Sapu Nano to present at the 2025 San Antonio Breast Cancer Symposium (SABCS) Highlighting Sapu003 (Deciparticle™ Everolimus)

Rhea-AI Summary

Oncotelic Therapeutics (OTLC) announced that Sapu Nano's investigational intravenous Deciparticle™ everolimus (Sapu003) has been accepted for presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS), December 9–12, 2025, in San Antonio, TX. The company said the accepted abstracts cover clinical rationale, molecular biomarkers, and pharmacokinetic support for an ongoing Phase 1 trial of Sapu003 in HR+/HER2- metastatic breast cancer, renal cell carcinoma (RCC), and neuroendocrine tumors (NET).

The presentation session is scheduled for Thursday, December 11, 2025, 5:00 PM–6:30 PM CST and includes three abstracts focused on a RICTOR/RPTOR biomarker signature, formulation and manufacturing, and pharmacokinetic rationale for IV everolimus.

AGOURA HILLS, Calif., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. (OTCQB: OTLC), a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat cancer patients by leveraging its novel PDAOAI platform and deep knowledge in nanomedicines and the tumor microenvironment, announced today that Sapu Nano will be featuring its investigational intravenous Deciparticle^™ everolimus (Sapu003) have been accepted for presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS), to be held December 9–12, 2025, at the Henry B. Gonzalez Convention Center, San Antonio, Texas. Sapu Nano is the developer of Deciparticle^TM and is part of Sapu family of companies and a joint venture between Oncotelic (OTCQB:OTLC) and Dragon Oversea.

Sapu003 is a novel Deciparticle^™ formulation of everolimus for intravenous administration, designed to overcome the pharmacologic limitations of oral mTOR inhibitors (Afinitor^®), including poor bioavailability, dose-limiting toxicity, and restricted tumor penetration. Collectively, the accepted abstracts highlight the clinical rationale, molecular biomarkers, and pharmacokinetic justification supporting the ongoing Phase 1 trial of Sapu003 in hormone receptor–positive (HR⁺)/HER2⁻ metastatic breast cancer and RCC and NET.

1. Renal Cell Carcinoma (RCC): FDA approved oral Everolimus for advanced RCC after failure of sunitinib and/or sorafenib. Approval was based on RECORD-1 randomized phase III (everolimus 10 mg PO daily vs placebo + best supportive care) showing a PFS benefit (median 4.9 vs 1.9 mo; HR≈0.33).
2. Pancreatic NET (pNET): FDA approved Everolimus for Pancreatic NET (pNET). Approval was based on RADIANT-3 (everolimus vs placebo in progressive, advanced pNET), which significantly prolonged PFS.
3. GI and Lung NET (lNET): FDA approved Everolimus for GI & lung NET. Approval was based on RADIANT-4 (non-functional, well-differentiated, nonresectable/metastatic GI or lung NET), showing a PFS benefit.

Patients and Investigators – please contact Ingenu for trial participation.

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Presentation Session:
Thursday, December 11, 2025 | 5:00 PM – 6:30 PM CST

Abstract Number	Presentation Number	Title
1834	PS4-04-04	High RICTOR / Low RPTOR Gene‐Expression Signature as a Predictive Biomarker for Intravenous Everolimus Nanoparticle (Sapu003): Rationale for the First‐in‐Human Trial
1702	PS4-04-21	Deciparticle™ Everolimus (Sapu003): From Cytostasis to Cytotoxicity via a Single mPEG Polymer and Clinic-Ready Manufacturing
1811	PS4-06-05	Sapu003: Everolimus for Injection — Pharmacokinetic Rationale for Phase I Evaluation in HR⁺/HER2⁻ Metastatic Breast Cancer

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The studies were conducted in collaboration with Southern Oncology Clinical Research Unit (SOCRU), Ingenu CRO, and Medicilon, and reflect a coordinated clinical–translational effort bridging molecular biomarker discovery, pharmacokinetic modeling, and scalable GMP manufacturing of Deciparticle^™ everolimus.

About Oncotelic

Oncotelic (f/k/a Mateon Therapeutics, Inc.), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November 2020. Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Oncotelic has rare pediatric designation for Diffuse Intrinsic Pontine Glioma “DIPG” (through OT-101) through its 45% joint venture, melanoma (through CA4P), and Acute Myeloid Leukemia “AML” (through OXi 4503). Oncotelic also acquired PointR Data Inc. in November 2019.

Oncotelic acquired AL-101, during the 4th quarter of 2021, for the intranasal delivery of apomorphine. We intend to develop AL-101 for the treatment of Parkinson Disease ("PD"). Over 60,000 new patients are being diagnosed with PD in the United States and currently there are over 1 million patients in the US and expected to increase to over 1.2 million by 2030. In addition, approximately 10 million suffer from this disease globally. https://www.parkinson.org/Understanding-Parkinsons/Statistics. AL-101 is also being developed for Erectile Dysfunction ("ED"). ED is the most prevalent male sexual disorder globally. The percentages of men affected by ED are as follows: 14.3-70% of men aged 60 years, 6.7-48% of men aged 70 years, and 38% of men aged 80 years (Geerkens MJM et al. (2019). Eur Urol Focus. pii: S2405-4569(19)30079-3). However, with the increasing administration of PDE5 inhibitors in clinical practice, it was found that approximately 30-35% of ED patients are treatment failures (McMahon CN et al. (2006). BMJ, 332: 589-92). AL-101 is designed to target treatment failure ED patients who do not respond to PDE5 inhibitors. Through similar mechanism of action, AL-101 is being developed for Female Sexual Dysfunction ("FSD"). Female sexual dysfunction is a prevalent problem, afflicting approximately 40% of women and there are few treatment options. FSD is more typical as women age and is a progressive and widespread condition. (Allahdadi, KJ et al. (2009) Cardiovascular & hematological agents in medicinal chemistry, 7(4), 260-269). There is no available drug for the treatment of FSD. In June 2019, the U.S. Food and Drug Administration approved Vyleesi (bremelanotide) to treat acquired, generalized hypoactive sexual desire disorder ("HSDD") in premenopausal women. This is the only available drug treatment. Vyleesi has essentially replaced the only other drug for HSDD - however, it has a long list of drug-drug interactions, including commonly used antidepressants, such as fluoxetine and sertraline. In addition, it has a black box warning regarding its use with alcohol, a combination that has been associated with hypotension and syncopal episodes. Therefore, there is an urgent need for effective therapy against FSD and HSDD.

