On March 9, 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 additional context regarding the recently reported topline dataset from the Phase 2 SKNJCT-003 study evaluating SkinJect microneedle delivery of D-MNA and P-MNA for basal cell carcinoma (BCC).

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The dataset demonstrated 73% clinical clearance and 40% histological clearance in the 200-µg treatment cohort at Day 57, representing the strongest treatment response observed in the study.

We believe that these findings are particularly notable given the device-based mechanism of SkinJect, where microneedle delivery itself may produce biological activity that can contribute to responses observed even in placebo active arm (P-MNA), that was not tip-loaded with the chemotherapeutic agent.

Active placebo arms are not uncommon in device-drug combination trials and can be an acceptable regulatory data point.

The study results demonstrate clear separation in clinical response between the D-MNA treatment arm (73%) and P-MNA treatment arm (38%) in the 200-µg cohort, supporting the continued development of SkinJect as a potential non-surgical treatment option for patients with basal cell carcinoma.

The Company believes the dataset represents decision-grade evidence supporting advancement of the SkinJect program toward regulatory discussions and potential strategic partnerships.

Interpreting Clinical and Histological Endpoints

The SKNJCT-003 study evaluated two complementary efficacy endpoints:

• Clinical clearance — visual disappearance of the treated lesion
• Histological clearance — absence of tumor cells on excisional biopsy

The 200-µg treatment cohort demonstrated the strongest efficacy signal, achieving 73% clinical clearance and 40% histological clearance at Day 57. Taken together, the results suggest that a meaningful proportion of treated lesions achieved both visual and histological clearance, supporting the therapeutic potential of the SkinJect platform.

Interpreting Biological Activity in the Placebo Active Arm (P-MNA) Cohort:

The biological activity observed in the P-MNA is consistent with mechanisms well recognized in intratumoral device therapies and microneedle-based delivery systems, and is consistent with what the company had observed in the SKNJCT-001 Phase 1 safety and tolerability study in March of 2021, and the positively trending interim analysis of SKNJCT-003 in March of 2023 which demonstrated more than sixty (60) percent of clinical clearance.

Microneedle insertion into tumor tissue produces localized micro-injury that can trigger and amplify several biological processes, including:

• mechanical disruption of tumor architecture
• activation of wound-healing pathways
• localized immune signaling

Basal cell carcinoma is known to be a highly immunogenic tumor, and these localized biological responses can contribute to tumor regression even in the absence of an active therapeutic agent.

These mechanisms have been described in dermatologic oncology literature and reflect the inherent biological activity of microneedle-based delivery platforms.

Microneedle-based tumor disruption is increasingly recognized as a biologically active delivery platform, and the therapeutic contribution of the active drug should be interpreted on top of this device-mediated biological effect.

Importantly, the study demonstrated clear separation between the P-MNA cohort and the 200-µg treatment cohort at Day 57, where the active treatment group achieved 73% clinical clearance compared with 38% in P-MNA, supporting the additional therapeutic contribution of the drug delivered through the SkinJect microneedle system.

The Company believes that the dataset should be interpreted in the context of both:

Biologic activity from the microneedle delivery platform
Additional drug-related therapeutic effect
Potential Clinical Impact

Basal cell carcinoma is the most common cancer worldwide, with millions of lesions treated each year.

The 73% clinical clearance observed in the 200-µg treatment cohort suggests that approximately three out of four treated lesions may achieve visual tumor clearance, potentially allowing many patients to avoid immediate surgical intervention.

In clinical practice, lesions that achieve visual clearance are often monitored through routine dermatologic follow-up, reserving surgical procedures for lesions that recur or persist.

If confirmed in future studies, this approach could provide dermatologists with a minimally invasive treatment option that may reduce the need for Mohs surgery, the current surgical standard for many basal cell carcinomas.

The treatment approach may be particularly relevant for patients with Gorlin Syndrome, a rare genetic condition in which individuals may develop dozens or hundreds of basal cell carcinomas throughout their lifetime. For these patients, repeated surgical procedures can be extremely burdensome, impractical and potentially disfiguring; a non-invasive treatment could be transformative.

Dataset Supports Next Development Milestones

Based on the available data, the Company considers the current dataset to be decision-grade and supportive of the next phase of development. The Company intends to use these results to advance regulatory discussions with the Food and Drug Administration (the "FDA") and to accelerate partnering discussions, as further elaborated on below.

Advance regulatory discussions with the FDA

The Company plans to proceed toward an End-of-Phase-2 meeting with the FDA to determine the optimal registrational development pathway, where the clinical development strategy may include:

• continued evaluation of the 200-µg dose
• potential optimization of patch application duration
• evaluation of additional treatment sessions
• potential refinement of treatment intervals

Accelerate partnering discussions

The dataset also provides a foundation for ongoing discussions with potential strategic partners, particularly companies active in dermatology and oncology.

