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Medicus Pharma Advances Transformation into a Precision Oncology-Led Biotechnology Company

On September 8, 2026 Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a precision-guided biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutic assets, reported a strategic update highlighting its transformation into a precision oncology-led biotechnology company, anchored by the advancement of CD228V, a second-generation CD228-targeted antibody-drug conjugate ("ADC"), while pursuing capital-efficient strategic partnerships to advance clinical development opportunities across its SkinJect and Teverelix Programs.

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CD228V now represents the principal strategic priority for Medicus, with initial development concentrated on establishing clinical proof-of-concept in a carefully selected tumor population, supported by an integrated clinical and translational strategy. Based on the existing biological, translational and clinical foundation, melanoma represents a compelling initial development opportunity, particularly in patients with relapsed or refractory disease.

The addition of CD228V represents a paradigm shift in Medicus’ clinical development portfolio and establishes precision oncology as a central component of the Company’s strategy.

CD228V is a second-generation ADC targeting melanotransferrin/CD228 in solid tumors. The program is supported by an active U.S. Investigational New Drug (IND), a first-in-human Phase 1 clinical study (NCT06799533), and substantial prior scientific, translational, and clinical development.

The Company believes successful demonstration of clinical proof-of-concept in melanoma, supported by an integrated translational and biomarker strategy, could provide an important foundation for subsequent development in other CD228-expressing solid tumors.

At the same time, Medicus is sharpening the development strategies for its two other therapeutic programs.

For SkinJect, the Company believes the strongest risk-adjusted opportunity lies in Gorlin syndrome rather than broad sporadic/nodular Basal Cell Carcinoma (BCC) lesions. FDA has authorized initiation of SKNJCT-005, the Company’s NDA-enabling registrational Phase 2b study in patients with Gorlin syndrome presenting with multiple BCCs. Gorlin syndrome is a rare autosomal dominant disease in which patients can develop numerous BCC lesions throughout their lifetime, frequently requiring repeated surgical or other lesion-directed procedures.

The Company believes concentrating SkinJect development on Gorlin syndrome could provide several potential strategic advantages beyond the more broadly competitive sporadic BCC market, which could include approvals for Orphan Drug Designation ("ODD") and Rare Pediatric Disease ("RPD") designation by the FDA as well as favorable rare-disease-anchored net pricing.

For Teverelix, Medicus intends to prioritize the optimized approximately 126-patient Phase 2 acute urinary retention ("AUR") program and PRECISION-E2, the Phase 2a study in women with symptomatic endometriosis, while continuing to advance the scientific and strategic positioning of Teverelix in advanced prostate cancer ("APC") through potential partnerships.

The Company believes this focused portfolio strategy provides multiple opportunities for meaningful clinical and shareholder value creation while enabling the Company to concentrate capital on programs with the most compelling near-term risk-adjusted potential.

(Press release, Medicus Pharma, SEP 8, 2026, View Source [SID1234670653])

BriaCell’s Pivotal Phase 3 Metastatic Breast Cancer Study Expands to Leading Cancer Center

On September 8, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported that Memorial Sloan Kettering Cancer Center (MSK) has joined BriaCell’s ongoing pivotal Phase 3 study of Bria-IMT plus an immune checkpoint inhibitor in metastatic breast cancer (ClinicalTrials.gov identifier: NCT06072612).

BriaCell’s Phase 3 study now has more than 80 active clinical sites across 15 states, including Penn Medicine’s Abramson Cancer Center, Mayo Clinic, DHR Health Oncology Institute, Hematology Oncology Associates of Fredericksburg, Los Angeles Cancer Network, Manhattan Hematology/Oncology Associates, New York Cancer & Blood Specialists, Northwestern University, Smilow Cancer Hospital at Yale New Haven, Sylvester Comprehensive Cancer Center, Texas Oncology-Baylor Charles A. Sammons Cancer Center, and University of Arizona.

"We are pleased to welcome MSK as a clinical site in BriaCell’s Phase 3 study," stated Dr. William V. Williams, BriaCell’s President & CEO. "MSK is one of the world’s leading cancer centers, and its participation expands patient access to the Bria-IMT regimen as we continue advancing a potential new therapeutic approach for heavily pretreated patients."

"We are pleased that MSK is now enrolling patients in BriaCell’s pivotal Phase 3 study evaluating Bria-IMT for advanced breast cancer in patients with limited therapeutic options. We look forward to collaborating with BriaCell," commented Phaedon Zavras, MD, the MSK Breast Medical Oncologist and Assistant Attending Physician who is serving as principal investigator for the MSK study site.

