MDCX

Company Highlights Significant Regulatory, Clinical and Strategic Progress Across SkinJect® and Teverelix® Programs and a Strengthened Financial Position Supporting Continued Pipeline Execution and Expansion PHILADELPHIA, PA / ACCESS Newswire / August 12, 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 therapeutic assets, today reported financial results for the three and six months ended June 30, 2026, and provided a corporate update highlighting significant regulatory, clinical and strategic achievements across its development portfolio. During the second quarter of 2026, Medicus continued to advance its transition into a diversified clinical-stage biotechnology company with meaningful progress and significant strengthening of its financial position to support execution across its growing pipeline. During and subsequent to the quarter, the Company achieved several important regulatory milestones, including FDA "Study May Proceed" authorization for the registrational SkinJect® program in Gorlin Syndrome and Institutional Review Board (IRB) authorization and positive FDA feedback for optimized Teverelix® Phase 2 study in acute urinary retention. The company also received authorization from UAE Department of Health (DOH) to initiate genomics-enabled PRECISION-E2 study evaluating Teverelix® in women with symptomatic endometriosis. We believe that these achievements further position Medicus as a diversified clinical-stage biotech/life sciences company with two differentiated therapeutic platforms, multiple anticipated clinical and regulatory catalysts, and a disciplined strategy focused on advancing innovative therapies towards late-stage development and commercialization. Management Commentary "The second quarter of 2026 marked a defining period for Medicus as we successfully advanced both of our lead therapeutic platforms into their next stages of clinical and regulatory development, while strengthening our balance sheet and financial flexibility," stated Dr. Raza Bokhari, Medicus Executive Chairman and CEO. "We believe Medicus is well positioned with two differentiated programs advancing towards late-stage development, each addressing significant commercial opportunities through distinct regulatory pathways and multiple anticipated value-creating milestones. We remain focused on disciplined execution, regulatory excellence and strategic growth as we continue building long-term shareholder value." Financial Highlights (Q2 2026) During the second quarter of 2026, the Company significantly strengthened its financial position through multiple financing initiatives, including utilization of its expanded At-the-Market ("ATM") equity program and completion of a new secured financing facility. Year to date, the Company has raised ~$40 million in equity and/or debt financing. These initiatives enhanced the Company's liquidity and financial flexibility to support continued advancement of its expanding clinical development programs. Nonetheless, substantial doubt exists regarding the Company's ability to continue as a going concern without additional financing. As disclosed in the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, financial results include: Cash, cash equivalents and restricted cash: $25.2 million as of June 30, 2026. Cash and cash equivalents: $15.2 million as of June 30, 2026 (vs. $9.7 million as of June 30, 2025). Operating expenses (loss from operations): $11.5 million (vs. $6.0 million in Q2 2025). General and administrative expenses: $6.6 million (vs. $4.6 million in Q2 2025). Research and development expenses: $4.9 million (vs. $1.4 million in Q2 2025). Net loss: $11.7 million (vs. $6.2 million in Q2 2025). Net loss per share: $0.21 (vs. $0.43 in Q2 2025). The Company's complete unaudited financial statements and results of operations for the quarter ended June 30, 2026, are included in its Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 12, 2026. Second Quarter 2026 Operational Highlights During the second quarter of 2026 and subsequent to quarter end, Medicus achieved significant regulatory, clinical and strategic milestones across both of its lead therapeutic platforms while strengthening its financial position and advancing long-term corporate objectives. SkinJect® Platform (Dermatologic Oncology / Rare Disease) During and subsequent to the quarter, the Company: Reported additional pre-specified analyses from the completed Phase 2 SKNJCT-003 study demonstrating positive dose response and clinically meaningful clinical and histological clearance rates of 64% and 55%, respectively, with the 200 µg SkinJect® dose. Received FDA "Study May Proceed" authorization permitting initiation of the Company's registrational SKNJCT-005 study to evaluate use of SkinJect® for patients with Gorlin Syndrome. Strengthened the Company's Gorlin Syndrome development program through continued collaboration with the Gorlin Syndrome Alliance and clinical investigators. Advanced regulatory initiatives supporting the Company's rare disease development strategy. Collectively, these achievements position SkinJect® to advance the Company's FDA 505(b)(2) regulatory strategy supporting future registration of SkinJect®. Teverelix® Platform (Urology, Oncology and Women's Health): During and subsequent to the quarter, the Company: Received Institutional Review Board (IRB) authorization and positive FDA feedback for its optimized Phase 2 study evaluating Teverelix® to prevent relapse of acute urinary retention. Received UAE Department of Health (DOH) authorization to initiate PRECISION-E2 genomics-enabled Phase 2 study evaluating Teverelix® in women with symptomatic endometriosis. Appointed Dr. Faisal Mehmud, Chief Executive Officer of Antev Limited, a subsidiary of the Company, in addition to his role as the Chief Medical Officer of the Company to further align the scientific, clinical and operational leadership. These milestones further expand the clinical development strategy for Teverelix® across multiple therapeutic indications and reinforce the Company's commitment to precision medicine and disciplined clinical execution. Corporate Development and Strategic Initiatives: During and subsequent to the quarter, Medicus also advanced initiatives, aimed at fostering long-term growth and shareholder value. The Company evaluated strategic acquisition, licensing and partnering opportunities aligned with the Company's multi-asset biotechnology strategy. Anticipated Clinical, Regulatory and Strategic Milestones: The Company expects the coming quarters to be marked by continued execution across both therapeutic platforms, with multiple anticipated clinical and regulatory milestones and strategic partnering discussions across both core programs, especially SkinJect®. The Company expects potential expansion of strategic collaborations and licensing discussions as well as continued execution of financing strategies supporting advancement of the Company's expanding clinical pipeline. For further information contact: Carolyn Bonner, President and Chief Financial Officer(610) [email protected] Anna Baran-Djokovic, SVP Investor Relations(305) [email protected] 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 therapeutic assets. The Company is actively engaged in multiple countries across three continents. The Company's current key therapeutic 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. Teverelix®, a next-generation GnRH antagonist, is a product under clinical development for cardiovascular high-risk advanced prostate cancer patients and patients with acute urinary retention relapse (AURr) episodes due to enlarged prostate, and endometriosis. Medicus' strategy is to advance select programs through Phase 2 proof-of-concept, key clinical and regulatory inflection points that substantially reduce development risk and increase attractiveness to potential pharmaceutical partners. By generating decision-grade clinical, regulatory and operational datasets, the Company seeks to create opportunities for strategic collaborations, regional licensing transactions and broader commercialization partnerships with established pharmaceutical companies. As data matures across its programs, Medicus intends to continue building differentiated development packages designed to maximize asset value while maintaining capital efficiency and development focus. 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 development of SkinJect® and the potential benefits thereof for those suffering with Gorlin Syndrome, Antev's future, the development of Teverelix® and expectations concerning, future outcomes relating to, the development, advancement and commercialization of Teverelix® for AURr, cardiovascular high-risk advanced prostate cancer, women's health indications like endometriosis, and the potential market opportunities related thereto and the Company's potential expansion of strategic collaborations, licensing discussions and financing strategies to advance its clinical pipeline. 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

