On March 30, 2026 Bicara Therapeutics Inc. (Nasdaq: BCAX) reported financial results for the fourth quarter and full year ended December 31, 2025 and provided a business update.

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"Bicara enters the year with exceptional momentum across our clinical, regulatory, and corporate priorities," said Claire Mazumdar, Ph.D., Chief Executive Officer at Bicara Therapeutics. "The continued advancement of our pivotal FORTIFI-HN01 study, the robust body of clinical data supporting ficerafusp alfa’s differentiated profile, and the alternate dosing option for ficerafusp alfa all underscore the significant progress we’ve made toward transforming outcomes for patients with HPV-negative head and neck cancer. Coupled with our fortified financial position from our recent financing, we are well positioned to execute on our milestones, scale our organization for potential commercialization, if approved, and deliver meaningful value for patients and shareholders throughout the year."

Fourth Quarter 2025 Highlights and Recent Progress

FORTIFI-HN01: Pivotal Phase 2/3 Clinical Trial of Ficerafusp Alfa in First Line (1L) Recurrent or Metastatic (R/M) HPV-Negative Head and Neck Squamous Cell Carcinoma (HNSCC)

Selected 1500mg of ficerafusp alfa as the optimal dose for the treatment of 1L HPV-negative R/M HNSCC in Phase 3 of the FORTIFI-HN01 pivotal trial.
Initiated Phase 3 of the FORTIFI-HN01 study, and expect to be substantially enrolled by the end of the year.
Announced plans to develop ficerafusp alfa with a loading and every-three-week (Q3W) maintenance schedule, with the goal of achieving regulatory alignment to enable data generation for potential U.S. approval.
Phase 1b Data of Ficerafusp Alfa in 1L R/M HPV-Negative HNSCC

Presented Phase 1b data at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia Congress 2025 demonstrating that ficerafusp alfa 750mg QW plus pembrolizumab was generally well-tolerated with an ORR comparable to 1500mg QW. Read the full presentation here. Biomarker analyses demonstrated that the 1500mg dose achieved greater TGF-β inhibition, stronger immune activation, and deeper clinical responses, supporting higher dose selection and further derisking the ORR interim analysis for the FORTIFI-HN01 pivotal study.
Presented Phase 1b data at the 2026 Multidisciplinary Head and Neck Cancers Symposium (MHNCS) showing that ficerafusp alfa 2000mg Q2W plus pembrolizumab was generally well‑tolerated and produced rapid, deep, and durable responses. Read the full presentation here. Updated biomarker analyses confirmed that the 2000mg Q2W regimen maintains TGF‑β inhibition and immune activation consistent with the differentiated profile of 1500mg QW, supporting development of a loading and Q3W maintenance schedule that maintains efficacy and safety while providing additional convenience.
Development of Ficerafusp Alfa Across Other Solid Tumor Types

Continued to enroll a Phase 1b expansion cohort evaluating ficerafusp alfa both as monotherapy and in combination with pembrolizumab in patients with 3L+ metastatic colorectal cancer (mCRC) (RAS/BRAF wild type MSS).
Corporate Highlights

Raised net proceeds of $161.8 million through an oversubscribed public offering. Net proceeds from the offering will be used to further invest in and build Bicara’s medical and commercial infrastructure to support a planned regulatory filing and commercial launch for ficerafusp alfa, if approved, in the U.S.; to further accelerate the development of ficerafusp alfa in 1L R/M HPV-negative HNSCC, including a less frequent dosing schedule; to fund manufacturing costs for ficerafusp alfa for ongoing and anticipated drug development efforts; to fund early signal-finding to support future indication expansion for ficerafusp alfa; and for other general corporate purposes.
Key Anticipated Upcoming Milestones

HNSCC

Present long-term follow-up data from Phase 1b study of ficerafusp alfa in combination with pembrolizumab in 1L R/M HPV-negative HNSCC at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held from May 29-June 2, 2026 in Chicago, IL.
Achieve substantial enrollment in FORTIFI-HN01 pivotal study by the end of 2026 to enable interim analysis readout in the middle of 2027.
Make critical commercial hires, including a Chief Commercial Officer, by the end of 2026 to advance organizational preparation for launch readiness.
Other Solid Tumors, Including mCRC

Present data from Phase 1b expansion cohort evaluating ficerafusp alfa both as monotherapy and in combination with pembrolizumab in patients with 3L+ mCRC (RAS/BRAF wild type MSS) in the second half of 2026.
Fourth Quarter 2025 Financial Results

