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Yahoo
21-05-2025
- Business
- Yahoo
Pliant Therapeutics Presents Clinical and Preclinical Data at the American Thoracic Society International Conference
SOUTH SAN FRANCISCO, Calif., May 21, 2025 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced that the Company led oral and poster presentations of clinical and preclinical data this week as part of the American Thoracic Society (ATS) 2025 International Conference, held from May 16-21, 2025. Characterizing the Antifibrotic Activity of Bexotegrast on Distinct Fibroblast Populations in PCLS from Multiple ILD SubtypesIn a featured oral presentation, Johanna Schaub, Ph.D., Director of Translational Sciences at Pliant Therapeutics, discussed an evaluation of the antifibrotic activity of bexotegrast in fibrotic human precision-cut lung slices (PCLS) generated from non-idiopathic pulmonary fibrosis (IPF) interstitial lung disease (ILD) patient lung explants. Results showed that bexotegrast, a dual inhibitor of αVβ6/αVβ1 integrins, reduced expression of genes related to TGF-β signaling and fibrogenesis in alveolar type 1 (AT1) cells and multiple fibroblast subpopulations. Plasma Proteome Analysis Reveals Shared and Unique Biomarkers of ILD SubtypesIn a poster presentation, Erine Budi, Ph.D., Senior Scientist II Translational Biology at Pliant Therapeutics, reviewed a comparative analysis assessing circulating plasma biomarkers of ILD in healthy subjects and patients with idiopathic pulmonary fibrosis (IPF), rheumatoid arthritis-ILD (RA-ILD), and scleroderma associated-ILD (SSc-ILD). Results identified biomarkers consistently dysregulated across multiple ILD subtypes that could assist in informing clinical decision making in ILD. Single-Cell Profiling Demonstrates the Antifibrotic Effects of Bexotegrast on Pathologic Lung Cell Populations in the Presence and Absence of Background TherapyIn a poster presentation, Mahru An, Ph.D., Director of Translational Sciences at Pliant Therapeutics, reviewed a single-nuclei RNAseq analysis of fibrotic human precision-cut lung slices comparing the pharmacodynamic effects of bexotegrast, a dual inhibitor of αVβ6 and αVβ1 integrins, alone, or in combination with nintedanib. Results showed that treatment with bexotegrast or nintedanib displayed distinct cell-specific pharmacodynamic profiles. In addition, bexotegrast alone, or in the presence of nintedanib, significantly reduced the expression of type I collagen and other profibrotic genes in aberrant basaloid cells (αVβ6-expressing) and fibroblasts (αVβ1-expressing), while treatment with nintedanib alone did not. The presentation and posters presented at the 2025 ATS Conference are available by accessing the links above or on Pliant's website under the Publications section at About Pliant Therapeutics, Inc. Pliant Therapeutics is a clinical-stage biopharmaceutical company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases. Pliant's lead product candidate, bexotegrast (PLN-74809), is an oral, small molecule, dual selective inhibitor of αvß6 and αvß1 integrins that is undergoing evaluation for the treatment of idiopathic pulmonary fibrosis, or IPF. Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) and Orphan Drug Designation from the European Medicines Agency in IPF. Pliant is conducting a Phase 1 study for PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of solid tumors. In addition, Pliant has received regulatory clearance for the conduct of a Phase 1 study of PLN-101325, a monoclonal antibody agonist of integrin α7β1 targeting muscular dystrophies. For additional information, please visit: Follow us on social media X, LinkedIn, and Facebook. Investor and Media Contact: Christopher KeenanVice President, Investor Relations and Corporate CommunicationsPliant Therapeutics,
Yahoo
21-05-2025
- Business
- Yahoo
Pliant Therapeutics Presents Clinical and Preclinical Data at the American Thoracic Society International Conference