Company Advances SkinJect® and Teverelix® Clinical Programs While Strengthening Financing Flexibility and Expanding Strategic Development Initiatives PHILADELPHIA, May 14, 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 reported financial results for the three months ended March 31, 2026, and provided a corporate update highlighting continued execution across its SkinJect® and Teverelix® development programs. During the first quarter of 2026, Medicus continued to advance its transition into a diversified clinical-stage biotechnology company with active development programs in dermatologic oncology and urology/oncology, while replenishing its balance sheet through multiple capital market initiatives. The Company recently reported positive, decision grade, expanded dataset findings from its Phase 2 SKNJCT-003 study evaluating SkinJect® Doxorubicin Microneedle Array (D-MNA) for the treatment of nodular basal cell carcinoma (BCC), including evidence of positive dose response and registrational grade clearance rates in the 200-µg treatment cohort. In parallel, Medicus advanced Teverelix®, its next-generation long-acting GnRH antagonist acquired through the acquisition of Antev Limited, with Food and Drug Administration (FDA) clearance to initiate a Phase 2b dose optimization study in advanced prostate cancer and submission of an optimized Phase 2 protocol in acute urinary retention recurrence prevention. Management Commentary: “During the first quarter of 2026, Medicus continued to execute on its transformation into a diversified clinical-stage biotechnology company, highlighted by expanded positive Phase 2 SkinJect® data, advancement of Teverelix® into additional clinical development pathways, and continued expansion of our regulatory and strategic initiatives,” stated Dr. Raza Bokhari, Medicus’ Executive Chairman & CEO. “We believe the growing strength of our clinical datasets, combined with expanded financing flexibility and continued development of AI-enabled clinical capabilities, positions the Company to pursue multiple value-driving milestones in dermatologic oncology, prostate cancer, acute urinary retention, and rare disease indications throughout 2026 and beyond.” First Quarter 2026 and Recent Corporate Highlights 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 a ~$2 billion market opportunity. In the first quarter 2026, the Company made the following noteworthy advances in the SkinJect® program: Reported positive topline and expanded dataset findings from the Phase 2 SKNJCT-003 clinical study evaluating D-MNA for nodular basal cell carcinoma. Expanded analysis demonstrated positive dose-response trends and clinically meaningful clearance activity in the 200-µg treatment cohort. Company believes the dataset supports continued FDA engagement regarding potential registrational development pathways. Completed enrollment of 90 patients in the U.S.-based Phase 2 SKNJCT-003 study. Continued expansion activities for the SKNJCT-004 UAE-based clinical study evaluating SkinJect® in additional geographic markets. Submitted an Orphan Drug Designation application to the FDA for SkinJect® in Gorlin Syndrome patients. Continued collaboration with the Gorlin Syndrome Alliance to support compassionate access and expanded access development initiatives. 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. In the first quarter 2026, the Company made the following noteworthy advances in the Teverelix® program: FDA provided “study may proceed” clearance for the Company’s Phase 2b dose optimization study evaluating Teverelix® in advanced prostate cancer. Submitted optimized Phase 2 protocol to the FDA for prevention of recurrent acute urinary retention in men with benign prostatic hyperplasia. Presented additional clinical data relating to Teverelix® at the American Association of Clinical Endocrinology (AACE) Annual Meeting 2026. Successfully amended the LifeArc licensing agreement, reducing the royalty rate payable on worldwide net sales from approximately 4% to 2%. Other Strategic and Corporate Initiatives: In the first quarter 2026, the Company continued to make progress in other relevant strategic and corporate initiatives, some of which are highlighted below: Continued development of the Company’s AI-enabled clinical development collaboration with Reliant AI. Expanded ATM financing capacity from up to approximately $15.3 million to up to $50 million subsequent to quarter end. Continued evaluation of additional strategic acquisition and partnering opportunities aligned with the Company’s multi-strategy development platform. Financial Highlights (Q1 2026): During the first quarter of 2026, the Company continued to replenish its capital position through utilization of its at-the-market (“ATM”) facility and Standby Equity Purchase Agreement (“SEPA”), securing approximately $10 million in aggregate gross financing proceeds during the quarter. Subsequent to quarter end, the Company also expanded its ATM facility from up to approximately $15.3 million to up to $50 million. The Company operates as a clinical-stage enterprise and expects to incur operating losses for the foreseeable future. As disclosed in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, substantial doubt exists regarding the Company’s ability to continue as a going concern without additional financing. However, management believes the Company continues to have access to additional capital resources through public and private equity offerings, debt financings, strategic collaborations, licensing arrangements, and other financing initiatives. Financial results of the Company for the quarter ended March 31, 2026, include: Cash and cash equivalents: $6.4 million as of March 31, 2026 (vs. $4.0 million as of March 31, 2025) Operating expenses: $8.6 million (vs. $5.1 million in Q1 2025) General & administrative: $5.9 million (vs. $3.1 million in Q1 2025) Research & development: $2.7 million (vs. $2.0 million in Q1 2025) Net loss: $9.0 million (vs. $5.1 million in Q1 2025) Loss from operations: $8.6 million (vs. $5.1 million in Q1 2025) Net loss per share: $0.31 (vs. $0.42 in Q1 2025) The Company’s complete unaudited financial statements and results of operations for the quarter ended March 31, 2026 are included in its Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 14, 2026. Expected Upcoming Catalysts in 2026 The Company expects 2026 to remain a catalyst-rich year with multiple anticipated milestones, 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 Orphan Drug designation, Registrational grade IND and Pediatrics Rare Disease Voucher Program Continued evaluation of HelixNano-enabled platform expansion opportunities 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 Potential expansion of strategic collaborations and licensing discussions The Company believes its current financing infrastructure, including the expanded ATM facility and existing capital market access, provides flexibility to support ongoing operations and advancement of its clinical development programs. For further information contact: Carolyn Bonner, President and Chief Financial Officer (610) 636-0184 [email protected] Anna Baran-Djokovic, SVP Investor Relations (305) 615-9162 [email protected] 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 a ~$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 a ~$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 Registrational IND Program to enable those suffering with Gorlin Syndrome to access SkinJect™ under physician-supervised treatment protocols, Orphan drug designation for Skinject 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, the Company’s ability to raise capital in future debt and equity offerings and the sufficiency of such financing infrastructure to support ongoing operations and advancement of its clinical development programs, and the potential expansion of strategic collaborations and licensing. 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.

