On April 27, 2026 Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics, reported that it met the key secondary endpoint of PFS and showed additional compelling results in the randomized COMPANION-002 study, which evaluated tovecimig plus paclitaxel versus paclitaxel alone in patients with unresectable advanced, metastatic or recurrent biliary tract cancer (BTC) treated in the second-line setting. The complete dataset, including Duration of Response (DoR), will be presented at a medical conference later this year.

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"In this study, tovecimig showed an impressive overall response rate which translated into a clinically meaningful and highly statistically significant improvement in PFS for patients with previously treated BTC. The remarkable 56% reduction in the risk of disease progression is unprecedented in this patient population without an actionable mutation in their tumor," said Thomas Schuetz, MD, PhD, Chief Executive Officer of Compass. "It is also notable that the 31 crossover patients survived a median of 12.8 months, similar to the median OS seen in front-line studies in this setting. Including crossover, 85% of patients in the study received tovecimig in combination with paclitaxel and the pooled median OS for all patients in the study was 8.9 months, which is also substantially longer than chemotherapy benchmarks of approximately 6 months."

"These findings reinforce our belief that tovecimig can address a significant unmet need for patients with limited and insufficient treatment options. We are immensely grateful to the patients, investigators, and clinical teams who made this study possible, and we look forward to presenting the full dataset at an upcoming medical meeting. We are now focused on engaging with the FDA to bring this much needed therapy to the cholangiocarcinoma community as quickly as possible."

"Patients with advanced biliary tract cancer have an urgent need for better treatment options," said Juan Valle, MD, Chief Medical Officer of the Cholangiocarcinoma Foundation. "These results are a significant step forward and I anticipate that, if approved, it will meaningfully change the way physicians care for these patients. I also applaud Compass for putting patients first in the design of this study by allowing patients to crossover to receive treatment with tovecimig. These patients clearly benefited from this innovative therapy. I look forward to supporting Compass as they work to bring tovecimig to patients with cholangiocarcinoma."

COMPANION-002 Data Summary:

Primary Endpoint (previously announced in April 2025):

Overall Response Rate: 17.1% ORR for tovecimig in combination with paclitaxel (19 of 111 patients) including one complete response, compared to 5.3% for paclitaxel alone (3 of 57 patients), in patients with BTC in the second line setting. This 11.8% improvement in ORR for those receiving tovecimig was statistically significant (p=0.031). All responses were assessed by blinded independent central review (BICR).
Key Secondary Endpoints:

Progression-Free Survival (PFS): Tovecimig in combination with paclitaxel demonstrated a statistically significant improvement in median PFS of 4.7 months compared to 2.6 months for paclitaxel alone (HR=0.44, p<0.0001). Progression was confirmed in each case by BICR.
Overall Survival (OS): Tovecimig did not meet the OS secondary endpoint due to high crossover from the control arm (31 of 57 patients, or 54%) and prolonged survival of those crossover patients after receiving tovecimig, as further described below. As a result of this crossover, 85% (142 of 168) of patients in the study received tovecimig plus paclitaxel with a pooled OS in the study of 8.9 months.

In the ITT OS analysis, tovecimig in combination with paclitaxel had a median OS of 8.9 months compared to 9.4 months for the control arm, which included 26 patients (46%) who received paclitaxel alone and 31 patients (54%) who crossed over to receive tovecimig in combination with paclitaxel (HR=1.05, p=0.78). In the rank-preserving structural failure time (RPSFT) OS analysis, the combination also had a median OS of 8.9 months compared to 9.4 months for paclitaxel alone (HR=1.13, p=0.65). Though the RPSFT analysis is intended to adjust for crossover, its validity depends on certain assumptions that were not met in this study and thus its results here are largely uninterpretable.
Progression-Free Survival of Crossover Patients (PFS2): An additional, pre-specified secondary endpoint analyzed PFS in the patients in the paclitaxel arm who crossed over to receive tovecimig plus paclitaxel. In this analysis, the pre-crossover PFS (PFS1) on paclitaxel alone was compared to PFS with tovecimig post-crossover (PFS2) in the same crossover patients (n=31). In this subset, tovecimig demonstrated a statistically significant improvement with median PFS2 of 3.5 months after treatment with tovecimig compared to median PFS1 of 1.9 months for paclitaxel (HR=0.36, p=0.0016).
Post Hoc Subset Analyses:

