Bicara Therapeutics (NASDAQ: BCAX) highlights deep responses with ficerafusp alfa

Rhea-AI Filing Summary

Bicara Therapeutics Inc. reported new preliminary Phase 1b data for its lead drug candidate ficerafusp alfa in first-line HPV-negative recurrent/metastatic head and neck squamous cell carcinoma, using a higher 2000mg every‑other‑week dose combined with pembrolizumab.

The 2000mg Q2W regimen showed a confirmed overall response rate of 48%, including 26% complete responses, and 77% of responders had deep responses with at least 80% tumor shrinkage. Safety was generally consistent with prior experience. Bicara plans to pursue a loading and every‑three‑week maintenance regimen, while its pivotal FORTIFI‑HN01 trial continues with a 1500mg weekly schedule, supported by Breakthrough Therapy Designation in this setting.

Insights

Biotech clinical development analyst

Early Phase 1b data support flexible dosing for Bicara’s lead asset.

Bicara Therapeutics shared exploratory Phase 1b results for ficerafusp alfa at a 2000mg every‑other‑week dose in HPV‑negative R/M HNSCC, combined with pembrolizumab. The cohort showed a 48% confirmed overall response rate, with 26% complete responses and a generally consistent safety profile.

The data suggest deep tumor shrinkage, with 77% of responders reaching at least 80% reduction and a median 24‑week depth of response of 100% in the 2000mg arm. Several time‑to‑event endpoints remain not estimable, reflecting immature follow‑up rather than confirmed durability.

Bicara plans to develop a loading and every‑three‑week maintenance regimen and is seeking regulatory alignment toward potential U.S. approval. The pivotal FORTIFI‑HN01 trial, using 1500mg weekly dosing, continues to enroll, and future readouts from this study will be key to understanding registrational prospects.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

___________________________________

FORM 8-K

___________________________________

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (date of earliest event reported): February 19, 2026

___________________________________

Bicara Therapeutics Inc.

(Exact name of registrant as specified in its charter)

___________________________________

Delaware (State or other jurisdiction of incorporation or organization)			001-42271 (Commission File Number)			83-2903745 (I.R.S. Employer Identification Number)
116 Huntington Avenue, Suite 703 Boston, MA 02116
(Address of principal executive offices and zip code)
(617) 468-4219
(Registrant's telephone number, including area code)

___________________________________

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐			Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐			Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐			Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐			Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:
Title of each class			Trading Symbol			Name of each exchange on which registered
Common Stock, $0.0001 par value			BCAX			The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 12b-2 of the Exchange Act.

Emerging growth company    ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

Item 8.01 - Other Events.

On February 19, 2026, Bicara Therapeutics Inc. issued a press release entitled “Ficerafusp Alfa 2000mg Q2W Demonstrates Deep, Durable Responses in 1L R/M HPV-Negative HNSCC and Supports Development of Less Frequent Dosing Regimen.” A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01 - Financial Statements and Exhibits

(d) The following exhibits are being filed herewith:

Exhibit No.						Description
99.1						Press Release, dated February 19, 2026.
104						Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

						Bicara Therapeutics Inc.
Date: February 19, 2026						By:			/s/ Claire Mazumdar
						Name:			Claire Mazumdar, Ph.D.
						Title:			Chief Executive Officer

Ficerafusp Alfa 2000mg Q2W Demonstrates Deep, Durable Responses in 1L R/M HPV-Negative HNSCC and Supports Development of Less Frequent Dosing Regimen

Phase 1b expansion cohort data evaluating 2000mg of ficerafusp alfa every other week in combination with pembrolizumab in 1L HPV-negative R/M HNSCC patients demonstrate rapid, deep, and durable responses with generally well-tolerated safety profile

Company plans to develop a loading and every-three-week maintenance regimen for ficerafusp alfa, pending regulatory alignment

Company to host conference call and webcast on Friday, February 20, 2026 at 8:30 a.m. ET

BOSTON, February 19, 2026 – Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today presented preliminary safety and efficacy data from an exploratory Phase 1b expansion cohort evaluating 2000mg of ficerafusp alfa every other week (Q2W) in combination with pembrolizumab in first-line (1L) human papillomavirus (HPV)-negative recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). The expansion cohort data, which explore a higher dose and less-frequent dosing regimen of ficerafusp alfa, are being highlighted in a plenary presentation today at the 2026 Multidisciplinary Head and Neck Cancers Symposium (MHNCS).

