On May 11, 2026 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs"; Stock Code: 9887.HK) reported its R&D Symposium in Shanghai. Under the theme "Leads Innovation, Future Forward", the event comprehensively presented the Company’s strategic elevation from "multi-platform synergy" to "multi-mechanism integration". Leads Biolabs highlighted its innovation ecosystem propelled by four proprietary technology platforms—IO 2.0, TCE, ADC, and the world-first TDC—alongside milestone advancements in core clinical pipelines, a preclinical pipeline matrix with global first-in-class potential, and forward-looking development roadmaps.

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Dr. Xiaoqiang Kang, Founder, Chairman, and CEO of Leads Biolabs, said: "Focusing on the prevailing unmet clinical needs and core challenges in immuno-oncology (IO), Leads Biolabs has established a differentiated layout by deeply integrating three frontier technologies: IO 2.0, TCE, and ADC. We have constructed a clinical pipeline matrix characterized by multi-mechanism fusion. By adhering to a phased development strategy encompassing single-agent validation, platform iteration, and combination expansion, we aim to systematically surmount clinical barriers such as ‘cold tumors’, immune resistance, and poor response. The year 2027 is poised to witness the launch of the Company’s first commercial product, marking its official transition into the inaugural year of commercialization. Propelled by our robust technology platforms, we aim to advance 20+ novel molecules into clinical trials, progress 4 to 8 assets into late-stage development, and achieve commercialization for 3 products by 2030. These milestones will drive us steadily toward our ultimate vision: ‘Transforming cancer into a manageable chronic disease’."

Clinical Breakthroughs & Value Realization: From Clinical-Stage Biotech to Integrated Biopharma

Since its inception, Leads Biolabs has remained committed to an "asymmetric competition" strategy, taking unaddressed clinical gaps left by PD-(L)1 inhibitors as its strategic cornerstone. By proactively anchoring its research in IO 2.0, the Company has pioneered the synergistic mechanism of "immune checkpoint inhibition plus co-stimulatory signal activation". This approach has successfully propelled LBL-024—a potential global first-in-class (FIC) PD-L1/4-1BB bispecific antibody—to the BLA (Biologics License Application) submission stage.

LBL-024: A Potential IO 2.0 Pan-Tumor Backbone Therapy with Survival Benefit. Utilizing the unique 2:2 molecular structure design of the X-body platform, LBL-024 releases PD-L1-mediated immunosuppression while conditionally activating the 4-1BB co-stimulatory pathway, achieving the synergistic effect of "releasing the brakes and stepping on the accelerator". Clinical studies have confirmed that LBL-024 not only overcomes the global technical challenge of the 4-1BB target, where no drugs have been marketed due to uncontrollable hepatotoxicity, but also demonstrates breakthrough efficacy across multiple cancer types and "cold tumors":

Safety: With over 600 patients enrolled, liver enzyme abnormalities in LBL-024 monotherapy or combination with chemotherapy occurred only in the early stages. No cumulative hepatotoxicity was observed with long-term treatment, and the overall safety profile is similar to that of PD-(L)1 monoclonal antibodies. Dose escalation up to 25.0 mg/kg did not reach the maximum tolerated dose (MTD), and no dose-limiting toxicities (DLTs) were observed.
Pan-cancer Efficacy: LBL-024 has demonstrated global first- or best-in-class potential in registrational or Phase II clinical studies for extrapulmonary neuroendocrine carcinoma (EP-NEC), non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and biliary tract cancer (BTC).
Cold Tumor Efficacy: LBL-024 is poised to become the first approved drug for EP-NEC, a typical cold tumor. In first-line SCLC combined with chemotherapy, the objective response rate (ORR) reached 88.1%, significantly superior to the approximately 60% of standard of care (SoC). It is also effective in PD-L1 low-expression NSCLC, achieving an efficacy breakthrough in populations difficult to cover with PD-1 monoclonal antibodies.
Durable Response: In late-line EP-NEC, the median overall survival (mOS) reached 11.9 months, doubling that of existing regimens. A clear survival benefit trend was also observed in first-line patients, offering the potential for long-term functional cure.
LBL-024 adopts a clear and progressive development strategy: advancing from late-line to first-line, from monotherapy to combination therapy, and from orphan diseases to major indications. Currently, LBL-024 covers 13 solid tumor indications, with one pivotal registrational study and eight proof-of-concept (PoC) studies underway.

