The call will highlight new analysis from its Phase 2 SkinJect® study, including an overall response rate (ORR) of 80% in the 200µg cohort at Day 57, and outline the Company’s planning toward an agentic AI–enabled clinical development platform.
The Company believes these results position the 200µg cohort as the leading dose regimen in the study, demonstrating the highest activity observed to date with continued improvement through Day 57.
Conference Call Details
- Time: 11:30 a.m. ET
- Pre-registration: https://dpregister.com/sreg/10207261/10379bd1029
- Dial-in. (US/
Canada ): 833-890-6070 - Dial-in. (International): 412-504-9736
- Q&A Web Link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=DeCGoBHR
The Key Highlights to be presented at the conference call are:
Independent Clinical Perspective —
The call will feature
- Professor of Dermatology and Pathology,
Rutgers Robert Wood Johnson Medical School - Clinical Associate Professor of Dermatology,
Weill Cornell Medical College
He has authored over 200 peer-reviewed publications and has served as principal investigator in multiple dermatology clinical trials.
- The clinical significance of 73% clearance at Day 57 in the 200µg cohort
- A clear separation versus device-only active control, supporting incremental drug effect
- The role of:
- Microneedle-mediated tumor disruption
- Local immune activation and wound-healing pathways
Importantly,
- BCC is the most common cancer worldwide, with millions of new cases diagnosed annually in
the United States alone - Standard treatments such as Mohs surgery, while effective, are capacity constrained.
As a result, there is a significant treatment backlog, where patients may face delays or undergo procedures that may not be immediately necessary.
The observed ~73% clinical clearance suggests that approximately three out of four treated lesions may achieve visual resolution, which in clinical practice could allow many patients to defer or avoid immediate surgical intervention.
If confirmed in future studies, this approach may:
- Reduce procedural burden on healthcare systems
- Improve patient access to care
- Allow prioritization of surgical resources for higher-risk or refractory cases
He is also expected to reinforce that:
- The dataset is clinically meaningful
- Supports continued development and regulatory engagement
- May be impactful in Gorlin Syndrome and other high-burden populations
Phase 2 Data Deep Dive — 200µg Cohort (Day 57)
- 73% Clinical (visual) clearance
- 40% Histological complete response (CR)
80% Overall Response Rate (CR + partial response) with potential to exceed this level pending final Clinical Study Report (CSR)
Previously reported Topline results of the study, along with additional preliminary dataset representing partial response (PR) and over-all response rate (ORR) for each cohort, are tabulated which demonstrates that clearance rates increased between Day 29 and Day 57, consistent with continued biological activity over time.
Table 1. SKNJCT-003 Phase 2 topline Data by Treatment Arm
| Treatment Arm | (n) | Day 29 post-treatment | (n) | Day 57 post-treatment | ||||||
| 47 | CC | CR | PR* | ORR* | 43 | CC | CR | PR* | ORR* | |
| 200 µg D-MNA | 15 | 40% | 27% | 20% | 47% | 15 | 73% | 40% | 40% | 80% |
| C-MNA | 15 | 33% | 20% | 20% | 40% | 16 | 38% | 38% | 6% | 44% |
| 100 µg D-MNA | 17 | 47% | 24% | 29% | 53% | 12 | 42% | 33% | 42% | 75% |
*Preliminary -pending final CSR (Clinical Study Report)
C-MNA: Microneedle device-only control arm, D-MNA: Doxorubicin-loaded microneedle array n:number of patients, CC: Clinical Clearance, CR: Histological Clearance, PR: Partial Response, ORR: Overall Response Rate
The Company will also highlight:
- Continued improvement from Day 29 to Day 57, supporting a durable and evolving treatment effect
- Evidence of biological activity across responders and partial responders
CEO Strategic and Clinical Positioning — Dr.
Dr.
- That the Phase 2 study was a proof-of-concept study “exploratory” study primarily designed to evaluate clinical (visual) clearance, with the objective of addressing a large unmet need and helping relieve the treatment backlog in basal cell carcinoma.
- That refinement of histological clearance endpoints is expected to be a focus of registrational study design discussions at the planned End-of-Phase 2 (EOP2) meeting with the FDA
- The Company’s view that the dataset is decision-grade and supports regulatory and business partnership engagement
He is also expected to discuss:
- Optimization strategies focused on the 200µg dose
- Treatment duration and repeat dosing strategies
And position the broader opportunity:
- Addressing a large and underserved BCC patient population
- Positioning SkinJect as a minimally invasive alternative to surgery
- Expansion into Gorlin Syndrome and additional indications
Advancing Toward Agentic AI–Enabled Drug Development
The Company is expected to highlight its planning toward an Agentic AI–driven clinical development platform
Designed to:
- Optimize clinical trial design and protocol simulation
- Enable dynamic site selection and enrollment forecasting
- Improve patient stratification and dose optimization
- Increase capital efficiency and probability of success
Financial Position and Capital Strategy —
- Approximately
$31.9 million raised during 2025 $8.7 million in cash and cash equivalents at year-end 2025- Continued disciplined investment in clinical development
She is expected to emphasize alignment of capital strategy with key upcoming value inflection points, including:
- Regulatory engagement
- Clinical data maturation
- Strategic partnering opportunities
Position Entering a Catalyst-Rich 2026
The Company believes it is entering a catalyst-rich period, including:
- End-of-Phase 2 FDA meeting (SkinJect)
- Potential registrational pathway alignment
- Initiation of Phase 2b Teverelix study
- Expansion into women’s health (endometriosis)
- Advancement of AI-enabled development platform
- Ongoing strategic partnering discussions
For further information contact:
(610) 636-0184
cbonner@medicuspharma.com
(305) 615-9162
adjokovic@medicuspharma.com
About
Company’s key therapeutics assets are:
SkinJect™, a novel localized immuno-oncology precision product focused on non-melanoma skin diseases, especially basal cell carcinoma (BCC) and Gorlin Syndrome, a rare autosomal dominant disease also called nevoid BCC syndrome, collectively representing an
Teverelix®, a next generation GnRH antagonist is a first-in-market product for cardiovascular high-risk advanced prostate cancer patients and patients with acute urinary retention relapse (AURr) episodes due to enlarged prostate, collectively representing an
The Company is actively engaged in following collaborations:
Skinject™ Platform Expansion
In
The Company is exploring co-development of thermostable infectious disease vaccines combining HelixNano’s proprietary mRNA technology with the
Patient Access and Advocacy
In
In collaboration with the
In
Cautionary Notice on Forward-Looking Statements
Certain information in this news release constitutes "forward-looking information" under applicable securities laws. "Forward-looking information" is defined as disclosure regarding possible events, conditions or financial performance that is based on assumptions about future economic conditions and courses of action and includes, without limitation, statements regarding the Company’s ability to continue as a going concern, statements regarding the Company’s leadership and prospects, the collaboration with GSA including the potential benefits thereof for GSA, those suffering with Gorlin Syndrome and
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