Conference Transcript - MDCX 2026-03-26

Operator

Good day, and welcome to the Medicus Pharma Business Update Conference Call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one, on your telephone keypad. And to withdraw your question, please press star, then two. Please note this event is being recorded. I would now like to turn the conference over to Ms. Anna Djokovic, Head of Investor Relations. Please go ahead.

Anna Djokovic, Head of Investor Relations

Good morning. This is Anna Djokovic, Head of Investor Relations at Medicus Pharma. Thank you all for joining today's Business Update conference call. Joining me are Dr. Raza Bokhari, Chairman and Chief Executive Officer, Karen Bonner, President and Chief Financial Officer, members of Medica's pharma leadership team, and Dr. Barbara Rao, a global dermatology key opinion leader and principal investigator of the SchemeJet Safe2 study. Our goal today is to provide a comprehensive update on our company, including a brief overview of the company's financial and business outlook, a discussion of the recently announced positive top-line Safe2 SchemeJet clinical data an independent clinical interpretation of the data set from the principal investigator of the study an update on the next steps for the skinject program in the review of the progress we are making with tevorelix our next generation gnrh antagonist program as a reminder some of the matters that will be discussed during today's call contain forward-looking statements within the meaning of federal securities laws. All statements other than historical facts that addresses activities medicus pharma, assumes, plans, expects, believes, intends, or anticipates, and other similar expressions will, should, or may occur in the future are forward-looking statements. The forward-looking statements are management beliefs based upon currently available information as of the date of this conference call, March 26, 2026. Medicus Pharma undertakes no obligation to revise or update any forward-looking statements except as required by law. All forward-looking statements are subject to risks and uncertainties as described in the company's most recent annual report on Form 10-K and other SEC findings. With that, I'd like to turn the call over to Rajesh Pari.

Dr. Raza Bokhari, CEO

Thank you, Anna. Good morning. On behalf of the entire team at Medicus Pharma, I would like to thank you all for joining us for today's business update call. Over the past year, Medicus has undergone a transformational evolution. From a single asset development company into a multi-asset phase two driven clinical platform with capabilities spanning dermatology, urology, oncology, and now precision medicine and AI enabled development focused on generating decision grade data. and strategic partnerships. We deployed capital to advance both Skinjet and Tavadelics into meaningful clinical milestones, expanded our global clinical footprint across these United States, United Kingdom, and United Arab Emirates, We completed the strategic acquisition of NTEF, adding Tavorelix to our drug development pipeline, strengthened our balance sheet through multiple financings, warrant exercises, and structured capital access. At the same time, we remain a clinical stage company with no revenue. We continue to operate with a going concern framework dependent on capital markets and strategic partnerships. That said, our strategy is clear. Number one, advance assets through phase two proof of concept. Number two, generate decision-grade data sets. Number three, partner for late-stage development and commercialization. I will now start with some highlights from Phase II study of skin jet in nodular basal cell carcinoma or BCC patients. In 2025, we completed a 90-patient randomized, double-blind, three-arm phase 2 study evaluating two-dose levels of microneedle-mediated delivery of microdoses of doxirubicin compared with a device-only control in patients with nodular basal cell carcinoma and earlier this month shared positive top-line data set. The primary endpoint for treatment of basal cell carcinoma is a binary, multi-component endpoint defined as achieving both clinical and histological clearance. That is the proportion of patients demonstrating both clinical clearance and histological clearance at a pre-specified post-treatment time The pre-specified post-treatment time points at the end of the study were day 29 for 47 patients and day 57 for 43 patients. Previously reported top-line results of the study, along with additional preliminary data set representing partial response and overall response rate for each cohort can be found in the press release issued earlier, which demonstrates that clearance rates increased between day 29 and day 57, consistent with continued biological activity over time. The 200-microgram cohort of 15 patients that demonstrated the highest observed biological activity at day 57, achieving 73% clinical clearance and 40% histological clearance, merit further discussion. The clinical study report has not been finalized, but we can state with confidence that this 15-patient 200-microgram cohort not only observed the highest biological activity at day 57, but also showed an overall response rate of 80%. Overall response rate is measured as a combination of complete response and partial response on histological examination. Additional findings in the clinical study report covering three patients in this 15-patient 200-microgram cohort at day 57 that neither showed clinical response or complete response on histological examination may show partial response, which could push the overall response rate over 80%. The findings and conclusions stated above are subject to confirmation in their entirety by the clinical study report, which is expected in not-so-distant future. Importantly, we believe that all these findings, especially the overall response rate, support the planned end of Phase II meeting with the FDA to determine the optimal registrational development pathway, where the clinical development strategy may include continued evaluation of the 200-microgram dose, potential optimization of patch application duration, evaluation of additional treatment sessions, and potential refinement of treatment intervals. It is also important to note that this Phase II study, which is a proof-of-concept exploratory study, is not statistically powered and is primarily focused on achieving meaningful clinical clearance to help address an unmet medical need where more than 7 million patients are waiting in the queue for a treatment opportunity. Mohs surgery, which is the standard of care, is painful, expensive, and often aesthetically not very pleasing. Currently, there are about 5,000 trained Mohs surgeons in the United States who can only performed nearly 1 million Mohs procedures every year, while there are nearly 5 million new cases diagnosed every year. Key findings of the study, 73% clinical clearance in the 200 microgram arm at day 57 suggests that approximately three out of four treated lesions may allow patients to avoid immediate surgical intervention. We believe that this finding alone signals that with a successful registrational study, we may be able to address the unmet medical need by clearing the backlog to make surgery available to those that need it the most. Additionally, the company believes the top-line results are not only positive but decision-grade and that they should support an end-of-phase-two meeting with the FDA as well as accelerate partnering readiness. We are fortunate to have with us today Dr. Barbara Rao, our principal investigator for the SkinJet 003 Phase II study for his independent perspective and clinical implications of the study results. Dr. Rao is widely recognized as a leading academic dermatologist, dermatopathologist, Mohs surgeon, and clinical investigator in skin oncology and skin diseases. He currently serves as professor of dermatology and pathology, Rutgers Robert Wood Johnson Medical School, Clinical Associate Professor of Dermatology, Cornell Medical Center, Cornell Medical College, and Adjunct Professor of Dermatology, California Health Sciences University. Dr. Rao is a board-certified dermatologist and a fellow of the American Academy of Dermatology with decades of experience in dermatologic oncology, dermatopathology, and clinical research. He completed his dermatology residency and chief residency at Cornell University Medical Center, followed by advanced training at internationally recognized institutions, including New York University Medical Center, Boston University School of Medicine, University of Texas Southwestern Medical Center, and St. John's Institute of Dermatology, University of London. Dr. Rao has authored more than 200 peer-reviewed scientific publications and multiple academic book chapters and has served as principal investigator in multiple dermatology clinical trials evaluating novel treatment for skin cancer and other skin diseases. I would now like to turn the call over to Dr. Babur Rao.