OS of Paclitaxel Control Arm (Crossover vs. Non-Crossover): In an analysis of OS in all patients randomized to the paclitaxel control arm (n=57), crossover patients who subsequently received tovecimig demonstrated a statistically significant improvement in median OS of 12.8 months compared to 6.1 months for non-crossover patients who received only paclitaxel (HR=0.54, p=0.04).
PFS of Paclitaxel Control Arm (Crossover vs. Non-Crossover): Another analysis of these same patients randomized to the paclitaxel control arm (n=57) demonstrated that the crossover patients initially progressed faster on paclitaxel monotherapy compared to the non-crossover patients, with a median PFS of 1.9 months versus 3.6 months (HR=2.31, p=0.007). Thus, notably, despite progressing more quickly on initial paclitaxel monotherapy, crossover patients still demonstrated a statistically significant median 12.8 months OS after being treated with tovecimig.
Safety:

Tovecimig was generally well tolerated and the safety profile was consistent with previously reported data from prior studies, with no new safety signals. The most commonly reported treatment emergent adverse events in the tovecimig combination arm were hypertension (69%) and fatigue (67%). The most common related treatment-emergent adverse events of Grade 3 or higher included hypertension (44%) and neutropenia (36%).
BTC is estimated to affect approximately 26,500 patients annually in the United States. For the vast majority of patients with BTC whose tumors do not harbor an actionable mutation with an approved targeted therapy, there is currently no FDA-approved treatment in the second line setting. The therapeutics most commonly used in this setting, which are not labeled or approved by the FDA for the treatment of patients with BTC, generally have an ORR of ~5% or less and patients face a median OS of approximately six months.

In the coming months, Compass intends to meet with the U.S. Food and Drug Administration (FDA) to discuss these data in advance of a planned BLA submission.

Webcast Information
Compass will host a webcast today, Monday, April 27, 2026 at 8:00 a.m. ET to provide a review of the tovecimig secondary endpoints COMPANION-002 data. Interested parties may register for the call-in advance via View Source;tp_key=efc315f5a6.

A replay of the webcast will be available via the Investors section of the Compass website at investors.compasstherapeutics.com.

About COMPANION-002
COMPANION-002 is a Phase 2/3 randomized, controlled study of tovecimig in patients with unresectable advanced, metastatic or recurrent biliary tract cancers who have received one prior systemic chemotherapy regimen (clinical trial information: NCT05506943). The study enrolled 168 adult patients, randomized in a 2:1 ratio to receive tovecimig plus paclitaxel (n=111) or paclitaxel alone (n=57). All patients were dosed with 80 mg/m2 of paclitaxel on days 1, 8 and 15 of every 28-day cycle. Patients in the tovecimig arm were also dosed with 10 mg/kg of tovecimig on days 1 and 15 of each 28-day cycle. The primary endpoint of the trial is ORR as confirmed by blinded independent central radiology review and secondary endpoints include PFS, OS, and DoR, among others. Patients in the paclitaxel-only arm who progressed could cross over to the tovecimig plus paclitaxel arm after centrally confirmed progression if they also still met the enrollment criteria for the study.

About Tovecimig (CTX-009)
Tovecimig is an investigational bispecific antibody that is designed to simultaneously block Delta-like ligand 4 (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which are critical to angiogenesis and tumor vascularization. Preclinical and clinical data of tovecimig suggest that blockade of both pathways provides robust anti-tumor activity across several solid tumors, including colorectal, gastric, cholangiocarcinoma, pancreatic and non-small cell lung cancer.

(Press release, Compass Therapeutics, APR 27, 2026, View Source [SID1234664829])

On April 27, 2026 Apollomics Inc. (Nasdaq: APLM), a clinical-stage biopharmaceutical company advancing innovative oncology therapies to transform the treatment landscape for patients with few or no options, reported financial results for the full year ended December 31, 2025.

