Medicus Pharma Ltd.
For the period ended Jun 30, 2026. Filed Aug 12, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Aug 12, 2026
MDCX$1.87+2.2%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-14.
0001062993-26-002629
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-12.
0001062993-26-004230
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 92 previous paragraphs and 95 current paragraphs.
44 unchanged; 29 reworded; 22 added; 18 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 2 previous and 6 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (22)
Current report
The Company has advanced SkinJect through a multi-stage clinical program. An initial Phase 1 dose-escalation study ("SKNJCT-001") established that the D-MNA patch was well tolerated with no dose-limiting toxicity in patients with basal cell carcinoma ("BCC"). The Company also initiated a study ("SKNJCT-002") to evaluate device penetration in healthy volunteers, but paused the study after enrolling seven of a planned 15 subjects due to variability in array application and ultimately closed the study without further enrollment - no adverse events were reported. The Company also conducted a Phase 2 study ("SKNJCT-003") which was a randomized, double-blinded, three arm study evaluating two dose levels of D-MNA compared with a device-only control (C-MNA or P-MNA) in patients with nodular type basal cell carcinoma ("nBCC"). The SKNJCT-003 study, conducted across sites in the United States and in Europe, reported topline results in March 2026 showing 73% clinical clearance and 40% histological clearance in the D-MNA arm compared to 38% clinical clearance in the device-only P-MNA arm in the 200-µg patient cohort at Day 57 of the study. The Company provided further updates on the results of the SKNJCT-003 study in June 2026, showing 55% histological clearance and 64% clinical clearance in patients in the 200 ug cohort that were treated with SkinJect. The Company is conducting a separate Phase 2 study in the United Arab Emirates ("SKNJCT-004") and, in September 2025, gained FDA alignment to pursue the 505(b)(2) regulatory pathway to treat BCC using D-MNA.
Current report
The Company is separately pursuing SkinJect as a treatment for Gorlin Syndrome (Nevoid Basal Cell Carcinoma Syndrome), a rare inherited genetic disorder associated with lifelong development of multiple basal cell carcinomas and recurrent skin cancers. In support of this program, the Company is pursuing a registrational Phase 2b study design ("SKNJCT-005") and filed applications for Orphan Drug Designation and Rare Pediatric Disease Designation.
Current report
The Company continues to engage with the FDA and international regulators to advance these programs toward registrational development and to pursue further developmental opportunities.
Current report
Recent Developments
Current report
On June 3, 2026, the Company announced its submission of Protocol SKNJCT-005 to the FDA under the Company's existing Investigational New Drug ("IND") application, for SkinJect into registrational development for patients with Gorlin Syndrome, also called Nevoid Basal Cell Carcinoma Syndrome, a rare inherited genetic disorder associated with lifelong development of multiple basal cell carcinomas and recurrent skin cancers, often resulting in repeated surgical procedures. The submitted protocol outlines a Phase 2b, open-label study designed to generate efficacy and safety data intended to support a future new drug application for SkinJect in Gorlin Syndrome.
Current report
On June 8, 2026, the Company announced its submission of a substantial modification application through the European Union Clinical Trials Information System supporting the planned Phase 2b study of Teverelix in APC. The planned Phase 2b study is designed to optimize dose selection and further characterize the pharmacokinetic, pharmacodynamic, efficacy and safety profile of Teverelix ahead of planned registrational development. Medicus has previously engaged extensively with the FDA regarding its APC development strategy, including future studies focused on patients with elevated cardiovascular risk.
Current report
On June 11, 2026, the Company announced its submission of an IND application to the DOH for PRECISION-E2, a first-of-its-kind, Phase 2a genomics-enabled clinical trial evaluating Teverelix in women with symptomatic endometriosis in the UAE. The PRECISION-E2 study is designed to combine clinical outcomes, hormonal biomarkers, pharmacokinetic and pharmacodynamic measurements, and genomic analyses to better understand treatment response variability in women suffering from endometriosis.
Current report
On June 15, 2026, the Company announced its submission of Rare Pediatric Disease Designation ("RPDD") request to the FDA for SkinJect, the Company's investigational D-MNA patch, for the treatment of BCC in patients with Gorlin Syndrome, also known as Nevoid Basal Cell Carcinoma Syndrome. The RPDD submission was made pursuant to Section 529 of the Federal Food, Drug, and Cosmetic Act and follows the Company's previously announced Orphan Drug Designation ("ODD") application (DRU-2026-11578), and Registrational study design (SKNJCT-005) which remains under FDA review. The design of the Company's Gorlin Syndrome development program has been informed through engagement with clinical experts and the Gorlin Syndrome Alliance, a patient advocacy group focused on the needs and priorities of this unique patient population.
Current report
On June 24, 2026, the Company participated in the 2026 Bio International Conference in San Diego, California, where Dr. Faisal Mehmud, Chief Medical Officer of Medicus, delivered a company presentation highlighting clinical, regulatory and strategic advancements across the Company's development portfolio. The presentation included, among other updates, the updated positive decision-grade dataset from the Phase 2 SKNJCT-003 study, which demonstrated a clear dose-response relationship and clinically meaningful complete response rates (55% histological clearance and 64% clinical clearance) in patients in the 200 ug cohort that were treated with SkinJect.
Current report
On July 16, 2026, the Company announced it received written feedback from the FDA and central Institutional Review Board approval, with modifications, for its optimized Phase 2 clinical study of Teverelix in men following a first episode of AUR. The Company submitted the optimized protocol to the FDA on April 2, 2026, under its existing IND application for Teverelix. The redesigned study is expected to enroll approximately 126 patients across the United States and Europe, compared with approximately 390 patients contemplated under the Company's previously disclosed development plan, and is intended to generate an early pharmacodynamic signal while supporting dose optimization, route selection and future clinical development.
