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AGOURA HILLS, Calif., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. (OTCQB: OTLC) 45% owned Joint Venture, Sapu Nano, a clinical-stage nanomedicine company, today announced new data demonstrating that its proprietary Deciparticle™ platform enables broad and consistent formulation of structurally diverse hydrophobic therapeutics—including macrolide mTOR inhibitors, cyclic peptides, linear peptides, ascomycin macrolactams, and polyketides—while maintaining a precise sub-20 nm nanoparticle profile suitable for intravenous (IV) delivery. These findings, presented at the 2025 San Antonio Breast Cancer Symposium (SABCS), confirm that the Deciparticle™ technology represents a chemically versatile, cGMP-ready delivery platform with the potential to support an expanding pipeline of oncology and immunology drug products. Presentation info: PS4-04-21. Deciparticle™ Everolimus (Sapu003): From Cytostasis to Cytotoxicity via a Single mPEG Polymer and Clinic-Ready Manufacturing. Sheng-Hao Min, Kevin Forero, Johnathan Anderson, William Putnam, Can Evizi, Cassidy McCallum, Robert Hoff, Mark Ostrander, and Kwun Ho. Deciparticle™ Platform Demonstrates Broad Formulation Capability Across Therapeutic Classes New data from a comprehensive screening effort show that Sapu Nano’s optimized polymer reproducibly forms monodisperse nanoparticles (~15 nm) capable of encapsulating multiple classes of hydrophobic drugs: Macrolide mTOR Inhibitors All five clinically relevant macrolide immunosuppressants formed stable Deciparticles™: SirolimusTemsirolimusRidaforolimusUmirolimusEverolimus Differences in substitution at the C-40/C-42 or C-33 positions did not impair nanoparticle formation, highlighting the platform’s tolerance for structural diversity within the macrolide family. Ascomycin Macrolactams Tacrolimus formed stable sub-20 nm Deciparticles™.Pimecrolimus, while encapsulated, produced particle sizes above the Deciparticle™ threshold—defining a steric upper bound for the platform and its suitability for optimized macrolactam design. Cyclic and Linear Peptides The Deciparticle™ platform successfully formulated two medically important peptide classes: Cyclosporine A (hydrophobic cyclic peptide)Exenatide (synthetic linear peptide) These findings demonstrate the platform’s ability to handle both compact hydrophobic macrocycles and amphipathic linear peptides—an important expansion for peptide-based therapeutic pipelines. Robust and Scalable cGMP Manufacturing The platform is supported by Sapu Nano’s ISO-5 cGMP facility capable of: One-pot bulk drug manufacturingSterile filtrationAutomated fill/finishLyophilization into a stable, clinic-ready drug productHigh batch reproducibilityDays to weeks post-reconstitution stabilityPrecision particle-size control with tight lot-to-lot consistency This cGMP infrastructure enables fast, reliable translation from formulation to Phase 1 supply, supporting multiple INDs annually. “With these new data, the Deciparticle™ platform has emerged as a broad, modular nanomedicine engine capable of formulating multiple classes of hydrophobic drugs that were previously constrained by solubility and delivery barriers,” said Dr. Vuong Trieu, Chief Executive Officer of Sapu Nano. “This platform advances beyond single-asset value to a multi-asset opportunity across oncology, immunology, and peptide therapeutics. Sapu003 is only the beginning.” About the Deciparticle™ Platform The Deciparticle™ platform is a proprietary nanotechnology engineered to encapsulate hydrophobic molecules as uniform, sub-20 nm nanoparticles for intravenous administration. The platform improves systemic exposure, reduces GI deposition, and supports precision delivery while maintaining manufacturability at clinical scale. About Sapu Nano Sapu Nano is a clinical-stage biotechnology company developing Deciparticle™ nanomedicine therapeutics designed to optimize the delivery of hydrophobic oncology agents and peptide-based therapeutics. The company operates an integrated ISO-5 cGMP manufacturing facility supporting rapid progression from formulation to clinical trial supply. For more information, visit www.sapunano.com. 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. Oncotelic's Cautionary Note on Forward-Looking Statements 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; our expectation that no dividends will be declared on our common stock in the foreseeable future; our ability to maintain an effective system of internal controls; the payment and reimbursement methods used by private or governmental third-party payers; our ability to retain adequate staffing levels; unfavorable global economic conditions; unfavorable global epidemic and pandemic conditions; a failure of our internal computer systems or those of our contractors and consultants; potential misconduct or other improper activities by our employees, contractors or consultants; the ability of our business continuity and disaster recovery plans to protect us in the event of a natural disaster; and other factors discussed elsewhere in this document or any document incorporated by reference herein or therein. Contact Information:For Oncotelic Therapeutics, Inc.:Investor Relationsir@oncotelic.com