Ficerafusp alfa is the first and only bifunctional epidermal growth factor receptor (EGFR)-directed antibody combined with a TGF-β ligand trap designed to drive increased tumor penetration and improve survival outcomes. Bicara is currently evaluating ficerafusp alfa at 1500mg weekly (QW) in Phase 3 of the ongoing FORTIFI-HN01 pivotal study.

“Results from this alternative dosing cohort, including rapid, deep and durable responses, a consistent safety profile, and sustained TGF-β neutralization in 1L HPV-negative R/M HNSCC patients, reinforce the strength of ficerafusp alfa’s differentiated mechanism of action,” said David Raben, MD, Chief Medical Officer of Bicara Therapeutics. “TGF-β inhibition is established quickly and sustained with less frequent dosing while maintaining deep and durable responses, creating a compelling opportunity to pursue a loading and maintenance regimen for ficerafusp alfa. We remain confident that ficerafusp alfa uniquely enables both meaningful tumor penetration and long-term benefit, and we are committed to advancing dosing options that strengthen both patient experience and outcomes.”

The Phase 1b expansion cohort data presented at MHNCS show that 2000mg Q2W ficerafusp alfa in combination with pembrolizumab was generally well-tolerated, with a safety profile consistent with the known safety profile of ficerafusp alfa plus pembrolizumab in R/M HNSCC. 2000mg Q2W of ficerafusp alfa demonstrated a 48% confirmed overall response rate (ORR), with 26% of patients achieving a complete response (CR) and 77% of responders demonstrating deep responses of at least 80% tumor

shrinkage. Preliminary efficacy data demonstrated enhanced durability and additional outcomes data continue to mature.

Table 1. Results from Phase 1b expansion cohorts of ficerafusp alfa in combination with pembrolizumab in 1L R/M HPV-negative HNSCC

			2000mg Q2W1 (n=27)			1500mg QW2 (n=28)
Confirmed ORR			48%			54%
CR rate			26%			21%
Deep (≥80%) responses			77%			80%
Median time to response			1.6 months			1.4 months
Median PFS			NE			9.9 months
Median DoR			NE			21.7 months
Median OS			NE			21.3 months
Depth of response at 24-weeks			(n=11)			(n=11)
Median depth of response at 24-weeks			100%			82%
Percent of responders achieving deep (≥80%) response at 24-weeks			73%			64%

1. Data snapshot as of December 16, 2025. 2. Data snapshot as of March 20, 2025. Chung CH, et al. J Clin Oncol. 2025;43(16 suppl):6017.

Updated biomarker results demonstrated that 2000mg Q2W maintains TGF-β inhibition and immune activation while delivering deep responses, consistent with the differentiated clinical profile established by 1500mg QW of ficerafusp alfa. The growing body of pharmacokinetic, translational and clinical data supports development of an additional dose regimen that optimizes efficacy, safety and convenience without compromising the depth nor durability of response that are characteristic of ficerafusp alfa’s differentiated clinical profile.

Bicara plans to develop ficerafusp alfa with a loading and every-three-week maintenance schedule and aims to achieve regulatory alignment to enable data generation by potential U.S. approval. The ongoing FORTIFI-HN01 pivotal study continues to enroll patients globally to be treated with 1500mg weekly of ficerafusp alfa in combination with pembrolizumab.

Conference Call and Webcast Details
Bicara Therapeutics will host a conference call and webcast on Friday, February 20, 2026 at 8:30 am ET. Individuals may register for the conference call by clicking the link here. Once registered, participants will receive dial-in details and a unique PIN that will allow them to access the call. An audio webcast will be accessible through the Investor Relations section of Bicara’s website under Events and Presentations. An archived replay will also be available for 30 days following the webcast.

About Head and Neck Squamous Cell Carcinoma

Head and neck squamous cell carcinomas (HNSCCs) develop from the mucosal epithelium in the oral cavity, pharynx and larynx and are the most common malignancies that arise in the head and neck. HNSCC is one of the most common cancers in the United States and globally with a rising incidence anticipated to reach one million new global cases annually by 2030. Ten percent of HNSCC patients are

diagnosed with metastatic disease and up to 30% develop a recurrence or metastases over time after receiving initial treatment for advanced HNSCC.