LBL-024 is set to reach a series of intensive milestones in the second half of 2026. Regarding data readouts, data from a large patient cohort for first-line NSCLC will be presented at the World Conference on Lung Cancer (WCLC) in September. In October, the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting will feature the pivotal single-arm registrational clinical trial data for late-line EP-NEC, alongside the latest clinical results for first-line EP-NEC, SCLC, and BTC. On the commercialization front, LBL-024 has garnered Breakthrough Therapy Designation (BTD) from the CDE, as well as Fast Track Designation (FTD) and Orphan Drug Designation (ODD) from the U.S. FDA, and ODD from the European Union. The Company expects to submit the BLA for LBL-024 to the CDE in Q3 2026. The approval of LBL-024 will signify a pivotal milestone in the Company’s transition from a clinical-stage Biotech to an integrated Biopharma.

Platform-Driven, Innovation from the Source: An In-house R&D System Integrating High-Efficiency Multi-functional Platforms and Technical Capabilities

The future of oncology treatment lies in synergy, with combinations such as IO + ADC and TCE + ADC emerging as essential expansion pathways under this prevailing trend. Leads Biolabs is dedicated to expanding the reach of immunotherapy through the deep integration of its platforms. Currently, the Company has established four core technology platforms:

X-body (4-1BB Engager) Platform (IO 2.0): This platform utilizes advanced antibody engineering to create differentiated bispecific antibodies with a 2:2 molecular architecture, successfully addressing the hepatotoxicity and narrow therapeutic window typically associated with 4-1BB agonists.
LeadsBody (CD3 T-cell Engager) Platform (TCE): Designed to enhance efficacy and overcome treatment resistance, the next-generation LeadsBody platform has been clinically validated in hematologic malignancies by the potential best-in-class (BIC) LBL-034 (GPRC5D/CD3 bispecific antibody). For solid tumors, the platform is advancing in three strategic directions: multi-TAA (Tumor-Associated Antigen) targeting, co-stimulatory trispecific TCE, and TCE-ADC.
TOPiKinectics Platform in the ADC Field: The differentiated TOPiKinectics platform possesses full-chain, in-house design capabilities, including payload release within the tumor microenvironment (TME). It enables targeted tumor killing while minimizing off-target toxicity, thereby resolving industry pain points such as the narrow therapeutic window and frequent resistance associated with traditional ADC treatments. Furthermore, it offers advantages such as synergistic anti-tumor effects between ADC and IO.

World-First TDC Platform ImBiTDC (TCE-ADC): Leveraging proprietary antibody platforms and the TOPiKinectics platform, this technology deeply integrates TCE modules targeting tumor-specific antigens with ADC technology. This pioneers a completely new therapeutic track designed to address challenges such as overlapping toxicities and patient compliance issues associated with separate administration in traditional combination regimens. The TDC platform offers two key advantages: broad-spectrum efficacy and optimized safety. Unconstrained by the single mechanisms of either ADC or TCE, it is adaptable to diverse tumor scenarios with varying T-cell infiltration levels, T-cell functional states, and antigen expression abundance. It can efficiently kill high-antigen, high-payload-sensitive tumors, while also covering low-antigen, immunosuppressive patient populations through bystander effects and T-cell redirection. This significantly expands the eligible patient population and substantially reduces the risk of CRS, enhancing efficacy while simultaneously improving safety.

Through the progressive synergy of its technology platforms and the deep integration of multiple mechanisms, Leads Biolabs is constructing an innovative R&D ecosystem characterized by the cross-empowerment of multiple targets, molecule types, and technological routes. This ecosystem aims to lead the next generation of immuno-oncology, ensuring more cancer patients benefit from the continuous evolution of immunotherapy.

