On August 13, 2025 Flatiron Health reported eight abstracts leveraging its high-quality multimodal data have been accepted for poster presentation and e-Poster presentation at the IASLC 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Barcelona, Spain (Press release, Flatiron Health, AUG 13, 2025, View Source [SID1234655219]).

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"AI is a transformative force enabling scale, speed, and novel insights that were previously impossible. By harnessing advanced AI across our global network of more than five million people with cancer, we’re setting a new standard for real-world data at scale," said Nathan Hubbard, Chief Business Officer, Flatiron Health. "Our research at this year’s World Conference on Lung Cancer exemplifies how high-quality, multimodal real-world data combined with responsible AI practices can illuminate treatment patterns, measure effectiveness, and reveal where innovation is most urgently needed."

A highlight of Flatiron’s presence at WCLC 2025 is the first published research leveraging the Flatiron Health–Caris Life Sciences Clinical-Molecular Database (CMDB), the largest and most robust multimodal dataset of its kind, to identify a novel gene signature that predicts risk of liver metastasis in patients with advanced non-small cell lung cancer (NSCLC). By integrating high-quality clinical data with comprehensive molecular profiling, the research addresses a critical unmet need—providing clinicians with a new tool to identify high-risk patients and potentially enable more personalized surveillance and treatment strategies.

Additional highlights include:

a poster highlighting ongoing gaps in biomarker testing after assessing over 13,000 patients with NSCLC in the US and UK
a poster providing new insights into how NSCLC is managed in the UK, including details on the most commonly used treatments, patterns in biomarker testing, and overall survival outcomes
Schedule a meeting with Flatiron Health at WCLC 2025 and follow Flatiron Health on X and LinkedIn for more updates from #WCLC25.

Abstracts and Poster Presentations
A Novel Predictive Gene Signature for Liver Metastasis (LM) in NSCLC Using a Comprehensive Linked Clinical-Molecular Database
Partner: Caris Life Sciences
Poster
Session: P2.06 – Pathology and Biomarkers
Presentation Number: P2.06.45
Location: Exhibit Hall
Session Start/End: Monday, September 8, 10:30AM – 12PM

Real-world Biomarker Testing and Treatment Initiation in Patients with Resected Early-stage NSCLC (eNSCLC) in the US and UK
Poster
Session: P1.07 – Early-Stage Non-small Cell Lung Cancer
Presentation Number: P1.07.05
Location: Exhibit Hall
Session Start/End: September 7, 10:30AM – 12PM

Real-World Outcomes of Prophylactic Cranial Irradiation in Extensive-Stage Small Cell Lung Cancer Treated with First-Line Immunotherapy and Platinum-Etoposide
Poster
Session: P3.13 – Small Cell Lung Cancer and Neuroendocrine Tumors
Presentation Number: P3.13.10
Location: Exhibit Hall
Session Start/End: September 9, 10 – 11:30AM

Real-World Survival Outcomes in Non–Small Cell Lung Cancer: Insights from UK EHR-Derived Data
E-Poster
Session: EP.17 – Global Health, Health Services, and Health Economics
Presentation Number: EP.17.34

Disease Burden and rwPFS as a Surrogate Endpoint for rwOS in NTRK+ NSCLC and Other Advanced/Metastatic Solid Tumors
Partners: Bristol-Myers Squibb, University of Colorado Cancer Center
E-poster
Session: EP.12 – Metastatic Non-small Cell Lung Cancer – Targeted Therapy
Presentation Number: EP.12.23

Real-World Treatment Patterns in ES-SCLC Highlight Continued Unmet Medical Need in the Era of New Therapies: ESSENCE Study
Partners: Montefiore Medical Center, GSK, Rush University
E-poster
Session: EP.13 – Small Cell Lung Cancer and Neuroendocrine Tumors
Presentation Number: EP.13.25

Evolving Treatment Patterns in Early-Stage Non-Small Cell Lung Cancer in the United States
Partners: Lilly
E-poster
Session: EP.17 – Global Health, Health Services, and Health Economics
Presentation Number: EP.17.33

Real-World Treatment Patterns and Clinical Outcomes in Patients With Metastatic Neuroendocrine Neoplasms of the Lung (NEN-L)
Partners: Merck & Co
E-poster
Session: EP.13 – Small Cell Lung Cancer and Neuroendocrine Tumors
Presentation Number: EP.13.44

On August 12, 2025 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease and cancer, reported a business and financial update for the second quarter 2025 (Press release, Cue Biopharma, AUG 12, 2025, View Source [SID1234655132]).

