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Medicus Pharma Reports Full-Year 2025 Financial Results and Provides Corporate Update

(Positive)
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Medicus Pharma (NASDAQ:MDCX) reported FY2025 results and a corporate update on March 25, 2026, highlighting a completed 90-patient Phase 2 SkinJect study with up to 73% clearance in the 200µg cohort and strengthened capital via ~$31.9M financing proceeds.

FY2025 financials: cash $8.7M, operating expenses $34.4M, net loss $35.4M, and disclosed substantial doubt about going concern; 2026 catalysts include an End-of-Phase 2 FDA meeting and initiation of Teverelix Phase 2b studies.

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Positive

  • Phase 2 SkinJect showed up to 73% clinical clearance in 200µg cohort
  • Secured ~$31.9M in financing proceeds during 2025
  • Cash balance increased to $8.7M (vs. $4.2M in 2024)
  • Planned End-of-Phase 2 FDA meeting for SkinJect in 2026

Negative

  • Net loss of $35.4M in 2025 (vs. $11.2M in 2024)
  • Operating expenses totaled $34.4M in 2025
  • Company disclosed substantial doubt about continuing as a going concern without more financing

News Market Reaction – MDCX

-5.71%
9 alerts
-5.71% Session close to close
-10.0% Trough in 26 hr 11 min
$12.40M Market Cap
0.2x Rel. Volume

In the Mar 26 session, MDCX declined 5.71%, reflecting a notable negative market reaction. Argus tracked a trough of -10.0% from its starting point during tracking. Our momentum scanner triggered 9 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock moved -5.7% in the session following this news. A negative reaction despite clinical and p...
Analysis

The stock moved -5.7% in the session following this news. A negative reaction despite clinical and pipeline progress would fit a narrative where investors refocused on the $35.4M net loss, $34.4M in operating expenses, and going-concern language. The stock already sat about 94% below its $8.94 52-week high at roughly $0.49, so further downside could reflect dilution and financing fatigue. Past earnings-tagged news produced a 4.55% gain, so a sharp decline would mark a departure from that limited history.

Key Figures

Financing proceeds: $31.9M Cash and equivalents: $8.7M Cash 2024: $4.2M +5 more
8 metrics
Financing proceeds $31.9M Total financing proceeds during FY 2025
Cash and equivalents $8.7M Year-end 2025 cash balance
Cash 2024 $4.2M Year-end 2024 cash balance
Operating expenses $34.4M FY 2025 total operating expenses
Net loss $35.4M FY 2025 net loss (vs. $11.2M in 2024)
Net loss 2024 $11.2M FY 2024 net loss
Net loss per share $2.74 FY 2025 net loss per share
Clinical clearance 73% SkinJect Phase 2 highest dose cohort clinical clearance at Day 57

Previous Earnings Reports

1 past event · Latest: Nov 14 (Positive)
Same Type Pattern 1 events
Date Event Sentiment 24h Move Catalyst
Nov 14 Earnings and update Positive +4.5% Q3 2025 financials plus SKNJCT-003 progress and Teverelix acquisition details.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Limited earnings history: the prior earnings-style update saw a modestly positive move that aligned with constructive operational and financing progress.

Recent Company History

Recent history shows Medicus emphasizing clinical and financing milestones. A prior earnings-tagged update on Nov 14, 2025 combined SKNJCT-003 progress, FDA feedback supporting a 505(b)(2) pathway, UK approvals, and the Antev (Teverelix) acquisition, alongside Q3 cash of $8.7M, operating expenses of $15.4M, and a net loss of $16.0M. That release produced a 4.55% gain. Today’s full-year 2025 results extend that narrative with completed Phase 2 SkinJect data, Teverelix expansion, AI-enabled development, and a significantly larger annual net loss and operating spend.

