On March 5, 2026 Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, reported topline results from its Phase 2 clinical study (SKNJCT-003) evaluating safety and efficacy of Doxorubicin Microneedle Array (D-MNA) to non-invasively treat basal cell carcinoma (BCC) of the skin.

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The Company believes the topline results are not only positive but decision-grade that should support an end of phase 2 (EOP2) meeting with the FDA in the first half of 2026 as well as accelerate partnering readiness.

SKNJCT-003 Clinical Trial Design and Topline Results:

The SKNJCT-003 clinical study was designed as a randomized, double-blind, placebo-controlled (P-MNA), multi-center study enrolling 90 patients presenting with nodular type BCC of the skin. The study evaluated the safety and efficacy of two dose levels of D-MNA compared to placebo control.

Participants were randomized 1:1:1 into three groups:

Placebo-controlled group receiving P-MNA
Low-dose group receiving 100μg of D-MNA
High-dose group receiving 200μg of D-MNA
The primary endpoint for treatment of BCC is a binary, multi-component endpoint defined as achieving both clinical and histological clearance (i.e. the proportion of patients demonstrating both clinical (visual) clearance and histological clearance (CR) at a prespecified post-treatment timepoint.

The prespecified post-treatment timepoints at the end of the study were:

Day 29 for 47 patients
Day 57 for 43 patients
The Topline results are tabulated below:

Dose # of
patients(n) Day 29 post-treatment # of
patients(n) Day 57 post-treatment
47 Clinical Clearance Histological Clearance (CR) 43 Clinical Clearance Histological Clearance (CR)
Placebo 15 33% 20% 16 38% 38%
100ug D-MNA 17 47% 24% 12 42% 33%
200ug D-MNA 15 40% 27% 15 73% 40%

The dataset demonstrates that clearance rates increased between Day 29 and Day 57, consistent with continued biological activity over time. The 200µg cohort demonstrated the highest observed activity at Day 57, achieving 73% Clinical Clearance and 40% Histological Clearance (CR).

"We are extremely encouraged by these topline results, which not only validate management’s scientific and investment thesis, but also provide what we consider to be decision-grade evidence of clinical activity, particularly at the 200-microgram dose level," said Dr. Raza Bokhari, Executive Chairman & CEO of Medicus.

"The observed increase in clearance rates at Day 57 in the higher-dose cohort reinforces the sustained biological activity of SkinJect and supports advancement into the next stage of development. Importantly, we believe this dataset strengthens our position in ongoing and prospective partnering discussions and may accelerate strategic engagement as we evaluate optimal pathways for value creation."

Clinical Study Report and Regulatory Pathway:

These results reflect the analysis of the primary and key secondary efficacy endpoints. Final compilation of the Clinical Study Report (CSR), including full safety analyses and procedural observations such as post-excisional biopsy site assessments, remains ongoing and is expected to be completed in Q2 2026. The Company does not anticipate material changes to the reported efficacy findings.

The SKNJCT-003 study was not powered for registrational endpoints and no conclusions regarding regulatory approval or the outcome of the planned EOP2 meeting with the FDA can be drawn at this time, there can be no assurance that SKNJCT-003 will be granted regulatory approval from the FDA.

Strategic Focus on Phase 2 De-Risking and Partnering

Medicus’ development strategy is to advance select programs through Phase 2 proof-of-concept and pursue licensing or strategic partnerships with established pharmaceutical companies for late-stage development and commercialization.

The Company continues to assemble decision-grade clinical and regulatory data packages across its portfolio to support this partnering-focused model.

(Press release, Skinject, MAR 5, 2026, View Source [SID1234663325])

On March 5, 2026 Aligos Therapeutics, Inc. (Nasdaq: ALGS, "Aligos"), a clinical stage biotechnology company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, reported recent business progress and financial results for the fourth quarter and full year 2025.

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"Our team has made tremendous progress recently in the global Phase 2 B-SUPREME study of pevifoscorvir sodium," stated Lawrence Blatt, Ph.D., M.B.A., Chairman, President, and Chief Executive Officer of Aligos Therapeutics. "With the completion of the planned enrollment in the HBeAg- cohort, we are continuing to enroll participants in the HBeAg+ cohort and look forward to the interim analyses in the first and second half of 2026. Additionally, the Phase 2 B-SUPREME study may demonstrate that pevifoscorvir sodium affects the three pillars of HBV disease pathogenesis: replication, integration, and maintenance of the viral reservoir. We are also excited to announce the advancement, in partnership with Xiamen Amoytop Biotech Co., Ltd. ("Amoytop"), of ALG-170675, a dual mechanism antisense oligonucleotide (ASO) into IND-enabling studies. Lastly, adding James Hassard as Executive Vice President, Chief Commercial Officer has allowed us to begin laying the groundwork for the future of our best-in-class programs."

