Every 8-K that Bicara Therapeutics Inc. (BCAX) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow BCAX and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full BCAX filings page.
Bicara Therapeutics Inc. (BCAX) entered into a Sub-Sublease Agreement with Wayfair LLC to lease approximately 35,090 square feet of office space for its new corporate headquarters at 10 St. James Avenue, Boston, Massachusetts 02116. The sublease term will commence on the later of October 1, 2026 or the date a required multi-party consent is fully executed, defined as the Commencement Date. The base rent is $105,279 per month, beginning nine months after the Commencement Date, and Bicara paid a $210,540 security deposit at signing. The sublease will end on the earlier of September 30, 2028 or an earlier termination under its terms and includes customary events of default, representations, warranties and covenants.
Bicara Therapeutics Inc. reported second quarter 2026 results and major leadership changes while advancing its lead oncology program ficerafusp alfa. Ryan Cohlhepp will become President and CEO on January 1, 2027, with current CEO Claire Mazumdar transitioning to Vice Chair of the Board and Strategic Advisor. Additional senior hires include a new CFO, Chief Business Officer and Chief Legal Officer, reflecting preparations for potential commercialization.
The company is enrolling the pivotal Phase 3 FORTIFI-HN01 trial in first-line recurrent or metastatic HPV-negative head and neck cancer and expects substantial enrollment by year-end, enabling interim topline data in mid-2027. A new FORTIFI-FLEX alternate dosing study has begun. Three-year follow-up from a Phase 1/1b cohort showed an estimated overall survival rate of 31%, approximately doubling survival seen in retrospective standard-of-care pembrolizumab data.
Financially, Bicara ended June 30, 2026 with $497.3 million in cash, cash equivalents and marketable securities and expects this to fund operations into the first half of 2029. Second quarter 2026 research and development expenses were $45.8 million and general and administrative expenses were $14.2 million, driving a net loss of $55.4 million, all higher than the prior-year period.
Bicara Therapeutics Inc. reported that Kiran Mazumdar‑Shaw will resign from its Board and Nominating and Corporate Governance Committee effective July 28, 2026; her decision was stated not to result from any disagreement with the company. The Board appointed Jeremy Bender as a Class I director through the 2028 annual meeting and Christy Oliger as a Class II director through the 2029 meeting, effective the same date, and increased the authorized Board size from nine to ten directors.
Both new directors are deemed independent under Nasdaq rules and, as non‑employee directors, will receive compensation that includes an initial stock option award of 38,950 shares of common stock and cash fees under Bicara’s director compensation policy. Bender joins the Audit Committee, while Oliger and Carolyn Ng join the Nominating and Corporate Governance Committee. The Board also created a Launch Readiness Committee, including Bender, Oliger and chair Kate Haviland, to provide strategic and operational guidance on Bicara’s commercialization strategy and launch readiness for its lead program, ficerafusp alfa.
Bicara Therapeutics Inc. held its 2026 annual meeting of stockholders on June 9, 2026. Of 65,600,370 common shares outstanding as of the record date, 55,924,987 shares, or about 85.25%, were present or represented.
Stockholders elected Christopher Bowden, M.D., and Carolyn Ng, Ph.D., as Class II directors to serve until the 2029 annual meeting, with each receiving substantially more votes for than withheld. Stockholders also ratified the appointment of KPMG LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2026.
Bicara Therapeutics reported three-year follow-up data from its Phase 1/1b study of ficerafusp alfa plus pembrolizumab in first-line HPV-negative recurrent/metastatic head and neck squamous cell carcinoma. At the pivotal 1500mg weekly dose, the combination showed an estimated 31% overall survival at three years, approximately doubling survival versus a retrospective standard-of-care pembrolizumab analysis.
Across 750mg weekly, 1500mg weekly and 2000mg every-other-week cohorts, confirmed response rates ranged from 48–57%, with complete response rates of 13%, 25% and 30% as of March 31, 2026. Deep responses of at least 80% tumor shrinkage were common at higher doses and were associated with longer duration of response, progression-free survival and overall survival. Bicara highlighted biomarker data supporting TGF-β inhibition as the driver of these deep, durable responses and noted that the pivotal FORTIFI-HN01 Phase 2/3 study and an alternate dosing study are ongoing or planned.
