Everolimus

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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