Current report
On July 27, 2026, the Company announced that the FDA completed its safety review of the Company's IND application for SKNJCT-005 and issued a "Study May Proceed" letter authorizing the initiation of the Company's NDA-enabling registrational Phase 2b clinical study evaluating SkinJect 200 mcg in patients with Gorlin Syndrome presenting with multiple BCCs.
Current report
On July 31, 2026, the Company announced that the UAE DOH has granted IND authorization for the Company's PRECISION-E2 Phase 2a clinical study evaluating Teverelix in women with moderate-to-severe symptomatic endometriosis.
Current report
On August 3, 2026, the Company announced the appointment of Faisal Mehmud, MD, MRCP, as chief executive officer of Antev, effective August 30, 2026. Dr. Mehmud will continue to serve as Chief Medical Officer of Medicus and Co-Chairman of Antev.
Current report
On June 3, 2026, at the Company's 2026 Annual General and Special Meeting of shareholders, the Company's shareholders approved a special resolution authorizing the Board, in its discretion, to effect a consolidation of the Company's common shares on the basis of a consolidation ratio to be determined by the Board, up to a maximum ratio of 50 pre-consolidation common shares for every one post-consolidation Common Share, if the Board determines such a consolidation is necessary or desirable, including, without limitation, for the purpose of meeting any applicable stock exchange or regulatory requirements. As of the date hereof, the Board has neither effected such share consolidation nor announced an intention to do so.
Current report
Secured Promissory Notes
Current report
On May 27, 2026, the Company entered into and closed on a note purchase agreement with Streeterville Capital, LLC, providing for the issuance of two secured promissory notes: (i) a Secured Promissory Note A in the original principal amount of $12,864,225 carrying an 8.75% interest rate and a 6.7% original issue discount (the “Note A”) and (ii) a Secured Promissory Note B in the original principal amount of $10,000,000 carrying a 5% interest rate with no original issue discount (the “Note B” and together with the Note A, the “Secured Promissory Notes”). The Secured Promissory Notes will mature on November 27, 2027.
Current report
Research and development expenses consist of costs incurred to research and develop our product candidates and are expensed as incurred. We do not track total R&D expense by program, therapeutic indication or product candidate, as our internal resources are shared across programs and our development priorities shift over time. We separately identify external costs that are directly attributable to the SkinJect and Teverelix programs, which primarily include costs related to clinical, manufacturing, and regulatory activities, as well as certain professional services and intellectual property costs. Internal personnel costs (salaries and benefits, including share-based compensation) are shared across programs, are not attributable to a single product candidate, and are presented as unallocated. Of the total research and development expense noted in the table below, the external, third-party costs that were directly attributable to our product candidates were as follows:
Current report
(1) Total research and development expense reconciles to the amount reported on the Company's consolidated statements of operations for each period presented.
Current report
On July 16, 2026, the Company announced it received written feedback from the FDA and central Institutional Review Board approval, with modifications, for its optimized Phase 2 clinical study of Teverelix in men following a first episode of AUR. The Company submitted the optimized protocol to the FDA on April 2, 2026, under its existing IND application for Teverelix. The redesigned study is expected to enroll approximately 126 patients across the United States and Europe, compared with approximately 390 patients contemplated under the Company's previously disclosed development plan, and is intended to generate an early pharmacodynamic signal while supporting dose optimization, route selection and future clinical development.
Current report
On July 27, 2026, the Company announced that the FDA completed its safety review of the Company's IND application for SKNJCT-005 and issued a "Study May Proceed" letter authorizing the initiation of the Company's NDA-enabling registrational Phase 2b clinical study evaluating SkinJect 200 mcg in patients with Gorlin Syndrome presenting with multiple BCCs.
Current report
On July 31, 2026, the Company announced that the UAE DOH has granted IND authorization for the Company's PRECISION-E2 Phase 2a clinical study evaluating Teverelix in women with moderate-to-severe symptomatic endometriosis.
Current report
On August 3, 2026, the Company announced the appointment of Faisal Mehmud, MD, MRCP, as chief executive officer of Antev, effective August 30, 2026. Dr. Mehmud will continue to serve as Chief Medical Officer of Medicus and Co-Chairman of Antev.
Removed paragraphs (18)
Previous report
The Company then completed a dose escalation study ("SKNJCT-001") that assessed the safety of D-MNA patch in patients with basal cell carcinoma ("BCC"). There were no serious systemic or local adverse events nor any demonstrated alterations in any clinical measurements during the trial. The conclusion of the study was that D-MNA patch was well tolerated with no evidence of dose limiting toxicity.
Previous report
The Company had initiated a clinical study ("SKNJCT-002") aimed at evaluating clinical efficacy. The first part involved the enrollment of 15 healthy volunteers and was designed to study the penetration of device only containing Dynamic Mechanical Allodynia patches at five different anatomic locations. After the first seven health volunteers were enrolled, due to the variability of array application observed by the investigator, SkinJect made the decision to pause the trial. The study was never resumed, and it was ultimately closed without further enrollment. There were no adverse events reported in the enrolled subjects.
Previous report
In January 2024, the Company submitted the clinical design for a randomized, double-blinded, three arm study evaluating two dose levels of microneedle-mediated delivery of doxorubicin (D-MNA) compared with a device-only control (C-MNA or P-MNA) in patients with nodular type of basal cell carcinoma (nBCC). It was a multi-center study ("SKNJCT-003") enrolling up to 60 subjects presenting with nodular type of BCC of the skin. The FDA responded in March 2024 and requested additional clinical information. A final protocol was submitted to the FDA in July 2024, which included the information requested by the FDA, along with updated chemistry, manufacturing and controls, stability and sterility data. On July 31, 2024, the FDA responded to the latest submission and requested certain additional information and clarification. The Company responded to the FDA on August 2, 2024 and commenced patient recruitment on August 27, 2024.
