Aura Biosciences Reports First Quarter 2026 Financial Results and Business Highlights

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


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.


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.


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.


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])

Daiichi Sankyo Unveils New Five-Year Business Plan Focused on Oncology Leadership and Innovation

On May 11, 2026 Daiichi Sankyo (TSE: 4568) reported its next Five-Year Business Plan (FY2026 – FY2030) that outlines how the company plans to deliver more than 2.3 trillion yen in oncology revenue by 2030 and be a global top five oncology company by 2035 as part of its larger 2035 Vision to be recognized as a "trusted healthcare innovator transforming the lives of people through science and technology."

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The new Five-Year Business Plan reinforces the enduring purpose of Daiichi Sankyo to contribute to the enrichment of quality of life around the world, and central to this growth strategy is an intensified focus on its mission to create new medicines for patients by leveraging the company’s expertise in science and technology.

"Our new five-year business plan represents a defining and transformative phase for Daiichi Sankyo," said Hiroyuki Okuzawa, President and CEO of Daiichi Sankyo. "By leveraging our strengths in science and technology, particularly maximizing the value of our established DXd antibody drug conjugate platform and prioritizing our efforts to identify new breakthrough generating technologies, Daiichi Sankyo is committed to delivering innovative medicines to patients faster while driving sustainable growth and long-term value for all stakeholders."

Advancing Towards Global Top Five Oncology Company with Strong Financial Targets
A core ambition of the Five-Year Business Plan is to establish Daiichi Sankyo as a global top five oncology company by 2035 as measured by more than three trillion yen in FY2030 revenue, an increase from 2.1 trillion yen in FY2025 revenue, demonstrating aggressive growth. Operating profit of more than 600 billion yen is expected to be achieved by end of fiscal year 2030. Target earnings per share (EPS) is estimated to be more than 260 yen in FY2030 with an adjusted dividend on equity (DOE) of 10.0% or higher each year and progressive dividends. Operating profit is expected to reach one trillion yen in the early 2030s.

To achieve these financial targets, Daiichi Sankyo will maximize the value of its DXd antibody drug conjugate (ADC) portfolio and additional oncology pipeline through rapid market penetration of more than 20 new indications across five medicines by 2030, reaching more than 700,000 new patients annually by 2035.

During FY2026, there are five practice-changing launches planned across the DXd ADC portfolio in various countries/regions globally, including four new breast cancer indications for Enhertu and Datroway and the company’s first-ever launch in small cell lung cancer with ifinatamab deruxtecan (I-DXd).

"Enhertu has changed the classification and treatment of breast cancer, becoming the most successful antibody drug conjugate ever by revenue. Datroway, our second DXd antibody drug conjugate, is on its way to changing the treatment paradigm for triple negative breast cancer," said Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc. "By leveraging this extensive expertise, we plan to expand our leadership into lung cancer where there are more than 10 new indication launches planned for this tumor type across our portfolio over the next five years."

Accelerating Innovation Through Science and Technology
The DXd ADC platform has achieved strong clinical development with high early-phase success rates, and Daiichi Sankyo is advancing research behind new ADCs with novel cytotoxic and immunological payloads to build upon this industry-leading scientific expertise.

Daiichi Sankyo is further strengthening its R&D engine through a breakthrough generating technology (BGT) approach, a platform-based drug discovery model, designed to deliver innovative medicines to patients faster and with a higher probability of success. By 2030, Daiichi Sankyo aims to identify additional BGTs, which may consist of multi-specific antibodies, targeted protein degradation and siRNA.

"Enhertu was one of the fastest developed biologics in oncology," said John Tsai, MD, Global Head, R&D, Daiichi Sankyo. "We aim to further accelerate the speed of development of our pipeline assets through increasing the efficiency of clinical development processes, including leveraging the latest digital and artificial intelligence tools as well as enhancing our biomarker capabilities for better patient selection strategies."

Driving Operational Excellence
A Business Transformation Function was established to drive company-wide operational excellence by enhancing productivity through AI and digital technologies and optimizing procurement processes, with the goal of achieving cost optimization and profit improvement of more than 200 billion yen by 2030. The company will centralize global commercialization activities to drive greater speed and consistency worldwide, while optimizing resources and investment decisions in line with global strategic priorities.

Contributing to Sustainable Society
Daiichi Sankyo reaffirms its commitment to being a trusted partner for a sustainable society, guided by meaningful engagement with diverse stakeholders, including patients, employees, the medical community and investors. The company will continue to attract specialized talent and foster a high-engagement culture that connects employees with patient voices, ensuring patients remain at the center of every decision. Trusted relationships with healthcare professionals will be strengthened by the creation of new standards of care through evidence generation while upholding the highest compliance standards.

