On May 6, 2026 BeOne Medicines, a global oncology company, reported financial results and corporate updates from the first quarter of 2026.

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John V. Oyler, Co-Founder, Chairman, and CEO, BeOne, said:

"These strong first-quarter results reinforce BeOne’s continued growth as a global oncology leader, driven by disciplined commercial execution, and underpinned by our established hematology leadership, and an impressive, rapidly emerging solid tumor pipeline. The sustained competitive advantages of our global superhighway for clinical development and manufacturing are now clear. BRUKINSA has firmly established itself as the foundational, best-in-class BTK inhibitor with unmatched long-term efficacy and safety data for the treatment of CLL and as the only BTKi with proven efficacy superiority over ibrutinib which has resulted in clear global revenue leadership. The fixed-duration combination of sonrotoclax, a foundational, next-generation BCL2 inhibitor, and BRUKINSA represents a potential new standard-of-care in first-line CLL, with BTK CDAC BGB-16673 emerging as a potential first-in-class therapy in the relapsed or refractory setting. With more than 20 abstracts across our hematology and solid tumor pipeline accepted for presentation at ASCO (Free ASCO Whitepaper), BeOne has solidified its position as a leading oncology company."

(Press release, BeiGene, MAY 6, 2026, View Source [SID1234669166])

On May 06, 2026 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported financial results for the first quarter ended March 31, 2026, and provided an overview of recent developments.

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"2026 is off to a strong start, with expanding usage of ZUSDURI (mitomycin) for intravesical solution and clear acceleration across key commercial indicators, including prescriber trial and adoption," said Liz Barrett, President and Chief Executive Officer of UroGen. "These trends reflect growing clinical confidence in ZUSDURI as a primary, non-surgical therapy for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The early launch momentum is now translating into meaningful revenue growth, providing early validation of our commercial model and reinforcing the blockbuster potential for ZUSDURI. In parallel, we continue to advance our broader pipeline, including next generation products UGN-103 in LG-IR-NMIBC and UGN-104 in low-grade upper tract urothelial carcinoma (LG-UTUC), as well as UGN-501, our investigational, potentially best-in-class, next-generation oncolytic virus. With this momentum, we are well positioned to execute our long-term growth strategy and continue to expand our leadership position in uro-oncology."

(Press release, UroGen Pharma, MAY 6, 2026, View Source [SID1234669308])

On May 6, 2026 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, reported financial results and business highlights for the first quarter ended March 31, 2026.

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First Quarter Updates and Recent Business Highlights

Ronde-cel: A next-generation dual-targeting CD19/CD20 CAR T-cell product candidate designed to increase complete response rates and prolong the duration of response as compared to approved CD19‑targeted CAR T-cell therapies for the treatment of large B-cell lymphoma (LBCL)

Ronde-cel is an autologous CAR T-cell product candidate with a true ‘OR’ logic gate to target B cells that express either CD19 or CD20 with full potency and is manufactured with a process that enriches for CD62L-positive cells to generate more naïve and central memory CAR T cells with enhanced stemlike features and antitumor activity. The U.S. Food and Drug Administration (FDA) has granted ronde-cel Regenerative Medicine Advanced Therapy (RMAT) designation in the third- and later-line (3L+) and second-line (2L) settings, as well as Fast Track designation for the treatment of adults with relapsed/refractory large B-cell lymphoma (R/R LBCL). Two pivotal trials for ronde-cel in LBCL are underway.

The ongoing PiNACLE pivotal single-arm trial, a seamless expansion of the 3L+ cohort in the Phase 1/2 multi‑cohort trial, is ongoing. Additional data from this trial are expected in the second half of 2026, and pivotal data are expected in mid-2027 with submission of a Biologics License Application (BLA) to the FDA expected to follow in 2027. The primary endpoint of the trial is the overall response rate, including an evaluation of duration of response.
In February 2026, patient dosing commenced in PiNACLE-H2H, the first-of-its-kind Phase 3 randomized controlled trial evaluating ronde-cel versus investigator’s choice of axicabtagene ciloleucel or lisocabtagene maraleucel in patients with R/R LBCL in the 2L setting. The trial’s primary endpoint is event-free survival.

