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Fighting cancer with precision and power. February 2026 Corporate Deck
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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 statements regarding our clinical development of ficerafusp alfa in combination with pembrolizumab and presentation of updated results from an open-label, multicenter Phase 1/1b trial of ficerafusp alfa with pembrolizumab in patients with recurrent or metastatic head and neck squamous cell carcinoma, the clinical development and presentation of data from Phase 1b trial of ficerafusp alfa both as monotherapy and in combination with pembrolizumab in patients with 3L+ metastatic CRC, and the expected therapeutic potential and ability, profile and clinical benefits of ficerafusp alfa, including potential and anticipated efficacy, depth, durability, tolerability, and success, the planned substantial enrollment in FORTIFI-HN01 pivotal study by Q4 2026 and potential interim analysis in the middle of 2027, the potential market opportunities, and the planned commercial preparations. 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, as well as the potential contribution of our employees and board to our growth and success as a Company; 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 Annual Report on Form 10-K for the year ended December 31, 2024, our Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, 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 – the first and only bifunctional 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 tumor cancers, 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
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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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Recent accomplishments position FICERA as potentially the next great advance in the treatment of HPV-negative HNSCC SOC, standard of care; mOS, median overall survival 1. Chung et al, ASCO 2025. 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 6 Thoughtful and efficient design to support potential accelerated approval Pivotal study initiated; optimal dose selected 1500 mg QW optimal dose First and only designation to specifically recognize a distinct and defined clinical subset of disease with unmet need Awarded Breakthrough Therapy Designation HPV-negative HNSCC Only investigational EGFR- directed therapy with mature, two-year1 clinical data showing promise over SoC Presented proven clinical data Depth, durability, mOS
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2026 plan to drive growth and value inflection 7QW, once a week; CRC, colorectal cancer Following the EGFR x TGF-β biological fingerprint into other solid tumors, starting with mCRC, to explore FICERA’s pipeline in a product potential Accelerating enrollment to enable interim analysis in mid-2027 Laying the foundation to achieve FICERA’s blockbuster potential within the large and growing HNSCC market Executing a strategic development plan for FICERA in 1L HPV-negative R/M HNSCC Preparing for commercial success Expanding FICERA’s potential while maintaining financial discipline
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Executing a Strategic Development Plan for FICERA in 1L R/M HPV-Negative HNSCC 8
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Significant unmet need for better treatment options that improve outcomes in HPV-negative HNSCC patients Pembro Pembro + chemo ORR ~19% ~36% mDOR ~23.4 months ~6.7 months Median OS HPV-all ~12.3 months ~13.6 months HPV-negative ~9 months ~7 months Current standard of care 9*HPV-negative R/M HNSCC patients only (CPS ≥ 1). Based upon historical data. 1. 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): 1160144. HPV-negative HNSCC… Represents the heavy 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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• Confirmed ORR: 54% (15/28) – Disease Control Rate: 89% (25/28) • Deep Responses: 80% (12/15) of responders achieved ≥ 80% tumor shrinkage – CR rate: 21% (6/28) • Rapid Responses – Median time to response: 1.4 months Activity Across Patient Subgroups 10 320 60 40 20 0 −20 −40 −60 −80 −100 Best change from baseline, % * CPS 1-19 CR * CRCRCRCR * CRPR * PRPR * PR * PRPR * PR * PR PR PRPR SDPR SD SD * SD * PD * * SD * SD * PDPD PD Deep PR / CR With ≥ 80% Shrinkage PR With < 80% Shrinkage SD PD FICERA 1500 mg QW drives deep responses in HPV-negative patients ORR with FICERA 1500 mg QW + Pembrolizumab in HPV-negative, CPS≥1 1L R/M HNSCC (Ph. 1b) ORR % (N) CPS CPS 1-19 54% (7/13) CPS ≥ 20 53% (8/15) Tumor Burden (SLD) ≤ 50mm 53% (8/15) > 50mm 54% (7/13) > 70mm 43% (3/7) HPV-negative efficacy-evaluable population (n=28). Data snapshot: March 20, 2025. Chung et al. ASCO 2025. Investigator-assessed best overall response per RECIST 1.1. CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; SLD = sum of target lesion diameters (mm).
