Ficerafusp alfa

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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Granted FDA Breakthrough Therapy Designation for ficerafusp alfa in combination with pembrolizumab in 1L HPV-negative R/M HNSCC Data from a Phase 1b expansion cohort evaluating 750mg of ficerafusp alfa weekly in combination with pembrolizumab in 1L HPV-negative R/M HNSCC patients expected at ESMO Asia 2025 Strong financial position with approximately $408 million in cash, cash equivalents, and investments as of September 30, 2025 BOSTON, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX) today announced financial results for the third quarter ended September 30, 2025 and provided a business update. “The FDA’s recent Breakthrough Therapy Designation for ficerafusp alfa in first-line HPV-negative HNSCC represents an important milestone for Bicara and validates the strength of our clinical data and our development plan, specifically underscoring the growing recognition of HPV-negative disease as a distinct clinical indication within HNSCC,” said Claire Mazumdar, PhD, MBA, Chief Executive Officer of Bicara Therapeutics. "As we head into 2026, our focus continues to be on executing the enrollment of our pivotal Phase 2/3 FORTIFI-HN01 trial in first-line HPV-negative HNSCC and presenting additional data for ficerafusp alfa across dose cohorts to further characterize its tolerability and efficacy profile and inform the dose selection for our pivotal FORTIFI-HN01 study. Ficerafusp alfa is the first and only bifunctional antibody that uses an EGFR antibody backbone to localize TGF-β inhibition to increase tumor penetration and drive deep and durable responses across tumor types. We are encouraged by the evolving base of evidence that continues to demonstrate the potential of ficerafusp alfa and targeted TGF-β inhibition in HNSCC and other tumors.” Third Quarter 2025 Highlights and Recent Progress FORTIFI-HN01: Pivotal Phase 2/3 Clinical Trial of Ficerafusp Alfa in 1L R/M HNSCC Received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for ficerafusp alfa in combination with pembrolizumab for the first-line (1L) treatment of patients with metastatic or with unresectable, recurrent (R/M) 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.Continued to enroll FORTIFI-HN01, a global, randomized, double-blind, placebo-controlled, pivotal Phase 2/3 trial of ficerafusp alfa in combination with pembrolizumab 1L HPV-negative R/M HNSCC.Initiated a Phase 1b expansion cohort evaluating ficerafusp alfa in combination with pembrolizumab in 1L R/M HPV-positive HNSCC patients with a history of heavy smoking. Development of Ficerafusp Alfa Across Other Solid Tumor Types Continued to enroll a Phase 1b expansion cohort evaluating ficerafusp alfa both as monotherapy and in combination with pembrolizumab in patients with 3L+ metastatic colorectal cancer (CRC) (RAS/BRAF wild type MSS).Presented data demonstrating the significantly improved and sustained anti-tumor effects of ficerafusp alfa compared to cetuximab in KRAS/BRAF wild-type MSS CRC cell lines, underscoring the importance of overcoming TGF-β-mediated drug resistance and facilitating immune cell tumor penetration with ficerafusp alfa, at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting. Access the poster presentation here.Presented data demonstrating the ability of ficerafusp alfa to block epithelial-mesenchymal transition (EMT) and fibroblast-myofibroblast transition (FMT) in tumor cells and cancer-associated fibroblasts (CAFs), supporting ficerafusp alfa’s ability to break down barriers in the tumor microenvironment (TME) and drive tumor penetration via targeted TGF-β inhibition, at the European Society for Medical Oncology (ESMO) 2025 Congress. Access the poster presentation here. Corporate Highlights Expanded management team with the appointments of Jenna Cohen, Chief Corporate Affairs Officer; Tanya Green, Chief Development Officer; and Bill Schelman, Senior Vice President, Clinical Development. Key Anticipated Upcoming Milestones Present data from a Phase 1b expansion cohort evaluating 750mg of ficerafusp alfa weekly in combination with pembrolizumab in 1L HPV-negative R/M HNSCC patients at the ESMO Asia 2025 Meeting.Present data from a Phase 1b expansion cohort evaluating 2000mg of ficerafusp alfa every other week in combination with pembrolizumab in 1L HPV-negative R/M HNSCC patients in the first quarter of 2026.Present data from a Phase 1b expansion cohort evaluating 1500mg weekly of ficerafusp alfa in combination with pembrolizumab in HPV-negative patients with combined positive scores (CPS) of 0 in 2026.Present data from Phase 1b expansion cohort evaluating ficerafusp alfa both as monotherapy and in combination with pembrolizumab in patients with 3L+ metastatic CRC (RAS/BRAF wild type MSS) in 2026. Third Quarter 2025 Financial Results Cash, Cash Equivalents and Investments: As of September 30, 2025, Bicara had cash, cash equivalents and investments of $407.6 million, compared to $489.7 million in cash and cash equivalents as of December 31, 2024. Based on its current operating and development plans, the Company expects that its existing cash, cash equivalents and investments will fund operations into the first half of 2029.Research and Development Expenses: Research and development expenses were $33.0 million for the third quarter of 2025 as compared to $15.9 million for the third quarter of 2024. The increase was primarily due to costs associated with ongoing pivotal Phase 2/3 clinical trial, FORTIFI-HN01, as well as the Company’s ongoing Phase 1/1b dose expansion cohorts, and an increase in personnel costs.General and Administrative Expenses: General and administrative expenses were $7.7 million for the third quarter of 2025 as compared to $4.8 million for the third quarter of 2024. The increase was primarily due to additional personnel costs and professional fees to support advancement of our clinical trials and operations as a public company.Net Loss: Net loss totaled $36.3 million for the third quarter of 