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BICARA THERAPEUTICS ™ Fighting cancer with precision and power . August 2026 Corporate Deck Copyright © 2026 Bicara Therapeutics
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Forward-looking statements 2 This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements other than historical factual information are forward-looking statements, including without limitation express or implied statements regarding our strategy, business plans and focus; the clinical development of ficerafusp alfa, including the initiation, timing, progress, results and future data releases of our ongoing and planned clinical trials; the advancement of the FORTIFI-HN01 pivotal trial in 1L HPV-negative R/M HNSCC and our expectation for the trial to be substantially enrolled by the end of the year and an interim analysis mid-2027; the timing of future data releases from our ongoing Phase 1/1b expansion cohorts, including an anticipated data release from the expansion cohort evaluating ficerafusp in patients with 3L+ mCRC (RAS/BRAF wild type MSS) in the second half of 2026; the initiation of an alternate dose study in the third quarter of 2026 to evaluate a loading and every-three-week maintenance dosing regimen of ficerafusp alfa and expectations for results in time for potential U.S. accelerated approval; the expected therapeutic potential and clinical benefits of ficerafusp alfa, including potential efficacy, depth, durability and tolerability as compared to the existing standard of care; our ability to scale and prepare for potential commercialization of ficerafusp alfa; the potential for U.S. regulatory approval and U.S. launch of ficerafusp alfa in 2028; the potential market opportunities for ficerafusp alfa in HPV-negative HNSCC and potential expansion opportunities across other solid tumors; and our expected operating expenses and capital expenditure requirements. In some cases, you can identify forward-looking statements because they contain words such as “may,” “might,” “will,” “would,” “shall,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “looks,” “seeks,” “predicts,” “potential,” “ongoing,” or “continue” or the negative of these words or other similar terms or expressions that concern our expectations, strategy, plans or intentions, although not all forward-looking statements are accompanied by such words. Forward-looking statements are based on assumptions and assessments made by our management in light of their experience and perceptions of historical trends, current conditions, expected future developments and other factors they believe to be appropriate, and speak only as of the date of this presentation. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or other events to be materially different from any future results, performance or other events expressed or implied by the forward-looking statements. Given these uncertainties, you should not place undue reliance on forward-looking statements. Our actual future results, performance or other events may be materially different from what we expect. Except as required by law, we assume no obligation to update these forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in these forward- looking statements, even if new information becomes available in the future. Factors that could cause actual results to differ from those predicted in our forward-looking statements include, among others, risks and uncertainties related to product development, including delays or challenges that may arise in the development and regulatory approval of our current and future product candidates or programs; uncertainties as to the availability and timing of results and data from preclinical and clinical studies; the timing of and our ability to submit and obtain regulatory clearance for investigational new drug applications, initiate additional clinical trials, and submit new drug applications or biologics license applications; our ability to initiate and complete our current and expected clinical trials; our ability to establish and maintain collaborations, strategic relationships and supply arrangements, or that we will not realize the intended benefits from such relationships or arrangements; whether our cash resources will be sufficient to fund our foreseeable and unforeseeable operating expenses and capital expenditure requirements; our ability to raise additional funding on favorable terms, or at all; the rate and degree of market acceptance and clinical utility of our product candidates; the ability and willingness of our third-party collaborators to continue research and, development and manufacturing activities relating to our product candidates; the accuracy of our data analyses or estimates for the potential and market for our products; our ability, and the ability of our collaborators, to protect our intellectual property and to conduct activities for the development and commercialization of our candidates in view of third party intellectual property positions; our financial performance; our ability to retain and recruit key personnel; developments and projections relating to our competitors or our industry; changes in general economic conditions and global instability, in particular economic conditions in the markets on which we or our suppliers operate; changes in laws and regulations; and those risks and uncertainties identified in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and such other risks and uncertainties that may be described in subsequent filings we may make with the SEC. You should not rely upon forward-looking statements as predictions of future events or performance, or as a representation or warranty (express or implied) by us or any other person that we will achieve our objectives and plans in any specified time frame, on such specified terms, or at all. Although our management believes that the expectations reflected in our statements are reasonable, we cannot guarantee that the future results, performance or events and circumstances described in the forward-looking statements will be achieved or occur. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein. Market data and industry information used throughout this presentation are based on management’s knowledge of the industry and the good faith estimates of management. We also relied, to the extent available, upon management’s review of independent industry surveys and publications and other publicly available information prepared by a number of third-party sources. All of the market data and industry information used in this presentation involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. Although we believe that these sources are reliable as of their respective dates, we cannot guarantee the accuracy or completeness of this information, and we have not independently verified this information. Projections, assumptions and estimates of our future performance and the future performance of the industry in which we operate are necessarily subject to a high degree of uncertainty and risk due to a variety of factors. These and other factors could cause results to differ materially from those expressed in our estimates and beliefs and in the estimates prepared by independent parties. This presentation discusses potential future product candidates that are investigational only and have not yet been approved for marketing by the U.S. Food and Drug Administration. No representation is made as to the safety or effectiveness of these potential future product candidates for the use for which such potential future product candidates are being studied.
