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Medicus Pharma Ltd.

Medicus Pharma Ltd.MDCX财报

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What changed in Medicus Pharma Ltd.'s 10-K — 2024 vs 2025

Top changes in Medicus Pharma Ltd.'s 2025 10-K

569 paragraphs added · 512 removed · 302 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

77 edited+106 added−164 removed98 unchanged
The laws that may affect our ability to operate include: 8 • the federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual, or the purchase, lease, order, arrangement, or recommendation of any good, facility, item or service for which payment may be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs.
The laws that may affect our ability to operate include: the federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual, or the purchase, lease, order, arrangement, or recommendation of any good, facility, item or service for which payment may be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs.
There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution; • the federal civil and criminal false claims laws, including the FCA, and civil monetary penalty laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, false, fictitious or fraudulent claims for payment to, or approval by Medicare, Medicaid, or other federal healthcare programs; knowingly making, using, or causing to be made or used, a false record or statement material to a false, fictitious or fraudulent claim or an obligation to pay or transmit money or property to the federal government; or knowingly concealing or knowingly and improperly avoiding, decreasing or concealing an obligation to pay money to the federal government.
There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution; 28 the federal civil and criminal false claims laws, including the FCA, and civil monetary penalty laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, false, fictitious or fraudulent claims for payment to, or approval by Medicare, Medicaid, or other federal healthcare programs; knowingly making, using, or causing to be made or used, a false record or statement material to a false, fictitious or fraudulent claim or an obligation to pay or transmit money or property to the federal government; or knowingly concealing or knowingly and improperly avoiding, decreasing or concealing an obligation to pay money to the federal government.
Other reasons for exclusion included current active malignancies, metastatic disease, in other regions; pregnancy; and any other reason that the investigator deemed as prejudicial to the outcome of the study. 31 The investigational product is chemotherapeutic agent, doxorubicin (25 µg, 50 µg, 100 µg, or 200 µg) delivered to the basal layer of skin by a novel delivery system, a MNA.
Other reasons for exclusion included current active malignancies, metastatic disease, in other regions; pregnancy; and any other reason that the investigator deemed as prejudicial to the outcome of the study. The investigational product is chemotherapeutic agent, doxorubicin (25 µg, 50 µg, 100 µg, or 200 µg) delivered to the basal layer of skin by a novel delivery system, a MNA.
Further, should new safety information arise, additional testing, product labeling or regulatory notification may be required. 7 Regulation of Combination Products in the United States Certain products may be comprised of components, such as drug components and device components that would normally be subject to different regulatory frameworks by the FDA and frequently regulated by different centers at the FDA.
Further, should new safety information arise, additional testing, product labeling or regulatory notification may be required. Regulation of Combination Products in the United States Certain products may be comprised of components, such as drug components and device components that would normally be subject to different regulatory frameworks by the FDA and frequently regulated by different centers at the FDA.
Submit IND application to FDA relating to licensed technology. 3. Raise $2.5 million of capital from investors or strategic partners (or combination thereof) in support of development or commercializing the licensed technology. 4. Submit a completed report to FDA of a Phase 2 trial of licensed technology or foreign equivalent. 5.
Submit IND application to FDA relating to licensed technology. 3. Raise $2.5 million of capital from investors or strategic partners (or combination thereof) in support of development or commercializing the licensed technology. 9 4. Submit a completed report to FDA of a Phase 2 trial of licensed technology or foreign equivalent. 5.
The doxorubicin-containing microneedle arrays ("D-MNA") in development by us utilizes this immunogenic apoptosis by applying very low doses of doxorubicin via the D-MNA to basal cell lesions. Doxorubicin is not currently approved for the treatment of BCC.
The doxorubicin-containing microneedle arrays, or D-MNA, in development by us utilizes this immunogenic apoptosis by applying very low doses of doxorubicin via the D-MNA to basal cell lesions. Doxorubicin is not currently approved for the treatment of BCC.
In addition, there were no systemic effects or clinically significant abnormal findings in laboratory parameters, vital signs, ECGs, and physical examination. The findings of the interim analysis are preliminary and may or may not correlate with the findings of the study once completed.
In addition, there were no systemic effects or clinically significant abnormal findings in laboratory parameters, vital signs, ECGs, and physical examination. The findings of the interim analysis were preliminary and may or may not correlate with the findings of the study once completed.
In addition, there may be additional federal, state and non-U.S. laws, including but not limited to: (i) General Data Protection Regulation (European Union); (ii) the Personal Information Protection and Electronic Documents Act (Canada); and (iii) Personal Information Protection Act (Canada), which govern the privacy and security of health and other personal information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts; 9 • the federal Physician Payments Sunshine Act , created under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, and its implementing regulations, which require manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children's Health Insurance Program (with certain exceptions) to report annually to the Centers for Medicare & Medicaid Services ("CMS"), information related to direct or indirect payments and other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as ownership and investment interests held by the physicians and their immediate family members.
In addition, there may be additional federal, state and non-U.S. laws, including but not limited to: (i) General Data Protection Regulation (European Union); (ii) the Personal Information Protection and Electronic Documents Act (Canada); and (iii) Personal Information Protection Act (Canada), which govern the privacy and security of health and other personal information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts; 29 the federal Physician Payments Sunshine Act , created under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, and its implementing regulations, which require manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children's Health Insurance Program (with certain exceptions) to report annually to CMS, information related to direct or indirect payments and other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as ownership and investment interests held by the physicians and their immediate family members.
Applicable Laws in the United States If we obtain FDA approval for the Product and begin commercializing the Product in the United States, our operations may be directly, or indirectly through our future potential customers and third-party payors, subject to various federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute, the federal False Claims Act ("FCA"), and data privacy and physician sunshine laws and regulations.
Applicable Laws in the United States If we obtain FDA approval for the Products and begin commercializing the Products in the United States, our operations may be directly, or indirectly through our future potential customers and third-party payors, subject to various federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute, the federal False Claims Act ("FCA"), and data privacy and physician sunshine laws and regulations.
The investigational product, D-MNA was found to be well-tolerated across all dose levels in all thirteen (13) participants enrolled in the study, with no dose-limiting toxicities (DLTs), serious adverse events (SAE), or study discontinuations. Furthermore, there were no systemic effects or clinically significant abnormal findings in laboratory parameters, vital signs, ECGs, and physical examinations.
The investigational product, D-MNA was found to be well-tolerated across all dose levels in all thirteen (13) participants enrolled in the study, with no dose-limiting toxicities (DLTs), serious adverse events (SAE), or study discontinuations. Furthermore, there were no systemic effects or clinically significant abnormal findings in laboratory parameters, vital signs, ECGs, and physical examination.
The third patent family entitled "Microneedle arrays for cancer therapy applications" includes a pending U.S. patent application as well as pending patent applications in Australia, Canada, Europe, Israel, Japan, and Korea relating to the use of microneedle arrays comprising one or more bioactive agents for the treatment of various cancers, which if issued, would have a natural expiration in 2035.
The third patent family entitled "Microneedle arrays for cancer therapy applications" includes issued patents in Canada and Israel, a pending U.S. patent application as well as pending patent applications in Australia, Canada, Europe, Japan, Korea and Singapore relating to the use of microneedle arrays comprising one or more bioactive agents for the treatment of various cancers, which if issued, would have a natural expiration in 2035.
Moreover, payment methodologies may be subject to changes in healthcare legislation and regulatory150 initiatives. For example, CMS may develop new payment and delivery models, such as bundled payment models. Recently, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their products. Such scrutiny has resulted in several recent U.S.
Moreover, payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives. For example, CMS may develop new payment and delivery models, such as bundled payment models. Recently, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their products. Such scrutiny has resulted in several recent U.S.
No clinically significant abnormal findings were observed with regard to laboratory parameters, vital signs, ECGs, and physical examinations. The SKNJCT-001 study was designed to assess the safety of the D-MNA patch in patients with BCC. There were no serious adverse events nor any demonstrated alterations in any clinical measurements during the trial.
No clinically significant abnormal findings were observed with regard to laboratory parameters, vital signs, ECGs, and physical examination. The SKNJCT-001 study was designed to assess the safety of the D-MNA patch in patients with BCC. There were no serious adverse events nor any demonstrated alterations in any clinical measurements during the trial.
The second patent family entitled "Tip loaded microneedle arrays for transdermal insertion" includes 1 issued U.S. patent expiring in 2033 claiming dissolvable microneedle arrays including one or more bioactive components. This family also includes issued patents in Australia, Canada, Japan and Mexico, and pending applications in the U.S., Australia, Europe, Hong Kong, India, Japan, and Mexico.
The second patent family entitled "Tip-loaded microneedle arrays for transdermal insertion" includes 1 issued U.S. patent expiring in 2033 claiming dissolvable microneedle arrays including one or more bioactive components. This family also includes issued patents in Australia, Canada, Japan and Mexico, India, and pending applications in the U.S., Australia, Brazil, China, Europe, Hong Kong, Japan, and Mexico.
Healthcare Laws and Regulations Coverage and Reimbursement In the United States, Canada, and markets in other countries, patients who are prescribed treatments for their conditions and providers performing the prescribed services generally rely on third-party payors to reimburse all or part of the associated healthcare costs.
Implications of Healthcare Laws and Regulations Coverage and Reimbursement In the United States and markets in other countries, patients who are prescribed treatments for their conditions and providers performing the prescribed services generally rely on third-party payors to reimburse all or part of the associated healthcare costs.
For further information see " Risk Factors ." 6 Phase 1 Clinical Trials Phase 1 clinical trials are typically conducted, on a small number of individuals (healthy volunteers or patients), to determine safety, dose limiting toxicities, tolerability, pharmacokinetics and to determine dose ranging for Phase 2 clinical trials in humans.
For further information see " Risk Factors ." 26 Phase 1 Clinical Trials Phase 1 clinical trials are typically conducted, on a small number of individuals (healthy volunteers or patients), to determine safety, dose limiting toxicities, tolerability, pharmacokinetics and to determine dose ranging for Phase 2 clinical trials in humans.
The first patent family entitled "dissolvable microneedle arrays for transdermal delivery to human skin" includes 2 issued U.S. patents expiring in 2030 and 2031 claiming dissolvable microneedle arrays including a variety of bioactive components. This family also includes a pending U.S application.
The first patent family entitled "dissolvable microneedle arrays for transdermal delivery to human skin" includes 3 issued U.S. patents expiring in 2030 and 2031 claiming dissolvable microneedle arrays including a variety of bioactive components. This family also includes a pending U.S application.
Conclusions: The Phase 1 study was designed as an open-label dose escalation trial of D-MNA in participants with BCC (subtype: superficial or nodular). The study followed a traditional 3+3 dose escalation design with 4 dose groups plus placebo to define a MTD by evaluating DLTs. Treatments consisted of one application administered weekly, three times over a two-week period.
Conclusions: The Phase 1 study was designed as an open-label dose escalation trial of D-MNA in participants with BCC (subtype: superficial or nodular). The study followed a traditional 3+3 dose escalation design with 4 dose groups plus device only to define a MTD by evaluating DLTs. Treatments consisted of one application administered weekly, three times over a two-week period.
Additionally, the former Trump administration has issued various Executive Orders which eliminated cost sharing subsidies and various provisions that would impose a fiscal burden on states or a cost, fee, tax, penalty or regulatory burden on individuals, healthcare providers, health insurers, or manufacturers of pharmaceuticals or medical devices and Congress has introduced several pieces of legislation aimed at significantly revising or repealing the ACA .
The first Trump administration issued various Executive Orders which eliminated cost sharing subsidies and various provisions that would impose a fiscal burden on states or a cost, fee, tax, penalty or regulatory burden on individuals, healthcare providers, health insurers, or manufacturers of pharmaceuticals or medical devices and Congress has introduced several pieces of legislation aimed at significantly revising or repealing the ACA .
If DLTs had been observed in one or more of the three additional participants, the MTD would have been exceeded. The first two dose groups, Placebo and 25 µg, screened and enrolled subjects concurrently in the study. SkinJect hypothesized that treatment with D-MNA would result in tumor destruction and the induction of potent, immunogenic anti-tumor responses.
If DLTs had been observed in one or more of the three additional participants, the MTD would have been exceeded. The first two dose groups, device only and 25 µg, screened and enrolled subjects concurrently in the study. SkinJect hypothesized that treatment with D-MNA would result in tumor destruction and the induction of potent, immunogenic anti-tumor responses.
Because MNAs enable this agent to be delivered at very low doses to a confined tumor microenvironment, the study sponsor expected only minimal, if any, systemic drug toxicity; thus, facilitating optimal local dose levels and durable clinical responses. The study design also included a placebo group (placebo-MNA).
Because MNAs enable this agent to be delivered at very low doses to a confined tumor microenvironment, the study sponsor expected only minimal, if any, systemic drug toxicity; thus, facilitating optimal local dose levels and durable clinical responses. The study design also included a device-only group (C-MNA).
For the Placebo subject (001-003) although it was assessed as a clinical responder according to the local site assessment, the local PI noted a new squamous cell carcinoma in situ (but no residual basal cell carcinoma) that was also confirmed as squamous cell carcinoma by the Central Reader assessment of the end of study excision.
For the device only subject (001-003) although it was assessed as a clinical responder according to the local site assessment, the local PI noted a new squamous cell carcinoma in situ, but no residual basal cell carcinoma, that was also confirmed as squamous cell carcinoma in-situ by the Central Reader assessment of the end of study excision.
The first part involved the enrollment of 15 healthy volunteers and was designed to study the penetration of placebo-containing DMA 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 first part involved the enrollment of 15 healthy volunteers and was designed to study the penetration of device only-containing DMA 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.
At the end of study, three subjects (01-001, Placebo; 01-008, D-MNA 25 µg and 01-011, D-MNA 50 µg) had differing results when Local/Site evaluation were compared to the Central Reader evaluation. In all three subjects, the Local/Site evaluation noted the presence of residual BCC compared to the Central Reader results which noted no residual BCC for all three subjects.
At the end of study, three subjects (01-001, device only; 01-008, D-MNA 25 µg and 01-011, D-MNA 50 µg) had differing results when Local/Site evaluation were compared to the Central Reader evaluation. In all three subjects, the Local/Site evaluation noted the presence of residual BCC compared to the Central Reader results which noted no residual BCC for all three subjects.
The table below summarizes the patents covered by the License Agreement, each of which is a utility patent. 36 Country Name Title Application No. Priority Date Filed Date Patent No.
The table below summarizes the patents covered by the License Agreement, each of which is a utility patent. 10 Country Name Title Application No. Priority Date Filed Date Patent No.
The interim analysis shows the clinical study SKNJCT-003 is trending positively with a proportion of subjects with complete clinical clearance of more than 60%.
The interim analysis showed the clinical study SKNJCT-003 is trending positively with a proportion of subjects with complete clinical clearance of more than 60%.
For the exploratory endpoint of quantification of doxorubicin released by the MNAs, doxorubicin delivery was confirmed, but across all dose groups it was observed that there was inconsistent doxorubicin deposition by the MNAs. 32 For the secondary endpoint of local tolerance of the MNA, at post-MNA application, assessments indicated that subjects had mild to moderate erythema restricted to the treatment area, at each visit with each dose level, including placebo.
For the exploratory endpoint of quantification of doxorubicin released by the MNAs, doxorubicin delivery was confirmed, but across all dose groups it was observed that there was inconsistent doxorubicin deposition by the MNAs. 6 For the secondary endpoint of local tolerance of the MNA, at post-MNA application, assessments indicated that subjects had mild to moderate erythema restricted to the treatment area, at each visit with each dose level, including device only.