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"Our primary focus is to advance the global development of vebreltinib for the treatment of patients with c-MET alterations across different tumors," said Hung-wen (Howard) Chen, Chief Executive Officer of Apollomics. "Based on guidance from the U.S. Food and Drug Administration (FDA), we anticipate submitting an Investigational New Drug Application for accelerated approval of vebreltinib for second-line treatment for non-small cell lung cancer (NSCLC) patients with c-MET amplification in the first half of 2027."

Pipeline Update

Vebreltinib (APL-101) – a highly specific, CNS-penetrant c-MET inhibitor for treating NSCLC, brain tumors, and other solid tumors with MET dysregulation. It also shows significant potential in combination regimens, particularly with EGFR inhibitors.
The China rights of APL-101 were out-licensed to Apollomics’ partner, Beijing Avistone Biotechnology Co., Ltd., while Apollomics retains the global (ex-China) rights.
Vebreltinib has been approved by China’s National Medical Products Administration (NMPA) for three distinct indications: METex14 skipping NSCLC, MET-amplified NSCLC, and PTPRZ1-MET fusion high-grade gliomas. Notably, it is the first c-MET inhibitor approved for the latter two conditions.
The Company is advancing global development of vebreltinib, prioritizing NSCLC with c-MET amplification while expanding its application across diverse MET alterations and tumor types. Simultaneously, the Company is investigating strategic combinations with other tumor inhibitors to fully maximize vebreltinib’s therapeutic potential.
The Phase 2 component of the SPARTA clinical study, APL-101-01, is an ongoing open-label multi-cohort study for evaluation of efficacy and safety of vebreltinib for the treatment of a number of solid tumors, including NSCLC with MET Exon 14 skipping, NSCLC with c-MET amplification, brain tumors with MET fusion or MET amplification and other solid tumors with MET amplification or MET fusion. Apollomics is currently conducting the ongoing Phase 2 portion of the global SPARTA study at approximately 25 study sites in over 10 countries in North America, Europe and Asia-Pacific. As of April 2026, over 282 subjects have enrolled in the SPARTA study.
Interim efficacy and safety data from the global multi-cohort Phase 2 SPARTA trial and from the multi-cohort Phase 2 KUNPENG trial demonstrated that vebreltinib appeared efficacious in NSCLC patients with MET Exon14 skipping mutation with or without co-occurring MET amplification.
In March 2025, the Company announced a development and commercialization agreement for vebreltinib with LaunXP International Co., Ltd., an affiliate of LaunXP Biomedical Co., Ltd (Collectively, "LaunXP"). LaunXP will receive exclusive development and commercialization rights for vebreltinib in combination with an EGFR inhibitor in Asia (excluding mainland China, Hong Kong and Macau) for the treatment of NSCLC.
Apollomics is committed to expanding its clinical pipeline through ongoing collaborations with global partners. These efforts will focus on investigating new combination therapies that maximize vebreltinib’s efficacy, ensuring the asset’s potential is fully realized across diverse patient populations.

Immuno-Oncology Product Candidates
APL-501 (Anti-PD-1 antibody): APL-501 is an investigational, humanized, IgG4 monoclonal antibody that selectively binds to PD-1 on T lymphocytes and other immune cells. The China rights of APL-501 were out-licensed to Apollomics’ partner, Edding Genor Group Holdings Ltd., while Apollomics retains the global (ex-China) rights. Data from a Phase 1 study in advanced or relapsed/refractory solid tumors in Australia are currently being analyzed.
APL-502 (benmelstobart, anti-PD-L1 antibody): APL-502 is a novel IgG1 humanized monoclonal antibody against PD-L1. The China rights of APL-502 were out-licensed to Apollomics’ partner, Chia Tai-Tianqing Pharmaceutical Holdings Co., Ltd. (CTTQ), while Apollomics retains the global (ex-China) rights.
APL-502 (also known as TQB-2450 in China) has been approved by China’s NMPA for three distinct indications: extensive-stage small cell lung cancer, recurrent/metastatic endometrial cancer, and late-stage unresectable or metastatic renal cell carcinoma. Ongoing clinical trials include the following tumor types: NSCLC, esophageal cancer, ovarian cancer, hepatocellular carcinoma, cholangiocarcinoma, primary mediastinal large B cell lymphoma, and alveolar soft part sarcoma.

