A Phase II Study of Elacestrant, an Oral Selective Estrogen Receptor Degrader (SERD) Combined With Everolimus in Patients With Recurrent or Metastatic ER-Positive (ER+) Endometrial Cancer (ELAVERA)

This phase II trial tests how well elacestrant with everolimus works for the treatment of estrogen receptor (ER) positive endometrial cancer that has come back after a period of improvement (recurrent), that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Estrogen can cause the growth of cancer cells. Elacestrant lowers the amount of estrogen made by the body. This may help stop the growth of cancer cells that need estrogen to grow. Everolimus is in a class of medications called kinase inhibitors. It is also a type of angiogenesis inhibitor. Everolimus works by stopping cancer cells from reproducing and by decreasing blood supply to the cancer cells. Giving elacestrant with everolimus may be effective for treating patients with recurrent, advanced or metastatic ER positive endometrial cancer.

Start Date18 Dec 2026

Sponsor / Collaborator

Jonsson Comprehensive Cancer Center

[+1]

NCT07218575

/ Not yet recruitingPhase 2/3IIT

A Randomized, Placebo Controlled Double-Blind Trial of Everolimus for Improving Social Abilities in PTEN Germline Mutations

The goal of this study is to examine the safety and treatment effects of everolimus in adults and children with PTEN Hamartoma Tumor Syndrome (PHTS) who experience social difficulties. The study will measure if everolimus can safely improve social abilities and functioning in this study population.
PTEN Hamartoma Tumor Syndrome (PHTS) is a genetic condition that results from alteration (germline variant) to the PTEN gene. It is associated with a wide range of symptoms and characteristics, which vary from individual to individual. These include symptoms such as harmatomas (non-cancerous lesions), an increased risk of certain types of cancer, having a larger than average head, and abnormalities in blood vessels. Some people also have neurobehavioral problems including social difficulties. It is estimated approximately 25% (1 in 4) of people with PHTS meet the criteria for an autism diagnosis.
The study lasts for one year. In the first 6 months half of participants will receive everolimus as a once daily oral tablet, and half will receive placebo tablets. For the second 6 months all participants will receive everolimus. Visits to the study clinic are required at the start, month 3, month 6, month 9 and month 12, with phone calls or virtual visits in between. Assessments include questionnaires, blood tests and urine tests, physical and neurological exams, and vital signs.
Everolimus is an existing FDA approved medication used to treat other conditions, including a genetic condition called tuberous sclerosis complex which has some similarities to PHTS, and several types of cancer.

Start Date01 Sep 2026

Sponsor / Collaborator

The Children's Hospital Corp.

CTIS2025-524031-39-00

/ Not yet recruitingPhase 1IIT

Phase I study of CDK8 inhibitor RVU120 in combination with everolimus in children with recurrent or progressive Group 3 or 4 medulloblastoma; MEDWAY

Start Date31 Jul 2026

Sponsor / Collaborator

Instytut "Pomnik - Centrum Zdrowia Dziecka"

100 Clinical Results associated with Everolimus

100 Translational Medicine associated with Everolimus

100 Patents (Medical) associated with Everolimus

7,575

Literatures (Medical) associated with Everolimus

31 Dec 2026·ANNALS OF MEDICINE

Comparative effectiveness of percutaneous coronary intervention strategies for coronary small-vessel disease: a network meta-analysis of randomized trials

Review

Author: Du, Zhiyan ; Xu, Yixin ; Fan, Chao ; Wang, ZhiLong ; Jiang, Zhihui ; Wu, Tingting ; Zheng, Yingying ; Lv, Mingming ; Adilijiang, Adilai. ; Pan, Ying ; Bai, Bingxin ; Deng, Changjiang ; Xie, Xiang

BACKGROUND:

Coronary small-vessel disease (SVD) remains challenging for percutaneous coronary intervention (PCI) because small lumens magnify restenosis and ischemic risk. Multiple devices are available, yet their comparative performance is uncertain. This study evaluated and ranked PCI strategies for SVD.

METHODS:

A systematic review and network meta-analysis was conducted in accordance with PRISMA. PubMed, Embase, the Cochrane Central Register of Controlled Trials, Web of Science, and Google Scholar were searched from inception to 15 August 2025. Eligible studies were English-language randomized controlled trials enrolling adults with angiographic SVD defined as reference vessel diameter ≤3.0 mm, comparing PCI strategies, and reporting target lesion revascularization (TLR), binary restenosis (BR), or myocardial infarction (MI). A frequentist random-effects network meta-analysis generated odds ratios (ORs) with 95% confidence intervals (CIs) and treatment rankings using the surface under the cumulative ranking curve (SUCRA).