Subjects were excluded from participation in this study if they had evidence of clinically significant, unstable medical conditions as assessed by the principal investigator; if they had an excisional biopsy performed on the lesion to be treated in this study; if they had recent therapy(ies) to the BCC treatment area; if they had recurrent BCC (previously treated) at the site presented for treatment; and if they previously demonstrated sensitivity to doxorubicin or carboxymethyl cellulose.
Laboratory values had to be within normal ranges. 5 Subjects were excluded from participation in this study if they had evidence of clinically significant, unstable medical conditions as assessed by the principal investigator; if they had an excisional biopsy performed on the lesion to be treated in this study; if they had recent therapy(ies) to the BCC treatment area; if they had recurrent BCC (previously treated) at the site presented for treatment; and if they previously demonstrated sensitivity to doxorubicin or carboxymethyl cellulose.
It is the most common type of skin cancer. Basal cell carcinoma often appears as a slightly transparent bump on the skin, though it can take other forms. Basal cell carcinoma occurs most often on areas of the skin that are exposed to the sun, such as your head and neck.
Basal cell carcinoma often appears as a slightly transparent bump on the skin, though it can take other forms. Basal cell carcinoma occurs most often on areas of the skin that are exposed to the sun, such as your head and neck.
The analysis also shows the investigational product, D-MNA was well tolerated for both dose levels, a low-dose group receiving 100ug of D-MNA and a high-dose group receiving 200ug of D-MNA in all participants so far enrolled in the study, with no dose limiting toxicities (DLTs), or serious adverse events (SAEs).
The analysis also shows the investigational product, D-MNA was well tolerated for both dose levels, a low-dose group receiving 100ug of D-MNA and a high-dose group receiving 200ug of D-MNA in all participants enrolled in the study at that time, with no dose limiting toxicities (DLTs), or serious adverse events (SAEs).
Clinical Development of D-MNA: SkinJect Experience Protocol SKNJCT-001 (Phase 1 Study) 30 Study Design: This study was designed as an open-label dose escalation trial of D-MNA in participants with BCC (subtype: superficial or nodular). The study followed a traditional 3+3 dose escalation design with 4 dose groups plus placebo to define a maximum tolerated dose ("MTD") by evaluating DLTs.
Clinical Development of D-MNA: Protocol SKNJCT-001 (Phase 1 Study) Study Design: This study was designed as an open-label dose escalation trial of D-MNA in participants with BCC (subtype: superficial or nodular). The study followed a traditional 3+3 dose escalation design with 4 dose groups plus device only to define a maximum tolerated dose ("MTD") by evaluating DLTs.
Drug approval laws in the Unites States, Canada and Europe generally require licensing of manufacturing facilities, carefully controlled research and testing of products, government review and approval of results prior to marketing and sale of drugs and drug delivery products.
Drug approval laws in the United States generally require licensing of manufacturing facilities, carefully controlled research and testing of products, government review and approval of results prior to marketing and sale of drugs and drug delivery products.
The process for pharmaceutical development and approval are subject to inherent risks, described in " Risk Factors ." The principal steps generally required for approval of drug and drug delivery products in the United States, Canada and Europe are described below.
The process for pharmaceutical development and approval are subject to inherent risks, described in " Risk Factors ." The principal steps generally required for approval of drug and drug delivery products in the United States and rest of the world are described below.
Several regulations have also been proposed partly in response to several executive orders issued by President Trump related to prescription drug pricing that seek to implement several of the administration's proposals.
Several regulations have also been proposed partly in response to several executive orders issued by President Trump during his first term related to prescription drug pricing that seek to implement several of the administration's proposals.
The clinical study report (CSR) also describes the efficacy of the investigational product, D-MNA, with 6 participants experiencing complete responses. The complete response is defined as the disappearance of basal cell carcinoma ("BCC") histologically in the final excision at the end of study visit.
The clinical study report (CSR) also describes the efficacy of the investigational product, D-MNA and C-MNA (as defined below), with 6 participants experiencing complete responses. The complete response is defined as the disappearance of BCC histologically in the final excision at the end of study visit.
A placebo array without doxorubicin hydrochloride but alike in every other respect ("P-MNA") has been fabricated for clinical testing and "blanks" for analytical testing. 11 The goal of our program is to demonstrate the D-MNA as a more robust alternative to the currently available non-surgical, and in many cases, surgical treatments for BCC.
A device only array without doxorubicin hydrochloride but alike in every other respect ("C-MNA") has been fabricated for clinical testing and "device-only" for analytical testing. 4 The goal of our program is to demonstrate the D-MNA as a more robust alternative to the currently available non-surgical, and in many cases, surgical treatments for BCC.
For the secondary endpoint of BCC clinical response, evaluations were performed both at the local/site level as well as independently by a central reader. For the local/site assessment, complete lesion response was observed in one subject each for Placebo, D-MNA 25 µg, D-MNA 100 µg, and D-MNA 200 µg. For D-MNA 50 µg, no subjects were observed to have CR.
For the secondary endpoint of BCC clinical response, evaluations were performed both at the local/site level as well as independently by a central reader. For the local/site assessment, complete lesion response was observed in one subject each for device only, D-MNA 25 µg, D-MNA 100 µg, and D-MNA 200 µg.
While some of these and other measures may require additional authorization to become effective, and the current Biden administration may reverse or otherwise change these measures, Congress has indicated that it will continue to seek new legislative and/or administrative measures to control drug costs.
While some of these and other measures may require additional authorization to become effective, Congress has indicated that it will continue to seek new legislative and/or administrative measures to control drug costs.
In addition, the clinical design also assessed the pre-established secondary efficacy endpoint described below. • Secondary Endpoint: Lesion response as assessed by a central reader after the 3-week course of treatment to be categorized as either absence or presence of a complete response defined as no evidence of residual BCC in the resected specimen on histological examination.
Secondary Endpoint: Lesion response as assessed by a central reader after the 3-week course of treatment to be categorized as either absence or presence of a complete response defined as no evidence of residual BCC in the resected specimen on histological examination.
Risk Factors." These risks include, but are not limited to, risks associated with: our financial results, including our ability to generate earnings and achieve and sustain profitability (as of December 31, 2024, we had an accumulated deficit of approximately US$28.9 million), may vary significantly from forecasts and from period to period; the progress, timing and completion of our research, development and preclinical studies and clinical trials for our products and product candidates; our ability to market, commercialize, achieve market acceptance for and sell our products and product candidates, our ability to develop, manage and maintain our direct sales and marketing organizations; our ability to continue as a going concern and if we are unable to obtain additional financing from outside sources and/or eventually generate enough revenues, we may be forced to curtail or discontinue our operations; our estimates regarding anticipated operating losses, future revenues, capital requirements and our needs for additional financing; 41 market risks regarding consolidation in the healthcare industry; the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing from third party payors for procedures using our products significantly declines; our ability to adequately protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; the fact that product quality issues or product defects may harm our business, any product liability claims; and the regulatory, legal and certain operating risks that our operations subject us to.
Risk Factors." These risks include, but are not limited to, risks associated with: our financial results, including our ability to generate earnings and achieve and sustain profitability (as of December 31, 2025, we had an accumulated deficit of approximately $64.3 million, which was comprised of approximately $12.4 million of accumulated deficit of SkinJect as of September 30, 2023, the day after it became a subsidiary of the Company, and approximately $51.9 million of deficit accumulated by the Company on a consolidated basis), may vary significantly from forecasts and from period to period; the progress, timing and completion of our research, development and preclinical studies and clinical trials for our products and product candidates we may not successfully integrate Antev into our business and operations or successfully develop Teverelix; our ability to market, commercialize, achieve market acceptance for and sell our products and product candidates, our ability to develop, manage and maintain our direct sales and marketing organizations; our ability to continue as a going concern and if we are unable to obtain additional financing from outside sources and/or eventually generate enough revenues, we may be forced to curtail or discontinue our operations; our estimates regarding anticipated operating losses, future revenues, capital requirements and our needs for additional financing; market risks regarding consolidation in the healthcare, pharmaceutical and biotech/life sciences industry; 33 the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing from third party payors for procedures using our products significantly declines; our ability to adequately protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; the fact that product quality issues or product defects may harm our business, any product liability claims; and the regulatory, legal and certain operating risks that our operations subject us to.
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 (CMC), stability and sterility data. On July 31, 2024, the FDA responded to the latest submission and requested certain additional information and clarification. The Company has responded to the FDA on August 2, 2024.
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 CMC, stability and sterility data. On July 31, 2024, the FDA responded to the latest submission and requested certain additional information and clarification.
The License Agreement was amended on February 26, 2020 and on April 23, 2024. The License Agreement covers products designed to deliver drugs and bioactive agents, such as, but not limited to doxorubicin, for the treatment of cancers and pre-cancerous lesions, but specifically excluding the treatment of in-transit melanoma.
The License Agreement covers products designed to deliver drugs and bioactive agents, such as, but not limited to doxorubicin, for the treatment of cancers and pre-cancerous lesions, but specifically excluding the treatment of in-transit melanoma.
The License Agreement also covers Know How that includes: (a) the University of Pittsburgh's IND Application 122488 for Microneedle Array (carboxymethylcellulose matrix) containing the active drug, doxorubicin for the treatment of cutaneous T-cell lymphoma, (b) experimental protocols, data, and any supporting materials relating to B16 Melanoma murine experiments comparing tumor growth over time for Microneedle Array -delivered chemo-immunotherapy for B16 melanoma, including control mice that did not receive any treatment and mice that were treated with doxorubicin incorporated into Microneedle Arrays, and (c) Response from the University of Pittsburgh for SkinJect's Know How Request provided April 29, 2016 and accompanying Batch Analysis documentation (the "Know How").
The License Agreement also covers Know How that includes: (a) the University of Pittsburgh's IND Application 122488 for Microneedle Array (carboxymethylcellulose matrix) containing the active drug, doxorubicin for the treatment of cutaneous T-cell lymphoma, (b) experimental protocols, data, and any supporting materials relating to B16 Melanoma murine experiments comparing tumor growth over time for Microneedle Array -delivered chemo-immunotherapy for B16 melanoma, including control mice that did not receive any treatment and mice that were treated with doxorubicin incorporated into Microneedle Arrays, and (c) Response from the University of Pittsburgh for SkinJect's Know How Request provided April 29, 2016 and accompanying Batch Analysis documentation (the "Know How"). 8 We have been granted an exclusive, worldwide license to make, have made, use and sell the Licensed Technology in the Field and to practice under the patent rights listed in the table below for the Term of the License.
Issue Date Projected Expiration Date Status Assignee(s) United States Dissolvable microneedle arrays for transdermal delivery to human skin 12/910,516 10/23/2009 10/22/2010 8,834,423 9/16/2014 6/14/2031 Issued University Of Pittsburgh of The Commonwealth System of Higher Education/Carnegie Mellon University United States Dissolvable microneedle arrays for transdermal delivery to human skin 16/861,112 10/23/2009 4/28/2020 11,744,927 9/5/2023 10/22/2030 Issued University Of Pittsburgh of The Commonwealth System of Higher Education/Carnegie Mellon University United States Dissolvable microneedle arrays for transdermal delivery to human skin 18/454,628 10/23/2009 8/23/2023 10/22/2030 Pending University Of Pittsburgh of The Commonwealth System of Higher Education/Carnegie Mellon University United States Tip-loaded microneedle arrays for transdermal insertion 14/398,375 5/1/2012 10/31/2014 9,944,019 4/17/2018 7/5/2033 Issued University Of Pittsburgh of The Commonwealth System of Higher Education/Carnegie Mellon University Canada Tip-loaded microneedle arrays for transdermal insertion 2871770 5/1/2012 5/1/2013 2871770 7/7/2020 5/1/2033 Issued University Of Pittsburgh of The Commonwealth System of Higher Education/Carnegie Mellon University Mexico Tip-loaded microneedle arrays for transdermal insertion MX/a/2014/013234 5/1/2012 5/1/2013 370579 12/17/2019 5/1/2033 Issued University Of Pittsburgh of The Commonwealth System of Higher Education/Carnegie Mellon University Australia Tip-loaded microneedle arrays for transdermal insertion 2013256348 5/1/2012 5/1/2013 2013256348 9/28/2017 5/1/2033 Issued University Of Pittsburgh of The Commonwealth System of Higher Education/Carnegie Mellon University India Tip-loaded microneedle arrays for transdermal insertion 10161/DELNP/2014 5/1/2012 5/1/2013 5/1/2033 Pending University Of Pittsburgh of The Commonwealth System of Higher Education/Carnegie Mellon University Europe Tip-loaded microneedle arrays for transdermal insertion 22192026.7 5/1/2012 5/1/2013 5/1/2033 Pending University Of Pittsburgh of The Commonwealth System of Higher Education/Carnegie Mellon University Japan Tip-loaded microneedle arrays for transdermal insertion 2017-078229 5/1/2012 5/1/2013 6712963 6/4/2020 5/1/2033 Issued University Of Pittsburgh of The Commonwealth System of Higher Education/Carnegie Mellon University Canada Tip-loaded microneedle arrays for transdermal insertion 3077452 5/1/2012 5/1/2013 3077452 8/9/2022 5/1/2033 Issued University Of Pittsburgh of The Commonwealth System of Higher Education/Carnegie Mellon University 37 Country Name Title Application No.
Issue Date Projected Expiration Date Status Assignee(s) United States Dissolvable microneedle arrays for transdermal delivery to human skin 19/046,918 10/23/2009 2/6/2025 10/22/2030 Pending University Of Pittsburgh of The Commonwealth System of Higher Education/ Carnegie Mellon University United States Tip-loaded microneedle arrays for transdermal insertion 14/398,375 5/1/2012 10/31/2014 9,944,019 4/17/2018 7/5/2033 Issued University Of Pittsburgh of The Commonwealth System of Higher Education/ Carnegie Mellon University Canada Tip-loaded microneedle arrays for transdermal insertion 2871770 5/1/2012 5/1/2013 2871770 7/7/2020 5/1/2033 Issued University Of Pittsburgh of The Commonwealth System of Higher Education/ Carnegie Mellon University Mexico Tip-loaded microneedle arrays for transdermal insertion MX/a/2014/ 013234 5/1/2012 5/1/2013 370579 12/17/2019 5/1/2033 Issued University Of Pittsburgh of The Commonwealth System of Higher Education/ Carnegie Mellon University Australia Tip-loaded microneedle arrays for transdermal insertion 2013256348 5/1/2012 5/1/2013 2013256348 9/28/2017 5/1/2033 Issued University Of Pittsburgh of The Commonwealth System of Higher Education/ Carnegie Mellon University India Tip-loaded microneedle arrays for transdermal insertion 10161/DELNP /2014 5/1/2012 5/1/2013 555176 11/27/2024 5/1/2033 Issued University Of Pittsburgh of The Commonwealth System of Higher Education/ Carnegie Mellon University Europe Tip-loaded microneedle arrays for transdermal insertion 22192026.7 5/1/2012 5/1/2013 5/1/2033 Pending University Of Pittsburgh of The Commonwealth System of Higher Education/ Carnegie Mellon University 12 Country Name Title Application No.
In 2018, SkinJect prepared an IND application and submitted it to the FDA for the conduct of a dose escalation study in human subjects ("Phase 1 study").
In 2017 and 2018, SkinJect completed pre-clinical animal studies and related verification analyses. In 2018, SkinJect prepared an IND application and submitted it to the FDA for the conduct of a dose escalation study in human subjects ("Phase 1 study").
On September 29, 2023, we completed a business combination (the "Business Combination") with SkinJect, Inc., a Pennsylvania corporation ("SkinJect"), pursuant to a business combination agreement dated May 12, 2023, as amended, among the Company, SkinJect and RBx Capital, LP ("RBx"), an investment entity owned and managed by Dr. Raza Bokhari.