SOUTH SAN FRANCISCO, Calif., May 21, 2025 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced that the Company led oral and poster presentations of clinical and preclinical data this week as part of the American Thoracic Society (ATS) 2025 International Conference, held from May 16-21, 2025. Characterizing the Antifibrotic Activity of Bexotegrast on Distinct Fibroblast Populations in PCLS from Multiple ILD SubtypesIn a featured oral presentation, Johanna Schaub, Ph.D., Director of Translational Sciences at Pliant Therapeutics, discussed an evaluation of the antifibrotic activity of bexotegrast in fibrotic human precision-cut lung slices (PCLS) generated from non-idiopathic pulmonary fibrosis (IPF) interstitial lung disease (ILD) patient lung explants. Results showed that bexotegrast, a dual inhibitor of αVβ6/αVβ1 integrins, reduced expression of genes related to TGF-β signaling and fibrogenesis in alveolar type 1 (AT1) cells and multiple fibroblast subpopulations. Plasma Proteome Analysis Reveals Shared and Unique Biomarkers of ILD SubtypesIn a poster presentation, Erine Budi, Ph.D., Senior Scientist II Translational Biology at Pliant Therapeutics, reviewed a comparative analysis assessing circulating plasma biomarkers of ILD in healthy subjects and patients with idiopathic pulmonary fibrosis (IPF), rheumatoid arthritis-ILD (RA-ILD), and scleroderma associated-ILD (SSc-ILD). Results identified biomarkers consistently dysregulated across multiple ILD subtypes that could assist in informing clinical decision making in ILD. Single-Cell Profiling Demonstrates the Antifibrotic Effects of Bexotegrast on Pathologic Lung Cell Populations in the Presence and Absence of Background TherapyIn a poster presentation, Mahru An, Ph.D., Director of Translational Sciences at Pliant Therapeutics, reviewed a single-nuclei RNAseq analysis of fibrotic human precision-cut lung slices comparing the pharmacodynamic effects of bexotegrast, a dual inhibitor of αVβ6 and αVβ1 integrins, alone, or in combination with nintedanib. Results showed that treatment with bexotegrast or nintedanib displayed distinct cell-specific pharmacodynamic profiles. In addition, bexotegrast alone, or in the presence of nintedanib, significantly reduced the expression of type I collagen and other profibrotic genes in aberrant basaloid cells (αVβ6-expressing) and fibroblasts (αVβ1-expressing), while treatment with nintedanib alone did not. The presentation and posters presented at the 2025 ATS Conference are available by accessing the links above or on Pliant's website under the Publications section at About Pliant Therapeutics, Inc. Pliant Therapeutics is a clinical-stage biopharmaceutical company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases. Pliant's lead product candidate, bexotegrast (PLN-74809), is an oral, small molecule, dual selective inhibitor of αvß6 and αvß1 integrins that is undergoing evaluation for the treatment of idiopathic pulmonary fibrosis, or IPF. Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) and Orphan Drug Designation from the European Medicines Agency in IPF. Pliant is conducting a Phase 1 study for PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of solid tumors. In addition, Pliant has received regulatory clearance for the conduct of a Phase 1 study of PLN-101325, a monoclonal antibody agonist of integrin α7β1 targeting muscular dystrophies. For additional information, please visit: Follow us on social media X, LinkedIn, and Facebook. Investor and Media Contact: Christopher KeenanVice President, Investor Relations and Corporate CommunicationsPliant Therapeutics, in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
12-05-2025
- Health
- Business Wire
Feinstein Institutes Researchers Explore Vagus Nerve Stimulation for Obesity and Related Diseases
MANHASSET, N.Y.--(BUSINESS WIRE)--Obesity affects over a third of the global population and is a major risk factor for numerous chronic diseases. To find better therapies to fight obesity and its related health problems, researchers at Northwell Health's Feinstein Institutes for Medical Research are investigating a promising new approach in which vagus nerve stimulation (VNS) interacts with growth factor-β (TGF-β) signaling, a driver and suppressor of metabolic function. Published today in Bioelectronic Medicine – an open-access journal published by the Feinstein Institutes and BMC, part of Springer Nature – and led by Lopa Mishra, MD, co-director and professor in the Institute of Bioelectronic Medicine at the Feinstein Institutes, the review shows growing evidence that stimulating the vagus nerve could offer a much-needed non-drug treatment for obesity. The review provides valuable insights into the complex processes in obesity and related illnesses, specifically looking at TGF-β signaling, which acts as a contributer to metabolic problems and other times helps to regulate them. The vagus nerve connects the brain to the stomach and other organs. Researchers are now investigating how VNS might interact with TGF-β signaling, potentially fine-tuning its effects to improve metabolic health, while also focusing on the SPTBN1 protein, which acts as a switch for the TGF-β system and may be a promising drug target. 