On August 6, 2025 Aligos Therapeutics, Inc. (Nasdaq: ALGS, "Aligos"), a clinical stage biotechnology company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, reported recent business progress and financial results for the second quarter 2025 (Press release, Aligos Therapeutics, AUG 6, 2025, View Source [SID1234654853]).

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"Initiation of the Phase 2 B-SUPREME study of ALG-000184 is well underway with regulatory approvals across a number of countries, including the US, China, Canada, Taiwan, UK, New Zealand, and Moldova," stated Lawrence Blatt, Ph.D., M.B.A., Chairman, President, and Chief Executive Officer of Aligos Therapeutics. "Site activations are in progress, subjects are being screened, and we expect dosing to commence in the coming weeks. This pertinent study is the next step in our journey to potentially deliver better therapies for patients living with HBV infection and create value for our stakeholders. The Phase 1 data showcasing 96 weeks of treatment presented at the EASL meeting suggests that ALG-000184 has the potential to replace standard of care treatment for chronic suppression of HBV infection and may become the backbone of treatments aimed at a functional cure. We remain excited about the potential of ALG-000184 and the entirety of our pipeline, including ALG-055009 which remains in discussions with potential partners."

Recent Business Progress

Pipeline Updates

ALG-000184: Potential first-/best-in-class small molecule CAM-E for chronic hepatitis B virus (HBV) infection

The Phase 2 B-SUPREME study (NCT04746183) of ALG-000184 in subjects with chronic HBV infection recently began obtaining regulatory approvals, activating global sites, and screening subjects. Dosing is expected to commence in the coming weeks.
The study is designed as a randomized, double-blind, active-controlled multicenter study evaluating the safety and efficacy of ALG-000184 monotherapy compared with tenofovir disoproxil fumarate in approximately 200 untreated HBeAg+ and HBeAg- adult subjects with chronic HBV infection for 48 weeks. The primary endpoint in the HBeAg+ part will be HBV DNA 96-week dosing recently completed in the Phase 1 study and data readouts, including post-treatment data, are planned for scientific conferences this year. Interim data from up to 96 weeks following an oral daily dose of 300 mg ALG-000184 in both HBeAg+ and HBeAg- subjects with chronic HBV infection were presented at the European Association for the Study of the Liver (EASL) Congress 2025.
ALG-000184 administered for up to 96 weeks was well tolerated by study participants, exhibited a favorable PK profile, and suggested potentially best-in-class antiviral activity.
In HBeAg+ subjects with a very high mean HBV DNA level of 8.0 log10 IU/mL at baseline, all experienced profound and persistent HBV DNA reductions after receiving an oral daily dose of 300 mg ALG-000184 monotherapy. At Week 48, 6 of 10 subjects (60%) achieved HBV DNA < LLOQ (10 IU/mL, target detected or target not detected). With treatment extension, this rate increased to 9 of 9 subjects (100%) at Week 96. Additionally, HBV DNA level continuously declined to < LLOQ (10 IU/mL, target not detected) in 5 of 9 subjects at Week 96.
In HBeAg- subjects, all 11 (100%) had rapid decline in HBV DNA levels and achieved sustained HBV DNA suppression (HBV DNA < LLOQ (10 IU/mL, target detected or target not detected)) by Week 24. The HBV DNA suppression level was maintained in the ALG-000184 monotherapy cohort for up to 96 weeks, with further decline in HBV DNA to < LLOQ (10 IU/mL, target not detected), observed in all subjects (8/8) at Week 96.
Multi-log10 reductions in HBsAg, HBeAg, and HBcrAg were observed in HBeAg+ subjects, and HBcrAg decline was observed in HBeAg- subjects.
In both patient populations in this study, ALG-000184 was well tolerated with no viral breakthrough observed and no known CAM resistant mutations identified with monotherapy treatment.
ALG-055009: Potential best-in-class small molecule THR-β agonist for metabolic dysfunction-associated steatohepatitis (MASH)