RESULTS:

Thirty-nine trials including 14,503 patients met the criteria. For TLR (37 studies; 11,980 patients), the highest SUCRA values were observed with sirolimus-eluting stents (SES 90.1%), zotarolimus-eluting stents (ZES 83.9%), and everolimus-eluting stents (EES 82.2%). For BR (32; 6,468), SES, ZES, and paclitaxel-coated balloons (DCB-PTX) ranked highest (95.0%, 80.0%, and 78.3%). For MI (37; 11,602), SES, DCB-PTX, and ZES ranked highest (79.0%, 78.7%, and 68.5%). Representative effects showed SES reduced TLR versus bare-metal stents (BMS) (OR, 0.25; 95% CI, 0.15-0.43) and MI versus BMS (OR, 0.41; 95% CI, 0.21-0.79). Conventional approaches such as BMS, plain old balloon angioplasty (POBA), and gold-plated balloon angioplasty (GPBA) ranked lowest across outcomes.

CONCLUSION:

SES provides the most consistent clinical benefit for coronary SVD. ZES, EES, and DCB-PTX are effective alternatives in selected settings, whereas BMS, POBA, and GPBA are less effective. These findings offer comparative evidence to guide device selection in SVD.

01 Aug 2026·EUROPEAN JOURNAL OF CANCER

A pooled analysis of phase 2 clinical trials in advanced chordoma

Article

Author: Lipplaa, Astrid ; Schuetze, Scott M ; Teleanu, Maria-Veronica ; Elliott, Corrine F ; Conley, Anthony P ; Lozinsky, Shannon ; Stacchiotti, Silvia ; Schlenk, Richard F ; Somaiah, Neeta ; Choy, Edwin ; George, Suzanne ; Kesari, Santosh ; Le Cesne, Axel ; Chemudupati, Teja ; Cote, Gregory M ; Chugh, Rashmi ; Sommer, Josh ; Freed, Daniel M ; Bompas, Emmanuelle ; Gelderblom, Hans ; Blay, Jean-Yves ; Wendelberger, Barbara ; Fröhling, Stefan ; Duffaud, Florence

AIM:

Chordoma is an ultra-rare malignancy with no approved therapies. In this study, we analyzed individual patient-level data (IPD) for patients with chordoma reconstructed from previously completed clinical trials. Our primary objectives were to synthesize the historical objective response rate (ORR) and to generate a pooled Kaplan-Meier progression-free survival (PFS) curve. Our overarching goal is that these data will inform future trial design and interpretation of results.

METHODS:

A literature review was conducted to identify prospective chordoma systemic therapy clinical trials. Eligible studies were required to be prospective; to include locally advanced/metastatic conventional chordoma; to report a PFS Kaplan-Meier curve; and to assess PFS/ORR by RECIST (1.0/1.1). IPD were reconstructed from the PFS curves and data were synthesized to estimate the pooled PFS and ORR.

RESULTS:

Twelve studies met eligibility, contributing 328 patients (320 response evaluable). The combined ORR was 4.7% and median PFS was 10.8 months (95% CI 9, 12). Sensitivity analyses revealed no significant differences in PFS between studies partitioned by study-level variables. In "leave-one-out" analyses of each study alone versus pooled data, only everolimus/imatinib showed a significantly longer PFS (p = 0.0014), with a median PFS of 14.0 months (95% CI 11.5, NA) compared to 10.0 months (95% CI 8.3,11.2) for the remaining pooled cohort (estimated hazard ratio: 0.50 [95% CI 0.33, 0.77]).

CONCLUSION:

IPD from 12 trials were reconstructed and analyzed, consolidating outcomes for 328 trial-eligible patients with chordoma. The estimated overall response rate (ORR) is 4.7% and median PFS 10.8 months, providing a historical benchmark useful for future trial design. Notably, everolimus/imatinib was the only study treatment associated with a statistically significant improvement in PFS, which may warrant further investigation.

01 Jul 2026·AMERICAN HEART JOURNAL

Impact of total stent length on long-term outcomes with different newer-generation drug-eluting stent designs in ST-segment elevation myocardial infarction: A subgroup analysis from the BIOSTEMI ES randomized trial

Article

Author: Pilgrim, Thomas ; Bossard, Matthias ; Muller, Olivier ; Windecker, Stephan ; Kaiser, Christoph ; Cook, Stéphane ; Girod, Grégoire ; Haegeli, Laurent ; Rigger, Johannes ; Iglesias, Juan F ; Roffi, Marco ; Losdat, Sylvain ; Heg, Dik ; Kurz, David J

BACKGROUND:

Longer total stent length (TSL) increases the risk of target lesion failure (TLF) in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention with second-generation drug-eluting stents (DES). We aimed to assess the long-term impact of TSL on patient- and stent-related outcomes in STEMI patients treated with different newer-generation DES designs.

METHODS:

We performed a post hoc subgroup analysis of the BIOSTEMI Extended Survival randomized trial (NCT05484310). Patients undergoing primary percutaneous coronary intervention for STEMI were randomized to ultrathin-strut biodegradable-polymer sirolimus-eluting stents (BP-SES) or thin-strut durable-polymer everolimus-eluting stents (DP-EES) and categorized according to TSL implanted at the culprit site (≤40 vs >40 mm). The device-oriented composite endpoint (TLF) was the composite of cardiac death, target-vessel myocardial reinfarction, or clinically indicated target lesion revascularization, and the patient-oriented composite endpoint was the composite of all-cause death, any myocardial reinfarction, any revascularization, or any stroke, at 5 years.