BriaCell’s pivotal Phase 3 clinical study is evaluating BriaCell’s lead clinical candidate, Bria-IMT in combination with an immune check point inhibitor (CPI), compared with physician’s choice of treatment in advanced metastatic breast cancer (the Bria-ABC study).

The study’s primary endpoint is overall survival (OS). An interim analysis is planned after 144 deaths have occurred, comparing OS in patients treated with the Bria-IMT combination regimen versus those treated with physician’s choice. BriaCell recently received a positive recommendation from the independent Data Safety Monitoring Board (DSMB) to continue the Phase 3 Study in metastatic breast cancer. At ASCO (Free ASCO Whitepaper) 2026, BriaCell also announced positive Phase 2 survival data in a similar metastatic breast cancer patient population treated with the same Bria-IMT combination regimen. The Bria-IMT combination regimen has received FDA Fast Track designation.

For additional information on BriaCell’s pivotal Phase 3 study of Bria-IMT please visit ClinicalTrials.gov NCT06072612.

Memorial Sloan Kettering Cancer Center (MSK) has institutional financial interests related to BriaCell.

(Press release, BriaCell Therapeutics, SEP 8, 2026, View Source [SID1234670652])

Pyxis Oncology to Host Webcast to Present Updated Data from Phase 1 Monotherapy Study of Micvotabart Pelidotin (MICVO) in Second-Line and Beyond Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (2L+ R/M HNSCC)

On September 8, 2026 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, reported that it will host a live webcast on September 9, 2026 at 7:30 a.m. Eastern Time to present updated clinical data from its ongoing Phase 1 monotherapy study evaluating micvotabart pelidotin (MICVO) in patients with second-line and beyond (2L+) recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC).

The presentation will include the scientific rationale for Pyxis Oncology’s novel ADC, MICVO; implications of the evolving treatment landscape in R/M HNSCC; detailed analyses of patients treated at 5.4 mg/kg intravenously once every three weeks with a dose equivalent to or below a dose cap; updated efficacy and safety results from the expansion trial; and next steps in clinical development.

The event will feature Alan L. Ho, M.D., Ph.D., Chief, Head and Neck Oncology Service and Attending Medical Oncologist at Memorial Sloan Kettering Cancer Center, together with members of Pyxis Oncology’s management team.

To participate in the live event, please register using this link. An archived webcast will be available following the event on the Company’s website at, View Source

(Press release, Pyxis Oncology, SEP 8, 2026, View Source [SID1234670651])

ME Therapeutics Advances In Vivo CAR and Therapeutic mRNA STING Programs

On September 8, 2026 ME Therapeutics Holdings Inc. ("ME Therapeutics" or the "Company") (CSE: METX) (FSE: Q9T), a publicly listed biotechnology company developing novel cancer fighting drugs that reprogram and redirect immune cells to fight cancer, reported a comprehensive update on its in vivo CD19/CD22-targeted chimeric antigen receptor (CAR) program, therapeutic mRNA STING program, and ongoing corporate initiatives.

In Vivo CAR Program

ME Therapeutics has successfully advanced its in vivo CAR pipeline to yield two differentiated lead constructs, each engineered with a distinct approach to targeting both CD19 and CD22 to treat certain blood cancers and autoimmune diseases.

The dual-targeting approach provides a route to more effectively target cancer cells that may have lost CD19 expression to escape immune recognition. The first configuration utilizes a co-expression strategy featuring two separate CARs: one targeting CD19 and a second, dual-targeting construct directed at CD22. The second configuration is a single, tandem CAR that fuses a CD19-targeting single-chain variable fragment (scFv) directly to a CD22-targeting single-domain antibody (VHH).

The company is conducting head-to-head preclinical testing of these two configurations to evaluate their comparative expression and functional profiles. Data generated from this comparative analysis will inform the selection of a final candidate. Once selected, the candidate will be formulated into T cell-targeting lipid nanoparticles (LNPs) for effective in vivo mRNA delivery.

ME Therapeutics expects to finalize its candidate selection and advance into the LNP formulation phase in Q4 2026.

Therapeutic mRNA STING Program

ME Therapeutics has also made advancements in its therapeutic mRNA program targeting the scientifically validated STING (Stimulator of Interferon Genes) pathway.

The company has successfully progressed the development of a novel liver-detargeted STING mRNA formulation. This detargeted formulation is designed to restrict STING activation in the liver and focus expression more heavily within the tumor microenvironment. In vitro testing of this new sequence has demonstrated a significant decrease in STING protein expression in a human hepatocyte cell line whereas expression in non-hepatocyte cells remains relatively unchanged. Greater tumor specificity aims to increase safety and specificity by minimizing potential systemic side effects while driving a potent anti-cancer immune response. The next step will be to formulate this therapeutic mRNA into an LNP for in vivo testing.