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"We made significant progress during the second quarter with highly encouraging clinical data from our ongoing Phase 1b clinical trial, supporting our belief that CUE-101, representative of the CUE-100 series, has the potential to establish a new standard of care for HPV+ HNSCC patients," said Daniel Passeri, chief executive officer of Cue Biopharma. "These maturing data, together with the continued advancements of our lead autoimmune programs, reinforces our commitment to provide patients with more effective and well tolerated therapies to treat serious disease."

Business Highlights

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Received FDA feedback on Pre-IND Briefing Document reinforcing Company’s intention to advance IND submission for CUE-401 to address unmet need in the treatment of autoimmune disease.
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Announced strategic research collaboration and license agreement with Boehringer Ingelheim to develop and commercialize CUE-501, a differentiated B cell depletion therapy for autoimmune and inflammatory diseases.
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Upfront payment of $12 million and ~$345 million in potential milestone payments
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Raised approximately $20 million through a public offering.
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Hosted virtual investor event, Mobilizing the Immune System: Cue Biopharma’s Novel Biologics Portfolio, featuring key opinion leaders, Richard DiPaolo, PhD, and Andrew Cope, MD PhD.

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Poster presentation delivered by Dana-Farber Cancer Institute at the American Society of Gene & Cell Therapy Annual Meeting presented proof-of-concept data on CUE-101 and its potential to control CAR-T cell expansion and persistence in vivo.
Reported new complete response and confirmed 50% overall response rate (ORR) in ongoing Phase 1 trial of CUE-101 and pembrolizumab (KEYTRUDA) in recurrent/metastatic HPV+ head and neck cancer. Data observed included 12-month overall survival of 88% and median overall survival (mOS) of 32 months.

Second Quarter 2025 Financial Results
The Company reported collaboration revenue of $3.0 million and $2.7 million for the three months ended June 30, 2025 and 2024, respectively. The increase was due to the timing of revenue earned from the collaboration and license agreement with Boehringer Ingelheim International GmbH (BI).

Research and development expenses were $7.9 million and $9.5 million for the three months ended June 30, 2025 and 2024, respectively. The decrease was primarily due to decreases in clinical trials costs and employee compensation.

General and administrative expenses were $3.7 million and $3.5 million for the three months ended June 30, 2025 and 2024, respectively. The increase was primarily due to an increase in professional fees.

On August 12, 2025 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies, reported financial results for the second quarter and year ended June 30, 2025 (Press release, Nkarta, AUG 12, 2025, View Source [SID1234655159]).

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"We remain focused on the execution of our clinical trials and continue to believe in the differentiated potential of NK cell therapy to address unmet needs in the treatment of autoimmune diseases," said Paul J. Hastings, CEO of Nkarta. "Welcoming Dr. Rose and other key new members of our clinical team with rheumatology experience has provided us with world-class medical expertise to inform our ongoing enrollment of patients across our clinical studies and investigator-sponsored trials. Dr. Rose’s track record as a seasoned rheumatologist, immunologist and accomplished drug developer in the autoimmune space will be invaluable as we continue to advance our NKX019 clinical trial programs."

NKX019 Clinical Program Progress and Upcoming Milestones

NKX019 clinical programs in autoimmune diseases continue to enroll patients. This includes Ntrust-1, Ntrust-2 and two investigator-sponsored trials.
Preliminary data from the Ntrust-1 and Ntrust-2 clinical trials is planned for release in the second half of 2025.
Other Corporate Updates

Shawn Rose, M.D. Ph.D, was appointed Chief Medical Officer and Head of Research and Development in June 2025. In previous roles with Johnson & Johnson, BMS and emerging biopharma companies, Dr. Rose brought forward more than a dozen programs from discovery into clinical development, and he has developed multiple pioneering approved medicines for autoimmune conditions.
Second Quarter 2025 and Recent Financial Highlights

