US Market News
2月前
Medicus Pharma Reports Full-Year 2025 Financial Results and Provides Corporate UpdateMarch 25, 2026 4:30 PM
ACCESS NewswireAdvances Clinical Pipeline Across Dermatology, Urology, Oncology and strengthens Capital Base to support Phase 2 ProgramsPHILADELPHIA, 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 response200 ug cohort at Day 57 suggest ~3 out of 4 treated patients may avoid immediate surgeryBiological 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 InnovationGorlin Syndrome ExpansionAdvancing SkinJect® for nevoid basal cell carcinoma syndrome, a rare genetic disorder characterized by multiple recurrent BCC lesionsPursuing Expanded Access IND program for patients with multiple or inoperable lesionsSupports potential orphan disease positioning and broader clinical utilityPlatform Extension via HelixNano CollaborationEntered 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 vaccinesTeverelix 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 flarePotential cardiovascular safety advantage vs. GnRH agonistsCore development programs:Advanced prostate cancer (cardiovascular risk population)Acute urinary retention (390-patient Phase 2b study)Women's Health ExpansionEvaluating Teverelix in symptomatic endometriosis, a high-prevalence condition with unmet needLeveraging a genomics-enabled clinical strategy, including:Hormonal pathway profilingBiomarker-driven patient stratificationPrecision trial designFuture economic profile strengthened through royalty reduction (~4% ? 2%) on worldwide net sales of TeverelixAI-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 simulationSite selection and enrollment forecastingPharmacodynamic-informed patient stratificationDose optimization and adaptive trial executionProposed platform is intended to enable:Capital-efficient developmentReduced clinical timelinesData-driven decision-making across all current and future development programsFinancial 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 millionGeneral & administrative: $17.9 millionResearch & development: $7.7 millionIn-process R&D (Teverelix acquisition): $8.7millionNet loss: $35.4 million (vs. $11.2 million in 2024)Loss from operations: $34.4 millionNet loss per share: $2.74The 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 2026The Company is entering a catalyst-rich period in 2026, including:End-of-Phase 2 FDA meeting (SkinJect®) to define registrational pathwayPotential registrational trial design alignment under 505(b)(2) frameworkAdvancement of Gorlin Syndrome Expanded Access programContinued evaluation of HelixNano-enabled platform expansion opportunitiesInitiation of Phase 2b Teverelix study in prostate cancer and AUR indicationsExpansion of Teverelix into women's health (endometriosis) using genomics-enabled clinical strategyProgression of agentic AI-driven clinical development platform with Reliant AIOngoing strategic partnering discussions across both core programs, Skinject and TeverelixBusiness update Conference CallThe Company will host a business update conference call on Thursday, March 26, 2026, beginning at 11:30 a.m. Eastern time. Babar K. Rao, MD, FAAD, an internationally recognized academic dermatologist and Principal Investigator of the SKNJCT-003 Phase 2 clinical study, will join the Company's leadership team during the call.Participants are encouraged to pre-register for the conference call using this link to receive a dial-in number and PIN to bypass the live operator. Participants may pre-register at any time, including up to and after the call start time. Those unable to pre-register can participate by dialing 833-890-6070 (U.S./Canada) or 412-504-9736 (international). A webcast of the call can be accessed here.For further information contact:Carolyn Bonner, President and Chief Financial Officer
(610) 636-0184
cbonner@medicuspharma.comAnna Baran-Djokovic, SVP Investor Relations
(305) 615-9162
adjokovic@medicuspharma.comAbout 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 ExpansionIn 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 AdvocacyIn 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 DevelopmentIn 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 StatementsCertain 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 LtdView the original press release on ACCESS NewswireOriginal: Medicus Pharma Reports Full-Year 2025 Financial Results and Provides Corporate Update
US Market News
3月前
Medicus Pharma To Discuss Positive Skinject(R) Phase 2 Topline Results In Fireside Chat Hosted By Brookline Capital Markets Biotechnology Equity Research AnalystMarch 18, 2026 7:30 AM
ACCESS NewswirePhase 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.Event:Fireside Chat with Kumar Raja, Brookline Capital MarketsDate:Thursday, March 19, 2026Time:11:00 a.m. Eastern TimeRegistration:https://us06web.zoom.us/webinar/register/WN_Qk7s5UgXQUGTymwxCJvKMwDr. 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 ArmTreatment Arm# of patients (47)Clinical clearance (Day 29)# of patients (43)Clinical Clearance (Day 57)200 µg D-MNA1540%1573%P-MNA1533%1638%100 µg D-MNA1747%1242%P-MNA: Microneedle device-only control arm
