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.

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 NKGen Biotech, Inc. (OTC: NKGN) ("NKGen" or the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer ("NK") cell therapeutics, reported that Paul Y. Song, M.D., Chairman and Chief Executive Officer of NKGen, will present at the 13th Annual Immuno-Oncology Summit (the "Summit") to be held in Philadelphia, PA, from August 11 – 13, 2025 (Press release, NKMax America, AUG 6, 2025, View Source [SID1234654868]).

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The Summit is a leading global event in cancer immunotherapy. Organized by Cambridge Healthtech Institute, the summit brings together top experts from industry and academia to explore the latest advances in cell therapies, innate immunity, bispecifics, and translational strategies. With multiple scientific tracks, high-impact presentations, and collaborative discussions, it serves as a premier forum for driving innovation and progress in the immuno-oncology field.

Presentation Details:

Title: Allogeneic Enhanced Natural Killer Cells without Lymphodepletion in Solid Tumors

Conference Track: Innate Immunity

Date and Time: Wednesday, August 13, 2025; 2:50 PM ET

Dr. Song’s presentation will focus on the pivotal role of natural killer (NK) cells as primary effector cells in the innate immune response against cancer. Traditional allogeneic donor-derived therapies often require lymphodepletion to prevent immunologic rejection, a process that can compromise combination strategies aimed at enhancing T cell activity. Dr. Song will present scientific data and early clinical findings on NKGen’s allogeneic NK cell therapy, SNK02, which is being evaluated in solid tumors without the need for lymphodepletion.

Previously disclosed Phase 1 data for SNK02 in solid tumors, which may not be included in this presentation, is available on the Scientific Publications page of the NKGen website under the "SNK02 Allogeneic" section.

On August 6, 2025 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, reported the presentation of encouraging preclinical data for its lead drug candidate, Annamycin, also known by its non-proprietary name of naxtarubicin, which demonstrated significant efficacy against various primary and metastatic liver cancers, including hepatocellular carcinoma (HCC), colorectal liver metastases, and pancreatic ductal adenocarcinoma (PDAC) liver metastases (Press release, Moleculin, AUG 6, 2025, View Source [SID1234654867]). This is believed to be the result of targeted accumulation in the liver and other organs.

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These findings were highlighted in a poster titled "Liposomal Annamycin (L-ANN) Efficacy Against Primary and Metastatic Liver Cancers," presented by Dr. Waldemar Priebe, Lead Author and Chairman of the Scientific Advisory Board at Moleculin at the recently held Shelby-Lavine Pancreatic Cancer Symposium at MD Anderson Cancer Center.

Key Highlights

Targeted Accumulation in Organs: The preclinical studies confirmed that Annamycin exhibits distinct organotropic properties, leading to significantly higher concentrations in the liver, spleen, lungs, and pancreas when compared to doxorubicin (DOX). This targeted accumulation is critical for effectively treating liver-localized tumors.
Efficacy in Orthotopic Hepatocellular Carcinoma (HCC) Models: Annamycin demonstrated excellent anti-tumor activity in orthotopic HCC models (Hepa 1-6 Luc), showing a marked reduction in tumor progression and improved survival rates in treated animals compared to vehicle controls.
Potent Impact on Colorectal Liver Metastasis: In an experimental liver metastatic model of colorectal carcinoma (CT26 Luc), Annamycin significantly inhibited metastatic growth and extended survival, highlighting its potential for addressing liver metastases in colon cancer that affects close to 50% of patients.
Promising Results in Pancreatic Cancer Liver Metastasis: Annamycin also showed compelling efficacy in liver-implanted human pancreatic ductal adenocarcinoma (MIA PaCa-2), leading to inhibition of tumor growth, suggesting its potential role in managing advanced pancreatic cancer with liver involvement.
Favorable Safety Profile: Consistent with previous preclinical and clinical findings, Annamycin continued to show low or no cardiotoxicity, a significant advantage over traditional anthracyclines like doxorubicin, which are often limited by dose-dependent cardiac side effects. This safety profile was previously observed in clinical trials, where 32 out of 42 subjects reviewed received more than the FDA-established lifetime maximum allowable level of anthracycline without evidence of cardiotoxicity.
"We are incredibly encouraged by these preclinical results, which further validate Annamycin’s potential as a powerful and differentiated therapeutic agent for liver cancers," said Dr. Priebe. "The ability of Annamycin to concentrate effectively in the liver, combined with its demonstrated efficacy across multiple aggressive liver cancer models and its favorable cardiotoxicity profile, positions it as a highly promising candidate for patients facing these devastating diseases. We believe these data provide a strong foundation for advancing Annamycin in clinical development for these indications, offering new hope where treatment options are often limited."