The Phase 2a HERALD data were presented at EASL 2025, demonstrating that ALG-055009 dose groups met the primary endpoint with statistically significant reductions in liver fat at week 12 as measured by MRI-PDFF.
Additionally, new data demonstrated substantial, dose-dependent reductions in liver fat were observed across all key subgroups with 12 weeks of once daily ALG-055009 treatment. Statistically significant improvements in atherogenic lipids were achieved with 12 weeks of ALG-055009 treatment. Reductions in lipids/lipoproteins were observed even in the context of stable GLP-1 agonist or statin use. This data suggests a potential added benefit of ALG-055009 for patients at risk for cardiovascular disease in addition to the previously reported liver fat lowering properties in a MASLD/MASH population.
As shared previously, ALG-055009 demonstrated a favorable tolerability profile with no evidence of clinical hyper/hypothyroidism. Incidence of gastrointestinal-related treatment emergent adverse events were similar in ALG-055009 dose groups compared to placebo. Specifically, similar rates of diarrhea were observed in ALG-055009 dose groups compared to placebo, with no dose-response. Significant reductions in atherogenic lipids, including LDL-C, lipoprotein (a), and apolipoprotein B, were also observed (Loomba et al, AASLD 2024).
The company is continuing to evaluate a variety of options to fund continued development, including potential out-licensing.
ALG-097558: Potential best-in-class ritonavir-free small molecule pan-coronavirus protease inhibitor

The AGILE platform study (NCT04746183) assessing ALG-097558 monotherapy or in combination with remdesivir in high-risk subjects with COVID-19 began in 2024.
The NIAID is sponsoring a drug-drug interaction and relative bioavailability study of ALG-097558 in healthy volunteers that began dosing in the second quarter of 2025.
The company expects any future development of ALG-097558 to be funded by external sources.
Financial Results for the Second Quarter 2025

Cash, cash equivalents and investments totaled $122.9 million as of June 30, 2025, compared with $56.9 million as of December 31, 2024. Our cash, cash equivalents and investments are expected to provide sufficient funding of planned operations into the second half of 2026.

Net loss for the three months ended June 30, 2025 was $15.9 million or basic and diluted net loss per common share of $(1.53), compared to net income of $5.1 million or basic and diluted net income per common share of $0.81 for the three months ended June 30, 2024.

Research and development (R&D) expenses for the three months ended June 30, 2025 were $14.0 million, compared with $21.1 million for the same period of 2024. The decrease was primarily due to a decrease in third-party expenses due to reduced clinical study costs as a result of the completion of the MASH Phase 2a clinical trial, partially offset by increased spend in the chronic HBV infection program. Total R&D stock-based compensation expense incurred for the three months ended June 30, 2025 was $0.6 million, compared with $1.2 million for the same period of 2024.

General and administrative (G&A) expenses for the three months ended June 30, 2025 were $5.6 million, compared with $6.4 million for the same period of 2024. The decrease in G&A expenses for this comparative period is primarily due to a decrease in third-party expenses including legal expenses. Total G&A stock-based compensation expense incurred for the three months ended June 30, 2025 was $0.5 million, compared with $0.9 million for the same period of 2024.

Interest and other income, net, was income of $1.2 million each for the three months ended June 30, 2025 and June 30, 2024.

Change in fair value of 2023 common warrants for the three months ended June 30, 2025 was income of $1.7 million compared with income of $30.4 million for the same period of 2024.

On August 6, 2025 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance, reported financial results for the three months ended June 30, 2025 (Press release, Purple Biotech, AUG 6, 2025, View Source [SID1234654869]).

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"Our CAPTN-3 tri-specific antibody platform is differentiated not only by its masked CD3 arm for conditional T cell activation, but also by the addition of an NKG2A arm for additional T cell and NK cell activation, and a third arm targeting the tumor-associated antigen. This approach is supported by other masked TCEs showing early safety and efficacy signals," stated Purple Biotech CEO Gil Efron. "We are focusing our activities on advancing IM1240, our first CAPTN-3 antibody, through IND-enabling studies, with the goal of initiating a Phase 1 study in 2026. Additionally, we have now established a clear path forward for CM24 for its Phase 2b study, utilizing the predictive biomarkers we observed in the Phase 2 trial, and we are seeking partners or investment to support this next study."