The Business Combination was completed pursuant to a business combination agreement dated May 12, 2023, as amended, among the Company, SkinJect and RBx Capital, LP ("RBx"), an investment entity owned and managed by Dr.
These authorities, in the United States, Canada and the rest of the world, regulate research, development, testing, manufacturing, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing and import/export of pharmaceutical products, among other things.
These authorities regulate research, development, testing, manufacturing, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing and import/export of pharmaceutical products, among other things. In the United States drugs and biological products are subject to regulation by the FDA.
Issue Date Projected Expiration Date Status Assignee(s) Mexico Tip-loaded microneedle arrays for transdermal insertion MX/a/2018/009573 5/1/2012 5/1/2013 11/6/2035 Pending University Of Pittsburgh of The Commonwealth System of Higher Education/Carnegie Mellon University Australia Tip-loaded microneedle arrays for transdermal insertion 2017225155 5/1/2012 5/1/2013 2017225155 9/19/2019 5/1/2033 Issued University Of Pittsburgh of The Commonwealth System of Higher Education/Carnegie Mellon University China Tip-loaded microneedle arrays for transdermal insertion 202110125343.0 5/1/2012 5/1/2013 5/1/2033 Pending University Of Pittsburgh of The Commonwealth System of Higher Education/Carnegie Mellon University United States Tip-loaded microneedle arrays for transdermal insertion 18/119,197 5/1/2012 3/8/2023 5/1/2033 Pending University Of Pittsburgh of The Commonwealth System of Higher Education/Carnegie Mellon University Brazil Tip-loaded microneedle arrays for transdermal insertion 112014027242-5 5/1/2012 5/1/2013 5/1/2033 Pending University Of Pittsburgh of The Commonwealth System of Higher Education/Carnegie Mellon University Australia Tip-loaded microneedle arrays for transdermal insertion 2021201365 5/1/2012 5/1/2013 2021201365 1/12/2023 5/1/2033 Issued University Of Pittsburgh of The Commonwealth System of Higher Education/Carnegie Mellon University Japan Tip-loaded microneedle arrays for transdermal insertion 2021-148376 5/1/2012 5/1/2013 5/1/2033 Pending University Of Pittsburgh of The Commonwealth System of Higher Education/Carnegie Mellon University Australia Tip-loaded microneedle arrays for transdermal insertion 2022291555 5/1/2012 5/1/2013 11/6/2035 Pending University Of Pittsburgh of The Commonwealth System of Higher Education/Carnegie Mellon University Hong Kong Tip-loaded microneedle arrays for transdermal insertion 42021044396.6 5/1/2012 5/1/2013 5/1/2033 Pending University Of Pittsburgh of The Commonwealth System of Higher Education/Carnegie Mellon University Japan Tip-loaded microneedle arrays for transdermal insertion 2023-175104 5/1/2012 5/1/2013 5/1/2033 Pending University Of Pittsburgh of The Commonwealth System of Higher Education/Carnegie Mellon University Europe Microneedle arrays for cancer therapy applications 15857785.8 11/6/2014 11/6/2015 11/6/2035 Pending University Of Pittsburgh of The Commonwealth System of Higher Education/Carnegie Mellon University 38 Country Name Title Application No.
Issue Date Projected Expiration Date Status Assignee(s) Japan Tip-loaded microneedle arrays for transdermal insertion 2017-078229 5/1/2012 5/1/2013 6712963 6/4/2020 5/1/2033 Issued University Of Pittsburgh of The Commonwealth System of Higher Education/ Carnegie Mellon University Canada Tip-loaded microneedle arrays for transdermal insertion 3077452 5/1/2012 5/1/2013 3077452 8/9/2022 5/1/2033 Issued University Of Pittsburgh of The Commonwealth System of Higher Education/ Carnegie Mellon University Mexico Tip-loaded microneedle arrays for transdermal insertion MX/a/2018/ 009573 5/1/2012 5/1/2013 11/6/2035 Pending University Of Pittsburgh of The Commonwealth System of Higher Education/ Carnegie Mellon University Australia Tip-loaded microneedle arrays for transdermal insertion 2017225155 5/1/2012 5/1/2013 2017225155 9/19/2019 5/1/2033 Issued University Of Pittsburgh of The Commonwealth System of Higher Education/ Carnegie Mellon University China Tip-loaded microneedle arrays for transdermal insertion 202110125343.0 5/1/2012 5/1/2013 5/1/2033 Pending University Of Pittsburgh of The Commonwealth System of Higher Education/ Carnegie Mellon University United States Tip-loaded microneedle arrays for transdermal insertion 18/119,197 5/1/2012 3/8/2023 5/1/2033 Pending University Of Pittsburgh of The Commonwealth System of Higher Education/ Carnegie Mellon University Brazil Tip-loaded microneedle arrays for transdermal insertion 112014027242-5 5/1/2012 5/1/2013 5/1/2033 Pending University Of Pittsburgh of The Commonwealth System of Higher Education/ Carnegie Mellon University 13 Country Name Title Application No.
Through our wholly owned subsidiary, SkinJect, we focus on the development of our in-licensed drug device combination product using novel dissolvable microneedle arrays for the treatment of non-melanoma skin cancers.
SkinJect: Through our wholly owned subsidiary, SkinJect, we focus on the development of our in-licensed drug device combination product using novel dissolvable microneedle arrays for the treatment of non-melanoma skin cancers, especially BCC, and Gorlin Syndrome, a rare autosomal dominant disease also called nevoid BCC syndrome.
Our combination product candidate is a doxorubicin tip-loaded D-MNA filed with the FDA under an Investigational New Drug Application and is regulated by the Center for Drug Evaluation and Registration (CDER), Oncology Division. The business conducted by the Company prior to the Business Combination was undertaken by SkinJect.
Our combination product candidate is a doxorubicin tip-loaded D-MNA filed with the FDA under an Investigational New Drug Application (IND) # 139837 and is regulated by the Center for Drug Evaluation and Research, Oncology Division.
We expect the patent legal expense reimbursement to continue at an average of approximately $7,000 per month. Should sales commence in the future, royalties are payable to the University of Pittsburgh as described above.
Payments made to the University of Pittsburgh in connection with the License Agreement, including patent legal expense reimbursement, have amounted to $720,256 since April 2016. We expect the patent legal expense reimbursement to continue at an average of approximately $7,000 per month. Should sales commence in the future, royalties are payable to the University of Pittsburgh as described above.
In addition, Section 107 of the JOBS Act also provides that an "emerging growth company" can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards.
The JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards.
Unregulated activation has been implicated in the development of multiple cancers, including BCC (Gupta et. al. 2010). Chemotherapeutic inhibition of Hedgehog signaling has been demonstrated to be effective against advanced BCC (Soura et. al. 2015).
Unregulated activation has been implicated in the development of multiple cancers, including BCC (Gupta et. al. 2010). Chemotherapeutic inhibition of Hedgehog signaling has been demonstrated to be effective against advanced BCC (Soura et. al. 2015). The Microneedle Array Solution and Doxorubicin Hydrochloride Why Doxorubicin Hydrochloride The binding of doxorubicin to cellular membranes may affect a variety of cellular functions.
Doxorubicin is a particularly well-suited chemotherapeutic drug for the chemo-immunization strategy, because it creates an immunogenic "good death" for tumor cells (Galluzzi et. al. 2012) and (Storkus and Falo Jr 2007).
Doxorubicin-induced apoptosis may be an integral component of the cellular mechanism of action relating to therapeutic effects, toxicities, or both. Doxorubicin is a particularly well-suited chemotherapeutic drug for the chemo-immunization strategy, because it creates an immunogenic "good death" for tumor cells (Galluzzi et. al. 2012) and (Storkus and Falo Jr 2007).
Item 1. Business. General Our company (formerly, Interactive Capital Partners Corporation) was incorporated pursuant to the Business Corporations Act (Ontario) on April 30, 2008 under the name Interactive Capital Partners Corporation.
Item 1. Business. Our company (formerly, Interactive Capital Partners Corporation) was incorporated pursuant to the Business Corporations Act (Ontario) on April 30, 2008 under the name Interactive Capital Partners Corporation. On September 29, 2023, the Company completed a business combination (the "Business Combination") with SkinJect Inc. ("SkinJect"), a company existing under the laws of Pennsylvania.
Effective at the close of business on February 21, 2025, the Company's common shares were delisted from the TSXV. The Company's common shares will continue to be listed and trade on the Nasdaq under the symbol "MDCX".
Effective on February 21, 2025, the Company's common shares were voluntarily delisted from the TSXV. The common shares continue to be listed on Nasdaq.
Future Intellectual Property Rights are defined as specific Know How encompassed within the University of Pittsburgh's IND 122488 and/or deriving from studies conducted under such IND which the University of Pittsburgh owns or controls before or after the April 26, 2016. 34 The University of Pittsburgh and Carnegie Mellon University have retained a royalty-free, nonexclusive right to practice under the Patent Rights and to use the Licensed Technology for Non-Commercial Education and Research Purposes.
Future Intellectual Property Rights are defined as specific Know How encompassed within the University of Pittsburgh's IND 122488 and/or deriving from studies conducted under such IND which the University of Pittsburgh owns or controls before or after the April 26, 2016.
It is also responsible for developing guidance and regulations to clarify the regulation of combination products, and for assignment of the FDA center that has primary jurisdiction for review of combination products where the jurisdiction is unclear or in dispute.
It is also responsible for developing guidance and regulations to clarify the regulation of combination products, and for assignment of the FDA center that has primary jurisdiction for review of combination products where the jurisdiction is unclear or in dispute. 27 A combination product with a primary mode of action attributable to the drug component generally would be reviewed and approved pursuant to the drug approval processes set forth in the FDCA.
References to the Company in this section as of a date prior to the completion of the Business Combination relate to the business undertakings of SkinJect. In 2016, SkinJect licensed certain intellectual property from the University of Pittsburgh of the Commonwealth System of Higher Education (the "University of Pittsburgh").
References to the Company in this section as of a date prior to the completion of the Business Combination relate to the business undertakings of SkinJect. In 2016, SkinJect licensed certain intellectual property from the University of Pittsburgh. During 2016 and 2017, SkinJect developed validated manufacturing methods for the manufacture of the microneedle arrays covered by the licensed patents.
Even if favorable coverage and reimbursement status is attained for one or more products for which a company or its collaborators receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future. 10 There have been a number of proposals during the last few years regarding the pricing of pharmaceutical products, limiting coverage and the amount of reimbursement for drugs and other medical products, government control and other changes to the healthcare system in the United States.
There have been a number of proposals during the last few years regarding the pricing of pharmaceutical products, limiting coverage and the amount of reimbursement for drugs and other medical products, government control and other changes to the healthcare system in the United States.
For the central reader assessment, histopathologic assessment showed six subjects (one Placebo, two D-MNA 25 µg, one D-MNA 50 µg, one D-MNA 100 µg, and one D-MNA 200 µg) with no residual BCC. A "complete response" was considered the absence of BCC in the final excision at 4 weeks.
For D-MNA 50 µg, no subjects were observed to have Complete Response. For the central reader assessment, histopathologic assessment showed six subjects (one device only, two D-MNA 25 µg, one D-MNA 50 µg, one D-MNA 100 µg, and one D-MNA 200 µg) with no residual BCC.
Submit an NDA or foreign equivalent for a covered product under Licensed Technology. 6. First commercial sale of Licensed Technology within five years of submission of a NDA or foreign equivalent for a product covered under Licensed Technology.
Submit an NDA or foreign equivalent for a covered product under Licensed Technology. 6. First commercial sale of Licensed Technology within five years of submission of a NDA or foreign equivalent for a product covered under Licensed Technology. The first four milestones have been achieved and noted as completed by the University of Pittsburgh on January 6, 2022.
As such, we are eligible to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not "emerging growth companies" including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a non-binding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved.
These reduced reporting requirements include, but are not limited to: not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended ("Sarbanes-Oxley Act"); reduced disclosure about our executive compensation arrangements in our periodic reports, proxy statements and registration statements; and an exemption from the requirements to obtain a non-binding advisory vote on executive compensation or stockholder approval of any golden parachute arrangements.
Employees As of the date of this annual report, we have 12 full-time employees, all of which are full-time employees. 40 Corporate information Our executive offices are located at 300 Conshohocken State Rd., Suite 200, W. Conshohocken, PA 19428. We maintain a corporate website at www.medicuspharma.com.
Corporate information Our executive offices are located at 300 Conshohocken State Rd., Suite 200, W. Conshohocken, PA 19428. We maintain a corporate website at www.medicuspharma.com. The information contained on or accessible through our corporate website or any other website that we may maintain is not part of this annual report.
The Business Combination resulted in a reverse takeover of the Company by the former shareholders of SkinJect, with SkinJect becoming a wholly owned operating subsidiary of the Company, and the Company being renamed "Medicus Pharma Ltd." On October 11, 2023, our common shares commenced trading on the TSX Venture Exchange (the "TSXV") under the symbol "MDCX." On November 15, 2024, we completed our initial public offering in the United States and our common shares and public warrants, with an exercise price of $4.64 and expiration date of November 15, 2029 (the "Public Warrants"), began trading on The Nasdaq Capital Market (the "Nasdaq") under the symbols "MDCX" and "MDCXW", respectively.
Raza Bokhari, and resulted in a reverse takeover of the Company by the former shareholders of SkinJect, with SkinJect becoming a wholly owned operating subsidiary of the Company, and the Company being renamed "Medicus Pharma Ltd." On October 11, 2023, the Company's common shares commenced trading on the TSX Venture Exchange (the "TSXV") under the symbol "MDCX".
Inclusion of placebo-MNA allowed the evaluation of two questions: • Tolerability: to assess if there was a cutaneous response to microneedle penetration that was independent of microneedle delivery of doxorubicin to the target tissue. • Efficacy: to assess if a placebo-containing array could stimulate a non-specific immune response in reaction to microneedle penetration of the skin, and compare to the response with the active compound doxorubicin delivered by the D-MNA.
Inclusion of C-MNA allowed the evaluation of two questions: Tolerability: to assess if there was a cutaneous response to microneedle penetration that was independent of microneedle delivery of doxorubicin to the target tissue.
Issue Date Projected Expiration Date Status Assignee(s) Canada Microneedle arrays for cancer therapy applications 2967017 11/6/2014 11/6/2015 2967017 3/24/2020 11/6/2035 Issued University Of Pittsburgh of The Commonwealth System of Higher Education/Carnegie Mellon University Israel Microneedle arrays for cancer therapy applications 252096 11/6/2014 11/6/2015 252096 10/2/2022 11/6/2035 Issued University Of Pittsburgh of The Commonwealth System of Higher Education/Carnegie Mellon University United States Microneedle arrays for cancer therapy applications 17/576,141 11/6/2014 1/14/2022 11/6/2035 Pending University Of Pittsburgh of The Commonwealth System of Higher Education/Carnegie Mellon University Israel Microneedle arrays for cancer therapy applications 293291 11/6/2014 11/6/2015 293291 2/1/2024 11/6/2035 Pending University Of Pittsburgh of The Commonwealth System of Higher Education/Carnegie Mellon University Australia Microneedle arrays for cancer therapy applications 2024256083 11/6/2014 11/6/2015 11/6/2035 Pending University Of Pittsburgh of The Commonwealth System of Higher Education/Carnegie Mellon University Korea Microneedle arrays for cancer therapy applications 10-2022-7039076 11/6/2014 11/6/2015 11/6/2035 Pending University Of Pittsburgh of The Commonwealth System of Higher Education/Carnegie Mellon University Japan Microneedle arrays for cancer therapy applications 2024189676 11/6/2014 11/6/2015 11/6/2035 Pending University Of Pittsburgh of The Commonwealth System of Higher Education/ Carnegie Mellon University Singapore Microneedle arrays for cancer therapy applications 1002004900T 11/6/2014 11/6/2015 11/6/2035 Pending University Of Pittsburgh of The Commonwealth System of Higher Education/ Carnegie Mellon University Recent Developments TSXV Delisting On February 11, 2025, the Company announced that the Company's board of directors has approved the voluntary delisting of its common shares from the TSXV.