LYL273: A next-generation guanylyl cyclase C (GCC)-targeted CAR T-cell product candidate for the treatment of metastatic colorectal cancer (mCRC) and other GCC-expressing cancers

LYL273 is a GCC-targeted CAR T-cell product candidate enhanced with CD19 CAR expression and controlled cytokine release, designed to improve CAR T-cell expansion, immune cell infiltration and cancer cell killing in the hostile solid tumor microenvironment. In November 2025, Lyell acquired global rights (excluding mainland China, Hong Kong, Macau and Taiwan) to LYL273, which has shown promising dose-dependent clinical activity in patients with advanced mCRC in a Phase 1 trial conducted in the U.S. following proof of concept in 15 patients in China. The FDA granted LYL273 Fast Track designation for the treatment of mCRC.

The U.S. Phase 1 clinical trial is continuing to enroll patients to determine the recommended Phase 2 dose. In March 2026, dosing commenced at Dose Level 3 (3 x 106 CAR T cells/kg). A data update focused on safety from this trial is expected in the first half of 2026, with a second data update including clinical outcomes expected in the second half of 2026.

Additional Business Highlights

In March 2026, Lyell closed the second $50 million tranche of its July 2025 equity private placement, following the successful achievement of a clinical milestone in PiNACLE. In the second tranche of the financing, which completed the total $100 million private placement, shares of common stock were sold at a purchase price of $25.61 per share.
In March 2026, Smital Shah was appointed Chief Financial and Business Officer.

First Quarter 2026 Financial Results

Lyell reported a net loss of $24.2 million for the first quarter ended March 31, 2026, compared to a net loss of $52.2 million for the same period in 2025. The $28.0 million decrease in net loss was primarily due to a $17.6 million gain on our Securities Purchase Agreement put/call asset relating to our July 2025 equity private placement. Non‑GAAP net loss, which excludes non-cash stock-based compensation, non-cash expenses related to the change in the estimated fair value of the Securities Purchase Agreement put/call asset and success payment liabilities, decreased by $8.5 million to $37.8 million for the first quarter ended March 31, 2026, compared to $46.3 million for the same period in 2025 primarily due to the decreased headcount from the successful technology transfer of ronde-cel to the Company’s LyFE Manufacturing CenterTM (LyFE) in 2025.

GAAP and Non-GAAP Operating Expenses

Research and development (R&D) expenses were $36.6 million for the first quarter ended March 31, 2026, compared to $43.4 million for the same period in 2025. The $6.8 million decrease was primarily due to a $7.5 million reduction in personnel expenses, partially offset by a $3.4 million increase in clinical trials activity and outside services. Non‑GAAP R&D expenses, which exclude non-cash stock-based compensation, for the first quarter ended March 31, 2026 were $34.4 million compared to $41.1 million for the same period in 2025.
General and administrative (G&A) expenses were $9.6 million for the first quarter ended March 31, 2026 compared to $14.0 million for the same period in 2025. The $4.5 million decrease was primarily due to a $4.0 million reduction in personnel‑related expenses, including a $1.5 million decrease in stock-based compensation expense. Non‑GAAP G&A expenses, which exclude non-cash stock‑based compensation, for the first quarter ended March 31, 2026 were $7.5 million compared to $10.4 million for the same period in 2025.

A discussion of non-GAAP financial measures, including reconciliations of the most comparable U.S. generally accepted accounting principles (GAAP) measures to non‑GAAP financial measures, is presented below under "Non-GAAP Financial Measures."

Cash, cash equivalents and marketable securities

Cash, cash equivalents and marketable securities as of March 31, 2026 were $261.0 million compared to $247.2 million as of December 31, 2025. Lyell believes that its current cash, cash equivalents and marketable securities balances will be sufficient to meet working capital and capital expenditure needs into the third quarter of 2027.