Recent Clinical and Corporate Highlights:

CAPTN-3 Tri-Specific Antibody Platform

● Showcased comprehensive in vivo and ex vivo data at EACR 2025, highlighting the synergistic activity of the platform’s masked CD3, NKG2A, and tumor-associated antigen arms

● Platform was spotlighted by Dr. Amir Horowitz at ASGCT (Free ASGCT Whitepaper) 2025 for its approach to targeting the HLA-E/NKG2A axis to selectively activate NK and CD8+ T cells, potentially addressing treatment resistance

● First investigational new drug (IND) application from the CAPTN-3 platform, for IM1240 capped-CD3x5T4xNKG2A antibody, is expected to be submitted in 2026

CM24 (α-CEACAM1 monoclonal antibody)

● Final Phase 2 data for CM24 study presented at AACR (Free AACR Whitepaper) Annual Meeting 2025

● Statistically significant efficacy in biomarker subgroup analyses was observed:

● 78% reduction in risk of death and 81% reduction in risk of progression or death in patients with defined pretreatment ranges of serum or tumor CEACAM1 and 37.5% objective response rate (ORR) in this subgroup compared to 0% in the respective control group.

● 61% reduction in risk of death and 72% reduction in risk of progression or death in patients with defined pretreatment ranges of serum CEACAM1 or myeloperoxidase (MPO) and 31% ORR in this subgroup compared to 0% in the respective control group.

● 90% reduction in risk of death and 81% reduction in risk of progression or death in high tumor CEACAM1 and low PD-L1 combined positive score (CPS) subgroup

● The biomarkers identified in the CM24 Phase 2 study are planned to be used for patient selection in the Phase 2b study

NT219 (IRS1/2 degrader and STAT3 blocker)

● Biomarker insights from the Phase 1 study were presented at AACR (Free AACR Whitepaper) Annual Meeting 2025

● Initiated NT219 Phase 2 study in recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) to evaluate NT219 in combination with pembrolizumab (Keytruda) or cetuximab (Erbitux)

● Phase 2 study is led by Dr. Antonio Jimeno, Professor and Director of the Head and Neck Cancer Program, and Principal Investigator Dr. Alice Weaver, at the University of Colorado Anschutz Medical Campus.

Financial Results for the Three Months Ended June 30, 2025

Research and Development Expenses were $0.6 million for the three months ended June 30, 2025, reflecting a decrease of $1.8 million, or 76.9%, from $2.4 million in the same period of 2024. The decrease was primarily due to reduced costs associated with the CM24 Phase 2 study.

General and Administrative Expenses were $0.7 million for the three months ended June 30, 2025, compared to $1.1 million in the same period of 2024, representing a decrease of $0.4 million, or 36.0%, mainly due to a $0.2 million decrease in a non-cash expense and $0.2 million reduction in cash and non-cash salaries and related expenses.

Operating Loss was $1.2 million for the three months ended June 30, 2025, a decrease of $2.2 million, or 64.3%, compared to $3.5 million in the same period of 2024, mainly due to the decrease in the CM24 Phase 2 study expenses.

Adjusted Operating Loss (as reconciled below) was $1.2 million for the three months ended June 30, 2025, a decrease of $2.0 million, compared to $3.2 million in the same period of 2024, primarily due to the decrease in the CM24 Phase 2 study expenses.

Finance Income, net was $0.1 million for the three months ended June 30, 2025, compared to $1.0 million in the same period of 2024, representing a decrease of $0.9 million, primarily attributable to a decrease in non-cash gain resulting from the revaluation of outstanding warrants.

Net Loss was $1.1 million, or $0.40 per basic and diluted ADS for the three months ended June 30, 2025, compared to a net loss of $2.4 million, or $1.80 per basic and diluted ADS, in the same period of 2024. The decrease in net loss was mainly due to the $2.2 million decrease in operating expenses and $0.9 million decrease in finance income, net.

As of June 30, 2025, Purple Biotech had cash and cash equivalents and short-term deposits of $5.6 million. The Company cash runway is expected into the third quarter of 2026.