RESULTS:

A total of 1,686 STEMI patients were included (mean age, 62.4 years; female, 23%; mean TSL, 33.8 mm), of whom 423 (25%) were treated with TSL >40 mm. At 5 years, TSL >40 mm was associated with a significantly higher risk of patient-oriented composite endpoint compared with TSL ≤40 mm (31.7% vs 27.4%; hazard ratio [HR], 1.30; 95% confidence interval [CI], 1.03-1.64; P = .029), whereas no difference was observed in TLF. However, there was a significant interaction between DES type and TSL for TLF at 5 years. Among patients with TSL >40 mm, BP-SES were associated with a lower risk of TLF compared with DP-EES (7.3% vs 17.1%; HR, 0.39; 95% CI, 0.21-0.74; P = .004; P for interaction = .032), a difference primarily driven by a lower rate of target vessel myocardial reinfarction. No significant differences between BP-SES and DP-EES were observed in patients with TSL ≤40 mm. After adjustment for multivessel treatment, increasing TSL with DP-EES, but not BP-SES, was independently associated with a higher risk of TLF (adjusted HR per 5-mm increase, 1.07; 95% CI, 1.02-1.11; P = .003).

CONCLUSION:

In STEMI patients treated with contemporary DES, TSL >40 mm was associated with an increased risk of patient-oriented, but not device-related, adverse outcomes at 5 years. Among patients requiring TSL >40 mm, ultrathin-strut BP-SES significantly reduced the risk of TLF compared with DP-EES, whereas no between-DES differences were observed in patients treated with TSL ≤40 mm.

TRIAL REGISTRATION:

The BIOSTEMI ES trial is registered at ClinicalTrials.gov (NCT05484310).

454

News (Medical) associated with Everolimus

09 Jul 2026

·www.globenewswire.com

Oncotelic Successfully Completes Initial Safety Cohort of Phase 1b SP-03-B101 Trial; Independent Safety Review Committee Recommends Dose Escalation and European Expansion Underway