(Press release, Lyell Immunopharma, MAY 6, 2026, View Source [SID1234665191])

On May 6, 2026 Nona Biosciences ("Nona" or the "Company"), a global biotechnology company advancing biotherapeutic discovery through innovative technology platforms, reported the appointment of Dr. Josh Xiao as Chief Scientific Officer (CSO). Dr. Xiao will be based in both US and China and report directly to Dr. Di Hong, Chief Executive Officer of Nona Biosciences.

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In this role, Dr. Xiao will lead the development of Nona’s global scientific strategy and oversee the continued evolution of its technology platforms, especially Hu-mAtrIx, the AI-driven drug discovery platform, with the goal of strengthening the company’s long-term competitive advantage through integrated technological capabilities and ecosystem collaboration. He will also guide the direction of scientific innovation and support the advancement of novel therapeutic approaches across multiple disease areas. In addition, Dr. Xiao will provide leadership to Nona’s global Project Leaders (PLs), establishing a structured and scalable capability development framework to enhance project execution, deepen scientific insight into partner needs, and enable efficient integration of platform resources.

Dr. Xiao brings more than 25 years of experience in drug discovery and leadership across both large biopharmaceutical companies and emerging biotechnology start-ups. He earned his Ph.D. in Biochemistry from Louisiana State University and did his postdoctoral training at Columbia University. Most recently, Dr. Xiao served as an entrepreneur in residence at RA Ventures, the healthcare incubator of RA Capital and co-founder of Starfish Medicines. Prior to that, he held scientific team leadership roles at Amgen, Tularik (acquired by Amgen), and Millennium Pharmaceuticals (acquired by Takeda), and led drug discovery function at several start-ups. His expertise spans target discovery and validation, antibody discovery and engineering, translational medicines, and IND filing.

Dr. Di Hong, Chief Executive Officer of Nona Biosciences, commented, "We are very pleased to welcome Josh to Nona at a pivotal stage in our growth. His extensive experience in drug discovery and translational medicines, as well as his strong track record in building high-performing scientific teams will be instrumental as we continue to enhance our platform capabilities and global scientific leadership. We believe he will further strengthen our ability to deliver high-quality innovation and create long-term value for our partners."

"Nona Biosciences has been a leader in discovery and development of fully human antibodies and multi-specifics with its proprietary H2L2 Harbour Mice platform, HCAb Harbour Mice platform, and Hu-mAtrIx AI-driven drug discovery platform, enabling several new ‘antibody+’ therapeutics modalities," said Dr. Josh Xiao, Chief Scientific Officer of Nona Biosciences. "I am thrilled to join the Nona Biosciences team, and very excited to help strengthen and expand our technology platforms to help our partners succeed."

(Press release, Nona Biosciences, MAY 6, 2026, View Source [SID1234665210])

On May 6, 2026 Kanvas Biosciences, a full-stack spatial biology company, reported it has raised a $48 million Series A funding round co-led by existing investors DCVC and Lions Capital LLC. Additional participating investors include Gates Foundation, ATHOS KG, Germin8, Ki Tua Fund, Pangaea Ventures and more. The fresh capital follows a July 2024 round and brings Kanvas’ total funding to $78 million. The funding will be used to conduct clinical trials for the lead drug candidate in the company’s immuno-oncology program, KAN-001, and advance commercial partnerships that leverage Kanvas’ spatial imaging and manufacturing platform for next generation live biotherapeutic product (LBP) development.

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A microbiome is a collection of microorganisms and their genes that live in the gut, lungs, on skin and in other tissue. Malfunctioning microbiomes can lead to inflammatory bowel disease, celiac disease, cardiovascular problems and even impact how cancer patients respond to immunotherapy. Kanvas has developed the unique ability to spatially map microbial cells and host cells, which allows the company to manufacture LBPs made of complex consortia containing hundreds of members that can restore microbiome health, and clearly visualize LBP engraftment and activity – two longstanding roadblocks in the quest to develop effective therapeutics for restoring the microbiome.