200µg Cohort Achieves 55% Complete Response at Day 57 Emerging as Registrational Grade Lead Regimen PHILADELPHIA, May 06, 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 results from a pre-specified expanded dataset analysis demonstrating positive dose response from its Phase 2 SKNJCT-003 study evaluating safety and efficacy of Doxorubicin Microneedle Array (D-MNA) to treat nodular basal cell carcinoma (BCC) of the skin, the most common type of skin cancer. These additional pre-specified analysis, build upon the previously reported positive topline results, provide expanded biological, histologic, and safety insights that further strengthen SkinJect’s therapeutic profile and future registrational discussions with the U.S. Food and Drug Administration (FDA). These additional findings are also consistent with prior Phase 1 clinical observations in the SKNJCT-001 study in March 2021, and interim analysis of SKNJCT-003 in March 2025, reinforcing reproducibility across studies. SKNJCT-003 Study Design Overview (NCT06608238):: The SKNJCT-003 (NCT06608238) clinical study was designed as 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. It was a multi-center study designed to enroll 90 participants presenting with nodular type basal cell carcinoma. The participants were randomized 1:1:1 into three groups: Device-controlled group receiving P-MNA Low-dose group receiving 100µg of D-MNA High-dose group receiving 200µg of D-MNA Expanded central pathology reconciliation demonstrated that 69 participants met intended nodular BCC inclusion criteria, while 21 participants were identified as superficial or mixed subtype lesions. The Results from Pre-specified Expanded Analysis of 69 participants are summarized below: The expanded analysis demonstrates a progressive and dose-dependent improvement, with the strongest separation emerging at Day 57. “We are encouraged by these additional findings in the expanded analysis, which we believe meaningfully strengthens the clinical and regulatory foundation of the SKNJCT-003 Program” stated Dr. Raza Bokhari, Chairman and CEO of Medicus. “We are confident that this dataset moves us from Proof-of-concept to a clear registrational path, and we believe Skinject has the potential to fundamentally change the current approach of treating patients with BCC, addressing a major un-met medical need”. From Positive Topline Dataset to Positive Dose-Response: The Company previously reported topline results from the population of 90 randomized patients, which demonstrated a positive topline and decision-grade dataset. The 69-patient refined efficacy analysis further strengthens the regulatory alignment of the study as the Company advances toward End-of-Phase 2 (EOP2) discussions with the FDA. The topline dataset showed that: The 200µg cohort achieved the highest observed activity at Day 57 Clearance rates improved from Day 29 to Day 57, consistent with continued biological activity over time The pre-specified expanded dataset analysis builds on this foundation by: Revealing a clear and consistent dose-response relationship across endpoints Demonstrating stronger separation between the 200µg cohort and control, particularly at Day 57 Strengthens differentiation between drug-driven efficacy and device-only biological activity Importantly, this expanded central pathology verified dataset provides a more precise and clinically interpretable view of treatment effect, with the 200µg cohort at Day 57 emerging as the leading dose with the most robust and consistent efficacy signal. These findings suggest that many treated lesions may in the future be able to avoid immediate surgical intervention, representing a potentially meaningful shift in the treatment paradigm for BCC. Given the short treatment and excision timeline evaluated, these results are particularly encouraging and may suggest clinically meaningful anti-tumor activity within a highly practical therapeutic window. Collectively, this dataset may support future registration-intent or NDA-enabling development discussions, including optimized patient population, lesion subtype, dose regimen, and treatment-to-excision interval. D-MNA continued to demonstrate a highly favorable safety and tolerability profile, was generally well tolerated with no drug-related serious adverse events, no evidence of systemic doxorubicin toxicity, and predominantly mild localized treatment-site reactions, supporting repeatable lesion-directed administration consistent with prior Phase 1 observations. Reinforcing Drug-Driven Therapeutic Effect: The device-only arm also demonstrated early biological activity consistent with microneedle-induced local immune response, but it did not show sustained or deepening efficacy over time. In contrast, the 200µg D-MNA cohort demonstrated progressive improvement from Day 29 to Day 57, resulting in clear separation across both clinical and histological endpoints. This pattern is consistent with drug-driven therapeutic effect, rather than a device-only response. Independent Investigator Validation Supports Clinical and Regulatory Read-Through These findings are further supported by independent investigator validation from a leading academic dermatologist and clinical investigator. Dr. Babar K. Rao, MD, FAAD, Principal Investigator of the SKNJCT-003 study, is an internationally recognized academic dermatologist, dermatopathologist, and clinical investigator in skin oncology. He serves as Professor of Dermatology and Pathology at Rutgers Robert Wood Johnson Medical School and holds academic appointments at Weill Cornell Medical College. Dr. Rao has evaluated the dataset and noted that he believes it demonstrates a clinically meaningful rapid onset efficacy, clear differentiation between drug and device effect and a profile that supports continued development and regulatory progress. Dr. Rao noted the consistency between visual, histologic, and central pathology findings is highly encouraging and provides growing confidence that SkinJect® is producing meaningful biologic anti-tumor effects. Notably, clinically meaningful anti-tumor responses were observed within weeks, potentially differentiating D-MNA from many existing non-surgical therapies that often require substantially longer treatment durations. This analysis also improves the understanding of the patient populations and treatment parameters most likely to optimize future clinical outcomes. The Company believes these findings further de-risk advancement of the 200µg regimen and informs the design of subsequent development studies, including assessment timing, lesion selection, and endpoint strategy. For further information, contact: Carolyn Bonner, President and Chief Financial Officer (610) 636-0184 [email protected] Anna Baran-Djokovic, SVP Investor Relations (305) 615-9162 [email protected] 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 a ~$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 a ~$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 Registrational IND Program to enable those suffering with Gorlin Syndrome to access SkinJect™ under physician-supervised treatment protocols, Orphan drug designation for Skinject 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.