On August 6, 2025 Caris Life Sciences (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, reported a new study in Communications Medicine, a Nature portfolio journal, demonstrating that Caris’ AI-based image analysis model has the potential to more accurately predict cancer biomarkers and patient survival than the conventional companion diagnostic (CDx) methods (Press release, Caris Life Sciences, AUG 6, 2025, View Source [SID1234654888]). By analyzing hematoxylin and eosin (H&E) images, the study demonstrated that Caris’ AI model can improve the assessment of critical cancer biomarkers and impact patient survival outcomes in breast and colorectal cancers.

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For this study, Caris’ AI model analyzed data from over 35,000 patients in the Caris clinico-genomic database. In breast cancer, the AI model scored PD-L1 positive phenotype status using an H&E image alone and assessed overall survival of patients treated with pembrolizumab, achieving a hazard ratio (HR) for overall survival of 0.511 (p<0.001), compared to an HR of 0.882 (p>0.1) for traditionally scored PD-L1 IHCs, a result consistent with an almost doubling of overall survival for patients treated with pembrolizumab. In colorectal cancer, AI predicted mismatch repair deficiency (MMRd) and microsatellite instability (MSI) equivalent to traditional scoring.

"Traditional PD-L1 testing can undercall positive cases, especially near the 1% threshold," said Matthew Oberley, MD, PhD, SVP, Chief Clinical Officer and Pathologist-in-Chief at Caris. "Caris’ AI model enhances predictive accuracy, integrating features from both staining methods, and exhibits superior prognostic precision compared to current biomarker assessments. Clinical adoption of this tool could improve the precision and efficiency of cancer patient evaluation and aid clinical decision making."

"This study highlights how AI can significantly improve the accuracy and efficiency of tissue sample evaluation, and down the line, this has the potential to guide immunotherapy decisions and enhance patient outcomes," said George W. Sledge, Jr., MD, Caris EVP and Chief Medical Officer.

The publication can be viewed in its entirety on the Caris Life Sciences website.

On August 6, 2025 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported financial results for the second quarter ended June 30, 2025, and provided a business update (Press release, AnaptysBio, AUG 6, 2025, View Source [SID1234654854]).

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"Rosnilimab’s Phase 2b data in rheumatoid arthritis (RA) delivered a compelling safety and tolerability profile and JAK-like efficacy through six months that is durable for at least three months off-drug. The strength of the data, as well as positive feedback from the KOL community, gives us confidence in the transformational potential of rosnilimab. With enrollment completed in the Phase 2 ulcerative colitis (UC) trial, we look forward to reading out top-line data through Week 12 in Q4 2025, as well as potential additional six- and 12-month data from this trial in 2026," said Daniel Faga, president and chief executive officer of Anaptys. "Additionally, we are excited to announce the initial indication for our CD122 antagonist, ANB033, is celiac disease (CeD), a serious autoimmune disease triggered by the ingestion of gluten, affecting more than 2.1 million people in the U.S. but with no approved therapies. We believe ANB033’s MoA, inhibiting both IL-2 and IL-15 signaling, is well-suited to target the multiple pathogenic drivers of CeD. We plan to initiate a Phase 1b cohort by Q4 2025 and will discuss the program in depth at a dedicated R&D event later this year."

PORTFOLIO UPDATES

Rosnilimab (Pathogenic T Cell Depleter)

