InSysBio to announce its collaboration with BeOne Medicines

On October 29, 2025 InSysBio, one of the world’s pioneers of Quantitative Systems Pharmacology (QSP) modeling, reported its collaboration with BeOne Medicines, a global oncology company.

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Mechanistic PK/RO modeling will be leveraged to support the selection of the optimal recommended phase 2 dose by predicting the dynamics of the various complexes formed when the BGB-B2033 binds to its targets. BGB-B2033, a GPC3 x 4-1BB bispecific antibody, is currently in early clinical development by BeOne Medicines.

"This project represents a valuable opportunity to apply our cutting-edge modeling approach since determining the optimal dose for therapies expected to exhibit a bell-shaped dose-response relationship poses a significant challenge," said Oleg Demin Jr, Scientific Director, InSysBio. "InSysBio’s QSP modeling expertise can help to address this issue. Namely, we have developed generic mechanistic PK/RO model for multispecific antibodies that accelerates project timelines and improves efficiency. Moreover, FDA’s Project Optimus encourages the application of mechanistic modeling approaches such as QSP to guide the selection of optimal dose in oncology."

(Press release, BeOne Medicines, OCT 29, 2025, View Source [SID1234657119])

Caris Data Validates TET2 Clonal Hematopoiesis as a Biomarker for Enhanced Immunotherapy Response

On October 29, 2025 Caris Life Sciences (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, reported collaborative new research identifying TET2 clonal hematopoiesis (CH) as a promising biomarker for improved response to immune checkpoint inhibitor (ICI) therapy in patients with solid tumors. The study titled, `TET2-mutant clonal hematopoiesis enhances macrophage antigen presentation and improves immune checkpoint therapy in solid tumors,’ was led by Padmanee Sharma, M.D., Ph.D. at the James P. Allison Institute at The University of Texas MD Anderson Cancer Center and published in Cancer Cell.

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The study’s purpose was to investigate how immune cells carrying CH-derived TET2 mutations influence solid tumor immunology and respond to ICI therapy. Dr. Sharma and Shelley Herbrich, Ph.D., postdoctoral fellow in Dr. Sharma’s lab, explored the underlying mechanisms using TET2-mutant laboratory models, which revealed how these mutations shape immune dynamics within the tumor microenvironment.

To validate the clinical relevance of these findings, the study leveraged Caris Life Sciences’ extensive clinico-genomic database, analyzing outcomes in a real-world cohort of nearly 36,000 patients with non-small cell lung cancer (NSCLC) and over 25,000 colorectal (CRC) cancer patients. This dual approach provided insight and large-scale evidence supporting TET2-CH as a potential biomarker for enhanced ICI response. Importantly, these findings represent a major observation that directly ties clonal hematopoiesis to therapy outcomes in solid tumors, suggesting a future role of CH for driving therapy selection.

"These findings represent a major step forward in understanding how clonal hematopoiesis influences cancer immunology," said Milan Radovich, Ph.D., Senior Vice President, Chief Scientific Officer at Caris. "It further demonstrates that we are only scratching the surface on the potential applications of CH, namely a novel function of CH as a predictive therapeutic biomarker that can be used to improve patient outcomes."

"These results are encouraging, highlighting TET2-mutated clonal hematopoiesis as a potential biomarker to select patients who are more likely to respond to immunotherapy," said Padmanee Sharma, M.D., Ph.D., professor of Immunology and Genitourinary Medical Oncology at MD Anderson and director of scientific programs for the Allison Institute.

(Press release, Caris Life Sciences, OCT 29, 2025, View Source [SID1234657118])

Immutep Quarterly Activities Report Q1 FY26

On October 29, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune disease, reported an update on its activities for the quarter ended 30 September 2025 (Q1 FY26).

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EFTI DEVELOPMENT PROGRAM IN ONCOLOGY

LUNG CANCER

TACTI-004 (KEYNOTE-F91) – Ongoing Phase III Trial in 1L NSCLC
Immutep’s pivotal TACTI-004 (KEYNOTE-F91) Phase III trial continues to build momentum and is recruiting patients at a growing number of activated clinical sites and countries. There are now over 100 clinical sites open for enrollment and 24 countries that have received regulatory approval.

The TACTI-004 trial evaluates eftilagimod alfa (efti), a first-in-class MHC Class II agonist, in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA and chemotherapy as first line treatment for patients with advanced or metastatic non-small cell lung cancer (1L NSCLC). The global Phase III trial with efti will randomise approximately 756 patients at more than 150 clinical sites and trial results will inform a potential marketing approval application in non-small cell lung cancer, one of the largest indications in oncology.

In July, Immutep announced that a Trials in Progress ePoster had been accepted at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 which took place 17- 21 October in Berlin, Germany.