Clinical Program Advances Following Favorable Safety Review; Peer-Reviewed Publication Further Validates Deciparticle™ Platform SAN DIEGO, Calif., July 07, 2026 (GLOBE NEWSWIRE) -- Oncotelic (OTCQB:OTLC), an AI/Robotic native biotechnology company, and its 45% owned subsidiary- Sapu Nano (US) LLC, a clinical-stage biotechnology company developing the proprietary Deciparticle™ nanomedicine platform, and today announced that the independent Safety Review Committee (SRC) has completed its review of the initial safety cohort in the Company's ongoing SP-03-B101 Phase 1b clinical trial evaluating Sapu003, an investigational intravenous formulation of everolimus. Following completion of the protocol-defined 28-day dose-limiting toxicity (DLT) evaluation period for the initial three-patient cohort, the SRC concluded that no dose-limiting toxicities (DLTs) were observed and recommended advancing the study to the next planned dose level in accordance with the study protocol. Sapu003 is currently being evaluated in the SP-03-B101 Phase 1b clinical trial, an open-label, multicenter, Bayesian Optimal Interval (BOIN) dose-escalation study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of weekly intravenous Sapu003 in patients with advanced mTOR-sensitive solid tumors. The study is registered on ClinicalTrials.gov (Identifier: NCT07369505). Following successful completion of the initial safety cohort, the Company has initiated expansion of the SP-03-B101 clinical program into Europe. Additional European clinical sites are expected to participate in the study, broadening patient access, accelerating enrollment, and supporting the global clinical development strategy for Sapu003. "Successful completion of the initial safety cohort represents an important milestone for the Sapu003 development program," said Dr. Vuong Trieu, CEO of Sapu Nano. "The independent Safety Review Committee's recommendation to advance to the next dose level provides important clinical validation of the program's progress. Combined with the expansion of SP-03-B101 into Europe, we believe these milestones position Sapu003 for accelerated clinical development while broadening access for patients with advanced mTOR-sensitive solid tumors." Peer-Reviewed Publication Supports Clinical Development The clinical milestone follows the Company's recent peer-reviewed publication describing the scientific foundation of Sapu003 and the proprietary Deciparticle™ nanoparticle platform. Min SH, Forero K, Putnam W, Anderson J, Hoff R, Lopp J, Trieu V, Ho K, Lee C. Intravenous Everolimus Formulation (Sapu003) for Clinical Trials. International Journal of Molecular Sciences. 2026;27(13):5775. doi: 10.3390/ijms27135775. The publication provides the first comprehensive description of the Deciparticle™ platform, including formulation discovery, scalable cGMP manufacturing, physicochemical characterization, stability, and preclinical evaluation supporting the ongoing clinical development of Sapu003. The published work demonstrated: Development of a stable intravenous everolimus nanoparticle formulation with a mean particle size below 20 nanometers.Development of a robust, scalable cGMP manufacturing process suitable for clinical production.Excellent product reproducibility and stability following lyophilization and refrigerated storage.Broad compatibility of the Deciparticle™ platform with multiple hydrophobic therapeutic compounds, supporting potential future pipeline expansion.Potent preclinical antitumor activity supporting advancement into clinical development. "The progression from peer-reviewed publication to successful completion of our first clinical safety cohort highlights the maturity of both the Sapu003 program and the Deciparticle™ platform," added Dr. Trieu. "We believe Deciparticle™ represents a differentiated nanomedicine platform capable of enabling intravenous delivery of numerous poorly water-soluble therapeutic compounds while supporting scalable commercial manufacturing." Clinical Trial Information Study Title: SP-03-B101: A Phase 1b Study of Sapu003 (Intravenous Everolimus) in Patients with Advanced mTOR-Sensitive Solid Tumors ClinicalTrials.gov Identifier: NCT07369505 About Sapu003 Sapu003 is an investigational intravenous formulation of everolimus developed using Sapu Nano's proprietary Deciparticle™ nanoparticle platform. Sapu003 is designed to overcome the formulation limitations associated with oral everolimus by enabling intravenous administration with a scalable cGMP manufacturing process. The program is currently being evaluated in the Phase 1b SP-03-B101 clinical trial in patients with advanced mTOR-sensitive solid tumors. About Deciparticle™ Deciparticle™ is Sapu Nano's proprietary nanomedicine platform designed to formulate poorly water-soluble therapeutic compounds into stable intravenous formulations. The platform combines amphiphilic polymer technology with scalable cGMP manufacturing to enable the clinical development of challenging hydrophobic therapeutics. In addition to Sapu003, the platform has demonstrated compatibility with multiple classes of hydrophobic molecules, supporting future pipeline expansion and potential strategic collaborations. About Sapu Nano Sapu Nano (US) LLC is a clinical-stage biotechnology company developing the proprietary Deciparticle™ nanomedicine platform for intravenous delivery of poorly water-soluble therapeutics. The Company's lead product candidate, Sapu003, an investigational intravenous formulation of everolimus, is currently in Phase 1b clinical development for patients with advanced mTOR-sensitive solid tumors. The Company is leveraging its Deciparticle™ platform to develop next-generation nanomedicine products for oncology and other serious diseases. For more information, visit www.sapunano.com. About Oncotelic Therapeutics 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 the robust portfolio of inventions created by its CEO, Dr. Vuong Trieu, who has filed over 500 patent applications and holds 75 issued U.S. patents. Beyond its internal programs, the Company also licenses and co-develops select drug candidates through joint ventures. Currently, Oncotelic owns 45% of GMP Bio, a joint venture under Dr. Trieu's leadership and guidance, which is advancing its own pipeline of drug candidates that further complement and strengthen Oncotelic's strategic position in oncology and rare disease therapeutics. Oncotelic also develops PDAOAI, its proprietary artificial intelligence platform for drug discovery, cleanroom automation, and AI-assisted GMP manufacturing. Through Oncotelic's relationship with SAPU Bio - an OEB-5 sterile injectable cGMP manufacturing facility - PDAOAI underpins the Company's joint development work with TechForce Robotics on intelligent automation for high-containment GMP biomanufacturing. 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: the completion, scope, timing, capabilities, and commercialization of Phase 2 objectives under our joint manufacturing automation initiative with TechForce Robotics; the operational utility, performance, and customer adoption of the AI-Powered GMP Manufacturing Services Platform; the application of PDAOAI to sterile manufacturing operations, electronic batch records, GMP workflow execution, cleanroom monitoring, and autonomous materials movement; the potential for future software licensing, automation deployment, manufacturing partnerships, and technology-enabled contract development and manufacturing services; the size, growth, and addressability of the pharmaceutical manufacturing software and automation market; the demonstration of PDAOAI and the integrated robotics platform at BIO International Convention 2026; the role of SAPU Bio as commercial deployment site and proving ground; regulatory interactions and potential approvals; development or commercialization of any product candidates within the Oncotelic / GMP Bio / Sapu ecosystem; 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 competitive market of AI-enabled GMP manufacturing software and AI-enabled robotics; the performance and continued cooperation of our robotics and automation partners, including TechForce Robotics; 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 Contact Oncotelic Therapeutics, Inc.Investor Relationsir@oncotelic.com Corporate Communications IBN | Austin, Texaswww.InvestorBrandNetwork.com Editor@InvestorBrandNetwork.com 512.354.7000

Phase 1

29 Jun 2026

·www.biospace.com

Oncotelic Announces Peer-Reviewed Validation of Deciparticle™ Platform Supporting Clinical Development of Sapu003