Walter Klemp, Chairman and CEO of Moleculin, added, "We continue to be strongly encouraged by the potential of Annamycin. Beyond our preliminary programs in AML and soft tissue sarcoma lung metastases (STS lung mets), we continue to advance and develop Annamycin through multiple investigator-initiated studies to further unlock its potential as a treatment option for many other types of cancers. We believe this preclinical data highlights that potential and provides additional validation of its unique pharmacological profile and importantly showcases the opportunity for its use across a wide range of cancers."

Moleculin’s novel drug candidate is being positioned to become the first ever non-cardiotoxic anthracycline to be approved and is currently being developed for the treatment of AML and STS lung mets. For more information, please visit moleculin.com.

On August 6, 2025 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported financial results for the quarter ended June 30, 2025 and provided a business update (Press release, Immunome, AUG 6, 2025, View Source [SID1234654866]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"Immunome made substantial progress in the second quarter of 2025, underscored by the continued advancement of our clinical programs towards key milestones," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Immunome. "We look forward to sharing topline data for the RINGSIDE trial of varegacestat before the end of this year, and we are well-positioned to support a new drug application submission for that program as appropriate."

"We recently dosed the third cohort of patients in the dose escalation study of IM-1021, our ROR1 ADC. We are excited by the profile of HC74, the proprietary TOP1 inhibitor payload contained in IM-1021, and are making progress towards IND submission for three additional ADCs utilizing that technology."

Pipeline Highlights

Varegacestat:

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Immunome expects to report topline data for the Phase 3 RINGSIDE Part B study before the end of 2025.
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Two additional analyses of the Phase 2 RINGSIDE Part A study were presented at 2025 ASCO (Free ASCO Whitepaper) Annual Meeting in June 2025, both of which can be found in the Investors portion of Immunome’s website:
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Subgroup Analysis of the Phase 2 Part of the RINGSIDE Phase 2/3 Trial of Varegacestat for Treatment of Desmoid Tumors
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Change in T2-Weighted Signal Intensity, Change in Tumor Volume, and Exposure-Response Analysis in the RINGSIDE Phase 2 Study of Varegacestat in Patients with Desmoid Tumors
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The European Medicines Agency granted Orphan Drug Designation to varegacestat in July 2025. Varegacestat previously received Orphan Drug Designation from the U.S. Food and Drug Administration in November 2023.
IM-1021: The Phase 1 clinical trial of IM-1021 is ongoing, with patients recently dosed at the third dose level. The trial is an open-label, multicenter dose-escalation and expansion study that is expected to include participants with advanced B-cell lymphomas and advanced solid tumors.

IM-3050: Immunome received IND clearance for IM-3050 in April 2025 and expects to initiate a Phase 1 clinical trial before the end of 2025.

Preclinical Pipeline: Immunome’s three preclinical ADCs against solid tumor targets, IM-1617, IM-1340 and IM-1335, each of which incorporates HC74, are currently undergoing IND-enabling work. Additional undisclosed ADCs are in discovery and lead optimization.

Second Quarter 2025 Financial Results

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As of June 30, 2025, cash, cash equivalents and marketable securities totaled $268.0 million. Immunome expects its current cash position to fund operations into 2027.
•
Research and development expenses for the quarter ended June 30, 2025 were $40.5 million, including stock-based compensation costs of $2.2 million.
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General and administrative expenses for the quarter ended June 30, 2025 were $10.0 million, including stock-based compensation expense of $3.1 million.
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Immunome reported a net loss of $43.4 million for the quarter ended June 30, 2025.