In September, Immutep presented a Trial in Progress poster presentation for TACTI-004 at the IASLC 2025 World Conference on Lung Cancer (WCLC), in Barcelona, Spain, where physician feedback continued to be encouraging. The Trial in Progress poster included an overview and study design of the trial.

Subsequent to the end of the quarter, the Company announced in October that this global Phase III trial has enrolled and randomised over 170 patients, reaching an important milestone as this is above the amount needed to conduct the futility analysis, which remains on track for completion in the first quarter of CY2026.

INSIGHT-003 – Phase I Trial in Non-Squamous 1L NSCLC
In July, Immutep announced that data from the INSIGHT-003 Phase I investigator-initiated trial in 1L NSCLC had been accepted for poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 which took place 17- 21 October in Berlin, Germany.

The multi-centre INSIGHT-003 study is evaluating efti in combination with the anti-PD-1 therapy, KEYTRUDA and doublet chemotherapy as first-line treatment for patients with advanced or metastatic non-squamous 1L NSCLC. This is the same immunotherapy/chemotherapy combination being used in the pivotal TACTI-004 Phase III in 1L NSCLC.

Encouraging data from this trial has been presented at ESMO (Free ESMO Whitepaper) 2025.

HEAD AND NECK CANCER

TACTI-003 (KEYNOTE-C34) Cohort B – Phase IIb Trial in 1L HNSCC with CPS <1

In August, Immutep received positive and constructive feedback from the US Food and Drug Administration (FDA), regarding future late-stage clinical development of efti in first line treatment of recurrent/metastatic head and neck squamous cell carcinoma (1L HNSCC) patients who have PD-L1 expression below 1 (Combined Positive Score [CPS] <1.

Based on its review of the encouraging data in 1L HNSCC with CPS <1 from TACTI-003 (KEYNOTE-C34), the FDA agreed on the potential of efti in combination with KEYTRUDA to address the high unmet need in this CPS <1 patient segment and is supportive of the combination’s further development.

Paths for future clinical development and potential accelerated approval in light of the FDA’s Project FrontRunner include a randomised registrational trial evaluating efti in combination with KEYTRUDA against standard-of-care therapy or alternatively a smaller single-arm study (e.g. 70 – 90 patients) with safety, response rate, and duration of response as key endpoints, followed by a confirmatory randomised study that builds on the existing data.

SOFT TISSUE SARCOMA

EFTISARC-NEO – Phase II Trial in Soft Tissue Sarcoma
In July, Immutep announced that an abstract for the EFTISARC-NEO Phase II investigator-initiated trial evaluating efti with radiotherapy plus KEYTRUDA in the neoadjuvant setting for resectable soft tissue sarcoma (STS) had been accepted as a Proffered Paper oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 which took place 17- 21 October in Berlin, Germany.

Additionally, in September, Immutep announced that an abstract for the EFTISARC-NEO Phase II trial had been accepted for oral presentation at the Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting taking place 12-15 November 2025, in Boca Raton, Florida, USA.

As previously announced, the investigator-initiated EFTISARC-NEO Phase II trial has met its primary endpoint. The novel combination significantly exceeded the study’s prespecified median of 35% tumour hyalinization/fibrosis versus 15% for historical data from radiotherapy alone in patients with resectable STS.

Encouraging data from this trial has been presented at ESMO (Free ESMO Whitepaper) 2025.

BREAST CANCER

AIPAC-003 – Phase II/III Trial in Metastatic Breast Cancer
Immutep continues to execute the AIPAC-003 trial, which enrolled 71 metastatic hormone receptor positive (HR+), HER2-negative/low or triple-negative breast cancer patients who exhausted endocrine therapy including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors.

Immutep completed patient enrolment in the randomised Phase II portion of the AIPAC-003 trial in late 2024. Patients across 22 clinical sites in Europe and the United States have been randomised 1:1 to receive either 30 mg or 90 mg dosing of efti in combination with paclitaxel to determine the optimal biological dose consistent with the FDA’s Project Optimus initiative and prior regulatory interaction with FDA.

Patient follow up, data cleaning and analysis is ongoing, and an update will be provided at the San Antonio Breast Cancer Symposium in San Antonio, Texas, USA in December 2025.

New Investigator-Initiated Phase II trial for Neoadjuvant Efti in HR+/HER2-negative Breast Cancer

In September, the Company announced the launch of an investigator-initiated Phase II trial evaluating neoadjuvant efti as monotherapy and in combination with chemotherapy prior to surgery in early-stage HR+/HER2-negative breast cancer patients. The trial, led by Dr. Pavani Chalasani, MD, MPH, Division Director of Hematology and Medical Oncology at The George Washington (GW) University Cancer Center, aims to assess pathological complete response (pCR) after neoadjuvant efti treatment and neoadjuvant chemotherapy (NAC).

