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Bicara Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update

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Bicara Therapeutics (NASDAQ:BCAX) reported Q2 2025 financial results and provided updates on its lead drug candidate ficerafusp alfa. The company highlighted strong Phase 1/1b trial results presented at ASCO 2025, showing a 54% confirmed objective response rate in HPV-negative head and neck cancer patients, with median duration of response of 21.7 months.

The company maintains a robust financial position with $436.6 million in cash, expected to fund operations into H1 2029. Q2 2025 saw increased R&D expenses of $24.8 million and a net loss of $27.4 million. The ongoing pivotal Phase 2/3 FORTIFI-HN01 trial continues enrollment, with additional Phase 1/1b expansion cohort data expected by Q1 2026.

Bicara Therapeutics (NASDAQ:BCAX) ha comunicato i risultati finanziari del secondo trimestre 2025 e ha fornito aggiornamenti sul suo principale candidato farmaco, ficerafusp alfa. L'azienda ha sottolineato i forti risultati della fase 1/1b presentati all'ASCO 2025, con un tasso di risposta obiettiva confermato del 54% nei pazienti con tumore della testa e del collo HPV-negativi e una durata mediana della risposta di 21,7 mesi.

L'azienda mantiene una solida posizione finanziaria con 436,6 milioni di dollari in cassa, importo ritenuto sufficiente a finanziare le operazioni fino alla prima metà del 2029. Nel Q2 2025 le spese R&S sono aumentate a 24,8 milioni di dollari e la perdita netta è stata di 27,4 milioni di dollari. Il trial pivotale in corso, Phase 2/3 FORTIFI-HN01, continua l'arruolamento, con dati aggiuntivi della coorte di espansione della fase 1/1b attesi entro il primo trimestre 2026.

Bicara Therapeutics (NASDAQ:BCAX) informó los resultados financieros del segundo trimestre de 2025 y ofreció actualizaciones sobre su principal candidato a fármaco, ficerafusp alfa. La compañía destacó los fuertes resultados de la fase 1/1b presentados en ASCO 2025, mostrando una tasa de respuesta objetiva confirmada del 54% en pacientes con cáncer de cabeza y cuello negativos para VPH, con una duración mediana de la respuesta de 21,7 meses.

La compañía mantiene una posición financiera sólida con 436,6 millones de dólares en efectivo, suficientes para financiar las operaciones hasta la primera mitad de 2029. En el 2T 2025 aumentaron los gastos de I+D a 24,8 millones de dólares y la pérdida neta fue de 27,4 millones de dólares. El ensayo pivotal en curso, Phase 2/3 FORTIFI-HN01, sigue reclutando, y se esperan datos adicionales de la cohorte de expansión de la fase 1/1b para el primer trimestre de 2026.

Bicara Therapeutics (NASDAQ:BCAX)� 2025� 2분기 재무실적� 발표하고 주요 후보약물 피세라푸스알�(ficerafusp alfa)� 대� 업데이트� 제공했습니다. 회사� ASCO 2025에서 발표� 강력� 1/1b� 결과� 강조했으�, HPV 음성 두경부� 환자에서 확인� 객관� 반응률이 54%였� 반응� 중앙 지속기간은 21.7개월이라� 밝혔습니�.

회사� 4�3660� 달러($436.6 million)� 현금� 보유� 2029� 상반기까지 운영 자금� 조달� 것으� 예상되며 견고� 재무상태� 유지하고 있습니다. 2025� 2분기 연구개발비는 2480� 달러� 증가했고 순손실은 2740� 달러였습니�. 진행 중인 중추� Phase 2/3 FORTIFI-HN01 시험은 등록� 계속하고 있으�, 1/1b� 확장 코호트의 추가 데이터는 2026� 1분기까지 발표� 예정입니�.

Bicara Therapeutics (NASDAQ:BCAX) a publié ses résultats financiers du deuxième trimestre 2025 et a donné des nouvelles de son principal candidat-médicament, ficerafusp alfa. La société a mis en avant les forts résultats de la phase 1/1b présentés à l'ASCO 2025, montrant un taux de réponse objective confirmé de 54 % chez des patients atteints de cancers de la tête et du cou HPV-négatifs, avec une durée médiane de réponse de 21,7 mois.

