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
Development of Ficerafusp Alfa Across Other Solid Tumor Types
Corporate Highlights
Key Anticipated Upcoming Milestones
Third Quarter 2025 Financial Results
Upcoming Investor Conferences
Bicara will participate in three upcoming investor conferences:
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 Ended September 30, | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Operating 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, 2024 | ||||
| Assets | |||||
| Current assets: | |||||
| Cash and cash equivalents | $ | 171,673 | $ | 489,711 | |
| Prepaid expenses and other assets | 7,205 | 12,822 | |||
| Short term investments | 118,494 | — | |||
| Total current assets | 297,372 | 502,533 | |||
| Property and equipment, net | 135 | 155 | |||
| Right of use asset – operating lease | 1,969 | 690 | |||
| Long term investments | 117,417 | — | |||
| Other assets | 7,795 | 6,618 | |||
| Total assets | $ | 424,688 | $ | 509,996 | |
| Liabilities and stockholders’ equity | |||||
| Current liabilities: | |||||
| Accounts payable | $ | 3,003 | $ | 3,893 | |
| Accounts payable – related party | 659 | 615 | |||
| Accrued expenses and other current liabilities | 14,986 | 12,875 | |||
| Accrued expenses and other current liabilities – related party | 1,285 | — | |||
| Operating lease liability – current portion | 1,095 | 607 | |||
| Total current liabilities | 21,028 | 17,990 | |||
| Operating lease liability – net of current portion | 880 | 131 | |||
| Total liabilities | 21,908 | 18,121 | |||
| Total stockholders' equity | 402,780 | 491,875 | |||
| Total liabilities and stockholders’ equity | $ | 424,688 | $ | 509,996 | |
Contacts
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| Last Trade: | US$13.93 |
| Daily Change: | -0.71 -4.85 |
| Daily Volume: | 439,983 |
| Market Cap: | US$760.720M |
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