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3EGFR, epidermal growth factor receptor; TGF- , transforming growth factor-beta; 1L, first-line; R/M, recurrent or metastatic; HPV, human papilloma virus; HNSCC, head and neck squamous cell carcinoma β Developing bifunctional antibodies that combine tumor-targeting mechanisms with therapeutic modulation of the tumor microenvironment Advancing ficerafusp alfa (FICERA), the first and only EGFR-directed antibody bound to a TGF-β ligand trap, with blockbuster potential in 1L R/M HPV- negative HNSCC Signal-seeking in additional solid tumors with a known EGFR x TGF-β biological fingerprint to explore FICERA’s pipeline-in-a-product potential A clinical-stage biotechnology company developing targeted tumor modulators
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4 FICERA – EGFR-directed antibody combined with a TGF-β ligand trap designed to drive tumor penetration Inadequate tumor penetration has challenged the treatment of many solid tumors including HPV-negative R/M HNSCC FICERA was specifically designed to enable tumor penetration and drive deep, durable responses to yield improved outcomes and survival Targeting EGFR 1. Direct anti-tumor effect 2. Drives tumor targeting 1 2 Trapping TGF-β 1. Enables tumor penetration 2. Prevents resistance Boreddy SR, et al. Cancer Res. 2023;83(11): 1883-904.
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Bedi, Atul, et al. Molecular cancer therapeutics (2012). 5 Following the science to establish a clinical foothold in HPV-negative HNSCC HNSCC is a fibrotic, immunosuppressive solid tumor Increased EGFR expression Elevated levels of TGF-β1 in serum High rate of therapeutic resistance HPV-negative is a distinct and compelling clinical subset of HNSCC
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6 Building momentum toward a potential breakthrough in HPV-negative HNSCC 1 5 4 3 2 Differentiated overall survival representing a ~2x increase vs. standard of care1 and generally well-tolerated safety out to three years at pivotal study dose TGF-β inhibition translates to unprecedented depth of response, driving clinically differentiated long-term outcomes including DOR, PFS, and OS Expect to be substantially enrolled in FORTIFI-HN01 pivotal trial of FICERA by the end of the year to enable topline results from an interim analysis in mid-2027 Initiated FORTIFI-FLEX alternate dose study and expect to have results by the time of a potential U.S. accelerated approval in 1L R/M HPV-negative HNSCC Exploring the EGFR x TGF-β biological fingerprint across additional solid tumors, including cSCC, anal canal and mCRC, to explore FICERA’s pipeline in a product potential Strong cash position of $497.3 million2 expected to fund operations into 1H 2029 1. Based on a retrospective analysis of Supplementary Figure 1C, Vasiliadou, Ifigenia, et al. International Journal of Cancer 155.5 (2024): 883-893. No head-to-head studies have been conducted, and cross-trial comparisons differences in molecule composition, trial design, and patient population and characteristics. 2. Cash, cash equivalents and marketable securities as of June 30, 2026 DOR = duration of response; PFS = progression-free survival; OS = overall survival; cSCC = cutaneous squamous cell carcinoma; mCRC = metastatic colorectal cancer;
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Executing a Strategic Development Plan for FICERA in 1L R/M HPV-Negative HNSCC 7
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8 1. Based upon historical data. Burtness, Barbara, et al. The Lancet 394.10212 (2019): 1915-1928. 2. Vasiliadou, Ifigenia, et al. International Journal of Cancer155.5 (2024): 883-893. 3. Black, Christopher M., et al. Frontiers in Oncology 13 (2023): 11601445 ORR = Overall Response Rate; DOR = Duration of Response; PFS = Progression-Free Survival; OS = Overall Survival Significant unmet need for better treatment options that improve outcomes in HPV-negative HNSCC patients Pembro1 Pembro + chemo1 ORR ~19% ~36% Median DOR ~23.4 months ~6.7 months Median PFS ~3.2 months ~5.0 months Median OS HPV-all ~12.3 months ~13.6 months HPV-negative ~9 months2,3 ~7 months2,3 Current standard of care HPV-negative HNSCC… Represents the vast majority (80 – 90%) of HNSCC in the R/M setting Characterized by high tumor burden and symptomatic disease Has worse prognosis vs. HPV-positive HNSCC Testing for HPV status is well-established in clinical guidelines due to prognostic nature of HPV-association