Recent Business Progress

Pipeline Updates

Pevifoscorvir sodium: Potential first-/best-in-class small molecule CAM-E for chronic hepatitis B virus (HBV) infection

The Phase 2 B-SUPREME study (NCT06963710) of pevifoscorvir sodium in subjects with chronic HBV infection completed the planned enrollment of 60 HBeAg- participants in January 2026. HBeAg+ participants continue to enroll in the study.
The first protocol defined interim analysis includes approximately 60% (or 36) HBeAg- participants that complete 12 weeks of the treatment period, with this enrollment threshold reached in Q4 2025.
A second protocol defined interim analysis is planned when approximately 50% (or 55) HBeAg+ participants complete 24 weeks of the treatment period, with this enrollment threshold reached in January 2026.
Topline data for both the HBeAg- and HBeAg+ cohorts are expected in 2027.
96-weeks of dosing have been completed in the Phase 1 study (NCT04536337) with post-treatment data expected to be presented at upcoming scientific meetings.
ALG-170675: Potential best-in-class antisense oligonucleotide (ASO) for chronic hepatitis B virus (HBV) infection

Along with our partner Xiamen Amoytop Biotech Co., Ltd. (Amoytop), ALG-170675 was recently selected to proceed into IND-enabling studies. Current costs for development in China are being funded by Amoytop, who maintain rights in China, Taiwan, Hong Kong and Macau.
This next-generation ASO works via two mechanisms of action. It targets and destroys HBsAg mRNA and activates the immune response through TLR-8 agonism.
ALG-055009: Potential best-in-class small molecule THR-β for obesity, MASH

Recently presented in vivo data in diet induced obese (DIO) mice treated with semaglutide (SEMA), tirzepatide (TIRZEP), or a combination of ALG-055009 and SEMA or TIRZEP for 28 days demonstrated synergistic weight loss in the combination groups compared to monotherapy groups. SEMA monotherapy resulted in a maximum of 23.9 ±2.6% body weight loss, while the combination of SEMA and ALG-055009 had an additional 8.6% decrease for a maximum 33% body weight loss. The low and high doses of TIRZEP led to a maxima of 27.1 ±2.7% and 34.4 ±1.6% body weight loss, respectively. Combination of TIRZEP (low) or TIRZEP (high) with ALG-055009 induced an additional 11.7% and 5.8% decrease for a maximum of 39% and 40% body weight loss respectively.
Furthermore, the additional weight loss in the combination therapy of either incretin receptor agonist and ALG-055009 was mainly due to additional loss of fat mass, with no significant effect on lean mass or food consumption as compared to incretin receptor agonist monotherapy. The data suggest the potential for a significant benefit of adding ALG-055009 to an incretin receptor agonist therapy for weight loss, especially in combination with a low-dose of a potent incretin receptor agonist, such as tirzepatide.
Evaluation of a variety of options to fund continued development, including potential out-licensing is ongoing.
Business Updates

James Hassard was appointed Executive Vice President, Chief Commercial Officer to build the Company’s global commercial capabilities.
Financial Results for the Fourth Quarter and Full Year 2025

Cash, cash equivalents and investments totaled $77.8 million as of December 31, 2025, compared with $56.9 million as of December 31, 2024. Our cash, cash equivalents and investments are expected to provide sufficient funding of planned operations into the third quarter of 2026.

Net loss for the three months ended December 31, 2025 was $19.9 million or basic and diluted net loss per common share of $(1.91), compared to net loss of $82.2 million or basic and diluted net loss per common share of $(13.08) for the three months ended December 31, 2024.

Net loss for the year ended December 31, 2025 was $24.2 million or basic and diluted net loss per common share of $(2.45), compared to net loss of $131.2 million or basic and diluted net loss per common share of $(20.94) for the year ended December 31, 2024.