Issue Date Projected Expiration Date Status Assignee(s) Israel Microneedle arrays for cancer therapy applications 252096 11/6/2014 11/6/2015 252096 10/2/2022 11/6/2035 Issued University Of Pittsburgh of The Commonwealth System of Higher Education/ Carnegie Mellon University United States Microneedle arrays for cancer therapy applications 17/576,141 11/6/2014 1/14/2022 11/6/2035 Pending University Of Pittsburgh of The Commonwealth System of Higher Education/ Carnegie Mellon University Israel Microneedle arrays for cancer therapy applications 293291 11/6/2014 11/6/2015 293291 2/1/2024 11/6/2035 Issued University Of Pittsburgh of The Commonwealth System of Higher Education/ Carnegie Mellon University Australia Microneedle arrays for cancer therapy applications 2024256083 11/6/2014 11/6/2015 11/6/2035 Pending University Of Pittsburgh of The Commonwealth System of Higher Education/ Carnegie Mellon University Korea Microneedle arrays for cancer therapy applications 10-2022-7039076 11/6/2014 11/6/2015 11/6/2035 Pending University Of Pittsburgh of The Commonwealth System of Higher Education/ Carnegie Mellon University Japan Microneedle arrays for cancer therapy applications 2024189676 11/6/2014 11/6/2015 11/6/2035 Pending University Of Pittsburgh of The Commonwealth System of Higher Education/ Carnegie Mellon University Singapore Microneedle arrays for cancer therapy applications 1002004900T 11/6/2014 11/6/2015 11/6/2035 Pending University Of Pittsburgh of The Commonwealth System of Higher Education/ Carnegie Mellon University Korea Microneedle arrays for cancer therapy applications 10-2024-7043044 11/6/2014 11/6/2015 11/6/2035 Pending University Of Pittsburgh of The Commonwealth System of Higher Education/ Carnegie Mellon University 15 Antev: On August 29, 2025, we completed the acquisition of 98.6% of the issued and outstanding shares of Antev, a clinical stage biotech company, developing Teverelix, a next generation GnRH antagonist, potentially as a first in market product for APC patients with high cardiovascular risk and patients with AURr episodes due to enlarged prostate.
The Company plans to submit its findings to the FDA in the second quarter of 2025 as a part of a package seeking a meeting with the FDA to advance clinical development. 33 Patents and Proprietary Information License Agreement with the University of Pittsburgh SkinJect entered into an exclusive license agreement with the University of Pittsburgh on April 26, 2016 (as amended, the "License Agreement").
Patents and Proprietary Information License Agreement with the University of Pittsburgh SkinJect entered into an exclusive license agreement with the University of Pittsburgh on April 26, 2016 (as amended, the "License Agreement"). The License Agreement was amended on February 26, 2020 and on April 23, 2024.
Tazarotene is a less-promising non-surgical alternative, with only 30.5% of patients remaining tumor-free at 3 years (Bianchi et. al. 2004). 5 Regulatory Environment The production and manufacture of the Product and its research and development activities are subject to regulation for safety, efficacy and ethics by various governmental authorities in the United States.
Implications of Regulatory Environment The production and manufacture of the Products and their research and development activities for use in the United States are subject to regulation for safety, efficacy and ethics by various governmental authorities in the United States.
The Microneedle Array Solution and Doxorubicin Hydrochloride Why Doxorubicin Hydrochloride The binding of doxorubicin to cellular membranes may affect a variety of cellular functions. Enzymatic electron reduction of doxorubicin by a variety of oxidases, reductases and dehydrogenases generates highly reactive species including the hydroxyl free radical (• OH).
Enzymatic electron reduction of doxorubicin by a variety of oxidases, reductases and dehydrogenases generates highly reactive species including the hydroxyl free radical (• OH). Cells treated with doxorubicin have been shown to manifest the characteristic morphologic changes associated with apoptosis or programmed cell death.
We will remain a smaller reporting company until the last day of the fiscal year in which (1) the market value of our ordinary shares held by non-affiliates exceeds $250 million as of the prior June 30, or (2) our annual revenues exceeded $100 million during such completed fiscal year and the market value of our ordinary shares held by non-affiliates exceeds $700 million as of the prior June 30.
We may continue to be a smaller reporting company as long as either (i) the market value of our common shares held by non-affiliates is less than $250 million or (ii) our annual revenue is less than $100 million during the most recently completed fiscal year and the market value of our common shares held by non-affiliates is less than $700 million.
The participants profile, demonstrating complete responses, was diverse and all participants (6/6) had nodular subtype of BCC.
The participants profile, demonstrating complete responses, was diverse and all participants (6/6) had nodular subtype of BCC. 3 Basal Cell Carcinoma Market Overview Basal cell carcinoma is a type of skin cancer that begins in the basal layer of the epidermis. It is the most common type of skin cancer.
The study will evaluate the efficacy of two dose levels of D-MNA compared to placebo in patients with nodular BCC. The participants will be randomized 1:1:1 to one of three groups: a placebo-controlled group receiving P-MNA, a low-dose group receiving 100μg of D-MNA, and a high-dose group receiving 200μg of D-MNA.
The participants will be randomized 1:1:1 to one of three groups: a device only group receiving C-MNA, a low-dose group receiving 100μg of D-MNA, and a high-dose group receiving 200μg of D-MNA. The clinical design was initially submitted to the FDA in January 2024 to seek comments to revise and amend the IND and finalize the protocol.
Interim Analysis for SKNJCT-003 Phase 2 Clinical Study On March 6, 2025, the Company announced a positively trending interim analysis for its SKNJCT-003 Phase 2 clinical study. The interim analysis shows the clinical study SKNJCT-003 is trending positively with a proportion of subjects with complete clinical clearance of more than 60%.
The Company responded to the FDA on August 2, 2024. Beginning August 13, 2024, the Company commenced activating its clinical trial sites and first participant was recruited on August 27, 2024. On March 6, 2025, the Company announced a positively trending interim analysis for its SKNJCT- 003 Phase 2 clinical study.
We are an "emerging growth company," as defined in Section 2(a) of the Securities Act of 1933, as amended, or the Securities Act, as modified by the Jumpstart Our Business Startups Act of 2012, or the JOBS Act.
Implications of Being an Emerging Growth Company As a company with less than $1.235 billion in revenues during our last fiscal year, we qualify as an "emerging growth company" as that term is defined in the Jumpstart Our Business Startups Act of 2012 (the "JOBS Act").
The study was never resumed, and it was ultimately closed without further enrollment. There were no adverse events reported in the enrolled subjects. Protocol SKNJCT-003 (Phase 2 Study) Study Design: The clinical study, SKNJCT-003, is designed to be a randomized, double-blinded, placebo-controlled (P-MNA), multi-center study enrolling up to 60 subjects presenting with nodular type BCC of the skin.
The study was never resumed, and it was ultimately closed without further enrollment. There were no adverse events reported in the enrolled subjects.
Since its enactment, there have been numerous judicial, administrative, executive, and legislative challenges to certain aspects of the ACA, and there are likely to be additional challenges and amendments to the ACA in the future. For example, various portions of the ACA are currently undergoing legal and constitutional challenges in the U.S. Supreme Court.
Since its enactment, there have been judicial, congressional, and executive branch challenges to the ACA, which have resulted in delays in the implementation of, and action taken to repeal or replace, certain aspects of the ACA. On June 17, 2021, the U.S.
Removed
We are a biotech/life sciences company focused on accelerating the clinical development programs of novel and disruptive therapeutic assets. Currently, we are developing one product, SkinJect TM , with an indication for basal cell carcinoma. Our principal purpose is to advance the clinical development program of the Product, while opportunistically identifying, evaluating, and acquiring accretive assets, properties or businesses.
Added
On November 15, 2024, we completed our initial public offering in the United States and our common shares and our outstanding public warrants to purchase common shares, issued as a component of the units sold by the Company in its U.S. initial public offering with an exercise price of $4.64 and expiration date of November 15, 2029 (the "Public Warrants"), began trading on Nasdaq under the symbols "MDCX" and "MDCXW", respectively.
Removed
During 2016 and 2017, SkinJect developed validated manufacturing methods for the manufacture of the microneedle arrays covered by the licensed patents. In 2017 and 2018, SkinJect completed pre-clinical animal studies and related verification analyses.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

173 edited+94 added−16 removed274 unchanged
Any adverse developments affecting manufacturing operations for the Product, if any are approved, may result in shipment delays, inventory shortages, lot failures, product withdrawals or recalls, or other interruptions in the supply of our products.
Any adverse developments affecting manufacturing operations for the Products, if any are approved, may result in shipment delays, inventory shortages, lot failures, product withdrawals or recalls, or other interruptions in the supply of our products.
If additional funds are raised through further issuances of equity or convertible debt securities, existing shareholders could suffer significant dilution, and any new equity securities issued could have rights, preferences and privileges superior to those of the common shares or terms superior to those of the Warrants.
If additional funds are raised through further issuances of equity or convertible debt securities, existing shareholders could suffer significant dilution, and any new equity securities issued could have rights, preferences and privileges superior to those of the common shares or terms superior to those of the existing warrants.
Thus, after the introduction of a generic competitor, a significant percentage of the sales of any branded product is typically lost to the generic product. Accordingly, competition from generic equivalents to our products would materially adversely impact our ability to successfully commercialize the Product. A variety of risks associated with potential international business relationships could materially adversely affect our business.
Thus, after the introduction of a generic competitor, a significant percentage of the sales of any branded product is typically lost to the generic product. Accordingly, competition from generic equivalents to our products would materially adversely impact our ability to successfully commercialize the Products. A variety of risks associated with potential international business relationships could materially adversely affect our business.
In addition, we may require significant additional funds to either acquire such businesses or products or to commercialize them, which may result in significant dilution to shareholders or the incurrence of significant indebtedness by us. We do not have any customer commitments. We may negotiate clinical and/or commercial supply agreements for the Product or product sub-components.
In addition, we may require significant additional funds to either acquire such businesses or products or to commercialize them, which may result in significant dilution to shareholders or the incurrence of significant indebtedness by us. We do not have any customer commitments. We may negotiate clinical and/or commercial supply agreements for the Products or product sub-components.
If product liability lawsuits are brought against us then we may incur substantial liabilities and may be required to limit commercialization of the Product, if approved, and any other future products. We face a potential risk of product liability as a result of distribution of our product candidate for testing and commercialization of the Product.
If product liability lawsuits are brought against us then we may incur substantial liabilities and may be required to limit commercialization of the Products, if approved, and any other future products. We face a potential risk of product liability as a result of distribution of our product candidate for testing and commercialization of the Products.
Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract our technical and management personnel from their normal responsibilities.
Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract our technical and management personnel from their normal responsibilities.
Our management may not be able to effectively and timely implement controls and procedures that adequately respond to the increased regulatory compliance and reporting requirements that are applicable to us as a public company listed on the Nasdaq.
Our management may not be able to effectively and timely implement controls and procedures that adequately respond to the increased regulatory compliance and reporting requirements that are applicable to us as a public company listed on Nasdaq.
If we are unable for any reason to meet the continued listing requirements of the Nasdaq, such action or inaction could result in a delisting of our common shares and our Public Warrants, as applicable.
If we are unable for any reason to meet the continued listing requirements of Nasdaq, such action or inaction could result in a delisting of our common shares and our Public Warrants, as applicable.
If we fail to satisfy the continued listing requirements of the Nasdaq (for example, the Nasdaq corporate governance requirements or the minimum closing bid price requirement), such exchanges may take steps to delist our common shares and our Public Warrants, as applicable.
If we fail to satisfy the continued listing requirements of Nasdaq (for example, Nasdaq corporate governance requirements or the minimum closing bid price requirement), such exchanges may take steps to delist our common shares and our Public Warrants, as applicable.
In the event of a delisting, we can provide no assurance that any action taken by us to restore compliance with listing requirements would allow our common shares and our Public Warrants, as applicable, to become listed again, stabilize the market price or improve the liquidity of our common shares and our Public Warrants, as applicable, prevent such securities from dropping below any minimum bid price requirement or prevent future non-compliance with the Nasdaq's listing requirements.
In the event of a delisting, we can provide no assurance that any action taken by us to restore compliance with listing requirements would allow our common shares and our Public Warrants, as applicable, to become listed again, stabilize the market price or improve the liquidity of our common shares and our Public Warrants, as applicable, prevent such securities from dropping below any minimum bid price requirement or prevent future non-compliance with Nasdaq's listing requirements.
As a U.S. public company, we operate in an increasingly demanding regulatory environment, which requires us to comply with the Sarbanes-Oxley Act, the regulations of the Nasdaq, the rules and regulations of the SEC and Canadian securities regulators, expanded disclosure requirements, accelerated reporting requirements and more complex accounting rules.
As a U.S. public company, we operate in an increasingly demanding regulatory environment, which requires us to comply with the Sarbanes-Oxley Act, the regulations of Nasdaq, the rules and regulations of the SEC and Canadian securities regulators, expanded disclosure requirements, accelerated reporting requirements and more complex accounting rules.
If we cannot provide reliable financial reports or prevent fraud, our business and results of operations could be harmed, investors could lose confidence in our reported financial information and we could be subject to sanctions or investigations by the Nasdaq, the SEC, Canadian securities regulators or other regulatory authorities.
If we cannot provide reliable financial reports or prevent fraud, our business and results of operations could be harmed, investors could lose confidence in our reported financial information and we could be subject to sanctions or investigations by Nasdaq, the SEC, Canadian securities regulators or other regulatory authorities.
We believe that our ability to compete effectively depends upon many factors both within and beyond our control, including: 46 • the usefulness, ease of use, performance and reliability of our technology compared to our competitors; • the activity and tolerability of the Product, including relative to marketed products and product candidates in development by third parties; • the ability to distinguish safety and efficacy from existing, alternative therapies; • the timing for the Product to complete clinical development and receive market approval; • acceptance of the Product by patients, physicians and other health providers, • our ability to monetize our technology; • the selection of licensing partners for our technology with the necessary skills and resources to drive uptake; • our marketing and selling efforts; • our financial condition and results of operations; • the ability to maintain a good relationship with regulatory authorities; • the price of our future products, including in comparison to branded or generic competitors; • whether coverage and adequate levels of reimbursement are available under private and governmental health insurance plans, • acquisitions or consolidations within our industry, which may result in more formidable competitors; • our ability to protect our intellectual property rights, • our ability to attract, retain and motivate talented employees; • our ability to cost-effectively manage and grow our operations; and • our reputation and brand strength relative to that of our competitors.
We believe that our ability to compete effectively depends upon many factors both within and beyond our control, including: the usefulness, ease of use, performance and reliability of our technology compared to our competitors; the activity and tolerability of the Products, including relative to marketed products and product candidates in development by third parties; the ability to distinguish safety and efficacy from existing, alternative therapies; the timing for the Products to complete clinical development and receive market approval; acceptance of the Products by patients, physicians and other health providers; our ability to monetize our technology; the selection of licensing partners for our technology with the necessary skills and resources to drive uptake; our marketing and selling efforts; 39 our financial condition and results of operations; the ability to maintain a good relationship with regulatory authorities; the price of our future products, including in comparison to branded or generic competitors; whether coverage and adequate levels of reimbursement are available under private and governmental health insurance plans; acquisitions or consolidations within our industry, which may result in more formidable competitors; our ability to protect our intellectual property rights, our ability to attract, retain and motivate talented employees; our ability to cost-effectively manage and grow our operations; and our reputation and brand strength relative to that of our competitors.