Management Commentary

Dr. Raza Bokhari, Executive Chairman and CEO of Medicus, commented:

"We believe the SKNJCT-003 dataset reinforces the premise of SkinJect as a potential new treatment modality for basal cell carcinoma. The separation observed in the 200-µg treatment cohort, combined with the known biological activity of microneedle-based delivery systems, provides a strong foundation for advancing the program toward regulatory discussions and potential strategic partnerships.

The 73% clinical clearance observed in the 200-µg treatment cohort suggests that approximately three out of four treated lesions may achieve visual tumor clearance, potentially allowing many patients to avoid immediate surgical intervention."

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 9, 2026, View Source [SID1234663391])

On March 9, 2026 Actuate Therapeutics, Inc. (NASDAQ: ACTU) ("Actuate" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), reported the launch of an expanded research initiative evaluating combinations of its clinical-stage GSK-3β inhibitor elraglusib with emerging RAS-targeted therapies.

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Despite recent advances in RAS-targeted therapies, adaptive resistance mechanisms and pathway reactivation remain some of the key barriers to achieving durable responses in patients (Dilly et al., Cancer Discov 2024).

Based on the mechanisms of action, GSK-3 inhibition may represent a critical complementary strategy capable of enhancing RAS-targeted therapies by suppressing downstream survival signaling and resistance pathways, including

NF-κB–mediated survival signaling
MYC-driven transcriptional programs
metabolic adaptation and oxidative stress buffering
tumor microenvironment immune suppression
In addition, RAS-mutant tumors — particularly pancreatic cancer — are widely considered immunologically resistant. Preclinical research suggests that GSK-3β inhibition may enhance antigen presentation, activate T cells and NK cells, and reduce exhausted T-cells. By simultaneously targeting tumor intrinsic survival pathways and modulating the tumor immune microenvironment, the combination of elraglusib and RAS inhibitors has the potential to create a multi-modal therapeutic strategy designed to overcome resistance and expand clinical benefit in RAS-driven cancers.

Expanding the Strategic Opportunity for Elraglusib

Elraglusib is a best-in-class, highly selective GSK-3β inhibitor with broad potential across multiple oncology indications, including pancreatic cancer, melanoma, colorectal cancer, and sarcoma. The investigational product has been administered to more than 500 patients and is currently being evaluated in a Phase 2 trial in metastatic pancreatic cancer (mPDAC).

The combination strategy is designed to simultaneously block proliferative signaling through RAS inhibition and disrupt tumor survival pathways via elraglusib’s GSK-3β inhibition, potentially enhancing apoptotic signaling beyond the threshold achieved with RAS inhibition alone.

The combination program is expected to include in-vitro studies of elraglusib with select RAS inhibitors using tumor models of RAS resistance, in-vivo tumor regression and survival studies, and translational biomarker analysis. Initial data from the program are expected in Q2 2026, with additional results in 2H26.

While next-generation RAS inhibitors are making meaningful progress, the emerging data suggest that combination strategies will be required to maximize clinical benefit (Long et al., Cancer Res 2026). By targeting GSK-3 – a central regulator of tumor survival – the Company believes that elraglusib has the potential to enhance depth and durability of RAS-targeted therapies. Actuate is advancing this work with leading academic collaborators and potential industry partners, further positioning elraglusib as a potential foundational component of next-generation treatment paradigms for RAS-driven cancers.

(Press release, Actuate Therapeutics, MAR 9, 2026, View Source [SID1234663390])

On March 9, 2026 Medidata, a Dassault Systèmes brand and leading provider of clinical trial solutions to the life sciences industry, reported a strategic expansion of its partnership with The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients. Through this partnership, Medidata AI Study Build technology will power Stemline’s oncology portfolio to initiate clinical trials faster to meet the urgent needs of people living with cancer. The announcement follows the milestone of Stemline launching its first oncology study entirely in-house, using the Medidata Data Experience.

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AI for Impact
By transitioning to unified, AI-driven workflows, Stemline is further modernizing the trial lifecycle from protocol to patient. AI Study Build allows Stemline to leverage a vast clinical data set of more than 38,000 trials to automate configurations — reducing the time between protocol finalization and trial startup from months to weeks with:

Rapid study startups: Accelerating the study builds at an unprecedented pace
Internal agility: Empowering Stemline to build and launch future oncology studies independently, powered by the Medidata Data Experience
Stronger oncology research at speed: Delivering high-quality data faster to meet the urgent requirements of research into different cancers

"Stemline is deepening its commitment to advancing oncology research by embracing our established AI foundation and latest AI Study Build capabilities," said Wayne Walker, senior vice president, Data Experience, Medidata. "Stemline’s commitment to adopting Medidata AI-powered technologies sets a high bar for how sponsors can independently harness a unified platform to accelerate the delivery of new therapies for patients. Together, we are setting a new standard for how oncology trials are built and executed."