The study will treat up to 50 evaluable patients in a two-stage design and will be primarily funded by grants and The GW University Cancer Center. Immutep will provide efti at no cost, technical support, and limited funding that falls within its existing budget.

IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASE

IMP761 – Phase I Trial
Immutep is progressing with the ongoing Phase I trial of its autoimmune candidate IMP761. IMP761 is a first-in-class LAG-3 agonist antibody designed to restore balance to the immune system by enhancing the "brake" function of LAG-3 to silence dysregulated self-antigen-specific memory T cells that cause many autoimmune diseases.

Following previously reported positive initial efficacy data and continued favourable safety data from the first-in-human Phase I study in June, additional data from the Phase I study is expected to follow in Q4 CY2025.

INTELLECTUAL PROPERTY
During the quarter, Immutep was granted four new patents.

The Israel and New Zealand Patent Office each granted a new patent protecting Immutep’s intellectual property for a binding assay for determining MHC Class II binding activity of LAG-3 protein used in characterisation of efti in GMP-grade manufacturing.

A new patent was also granted for IMP761 in New Zealand. For LAG525, which is exclusively licensed to Novartis by Immutep, a new patent was granted in Taiwan.

CORPORATE & FINANCIAL SUMMARY

Senior Management Changes
As previously reported Stephan Winckels M.D, Ph.D., has been appointed to the permanent position of Chief Medical Officer effective 1 July 2025. Stephan has over 15 years of experience in oncology drug development and has been working on efti trials as Medical Monitor or Data Monitoring Committee member for more than nine years.

Cash Flow Summary
During the quarter, Immutep continued to exercise prudent cash management as it advanced its clinical trial programs for efti and for IMP761.

The Company is well funded with a strong cash and cash equivalent, and term deposit balance as at 30 September 2025 of approximately A$109.85 million, which is in line with budget as at the beginning of FY2026, while progressing our clinical programs within announced timeframes. The total balance consists of: 1) a cash and cash equivalent balance of A$83.41 million and 2) bank term deposits totaling A$26.44 million, which have been recognised as short-term investments due to having maturities of more than 3 months and less than 12 months.

In Q1 FY26, cash receipts from customers were A$15k. The net cash used in G&A activities in the quarter was A$578k, compared to A$1.44 million in Q4 FY25. Payments to Related Parties comprises Non-Executive Directors’ fees and Executive Directors’ remuneration of A$720k.

The net cash used in R&D activities during the quarter was A$15.83 million, compared to A$15.66 million in Q4 FY25. The increase is in line with increased clinical trial activities.

Payment for staff costs was A$3.4 million in the quarter, compared to A$2.5 million in Q4 FY25. Total net cash outflows used in operating activities in the quarter were A$19.04 million compared to A$18.92 million in Q4 FY25.

Total cash inflow from investing activities for the quarter was A$35.46 million, mainly due to the net decrease of short-term investments. The short-term investments are comprised of term deposits with maturities of greater than 3 months and less than 12 months. During the quarter, the company transferred back A$40.46 million from short-term investments that had matured to cash at bank and invested A$5 million in short-term investments.

(Press release, Immutep, OCT 29, 2025, View Source [SID1234657116])

BridgeBio Reports Third Quarter 2025 Financial Results and Business Updates

On October 29, 2025 BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a new type of biopharmaceutical company focused on genetic diseases, reported its financial results for the third quarter ended September 30, 2025, and provided business updates.

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Commercial Progress:
As of October 25, 2025, 5,259 unique patient prescriptions have been written by 1,355 unique prescribers since FDA approval in November 2024. The third quarter revenue totaled $120.7 million, comprised of $108.1 million of U.S. Attruby net product revenue, $4.3 million from royalty revenue, and $8.3 million in license and services revenue.

"Attruby’s first year on the market has been remarkable, with continued growth across all market segments and strong physician adoption that reflects both the differentiated clinical profile and the trust we’re earning within the community. We’re seeing meaningful momentum where prescribers are not only initiating more patients on therapy but continuing treatment, underscoring Attruby’s real-world impact," said Matt Outten, Chief Commercial Officer of BridgeBio. "Importantly, this launch has also given us an invaluable blueprint for how we bring best-in-class medicines to patients with genetic diseases. With the promising results seen in BBP-418 for LGMD2I/R9 and encaleret for ADH1, we are building on a proven commercial foundation to ensure these communities, each living with urgent, unmet needs, have timely access to transformative therapies and we will apply the playbook we’ve developed to prepare for our next potential approvals."