2025 as compared to $17.5 million for the third quarter of 2024. Upcoming Investor Conferences Bicara will participate in three upcoming investor conferences: Stifel Healthcare Conference 2025 on Tuesday, November 11, 2025 at 9:20 am ET.Piper Sandler 37th Annual Healthcare Conference on Tuesday, December 2, 2025 at 4:30 pm ET.Evercore 8th Annual Healthcare Conference on Wednesday, December 3, 2025 at 1:20 pm ET. Live webcasts of the fireside chats will be accessible through the Investor Relations section of Bicara’s website under Events and Presentations. Replays of the webcasts will be archived and available for 30 days following each event. About Bicara Therapeutics Bicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara’s lead program, ficerafusp alfa, is a first-in-class bifunctional antibody designed to drive tumor penetration by breaking barriers in the tumor microenvironment that have challenged the treatment of multiple solid tumor cancers. Specifically, ficerafusp alfa combines two clinically validated targets: an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β). Through this targeted mechanism, ficerafusp alfa reverses the fibrotic and immune-excluded tumor microenvironment driven by TGF-β signaling to enable tumor penetration that drives deep and durable responses. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types. For more information, please visit www.bicara.com or follow us on LinkedIn and X. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by words such as “may,” “might,” “will,” “could,” “would,” “should,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” and similar words or expressions, or the negative thereof, are intended to identify forward-looking statements, although not all contain identifying words. Any statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, Bicara’s strategy, business plans and focus; express or implied statements regarding the clinical development of ficerafusp alfa, including enrollment and progress of the FORTIFI-HN01 trial, the additional ongoing expansion cohorts of Bicara’s Phase 1b trial of ficerafusp alfa and future data releases; the expected therapeutic potential and clinical benefits of ficerafusp alfa, including potential efficacy, depth, durability and tolerability; Bicara’s expected operating expenses and capital expenditure requirements, including its cash runway into the first half of 2029; and participation at upcoming conferences. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks and uncertainties that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to uncertainties inherent in the development of product candidates, including the conduct of research activities and the conduct of clinical trials; uncertainties as to the availability and timing of results and data from clinical trials; whether results from prior preclinical studies and clinical trials will be predictive of the results of subsequent preclinical studies and clinical trials; regulatory developments in the United States and foreign countries; whether Bicara’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; as well as the risks and uncertainties identified in Bicara’s filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2024, its upcoming Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 and any subsequent filings Bicara makes with the SEC. In addition, any forward-looking statements represent Bicara’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Bicara explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Bicara intends to use its Investor Relations website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Company’s Investor Relations website, in addition to following the Company’s press releases, SEC filings, public conference calls, presentations, and webcasts. BICARA THERAPEUTICS INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(Unaudited, in thousands except shares and per share data) Three Months Ended September 30, Nine Months EndedSeptember 30, 20252024 2025 2024Operating expenses Research and development - related party$5,817 $2,310 $15,324 $7,400 Research and development 27,158 13,554 76,782 36,336 General and administrative 7,701 4,764 22,376 12,016 Total operating expenses1 40,676 20,628 114,482 55,752 Loss from operations (40,676) (20,628) (114,482) (55,752) Other income Interest income 4,386 3,147 14,082 8,715 Total other income 4,386 3,147 14,082 8,715 Net loss before income taxes (36,290) (17,481) (100,400) (47,037)Income tax expense (40) – (164) (1)Net loss$(36,330) $(17,481) $(100,564) $(47,038) Net Loss per share, basic and diluted$(0.67) $(1.60) $(1.84) $(11.27) Weighted-average number common shares outstanding, basic and diluted 54,563,864 10,901,138 54,519,496 4,174,353 1Expenses include the following non-cash stock-based compensation expense Research & Development$1,384 $562 $3,684 $1,044 General and administrative 2,230 1,469 6,873 3,172 Total stock-based compensation expense$3,614 $2,031 $10,557 $4,216 BICARA THERAPEUTICS INC.CONDENSED CONSOLIDATED BALANCE SHEETS(Unaudited, in thousands) September 30, 2025 December 31, 2024Assets Current assets: Cash and cash equivalents$ 171,673 $ 489,711Prepaid expenses and other assets 7,205 12,822Short term investments 118,494 —Total current assets 297,372 502,533 Property and equipment, net 135 155Right of use asset – operating lease 1,969 690Long term investments 117,417 —Other assets 7,795 6,618Total assets$ 424,688 $ 509,996 Liabilities and stockholders’ equity Current liabilities: Accounts payable$ 3,003 $ 3,893Accounts payable – related party 659 615Accrued expenses and other current liabilities 14,986 12,875Accrued expenses and other current liabilities – related party 1,285 —Operating lease liability – current portion 1,095 607Total current liabilities 21,028 17,990 Operating lease liability – net of current portion 880 131Total liabilities 21,908 18,121Total stockholders' equity 402,780 491,875Total liabilities and stockholders’ equity$ 424,688 $ 509,996 Contacts InvestorsJenna Cohen IR@bicara.com MediaAmanda Lazaro1ABAmanda@1abmedia.com