'This research is our response to the urgent need for innovative strategies that combat the global obesity epidemic and its devastating consequences,' said Dr. Mishra. 'By elucidating the intricate interplay between TGF-β signaling, vagus nerve stimulation and metabolic dysfunction, there's potential to identify more precise and effective therapeutic targets.' Obesity significantly increases the risk of developing several serious diseases, including fatty liver disease, liver damage and liver cancer. Current drug treatments often face limitations, including lack of effectiveness for some individuals, high discontinuation rates due to side effects, and the potential for weight regain after stopping the medication. VNS offers a potential alternative or complementary approach, especially given recent advancements in non-invasive ultrasound stimulation techniques by delivering small, safe electrical pulses to the vagus nerve. Researchers believe they can help people feel fuller faster, leading to reduced food intake and weight loss as the vagus nerve plays a critical role in the signaling the feeling of fullness. 'Dr. Mishra and her team's research on TGF-β and vagus nerve stimulation provides an interesting new insight into the mechanisms of obesity,' said Kevin J. Tracey, MD, president and CEO of the Feinstein Institutes and Karches Family Distinguished Chair in Medical Research. 'These are novel pathways and targets that may one day lead to new therapies.' The Feinstein Institutes for Medical Research is the global scientific home of bioelectronic medicine, which combines molecular medicine, neuroscience and biomedical engineering. At the Feinstein Institutes, medical researchers use modern technology to develop new device-based therapies to treat disease and injury. Building on years of research in molecular disease mechanisms and the link between the nervous and immune systems, Feinstein Institutes' researchers discovered neural targets that can be activated or inhibited with neuromodulation devices, like vagus nerve implants, to control the body's immune response and inflammation. If inflammation is successfully controlled, diseases – such as arthritis, pulmonary hypertension, heart failure, inflammatory bowel diseases, diabetes, cancer and autoimmune diseases – can be treated more effectively. Beyond inflammation, using novel brain-computer interfaces, Feinstein Institutes' researchers developed techniques to bypass injuries of the nervous system so that people living with paralysis can regain sensation and use their limbs. By producing bioelectronic medicine knowledge, disease and injury could one day be treated with our own nerves without costly and potentially harmful pharmaceuticals. About the Feinstein Institutes The Feinstein Institutes for Medical Research is the home of the research institutes of Northwell Health, the largest health care provider and private employer in New York State. Encompassing 50+ research labs, 3,000 clinical research studies and 5,000 researchers and staff, the Feinstein Institutes raises the standard of medical innovation through its six institutes of behavioral science, bioelectronic medicine, cancer, health system science, molecular medicine, and translational research. We are the global scientific leader in bioelectronic medicine – an innovative field of science that has the potential to revolutionize medicine. The Feinstein Institutes publishes two open-access, international peer-reviewed journals Molecular Medicine and Bioelectronic Medicine. Through the Elmezzi Graduate School of Molecular Medicine, we offer an accelerated PhD program. For more information about how we produce knowledge to cure disease, visit and follow us on LinkedIn.