Dr. Barbara Rao, Analyst — Principal Investigator

Thank you, Dr. Bukhari. That was a nice introduction. As the principal investigator of SkinJet 003 study, I would like to provide an independent clinical perspective on the data set and the commentary that the company has shared today and in other communications. I generally agree with the company's interpretation of top-line data set and consider the finding to be positive and decision-grade. The randomized double-blind three-arm designed SkinJet 003, including a device-only active control arm, provides a rigorous framework for evaluating the incremental therapeutic contributions of Doxorubicin delivered through SkinJet micro-needle system. The design is important because it allows us to, number one, isolate the true therapeutic contribution of the drug, number two, with the two key endpoints, a clinical clearance and histological clearance together, it provides the robust measures of therapeutic effect. the key clinical findings of 73% clinical clearance and 40% histological clearance at day 57 in 200 microgram arm and a clear separation from 38% device only active control demonstrates a clinically meaningful drug effect on top of a biologically active platform due to mechanical disruption of tumor architecture activation of wound healing pathways and localized immune signaling signaling a basal cell carcinoma is highly immunogenic tumor and is the most common cancer worldwide with millions of lesions are treated each year the 73 percent of clinical clearance observed in 200 microgram treatment cohort at day 57 suggests that approximately three out of four treated lesions may achieve visual tumor clearance potentially allowing many patients to avoid immediate surgical interventions in clinical practice lesions that achieve visual clearance are are often monitored or can be treated with with the electro desiccation cryotherapy or surgery depending on the patient and the tumor type if confirmed in future future studies this approach could provide a dermatologist with a minimally invasive treatment option that may reduce the need for skin surgery the current surgical standard for many basal cell carcinoma the treatment approach may particularly be relevant for patient with a borling syndrome it's a rare genetic condition in which individuals may develop dozens or hundreds of basal cell carcinoma throughout their lifetime but these patient repeated surgical procedures can be extremely burdensome impractical and potentially disfiguring so a non-invasive treatment could be transformative in these cases. As the principal investigator of SkinJet 003, it is my view that number one, the data test is clinically meaningful. Number two, it supports continued development. Number three, it justifies regulatory engagement and further trials. I am available to answer any specific question during our Q&A, I now turn you back to Dr. Bukhari. Thank you, Dr. Bukhari.