Pipeline Overview:

Program Status Next expected milestone
Acoramidis for ATTR-CM Approved in U.S., EU, Japan, and UK New variant data to be shared at AHA Scientific Sessions
BBP-418 for LGMD2I/R9 FORTIFY, Phase 3 study interim analysis topline results released File NDA with FDA in 1H 2026
Encaleret for ADH1 CALIBRATE, Phase 3 study topline results released File NDA with FDA in 1H 2026
Infigratinib for achondroplasia PROPEL 3, Phase 3 study enrollment completed  Topline results in early 2026
Encaleret for chronic hypoparathyroidism Phase 2 proof-of-principle study completed Phase 3 study to be initiated in 2026
Infigratinib for hypochondroplasia ACCEL 2/3, Phase 2 study first participant dosed Enrollment completion for Phase 2 portion by end of 2025

Key Program Updates:

"Attruby’s strong commercial performance continues to validate our model, delivering a potential best-in-class medicine to patients who were historically overlooked and building meaningful momentum across all market segments," said Neil Kumar, Ph.D., founder and CEO of BridgeBio. "We are now seeing that same success echoed in our pipeline with home-run data in both ADH1 and LGMD2I/R9, and we continue to advance one of the broadest and fastest-moving portfolios in genetic medicine. With achondroplasia data expected in 2026, enrollment nearing completion for the Phase 2 potion of the hypochondroplasia study, and registrational studies for encaleret in chronic hypoparathyroidism and pediatric ADH1 planned next year, we are not slowing down and continue to be impatient for patients. These milestones reflect our growing scalability and strengthen our conviction that BridgeBio is only beginning to show what’s possible as we evolve into a durable, multi-medicine company built for patients with genetic diseases for decades to come."

Attruby (acoramidis) – First near-complete (≥90%) transthyretin (TTR) stabilizer for treatment of transthyretin amyloid cardiomyopathy (ATTR-CM):

At this year’s Heart Failure Society of America (HFSA) Annual Scientific Meeting, BridgeBio presented data from the ATTRibute-CM study showing that acoramidis reduced cumulative cardiovascular outcomes, including cardiovascular mortality (CVM) or recurrent cardiovascular-related hospitalizations (CVH), within the first month of treatment in patients with ATTR-CM. At Month 30, Acoramidis significantly reduced the cumulative risk of CVM or recurrent CVH versus placebo with a 49% hazard reduction (p<0.0001). Acoramidis also showed that 53 events were avoided per 100 treated participants (95% CI:29–79) at Month 30. These data were presented in a Late Breaking Clinical Trials Oral Presentation at the HFSA Annual Scientific Meeting 2025 and simultaneously published in Journal of the American College of Cardiology (JACC).
Earlier in the year at the European Society of Cardiology Congress, BridgeBio shared a post-hoc analysis of ATTRibute-CM, demonstrating a significant reduction in risk of CVM through 42 months post-randomization, with a 44% hazard reduction, setting a new standard for CVM outcomes for patients with ATTR-CM. Acoramidis also demonstrated a significant 46% hazard reduction in the risk of the composite outcome of CVM or first CVH through 42 months.
More data on Attruby will be shared at the American Heart Association (AHA) Congress in November 2025 and in medical congresses throughout 2026.

BBP-418 – Glycosylation substrate for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9):

FORTIFY, the Phase 3 clinical trial of BBP-418, successfully achieved all primary and secondary endpoints of its interim analysis.
Findings included a highly statistically significant increase of 1.8x change from baseline (p<0.0001) of glycosylated alpha-dystroglycan (αDG) observed in the BBP-418 group compared to approximately no change in the placebo group from baseline to 3 months, which was sustained at 12 months (p<0.0001).
An average reduction in serum creatine kinase (CK), a marker of muscle breakdown, of 82% change from baseline (p<0.0001) was observed in BBP-418 treated individuals.
Importantly, statistically significant and clinically meaningful improvements in ambulation [100-meter timed test (100MTT) velocity, p<0.0001] and pulmonary function [forced vital capacity (FVC) % predicted, sitting position, p=0.0071] were also observed at 12 months in the BBP-418 group compared with the placebo group.
BBP-418 was well-tolerated with no new or unexpected safety findings observed.
BridgeBio intends to file a New Drug Application (NDA) for approval with the FDA in the first half of 2026.
If successful, BBP-418 could be the first approved therapy for individuals living with LGMD2I/R9, potentially representing the first approval of a therapy for any form of LGMD.
The Company intends to initiate clinical studies of BBP-418 in LGMD2I/R9 for individuals less than 12 years of age and in LGMD2M/2U in the near future.