Nkarta had cash, cash equivalents, restricted cash, and investments in marketable securities of $334.0 million as of June 30, 2025.
Research and development (R&D) expenses were $20.8 million for the second quarter of 2025. Non-cash stock-based compensation expense included in R&D expense was $0.9 million for the second quarter of 2025.
General and administrative (G&A) expenses were $6.4 million for the second quarter of 2025. Non-cash stock-based compensation expense included in G&A expense was $1.2 million for the second quarter of 2025.
Net loss was $23.0 million, or $0.31 per basic and diluted share, for the second quarter of 2025. This net loss includes non-cash charges of $3.4 million that consisted primarily of share-based compensation and depreciation expenses.
Financial Guidance

Nkarta expects its current cash and cash equivalents will be sufficient to fund its current operating plan into 2029.
About the Ntrust℠ Clinical Trials in Autoimmune Disease
Ntrust-1 (NCT06557265) and Ntrust-2 (NCT06733935) are multi-center, open label, dose escalation clinical trials that build on academic studies of durable, drug-free remissions in patients with autoimmune disease after CD19-targeted cell therapy. Both trials will assess the safety of NKX019 in people living with autoimmune diseases as well as its ability to enable long-term remissions via a "reset" of the immune system through the elimination of pathogenic B cells.

Ntrust-1 is initially enrolling up to 24 patients with lupus nephritis or primary membranous nephropathy. Ntrust-2 is initially enrolling up to 36 patients with systemic sclerosis, idiopathic inflammatory myopathy, or ANCA-associated vasculitis.

In both studies, patients receive a three-dose cycle of NKX019 on Days 0, 3, and 7 following lymphodepleting conditioning with either fludarabine and cyclophosphamide or cyclophosphamide alone. Leveraging the engineering of NKX019, no patients in either trial will receive supplemental cytokines or antibody-based therapeutics. This approach is designed to evaluate the single-agent activity of NKX019 and facilitate a more rapid path to regulatory approval. Patients in Ntrust-1 may also receive additional cycles, if necessary, to restore response.

About the Investigator-Sponsored Clinical Trial of NKX019 for Generalized Myasthenia Gravis
The single-arm, open-label Phase 1 investigator-sponsored clinical trial is designed to enroll patients with generalized myasthenia gravis and will evaluate safety and clinical outcomes. Translational and biomarker studies, including autoantibodies, cytokine profiles and pharmacokinetics are planned. Patients receive 3 doses of NKX019 following lymphodepletion. The clinical trial is being co-led by Ali A. Habib, M.D., Clinical Professor of Neurology at the University of California, Irvine, and other investigators.

About the Investigator-Sponsored Clinical Trial of NKX019 for Systemic Lupus Erythematosus
The single-center, single-arm, open-label Phase 1 investigator-sponsored clinical trial (NCT06518668) is designed to enroll up to 6 patients with systemic lupus erythematosus, regardless of renal involvement, and will evaluate safety and clinical outcomes in a potentially different population than Ntrust-1. Translational and biomarker studies, including autoantibodies, cytokine profiles and pharmacokinetics are planned. Patients receive 3 doses of NKX019 following lymphodepletion. The clinical trial is being led by Anca D. Askanase, M.D., M.P.H., Director, Lupus Center at Columbia University Irving Medical Center and the Director of Rheumatology Clinical Trials.

About NKX019
NKX019 is an allogeneic, cryopreserved, off-the-shelf immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed chimeric antigen receptor (CAR) for enhanced cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal B cells as well as those implicated in autoimmune disease. Nkarta is evaluating NKX019 in multiple autoimmune conditions.

On August 12, 2025 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported business updates and reported financial results for the fiscal quarter ended June 30, 2025 (Press release, Erasca, AUG 12, 2025, View Source [SID1234655133]).

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"We are excited by the continued momentum of our RAS-targeting franchise, including its early advancement into the clinic, which has broad application in multiple areas of high unmet medical need," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "Importantly, we expect to deliver initial Phase 1 monotherapy data for our potential best-in-class pan-RAS molecular glue ERAS-0015 and our potential first-in-class and best-in-class pan-KRAS inhibitor ERAS-4001 in 2026. Backed by a robust balance sheet and anticipated cash runway into the second half of 2028, we believe that we are strongly equipped to advance our differentiated approaches against this challenging oncogenic driver and bring new hope to patients with RAS-driven tumors."

Research and Development (R&D) Highlights

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IND Cleared for ERAS-4001: In June 2025, Erasca announced clearance of an investigational new drug (IND) application with the United States Food and Drug Administration (FDA) for its pan-KRAS inhibitor ERAS-4001 for patients with KRAS-mutant (KRASm) solid tumors, which is being evaluated in the BOREALIS-1 Phase 1 trial.