Additionally, the BBA, among other things, amended the ACA, effective January 1, 2019, by increasing the point-of-sale discount (from 50% under the ACA to 70%) that is owed by pharmaceutical manufacturers who participate in Medicare Part D and closing the coverage gap in most Medicare drug plans, commonly referred to as the "donut hole." 68 Moreover, payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives.
Additionally, the BBA, among other things, amended the ACA, effective January 1, 2019, by increasing the point-of-sale discount (from 50% under the ACA to 70%) that is owed by pharmaceutical manufacturers who participate in Medicare Part D and closing the coverage gap in most Medicare drug plans, commonly referred to as the "donut hole." Moreover, payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives.
In addition, there are additional federal, state and non-U.S. laws which govern the privacy and security of health and other personal information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts; 66 ● the federal Physician Payments Sunshine Act, created under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, or, collectively, the Affordable Care Act, and its implementing regulations, which require manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children's Health Insurance Program (with certain exceptions) to report annually to CMS information related to direct or indirect payments and other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as ownership and investment interests held by the physicians and their immediate family members.
In addition, there are additional federal, state and non-U.S. laws which govern the privacy and security of health and other personal information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts; 59 the federal Physician Payments Sunshine Act, created under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, or, collectively, the Affordable Care Act, and its implementing regulations, which require manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children's Health Insurance Program (with certain exceptions) to report annually to CMS information related to direct or indirect payments and other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as ownership and investment interests held by the physicians and their immediate family members.
We may also have to take inventory write-offs and incur other charges and expenses for products that fail to meet specifications, undertake costly remediation efforts or seek more costly manufacturing alternatives. We rely on external contract research organizations to provide clinical and nonclinical research services and agreements with these organizations of which one agreement is currently in place.
We may also have to take inventory write-offs and incur other charges and expenses for products that fail to meet specifications, undertake costly remediation efforts or seek more costly manufacturing alternatives. 36 We rely on external contract research organizations to provide clinical and nonclinical research services and agreements with these organizations of which one agreement is currently in place.
These manufacturers might only be required to conduct a relatively inexpensive study to show that their product has the same active ingredient(s), dosage form, strength, route of administration, conditions of use, or labeling as our product candidate and that the generic product is bioequivalent to us, meaning it is absorbed in the body at the same rate and to the same extent as the Product.
These manufacturers might only be required to conduct a relatively inexpensive study to show that their product has the same active ingredient(s), dosage form, strength, route of administration, conditions of use, or labeling as our product candidate and that the generic product is bioequivalent to us, meaning it is absorbed in the body at the same rate and to the same extent as the Products.
Our intellectual property is held under a third-party license and we may require additional third-party licenses to effectively develop and manufacture our key products or future technologies. There can be no assurance as to the availability or cost of such additional licenses. A substantial number of patents have already been issued to other biotechnology and pharmaceutical companies.
Certain of our intellectual property is held under a third-party license and we may require additional third-party licenses to effectively develop and manufacture our key products or future technologies. There can be no assurance as to the availability or cost of such additional licenses. A substantial number of patents have already been issued to other biotechnology and pharmaceutical companies.
In addition, the competition for qualified personnel in the biotech industry is intense and there can be no assurance that we will be able to continue to attract and retain all personnel necessary for the development and operation of our business. Investors must rely upon the ability, expertise, judgment, discretion, integrity and good faith of ours management.
In addition, the competition for qualified personnel in the biotech industry is intense and there can be no assurance that we will be able to continue to attract and retain all personnel necessary for the development and operation of our business. Investors must rely upon the ability, expertise, judgment, discretion, integrity and good faith of our management.
We cannot predict what affect further changes to the ACA would have on our business. In addition, other legislative changes have been proposed and adopted in the United States since the ACA was enacted. For example, on August 2, 2011, the Budget Control Act of 2011, among other things, created measures for spending reductions by Congress.
We cannot predict what affect further changes to the ACA would have on our business. In addition, other legislative changes have been proposed and adopted in the United States since the ACA was enacted. For example, on August 2, 2011, the Budget Control Act, among other things, created measures for spending reductions by Congress.
If securities analysts or investors perceive these results to be negative, it could harm the price of our securities. Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities and have a harmful effect on the success of our business.
If securities analysts or investors perceive these results to be negative, it could harm the price of our securities. 50 Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities and have a harmful effect on the success of our business.
Because we do not have any contracts for the Product, management may not accurately predict future revenue streams and there may be no assurance that customers would continue to use our products, or that we would be able to replace departing potential customers with new potential customers that provide us with comparable revenue.
Because we do not have any contracts for the Products, management may not accurately predict future revenue streams and there may be no assurance that customers would continue to use our products, or that we would be able to replace departing potential customers with new potential customers that provide us with comparable revenue.
If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell the Product, if approved, we may be unable to generate any product revenue. To successfully commercialize the Product, we will need to build out sales and marketing capabilities, either on our own or with others.
If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell the Products, if approved, we may be unable to generate any product revenue. To successfully commercialize the Products, we will need to build out sales and marketing capabilities, either on our own or with others.
We cannot assure that any decision or recommendation made by these persons involving us will be made in accordance with his or her duties and obligations to deal fairly and in good faith with us and such other organizations. Our business is affected by macroeconomic conditions.
We cannot assure that any decision or recommendation made by these persons involving us will be made in accordance with his or her duties and obligations to deal fairly and in good faith with us and such other organizations. 55 Our business is affected by macroeconomic conditions.
The amount of future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue. To the extent that we have negative operating cash flow in future periods, we may need to allocate a portion of our cash reserves to fund such negative cash flow.
The amount of future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue. 38 To the extent that we have negative operating cash flow in future periods, we may need to allocate a portion of our cash reserves to fund such negative cash flow.
There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution; 65 ● the federal civil and criminal false claims laws, including the FCA, and civil monetary penalty laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, false, fictitious or fraudulent claims for payment to, or approval by Medicare, Medicaid, or other federal healthcare programs; knowingly making, using, or causing to be made or used, a false record or statement material to a false, fictitious or fraudulent claim or an obligation to pay or transmit money or property to the federal government; or knowingly concealing or knowingly and improperly avoiding, decreasing or concealing an obligation to pay money to the federal government.
There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution; 58 the federal civil and criminal false claims laws, including the FCA, and civil monetary penalty laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, false, fictitious or fraudulent claims for payment to, or approval by Medicare, Medicaid, or other federal healthcare programs; knowingly making, using, or causing to be made or used, a false record or statement material to a false, fictitious or fraudulent claim or an obligation to pay or transmit money or property to the federal government; or knowingly concealing or knowingly and improperly avoiding, decreasing or concealing an obligation to pay money to the federal government.
Due to the small size of our public float, our securities may experience extreme price volatility unrelated to our actual or expected operating performance, financial condition, or prospects, making it difficult for prospective investors to assess the rapidly changing value of our securities.
Due to the relatively small size of our public float, our securities may experience extreme price volatility unrelated to our actual or expected operating performance, financial condition, or prospects, making it difficult for prospective investors to assess the rapidly changing value of our securities.
We may be subject to securities litigation, which is expensive and could divert management attention. The market price of our securities may be volatile, and in the past companies that have experienced volatility in the market price of their shares have been subject to securities class action litigation.
We may be subject to securities litigation, which is expensive and could divert management attention. 68 The market price of our securities may be volatile, and in the past companies that have experienced volatility in the market price of their shares have been subject to securities class action litigation.
We can provide no assurance that any of our pending patent applications will provide any protectable, maintainable or enforceable rights or competitive advantages to it. Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
We can provide no assurance that any of our pending patent applications will provide any protectable, maintainable or enforceable rights or competitive advantages to it. 44 Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
We have started the process of designing, implementing and testing our internal control over financial reporting required to comply with Section 404(a) of the Sarbanes-Oxley Act. This process is time-consuming, costly and complicated.
We have started and continue the process of designing, implementing and testing our internal control over financial reporting required to comply with Section 404(a) of the Sarbanes-Oxley Act. This process is time-consuming, costly and complicated.
Accordingly, our future success depends upon our ability to enhance the Product and to develop, introduce and sell the most accurate products at competitive prices. The development of new technologies and products involves time, substantial costs and risks.
Accordingly, our future success depends upon our ability to enhance the Products and to develop, introduce and sell the most accurate products at competitive prices. The development of new technologies and products involves time, substantial costs and risks.
Regulatory constraints ultimately imposed on our products, if approved, could limit our ability to commercialize, thus impacting on our financial condition and results. Manufacture and marketing of the Product is subject to government regulation.
Regulatory constraints ultimately imposed on our products, if approved, could limit our ability to commercialize, thus impacting on our financial condition and results. Manufacture and marketing of the Products is subject to government regulation.
In most countries, we will be required to complete extensive non-clinical studies and clinical trials to demonstrate the safety and efficacy of the Product in order to apply for regulatory approval to market the product.
In most countries, we will be required to complete extensive non-clinical studies and clinical trials to demonstrate the safety and efficacy of the Products in order to apply for regulatory approval to market the product.
Coverage may be more limited than the purposes for which a therapeutic is approved by the FDA or comparable regulatory authorities in other jurisdictions. 64 In the United States and some other jurisdictions, patients who are provided medical treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment.
Coverage may be more limited than the purposes for which a therapeutic is approved by the FDA or comparable regulatory authorities in other jurisdictions. 57 In the United States and some other jurisdictions, patients who are provided medical treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment.
We may attempt to raise additional funds for these purposes through public or private equity or debt financing, collaborations with other therapeutic companies, government grants or other sources. There can be no assurance that additional funding or partnerships will be available on terms acceptable to us and which would foster the successful commercialization of the Product.
We may attempt to raise additional funds for these purposes through public or private equity or debt financing, collaborations with other therapeutic companies, government grants or other sources. There can be no assurance that additional funding or partnerships will be available on terms acceptable to us and which would foster the successful commercialization of the Products.
Risks Related to Marketing, Reimbursement, Healthcare Regulations and Ongoing Regulatory Compliance Coverage and reimbursement may be limited or unavailable in certain market segments for the Product, which could make it difficult for us to sell the Product profitably. The success of the Product, if approved, depends on the availability of adequate coverage and reimbursement from third-party payors, including government agencies.
Risks Related to Marketing, Reimbursement, Healthcare Regulations and Ongoing Regulatory Compliance Coverage and reimbursement may be limited or unavailable in certain market segments for the Products, which could make it difficult for us to sell the Products profitably. The success of the Products, if approved, depends on the availability of adequate coverage and reimbursement from third-party payors, including government agencies.
Although the SkinJect Phase 1 study indicated that the patch is well-tolerated, there is no guarantee that the Phase 2 study will produce similar results or that the Product will ultimately be brought to market or, if it does, that it will be positively received or obtain favorable pricing, which would have a material adverse effect on our results of operations.
Although the SkinJect Phase 1 study indicated that the patch is well-tolerated, there is no guarantee that the Phase 2 study will produce similar results or that SkinJect TM will ultimately be brought to market or, if it does, that it will be positively received or obtain favorable pricing, which would have a material adverse effect on our results of operations.
As the Product is developed through further clinical trials towards approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize processes and results. Such changes carry the risk that they will not achieve these intended objectives.
As the Products are developed through further clinical trials towards approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize processes and results. Such changes carry the risk that they will not achieve these intended objectives.
Additionally, pending patent applications that have been published can, subject to certain limitations, be later amended in a manner that could cover our product candidates or the use of our products. 56 The scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent's prosecution history.
Additionally, pending patent applications that have been published can, subject to certain limitations, be later amended in a manner that could cover our product candidates or the use of our products. 49 The scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent's prosecution history.
Prior to marketing approval in the United States, required steps include non-clinical (animal and laboratory) testing; performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the Product in the intended target population; performance of a consistent and reproducible manufacturing process intended for commercial use; and successful filing and approval of an NDA.
Prior to marketing approval in the United States, required steps include non-clinical (animal and laboratory) testing; performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the Products in the intended target population; performance of a consistent and reproducible manufacturing process intended for commercial use; and successful filing and approval of an NDA.
There can be no assurance that these regulatory bodies will approve the Product in the manner or time frame suggested. Although we intend to work with regulatory consultants and third parties knowledgeable in the area, we cannot ensure that the Product will obtain market authorization in a timely manner, or at all.
There can be no assurance that these regulatory bodies will approve the Products in the manner or time frame suggested. Although we intend to work with regulatory consultants and third parties knowledgeable in the area, we cannot ensure that the Products will obtain market authorization in a timely manner, or at all.
These measures could cause significant delays or entirely prevent the Company’s continued efforts to commercialize its current or future products, which are critical to the realization of its business plan and the future operations of the Company. If any of these events happens, the Company’s investors could lose all or parts of their investments.
These measures could cause significant delays or entirely prevent the Company's continued efforts to commercialize its current or future products, which are critical to the realization of its business plan and the future operations of the Company. If any of these events happens, the Company's investors could lose all or part of their investments.
Future technology will require regulatory approval, which is costly and we may not be able to obtain it and we may fail to obtain regulatory approvals or only obtain approvals for limited uses or indications. Market authorization of the Product falls under the regulatory purview of the FDA and other equivalent regulatory bodies worldwide.
Future technology will require regulatory approval, which is costly and we may not be able to obtain it and we may fail to obtain regulatory approvals or only obtain approvals for limited uses or indications. Market authorization of the Products falls under the regulatory purview of the FDA and other equivalent regulatory bodies worldwide.
However, any party with whom we have executed such an agreement may breach that agreement and disclose our proprietary information, including our trade secrets. 61 Accordingly, these agreements may not effectively prevent disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information.
However, any party with whom we have executed such an agreement may breach that agreement and disclose our proprietary information, including our trade secrets. 54 Accordingly, these agreements may not effectively prevent disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information.
Item 1A. Risk Factors. An investment in our securities involves a high degree of risk. You should consider carefully all of the risks described below, together with the other information contained in this annual report, including the financial statements, before making a decision to invest in our securities.
Item 1A. Risk Factors. An investment in our securities involves a high degree of risk. You should consider carefully all of the risks described below, together with all other information contained in this annual report, including the financial statements, before making an investment decision.
Such non-compliance or breaches by such third parties could in turn result in breaches or defaults under any agreements with other collaboration partners, and we could be found liable for damages or lose certain rights, including rights to develop and/or commercialize the Product.
Such non-compliance or breaches by such third parties could in turn result in breaches or defaults under any agreements with other collaboration partners, and we could be found liable for damages or lose certain rights, including rights to develop and/or commercialize the Products.
This could delay completion of clinical trials, require the conduct of bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of the Product and jeopardize our ability, or our strategic partners' ability, to commence product sales and generate revenue. 43 The manufacture of the Product is complex.
This could delay completion of clinical trials, require the conduct of bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of the Products and jeopardize our ability, or our strategic partners' ability, to commence product sales and generate revenue. The manufacture of the Products is complex.
The establishment and development of our own commercial team or the establishment of a contract field force to market the Product will be expensive and time-consuming and could delay launch. Moreover, we cannot be certain that we will be able to successfully develop this capability.