D-MNA: Doxorubicin-loaded microneedle arrayThe 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:Biologic activity from the microneedle delivery platformAdditional tumor-killing activity from the chemotherapeutic agentBiological 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 architectureactivation of wound-healing pathwayslocalized immune signalingBasal 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 2025Separation Between Drug and Device ArmsThe 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 clearanceP-MNA cohort: 38% clinical clearanceImportantly, 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
cbonner@medicuspharma.comAnna Baran-Djokovic, SVP Investor Relations
(305) 615-9162
adjokovic@medicuspharma.comAbout 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 ExpansionIn 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 AdvocacyIn 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 DevelopmentIn 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 StatementsCertain 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 LtdView the original press release on ACCESS NewswireOriginal: Medicus Pharma To Discuss Positive Skinject(R) Phase 2 Topline Results In Fireside Chat Hosted By Brookline Capital Markets Biotechnology Equity Research Analyst
US Market News
3月前
Medicus Pharma Ltd. To Participate In The Longwood Miami CEO ForumMarch 10, 2026 7:30 AM
ACCESS NewswireDr. Raza Bokhari, Executive Chairman & CEO will participate in panel discussions and highlight Company's AI-enabled Drug Development StrategyPHILADELPHIA, PA / ACCESS Newswire / March 10, 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, is pleased to announce its participation in the Longwood Miami CEO forum being held March 11-13, 2026, at the Ritz-Carlton Key Biscayne.Dr. Raza Bokhari, Executive Chairman & CEO of Medicus, will serve on a panel titled "Accelerating the Path to Patient Care" and will highlight company's AI enabled Drug development strategy designed to make clinical trials not only cost efficient but also time efficient.Other panelists include Lindsay Edwards, CTO & President of Platform, Relation Therapeutics; Julie Gerberding, CEO, Foundation for the NIH and Former Director, CDC; and Gilmore O'Neill, CEO, Editas Medicine. The panel will be moderated by Jon Cohen, Head of Life Sciences Go-To-Market at ServiceNow.Event details:Event: Longwood Healthcare Leaders Miami CEODate: March 12-13, 2026Venue: The Ritz-Carlton Key Biscayne.Information and registration: https://www.longwoodhealthcareleaders.com/miamiceoLongwood Miami CEO is an invitation-only event, that brings together Industry leaders, innovators, thought leaders and opinion makers, who will speak on curated fireside chats, roundtables, and discussion panels.Notable Participants in the conference include Brent Saunders (CEO, Bausch + Lomb), Chris Boshoff (CSO & President, R&D, Pfizer), Rob Califf (former Commissioner, FDA), Sidney Taurel (Chair Emeritus, Lilly), Bill Mezzanotte (Head, R&D, CSL), David Redfern (President, Corporate Development, GSK), Pablo Cagnoni (Head, R&D, Incyte), Julie Gerberding (former Director, CDC), Bill Hait (Chief Scientific Advisor, AACR; former CMO, J&J), Jeremy Levin (Chair & CEO, Ovid Therapeutics), David Meek (former CEO, Ipsen; CEO, Genetix), Frank Nestle (CEO, Deerfield Discovery), Benj Garrett (Managing Director, Stifel), among others.For further information contact:Carolyn Bonner, President and Chief Financial Officer
(610) 636-0184
cbonner@medicuspharma.comAnna Baran-Djokovic, SVP Investor Relations
(305) 615-9162
adjokovic@medicuspharma.comAbout Medicus Pharma Ltd.Medicus Pharma Ltd. (Nasdaq:MDCX) is a precision-guided biotech/life sciences company focused on accelerating the clinical development programs of novel and potentially disruptive therapeutics assets. The Company is actively engaged in multiple countries across three continents.SkinJect Inc., a wholly owned subsidiary of Medicus Pharma Ltd., is a development-stage life sciences company focused on commercializing a novel, non-invasive treatment for basal cell skin cancer using a patented dissolvable microneedle patch to deliver a chemotherapeutic agent to eradicate tumor cells.In August 2025, the Company announced its entry into a non-binding memorandum of understanding (MoU) with Helix Nanotechnologies, Inc. (HelixNano), a Boston-based biotech company focused on developing a proprietary advanced mRNA platform, in respect of their shared mutual interest in the development or commercial arrangement contemplated by the MoU. The MoU is non-binding and shall not be construed to obligate either party to proceed with a joint venture or any further development or commercial arrangement, unless and until definitive agreements are executed.In August 2025, the Company completed the acquisition of Antev, a UK-based late clinical stage biotech company, developing Teverelix, a next-generation gonadotrophin-releasing hormone (GnRH) antagonist, as a first-in-market product for cardiovascular high-risk advanced prostate cancer patients and patients with first acute urinary retention relapse (AURr) episodes due to enlarged prostate.Unlike GnRH agonists, which can cause an initial surge in testosterone levels, Teverelix directly suppresses sex hormone production without this surge, potentially reducing cardiovascular