Cash, Cash Equivalents and Marketable Securities: As of December 31, 2025, Bicara had cash, cash equivalents and marketable securities of $414.8 million, compared to $489.7 million in cash and cash equivalents as of December 31, 2024. An additional $161.8 million in net proceeds was raised via an oversubscribed public offering in the first quarter of 2026. Based on its current operating and development plans, the Company expects that its existing cash, cash equivalents and marketable securities will fund operations into the first half of 2029.
Research and Development Expenses: Research and development expenses were $33.0 million for the fourth quarter of 2025 as compared to $19.9 million for the fourth quarter of 2024, and $125.1 million for the full year 2025 as compared to $63.6 million for the full year 2024. The increase was primarily due to costs associated with ongoing pivotal Phase 2/3 clinical trial, FORTIFI-HN01, as well as the Company’s ongoing Phase 1/1b dose expansion cohorts, and an increase in personnel costs.
General and Administrative Expenses: General and administrative expenses were $8.1 million for the fourth quarter of 2025 as compared to $6.8 million for the fourth quarter of 2024, and $30.5 million for the full year 2025 as compared to $18.8 million for the full year 2024. The increase was primarily due to additional personnel costs and professional fees to support advancement of our clinical trials and operations as a public company.
Net Loss: Net loss totaled $37.4 million and $138.0 million for the fourth quarter and full year ended December 31, 2025, respectively, as compared to $21.0 million and $68.0 million for the fourth quarter and full year ended December 31, 2024, respectively.
Upcoming Investor Conferences

Bicara Therapeutics will participate in one upcoming investor conference:

BofA Securities Health Care Conference 2026 on Wednesday, May 13, 2026 at 9:20 a.m. PT.
A live webcast of the fireside chat will be accessible through the Investor Relations section of Bicara’s website under Events and Presentations. A replay of the webcast will be archived and available for 30 days following the event.

Conference Call Information

Bicara will host a live conference call and webcast at 8:30 a.m. ET today to discuss fourth quarter and full year 2025 financial results and recent business activities. Individuals may register for the conference call by clicking the link here. Once registered, participants will receive dial-in details and a unique PIN that will allow them to access the call. An audio webcast will be accessible through the Investor Relations section of Bicara’s website under Events and Presentations. An archived replay will also be available for 30 days following the event.

(Press release, Bicara Therapeutics, MAR 30, 2026, View Source [SID1234664046])

On March 30, 2026 SEED Therapeutics, Inc. ("SEED"), a clinical-stage biotechnology company specializing in molecular glue degraders, reported that it will have a poster presentation at the 2026 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR"), taking place on April 17 through 22, 2026 in San Diego, California.

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Presentation Details:

Title: RBM39 Degrader Anticancer Activity Against Neuroblastoma; MYC and CDKN2A/B as Potential Response Biomarkers
Presenter / Authors: James Finn, Imad Salhab, Haihong Jin, Fei Liu, Dong Liu, Yunkai Zhang, Xing Liu, James Tonra, Lan Huang, Dan Lu
Presentation Time: April 21, 2026, 2PM to 5PM PT
Location: Poster Section 15 at San Diego Convention Center
Session Category: Experimental and Molecular Therapeutics
Session Title: Proximity-Induced Drug Discovery 2
Poster Board Number: 12
Poster Number: 5785

(Press release, Seed Therapeutics, MAR 30, 2026, View Source [SID1234664045])

On March 30, 2026 Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, reported independent clinical validation of its Phase 2 SkinJect dataset from Dr. Babar Rao, principal investigator of the SKNJCT-003 study and a globally recognized dermatology key opinion leader.

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Dr. Rao’s independent assessment reinforces the Company’s view that the dataset is clinically meaningful, decision-grade, and supportive of continued development and regulatory engagement.

Dr. Rao, speaking in his capacity as principal investigator during the Company’s business update call, stated: "In my view as principal investigator, the dataset is clinically meaningful, supports continued development, and justifies regulatory engagement and further trials."

Independent KOL Validation of Phase 2 Results

The SKNJCT-003 study is a randomized, double-blind, three-arm Phase 2 trial evaluating microneedle-mediated delivery of doxorubicin compared with a biologically active device-only control in patients with nodular basal cell carcinoma (BCC).

Dr. Rao described that the study design provides a rigorous clinical framework, enabling:

Isolation of the incremental therapeutic contribution of doxorubicin
Evaluation of both clinical (visual) and histological clearance endpoints
Interpretation of outcomes in the context of a biologically active microneedle platform

"The clear separation between active drug and device-only control demonstrates a clinically meaningful therapeutic effect on top of a biologically active platform," Dr. Rao noted.

The 200µg cohort at Day 57 demonstrated the highest observed activity in the study, including:

~80% overall response rate
73% clinical clearance
40% histological clearance
Evidence of continued biological activity over time

These findings support the Company’s selection of the 200µg dose as the lead regimen for further development.