Announced positive data for rosnilimab from robust, 424-patient Phase 2b RA trial demonstrating –
Best-in-disease profile with JAK-like efficacy and monthly (Q4W) dosing in both three-month placebo-controlled and six-month​ blinded treatment period
Favorable safety and tolerability, particularly when compared to standard of care biologics or JAK inhibitors
Max response rates have not yet been observed; strict continuation criteria at three months in this Phase 2b trial excluded many patients who either achieved or were trending toward LDA and ACR50
Trial now complete with CDAI LDA responders at Week 28 demonstrating durable responses for at least 12-14 weeks off drug through Week 38
Data consistent with previously reported partial data results through Week 34
Supports potential for maintenance dosing with extended dosing intervals (e.g. Q8W or Q12W)
Safety profile remains favorable and consistent with previously reported data
Plan to present complete RA Phase 2b data at a future medical congress
Enrollment complete for global Phase 2 trial in moderate-to-severe UC (N=136, ~50% advanced therapy experienced)
Assessing Q2W and Q4W dose levels of subcutaneously administered rosnilimab vs. placebo (randomized 1:1:1)
Primary statistical analysis at Week 12 on well-established endpoints, including the primary endpoint of change from baseline in modified Mayo score (mMS) and key secondary endpoints, such as clinical response and remission on mMS
All patients in all three study arms treat-through to Week 24 and remain blinded to treatment arm. Placebo-treated patients who achieved clinical response on partial modified Mayo score (pmMS) at Week 12 remain on placebo, while placebo-treated patients who are non-responders are crossed over to the high dose Q2W rosnilimab treatment arm
Patients who are in clinical response on pmMS at Week 24 are eligible for an additional 26-week (50 weeks of total treatment) blinded treatment extension period (TEP)
Top-line data through Week 12, including primary and key secondary endpoints, on track for Q4 2025
Blinded surveillance data to date suggest a favorable safety and tolerability profile consistent with prior rosnilimab trials
ANB033 (CD122 antagonist)

Phase 1 trial ongoing in healthy volunteers
Plan to initiate Phase 1b cohort for ANB033 in initial indication, celiac disease, by Q4 2025
Additional information to be disclosed at ANB033-focused R&D event in Q4 2025
ANB101 (BDCA2 modulator)

Phase 1 trial ongoing in healthy volunteers
COLLABORATION UPDATES

GSK Immuno-Oncology Financial Collaboration

GSK announced strong commercial performance for Jemperli ($262 million/£196 million in Q2 2025 sales; $482 million/£370 million in 1H 2025 sales) with >19% USD and >12% GBP quarter-over-quarter growth
Anaptys anticipates triggering a one-time $75 million commercial sales milestone from GSK in 2025 once Jemperli achieves $1 billion in worldwide net sales in a calendar year
Substantial GSK investment in additional indications of Jemperli monotherapy and combinations ongoing –
AZUR-1 pivotal Phase 2 trial of dostarlimab monotherapy in patients with untreated stage II/III dMMR/MSI-H locally advanced rectal cancer
Top-line data in H2 2026
Jemperli received U.S. FDA Breakthrough Therapy Designation for this indication
AZUR-2 pivotal Phase 3 trial of perioperative dostarlimab monotherapy versus standard of care in participants with untreated T4N0 or stage III dMMR/ MSI-H resectable colon cancer ongoing
AZUR-4 Phase 2 trial of neoadjuvant dostarlimab plus capecitabine plus oxaliplatin (CAPEOX) versus CAPEOX alone in previously untreated T4N0 or stage III mismatch repair proficient/microsatellite stable resectable colon cancer ongoing
JADE pivotal Phase 3 trial of dostarlimab versus placebo as sequential therapy after chemoradiation in participants with locally advanced unresected head and neck squamous cell carcinoma (HNSCC) ongoing
GSK announced that COSTAR Lung Phase 3 trial did not meet primary endpoint of overall survival
Vanda Imsidolimab Financial Collaboration

Vanda anticipates FDA BLA submission for generalized pustular psoriasis (GPP) in 2H 2025
Anaptys eligible to receive up to $35 million for future regulatory approval, including a $5 million milestone upon U.S. FDA approval, and sales milestones, in addition to a 10% royalty on net sales
FINANCIAL UPDATES

Stock Repurchase Program and Cash Runway

The Company has repurchased a total of 2,853,836 shares of common stock (9.3% shares outstanding) with $55.5 million as of June 30, 2025 from its $75.0 million Stock Repurchase Program
Cash and investments of $293.7 million as of June 30, 2025, and reiterating cash runway through year-end 2027
Second Quarter 2025 Financial Results

