial potential, like seeing a product gain market traction even though it hasn’t achieved a complete cure.

microneedle medical

"The role of: Microneedle-mediated tumor disruption"

A microneedle is a tiny, often patch-like array of microscopic needles designed to deliver drugs, vaccines or other substances through the outer layer of the skin with minimal pain. Think of it as a bandage with very fine pins that bypass the skin barrier to release medicine directly where it can be absorbed faster and more reliably. Investors care because microneedle technology can create new product formats, improve patient uptake, reduce dosing costs and manufacturing challenges, and affect market size, regulatory pathways and intellectual property value.

gorlin syndrome medical

"Gorlin Syndrome, a rare autosomal dominant disease also called nevoid BCC syndrome"

A rare inherited genetic condition that increases a person’s lifetime risk of developing multiple skin cancers and other growths, often beginning in childhood or early adulthood. For investors it matters because the small, defined patient group and predictable medical needs make the condition a target for specialized drugs, diagnostics and long‑term care markets; think of it like a known design flaw that creates steady demand for fixes and monitoring.

gnrh antagonist medical

"Teverelix®, a next generation GnRH antagonist is a first-in-market product"

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.

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.

AI-generated analysis. Not financial advice.

200µg Cohort at Day 57 Dataset suggests majority of treated Lesions may Avoid Surgery as Company targets larger unmet medical need in Non-melanoma Skin Cancer

PHILADELPHIA, March 26, 2026 (GLOBE NEWSWIRE) -- 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, today announced it will host a business update conference call at 11:30 a.m. Eastern Time.

The call will highlight new analysis from its Phase 2 SkinJect® study, including an overall response rate (ORR) of 80% in the 200µg cohort at Day 57, and outline the Company’s planning toward an agentic AI–enabled clinical development platform.

The Company believes these results position the 200µg cohort as the leading dose regimen in the study, demonstrating the highest activity observed to date with continued improvement through Day 57.

Conference Call Details

• Time: 11:30 a.m. ET
• Pre-registration: https://dpregister.com/sreg/10207261/10379bd1029 
• Dial-in. (US/Canada): 833-890-6070
• Dial-in. (International): 412-504-9736
• Q&A Web Link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=DeCGoBHR
  

The Key Highlights to be presented at the conference call are:

Independent Clinical Perspective — Dr. Babar Rao (Principal Investigator)

The call will feature Dr. Babar Rao, an internationally acclaimed dermatology key opinion leader and Principal Investigator of the SKNJCT-003 study, who will provide an independent clinical interpretation of the dataset.

Dr. Rao is a board-certified dermatologist and dermatopathologist, and currently serves as:

• Professor of Dermatology and Pathology, Rutgers Robert Wood Johnson Medical School
• Clinical Associate Professor of Dermatology, Weill Cornell Medical College

He has authored over 200 peer-reviewed publications and has served as principal investigator in multiple dermatology clinical trials.

Dr. Rao is expected to highlight:

• The clinical significance of 73% clearance at Day 57 in the 200µg cohort
• A clear separation versus device-only active control, supporting incremental drug effect
• The role of:
  • Microneedle-mediated tumor disruption
  • Local immune activation and wound-healing pathways
    

Importantly, Dr. Rao is expected to place these findings in the context of the broader basal cell carcinoma (BCC) treatment landscape:

• BCC is the most common cancer worldwide, with millions of new cases diagnosed annually in the United States alone
• Standard treatments such as Mohs surgery, while effective, are capacity constrained.

As a result, there is a significant treatment backlog, where patients may face delays or undergo procedures that may not be immediately necessary.

Dr. Rao is expected to emphasize:

The observed ~73% clinical clearance suggests that approximately three out of four treated lesions may achieve visual resolution, which in clinical practice could allow many patients to defer or avoid immediate surgical intervention.

If confirmed in future studies, this approach may:

• Reduce procedural burden on healthcare systems
• Improve patient access to care
• Allow prioritization of surgical resources for higher-risk or refractory cases
  

He is also expected to reinforce that:

• The dataset is clinically meaningful
• Supports continued development and regulatory engagement
• May be impactful in Gorlin Syndrome and other high-burden populations
  

Phase 2 Data Deep Dive — 200µg Cohort (Day 57)

Medicus will present expanded analysis of the 15-patient 200µg cohort, which demonstrated the highest activity in the study:

• 73% Clinical (visual) clearance
• 40% Histological complete response (CR)

80% Overall Response Rate (CR + partial response) with potential to exceed this level pending final Clinical Study Report (CSR)

Previously reported Topline results of the study, along with additional preliminary dataset representing partial response (PR) and over-all response rate (ORR) for each cohort, are tabulated which demonstrates that clearance rates increased between Day 29 and Day 57, consistent with continued biological activity over time.

