On May 11, 2026 Bicara Therapeutics Inc. (Nasdaq: BCAX) reported financial results for the first quarter ended March 31, 2026 and provided a business update.

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"The first quarter of 2026 reflects strong progress as we work to position ficerafusp alfa as the cornerstone of treatment in HPV-negative head and neck cancer. In addition to advancing our FORTIFI-HN01 pivotal trial, we continued to enroll patients in additional Phase 1b signal-seeking studies as we aim to unlock the full blockbuster potential of ficerafusp alfa. Based on recent FDA discussions, we plan to initiate a randomized study to evaluate a loading and every-three-week maintenance dosing regimen – further differentiating ficerafusp alfa and expanding optionality for patients and providers. We also look forward to sharing an important data update at ASCO (Free ASCO Whitepaper) 2026, which will further characterize the role of TGF-β in driving depth and durability of response across three 1L R/M HNSCC expansion cohorts," said Claire Mazumdar, Ph.D., Chief Executive Officer at Bicara Therapeutics. "Alongside our clinical progress, we are rapidly evolving toward becoming a commercial-stage company, and to support that evolution, today we announced several executive changes. David Raben has transitioned from Chief Medical Officer to a Senior Executive Advisor role after three years of instrumental contributions, and Bill Schelman, formerly Executive Vice President of Clinical Development, has stepped into the Chief Medical Officer role. We have also welcomed Chris Sarchi as our Chief Commercial Officer, who brings extensive oncology commercialization and leadership experience as we build toward launch."

First Quarter 2026 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)

Continued strong execution in FORTIFI-HN01, our pivotal trial in 1L HPV-negative R/M HNSCC; expect to be substantially enrolled by the end of the year to enable an interim analysis in mid-2027 to support potential accelerated approval.
Based on recent discussions with the U.S. Food and Drug Administration (FDA), the company plans to initiate a randomized clinical study that will evaluate ficerafusp alfa in combination with pembrolizumab, administered as a 12-week loading dose of 1500mg weekly (QW) followed by maintenance dosing of 2250mg every three weeks (Q3W). The company expects to initiate the study in the third quarter of 2026 to have results in time for potential U.S. accelerated approval.
Phase 1b Studies of Ficerafusp Alfa Across HNSCC and Other Solid Tumor Types

Continued to enroll multiple Phase 1b expansion cohorts to identify early proof-of-concept signals and inform ficerafusp alfa development strategy beyond 1L R/M HPV-negative HNSCC.
Published a manuscript detailing results from a Phase 1b expansion cohort evaluating 1500mg of ficerafusp alfa QW in combination with pembrolizumab in 1L R/M HNSCC in the Journal of Clinical Oncology. Read the manuscript here.
Corporate Highlights

Announced that effective May 8, 2026, Bill Schelman, M.D., Ph.D., previously the company’s Executive Vice President, Clinical Development, has succeeded David Raben, M.D., as Chief Medical Officer, and Dr. Raben has transitioned to serve as a Senior Executive Advisor. With this promotion, Dr. Schelman is responsible for medical affairs and clinical development. In his new role, Dr. Raben will advise on clinical development strategy across the company’s portfolio.
Announced that effective May 8, 2026, Chris Sarchi was appointed as Chief Commercial Officer. In this role, he will lead the commercial organization in preparation for launch readiness.
Key Anticipated Upcoming Milestones

HNSCC

Present long-term follow-up data, which will further characterizing the role of TGF-β inhibition in driving depth and durability of response, from three Phase 1b expansion cohorts 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.
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.
First Quarter 2026 Financial Results

Cash, Cash Equivalents and Marketable Securities: As of March 31, 2026, Bicara had cash, cash equivalents and marketable securities of $539.8 million, compared to $414.8 million in cash, cash equivalents and marketable securities as of December 31, 2025. The company received approximately $161.8 million in net proceeds from 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 $47.5 million for the first quarter of 2026 as compared to $34.3 million for the first quarter of 2025. The increase was primarily due to costs associated with the ongoing FORTIFI-HN01 pivotal trial, 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 $12.7 million for the first quarter of 2026 as compared to $7.5 million for the first quarter of 2025. The increase was primarily due to additional personnel costs and professional fees to support advancement of our clinical trials.
Net Loss: Net loss totaled $56.2 million for the first quarter of 2026 compared to $36.8 million for the first quarter of 2025.
Upcoming Investor Conferences

Bicara Therapeutics will participate in two upcoming investor conferences:

BofA Securities Health Care Conference 2026 on Wednesday, May 13, 2026 at 9:20 a.m. PT.
TD Cowen 7th Annual Oncology Innovation Summit: Insights for ASCO (Free ASCO Whitepaper) & EHA (Free EHA Whitepaper) on Wednesday, May 27, 2026 at 10:30 a.m. ET.
A live webcast of the fireside chats 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 first quarter 2026 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, MAY 11, 2026, View Source [SID1234665476])

On May 11, 2026 Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, reported financial results for the three months ended March 31, 2026, and highlighted recent corporate updates.