Medicus Pharma (NASDAQ:MDCX) has reported additional results from a pre-specified expanded dataset analysis of its Phase 2 SKNJCT-003 trial, showing a positive dose-response relationship for its Doxorubicin Microneedle Array (D-MNA) in treating nodular basal cell carcinoma (BCC). The analysis builds on previously disclosed topline results and incorporates biological, histologic, and safety data from a refined group of 69 patients whose diagnoses met the study’s intended inclusion criteria. The company said the findings may support future regulatory discussions with the US Food and Drug Administration as it advances the program. The randomized, double-blind, three-arm study evaluated two dose levels of D-MNA, 100 micrograms and 200 micrograms, against a device-only control in patients with nodular BCC. Participants were assessed at 29 and 57 days following treatment. According to the expanded analysis, outcomes improved over time and showed a dose-dependent pattern. At Day 57, the 200 microgram group demonstrated the highest response rates, with clinical clearance observed in 64% of patients and histological clearance in 55%. This compared with 44% and 33%, respectively, in the 100 microgram group, and 29% for both measures in the device-only arm. Earlier timepoint data at Day 29 showed more limited differentiation between groups, though the higher-dose cohort still recorded the strongest results. The company said the increasing separation by Day 57 supports a drug-driven therapeutic effect rather than a response attributable solely to the microneedle device. Medicus stated that the expanded dataset reinforces trends seen in prior analyses, including earlier Phase 1 findings and interim Phase 2 data, suggesting reproducibility across studies. The company added that the results provide a more precise view of treatment effect and may help guide future study design and endpoint selection ahead of end-of-Phase 2 regulatory discussions. Safety findings remained consistent with earlier reports. The treatment was generally well tolerated, with no drug-related serious adverse events or evidence of systemic doxorubicin toxicity. Reported side effects were primarily mild, localized reactions at the treatment site. The company noted that the device-only arm showed some early biological activity, potentially linked to a localized immune response, but did not demonstrate sustained improvement over time. In contrast, the higher-dose D-MNA cohort showed continued gains between Day 29 and Day 57 across both clinical and histological measures. “We are encouraged by these additional findings in the expanded analysis, which we believe meaningfully strengthens the clinical and regulatory foundation of the SKNJCT-003 Program” Medicus CEO Dr Raza Bokhari said in a statement. “We are confident that this dataset moves us from Proof-of-concept to a clear registrational path, and we believe Skinject has the potential to fundamentally change the current approach of treating patients with BCC, addressing a major un-met medical need." An independent investigator involved in the study, Dr Babar Rao of Rutgers Robert Wood Johnson Medical School, said the dataset indicates rapid onset of efficacy and consistency across visual and pathological assessments, supporting further clinical development. Shares of Medicus gained around 9.3% on the Nasdaq in early Wednesday trading.

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 [email protected] Anna Baran-Djokovic, SVP Investor Relations (305) 615-9162 [email protected] 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

Phase 2 Study Demonstrated 73% clinical Clearance in the 200-µg Arm suggests that ~3 out of 4 treated lesions may allow patients to avoid immediate surgical intervention. PHILADELPHIA, PA / ACCESS Newswire / March 18, 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, announced today that members of its executive management team, led by Dr. Raza Bokhari, Executive Chairman & CEO, will participate in a live fireside chat on Thursday, March 19, 2026, hosted by Kumaraguru (Kumar) Raja, Ph.D., Senior Biotechnology Analyst at Brookline Capital Markets. Dr. Bokhari will provide a company update including a review of the positive SkinJect® SKNJCT-003 Phase 2 clinical trial topline results that were reported earlier this month. Key findings of the study include 73% clinical Clearance in the 200-µg Arm suggests that ~3 out of 4 treated lesions may allow patients to avoid immediate surgical intervention. The SKNJCT-003 Phase 2 study is 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. Previously reported Topline results of the clinical clearance of study are tabulated below: Table 1. Clinical Clearance by Treatment Arm P-MNA: Microneedle device-only control arm D-MNA: Doxorubicin-loaded microneedle array The study results demonstrate clear separation in clinical response between the D-MNA treatment arm (73%) and P-MNA treatment arm (38%) in the 200-µg cohort at Day 57, supporting the continued development of SkinJect as a potential non-surgical treatment option for patients with basal cell carcinoma. The dataset reflects two complementary components of the SkinJect mechanism: Biological Activity of the Microneedle Device-Only Control (P-MNA) The SKNJCT-003 study included a microneedle device-only control arm (P-MNA) that did not contain the chemotherapeutic agent. Microneedle insertion into tumor tissue is known to produce localized biological activity, including: mechanical disruption of tumor architecture activation of wound-healing pathways localized immune signaling Basal cell carcinoma is recognized as a highly immunogenic tumor, and these localized biological responses are designed to contribute to tumor regression even without drug loading. The Company previously observed similar biological effects in: the SKNJCT-001 Phase 1 safety study (2021) the interim analysis of SKNJCT-003 in March 2025 Separation Between Drug and Device Arms The SKNJCT-003 study demonstrated substantially higher clinical clearance in the drug-loaded microneedle cohort compared with the device-only control arm atDay 57: 200-µg D-MNA cohort: 73% clinical clearance P-MNA cohort: 38% clinical clearance Importantly, the magnitude of response observed in the active treatment cohort relative to the device-only control arm provides clinically meaningful evidence of drug-mediated therapeutic effect within a biologically active microneedle delivery platform. The Company believes the dataset represents decision-grade evidence supporting continued development of the SkinJect program and advancement toward regulatory discussions and potential strategic partnerships. The fireside chat will conclude with a Q&A session during which participants can ask questions. Please note this event will be live only; there will be no publicly available recording or archived webcast. For further information contact: Carolyn Bonner, President and Chief Financial Officer (610) 636-0184 [email protected] Anna Baran-Djokovic, SVP Investor Relations (305) 615-9162 [email protected] 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 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 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, 2024 (the "Annual Report"), and in the Company's other public filings on EDGAR and SEDAR+, which may impact, among other things, the trading price and liquidity of the Company's common shares. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect our expectations as of the date hereof and thus are subject to change thereafter. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Readers are further cautioned not to place undue reliance on forward-looking statements as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. SOURCE: Medicus Pharma Ltd View the original press release on ACCESS Newswire

Medicus Pharma (NASDAQ:MDCX) said on Thursday that its experimental microneedle-based therapy showed encouraging efficacy in a mid-stage clinical trial for treating Basal Cell Carcinoma, with the highest-dose group achieving 73% clinical clearance of lesions. The Phase 2 randomized, double-blind, placebo-controlled study enrolled 90 patients with nodular basal cell carcinoma and evaluated two doses of the company’s doxorubicin microneedle array (D-MNA), a non-invasive treatment designed to deliver chemotherapy through the skin. At 57 days after treatment, the 200-microgram dose group achieved 73% clinical clearance and 40% histological clearance confirmed by biopsy, according to a statement from Medicus. In comparison, the placebo group recorded clinical clearance of 38% and histological clearance of 38% at the same timepoint. The trial also included a 100-microgram dose group, which achieved clinical clearance of 42% and histological clearance of 33% at Day 57. The company said clearance rates increased between the first evaluation at Day 29 and the later assessment at Day 57, suggesting continued biological activity of the therapy over time. “We are extremely encouraged by these topline results, which not only validate management’s scientific and investment thesis, but also provide what we consider to be decision-grade evidence of clinical activity, particularly at the 200-microgram dose level,” said CEO Dr Raza Bokhari. “The observed increase in clearance rates at Day 57 in the higher-dose cohort reinforces the sustained biological activity of SkinJect and supports advancement into the next stage of development. Importantly, we believe this dataset strengthens our position in ongoing and prospective partnering discussions and may accelerate strategic engagement as we evaluate optimal pathways for value creation.” The company said the results could support an end-of-Phase-2 meeting with the U.S. Food and Drug Administration in the first half of 2026. Medicus added that the full clinical study report, including safety analyses and additional procedural observations, is expected to be completed in the second quarter of 2026, and the company does not anticipate material changes to the reported efficacy findings. The trial was not designed as a registrational study, and the company cautioned that the results do not guarantee regulatory approval. Medicus said its development strategy is to advance select programs through Phase 2 proof-of-concept trials and then seek licensing or strategic partnerships with established pharmaceutical companies for late-stage development and commercialization.