Cash, cash equivalents and investments totaled $293.7 million as of June 30, 2025, compared to $420.8 million as of December 31, 2024, for a decrease of $127.1 million due primarily to operating activities and $55.5 million in shares repurchased, offset by $15.0 million received from Vanda Pharmaceuticals for the license of imsidolimab.
Collaboration revenue was $22.3 million and $50.0 million for the three and six months ended June 30, 2025, compared to $11.0 million and $18.2 million for the three and six months ended June 30, 2024. This was due primarily to Jemperli royalties increasing $11.0 million and $22.1 million for the three and six months ended June 30, 2025 and $9.7 million in revenue recognized for the Vanda license agreement.
Research and development expenses were $37.8 million and $79.0 million for the three and six months ended June 30, 2025, compared to $42.0 million and $79.0 million for the three and six months ended June 30, 2024. The decrease for the three months ended June 30, 2025, was primarily due to lower development costs for ANB032 and imsidolimab offset by higher costs relating to the Phase 2 trials in RA and UC for rosnilimab and the Phase 1 trials for ANB033 and ANB101. The R&D non-cash, stock-based compensation expense was $4.5 million and $8.9 million for the three and six months ended June 30, 2025 as compared to $3.5 million and $7.0 million in the same period in 2024.
General and administrative expenses were $10.6 million and $24.7 million for the three and six months ended June 30, 2025, compared to $9.3 million and $21.6 million for the three and six months ended June 30, 2024. The increase was due primarily to transaction costs associated with the Vanda Pharmaceuticals license agreement. The G&A non-cash, stock-based compensation expense was $4.8 million and $9.5 million for the three and six months ended June 30, 2025 as compared to $4.0 million and $10.7 million in the same period in 2024.
Net loss was $38.6 million and $78.0 million for the three and six months ended June 30, 2025, or a net loss per share of $1.34 and $2.62, compared to a net loss of $46.7 million and $90.6 million for the three and six months ended June 30, 2024, or a net loss per share of $1.71 and $3.35.

On August 6, 2025 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported its financial results for the quarter ended June 30, 2025, and provided an update on corporate progress (Press release, Revolution Medicines, AUG 6, 2025, View Source [SID1234654870]).

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The company continues to make meaningful progress on its near-term strategic priorities:

Execute pivotal trials with daraxonrasib monotherapy in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC)

RASolute 302, a global Phase 3 trial of daraxonrasib in patients with previously treated PDAC, continues to enroll well. The company is winding down enrollment in the U.S. while continuing to enroll patients outside the U.S. to support global registration. The company expects to complete enrollment in this trial this year to enable an expected data readout in 2026.

The company recently announced that daraxonrasib received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for previously treated metastatic PDAC in patients with KRAS G12 mutations.

In RASolve 301, a global Phase 3 trial of daraxonrasib in patients with previously treated NSCLC, the company continues enrolling patients in the U.S. and is now activating trial sites in Europe and Japan.

Advance daraxonrasib into earlier line randomized pivotal trials in patients with PDAC and NSCLC

The company remains on track to initiate a registrational trial this year with daraxonrasib as first line treatment for patients with metastatic PDAC; this is planned as a three-arm trial comparing daraxonrasib or daraxonrasib plus chemotherapy to chemotherapy. Later this year, the company expects to share the trial design and clinical combination data that informed this planned trial.

The company also remains on track to initiate a registrational trial this year with daraxonrasib as adjuvant treatment for patients with resectable PDAC and expects to share the trial design later this year.

Based on new clinical data disclosed by the company last quarter indicating that daraxonrasib can be combined productively with pembrolizumab with or without platinum doublet chemotherapy as a first line treatment of patients with RAS mutant NSCLC, the company expects to initiate a Phase 3 registrational trial in this indication in 2026.

Generate sufficient data to inform development priorities for the mutant-selective inhibitors elironrasib and zoldonrasib and prepare to initiate one or more pivotal trials either as monotherapy or in a drug combination

The company continues to study its mutant-selective inhibitors elironrasib and zoldonrasib as monotherapy and in drug combinations.

The company recently reported an updated clinical data set from patients with previously treated KRAS G12C NSCLC treated with elironrasib as monotherapy that showed a highly competitive profile, including differentiated safety and tolerability along with a compelling objective response rate and progression-free survival. The company also showed clinical evidence that elironrasib can be combined productively with pembrolizumab in first line NSCLC patients with an acceptable safety and tolerability profile.