The establishment and development of our own commercial team or the establishment of a contract field force to market the Products will be expensive and time-consuming and could delay launch. Moreover, we cannot be certain that we will be able to successfully develop this capability.
While some of these and other measures may require additional authorization to become effective, and the Biden administration may reverse or otherwise change these measures, Congress has indicated that it will continue to seek new legislative and/or administrative measures to control drug costs.
While some of these and other measures may require additional authorization to become effective, and the Trump administration may reverse or otherwise change these measures, Congress has indicated that it will continue to seek new legislative and/or administrative measures to control drug costs.
Medicus intends to seek approval to market the Product in different jurisdictions, which could include Canada and other selected foreign jurisdictions in addition to the United States. If Medicus obtains approval in any of these jurisdictions for the Product, Medicus will be subject to rules and regulations in those jurisdictions.
Medicus intends to seek approval to market the Products in different jurisdictions, which could include Canada and other selected foreign jurisdictions in addition to the United States. If Medicus obtains approval in any of these jurisdictions for the Products, Medicus will be subject to rules and regulations in those jurisdictions.
If any current or future collaborators do not commit sufficient resources to commercialize the Product, or we are unable to develop the necessary capabilities on our own, we may be unable to generate sufficient revenue to sustain our business.
If any current or future collaborators do not commit sufficient resources to commercialize the Products, or we are unable to develop the necessary capabilities on our own, we may be unable to generate sufficient revenue to sustain our business.
Market acceptance and sales of the Product will depend significantly on the availability of adequate coverage and reimbursement from third party payors for the Product and may be affected by existing and future health care reform measures.
Market acceptance and sales of the Products will depend significantly on the availability of adequate coverage and reimbursement from third party payors for the Products and may be affected by existing and future health care reform measures.
If we do not obtain such a license or find a cost-efficient workaround, our business, operating results and financial condition could be materially adversely affected and we could be required to cease related business operations in some markets and restructure our business to focus on our continuing operations in other markets. Our general liability insurance expires on October 11, 2025.
If we do not obtain such a license or find a cost-efficient workaround, our business, operating results and financial condition could be materially adversely affected and we could be required to cease related business operations in some markets and restructure our business to focus on our continuing operations in other markets. Our general liability insurance expires in October 2026.
Even if we complete the necessary non-clinical studies and clinical trials, the marketing approval process is expensive, time-consuming, and uncertain and may prevent us from obtaining approvals for the commercialization of the Product.
Even if we complete the necessary non-clinical studies and clinical trials, the marketing approval process is expensive, time-consuming, and uncertain and may prevent us from obtaining approvals for the commercialization of the Products.
The following examples are illustrative: ● others may be able to make product that is similar to product candidates we intend to commercialize that is not covered by the patents that we own; 52 ● we, or any collaborators might not have been the first to make or reduce to practice the inventions covered by the issued patents or pending patent applications that we own; ● we or any collaborators might not have been the first to file patent applications covering certain of our inventions; ● others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; ● it is possible that our pending patent applications will not lead to issued patents; ● issued patents that we own may not provide us with any competitive advantages, or may be held invalid or unenforceable as a result of legal challenges; ● our competitors might conduct research and development activities in the United States and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where we do not have patent rights, and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; and we may not develop additional proprietary technologies that are patentable; ● third parties performing manufacturing or testing for us using our products or technologies could use the intellectual property of others without obtaining a proper license; ● parties may assert an ownership interest in our intellectual property and, if successful, such disputes may preclude us from exercising exclusive rights over that intellectual property; ● we may not develop additional proprietary technologies that are patentable; ● we may not be able to obtain and maintain necessary licenses on commercially reasonable terms, or at all; and ● the patents of others may harm our business.
The following examples are illustrative: others may be able to make product that is similar to product candidates we intend to commercialize that is not covered by the patents that we own; we, or any collaborators might not have been the first to make or reduce to practice the inventions covered by the issued patents or pending patent applications that we own; we or any collaborators might not have been the first to file patent applications covering certain of our inventions; others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; it is possible that our pending patent applications will not lead to issued patents; issued patents that we own may not provide us with any competitive advantages, or may be held invalid or unenforceable as a result of legal challenges; our competitors might conduct research and development activities in the United States and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where we do not have patent rights, and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; and we may not develop additional proprietary technologies that are patentable; third parties performing manufacturing or testing for us using our products or technologies could use the intellectual property of others without obtaining a proper license; parties may assert an ownership interest in our intellectual property and, if successful, such disputes may preclude us from exercising exclusive rights over that intellectual property; we may not develop additional proprietary technologies that are patentable; we may not be able to obtain and maintain necessary licenses on commercially reasonable terms, or at all; and the patents of others may harm our business. 45 Should any of these events occur, they could significantly harm our business and results of operations.
All of these could harm our ability to operate our business and our financial results. 67 Ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations.
All of these could harm our ability to operate our business and our financial results. 60 Ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations.
If we are unable to continue to attract and retain high-quality personnel, the rate of and success with which we can develop and commercialize the Product would be limited. 44 As a technology-driven company, intellectual input from key management and personnel is critical to achieve our business objectives.
If we are unable to continue to attract and retain high-quality personnel, the rate of and success with which we can develop and commercialize the Products would be limited. As a technology-driven company, intellectual input from key management and personnel is critical to achieve our business objectives.
Regardless of the merits or eventual outcome, liability claims may result in: 60 ● decreased demand for current and future products; ● injury to our reputation; ● costs to defend any related litigation; ● diversion of management's time and our resources; ● product recalls, withdrawals or labeling, marketing or promotional restrictions; ● loss of revenue; ● inability to commercialize the Product and other products, if approved; ● decline in our stock price; and ● exposure to adverse publicity.
Regardless of the merits or eventual outcome, liability claims may result in: 53 decreased demand for current and future products; injury to our reputation; costs to defend any related litigation; diversion of management's time and our resources; product recalls, withdrawals or labeling, marketing or promotional restrictions; loss of revenue; inability to commercialize the Products and other products, if approved; decline in our share price; and exposure to adverse publicity.
There can be no assurance that we will be able to comply with the License Agreement going forward or that the University of Pittsburgh will grant any necessary waivers if we are unable to do so. The obligations under the License Agreement principally require the trial of the Product on specified timelines.
There can be no assurance that we will be able to comply with the License Agreement going forward or that the University of Pittsburgh will grant any necessary waivers if we are unable to do so. The obligations under the License Agreement principally require the trial of SkinJect TM on specified timelines.
If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize, or will be delayed in commercializing, the Product, and our ability to generate revenue will be materially impaired. 51 We rely on the protection of intellectual property rights.
If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize, or will be delayed in commercializing, the Products, and our ability to generate revenue will be materially impaired. We rely on the protection of intellectual property rights.
The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process.
The USPTO and various foreign governmental patent agencies require compliance with a number of procedurals, documentary, fee payment and other similar provisions during the patent application process.
We intend to patent concepts, components, processes, industrial designs and methods, and other inventions and technologies that we considers to have commercial value or that will likely give us a competitive advantage. Despite devoting resources to the research and development of proprietary technology, we may not be able to develop new technology that is patentable or protectable.
We intend to patent concepts, components, processes, industrial designs and methods, and other inventions and technologies that we consider having commercial value or that will likely give us a competitive advantage. Despite devoting resources to the research and development of proprietary technology, we may not be able to develop new technology that is patentable or protectable.
If we do so, we would be subject to additional risks related to entering into international business relationships, including: ● differing regulatory requirements in other countries including, among others, marketing approval, pricing, reimbursement and sales and marketing practices; ● potentially reduced protection for intellectual property rights; 48 ● potential for so-called parallel importing, which is when a local seller, faced with higher local prices, opts to import goods from a foreign market with lower prices, rather than buying them locally; ● unexpected changes in tariffs, trade barriers and regulatory requirements, including the imposition of new tariffs by the U.S. government on imports to the U.S. and/or the imposition of retaliatory tariffs by foreign countries; ● economic weakness, including inflation, or political instability in foreign economies and markets; ● compliance with tax, employment, immigration and labor laws for employees traveling and working abroad; ● foreign taxes; ● foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other risks incident to doing business in another country; ● workforce uncertainty in countries where labor unrest is more common than in Canada or the United States; ● production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad or supply chain disruptions; and ● business interruptions resulting from geo-political actions, including war and terrorism, or natural disasters, including earthquakes, volcanoes, typhoons, floods, tsunamis, hurricanes and fires.
If we do so, we would be subject to additional risks related to entering into international business relationships, including: differing regulatory requirements in other countries including, among others, marketing approval, pricing, reimbursement and sales and marketing practices; potentially reduced protection for intellectual property rights; potential for so-called parallel importing, which is when a local seller, faced with higher local prices, opts to import goods from a foreign market with lower prices, rather than buying them locally; unexpected changes in tariffs, trade barriers and regulatory requirements, including the imposition of new tariffs by the U.S. government on imports to the U.S. and/or the imposition of retaliatory tariffs by foreign countries; economic weakness, including inflation, or political instability in foreign economies and markets; compliance with tax, employment, immigration and labor laws for employees traveling and working abroad; foreign taxes; foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other risks incident to doing business in another country; workforce uncertainty in countries where labor unrest is more common than the United States; production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad or supply chain disruptions; and business interruptions resulting from geo-political actions, including war and terrorism, or natural disasters, including earthquakes, volcanoes, typhoons, floods, tsunamis, hurricanes and fires. 41 These and other risks may materially adversely affect our ability to develop and commercialize products in international markets and may harm our business.
For example, in the US, once an NDA is approved, the product covered thereby becomes a "listed drug" which can, in turn, be cited by potential competitors in support of approval of an abbreviated new drug application ("ANDA").
For example, in the United States, once an NDA is approved, the product covered thereby becomes a "listed drug" which can, in turn, be cited by potential competitors in support of approval of an abbreviated new drug application ("ANDA").
We may fail to manage growth successfully which may adversely impact operating results. Our failure to manage our growth successfully may adversely impact our operating results. Our ability to manage growth will require us to continue to build our operational, financial and management controls, contracting relationships, marketing and business development plans and controls and reporting systems and procedures.
Our failure to manage our growth successfully may adversely impact our operating results. Our ability to manage growth will require us to continue to build our operational, financial and management controls, contracting relationships, marketing and business development plans and controls and reporting systems and procedures.
If we or any future licensors fail to maintain the patents and patent applications covering the Product, our competitive position would be adversely affected. 55 We may infringe the intellectual property rights of others. Our commercial success depends, in part, upon it not infringing or violating intellectual property rights owned by others.
If we or any future licensors fail to maintain the patents and patent applications covering the Products, our competitive position would be adversely affected. 48 We may infringe the intellectual property rights of others. Our commercial success depends, in part, upon it not infringing or violating intellectual property rights owned by others.
Any of these changes could cause the Product to perform differently and affect the results of future clinical trials conducted with the altered materials.
Any of these changes could cause the Products to perform differently and affect the results of future clinical trials conducted with the altered materials.
If microbial, viral or other contaminations are discovered in the Product or in the manufacturing facilities in which the Product is made, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination.
If microbial, viral or other contaminations are discovered in the Products or in the manufacturing facilities in which the Products are made, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination.
These include allowing third parties to submit prior art during patent prosecution by the U.S. Patent and Trademark Office ("USPTO"), and additional procedures to attack the validity of a patent in post-grant proceedings including opposition, derivation, re-examination, inter partes review or interference proceedings challenging our patent rights or the patent rights of others.
These include allowing third parties to submit prior art during patent prosecution by the USPTO, and additional procedures to attack the validity of a patent in post-grant proceedings including opposition, derivation, re-examination, inter partes review or interference proceedings challenging our patent rights or the patent rights of others.
Patent reform legislation in the United States, including the Leahy-Smith Act, could increase those uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents. The Leahy-Smith Act was signed into law on September 16, 2011, and includes a number of significant changes to U.S. patent law.
Patent reform legislation in the United States, including the AIA, could increase those uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents. The AIA was signed into law on September 16, 2011, and includes a number of significant changes to U.S. patent law.
After March 15, 2013, under the Leahy-Smith Act, the United States transitioned to a first inventor to file system in which, assuming that the other statutory requirements are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention.
After March 15, 2013, under the AIA, the United States transitioned to a first inventor to file system in which, assuming that the other statutory requirements are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention.
We or our third-party manufacturers may encounter difficulties in production. If we encounters any such difficulties, our ability to supply the Product for clinical trials or, if approved, for commercial sale could be delayed or halted entirely.
We or our third-party manufacturers may encounter difficulties in production. If we encounter any such difficulties, our ability to supply the Products for clinical trials or, if approved, for commercial sale could be delayed or halted entirely.
Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches.
Despite these efforts, any of these parties may unintentionally or willfully breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches.
The University of Pittsburgh has the right to terminate the License Agreement if breaches are not cured within 30 days of our receipt of notice thereof from the University of Pittsburgh or in certain insolvency-related situations or if we cease to carry out our business.
The University of Pittsburgh of the Commonwealth System of Higher Education (the "University of Pittsburgh") has the right to terminate the License Agreement if breaches are not cured within 30 days of our receipt of notice thereof from the University of Pittsburgh or in certain insolvency-related situations or if we cease to carry out our business.
We may enter into agreements with third parties for the development and commercialization of the Product in international markets.
We may enter into agreements with third parties for the development and commercialization of the Products in international markets.
The Company's auditor has indicated in the Company's audited annual financial statements that there is substantial doubt about the Company's ability to continue as a going concern. The Company is in the preliminary stages of its planned operations and has not yet determined whether its processes and business plans are economically viable.
The Company's current auditor has indicated in its report accompanying the Company's audited annual financial statements that substantial doubt exists about the Company's ability to continue as a going concern. The Company is in the preliminary stages of its planned operations and has not yet determined whether its processes and business plans are economically viable.
Loss of our rights to any license granted to us in the future, or the exclusivity rights provided therein, could harm our financial condition and operating results. 42 The University of Pittsburgh may terminate our license agreement in certain circumstances. The License Agreement is our main asset and the basis for the development of the Product.
Loss of our rights to any license granted to us in the future, or the exclusivity rights provided therein, could harm our financial condition and operating results. 34 The University of Pittsburgh may terminate our license agreement in certain circumstances. The License Agreement is our main asset and the basis for the development of SkinJect TM .
As a dual U.S.-Canadian public company, we are subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, as well as rules adopted, and to be adopted, by the SEC, Canadian securities regulators and the Nasdaq.
As a U.S. public company, domiciled in Ontario, Canada, we are subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, as well as rules adopted, and to be adopted, by the SEC, Canadian securities regulators and Nasdaq.
The process of manufacturing the Product is susceptible to product loss due to contamination, equipment failure or improper installation or operation of equipment, vendor or operator error, contamination and inconsistency in yields, variability in product characteristics and difficulties in scaling the production process.
The processes of manufacturing the Products are susceptible to product loss due to contamination, equipment failure or improper installation or operation of equipment, vendor or operator error, contamination and inconsistency in yields, variability in product characteristics and difficulties in scaling the production process.
At the time of this annual report, there are no commitments from customers for the Product.
At the time of this annual report, there are no commitments from customers for the Products.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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We assess material risks from cybersecurity threats on an ongoing basis, including any potential unauthorized occurrence on or conducted through our information systems that may result in adverse effects on the confidentiality, integrity, or availability of our information systems or any information residing therein.
We believe we appropriately assess material risks from cybersecurity threats, including any potential unauthorized occurrence on or conducted through our information systems that may result in adverse effects on the confidentiality, integrity, or availability of our information systems or any information residing therein.