Most cases of HNSCC are thought to result from accumulated mutations caused by carcinogenic exposures such as tobacco smoke or HPV infection. Approximately 80% of patients with R/M HNSCC are HPV-negative. These HPV-negative tumors often exhibit a recurrence pattern that is primarily local and are associated with severe morbidities, including fatal tumor bleeding, intense pain, difficulty swallowing, significant weight loss, and cachexia. This highlights a critical unmet need for therapies that have the potential to deliver durable anti-tumor responses, ultimately leading to meaningful improvements in patients' quality of life.

About Ficerafusp Alfa

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. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to 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.

Ficerafusp alfa is currently being evaluated in FORTIFI-HN01, a pivotal Phase 2/3 clinical trial in patients with 1L R/M 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 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, express or implied statements regarding Bicara’s clinical development of ficerafusp alfa in combination with pembrolizumab in 1L HPV-negative R/M HNSCC, including expectations for safety, efficacy, and depth and durability of response; the potential for a less frequent dosing regimen based on data from the Phase 1b expansion cohort of 2000mg Q2W, including expectations for future U.S. regulatory alignment and improvements in convenience, patient experience and outcomes with a loading and Q3W maintenance dosing regimen; the planned presentation of data from the 2000mg expansion cohort during an upcoming corporate call and webcast; enrollment and progress of the ongoing pivotal FORTIFI-HN01 clinical trial; potential for U.S. regulatory approval and launch of ficerafusp alfa; and the commercial opportunity for ficerafusp alfa, if approved. 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, preliminary or interim data from earlier stage 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 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.

Contacts

Investors
Jenna Cohen
IR@bicara.com

Media
Amanda Lazaro
1AB
Amanda@1abmedia.com

FAQ

What did Bicara Therapeutics (BCAX) announce about ficerafusp alfa in its latest 8-K?

Bicara announced preliminary Phase 1b data for ficerafusp alfa 2000mg every other week plus pembrolizumab in first-line HPV-negative recurrent/metastatic head and neck cancer, showing deep, durable responses and a generally consistent safety profile compared with prior experience at a 1500mg weekly dose.

What were the key efficacy results for Bicara Therapeutics’ ficerafusp alfa 2000mg Q2W cohort?

The 2000mg every-other-week cohort achieved a 48% confirmed overall response rate, with 26% of patients having complete responses. Among responders, 77% experienced deep responses of at least 80% tumor shrinkage, and several time-to-event endpoints such as median progression-free survival were not yet estimable.

How does the 2000mg Q2W ficerafusp alfa regimen compare with the 1500mg weekly regimen?

In Phase 1b expansion cohorts, the 2000mg every-other-week arm showed a 48% confirmed response rate versus 54% with 1500mg weekly. Complete response rates were 26% versus 21%, and deep response rates were 77% versus 80%, with some long-term outcomes still maturing for the higher-dose cohort.

What future dosing strategy is Bicara Therapeutics planning for ficerafusp alfa?

Bicara plans to develop ficerafusp alfa using a loading dose followed by an every-three-week maintenance schedule. The company aims to secure regulatory alignment so this dosing strategy can generate data in time for a potential future U.S. approval in first-line HPV-negative recurrent/metastatic head and neck cancer.

What is the status of the FORTIFI-HN01 trial for Bicara Therapeutics’ ficerafusp alfa?

Ficerafusp alfa is being evaluated in the ongoing pivotal FORTIFI-HN01 Phase 2/3 trial at 1500mg weekly plus pembrolizumab in first-line recurrent/metastatic head and neck squamous cell carcinoma. The study continues to enroll patients globally and will be central to supporting potential regulatory submissions.

What special regulatory designation has ficerafusp alfa received from the FDA?

The FDA has granted Breakthrough Therapy Designation to ficerafusp alfa in combination with pembrolizumab for first-line treatment of metastatic or unresectable, recurrent head and neck squamous cell carcinoma with PD-L1 CPS ≥1, excluding HPV-positive oropharyngeal disease, highlighting its potential in this high-need population.

Filing Exhibits & Attachments

4 documents

Press Releases

• EX-99.1 EX-99.1 32.4 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA DOCUMENT 1.7 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE DOCUMENT 22.9 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE DOCUMENT 13.3 KB