Yahoo
23-04-2025
- Business
- Yahoo
Bicara Therapeutics to Present Updated Data from Ongoing Phase 1/1b Trial of Ficerafusp alfa in 1L R/M HNSCC at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting
BOSTON, April 23, 2025 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today announced that updated data from the company's ongoing Phase 1/1b clinical trial of ficerafusp alfa in 1L (first line) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) will be highlighted in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held from May 30-June 3, 2025 in Chicago, IL. Ficerafusp alfa is a first-in-class bifunctional antibody that 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) and is being evaluated across multiple solid tumor types. 'We're honored to have been selected for an oral presentation at ASCO, which we believe reflects the strong interest from the clinical community in our updated survival and durability data,' said David Raben, MD, Chief Medical Officer of Bicara Therapeutics. 'We believe these data continue to build confidence in the potential of ficerafusp alfa to provide meaningful, durable clinical benefit to HPV-negative recurrent/metastatic head and neck squamous cell carcinoma patients, who typically have a worse prognosis and poorer outcomes as compared to those with HPV-positive disease.' Details of the oral presentation are as follows: Title: Ficerafusp alfa with pembrolizumab in patients with recurrent or metastatic head and neck squamous cell carcinoma: Updated results from an expansion cohort of an open-label, multicenter, phase 1/1b trial Abstract #: 6017 Session Title: Rapid Oral Abstract Session Session Category: Rapid Oral Abstract Session Session Date and Time: 6/1/2025 12:12 - 12:18 p.m. CT Location: McCormick Place Convention Center Following the meeting, the presentation will be available on Bicara's website at About Ficerafusp AlfaFicerafusp alfa is a first-in-class bifunctional antibody that 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 dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-b signaling within the tumor microenvironment. Ficerafusp alfa is currently being evaluated in FORTIFI-HN01, a pivotal Phase 2/3 clinical trial 1L (first line) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). 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 bifunctional antibody that 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 dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the tumor microenvironment. 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 or follow us on LinkedIn or X. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding Bicara's clinical development of ficerafusp alfa in combination with pembrolizumab and presentation of updated results from an expansion cohort of an open-label, multicenter, phase 1/1b trial of ficerafusp alfa with pembrolizumab in patients with recurrent or metastatic head and neck squamous cell carcinoma, and the expected therapeutic potential and clinical benefits of ficerafusp alfa, including potential efficacy and tolerability. The words '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 forward-looking statements contain these identifying words. 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 and enrollment 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 and 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 in Bicara's most recent Annual Report on Form 10-K, as well as any subsequent filings that Bicara makes with the SEC. In addition, 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. Contacts InvestorsRachel FrankIR@ MediaDan Budwick1ABdan@ in to access your portfolio
Associated Press
27-03-2025
- Business
- Associated Press
Bicara Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
Dosing commenced in FORTIFI-HN01, a pivotal Phase 2/3 trial of ficerafusp alfa in 1L R/M HNSCC Updated data from ongoing Phase 1/1b trial in 1L R/M HNSCC to be presented at 2025 ASCO Annual Meeting Strong financial position with approximately $490 million in cash and cash equivalents expected to fund operations into the first half of 2029 BOSTON, March 27, 2025 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today announced financial results for the fourth quarter and full year ended December 31, 2024 and provided a business update. '2024 was a remarkable year for Bicara, marked by our successful transition to a public company, the advancement of our lead asset, ficerafusp alfa, and the addition of key leaders to our executive team and Board of Directors. We continue to make strong progress in 2025, with patient dosing actively underway in FORTIFI-HN01, the pivotal Phase 2/3 trial of ficerafusp alfa in recurrent/metastatic head and neck squamous cell carcinoma,' said Claire Mazumdar, PhD, MBA, Chief Executive Officer of Bicara Therapeutics. 