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CytoDyn and QLHC Advance Leronlimab into Two New PRE-I-SPY Studies in Metastatic Triple-Negative Breast Cancer

On November 10, 2026 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including colorectal cancer (CRC) and metastatic triple-negative breast cancer (mTNBC), reported that leronlimab will be evaluated in two new mTNBC regimens within the Quantum Leap Healthcare Collaborative’s (QLHC) PRE-I-SPY Phase 1-1b platform study, with enrollment expected to begin shortly.

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The two studies will evaluate leronlimab in distinct immunotherapy-based combinations, each incorporating a PD-1 inhibitor. PRE5 will evaluate leronlimab alongside Merck’s pembrolizumab and the antibody-drug conjugate sacituzumab, while PRE7 will evaluate leronlimab in combination with Akeso’s penpulimab and the standard chemotherapy agents gemcitabine and carboplatin. Both studies are designed to assess safety and tolerability in earlier-line metastatic treatment settings while exploring preliminary signals of clinical activity.

"These studies represent an important opportunity to further investigate the potential of CCR5 inhibition as part of combination treatment strategies for patients with metastatic triple-negative breast cancer," said Jacob Lalezari, M.D., Head of Research and Translational Sciences at CytoDyn. "By evaluating leronlimab alongside different immunotherapy-based regimens and incorporating exploratory biomarker analyses, we hope to gain a better understanding of its potential role in modulating the tumor microenvironment and informing future treatment approaches for patients with this aggressive disease."

mTNBC is an aggressive form of breast cancer characterized by the absence of estrogen receptor, progesterone receptor, and HER2 expression, limiting the applicability of several targeted treatment approaches used in other breast cancer subtypes. The two Phase 1 studies will evaluate leronlimab in combination with established treatment regimens and will incorporate exploratory biomarker assessments, including circulating tumor DNA (ctDNA) and PD-L1 expression, to generate early insights that may help inform subsequent clinical development.

"There remains a need to better understand how novel combination strategies can improve treatment for patients with metastatic triple-negative breast cancer," said Paula Pohlmann, M.D., Ph.D., of The University of Texas MD Anderson Cancer Center and principal investigator for both studies. "PRE-I-SPY allows us to evaluate safety while simultaneously examining biological markers that may provide an early indication of how these treatment combinations are affecting the disease."

PRE-I-SPY Study Design and Patient Populations

Both studies will primarily evaluate the safety and tolerability of leronlimab-containing combinations while assessing preliminary signals of clinical activity and exploratory biomarkers, including ctDNA and PD-L1 expression as measured by combined positive score (CPS).

PRE5 will primarily enroll patients receiving first- or second-line treatment, while PRE7 will focus on patients receiving second-line treatment. Both studies will include patients with a CPS of less than 10.

Both study arms will use a de-escalation design that starts at the highest dose of leronlimab (700mg) and evaluates dose reductions based on a one-cycle, 21-day dose-limiting toxicity (DLT) observation period. Cohorts will include six patients each and are designed to potentially expand if no DLTs are observed in the first cohort.

PRE-I-SPY is a Phase 1 platform study designed to efficiently evaluate the safety and optimal dosing of new therapeutic agents and combinations for breast cancer. QLHC is the sponsor of the PRE-I-SPY platform study, while CytoDyn is providing leronlimab for evaluation in the two new regimens.

"An important goal of PRE-I-SPY is to identify promising therapeutic combinations with acceptable safety profiles that could potentially be evaluated in earlier-stage, high-risk breast cancer through the I-SPY 2.2 platform," said Laura Esserman, M.D., Co-founder of QLHC and Principal Investigator of the I-SPY 2 platform.

Preparations are already underway for both studies, and enrollment for PRE5 is expected to begin in the first quarter of calendar 2027. Enrollment for PRE7 is likely to begin in the second or third quarter of calendar 2027. Additional information and updates on both studies will be provided in future Company communications.

(Press release, CytoDyn, NOV 10, 2026, View Source [SID1234674601])

Legend Biotech Reports Third Quarter 2026 Results and Recent Highlights

On November 10, 2026 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, reported its third quarter 2026 unaudited financial results and recent highlights.