Previous report
The SKNJCT-003 Phase 2 clinical study is currently underway in nine clinical sites across United States. In March 2025, the Company announced a positively trending interim analysis for SKNJCT-003 demonstrating more than 60% clinical clearance. The interim analysis was conducted after more than 50% of the then-targeted 60 patients in the study were randomized. The findings of the interim analysis were 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 90 subjects. The Company also announced expanding clinical trial sites in Europe. In December 2025, the Company announced it successfully completed enrolment of 90 patients in the United States.
Previous report
In May 2025, the Company received notice that a study may proceed with approval from United Arab Emirates (UAE) Department of Health (DOH) to commence clinical study (SKNJCT-004) to non-invasively treat BCC of the skin. The study is expected to randomize 36 patients in four clinical sites in the UAE. Cleveland Clinic Abu Dhabi is the principal investigator, along with Sheikh Shakbout Medical City, Burjeel Medical City, and American Hospital of Dubai. Insights Research Organization and Solutions (IROS), a UAE-based contract research organization that is an M42 portfolio company, is coordinating the clinical study for the Company. In October 2025, the Company announced the enrollment of the first patient in its SKNJCT-004 Phase 2 clinical study.
Previous report
In July 2025, the Company submitted a comprehensive package to the FDA seeking a Type C meeting. In August 2025, the Company announced that the FDA accepted the Company's Type C Meeting request to formally discuss the D-MNA product development and gain further alignment on the clinical pathway. In September 2025, the FDA provided written responses to the Company's queries, and agreed that the Company can rely on the 505(b)(2) regulatory pathway to treat BCC using D-MNA.
Previous report
In August 2025, the Company announced its entry into a non-binding memorandum of understanding ("MoU") with Helix Nanotechnologies, Inc., a Boston-based biotech company focused on developing a proprietary advanced mRNA platform, in respect of their mutual interest in the development or commercial arrangement contemplated by the MoU.
Previous report
On October 22, 2025, the Company announced the enrollment of the first patient in the SKNJCT-004 phase 2 clinical study, to non-invasively treat BCC of the skin. On October 29, 2025, the Company announced a strategic collaboration with the Gorlin Syndrome Alliance to advance compassionate access to SkinJect™ for patients suffering from Gorlin Syndrome (nevoid basal cell carcinoma syndrome). Under the collaboration, the parties intend to pursue an Expanded Access IND program with the FDA to allow physician-supervised access for patients with multiple, recurrent, or inoperable BCCs.
Previous report
In November 2025, the Company announced that it received full regulatory and ethical approvals in the United Kingdom to expand its ongoing Phase 2 clinical study (SKNJCT-003) evaluating D-MNA for the non-invasive treatment of BCC and announced that it submitted an application for an FDA Commissioner's National Priority Voucher in connection with SKNJCT-003.
Previous report
On December 15, 2025, the Company announced that its Phase 2 clinical study (SKNJCT-003) evaluating safety and efficacy of D-MNA and C-MNA to non-invasively treat nodular BCC of the skin successfully completed enrolment of ninety (90) patients in the United States.
Previous report
On December 22, 2025, the Company announced that it entered into a non-binding letter of intent with Reliant AI Inc., a decision-intelligence company for the life sciences, specializing in generative AI, to collaborate on the development of an artificial-intelligence-powered data analytics platform designed to support clinical trial execution through data-driven insights.
Previous report
On January 12, 2026, the Company announced that a detailed clinical data on Teverelix, it long acting next generation GnRH antagonist, have been accepted for e-poster presentation at the American Association of Clinical Endocrinology (AACE) Annual meeting 2026, held April 22-24 in Las Vegas, Nevada.
Previous report
On January 22, 2026, the Company announced that its subsidiary,Antev, has entered intoAmendment No. 3 to its license agreement withLifeArc relating toTeverelix, an investigational next generation long-acting GnRH antagonist. Under the amended agreement, theroyalty rate payable on worldwide net sales of Teverelix has been reduced from ~4% to 2%, with the royalty term clarified on a country-by-country basis in line with standard industry practice. The amendment doesnot alter the scope of the license, the underlying intellectual property, or the respective development responsibilities of the parties, and all other terms of the original agreement remain in full force and effect.
Previous report
On February 10, 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).
Previous report
On March 5, 2026, the Company announced topline results from its Phase 2 clinical study (SKNJCT-003) evaluating safety and efficacy of Doxorubicin Microneedle Array (D-MNA) to non-invasively treat basal cell carcinoma (BCC) of the skin.
Previous report
On March 9, 2026, the Company announced additional context regarding the recently reported topline dataset from the Phase 2 SKNJCT-003 study evaluating SkinJect® microneedle delivery of D-MNA and P-MNA for basal cell carcinoma (BCC). The dataset demonstrated 73% clinical clearance and 40% histological clearance in the 200-µg treatment cohort at Day 57, representing the strongest treatment response observed in the study. The company described these findings as particularly notable given thedevice-based mechanism of SkinJect, where microneedle delivery itself may produce biological activity that can contribute to responses observed even in placebo active arm (P-MNA), that was not tip-loaded with the chemotherapeutic agent.Active placebo arms are not uncommon in device-drug combination trials and can be an acceptable regulatory data point. The study results demonstrateclear separation in clinical response between the D-MNA treatment arm (73%) and P-MNA treatment arm (38%) in the 200-µg cohort, supporting the continued development of SkinJect as a potential non-surgical treatment option for patients with basal cell carcinoma.