Publication Highlights Novel Intravenous Everolimus Formulation and Demonstrates Broad Potential of Deciparticle ™ Technology for Hydrophobic Therapeutics SAN DIEGO, Calif., June 29, 2026 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB: OTLC) and Sapu Nano today announced today announced the publication of a peer-reviewed scientific manuscript validating its proprietary Deciparticle ™ nanoparticle platform through the successful development of Sapu003 , the Company's investigational intravenous everolimus formulation currently being evaluated in an ongoing Phase 1b clinical trial. The publication, "Intravenous Everolimus Formulation (Sapu003) for Clinical Trials," has been published in the International Journal of Molecular Sciences and provides the first comprehensive description of the Deciparticle ™ platform, including formulation design, scalable cGMP manufacturing, product characterization, stability, and preclinical evaluation. Publication Citation Min SH, Forero K, Putnam W, Anderson J, Hoff R, Lopp J, Trieu V, Ho K, Lee C. Intravenous Everolimus Formulation (Sapu003) for Clinical Trials. International Journal of Molecular Sciences. 2026;27(13):5775. doi:10.3390/ijms27135775. Everolimus is a well-established inhibitor of the mammalian target of rapamycin (mTOR) approved for the treatment of multiple cancers. However, because of its poor aqueous solubility and limited oral bioavailability, clinical use has historically been restricted to oral administration. Sapu003 was developed using the Deciparticle ™ platform to enable intravenous delivery through a stable nanoparticle formulation. The publication reports several significant achievements, including: Development of a stable intravenous everolimus formulation with mean particle sizes below 20 nanometers. A robust, scalable cGMP manufacturing process capable of producing clinical-grade material with high batch-to-batch reproducibility. Favorable product stability following lyophilization and refrigerated storage. Successful formulation of multiple hydrophobic therapeutic compounds, demonstrating the broader applicability of the Deciparticle ™ platform beyond everolimus. Potent preclinical antitumor activity supporting continued clinical development of Sapu003. "The publication of this work represents an important milestone for Sapu Bioscience," said Vuong Trieu, Ph.D., CEO and Chairman of Oncotelic. "Independent peer review validates not only the scientific foundation supporting Sapu003, but also the broader Deciparticle ™ platform. We believe this technology has the potential to address one of the longstanding challenges in drug development—enabling intravenous delivery of poorly water-soluble therapeutic compounds through a scalable and reproducible manufacturing process." Unlike many formulation technologies developed for a single product, the published research demonstrates that the Deciparticle ™ platform is compatible with wide range of hydrophobic molecules, including rapalogs, macrocyclic compounds, immunosuppressants, and selected peptide therapeutics. The Company believes this broad formulation capability may support future pipeline expansion and collaborative development opportunities. Sapu003 is currently being evaluated in an ongoing Phase 1b open-label dose-escalation study in patients with advanced mTOR-sensitive solid tumors. The study is assessing the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of weekly intravenous Sapu003 administered in combination with exemestane. "The publication marks the successful translation of the Deciparticle ™ platform from laboratory research to clinical-stage manufacturing," added Dr. Trieu. "As our Phase 1b clinical study progresses, we look forward to further evaluating the potential of Sapu003 while continuing to expand the application of the Deciparticle ™ platform to additional therapeutic programs." About Sapu003 Sapu003 is an investigational intravenous formulation of everolimus developed using Sapu Bioscience's proprietary Deciparticle ™ nanoparticle platform. The program is designed to overcome the formulation limitations associated with oral everolimus while enabling predictable intravenous administration for the treatment of patients with advanced cancers. About Deciparticle ™ Deciparticle ™ is Sapu Bioscience's proprietary nanoparticle formulation platform designed to enable intravenous delivery of poorly water-soluble therapeutic compounds. The technology combines amphiphilic polymer design with scalable cGMP manufacturing to generate stable nanoparticle formulations suitable for clinical development. The platform has demonstrated compatibility across multiple classes of hydrophobic therapeutic agents and is being evaluated for broader pharmaceutical applications. About Sapu Nano Sapu Nano (US) LLC is a clinical-stage biotechnology company developing the proprietary Deciparticle ™ nanomedicine platform for intravenous delivery of poorly water-soluble therapeutics. The Company's lead product candidate, Sapu003 (intravenous everolimus), is currently in Phase 1b clinical development for advanced mTOR-sensitive solid tumors. In addition to Sapu003, the Deciparticle ™ platform is being developed to enable next-generation nanomedicine products across oncology and other serious diseases. For more information, please visit . About Oncotelic Therapeutics 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 the robust portfolio of inventions created by its CEO, Dr. Vuong Trieu, who has filed over 500 patent applications and holds 75 issued U.S. patents. Beyond its internal programs, the Company also licenses and co-develops select drug candidates through joint ventures. Currently, Oncotelic owns 45% of GMP Bio, a joint venture under Dr. Trieu's leadership and guidance, which is advancing its own pipeline of drug candidates that further complement and strengthen Oncotelic's strategic position in oncology and rare disease therapeutics. Oncotelic also develops PDAOAI, its proprietary artificial intelligence platform for drug discovery, cleanroom automation, and AI-assisted GMP manufacturing. Through Oncotelic's relationship with SAPU Bio — an OEB-5 sterile injectable cGMP manufacturing facility — PDAOAI underpins the Company's joint development work with TechForce Robotics on intelligent automation for high-containment GMP biomanufacturing. For more information, please visit . 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: the completion, scope, timing, capabilities, and commercialization of Phase 2 objectives under our joint manufacturing automation initiative with TechForce Robotics; the operational utility, performance, and customer adoption of the AI-Powered GMP Manufacturing Services Platform; the application of PDAOAI to sterile manufacturing operations, electronic batch records, GMP workflow execution, cleanroom monitoring, and autonomous materials movement; the potential for future software licensing, automation deployment, manufacturing partnerships, and technology-enabled contract development and manufacturing services; the size, growth, and addressability of the pharmaceutical manufacturing software and automation market; the demonstration of PDAOAI and the integrated robotics platform at BIO International Convention 2026; the role of SAPU Bio as commercial deployment site and proving ground; regulatory interactions and potential approvals; development or commercialization of any product candidates within the Oncotelic / GMP Bio / Sapu ecosystem; 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 competitive market of AI-enabled GMP manufacturing software and AI-enabled robotics; the performance and continued cooperation of our robotics and automation partners, including TechForce Robotics; 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 Contact Oncotelic Therapeutics, Inc. Investor Relations ir@oncotelic.com Corporate Communications IBN | Austin, Texas Editor@InvestorBrandNetwork.com 512.354.7000

