Everolimus

Encouraging safety and preliminary efficacy analysis from the elacestrant and capivasertib Phase 1b regimen of the ELEVATE study will be presented.The efficacy data highlight how the combination of elacestrant and capivasertib has the potential to address key resistance mechanisms for patients with ER+/HER2- mBC, including ESR1 and PIK3CA co-existing mutations. The company will also share updates on its elacestrant clinical development program, underscoring its potential in both mBC combination settings and as a monotherapy in early breast cancer. FLORENCE, Italy and NEW YORK, May 28, 2026 (GLOBE NEWSWIRE) -- 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, will present safety and preliminary efficacy for the elacestrant and capivasertib combination arm of the Phase 1b/2 ELEVATE study in patients with estrogen receptor-positive (ER+), HER2-negative (HER2-) locally advanced or metastatic breast cancer (mBC). Additionally, various other trial-in-progress updates will be presented, underscoring elacestrant’s potential as an endocrine therapy (ET) backbone across the spectrum of breast cancer. These data will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The ELEVATE study was designed to evaluate the safety and efficacy of combination treatment options with elacestrant, to overcome different resistance mechanisms observed in ER+/HER2- mBC and improve patient outcomes, irrespective of ESR1 mutation status. The study is composed of six treatment regimens evaluating elacestrant in combination with CDK4/6 inhibitors (palbociclib, abemaciclib and ribociclib) and with inhibitors of the PI3K/AKT/mTOR pathway (everolimus, alpelisib and capivasertib). ELEVATE results reported at ASCO 2026 (abstract 1098) include safety and preliminary efficacy data from the phase 1b elacestrant (258-345 mg) plus capivasertib (320-400 mg) cohorts (n=31), which demonstrate preliminary median progression-free survival (mPFS) benefit in the recommended phase 2 dose (RP2D) cohort. The RP2D was determined in cohort 2 (n=9) to be elacestrant 345 mg plus capivasertib 320 mg BID (4 days on/3 days off). In RP2D response-evaluable patients, preliminary efficacy showed an 88.9% disease control rate (DCR), a 66.7% clinical benefit rate at 24 weeks (CBR24), and a 33.3% objective response rate (ORR). All patients with ORR had co-existing ESR1 and PIK3CA mutations. The median duration of response (mDOR) has not yet been reached. The preliminary mPFS was 11.3 months in the overall RP2D population, and 10.9 months in patients with co-existing ESR1 and PIK3CA mutations. Additionally, these initial results show that the combination is consistent with the known safety profiles of each targeted therapy plus standard of care endocrine therapy. “The combination of elacestrant plus capivasertib is designed to address an unmet need for patients with ER+/HER2- PI3K-pathway altered metastatic breast cancer, particularly when co-existing ESR1 and PIK3CA mutations are present.” said Sara Tolaney, MD, MPH, Chief of the Division of Breast Oncology, Dana-Farber Cancer Institute. “These encouraging preliminary data suggest the potential for extended clinical benefit with a manageable safety profile, as the combination regimen could simultaneously target ESR1 and PIK3CA mutations, potentially avoiding the need for sequential regimens that address each target individually.” “Building on the data we saw last year at SABCS, we continue to be encouraged by elacestrant’s potential clinical benefit observed across numerous combinations with different agents targeting ER+/HER2- metastatic breast cancer,” said Elcin Barker Ergun, CEO of the Menarini Group. “The breadth of our studies, including early breast cancer and various combinations for ER+/HER2- metastatic breast cancer, including with capivasertib, demonstrate our commitment to bringing potentially transformational therapies to cancer patients.” In addition, other elacestrant data will be presented at the ASCO congress. See below for a complete list of upcoming presentations: Presentation Title: Elacestrant in combination with capivasertib in patients with ER+/HER2- advanced breast cancer: Update from ELEVATE, a phase 1b/2 open-label, umbrella studyAbstract Number: 1098Presentation Date & Time: June 1, 2026; 1:30 – 4:30 PM CTLocation: Poster Board 212Presenting