Dr. Raza Bokhari, CEO

Thank you, Dr. Rao, for your support and leadership. Looking ahead, our next steps for SkinJet is a planned end of Phase 2 meeting with the FDA and to pick up momentum in our partnering discussions. As we have shared before, SkinJet is not only a single indication asset, but is a platform technology. In collaboration with Gorlin Syndrome Alliance, we are now advancing SkinJet into Gorlin Syndrome, a rare and underserved patient population. Golan syndrome is an inherited condition affecting approximately 1 in 31,000 people worldwide and 11,000 Americans. patients. Patients can develop hundreds to over 1,000 basal cell carcinomas over their lifetime, often beginning in early childhood. Patients with Golan syndrome endure a lifelong burden of recurring skin cancers that often require repeated surgeries and disfiguring treatments and lifelong skin care. Our aim is to unite clinical science, regulatory leadership, and advocacy to deliver hope for individuals facing lifelong burdens of Golden Syndrome, reinforcing our mission to deliver targeted innovation where medical need is greatest. Our strategy includes, number one, pursuing an expanded access IND program for Gorlin Syndrome. Number two, supporting potential orphan disease positioning. And number three, expanding the clinical utility of the platform beyond single lesions. In parallel, in 2025, we entered a non-binding collaboration with Helix Nano, a biotechnology company focused on building a universal interface to the immune system to tap into the innate power of the human body to fight disease and is currently developing mRNA-based drug products in infectious diseases, solid organ transplant, oncology, and other indications. This opens the door to potentially combine our microneedle delivery system with next-generation mRNA technologies. The long-term vision is development of thermostable vaccines and expansion into infectious diseases and broader immunology applications. Turning now to Tevorelix, our second core platform asset, in August of 2025, Medicus acquired 98.6% of the issued and outstanding shares of NTEV Limited in the United Kingdom. NTEV is a clinical stage biotech company developing Tevorelix, a next generation GnRH antagonist as a first in market product for cardiovascular high risk prostate cancer patients and patients with first acute urinary retention episodes primarily due to enlarged prostate. Tavarellix is designed to suppress testosterone without flare. Number two, potentially offer a cardiovascular safety advantage versus GNRH agonist. Our core programs include, number one, a phase two study in acute urinary retention. Number two, continued development in advanced prostate cancer. We are also expanding Tevorelix into women's health, specifically symptomatic endometriosis. This program is being built in collaboration with Omics Labs in the United Arab Emirates using a genomics-enabled clinical strategy including, number one, hormonal pathway profiling, number two, biomarker-driven patient stratification, number three, precision trial design. Additionally, we have strengthened the economic profile of Tevorelix through a reduction in royalty obligations post-commercialization from approximately 4% to 2%. A major strategic step forward for Medicus is to evolve towards an agentic AI-driven clinical development platforms to reduce timelines, deploy capital more efficiently, and improve probability of success across all current and future programs. This proposed platform will be designed to optimize, number one, clinical trial design and protocol simulation, number two, dynamic site selection and enrollment forecasting, number three, patient stratification using pharmacodynamic data, and number four, dose optimization and adaptive execution. In summary, we have two phase two validated assets. we have generated decision-grade data. We believe that we are entering a catalyst-rich 2026. I will now turn it over to Carolyn Bonner, Chief Financial Officer, to discuss our financial

Carolyn Bonner, CFO

position and outlook. Thank you, Raza. Let me touch on a few of the financial highlights of our financial position, which you can find in greater detail in the annual report on Form 10-K we filed yesterday after market close. From a financial standpoint, 2025 reflects disciplined capital formation and investment into value creation. We secured approximately $31.9 million in financing. As of December 31, 2025, the company had approximately $8.7 million in cash and cash equivalents. Our operating expenses continue to be primarily driven by clinical development activities, regulatory preparation, and general corporate operations. For the year-end, we reported R&D-related expenses of approximately $16.4 million, which also included $8.7 million associated with Kevorelic's IP and R&D acquisition, and G&A expenses of approximately $17.9 million. In summary, we have successfully financed a major clinical expansion year and consider ourselves adequately positioned for the value inflection through decision-grade data set and potential partnerships. Thank you again for joining today's call. Operator, we can now open the call for questions.

Operator

Thank you. Welcome to the manager session. To ask a question, you may press star than 1 on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. And to withdraw your question, please press star, then two. And our first question for today will come from Kumar Raja with Brookline Capital Markets. Please go ahead.