Proposed NASDAQ Listing

On the corporate front, ME Therapeutics continues to execute its strategy with the goal of securing a listing on the NASDAQ exchange. The company is actively working with its U.S. counsel and is in the process of addressing the initial round of comments on its draft F-1 registration statement.

"We are highly encouraged by the rapid advancement of our in vivo CAR program and the successful engineering of these two sophisticated CD19/CD22-targeted constructs," said Salim Dhanji, PhD, CEO of ME Therapeutics. "By rigorously comparing a dual-CAR approach against a fused single-CAR design, we are working to ensure our final candidate possesses an optimal profile for target engagement. By targeting both CD19 and CD22 using clinically tested binders, we believe our approach is differentiated from our competitors. Furthermore, the progression of our liver-detargeted STING therapeutic mRNA program highlights our commitment to maximizing the safety and efficacy of our next-generation immunotherapies. Alongside our scientific milestones, our ongoing dialogue with the SEC regarding our draft F-1 statement represents progress forward in our pathway to a NASDAQ listing, which we anticipate will expand our investor base and support our long-term growth."

(Press release, ME Therapeutics, SEP 8, 2026, View Source [SID1234670649])

Pilatus Biosciences Strengthens Global Intellectual Property Position for Lead CD36-Targeted Immunometabolic Therapy

On September 8, 2026 Pilatus Biosciences, a biopharmaceutical company developing novel metabolic checkpoint immunotherapies for cancer, reported two intellectual property milestones for PLT012, its lead investigational anti-CD36 monoclonal antibody: receipt of a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for U.S. Patent Application No. 18/844,588 and completion of the acquisition of worldwide rights to the related patent family derived from PCT/US2023/063766.

These achievements followed the Company’s previously announced dosing of the first patient in the United States and completion of the associated development efforts. Together, these milestones give Pilatus direct ownership and control of the worldwide patent family, enabling the Company to manage its prosecution, maintain and enforce these patent rights as it advances the program in connection with potential future development, partnering and other strategic opportunities.

The patent family, titled "Anti-CD36 Antibodies and Uses Thereof," is derived from PCT/US2023/063766 and relates to anti-CD36 antibodies including PLT012 and their therapeutic applications. The patent family describes antibodies designed to bind to human CD36 with high affinity and inhibit CD36-mediated biological functions, including fatty acid transport and associated immune-regulatory effects.

"These developments mark an important step in strengthening the IP foundation for PLT012 as we continue to advance the program," said Raven Lin, Ph.D., Co-Founder and Chief Executive Officer, Pilatus Biosciences. "Following our first-patient-dosing milestone in the United States, we have consolidated ownership of the worldwide patent family supporting PLT012 and secured a Notice of Allowance for a key U.S. patent application. These milestones further strengthen our IP position around our lead program and our ability to protect and advance PLT012 through clinical development while pursuing future development and strategic opportunities."

PLT012 is designed to block CD36-mediated lipid uptake, a mechanism implicated in metabolic dysfunction and immune suppression within the tumor microenvironment ("TME"). By inhibiting this pathway, Pilatus aims to restore antitumor immune activity via TME reprogramming. These developments build on Pilatus’ expanding IP portfolio around CD36. In October 2025, the Company announced the grant of foundational patents in Europe and Australia from a separate patent family exclusively licensed to Pilatus from the Ludwig Institute for Cancer Research and the University of Lausanne, covering the modulation of regulatory T cells and inhibition of tumor growth through CD36 targeting. This exclusively licensed patent family, and the newly acquired worldwide patent family directly owned by Pilatus, provide complementary layers of IP protection around Pilatus’ CD36-targeted approach and PLT012 as the Company advances its broader metabolic checkpoint platform.

About PLT012

PLT012 is the lead investigational therapy from Pilatus Biosciences’ first-in-class CD36 metabolic checkpoint platform. The humanized IgG4 monoclonal antibody selectively blocks CD36, a key regulator of lipid metabolism, inflammation and tissue repair. PLT012 is currently being evaluated in an ongoing Phase 1 oncology clinical trial, where it has demonstrated early evidence of disease control together with a favorable safety profile. In preclinical studies, PLT012 has demonstrated disease-modifying activity across oncology, MASH and COPD, supporting Pilatus’ Pipeline-in-a-Product strategy to develop a single differentiated mechanism across multiple high-unmet-need indications.

(Press release, Pilatus Biosciences, SEP 8, 2026, View Source [SID1234670648])