Author: Wassim McHayleh Presentation Title: ADELA: A double-blind, placebo-controlled, randomized phase 3 trial of elacestrant + everolimus versus elacestrant + placebo in ER+/HER2- advanced breast cancer patients with ESR1-mutated tumors progressing on endocrine therapy + CDK4/6i*#Abstract Number: TPS1154Presentation Date & Time: June 1, 2026; 1:30 – 4:30 PM CTLocation: Poster Board 262bPresenting Author: Antonio Llombart-Cussac Presentation Title: ELECTRA: An open-label, multicenter, phase 1b/2 study of elacestrant in combination with abemaciclib in patients with brain metastasis from ER+/HER2- breast cancerAbstract Number: TPS1155Presentation Date & Time: June 1, 2026; 1:30 – 4:30 PM CTLocation: Poster Board 263aPresenting Author: Nuhad Ibrahim Presentation Title: CAPELA: A phase II multicenter open-label randomized study of capecitabine in combination with elacestrant versus capecitabine alone in advanced estrogen receptor (ER)–positive breast cancer (TBCRC 070)*Abstract Number: TPS1156Presentation Date & Time: June 1, 2026; 1:30 – 4:30 PM CTLocation: Poster Board 263bPresenting Author: Kristina Fanucci Presentation Title: ELEGANT: Elacestrant versus standard endocrine therapy in women and men with node-positive, estrogen receptor-positive (ER+), HER2-negative (HER2-), early breast cancer with high risk of recurrence in a global, multicenter, randomized, open-label phase 3 studyAbstract Number: TPS1153Presentation Date & Time: June 1, 2026; 1:30 – 4:30 PM CTLocation: Poster Board 262aPresenting Author: Aditya Bardia *Denotes investigator sponsored research or collaborative research#The ADELA study is a pivotal study co-sponsored with MEDSIR About The Elacestrant Clinical Development ProgramElacestrant is also being investigated in several company-sponsored clinical trials in metastatic breast cancer disease, alone or in combination with other therapies. ELEVATE (NCT05563220) is a phase 1b/2 clinical trial evaluating the safety and efficacy of elacestrant combined with alpelisib, everolimus, capivasertib, palbociclib, ribociclib or abemaciclib. ELECTRA (NCT05386108) is an open-label phase 1b/2, multicenter study evaluating elacestrant in combination with abemaciclib in patients with ER+, HER2- breast cancer. The phase 2 portion evaluates this treatment regimen in patients with brain metastases. ELCIN (NCT05596409) is a phase 2 trial evaluating the efficacy of elacestrant in patients with ER+, HER2- advanced/metastatic breast cancer who received one or two prior hormonal therapies and no prior CDK4/6 inhibitors in the metastatic setting. ADELA (NCT06382948) is a phase 3 randomized, double-blinded trial evaluating elacestrant in combination with everolimus in patients with ER+, HER2- mBC with ESR1-mut tumors. ELEGANT (NCT06492616) is a phase 3 trial evaluating the effectiveness of elacestrant versus standard endocrine therapy in women and men with node-positive, ER+, HER2- early breast cancer with high risk of recurrence. Elacestrant is also being evaluated in additional investigator-led trials, in trials conducted in collaboration with other companies, in metastatic breast cancer as well as in early disease. About ORSERDU (elacestrant)U.S. Indication: ORSERDU (elacestrant), 345 mg tablets, is 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. Full prescribing information for the U.S. can be found at www.orserdu.com. Important Safety InformationWarning and Precautions Dyslipidemia: Hypercholesterolemia and hypertriglyceridemia occurred in patients taking ORSERDU at an incidence of 30% and 27%, respectively. The incidence of Grade 3 and 4 hypercholesterolemia and hypertriglyceridemia were 0.9% and 2.2%, respectively. Monitor lipid profile prior to starting and periodically while taking ORSERDU. Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action, ORSERDU can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ORSERDU and for 1 week after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ORSERDU and for 1 week after the final dose. Adverse Reactions Serious adverse reactions occurred in 12% of patients who received ORSERDU. Serious adverse reactions in >1% of patients who received ORSERDU were musculoskeletal pain (1.7%) and nausea (1.3%). Fatal adverse reactions occurred in 1.7% of patients who received ORSERDU, including cardiac arrest, septic shock, diverticulitis, and unknown cause (one patient each).The most common adverse reactions (>10%), including laboratory abnormalities, of ORSERDU were musculoskeletal pain (41%), nausea (35%), increased cholesterol (30%), increased AST (29%), increased triglycerides (27%), fatigue (26%), decreased hemoglobin (26%), vomiting (19%), increased ALT (17%), decreased sodium (16%), increased creatinine (16%), decreased appetite(15%), diarrhea(13%), headache (12%), constipation (12%), abdominal pain (11%), hot flush (11%), and dyspepsia (10%). Drug interactions Concomitant use with CYP3A4 Inducers and/or inhibitors: Avoid concomitant use of strong or moderate CYP3A4 inhibitors with ORSERDU. Avoid concomitant use of strong or moderate CYP3A4 inducers with ORSERDU. Use in specific populations Lactation: Advise lactating women to not breastfeed during treatment with ORSERDU and for 1 week after the last dose.Hepatic Impairment: Avoid use of ORSERDU in patients with severe hepatic impairment (Child-Pugh C). Reduce the dose of ORSERDU in patients with moderate hepatic impairment (Child-Pugh B).The safety and effectiveness of ORSERDU in pediatric patients have not been established. To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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. Media Contacts The Menarini GroupValeria Speroni CardiEmail: pressoffice@menarini.com Stemline Therapeutics, Inc.Cheya PopeEmail: media@menarinistemline.com

SAN DIEGO, Calif., May 28, 2026 (GLOBE NEWSWIRE) -- via IBN -- Sapu Nano and Oncotelic Therapeutics, Inc. (“Oncotelic” or the “Company”) today announced that Vuong Trieu, Chief Executive Officer, will present the Company’s Deciparticle™ nanomedicine platform at the BIO International Convention 2026 in San Diego, California. The presentation will focus on Oncotelic’s development of ultra-small nanomedicine formulations designed to enable intravenous administration of highly water-insoluble therapeutics that are otherwise difficult or impossible to formulate using conventional technologies. The Deciparticle™ platform is based on proprietary amphiphilic polymer systems capable of forming sub-20 nanometer particles for oncology and other therapeutic applications. The Company believes the platform may enable improved aqueous compatibility, reduced reliance on toxic excipients, enhanced manufacturability, and broader development flexibility for challenging compounds. At BIO 2026, the Company plans to highlight development progress across multiple Deciparticle™ programs, including: Sapu006, a polysorbate-free intravenous docetaxel formulation currently moving into Phase 1b clinical evaluation;Sapu003, an intravenous everolimus nanomedicine program designed to potentially reduce gastrointestinal exposure associated with oral administration currently in a global Phase 1b clinical trial; andBroader applications of the Deciparticle™ platform for difficult-to-formulate small molecules and macrolide therapeutics. The Company will also discuss how artificial intelligence and knowledge-organization technologies are being integrated into formulation development, manufacturing intelligence, and translational oncology workflows through its PDAOAI™ platform. “Many important therapeutics remain limited by formulation complexity, poor aqueous solubility, excipient-related toxicity, or manufacturing challenges,” said Vuong Trieu, Chief Executive Officer. “Our objective with Deciparticle™ is to create a scalable nanomedicine platform capable of enabling intravenous delivery of highly insoluble molecules while simplifying formulation architecture and supporting clinical translation.” According to the Company, Deciparticle™ formulations are designed to address key limitations associated with conventional solubilizing systems, including hypersensitivity reactions, surfactant burden, formulation instability, and manufacturing complexity. Oncotelic believes the combination of nanomedicine engineering, translational oncology, manufacturing expertise, and AI-driven scientific cognition may provide a differentiated platform for future drug development. BIO International Convention is one of the biotechnology industry’s largest partnering and innovation events, bringing together biotechnology companies, pharmaceutical companies, investors, and scientific leaders from around the