Phase 1ImmunotherapyDrug Approval

18 Jun 2026

·www.globenewswire.com

Oncotelic Launches AI-Powered GMP Manufacturing Services Platform at BIO International Convention 2026

Company to Showcase Integration of AI, Digital Batch Records, and Intelligent Robotics to Accelerate Pharmaceutical Manufacturing AGOURA HILLS, Calif., June 18, 2026 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB: OTLC) today announced the launch of its artificial intelligence ("AI") powered good manufacturing practices ("GMP") manufacturing services platform (the "Platform") at the 2026 BIO International Convention in San Diego, California. The initiative combines the Company's PDAOAI™ AI platform with advanced robotics — delivered in collaboration with TechForce Robotics, Inc. ("TechForce"), Oncotelic's strategic robotics and automation partner — and digital manufacturing technologies to support pharmaceutical, biotechnology, and advanced therapeutics companies seeking to modernize GMP operations. As part of the initiative, Oncotelic will demonstrate the integration of intelligent robotic systems and AI-driven manufacturing workflows capable of assisting personnel with routine GMP operations, batch record execution, material handling, manufacturing documentation, and quality management activities. "The future of pharmaceutical manufacturing will be shaped by the convergence of artificial intelligence, digital quality systems, and intelligent automation," said Dr. Vuong Trieu, Chairman and Chief Executive Officer of Oncotelic. "Our objective is to provide manufacturers with practical tools that improve productivity, strengthen compliance, and accelerate the path from development to commercialization. BIO 2026 provides an ideal venue to introduce these capabilities to prospective industry partners." "Following the successful Phase 1 and 2 deployments with Oncotelic this year, BIO 2026 marks the next milestone in our shared roadmap," said Ried Floco, President of TechForce Robotics. "Bringing intelligent robotics together with PDAOAI inside a GMP environment shows what purpose-built automation can do for pharmaceutical manufacturers, and we look forward to demonstrating that capability alongside Oncotelic on the BIO floor." The Platform leverages PDAOAI™, Oncotelic's proprietary AI architecture, to support: Electronic batch record generation and managementAI-assisted manufacturing documentationGMP workflow digitizationQuality and compliance supportManufacturing process monitoringKnowledge management and operational intelligenceIntegration with intelligent robotic systems through the Company's collaboration with TechForce The Company believes these capabilities may be particularly valuable for emerging biotechnology companies, contract development and manufacturing organizations ("CDMOs"), cell and gene therapy developers, radiopharmaceutical manufacturers, and organizations seeking to accelerate technology transfer and manufacturing scale-up activities. In addition to the commercial launch of the Platform, Oncotelic will highlight ongoing progress of its Deciparticle™ nanomedicine platform, including SAPU003, the Company's clinical-stage intravenous everolimus program currently being evaluated in a Phase 1b clinical study. BIO International Convention attendees interested in learning more about the Platform, PDAOAI™, or potential commercial collaborations are encouraged to schedule meetings with Oncotelic during the conference at Booth #1525, California Life Sciences Pavilion. Additional information, conference materials, and meeting requests are available at the Company's BIO 2026 landing page at www.techforcerobotics.com/bio-2026. About Oncotelic Therapeutics 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 the robust portfolio of inventions created by its CEO, Dr. Vuong Trieu, who has filed over 500 patent applications and holds 75 issued U.S. patents. Beyond its internal programs, the Company also licenses and co-develops select drug candidates through joint ventures. Currently, Oncotelic owns 45% of GMP Bio, a joint venture under Dr. Trieu's leadership and guidance, which is advancing its own pipeline of drug candidates that further complement and strengthen Oncotelic's strategic position in oncology and rare disease therapeutics. Oncotelic also develops PDAOAI, its proprietary AI platform for drug discovery, lab automation, and AI-assisted GMP manufacturing. Through Oncotelic's relationship with SAPU Bio — an OEB-5 sterile injectable cGMP manufacturing facility — PDAOAI underpins the Platform and its ongoing joint development work with TechForce Robotics, Oncotelic's strategic robotics and automation partner. For more information, please visit www.oncotelic.com. About TechForce Robotics TechForce Robotics, Inc. is the operating brand of Nightfood Holdings, Inc., doing business as TechForce Robotics. TechForce designs, develops, and deploys purpose-built robotics and automation solutions for service, hospitality, and pharmaceutical manufacturing applications, in partnership with global robotics and manufacturing leaders. For more information, please visit www.techforcerobotics.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: the launch, commercialization, scope, capabilities, performance, and customer adoption of the AI-Powered GMP Manufacturing Services Platform; the utility, development, and potential commercialization of our PDAOAI platform across electronic batch records, manufacturing workflow management, quality documentation, process monitoring, and AI-assisted manufacturing execution; the integration of intelligent robotic systems with PDAOAI for GMP operations; the scope, execution, performance, and commercialization of our joint development work with TechForce Robotics; regulatory interactions and potential approvals; development or commercialization of any product candidates within the Oncotelic / GMP Bio / Sapu ecosystem, including SAPU003 and the Deciparticle™ nanomedicine 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 competitive market of AI-enabled GMP manufacturing software and AI-enabled robotics; the performance and continued cooperation of our robotics and automation partners, including TechForce Robotics; 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 TechForce RoboticsNightfood Holdings, Inc. d/b/a TechForce RoboticsInvestor Relationsir@techforcerobotics.com(866) 291-7778www.techforcerobotics.com Corporate CommunicationsIBN | Austin, Texaswww.InvestorBrandNetwork.com Editor@InvestorBrandNetwork.com512.354.7000 # # #