Clinical development programs for doxorubicin-containing microneedle array (D-MNA) and Teverelix, a next generation GnRH antagonist, are steadily advancing PHILADELPHIA, PENNSYLVANIA / ACCESS Newswire / November 14, 2025 / Medicus Pharma Ltd. (NASDAQ:MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutic assets, announced today its financial and operating results for the quarter ending September 30, 2025, and highlighted important corporate updates. Third Quarter Corporate Highlights: Skinject Clinical Development Program SKNJCT-003 & SKNJCT-004 Progress: The Company is currently conducting a Phase 2 clinical study for SKNJCT-003 in nine (9) clinical sites across the United States. SKNJCT-003, which commenced randomizing patients in August 2024, is a double blinded, placebo controlled triple arm proof of concept Phase 2 clinical study, designed to non-invasively treat basal cell carcinoma (BCC) of the skin using novel, patent protected, dissolvable doxorubicin-containing microneedle arrays (D-MNA). In August 2025, the Company announced that SKNJCT-003 has randomized more than seventy-five percent (75%) of the ninety (90) participants expected to be randomized in the study. In September 2025, the Company received positive feedback from the Food and Drug Administration (FDA) regarding its Type C meeting supporting the development of SkinJect, indicating that the Company may follow the FDA's 505(b)(2) regulatory pathway to non-invasively treat BCC of the skin using dissolvable D-MNA. In October 2025, the Company treated its first patient in the clinical study (SKNJCT-004) currently underway in the United Arab Emirates (UAE). The study is expected to randomize thirty-six (36) patients in six (6) sites in the UAE. Cleveland Clinic Abu Dhabi is the principal investigator. 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 U.K. Good Clinical Practice and National Health Service capacity and capability standards. Skinject Platform Expansion: 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, to explore co-development of thermostable infectious disease vaccines. Pipeline Expansion-Acquisition of Antev In August 2025, the Company completed the acquisition of Antev Limited ("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. Patient Access & Advocacy-Gorlin Syndrome Alliance Collaboration 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 FDA to allow patients with multiple, recurrent, or inoperable BCCs of the skin 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. Today the Company also announced its financial and operating results for the quarter ended September 30, 2025, highlights of which are provided below. Third Quarter Financial Highlights The addition of $10.4 million of aggregate net proceeds from financing transactions and the exercise of warrants has bolstered the Company's already strong balance sheet as it continues to progress its clinical development program while pursuing strategic acquisition, building out its core management team and strengthening its board of directors. Cash and cash equivalents were $8.7 million at the end of the third quarter compared to $5.3 million at the end of the same period in 2024. Total operating expenses were $15.4 million for the third quarter compared to $2.3 million for the same period in 2024. Research and development expenses were $1.7 million for the third quarter compared to $0.6 million for the same period in 2024. General and administrative expenses were $5.0 million for the third quarter compared to $1.8 million for the same period in 2024. Net loss for the third quarter was $16.0 million compared to $2.3 million for the same period in 2024. This reflects increased expenses as the Company accelerates its clinical development program in United States, Europe and the Middle East, raises additional capital, completed the acquisition of Antev in the United Kingdom and continues to integrate Antev into its business and operations, as well as continues to pursue strategic growth. The Company's complete financial statements for the quarter are included in its quarterly report on Form 10-Q, which was filed with the Securities and Exchange Commission on November 14, 2025, and are also available on SEDAR+. Management Commentary "The fundamentals of the Company continue to remain strong," stated Dr. Raza Bokhari, Medicus's Executive Chairman and CEO. "The clinical development program of SkinJect, which we believe represents more the $2 billion in potential market opportunity, is now active across the United States, Europe, and the Middle East. This expansion is enhancing global patient recruitment and our clinical dataset, which, among other things, is expected to assist us in designing a robust pivotal program. Completing the acquisition of Antev has been the highlight of the third quarter, which not only adds strategic depth to our drug development pipeline but also strengthens our team, both at the board and management levels. We believe, Teverelix, a next generation GnRH antagonist, is well positioned to become a first in class product to prevent acute urinary retention relapse due to enlarged prostate, and to treat advanced prostate cancer in patients with high cardiovascular risk profile, collectively representing approximately US$6 billion in potential market opportunity. The Company's balance sheet is stable, and management's confidence level is high." For further information contact: Carolyn Bonner, President and Acting Chief Financial Officer (610) 636-0184 [email protected] Anna Baran-Djokovic, SVP Investor Relations (305) 615-9162 [email protected] About Medicus Pharma Ltd. Medicus Pharma Ltd. (Nasdaq:MDCX) is a biotech/life sciences company focused on accelerating the clinical development programs of novel and potentially disruptive therapeutics assets. The Company is actively engaged in multiple countries, spread over three continents. SkinJect Inc. a wholly owned subsidiary of Medicus Pharma Ltd., is a development stage, life sciences company focused on commercializing novel, non-invasive treatment for basal cell skin cancer using a patented dissolvable microneedle patch to deliver a chemotherapeutic agent to eradicate tumors cells. The Company completed a phase 1 safety & tolerability study (SKNJCT-001) in March of 2021, which met its primary objective of safety and tolerability; the study also describes the efficacy of the investigational product D-MNA, with six (6) participants experiencing complete response on histological examination of the resected lesion. The Company is currently conducting a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-003) in the United States and Europe. The Company has also commenced a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-004) in the United Arab Emirates. In August 2025, the Company announced its entry into a non-binding memorandum of understanding (the "MoU") with Helix Nanotechnologies, Inc. ("HelixNano"), a Boston-based biotech company focused on developing a proprietary advanced mRNA platform, in respect of their shared mutual interest in the development or commercial arrangement contemplated by the MoU. The MoU is non-binding and shall not be construed to obligate either party to proceed with a joint venture or any further development or commercial arrangement, unless and until definitive agreements are executed. In August 2025, the Company completed the acquisition of Antev, a UK-based late clinical stage biotech company, developing Teverelix, a next generation GnRH antagonist, as a first in market product for cardiovascular high-risk advanced prostate cancer patients and patients with first acute urinary retention relapse (AURr) episodes due to enlarged prostate. Antev's flagship drug candidate is Teverelix trifluoroacetate, 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 Cautionary Notice on Forward-Looking Statements Certain information in this news release constitutes "forward-looking information" under applicable securities laws. "Forward-looking information" is defined as disclosure regarding possible events, conditions or financial performance that is based on assumptions about future economic conditions and courses of action and includes, without limitation, the 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, 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 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. SOURCE: Medicus Pharma Ltd View the original press release on ACCESS Newswire