Research and development (R&D) expenses for the three months ended December 31, 2025 were $17.0 million, compared with $16.0 million for the same period of 2024. The increase was primarily due to an increase in third-party expenses for the pevifoscorvir sodium Phase 2 clinical trial. Total R&D stock-based compensation expense incurred for the three months ended December 31, 2025 was $0.7 million, compared with $1.0 million for the same period of 2024.

R&D expenses for the year ended December 31, 2025 were $69.5 million, compared with $70.3 million for the same period of 2024. The decrease was due to increased government funds received for the coronavirus program which offset related costs.

General and administrative (G&A) expenses for the three months ended December 31, 2025 were $4.9 million, compared with $5.2 million for the same period of 2024. The decrease in G&A expenses for this comparative period is primarily due to a decrease in legal and other related expenses. Total G&A stock-based compensation expense incurred for the three months ended December 31, 2025 was $0.6 million, compared with $0.7 million for the same period of 2024.

G&A expenses for the year ended December 31, 2024 were $20.7 million, compared with $22.8 million for the same period of 2024. The decrease in G&A expenses for this comparative period is primarily due to a decrease in third party expenses including legal expenses.

Interest and other income, net, for the three months ended December 31, 2025 was income of $0.8 million compared with income of $0.6 million for the same period in 2024.

Interest and other income, net, for the year ended December 31, 2025 was income of $3.9 million compared with income of $4.4 million for the same period of 2024.

Change in fair value of 2023 common warrants for the three months ended December 31, 2025, was income of $1.2 million compared with a loss of $62.1 million for the same period of 2024.

Change in fair value of common warrants for the year ended December 31, 2025, was income of $60.2 million compared with a loss of $46.1 million for the same period of 2024.

(Press release, Aligos Therapeutics, MAR 5, 2026, View Source [SID1234663291])

On March 5, 2026 SkylineDx reported the launch of the Guideline-Informed Risk Assessment Initiative, a clinical program designed to support surgeons and multidisciplinary teams in evaluating patients with T1 and T2 melanoma. The program aligns with the updated NCCN Guidelines, where it is stated that CP-GEP (Merlin CP-GEP¹) testing may be used in select patients with T1b ± T2a melanoma to support shared decision-making².

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Each year in the United States, approximately 20,000 patients are diagnosed with T1b melanoma and 15,000 with T2a disease³. Despite guideline recommendations to consider and/or offer SLNB in these populations, an estimated 50% of T1b patients and 25% of T2a patients do not undergo SLNB⁴. In some cases, this may be due to patient-related factors; in others, decisions may be influenced by clinicopathologic features alone or by results from commercially available gene expression profile tests (‘Alternative GEP’ assays) not recommended within current guideline direction.

Merlin CP-GEP is the only gene expression profile assay prospectively validated in a large, multi-center blinded trial (MERLIN_001) to assess metastatic potential and SLN positivity risk. In this prospective validation study, patients classified as high risk by Merlin CP-GEP demonstrated approximately a three-fold increased risk of SLN involvement compared to low-risk patients⁵.

The NCCN Guidelines also include language stating that "alternative GEP tests for SLNB risk prediction are not recommended outside of the context of a clinical study or trial based on current data" ³. This distinction positions CP-GEP (Merlin CP-GEP) as a molecular assay recognized by NCCN Guidelines that may be used in specific T-categories to support SLN metastatic risk assessment.

"Melanoma mortality is not confined to advanced stages. A significant proportion of deaths occur in patients initially diagnosed with stage I and II disease," said Dharminder Chahal, CEO of SkylineDx. "By incorporating biologic metastatic potential into SLNB discussions and follow-up strategies for patients with cutaneous melanoma, we can move toward more precise, guideline-aligned care."

The Guideline-Informed Risk Assessment Initiative will:

Support surgeons evaluating T1 and T2 melanoma patients where SLNB is being considered, declined, or has resulted in a negative test by integrating biologic metastatic risk assessment into clinical decision-making.
Empower patients with T1 and T2 melanoma to better understand their individualized risk of nodal metastasis through a guideline-recognized test, supporting more informed shared decision-making and surveillance planning.
Patient Impact

For patients diagnosed with melanoma, uncertainty regarding nodal involvement can significantly affect treatment decisions, anxiety levels, and long-term follow-up intensity. With access to a guideline-recognized test that integrates tumor biology into SLN risk assessment — and validated in a prospective, multi-center, blinded trial from top U.S. academic centers — patients and physicians can engage in more confident, personalized discussions about the potential benefit of SLNB and appropriate surveillance strategies. This initiative supports greater clarity and precision in early-stage melanoma care.