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9 Baseline characteristics were balanced across cohorts and evaluated in patients across the spectrum of disease burden CPS, combined positive score; DM, distant metastatic; ECOG PS, Eastern Cooperative Oncology Group performance status; HPV, human papillomavirus; LR, locoregional; max, maximum; min, minimum; Q2W, every 2 weeks; QW, once weekly. Data snapshot: March 31, 2026 750mg QW (N=31) 1500mg QW (N=30) 2000mg Q2W (N=30) Age, median (min-max) 64 (28-78) 63 (31-84) 63 (32-94) Sex, n (%) Male Female 20 (65) 11 (35) 19 (63) 11 (37) 20 (67) 10 (33) Primary disease site, n (%) Oral cavity Oropharynx (HPV-negative) Hypopharynx Larynx 19 (61) 4 (13) 5 (16) 3 (10) 14 (47) 8 (27) 4 (13) 4 (13) 19 (63) 6 (20) 2 (7) 3 (10) CPS, n (%) 1-19 ≥20 12 (39) 19 (61) 15 (50) 15 (50) 15 (50) 15 (50) LR vs DM disease, (%) LR only DM only LR + DM 16 (52) 5 (16) 10 (32) 9 (30) 7 (23) 14 (47) 19 (63) 5 (17) 6 (20) Target lesion diameter (mm) at baseline, median (min-max) 41 (11-131) 49 (10-133) 33 (10-187) Sum of target lesion diameters at baseline, n (%) >50 mm >70 mm 10 (32) 4 (13) 14 (47) 8 (27) 11 (37) 7 (23) ECOG PS, n (%) 0 1 11 (35) 20 (65) 11 (37) 19 (63) 10 (33) 20 (67)
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10 *1 patient had grade 4 hypokalemia. †1 patient had grade 4 pericarditis. AE, adverse event; EGFR, epidermal growth factor receptor; Q2W, every 2 weeks; QW, once weekly; TEAE, treatment- emergent adverse event; TGF-β, transforming growth factor beta; TRAE, treatment-related adverse event. Preferred term 750mg QW (N=31) 1500mg QW (N=30) 2000mg Q2W (N=30) Any Grade* Grade 3 Any Grade† Grade 3 Any Grade* Grade 3 Any TRAE 31 (100) 11 (35) 28 (93) 15 (50) 29 (97) 16 (53) Dermatitis acneiform 27 (87) 1 (3) 23 (77) 4 (13) 24 (80) 3 (10) Pruritus 13 (42) 1 (3) 16 (53) 1 (3) 11 (37) 1 (3) Anemia 8 (26) 3 (10) 13 (43) 7 (23) 15 (50) 8 (27) Hypomagnesemia 7 (23) 0 13 (43) 0 6 (20) 0 Fatigue 13 (42) 0 (0) 11 (37) 1 (3) 12 (40) 1 (3) Dry skin 10 (32) 0 9 (30) 0 9 (30) 0 Hypophosphatemia 10 (32) 0 8 (27) 0 6 (20) 0 Hypokalemia 8 (26) 1 (3) 8 (27) 0 5 (17) 0 Stomatitis 13 (42) 4 (13) 8 (27) 0 11 (37) 3 (10) Nausea 5 (16) 0 6 (20) 0 9 (30) 1 (3) Epistaxis 11 (35) 1 (3) 5 (17) 0 12 (40) 0 Skin fissures 10 (32) 0 6 (20) 0 7 (23) 0 Headache 6 (19) 0 4 (13) 1 (3) 10 (33) 0 Infusion related reaction 6 (19) 1 (3) 4 (13) 1 (3) 7 (23) 0 Lipase increased 7 (23) 1 (3) 6 (20) 1 (3) 2 (7) 1 (3) Amylase increased 8 (26) 1 (3) 4 (13) 0 1 (3) 0 Mouth bleeding 8 (26) 1 (3) 0 0 4 (13) 0 FICERA continued to exhibit a generally well-tolerated safety profile Most frequently reported (≥20%) TEAEs related to ficerafusp alfa • The combination was generally well- tolerated with no new safety signals • No treatment-related deaths were reported • Low discontinuation rates due to TRAEs across dose levels: 750mg (6%), 1500mg (10%), 2000mg (7%) FICERA + pembrolizumab safety profile: Data snapshot: March 31, 2026
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11 *Data snapshot as of March 31, 2026. ^Deep response refers to ≥ 80% tumor shrinkage from baseline. †Data maturation reflects a bimodal enrollment distribution: in the initial 15 efficacy evaluable patients (median follow-up: 27 months) median OS is not mature but has surpassed 23.6 months. The remaining 12 efficacy evaluable patients had a median follow-up of 11.7 months. #Includes both HPV-positive and HPV-negative R/M HNSCC patients (CPS ≥ 1). Based on historical published data. No head-to-head studies have been conducted, and cross-trial comparisons may not be reliable due to differences in molecule composition, trial design, and patient population and characteristics. Data compiled from: Burtness, Barbara, et al. The Lancet 394.10212 (2019): 1915-1928; Vasiliadou, Ifigenia, et al. International Journal of Cancer 155.5 (2024): 883-893; Black, Christopher M., et al. Frontiers in Oncology 13 (2023): 1160144; European Medicines Agency (CHMP); Keytruda Assessment Report, Procedure No. EMEA/H/C/003820/II/0065 (2019). EE = efficacy evaluable; ORR = objective response rate; CR = complete response; NR = not reached; NM = not mature FICERA Phase 1b clinical experience in 1L R/M HPV-negative HNSCC 2000mg Q2W* 1500mg QW* 750mg QW* Metric EE set (N=27) EE set (N=28) EE set (N=30) Confirmed ORR % (N) 48% (13/27) 54% (15/28) 57% (17/30) CPS 1-19 57% (8/14) 54% (7/13) 73% (8/11) CPS ≥ 20 38% (5/13) 53% (8/15) 47% (9/19) CR Rate % (N) 30% (8/27) 25% (7/28) 13% (4/30) Deep Responses^ % (N) 77% (10/13) 80% (12/15) 47% (8/17) Median PFS 12.7 months 9.9 months 6.9 months Median DoR NR (>12.8 months) 21.7 months NR (>16.6 months) Median OS NM (>12.7 months; >23.6 months in patients >2-year follow-up)† 21.3 months NM (>19.4 months) Median Time to Response 1.6 months 1.4 months 1.6 months Phase 1b data from exploratory higher dose, less frequent regimen Phase 1b data from dose selected for pivotal study Pembrolizumab# Current standard of care ~19% 15% 23% ~5% N/A ~3.2 months ~23.4 months ~9 months (HPV-negative) 2.1 months • Consistent safety, efficacy, depth of response, and rapid time to response supports further exploration for less frequent dosing schedule • Data further increase confidence in the pivotal study