"We made meaningful progress during the third quarter, expanding the reach of CARVYKTI and advancing our pipeline," said Ingrid Zhang, Chief Executive Officer of Legend Biotech. "Five-year CARTITUDE-2 Cohort A data added to the growing body of long-term evidence supporting the curative potential of CARVYKTI, especially in earlier-line multiple myeloma, demonstrating that half of the 20 patients remained alive and progression-free after a single infusion. Together, the promising early line data and updated NCCN guidelines preferring CAR-T ahead of other BCMA-directed therapies well positions CARVYKTI to potentially gain market share in the second- and third-line setting. We also achieved an important milestone for our next generation cell therapy pipeline with the IND clearance for LB2501. We remain focused on disciplined execution, expanding access to CARVYKTI worldwide, advancing our innovative pipeline, and delivering sustained profitability."

Recent Data Highlights
Five-Year CARTITUDE-2 Cohort A Data Demonstrate Durable Outcomes Earlier-Line RRMM

Data from CARTITUDE-2 (NCT04133636) Cohort A, which evaluated patients with relapsed or refractory multiple myeloma (RRMM) after one to three prior lines of therapy (n=20; median follow‑up, 60.7 months), were presented at the 23rd International Myeloma Society (IMS) Annual Meeting in September.
With extended follow-up, patients continued to experience durable clinical benefit, with a median progression-free survival (PFS) of 60.5 months.
Median overall survival was not reached at the time of analysis, and 69.2% of patients were alive at five years.
With a median follow-up of 60.7 months, 10 of 20 patients (50%) remained alive and progression-free without further anti-myeloma treatment ≥5 years after a single CARVYKTI infusion.
The safety profile observed with longer follow-up was consistent with the known safety profile of CARVYKTI, with no new CAR-T-cell-related neurotoxicity reported. Since the previous analysis of CARTITUDE-2 Cohort A with a median follow-up of approximately 30 months[1], one patient developed a new hematologic malignancy (acute myeloid leukemia) and two deaths occurred due to progressive disease and new cancer.
These findings build on five-year CARTITUDE-1 results presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting (Abstract #7505), in which 32 of 97 patients (33%) with more heavily pretreated RRMM remained progression-free for five years or more after a single infusion with no further myeloma therapy.
Key Business Developments

Compared to the third quarter of 2025, CARVYKTI net trade sales increased 36% in the third quarter of 2026 to approximately $710 million, with U.S. net trade sales growth of 19% and ex-U.S. net trade sales growth of 86%.
CARVYKTI is now available across 373 treatment sites in 20 global markets.
National Comprehensive Cancer Network (NCCN) updated Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Multiple Myeloma. The updated NCCN Guidelines recommend that all patients with multiple myeloma be referred to a T-cell therapy capable center at first relapse for consideration of available therapies. The guidelines also state that when both BCMA CAR-T therapy and T-cell engagers (TCEs) are viable options, current data suggest that CAR-T is preferred, given the established efficacy of TCEs following CAR-T therapy failure, and that prior BCMA-directed therapies should be minimized in patients planning to receive BCMA CAR-T cell therapy.
Received U.S. Food and Drug Administration (FDA) clearance of the investigational new drug (IND) application for LB2501, an investigational, CD19/CD20 dual-targeting in vivo CAR-T therapy for relapsed or refractory B-cell malignancies, including B-cell non-Hodgkin lymphoma. Early LB2501 clinical data was presented at the European Hematology Association (EHA) (Free EHA Whitepaper) in June 2026 which support the planned Phase I/II trial in the U.S. following the IND clearance. LB2501 is designed to generate CAR-T cells directly within the patient following a single intravenous infusion, making it the first known dual-targeting in vivo CAR-T therapy to receive FDA IND clearance.
Appointed Ingrid Zhang as Chief Executive Officer, effective September 15, 2026. Ingrid Zhang succeeds Alan Bash, who served as Interim Chief Executive Officer beginning in July 2026 and has resumed his role as President, CARVYKTI.
Cash and cash equivalents, and time deposits of approximately $853 million as of September 30, 2026.
Third Quarter 2026 Financial Results

Collaboration Revenue: Collaboration revenue was $353.2 million for the three months ended September 30, 2026, compared to $261.8 million for the three months ended September 30, 2025. The increase of $91.4 million was due to an increase in revenue generated from sales of CARVYKTI in connection with the Janssen collaboration and license agreement (the "Janssen Agreement").

License and Other Revenue: License and other revenue was $6.3 million for the three months ended September 30, 2026, compared to $10.6 million for the three months ended September 30, 2025. The decrease of $4.3 million was primarily attributable to revenue recognized pursuant to our license agreement with Novartis for the development, manufacture, and commercialization of LB2102 and other potential CAR-T therapies selectively targeting DLL-3 (the "Novartis License Agreement"). This revenue is recognized over time in connection with our Phase 1 clinical trial for LB2102.

