Aankondiging • Apr 29

Erasca Inc Announces Positive Preliminary Phase 1 Dose Escalation Data for Pan-RAS Molecular Glue ERAS-0015 in KRAS-Mutant Solid Tumors

Erasca, Inc. announced 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. 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. Robust monotherapy efficacy in KRAS G12X NSCLC: 62% uORR in 2L+ and 75% uORR in post-ICI/platinum 2/3L at 16-32 mg QD PAD, and 64% uORR in 2L+ at 24-32 mg QD RDE. Robust monotherapy efficacy in 2L KRAS G12X PDAC: 40% uORR at 16-32 mg QD PAD, 42% uORR at 24-32 mg QD RDE, and 50% uORR at 32 mg QD. Monotherapy generally well-tolerated with mostly low-grade AEs, no DLTs as of DCO, and low rate of dose reductions and no discontinuations due to TRAEs. Preliminary data suggest ERAS-0015 may combine safely with standard-of-care doses of panitumumab with no DLTs as of DCO (N=3) and 1/1 uPR in CRC. Well-behaved PK, with dose-dependent increase in PK exposure up to MAD of 40 mg QD and no exposure plateau observed. Anticipated data disclosure of select ERAS-0015 monotherapy dose expansion and combination dose escalation cohorts narrowed to First Half 2027. 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): 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 points. 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 points. At recommended doses for expansion (RDEs) of 24-32 mg QD, 64% uORR8wk (N=25) in 2L+ KRAS G12X NSCLC. PDAC: At PADs of 16-32 mg QD, 40% uORR14wk (N=20) in 2L KRAS G12X PDAC, which exceeded comparator by 11 percentage points. At RDEs of 24-32 mg QD, 42% uORR14wk (N=12) in 2L KRAS G12X PDAC, which exceeded comparator by 13 percentage points. At RDE of 32 mg QD, 50% uORR14wk (N=2) in 2L KRAS G12X PDAC, which exceeded comparator by 15 percentage points. 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). The Company initiated ERAS-0015 monotherapy expansion and combination dose escalation cohorts in the US (in Second Quarter 2026 and First Quarter 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 First Half 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. 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. 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.

Aankondiging • Jun 06

Erasca, Inc. Provides Update on Clinical Program for ERK Inhibitor ERAS-007 and Refines Pipeline