(Press release, Nanjing Leads Biolabs, MAY 11, 2026, View Source [SID1234665457])

On May 11, 2026 Ranok Therapeutics, a clinical-stage biotechnology company developing innovative therapies, reported the publication of preliminary clinical results from its Phase 1a study of RNK08954 in the peer-reviewed journal Cancer Discovery. RNK08954 is a proprietary, highly selective, oral small-molecule inhibitor targeting KRAS G12D mutation in patients with advanced solid tumors.

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The study evaluated the safety, tolerability, and clinical activity of RNK08954 in patients harboring KRAS G12D mutation across multiple sites in China. The study enrolled patients with advanced solid tumors, primarily focusing on safety and the determination of the Recommended Dose for Expansion. A total of 36 patients were evaluable for clinical activity. The overall objective response rate (ORR) was 28%, with a disease control rate (DCR) of 86%. Notably, patients with non-small cell lung cancer (NSCLC) achieved an ORR of 58.33% and a DCR of 100%. RNK08954 was generally well tolerated, with treatment-related adverse events consisting predominantly of Grade 1-2 gastrointestinal adverse events and decreased appetite. No dose-limiting toxicities were observed during the dose-escalation phase. [1]

"I am grateful that the editors of Cancer Discovery selected our study for publication," said Professor Song Zhengbo, Director of Phase I Clinical Trial Unit at Zhejiang Cancer Hospital, and the study’s Principal Investigator. "RNK08954 represents a critical step in advancing KRAS G12D-targeted therapy from concept to clinical validation. These findings not only accelerate the clinical translation of precision oncology but also lay a solid data foundation for subsequent pivotal clinical studies."

"The publication of these data underscores the potential for RNK08954 to provide a meaningful option for KRAS G12D-mutant cancers," commented Dr. Iman Elhariry, Chief Medical Officer at Ranok Therapeutics and co-author of the article. "Seeing a 58.33% objective response rate in the NSCLC cohort is particularly encouraging as it validates our approach of targeting the Switch II pocket with high selectivity. Based on these strong signals of clinical activity and the clean safety profile, we have already initiated our Phase 1b expansion study to further explore the drug’s potential as a monotherapy and in combination regimens across NSCLC, pancreatic and other indications."

Dr. Weiwen, Founder and CEO of Ranok Therapeutics, added: "The significant progress in KRAS inhibitors has been made possible by over a decade of accumulated knowledge in structural biology and medicinal chemistry. These clinical research achievements will inspire our team to further explore the clinical potential of RNK08954, fully unlocking its value for patients who currently lack effective targeted therapies."

About RNK08954 and KRAS G12D

KRAS G12D is one of the most prevalent oncogenic drivers in solid tumors, including pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), and non-small cell lung cancer (NSCLC). For decades, this mutation was considered "undruggable". RNK08954 is designed to bind directly to the Switch II pocket of the KRAS G12D protein in its active and inactive states, effectively blocking downstream signaling pathways that drive tumor growth.

(Press release, Ranok Therapeutics, MAY 11, 2026, View Source [SID1234665456])

On May 11, 2026 Aktis Oncology, Inc. (NASDAQ:AKTS) (Aktis or the Company), a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large populations, including those not addressed by existing platform technologies, reported financial results and business highlights for the first quarter ended March 31, 2026.

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"We continue to build momentum toward delivering a new class of radiopharmaceuticals targeting tumor types with large patient populations, leveraging our differentiated miniprotein radioconjugate platform and patient-first end-to-end supply chain," said Matthew Roden, Ph.D., President and Chief Executive Officer of Aktis Oncology. "Last week, we announced the initiation of our Phase 1b clinical trial of AKY-2519 in patients with mCRPC. This is the first of two trials in our clinical development strategy designed to expand the breadth of tumors studied and augment speed to data, with preliminary data from the mCRPC trial anticipated in 2027. We plan to initiate a second Phase 1b basket trial of AKY-2519 in additional solid tumors in the second half of this year. We also look forward to presenting our first AKY-2519 clinical imaging and dosimetry data for AKY-2519 at ASCO (Free ASCO Whitepaper), which informed our clinical development strategy."