Our audit committee is responsible for overseeing the Company's risk management policies and procedures with regard to identification of the Company's principal risks and implementation of appropriate systems to manage such risks. 74 As of the date of this annual report, we are not aware of any material risks from cybersecurity threats that have materially affected or are reasonably likely to materially affect the Company.
Our audit and risk assessment committee is responsible for overseeing the Company's risk management policies and procedures with regard to identification of the Company's principal risks and implementation of appropriate systems to manage such risks. 69 As of the date of this annual report, we are not aware of any material risks from cybersecurity threats that have materially affected or are reasonably likely to materially affect the business strategy, results of operations or financial condition of the Company.
Assessment, identification and management of cybersecurity related risks are integrated into our overall risk management process. Our risk management process is designed to identify, prioritize, and monitor risks that could affect our ability to execute our corporate strategy and fulfill our business objectives and to appropriately mitigate such risks.
Our risk management process is designed to identify, prioritize, and monitor risks that could affect our ability to execute our corporate strategy and fulfill our business objectives and to appropriately mitigate such risks.
As our company grows, we plan to expand our strategy for cybersecurity in accordance with nationally accepted standards. Governance Management is responsible for the day-to-day management of the risks we face, while our board of directors has responsibility for the oversight of risk management, including risks from cybersecurity threats.
Governance Management is responsible for the day-to-day management of the risks we face, while our board of directors has responsibility for the oversight of risk management, including risks from cybersecurity threats.
Item 1C. Cybersecurity Risk Management and Strategy We are a biotech/life sciences company focused on accelerating the clinical development programs of novel and disruptive therapeutic assets. We current do not sell any products or maintain any customer lists and have limited exposure to cybersecurity risks due to the small size of our company and the nature of our operations.
Item 1C. Cybersecurity. Risk Management and Strategy We are a biotech/life sciences company focused on accelerating the clinical development programs of novel and disruptive therapeutic assets.
Added
We current do not sell any products or maintain any customer lists and have exposure to cybersecurity risks commensurate with the small size of our company and the nature of our operations, which we believe at this time is limited. Assessment, identification and management of cybersecurity related risks are integrated into our overall risk management process.
Added
As our company grows, we plan to expand our strategy for cybersecurity in accordance with nationally accepted standards. As of the date of this annual report we do not currently engage assessors, consultants, auditors, or other third parties in connection with cybersecurity processes or have processes to oversee and identify such risks from third-party service providers.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Item 5. Market for Registrant's Ordinary Shares, Related Shareholder Matters and Issuer Purchases of Equity Securities. Market Information. Our common shares and Public Warrants are traded on the Nasdaq under the symbols "MDCX" and "MDCXW", respectively.
Item 5. Market for Registrant's Common Shares, Related Shareholder Matters and Issuer Purchases of Equity Securities. Market Information. Our common shares and Public Warrants are traded on the Nasdaq under the symbols "MDCX" and "MDCXW", respectively.
Holders As of March 18, 2025, there were approximately 155 record holders of our common shares and one holder of record of our Public Warrants. Such numbers do not include beneficial owners holding our securities through nominee names.
Holders As of March 17, 2026, there were approximately 189 record holders of our common shares and one holder of record of our Public Warrants. Such numbers do not include beneficial owners holding our securities through nominee names.
Recent Sales of Unregistered Securities; Use of Proceeds from Registered Offerings On November 13, 2024, our Registration Statement on Form F-1 (SEC File No. 333-279771), for the initial public offering of 970,000 units (each, a "Unit") at a price of $4.125 per Unit, each Unit consisting of one common share and one Public Warrant, was declared effective by the SEC.
On November 13, 2024, our Registration Statement on Form F-1 (SEC File No. 333-279771), for the initial public offering (the "IPO") of 970,000 units (each, a "Unit") at a price of $4.125 per Unit, each Unit consisting of one common share and one Public Warrant, was declared effective by the SEC.
In the aggregate, the IPO generated approximately $1.88 million in net proceeds for the Company, which amount is net of approximately $0.42 million in underwriters' discounts and commissions and offering costs of approximately $ 1.7 million.
In the aggregate, the IPO generated approximately $1.88 million in net proceeds for the Company, which amount is net of approximately $0.42 million in underwriters' discounts and commissions and offering costs of approximately $1.7 million. Maxim Group LLC acted as the sole book-running manager for the offering and Brookline Capital Markets, a division of Arcadia Securities, LLC, acted as co-manager.
Removed
Maxim Group LLC acted as the sole book-running manager for the offering and Brookline Capital Markets, a division of Arcadia Securities, LLC, acted as co-manager. There has been no material change in the use of proceeds described in the final prospectus filed with the SEC on November 15, 2024.
Added
Equity Incentive Plans Information relating to the Company's equity incentive plan will be included in the proxy statement for our 2026 Annual Meeting of Shareholders and is hereby incorporated by reference in this Annual Report on Form 10-K, unless the Proxy Statement is not filed prior to 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K, in which case the information relating to this item will be filed by amendment to this Annual Report on Form 10-K. 70 Recent Sales of Unregistered Securities; Use of Proceeds from Registered Offerings We have not issued or sold securities without registration under the Securities Act in the prior three years and required to reported hereunder other than has been previously disclosed in a Quarterly Report on Form 10-Q or in a Current Report on Form 8-K, except for 1,000,000 common shares sold to Yorkville pursuant to the SEPA on March 11, 2026 for gross proceeds to the Company of $477,300.
Removed
On March 10, 2025, the Company completed an offering of 1,490,000 units, each unit consisting of one common share and 2030 Warrant pursuant to Tier II of Regulation A under the Securities Act. The aggregate gross proceeds to the Company from the Offering were $4.17 million, before deducting placement agent fees of approximately $0.31 million and other offering expenses.
Added
There has been no material change in the use of proceeds described in the final prospectus for the IPO. Item 6. [Reserved].
Removed
Maxim Group LLC acted as lead placement agent for the offering and Brookline Capital Markets, a division of Arcadia Securities, LLC, acted as co-placement agent for the offering. There has been no material change in the use of proceeds described in the final offering circular filed with the SEC on March 7, 2025.
Removed
In the prior three years, we have issued and sold the securities described below without registering the securities under the Securities Act. None of these transactions involved any underwriters' underwriting discounts or commissions, or any public offering.
Removed
We believe that each of the following issuances was exempt from registration under the Securities Act in reliance on Regulation S promulgated under the Securities Act regarding sales by an issuer in offshore transactions, Regulation D under the Securities Act, Rule 701 under the Securities Act or pursuant to Section 4(a)(2) of the Securities Act regarding transactions not involving a public offering. 76 The Registrant granted 812,500 stock options on October 24, 2023, each having an exercise price of C$1.16 and an expiry date of October 24, 2028, of which 50,000 were forfeited on March 15, 2024.
Removed
The Registrant granted 62,500 stock options on April 1, 2024, each having an exercise price of C$4.80 and an expiry date of April 1, 2029. The Registrant granted 37,500 stock options on April 1, 2024, each having an exercise price of C$4.84 and an expiry date of April 1, 2029.
Removed
The Registrant issued $5,172,500 aggregate principal amount of f 10.00% Unsecured Convertible Notes due 2025 (the "2025 Convertible Notes") on May 3, 2024. The Registrant granted 25,000 stock options on June 25, 2024, each having an excise price of C$3.34 and an expiry date of June 25, 2029.
Removed
The Registrant issued approximately 2,770,047 common shares on June 28, 2024, including 1,461,250 common shares issued at US$4.00 per share pursuant to a private placement of its common shares, 1,293,125 common shares issued upon conversion of the 2025 Convertible Notes at a conversion price of US$4.00 per share and approximately 15,672 common shares issued in respect of accrued and unpaid interest on the 2025 Convertible Notes at a price of C$3.36 per share.
Removed
The Registrant granted 100,000 stock options on November 14, 2024, each having an exercise price of C$3.25 and an expiry date of November 14, 2029. The Registrant granted 50,000 stock options on November 20, 2024, each having an exercise price of C$2.70 and an expiry date of November 20, 2029.
Removed
The Registrant granted 210,000 stock options on December 17, 2024, each having an exercise price of C$3.95 and an expiry date of December 17, 2029. Item 6. [Reserved].

Item 6. [Reserved]

Selected Financial Data — reserved (removed by SEC in 2021)

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Item 6. [Reserved]. 77 Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 77 Item 7A. Quantitative and Qualitative Disclosures about Market Risk 84 Item 8. Financial Statements and Supplementary Data 84 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 84 Item 9A. Controls and Procedures. 84
Item 6. [Reserved]. 71 Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 71 Item 7A. Quantitative and Qualitative Disclosures about Market Risk 80 Item 8. Financial Statements and Supplementary Data 80 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 80 Item 9A. Controls and Procedures. 81 Item 9B.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Research and development ("R&D") Research and development ("R&D") 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.
Research and development ("R&D") 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.
However, 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.
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.
Common shares issued and sold to the Investor under the SEPA will be priced at 97% of the market price (as defined in the SEPA) of the common shares during a specified three-day pricing period. The Company reserves the right to set a minimum acceptable price for the common share issuances.
Common shares issued and sold to Yorkville under the SEPA will be priced at 97% of the market price (as defined in the SEPA) of the common shares during a specified three-day pricing period. The Company reserves the right to set a minimum acceptable price for the common share issuances.
The issuance of common shares under the SEPA is subject to further limitations, including that the common shares beneficially owned by the Investor and its affiliates at any one time will not exceed 4.99% of the then-outstanding common shares.
The issuance of common shares under the SEPA is subject to further limitations, including that the common shares beneficially owned by Yorkville and its affiliates at any one time will not exceed 4.99% of the then-outstanding common shares.
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 the Investor at any time during the 36-months following the date of the SEPA.
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.
The par value of the Company's common shares remains unchanged at $nil per share after the Share Consolidation. The Share Consolidation was completed in preparation for a U.S. listing.
The par value of the Company's common shares remains unchanged at $0 per share after the Share Consolidation. The Share Consolidation was completed in preparation for a U.S. listing.
The first part involved the enrollment of 15 healthy volunteers and was designed to study the penetration of placebo-containing Dynamic Mechanical Allodynia ("DMA") 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 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.
There were no serious adverse events nor any demonstrated alterations in any clinical measurements during the trial. The conclusion of the study was that MNA patch was well tolerated with no evidence of dose limiting toxicity. The Company had initiated a clinical study ("SKNJCT-002") aimed at evaluating clinical efficacy.
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. The Company had initiated a clinical study ("SKNJCT-002") aimed at evaluating clinical efficacy.
This uncertainty, along with the Company’s history of losses, indicates that there is substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued.
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.
Regulation A Offering On March 10, 2025, the Company completed an 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 to purchase one common share. The warrants have an exercise price of $2.80 and expire on March 10, 2030.
Regulation A Offering 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 increase is primarily due to increased spending on research and development and general and administrative expenses. Cash flows provided by financing activities Cash flows provide by financing activities for the year ended December 31, 2024, were $12,692,216 compared to cash flows provided by financing activities of $5,609,950 for the year ended December 31, 2023.
The increase is primarily due to increased spending on research and development and general and administrative expenses. Cash flows provided by financing activities Cash flows provide by financing activities for the year ended December 31, 2025, were $31,939,785 compared to cash flows provided by financing activities of $12,692,216 for the year ended December 31, 2024.
The Company established and validated fabrication processes relative to the MNAs, completed pre-clinical testing and secured approval to proceed with clinical trials activity from the Food and Drug Administration. The Company then completed a dose escalation study ("'SKNJCT-001") that assessed the safety of MNA patch in patients with BCC.
The Company established and validated fabrication processes relative to the C-MNAs and D-MNAs, completed pre-clinical testing and secured approval to proceed with clinical trials activity from the FDA. The Company then completed a dose escalation study ("SKNJCT-001") that assessed the safety of D-MNA patch in patients with BCC.
As part of this process, we have reviewed our selection, application and communication of critical accounting policies and financial disclosures. Management has discussed the development and selection of the critical accounting policies with our audit committee, and our audit committee has reviewed the disclosure relating to critical accounting policies in this MD&A.
Management has discussed the development and selection of the critical accounting policies with our audit committee, and our audit committee has reviewed the disclosure relating to critical accounting policies in this MD&A.
We expect our R&D expenses to increase substantially for the foreseeable future as we continue with the SKNJCT-003 study and trials. 80 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.
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.
The Company expects to continue to incur significant operating losses for the foreseeable future and may never become profitable. In addition to the SEPA (as defined below), 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.
In addition to the ATM, SEPA and Debenture (as defined below), 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.
These measures could cause significant delays or entirely prevent the Company’s continued efforts to commercialize its current or future products, which are critical to the realization of its business plan and the future operations of the Company.
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.
Initial Public Offering On November 14, 2024, the Company completed the sale of 970,000 Units, with each Unit consisting of one common share and one warrant to purchase one common share at the price of $4.125 per Unit.
Initial Public Offering On November 14, 2024, the Company completed its initial public offering with the sale of 970,000 Units at the price of $4.125 per Unit, with each Unit (the "Unit") consisting of one common share and one Public Warrant. The Public Warrants expire five years from their date of issuance on November 15, 2029.
SkinJect is focused on the development of a novel drug delivery system using dissolvable microneedle arrays ("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.
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") 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.
Significant accounting judgments and estimates Management's assessment of our ability to continue as a going concern involves making a judgment, at a particular point in time, about inherently uncertain future outcomes and events or conditions. Please see the "Liquidity and Capital Resources" section in this document for a discussion of the factors considered by management in arriving at its assessment.
Significant accounting judgments and estimates Management's assessment of our ability to continue as a going concern involves making a judgment, at a particular point in time, about inherently uncertain future outcomes and events or conditions.
Off-Balance Sheet Arrangements As of December 31, 2024, we have not entered into any off-balance sheet arrangements. 82 Critical Accounting Policies Critical Accounting Policies and Estimates We periodically review our financial reporting and disclosure practices and accounting policies to ensure that they provide accurate and transparent information relative to the current economic and business environment.
Critical Accounting Policies Critical Accounting Policies and Estimates We periodically review our financial reporting and disclosure practices and accounting policies to ensure that they provide accurate and transparent information relative to the current economic and business environment. As part of this process, we have reviewed our selection, application and communication of critical accounting policies and financial disclosures.
The Company looks into opportunities across all therapeutics areas where an unmet need exists for improved patient safety and efficacy.
The Company looks into opportunities across all therapeutics areas where an unmet need exists for improved patient safety and efficacy. The Company is opportunistically exploring to expand its drug development pipeline through qualified and accretive acquisitions and partnerships.
The Company accounts for forfeitures as they occur. All stock-based compensation costs are recorded in the statements of operations and comprehensive loss based upon the underlying employees or non-employee's roles within the Company. Updated share information As of December 31, 2024, we had 11,816,721 Common Shares issued and outstanding.
The Company accounts for forfeitures as they occur. All stock-based compensation costs are recorded in the statements of operations and comprehensive loss based upon the underlying employees or non-employee's roles within the Company. Warrants The Company records warrants based on the estimated grant-date fair value of the warrants.
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 CMC, stability and sterility data. On July 31, 2024, the FDA responded to the latest submission and requested certain additional information and clarification.
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 CMC, stability and sterility data.
Finance (income) expense, net Finance income, net, for the year ended December 31, 2024, was $25,386 compared to a net finance expense of $584,820 for the year ended December 31, 2023.
Other income (expense) Other income (expense) for the year ended December 31, 2025, was an expense of $1,085,059 compared to an income of $25,386 for the year ended December 31, 2024.
On March 10, 2025, the Company closed the Regulation A Offering of 1,490,000 Regulation A Offering Units, with each Regulation A Offering Units consisting of one common share and one warrant to purchase one common share at the price of $2.80 per Regulation A Offering Unit. Total gross proceeds from the Regulation A Offering were $4,172,000.