On the environmental front, Daiichi Sankyo is targeting a 63% reduction in Scope 1 and 2 CO2 emissions versus 2015 levels, 100% renewable energy adoption and supplier alignment with 1.5-degree climate goals by 2030.

(Press release, Daiichi Sankyo, MAY 11, 2026, https://www.businesswire.com/news/home/20260510205619/en/Daiichi-Sankyo-Unveils-New-Five-Year-Business-Plan-Focused-on-Oncology-Leadership-and-Innovation [SID1234665468])

Cellectis Reports Financial Results for the First Quarter 2026

On May 11, 2026 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene editing platform to develop life-saving cell and gene therapies, reported financial results for the first quarter 2026, ending March 31, 2026 and provided a business update.

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"The interim pivotal data published by Allogene on cema-cel, a product originally developed by Cellectis as UCART19, are a proud validation of our vision: that allogeneic, off-the-shelf cell therapy candidates could deliver transformative outcomes for cancer patients. We believe this approach has the potential to dramatically expand access to CAR-T beyond what autologous therapies can reach today" said André Choulika, Ph.D., Co-Founder and Chief Executive Officer of Cellectis. "As we look ahead to Q4 2026, with the expected interim pivotal Phase 2 data for lasme-cel in relapsed or refractory B-ALL, and the full Phase 1 dataset for eti-cel in relapsed or refractory NHL, Cellectis is approaching its own defining moment. We are excited about what lies ahead."

Allogeneic CAR-T Pipeline

Lasme-cel in relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) – BALLI-01

The Pivotal Phase 2 BALLI-01 trial is ongoing.

Phase 1 data highlights :

100% ORR in the target Phase 2 population
83% overall response rate (ORR) at recommended Phase 2 dose (RP2D)
In target Phase 2 population: all patients became eligible to transplant
Favorable safety profile: low rates of ≥ grade 3 cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) at 2.5% and 5% respectively
14.8 months median overall survival (OS) in patients who achieved minimal residual disease (MRD)-negative complete remission with incomplete hematology recovery (CR/CRi)
The first interim analysis for the pivotal Phase 2 of the BALLI-01 trial is expected in Q4 2026 (n=40). Cellectis anticipates submitting a Biologics License Application (BLA) in 2028.

Eti-cel in relapsed or refractory non-Hodgkin lymphoma (r/r NHL) – NATHALI-01

The Phase 1 NATHALI-01 trial is ongoing.

Preliminary Phase 1 data highlights:

At current dose level: 88% ORR, 63% complete response (CR) rate after 2+ prior lines of therapy
93% of subjects had prior CD19 CAR-T
Cellectis expects to present the full Phase 1 dataset in Q4 2026, including results from the low dose interleukin-2 (IL-2) combination cohorts.

TALE-based epigenetic editing platform to turn genes off without altering DNA

On April 27, 2026, Cellectis announced new research on a TALE-based epigenetic editing approach, that does not cut or permanently modify the DNA sequence, making it a potentially safer alternative for genome editing, at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) annual meeting, that is taking place on May 11-15, 2026.
Key data highlights:

Cellectis developed TALEM (Transcription Activator-Like Effector-based epigenetic Modulators), engineered fusion proteins that precisely target genomic loci to switch genes on or off through epigenetic editing, without cutting or permanently modifying the DNA sequence. Using a high-throughput screening system capable of rapidly assembling and testing hundreds of TALEM candidates, Cellectis demonstrated >90% stable gene silencing across two distinct targets: a gene highly expressed in liver cells and a gene implicated in T-cell exhaustion, a key challenge in cancer immunotherapy.
The abstract is live on the ASGCT (Free ASGCT Whitepaper) website. The poster will be available on Cellectis’ website on May 13, 2026 at 5 pm ET.

Partnerships

AstraZeneca – Joint Research and Collaboration Agreement

Activities are continuing under the Joint Research and Collaboration Agreement with AstraZeneca, which leverages Cellectis’ gene editing expertise and manufacturing capabilities to develop up to 10 novel cell and gene therapy products for areas of high unmet medical need, including oncology, immunology and rare genetic disorders.
Servier (through its sublicensee Allogene) – Anti-CD19 CAR-T

Cema-cel is a product candidate licensed to Servier under the License, Development and Commercialization Agreement signed by and between les Laboratoires Servier and Institut de Recherches Internationales Servier ("Servier") and Cellectis (the "Servier Agreement") and sublicensed by Servier to Allogene in certain territories.