Encaleret – Calcium-sensing receptor (CaSR) antagonist for autosomal dominant hypocalcemia type 1 (ADH1) and chronic hypoparathyroidism:

CALIBRATE, the Phase 3 clinical trial of oral encaleret in ADH1, a genetic form of hypoparathyroidism, successfully achieved all pre-specified primary and key secondary efficacy endpoints.
The primary endpoint was met with 76% of participants administered encaleret achieving both serum and urine calcium within the respective target ranges at Week 24 compared to 4% when on conventional therapy at Week 4 (p<0.0001).
In a key secondary analysis, 91% of participants administered encaleret achieved intact parathyroid hormone above the lower limit of the reference range at Week 24 compared to 7% of participants when on conventional therapy at Week 4 (p<0.0001).
Encaleret was well-tolerated with no discontinuations related to study drug.
BridgeBio intends to submit a NDA to the FDA in the first half of 2026, and a Marketing Authorization Application to the European Medicines Agency to follow.
If approved, encaleret would be the first therapy indicated for individuals living with ADH1.
The Company plans to initiate a registrational clinical trial of encaleret in pediatric ADH1 in the first quarter of 2026
The Company also plans to initiate a Phase 3 study of encaleret in chronic hypoparathyroidism in 2026.

Infigratinib – FGFR1-3 inhibitor for achondroplasia and hypochondroplasia:

PROPEL 3, the Phase 3 clinical trial of infigratinib in achondroplasia, the most common form of disproportionate short stature, is fully enrolled with 114 participants randomized.
BridgeBio expects topline results of PROPEL 3 in early 2026.
BridgeBio has reached regulatory alignment with the FDA on the clinical development plan for infigratinib in infants and toddlers with achondroplasia from birth to less than 3 years old. Based on the discussion, the Company initiated clinical development in this important age range.
The first participant in the Phase 2 portion of ACCEL 2/3 in hypochondroplasia was dosed in April 2025 and the Company expects to fully enroll the Phase 2 portion of the study by the end of 2025. The Phase 2 data is expected in the second half of 2026.
Infigratinib demonstrates single-digit nanomolar potency in vitro across causative FGFR3 variants in hypochondroplasia, consistent with its activity in achondroplasia, highlighting robust preclinical efficacy across FGFR3-driven skeletal dysplasias (Demuynck et al., JBMR, 2025).
In achondroplasia, infigratinib has received Breakthrough Designation from the FDA, Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation. To date, in hypochondroplasia, infigratinib has received Fast Track Designation and Orphan Drug Designation from the FDA and EMA.
If successful, infigratinib would be the first approved oral therapy option for children living with achondroplasia and hypochondroplasia.

Financial Updates:

Cash, Cash Equivalents and Marketable Securities

Cash, cash equivalents and marketable securities totaled $645.9 million as of September 30, 2025, compared to cash and cash equivalents of $681.1 million as of December 31, 2024. The $35.2 million decrease is primarily attributable to net cash used in operating activities of $389.5 million for the nine months ended September 30, 2025, the repayment of the Company’s previous term loan under its credit facility (including prepayment fees) of $459.0 million in February 2025, and the repurchase of common stock of $48.3 million using proceeds from the 2031 Notes in February 2025. These outflows were partially offset by net proceeds of $563.0 million from the issuance of the 2031 Notes in February 2025 and net proceeds of $297.0 million from the execution of the Royalty Interest Purchase and Sale Agreement with HealthCare Royalty, a related party, and Blue Owl Capital in June 2025.

Total Revenues, Net

Three Months Ended September 30, Nine Months Ended September 30,
2025 2024 2025 2024
(in thousands)
Net product revenue $ 108,111 $ — $ 216,351 $ —
License and services revenue 8,311 2,732 125,441 216,020
Royalty revenue 4,278 — 6,106 —
Total revenues, net $ 120,700 $ 2,732 $ 347,898 $ 216,020

Total revenues, net for the three months ended September 30, 2025, were $120.7 million compared to $2.7 million for the same period in the prior year. The $118.0 million increase was primarily driven by a $108.1 million increase in net product revenue from the Company’s commercial product, Attruby, a $5.6 million increase in license and services revenue, and a $4.3 million increase in royalty revenue earned on net product sales of BEYONTTRA in the EU and Japan.

Total revenues, net for the nine months ended September 30, 2025, were $347.9 million compared to $216.0 million for the same period in the prior year. The $131.9 million increase was primarily driven by a $216.4 million increase in net product revenue from the Company’s commercial product, Attruby, and a $6.1 million increase in royalty revenue earned on net product sales of BEYONTTRA in the EU and Japan. These increases were partially offset by a $90.6 million decrease in license and services revenue, reflecting the timing of recognition of upfront payments from the Company’s exclusive license agreements with collaboration partners as well as regulatory-related milestones recognized upon the approval of BEYONTTRA in the EU and pricing approval in Japan.