Cost of Collaboration Revenue: Cost of collaboration revenue was $147.0 million for the three months ended September 30, 2026, compared to $113.2 million for the three months ended September 30, 2025. The increase of $33.8 million was primarily due to Legend Biotech’s share of the cost of sales in connection with CARVYKTI sales under the Janssen Agreement.

Research and Development Expenses: Research and development expenses were $95.3 million for the three months ended September 30, 2026, compared to $113.2 million for the three months ended September 30, 2025. The decrease of $17.9 million was primarily driven by lower expenditures in the cilta-cel clinical program as the patient dosing phases of major trials substantially concluded, partially offset by increased research and development activities primarily related to our in vivo CAR-T programs.

Administrative Expenses: Administrative expenses were $14.8 million for the three months ended September 30, 2026, compared to $34.7 million for the three months ended September 30, 2025. The decrease of $19.9 million was primarily driven by lower share-based compensation expense associated with the forfeiture of certain unvested equity awards and the resulting reversal of previously recognized compensation expense, partially offset by higher professional fees.

Selling and Distribution Expenses: Selling and distribution expenses were $55.0 million for the three months ended September 30, 2026, compared to $52.5 million for the three months ended September 30, 2025. The increase of $2.5 million was primarily due to higher commercial costs, including sales force expansion and Janssen-related marketing and market access activities, which rose with collaboration revenue.

Operating Income (Loss): Operating income for the three months ended September 30, 2026 was $46.8 million compared to an operating loss of $43.3 million for the three months ended September 30, 2025. The year-over-year improvement of $90.1 million was primarily due to higher gross profit from CARVYKTI, as well as lower research and development expenses and lower administrative expenses.

Net Income (Loss): Net income was $51.7 million for the three months ended September 30, 2026, compared to a net loss of $39.6 million for the three months ended September 30, 2025. The year-over-year improvement of $91.3 million was primarily driven by improved operating income.

Adjusted Net Income: Adjusted net income was $55.6 million for the three months ended September 30, 2026, compared to an adjusted net loss of $18.7 million for the three months ended September 30, 2025. The year-over-year improvement of $74.3 million was mainly driven by higher net income, partially offset by a lower share-based compensation adjustment.
Webcast/Conference Call Details:

Legend Biotech will host its quarterly earnings call and webcast today at 8:00am ET. To access the webcast, please visit this weblink.

A replay of the webcast will be available on Legend Biotech’s website at View Source

(Press release, Legend Biotech, NOV 10, 2026, View Source [SID1234674600])

ALX Oncology to Present at Upcoming Investor Conferences

On November 10, 2026 ALX Oncology Holdings Inc. ("ALX Oncology"; Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, reported that ALX Oncology leadership will participate in fireside chats at three upcoming investor conferences.

The details of the meetings are as follows:

UBS London Healthcare Conference

Format: Fireside Chat and One-on-one Meetings
Date: Tuesday, November 17, 2026
Location: London, UK
Time of Fireside Chat Presentation: 4:40 PM GMT / 11:40 AM EST
Webcast Link: Available here

Jefferies London Healthcare Conference

Format: Fireside Chat and One-on-one Meetings
Date: Wednesday, November 18, 2026
Location: London, UK
Time of Fireside Chat Presentation: 1:00 PM GMT / 8:00 AM EST
Webcast Link: Available here

Piper Sandler Annual Healthcare Conference

Format: Fireside Chat and One-on-one Meetings
Date: Tuesday, December 1, 2026
Location: New York, NY
Time of Fireside Chat Presentation: 3:30 PM EST
Webcast Link: Available here

The webcasts of the fireside chats can be accessed through the links above or by visiting the Investors section of ALX Oncology’s website at www.alxoncology.com under the Events section of the Events and Presentations tab. Replays of the webcasts will be archived for up to 90 days following the presentation dates.

(Press release, ALX Oncology, NOV 10, 2026, View Source [SID1234674599])

ORYZON Reports Third Quarter 2026 Financial Results and Provides Corporate Update

On November 10, 2026 Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and a global leader in epigenetics, reported financial results for the three months ended September 30, 2026, and provided a corporate update on recent developments.