Phase 1

100 Deals associated with Everolimus

External Link

KEGG	Wiki	ATC	Drug Bank
D02714	Everolimus	L04AA18 L01XE10	DB01590

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Epilepsy	United States	Novartis Pharmaceuticals Corp.	30 Dec 2021
Epilepsies, Partial	United States	Novartis Pharmaceuticals Corp.	10 Apr 2018
Renal angiomyolipoma with tuberous sclerosis complex	China	Novartis Pharma AG	12 Dec 2016
Breast cancer recurrent	Japan	Novartis Pharma AG	17 Mar 2014
Pancreatic Islet Cell Tumors	China	Novartis Pharma AG	01 Feb 2014
Subependymal Giant Cell Astrocytoma	China	Novartis Pharma AG	01 Feb 2014
Hormone receptor positive HER2 negative breast cancer	United States	Novartis Pharmaceuticals Corp.	20 Jul 2012
Gastro-Enteropancreatic Neuroendocrine Tumor	Japan	Novartis Pharma AG	22 Dec 2011
Tuberous Sclerosis	European Union	Novartis Europharm Ltd.	02 Sep 2011
Tuberous Sclerosis	Iceland	Novartis Europharm Ltd.	02 Sep 2011
Tuberous Sclerosis	Liechtenstein	Novartis Europharm Ltd.	02 Sep 2011
Tuberous Sclerosis	Norway	Novartis Europharm Ltd.	02 Sep 2011
Astrocytoma	United States	Novartis Pharmaceuticals Corp.	29 Oct 2010
Angiomyolipoma	Canada	Novartis Pharmaceuticals Canada, Inc.	15 Mar 2010
Hormone receptor positive breast cancer	European Union	Novartis Europharm Ltd.	02 Aug 2009
Hormone receptor positive breast cancer	Iceland	Novartis Europharm Ltd.	02 Aug 2009
Hormone receptor positive breast cancer	Liechtenstein	Novartis Europharm Ltd.	02 Aug 2009
Hormone receptor positive breast cancer	Norway	Novartis Europharm Ltd.	02 Aug 2009
Neuroendocrine Tumors	European Union	Novartis Europharm Ltd.	02 Aug 2009
Neuroendocrine Tumors	Iceland	Novartis Europharm Ltd.	02 Aug 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Seizures	Phase 3	United States	Novartis Pharmaceuticals Canada, Inc.	08 Jun 2017
Seizures	Phase 3	Japan	Novartis Pharmaceuticals Canada, Inc.	08 Jun 2017
Seizures	Phase 3	Australia	Novartis Pharmaceuticals Canada, Inc.	08 Jun 2017
Seizures	Phase 3	Belgium	Novartis Pharmaceuticals Canada, Inc.	08 Jun 2017
Seizures	Phase 3	Canada	Novartis Pharmaceuticals Canada, Inc.	08 Jun 2017
Seizures	Phase 3	Colombia	Novartis Pharmaceuticals Canada, Inc.	08 Jun 2017
Seizures	Phase 3	France	Novartis Pharmaceuticals Canada, Inc.	08 Jun 2017
Seizures	Phase 3	Hungary	Novartis Pharmaceuticals Canada, Inc.	08 Jun 2017
Seizures	Phase 3	Italy	Novartis Pharmaceuticals Canada, Inc.	08 Jun 2017
Seizures	Phase 3	Mexico	Novartis Pharmaceuticals Canada, Inc.	08 Jun 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2026	Not Applicable	Recurrent ovarian cancer	8	Everolimus 10mg + Everolimus 10mgitors	nwsayuvnne(otiubxibzr) = hlduidbcyz sezdfrkhac (jekuasnnjp ) View more	Positive	29 May 2026