Operating Costs and Expenses

Three Months Ended September 30, Nine Months Ended September 30,
2025 2024 2025 2024
(in thousands)
Total cost of revenues $ 6,563 $ 598 $ 12,855 $ 1,794
Research and development 112,874 120,444 335,536 376,111
Selling, general and administrative 137,621 68,819 373,140 194,149
Restructuring, impairment and related charges 8,841 4,621 10,216 10,912
Total operating costs and expenses $ 265,899 $ 194,482 $ 731,747 $ 582,966

Operating costs and expenses for the three months ended September 30, 2025 were $265.9 million compared to $194.5 million for the same period in the prior year. The $71.4 million increase was primarily driven by a $68.8 million increase in selling, general and administrative ("SG&A") expenses largely reflecting the Company’s investments in support of the commercial launch and ongoing activities of Attruby, and a $6.0 million increase in total cost of revenues, primarily due to the cost of Attruby products sold. These increases were partially offset by a $7.6 million decrease in research and development ("R&D") expenses as a result of the Company’s reprioritization of its R&D programs.

Operating costs and expenses for the nine months ended September 30, 2025 were $731.7 million compared to $583.0 million for the same period in the prior year. The $148.7 million increase was primarily driven by a $179.0 million increase in SG&A largely reflecting the Company’s investments to support the commercial launch and ongoing activities of Attruby, and an $11.1 million increase in total cost of revenues, primarily due to the cost of Attruby products sold. The increases were partially offset by a $40.6 million decrease in R&D expenses as a result of the Company’s reprioritization of its R&D programs.

Stock-based compensation expenses included in operating costs and expenses for the three months ended September 30, 2025 were $35.3 million, of which $21.9 million is included in SG&A expenses, $12.3 million is included in R&D expenses, $0.7 million is included in restructuring impairment and related charges, and $0.4 million is included in cost of goods sold. Stock-based compensation expenses included in operating costs and expenses for the same period in 2024 were $27.1 million, of which $15.0 million was included in SG&A expenses and $12.1 million was included in R&D expenses.

Stock-based compensation expenses included in operating costs and expenses for the nine months ended September 30, 2025 were $102.0 million, of which $63.1 million is included in SG&A expenses, $37.5 million is included in R&D expenses, $0.8 million is included in restructuring impairment and related charges, and $0.6 million is included in cost of goods sold. Stock-based compensation expenses included in operating costs and expenses for the same period in the prior year were $77.4 million, of which $47.5 million was included in SG&A expenses and $29.8 million was included in R&D expenses, and $0.1 million was included in restructuring, impairment and related charges.

Total Other Income (Expense), Net

Total other income (expense), net for the three and nine months ended September 30, 2025, was $(41.3) million and $(153.9) million, respectively, compared to $27.5 million and $91.0 million, respectively, for the same periods in the prior year.

The change in total other income (expense), net of $68.8 million for the three months ended September 30, 2025, compared to 2024 was primarily due to a decrease in gain on deconsolidation of subsidiaries of $52.0 million, and an increase in noncash interest expense on deferred royalty obligations of $36.4 million, partially offset by a decrease in interest expense of $11.3 million, and an increase in other income of $7.8 million related to noncash income from the Company’s equity method investment.

The change in total other income (expense), net of $244.9 million for the nine months ended September 30, 2025, compared to 2024 was primarily due to a decrease in gain on deconsolidation of subsidiaries of $178.3 million, an increase in noncash interest expense on deferred royalty obligations of $86.5 million, and an increase in net loss from equity method investments of $37.1 million; partially offset by a decrease in interest expense of $28.0 million, an increase in other income of $11.1 million for the change in fair value of the embedded derivative liability component of the Company’s deferred royalty obligation, an increase in other income of $7.5 million for services provided under the transition service agreements, and an increase in other income of $7.8 million related to noncash income from the Company’s equity method investment.

Net Loss Attributable to Common Stockholders of BridgeBio and Net Loss per Share

For the three and nine months ended September 30, 2025, the Company recorded a net loss attributable to common stockholders of BridgeBio of $182.7 million and $532.1 million, respectively, compared to $162.0 million and $270.7 million, respectively, for the same periods in the prior year.

For the three and nine months ended September 30, 2025, the Company reported a net loss per share of $0.95 and $2.79, respectively, compared to $0.86 and $1.46, respectively, for the same periods in the prior year.

BRIDGEBIO PHARMA, INC.
Condensed Consolidated Statements of Operations
(in thousands, except shares and per share amounts)