Clinical Applications and Development Pathway
KAN-001 is a LBP designed for cancer patients who don’t respond to immune checkpoint inhibitors (ICIs). While over 50% of solid organ cancer patients receive ICIs, only 10% achieve complete responses. Fecal microbiota transplants (FMT) from ICI responders can convert non-responders into responders, but they pose manufacturing challenges, pathogen risks and scalability issues. KAN-001 addresses these limitations, and has demonstrated safety and efficacy across multiple mouse models and tumor types. Importantly, the clinical pathway has been substantially de-risked: In a recent FMT trial for anti-PD-1 refractory microsatellite instability high cancers, fecal material from the same donor from which the specific KAN-001 strains were isolated was delivered to study participants via FMT. Results showed high engraftment rates, restored anti-PD-1 response and no ICI-induced colitis. Kanvas will now launch its own clinical trials and operationalize its newly opened GMP manufacturing suite.

"I began my career as a physician and always dreamed of being able to develop new drugs that could help the patients I hadn’t been able to treat with existing therapies," said Matthew Cheng, co-founder and CEO of Kanvas Biosciences. "Most physicians never get the opportunity to realize this dream, so it’s an incredible privilege to bring Kanvas’ technology to the broader LBP market and begin conducting clinical trials of our lead drug candidate, which offers a new way to improve the therapeutic efficacy and safety of immunotherapy for cancer patients."

Recent Company Momentum
Since announcing its Seed round in 2024, Kanvas has made significant progress. Recent milestones include:

Investment from Gates Foundation: With new funding from Gates Foundation and other investors, Kanvas is developing the world’s first fully synthetic microbiome replacement product designed to treat and prevent maternal environmental enteric dysfunction, a major contributor to maternal undernutrition, low infant birthweight and heightened neonatal health risk.
Clinical Trial: Preparations for patient recruitment are underway for a Phase 1 clinical trial of KAN-004, Kanvas’ immuno-oncology drug candidate that targets ICI-induced colitis and may allow cancer patients to stay on ICI therapy longer with improved response rates.
Board Additions: Stephen Quake, the Lee Otterson Professor of Bioengineering and Professor of Applied Physics at Stanford University and former Chief Science Advisor for the Chan Zuckerberg Initiative, joined Kanvas’ Board.
New Research: Kanvas recently unveiled new research that demonstrates how the company’s spatial imaging platform outperforms gold standard methods such as metagenomics sequencing, especially in low biomass settings.
Novel Lightsheet Microscope: The company has developed the Kanvas Spectral Lightsheet, a high-resolution, multispectral lightsheet microscope that generates vastly more spatial biology data to train Kanvas’ AI platform and build the world’s first microbiome atlas.
"Creating a brand new microscope capable of collecting spatial biology data at unprecedented scale and quality is a testament to Kanvas’ deep engineering prowess and relentless commitment to unlocking the gut microbiome as a distinct organ that can be safely modified using microbial-based drugs," said Jason Pontin, General Partner at DCVC and chair of Kanvas’ board. "Kanvas’ ability to generate novel data about host-microbiome interactions is fueling powerful AI models that are helping the company design new cancer treatments, nutritional supplements and even gastrointestinal restoration products for animals."

Additional investors in Kanvas’ Series A include Alumni Ventures, Boutique Venture Partners, Cornell University, FemHealth Ventures, Gaingels, Mana Ventures, Red Bear Ventures, RIT Venture Fund, Triple Impact Capital, Kicker Ventures and Uncommon Denominator. For more information on Kanvas or to inquire about clinical trial site opportunities and/or LBP development partnerships, visit View Source

(Press release, Kanvas Bioscience, MAY 6, 2026, View Source [SID1234665226])