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11 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 + chemotherapy Pembro + lenvatinib Pembro + cetuximab Pembro + petosemtamab 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: KN-048: Burtness, Barbara, et al. The Lancet 394.10212 (2019): LEAP-010: Licitra et al. MHNCS 2024, 18(5) Abs 1; Sacco, et al. The Lancet Oncology 22.6 (2021): 883-892. *Pembro + petosemtamab mDOR reported as of 9/16/24 data cutoff: Van Herpen, Carla ML, et al. (2025).
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12 At risk 28 26 19 17 16 7 2 1 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 Months OS, % 0 20 40 60 80 100 Censored Overall Survival with FICERA 1500 mg QW + Pembrolizumab in HPV-negative, CPS≥1 1L R/M HNSCC n=28 Median OS 21.3 months 2-year OS Rate 46%* Median Follow-up 25.2 months 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. Chung et al, ASCO 2025. HPV-negative efficacy-evaluable population (n=28). Data snapshot: March 20, 2025. In the safety population (n=30), median OS was 20.6 months and the 2-year rate OS was 43%. 1. Subsequent follow-up after data snapshot in patients with ~22-23 months of follow-up confirmed that these patients remained alive at 24 months. Depth and durability observed with FICERA translates to OS benefit HPV-negative mOS of 7 – 9 months in SOC
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Impact of depth of response to durability and outcomes 13 Evaluating whether deep responses (≥80% shrinkage) impact outcomes Duration of Response Progression Free Survival Overall Survival Observing deep responders (≥80% shrinkage) trend to benefits of more durable responses, longer PFS, and prolonged OS Analysis of FICERA + Pembrolizumab in HPV-neg, CPS≥1 1L R/M HNSCC (Ph. 1b) Analysis conducted amongst HPV-neg patients (n=30). March 20, 2025 data snapshot. No tumor shrinkage Tumor shrinkage ≥80% Tumor shrinkage <80%
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FICERA’s clinical profile shows promise for improved outcomes compared to SOC Pembro Pembro + chemo ORR ~19% ~36% mDOR ~23.4 months ~6.7 months Median OS HPV-all ~12.3 months ~13.6 months HPV-negative ~9 months ~7 months Current standard of care 14 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. *HPV-negative R/M HNSCC patients only (CPS ≥ 1). Based upon historical data. 1. 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): 1160144. 4. Chung et al. ASCO 2025. FICERA (1500mg QW)* + pembro4 ~54%* 21.7 months* NA 21.3 months* ~3X increase in ORR vs. pembro alone >3X increase in mDOR vs. pembro + chemo >2X increase in mOS vs. pembro +/- chemo
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Data snapshot: March 20, 2025. Chung et al. ASCO 2025. *One grade 4 event of ‘pericarditis’ which does not appear in this table because not >20% 15 FICERA 1500 mg QW is generally well-tolerated with no treatment-related deaths Most common (>20%) adverse events related to FICERA – summary by preferred term and maximum grade: All 1L R/M HNSCC subjects received 1500mg QW and pembrolizumab (n=42) Preferred term All Grades Grade 3 Grade 4 Grade 5 Any Related AE 40 (95%) 17 (40%) 1 ( 2%)* 0 (0%) Dermatitis acneiform 32 (76%) 5 (12%) 0 (0%) 0 (0%) Fatigue 18 (43%) 1 (2%) 0 (0%) 0 (0%) Pruritus 18 (43%) 0 (0%) 0 (0%) 0 (0%) Hypophosphataemia 16 (38%) 0 (0%) 0 (0%) 0 (0%) Anaemia 15 (36%) 6 (14%) 0 (0%) 0 (0%) Hypomagnesaemia 15 (36%) 0 (0%) 0 (0%) 0 (0%) Dry skin 13 (31%) 0 (0%) 0 (0%) 0 (0%) Stomatitis 10 (24%) 1 (2%) 0 (0%) 0 (0%) FICERA 1500 mg QW + pembro in 1L R/M HNSCC safety profile: • EGFR-related AEs: – 76% had dermatitis acneiform, majority (27/32; 84%) are grade 1-2 in severity • Hypothesized TGF-β-related AEs: – Nearly all AEs were transient Grade 1-2 local mucosal bleeds or epistaxis • No treatment related deaths were reported • Designed specifically to spare TGF-β2 isoform and avoid historical TGF-β-related toxicity