Three Months Ended September 30, Nine Months Ended September 30,
2025 2024 2025 2024
(Unaudited) (Unaudited)
Revenues:
Net product revenue $ 108,111 $ — $ 216,351 $ —
License and services revenue 8,311 2,732 125,441 216,020
Royalty revenue 4,278 — 6,106 —
Total revenues, net 120,700 2,732 347,898 216,020
Operating costs and expenses:
Cost of revenues:
Cost of goods sold 4,028 — 8,910 —
Cost of license, services and royalty revenue 2,535 598 3,945 1,794
Total cost of revenues 6,563 598 12,855 1,794
Research and development 112,874 120,444 335,536 376,111
Selling, general and administrative 137,621 68,819 373,140 194,149
Restructuring, impairment and related charges 8,841 4,621 10,216 10,912
Total operating costs and expenses 265,899 194,482 731,747 582,966
Loss from operations (145,199 ) (191,750 ) (383,849 ) (366,946 )
Other income (expense), net:
Interest income 6,239 3,296 15,522 12,566
Interest expense (11,739 ) (23,061 ) (41,467 ) (69,469 )
Noncash interest expense on deferred royalty obligations (1) (36,410 ) — (86,460 ) —
Gain on deconsolidation of subsidiaries — 52,027 — 178,321
Loss on extinguishments of debt — — (21,155 ) (26,590 )
Net loss from equity method investments (15,834 ) (6,563 ) (51,579 ) (14,488 )
Other income, net 16,461 1,797 31,240 10,648
Total other income (expense), net (41,283 ) 27,496 (153,899 ) 90,988
Loss before income taxes (186,482 ) (164,254 ) (537,748 ) (275,958 )
Provision for (benefit from) income taxes (1,545 ) — 555 —
Net loss (184,937 ) (164,254 ) (538,303 ) (275,958 )
Net loss attributable to redeemable convertible noncontrolling interests and noncontrolling interests 2,194 2,214 6,235 5,246
Net loss attributable to common stockholders of BridgeBio $ (182,743 ) $ (162,040 ) $ (532,068 ) $ (270,712 )
Net loss per share attributable to common stockholders of BridgeBio, basic and diluted $ (0.95 ) $ (0.86 ) $ (2.79 ) $ (1.46 )
Weighted-average shares used in computing net loss per share attributable to common stockholders of BridgeBio, basic and diluted 191,854,152 188,510,372 190,845,133 184,947,173

(1) Including related party amounts of $(5,383) and $(5,560) for the three and nine months ended September 30, 2025, respectively.

Three Months Ended September 30,
Nine Months Ended September 30,
Stock-based Compensation 2025 2024 2025 2024
(Unaudited) (Unaudited)
Cost of goods sold $ 361 $ — $ 578 $ —
Research and development 12,328 12,124 37,582 29,840
Selling, general and administrative 21,866 14,969 63,077 47,511
Restructuring, impairment and related charges 709 38 755 81
Total stock-based compensation $ 35,264 $ 27,131 $ 101,992 $ 77,432


BRIDGEBIO PHARMA, INC.
Condensed Consolidated Balance Sheets
(In thousands)

September 30,
2025 December 31,
2024
(Unaudited) (1)
Assets
Cash, cash equivalents and marketable securities $ 645,942 $ 681,101
Accounts receivable, net 116,518 4,722
Inventories 24,527 —
Prepaid expenses and other current assets 52,395 34,869
Investment in nonconsolidated entities 92,168 143,747
Property and equipment, net 5,830 7,011
Operating lease right-of-use assets 6,553 5,767
Intangible assets, net 28,795 23,926
Other assets 25,522 18,195
Total assets $ 998,250 $ 919,338
Liabilities, Redeemable Convertible Noncontrolling Interests and Stockholders’ Deficit
Accounts payable $ 18,702 $ 9,618
Accrued and other current liabilities (2) 183,517 125,672
Operating lease liabilities 8,721 9,202
Deferred revenue 22,218 31,699
2031 Notes, net 564,087 —
2029 Notes, net 740,380 738,872
2027 Notes, net 546,549 545,173
Term loan, net — 437,337
Deferred royalty obligations, net (3) 836,126 479,091
Other long-term liabilities 679 286
Redeemable convertible noncontrolling interests 23 142
Total BridgeBio stockholders’ deficit (1,933,070 ) (1,467,904 )
Noncontrolling interests 10,318 10,150
Total liabilities, Redeemable Convertible Noncontrolling Interests and Stockholders’ Deficit $ 998,250 $ 919,338

(1) The condensed consolidated financial statements as of and for the year ended December 31, 2024 are derived from the audited consolidated financial statements as of that date.
(2) Including a related party amount of $1,647 as of September 30, 2025.
(3) Including a related party amount of $201,242 as of September 30, 2025.

BRIDGEBIO PHARMA, INC.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(In thousands)