'As FORTIFI-HN01 progresses, we look forward to presenting updated data from our ongoing Phase 1/1b study of ficerafusp alfa in 1L R/M HNSCC at the 2025 ASCO Annual Meeting. We also continue to evaluate the potential broad utility of ficerafusp alfa across other areas of head and neck cancer, as well as other solid tumor types.' Pipeline Highlights Bicara is developing ficerafusp alfa, a first-in-class, dual-action bifunctional epidermal growth factor receptor (EGFR)/transforming growth factor beta (TGF-β) antibody for multiple different solid tumor cancer types. Pivotal Phase 2/3 Clinical Trial in 1L R/M HNSCC In February 2025, Bicara dosed the first patients in FORTIFI-HN01, a global, randomized, double-blind, placebo-controlled, pivotal Phase 2/3 trial of ficerafusp alfa in combination with pembrolizumab in 1L (first line) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC), excluding patients with oropharyngeal squamous cell carcinoma associated with human papillomavirus infection (HPV-positive). Ongoing Phase 1/1b Clinical Trial in 1L R/M HNSCC Updated data from an ongoing Phase 1/1b trial will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held from May 30-June 3, 2025 in Chicago, IL. Ongoing Phase 1/1b Expansion Cohorts and Development of Ficerafusp Alfa Across Other HNSCC Populations and Solid Tumor Types In January 2025, Bicara presented data from the Phase 1/1b dose expansion cohort of ficerafusp alfa in combination with pembrolizumab in patients with second line (2L) or later squamous cancer of the anal canal (SCAC) at the 2025 ASCO Gastrointestinal Cancers Symposium, providing additional support for the complementary mechanisms of ficerafusp alfa and pembrolizumab. Updated data from a Phase 1b expansion cohort evaluating ficerafusp alfa monotherapy in patients with 2L or later cutaneous squamous cell carcinoma (cSCC) will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2025, which will be held from April 25-30, 2025 in Chicago, IL. A Phase 1b expansion cohort evaluating ficerafusp alfa both as monotherapy and in combination with pembrolizumab in patients with 3L+ metastatic colorectal cancer (RAS / BRAF wild type) is expected to initiate in 2025. A Phase 1b expansion cohort evaluating ficerafusp alfa in combination with pembrolizumab in HPV-positive patients with a history of heavy smoking is expected to initiate in the first half of 2025. Upcoming Events and Presentations Three abstracts related to ficerafusp alfa will be presented at the upcoming AACR Annual Meeting 2025, which will be held from April 25-30, 2025 in Chicago, IL: Dose expansion results of single agent ficerafusp alfa (BCA101), a bifunctional EGFR/TGF-β inhibitor in patients with metastatic or advanced cutaneous squamous cell carcinoma (cSCC) (Abstract #: CT034). This presentation will highlight data from a Phase 1/1b dose expansion cohort of ficerafusp alfa monotherapy in second line or later cSCC patients. Dual blockade of EGFR and TGF-β with ficerafusp alfa has the potential to overcome resistance mechanisms in 1L R/M HNSCC in combination with Pembrolizumab (Abstract #: 3284). This presentation will highlight a translational medicine biomarker dataset that provides insights into the effects of targeted inhibition of TGF-β with ficerafusp alfa. Ficerafusp alfa reverses acquired resistance to the KRAS-G12C inhibitor sotorasib in KRAS-G12C-mutated lung tumors (Abstract #: 4434). This presentation will highlight a preclinical dataset that provides insights into the role of inhibiting TGF-β in overcoming acquired KRAS-G12C-inhibitor drug-resistant KRAS-G12C-mutated lung cancer. Members of the Bicara management team will participate in the Stifel 2025 Virtual Targeted Oncology Forum on Tuesday, April 8, 2025 at 2:00 p.m. ET. A live webcast of the presentation will be available on the Events and Presentations section of Bicara's website. A replay of the webcast will be archived and available following the event. Fourth Quarter and Full Year 2024 Financial Results Cash Position: As of December 31, 2024, Bicara had cash and cash equivalents of $489.7 million, compared to $230.4 million as of December 31, 2023. Based on its current operating and development plans, the Company expects that its existing cash and cash equivalents will fund operations into the first half of 2029. Research and Development Expenses: Research and development expenses