AUSTIN, Texas, Nov. 24, 2025 (GLOBE NEWSWIRE) -- BioMedWire Editorial Coverage: As advanced biotech programs move closer to commercialization, fair-value adjustments under U.S. Generally Accepted Accounting Principles (GAAP) are increasingly recognized as meaningful signals of real scientific and business advancement. These valuations help translate research achievements into quantifiable economic impact, giving investors clearer insight into how innovation converts into company value. Oncotelic Therapeutics Inc. (OTCQB: OTLC) (profile) this trend as it prepares for a major fair-value update on its 45% ownership in joint venture (JV) partner GMP Bio, following a new independent assessment that points to a substantial increase in the asset’s worth. This development further reinforces Oncotelic Therapeutics’ position as a treatment leader, along with others in the oncology-treatment space, including Iovance Biotherapeutics Inc. (NASDAQ: IOVA), Merck & Co. Inc. (NYSE: MRK), Eli Lilly and Company (NYSE: LLY) and Johnson & Johnson (NYSE: JNJ). Oncotelic and GMP initially formalized their partnership in 2022, but the joint venture’s newly assessed valuation has introduced a significant new layer of value to the collaboration. With a 45% interest in GMP Bio, Oncotelic’s proportional implied asset value adds up to an estimated $765 million.The JV valuation is closely aligned with progress in Oncotelic’s Deciparticle nanomedicine portfolio, notably Sapu-003.Fair-value reporting under U.S. GAAP is becoming a more essential tool for development-stage biopharma companies.The upward valuation revision, combined with maturing clinical programs and the anticipated GAAP fair-value adjustment, reflects a company transitioning from scientific validation to broader financial recognition. Click here to view the custom infographic of the Oncotelic Therapeutics editorial. Rising Valuation Reflects Growing Market Trust Oncotelic and GMP initially formalized their partnership in 2022, but the joint venture’s newly assessed valuation, approximately $1.7 billion based on an independent analysis by Frost & Sullivan (Hong Kong), has introduced a significant new layer of value to the collaboration. This updated estimate reflects the ongoing scientific and clinical progress within GMP Bio’s development programs, including the advancement of OT-101, an RNA therapeutic designed to inhibit TGF-β in oncology applications. As the company notes, Oncotelic’s 45% equity position in the JV translates into an illustrative potential value of roughly $765 million. This figure is forward-looking, nonbinding, and does not represent a U.S. GAAP fair-value measurement. “This represents one of the most significant milestones in Oncotelic’s history,” said Oncotelic CEO Dr. Vuong Trieu. “The independent valuation recognizes the multiyear scientific and clinical progress achieved through our GMP Bio joint venture and affirms the long-term potential of OT-101 and our Deciparticle nanomedicine platform.” Clinical Progress Strengthens Development Momentum The company recently highlighted a series of additional accomplishments across its clinical and regulatory programs, offering further evidence of a pipeline transitioning into later-stage maturity. Oncotelic’s portfolio includes multiple advanced candidates targeting oncology and rare diseases, each of which has achieved noteworthy developmental progress. Those accomplishments include the following: OT-101 (TGF-β inhibitor): Phase 3 for pancreatic cancerOXi4503 (vascular disrupting agent): Phase 2 acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), advancing toward pivotal phase 3 designCA4P/Fosbretabulin: Late-stage oncology asset currently under repositioningAL-101 (intranasal apomorphine): phase 2 for Parkinson’s disease and sexual dysfunctionsAL-102 (oligonucleotide antisense via intrathecal injection): Discovery stage for Alzheimer’s diseasePediatric rare disease programs: Targeting orphan indications with the potential to generate Priority Review Vouchers (PRVs)Nanomedicine Deciparticle pipeline: Advancing multiple 505(b)(2) drug candidates into clinical testing, leveraging the 505(b)(2) pathway—a faster and more cost-efficient route to market approval compared to a full New Drug Application (NDA). “OTLC has achieved steady progress across multiple programs, strengthening our position as a late-stage biotech with broad value creation potential,” commented Dr. Trieu. “Our pipeline addresses multibillion-dollar markets with high unmet