Business Highlights

New senior management team: In September 2025, Apollomics appointed a new management team, led by Hung-wen (Howard) Chen, Chief Executive Officer, and Yi-kuei (Alex) Chen, Chief Operating Officer, and Peter Lin, Chief Financial Officer.
Positive Turnaround Developments: With the appointment of a new board of directors and management team, the Company has made meaningful progress executing its strategic turnaround plan. In 2025, the Company successfully implemented significant cost reduction initiatives to streamline operations and enhance financial discipline. In parallel, Apollomics has strengthened its financial and legal position through the resolution of legacy matters, including the settlement of the Cayman litigation in November 2025, and the clearance of substantial outstanding legal and clinical program-related obligations. Furthermore, Apollomics has a renewed commitment to advancing its pipeline, including the relaunch of a previously paused clinical program for vebreltinib.
Full Year 2025 Financial Results

Cash, cash equivalents, bank deposits and money market funds as of December 31, 2025, were approximately $3.3 million, compared with $9.8 million as of December 31, 2024. In September 2025, the Company raised $4.1 million in a private investment in public equity (PIPE) financing, before transaction expenses.
Revenue for the full year 2025 was $8.5 million compared to $0 for full year 2024. Revenue in 2025 is a result of the upfront payment related to the LaunXP licensing agreement for the development and commercialization in Asia (excluding mainland China, Hong Kong and Macau) of vebreltinib.
Research and development expenses were approximately $5.5 million for full year 2025, compared to approximately $24.6 million for full year 2024.
General and administrative expenses were approximately $12.4 million for full year 2025, compared to approximately $17.8 million for full year 2024.
Net loss for the full year 2025 was $(10.9) million, or $(7.57) per diluted share, compared with a net loss of $(53.9) million, or $(52.80) per diluted share, for the full year 2024.
As part of its strategic turnaround plan, Apollomics significantly reduced costs and expenses in 2025 compared to the previous year. For the full year 2025, operating expenses were $19.8 million compared to $55.7 million for the prior year, representing a 64% decrease year-over-year.

(Press release, Apollomics, APR 27, 2026, View Source [SID1234664828])

On April 27, 2026 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including metastatic triple-negative breast cancer ("mTNBC") and colorectal cancer ("mCRC"), reported the successful enrollment and initial dosing of the first participant in its Expanded Access Program (EAP) for patients with triple-negative breast cancer (TNBC).

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The EAP is designed to provide eligible patients access to leronlimab outside of a clinical study setting. The program is intended for patients who have exhausted available treatment options and are not eligible for ongoing or planned clinical studies, in accordance with U.S. Food and Drug Administration (FDA) guidelines.

"Dosing the first patient in our EAP marks an important step in making leronlimab available to individuals with urgent unmet medical needs, while also advancing our understanding of CCR5 biology in the treatment of aggressive cancers," said Jacob Lalezari, M.D., CEO of CytoDyn. "Data generated through this program may further inform how CCR5 inhibition influences the tumor microenvironment, including its potential role in modulating PD-L1 expression and supporting combination approaches with immune checkpoint inhibitors."

"For patients with advanced triple-negative breast cancer who have exhausted standard treatment options, expanded access programs can provide additional avenues for care," said Namita Chittoria, M.D., Assistant Professor at the Huntsman Cancer Institute and the University of Utah, and a member of CytoDyn’s Scientific Advisory Board. "Leronlimab is an investigational therapy being evaluated in this difficult-to-treat setting, and access outside of a clinical study may offer a meaningful option for select patients – both as an additional treatment opportunity and as a way to preserve valuable time with family. Beyond individual use, these programs also inform our understanding of emerging therapies."