Bicara Therapeutics reported first quarter 2026 results and highlighted progress advancing its lead cancer asset ficerafusp alfa. Cash, cash equivalents and marketable securities were $539.8 million as of March 31, 2026, up from $414.8 million at December 31, 2025, helped by approximately $161.8 million in net proceeds from an oversubscribed public offering. The company expects this cash to fund operations into the first half of 2029.
Research and development expenses rose to $47.5 million from $34.3 million a year earlier, and general and administrative expenses increased to $12.7 million from $7.5 million, reflecting pivotal FORTIFI-HN01 trial costs, Phase 1/1b expansions and higher personnel and professional fees. Net loss widened to $56.2 million, or $0.93 per share, compared with $36.8 million, or $0.68 per share, in the prior-year quarter.
Operationally, Bicara continued enrollment in its pivotal FORTIFI-HN01 trial in first-line HPV-negative head and neck cancer and plans a randomized alternate-dose study of ficerafusp alfa with pembrolizumab starting in the third quarter of 2026. The company expects to present long-term Phase 1b data at ASCO 2026 and additional data in other solid tumors later in 2026. Leadership changes included promoting Bill Schelman to Chief Medical Officer and appointing Chris Sarchi as Chief Commercial Officer to support potential commercialization.
Bicara Therapeutics reported fourth quarter and full year 2025 results and outlined progress on its lead oncology program ficerafusp alfa. For 2025, net loss was $137.95 million, up from $67.99 million in 2024, driven mainly by higher research and development spending.
Cash, cash equivalents and marketable securities totaled $414.8 million as of December 31, 2025, plus $161.8 million in net proceeds from an oversubscribed public offering in early 2026, and the company expects this to fund operations into the first half of 2029. Bicara initiated Phase 3 of its pivotal FORTIFI-HN01 trial in HPV‑negative head and neck cancer, selected a 1500 mg weekly dose of ficerafusp alfa, and is developing a less frequent loading and every‑three‑week maintenance regimen. Management highlighted plans for substantial FORTIFI‑HN01 enrollment by the end of 2026 and an interim analysis in mid‑2027.
Bicara Therapeutics Inc. completed an underwritten equity offering combining common stock and pre-funded warrants. The company sold 7,175,000 common shares and pre-funded warrants to purchase up to 2,200,000 shares, with underwriters also exercising a 1,406,250-share option in full. Net proceeds were approximately $161.8 million, all to the company.
Bicara plans to use the cash to build medical and commercial infrastructure for a planned U.S. regulatory filing and potential launch of ficerafusp alfa, advance development in first-line HPV-negative head and neck cancer, fund manufacturing and signal-finding for indication expansion, and for general corporate purposes. The company also reported preliminary, unaudited cash, cash equivalents and investments of about $414.8 million as of December 31, 2025.
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.
Bicara Therapeutics Inc. filed a Form 8-K to report that it issued a press release on January 12, 2026 titled “Bicara Therapeutics Announces Phase 3 Optimal Dose and Provides 2026 Corporate Outlook.”
The company states that this press release is furnished as Exhibit 99.1 and incorporated by reference, indicating it contains details on the chosen Phase 3 dose and management’s outlook for 2026.
Bicara Therapeutics (BCAX) furnished an 8-K announcing it issued a press release with financial results and business highlights for the quarter ended September 30, 2025. The press release is attached as Exhibit 99.1 and is incorporated by reference.
The information under Item 2.02 and Exhibit 99.1 is being furnished, not filed, under the Exchange Act, and therefore is not subject to Section 18 liabilities. BCAX common stock trades on The Nasdaq Global Market.
Bicara Therapeutics Inc. filed a current report to note that it has released its financial results and business highlights for the quarter ended June 30, 2025. On August 12, 2025, the company issued a press release describing its quarterly performance and key developments.
The press release is attached as Exhibit 99.1 and is incorporated by reference for informational purposes, but is designated as furnished rather than filed under the Exchange Act. The filing also includes an Inline XBRL cover page data file as Exhibit 104.