medical need.” The increasing global validation of nanomedicine platforms such as Deciparticle(TM) adds even more context to the valuation. Worldwide nanomedicine revenues are projected to surpass $350 billion by 2032, propelled by oncology applications, improved therapeutic indices and advances in targeted drug delivery. As the economic footprint of nanomedicine grows, technologies such as GMP Bio’s Deciparticle platform may command increasingly higher value as they advance toward commercialization. This valuation event signals a broader trend in capital markets, where investors are beginning to quantify scientific advancement earlier in the development cycle, narrowing the traditional divide between bench research and recognized enterprise value. Minority Interest Positioned for Major Upside With a 45% interest in GMP Bio, Oncotelic’s proportional implied asset value adds up to an estimated $765 million. Although this figure is not yet recognized on the balance sheet under U.S. GAAP, it lays the groundwork for a potential significant increase in reported assets once the company completes its ASC-compliant valuation review. “If the forthcoming ASC-compliant valuation supports a carrying value materially higher than the current balance sheet amount, Oncotelic may recognize an increase in the reported value of its minority interest in GMP Bio in future reporting periods,” the company stated. “Any such adjustment would be recorded in accordance with U.S. GAAP fair-value measurement standards and could result in a meaningful increase to total assets and shareholders’ equity. The magnitude and timing of any accounting impact will depend entirely on the conclusions of the independent valuation and applicable accounting guidance.” Minority-interest valuations have become increasingly important as joint ventures and platform-based business models take on a larger role in biotechnology. For investors, these remeasurements provide a clearer benchmark for assessing how early-stage therapeutic platforms compare with peers in immuno-oncology, RNA therapeutics and next-generation drug delivery. Nanomedicine Platform Moves Toward Commercialization The JV valuation is closely aligned with progress in Oncotelic’s Deciparticle nanomedicine portfolio, notably Sapu-003, an intravenous reformulation of oral everolimus, labeled as Afinitor(R) and designed to achieve full bioavailability and enhanced tumor penetration. The company has confirmed the program’s progression toward a first-in-human clinical study in Australia for metastatic breast cancer. Nanoparticle-based delivery systems are designed to address long-standing problems associated with conventional therapeutics. As Science Direct reports, “Nanoparticles have transformed contemporary medicine by improving bioavailability, targeting and drug release mechanisms. . . . Traditional drug delivery methods typically exhibit minimal therapeutic efficacy due to rapid elimination, inadequate solubility and systemic toxicity. The distinctive physicochemical characteristics of nanoparticles provide targeted drug distribution to specific areas, reducing harmful consequences.” Oncotelic has previously stated that Sapu-003 is expected to deliver full bioavailability compared to oral everolimus, which is currently approved as Afinitor across several cancer indications. Alongside Sapu-003, the company and GMP Bio plan to expand OT-101 development into pancreatic cancer and other difficult-to-treat solid tumors, with opportunities for biomarker-driven patient selection. As nanomedicine enters a phase of wider commercial adoption, platforms with strong IP protection and scalable GMP manufacturing capacity stand to gain from increased licensing and partnership activity. Fair-Value Reporting Mirrors Scientific Gains Fair-value reporting under U.S. GAAP is becoming a more essential tool for development-stage biopharma companies, especially those structured through joint ventures or IP-driven licensing models. Under ASC 820, fair-value adjustments can be recognized when supported by reliable, independently produced valuation evidence, subject to audit and disclosure requirements. The recent valuation reinforces alignment between scientific achievement and financial reporting, helping investors better understand progression in early- and mid-stage biotech assets. Unlike milestone-based accounting, fair-value remeasurement enables the market to assess progress across therapeutic candidates, modalities and clinical stages with greater precision. This shift signals a more transparent alignment between actual scientific advancement and recognized enterprise value. Expansive IP Foundation Enables Future Growth The upward valuation revision, combined with maturing clinical programs and the anticipated GAAP fair-value adjustment, reflects a company transitioning from scientific validation to broader financial