US Food and Drug Administration (FDA) has accepted the company's Type C meeting request and SKNJCT-003 Phase 2 study has randomized more than 75% of patients Philadelphia, Pennsylvania--(Newsfile Corp. - August 21, 2025) - Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutic assets, is pleased to announce, following the acceptance of the Type C meeting request by the United States Food and Drug Administration (the "FDA"), the Company has submitted its queries in writing and expect to receive a response from the FDA before the end of Q3 2025. The purpose of the Type C meeting is to formally discuss the D-MNA product development and gain further alignment on the clinical pathway. The Company's aim is to gain the FDA's consent to fast-track the clinical development program and seek feedback on future clinical plans for the D-MNA development program. The Company also announced that its phase 2 clinical study to non-invasively treat BCC using novel D-MNA (SKNJCT-003) has now randomized more than seventy five percent (75%) of the ninety (90) participants expected to be randomized in the study. Clinical Trial Design The clinical study (SKNJCT-003) is designed to be a randomized, double-blind, placebo-controlled (P-MNA), multi-center study originally enrolling up to sixty (60) subjects presenting with BCC of the skin. The study will evaluate the efficacy of two dose levels of D-MNA compared to a placebo control. The participants will be randomized 1:1:1 to one of three groups: a placebo-controlled group receiving P-MNA, a low-dose group receiving 100μg of D-MNA, and a high-dose group receiving 200μg of D-MNA. The high-dose, 200μg D-MNA, proposed in the study is the maximum dose that was used in the Company's Phase 1 safety and tolerability study (SKNJCT-001) completed in March 2021. SKNJCT-001 met its primary objective of safety and tolerability. The investigational product, D-MNA, was well tolerated across all dose levels in all thirteen (13) participants enrolled in the study, with no dose-limiting toxicities (DLTs), or serious adverse events (SAEs). Furthermore, there were no systemic effects or clinically significant abnormal findings in laboratory parameters, vital signs, ECGs, and physical examinations. The study also describes the efficacy of the investigational product, D-MNA, with six (6) participants experiencing complete responses. The complete response is defined as the disappearance of BCC histologically in the final excision at the end of study visit. The participants profile demonstrating complete responses was diverse, and all participants (6/6) had nodular subtype of BCC. SKNJCT-003 Phase 2 clinical study is currently underway in nine (9) clinical sites across the United States which commenced randomizing patients in August 2024. In March 2025, the Company also announced a positively trending interim analysis for SKNJCT-003 demonstrating more than sixty percent (60%) clinical clearance. The interim analysis was conducted after more than fifty percent (50%) of the then-targeted sixty (60) patients in the study were randomized. The findings of the interim analysis are preliminary and may or may not correlate with the findings of the study once completed. In April 2025, the investigational review board increased the number of participants in SKNJCT-003 to ninety (90) subjects. The Company also announced expanding clinical trial sites in Europe. The Company also has a clinical design (SKNJCT-004) currently underway in the United Arab Emirates (UAE). The study is expected to randomize thirty-six (36) patients in four (4) sites in the UAE. Cleveland Clinic Abu Dhabi (CCAD) is the principal investigator, along with Sheikh Shakbout Medical City (SSMC), Burjeel Medical City (BMC), and American Hospital of Dubai (AHD). Insights Research Organization and Solutions (IROS), a UAE-based contract research organization, is coordinating the clinical study for the Company. IROS is a M42 portfolio company. In June 2025, the Company announced its entry into a definitive agreement to acquire Antev Ltd. ("Antev"), a UK-based 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. 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 of thermostable infectious diseases mRNA vaccines. The MoU is non-binding and shall not be construed to obligate either party to proceed with the joint venture or any further development or commercial arrangement contemplated by the MoU, unless and until definitive agreements are executed. In August 2025, certain insiders of the Company exercised 145,000 stock options at an exercise price of $0.84 and $2.87. These insiders exercised these stock options for tax and other personal financial planning purposes. In August 2025, the Company also announced its financial and operating results for the quarter ended June 30, 2025, highlights of which are provided below. Second Quarter Financial Highlights The addition of $11.5 million of aggregate net proceeds from financing transactions and the exercise of warrants has bolstered the Company's already strong balance sheet as it continues to progress its clinical development program while pursuing strategic transactions and building out its core management team. Cash and cash equivalents were $9.7 million at the end of the second quarter compared to $4.0 million at the end of the first quarter. Total operating expenses were $6.0 million for the second quarter compared to $3.6 million for the same period in 2024. Research and development expenses were $1.4 million for the second quarter compared to $1.3 million for the same period in 2024. General and administrative expenses were $4.6 million for the second quarter compared to $2.3 million for the same period in 2024. Net loss for the second quarter was $6.2 million compared to $3.6 million for the same period in 2024. This reflects increased expenses as the Company accelerates its clinical development program, raises additional funding and pursues strategic growth. The completion of a public offering of units for gross proceeds of $7.0 million. The Company's complete financial statements for the quarter are included in its quarterly report on Form 10-Q, which was filed with the United States Securities and Exchange Commission on August 11, 2025, and are also available on SEDAR+. Management Commentary "The fundamentals of the Company are extremely strong today" stated Dr. Raza Bokhari, Executive Chairman and CEO "as we navigate through various opportunities available to us as a clinical stage company, we are making great progress with SkinJect while evaluating and selectively