Bicara Therapeutics (NasdaqGM:BCAX) Update / briefing February 20, 2026 08:30 AM ET Company ParticipantsBill Schelman - EVP of Clinical DevelopmentClaire Mazumdar - CEOJenna Cohen - Chief Corporate Affairs OfficerReni Benjamin - Managing DirectorStephen Willey - Managing DirectorConference Call ParticipantsEric Schmidt - Biotechnology AnalystJeet Mukherjee - VP and Biotechnology AnalystJudah Frommer - Executive Director and Senior Equity Research AnalystKelsey Goodwin - Director and Senior Research AnalystT ...

Core Insights - Johnson & Johnson announced promising results from the Phase 1b/2 OrigAMI-4 study, showing a 56% overall response rate for RYBREVANT FASPRO™ in first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) [1][2] - The study demonstrated a 10% complete response rate and a clinical benefit rate of 74%, indicating significant antitumor activity compared to current standards of care [1][2] - The combination of subcutaneous amivantamab and pembrolizumab targets key drivers of tumor growth and resistance, suggesting a potential shift in treatment paradigms for HNSCC [1][2] Study Results - In Cohort 2 of the OrigAMI-4 study, the confirmed overall response rate was 56% (22 out of 39 patients), with 6 complete responses and 18 partial responses [1] - At a median follow-up of 10.4 months, 46% of patients remained on treatment, and tumor shrinkage was observed in 82% of patients [1] - The median progression-free survival was reported at 7.7 months, with a median time to first response of 9.7 weeks [1] Safety Profile - The safety profile of RYBREVANT FASPRO™ combined with pembrolizumab was consistent with individual agents, with no new safety signals identified [1] - Common treatment-emergent adverse events included rash (49%), paronychia (46%), and hypoalbuminemia (41%), with 15% of patients experiencing administration-related reactions [1][2] - Treatment discontinuation due to adverse events occurred in four patients, indicating manageable safety concerns [1] Industry Context - HNSCC is an aggressive cancer type, with current standard treatments yielding low response rates (approximately 18% for PD-1 monotherapy) [1][2] - The introduction of RYBREVANT FASPRO™ represents a significant advancement in addressing unmet needs in HNSCC treatment, particularly for HPV-unrelated cases [1][2] - Ongoing studies, including the Phase 3 OrigAMI-5 study, will further evaluate the efficacy of RYBREVANT FASPRO™ in combination with carboplatin and pembrolizumab [1][2]

Core Insights - Bicara Therapeutics presented preliminary data from a Phase 1b expansion cohort evaluating ficerafusp alfa in combination with pembrolizumab for treating first-line HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), showing rapid, deep, and durable responses with a well-tolerated safety profile [1][3][4] Company Overview - Bicara Therapeutics is a clinical-stage biopharmaceutical company focused on developing bifunctional therapies for solid tumors, with ficerafusp alfa being its lead program [12][13] - Ficerafusp alfa is a first-in-class bifunctional antibody designed to enhance tumor penetration and improve survival outcomes by combining an EGFR-directed antibody with a TGF-β ligand trap [2][10] Clinical Data - The Phase 1b expansion cohort data indicated a 48% confirmed overall response rate (ORR) for the 2000mg every other week (Q2W) dosing regimen, with 26% of patients achieving a complete response (CR) and 77% of responders showing at least 80% tumor shrinkage [3][4] - The safety profile of the 2000mg Q2W regimen was consistent with previous findings for ficerafusp alfa combined with pembrolizumab [3][4] - Updated biomarker results confirmed that the 2000mg Q2W regimen maintains TGF-β inhibition and immune activation while delivering deep responses [5] Future Development Plans - The company plans to develop a loading and every-three-week maintenance regimen for ficerafusp alfa, pending regulatory alignment [1][6] - Ongoing enrollment in the pivotal FORTIFI-HN01 study continues to evaluate ficerafusp alfa at 1500mg weekly in combination with pembrolizumab [6][11] Industry Context - HNSCC is one of the most common cancers globally, with a rising incidence expected to reach one million new cases annually by 2030, highlighting a significant unmet need for effective therapies [8][9]