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This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”) that involve substantial risks and uncertainties. We generally identify forward-looking statements by terminology such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “would,” “intend,” “target,” “aim,” “project,” “believe,” “estimate,” “predict,” “potential,” “seek,” “indicate,” or “continue” or the negative of these terms or other similar words, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements regarding our or our management’s expectations, hopes, beliefs, intentions or strategies regarding the future, such as our estimates regarding anticipated operating income or losses, future performance, future revenues and projected expense, including that to fund our clinical and other development programs; our liquidity and our expectations regarding our needs for and ability to raise additional capital; our ability to continue as a going concern; our ability to select and capitalize on commercially desirable product opportunities as a result of limited financial resources; our ability to manage our expenses effectively and raise the funds needed to continue our business; our ability to retain the services of our current or future executive officers, directors and principal consultants; the competitive nature of our industry and the possibility that our products or product candidates may become obsolete or may not generate revenues as expected or at all; our ability to obtain and maintain regulatory approval of our existing products and any future products we may develop; the development of and the process of commercializing AI/Blockchain and other technologies for supporting the development of OT- 101 and Artemisinin for COVID-19, OT-101, including development of OT-101, Artemisinin, OXi4503, CA4P and our 2021 in-licensing of apomorphine; the initiation, timing, progress and results of our preclinical and clinical trials, research and development programs; regulatory and legislative developments in the United States and foreign countries; the timing, costs and other limitations involved in obtaining regulatory approval for any product; the further preclinical or clinical development and commercialization of our product candidates; the entering into any corporate transactions to develop our products through partnerships, joint ventures or other corporate transactions; our ability to make a proposed initial public offering between us and our joint-venture partners for the joint venture, statements about future plans related to the operations of the JV, taking the JV into an initial public offering or the success thereof: building and the success of our nanoparticle platform and the related success of launching the platform; the expected valuation of the JV, and therefore a corresponding increase in the valuation of the Company, by virtue of it’s ownership in the JV; the success of the launch of Pet2DAO, a corporation with a DAO infrastructure, the success of Pet2DAO and the plans surrounding the pet and animal health, the ability for the Company to register the tokens of Pet2DAO, the actual filing of a registration statement and approval of the tokens as registrable securities with the Securities and Exchange Commission (“SEC”) through a registration statement, the ability of the tokens to be tradable or any value such tokens may have if they become tradable; our ability to obtain and maintain orphan drug exclusivity for some of our product candidates; the potential benefits of our product candidates over other therapies; our ability to enter into and maintain any collaboration with respect to product candidates; our ability to continue to develop or commercialize our products or product candidates in the event any license agreements in place with third parties expire or are terminated; the performance and conduct of third parties, including our third-party manufacturers and third party service providers used in our clinical trials; our ability to obtain and maintain intellectual property protection for our products and operate our business without infringing upon the intellectual property rights of others; the potential liability exposure related to our products and our insurance coverage for such exposure; our ability to form alliances with other third parties to develop the products in our pipeline through partnerships, joint ventures, mergers or acquisitions; the successful development of our sales and marketing capabilities; the size and growth of the potential markets for our products and our ability to serve those markets; the rate and degree of market acceptance of any future products; the volatility of the price of our common stock; the ability to achieve secondary trading of our stock in certain states; the dilutive effects of potential future equity issuances; 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Contact Information:
For Oncotelic Therapeutics, Inc.:
Investor Relations
ir@oncotelic.com

FAQ

What will Oncotelic (OTLC) present about Sapu003 at SABCS 2025?

Oncotelic will present three abstracts on Sapu003 covering a RICTOR/RPTOR biomarker, Deciparticle formulation and manufacturing, and pharmacokinetic rationale for a Phase 1 trial.

When and where is the Sapu003 presentation at SABCS 2025 for OTLC (OTLC)?

The presentation is scheduled for Thursday, December 11, 2025, 5:00 PM–6:30 PM CST at the Henry B. Gonzalez Convention Center in San Antonio, Texas.

Which indications are being evaluated for Sapu003 in the Phase 1 trial mentioned by OTLC (OTLC)?

The ongoing Phase 1 trial evaluates Sapu003 in HR+/HER2- metastatic breast cancer, renal cell carcinoma (RCC), and neuroendocrine tumors (NET).

How does Sapu003 differ from oral everolimus according to the OTLC announcement?

Sapu003 is an intravenous Deciparticle formulation designed to address oral everolimus' limitations including bioavailability, dose-limiting toxicity, and tumor penetration.

Who should investigators or patients contact to participate in the Sapu003 trial referenced by OTLC (OTLC)?

Investigators and patients are directed to contact Ingenu (contact details provided) for trial participation and site information.