acting on other assets, as reflected by our agreement to acquire Antev and the possibility of a collaboration with HelixNano. Medicus' balance sheet is trending in a positive direction and management confidence level is high. Certain insiders have exercised stock options and expressed their intent to hold the shares, signaling their positive outlook for the prospects of the Company." For further information contact: Carolyn Bonner, President (610) 636-0184 [email protected] Anna Baran-Djokovic, SVP Investor Relations (305) 615-9162 [email protected] About Medicus Pharma Ltd. Medicus Pharma Ltd. (NASDAQ: MDCX) is a biotech/life sciences company focused on accelerating the clinical development programs of novel and 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 patented dissolvable microneedle patch to deliver 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 UAE. In June 2025, the Company announced its entry into a definitive agreement to acquire 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. The transaction with Antev is subject to the fulfillment of certain closing conditions, including obtaining Antev shareholder approval and other applicable corporate, regulatory and third-party approvals. No assurances can be given that the parties will successfully close the proposed transaction on the terms or timeframe currently contemplated or at all. 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 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' 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, the Company's expectation of receiving a response from the FDA regarding its queries for its Type C Meeting before the end of Q3 2025, the commencement of the SKNJCT-004 study and the potential results of and benefits of such study, the Antev transaction, including the closing of the transaction or the timing thereof, the potential benefits of the Antev transaction, if consummated, including plans and expectations concerning, and future outcomes relating to, the development, advancement and commercialization of Teverelix, and the potential market opportunities related thereto. 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" 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 public filings on EDGAR and on 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 cautioned that the foregoing list is not exhaustive, and readers are encouraged to review the Company's long form prospectus accessible on the Company's profile on EDGAR at www.sec.gov and on SEDAR+ at www.sedarplus.ca. 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. To view the source version of this press release, please visit https://www.newsfilecorp.com/release/263287

The Company added Congresswoman Cathy McMorris Rodgers & Ajay Raju, Esq. to the Board of Directors. Philadelphia, Pennsylvania--(Newsfile Corp. - July 23, 2025) - Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company") is pleased to announce the voting results of the Company's annual and special meeting (the "Meeting") of shareholders that was held on July 22, 2025, at 10:00 a.m. (Eastern Time), at the law offices of Bennett Jones in Toronto, Ontario. The Company's shareholders passed all the resolutions put before them. At the Meeting, all eight nominees for the board of directors of the Company were elected, the voting results of which are as follows: "The shareholders of the company are proud to elect and re-elect a balanced, diverse, entrepreneurial and experienced leadership in drug development, good governance, capital markets and mergers & acquisitions," stated Dr. Raza Bokhari, Executive Chairman & CEO. "We are honored to welcome the Honorable Cathy McMorris Rodgers and Ajay Raju to the board. Ajay's contributions as a thought leader, opinion maker, and an emerging disruptor in the life sciences and biotech sector in the keystone region are noteworthy; his seed investment of $8M in our pre-IPO round was pivotal to get us off the ground." Dr. Bokhari also highlighted Congresswoman Rodgers's distinguished record of public service. "Cathy, as a law maker for three decades, broke the glass ceiling to become the first female Chair of the powerful House Committee on Energy & Commerce, where she had jurisdiction over 80% of the U.S. economy, including energy production, telecommunication, internet, interstate commerce, healthcare and Food and Drug Safety." Dr. Bokhari proudly announced, "We couldn't be more fortunate to be Congresswoman's first choice as she sought election as a board member, following her retirement from the U.S. Congress in 2024." New Board Members Hon. Cathy McMorris Rodgers The Honorable Cathy McMorris Rodgers is a trailblazer and dedicated public servant who has spent three decades serving her state and country. She served as the U.S. Representative for Washington's 5th Congressional District from 2004 to 2025. As a high-profile congressional leader, innovative policymaker, and trust-builder, she is regarded as a unifying force and a high-impact leader with a long history of accomplishments. Cathy is people-centric, guided by values, and motivated by a mission. In 1994, Cathy was appointed to the Washington State House of Representatives; in 2002, her colleagues elected her Republican Leader, the first female House Leader in Washington State. Cathy was elected to Congress in 2004. In the U.S. Congress, Cathy quickly rose to leadership: in her freshman class, as Conference Vice Chair, and later as Republican Conference Chair, one of the top four House leadership positions. In 2021, she assumed Republican Leadership of the powerful Energy and Commerce Committee (E&C) and Chairmanship of the E&C Committee after the 2022 election. She is the first female Chair since the E&C Committee's founding in 1795. Gaining national attention in 2014, Cathy authored and delivered the Republican response to President Obama's 2014 State of the Union Address. Cathy frequently appears on major media networks, including Meet the Press, Fox News Sunday, Special Report with Brett Baier, The Lead with Jake Tapper, and ABC Evening News. Ajay Raju Mr. Raju is an attorney and a venture capitalist, who is highly involved in the civic interests of his community. His experience includes representation of clients in the structured finance, real estate, capital markets and life sciences/biotech sectors. He currently serves as Chairman and CEO of Raju LLP, managing partner of 215 Capital, and co-founder of Avstera Therapeutics. Ajay holds leadership roles in 16 portfolio companies. He previously served as Chairman and CEO of Dilworth Paxson LLP and as Managing Partner of Reed Smith's Philadelphia office, where he was a member of the Global Executive Committee. Mr. Raju is also the Co-Founder and Chairman of The Germination Project, The Philadelphia Citizen, The Ten Program, Vision 20/20 and The Ark Institute. He serves on several civic boards, including the Philadelphia Museum of Art, Penn Medicine, and the Greater Philadelphia Chamber of Commerce. Continuing Board Members Dr. Raza Bokhari Dr. Raza Bokhari, Executive Chairman and CEO, is a physician turned serial entrepreneur with a track record of successfully aggregating and accelerating life sciences, healthcare services, and pharmaceutical R&D companies. He previously served as Executive Chairman and CEO of FSD Pharma (NASDAQ: HUGE), where his strategies successfully pivoted the company out of medicinal cannabis and into clinical stage pharmaceutical R&D, a transition marked by a NASDAQ listing in January 