Key Terms

basal cell carcinoma, gorlin syndrome, expanded access ind, gnrh antagonist, +4 more
8 terms
basal cell carcinoma medical
"focused on non-melanoma skin diseases, especially basal cell carcinoma (BCC)"
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.
gorlin syndrome medical
"especially basal cell carcinoma (BCC) and Gorlin Syndrome, a rare autosomal dominant"
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.
expanded access ind regulatory
"Pursuing Expanded Access IND program for patients with multiple or inoperable lesions"
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.
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.
acute urinary retention medical
"advanced prostate cancer patients and patients with acute urinary retention relapse (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.
endometriosis medical
"Evaluating Teverelix in symptomatic endometriosis, a high-prevalence condition"
Endometriosis is a chronic condition where tissue similar to the lining of the uterus grows outside the uterus, often causing pain and fertility problems. It can impact a person's health and quality of life, potentially leading to increased healthcare costs and affecting workforce productivity. For investors, understanding conditions like endometriosis highlights the importance of healthcare innovations and markets related to women's health.
biomarker-driven medical
"Biomarker-driven patient stratification Precision trial design"
An approach where medical decisions—like choosing patients for a treatment or designing a clinical trial—are guided by measurable biological signs (such as a gene change, protein level, or imaging result). For investors, biomarker-driven programs can raise the odds of clinical success, shrink development costs and speed regulatory review by targeting therapies to the people most likely to benefit, much like using a map to find the best route instead of driving aimlessly.
adaptive trial execution medical
"Dose optimization and adaptive trial execution Proposed platform is intended"
Adaptive trial execution is a way of running clinical studies that allows researchers to make planned changes—like altering sample size, dosing, or patient groups—while the study is underway based on interim results. For investors this matters because those built-in adjustments can speed development, reduce wasted spending, or change the odds of success, which directly affects a drug developer’s timeline, costs and valuation.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Advances Clinical Pipeline Across Dermatology, Urology, Oncology and strengthens Capital Base to support Phase 2 Programs

PHILADELPHIA, PA / ACCESS Newswire / March 25, 2026 / 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 reported audited financial results for the year ended December 31, 2025, and provided a corporate update highlighting significant progress across its SkinJect® and Teverelix development programs, as well as expansion into precision medicine and AI-enabled clinical development.

Management Commentary

"2025 marked a pivotal year for Medicus, highlighted by completion of our Phase 2 SkinJect study, efforts to expand into rare disease and women's health indications, and the integration of agentic AI-driven clinical development capabilities." stated Dr. Raza Bokhari. Executive Chairman & CEO of Medicus "The strength of our clinical dataset, combined with regulatory alignment and potential access to capital resources, positions the Company to advance toward registrational planning and strategic partnerships in 2026 and beyond."

SkinJect® Platform (Dermatology / Oncology / Rare Disease)

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.

Skinject Phase 2 Positive Topline Dataset Highlights:

The company completed a 90 patient Phase 2 clinical study, titled, "A randomized, double-blind, three-arm Phase 2 study evaluating two dose levels of microneedle-mediated delivery of doxorubicin compared with a device-only control in patients with nodular basal cell carcinoma."

The randomized design of SKNJCT-003, including a device-only active control arm, provides a rigorous framework for evaluating the incremental therapeutic contribution of doxorubicin delivered through the SkinJect microneedle system.

The Study positive Topline data demonstrated:

  • Up to 73% clinical clearance in the highest dose cohort (200ug dose)

  • continued biological activity between Day 29 and Day 57, supporting durability of response

  • 200 ug cohort at Day 57 suggest ~3 out of 4 treated patients may avoid immediate surgery

  • Biological activity observed in the device-only arm reflects tumor disruption, also observed in March 2021 SKNJCT-001 Phase 1 study and SKNJCT-003 interim analysis in March 2025.

Pipeline Expansion and Strategic Innovation

  • Gorlin Syndrome Expansion

    • Advancing SkinJect® for nevoid basal cell carcinoma syndrome, a rare genetic disorder characterized by multiple recurrent BCC lesions

    • Pursuing Expanded Access IND program for patients with multiple or inoperable lesions

    • Supports potential orphan disease positioning and broader clinical utility

  • Platform Extension via HelixNano Collaboration

    • Entered into a non-binding collaboration with Helix Nanotechnologies, Inc.

    • Exploring integration of microneedle delivery with next-generation mRNA technologies, with potential applications in developing thermostable vaccines

Teverelix Platform (Prostate + Women's Health)

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.

  • Long-acting GnRH antagonist designed to suppress testosterone without flare

  • Potential cardiovascular safety advantage vs. GnRH agonists

  • Core development programs:

    • Advanced prostate cancer (cardiovascular risk population)

    • Acute urinary retention (390-patient Phase 2b study)

  • Women's Health Expansion

    • Evaluating Teverelix in symptomatic endometriosis, a high-prevalence condition with unmet need

    • Leveraging a genomics-enabled clinical strategy, including:

      • Hormonal pathway profiling

      • Biomarker-driven patient stratification

      • Precision trial design

  • Future economic profile strengthened through royalty reduction (~4%2%) on worldwide net sales of Teverelix

AI-Enabled Clinical Development (Reliant AI Collaboration)

  • Entered into a non-binding collaboration with Reliant AI Inc.