On April 13, 2026, Cellectis highlighted the interim pivotal data announced by Allogene, from Allogene’s sponsored ALPHA3 trial evaluating cema-cel in first-line consolidation for large B-cell lymphoma (LBCL). Cema-cel is derived from the UCART19 product initially developed by Cellectis.
Key data highlights reported by Allogene:

The futility analysis (n=24) showed that 58.3% of patients in the cema-cel arm achieved MRD negativity versus 16.7% in the observation arm, a 41.6% absolute difference. Allogene reported that based on specific benchmark literature, a difference of 25-30% in the MRD clearance could translate into meaningful clinical benefit at study completion.
The cema-cel treatment was generally well-tolerated, with most patients (10/12) managed on an outpatient basis post-infusion and no cases of CRS, ICANS, graft-versus-host disease (GvHD), treatment-related Serious Adverse Events and no hospitalizations for treatment-related Adverse Events.
Allogene announced that study accrual is anticipated to be complete by the end of 2027 and that it anticipates an interim Event-Free Survival (EFS) analysis in mid-2027 and the primary EFS analysis in mid-2028. If positive, Allogene announced that these results could support a BLA submission.
Under the Servier Agreement, Cellectis is eligible to up to $340 million in development and sales milestones as well as low double-digit royalties on sales of licensed CD19 products, including cema-cel developed in LBCL.

Iovance

In May 2026, Iovance announced that a Phase 1/2 trial, IOV-GM1-201, is enrolling using IOV-4001, a PD-1 inactivated TIL therapy, in previously treated advanced melanoma and non-small cell lung cancer (NSCLC).
Subsequent events

On April 20, 2026, Life Technologies Corporation ("LTC"), a subsidiary of Thermo Fisher, purported to terminate license agreements between LTC and Cellectis in 2014, which grant Cellectis non-exclusive rights under certain patents, the Halle Patent Therapeutic License, the Halle Patent Research License, and the GeneArt and Seamless Cloning Patent Therapeutic License (the « LTC Agreements »). This purported termination follows TFS’s allegations that we failed to comply with our obligations under the LTC Agreements, as previously disclosed. Simultaneously therewith, LTC commenced an arbitration before the American Arbitration Association, naming Cellectis S.A. and Cellectis Bioresearch, Inc. as Respondents. LTC’s arbitration demand alleges that Cellectis has breached the LTC License Agreements by underpaying sublicense royalties and otherwise failing to comply with our obligations under the LTC Agreements. According to us, this termination is invalid and LTC’s claims under this arbitration demand are without merit.
Financial Results

Cash: As of March 31, 2026, Cellectis had $188 million in consolidated cash, cash equivalents, restricted cash and fixed-term deposits classified as current financial assets. The Company believes its cash, cash equivalents and fixed-term deposits will be sufficient to fund its operations into Q4 2027.

This compares to $211 million in consolidated cash, cash equivalents, restricted cash and fixed-term deposits classified as current financial assets as of December 31, 2025. The $23 decrease was mainly driven by cash inflows of $13.0 million from revenue and $2.9 million of interest received from our financial and cash-equivalent investments, offset by payments to suppliers of $14.5 million, payroll-related payments (wages, bonuses and social charges) totaling $18.6 million, lease liability payments of $3.4 million, repayment of $1.4 million under the "PGE" loan, and capital expenditures of $0.3 million.

We currently foresee focusing our cash spending at Cellectis in supporting the development of our pipeline of product candidates, including the manufacturing and clinical trial expenses of lasme-cel, eti-cel and potential new product candidates, and operating our state-of-the-art manufacturing capabilities in Paris (France) and Raleigh (North Carolina).

Revenues and Other Income: Consolidated revenues and other income were $7.5 million for the three-month period ended March 31, 2026, compared to $12.0 million for the same period in 2025. This $4.5 million decrease between the three-month periods ended March 31, 2025 and 2026 was mainly attributable to a $4.9 million decrease in revenues driven by the evolution of activities performed under the AZ JRCA.

R&D Expenses: Consolidated R&D expenses were $27.2 million for the three-month period ended March 31, 2026, compared to $21.9 million for the same period in 2025, representing an increase of $5.3 million, mainly due to a $3.6 million increase in personnel expenses and a $2.0 million increase in purchases and external expenses.

SG&A Expenses: Consolidated SG&A expenses were $5.6 million for the three-month period ended March 31, 2026, compared to $4.7 million for the same period in 2025. The $0.9 million increase was mainly due to a $0.4 million increase in stock-based compensation expenses and related social charges as well as a $0.4 million increase in purchases and other expenses.