In addition to providing compassionate access, the EAP is expected to generate real-world insights into the biological activity of leronlimab in heavily pretreated patients. Recent data, presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, highlight the potential role of CCR5 inhibition in modulating the tumor microenvironment in metastatic triple-negative breast cancer, with observed associations in PD-L1 expression and broader immune signaling pathways. Together, these findings provide a scientific foundation for the EAP and support continued exploration of leronlimab as a strategy to enhance responses to immune checkpoint inhibitor (ICI) therapies.

To support execution of the program, the Company has engaged With Every Patient (WEP Clinical) as the clinical research organization to support program execution, including patient identification, site coordination, and regulatory compliance. The EAP is now open for physician referrals, and CytoDyn expects to expand participation as additional sites are activated. The program will operate under applicable U.S. Food and Drug Administration (FDA) guidelines, and additional information for physicians and eligible patients, including referral details, is available on the Company’s website at www.cytodyn.com.

(Press release, CytoDyn, APR 27, 2026, View Source [SID1234664827])

On April 27, 2026 Siren Biotechnology reported the publication of its first peer-reviewed manuscript in Molecular Therapy Oncology, alongside upcoming presentations at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2026 Annual Meeting.

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The publication reports preclinical data supporting Siren’s Universal AAV Immuno-Gene Therapy platform and its application to high-grade glioma, a setting with significant unmet need and limited therapeutic options.

Publication Highlights Platform Potential and Translational Depth

The study demonstrates that localized delivery of AAV-encoded cytokines enables sustained intratumoral expression and drives robust anti-tumor activity across multiple preclinical models of high-grade glioma, including human organoids and orthotopic in vivo systems.

Across these studies, treatment was associated with tumor regression and prolonged survival, alongside evidence of tumor-localized immune activation and transcriptional reprogramming.

The study includes extensive in vivo validation across multiple orthogonal glioma models, representing one of the most comprehensive preclinical datasets reported to date for AAV-based approaches in oncology.

The publication also establishes a foundation for the continued clinical development of Siren’s platform in high-grade glioma.

"This paper represents the most complete view to date of how our platform performs across systems that matter for translation," said Nicole K. Paulk, PhD, Founder and CEO of Siren Biotechnology. "We were deliberate about building a dataset that goes beyond a single model or readout, and instead shows reproducible consistency across orthogonal approaches. That level of rigor is important as we continue advancing into the clinic."

Access the full open-access manuscript here.

Upcoming ASGCT (Free ASGCT Whitepaper) 2026 Presentations

Siren Biotechnology will present new data spanning preclinical and CMC advances at the ASGCT (Free ASGCT Whitepaper) 2026 Annual Meeting in Boston, MA.

MRI-Guided Convection-Enhanced Delivery of an AAV-hIFNβ Vector Achieves Targeted Brain Retention and Durable Transgene Expression in a Large-Animal Model

Wednesday, May 13, 2026, 5:00 – 6:30 pm EST, Poster Hall, Abstract #2241

End-to-End Device Compatibility and In-Use Stability Assessment of an AAV Gene Therapy Delivered by Convection-Enhanced Delivery

Friday, May 15, 2026, 8:15 – 8:30 am EST, MCEC Room 162AB

"Together, these presentations extend the platform story into delivery, manufacturability, and real-world use considerations," added Dr. Paulk. "We’re excited to share data that we believe helps define what effective AAV-based therapies in oncology can look like."

This research was additionally made possible by funding from the California Institute for Regenerative Medicine (CIRM), a state of California Agency that funds regenerative medicine, stem cell, gene therapy research, and clinical trials (Grant number: TRAN1-15325).

(Press release, Siren Biotechnology, APR 27, 2026, View Source [SID1234664826])

On April 27, 2026 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 positive preliminary Phase 1 dose escalation data for its potentially best-in-class, pan-RAS molecular glue ERAS-0015 in patients with RAS-mutant solid tumors.

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The preliminary data are from Erasca’s ongoing AURORAS-1 Phase 1 dose escalation trial in the U.S. and the ongoing JYP0015M101 Phase 1 dose escalation trial in China sponsored by Joyo Pharmatech Co., Ltd. (Joyo), both evaluating ERAS-0015 in patients with RAS-mutant solid tumors.