Dr. Roden continued, "AKY-2519 marks the second program we have advanced from our proprietary miniprotein radioconjugate platform to the clinic in the last twelve months. In parallel, we continue to enroll patients in our ongoing Phase 1b trial of AKY-1189 targeting Nectin-4 expressing tumors, with preliminary data expected in the first quarter of 2027. We remain focused on generating clinical data intended to support advancement of both programs and maximizing the potential clinical benefit for patients."

Q1 and recent business highlights

AKY-1189 highlights

AKY-1189 is a novel, clinical-stage miniprotein radioconjugate designed to selectively deliver actinium-225 (225Ac) to Nectin-4 expressing tumors.

Received Fast Track designation from the U.S. Food and Drug Administration (FDA) for AKY-1189 for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have progressed on or after prior systemic therapies.
Enrolling patients in the ongoing Phase 1b clinical trial of AKY-1189 in patients with locally advanced or mUC, breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer.
Expect to report preliminary data from the Phase 1b trial in the first quarter of 2027.

AKY-2519 highlights

AKY-2519 is a novel, clinical-stage miniprotein radioconjugate designed to selectively deliver 225Ac to B7-H3 expressing tumors, including prostate, lung, and other solid tumors.

Received FDA clearance for the Company’s Investigational New Drug (IND) applications to proceed to a Phase 1b clinical trial with AKY-25191.
Announced two-trial clinical development strategy for AKY-2519, which was informed by insights from the Company’s clinical advisory boards and reflects the distinct treatment patterns and clinical needs of patients with mCRPC compared to other solid tumor patients. This strategy is designed to enable the broad evaluation of AKY-2519 in multiple patient segments while efficiently generating indication-relevant data.
Initiated Phase 1b, multicenter, open label clinical trial of AKY-2519 in PLUVICTO-naïve and PLUVICTO-experienced patients with mCRPC.
Plan to initiate a Phase 1b basket trial in patients with lung, colorectal, and other B7-H3 expressing solid tumors in the second half of 2026. The protocol for this trial has been finalized and is currently under regulatory review.
Announced clinical imaging and dosimetry data for AKY-2519 has been accepted for presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held May 29 – June 2, 2026, in Chicago. The data facilitate initial understanding of AKY-2519 biodistribution and predicted absorbed doses in tumors and normal tissues in patients with B7-H3 expressing solid tumors.
1 IND applications were cleared for [64Cu]Cu-AKY-2519 for imaging and [225Ac]Ac-AKY-2519 for therapeutic use.

General corporate highlights

Appointed industry veteran Glenn Gormley, MD, PhD as an independent director to the Company’s Board of Directors (Board) and as co-chair of the Board’s newly established Science and Technology Committee.
In January 2026, completed an initial public offering of 20,297,500 shares of common stock, including the exercise in full by the underwriters of their option to purchase an additional 2,647,500 shares of common stock, at $18.00 per share, resulting in gross proceeds of approximately $365.4 million, before deducting underwriting discounts and commissions and other offering expenses.

Anticipated pipeline and corporate milestones for the next 12 months

AKY-1189: Expect preliminary data from the ongoing Phase 1b clinical trial in the first quarter of 2027.
AKY-2519:
Will present clinical imaging and dosimetry data of AKY-2519 in patients with mCRPC and various solid tumors at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting.
Expect to commence Phase 1b basket trial in lung, colorectal, and other solid tumor cancers in the second half of 2026.
Expect preliminary data from the Phase 1b mCRPC clinical trial in 2027.
Early pipeline: Two programs are tracking toward development candidate nomination and commencement of IND-enabling activities in the first quarter of 2027.
Corporate: In-house Good Manufacturing Practices (GMP) facility expected to be operational in the second half of 2026 as part of the Company’s hybrid manufacturing strategy to expand capabilities and support clinical supply demand.