La société conserve une position financière solide avec 436,6 millions de dollars de trésorerie, censés financer les opérations jusqu'au premier semestre 2029. Au T2 2025, les dépenses de R&D ont augmenté à 24,8 millions de dollars et la perte nette s'est élevée à 27,4 millions de dollars. L'essai pivotal en cours, Phase 2/3 FORTIFI-HN01, continue son recrutement, et des données supplémentaires de la cohorte d'extension de la phase 1/1b sont attendues d'ici le premier trimestre 2026.

Bicara Therapeutics (NASDAQ:BCAX) meldete die Finanzergebnisse für das zweite Quartal 2025 und gab Updates zu seinem führenden Wirkstoffkandidaten ficerafusp alfa. Das Unternehmen hob die starken Phase�1/1b‑Ergebnisse hervor, die auf der ASCO 2025 präsentiert wurden und eine bestätigte objektive Ansprechrate von 54% bei HPV‑negativen Kopf‑und‑Hals‑Krebs‑Patienten zeigten, mit einer medianen Ansprechdauer von 21,7 Monaten.

Das Unternehmen verfügt über eine robuste Finanzlage mit 436,6 Millionen US‑Dollar an liquiden Mitteln, die voraussichtlich die Geschäftstätigkeit bis in die erste Hälfte 2029 finanzieren. Im Q2 2025 stiegen die F&E‑Aufwendungen auf 24,8 Millionen US‑Dollar und der Nettoverlust belief sich auf 27,4 Millionen US‑Dollar. Die laufende pivotale Phase 2/3 FORTIFI‑HN01‑Studie setzt die Rekrutierung fort; zusätzliche Daten der Expansionskohorte der Phase 1/1b werden bis Q1 2026 erwartet.

Positive
  • Strong cash position of $436.6M expected to fund operations into H1 2029
  • 54% confirmed objective response rate in Phase 1/1b trial for HPV-negative HNSCC
  • Impressive 21.7-month median duration of response in trial responders
  • 80% of responders achieved deep response with �80% tumor shrinkage
  • 89% disease control rate in Phase 1/1b trial
Negative
  • Increased net loss of $27.4M in Q2 2025, up from $17.0M in Q2 2024
  • R&D expenses increased 57% to $24.8M compared to Q2 2024
  • General and administrative expenses nearly doubled to $7.2M year-over-year

Insights

Bicara's ficerafusp alfa shows promising 54% response rate and 21.7-month duration in HPV-negative head and neck cancer with strong financials.

The updated Phase 1/1b data for ficerafusp alfa presents remarkably strong efficacy signals in HPV-negative head and neck cancer patients. The 54% confirmed objective response rate significantly exceeds historical benchmarks for standard-of-care therapies in this challenging population, where response rates typically hover around 20-25%. Most impressive is the median duration of response reaching 21.7 months - exceptionally long for this aggressive cancer type where responses often last only 4-6 months with existing treatments.

The 21.3-month median overall survival with a 46% 2-year survival rate demonstrates meaningful clinical benefit beyond tumor shrinkage. For context, current first-line standard-of-care typically yields median survival of 12-15 months in this population. The 80% deep response rate (�80% tumor shrinkage) among responders suggests the dual-targeting mechanism effectively overcomes the immunosuppressive tumor microenvironment that has historically limited treatment efficacy.

The trial expansion into multiple dosing regimens (750mg weekly, 2000mg biweekly) and a CPS 0 cohort represents strategic clinical development - targeting dose optimization while exploring efficacy in the most treatment-resistant subgroup (CPS 0). The progression to a pivotal Phase 2/3 trial indicates regulatory confidence in the existing dataset. The expansion into colorectal cancer suggests potential broader application of the EGFR/TGF-β targeting mechanism across tumor types characterized by stromal barriers.

Bicara's $437M cash position provides 4-year runway through key clinical milestones, strengthening investment thesis despite increasing R&D spend.

Bicara's financial position remains exceptionally strong with $436.6 million in cash, providing an extended runway into the first half of 2029 - nearly 4 years of operational funding. This represents uncommon financial stability for a clinical-stage biotech with a single lead asset, significantly de-risking the investment case. The cash burn rate of approximately $53 million for the first half of 2025 (calculated from the December 2024 position of $489.7M) indicates disciplined capital management despite scaling clinical operations.

The increase in R&D expenses to $24.8 million (up from $15.8M year-over-year) reflects appropriate investment scaling as ficerafusp alfa advances into pivotal Phase 2/3 testing. This 57% increase aligns with the expanded development program now supporting multiple dose regimens and additional cohorts. Similarly, the G&A expense increase to $7.2 million (from $3.9M) represents the operational infrastructure buildout necessary to support a maturing clinical program.