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12 TGF-β inhibition drives rapid, deep responses and dose-dependent CR rates across cohorts Waterfall plots show best overall response (sum of target lesion diameters at baseline) for each patient. CR, complete response; CPS, combined positive score; DCR, disease control rate; ORR, objective response rate; Q2W, every 2 weeks; QW, once weekly. 100 80 60 40 20 0 −20 −40 −60 −80 −100 Best change from baseline, % CPS ≥20 1-19 750mg QW 2000mg Q2W Confirmed ORR (95% CI) 57% (37%-74%) DCR 80% CR 13% Median time to response 1.6 months Deep response: 47% (8/17) Deep response: 80% (12/15) Deep response: 77% (10/13) Deep responseDeep responseDeep response CPS ≥20 1-19 CPS ≥20 1-19 Confirmed ORR (95% CI) 54% (34%-72%) DCR 89% CR 25% Median time to response 1.4 months Confirmed ORR (95% CI) 48% (29%-68%) DCR 85% CR 30% Median time to response 1.6 months 320 80 60 40 20 0 −20 −40 −60 −80 −100 100 80 60 40 20 0 −20 −40 −60 −80 −100 1500mg QW Data snapshot: March 31, 2026
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13 FICERA’s tumor penetration was designed to drive durability Median Duration of Response: Pembro Combinations in 1L R/M HNSCC HPV-All HPV-Negative Median DOR (Months) FICERA 1500 mg + pembro 21.7 months in HPV-negative* 2 6 10 14 18 22 4 8 12 16 20 240 Pembro + chemotherapy1 Pembro + lenvatinib2 Pembro + cetuximab4 Pembro + petosemtamab3 Non-Tumor Penetrant (Chemo / EGFR) Responses ~6.7 months 10.1 months 13.1 months ~11.0 months Tumor Penetrant (PD-1 / FICERA) Responses Based on historical published data. No head-to-head studies have been conducted, and cross-trial comparisons may not be reliable due to differences in molecule composition, trial design, and patient population and characteristics. Sources: 1. KEYNOTE-048: Burtness, Barbara, et al. The Lancet 394.10212 (2019). 2. LEAP-010: Licitra et al. MHNCS 2024,18(5) Abs 1. 3. Van Herpen, Carla ML, et al. J Clin Oncol 43, 6024(2025). 4. Sacco, et al. The Lancet Oncology 22.6 (2021): 883-892 *Data snapshot: March 31, 2026
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DOR, duration of response; NE, not estimable; Q2W, every 2 weeks; QW, once weekly; TGF-β, transforming growth factor beta; TME, tumor microenvironment. FICERA demonstrated clinically meaningful DOR across dose cohorts Data snapshot: March 31, 2026 Median DOR: not yet reached; has surpassed 16.6 months Median DOR: 21.7 months Median DOR: not yet reached; has surpassed 12.8 months 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 38 4036 42 Months since first objective response 0 20 40 60 100 80 Censored 15 15 14 10 10 9 9 8 8 8 7 5 4 4 4 4 3 2 1 11 0 13 13 11 9 9 8 7 6 6 6 5 4 3 0 0 0 0 0 0 00 0 Months since first objective response 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 38 4036 42 0 20 40 60 100 80 Censored Ongoing response, % 0 20 40 60 100 80 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 38 4036 42 Months since first objective response Censored 17 17 15 13 12 11 10 9 8 6 4 1 0 0 0 0 0 0 0 00 0No. at risk Total, n Events, n Censored, n Median DOR, months 17 7 10 Not reached Total, n Events, n Censored, n Median DOR (95% CI), months 15 9 6 21.7 (6.0-NE) Total, n Events, n Censored, n Median DOR, months 13 3 10 Not reached 1500mg QW750mg QW 2000mg Q2W Median DOR has surpassed 16.6 months Median DOR has surpassed 12.8 months 14
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15 1. Includes both HPV-positive and HPV-negative R/M HNSCC patients. Based on historical published data. No head-to-head studies have been conducted, and cross -trial comparisons may not be reliable due to differences in molecule composition, trial design, and patient population and characteristics. Vasiliadou, Ifigenia, et al. International Journal of Cancer 155.5 (2024): 883-893 PFS, progression-free survival; Q2W, every 2 weeks; QW, once weekly FICERA demonstrated clinically meaningful PFS across dose cohorts Median PFS: 6.9 months Data snapshot: March 31, 2026 Median PFS: 9.9 months Median PFS: 12.7 months FICERA’s median PFS of 9.9 months represents a >3x increase vs. pembrolizumab (~3.2 months1) 1500mg QW750mg QW 2000mg Q2W Censored 100 80 60 40 20 0 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 Months 28 25 20 17 12 11 11 9 9 8 8 8 5 5 4 4 4 4 2 1 1 1 0 PFS, % Censored 100 80 60 40 20 0 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 Months No. at risk 30 23 21 16 14 13 12 11 11 9 5 4 1 0 0 0 0 0 0 0 0 0 0 27 23 21 15 13 13 11 8 7 7 7 6 4 3 0 0 0 0 0 0 0 0 0 Censored 100 80 60 40 20 0 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 Months Total, n Events, n Censored, n Median PFS (95% CI), months 30 19 11 6.9 (4.6-NE) Total, n Events, n Censored, n Median PFS (95% CI), months 28 21 7 9.9 (4.4-22.7) Total, n Events, n Censored, n Median PFS (95% CI), months 27 14 13 12.7 (4.9-NE)