Net financial gain (loss): We had a consolidated net financial gain of $7.4 million for the three-month period ended March 31, 2026, compared to a $3.9 million net financial loss for the three-month period ended March 31, 2025. This $11.4 million increase in net financial result reflects a $5.6 million increase in financial income and a $5.8 million decrease in financial expenses. The rise in financial income was mainly attributable to (i) a $4.5 million increase in non-cash gains on fair value measurements primarily explained by a $6.5 million gain on the fair value measurement of the Tranches A, B and C of EIB warrants in the three months ended March 31, 2026 compared to a $1.8 million gain in the three months ended March 31, 2025, (ii) a $2.0 million increase in foreign exchange gains, partially offset by (iii) a $1.1 million decrease in income from cash, cash equivalents and financial assets. The decrease in financial expenses was mainly due to a (i) $6.5 million decrease in foreign exchange loss, partially offset by (ii) a $0.2 million increase in interests on financial liabilities.

Net Income (loss) Attributable to Shareholders of Cellectis: Consolidated net loss attributable to shareholders of Cellectis was $17.8 million (or a $0.18 loss per share) for the three-month period ended March 31, 2026, compared to a $18.1 million net loss (or a $0.18 loss per share) for the three-month period ended March 31, 2025. The $0.4 million decrease in net loss was primarily driven by (i) a $11.4 million improvement in net financial result, from a net financial loss of $3.9 million as of March 31, 2025 to a net financial gain of $7.4 million as of March 31, 2026, partly offset by (ii) a $11.0 million increase in operating loss.

Adjusted Net Income (Loss) Attributable to Shareholders of Cellectis: Consolidated adjusted net loss attributable to shareholders of Cellectis was $16.1 million (or a $0.16 loss per share) for the three-month period ended March 31, 2026, compared to a net loss of $17.2 million (or a $0.17 loss per share) for the three-month period ended March 31, 2025.

The interim condensed consolidated financial statements of Cellectis have been prepared in accordance with IAS 34 Interim Financial Reporting, and should be read in conjunction with the Group’s last annual consolidated financial statements as at and for the year ended December 31, 2025.

(Press release, Cellectis, MAY 11, 2026, View Source [SID1234665429])

Biomea Fusion Reports First Quarter 2026 Financial Results and Corporate Highlights

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])

CG Oncology’s Presence at American Urological Association (AUA) Annual Meeting Underscores its Strong Commitment to NMIBC

On May 11, 2026 CG Oncology, Inc. (NASDAQ: CGON) reported its participation in the American Urological Association (AUA) 2026 Annual Meeting, taking place May 15–18, 2026, in Washington, D.C. CG Oncology will present first results from CORE-008 Cohort CX Phase 2 Trial evaluating intravesical combination therapy in High-Risk BCG-Exposed and BCG-Unresponsive patients and will be exhibiting at booth #3051. The AUA Annual Meeting is the largest global gathering of urologists and urologic professionals, showcasing the latest advances in urologic medicine, clinical research and patient care.

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First Results from CORE-008 Cohort CX
Title: Phase 2 Study of Intravesical Cretostimogene Grenadenorepvec with Gemcitabine in Patients with High-Risk BCG-Exposed or BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

Poster Presentation May 15, 2026, 3:30 – 5:30 PM ET
Podium Presentation at the SUO 2026 Annual Meeting at the AUA May 16, 2026, 4:25–4:30 PM ET
Additionally, the grant recipients of the annual CG-SUO-CTC NMIBC Research Fellowship will present their research at the SUO 2026 Annual Meeting at the AUA. This Fellowship is designed to support the development of outstanding clinical cancer research investigators who have demonstrated a commitment to improving the understanding and treatment of Non-Muscle Invasive Bladder Cancer (NMIBC). Details of the presentations are below:

Grant Recipient Taylor A. Goodstein, MD Presents: Spatial Transcriptomic Profiling of the Tumor Microenvironment in BCG-Unresponsive NMIBC Patients Treated with Novel Intravesical Gene Therapies
May 16, 4:45 PM-4:50 PM ET
Grant Recipient Saum B. Ghodoussipour, MD Presents : Dynamic intra-tumor heterogeneity in non-muscle invasive bladder cancer
May 16, 4:50 PM-4:55 PM ET
Attendees of AUA 2026 are encouraged to visit CG Oncology at booth #3051 to learn more about the company’s clinical development program and its commitment to advancing innovative therapies for patients with bladder cancer.

(Press release, CG Oncology, MAY 11, 2026, View Source [SID1234665469])