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AUSTIN, Texas, Nov. 20, 2025 (GLOBE NEWSWIRE) -- BioMedWire Editorial Coverage: As late-stage biotech pipelines mature, fair-value remeasurements under U.S. Generally Accepted Accounting Principles (GAAP) are emerging as critical indicators of tangible scientific and commercial progress. These revaluations provide a financial bridge between laboratory breakthroughs and shareholder value, offering investors a clearer picture of how innovation becomes measurable enterprise worth. Oncotelic Therapeutics Inc. (OTCQB: OTLC) (profile) exemplifies this shift as the company prepares for a significant fair-value remeasurement of its 45% stake in joint venture (JV) entity GMP Bio, driven by a new independent valuation https://nnw.fm/5K7hg indicating a potential step-up in asset value. This key shift strengthens Oncotelic Therapeutics position in the oncology space as the company works to make a difference, along with other innovative leaders such as IO Biotech Inc. (NASDAQ: IOBT), Novartis AG (NYSE: NVS), Bicara Therapeutics Inc. (NASDAQ: BCAX) and Pfizer Inc. (NYSE: PFE) The JV’s newly estimated valuation of approximately $1.7 billion has added value to the partnership.With 45% ownership in GMP Bio, Oncotelic’s proportional implied asset value stands at approximately $765 million. The valuation is closely tied to progress in the Oncotelic’s Deciparticle(TM) nanomedicine platform, including Sapu-003, injectible Everolimus (Afinitor(R))Fair-value remeasurement under U.S. GAAP has become increasingly relevant for development-stage biopharmaceutical companies.Taken together, the valuation step-up, maturing clinical programs and forthcoming fair-value remeasurement illustrate a company moving from scientific promise to financial recognition. Click here to view the custom infographic of the Oncotelic Therapeutics editorial. New Valuation Signals Evolving Market Confidence Oncotelic and GMP announced their venture in 2022, but the JV’s newly estimated valuation of approximately $1.7 billion, based on an independent third-party analysis conducted by Frost & Sullivan (Hong Kong), has added value to the partnership. The valuation reflects continued research and development (R&D) advances in clinical programs governed by GMP Bio, including development of OT-101, an RNA therapeutic candidate targeting TGF-β for oncology indications. According to the company, based on Oncotelic’s 45% ownership interest, this valuation represents an illustrative potential value to the company of approximately $765 million; the valuation is nonbinding, forward looking and does not represent fair value under U.S. GAAP. “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.” Pipeline Milestones The company recently outlined additional meaningful progress in clinical development and regulatory strategy across its pipeline, reinforcing a trend toward late-stage maturation. Oncotelic’s pipeline includes multiple late-stage programs targeting oncology and rare diseases, with several drug candidates achieving significant key milestones. Those milestones 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,” said Oncotelic chair and CEO Dr. Vuong Trieu. “Our pipeline addresses multibillion-dollar markets with high unmet medical need.” The growing market credibility of nanomedicine Deciparticle technologies further contextualizes this valuation. Global nanomedicine revenue is projected to exceed $350 billion by 2032, driven by oncology applications, improved therapeutic index and targeted delivery methodologies. This expanding economic footprint underscores why platforms such as GMP Bio’s Deciparticle(TM) nanomedicine engine may command substantially greater valuation premiums as clinical translation advances. This valuation milestone illustrates how capital markets are beginning to quantify and price biotech innovation earlier in the drug-development lifecycle, narrowing the traditional gap between scientific progress and accounting recognition. Strategic Stake with Transformational Potential With 45% ownership in GMP Bio, Oncotelic’s proportional implied asset value stands at approximately $765 million. This illustrative estimate does not yet represent U.S. GAAP-recognized value, but it sets the stage for a substantial potential balance-sheet expansion when the company completes an ASC-compliant valuation process. “If the forthcoming ASC-compliant valuation supports a carrying value materially higher than the amount currently reflected on balance sheet, 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.” The importance of minority-interest remeasurement has expanded as joint venture and platform-licensing models become more common in biotech. For investors, such metrics provide an improved lens