"Innovation is at the core of our mission to bring transformational treatments to patients, and we recognize the impact of Medidata AI to further streamline our workflows," said Elcin Barker Ergun, CEO of the Menarini Group. "Our expanded partnership with Medidata supports our internal expertise, enabling us to advance crucial research and reflecting the urgency of our team in bringing new options to patients as quickly and safely as possible."

A Foundation of Trusted Collaboration
This expansion builds upon a 14-year relationship between the Menarini Group and Medidata. While the Menarini Group has long utilized the Medidata platform — including Medidata Rave EDC and Medidata eCOA — to manage the end-to-end cycle of its clinical studies, the move to Medidata AI Study Build marks a significant transition. By combining the Menarini Group’s clinical expertise with Medidata’s established AI and Data Experience leadership, Stemline is positioned to advance its oncology portfolio with unprecedented speed and independence.

(Press release, Medidata, MAR 9, 2026, View Source [SID1234663389])

On March 9, 2026 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, reported publication of efficacy and safety results from the PIK3CA wild-type ("WT") cohort of the Phase 3 VIKTORIA-1 clinical trial of gedatolisib, an investigational pan-PI3K/mTORC1/2 inhibitor, in the Journal of Clinical Oncology. The cohort consists of patients with hormone receptor positive ("HR+"), human epidermal growth factor receptor 2 negative ("HER2-") PIK3CA WT advanced breast cancer ("ABC"), following progression on or after treatment with a CDK4/6 inhibitor and an aromatase inhibitor.

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The publication is titled "VIKTORIA-1 Trial of Gedatolisib Plus Fulvestrant With or Without Palbociclib in Hormone Receptor-Positive/HER2-/PIK3CA Wild-Type Advanced Breast Cancer."

"VIKTORIA-1 is the first Phase 3 study to show a significant improvement in median progression-free survival with inhibition of the PI3K/AKT/mTOR pathway in patients with PIK3CA wild-type HR+/HER2- advanced breast cancer who previously received a CDK4/6 inhibitor," said Sara Hurvitz, MD, lead study author and Senior Vice President, Clinical Research Division, Fred Hutchinson Cancer Center, Smith Family Endowed Chair in Women’s Health, Professor and Head, Division of Hematology and Oncology, University of Washington, Department of Medicine.

In the PIK3CA WT cohort of the Phase 3 VIKTORIA-1 trial, median progression-free survival ("PFS") with the gedatolisib triplet was 9.3 months versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months (HR=0.24; 95% CI: 0.17-0.35; p<0.0001). The objective response rate ("ORR") of the gedatolisib triplet was 31.5% compared to 1% with fulvestrant and the median duration of response ("DOR") was 17.5 months. For the gedatolisib doublet, the median PFS was 7.4 months versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months (HR=0.33; 95% CI: 0.24-0.48; p<0.0001). The ORR of the gedatolisib doublet was 28.3% and the median DOR was 12.0 months. The median DOR was not determinable for fulvestrant because there was only one objective response.

The gedatolisib triplet and doublet were generally well tolerated in the trial with mostly low-grade treatment-related adverse events ("TRAEs"). The most common grade 3 TRAEs for the gedatolisib triplet, gedatolisib doublet, and fulvestrant groups included neutropenia (52.3%, 0%, and 0.8% of patients, respectively); stomatitis (19.2%, 12.3%, and 0%) rash (4.6%, 5.4%, and 0%); and hyperglycemia (2.3%, 2.3%, and 0%). The primary grade 4 TRAEs for the gedatolisib triplet and gedatolisib doublet groups were neutropenia (10.0% and 0.8%, respectively), leukopenia (0.8% in the gedatolisib triplet group), and pneumonitis (0.8% in gedatolisib doublet group). TRAEs led to the discontinuation of study treatment in 2.3% of patients in the gedatolisib triplet group, 3.1% in the gedatolisib doublet group, and 0% in the fulvestrant group.

"The efficacy data from the VIKTORIA-1 PIK3CA wild-type cohort represent an important addition to the clinical evidence in HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer," said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. "Importantly, these findings are potentially practice changing for patients with limited options."

The U.S. Food and Drug Administration has granted Priority Review of Celcuity’s New Drug Application for gedatolisib and assigned a Prescription Drug User Fee Act goal date of July 17, 2026.