Further, the company recently announced that elironrasib received FDA Breakthrough Therapy Designation for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received prior chemotherapy and immunotherapy but have not been previously treated with a KRAS G12C inhibitor. The company believes this designation is a recognition of the significant unmet medical need and elironrasib’s potential to serve these patients. Currently there are no RAS-targeted inhibitors with full FDA approval for treating patients with KRAS G12C NSCLC.

For zoldonrasib, clinical data presented in April demonstrated acceptable tolerability and encouraging initial antitumor activity in patients with previously treated KRAS G12D NSCLC, which follows encouraging data reported previously in patients with KRAS G12D PDAC.

The company expects to initiate one or more pivotal combination trials in 2026 that incorporate either zoldonrasib or elironrasib.

Progress earlier stage pipeline, including advancing next-generation innovations from the company’s highly productive discovery organization

Clinical development of RMC-5127, a RAS(ON) G12V-selective inhibitor, remains on track to reach a clinic-ready stage in 2025 to enable an expected Phase 1 initiation in 2026.

The company also continues to invest in collaborations designed to enhance its discovery efforts, recently announcing a drug discovery collaboration with Iambic Therapeutics, in which Iambic will use its cutting-edge AI capabilities to generate customized models through training with Revolution Medicines’ proprietary data. This collaboration aims to enhance Revolution Medicines’ lead discovery and optimization processes directed against both current and new drug targets to ensure the company continues building a highly impactful and sustainable pipeline.

Grow global commercialization and operational capabilities and advance launch readiness

The company recently announced a partnership with Royalty Pharma, which provides $2 billion in committed capital to Revolution Medicines upon achievement of agreed-upon milestones through a flexible mix of synthetic royalty and debt instruments. This flexible funding agreement provides the company with strategic agility and ability to secure the resources needed to advance its ambitious global clinical development and commercialization plans. The company continues to grow its commercial and operational capabilities and increase activities in support of a potential launch.

"As we advance our innovative RAS(ON) inhibitors through late-stage development and prepare for potential commercialization, we are scaling the effort to meet the ever-growing opportunities afforded by our pipeline," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "With our maturing pipeline, organizational capabilities and recently bolstered financial wherewithal, we are on a path toward becoming a fully integrated, global oncology company with an industry-leading franchise of targeted therapies for patients with RAS-addicted cancers."

Other Corporate Updates

Building on recently disclosed clinical data supporting combinations of its RAS(ON) inhibitors with pembrolizumab, a leading PD-1 antibody, the company announced that it had entered into a clinical collaboration with Summit Therapeutics in multiple solid tumor settings to evaluate the safety and efficacy of Revolution Medicines’ clinical-stage RAS(ON) inhibitors in combination with Summit Therapeutics’ ivonescimab, an innovative PD-1 / VEGF bispecific antibody.

Financial Highlights

Second Quarter Results

Cash Position: Cash, cash equivalents and marketable securities were $2.1 billion as of June 30, 2025. This balance includes receipt of the first $250 million royalty monetization tranche from Royalty Pharma.

R&D Expenses: Research and development expenses were $224.1 million for the quarter ended June 30, 2025, compared to $134.9 million for the quarter ended June 30, 2024. The increase in expenses was primarily due to increases in clinical trial expenses and manufacturing expenses for daraxonrasib, zoldonrasib and elironrasib, and personnel-related expenses and stock-based compensation expense related to additional headcount.

G&A Expenses: General and administrative expenses were $40.6 million for the quarter ended June 30, 2025, compared to $21.7 million for the quarter ended June 30, 2024. The increase was primarily due to increases in personnel-related expenses and stock-based compensation expense associated with additional headcount, and an increase in commercial preparation activities.

Net Loss: Net loss was $247.8 million for the quarter ended June 30, 2025, compared to net loss of $133.2 million for the quarter ended June 30, 2024.

Financial Guidance
Revolution Medicines is projecting full year 2025 GAAP net loss guidance of between $1.03 billion and $1.09 billion, which includes estimated non-cash stock-based compensation expense of between $115 million and $130 million.

Webcast
Revolution Medicines will host a webcast this afternoon, August 6, 2025, at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). To listen to the live webcast, or access the archived webcast, please visit: View Source Following the live webcast, a replay will be available on the company’s website for at least 14 days.