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"Despite typical first-quarter seasonality and unusual weather-related disruption early in the quarter, we saw a clear recovery in February and March," said Craig Collard, Chief Executive Officer of Heron. "Our Acute Care franchise continues to perform with strong year-over-year growth, and we remain confident in our full-year framework as deferred elective procedures return and our commercial catalysts such as IGNITE 2.0, unique J-Codes, and planned sales force expansion for the Acute Care franchise continue to build through 2026."

"As environmental conditions normalized, we saw momentum rebuild through February and exited March with improved trends. We maintained disciplined cost management and expect temporary gross margin pressure to normalize as we work through higher-cost CINVANTI inventory over the next two quarters," said Ira Duarte, Executive Vice President and Chief Financial Officer of Heron.

Business Highlights

•
Heron generated total net revenue of $34.7 million in Q1 2026 and ended the first quarter with $44.8 million in cash, cash equivalents and short-term investments. The Company reaffirmed full-year 2026 guidance of net revenue of $173 million to $183 million and Adjusted EBITDA of $10 million to $20 million.

•
Acute Care franchise updates: Net revenue increased 32% year-over-year, including ZYNRELEF net revenue of $10.2 million and APONVIE net revenue of $3.4 million in Q1 2026.

•
Commercial expansion: Heron’s planned sales force expansion remains on track for Q3 2026, with recruitment underway to increase coverage and account depth across the portfolio.

ZYNRELEF:
•
Demand units increased by 22% year-over-year. IGNITE, the commercial alignment program for ZYNRELEF, demonstrated 111% growth in target accounts by year-end 2025. This success resulted in expansion of included target accounts in January 2026 by 40% and extension of the program throughout 2026 with IGNITE 2.0.

•
ZYNRELEF continues to benefit from NOPAIN Act reimbursement and an increasingly predictable payment experience among 110 million covered commercial lives as accounts increasingly apply the permanent product-specific J-code (J0668).

APONVIE:

•
APONVIE demand units increased 68% year-over-year. Accordingly, a key performance metric, Average Daily Units, in Q1 2026 increased 70% over Q1 2025.

•
APONVIE has gained P&T approval in 1,902 accounts totaling 5.8 million medium-to-high PONV risk procedures. Broad adoption of APONVIE continued, with ordering accounts increasing 67% year-over-year.

•
APONVIE’s permanent product-specific J-code (J8502) became active April 1, 2026, which further streamlines billing and supports broader access as utilization expands.

•
Fifth Consensus Guidelines for the Management of PONV included APONVIE as the only FDA-approved intravenous NK-1 antagonist for prevention of PONV in adults and elevated the role of NK-1 antagonists in multimodal prophylaxis strategies.

•
Oncology Supportive Care franchise updates: Net revenue was $21.1 million in Q1 2026, including CINVANTI net revenue of $20.5 million and SUSTOL net revenue of $0.6 million reflecting the previously communicated wind-down of SUSTOL by the end of 2026.

CINVANTI:

•
CINVANTI maintained 25% market share in the NK1 CINV category in Q1 2026, equivalent to the average of 25% for the past 12 months.

•
The REIGNITE program, with a goal of returning CINVANTI to steady growth, secured formulary wins and the near-term pipeline represents an increase of approximately $10 million net revenue on an annual basis in potential new opportunity.

•
Heron reached a settlement agreement with Baxter Healthcare Corporation in CINVANTI patent litigation, and the U.S. District Court for the District of Delaware dismissed the pending litigation between the parties on April 28, 2026.

•
Active promotion of CINVANTI as part of Heron’s planned expansion of its sale force for Q3 2026.

•
CINVANTI surpassed 5 million demand units sold since launch

•
Development update: The ZYNRELEF prefilled syringe (PFS) lifecycle program

•
This late-stage program to improve Operating Room efficiency with a Ready-to-Use product remains funded and on track. As previously announced, registration batches have been manufactured and placed on stability, and the Company will receive 12-month stability data in the first quarter of 2027. Heron is continuing CMC and device-related readiness activities to support the filing.

