Ficerafusp alfa

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 visit www.bicara.com 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. 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 EndedJune 30, 2025 2024 2025 2024Operating expenses Research and development - related party$2,932 $1,510 $9,507 $5,091 Research and development 21,866 14,331 49,624 22,782 General and administrative 7,220 3,909 14,675 7,251 Total operating expenses1 32,018 19,750 73,806 35,124 Loss from operations (32,018) (19,750) (73,806) (35,124) Other income Interest income 4,682 2,701 9,696 5,568 Total other income 4,682 2,701 9,696 5,568 Net loss before income taxes (27,336) (17,049) (64,110) (29,556)Income tax expense (52) – (124) (1)Net loss$(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 diluted 54,539,230 896,744 54,496,862 774,012 1 Expenses include the following non-cash stock-based compensation expense Research & Development$1,159 $251 $2,300 $481 General and administrative 2,333 787 4,643 1,704 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, 2024Assets Current assets: Cash and cash equivalents$436,606 $489,711 Prepaid expenses and other assets 7,785 12,822 Total current assets 444,391 502,533 Property and equipment, net 117 155 Right of use asset – operating lease 2,237 690 Other assets 6,842 6,618 Total assets$453,587 $509,996 Liabilities and stockholders’ equity Current liabilities: Accounts payable$2,041 $3,893 Accounts payable – related party 870 615 Accrued expenses and other current liabilities 12,000 12,875 Accrued expenses and other current liabilities – related party 1,242 — Operating lease liability – current portion 1,074 607 Total current liabilities 17,227 17,990 Operating lease liability – net of current portion 1,164 131 Total liabilities 18,391 18,121 Total stockholders' equity 435,196 491,875 Total liabilities and stockholders’ equity$453,587 $509,996 Contacts InvestorsRachel FrankIR@bicara.com MediaAmanda Lazaro1ABAmanda@1abmedia.com

Bicara CEO Claire Mazumdar, Ph.D., told Fierce Biotech that the analysts who are calling the race for Merus are “missing the key aspect of head and neck.”\n Several analysts are hailing Merus as the sure winner in the race to a new treatment for head and neck squamous cell carcinoma (HNSCC). But the chase is still in its early days and is likely too soon to call.Yesterday, Bicara shared updated data for its bifunctional antibody paired with Keytruda in HNSCC, including a first look at overall survival (OS) data for HPV-negative patients, a subpopulation that typically has worse treatment outcomes than HPV-positive patients.A phase 1/1b trial demonstrated a two-year OS rate of 46% among patients with first-line, PD-L1-positive recurrent or metastatic HNSCC. Bicara’s EGFR/TGF-β asset, dubbed ficerafusp alfa, was also tied to a median OS of 21.3 months for 28 HPV-negative patients.In a June 2 note, analysts at Leerink Partners said Bicara’s “data do not tip the scale meaningfully,” and that they favored Merus, a Dutch biotech that touts a clinical bispecific targeting EGFR and LGR5 in HNSCC. Leerink provides coverage for Merus, which has about a $4 billion market cap, and does not cover Bicara, which has a $500 million market cap.Recently, Merus recorded a 79% 12-month OS rate in a phase 2 trial for patients with PD-L1-positive recurrent or metastatic HNSCC—regardless of HPV status. Merus’ asset, called petosemtamab, was also paired with Keytruda.Leerink said they believe Merus’ meaningfully higher 12-month OS rate, compared to a 62% OS at 12 months for Bicara’s program, bodes well for petosemtamab’s eventual OS duration.The analyst also cited the median progression free survival (PFS) rates, which was nine months for Merus and 7.4 months for Bicara in an HPV-unselective population. However, Bicara’s mPFS rose to 9.9 months when evaluated in only HPV-negative patients.Bicara CEO Claire Mazumdar, Ph.D., told Fierce Biotech that the analysts who are calling the race for Merus are “missing the key aspect of head and neck.” “If you talk to any investigator, what they\'ll tell you is that these 12-month landmarks really mean nothing in the context of prolonged overall survival,” Mazumdar said on the sidelines of this year’s American Society of Clinical Oncology conference. “The key message for us is really that our data is resonating far more with the people that matter, which are the head and neck oncologists, and really the fact that we\'ve listened to them understand that these are different diseases, HPV-negative and HPV-positive.”Several studies have shown that patients with HPV-positive HNSCC have significantly better survival outcomes after standard-of-care treatment compared to HPV-negative patients, with several reasons emerging for this difference, including risk factors such as smoking and alcohol use association.Mazumdar underscored how treatment is influenced by patients’ baseline characteristics and subsequent therapies, which is why she said the “more statistically stable endpoint” of a median of two-years follow up.  “A lot of what the investigators have been telling us that our data points are far stronger from that perspective, because we have a long-term dialogue,” the Bicara leader said.Eric Schmidt with Cantor Fitzgerald views the data from Bicara and Merus as “more similar than different at this stage,” and noted that both are highly promising, according to a June 1 analyst note. It’s decidedly too soon to call a winner, Schmidt said. When looking at phase 3 timelines, Merus has the upper hand, but the analyst writes that it would be premature to “call how the battle for 1L market share might play out based on these single-arm datasets.”Cantor’s Schmidt did list several differences between petosemtamab and ficerafusp that could “turn the tables” in favor of the latter, including ficerafusp\'s TGF-beta mechanism that provides potential for more durable responses. He also highlighted the design of Bicara’s ongoing pivotal trial, which features a HPV-negative population that is more responsive to EGFR inhibition.The biotech is currently enrolling for the pivotal phase 2/3 trial, with an expected enrollment of 650 patients.“The head and neck community, I think, have been burned by so many of these high response rates [and] one-year landmark OS that didn\'t translate to anything,” Mazumdar said. “So, that\'s really the community we\'re developing this for. It\'s for the patients. And I do think there is a part of the investor community that\'s realizing the true potential of this, but they were swayed by a flashy headline two weeks ago.”