First quarter 2026 financial results

Cash position: Cash, cash equivalents and marketable securities were $538.5 million as of March 31, 2026, compared to $226.8 million as of December 31, 2025. The increase of $311.7 million primarily reflects net proceeds from the Company’s initial public offering in January 2026, primarily offset by cash used in operations. The Company’s cash, cash equivalents and marketable securities as of March 31, 2026 are expected to fund its operations into 2029.
Collaboration revenue: Collaboration revenue was $3.2 million for the quarter ended March 31, 2026, compared to $1.4 million for the comparable prior year period. The increase of $1.8 million was attributable to continued advancement of the Company’s research collaboration with Eli Lilly and Company, with revenue recognized over time using the cost incurred input method.
R&D expenses: Research and development expenses were $20.0 million for the quarter ended March 31, 2026, compared to $15.9 million for the comparable prior year period. The increase of $4.1 million was primarily driven by Phase 1b clinical trial expenses for AKY-1189, which initiated in the second quarter of 2025, increased expenses with advancing AKY-2519 through IND-enabling studies, and increased employee-related costs (including stock-based compensation) associated with increased hiring to support the advancing clinical pipeline.
G&A expenses: General and administrative expenses were $5.9 million for the quarter ended March 31, 2026, compared to $3.7 million for the comparable prior year period. The increase of $2.2 million was primarily due to higher employee-related costs (including stock-based compensation) related to increased hiring to support the Company’s growth, and increased expenses associated with operating as a public company.
Net loss: Net loss was $18.3 million for the quarter ended March 31, 2026, compared to $15.0 million for the comparable prior year period. The increase in net loss of $3.3 million was primarily driven by increased operating expenses.

About Aktis’ miniprotein radioconjugate platform
Aktis has developed a proprietary, isotope-agnostic miniprotein radioconjugate platform to selectively deliver the tumor-killing properties of radioisotopes to targeted tumors. Aktis’ therapeutic miniprotein radioconjugates are designed to maximize anti-cancer activity through high tumor penetration coupled with internalization and retention in cancer cells, while rapidly clearing from normal organs and tissues. The Aktis platform further enables clinicians to visualize and verify target engagement with imaging isotopes prior to exposure to therapeutic radioisotopes. Leveraging this platform, and its patient-first end-to-end supply chain, Aktis is advancing a pipeline of next-generation targeted radiopharmaceuticals to address the unmet needs of patients across a broad spectrum of solid tumors.

(Press release, Aktis Oncology, MAY 11, 2026, View Source [SID1234665455])

On May 11, 2026 Biomea Fusion, Inc. ("Biomea" or "Biomea Fusion" or "the Company") (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, reported its financial results for the first quarter ended March 31, 2026, and provided a business update.

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"Across our portfolio, we continue to execute with focus and discipline, with all of our key clinical programs progressing on track toward important upcoming milestones, while maintaining a disciplined approach to managing our cash burn," said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. "The recent 52-week data from the Phase II COVALENT-112 clinical trial in type 1 diabetes further support targeting menin as a novel approach across both type 1 and type 2 diabetes, which offers a paradigm shift and differs materially from existing therapeutic approaches. We are building on these findings with plans to initiate an investigator-sponsored Phase II clinical trial in collaboration with leading academic institutions specializing in T1D. We believe this collaboration, alongside the continued advancement of our type 2 diabetes and obesity programs, positions Biomea to deliver meaningful data across multiple indications in 2026."

Recent Corporate Highlights:

Icovamenib
Potential First-in-Class Oral Small Molecule Product Candidate Targeting Menin for Diabetes