Dr. Rao highlighted the real-world clinical implications of the dataset, particularly the importance of clinical (visual) clearance:

"Approximately three out of four treated lesions may achieve visual tumor clearance, potentially allowing many patients to avoid immediate surgical intervention."

In clinical practice, lesions achieving visual clearance may be monitored or treated with less invasive approaches, suggesting SkinJect could serve as a non-surgical treatment alternative in appropriate patients.

This may be particularly impactful in:

Patients with limited access to Mohs surgery
Patients seeking less invasive treatment options
Individuals with high lesion burden, including those with Gorlin Syndrome

Dr. Babar Rao is a globally recognized dermatologist, dermatopathologist, Mohs surgeon, and clinical investigator with extensive experience in skin oncology and dermatologic research.

He currently serves as Professor of Dermatology and Pathology and Director of Clinical Research at Rutgers Robert Wood Johnson Medical School. He also holds academic appointments as Clinical Associate Professor of Dermatology at Weill Cornell Medical College and Adjunct Professor of Dermatology at California Health Sciences University.

Dr. Rao is board certified in dermatology and is a Fellow of the American Academy of Dermatology. He completed his dermatology residency and chief residency at Cornell University Medical Center, followed by advanced training at leading institutions including New York University Medical Center, Boston University School of Medicine, UT Southwestern Medical Center, and St. John’s Institute of Dermatology at the University of London.

He has authored more than 200 peer-reviewed scientific publications and multiple academic book chapters and has served as principal investigator in numerous clinical trials evaluating novel therapies for skin cancer and other dermatologic conditions.

Dr. Rao has served as principal investigator across multiple dermatology clinical programs evaluating emerging therapeutic modalities in skin cancer.

(Press release, Skinject, MAR 30, 2026, View Source [SID1234664044])

On March 30, 2026 Eikon Therapeutics, Inc. (Nasdaq: EIKN) ("Eikon"), a late-stage clinical biopharmaceutical company dedicated to developing innovative medicines to address serious unmet medical needs, reported fourth quarter and full year 2025 financial results and provided corporate updates.

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"2025 was an important year of progress for Eikon’s business and clinical programs," said Roger M. Perlmutter, M.D., Ph.D., Chief Executive Officer and Board Chair of Eikon. "With our initial public offering, and the consequent strengthening of our balance sheet, we believe we are well-positioned to advance multiple registration-enabling programs, bringing us closer to our mission of delivering breakthrough therapeutics to patients with serious illnesses."

Pipeline Updates

The following paragraphs describe progress made in advancing Eikon’s clinical programs through the end of 2025.

EIK1001 is a systemically administered dual-agonist of Toll-like receptors 7 and 8 designed to stimulate both innate and adaptive immune responses. Phase 1 studies have previously shown that EIK1001 exhibits single-agent activity in patients with advanced malignancy. This mechanism may complement the antitumor immune response engendered by PD-(L)1 blockade. Updates include:

Enrollment was completed in the TeLuRide-005 Phase 2 study evaluating the use of EIK1001 in combination with pembrolizumab and histology-appropriate chemotherapy for the first-line treatment of non-small cell lung cancer. The company expects a comprehensive data set to become available in 2H 2026.

EIK1003 & EIK1004 are next-generation, highly-selective PARP1 inhibitors that have been observed to leave PARP2 signaling intact. PARP2 inhibition may be a key driver of the hematological toxicity associated with first generation, non-selective PARP inhibitors. Updates include:

EIK1003 is under evaluation in a Phase 1/2 trial as monotherapy and in combination with hormonal blockade (prostate cancer) or chemotherapy (breast or ovarian cancer) to establish the feasibility of combination-based approaches.
Initiation of Cohort 1D, combining EIK1003 with platinum and paclitaxel therapy in breast and ovarian cancer treatment is anticipated in 2H 2026.
EIK1004, a highly-selective PARP1 inhibitor differentiated by its ability to cross the blood-brain barrier, is being evaluated in a Phase 1/2 trial in advanced solid tumors in patients with or without active brain metastases.

EIK1005 is a WRN helicase inhibitor with demonstrated in vitro activity in MSI-high cancer cells. EIK1005 was optimized using Eikon’s technology platform, which includes its imaging instruments that permit single molecule tracking in living cells. Updates include:

An abstract describing the pre-clinical characterization of EIK1005 was accepted for presentation at 2026 Annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper).
Successful completion of a healthy volunteer study by year-end 2025 permitted initiation of a Phase 1/2 trial in patients with malignant disease that is now underway.

Board Update
In December 2025, Eikon announced the election of David W. Meline as an independent director. Mr. Meline is the former Chief Financial Officer at Moderna Inc. Prior to Moderna, Mr. Meline served as CFO of Amgen Inc. and 3M Company, and he spent more than 20 years at General Motors Company in a range of finance and management roles.