2020, and raising nearly $100M institutional capital to fuel growth and expansion. In addition to his corporate roles, Dr. Bokhari serves as the Vice Chairman of the World Affairs Council of Philadelphia. He is also the founding Director of Pakistan Human Development Foundation, focused on improving basic health, education and infant and mother mortality in his country of origin. He formerly served on the Board of Temple University's Fox School of Business and Management, as Chairman of the Executive Advisory Committee and was a Trustee of the esteemed Franklin Institute and Foreign Policy Research Institute (FPRI). Dr. Bokhari, through his family foundation, believes in giving back and investing in the community. In recognition of a $1 million gift, he made to his alma mater, Temple University, its Fox Business School named the Innovation & Entrepreneurship Institute Suite in his honor. The school acknowledged Dr. Bokhari in 2018 by naming him a Centennial Honoree, a special collection of entrepreneurs, visionaries, and disruptors who helped shape the Fox School and the business world since 1918. Dr. Larry Kaiser Dr. Larry Kaiser is the President & CEO of the College of Physicians of Philadelphia. He was a Managing Director with the Healthcare Industry Group at Alvarez and Marsal from 2020 to 2025. Dr. Kaiser is a world-renowned Cardio-thoracic surgeon, who has authored twenty textbooks and published over 350 peer reviewed research articles. He has also held the positions of President and CEO of the $2.2 billion Temple University Health System and Dean of Temple University's Lewis Katz School of Medicine. Prior to his service at Temple, he was the President of the University of Texas Health Science Center at Houston. Robert J. Ciaruffoli Mr. Ciaruffoli is the co-founder, past Chairman and current executive committee member of Broad Street Angels, a 120-member Philadelphia-based angel investor network. Mr. Ciaruffoli is a CPA and served as the Chairman and CEO of the Parente Beard/Baker Tilly accounting and advisory firm from 2000 to 2015. Mr. Ciaruffoli also served on the board of directors and executive committee of Baker Tilly International as it grew from an unranked network to the eighth largest global accounting network. William L. Ashton William Ashton is a former Fortune 100 senior executive with over 35 years' experience in the biotechnology and pharmaceutical business. Mr. Ashton retired from a successful career at Amgen Inc. where he served in various positions from 1989, including as Vice President of U.S. Sales, Vice President/General Manager of Corporate Accounts, and Vice President of Government and Commercial Affairs. Mr. Ashton was the Founding Dean and assistant professor at the Mayes College of Healthcare Business and Policy at the University of the Sciences of Philadelphia (now St. Joseph University). Barry Fishman Mr. Fishman has almost 25 years of experience as an entrepreneurial business leader and he has held executive leadership roles in branded and generic pharmaceutical companies including Eli Lilly, Taro, Teva, and Merus Labs. Mr. Fishman has significant experience as a public company director and is a past Chair of the Canadian Generic Pharmaceutical Association (CGPA). Mr. Fishman has served as an independent director on high-profile boards, including Aurora Cannabis Inc. and Canopy Growth Corporation. Dr. Sara R. May Dr. May is a highly skilled professional with over 10 years of experience managing large-scale commercial and research projects within regulated industries. Dr. May brings a multidisciplinary background in quality assurance and compliance, clinical trial management, environmental consulting, and data analytics. She had direct experience working with regulators, including the FDA, Health Canada and Canada Revenue Agency. She was the President of FV Pharma, a wholly owned subsidiary of FSD Pharma, Inc. (NASDAQ: HUGE) and a member of the board of directors of Cannara Biotech (CSE: LOVE). Dr. May holds a PhD in Evolutionary Genetics from Queen's University. Other Matters Approved Shareholders at the meeting also approved (i) the appointment of KPMG LLP as auditors for the Company and the authorization of the board of directors of the Company to fix the auditors' remuneration and terms of engagement; (ii) an amendment to the Company's by-laws to increase the quorum requirement for the transaction of business at a meeting of shareholders; (iii) the approval in accordance with Nasdaq Rule 5635(d) (the "Nasdaq 20% Rule") of the issuance of common shares of the Company (the "Common Shares") pursuant to the Standby Equity Purchase Agreement, dated February 10, 2025, between the Company and YA II PN, Ltd., which may exceed 20% or more of the Common Shares outstanding at the applicable time and be at a price per share below the minimum price specified by the Nasdaq 20% Rule; and (iv) an amendment to the Company's articles of incorporation increasing the voting threshold required to remove the Chairman of the Board to a vote of at least 75% of the board. Full details of the foregoing are contained in the Form 8-K, which has been filed on EDGAR at www.sec.gov and the Report of Voting Results for the Meeting, which has been filed on SEDAR+ at www.sedarplus.ca. For further information contact: Carolyn Bonner, President (610) 636-0184 [email protected] Anna Baran-Djokovic, SVP Investor Relations (305) 615-9162 [email protected] About Medicus Pharma Ltd. Medicus Pharma Ltd. (NASDAQ: MDCX) is a biotech/life sciences company focused on accelerating the clinical development programs of novel and 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 patented dissolvable microneedle patch to deliver 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 UAE. In June 2025, the Company announced its entry into a definitive agreement to acquire 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. The transaction with Antev is subject to the fulfillment of certain closing conditions, including obtaining Antev shareholder approval and other applicable corporate, regulatory and third-party approvals. No assurances can be given that the parties will successfully close the proposed transaction on the terms or timeframe currently contemplated or at all.. 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 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, the commencement of the SKNJCT-004 study and the potential results of and benefits of such study, the Antev transaction, including the closing of the transaction or the timing thereof, the potential benefits of the Antev transaction, if consummated, including plans and expectations concerning, and future outcomes relating to, the development, advancement and commercialization of Teverelix, and the potential market opportunities related thereto. 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", "would", "should", "estimate", "plan", "project", "forecast", "intend", "expect", "anticipate", "believe", "seek", "continue", "target" 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 public filings on EDGAR and on 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 cautioned that the foregoing list is not exhaustive, and readers are encouraged to review the Company's long form prospectus accessible on the Company's profile on EDGAR at www.sec.gov and on SEDAR+ at www.sedarplus.ca. 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. To view the source version of this press release, please visit https://www.newsfilecorp.com/release/259702