About HR+/HER2- Breast Cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million breast cancer cases were diagnosed globally in 2022.1 While survival rates are high for those diagnosed with early breast cancer, approximately 30% of patients who are diagnosed with or who progress to metastatic disease are expected to live five years after their diagnosis.2 HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.2

Three interconnected signaling pathways, estrogen, cyclin D1-CDK4/6, and PI3K/AKT/mTOR (PAM), are primary oncogenic drivers of HR+, HER2- breast cancer.3 Therapies inhibiting these pathways are approved and used in various combinations for advanced breast cancer. Currently approved inhibitors of the PAM pathway for breast cancer target a single PAM pathway component, such as PI3Kα, AKT, or mTORC1.4,5,6,7 However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease.8 Optimizing the inhibition of the PAM pathway is an active area of focus for breast cancer research.

About the VIKTORIA-1 Phase 3 Trial

VIKTORIA-1 is a Phase 3 open-label, randomized clinical trial to evaluate the efficacy and safety of gedatolisib in combination with fulvestrant, with or without palbociclib, in adults with HR+/HER2- ABC whose disease progressed on or after prior CDK4/6 therapy in combination with an aromatase inhibitor. The clinical trial is fully enrolled. The trial enrolled subjects regardless of PIK3CA status while enabling separate evaluation of subjects according to their PIK3CA status. Subjects who met eligibility criteria and did not have confirmed PI3KCA mutations (WT) were randomly assigned (1:1:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant, gedatolisib and fulvestrant, or fulvestrant. Subjects who met eligibility criteria and had confirmed PI3KCA mutations (MT) were randomly assigned (3:3:1) to receive a regimen of either the gedatolisib triplet, alpelisib and fulvestrant, or the gedatolisib doublet.

About Gedatolisib

Gedatolisib is an investigational, multi-target PAM inhibitor that potently targets all four class I PI3K isoforms, mTORC1, and mTORC2 to induce comprehensive blockade of the PAM pathway.9,10,11 As a multi-target PAM inhibitor, gedatolisib’s mechanism of action is highly differentiated from currently approved single-target inhibitors of the PAM pathway.11 Inhibition of only a single PAM component gives tumors an escape mechanism through cross-activation of the uninhibited targets. Gedatolisib’s comprehensive PAM pathway inhibition ensures full suppression of PAM activity by eliminating adaptive resistance cross-activation that occurs with single-target inhibitors. Unlike single-target inhibitors of the PAM pathway, gedatolisib has demonstrated equal potency and comparable cytotoxicity in PIK3CA-mutant and wild-type breast tumor cells in nonclinical studies and early clinical data.

(Press release, Celcuity, MAR 9, 2026, View Source [SID1234663388])

On March 9, 2026 Calidi Biotherapeutics, Inc. (NYSE AMERICAN: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported the closing of its previously announced underwritten public offering and the exercise in full of the underwriters’ over-allotment option for gross proceeds of approximately $6.0 million, prior to deducting underwriting commissions and offering expenses.

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In connection with the offering, the Company sold 12,094,631 shares of common stock (or pre-funded warrants in lieu thereof) Series J warrants to purchase 12,094,631 shares of common stock, Series K warrants to purchase 12,094,631 shares of common stock, and Series L warrants to purchase 12,094,631 shares of common stock, including the full exercise of the underwriter’s option to purchase 1,575,000 shares of common stock and accompanying warrants..

Ladenburg Thalmann & Co. Inc. acted as sole book-running manager for the offering.

The securities described above were offered pursuant to a shelf registration statement on Form S-3 (File No. 333-284229), which was declared effective by the United States Securities and Exchange Commission ("SEC") on February 7, 2025 and the related registration statement filed under Rule 462(b) of the Securities Act of 1933, as amended, which became automatically effective upon filing. A final prospectus supplement was filed with the SEC and is available on the SEC’s website at View Source Electronic copies of the final prospectus may also be obtained by contacting Ladenburg Thalmann & Co. Inc., Prospectus Department, 640 Fifth Avenue, 4th Floor, New York, New York 10019 or by email at [email protected].

The Series J warrant has an initial exercise price of $0.50 per share, is exercisable upon issuance, and has a term expiring five years from issuance. The Series K warrant has an initial exercise price of $0.50 per share, is exercisable upon issuance, and has a term expiring one year from issuance. The Series L warrant has an initial exercise price of $0.50 per share, is exercisable upon issuance, and has a term expiring six months from issuance. The warrants issued in this offering each include a reset of the exercise price on two separate occasions: (i) on the forty-fifth (45th) calendar day following the date of issuance and (ii) the sixth (6th) trading day immediately following the date on which a reverse stock split is approved and deemed effective during the fiscal year ended December 31, 2026.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

(Press release, Calidi Biotherapeutics, MAR 9, 2026, View Source [SID1234663387])