for comparing therapeutic enterprise value relative to peers in immuno-oncology, RNA therapeutics, and advanced drug delivery. Advancing Nanomedicine from Trials to Markets The valuation is closely tied to progress in the Oncotelic’s Deciparticle nanomedicine platform, including Sapu-003, an intravenous reformulation of oral everolimus (Afinitor) designed for full bioavailability and improved tumor penetration. The company recently confirmed advancement toward first-in-human clinical trial evaluation in Australia for metastatic breast cancer. The technology aims to address the well-documented challenges of targeted drug delivery, as nanoparticles have demonstrated capacity to overcome systemic and cellular barriers that limit therapeutic efficacy. “Nanoparticles have transformed contemporary medicine by improving bioavailability, targeting and drug release mechanisms,” reported Science Direct. “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.” The company previously announced that Sapu-003 will deliver full bioavailability relative to oral everolimus, which is currently marketed as Afinitor for multiple cancers indications. Beyond Sapu-003, GMP Bio and Oncotelic plan expanded clinical development for OT-101 in pancreatic and other solid tumors, with potential biomarker-driven selection strategies. As nanomedicine approaches commercial inflection, platforms with robust IP protection and scalable manufacturing infrastructure, such as GMP-certified facilities, may benefit from accelerated licensing and co-development demand. Accounting That Reflects Real Progress Fair-value remeasurement under U.S. GAAP has become increasingly relevant for development-stage biopharmaceutical companies, particularly those relying on joint ventures and IP licensing rather than wholly owned pipelines. The Accounting Standards Codification governing fair-value reporting (ASC 820) permits changes in fair value to be recognized when supported by credible independent valuation evidence, subject to audit and reporting requirements. The recent revaluation may create a clearer alignment between scientific progress and enterprise valuation, addressing long-standing investor challenges in measuring early-stage biotech asset appreciation. Unlike traditional milestone-driven accounting, fair-value recognition enables investors to assess relative progress across candidates, modalities and clinical development stages. This approach supports an evolution toward more transparent biotechnology finance where value attribution more closely matches real-world medical and regulatory progression. Patent-Backed Platform Built for Scaling Taken together, the valuation step-up, maturing clinical programs and forthcoming fair-value remeasurement illustrate a company moving from scientific promise to financial recognition. And perhaps the most compelling signal of long-term potential lies not only in what has been built so far, but in what this platform can enable next, particularly as Oncotelic prepares to leverage its technology and intellectual property across additional partnerships. The company’s CEO, Dr. Vuong Trieu, holds 75 issued patents and filed more than 500 total patent applications. IP assets form the cornerstone of potential future collaborations, licensing models and joint venture structures. IP-anchored nanomedicine platforms have historically drawn significant partner interest, with notable precedent-setting transactions in lipid nanoparticle delivery, such as mRNA vaccine platforms, and antibody-drug conjugates. Oncotelic’s structure allows for selective codevelopment strategies, enabling shared risk while maintaining economic exposure to platform-driven therapeutic opportunities. With GMP Bio reportedly assessing a potential Hong Kong Stock Exchange IPO in late 2026, the company may benefit from expanded access to capital markets that have shown increasing appetite for advanced oncology and drug-delivery technologies. Oncotelic’s anticipated fair-value remeasurement for its GMP Bio stake is more than an accounting development; it represents a broader shift in how public markets measure the value of biotech innovation. As the JV’s valuation reaches a potential $1.7 billion, these adjustments may offer investors a clearer financial link between bench-side invention and real commercial potential. With a maturing nanomedicine pipeline, expanding intellectual-property estate, and increasing clinical momentum, Oncotelic stands as an example of how scientific progress, financial reporting transparency and shareholder value creation can converge. Advances in Oncology Research Accelerate New Treatment Paths New developments in cancer research are driving momentum across the oncology landscape, with novel immunotherapies, next-generation