Previous report
On March 30, 2026, the Company reported independent clinical validation of its Phase 2 SkinJect® dataset from Dr. Babar Rao, principal investigator of the SKNJCT-003 study and a globally recognized dermatology key opinion leader. Dr. Rao's independent assessment reinforces the Company's view that the dataset isclinically meaningful, decision-grade, and supportive of continued development and regulatory engagement.
Previous report
Research and development costs include costs incurred under agreements with third-party contract research organizations, contract manufacturing organizations and other third parties that conduct preclinical and clinical activities on our behalf and manufacture our product candidates, and other costs associated with our R&D programs, including laboratory materials and supplies.
Reworded paragraphs (29)
Previous wording
This Item and other sections of this Quarterly Report contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that involve risks and uncertainties. When reviewing the discussion below, you should keep in mind the substantial risks and uncertainties that impact our business. In particular, we encourage you to review the risks and uncertainties described in "Risk Factors" in Part I, Item 1A in the 2025 Annual Report and Part II, Item 1A of this Quarterly Report. These risks and uncertainties could cause actual results to differ materially from those projected or implied by our forward-looking statements contained in this Quarterly Report. These forward-looking statements are made as of the date of this Quarterly Report, and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by law. All amounts are expressed in United States dollars unless otherwise stated. This discussion should be read in conjunction with the Company's interim unaudited condensed consolidated financial statements for the three months ended March 31, 2026 and 2025.
Current wording
This Item and other sections of this Quarterly Report contain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that involve risks and uncertainties. When reviewing the discussion below, you should keep in mind the substantial risks and uncertainties that impact our business. In particular, we encourage you to review the risks and uncertainties described in "Risk Factors" in Part I, Item 1A in the 2025 Annual Report and Part II, Item 1A of this Quarterly Report. These risks and uncertainties could cause actual results to differ materially from those projected or implied by our forward-looking statements contained in this Quarterly Report. These forward-looking statements are made as of the date of this Quarterly Report, and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by law. All amounts are expressed in United States dollars unless otherwise stated. This discussion should be read in conjunction with the Company's interim unaudited condensed consolidated financial statements for the three and six months ended June 30, 2026 and 2025.
Previous wording
The Company has two wholly owned subsidiaries, Medicus Pharma Inc., a company incorporated in the state of Delaware on October 12, 2023, and SkinJect, Inc. ("Skinject"), a company incorporated in the state of Pennsylvania on March 3, 2015.
Current wording
The Company has three wholly owned subsidiaries, Medicus Pharma Inc., a company incorporated in the state of Delaware on October 12, 2023, SkinJect, Inc. ("SkinJect"), a company incorporated in the state of Pennsylvania on March 3, 2015 and, for purposes of engaging in the Secured Promissory Notes (as defined below) transactions, MDCX Holdings, LLC, a limited liability company organized in the state of Utah on May 19, 2026.
Previous wording
SkinJect is focused on the development of a novel "innovation combination product", as an investigational new drug, using uniquely designed, patent protected dissolvable microneedle arrays ("C-MNAs or P-MNAs") and doxorubicin containing dissolvable microneedle arrays ("D-MNAs") for the treatment of certain skin cancers. To that end, the Company licensed certain technology co-developed by the University of Pittsburgh and Carnegie Mellon University. The Company established and validated fabrication processes relative to the C-MNAs or P-MNAs and D-MNAs, completed pre-clinical testing and secured approval to proceed with clinical trials activity from the Food and Drug Administration ("FDA").
Current wording
SkinJect is focused on the development of a novel "innovation combination product", as an investigational new drug, using uniquely designed, patent protected dissolvable microneedle arrays ("C-MNA" or "P-MNA") and doxorubicin containing dissolvable microneedle arrays ("D-MNA") for the treatment of certain skin cancers. To that end, the Company licensed certain technology co-developed by the University of Pittsburgh and Carnegie Mellon University. The Company established and validated fabrication processes relative to the C-MNAs or P-MNAs and D-MNAs, completed pre-clinical testing and secured approval to proceed with clinical trials activity from the Food and Drug Administration ("FDA").
Previous wording
In June 2025, the Company entered into a definitive agreement to acquire Antev, a UK-based clinical biotech company developing Teverelix, a next-generation GnRH antagonist, as first in market product for cardiovascular high-risk prostate cancer patients and patients with first acute urinary retention episodes due to enlarged prostate. Subsequently, in August 2025, the Company completed the acquisition of Antev and acquired 98.6% of the issued and outstanding shares of Antev for aggregate consideration consisting of approximately $2.97 million in cash and 1,603,164 common shares of the Company.
Current wording
In August 2025, the Company completed its acquisition of Antev, a UK-based clinical biotech company developing Teverelix, a next-generation gonadotropin-releasing hormone ("GnRH") antagonist, as a first in market product for cardiovascular high-risk prostate cancer patients and patients with first acute urinary retention ("AUR") episodes due to enlarged prostate. The Company has received FDA clearance to proceed with a Phase 2b dose-optimization study of Teverelix in men with advanced prostate cancer ("APC") and has submitted an optimized Phase 2 study design for the prevention of recurrent AUR in men with benign prostatic hyperplasia. The Company has also submitted an investigational new drug application to the United Arab Emirates ("UAE") Department of Health, Abu Dhabi ("DOH") for its planned PRECISION-E2 study, a first-of-its-kind, Phase 2a genomics-enabled clinical trial, that will evaluate Teverelix in women with symptomatic endometriosis in the UAE.