Fourth Quarter and Full Year 2025 Financial Results

Cash Position: As of December 31, 2025, Eikon had cash, cash equivalents, and marketable securities of $336.0 million. In February 2026, Eikon raised $381.2 million in gross proceeds from an upsized IPO of common stock. Eikon expects its current cash, cash equivalents, and marketable securities, which includes proceeds from its February 2026 IPO, will fund operations into the second half of 2027.

Research and Development ("R&D") expenses: R&D expenses were $65.2 million for the fourth quarter of 2025 compared to $53.9 million for the fourth quarter of 2024, an increase of $11.3 million, or 21%. The increase was primarily due to accelerating clinical trial activity and increased facility and information technology expenses following the move into our new Millbrae, CA headquarters in April 2025. R&D expenses were $250.3 million for the year ended December 31, 2025 compared to $204.5 million for the year ended December 31, 2024, an increase of $45.8 million, or 22%. The increase was primarily due to expansion of our clinical trial activity, increased facility and information technology expenses associated with occupancy our new Millbrae headquarters in April 2025, and compensation costs from headcount growth.

General and Administrative ("G&A") expenses: G&A expenses were $17.9 million for the fourth quarter of 2025 compared to $13.9 million for the fourth quarter of 2024, an increase of $4.0 million, or 29%. The increase was primarily due to higher compensation costs, mainly higher corporate bonuses, and increased depreciation expense following the move into our Millbrae headquarters in April 2025. G&A expenses were $88.6 million for the year ended December 31, 2025, compared to $55.8 million for the year ended December 31, 2024, an increase of $32.8 million, or 59%. This increase was primarily due to the impairment of $21.3 million of assets relating to properties in Hayward, CA and New York, NY that we vacated during the year. An additional primary driver of the increase was compensation costs, mainly from stock option modification charges, higher corporate bonuses, and increased depreciation expense following occupancy of our Millbrae headquarters in April 2025.

Net Loss: Net loss attributable to common stockholders was $79.7 million for the fourth quarter of 2025, as compared to $64.9 million for the prior-year period. For the full year 2025, net loss attributable to common stockholders was $333.6 million as compared to $243.8 million for the full year 2024.

(Press release, Eikon Therapeutics, MAR 30, 2026, View Source [SID1234664043])

On March 30, 2026 Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported that the U.S. Food and Drug Administration (FDA) has completed its filing review of the New Drug Application (NDA) for lirafugratinib, an investigational therapy, for the treatment of patients with cholangiocarcinoma (CCA) with FGFR2 fusions or rearrangements who have received prior therapy. The FDA determined that the NDA is sufficiently complete to permit a substantive review and granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) target action date of September 27, 2026.

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Priority Review designations are given to applications for medicines that, if approved, would lead to "significant improvements in the safety or effectiveness of the treatment" of a serious condition, according to the FDA. The Priority Review designation of the lirafugratinib NDA was supported by positive clinical data from the Phase 1/2 ReFocus trial (NCT04526106), which demonstrated a confirmed objective response rate (ORR) of 46.5% in the patients with the proposed indication. Its safety profile in the clinical data has been shown to be predictable and manageable through dose adjustments.

"Lirafugratinib has established a compelling clinical profile that differentiates it from existing treatment options," said Dong-Gun Kim, chief executive officer of Elevar. "We are very pleased with the FDA’s priority review designation and focused on advancing the review process efficiently to bring this therapy to patients as quickly as possible."

CCA, also known as bile duct cancer, is rare, with about 8,000 people in the U.S. diagnosed each year, according to the American Cancer Society.

Elevar Therapeutics continues to evaluate lirafugratinib in ongoing clinical development programs, including studies in other FGFR2-altered solid tumors. Any future indications will be subject to regulatory review and approval.

About Lirafugratinib

Lirafugratinib (RLY-4008) is a potent, selective, and oral small molecule inhibitor of FGFR2, a receptor tyrosine kinase that is frequently altered in certain cancers. FGFR2 is one of four members of the FGFR family, a set of closely related proteins with highly similar protein sequences and properties. Preclinically, lirafugratinib demonstrated FGFR2-dependent killing in cancer cell lines and induced regression in in vivo models with minimal inhibition of other targets, including other members of the FGFR family. In addition, lirafugratinib demonstrated strong activity against known clinical on-target resistance mutations in vitro and in vivo preclinical models. Lirafugratinib is currently being evaluated in a clinical trial to enroll additional patients with previously treated, advanced or metastatic solid tumors other than CCA harboring FGFR2 fusion or rearrangement, who have not been treated with prior FGFR inhibitors.

(Press release, Elevar Therapeutics, MAR 30, 2026, View Source [SID1234664042])