Financial Performance - The company reiterated its revenue guidance for 2026, expecting total revenue between $59.5 billion and $62.5 billion, with approximately $5 billion from COVID-related products and an impact of about $1.5 billion from patent expirations. Adjusted earnings per share guidance is set at $2.80 to $3.00 [2] Product Development Progress - The company plans to initiate around 20 key clinical trials in 2026, with 10 focused on obesity assets, including the further development of the long-acting GLP-1 receptor agonist PF-3944 (MET-097i), which has shown significant weight loss effects in its phase 2b study [3] - In oncology, Padcev (enfortumab vedotin) in combination with pembrolizumab received FDA approval in November 2025 for perioperative treatment of bladder cancer, while Tukysa and Braftovi have shown positive efficacy in breast and colorectal cancer trials [3] Strategic Initiatives - In November 2025, the company completed the acquisition of Metsera for approximately $7 billion, aimed at strengthening its pipeline in obesity and metabolic diseases, marking its entry into this high-growth area [4] - The company continues to expand its pipeline through collaborations, such as the agreement with YaoPharma for small molecule GLP-1 receptor agonists, although this is still in the early stages [4] Operational Efficiency - The adjusted sales cost ratio decreased to 24.2% in 2025, with sales and administrative expenses declining by 7% year-over-year, reflecting the company's ongoing efforts to enhance operational efficiency through digitalization and resource optimization [5]

Financial Performance - In Q4 2025, the company reported revenue of $17.56 billion, with a 9% year-over-year growth in non-COVID business [1] - Total revenue for the year 2025 was $62.6 billion, with a 6% growth in core non-COVID business [1] - The company reaffirmed its revenue guidance for 2026, projecting between $59.5 billion and $62.5 billion, including approximately $5 billion from COVID-related products and accounting for about $1.5 billion impact from patent expirations [1] - Adjusted earnings per share guidance for 2026 is set between $2.80 and $3.00 [1] Product Development Progress - In 2026, the company plans to initiate around 20 key clinical trials, with 10 focused on obesity assets [2] - The Phase 2b study of the ultra-long-acting GLP-1 receptor agonist PF-3944 (MET-097i) has achieved its primary endpoint [2] - The oncology sector has seen several regulatory breakthroughs, including FDA approval in November 2025 for Padcev in combination with pembrolizumab for perioperative treatment of bladder cancer [2] - Tukysa and Braftovi have shown significant efficacy in trials for breast and colorectal cancers [2] Strategic Initiatives - In November 2025, the company completed the acquisition of Metsera, with a total transaction value of approximately $7 billion, aimed at strengthening its pipeline in obesity and metabolic diseases [3] - The company has improved operational efficiency through cost control, with the adjusted sales cost ratio decreasing to 24.2% in 2025, and sales and administrative expenses declining by 7% year-over-year [3]

Core Insights - Kazia Therapeutics provided a clinical update on its Phase 1b study evaluating paxalisib in combination with pembrolizumab and chemotherapy for late-stage metastatic triple-negative breast cancer (TNBC) [1] Clinical Highlights - The Phase 1b trial is a multi-center, open-label, randomized study initiated in June 2025, focusing on the safety, tolerability, and preliminary clinical activity of paxalisib in advanced breast cancer patients [4] - Three patients with metastatic TNBC have shown meaningful clinical responses, including two partial responses and one confirmed complete metabolic response [2][9] Patient Responses - Patient 1, a 61-year-old female, achieved a partial response after nine cycles of treatment with paxalisib, pembrolizumab, and chemotherapy [5] - Patient 2, a 47-year-old female, demonstrated a partial response with complete resolution of a target lung lesion after three treatment cycles [6] - Patient 3, a 44-year-old female, achieved a confirmed complete metabolic response after re-treatment with paxalisib and pembrolizumab [7] Safety and Tolerability - Paxalisib has been generally well tolerated, with approximately 75% of adverse events assessed as unlikely or unrelated to the drug [8] - Most adverse events were mild to moderate, with only one case of Grade 1 hyperglycemia reported [8] Future Plans - Kazia plans to activate two additional clinical sites by April 2026 and aims to enroll twelve TNBC patients by the end of 2026, with topline data expected in early 2027 [9] - The company is also exploring paxalisib in other breast cancer populations, including earlier-stage TNBC and hormone receptor-positive, HER2-negative breast cancer [10] Executive Commentary - Dr. John Friend, CEO of Kazia Therapeutics, expressed optimism about the preliminary results, highlighting the rarity of confirmed complete responses in metastatic TNBC and the potential of paxalisib to enhance existing immunotherapy regimens [11]