Nine Months Ended September 30,
2025 2024
Operating activities:
Net loss $ (538,303 ) $ (275,958 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation 98,385 65,673
Loss on extinguishments of debt 21,155 26,590
Noncash interest expense on deferred royalty obligations (1) 86,460 —
Amortization of debt discount and issuance costs 4,515 5,399
Depreciation and amortization 3,999 4,708
Noncash lease expense 3,443 3,119
Net loss from equity method investments 51,579 14,488
Change in fair value of the embedded derivative associated with the deferred royalty obligation (11,062 ) —
Noncash income from an equity method investment (7,769 ) —
Gain on deconsolidation of subsidiaries — (178,321 )
Gain from investment in equity securities, net — (8,136 )
Other noncash adjustments, net (1,217 ) (2,059 )
Changes in operating assets and liabilities:
Accounts receivable, net (111,796 ) 1,273
Inventories (23,356 ) —
Prepaid expenses and other current assets (17,527 ) (17,543 )
Other assets 568 (428 )
Accounts payable 9,084 5,257
Accrued compensation and benefits 3,212 5,580
Accrued research and development liabilities 347 15,454
Operating lease liabilities (4,757 ) (4,459 )
Deferred revenue (9,480 ) 20,575
Other liabilities (2) 53,030 (6,612 )
Net cash used in operating activities (389,490 ) (325,400 )
Investing activities:
Purchases of marketable securities (10,876 ) (93,811 )
Maturities of marketable securities 8,000 95,000
Purchases of investments in equity securities — (20,271 )
Proceeds from sales of investments in equity securities — 63,229
Proceeds from special cash dividends received from an investment in equity securities 2,302 25,682
Payment for intangible assets (8,495 ) (4,785 )
Purchases of property and equipment (1,064 ) (886 )
Decrease in cash and cash equivalents resulting from deconsolidation of subsidiaries — (140 )
Net cash provided by (used in) investing activities (10,133 ) 64,018
Financing activities:
Proceeds from issuance of 2031 Notes 575,000 —
Issuance costs and discounts associated with 2031 Notes (12,034 ) —
Repurchase of common stock (48,276 ) —
Proceeds from a royalty obligation under the Royalty Purchase Agreement 300,000 —
Issuance costs associated with a royalty obligation under the Royalty Purchase Agreement (3,010 ) —
Proceeds from term loan under the Amended Financing Agreement — 450,000
Issuance costs and discounts associated with term loan under the Amended Financing Agreement — (15,986 )
Repayment of term loans (459,000 ) (473,417 )
Repayments of deferred royalty obligations (3) (6,896 ) —
Proceeds from issuance of common stock through public offerings, net — 314,741
Proceeds from common stock issuances under ESPP 6,414 4,502
Proceeds from stock option exercises, net of repurchases 14,523 808
Transactions with noncontrolling interests 1,550 —
Repurchase of RSU shares to satisfy tax withholding (6,796 ) (6,122 )
Net cash provided by financing activities 361,475 274,526
Net increase (decrease) in cash, cash equivalents and restricted cash (38,148 ) 13,144
Cash, cash equivalents and restricted cash at beginning of period 683,244 394,732
Cash, cash equivalents and restricted cash at end of period $ 645,096 $ 407,876

(1) Including a related party amount of $5,560 for the nine months ended September 30, 2025.
(2) Including a related party amount of $1,647 for the nine months ended September 30, 2025.
(3) Including a related party amount of $(665) for the nine months ended September 30, 2025.

Nine Months Ended September 30,
2025 2024
Supplemental Disclosure of Cash Flow Information:
Cash paid for interest $ 43,670 $ 78,236
Cash paid for income taxes $ 1,153 $ —
Supplemental Disclosures of Noncash Investing and Financing Information:
Unpaid property and equipment $ 12 $ 274
Transfers to noncontrolling interests $ (4,734 ) $ (4,719 )
Reconciliation of Cash, Cash Equivalents and Restricted Cash:
Cash and cash equivalents $ 642,951 $ 266,324
Restricted cash — Included in "Prepaid expenses and other current assets" 126 139,409
Restricted cash — Included in "Other assets" 2,019 2,143
Total cash, cash equivalents and restricted cash at end of periods shown in the condensed consolidated
statements of cash flows $ 645,096 $ 407,876

Webcast Information
BridgeBio will host its quarterly earnings call and simultaneous webcast on Wednesday, October 29th 2025 at 4:30 pm ET. To access the live webcast of BridgeBio’s presentation, please visit the "Events" page within the Investors section of the BridgeBio website at View Source or register online using the following link, View Source A replay of the conference call and webcast will be archived on the Company’s website and will be available for at least 30 days following the event.

(Press release, BridgeBio, OCT 29, 2025, View Source [SID1234657114])

Recursion Pharmaceuticals, Inc. (the “Company” or “Recursion”) announced the exercise of the option by Roche

On October 29, 2025 Recursion Pharmaceuticals, Inc. (the "Company" or "Recursion") reported the exercise of the option by Roche (as defined below) for a Microglia Map—a first-of-its-kind whole genome map of the brain’s immune cells—generated by Recursion under the Collaboration and License Agreement with Genentech, Inc. and F. Hoffmann-La Roche Ltd (collectively "Roche") dated December 5, 2021 (the "Agreement"). Pursuant to the terms of the Agreement, Roche will pay to the Company an Acceptance Fee of $30 million.

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(Press release, Recursion Pharmaceuticals, OCT 29, 2025, View Source [SID1234657113])