Erasca, Inc. announced promising preliminary Phase 1b data for ERK inhibitor ERAS-007 in patients with metastatic BRAF V600E-mutated (BRAFm) colorectal cancer (CRC) and provided a portfolio update. ERAS-007 Development Update Meaningful activity in patients with EC-naïve BRAFm CRC supports initial focus on and dose expansion of this patient population: 50% (3/6) response rate, including two confirmed partial responses (cPR) and one unconfirmed partial response (uPR), and 67% (4/6) disease control rate (DCR; defined as complete response + partial response + stable disease) in EC-naïve response evaluable patients at the highest dose of ERAS-007 tested (100 mg BID-QW), with duration of exposure for both cPRs >40 weeks as of the data cutoff date; across all dose levels in EC-naïve response evaluable patients, 38% (3/8) response rate, including two cPRs and one uPR, and 63% (5/8) DCR. Per site communication, the patient with the uPR was still in response at the subsequent scan (May 26, 2023), which was conducted 25 days after the first post-baseline scan ERAS-007 + EC was generally well tolerated with mostly low-grade treatment-related adverse events (TRAEs) at all combination doses tested. No Grade 4 or 5 TRAEs were observed One dose-limiting toxicity (DLT) was reported for ERAS-007 100 mg BID-QW + EC (Grade 3 macular edema) Pharmacokinetic (PK) exposures of ERAS-007, encorafenib, and cetuximab were comparable to the respective monotherapy PK data, suggesting no apparent PK drug-drug interactions (DDI) between the study drugs * Safety data cutoff date was March 23, 2023. Efficacy data cutoff date was May 21, 2023 Across the HERKULES studies, early clinical data reinforce ERAS-007’s potential to be a backbone for combination therapy: Target PK profile achieved with adequate exposures and well-defined PK in monotherapy and combinations No apparent PK DDI liabilities were observed for ERAS-007 when dosed in combination with multiple approved therapies ERAS-007 has been safely combined with other agents at biologically relevant doses and schedules ERAS-007 monotherapy responses observed in multiple tumor types support further evaluation of intermittent scheduling in combination Encouraging signs of efficacy for select ERAS-007 combinations Portfolio Update A data-driven prioritization focuses Erasca’s resources on opportunities with the highest probability of success for patients. Development Programs HERKULES-3: ERAS-007 + EC in EC-naïve patients with BRAFm CRC (preventing in-pathway resistance): Conducting dose expansion based on encouraging early efficacy data in EC-naïve patients HERKULES-3: ERAS-007 + EC in EC-treated patients with BRAFm CRC (reversing in-pathway resistance): Gating evaluation on efficacy data in EC-naïve CRC population (i.e., EC-treated population may be explored if efficacy data continue to be promising in the EC-naïve population), as it is more challenging to show treatment benefit in EC-treated population than in EC-naïve population HERKULES-2: ERAS-007 + osimertinib in patients with post-osimertinib EGFR-mutant NSCLC (reversing in-pathway resistance): Deprioritized as clinical efficacy data do not support continued evaluation HERKULES-3: ERAS-007 + palbociclib in patients with KRAS- or NRAS-mutant CRC and KRAS-mutant PDAC (targeting adjacent pathways): Deprioritized as clinical efficacy data do not support continued evaluation HERKULES-1: ERAS-007 + ERAS-601 in patients with advanced solid tumors: Deprioritized as dose escalation safety data do not support continued evaluation of regimen tested AURORAS-1: ERAS-3490 in patients with KRAS G12C-mutated solid tumors: Deprioritized due to increasingly competitive landscape for small- and mid-cap biopharma companies despite the program's potential differentiation Research Programs ERAS-9 SOS1: Deprioritized to focus on SHP2 as the key upstream RAS/MAPK pathway node due to promise of ERAS-601 SHP2 inhibitor ERAS-11 MYC: Deprioritized as preclinical characterization does not support continued work ERAS-2/3 RAS Switch-II Groove targeting: Deprioritized and pursuing other promising research approaches to target RAS mutations beyond G12C Key Upcoming Milestones Erasca re-affirmed its prior guidance for the following, with respect to anticipated key milestones and clinical trial readouts: Naporafenib (pan-RAF inhibitor) SEACRAFT-1: Phase 1b trial for naporafenib plus trametinib in patients with RAS Q61X solid tumors First patient dosing expected in second half of 2023 Initial Phase 1b combination signal-seeking efficacy data in relevant tumor types expected between the second and fourth quarters of 2024 SEACRAFT-2: Randomized pivotal Phase 3 trial for naporafenib plus trametinib in patients with NRASm melanoma First patient dosing expected in first half of 2024 ERAS-007 (ERK1/2 inhibitor) HERKULES-3: Phase 1b trial for ERAS-007 plus EC in EC-naïve BRAFm CRC patients Phase 1b combination expansion data in patients with BRAFm CRC expected between the second half of 2023 and the first half of 2024 ERAS-601 (SHP2 inhibitor) FLAGSHP-1: Phase 1b trial in patients with advanced solid tumors Phase 1b combination expansion data in relevant patient populations, including patients with human papillomavirus (HPV)-negative advanced head and neck squamous cell carcinoma (HNSCC) expected in first half of 2024 ERAS-801 (CNS-penetrant EGFR inhibitor) THUNDERBBOLT-1: Phase 1 trial in patients with recurrent glioblastoma (GBM) Initial Phase 1 monotherapy dose escalation data in patients with recurrent GBM expected in second half of 2023.

Rente dekkingsratio	n/a
Contant	US$243.79m
Aandelen	US$393.53m
Totaal verplichtingen	US$67.71m
Totaal activa	US$461.23m

Gegevens	Laatst bijgewerkt (UTC-tijd)
Bedrijfsanalyse	2026/07/17 23:53
Aandelenkoers aan het einde van de dag	2026/07/17 00:00
Inkomsten	2026/03/31
Jaarlijkse inkomsten	2025/12/31