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16 OS, overall survival; Q2W, every 2 weeks; QW, once weekly. FICERA demonstrated clinically meaningful OS across dose cohorts Data snapshot: March 31, 2026 Median OS: not yet mature; has surpassed 19.4 months Median OS: 21.3 months Median OS: not yet mature; has surpassed 12.7 months; >23.6 months in patients with ≥2-year follow-up)2 1. Based on a retrospective analysis of Supplementary Figure 1C, Vasiliadou, Ifigenia, et al. International Journal of Cancer 155.5 (2024): 883-893. No head-to-head studies have been conducted, and cross-trial comparisons differences in molecule composition, trial design, and patient population and characteristics. 2. Data maturation reflects a bimodal enrollment distribution: in the initial 15 efficacy evaluable patients (median follow-up: 27 months) median OS is not mature but has surpassed 23.6 months. The remaining 12 efficacy evaluable patients had a median follow-up of 11.7 months. Censored 28 26 26 24 20 19 17 17 17 16 16 13 13 11 9 9 9 8 7 2 2 2 1 1 1 0 0 20 40 60 100 80 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 Months Censored No at risk 30 30 27 26 25 23 20 20 19 17 8 6 3 0 0 0 0 0 0 0 0 0 0 0 0 0 0 20 40 60 100 80 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 OS, % Months 27 27 25 24 23 19 14 12 9 9 9 9 7 4 1 0 0 0 0 0 0 0 0 0 0 0 Censored 0 20 40 60 100 80 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 Months Total, n Events, n Censored, n Median OS (95% CI), months 28 20 8 21.3 (9.9-33.6) Total, n Events, n Censored, n Median OS, months 30 15 15 Not mature Total, n Events, n Censored, n Median OS, months 27 11 16 Not mature 1500mg QW750mg QW 2000mg Q2W Median OS has surpassed 19.4 months Median OS has surpassed 12.7 months* At three years (median) FICERA delivered an estimated 31% OS, representing a ~2x increase vs. standard of care1
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17 CPS, combined positive score; DM, distant metastatic; LR, locoregional; ORR, objective response rate; Q2W, every 2 weeks; QW, once weekly. Confirmed ORR by CPS score, tumor burden and disease site 750mg QW (n=30) 1500mg QW (n=28) 2000mg Q2W (n=27) CPS, % (n/N) 1-19 73 (8/11) 54 (7/13) 57 (8/14) ≥20 47 (9/19) 53 (8/15) 38 (5/13) Tumor burden, % (n/N) (sum of target lesion diameters) ≤50 mm 55 (11/20) 53 (8/15) 53 (9/17) >50 mm 60 (6/10) 54 (7/13) 40 (4/10) >70 mm 50 (2/4) 43 (3/7) 33 (2/6) Extent of disease, % (n/N) LR only 38 (6/16) 62 (5/8) 50 (7/14) DM only 100 (5/5) 29 (2/7) 40 (2/5) LR + DM 67 (6/9) 62 (8/13) 50 (4/8) FICERA demonstrated rapid, deep responses across disease burden, supporting a chemo-free therapeutic approach Data snapshot: March 31, 2026 CPS 1-19: FICERA delivered 54-73% ORR, more than 3x pembrolizumab monotherapy (~15%)1 1. Includes both HPV-positive and HPV-negative R/M HNSCC patients (CPS ≥ 1). Based on historical published data. No head-to-head studies have been conducted, and cross-trial comparisons may not be reliable due to differences in molecule composition, trial design, and patient population and characteristics. European Medicines Agency (CHMP); Keytruda Assessment Report, Procedure No. EMEA/H/C/003820/II/0065 (2019)
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18 DOR: deep responders with ≥ 80% tumor shrinkage maintained DOR for a median 31.6 months across pooled cohort analysis Data snapshot: March 31, 2026 N=45 across 750mg, 1500mg, 2000mg dose cohorts CI, confidence interval; DOR, duration of response; HR, hazard ratio; NE, not estimable; OS, overall survival; PR, partial response. Depth of response Events, n Censored, n Median DOR (95% CI), months Deep response (n=30) 11 19 31.6 (21.6-NE) PR <80% (n=15) 8 7 8.2 (4.0-NE) HR, 0.31 (95% CI, 0.11-0.84) 30 30 29 25 25 24 22 20 20 18 14 8 6 3 3 3 2 1 1 11 0Deep response 15 15 11 7 6 4 4 3 2 2 2 2 1 1 1 1 1 1 0 00 0PR <80% 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 38 4036 42 Months since first objective response Censored 0 20 40 60 100 80 Ongoing response, % No. at risk