"Since our last results update, Oryzon has continued to build the clinical evidence needed to advance our key development programs," said Dr. Carlos Buesa, Oryzon’s Chief Executive Officer. "The three iadademstat abstracts accepted for ASH (Free ASH Whitepaper) 2026 add to the growing body of clinical evidence supporting the activity of iadademstat across hematological malignancies. We are particularly encouraged by the high remission rates and promising survival results observed with iadademstat in combination with azacitidine and venetoclax in the Phase Ib ALICE-2 study in newly diagnosed AML. We look forward to presenting updated data at ASH (Free ASH Whitepaper) in December."

"Building on the ALICE-2 findings, we are preparing to engage with the FDA on the design of ALICE-3, our planned potentially registrational Phase III trial in first-line AML," Dr. Buesa continued. "Our objective remains to initiate the study in 2027, subject to regulatory agreement and financing. Alongside our AML program, preliminary positive findings in accelerated/blast-phase myeloproliferative neoplasms and ongoing clinical evaluation in myelodysplastic syndromes are helping us explore the broader potential of iadademstat."

"In CNS, we continue to advance the clinical development of vafidemstat across several indications," Dr. Buesa added. "The Phase IIb trial in schizophrenia, EVOLUTION, continues to enroll patients across several European countries, and we expect to complete enrollment in spring 2027, with topline data anticipated by the end of 2027. This readout could represent an important inflection point for the company’s CNS program. The recent authorization of the HOPE-2 Phase II study in Phelan-McDermid syndrome marks another step forward for the program. In parallel, we are progressing with preparations for thePORTICO-2 Phase III trial in BPD and plan to request a Type C meeting with the FDA. Across our portfolio, we remain focused on disciplined execution, responsible allocation of resources and the continued strengthening of our intellectual property as we prepare for the next stages of clinical development."

Third Quarter and Recent Highlights

Iadademstat:

Updated positive clinical data for iadademstat in hematological malignancies will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 68th Annual Meeting, taking place December 12-15, 2026. Three abstracts, accepted for poster presentation, were published on November 4. A summary of the clinical data contained in the abstracts is provided below.
One of the ASH (Free ASH Whitepaper) abstracts relates to the ongoing ALICE-2 (NCT06357182) Phase Ib clinical trial of iadademstat in combination with azacitidine and venetoclax in patients with newly diagnosed AML, sponsored by the Oregon Health & Science University (OHSU) Knight Cancer Institute. As reported in the abstract, the iadademstat-azacitidine-venetoclax triplet combination continued to show high remission rates, rapid responses and encouraging early survival with a manageable safety profile. As of the July 2026 data for ASH (Free ASH Whitepaper) abstract submission, among evaluable patients (n=19), overall response rate (ORR) was 95%, including an 84% composite complete remission (CRc) rate and a 74% pure complete response (CR) rate. After median follow-up of 8 months, 12-month overall survival (OS) was 76%, with median OS not yet reached. In patients with ELN2022 intermediate- or adverse-risk disease, 12-month OS rates were 100% and 74%, respectively, with median OS not reached. Updated data with additional patients and more mature responses will be presented at the meeting.
Topline positive data from the Phase Ib FRIDA (NCT05546580) clinical trial of iadademstat in combination with gilteritinib in high-risk, heavily pre-treated patients with relapsed or refractory (R/R) FLT3-mutated AML were also published in a second ASH (Free ASH Whitepaper) abstract. The iadademstat/gilteritinib combination demonstrated a manageable safety profile, similar to SoC treatment. The combination achieved a high composite complete remission rate of 67% (12/18) and a 31% 12-month survival rate at the recommended Phase 2 dose (RP2D).
Interim results from a Phase II study evaluating ASTX727 with or without iadademstat in patients with accelerated/blast-phase myeloproliferative neoplasms (NCT06661915) were also reported at an ASH (Free ASH Whitepaper) abstract. This study is sponsored by the U.S. National Cancer Institute (NCI) and is conducted under the Cooperative Research and Development Agreement (CRADA) between Oryzon and the NCI. Based on data available as of the ASH (Free ASH Whitepaper) 2026 abstract submission cut-off date, the combination of iadademstat and ASTX727 was well tolerated, with no dose-limiting toxicities (DLTs) observed. 50% of patients treated with the combination achieved acute leukemia response-partial (ALR-P) as best response. The trial continues in the dose escalation phase, and higher iadademstat dose level cohorts will be explored to inform the selection of a recommended Phase 2 dose of iadademstat for the randomized portion of the study.
VIVALDI, a new Phase Ib pilot study sponsored by CETLAM (Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplásicas), has been authorized in Spain. The study will evaluate iadademstat in combination with azacitidine and venetoclax in patients with newly diagnosed AML in subpopulations with poor responses to current standard-of-care treatment. CETLAM is a Spanish cooperative clinical research group that brings together specialists from leading hospitals in the research and treatment of acute myeloid leukemia and myelodysplastic syndromes. Oryzon is collaborating with CETLAM and supplying iadademstat for the study. This clinical study complements Oryzon’s planned ALICE-3 Phase III program in the U.S., and will provide operational experience relevant to the program’s future European arm.
Enrollment continued across ongoing iadademstat clinical studies in myelodysplastic syndromes (MDS, IIS-X005), essential thrombocythemia (IDEAL study), sickle cell disease (RESTORE study), and extensive-stage small cell lung cancer (ED-SCLC). These include studies conducted under the CRADA with the NCI, investigator-initiated studies (IIS), and Oryzon-sponsored trials. The company plans to share preliminary data from selected studies at future scientific meetings, subject to data availability and abstract acceptance.
Oryzon has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a U.S. patent application covering combinations of iadademstat, or certain other LSD1 inhibitors, with gilteritinib and their use for the treatment of myeloid cancers, including AML. Once granted, the U.S. patent is expected to expire in 2042, excluding any potential patent term adjustment or patent term extension.
Vafidemstat:

EVOLUTION Phase IIb trial of vafidemstat in schizophrenia continues to actively enroll patients. The study is primarily assessing its effects on negative symptoms, with cognitive impairment and positive symptoms included as secondary endpoints. Initially launched in Spain, EVOLUTION has been expanded to additional European countries (Bulgaria, Poland, Romania and Slovakia).
Oryzon continues preparations for the Phase III PORTICO-2 trial of vafidemstat in aggression in borderline personality disorder (BPD). Following FDA feedback, the Company is refining the trial protocol and conducting additional work to support the proposed clinical outcome measures ahead of resubmission. The company plans to request a type C meeting with the FDA by the end of 2026 or in the first quarter of 2027.
Oryzon has received approval to initiate the HOPE-2 Phase II study of vafidemstat for the treatment of Phelan-McDermid syndrome (PMS), a genetic disease associated with autism spectrum disorder. The study is a single-center, single-arm, open-label study and will be conducted in Spain. The primary objective of the study is to evaluate the safety and tolerability of vafidemstat in adults with PMS. Secondary objectives include assessing the effect of vafidemstat on anger and aggression and overall disease. The HOPE-2 study forms part of the activities supported by the Med4Cure IPCEI EU initiative.

Oryzon has continued to reinforce its IP portfolio for vafidemstat with new Decisions to Grant in South Korea and the Philippines for patent applications covering the use of vafidemstat for the treatment of non-aggressive symptoms of borderline personality disorder, in New Zealand for a patent application covering the use of vafidemstat for the treatment of aggression and social withdrawal, and in Mexico for a patent application covering the use of vafidemstat for the treatment of certain non-aggressive symptoms of autism spectrum disorder.

Earlier stage programs:

ORY-4001, Oryzon’s highly selective histone deacetylase 6 (HDAC6) inhibitor for neurological disorders, continues IND-enabling studies to enable future clinical trials. The program remains focused on potential applications in Amyotrophic Lateral Sclerosis (ALS), Charcot-Marie-Tooth disease (CMT) and other neurological disorders.
Financial Update: Third quarter 2026 Financial Results

Research and development (R&D) expenses were $4.6 million and $16.0 million for the quarter and nine months ended September 30th, 2026, compared to $3.9 and $9.6 million for the quarter and nine months ended September 30th, 2025.

General and administrative expenses were $1.0 and $3.8 million for the quarter and nine months ended September 30th, 2026, compared to $1.2 and $3.9 million for the quarter and nine months ended September 30th, 2025.

Net losses were $1.6 and $5.2 million for the quarter and nine months ended September 30th, 2026, compared to $1.2 and $4.6 million for the quarter and nine months ended September 30th, 2025. The result is as expected, given the biotechnology business model where companies in the development phase typically have a long-term maturation period for products and do not have recurrent income.

Negative net result was $3.0 million (–$0.04 per share) for the nine months ended September 30th, 2026, compared to a negative net result of $1.4 million (–$0.02 per share) for the nine months ended September 30th, 2025.