Pakket	Gegevens	Tijdframe	Voorbeeld Amerikaanse bron ^*
Financiële gegevens bedrijf	10 jaar	Resultatenrekening Kasstroomoverzicht Balans	SEC-formulier 10-K SEC-formulier 10-Q
Consensus schattingen analisten	+3 jaar	Financiële prognoses Koersdoelen analisten	Onderzoeksrapporten van analisten Blue Matrix
Marktprijzen	30 jaar	Aandelenprijzen Dividenden, splitsingen en acties	ICE Marktgegevens SEC-formulier S-1
Eigendom	10 jaar	Top aandeelhouders Handel met voorkennis	SEC-formulier 4 SEC-formulier 13D
Beheer	10 jaar	Leiderschapsteam Raad van bestuur	SEC-formulier 10-K SEC-formulier DEF 14A
Belangrijkste ontwikkelingen	10 jaar	Bedrijfsaankondigingen	SEC-formulier 8-K

Analist	Instelling
Alec Stranahan	BofA Global Research
Naureen Quibria	Capital One Securities, Inc.
Kevin Strang	Goldman Sachs

Erasca Balans Gezondheid

Financiële gezondheid criteriumcontroles 6/6

Belangrijke informatie

Recente financiële gezondheidsupdates

Recent updates

New minor risk - Shareholder dilution

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New major risk - Financial position

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Price target increased by 10% to US$20.00

New major risk - Revenue and earnings growth

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Price target increased by 15% to US$5.89

General Counsel & Corporate Secretary exercised options and sold US$467k worth of stock

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Price target increased by 7.9% to US$5.13

Price target increased by 11% to US$5.00

Price target decreased by 8.6% to US$4.57

New major risk - Revenue and earnings growth

Price target decreased by 7.5% to US$5.29

Erasca, Inc. Announces Ind Clearance for Potential First-In-Class and Best-In-Class Pan-Kras Inhibitor Eras-4001

Price target increased by 14% to US$5.71

Erasca, Inc. Announces Early Clinical Advancement and Prioritization of RAS-Targeting Franchise Coupled with More Than 3 Years of Projected Cash Runway

Erasca, Inc., Annual General Meeting, Jun 24, 2025

Erasca, Inc.: Carving A Different Niche In RAS Signaling

New minor risk - Share price stability

Erasca's Naporafenib Is Shaping Up Nicely For NRASm Melanoma

Price target decreased by 11% to US$5.00

Erasca: New Focus After Restructuring, But Need More Differentiation

Erasca, Inc. Initiates SEACRAFT-2 Pivotal Phase 3 Trial Evaluating Naporafenib Plus Trametinib in Patients with NRAS-Mutant Melanoma

Independent Director recently bought US$182k worth of stock

Price target decreased by 11% to US$6.25

New major risk - Shareholder dilution

Erasca, Inc. has completed a Follow-on Equity Offering in the amount of $159.999999 million.

New minor risk - Shareholder dilution

Erasca, Inc., Annual General Meeting, Jun 20, 2024

Insufficient new directors

New major risk - Revenue and earnings growth

Erasca, Inc. announced that it expects to receive $45 million in funding

Erasca, Inc. Announces Two Clinical Trial Collaboration and Supply Agreements for Trametinib to Evaluate Naporafenib Combination in SEACRAFT-1 and SEACRAFT-2 Trials

Erasca, Inc. Receives FDA Fast Track Designation for Pan-RAF Inhibitor Naporafenib in Patients with Advanced NRAS-Mutated Melanoma

Co-Founder recently bought US$1.7m worth of stock

Price target decreased by 7.4% to US$9.00

Erasca, Inc. Achieves Key Milestones for Naporafenib and ERAS-801 Programs and Extends Cash Runway

New major risk - Revenue and earnings growth

New minor risk - Share price stability

Co-Founder recently bought US$2.0m worth of stock

New minor risk - Share price stability

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New minor risk - Share price stability

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Independent Director recently bought US$55k worth of stock

Price target decreased by 9.3% to US$15.57

Co-Founder recently bought US$284k worth of stock

Co-Founder recently bought US$231k worth of stock

Co-Founder recently bought US$200k worth of stock

Price target decreased to US$18.60

Erasca, Inc. Announces FDA Clearance of IND Application for CNS-Penetrant KRAS G12C Inhibitor ERAS-3490 in KRAS G12C-Mutated Advanced or Metastatic Solid Tumors

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Erasca, Inc.(NasdaqGS:ERAS) dropped from Russell 2000 Growth Index

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