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IND Cleared for ERAS-0015: In May 2025, Erasca announced clearance of an IND application with the FDA for its pan-RAS molecular glue ERAS-0015 for patients with RAS-mutant (RASm) solid tumors, which is being evaluated in the AURORAS-1 Phase 1 trial.

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Presented Encouraging Preclinical Data for RAS-Targeting Franchise: In April 2025, Erasca presented new preclinical data reinforcing the potential best-in-class profiles of Erasca’s RAS-targeting franchise at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.
Key Upcoming Milestones

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AURORAS-1: Phase 1 trial for ERAS-0015 (pan-RAS molecular glue) in patients with RASm solid tumors
o
Initial Phase 1 monotherapy data expected in 2026
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BOREALIS-1: Phase 1 trial for ERAS-4001 (pan-KRAS inhibitor) in patients with KRASm solid tumors
o
Initial Phase 1 monotherapy data expected in 2026

Second Quarter 2025 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $386.7 million as of June 30, 2025, compared to $440.5 million as of December 31, 2024. Erasca expects its cash, cash equivalents, and marketable securities balance of $386.7 million to fund operations into the second half of 2028.

Research and Development (R&D) Expenses: R&D expenses were $21.2 million for the quarter ended June 30, 2025, compared to $33.0 million for the quarter ended June 30, 2024. The decrease was primarily driven by an impairment charge on operating lease assets and property and equipment during the quarter ended June 30, 2024, and decreases in personnel costs, including stock-based compensation expense, outsourced services and consulting fees, expenses incurred in connection with clinical trials, preclinical studies, and discovery activities, and facilities-related expenses and depreciation. Erasca also recorded $7.5 million and $22.5 million of in-process R&D expense during the quarters ended June 30, 2025 and 2024, respectively, for upfront and milestone payments under Erasca’s ERAS-0015 and ERAS-4001 license agreements.

General and Administrative (G&A) Expenses: G&A expenses were $9.5 million for the quarter ended June 30, 2025, compared to $12.3 million for the quarter ended June 30, 2024. The decrease was primarily driven by an impairment charge on operating lease assets and property and equipment during the quarter ended June 30, 2024, and a decrease in legal fees.

Net Loss: Net loss was $33.9 million, or $(0.12) per basic and diluted share, for the quarter ended June 30, 2025, compared to $63.2 million, or $(0.29) per basic and diluted share, for the quarter ended Ju

On August 12, 2025 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported financial results and operational updates for the quarter ended June 30, 2025 (Press release, ORIC Pharmaceuticals, AUG 12, 2025, View Source [SID1234655160]).

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"In the first half of the year, we’ve continued to make steady progress towards the potential initiation of Phase 3 studies in 2026 for ORIC-944 in prostate cancer and ORIC-114 (now enozertinib) in lung cancer, and we were pleased to further strengthen our cash position and runway with recent financing activity," stated Jacob M. Chacko, M.D., president and chief executive officer. "As our clinical programs have progressed closer to registrational studies, it necessitates that we increase our focus and direct our expenditures solely on those programs, and so we’ve made the tough, but prudent, decision to substantially reduce our investment in discovery research. This reprioritization and additional financing further extend our cash runway into the second half of 2028. It’s with a heavy heart that we say goodbye to our colleagues impacted by the resulting workforce reduction. We are grateful for their many contributions to ORIC, we’re deeply sorry for the upheaval they are experiencing, and we sincerely hope to honor them by advancing our clinical pipeline to benefit patients as rapidly as possible."