Table 1. SKNJCT-003 Phase 2 topline Data by Treatment Arm

Treatment Arm	(n)	Day 29 post-treatment				(n)	Day 57 post-treatment
	47	CC	CR	PR*	ORR*	43	CC	CR	PR*	ORR*
200 μg D-MNA	15	40%	27%	20%	47%	15	73%	40%	40%	80%
C-MNA	15	33%	20%	20%	40%	16	38%	38%	6%	44%
100 μg D-MNA	17	47%	24%	29%	53%	12	42%	33%	42%	75%

*Preliminary -pending final CSR (Clinical Study Report)
C-MNA: Microneedle device-only control arm, D-MNA: Doxorubicin-loaded microneedle array n:number of patients, CC: Clinical Clearance, CR: Histological Clearance, PR: Partial Response, ORR: Overall Response Rate

The Company will also highlight:

• Continued improvement from Day 29 to Day 57, supporting a durable and evolving treatment effect
• Evidence of biological activity across responders and partial responders

CEO Strategic and Clinical Positioning — Dr. Raza Bokhari

Dr. Raza Bokhari, Chairman and Chief Executive Officer, is expected to outline:

• That the Phase 2 study was a proof-of-concept study “exploratory” study primarily designed to evaluate clinical (visual) clearance, with the objective of addressing a large unmet need and helping relieve the treatment backlog in basal cell carcinoma.
• That refinement of histological clearance endpoints is expected to be a focus of registrational study design discussions at the planned End-of-Phase 2 (EOP2) meeting with the FDA
• The Company’s view that the dataset is decision-grade and supports regulatory and business partnership engagement
  

He is also expected to discuss:

• Optimization strategies focused on the 200µg dose
• Treatment duration and repeat dosing strategies

And position the broader opportunity:

• Addressing a large and underserved BCC patient population
• Positioning SkinJect as a minimally invasive alternative to surgery
• Expansion into Gorlin Syndrome and additional indications
  

Advancing Toward Agentic AI–Enabled Drug Development

The Company is expected to highlight its planning toward an Agentic AI–driven clinical development platform

Designed to:

• Optimize clinical trial design and protocol simulation
• Enable dynamic site selection and enrollment forecasting
• Improve patient stratification and dose optimization
• Increase capital efficiency and probability of success

Financial Position and Capital Strategy — Carolyn Bonner, CFO

Carolyn Bonner, President and Chief Financial Officer, is expected to provide an update on:

• Approximately $31.9 million raised during 2025
• $8.7 million in cash and cash equivalents at year-end 2025
• Continued disciplined investment in clinical development
  

She is expected to emphasize alignment of capital strategy with key upcoming value inflection points, including:

• Regulatory engagement
• Clinical data maturation
• Strategic partnering opportunities
  

Position Entering a Catalyst-Rich 2026

The Company believes it is entering a catalyst-rich period, including:

• End-of-Phase 2 FDA meeting (SkinJect)
• Potential registrational pathway alignment
• Initiation of Phase 2b Teverelix study
• Expansion into women’s health (endometriosis)
• Advancement of AI-enabled development platform
• Ongoing strategic partnering discussions

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.

Company’s key therapeutics assets are:

SkinJect™, a novel localized immuno-oncology precision product focused on non-melanoma skin diseases, especially basal cell carcinoma (BCC) and Gorlin Syndrome, a rare autosomal dominant disease also called nevoid BCC syndrome, collectively representing an ~$2 billion market opportunity.

Teverelix^®, a next generation GnRH antagonist is a first-in-market product for cardiovascular high-risk advanced prostate cancer patients and patients with acute urinary retention relapse (AURr) episodes due to enlarged prostate, collectively representing an ~$6 billion market opportunity.

The Company is actively engaged in following collaborations:

Skinject™ Platform Expansion

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, and there can be no assurance that such definitive agreements will be executed.

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

Patient Access and Advocacy

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.

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 D-MNAs, under physician supervision.

AI Enabled Clinical Development

In December 2025, the Company signed a non-binding letter of intent to collaborate with Reliant AI Inc., a decision-intelligence company specializing in generative AI for the life sciences, to develop an AI-driven clinical data analytics platform to support capital-efficient and time-efficient clinical development through data-driven dynamic clinical-site selection, pharmacodynamic (PD) informed patient stratification, and enrollment forecasting. The initial phase of the collaboration is expected to support the upcoming Teverelix clinical study planned for 2026. There can be no assurance that a definitive agreement will be executed or that the proposed collaboration will proceed as contemplated.

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 ability to continue as a going concern, 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 expectations regarding reported efficacy findings, the overall response rate and potential changes thereto, and whether there will be material changes to its reported SKNJCT-003 topline results 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, 2025, 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 did Medicus (MDCX) report for SkinJect 200µg cohort at Day 57?

Medicus reported an 80% overall response rate (ORR) for the 200µg cohort at Day 57. According to the company, that cohort also showed 73% clinical clearance and 40% histological complete response in the 15-patient analysis.

How might the MDCX SkinJect results affect surgical treatment for basal cell carcinoma?

The data suggest many lesions could defer surgery based on visual clearance observed. According to the company, ~73% clinical clearance may allow patients to avoid or delay Mohs surgery and reduce procedural burden on healthcare systems.

What regulatory steps is Medicus (MDCX) planning after the SKNJCT-003 dataset?

Medicus plans an End-of-Phase 2 (EOP2) meeting with the FDA to discuss registrational study design. According to the company, discussions will focus on refining histological clearance endpoints and potential pivotal trial alignment.

What is Medicus's cash position and recent fundraising (MDCX) as of year-end 2025?

Medicus reported approximately $8.7 million in cash and cash equivalents at year-end 2025. According to the company, it raised about $31.9 million during 2025 and plans disciplined investment in clinical development.

What is Medicus (MDCX) planning with agentic AI for clinical development?

Medicus is developing an agentic AI-enabled platform to optimize trials, site selection, and patient stratification. According to the company, the platform aims to improve enrollment forecasting, dose optimization, and capital efficiency for upcoming studies.