Chronic toxicology studies in two species were successfully completed for icovamenib, providing nonclinical support for chronic clinical dosing beyond the 12-week duration used to date; findings demonstrated a favorable safety profile consistent with previously reported preclinical and clinical data.
With more than 400 subjects dosed to date, icovamenib was generally well tolerated and demonstrated a favorable safety profile throughout the observation periods.
Two Phase II clinical trials evaluating icovamenib in T2D have been initiated and enrollment is ongoing:
COVALENT-211, a Phase II, randomized, double-blind, placebo-controlled trial in patients with insulin-deficient T2D not achieving glycemic targets despite standard of care therapy.
COVALENT-212, a Phase II, randomized, double-blind, placebo-controlled trial in patients with T2D not achieving glycemic targets while on a GLP-1 RA-based therapy.
Both trials include a 26-week primary endpoint, with topline data anticipated in the fourth quarter of 2026.
Topline data from the Phase II COVALENT-112 clinical trial evaluating icovamenib in T1D patients were reported from the 52-week follow-up:
A 52% increase from baseline in mean C-peptide AUC at Week 12, after completion of the dosing period, in patients diagnosed within 0-3 years (n=5) receiving icovamenib 200 mg, with a dose response observed vs 100 mg (n=6). Persistence observed through Week 52, with mean C-peptide AUC largely preserved in the 200 mg group (~7% decline from baseline).
Preservation of C-peptide also observed in patients diagnosed between 3-15 years (n=9).
Icovamenib was generally well tolerated across all dosing arms and demonstrated a favorable safety and tolerability profile through Week 52.
Comprehensive dataset to be presented at the American Diabetes Association’s (ADA) Scientific Sessions (abstract is preliminary until time of presentation; full release scheduled for June 5, 2026 at 6:30 pm CDT).
Planning a Phase II trial in recently diagnosed T1D patients (≤ 3 years since diagnosis), in collaboration with four U.S. academic centers, to evaluate extended dosing (6–12 months) of icovamenib 200 mg and assess potential combination with an immunosuppressive agent; trial initiation expected in the second half of the year at leading centers including the Barbara Davis Center for Diabetes, Joslin Diabetes Center, University of Texas Health Science Center at San Antonio Diabetes Division, and the University of Miami Diabetes Research Institute.

BMF-650
Next-generation Oral Small Molecule GLP-1 RA Product Candidate for Obesity

GLP-131, a Phase I randomized, double-blind, placebo-controlled clinical trial evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMF-650 in otherwise healthy overweight or obese participants is ongoing.
Initial 28-day clinical weight reduction data from the Phase I GLP-131 clinical trial is anticipated in the second quarter of 2026.

First Quarter 2026 Financial Results

Cash, Cash Equivalents, and Restricted Cash: As of March 31, 2026, the Company had cash, cash equivalents and restricted cash of $45.1 million.

Net Loss: The Company reported a net loss attributable to common stockholders of $12.4 million for the three months ended March 31, 2026, which included $1.6 million of stock-based compensation, compared to a net loss of $29.3 million for the same period in 2025, which included $3.2 million of stock-based compensation.
Research and Development ("R&D") Expenses: R&D expenses were $9.1 million for the three months ended March 31, 2026, compared to $22.9 million for the same period in 2025. The decrease of approximately $13.8 million was primarily driven by a decrease of $7.6 million in external costs primarily driven by a decrease of $3.8 million related to clinical activities, a decrease of $1.9 million related to preclinical and exploratory programs, and a decrease of $1.9 million in other external costs related to consultants, advisors and other professional services to support our clinical trials. Personnel-related expenses decreased by $4.5 million, including stock-based compensation, due to a decrease in headcount. Facilities and other allocated expenses decreased by $1.7 million due to a decrease in rent and facilities-related costs.

General and Administrative ("G&A") Expenses: G&A expenses were $3.7 million for the three months ended March 31, 2026 compared to $6.8 million for the same period in 2025. The decrease of $3.2 million was primarily driven by a decrease of $1.9 million related to personnel-related expenses, including stock-based compensation, due to a decrease in headcount and a decrease of $1.1 million of corporate-related expenses. Facilities and other allocated expenses decreased by $0.2 million.

(Press release, Biomea Fusion, MAY 11, 2026, View Source [SID1234665452])

On May 11, 2026 Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies for solid tumors designed to preserve organ function, reported financial results for the first quarter ended March 31, 2026, and provided recent business highlights.

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"We are entering a pivotal period for Aura as we advance our Phase 3 CoMpass trial toward enrollment completion and potential registration," said Natalie Holles, Chief Executive Officer of Aura Biosciences. "Bel-sar has the potential to become the first frontline, vision-preserving therapy for patients with early choroidal melanoma, and we are on track to deliver topline data from the CoMpass trial in the second half of 2027. Supported by our strengthened balance sheet, we are focused on executing against these priorities and translating this progress into long-term value for patients and shareholders."