risks. This mechanism is particularly beneficial for patients with existing cardiovascular conditions. Teverelix is formulated as a microcrystalline suspension, allowing for sustained release and a six-week dosing interval, which may improve patient compliance and outcomes.In October 2025, the Company announced a strategic collaboration with the Gorlin Syndrome Alliance (GSA) to advance compassionate access to SkinJect for patients suffering from Gorlin Syndrome, also known as nevoid basal cell carcinoma syndrome.Under the collaboration, Medicus and the GSA will jointly pursue the Expanded Access IND Program with the FDA to allow patients with multiple, recurrent, or inoperable basal cell carcinomas (BCCs) to access SkinJect under physician-supervised treatment protocols. The initiative aims to establish a framework for expanded access while collecting valuable real-world safety and tolerability data to inform future regulatory filings. It will also more tightly integrate patient community-led insights and data into the design, monitoring, and long-term development of SkinJect in this rare disease population.In November 2025, the Company received full regulatory and ethical approvals in the United Kingdom to expand its ongoing Phase 2 clinical study (SKNJCT-003) evaluating D-MNA to non-invasively treat BCC of the skin. The approvals were issued by the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority (HRA) and the Wales Research Ethics Committee (WREC). The MHRA approval followed a comprehensive scientific review of the Investigational Medicinal Product Dossier (IMPD) and protocol. The WREC issued a favorable ethical opinion, and the HRA granted study-wide governance approval, confirming compliance with UK Good Clinical Practice and National Health Service capacity and capability standards.In December 2025, the Company announced that it has successfully completed enrolment of 90 patients in the United States for Phase 2 clinical study (SKNJCT-003) evaluating D-MNA to non-invasively treat BCC of the skin. The Company expects to secure an end-of-Phase 2 meeting with the FDA in the first half of 2026.In December 2025, Medicus announced a non-binding letter of intent with Reliant AI Inc., a decision-intelligence company specializing in generative AI for the life sciences industry, to collaborate on the development of an AI-driven clinical data analytics platform. Subject to execution of definitive agreements, the platform is expected to support capital-efficient clinical development through data-driven dynamic clinical-site selection, patient stratification and enrollment forecasting. The initial phase of the collaboration is expected to support an upcoming Teverelix clinical study planned for 2026, with potential expansion into later-stage development programs in collaboration with a strategic partner.In February 2026, the Company announced that it has received "study may proceed" clearance from the U.S. Food and Drug Administration (FDA) to initiate its Phase 2b dose-optimization study of Teverelix®, an investigational next generation long-acting GnRH antagonist, in men with advanced prostate cancer (APC).Cautionary Notice on Forward-Looking StatementsCertain 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 LtdView the original press release on ACCESS NewswireOriginal: Medicus Pharma Ltd. To Participate In The Longwood Miami CEO Forum
US Market News
4月前
Medicus Pharma on Bloomberg WorldFebruary 12, 2026 7:30 AM
ACCESS NewswireDr. Raza Bokhari, Exec Chairman & CEO, Interviewed by Bloomberg Open Interest Anchor Matt MillerPHILADELPHIA, PA / ACCESS Newswire / February 12, 2026 / Medicus Pharma Ltd. (NASDAQ:MDCX) ("Medicus" or the "Company"), a precision guided biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, CEO Dr Raza Bokhari joined Matt Miller from Bloomberg World for a live interview on February 10, 2026. https://youtu.be/2-naOb7uJRc?si=eumsbejKNkAdQ62GIn this live interview on Bloomberg World, Dr. Raza Bokhari, Executive Chairman and CEO of Medicus Pharma, discusses the company's strategy, the challenges facing biotech stocks, and how artificial intelligence is shaping its drug development efforts.Central to the discussion is the role of AI in accelerating drug development. Dr. Bokhari outlines Medicus Pharma's AI-driven approach, positioning the company's leadership as both. investors and operators that have committed nearly $14 million of personal capital at $4 per share toward advancing its pipeline. He expresses confidence in his beliefs that continued AI-enabled progress, regulatory optionality, and upcoming catalysts, including Phase 2 clinical data readouts for Skinject in the first half of 2026, should materially change investor perception and unlock value, in the same manner it did in the first half of 2025, following the of a positively trending interim data analysis.The conversation underscores both the short-term volatility in biotech markets and the company's long-term belief in the potential of AI to transform innovative therapy development.Click here to watch the full interview.For further information contact:Carolyn Bonner, President and Chief Financial Officer
(610) 636-0184
cbonner@medicuspharma.comAnna Baran-Djokovic, SVP Investor Relations