Financial Guidance for 2026

Item

2026 Full-Year Guidance for Net Revenue and Adjusted EBITDA

(in millions)

Net Revenue

$173 to $183 million

Adjusted EBITDA

$10 to $20 million

Cash, cash equivalents, and short-term investments were $44.8 million as of March 31, 2026.

Net Revenue Performance – Three Months Ended March 31

(in thousands)

(unaudited)

2026

2025

Dollar Change

Percentage Change

Acute Care

$ 13,629

$ 10,302

$ 3,327

32.3%

APONVIE

$ 3,394

$ 2,260

$ 1,134

50.2%

ZYNRELEF

$ 10,235

$ 8,042

$ 2,193

27.3%

Oncology

$ 21,082

$ 28,601

($ 7,519)

(26.3%)

CINVANTI

$ 20,535

$ 25,742

($ 5,207)

(20.2%)

SUSTOL

$ 547

$ 2,859

($ 2,312)

(80.9%)

Total Net Revenue

$ 34,711

$ 38,903

($ 4,192)

(10.8%)

Conference Call and Webcast

Heron will host a conference call and live webcast on Monday, May 11, 2026, at 8:30 a.m. ET. The conference call can be accessed by phone by utilizing the following registration link which will provide participants with dial-in details. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. The conference call will also be available via webcast under the Investor Relations section of Heron’s website at www.herontx.com. The investor presentation to be used for the conference call and webcast can be accessed from Heron’s website prior to the conference call and webcast. An archive of the teleconference, webcast, and investor presentation will also be made available on Heron’s website for sixty days following the call.

(Press release, Heron Therapeutics, MAY 11, 2026, View Source [SID1234665438])

On May 11, 2026 ProBio Inc. and Curocell reported to have achieved a significant milestone with the BLA regulatory approval and commercial readiness of Anbalcabtagene autoleucel (Anbal-cel; code: CRC01). This next-generation CD19-targeted CAR-T cell therapy is developed for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This approval not only highlights Korea’s growing innovation in advanced therapies but also marks a critical step towards bringing transformative treatment options to patients. To learn more about ProBio’s contributions to advanced therapeutic manufacturing, visit www.probiocdmo.com.

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Clinical data from Phase 1/2 studies has demonstrated compelling efficacy, with an overall response rate (ORR) of 82% and a complete response (CR) rate of 82% in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The therapy also exhibited a manageable safety profile, with the most commonly reported grade 3/4 adverse events including neutropenia, anemia, and thrombocytopenia.

A key differentiating feature of CRC01 lies in Curocell’s proprietary OVIS platform, which suppresses the expression of immune checkpoint receptors PD-1 and TIGIT in CAR-T cells. This innovative mechanism is designed to address immune suppression within the tumor microenvironment, potentially enhancing therapeutic efficacy compared to conventional CAR-T approaches.

As a strategic partner of Curocell, Probio has supported the journey from post-IND supplier change to BLA application and commercial production. We partnered closely with the client to manage complex change control activities and secure rapid regulatory approval for major process and site changes. With deep expertise in lentiviral vector manufacturing, we completed process characterization within four months, defined critical process parameters, implemented a robust control strategy, and achieved first‑pass success across all three validation batches. Our strong performance during the MFDS pre‑approval inspection, from audit readiness to real‑time responses, was recognized by both regulators and the client. We successfully obtained MFDS GMP certification, representing the first GMP approval for a lentiviral vector manufacturing facility in Korea and reinforcing our role as a pioneer in the local cell and gene therapy supply chain.

The program has now progressed into the commercial manufacturing phase. ProBio remains committed to delivering high-quality plasmid and viral products, supporting the broader adoption of CAR-T therapy, enabling patient access. "We are thrilled to witness this landmark achievement by Curocell," said Allen GUO, CEO from ProBio. "This approval not only represents a major step forward for patients in Korea but also reinforces the global potential of innovative CAR-T therapies. At ProBio, we remain committed to empowering our partners with integrated CDMO solutions to accelerate the development and commercialization of advanced therapies worldwide."

"The approval of Rimqarto is highly meaningful as it represents the commercialization of Korea’s first CAR-T therapy," said Kim Gun-soo, CEO of Curocell. "ProBio has played a key role throughout the entire process, from the clinical stage to process development, quality management, regulatory response, and preparation for commercial production, serving as an important partner in supporting the successful approval and laying the foundation for commercialization." He added, "Moving forward, Curocell plans to improve treatment access for patients in Korea based on a stable global supply chain and quality competitiveness, while continuing to expand into global markets and advance the development of next-generation CAR-T therapies."