Second Quarter 2025 and Other Recent Highlights

ORIC-944: a potent and selective allosteric inhibitor of PRC2

Reported preliminary efficacy and safety data in May 2025, from the ongoing Phase 1b trial of ORIC-944 in combination with AR inhibitors, supporting the potential of ORIC-944 as a best-in-class PRC2 inhibitor that may benefit a broad range of patients with prostate cancer. The data reported as of the May 2025 presentation cutoff dates included:
Broad and deep PSA responses achieved, with 59% PSA50 response rate (confirmed rate of 47%) and 24% PSA90 response rate (all confirmed) in patients with metastatic castration-resistant prostate cancer (mCRPC).
PSA responses were observed across all ORIC-944 dose levels and at comparable rates in combination with apalutamide and with darolutamide; majority of patients were still ongoing with multiple patients approaching one year or more.
Both combination regimens demonstrated a safety profile compatible with long term dosing, with the vast majority of adverse events Grade 1 or 2 and no Grade 4 events.
Presented preclinical ORIC-944 data at the 2025 AACR (Free AACR Whitepaper) Annual Meeting demonstrating synergistic activity and improved progression-free survival when combined with androgen receptor pathway inhibitors in both castration-resistant and castration-sensitive prostate cancer models, validating the clinical exploration of ORIC-944 across the continuum of prostate cancer.
Enozertinib (formerly ORIC-114): a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations

Continue to enroll Phase 1b trial of enozertinib as a single-agent in patients with advanced non-small cell lung cancer (NSCLC) with EGFR exon 20, HER2 exon 20, or EGFR atypical mutations, including patients with CNS metastases that are either treated or untreated but asymptomatic, across our 2L+ dose optimization cohorts and 1L expansion cohorts.
Continue to enroll Phase 1b trial of enozertinib in combination with subcutaneous (SC) amivantamab in 1L NSCLC patients with EGFR exon 20 mutations.
The World Health Organization International Nonproprietary Names (INN) expert committee has approved "enozertinib" as the nonproprietary (generic) name for ORIC-114.
Corporate Highlights:

Completed a $125 million private placement financing with participation from new and existing healthcare specialist funds and $119 million in issuances from the ATM (at-the-market) facility. Given current cash and investment position, the Company concluded ATM usage and doesn’t expect to utilize the ATM facility for the foreseeable future.
Announced strategic pipeline prioritization to focus operational and financial resources on the continued advancement of the two lead clinical programs, ORIC-944 and enozertinib. This initiative will result in the elimination of the discovery research group with a corresponding 20% workforce reduction. The Company expects to incur a one-time charge of approximately $1.9 million in the third quarter, primarily related to termination benefits, including severance and healthcare-related benefits. The Company will explore potential partnering of its preclinical programs.
As a result of the strategic pipeline prioritization, cash runway is expected to fund the revised operating plan into 2H 2028 (previously 2H 2027), which is beyond anticipated primary endpoint readouts from the first Phase 3 trials for ORIC-944 and enozertinib.
Anticipated Program Milestones:

ORIC anticipates the following upcoming data milestones:

ORIC-944 (mCRPC):
2H 2025: Updated Phase 1b combination data with AR inhibitor(s)
1Q 2026: Combination dose optimization data with AR inhibitor(s)
Enozertinib (ORIC-114) (NSCLC):
2H 2025: 1L EGFR exon 20, 2L EGFR exon 20, 2L+ HER2 exon 20 and 2L+ EGFR atypical data
Mid-2026: 1L EGFR atypical data and 1L EGFR exon 20 combination with SC amivantamab data
Second Quarter 2025 Financial Results

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $327.7 million as of June 30, 2025, which includes proceeds from $125.0 million private placement financing in May 2025 and $8.9 million in proceeds from an at-the-market offering of common stock during the quarter. Subsequent to the quarter ended June 30, 2025, the Company raised an additional $108.7 million in net proceeds under the ATM program resulting in proforma cash and investments of $436.4 million as of June 30, 2025. The Company now expects its cash and investments to fund the revised operating plan into 2H 2028.
R&D Expenses: Research and development (R&D) expenses were $30.5 million for the three months ended June 30, 2025, compared to $28.9 million for the three months ended June 30, 2024, an increase of $1.6 million. For the six months ended June 30, 2025, R&D expenses were $55.2 million, compared to $50.9 million for the six months ended June 30, 2024, an increase of $4.3 million. The increases were due to higher personnel costs, including additional non-cash stock-based compensation, and costs related to the advancement of enozertinib, offset primarily by lower costs from discontinued programs.
G&A Expenses: General and administrative (G&A) expenses were $8.5 million for the three months ended June 30, 2025, compared to $7.1 million for the three months ended June 30, 2024, an increase of $1.4 million. For the six months ended June 30, 2025, G&A expenses were $16.6 million, compared to $14.1 million for the six months ended June 30, 2024, an increase of $2.5 million. The increases were primarily due to higher personnel costs and professional services, including additional non-cash stock-based compensation.