world. About Deciparticle™ Deciparticle™ is Oncotelic’s proprietary nanomedicine platform designed to formulate highly water-insoluble therapeutics into ultra-small nanoparticles for intravenous administration. The platform utilizes amphiphilic polymer architectures intended to improve aqueous compatibility, stability, manufacturability, and translational flexibility across multiple therapeutic classes. About Sapu Nano Sapu Nano is a biotechnology company developing next-generation nanomedicine platforms to improve drug delivery, enhance therapeutic index, and unlock new clinical potential for established and novel therapeutics, with a primary focus in oncology. For more information, visit www.sapunano.com. About Oncotelic Therapeutics, Inc. Oncotelic Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of oncology and immunotherapy products. The Company’s mission is to address high-unmet-need cancers and rare pediatric indications with innovative, late-stage therapeutic candidates. In addition to its directly owned and developed drug pipeline, Oncotelic benefits from a robust portfolio of inventions created by its CEO, Dr. Vuong Trieu, who has filed over 500 patent applications and holds 75 issued patents. The Company also leverages its proprietary AI-enabled PDAOAI platform, which supports research, biomarker discovery, and regulatory processes through advanced data analysis and knowledge integration. Beyond its internal programs, Oncotelic licenses and co-develops select drug candidates through strategic partnerships and joint ventures. The Company currently owns a 45% interest in GMP Bio, a joint venture advancing a complementary pipeline of therapeutic candidates that further strengthens Oncotelic’s position in oncology and rare disease therapeutics. For more information, please visit: www.oncotelic.com Oncotelic Cautionary Note on Forward‑Looking Statements This press release contains forward‑looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this release other than statements of historical fact are forward‑looking and are based on current expectations, estimates, and projections about our business and future plans. In some cases, you can identify forward‑looking statements by terms such as “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “project,” “forecast,” “potential,” “continue,” and similar expressions (including the negative of such terms). Forward‑looking statements in this release include, without limitation: our plans, timelines, and priorities for the OT‑101 program in PDAC and other indications; potential biomarker‑driven development strategies; the advancement, scope, timing, and results of current or future preclinical and clinical studies; regulatory interactions and potential approvals; development or commercialization of any product candidates within the Oncotelic/GMP Bio/Sapu ecosystem; the utility of our PDAOAI platform; future financings, strategic transactions, and/or public offerings involving our joint ventures or affiliates; and other statements that are not historical facts. Actual results may differ materially from those indicated by such forward‑looking statements as a result of various important factors, including, but not limited to: the inherent uncertainties of drug discovery and development; our ability to enroll patients and complete studies on expected timelines; whether preclinical or early clinical findings (including biomarker associations) will be replicated in larger, controlled trials; regulatory developments in the United States and other jurisdictions; competitive developments; our ability to obtain or maintain intellectual property protection; our liquidity and access to capital; the performance of collaborators, suppliers, and manufacturers; and other risks described in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our most recent Form 10‑K and subsequent periodic reports. Forward‑looking statements speak only as of the date of this press release, and we undertake no obligation to update or revise such statements, whether as a result of new information, future events, or otherwise, except as required by law. Investor & Media ContactOncotelic Therapeutics, Inc.Investor Relationsir@oncotelic.com Corporate CommunicationsIBNAustin, Texaswww.InvestorBrandNetwork.com512.354.7000 OfficeEditor@InvestorBrandNetwork.com