Previous wording
On April 6, 2026, the Company announced its submission of an optimized Phase 2 clinical study design to the FDA for Teverelix, for the prevention of recurrent acute urinary retention in men with benign prostatic hyperplasia as part of the Company's existing open investigational new drug for Teverelix.
Current wording
On April 6, 2026, the Company announced its submission of an optimized Phase 2 clinical study design to the FDA for Teverelix, for the prevention of recurrent AUR in men with benign prostatic hyperplasia as part of the Company's existing open investigational new drug for Teverelix.
Previous wording
On May 6, 2026, the Company 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. This additional pre-specified analysis, builds upon the previously reported positive topline results, provides 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.
Current wording
On May 6, 2026, the Company 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 D-MNA to treat nBCC of the skin, the most common type of skin cancer. This additional pre-specified analysis, builds upon the previously reported positive topline results, provides expanded biological, histologic, and safety insights that further strengthen SkinJect's therapeutic profile and future registrational discussions with the FDA. The expanded analysis showed clear and consistent dose response relationship across endpoints, demonstrating stronger separation between the 200ug cohort and control, particularly at Day 57. 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.
Previous wording
On June 25, 2024, the Company's shareholders approved an amendment to the Company's articles of incorporation to provide for a share consolidation (the "Share Consolidation"), or reverse stock split, of the Company's issued and outstanding common shares at such a consolidation ratio to be determined by the Company's board of directors in its sole discretion, to permit the Company to satisfy all conditions and necessary regulatory approvals to list the common shares on a U.S. national securities exchange as the Company's board of directors may determine in its sole direction. Our board of directors approved the Share Consolidation on October 15, 2024, and the Share Consolidation was completed by the Company on October 28, 2024, at the ratio of 1-for-2.
Current wording
On June 25, 2024, the Company's shareholders approved an amendment to the Company's articles of incorporation to provide for a share consolidation (the "Share Consolidation"), or reverse stock split, of the Company's issued and outstanding common shares at such a consolidation ratio to be determined by the Company's board of directors in its sole discretion, to permit the Company to satisfy all conditions and necessary regulatory approvals to list the common shares on a U.S. national securities exchange as the Company's board of directors may determine in its sole discretion. Our board of directors approved the Share Consolidation on October 15, 2024, and the Share Consolidation was completed by the Company on October 28, 2024, at the ratio of 1-for-2.
Previous wording
Total gross proceeds from our initial public offering were $4.0 million, including the proceeds from the Overallotment Warrants. The Company incurred total issuance costs of $2.1 million, including underwriter fees, and legal and other professional fees incurred directly related to the issuance. No Public Warrants issued as part of our initial public offering were exercised during the three months ended March 31, 2026.
Current wording
Total gross proceeds from our initial public offering were $4.0 million, including the proceeds from the Overallotment Warrants. The Company incurred total issuance costs of $2.1 million, including underwriter fees, and legal and other professional fees incurred directly related to the issuance. No Public Warrants issued as part of our initial public offering were exercised during the three and six months ended June 30, 2026.
Previous wording
On March 10, 2025, the Company completed an offering (the "Regulation A Offering") of 1,490,000 units at $2.80 per unit pursuant to Tier II of Regulation A under the Securities Act, with each unit consisting of one common share and one warrant (each, a "Regulation A Warrant"). The Regulation A Warrants have an exercise price of $2.80 and expire on March 10, 2030. The aggregate gross proceeds to the Company from the Regulation A Offering were $4.2 million. No Regulation A Warrants were exercised during the three months ended March 31, 2026.
Current wording
On March 10, 2025, the Company completed an offering (the "Regulation A Offering") of 1,490,000 units at $2.80 per unit pursuant to Tier II of Regulation A under the Securities Act, with each unit consisting of one common share and one warrant (each, a "Regulation A Warrant"). The Regulation A Warrants have an exercise price of $2.80 and expire on March 10, 2030. The aggregate gross proceeds to the Company from the Regulation A Offering were $4.2 million. No Regulation A Warrants were exercised during the three and six months ended June 30, 2026.
Previous wording
On May 2, 2025, the Company entered into a securities purchase agreement with YA II PN, Ltd. ("Yorkville"), under which the Company has issued and sold three debentures (the "Initial Debentures") to Yorkville in an aggregate principal amount totaling $5,000,000. The Initial Debentures were issued at a discounted price of 90% for proceeds to the Company of $4,500,000. Interest accrued on the outstanding principal amount of each Initial Debentures at an annual rate of 8%, subject to a potential increase to 18% per annum upon the occurrence of certain events of default. The Initial Debentures had a maturity date of February 2, 2026.
Current wording
On May 2, 2025, the Company entered into a securities purchase agreement with YA II PN, Ltd. ("Yorkville"), under which the Company has issued and sold three debentures (the "Initial Debentures") to Yorkville in an aggregate principal amount totaling $5,000,000. The Initial Debentures were issued at a discounted price of 90% for proceeds to the Company of $4,500,000. Interest accrued on the outstanding principal amount of each Initial Debenture at an annual rate of 8%, subject to a potential increase to 18% per annum upon the occurrence of certain events of default. The Initial Debentures had a maturity date of February 2, 2026.
Previous wording
On September 17, 2025, the Company entered into securities purchase agreement with Yorkville to issue a new debenture (the "Debenture") with the principal amount of $8,000,000 issued at a discount of $633,707 for proceeds of approximately $7,366,293. Interest will accrue on the outstanding principal amount of the Debenture at an annual rate of 8%, subject to a potential increase to 18% per annum upon the occurrence of certain events of default. The Debenture will mature on September 17, 2026 and will be partially repaid using proceeds from the SEPA (as defined below).