The net loss of $27.4 million for Q2 remains manageable relative to the cash position, with approximately 16 quarters of funding at current burn rates. This financial buffer provides considerable flexibility to pursue the comprehensive clinical development strategy outlined, including multiple readouts through 2026, without near-term financing pressure. This extended runway through multiple value-creating clinical milestones significantly enhances Bicara's negotiating position for potential partnerships or future capital raises.

Updated data from Phase 1/1b trial presented at 2025 ASCO Annual Meeting demonstrated deep and durable responses in 1L HPV-negative R/M HNSCC

Data from additional Phase 1/1b expansion cohorts evaluating alternate dose regimens in HPV-negative patients expected by Q1 2026

Strong financial position with approximately $437 million in cash and cash equivalents as of June 30, 2025 expected to fund operations into the first half of 2029

BOSTON, Aug. 12, 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 second quarter ended June 30, 2025 and provided a business update.

“We continue to make excellent progress with the development of ficerafusp alfa,� said Claire Mazumdar, PhD, MBA, Chief Executive Officer of Bicara Therapeutics. “Updated Phase 1/1b data recently presented at ASCO 2025 from the 1500mg weekly cohort underscore the differentiated ability of ficerafusp alfa to remodel the tumor stroma and drive tumor penetration, with deep, durable anti-tumor responses observed in HPV-negative recurrent/metastatic head and neck squamous cell carcinoma patients. These data provide a strong foundation for the continued advancement of our pivotal Phase 2/3 FORTIFI-HN01 trial, and reinforce our confidence in the study design. We also look forward to presenting data from two additional Phase 1/1b expansion cohorts evaluating alternate dose regimens in patients with HPV-negative disease, which are expected to further characterize the safety and efficacy profile of ficerafusp alfa in this population with high unmet need.�

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 designed to enhance tumor penetration by breaking barriers in the tumor microenvironment that have challenged the treatment of multiple solid tumor cancers.

FORTIFI-HN01: Pivotal Phase 2/3 Clinical Trial in 1L R/M HNSCC

Enrollment is ongoing in FORTIFI-HN01, a global, randomized, double-blind, placebo-controlled, pivotal Phase 2/3 trial of ficerafusp alfa in combination with pembrolizumab in first line (1L) 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).

Phase 1/1b Clinical Trial in 1L R/M HNSCC

  • Updated data with extended follow-up from a Phase 1/1b trial evaluating 1500mg ficerafusp alfa weekly in patients with 1L R/M HNSCC was highlighted in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
    • In the efficacy evaluable human papillomavirus (HPV)-negative population (n=28):
      • Median duration of response (DOR) of 21.7 months amongst responders (n=15).
      • Median overall survival (OS) of 21.3 months; 2-year OS rate of 46%.
      • 54% (15/28) confirmed objective response rate (ORR); 64% (18/28) ORR, including three additional unconfirmed responses and 21% (6/28) complete response rate.
      • 80% (12/15) of responders achieved a deep response (�80% tumor shrinkage).
      • Disease control rate of 89% (25/28 patients).
      • Median progression-free survival of 9.9 months.
      • Manageable safety profile consistent with previously reported adverse events.
  • Additional Phase 1b expansion cohorts evaluating ficerafusp alfa in 1L R/M HNSCC remain ongoing:
    • Data from a cohort evaluating 750mg of ficerafusp alfa weekly in combination with pembrolizumab in HPV-negative patients are expected to be presented at a medical meeting in the fourth quarter of 2025 or the first quarter of 2026.
    • Data from a cohort evaluating 2000mg of ficerafusp alfa every other week in combination with pembrolizumab in HPV-negative patients are expected to be presented at a medical meeting in the first quarter of 2026.
    • A cohort evaluating 1500mg weekly of ficerafusp alfa in combination with pembrolizumab in HPV-negative patients with combined positive scores (CPS) of 0 continues to enroll. Data from this cohort are expected to be presented at a medical meeting in 2026.

Development of Ficerafusp Alfa Across Other Solid Tumor Types

  • A Phase 1b expansion cohort evaluating ficerafusp alfa both as monotherapy and in combination with pembrolizumab in patients with 3L+ metastatic colorectal cancer (RAS/B-Rapidly Accelerated Fibrosarcoma (BRAF) wild type) is enrolling.