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16 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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17 Phase 1b data evaluating higher, less frequent (2000mg FICERA Q2W) dose support development of alternate dosing regimen Data snapshot: December 16, 2025. Investigator-assessed best overall response per RECIST 1.1. HPV-negative efficacy-evaluable population (N=27). ORR = objective response rate; CR = complete response; PR = partial response; SD = stable disease; SLD = sum of target lesion diameters (mm); PD = progressive disease • Confirmed ORR: 48% (13/27) Disease Control Rate: 85% (23/27) • Deep Responses: 77% (10/13) of responders achieved ≥ 80% tumor shrinkage CR rate: 26% (7/27) • Rapid Responses Median time to response: 1.6 months ORR % (N) CPS CPS 1-19 57% (8/14) CPS ≥ 20 39% (5/13) Tumor Burden (SLD) ≤ 50mm 53% (9/17) > 50mm 40% (4/10) > 70mm 33% (2/6) Activity Across Patient Subgroups FICERA 2000mg Q2W + pembrolizumab in HPV-neg, CPS≥1 1L R/M HNSCC −100 −80 −60 −40 −20 0 40 80 100 20 Best change from baseline (%) 60 SD * SD SDPR SDSDSD * SD * PDPDPD * PD CR CR * CR * CR * CRCR * CRPR * PRPR * SD SD SD * PR * PR * Deep PR / CR With ≥ 80% Shrinkage PR With < 80% Shrinkage SD PD * CPS 1-19
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18 Safety Data Data snapshot: December 16, 2025 *There was 1 Grade 4 event of hypokalemia; there were no Grade 5 events 1. Related TEAEs are those with relationship of “Possibly Related”, “Probably Related”, and “Definitely Related” to ficerafusp alfa considered by the investigator. They also include TEAEs with missing drug relationships, which is treated as “Possibly Related”. AE = adverse event; TEAE = treatment-emergent adverse event; TRAE = treatment related adverse event. FICERA continues to exhibit a generally well-tolerated safety profile FICERA 2000mg Q2W + pembrolizumab in HPV-neg, CPS≥1 1L R/M HNSCC 2000mg Q2W FICERA + pembrolizumab safety profile: • The combination was tolerable with a manageable safety profile* • No treatment-related deaths were reported • Safety profile at 2000mg Q2W was consistent with established safety profile of 1500mg FICERA + pembrolizumab in R/M HNSCC Preferred term, n (%) Safety set (N=30) Any grade Grade 3 Grade 4 Grade 5 Any TEAE 29 (97%) 16 (53%) 1 (3%) 0 Dermatitis acneiform 24 (80%) 3 (10%) 0 0 Anemia 14 (47%) 8 (27%) 0 0 Fatigue 12 (40%) 1 (3%) 0 0 Epistaxis 12 (40%) 0 0 0 Stomatitis 11 (37%) 3 (10%) 0 0 Pruritus 11 (37%) 1 (3%) 0 0 Headache 10 (33%) 0 0 0 Nausea 9 (30%) 1 (3%) 0 0 Dry skin 9 (30%) 0 0 0 Skin fissures 7 (23%) 0 0 0 Infusion-related reactions 7 (23%) 0 0 0 Hypophosphatemia 6 (20%) 0 0 0 Hypomagnesemia 6 (20%) 0 0 0 TRAE leading to ficerafusp alfa discontinuation 3 (10%) Most frequently reported (≥20%) TEAEs related1 to FICERA
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19 Efficacy Data Preliminary efficacy data demonstrated enhanced durability FICERA 2000mg Q2W + pembrolizumab in HPV-neg, CPS≥1 1L R/M HNSCC confirmed responders Data snapshot: December 16, 2025. Investigator-assessed best overall response per RECIST 1.1. *Deep response refers to ≥ 80% tumor shrinkage from baseline
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20 Efficacy Data By Dose Data snapshot: December 16, 2025. *Data snapshot: July 9, 2025, Kaczmar, JM, et al. Ann Oncol. 2025;36(Suppl 4):667O. †Data snapshot: March 20, 2025. Chung CH, et al. J Clin Oncol. 2025;43(16 suppl):6017. HPV-negative efficacy-evaluable population. Investigator-assessed best overall response per RECIST 1.1. #Deep response refers to ≥ 80% tumor shrinkage from baseline. EE = efficacy evaluable; ORR = objective response rate; CR = complete response. NE = not estimable. FICERA clinical experience across Phase 1b cohorts FICERA 2000mg Q2W, 1500mg QW, and 750mg QW in HPV-neg, CPS≥1 1L R/M 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 39% (5/13) 53% (8/15) 47% (9/19) CR Rate % (N) 26% (7/27) 21% (6/28) 10% (3/30) Deep Responses# % (N) 77% (10/13) 80% (12/15) 29% (5/17) Median PFS NE 9.9 months NE Median DoR NE 21.7 months NE Median OS NE 21.3 months NE Median Time to Response 1.6 months 1.4 months 1.6 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 Phase 1b data from exploratory higher dose, less frequent regimen Phase 1b data from dose selected for pivotal study
