Bicara Therapeutics Inc. Common Stock (BCAX) Earnings

Management highlights

### Leadership Transition • Multiple planned leadership transitions were announced, aligned with the company's approaching late-stage clinical milestones and potential commercialization: - Early 2027: Current President and COO Ryan Cohlhepp will become President and CEO; outgoing CEO Claire Mazumdar will transition to Vice Chair of the Board and Strategic Advisor, remaining full-time at the company. - Effective immediately: Jen Larson will join as CFO, succeeding outgoing CFO Ivan Hyep, who helped build the company's finance function, lead over $800 million in capital raises, and steward the company's public market transition. - Early 2027: Tanya Green (current Chief Development Officer) will become COO; Jenna Cohen (current Chief Corporate Affairs Officer) will be promoted to Chief Business Officer; Greg Schifferman will join as Chief Legal Officer. • Two new independent directors (Jeremy Bender and Christy Olinger) were added to the board, bringing deep experience guiding biotechs through growth, commercialization, and pipeline development. ### Clinical Development Progress • The pivotal Phase III Fortify HN01 study of Fisera for frontline recurrent/metastatic HPV-negative head and neck squamous cell carcinoma (HNSCC) remains on track, with over 200 active sites and strong investigator engagement. The company expects substantial enrollment by the end of 2026, positioning for a top-line interim analysis in mid-2027 and a potential path to accelerated approval. • At ASCO 2026, Bicara presented 3-year follow-up data showing Fisera nearly doubled 3-year overall survival compared to standard-of-care pembrolizumab, with a consistent safety profile. The data confirmed that Fisera's TGF-beta inhibition enables deeper, more durable responses than existing therapies, with an estimated 33% 3-year survival rate for patients on the pivotal 1500mg weekly dose. • The company has initiated Fortify FLEX, an alternative dosing study evaluating a loading dose followed by every-three-week maintenance dosing. The company aims to have study data available by the time of potential U.S. approval to support label inclusion of this more convenient, streamlined regimen. • Early development continues beyond frontline HNSCC, with proof-of-concept already established in cutaneous squamous cell carcinoma and anal canal cancer. Signal-seeking cohorts for third-line plus MSS colorectal cancer (CRC) are ongoing, with plans to explore biomarker stratification and combinations with RAS inhibitors.

Guidance

• Quarter-over-quarter operating expenses are expected to increase for the remainder of 2026, driven by continued investment in clinical operations for Fortify HN01, new spending on the recently initiated Fortify FLEX study, workforce growth, and increased investment in launch readiness functions (medical affairs, commercial organization) ahead of potential regulatory approval. • The company's current $497 million cash balance provides sufficient runway to fund operations into the first half of 2029, covering all key milestones including completion of the Fortify HN01 study, regulatory filing, initial commercial infrastructure build-out, Fortify FLEX development, and manufacturing for ongoing programs. • The company remains on track to meet its target of substantial Fortify HN01 enrollment by the end of 2026, with interim analysis in mid-2027, and expects to have Fortify FLEX data available in time for the initial U.S. approval submission.

Segment performance

Bicara Therapeutics is a clinical-stage biotech company with a single lead product candidate, Fisera (Phycerophis alpha). No separate product segment revenue is reported, as the company has not launched any commercial products and is still in the development stage. Total operating expenses for Q2 2026 increased compared to Q2 2025, driven by clinical operations and development costs for the pivotal Fortify HN01 study, higher manufacturing costs, and increased personnel-related costs (including stock-based compensation) for workforce growth supporting development activities. As of Q2 end 2026, the company held $497 million in cash, cash equivalents, and marketable securities.

Risks & headwinds

• Forward-looking statements (including clinical milestone timelines, approval expectations, and cash runway projections) are subject to inherent risks, including potential delays in clinical enrollment, unexpected safety or efficacy outcomes, regulatory delays, and competitive developments that could materially alter actual results, as disclosed in the company's SEC filings. • The company faces increasing competition in the EGFR-targeted HNSCC space, with multiple competitors advancing bispecific therapies to late-stage development and potential approvals ahead of Fisera's readout, which could impact market adoption and treatment sequencing dynamics. • Early signal-seeking data in additional indications (including colorectal cancer) is exploratory and small-sized, with no guarantee of positive efficacy signals that would justify further large-scale development investment.

Analyst Q&A

• Q: Why is this leadership transition happening now, before the Phase 3 readout, rather than after topline data is available? /

  A: Claire Mazumdar and Ryan Cohlhepp planned this succession from the company's founding, aligned with the need to build commercial infrastructure and prepare for launch in advance of topline data. This intentional transition from a position of strength elevates an executive team with deep commercial launch experience to lay the groundwork for potential approval, and Claire will remain fully involved as Vice Chair and Strategic Advisor.

• Q: How will you avoid disrupting enrollment for the primary Fortify HN01 study while initiating Fortify Flex, and are you watching any competitive data at upcoming ESMO presentations? /

  A: Only around one-third of Fortify Flex sites overlap with Fortify HN01, and the company is stage-gating enrollment, prioritizing Fortify HN01 and adding sites in non-overlapping regions globally. Management is aware of upcoming data from amivantamab (J&J) and padosimidimab, and will monitor these presentations closely.

• Q: What feedback have you received from physicians on your ASCO 2026 TGF-beta data, and has this impacted Fortify HN01 enrollment? Why aren't you rushing into Phase 3 development for colorectal cancer like your competitors? /

  A: Physicians have reacted very positively to the mature data on Fisera's durable responses, overall survival benefit, and consistent tolerability, and this positive reception has boosted enrollment momentum in the Fortify HN01 study. Bicara is following its own scientific rationale rather than following competitors, focusing first on third-line CRC where TGF-beta is known to drive EGFR resistance, and prioritizing high-potential opportunities in cutaneous squamous cell carcinoma, anal cancer, and locally advanced HNSCC before expanding further in CRC.

• Q: What is the clinical rationale for the Fortify Flex dosing regimen, and how will its data support approval for inclusion in the label? /

  A: Fortify Flex compares Fisera's standard 1500mg weekly dosing to a loading dose followed by every-three-week maintenance dosing, and the study is designed to confirm comparable durability of response between the two regimens. This design satisfied FDA requirements for study size and endpoints, so positive data can be included in the label at the time of initial approval.

• Q: How do you differentiate Fisera from competing EGFR bispecifics, particularly on safety? /

  A: Management continues to receive strong feedback on Fisera's favorable tolerability in combination with pembrolizumab, which differentiates it from competing regimens. Unlike competitor amivantamab, which is studied in combination with chemotherapy, Fisera offers a chemo-sparing regimen that is strongly preferred by practicing investigators.