Second Quarter 2025 Financial Results

  • Cash Position: As of June 30, 2025, Bicara had cash and cash equivalents of $436.6 million, compared to $489.7 million as of December 31, 2024. 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 $24.8 million for the second quarter of 2025 as compared to $15.8 million for the second quarter of 2024. The increase was primarily due to additional costs associated with the initiation of FORTIFI-HN01, a pivotal Phase 2/3 clinical trial, as well as the Company’s ongoing Phase 1/1b clinical trials to advance ficerafusp alfa and an increase in personnel costs.
  • General and Administrative Expenses: General and administrative expenses were $7.2 million for the second quarter of 2025 as compared to $3.9 million for the second 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 $27.4 million for the second quarter of 2025 as compared to $17.0 million for the second quarter of 2024.

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 visitor 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 enrollment, progress and anticipated data readouts of Bicara’s Phase 2/3 trial of ficerafusp alfa in combination with pembrolizumab and the additional ongoing expansion cohorts of Bicara’s Phase 1b trial of ficerafusp alfa; 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 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 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 June 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
June 30,
Six Months Ended
June 30,
2025202420252024
Operating expenses
Research and development - related party$2,932$1,510$9,507$5,091
Research and development21,86614,33149,62422,782
General and administrative7,2203,90914,6757,251
Total operating expenses132,01819,75073,80635,124
Loss from operations(32,018)(19,750)(73,806)(35,124)
Other income
Interest income4,6822,7019,6965,568
Total other income4,6822,7019,6965,568
Net loss before income taxes(27,336)(17,049)(64,110)(29,556)
Income tax expense(52)(124)(1)
Net loss$(27,388)$(17,049)$(64,234)$(29,557)
Net Loss per share, basic and diluted$(0.50)$(19.01)$(1.18)$(38.19)
Weighted-average number common shares outstanding, basic and diluted54,539,230896,74454,496,862774,012
1 Expenses include the following non-cash stock-based compensation expense
Research & Development$1,159$251$2,300$481
General and administrative2,3337874,6431,704
Total stock-based compensation expense$3,492$1,038$6,943$2,185


BICARA THERAPEUTICS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited, in thousands)
June 30,
2025
December 31,
2024
Assets
Current assets:
Cash and cash equivalents$436,606$489,711
Prepaid expenses and other assets7,78512,822
Total current assets444,391502,533
Property and equipment, net117155
Right of use asset � operating lease2,237690
Other assets6,8426,618
Total assets$453,587$509,996
Liabilities and stockholders� equity
Current liabilities:
Accounts payable$2,041$3,893
Accounts payable � related party870615
Accrued expenses and other current liabilities12,00012,875
Accrued expenses and other current liabilities � related party1,242
Operating lease liability � current portion1,074607
Total current liabilities17,22717,990
Operating lease liability � net of current portion1,164131
Total liabilities18,39118,121
Total stockholders' equity435,196491,875
Total liabilities and stockholders� equity$453,587$509,996

Contacts

Investors
Rachel Frank

Media
Amanda Lazaro
1AB


FAQ

What were the key Phase 1/1b trial results for Bicara's (BCAX) ficerafusp alfa in head and neck cancer?

The trial showed a 54% confirmed objective response rate, 21.7-month median duration of response, and 21.3-month median overall survival in HPV-negative HNSCC patients. Additionally, 80% of responders achieved deep response with �80% tumor shrinkage.

How much cash does Bicara Therapeutics (BCAX) have and how long will it last?

As of June 30, 2025, Bicara has $436.6 million in cash and cash equivalents, which is expected to fund operations into the first half of 2029.

What is ficerafusp alfa and how does it work?

Ficerafusp alfa is a first-in-class, dual-action bifunctional antibody targeting EGFR and TGF-β, designed to enhance tumor penetration by breaking barriers in the tumor microenvironment for treating solid tumors.

When will Bicara (BCAX) report additional clinical trial data?

Bicara expects to present data from two Phase 1/1b expansion cohorts by Q1 2026, including results from the 750mg weekly dose cohort in Q4 2025 or Q1 2026, and the 2000mg bi-weekly dose cohort in Q1 2026.

What was Bicara Therapeutics' (BCAX) net loss in Q2 2025?

Bicara reported a net loss of $27.4 million for Q2 2025, compared to $17.0 million in Q2 2024, primarily due to increased R&D and administrative expenses.
Bicara Therapeutics

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