Recent Pipeline Developments

Early Choroidal Melanoma

The ongoing Phase 3 CoMpass trial is the first registration-enabling study in early choroidal melanoma. This global, randomized Phase 3 trial is evaluating bel-sar versus a sham control. The trial is advancing toward enrollment completion, which is expected by mid-2026, with topline data for the 15-month primary endpoint anticipated in the second half of 2027.

Bel-sar has the potential to become the first frontline vision-preserving therapy in this setting. The Company previously received Orphan Drug Designation from the United States Food and Drug Administration (FDA) and the European Medicines Agency and Fast Track designation from the FDA for the treatment of early choroidal melanoma. The CoMpass trial is under a Special Protocol Assessment agreement with the FDA.

Metastases to the Choroid

The ongoing Phase 2 clinical trial of bel-sar in metastases to the choroid continues to enroll patients. The study is designed to include patients with choroidal metastases arising from a range of primary solid tumors and to evaluate early proof-of-concept based on a four-week efficacy endpoint. The Company remains on track to report early data from this trial in 2026.

Cancers of the Ocular Surface

The Company is initiating a Phase 1 proof-of-concept trial in Australia to assess safety, feasibility and tumor response through histopathologic evaluation at a 2–4-week time point. Development activities for this program are ongoing, with early proof-of-concept data expected in 2026.

Bladder Cancer

The ongoing Phase 1b/2 trial evaluating additional doses and cycles of bel-sar across intermediate- and high-risk non-muscle invasive bladder cancer (NMIBC) patients continues to advance, with initial 3-month clinical data expected mid-2026.

The trial is evaluating two approaches: immune ablative and neoadjuvant. In the immune ablative arm, bel-sar is given in two cycles without a transurethral resection of the bladder tumor (TURBT). In the neoadjuvant arm, bel-sar is given in two cycles before TURBT. Patients are monitored for response, recurrence (at 3, 6, 9, and 12 months), and safety.

Corporate Updates

As previously announced on May 4, 2026, the Company’s Board of Directors appointed Natalie Holles as Chief Executive Officer and President and member of the Board of Directors, effective April 30, 2026. Ms. Holles succeeds Elisabet de los Pinos, Ph.D., the Company’s founder, who stepped down from her roles as Chief Executive Officer and President and a member of the Board of Directors, effective on the same date.

First Quarter 2026 Financial Results

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As of March 31, 2026, the Company had cash and cash equivalents and marketable securities totaling $114.7 million. On May 5, 2026, the Company completed an underwritten public offering of common stock and pre-funded warrants, which included the underwriters’ full exercise of their option to purchase additional shares of common stock. After deducting the underwriting discounts and commissions and estimated offering expenses, the Company received approximately $280.8 million in net proceeds from the offering, of which it subsequently used approximately $39.0 million to repurchase all the shares of its common stock held by Matrix Capital Management Master Fund, LP in the previously announced stock repurchase. The Company believes its current cash and cash equivalents and marketable securities, together with the net proceeds of the offering to the Company, are sufficient to fund its operations into the second half of 2028.

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Research and development expenses increased to $28.0 million for the three months ended March 31, 2026 from $23.3 million for the three months ended March 31, 2025, primarily due to ongoing clinical and clinical research organization (CRO) costs associated with the progression of our global Phase 3 trial of bel-sar in early choroidal melanoma and manufacturing and development costs for bel-sar.

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General and administrative expenses increased to $6.9 million for the three months ended March 31, 2026 from $5.7 million for the three months ended March 31, 2025. General and administrative expenses include $1.6 million of stock-based compensation for each of the three months ended March 31, 2026 and 2025. The increase in general and administrative expenses was primarily driven by higher personnel expenses related to growth of the Company and increased professional fees.

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Net loss for the three months ended March 31, 2026, was $33.7 million, compared to $27.5 million for the three months ended March 31, 2025.

(Press release, Aura Biosciences, MAY 11, 2026, View Source [SID1234665451])