Current wording
On September 17, 2025, the Company entered into a securities purchase agreement with Yorkville to issue a new debenture (the "Debenture") with the principal amount of $8,000,000 issued at a discount of $633,707 for proceeds of approximately $7,366,293. Interest accrued on the outstanding principal amount of the Debenture at an annual rate of 8%, subject to a potential increase to 18% per annum upon the occurrence of certain events of default. The Debenture had a maturity date of September 17, 2026 and was to be partially repaid using proceeds from the SEPA (as defined below). On May 27, 2026, the Company used part of the proceeds of its issuance of the Secured Promissory Notes to repay and extinguish the outstanding balance and accrued interest owing on the Debenture.
Previous wording
On June 2, 2025, the Company closed a public offering with gross proceeds of $7.0 million (the "June 2025 Public Offering"). The Company issued 2,260,000 units at a price of $3.10 per unit. Each unit consisted of one common share of the Company and one warrant to purchase one common share (the "June 2030 Warrants"). The June 2030 Warrants have an exercise price of $3.10 per share and will expire on June 2, 2030. No June 2030 Warrants were exercised during the three months ended March 31, 2026.
Current wording
On June 2, 2025, the Company closed a public offering with gross proceeds of $7.0 million (the "June 2025 Public Offering"). The Company issued 2,260,000 units at a price of $3.10 per unit. Each unit consisted of one common share of the Company and one warrant to purchase one common share (the "June 2030 Warrants"). The June 2030 Warrants have an exercise price of $3.10 per share and will expire on June 2, 2030. No June 2030 Warrants were exercised during the three and six months ended June 30, 2026.
Previous wording
On December 29, 2025, we entered into an equity distribution agreement (the "Equity Distribution Agreement") with Maxim Group LLC and Yorkville Securities, LLC, an affiliate of Yorkville as agents (together, the "Agents"), whereby the Agents may sell up to $15.3 million of our common shares as part of an at-the-market program (the "ATM").
Current wording
On December 29, 2025, we entered into an equity distribution agreement (the "Equity Distribution Agreement") with Maxim Group LLC and Yorkville Securities, LLC, an affiliate of Yorkville as agents (together, the "Agents"), whereby the Agents may sell up to $15.3 million of our common shares as part of an at-the-market program (the "ATM"). On April 23, 2026, the Company and the Agents entered into an amendment to the Equity Distribution Agreement, up-sizing the ATM program from $15.3 million to up to $50 million.
Previous wording
The following table outlines our statements of loss and comprehensive loss for the three months ended March 31, 2026 and 2025:
Current wording
The following table outlines our statements of loss and comprehensive loss for the three and six months ended June 30, 2026 and 2025:
Previous wording
General and administrative expenses increased by $2,772,624 or 88.9% for the three months ended March 31, 2026, compared to the three months ended March 31, 2025. This increase was primarily due to an increase in consulting fees, salaries and wages with increased headcount at board and management level and fees, expenses related to business development and investor relations and stock-based compensation. General and administrative expenses primarily include professional fees, consulting fees, salaries, wages and benefits, general office, insurance, administration expenditures, costs related to business development and investor relations, public relations, market awareness, advocacy and stock-based compensation associated with maintaining investor relations, public relations, market awareness, advocacy, director and officer insurance and compliance with applicable securities law requirements. In addition, there are additional costs, recurring and non-recurring, associated with increased regulatory requirements following the Company's initial public offering, transition to U.S. domestic issuer status, multiple financing transactions and the Antev acquisition.
Current wording
General and administrative expenses increased by $1,994,573 or 43.6% for the three months ended June 30, 2026, compared to the three months ended June 30, 2025, and increased by $4,767,197 or 61.9% for the six months ended June 30, 2026, compared to the six months ended June 30, 2025. This increase was primarily due to an increase in consulting fees, salaries and wages with increased headcount at board and management level and fees, expenses related to business development and investor relations and stock-based compensation. General and administrative expenses primarily include professional fees, consulting fees, salaries, wages and benefits, general office, insurance, administration expenditures, costs related to business development and investor relations, public relations, market awareness, advocacy and stock-based compensation associated with maintaining investor relations, public relations, market awareness, advocacy, director and officer insurance and compliance with applicable securities law requirements. In addition, there are additional costs, recurring and non-recurring, associated with increased regulatory requirements following the Company's initial public offering, transition to U.S. domestic issuer status, multiple financing transactions and the Antev acquisition.
Previous wording
R&D expenses increased by $698,179 or 34.8% for the three months ended March 31, 2026, compared to the three months ended March 31, 2025. This increase is primarily due to to the start of the development of Teverelix, offset with a reduction in costs relating to SkinJect as we come to end of its Phase II trials. We expect our R&D expenses to increase going forward with the costs of two separate Phase II trials associated with Teverelix advancing.
Current wording
R&D expenses increased by $4,166,307 or 120.9% for the six months ended June 30, 2026, compared to the six months ended June 30, 2025. This increase is primarily due to the development of Teverelix, offset with a reduction in costs relating to SkinJect as we come to the end of its Phase 2 trials. We expect our R&D expenses to increase going forward with the costs of two separate Phase 2 trials associated with Teverelix advancing.
Previous wording
The principal risks related to the Company's future performance are that the trials are unsuccessful, the Company does not receive FDA approval to proceed with the next stage of its research and development, or the Company is unsuccessful in obtaining future funding needed to continue its research and development. These are customary risks for a development stage pharmaceutical Company and are less acute than for a Company with a less advanced product. Nevertheless, there can be no assurance that the Company will be able to complete its trials of the MNA, that the trials will be successful, or that the product will ultimately reach commercialization.