(Press release, ProBio, MAY 11, 2026, View Source [SID1234665461])

On May 11, 2026 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported a clinical trial collaboration and supply agreement (CTCSA) with Merck, known as MSD outside of the United States and Canada.

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This agreement supports a clinical proof-of-concept study, AURORAS-1, evaluating the pan-RAS molecular glue ERAS-0015 in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, for the treatment of patients with RAS-mutant (RASm) solid tumors. Erasca is sponsoring the study, and Merck is supplying pembrolizumab at no cost.

"We are excited to work with Merck to advance this promising investigational combination in RAS-driven cancers," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "RAS mutations activate the RAS/MAPK pathway and promote an immunosuppressive environment. Non-clinical data suggest that targeting the pathway with ERAS-0015 may complement PD-1 blockade by reducing immunosuppression and driving more robust and durable tumor responses."

Worldwide, approximately 2.7 million patients are diagnosed annually with RASm tumors. Lack of effective treatments targeting multiple mutations and emergence of resistance mechanisms continue to challenge the ability to achieve and maintain responses across RAS-driven tumors. Erasca is exploring whether pan-RAS inhibition with ERAS-0015 in combination with pembrolizumab can further improve therapeutic benefits and limit the development of treatment resistance.

About ERAS-0015
ERAS-0015 is an investigational, oral, highly potent pan-RAS molecular glue designed to inhibit RAS signaling with a potential best-in-class profile. Erasca is evaluating ERAS-0015 in the AURORAS-1 Phase 1 trial in patients with RAS-mutant solid tumors. Early dose escalation data in AURORAS-1 demonstrated favorable safety and tolerability results, well-behaved, linear PK, and confirmed and unconfirmed partial responses in multiple patients across multiple tumor types with different RAS mutations, including confirmed and unconfirmed partial responses at doses as low as 8 mg once daily (QD). ERAS-0015 is also designed to prevent resistance against mutant-selective inhibitors through inhibition of RAS wildtype variants. In addition, ERAS-0015 has demonstrated favorable absorption, distribution, metabolism, and excretion (ADME) and pharmacokinetic (PK) properties in multiple animal species.

(Press release, Erasca, MAY 11, 2026, View Source [SID1234665477])

On May 11, 2026 HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, reported HCB206, the company’s internally developed dual-target fusion protein candidate, is advancing toward IND-enabling studies following preclinical data supporting its potential application across oncology and autoimmune diseases.

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HCB206 is built on HanchorBio’s proprietary FBDB platform and is designed to combine targeted cell binding and Fc-mediated immune effector functions, including antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis. By engaging immune clearance mechanisms against pathogenic or abnormal cells, HCB206 is being evaluated as a potential therapeutic candidate in both malignant B-cell diseases and autoimmune diseases characterized by pathogenic B-cell activity.

In preclinical studies, HCB206 demonstrated tumor growth inhibition across multiple animal tumor models and showed therapeutic potential in immune disease models. HanchorBio has also generated pharmacology data supporting HCB206’s ability to modulate immune cell activity and improve immune microenvironment responses, providing a rationale further IND-enabling development.

"HCB206 is being developed to evaluate whether a dual-target fusion protein approach can extend oncology into autoimmune diseases where pathogenic immune cells contribute to disease activity and relapse," said Wen-Wu Zhai, Ph.D., Chief Research and Development Officer of HanchorBio. "Based on the preclinical data generated to date, we are advancing formal toxicology studies and other IND-enabling activities while assessing the clinical development pathways in selected autoimmune disease indications."

"HCB206 represents an important step in HanchorBio’s broader platform strategy," said Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio. "Our goal is to build a differentiated pipeline of next-generation fusion protein therapeutics that can address complex immune biology across both oncology and immune-mediated diseases. The expansion of HCB206 into autoimmune disease reflects the versatility of our FBDB platform and our commitment to developing biologics with global clinical and partnering potential."

Autoimmune diseases affect a substantial portion of the global population, and many patients require chronic treatment with therapies that may be limited by incomplete response, relapse, infection risk, or long-term immunosuppression. HanchorBio is pursuing a dual-track autoimmune research strategy that includes targeted depletion of pathogenic B-cells as well as multifunctional immune-modulating biologics designed to address T-cell regulation and cytokine-driven inflammation.

HanchorBio currently has two FBDB-derived drug candidates in clinical development and continues to leverage its platform capabilities to expand its oncology and autoimmune disease pipeline. The company plans to advance HCB206 through IND-enabling studies while exploring and partnering opportunities for next-generation immunotherapies.

(Press release, Hanchor Bio, MAY 11, 2026, View Source [SID1234666359])