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19 PFS and OS: Deep responders showed durable and clinically meaningful benefit across pooled cohort analysis Deep responders: 65% reduction in the risk of disease progression or death compared with PR <80% Deep responders: 63% reduction in the risk of death compared with PR <80% Data snapshot: March 31, 2026 PFS OS N=45 across 750mg, 1500mg, 2000mg dose cohorts CI, confidence interval; DOR, duration of response; HR, hazard ratio; NE, not estimable; PFS, progression-free survival; OS, overall survival; PR, partial response. Depth of response Median PFS (95% CI), months Deep response (n=30) 36.9 (22.7-NE) PR <80% (n=15) 10.9 (5.6-NE) SD (n=26) 5.8 (3.6-6.8) PD (n=14) 1.4 (1.3-1.5) HR, 0.35 (95% CI, 0.15-0.91) Depth of response Median OS (95% CI), months Deep response (n=30) Not reached (26.3- NE) PR <80% (n=15) 33.6 (10.9-NE) SD (n=26) 11.3 (9.0-20.6) PD (n=14) 7.3 (2.4-17.1) HR, 0.37 (95% CI, 0.13-1.10) PFS, % 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 100 80 60 40 20 0 PD 14 1 0 SD 26 25 17 8 5 4 3 1 1 0 PR <80% 15 15 15 11 8 7 6 5 5 4 3 3 2 1 1 1 1 1 0 Deep response ( ≥80%) 30 30 30 29 26 26 25 22 21 20 17 15 8 7 3 3 3 3 2 1 1 1 0 Months Months 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 OS, % 100 80 60 40 20 0 30 30 30 30 29 28 27 26 25 25 21 18 16 12 7 6 6 6 5 2 2 2 1 1 1 0Deep response ( ≥80%) 15 15 15 15 15 12 9 8 8 7 6 5 5 2 2 2 2 1 1 0PR <80% 26 25 24 22 19 16 10 10 9 8 6 5 2 1 1 1 1 1 1 0SD 14 12 9 7 5 5 5 5 3 2 0PD No. at risk No. at risk Censored Censored
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20 -63% 27% -82% 64% -100% 73% 750 mg QW (n=15) 1500 mg QW (n=11) 2000 mg Q2W (n=11) Median Depth of Response % Of Responders Achieving Deep (≥80%) Response Increases in TGF-β inhibition directly in the TME enabled greater tumor penetration to drive deeper and more durable responses FICERA’s TGF-β inhibition and tumor penetration are associated with deeper responses Bicara Therapeutics data on file. Paired tumor biopsies were analyzed by immunohistochemistry for pSMAD2. Cytokine analysis was performed on pre- and post-treatment (QW: 3 weeks, Q2W: 6 weeks) plasma samples using the Meso Scale Discovery platform. *p≤.05, **p ≤.01 (Mann-Whitney test).pSMAD2, phosphorylated SMAD2; Q2W, every 2 weeks; QW, once weekly; TGF-β, transforming growth factor beta; TNF-α, tumor necrosis factor alpha. Median depth of response represents the median of the best percent change from baseline amongst the confirmed responders at 24-weeks follow-up. Plots show mean with SEM. Mann-Whitney Test from Log2 Baseline adjusted *p≤.05, **p ≤.01 Tumor Penetration pSMAD2 TGF-β Inhibition CD8+ T Cell Tumor Infiltration Depth of Response At 24-Weeks 1500 mg QW750 mg QW 2000 mg Q2W Data snapshot: March 31, 2026
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21 FICERA case highlight: rapid lesion shrinkage and deep response in aggressive HNSCC Disease characteristics • Oral Cavity • LR only • CPS 20 Multiple Comorbidities ECOG 1 Performance Status Baseline Two Weeks Eight Weeks Tumor assessment Baseline: One target lesion of 49 mm 6-week scan: 55% shrinkage in target lesion Survival: Patient is in survival follow up- and alive as of last contact date of December 2025. 66-year-old male with recurrent oral cavity cancer Prior Therapy: • Oct 2021: Partial glossectomy + (L) neck dissection • Jun–Aug 2023: (L) neck recurrence → chemoradiation • Dec 2023: (L) neck recurrence → (L) radical neck dissection Study Therapy: • May 2024 – Jan 2025: FICERA 750 mg QW + pembrolizumab
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22 FICERA's clinical profile aligns with what oncologists say matters most at the point of treatment selection More impact on treatment decisions Source: Internal Bicara market research, 2026 Overall survival (mOS), Hazard Ratio (HR) Progression Free Survival (mPFS) KEY DIFFERENTIATORS Complete Response (CR) + Duration of Response (DOR) Depth of response Overall Response Rate (ORR) Time to response (TTR) More impact on treatment decisions In addition to OS and PFS, CR rates, DOR, and depth of response are being recognized as important differentiators in head and neck cancer
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23 Key principles guiding less frequent dose exploration for FICERA Mechanistic Differentiation Maintain FICERA’s hallmark TGF-β inhibition at a less frequent dose while being responsive to the tumor as it shrinks Meaningful Clinical Data Rapid and deep responses that yield durability and long-term outcomes due to TGF-β inhibition Patient Optionality Enhance convenience and patient flexibility by offering less-frequent dosing option in combination with pembrolizumab
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24 Totality of data support development of a loading and Q3W maintenance regimen for FICERA Mechanistic Differentiation Rapid tumor penetration and shrinkage with TGF-β targeting creates a natural opportunity to extend the dosing interval while preserving potency TGF-β neutralization (plasma) at 2000mg Q2W FICERA plus pembrolizumab ****p<.0001;***p<.001, ** p<.01, *p<.05 Bicara Therapeutics data on file; data snapshot March 31, 2026 PK/PD = pharmacokinetic/pharmacodynami Meaningful Clinical Activity Integrated clinical and PK/PD modeling data support that deep, durable responses can be maintain with loading and maintenance Advancing an Alternate Dosing Regimen Strategy Initiated FORTIFI-FLEX alternate dose study to evaluate FICERA + pembrolizumab in 1L R/M HPV-negative HNSCC, and expect to have results from this study by the time of a potential U.S. accelerated approval in 1L R/M HPV-negative HNSCC