were $19.9 million and $63.6 million for the fourth quarter and full year ended December 31, 2024, respectively, as compared to $10.6 million and $30.6 million for the same periods in 2023. The increase was primarily due to additional costs associated with the initiation of the FORTIFI-HN01 Phase 2/3 clinical trial, as well as the Company's ongoing Phase 1/1b clinical trial to advance ficerafusp alfa. General and Administrative Expenses: General and administrative expenses were $6.8 million and $18.8 million for the fourth quarter and full year ended December 31, 2024, respectively, as compared to $3.1 million and $9.3 million for the same periods in 2023. The increase was primarily due to additional personnel costs and professional fees to prepare Bicara to operate as a public company. Net Loss: Net loss totaled $21.0 million and $68.0 million for the fourth quarter and full year ended December 31, 2024, respectively, as compared to $12.4 million and $52.0 million for the same periods in 2023. Net loss for the year ended December 31, 2023 included a $13.4 million non-cash expense that represents the change in fair value of Bicara's Series B preferred stock tranche rights liability. 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 bifunctional antibody that 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 dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the tumor microenvironment. 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 or follow us on LinkedIn or 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 the initiation, timing, progress and results of ongoing and planned clinical trials; the expected therapeutic potential and clinical benefits of ficerafusp alfa, including potential efficacy and tolerability; Bicara's expected operating expenses and capital expenditure requirements, including its cash runway through the first half of 2029; and participation at upcoming conferences and the timing of data readouts. 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 Bicara's upcoming Annual Report on Form 10-K for the year ended December 31, 2024 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. CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands except shares and per share data) Three Months Ended December 31, Year Ended December 31, 2024 2023 2024 2023 Operating expenses Research and development - related party $ 816 $ 2,733 $ 8,216 $ 9,244 Research and development 19,067 7,829 55,403 21,373 General and administrative 6,754 3,125 18,770 9,272 Total operating expenses1 26,637 13,687 82,389 39,889 Loss from operations (26,637) (13,687) (82,389) (39,889) Other (expenses) income Interest income 5,866 1,301 14,581 1,314 Change in fair value of Series B preferred stock tranche rights liability — (49) — (13,405) Total other income (expense) 5,866 1,252 14,581 (12,091) Net loss before income taxes (20,771) (12,435) (67,808) (51,980) Income tax expense (186) (5) (187) (5) Net loss $ (20,957) $ (12,440) $ (67,995) $ (51,985) Net Loss per share, basic and diluted $ (0.39) $ (19.71) $ (4.05) $ (89.61) Weighted-average number common shares outstanding, basic and diluted 54,424,607 631,286 16,805,524 580,109 1 Expenses include the following non-cash stock-based compensation expense Research & Development $ 1,040 $ 171 $ 2,084 $ 381 General and administrative 2,141 594 5,313 1,518 Total stock-based compensation expense $ 3,181 $ 765 $ 7,397 $ 1,899 BICARA THERAPEUTICS INC. CONSOLIDATED BALANCE SHEETS (in thousands) December 31, 2024 December 31, 2023 Assets Current assets: Cash and cash equivalents $ 489,711 $ 230,440 Prepaid expenses and other assets 12,822 633 Total current assets 502,533 231,073 Property and equipment, net 155 202 Right of use asset – operating lease 690 613 Other assets 6,618 2,094 Total assets $ 509,996 $ 233,982 Liabilities, redeemable convertible preferred stock, and stockholders' equity (deficit) Current liabilities: Accounts payable $ 3,893 $ 2,142 Accounts payable – related party 615 1,044 Accrued expenses and other current liabilities 12,875 8,053 Accrued expenses and other current liabilities – related party — 3,561 Operating lease liability – current portion 607 285 Total current liabilities 17,990 15,085 Operating lease liability – net of current portion 131 372 Other liabilities — 17 Total liabilities 18,121 15,474 Total redeemable convertible preferred stock — 367,277 Total stockholders' equity (deficit) 491,875 (148,769) Total liabilities, redeemable convertible preferred stock, and stockholders' equity (deficit) $ 509,996 $ 233,982 Contacts Investors Rachel Frank Media Dan Budwick 1AB