June 2025 Public Offering 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").
In addition, the underwriters exercised an option to purchase 145,500 warrants (the "Overallotment Warrants") at a price of $0.01 per warrant. 78 Total gross proceeds from the IPO were $4,002,705, including the proceeds from the Overallotment Warrants. The Company incurred total issuance costs of $2,128,014, including underwriter fees, and legal and other professional fees incurred directly related to the issuance.
In addition, the underwriters exercised an option to purchase 145,500 Public Warrants (the "Overallotment Warrants") at a price of $0.01 per warrant. Total gross proceeds from our initial public offering were $4.0 million, including the proceeds from the Overallotment Warrants.
R&D expenses increased by $3,334,280 or 1722% for the year ended December 31, 2024, compared to the equivalent periods in the prior year. This increase is primarily due to costs incurred related to SKNJCT-003 and $308,828 of stock-based compensation recognized within R&D expenses for the year ended December 31, 2024 (2023 - $0).
R&D expenses increased by $4,193,650 or 118.9% for the year ended December 31, 2025, compared to the equivalent periods in the prior year. This increase is primarily due to costs incurred related to SKNJCT-003, SKNJCT-004 and Teverelix, which had increased clinical trial activity in the current year.
Finance income for the year ended December 31, 2024, is primarily related to interest income earned on short-term money market investments of $104,411, offset by interest expense of $79,025 on convertible notes.
Other income for the year ended December 31, 2024, is primarily related to interest income earned on short-term money market investments of $104,411, offset by interest expense of $79,025 on convertible notes. 75 Liquidity and Capital Resources We are a clinical stage development company, and we currently do not earn any revenues from our drug development programs and are therefore considered to be in the R&D stage.
The financial statements and this MD&A do not include any adjustments to the amounts and classification of assets and liabilities that would be necessary should the Company be unable to continue as a going concern. Such adjustments could be material.
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. The Company is subject to risks associated with any specialty biotechnology company that has substantial expenditures for research and development.
Cash flows For the year ended December 31 2024 2023 $ $ Cash used in operating activities (10,247,231 ) (4,158,264 ) Cash provided by financing activities 12,692,216 5,609,950 Net change in cash during the year 2,444,985 1,451,686 Cash, beginning of the year 1,719,338 267,652 Cash, end of the year 4,164,323 1,719,338 Cash flows used in operating activities Cash flows used in operating activities for the year ended December 31, 2024 were $10,247,231 compared to cash flows used in operating activities of $4,158,264 for the year ended December 31, 2023.
During the year ended December 31, 2025, $4,430,833 of the gross proceeds were held back to partially repay the Company's outstanding debenture and interest to Yorkville. 77 Cash flows For the year ended December 31 2025 2024 $ $ Cash used in operating activities (22,776,769 ) (10,247,231 ) Cash provided by financing activities 31,939,785 12,692,216 Cash used in investing activities (4,619,152 ) - Foreign currency effect on cash and cash equivalents (2,969 ) - Net change in cash during the year 4,540,895 2,444,985 Cash, beginning of the year 4,164,323 1,719,338 Cash, end of the year 8,705,218 4,164,323 Cash flows used in operating activities Cash flows used in operating activities for the year ended December 31, 2025 were $22,776,769 compared to cash flows used in operating activities of $10,247,231 for the year ended December 31, 2024.
Upfront costs, such as costs associated with setting up clinical trial sites for participation in the trials, are expensed immediately once incurred as research and development expenses. Stock-based compensation The Company expenses stock-based compensation to employees and non-employees over the requisite service period based on the estimated grant-date fair value of the awards.
Upfront costs, such as costs associated with setting up clinical trial sites for participation in the trials, are expensed immediately once incurred as research and development expenses. 79 Fair Value Measurements Our recurring fair value measurements primarily include cash and cash equivalents and Initial Debenture, for which we elected the fair value option.
Liquidity and Capital Resources We are a clinical stage development company and we currently do not earn any revenues from our preclinical programs and are therefore considered to be in the R&D stage. As required, the Company will continue to finance its operations through the sale of equity or pursue non-dilutive funding sources available to the Company in the future.
As required, the Company will continue to finance its operations through the sale of equity or pursue non-dilutive funding sources available to the Company in the future. The continuation of our R&D activities is dependent on our ability to obtain financing.
The increase is primarily due to increased proceeds from the issuance of convertible notes and proceeds from the issuance of common shares during the year ended December 31, 2024, compared to proceeds from concurrent financing during the year ended December 31, 2023. Contractual Obligations We have no significant contractual arrangements other than those noted in our financial statements.
The increase is primarily due to increased proceeds from issuance of common shares in equity offerings and under SEPA, issuance of debentures and exercise of warrants and stock options during the year ended December 31, 2025, compared to proceeds from our initial public offering, issuance of convertible notes and issuance of common shares during the year ended December 31, 2024.
Other important accounting policies and estimates made by management are the assumptions used in determining the valuation of stock-based compensation. Research and development All research and development costs are expensed as incurred.
Please see the "Liquidity and Capital Resources" section in this document for a discussion of the factors considered by management in arriving at its assessment. 78 Other important accounting policies and estimates made by management are the assumptions used in determining the valuation of stock-based compensation.
The Company is actively exploring to expand its drug development pipeline through qualified and accretive acquisitions and partnerships. 77 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").
The Company has two wholly owned subsidiaries, Medicus Pharma Inc., a company incorporated in the state of Delaware on October 12, 2023, and SkinJect. The Company also has one non-wholly owned subsidiary, Antev, of which it owns 98.6% of the issued and outstanding shares.
For the year ended December 31, 2024, cash used in operating activities was $10,247,231 compared to $4,158,264 for the equivalent period in the prior year.
For the year ended December 31, 2025, cash used in operating activities was $22,776,769 compared to $10,247,231 for the equivalent period in the prior year. As of December 31, 2025, the Company has an accumulated deficit of $64,348,118 (December 31, 2024 - $28,903,903) and net loss of $35,444,361 for the year ended December 31, 2025 (2024 - $11,155,516).
Each unit consisted of one common share of the Company and one warrant to purchase one common share. The warrants have an exercise price of $2.80 per share and will expire five years from the date of issuance. Recent Accounting Pronouncements See Note 2 to our consolidated financial statements.
Each unit consisted of one common share of the Company and one June 2030 Warrant. The June 2030 Warrants have an exercise price of $3.10 per share and will expire June 2, 2030. As of December 31, 2025, no June 2030 Warrants have been exercised.
It is expected that negative cash flow from operations will continue until such time, if ever, that we receive regulatory approval to commercialize any of our products under development and/or we receive royalty or milestone revenue from any such products that exceeds our expenses. 81 Standby Equity Purchase Agreement The Company has entered into a Standby Equity Purchase Agreement dated February 10, 2025 (the "SEPA") with YA II PN, LTD (the "Investor"), an investment fund managed by Yorkville Advisors Global, LP.
Standby Equity Purchase Agreement 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.
The study was never resumed, and it was ultimately closed without further enrollment. There were no adverse events reported in the enrolled subjects. In January 2024, the Company submitted the clinical design for a randomized, double-blinded, placebo-controlled ("P-MNA"), multi-center study ("SKNJCT-003") enrolling up to 60 subjects presenting with nodular type BCC of the skin.
There were no adverse events reported in the enrolled subjects. 71 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) in patients with nodular type of basal cell carcinoma (nBCC).
There is an expected increase in general and administrative expenses associated with being a public company, including costs related to accounting, audit, legal, regulatory, and tax-related services associated with maintaining compliance with applicable securities law requirements; additional director and officer insurance costs; and investor and public relations costs.
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.
Results of Operations The following table outlines our statements of loss and comprehensive loss for the years ended December 31, 2024 and 2023: Years ended December 31, 2024 2023 $ $ General and administrative 7,653,116 4,536,367 Research and development 3,527,786 193,578 Total operating expenses 11,180,902 4,729,945 Loss from operations (11,180,902 ) (4,729,945 ) Finance (income) expense, net (25,386 ) 584,820 Net loss and comprehensive loss (11,155,516 ) (5,314,765 ) Net loss per common share (basic and diluted) (1.16 ) (1.53 ) General and administrative General and administrative expenses for the years ended December 31, 2024 and 2023 are comprised of: Years ended December 31, 2024 2023 $ $ Professional fees 1,910,801 735,234 Consulting fees 1,917,573 957,967 Salaries, wages and benefits 1,445,812 143,284 General office, insurance and administration expenditures 1,150,054 432,204 Business development and investor relations 824,585 97,513 Stock-based compensation 404,291 98,585 Listing fees - 2,071,580 7,653,116 4,536,367 Professional fees increased by $1,175,567 or 160% for the year ended December 31, 2024, compared to the equivalent period in the prior year.
Results of Operations The following table outlines our statements of loss and comprehensive loss for the years ended December 31, 2025 and 2024: Years Ended December 31, 2025 2024 Operating expenses: General and administrative $ 17,920,391 $ 7,653,116 Research and development 7,721,436 3,527,786 In-process research and development (IPR&D) - Teverelix 8,717,475 - Total operating expenses 34,359,302 11,180,902 74 Loss from operations (34,359,302 ) (11,180,902 ) Other income (expense) Interest income (expense) (197,382 ) 25,386 Loss on SEPA settlements (278,854 ) - Change in fair value of debentures (583,823 ) - Loss on extinguishment of debentures (25,000 ) - Total other income (expense) (1,085,059 ) 25,386 Net loss for the year (35,444,361 ) (11,155,516 ) Net loss per common share (basic and diluted) (2.74 ) (1.16 ) General and administrative General and administrative expenses increased by 10,267,275 or 134.2% for the year ended December 31, 2025, compared to the equivalent periods in the prior year.
In addition, there were 1,185,000 Common Shares issuable upon the exercise of outstanding stock options and 1,115,500 Common Shares issuable upon the exercise of warrants. 83 On March 10, 2025, the Company closed the Regulation A Offering of $4.2 million. The Company issued 1,490,000 units at a price of $2.80 per unit.
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.
Removed
Company Overview The Company is a clinical stage, multi-strategy holding company focused on investing in and accelerating novel life sciences and bio-technology companies through FDA approved clinical trials. Utilizing a thesis driven collaborative process, the Company attempts to acquire and advance clinical stage assets through clinical development and commercialization.
Added
This discussion should be read in conjunction with the Company's audited consolidated financial statements for the years ended December 31, 2025 and 2024. Company Overview The Company is a clinical stage, multi-strategy biotech/life sciences company focused on investing in and accelerating clinical development programs of novel and potentially disruptive therapeutic assets.
Removed
The Company has responded to the FDA on August 2, 2024. On August 13, 2024, the Company commenced activating its clinical trial sites and had enrolled over 25% of the 60 expected patients by December 2024.
Added
The study was never resumed, and it was ultimately closed without further enrollment.
Removed
The aggregate gross proceeds to the Company from the Offering were $4,172,000.
Added
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. The SKNJCT-003 Phase 2 clinical study is currently underway in nine clinical sites across United States.
Removed
The increase was primarily due to increases in legal and accounting fees related to the Company's operations. Professional fees include fees incurred for legal and accounting services that fluctuate from period to period based on the nature of the transactions the Company undertakes.
Added
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.
Removed
The primary reason for the increase is due to increased business activity in the current year compared to the prior year when the Company was focused on completing the RTO transaction. 79 Consulting fees increased by $959,606 or 100% for the year ended December 31, 2024, compared to the equivalent period in the prior year.
Added
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 has successfully completed enrolment of 90 patients in the United States.
Removed
Consulting fees include fees paid to individuals and professional firms who provide advisory services to the Company and fluctuate from period to period based on the nature of the transactions the Company undertakes.
Added
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.
Removed
The primary reason for the increase is due to increased business activity in the current year compared to the prior year when the Company was focused on completing the RTO. Salaries, wages and benefits increased by $1,302,528 or 909% for the year ended December 31, 2024, compared to the equivalent period in the prior year.
Added
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.
Removed
The increase was primarily due to the Company not having employees throughout the majority of the equivalent period in the prior year. General office, insurance and administration expenditures increased by $717,850 or 166% for the year ended December 31, 2024, compared to the equivalent period in the prior year.
Added
In October 2025, the Company announced the enrollment of the first patient in its SKNJCT-004 Phase 2 clinical study.
Removed
The increase was primarily due to the Company now incurring more significant insurance related expenses and general office related expenditures in support of expanded operations. Business development and investor relations expenses increased by $727,072 or 746% for the year ended December 31, 2024, compared to the equivalent period in the prior year.
Added
In June 2025, the Company entered into a definitive agreement to acquire Antev Limited, 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.
Removed
Business development and investor relations expenses for the year ended December 31, 2024, were primarily incurred as a result of the Company becoming a listed public entity after the RTO and getting listed on the Nasdaq. Stock-based compensation increased by $305,706 or 310% for the year ended December 31, 2024, compared to the equivalent period in the prior year.
Added
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. In July 2025, the Company submitted a comprehensive package to the FDA seeking a Type C meeting.
Removed
Stock-based compensation changes based on the variability in the number of options granted, vesting periods of the options and the grant date fair value. During the year ended December 31, 2024, the stock-based compensation expense relates to the vesting of share options granted during the year.
Added
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.
Removed
On June 25, 2024, our board of directors approved the acceleration of vesting for all outstanding share options resulting in the Company recognizing the remaining expense for all share options outstanding and unvested as of that date. Listing expenses were $nil for the year ended December 31, 2024, and $2,071,580 for the year ended December 31, 2023.
Added
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.
Removed
Listing expenses were incurred to complete the RTO transaction and include the cost related to the assumed liabilities of RBx Capital, LP.
Added
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 basal cell carcinoma ("BCC") of the skin.
Removed
As of March 20, 2025, the Company has commenced activating its clinical trial sites and has randomized more than 50% of the 60 patients expected to be enrolled in the study.
Added
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.
Removed
Finance expense for the year ended December 31, 2023 is primarily related to interest and accretion expense on convertible notes of $823,337 and dividend expense of $431,586, partially offset by a gain on adjustment to the fair value of the convertible promissory notes of $670,103.
Added
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. 72 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, has successfully completed enrolment of ninety (90) patients in the United States.
Removed
The continuation of our R&D activities is dependent on our ability to obtain financing.
Added
On December 22, 2025, the Company announced that it has 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.
Removed
As of December 31, 2024, the Company had cash and cash equivalents of $4,164,323 compared to cash and cash equivalents of $1,719,338 as of December 31, 2023.
Added
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. As of December 31, 2025, 129,905 Warrants issued as part of the IPO have been exercised for cash for proceeds to the Company of $602,756 during the year ended December 31, 2025.
Removed
During the year ended December 31, 2024, the Company received $5,172,500 of proceeds from the issuance of convertible notes, $5,470,000 net proceeds from the issuance of common shares in a non-brokered private placement and $1,784,691 net proceeds from the issuance of common shares related to the Nasdaq listing.
Added
As of December 31, 2025, 1,473,800 of the 1,490,000 Regulation A Warrants have been exercised for cash, for proceeds to the Company of $4,126,639 during the year ended December 31, 2025. Debentures On May 2, 2025, the Company entered into a securities purchase agreement with YA II PN, Ltd.
Removed
As of December 31, 2024, the Company has an accumulated deficit of $28,903,903 (December 31, 2023 - $17,698,387) and net loss and comprehensive loss of $11,155,516 for the year ended December 31, 2024 (2023 - $5,314,765). The Company has a working capital surplus of $3,072,078 as of December 31, 2024 (December 31, 2023 - $1,111,448).
Added
("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.

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