Current wording
The principal risks related to the Company's future performance are that the trials are unsuccessful, the Company does not receive FDA approval to proceed with the next stages of its multiple research and development tracks, or the Company is unsuccessful in obtaining future funding needed to continue its research and development tracks. These are customary risks for a development stage pharmaceutical Company and are less acute than for a Company with a less advanced product. Nevertheless, there can be no assurance that the Company will be able to complete its trials, that the trials will be successful, or that the product will ultimately reach commercialization.
Previous wording
Other income (expense) for the three months ended March 31, 2026, was an expense of $445,234 compared to an income of $23,866 for the three months ended March 31, 2025. Other income (expense) for the three months ended March 31, 2026 is primarily related to finance income of $56,561, interest expense of $374,712 and loss of SEPA settlements of $127,083. Other income (expense) for the three months ended March 31, 2025 is primarily related to interest income earned on short-term money market investments of $23,866.
Current wording
Other income (expense) for the three and six months ended June 30, 2026, was an expense of $205,638 and $650,872, respectively, compared to an expense of $159,996 and $136,130 for the three and six months ended June 30, 2025, respectively. Other income (expense) for the three and six months ended June 30, 2026 is primarily related to interest expense of $205,638 and $523,789, respectively, a loss on SEPA settlements of $nil and $127,083, respectively. Other income (expense) for the three and six months ended June 30, 2025 consisted primarily of finance income of $40,004 and $63,870, respectively, more than offset by a $200,000 change in the fair value of debentures recognized in each period.
Previous wording
The Company expects to continue to incur significant operating losses for the foreseeable future and may never become profitable. In addition to the ATM, SEPA and Debenture (as defined herein), management believes that the Company has access to additional capital resources through public and/or private equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. However, it is possible that the Company may not be able to obtain financing on acceptable terms, or at all, and the Company may not be able to enter into strategic alliances or other arrangements on favorable terms, or at all. Further, the terms of any financing may adversely affect the holdings or the rights of the Company's shareholders. If the Company is unable to secure additional capital, it may be required to take additional measures to reduce costs in order to conserve its cash in amounts sufficient to sustain operations and meet its obligations. These measures could cause significant delays or entirely prevent the Company's continued efforts to progress its research and development program, pursue product portfolio expansion or commercialize its current or future products, each of which is critical to the realization of the Company's business plan and its future operations. This uncertainty, along with the Company's history of losses, indicates that substantial doubt exists about the Company's ability to continue as a going concern within one year after the date that the financial statements are issued. The financial statements and this MD&A do not include any adjustments that may be necessary should the Company be unable to continue as a going concern.
Current wording
The Company expects to continue to incur significant operating losses for the foreseeable future and may never become profitable. In addition to the ATM, SEPA and Secured Promissory Notes (as defined herein), management believes that the Company has access to additional capital resources through public and/or private equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. However, it is possible that the Company may not be able to obtain financing on acceptable terms, or at all, and the Company may not be able to enter into strategic alliances or other arrangements on favorable terms, or at all. Further, the terms of any financing may adversely affect the holdings or the rights of the Company's shareholders. If the Company is unable to secure additional capital, it may be required to take additional measures to reduce costs in order to conserve its cash in amounts sufficient to sustain operations and meet its obligations. These measures could cause significant delays or entirely prevent the Company's continued efforts to progress its research and development program, pursue product portfolio expansion or commercialize its current or future products, each of which is critical to the realization of the Company's business plan and its future operations. This uncertainty, along with the Company's history of losses, indicates that substantial doubt exists about the Company's ability to continue as a going concern within one year after the date that the financial statements are issued. The financial statements and this MD&A do not include any adjustments that may be necessary should the Company be unable to continue as a going concern.
Previous wording
As of March 31, 2026, the Company had cash and cash equivalents of $6,365,624 compared to cash and cash equivalents of $3,982,430 as of March 31, 2025. During the three months ended March 31, 2026, the Company received $5,808,013 of net proceeds from issuance of common shares other than under the SEPA and $4,102,740 of proceeds from issuance of common shares under the SEPA. For the three months ended March 31, 2026, cash used in operating activities was $(8,969,688) compared to $(3,940,994) for the three months ended March 31, 2025. As of March 31, 2026, the Company has an accumulated deficit of $(73,390,261) (March 31, 2025 - $(34,006,311)) and net loss of $(9,042,311) for the three months ended March 31, 2026 (March 31, 2025 - $(5,102,408)). The Company has a working capital of $1,328,773 as of March 31, 2026 (March 31, 2025 - $1,751,860).
Current wording
As of June 30, 2026, the Company had cash and cash equivalents of $15,174,128 and restricted cash of $10,017,412 compared to cash and cash equivalents of $8,705,218 and restricted cash of $nil as of December 31, 2025. During the six months ended June 30, 2026, the Company received $21,385,000 of net proceeds from the issuance of the Secured Promissory Notes, $12,399,815 of net proceeds from the issuance of common shares under the ATM and $4,102,740 of proceeds from the issuance of common shares under the SEPA. For the six months ended June 30, 2026, cash used in operating activities was $15,953,129 compared to $9,409,825 for the six months ended June 30, 2025. As of June 30, 2026, the Company had an accumulated deficit of $85,007,966 (December 31, 2025 – $64,348,118) and net loss of $11,684,427 and $20,726,738 for the three and six months ended June 30, 2026, respectively (June 30, 2025 - $6,176,084 and $11,278,492, respectively). The Company has a working capital of $6,140,096 as of June 30, 2026.
Previous wording
On March 10, 2025, the Company completed the Regulation A Offering of 1,490,000 units at $2.80 per unit. None of the 1,490,000 Regulation A Warrants have been exercised during the three months ended March 31, 2026.