cell therapies and late-stage clinical results offering promising signs for patients and clinicians. Recent data presentations, regulatory milestones and trial initiations highlight the expanding potential of targeted treatments designed to address both solid tumors and complex immune-related diseases. IO Biotech Inc. presented new preclinical data for its next vaccine candidate, IO112, and additional candidate, IO170, at the Society for Immunotherapy of Cancer’s 40th Annual Meeting. “This new data is extremely important for our development path as it points toward more potential indications for our novel, immune-modulatory therapeutic vaccines to treat patients with a range of cancers,” said IO Biotech CEO and president Mai-Britt Zocca. “We look forward to advancing our cancer immunotherapy pipeline and expect to file an Investigational New Drug Application for IO112, our next candidate expected to enter clinical development, in 2026.” Novartis AG announced positive results from KALUMA, a phase 3 study for new malaria treatment KLU156 (ganaplacide/lumefantrine, or GanLum). The novel nonartemisinin antimalarial, which was developed with Medicines for Malaria Venture, met the study’s primary endpoint of noninferiority to the current standard of care. The trial studied 1,688 adults and children across 34 sites in 12 African countries, with GanLum given as a sachet of granules once a day for three days. Additional analysis indicated the treatment was highly effective against mutant malaria parasites associated with partial drug resistance. Bicara Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to ficerafusp alfa in combination with pembrolizumab. The designation is for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) whose tumors express programmed death-ligand 1 with combined positive score (CPS) ≥1, excluding human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma. Pfizer Inc. and Astellas Pharma U.S. Inc. are reporting final overall survival results from its phase 3 EMBARK study. The study evaluated XTANDI(R) (enzalutamide), in combination with leuprolide and as monotherapy, in men with nonmetastatic hormone-sensitive prostate cancer with biochemical recurrence at high risk for metastasis. According to the report, XTANDI plus leuprolide reduced the risk of death by 40.3% compared to leuprolide alone, making this the first and only androgen receptor inhibitor-based regimen to demonstrate an OS benefit in nmHSPC with high-risk BCR. As innovation continues to advance, transformative oncology platforms are moving closer to delivering more personalized and effective treatment options. The progress reflected in new vaccine programs, cell therapy trials, regulatory designations and survival data underscores a rapidly evolving field focused on improving outcomes and reshaping standards of care for patients worldwide. For more information, visit Oncotelic Therapeutics Inc. 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Breakthrough Review Defines the Next Frontier in Precision Nanomedicine Agoura Hills, CA, and San Diego, CA, Nov. 11, 2025 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics Inc. (OTLC) and JV partner Sapu Bioscience today announced the publication of their landmark review article, “Sub-15 nm Nanoparticles for Drug Delivery: Emerging Frontiers and Therapeutic Potential,” in the International Journal of Molecular Sciences (IJMS 2025, 26, 10842; https://doi.org/10.3390/ijms262210842) . Authored by Dr. Tapas De, Vuong Trieu, Scott Myers, Sanjive Qazi, Saran Saund, and Cynthia Lee, the paper is the first comprehensive review to systematically examine nanoparticles strictly within the 5–15 nm size domain—a scale that is now emerging as the most transformative scale in nanomedicine. Defining a New Size Regime in Nanomedicine While most clinical nanodrugs today rely on carriers between 50 nm and 200 nm, this review highlights how ultrasmall nanoparticles below 15 nm demonstrate fundamentally distinct biological behavior. These sub-15 nm systems exhibit: Deeper tissue and tumor penetration, reaching desmoplastic or poorly vascularized regions that larger nanocarriers cannot access;Reduced reticuloendothelial accumulation and rapid renal clearance, minimizing long-term organ toxicity;Enhanced diffusion across biological barriers, including the blood–brain barrier; andQuantum-scale surface properties enabling multifunctional imaging and therapeutic applications. This nanoscale window represents a new pharmacological paradigm where therapeutic delivery, tissue penetration, and clearance kinetics can be simultaneously optimized—offering the potential to overcome limitations of both small molecules and traditional nanocarriers. A Platform for the Next Generation of Precision Therapies “Sub-15 nm nanoparticles are not just smaller versions of conventional nanomedicines—they behave as an entirely new class of therapeutic entities,” said Saran Saund, CBO of Oncotelic Therapeutics. “They open the door to safer, smarter, and more selective cancer treatments capable of crossing biological barriers that have limited drug delivery for decades.” Dr. Tapas De, Director of NanoFormulation at Oncotelic and lead author, added: “Our analysis reveals that this ultrasmall size range achieves an optimal balance between deep tumor diffusion and systemic safety.It’s the same size regime where nature’s own biomolecules—like antibodies and enzymes—operate most effectively.” Impact on Sapu’s Nanomedicine Pipeline The findings directly inform the Sapu Deciparticle™ platform, including Sapu-003, an intravenous everolimus nanomedicine currently preparing for first-in-human evaluation. “Publishing this comprehensive review validates the foundation of our Deciparticle™ technology,” said Saran Saund, CBO of Oncotelic.“Our ability to manufacture highly stable nanoparticles below 15 nm will be key to unlocking new therapeutic frontiers—from oncology to neurological and immune disorders.” About the Publication Sub-15 nm Nanoparticles for Drug Delivery: Emerging Frontiers and Therapeutic PotentialAuthors: Tapas De, Vuong Trieu, Scott Myers, Sanjive Qazi (Oncotelic Therapeutics); Saran Saund, Cynthia Lee (Sapu Bioscience)Journal: International Journal of Molecular Sciences (ISSN 1422-0067)DOI: 10.3390/ijms262210842Published: November 8, 2025 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, GMP Bio, melanoma (through CA4P) and its wholly owned subsidiary Sapu, and Acute Myeloid Leukemia (“AML” through OXi 4503). Oncotelic also acquired PointR Data Inc. in November 2019 to build an AI driven biotechnology company. Further, 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, erectile dysfunction, female sexual disorder and hypoactive sexual desire disorder. All these ailments have a very large population suffering from them and there is a need for treatments for each. For more information on AL-101, refer to our 2024 Annual Report on form 10-K filed with the SEC on April 15, 2025. Oncotelic's 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, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. Words such as "may", "expect", "anticipate" "hope", "vision", "optimism", "design", "exciting", "promising", "will", "conviction", "estimate," "intend," "believe", "quest for a cure of cancer", "innovation-driven", "paradigm-shift", "high scientific merit", "impact potential" and similar expressions are intended to identify forward-looking statements. Forward looking statements contained in this press release include, but are not limited to, statements about future plans related to the operations of the JV, taking the JV into an initial public offering or the success thereof, the progress, timing of clinical development, scope and success of future clinical trials, the reporting of clinical data for the company's product candidates and the potential use of the company's product candidates to treat various cancer indications as well as obtaining required regulatory approval to conduct clinical trials and upon granting of approval by the regulatory agencies, the successful marketing of the products; building and the success of our nanoparticle platform and the related success of launching the platform, the success of the launch of a company with a DAO infrastructure, the success of the entity 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 PDAO, or any other tokens that we may launch, as registrable securities with the SEC through a registration statement, the ability of the tokens to be tradable or any value such tokens may have if they become tradable.. Each of these forward-looking statements involves risks and uncertainties, and actual results may differ materially from these forward-looking statements or may not occur at all. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes, taking the Company or its affiliates through initial public offerings. These risks are not exhaustive, the Company faces known and unknown risks, including the risk factors described in the Company's 2024 Annual Report on Form 10-K filed with the SEC on April 15, 2025 and in the company's other periodic filings. Forward-looking statements are based on expectations and assumptions as of the date of this press release. Except as required by law, the company does not assume any obligation to update forward-looking statements contained herein to reflect any change in expectations, whether because of new information, future events, or otherwise. Contact Information: For Oncotelic Therapeutics, Inc.:Investor Relationsir@oncotelic.com