(305) 615-9162
adjokovic@medicuspharma.comAbout Medicus Pharma Ltd.Medicus Pharma Ltd. (Nasdaq:MDCX) is a precision-guided biotech/life sciences company focused on accelerating the clinical development programs of novel and potentially disruptive therapeutics assets. The Company is actively engaged in multiple countries across three continents.SkinJect Inc., a wholly owned subsidiary of Medicus Pharma Ltd., is a development-stage life sciences company focused on commercializing a novel, non-invasive treatment for basal cell skin cancer using a patented dissolvable microneedle patch to deliver a chemotherapeutic agent to eradicate tumor cells. The Company completed a Phase 1 study (SKNJCT-001) in March of 2021, which met its primary objective of demonstrating safety and tolerability; the study also describes the efficacy of the investigational product doxorubicin-containing microneedle arrays (D-MNA), with six participants experiencing complete response on histological examination of the resected lesion. The Company is currently conducting a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-003) in the United States and Europe. The Company has also commenced a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-004) in the United Arab Emirates.In August 2025, the Company announced its entry into a non-binding memorandum of understanding (MoU) with Helix Nanotechnologies, Inc. (HelixNano), a Boston-based biotech company focused on developing a proprietary advanced mRNA platform, in respect of their shared mutual interest in the development or commercial arrangement contemplated by the MoU. The MoU is non-binding and shall not be construed to obligate either party to proceed with a joint venture or any further development or commercial arrangement, unless and until definitive agreements are executed.In August 2025, the Company completed the acquisition of Antev, a UK-based late clinical stage biotech company, developing Teverelix, a next-generation gonadotrophin-releasing hormone (GnRH) antagonist, as a first-in-market product for cardiovascular high-risk advanced prostate cancer patients and patients with first acute urinary retention relapse (AURr) episodes due to enlarged prostate.Unlike GnRH agonists, which can cause an initial surge in testosterone levels, Teverelix directly suppresses sex hormone production without this surge, potentially reducing cardiovascular risks. This mechanism is particularly beneficial for patients with existing cardiovascular conditions. Teverelix is formulated as a microcrystalline suspension, allowing for sustained release and a six-week dosing interval, which may improve patient compliance and outcomes.In September 2020, Antev completed a Phase 1 clinical trial in which Teverelix was shown to be well tolerated with no dose-limiting toxicities and demonstrated rapid testosterone suppression. The study included 48 healthy male volunteers. In February 2023, Antev also completed a Phase 2a study in 50 patients with advanced prostate cancer (APC), where Teverelix achieved the primary endpoint of greater than 90% probability of castration levels of testosterone suppression (97.5%) but the secondary endpoint of maintaining this rate above 90% was not met, with the probability dropping to 82.5% by Day 42.In January 2023, the U.S. Food and Drug Administration (FDA) reviewed the Phase 1 and Phase 2a data and provided written guidance on Antev's proposed Phase 3 trial design for Teverelix. This milestone supports the Company's clinical plans to develop Teverelix as a treatment for advanced prostate cancer patients with increased cardiovascular risk.In December 2023, the FDA approved the Phase 2b study design in advanced prostate cancer covering 40 patients.In November 2024, the FDA approved the Phase 2b study design in AURr covering 390 patients.In October 2025, the Company announced a strategic collaboration with the Gorlin Syndrome Alliance (GSA) to advance compassionate access to SkinJect for patients suffering from Gorlin Syndrome, also known as nevoid basal cell carcinoma syndrome.Under the collaboration, Medicus and the GSA will jointly pursue the Expanded Access IND Program with the FDA to allow patients with multiple, recurrent, or inoperable basal cell carcinomas (BCCs) to access SkinJect under physician-supervised treatment protocols. The initiative aims to establish a framework for expanded access while collecting valuable real-world safety and tolerability data to inform future regulatory filings. It will also more tightly integrate patient community-led insights and data into the design, monitoring, and long-term development of SkinJect in this rare disease population.In November 2025, the Company received full regulatory and ethical approvals in the United Kingdom to expand its ongoing Phase 2 clinical study (SKNJCT-003) evaluating D-MNA to non-invasively treat BCC of the skin. The approvals were issued by the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority (HRA) and the Wales Research Ethics Committee (WREC). The MHRA approval followed a comprehensive scientific review of the Investigational Medicinal Product Dossier (IMPD) and protocol. The WREC issued a favorable ethical opinion, and the HRA granted study-wide governance