Georgiamune and Menarini Group Enter Exclusive Global License and Collaboration Agreement for GIM-621, a First-in-Class Oral Immuno-Oncology Agent

• GIM-621 is a preclinical-stage, first-in-class oral small molecule immunotherapy with potential application across multiple solid tumors.
• Georgiamune to receive $45 million in upfront and near-term payments, as part of a total deal value of up to $1.1 billion, plus royalties.

FLORENCE, Italy and GAITHERSBURG, Md., Oct. 22, 2026 /PRNewswire/ -- 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, along with Georgiamune Inc., a clinical-stage biotechnology company discovering and developing first-in-class therapies that reprogram immune signaling pathways to treat cancer and autoimmune diseases, today announced an exclusive worldwide license and collaboration agreement for GIM-621.

GIM-621 is a preclinical-stage first-in-class oral small molecule immunotherapy with potential application across multiple solid tumors. It is one of multiple therapeutic candidates generated from Georgiamune's research into novel mechanisms governing immune activation, suppression and homeostasis.

Under the terms of the license and collaboration agreement, Stemline receives an exclusive, worldwide license to develop, manufacture and commercialize GIM-621. Georgiamune will receive $45 million in upfront and near-term payments. Georgiamune is also eligible for preclinical, development, regulatory and commercial milestone payments, for a total potential deal value of up to $1.1 billion, plus royalties.

"At Georgiamune, we are focused on uncovering novel mechanisms that control immune-cell function and translating that biology into first-in-class medicines across autoimmune disease and oncology," said Samir N. Khleif, M.D., Founder and Chief Executive Officer of Georgiamune. "GIM-621 is one of multiple programs to emerge from that work, alongside three programs already in clinical development across autoimmune disease and oncology. This agreement brings Menarini's global oncology development and commercial capabilities to GIM-621 while allowing Georgiamune to continue advancing a broad pipeline built on distinct immune mechanisms."

 "We are delighted to partner with Georgiamune, a company with deep expertise in immuno-oncology which has led to the discovery of GIM-621, a first-in-class oral immunotherapy with promise across multiple solid tumors," said Elcin Barker Ergun, CEO of the Menarini Group. "This program is a strong complement to our solid tumor portfolio, and our established oncology development and commercial capabilities position us well to accelerate its progress. We look forward to working closely with the Georgiamune team to unlock the full potential of this innovative approach to benefit patients with cancer."

About Georgiamune
Georgiamune is a clinical-stage biotechnology company discovering and developing first-in-class therapies designed to reprogram immune signaling pathways to treat cancer and autoimmune disease. The company's research focuses on novel mechanisms that govern T-cell activation, regulatory T-cell function and immune homeostasis. Georgiamune has three clinical-stage programs: GIM-407, an oral Treg activator in autoimmune disease; GIM-122, a dual-functioning antibody in oncology; and GIM-531, an oral Treg inhibitor in oncology. Georgiamune is also advancing a broader pipeline of preclinical candidates across oncology and autoimmune disease, including GIM-621. The company was founded by Dr. Samir N. Khleif based on discoveries from his laboratory into mechanisms that control immune responses. For more information, visit www.georgiamune.com.

About The Menarini Group
The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of $5.5 billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. With 18 production sites and 9 Research and Development centers, Menarini's products are available in 140 countries worldwide. For further information, please visit www.menarini.com.

About Stemline Therapeutics Inc.
Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical company focused on bringing transformational oncology treatments to patients. Stemline commercializes elacestrant, an oral endocrine therapy indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy, in the U.S., Europe, and other global regions. Stemline also commercializes tagraxofusp-erzs, a novel targeted therapy directed to CD123, for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic cancer, in the United States, Europe, and other global regions. In addition, Stemline commercializes selinexor, an XPO1 inhibitor for multiple myeloma, in Europe. The company is also conducting multiple label-expansion studies with elacestrant and tagraxofusp in breast and hematologic cancer indications, respectively, and has an extensive clinical pipeline of additional drug candidates in various stages of development for a host of solid and hematologic cancers.

SOURCE Menarini Industrie Farmaceutiche Riunite