NCT02233049 (BIOMEDE, Pubmed \| Nat Med)	Phase 2	Diffuse Intrinsic Pontine Glioma EGFR overexpression \| PTEN loss \| TP53 mutations	233	Erlotinib + Radiotherapy	bfjpnyjugw(irugtmsuqf) = jtcqepiadh tihhxhksfi (uxakzacoar, 7.8 - 14.6)	Negative	24 Apr 2026
				Dasatinib + Radiotherapy	bfjpnyjugw(irugtmsuqf) = ibjoayvlja tihhxhksfi (uxakzacoar, 8.8 - 11.2)
NCT02985125 (CTgov)	Phase 1/2	Pancreatic adenocarcinoma metastatic	12	LEE011+everolimus (Phase I - Dose Level 1)	sfzvowfeit(kduvxysdie) = hfxwlazxqm pwbzivhaaw (ncbshcrmeo, swcmmzbpxm - vjtufqxnds) View more	-	07 Apr 2026
				LEE011+everolimus (Phase I - Dose Level 2)	sfzvowfeit(kduvxysdie) = axenkgsdrz pwbzivhaaw (ncbshcrmeo, lmdzxbsdfi - ojzgzckfau) View more
SABCS2025	Phase 1	Breast Cancer RICTOR \| RPTOR	9	Everolimus Nanoparticle (Sapu003) (high-RICTOR / low-RPTOR signature)	caxdsgmuvg(fdatffwomz) = liusetrpfd ygrgntdwyf (ktmdytkxbo ) View more	Positive	11 Dec 2025
NCT03032406 (CLEVER, SABCS2025)	Phase 2	Breast Cancer ER+ \| HER2+ \| CK	51	Hydroxychloroquine (HCQ)	kwyuvcbiel(swsgvjcdff) = wbucgvjmxq sikifjqscu (vajnhbsflo ) View more	Positive	11 Dec 2025
				Everolimus (EVE)	-
SABCS2025	Not Applicable	Hormone receptor positive HER2 negative breast cancer HR+ \| HER2- \| PI3K/AKT/PTEN pathway alterations	72	≥2 pathway inhibitors sequentially	svacebmfuw(vylshogtjm) = fjcyskfspx hhwxuebzky (sulhdkxoif, 9 - 28)	Positive	10 Dec 2025
				alpelisib alone	svacebmfuw(vylshogtjm) = ftfzzheexo hhwxuebzky (sulhdkxoif, 5 - 8)
SABCS2025	Not Applicable	Hormone receptor positive HER2 negative breast cancer Second line	281	Everolimus plus endocrine therapy	vgfbsmpncx(fhimhkkeme): HR = 1.8 (95.0% CI, 1.07 - 3.04), P-Value = 0.0269 View more	Positive	10 Dec 2025
				Chemotherapy alone or combined with maintenance endocrine therapy
ESMO_ASIA2025	Not Applicable	Advanced Neuroendocrine Neoplasm First line	67	Everolimus + Somatostatin analogues	zuibjvcsej(qmamjnvmmr) = wgqgxtegdm szvinjbyfq (syrkoycigk ) View more	Positive	05 Dec 2025
				Everolimus	zuibjvcsej(qmamjnvmmr) = noovtaywuz szvinjbyfq (syrkoycigk ) View more
NCT03386539 (Pubmed \| JAMA)	Phase 3	Cardiac transplant rejection	211	Everolimus and low-dose tacrolimus	abimtgwprn(sffiduwinw): HR = 0.5 (95.0% CI, 0.26 - 0.93) View more	Positive	21 Oct 2025
				Standard-dose tacrolimus and mycophenolate mofetil
JPRN-jRCT1031200023 (JCOG1901, ESMO2025)	Phase 3	Gastro-Enteropancreatic Neuroendocrine Tumor First line	178	Everolimus + Lanreotide	syzqgicdlh(lnwtbchhwq) = kyiaufkwat wxbcshtdcs (jepvoveilm ) View more	Positive	17 Oct 2025
				Everolimus	syzqgicdlh(lnwtbchhwq) = tzcjlltfas wxbcshtdcs (jepvoveilm ) View more

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