Kumar Raja, Analyst — Brookline Capital Markets

Thanks for taking my questions. Very nice clinical perspective by Dr. Barber. Raza when you were making your comment you were mentioning that you know about 5,000 dermatologists about 1 million surgeries being performed and we have 5 million cases maybe Dr. Barber can provide his perspective what is happening to this rest of these patients who are unable to get on the most surgery and also maybe you can provide your perspective in terms of the differences in the clinical clearance versus the histological clearance, how that would help you in terms of, like, you know, how you are treating this patient?

Dr. Barbara Rao, Analyst — Principal Investigator

Yeah, so thank you. Thank you for the question. So generally, the skin cancer, the basal, let's just talk about basal cell carcinoma. It can come in various shapes and sizes and histological types. It could be small like 2, 3, 4, 5 millimeters, or it could be large like 3, 4 centimeters. And also, some of them are not that much visible on the skin. They are more under the skin. We call them infiltrating type and other types. so and depending on that then the treatments are defined or designed so what happens is if usually the case or other cancer is let's say on the face or scalp or any sensitive area where you cannot just cut out the cancer traditionally will do an excision which is on anywhere on the body like trunk, leg arm, we can just cut the cancer out with the appropriate margin, usually about half a centimeter, and send it to a lab to make sure we got it out. That is the number one type of surgeries which happen for basal cells. Now, in instances where it is either on the sensitive area, as I said, face, or it has a certain histological type where a simple excision on the face may be very wide and scar will be not good-looking in that case we may go on more surgery and more surgery has pretty good clearance and usually it is only defined for those areas now there are third other type of treatments something called cryotherapy which is basically freezing the lesion and but it has to be like superficial lesion big lesions won't work that way then we also have like electro desiccation where we just burning and and scraping the lesion off so we have a whole slew of options available from exercising it just cutting it out to more surgery to then cryotherapy electro desiccation and then in superficial one there are even some creams which can if used properly can can work nowhere dispatch treatment will fit in if the lesion obviously the studies right now in just on five millimeter so if it is a small lesion and patient doesn't want a surgery or don't have access to the surgery then this will be a very good fit for those patients as it as I mentioned patient with lots of skin cancer gardening or other type of patients your second question was in reference to like histological clearance versus clinical clearance so clinically obviously for any medication to work or anything we're trying to do the lesion has to first clinically disappear or start disappearing but that doesn't mean that if you cut that scar out while there's still a lesion present under the skin which is which will you'll see in histology so clinical clearance is important otherwise medication is not working and then to prove it by histology that in many of them there was nothing left histologically also so that's that's the difference i hope that answer your question

Kumar Raja, Analyst — Brookline Capital Markets

yeah that's great and you also mentioned about the platform having some you know immunologic immunogenic effects and seeing some efficacy there maybe you can add some thoughts on you

Dr. Barbara Rao, Analyst — Principal Investigator

know what to think about that thank you yeah it is it has been known previously also there is another treatment which is a cream called mukamad or with brand name is different where basically you use it for many weeks and it creates an immunogenic response and eventually that that defense system or the immunological response of the body gets rid of the tumor and it's already known. So, by using this treatment, that is also working partially with that mechanism.

Kumar Raja, Analyst — Brookline Capital Markets

Okay, great. Thank you so much. Thank you.

Operator

Again, if you have a question, please press star, then one. And this will conclude our question and answer session. I would like to turn the conference back over to management for any closing remarks. Please go ahead.

Dr. Raza Bokhari, CEO

Thank you, Operator. I would like to thank everyone for joining us today, especially Dr. Barbara Rao, a key dermatology opinion leader and SkinJet Phase II study principal investigator. We are now entering what we believe is a catalyst-rich period in 2026. Key anticipated milestones include end of phase 2 FDA meeting for skin jet, alignment on a potential registrational pathway under 505B2 for skin jet, advancement of the Golan Syndrome Expanded Access Program, initiation of Phase II Tavarellic Study for Advanced Prostate Cancer and Acute Urinary Retention Relapse Prevention, number five, expansion into women's health indications, especially genomic-enabled study for symptomatic endometriosis, progress of agentic AI platform, and ongoing strategic partnering discussions across programs, especially SkinJet. To summarize, Medicus today is a multi-asset Phase II-driven company with validated clinical signals expanding into high-value indications and building an AI-enabled and technology-enabled development engine. Our focus remains clear. Number one, generate decision-grade clinical data. Number two, advance towards registrational pathways. And number three, pursue strategic partnerships that maximize long-term shareholder value. We look forward to updating you on our progress through news releases, presentations, and periodic business update conference calls, such as this one. If you have any questions, please reach out to our investor relation team. Thank you again for your time and continued support of Medicus Pharma.

Operator

The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.