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21Bicara Therapeutics data on file. Plots show mean with SEM. pSMAD2 Analysis: N=5 samples at 750mg, N=7 samples at 1500mg N=4 samples at 2000mg. Immune-activation cytokine analysis: N=24 samples for 750mg (except N=25 for CXCL10), N=27 for 1500mg, and N=11 for 2000mg (except N=12 for CXCL10). Blood FICERA plus pembrolizumab maintains TGF-β inhibition and immune activation at a higher and less frequent (2000mg Q2W) dose, supporting development of less frequent dosing regimen Increased Immune-Activation at 1500mg QW and 2000mg Q2W pSMAD2 Tumor tissue Increased TGF-β Inhibition at 1500mg QW and 2000mg Q2W TNFA IFNG CXCL9 CXCL10 TGF-β inhibition is maintained with less frequent dose of FICERA
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22 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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23 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**** * N=16 N=12 N=13 N=7 **** TGF-β neutralization (plasma) at 2000mg Q2W FICERA plus pembrolizumab ****p<.0001;***p<.001, ** p<.01, *p<.05 Bicara Therapeutics data on file. Meaningful Clinical Activity Integrated clinical and PK/PD modeling data support that deep, durable responses can be maintain with loading and maintenance Advancing a Loading + Q3W Maintenance Strategy Finalizing the optimal loading schedule and maintenance dose to align with regulators; no change to ongoing Phase 3 FORTIFI-HN01 study of 1500mg QW, but aim to have loading and maintenance data in hand by potential approval
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24 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 trend toward more durable responses, longer PFS, and prolonged 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 Expanding data set reinforces established clinical differentiation Pursuing less frequent dosing for optionality, convenience FICERA as the first and only EGFR-directed antibody combined with a TGF-β ligand trap has a differentiated ability to improve outcomes in HPV-negative HNSCC
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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 1. Chung et al. ASCO 2025; 2. Kaczmar et al. ESMO Asia 2025 25 Pivotal FORTIFI-HN01 trial design has enabled accelerated dose selection and efficient Phase 3 initiation Phase 1b Phase 2 Phase 3 Open-label safety and dose selection Blinded safety and efficacyBlinded safety, efficacy, and dose selection FICERA 1500mg QW + 200mg pembro Q3W Pembro 200mg Q3W FICERA 750mg QW + 200mg pembro Q3W FICERA 1500mg QW + 200mg pembro Q3W1 FICERA 750mg QW + 200mg pembro Q3W2 1:1:1 2:1 Primary endpoints: ORR, OS Secondary endpoints: DOR, PFS, safety Additional cohorts allow for: • Less frequent dosing for 1L R/M HNSCC to support commercialization efforts • HNSCC market opportunity expansion 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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Preparing for Commercial Success 26
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27†Rest of World includes other viable markets (Emerging markets: 111K; China: 50K; Rest of EU: 12K) 1. Tessellon patient flow modeling; SEER; country specific registries; literature review; 2. EvaluatePharma 2025 HPV-negative HNSCC is a sizable and growing global market ~50K HPV-negative HNSCC patients annually in the US, EU5, and Japan1 $5B+ projected global market for HNSCC by 20302
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FICERA has the potential to significantly expand the HPV-negative HNSCC market 28 Significant Untapped Potential for Market Expansion Continue to build market understanding of HPV-negative HNSCC as a distinct clinical disease 2-3X responses 2-3X duration of response 2X survival >2X potential growth in patient months Additional opportunities to further grow the market (e.g., CPS = 0, HPV-positive smokers) Pioneer Treatment Paradigm Shift Drive Better Patient Outcomes Expand The Market 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.