"We are thrilled with the robust efficacy results demonstrated so far by our pan-RAS inhibitor ERAS-0015 in patients with lung and pancreatic cancer," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "The magnitude of clinical benefit seen during dose escalation is particularly striking and compares favorably with other pan-RAS, pan-KRAS, or KRAS-mutant selective inhibitors. This efficacy is accompanied by generally well-tolerated safety results, primarily characterized by manageable, low-grade adverse events. Notably, preliminary data support ERAS-0015 may be combined with standard-of-care doses of panitumumab, positioning it as a potential backbone therapy for future combination regimens. Together, we believe these findings support the best-in-class potential of ERAS-0015, and we look forward to continued progress in our Phase 1 monotherapy dose expansion cohorts and combination dose escalation cohorts."

Highlights of Phase 1 Preliminary Results

Pharmacokinetics (PK):
Well-behaved PK, with dose-dependent increase in PK exposure up to the maximum administered dose (MAD) of 40 mg once daily (QD) and no exposure plateau observed
Pharmacologically active dose (PAD) range of 16-32 mg QD defined based on mean steady-state average exposures that exceeded target exposure threshold (based on the insensitive xenograft model)
Pharmacodynamics (PD):
Substantial reductions in KRAS G12X circulating tumor DNA (ctDNA) were observed at the PAD doses (16-32 mg QD), with 100% of patients (14/14) showing at least 75% reduction in KRAS G12X variant allele fraction, including 5 out of 14 patients showing 100% reduction
Efficacy: Robust monotherapy overall response rates (ORR) in patients with KRAS G12X non-small cell lung cancer (NSCLC) and with KRAS G12X pancreatic cancer (PDAC), in each case as of the relevant data cutoff (DCO)1,2:
NSCLC
At PADs of 16-32 mg QD, 62% uORR8wk (N=37) in second line or greater (2L+) KRAS G12X NSCLC, which exceeded comparator by 24 percentage points3,4
At PADs of 16-32 mg QD, 75% uORR8wk (N=16) in post-ICI/platinum (2/3L) KRAS G12X NSCLC, which exceeded comparator by 37 percentage points3,4
At recommended doses for expansion (RDEs) of 24-32 mg QD, 64% uORR8wk (N=25) in 2L+ KRAS G12X NSCLC3
PDAC
At PADs of 16-32 mg QD, 40% uORR14wk (N=20) in 2L KRAS G12X PDAC, which exceeded comparator by 11 percentage points5,6
At RDEs of 24-32 mg QD, 42% uORR14wk (N=12) in 2L KRAS G12X PDAC, which exceeded comparator by 13 percentage points5,6
At RDE of 32 mg QD, 50% uORR14wk (N=2) in 2L KRAS G12X PDAC, which exceeded comparator by 15 percentage points5,7
Multiple ongoing responses: Nearly all responding patients—including all unconfirmed responders—remain on treatment as of the DCO:
NSCLC
23 out of 24 responding patients remain on treatment, including all responders treated at 24-32 mg QD RDEs
PDAC
20 out of 23 responding patients remain on treatment, including all responders treated at 24-32 mg QD RDEs
Safety and Tolerability: Generally well-tolerated with mostly low-grade adverse events (AEs), no dose-limiting toxicities (DLTs), low rate of dose interruptions or reductions due to treatment-related adverse events (TRAEs), and no discontinuations due to TRAEs
Monotherapy RDE: Based on the totality of the preliminary Phase 1 dose escalation data, 24 mg and 32 mg QD were selected as the go-forward monotherapy RDEs
Combinability: ERAS-0015 showed promising clinical potential to combine with panitumumab (anti-EGFR monoclonal antibody)
No DLTs observed through the 31Mar2026 DCO (N=3) with 1 unconfirmed partial response (uPR) in 1 efficacy-evaluable patient with metastatic colorectal cancer (CRC)
1 AURORAS-1 data cutoff (DCO) 4Apr2026; JYP0015M101 data cutoff (DCO) 27Feb2026
2 Pooled data from the Company’s Phase 1 trial (US trial, or AURORAS-1) and Joyo’s Phase 1 trial (China (CN) trial, or JYP0015M101) of ERAS-0015
3 The uORR8wk is the ORR (confirmed and unconfirmed responses) for patients who received first dose of ERAS-0015 at least 8 weeks prior to data cutoff date (US trial) or at least one post-dose tumor assessment (CN trial)
4 Comparator as used in this press release, RMC-6236. Punekar et al. Journal of Thoracic Oncology 2025; data cutoff (DCO) 30Sep2024
5 The uORR14wk is the ORR (confirmed and unconfirmed responses) for patients who received first dose of ERAS-0015 (US, CN) at least 14 weeks prior to data cutoff date
6 Wolpin et al. EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) 2024; DCO 23Jul2024
7 Revolution Medicines Press Release (10Sep2025); data cutoff (DCO) 30Jun2025