  • Evolving toward development of an agentic AI-driven platform to optimize:

    • Clinical trial design and protocol simulation

    • Site selection and enrollment forecasting

    • Pharmacodynamic-informed patient stratification

    • Dose optimization and adaptive trial execution

  • Proposed platform is intended to enable:

    • Capital-efficient development

    • Reduced clinical timelines

    • Data-driven decision-making across all current and future development programs

Financial Highlights (FY 2025)

During 2025, the Company strengthened its capital position through multiple financing initiatives securing ~$31.9 million in total financing proceeds.

The Company operates as a clinical-stage enterprise and expects to incur operating losses for the foreseeable future. As disclosed in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 (the "Annual Report"), substantial doubt exists regarding the Company's ability to continue as a going concern without additional financing.

  • Cash and cash equivalents: $8.7 million (vs. $4.2 million in 2024)

  • Operating expenses: $34.4 million

    • General & administrative: $17.9 million

    • Research & development: $7.7 million

    • In-process R&D (Teverelix acquisition): $8.7million

  • Net loss: $35.4 million (vs. $11.2 million in 2024)

  • Loss from operations: $34.4 million

  • Net loss per share: $2.74

The Company's complete financial statements and results of operations for the year ended December 31, 2025, are included in its Annual Report, filed with the Securities and Exchange Commission on March 25, 2026.

Expected Upcoming Catalysts in 2026

The Company is entering a catalyst-rich period in 2026, including:

  • End-of-Phase 2 FDA meeting (SkinJect®) to define registrational pathway

  • Potential registrational trial design alignment under 505(b)(2) framework

  • Advancement of Gorlin Syndrome Expanded Access program

  • Continued evaluation of HelixNano-enabled platform expansion opportunities

  • Initiation of Phase 2b Teverelix study in prostate cancer and AUR indications

  • Expansion of Teverelix into women's health (endometriosis) using genomics-enabled clinical strategy

  • Progression of agentic AI-driven clinical development platform with Reliant AI

  • Ongoing strategic partnering discussions across both core programs, Skinject and Teverelix

Business update Conference Call

The Company will host a business update conference call on Thursday, March 26, 2026, beginning at 11:30 a.m. Eastern time. Babar K. Rao, MD, FAAD, an internationally recognized academic dermatologist and Principal Investigator of the SKNJCT-003 Phase 2 clinical study, will join the Company's leadership team during the call.

Participants are encouraged to pre-register for the conference call using this link to receive a dial-in number and PIN to bypass the live operator. Participants may pre-register at any time, including up to and after the call start time. Those unable to pre-register can participate by dialing 833-890-6070 (U.S./Canada) or 412-504-9736 (international). A webcast of the call can be accessed here.

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 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.

# # #

SOURCE: Medicus Pharma Ltd



View the original press release on ACCESS Newswire

FAQ

What did Medicus Pharma (MDCX) report for cash and financing in FY2025?

Medicus reported cash and cash equivalents of $8.7M and ~$31.9M in financing proceeds. According to the company, financings during 2025 strengthened its capital base to support Phase 2 programs and near-term operations.

What were the topline results from the SkinJect Phase 2 (SKNJCT-003) reported by Medicus (MDCX)?

The Phase 2 topline showed up to 73% clinical clearance in the 200µg cohort at Day 57. According to the company, durability of response was observed and the 200µg cohort suggests many treated patients may avoid immediate surgery.

How did Medicus (MDCX) perform financially in FY2025 and what concern did management disclose?

Medicus recorded a net loss of $35.4M and operating expenses of $34.4M in 2025. According to the company, substantial doubt exists about its ability to continue as a going concern without additional financing.

What near-term clinical catalysts did Medicus (MDCX) outline for 2026?

Key 2026 catalysts include an End-of-Phase 2 FDA meeting for SkinJect and initiation of Phase 2b Teverelix studies. According to the company, these steps aim to define registrational pathways and advance core programs toward partnerships.

What strategic collaborations did Medicus (MDCX) announce to support development efforts?

Medicus entered non-binding collaborations with Helix Nanotechnologies and Reliant AI to explore microneedle-mRNA integration and agentic AI-driven trial design. According to the company, collaborations target platform extension and capital-efficient development.

How is Medicus (MDCX) expanding Teverelix development into new indications?

Teverelix development includes advanced prostate cancer, a 390-patient Phase 2b AUR study, and evaluation in endometriosis. According to the company, a genomics-enabled strategy will support biomarker-driven patient stratification for women's health.