Summary of BridgeBio Oncology Therapeutics FY Conference Call Company Overview - **Company**: BridgeBio Oncology Therapeutics (NasdaqGM:BBOT) - **Date of Conference**: January 12, 2026 Key Points Industry and Product Focus - The company is focused on developing innovative therapies for KRAS G12C mutant non-small cell lung cancer (NSCLC) and other cancers, utilizing novel inhibitors such as 8520, BBO-11818, and BBO-10203 [1][2][3] Core Findings and Data - **8520**: - First direct KRAS G12C on-off inhibitor with a monotherapy efficacy overall response rate of 65% and a disease control rate of 100% in previously treated patients [6][12] - 83% of patients eligible for six-month follow-up remained on treatment for over six months, indicating promising durability [6] - Safety profile is differentiated from off inhibitors, particularly regarding liver toxicities, with no grade three or higher liver toxicity reported [7][9] - **BBO-11818**: - A pan-KRAS inhibitor showing encouraging dose escalation data and confirmed partial response in heavily pretreated pancreatic cancer patients [2][15] - Demonstrates anti-tumor activity across dose levels with tumor reductions observed [2][15] - **BBO-10203**: - A novel RAS PI3K alpha breaker that has achieved all phase one monotherapy objectives with no hyperglycemia observed, differentiating it from other PI3K alpha inhibitors [3][21] - The drug is designed to avoid affecting glucose homeostasis, making it suitable for a broader patient population [18][21] Combination Therapy Insights - The combination of 8520 with pembrolizumab has shown promising efficacy, with three of three partial responses in first-line patients and two of five in pretreated patients [8][12] - The safety profile of the combination remains favorable, with manageable treatment-related adverse events [9][12] - The company plans to explore combinations of 8520 and 203, as well as 818 and 203, to enhance therapeutic outcomes [24][26] Competitive Landscape - The KRAS G12C space is described as crowded, but the company believes its differentiated efficacy and safety profile positions it as a best-in-class option [30] - The focus on sparing H&N RAS in BBO-11818 is expected to drive higher levels of inhibition safely, avoiding common toxicities associated with other treatments [32] Future Directions - The company is set to release additional data on combination therapies and monotherapy results throughout 2026, with a focus on expanding treatment options for underserved patient populations [25][26] - There is a strong emphasis on the potential of the 203 program in combination with other therapies, particularly in addressing unmet needs in the PI3K alpha space [34] Additional Considerations - The company has observed early encouraging signals in resistant patient populations, particularly those with STK11 KEAP1 co-mutations, where all five patients treated have responded positively [2][12] - The strategic focus on rapid dose escalation and combination studies is aimed at addressing the high unmet need in cancer treatment [33][34] This summary encapsulates the key insights and data presented during the conference call, highlighting the company's innovative approaches and future plans in the oncology space.