approval, confirming compliance with UK Good Clinical Practice and National Health Service capacity and capability standards.In December 2025, the Company announced that it has successfully completed enrolment of 90 patients in the United States for Phase 2 clinical study (SKNJCT-003) evaluating D-MNA to non-invasively treat BCC of the skin. The Company expects to release topline results for SKNJCT-003 in the first quarter of 2026 and secure an end-of-Phase 2 meeting with the FDA in the first half of 2026.In December 2025, Medicus announced a non-binding letter of intent with Reliant AI Inc., a decision-intelligence company specializing in generative AI for the life sciences industry, to collaborate on the development of an AI-driven clinical data analytics platform. Subject to execution of definitive agreements, the platform is expected to support capital-efficient clinical development through data-driven dynamic clinical-site selection, patient stratification and enrollment forecasting. The initial phase of the collaboration is expected to support an upcoming Teverelix clinical study planned for 2026, with potential expansion into later-stage development programs in collaboration with a strategic partner.In February 2026, Medicus announced that it has received "study may proceed" clearance from the U.S. Food and Drug Administration (FDA) to initiate its Phase 2b dose-optimization study of Teverelix®, an investigational next generation long-acting GnRH antagonist, in men with advanced prostate cancer (APC).Cautionary Notice on Forward-Looking StatementsCertain information in this news release constitutes "forward-looking information" under applicable securities laws. "Forward-looking information" is defined as disclosure regarding possible events, conditions or financial performance that is based on assumptions about future economic conditions and courses of action and includes, without limitation, statements regarding the Company's leadership and prospects, the collaboration with GSA including the potential benefits thereof for GSA, those suffering with Gorlin Syndrome and Medicus (including as it relates to the development of SkinJect™), ability to be approved for the Expanded Access IND Program to enable those suffering with Gorlin Syndrome to access SkinJect™ under physician-supervised treatment protocols, the development of Teverelix and expectations concerning, and future outcomes relating to, the development, advancement and commercialization of Teverelix for AURr, high CV risk prostate cancer, women's health indications like endometriosis, and the potential market opportunities related thereto, the MOU, including the potential signing of definitive agreements between Medicus and HelixNano and the development of thermostable infectious diseases vaccines by combining HelixNano's proprietary mRNA vaccine platform with Medicus's proprietary microneedle array (MNA) delivery platform, the Company's aim to fast-track the clinical development program and convert the SKNJCT-003 exploratory clinical trial into a pivotal clinical trial, and approval from the FDA and the timing thereof, including with respect to the Company's submission for approval in the FDA Commissioner's National Priority Voucher program, plans and expectations concerning, and future outcomes relating to, the development, advancement and commercialization of SkinJect through SKNJCT-003 and SKNJCT-004, and the potential market opportunities related thereto, the Company's expectation to release topline results for SKNJCT-003 in the first quarter of 2026 and to secure an EOP2 meeting with the FDA in the first half of 2026, entry into definitive documents with Reliant and the expected terms thereof, engaging in proposed Medicus-sponsored studies currently contemplated in the Reliant non-binding letter of intent and the expected benefits thereof, the expansion of SKNJCT-003 into the United Kingdom and the potential benefits therefrom, the advancement of the SKNJCT-004 study and the potential results of and benefits of such study. Forward-looking statements are often but not always, identified by the use of such terms as "may", "on track", "aim", "might", "will", "will likely result", "could," "designed," "would", "should", "estimate", "plan", "project", "forecast", "intend", "expect", "anticipate", "believe", "seek", "continue", "target", "potential" or the negative and/or inverse of such terms or other similar expressions. These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including those risk factors described in the Company's annual report on form 10-K for the year ended December 31, 2024 (the "Annual Report"), and in the Company's other public filings on EDGAR and SEDAR+, which may impact, among other things, the trading price and liquidity of the Company's common shares. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect our expectations as of the date hereof and thus are subject to change thereafter. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Readers are further cautioned not to place undue reliance on forward-looking statements as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.SOURCE: Medicus Pharma LtdView the original press release on ACCESS NewswireOriginal: Medicus Pharma on Bloomberg World