Cash, cash equivalents, and marketable securities totaled $21.7 million (€19.1 million) as of September 30, 2026.

(Press release, Oryzon, NOV 10, 2026, View Source [SID1234674598])

BBOT Reports Third Quarter 2026 Financial Results and Update on Corporate Progress

On November 10, 2026 BridgeBio Oncology Therapeutics, Inc. ("BBOT") (Nasdaq: BBOT), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, reported financial results for the quarter ended September 30, 2026, and provided a business update.

BBOT’s portfolio of RAS-pathway inhibitors is designed to enable direct dual inhibition of KRASG12C (BBO-8520), or KRASG12D/V (BBO-11818) in both their ON and OFF states as well as disruption of RAS-driven PI3Kα activation (BBO-10203) to achieve optimal target coverage of the most mutated driver oncogene in human cancer. Together, these assets uniquely position BBOT to achieve concurrent, high-level suppression of both the MAPK and PI3Kα pathways through a wholly-owned internal combination strategy.

"The third quarter was an important period for BBOT as we reported updated clinical data for BBO-8520 and delineated our strategic focus. Driven by encouraging clinical data across all three programs we are executing on multiple combinations with the potential for significant patient benefit," said Pedro J. Beltran, Ph.D., Chief Executive Officer of BBOT. "With a strong balance sheet, multiple data catalysts expected through mid-2027, and cash runway into 2029, we believe BBOT is well positioned to advance differentiated therapies for patients with KRAS-driven cancers."

Key Program Highlights and Updates

BBO-8520: An orally bioavailable small molecule direct inhibitor targeting both the ON and OFF states of KRASG12C.

In September 2026, BBOT announced new data from the ongoing ONKORAS-101 (NCT06343402) Phase 1 study. BBO-8520 in combination with pembrolizumab in KRASG12C inhibitor-experienced NSCLC patients showed an objective response rate (ORR) of 75% at the 500 mg once-daily (QD) dose level and 53% across all dose levels (N=17), with a generally tolerable and manageable safety profile. Adverse events were primarily gastrointestinal (GI)-related, and a favorable liver safety profile was observed. We believe this data positions BBOT to address a new G12Ci-experienced patient population created by G12C OFF-only inhibitors in combination with pembrolizumab in 1L KRASG12C positive NSCLC.
BBO-8520 monotherapy in 2L+ KRASG12C inhibitor-naïve NSCLC patients showed an ORR of 63% (26/41) and a disease control rate (DCR) of 100% (41/41). Among 28 patients eligible for a six-month follow-up, 75% (21/28) remained on treatment beyond six months. The safety profile was tolerable and manageable, with no grade 3 or higher liver enzyme elevations.
BBO-11818: An orally bioavailable small molecule pan-KRAS inhibitor that targets KRAS in both the ON and OFF states.

Initiated dosing of BBO-11818 in combination with BBO-10203 as well as in combination with cetuximab in CRC and PDAC.
Monotherapy data update expected in the fourth quarter of 2026
BBO-10203: An orally bioavailable small molecule with a novel mechanism of action designed to block the physical interaction between RAS and PI3Kα, inhibiting RAS-driven PI3Kα-AKT signaling in tumors.

Prioritized BBO-10203 in internal combinations with BBO-11818 and in combination with standard-of-care agents in KRAS-mutant cancers; combination cohorts are enrolling in CRC and PDAC.
Monotherapy data update expected in the fourth quarter of 2026.
Third Quarter 2026 Financial Results

Cash Position: As of September 30, 2026, BBOT had cash, cash equivalents and marketable securities totaling $315.3 million, which is expected to provide cash runway into 2029.
Research and development (R&D) expenses: R&D expenses were $29.6 million for the third quarter of 2026 compared to $35.1 million for the third quarter of 2025. The decrease in R&D expense was primarily driven by a decrease in clinical stage program related expenses.
General and administrative (G&A) expenses: G&A expenses were $7.9 million for the third quarter of 2026 compared to $14.1 million for the third quarter of 2025. The decrease in G&A expense reflects a decrease in payroll and personnel-related expenses primarily due to a $7.8 million charge recognized in the third quarter of 2025 related to common stock issuable to BridgeBio Pharma, partially offset by an increase in legal and other business expenses.
Net Loss: Net loss was $34.2 million for the third quarter of 2026 compared to $44.8 million for the third quarter of 2025.

(Press release, BridgeBio Oncology Therapeutics, NOV 10, 2026, View Source [SID1234674597])