recognition. What may be most promising is how the platform positions Oncotelic for future expansion, particularly through additional partnerships and licensing opportunities. Oncotelic CEO Dr. Vuong Trieu holds 75 issued patents and has filed more than 500 patent applications. This extensive IP portfolio forms the foundation for future collaborations, co-development structures and potential joint ventures. Historically, IP-rich nanomedicine platforms, including lipid nanoparticle systems and antibody-drug conjugate technologies, have generated significant partnering interest and high-value transactions. Oncotelic’s structure supports selective partnership models that share development risk while maintaining meaningful economic exposure to platform-generated therapeutic opportunities. With GMP Bio reportedly exploring a potential Hong Kong Stock Exchange IPO in late 2026, Oncotelic may gain further access to capital markets increasingly focused on advanced oncology and precision drug delivery. The company’s anticipated fair-value reassessment for its GMP Bio stake represents more than an accounting update; it reflects a fundamental evolution in how the market captures the worth of biopharmaceutical innovation. As the JV’s valuation moves toward a potential $1.7 billion, investors may gain a clearer financial link between scientific advancements and commercial potential. With an advancing nanomedicine pipeline, a strong intellectual property base and rising clinical momentum, Oncotelic illustrates how technical progress, transparent financial reporting and emerging shareholder value can align. Advances Accelerate Across Global Cancer Treatment Landscape New developments in oncology continue to reshape the therapeutic landscape as researchers, regulators and innovators push forward with next-generation cancer treatments. Recent updates across immunotherapy, targeted therapies and novel mechanism platforms highlight the growing momentum behind efforts to improve survival outcomes and expand options for patients facing complex and aggressive diseases. Iovance Biotherapeutics Inc. (NASDAQ: IOVA) announced interim data from its registrational phase 2 IOV-LUN-202 trial of lifileucel monotherapy in patients with previously treated advanced nonsquamous NSCLC without actionable genetic mutations. According to the company, the objective response rate was 25.6% by RECIST v1.1 following one-time treatment with lifileucel monotherapy in patients with advanced nonsquamous NSCLC. An objective response was observed in 10 out of 39 patients, including 2 complete responses, 7 partial responses and 1 unconfirmed PR (pending confirmatory assessment), with a disease control rate of 71.8%. The median duration of response was not reached after a median follow up of 25.4 months. Merck & Co. Inc. (NYSE: MRK) has received approval from the European Commission (EC) for KEYTRUDA(R) (pembrolizumab), Merck’s anti-PD-1 therapy. The approval is for monotherapy for the treatment of resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adults whose tumors express PD-L1 with a Combined Positive Score ≥1. This approval marks the first and only anti-PD-1 treatment option for certain patients with resectable LA-HNSCC in the European Union (EU) and the third approval for KEYTRUDA in HNSCC in the EU. Eli Lilly and Company (NYSE: LLY) announced results from the primary overall survival (OS) analysis of the phase 3 monarchE trial showing that two years of adjuvant Verzenio plus endocrine therapy (ET) reduced the risk of death by 15.8% versus ET alone and resulted in sustained long-term improvements in invasive disease-free survival and distant relapse-free survival, in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, high-risk early breast cancer. These results were published in the “Annals of Oncology.” Johnson & Johnson (NYSE: JNJ) has entered into a definitive agreement to acquire Halda Therapeutics OpCo Inc. (Halda), a clinical-stage biotechnology company. Halda has a proprietary Regulated Induced Proximity TArgeting Chimera (RIPTAC) platform to develop oral, targeted therapies for multiple types of solid tumors, including prostate cancer. According to the company, the transaction will total $3.05 billion in cash and is expected to close within the next few months, subject to antitrust clearance and other customary closing conditions. These milestones demonstrate the steady and diverse evolution of modern oncology, where new approvals, promising clinical results and strategic acquisitions signal expanding investment in life-extending cancer therapies. As research deepens and treatment strategies become more sophisticated, these advancements will continue to influence standards of care and shape the future direction of cancer medicine worldwide. For more information, visit Oncotelic Therapeutics Inc. 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