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25 Totality of Phase 1b data across all doses of FICERA supports mechanism-driven clinical differentiation Observed consistent, generally well-tolerated safety profile and rapid, deep responses in Phase 1b cohorts from 1500mg QW (ongoing Phase 3 pivotal study dose) and 2000mg Q2W FICERA (exploratory cohort to inform alternate dose regimen) Deep responses translate into durable long-term outcomes across DOR, PFS, and OS Sustained TGF-β inhibition, immune activation, tumor penetration, and deep responses observed at 1500mg QW and 2000mg Q2W FICERA, supporting development of less frequent dosing regimen Growing body of PK, translational, exposure-response, and clinical data support development of loading and Q3W maintenance regimen designed to optimize efficacy, safety, and schedule; pursuing regulatory alignment with aim to generate data in time for potential US launch Pursuing less frequent dosing for optionality, convenience FICERA, a potential best- and first-in-class EGFR-directed antibody combined with a TGF-β ligand trap, has demonstrated improved outcomes in HPV-negative HNSCC Expanding data set reinforces established clinical differentiation
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CPS, combined positive score; Q3W, every three weeks; ORR, objective response rate; DOR, duration of response; PFS, progression-free survival; pembro, pembrolizumab 26 Pivotal FORTIFI-HN01 trial design has enabled accelerated dose selection and efficient Phase 3 initiation Phase 2 Phase 3 Blinded safety and efficacyBlinded safety, efficacy, and dose selection FICERA 1500mg QW + 200mg pembro Q3W Pembro 200mg Q3W FICERA 750mg QW + 200mg pembro Q3W1:1:1 2:1 Primary endpoints: ORR, OS Secondary endpoints: DOR, PFS, safety Drop 750mg QW arm in Phase 3 and move to 2:1 randomization Phase 3 initiated and currently enrolling with 1500mg QW FICERA • Patients enrolled at 1500mg FICERA QW in the Phase 2 portion continue treatment and contribute to pivotal efficacy analysis FORTIFI: seamless registration-enabling Phase 2/3 study
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27 FICERA’s alternate dosing regimen study to expand optionality and convenience for patients and providers Primary endpoint: Progression free survival Results expected by the time of a potential U.S. accelerated approval in 1L R/M HPV-negative HNSCC Loading phase 12 weeks Maintenance phase FICERA 1500mg QW + 200mg pembro Q3W (n=150-200) R FICERA 1500mg QW + 200mg pembro Q3W FICERA 2250mg Q3W + 200mg pembro Q3W 1L R/M HPV-negative HNSCC QW, every week; Q3W, every three weeks; R, randomize
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Preparing for Commercial Success 28
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29 $5B+ projected global market for HNSCC by 20301 No head-to-head studies have been conducted, and cross-trial comparisons may not be reliable due to differences in molecule composition, trial design, and patient population and characteristics. 1. Tessellon patient flow modeling; SEER; country specific registries; literature review; 2. Evaluate Pharma 2025 Large & Growing Patient Population With ~50K HPV-negative HNSCC patients annually incident in the US, EU5, and Japan2 Pioneer Treatment Paradigm Shift Continue to build market understanding of HPV-negative HNSCC as a distinct clinical disease Drive Better Patient Outcomes 2-3X responses 2-3X duration of response 2X survival Expand The Market >2X potential growth in patient months Additional opportunities to further grow the market (e.g., CPS <1, HPV-positive smokers) FICERA has the potential to significantly expand the HPV-negative HNSCC market
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Expanding FICERA’s Potential While Maintaining Financial Discipline 30
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3131 Broader opportunity for FICERA in head and neck cancer Source: Bicara market research, represents annual incidence in U.S. SEER data; Tessellon patient flow modeling *Patients who progressed within 6 months after multimodal treatment for locally advanced disease ~26,000 Locally Advanced HPV-negative HNSCC Earlier-line setting ~4,000 CPS < 1 1L R/M HPV-negative HNSCC R/M subsegment ~2,000 HPV-positive Smokers 1L R/M HNSCC R/M subsegment ~1,000 Rapidly Recurrent* 1L R/M HPV-negative HNSCC R/M subsegment Registration-enabling Phase 3 ongoing Multiple expansion opportunities representing ~50,000 patients in HNSCC (U.S. incidence) 1L R/M HPV-negative HNSCC ~18,000