The Initiative will be formally introduced to the surgical oncology community at the Society of Surgical Oncology Annual Meeting, taking place March 5–7 in Phoenix, Arizona, where SkylineDx will share educational materials and clinical implementation resources.

For more information about the Guideline-Informed Risk Assessment Initiative and Merlin CP-GEP, please contact: [email protected]

About the Merlin CP-GEP

CP-GEP is a non-invasive prediction model for cutaneous melanoma patients and is the only commercially available GEP test that combines clinicopathologic (CP) variables with gene expression profiling (GEP) into a single integrated algorithm. In addition, it is the only GEP test that provides binary stratification of all patients into High or Low Risk for metastasis, allowing clinicians to assign patients to the appropriate surgical action categories as listed in evidence-based cancer treatment, prevention, and screening guidelines. The advanced CP-GEP model was developed by Mayo Clinic and SkylineDx and is the latest commercially launched GEP test, which has been clinically validated in multiple studies on a global basis. The test has been launched in the United States and Europe as Merlin. SkylineDx collaborates with diagnostic service providers globally to bring this test to market and increase patient access. More information (including references) may be obtained at www.merlinmelanomatest.com

(Press release, SkylineDx, MAR 5, 2026, View Source [SID1234663310])

On March 5, 2026 Amgen (NASDAQ:AMGN) reported it will present at the Leerink Partners 2026 Global Healthcare Conference at 9:20 a.m. ET on Wednesday, March 11, 2026. Peter Griffith, executive vice president and chief financial officer at Amgen, and Jasper van Grunsven, senior vice president of rare disease at Amgen, will participate in a fireside chat at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

(Press release, Amgen, MAR 5, 2026, View Source [SID1234663292])

On March 5, 2026 SimBioSys, an AI-driven precision medicine company revolutionizing how cancer is understood and treated, reported that compelling clinical data from its multi-institutional study has been selected for presentation at the Miami Breast Cancer Conference (MBCC), being held March 5–8, 2026 in Miami, FL.

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The abstract, titled "An AI Digital Twin Compares Favorably to Radiologists for Landmark Identification and Measurement in Early-Stage Breast Cancer: A Retrospective, Multi-Institution Clinical Study," will be presented as Poster #040 on Thursday, March 5, 2026. The study evaluates the accuracy of TumorSight Viz (v1.3), an AI-driven digital twin platform that generates patient-specific 3D representations from standard breast MRI to support anatomical assessment and surgical strategy.

"This body of clinical evidence represents an important milestone in validating how AI-generated digital twins can deliver reproducible and radiologist-comparable insight into tumor anatomy," said Stacey Stevens, President and CEO of SimBioSys. "These findings underscore our commitment to advancing tools that support greater precision, consistency, and confidence in preoperative assessment — ultimately helping multidisciplinary teams make more informed decisions in breast cancer care."

Key outcomes from the retrospective multi-institution analysis include:

AI performance comparable to expert radiologists — TumorSight Viz’s disease measurements fell within inter-reader variability for US-board certified, fellowship-trained breast radiologists.
High spatial concordance — TumorSight Viz achieved a 0.92 surface Dice score, indicating strong agreement between the AI’s tumor delineation and measurements confirmed by expert radiologists.
Consistent results across imaging environments — Performance remained stable regardless of MRI system manufacturer, field strength, tumor subtype, or clinical site.
Rapid quantitative output — TumorSight Viz produced landmark features and measurements in minutes per case following MRI upload.
These results highlight the potential for AI-enabled digital twin technology to provide objective, anatomy-specific insights that complement expert clinical interpretation — a critical need in surgical planning for early-stage breast cancer.

"Accurate visualization and quantitation of tumor extent are fundamental to surgical decision-making. Technologies that can reliably mirror radiologist assessments have the potential to improve clarity, reproducibility, and communication across care teams," added Barry Rosen, MD, FACS, Breast Surgical Oncologist and Chief Medical Officer of SimBioSys.

This study adds to a growing portfolio of clinical evidence supporting the utility of AI-driven quantitative imaging tools — reinforcing SimBioSys’ mission to accelerate adoption of data-driven decision support across breast cancer care.

(Press release, SimBioSys, MAR 5, 2026, View Source [SID1234663311])