Key Upcoming and Completed Milestones
The Company initiated ERAS-0015 monotherapy expansion and combination dose escalation cohorts in the US (in Q2 2026 and Q1 2026, respectively), both ahead of previous guidance.

Upcoming milestones include:

AURORAS-1: Phase 1 trial for ERAS-0015 (pan-RAS molecular glue) in patients with RAS-mutant solid tumors
Monotherapy expansion data and combination dose escalation data narrowed to an expected date of H1 2027
BOREALIS-1: Phase 1 trial for ERAS-4001 (pan-KRAS inhibitor) in patients with KRAS-mutant solid tumors
Preliminary Phase 1 monotherapy data expected in the second half of 2026
Initiation of monotherapy expansion cohorts and combination dose escalation cohorts planned for 2027
Conference Call and Webcast Information
Erasca will hold a conference call and webcast Monday, April 27, 2026, at 4:30 pm ET. The webcast link for the conference call is here. The dial-in number is 1-877-407-3982 (U.S./Canada) or 1-201-493-6780 (international) or click the Call me Link. The live webcast and replay may be accessed by visiting Erasca’s website at Erasca.com/events.

About ERAS-0015
ERAS-0015 is an investigational, oral, highly potent pan-RAS molecular glue designed to inhibit RAS signaling with a potential best-in-class profile. Erasca is evaluating ERAS-0015 in the AURORAS-1 Phase 1 trial in patients with RAS-mutant solid tumors. Early dose escalation data in AURORAS-1 demonstrated favorable safety and tolerability results, well-behaved, linear PK, and confirmed and unconfirmed partial responses in multiple patients across multiple tumor types with different RAS mutations, including confirmed and unconfirmed partial responses at doses as low as 8 mg once daily (QD). ERAS-0015 is also designed to prevent resistance against mutant-selective inhibitors through inhibition of RAS wildtype variants. In addition, ERAS-0015 has demonstrated favorable absorption, distribution, metabolism, and excretion (ADME) and pharmacokinetic (PK) properties in multiple animal species.

About ERAS-4001
ERAS-4001 is an investigational, oral, highly potent, and selective pan-KRAS inhibitor with a potential first-in-class and best-in-class profile. Erasca is evaluating ERAS-4001 in the BOREALIS-1 Phase 1 trial in patients with KRAS-mutant solid tumors. ERAS-4001 demonstrated favorable preclinical in vitro potency against KRAS G12X mutations as well as KRAS wildtype amplifications, which may limit treatment resistance mediated through KRAS wildtype activation. No activity was observed for ERAS-4001 against HRAS or NRAS wildtype proteins in preclinical studies, which may enable a better therapeutic window compared to pan-RAS inhibitors. ERAS-4001 showed potent activity against both GTP-bound (active state) and GDP-bound (inactive state) KRAS with single digit nanomolar IC50s. In vivo, ERAS-4001 induced tumor regression in multiple KRAS-mutant models. In preclinical studies, ERAS-4001 showed encouraging ADME and PK properties.

(Press release, Erasca, APR 27, 2026, View Source [SID1234664825])