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FICERA has the potential to achieve blockbuster status in HNSCC 29Based 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. 1. EvaluatePharma 2025 $5B+ projected global market for HNSCC by 20301 Large and growing market with room for multiple therapeutic options Evidence-based development and commercialization strategy focused on greatest unmet need, HPV-negative disease First-and-only mechanism, an EGFR-directed antibody x TGF-B ligand trap designed to drive tumor penetration Proven clinical dataset that more than doubles median overall survival in HPV-negative patients compared to standard of care
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Expanding FICERA’s Potential While Maintaining Financial Discipline 30
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31Source: Bicara market research, represents annual incidence in U.S. SEER data; advanced PDAC includes metastatic and unresectable, locally advanced patients Known EGFR, TGF-β biological fingerprint provides strong rationale for FICERA expansion potential across solid tumors HPV- R/M HNSCC ~18,000 Registration-enabling Phase 3 ongoing mCRC 65,000+ Mono- and combo-therapy signal- finding Phase 1/1b in 3L+ ongoing Biologic and mechanistic rationale for future signal-finding, including in combination Advanced PDAC 40,000+ Ex-US market expansion represents >2X opportunity growth Frequent EGFR overexpression TGF-β signaling is pro-tumorigenic Strong unmet need in solid tumors that could benefit from enhanced tumor penetration
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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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2026 Milestones Timing Determine OBD for Phase 2/3 FORTIFI-HN01 study of ficerafusp alfa in 1L R/M HPV-negative HNSCC Present data from an exploratory Phase 1b expansion cohort evaluating 2000 mg of ficerafusp alfa every other week in combination with pembrolizumab in 1L HPV-negative R/M HNSCC patients Present long-term follow-up data from Phase 1b study of ficerafusp alfa in combination with pembrolizumab in 1L R/M HPV-negative HNSCC Q2 2026 Present data from Phase 1b expansion cohort evaluating ficerafusp alfa both as monotherapy and in combination with pembrolizumab in patients with 3L+ metastatic CRC (RAS/BRAF wild type MSS) 2H 2026 Achieve substantial enrollment in FORTIFI-HN01 pivotal study to enable interim analysis in mid-2027 Q4 2026 Make critical Commercial hires, including CCO, to advance organizational preparation for launch readiness Q4 2026 Anticipated key milestones in 2026 to drive growth and value inflection 35
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Indication Phase 1b Phase 2 Phase 3 Commercial 36 Maximizing the franchise value of FICERA 1L R/M HPV-Negative Head and Neck Squamous Cell Carcinoma 1500mg QW plus pembrolizumab to support OBD selection 750mg QW plus pembrolizumab to support OBD selection 2000mg Q2W plus pembrolizumab to support alternate dosing 1500mg QW plus pembrolizumab expansion cohort CPS<1 1L R/M HPV-Positive Smokers Head and Neck Squamous Cell Carcinoma 1500mg QW plus pembrolizumab expansion cohort Other Solid Tumors 1500mg QW monotherapy 3L+ mCRC (MSS RASwt) 1500mg QW plus pembrolizumab 3L+ mCRC (MSS RASwt) Pivotal study dose selected
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Thank You