Core Insights - Bicara Therapeutics has selected 1500 mg of ficerafusp alfa as the optimal dose for the Phase 3 FORTIFI-HN01 pivotal study targeting HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) [1][2][3] - The company anticipates substantial enrollment in the FORTIFI-HN01 study by the end of 2026, enabling an interim analysis in mid-2027 [1][4] - Ficerafusp alfa is positioned to address a significant unmet need in the HPV-negative HNSCC market, which is a multi-billion-dollar sector [5] Company Strategy - Bicara aims to accelerate enrollment in the FORTIFI-HN01 study and is focused on achieving a clear path for potential accelerated filing based on interim analysis results [2][4] - The company plans to make critical commercial hires in 2026 to prepare for the launch of ficerafusp alfa, ensuring a strong foundation for future commercial success [6][15] - Bicara is exploring ficerafusp alfa's potential in other solid tumors, including metastatic colorectal cancer (mCRC), to further evaluate its pipeline-in-a-product potential [9][11] Clinical Development - Ficerafusp alfa has demonstrated a clinical dataset that more than doubles median overall survival in HPV-negative patients compared to standard care [6] - The drug is designed to improve tumor penetration and survival outcomes by targeting EGFR-expressing tumor cells and modulating TGF-β signaling [7][8] - The company plans to present data from various studies in 2026, including long-term follow-up data and exploratory studies evaluating different dosing strategies [11][15] Market Potential - The HPV-negative R/M HNSCC market is characterized by immune exclusion and a hostile tumor microenvironment, highlighting the need for more effective treatment options [5] - Ficerafusp alfa's unique mechanism of action positions it to potentially achieve blockbuster status in this growing market [5][6]

Group 1 - Eikon Therapeutics has officially submitted its IPO application to raise funds for its advanced drug pipeline, aiming for a listing in early 2026 [1] - The company plans to list on the NASDAQ under the ticker symbol "EIKN," with major underwriters including JPMorgan, Morgan Stanley, Bank of America, and Cantor Fitzgerald [1] - Eikon is led by former Merck executives Roger Perlmutter and Roy Baynes, who previously contributed to the development of pembrolizumab, the highest-grossing cancer therapy globally [1] Group 2 - Founded in 2019, Eikon has secured substantial funding, raising $350.7 million in a Series D round led by Lux Capital, Foresite Capital, Soros Fund Management, and accounts advised by T. Rowe Price [2] - As of September 30 last year, the company reported cash, cash equivalents, and short-term investments totaling $375.9 million [2] - The IPO application follows a trend of several companies, including Bob's Discount Furniture, Forgent Power Solutions, and Veradermics, also planning to go public in early 2026 [2]

Core Insights - BridgeBio Oncology Therapeutics, Inc. (BBOT) announced positive preliminary safety and antitumor data for its three small molecule RAS and PI3Kα programs, including BBO-8520, BBO-11818, and BBO-10203 [1][2] BBO-8520 Findings - BBO-8520 demonstrated a 65% objective response rate (ORR) and a 66% six-month progression-free survival (PFS) in patients with KRAS mutant non-small cell lung cancer (NSCLC) [3][9] - The safety profile of BBO-8520 was generally well-tolerated, with no dose-limiting toxicities (DLTs) and no grade ≥4 treatment-related adverse events (TRAEs) reported [9][15] - In combination with pembrolizumab, BBO-8520 showed promising efficacy, with all patients experiencing tumor reduction regardless of PD-L1 status [9][15] BBO-11818 Findings - BBO-11818 showed early anti-tumor activity, including a confirmed partial response in a patient with pancreatic ductal adenocarcinoma (PDAC) and a 56% tumor reduction [9][10] - The monotherapy treatment appeared generally tolerable with no DLTs and primarily gastrointestinal-related TRAEs [9][10] - Ongoing studies are evaluating BBO-11818 in heavily pretreated patients with KRAS mutant solid tumors [6][9] BBO-10203 Findings - BBO-10203 demonstrated a differentiated safety profile with no observed hyperglycemia and no DLTs [15] - The recommended go-forward dose for BBO-10203 is 500 mg, with combination studies initiated in colorectal cancer and breast cancer [10][15] - Clinical benefits were observed in heavily treated patients with colorectal cancer and hormone receptor-positive breast cancer [15] Upcoming Catalysts - BBOT plans to provide additional data updates for BBO-8520, BBO-11818, and BBO-10203 in the second half of 2026 [12][15] - Combination studies with BBO-10203 and other product candidates are expected to open later in 2026 [15]