Current wording
On March 10, 2025, the Company completed the Regulation A Offering of 1,490,000 units at $2.80 per unit. None of the 1,490,000 Regulation A Warrants have been exercised during the three and six months ended June 30, 2026.
Previous wording
On December 29, 2025, the Company entered into the Equity Distribution Agreement with Maxim Group LLC and Yorkville Securities, LLC, an affiliate of Yorkville as agents, whereby the Agents may sell up to $15.3 million of our common shares as part of an at-the-market program. As of March 31, 2026, the Company has issued 9,482,380 common shares as part of the program. The gross proceeds from the issuance were $5,808,013.
Current wording
On December 29, 2025, the Company entered into the Equity Distribution Agreement with Maxim Group LLC and Yorkville Securities, LLC, an affiliate of Yorkville as agents, whereby the Agents may sell up to $15.3 million of our common shares as part of an at-the-market program. On April 23, 2026, the Company and the Agents entered into an amendment to the Equity Distribution Agreement, up-sizing the ATM program from $15.3 million to up to $50 million. As of June 30, 2026, the Company has issued 28,248,981 common shares as part of the program. The gross proceeds from the issuances were $12,868,181.
Previous wording
As of March 31, 2026, no Public Warrants issued as part of the initial public offering have been exercised for cash for nil proceeds to the Company during the three months ended March 31, 2026.
Current wording
As of June 30, 2026, no Public Warrants issued as part of the initial public offering have been exercised for cash for nil proceeds to the Company.
Previous wording
The Company has entered into a standby equity purchase agreement dated February 10, 2025 (the "SEPA") with Yorkville, an investment fund managed by Yorkville Advisors Global, LP. Pursuant to the SEPA, the Company has the option, at its sole discretion, to sell up to $15,000,000 of the Company's common shares to Yorkville at any time during the 36-months following the date of the SEPA.
Current wording
The Company entered into a standby equity purchase agreement dated February 10, 2025 (the "SEPA") with Yorkville, an investment fund managed by Yorkville Advisors Global, LP. Pursuant to the SEPA, the Company has the option, at its sole discretion, to sell up to $15,000,000 of the Company's common shares to Yorkville at any time during the 36-months following the date of the SEPA.
Previous wording
The Investor's obligation to purchase the common shares is subject to a number of conditions, including that the Company file a registration statement with the SEC registering the resale of the common shares issuable thereunder, and that the registration statement is declared effective by the SEC. Such current registration statement, as amended, was originally filed with the SEC on September 29, 2025 and declared effective by the SEC on November 14, 2025.
Current wording
Yorkville's obligation to purchase the common shares is subject to a number of conditions, including that the Company file a registration statement with the SEC registering the resale of the common shares issuable thereunder, and that the registration statement is declared effective by the SEC. Such current registration statement, as amended, was originally filed with the SEC on September 29, 2025 and declared effective by the SEC on November 14, 2025.
Previous wording
As of March 31, 2026, the Company issued 5,336,780 common shares at market price of $4,229,823 for proceeds of $4,102,740. During the three months ended March 31, 2026, $3,223,980 of the gross proceeds were held back to partially repay the Company's outstanding debenture and interest to Yorkville.
Current wording
As of June 30, 2026, the Company issued 5,336,780 common shares at market price of $4,229,823 for proceeds of $4,102,740. During the six months ended June 30, 2026, $3,223,980 of the gross proceeds were held back to partially repay the Company's outstanding debenture and interest to Yorkville, which was fully repaid and extinguished on May 27, 2026. As of June 30, 2026, the Company has capacity to issue up to approximately $2.5 million worth of common shares under the SEPA.
Previous wording
Cash flows used in operating activities for the three months ended March 31, 2026 were $(8,969,688) compared to cash flows used in operating activities of $(3,940,994) for the three months ended March 31, 2025. The increase is primarily due to increased spending on research and development and general and administrative expenses.
Current wording
Cash flows used in operating activities for the six months ended June 30, 2026, were $15,953,129 compared to cash flows used in operating activities of $9,409,825 for the six months ended June 30, 2025. The increase is primarily due to increased spending on research and development and general and administrative expenses.
Previous wording
Cash flows provided by financing activities for the three months ended March 31, 2026, were $6,825,151 compared to cash flows provided by financing activities of $3,759,101 for the three months ended March 31, 2025. The increase is primarily due to increased proceeds from issuance of common shares in equity offerings and under SEPA**,**during the three months ended March 31, 2026, compared to proceeds from the issuance of common shares and warrants, net of offering costs from the Regulation A Offering, during the three months ended March 31, 2025.
Current wording
Cash flows provided by financing activities for the six months ended June 30, 2026, were $32,354,942 compared to cash flows provided by financing activities of $14,915,048 for the six months ended June 30, 2025. The increase is primarily due to increased proceeds from the issuance of common shares in equity offerings and under the SEPA, during the six months ended June 30, 2026, compared to proceeds from the issuance of common shares and warrants, net of offering costs from the Regulation A Offering, during the six months ended June 30, 2025.
Previous wording
As of March 31, 2026, we had 39,995,463 common shares issued and outstanding. In addition, there were 3,435,000 common shares issuable upon the exercise of outstanding stock options and 7,281,795 common shares issuable upon the exercise of warrants.
Current wording
As of June 30, 2026, we had 60,168,044 common shares issued and outstanding. In addition, there were 5,510,000 common shares issuable upon the exercise of outstanding stock options and 7,281,795 common shares issuable upon the exercise of warrants.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
On April 23, 2026, the Company and the Agents entered into an amendment to the Equity Distribution Agreement, up-sizing the ATM program from $15.3 million to up to $50 million.