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32 TGF-β is heavily implicated in CRC metastasis and resistance to treatment Key Drivers of Metastatic CRC TGF-β is highly expressed in CRC and drives metastasis via: • EMT: Tumor cells undergo the epithelial-mesenchymal transition (EMT) process and then spread to distant sites • Angiogenesis: TGF-β signaling mediates the formation of new blood vessels, which promotes intravasation of tumor cells • Immunosuppression: TGF-β signaling from immune cells such as CAFs and TAMs contribute to an immunosuppressive TME CAF, cancer-associated fibroblast; TAM, tumor-associated macrophage; TME, tumor microenvironment EMT (EGFR Resistance) Angiogenesis Immunosuppressive TME TGF-β FICERA combines two historical mechanisms for treating mCRC, simultaneously targeting both anti-EGFR and anti-angiogenic pathways via TGF-β inhibition
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33 FICERA positioned to address multiple pathways in mCRC Standard of care agents Anti-EGFR Anti-Angiogenic / Anti-VEGF Approved Agents: • Cetuximab • Panitumumab In Development • Amivantamab (EGFR x MET) • Petosemtamab (EGFR x LGR5) Currently, two main targeted approaches to treating RAS/BRAFwt mCRC (MSS): Simultaneously targeting both anti-EGFR and anti- angiogenic pathways via TGF-β inhibition Potential to address both left-sided and right-sided mCRC in 1L Combat resistance mechanisms to drive durability and PFS FICERA Approved Agents: • Bevacizumab • Fruquintinib • Regorafenib In Development • Zanzalintinib (multi TKI) • INCA33890 (PD-1 x TGF-βR2)
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34 Expansion to 3L+ MSS RASwt metastatic colorectal cancer (mCRC) Initial Ph. 1/2 Proof of Concept Study Primary aims: safety, tolerability, and initial efficacy (ORR/DCR) Unmet need: Current approved treatment options in 3L+ mCRC demonstrate 2 - 6% ORR and less than 6-month PFS1,2,3 Unresectable mCRC: • 2-3 previous lines – Anti-EGFR is not the last line of treatment – Received prior biologics i.e. anti-VEGF • Confirmed RAS/BRAF wt and MSS • ECOG 0-1 Randomized 1:1 N ~20 FICERA N ~20 FICERA + pembro 1. Prager, et al. New England Journal of Medicine (2023). 2. Mayer, et al. New England Journal of Medicine (2015). 3. Dasari, et al. The Lancet (2023).
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Confidential | Copyright © 2025 Bicara Therapeutics 35 Anticipated key milestones in 2026 to drive growth and value inflection Determined OBD for FORTIFI-HN01 pivotal study of FICERA in 1L R/M HPV-negative HNSCC Presented data from Phase 1b cohort evaluating 2000 mg of FICERA Q2W + pembrolizumab in 1L HPV- negative R/M HNSCC Hired a CCO to advance organizational preparation for launch readiness Presented long-term follow-up data from Phase 1b study of FICERA + pembrolizumab in 1L R/M HPV-negative HNSCC Initiated FORTIFI-FLEX alternate dose study to evaluate FICERA + pembrolizumab in 1L R/M HPV-negative HNSCC Expect to present data from Phase 1b cohort evaluating FICERA both as monotherapy and + pembrolizumab in patients with 3L+ mCRC (RAS/BRAF wild type MSS) Expect to achieve substantial enrollment in FORTIFI-HN01 pivotal study to enable interim analysis in mid-2027 2H 2026 Q4 20262026
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Indication Phase 1b Phase 2 Phase 3 Commercial 36 Maximizing the franchise value of FICERA 1L R/M Head and Neck Squamous Cell Carcinoma Other Solid Tumors Expansion cohort of 1500mg QW plus pembrolizumab in HPV-positive smokers Expansion cohort of 1500mg QW plus pembrolizumab in HPV-negative CPS<1 FORTIFI-HN01 pivotal study of 1500mg QW plus pembrolizumab in HPV- negative CPS>1 Interim analysis expected mid-2027 and potential U.S. launch in 2028 FORTIFI-FLEX alternate dosing study (1500mg QW plus pembrolizumab for 12 weeks followed by 2250mg Q3W plus pembrolizumab) in HPV- negative CPS>1 Results expected by the time of a potential U.S. accelerated approval in 1L R/M HPV-negative HNSCC 750mg QW plus pembrolizumab in HPV-negative CPS>1 Long-term follow-up presented at ASCO 2026. Dose not selected for Phase 3 2000mg Q2W plus pembrolizumab in HPV-negative CPS>1 Long-term follow-up presented at ASCO 2026. Informed loading and maintenance dosing study 1500mg QW monotherapy in 2L+ cSCC Phase 1b data presented at AACR 2025; may evaluate future development paths 1500mg QW plus pembrolizumab in 2L+ SCAC Phase 1b data presented at ASCO GI 2025; may evaluate future development paths 1500mg QW +/- pembrolizumab in 3L+ mCRC (MSS RASwt) Data expected 2H 2026
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Thank You