What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-05-11 compared with 2025-11-12 · 160 added, 139 removed, 205 unchanged (59% of the section changed)

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This Quarterly Report contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act).

All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding our future results of operations and financial position, business strategy, research and development plans, the anticipated timing, costs, design and conduct of our ongoing and planned preclinical studies and planned clinical trials for our product candidates, the timing and likelihood of regulatory filings and approvals for our product candidates, our ability to commercialize our product candidates, if approved, the impact of global geopolitical and economic events and war on our business, the pricing and reimbursement of our product candidates, if approved, the potential to develop future product candidates, the potential benefits of current and future licenses, acquisitions, and strategic arrangements with third parties, and our intent to enter into any future strategic arrangements, the timing and likelihood of success, plans and objectives of management for future operations and future results of anticipated product development efforts, are forward-looking statements.

In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “could,” “expect,” “intend,” "target," “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” or the negative of these terms or other similar expressions.

All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding our future results of operations and financial position, business strategy, research and development plans, the anticipated timing, costs, design, and conduct of our ongoing and planned preclinical studies and clinical trials for our product candidates, the timing and likelihood of regulatory filings and approvals for our product candidates, our ability to commercialize our product candidates, if approved, the pricing and reimbursement of our product candidates, if approved, the impact of global geopolitical and economic events and war on our business, the potential to develop future product candidates, the potential benefits of current and future licenses, acquisitions, and strategic arrangements with third parties, and our intent to enter into any future strategic arrangements, the timing and likelihood of success, plans and objectives of management for future operations, and future results of anticipated product development efforts, are forward-looking statements.

In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “could,” “expect,” “intend,” “target,” “project,” “contemplate,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” or the negative of these terms or other similar expressions.

These forward-looking statements are only predictions.

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Our company was co-founded by leading pioneers in precision oncology and RAS targeting to create novel therapies and combination regimens designed to comprehensively shut down the RAS/MAPK pathway for the treatment of patients with cancer.

Our focused RAS/MAPK pipeline comprises modality-agnostic programs aligned with our three therapeutic strategies of:

Our focused RAS/MAPK pathway pipeline comprises modality-agnostic programs aligned with our three therapeutic strategies of:

(1) targeting key upstream and downstream signaling nodes in the RAS/MAPK pathway;

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Our modality-agnostic approach aims to allow us to selectively and potently target critical signaling nodes with the most appropriate modality, including small and large molecule therapeutics.

Our purpose-built pipeline includes three clinical-stage programs (ERAS-0015, a pan-RAS molecular glue;

ERAS-4001, a pan-KRAS inhibitor;

and naporafenib, a pan-RAF inhibitor), and ERAS-12, a discovery-stage program (an EGFR D2/D3 biparatopic antibody).

Our purpose-built pipeline includes two clinical-stage programs (ERAS-0015, a pan-RAS molecular glue;

and ERAS-4001, a pan-KRAS inhibitor), and ERAS-12, a discovery-stage program (an EGFR D2/D3 biparatopic antibody) for which we have identified a lead candidate.

We believe our world-class team’s capabilities and experience, further guided by our scientific advisory board, which includes the world’s leading experts in the RAS/MAPK pathway, uniquely position us to achieve our bold mission of erasing cancer.

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We believe pan-RAS and pan-KRAS targeting molecules can address a broad population of patients with G12X, G13X, and possibly Q61X mutations, and also have the potential to address or prevent resistance by blocking wildtype RAS activation.

ERAS-0015 is a potential best-in-class pan-RAS molecular glue in development for the treatment of patients with RAS-mutated solid tumors.

ERAS-0015 is a potential best-in-class, next-generation pan-RAS molecular glue in clinical development for the treatment of patients with RAS-mutated solid tumors.

In vitro, ERAS-0015 has shown approximately 8-21 times higher binding affinity to cyclophilin A versus the most advanced pan-RAS molecular glue in development.

We believe this higher binding affinity results in approximately 5 times more potent RAS inhibition in cell-based assays compared with the comparator.

ERAS-0015 also has favorable absorption, distribution, metabolism and excretion (ADME) and PK properties in multiple animal species.

We believe this higher binding affinity results in approximately 5 times more potent RAS inhibition in cell-based assays versus the comparator.

ERAS-0015 also has favorable absorption, distribution, metabolism, and excretion (ADME) and pharmacokinetics (PK) properties in multiple animal species.

As a result of these favorable in vitro potency and ADME/PK attributes, ERAS-0015 has demonstrated comparable to greater in vivo antitumor activity at doses which are approximately one-tenth to one-eighth of the dose of the most advanced pan-RAS molecular glue.

In combination with an anti-PD-1 antibody, ERAS-0015 was able to achieve complete disappearance of tumors in mice on day 31.

The combination of ERAS-0015 plus the anti-EGFR antibody cetuximab induced significant tumor growth inhibition and demonstrated the combination benefit of blocking both oncogenic drivers.

The initial clinical trial for ERAS-0015 is AURORAS-1.

We anticipate a Phase 1 monotherapy data readout from the AURORAS-1 trial in 2026.

ERAS-4001 is a potential first-in-class pan-KRAS inhibitor in development for the treatment of patients with KRAS-mutated solid tumors.

The combination of ERAS-0015 plus the anti-EGFR antibody cetuximab induced significant tumor growth inhibition and demonstrated the potential combination benefit of blocking both oncogenic drivers.

Our initial clinical trial for ERAS-0015 is called AURORAS-1.

The investigational new drug application (IND) for AURORAS-1 was cleared by the US Food and Drug Administration (FDA) in May 2025.

ERAS-0015 is also being evaluated in the JYP0015M101 clinical trial in China for adult patients with advanced solid tumors harboring specific RAS mutations.

The JYP0015M101 clinical trial is sponsored by Joyo.

We initiated monotherapy expansion cohorts and combination dose escalation cohorts, including a pembrolizumab combination cohort, as part of the AURORAS-1 trial in the second quarter of 2026 and the first quarter of 2026, respectively, ahead of our previous guidance.

We anticipate the associated data readouts in the first half of 2027.

In March 2026, we announced that we had entered into a clinical trial collaboration and supply agreement with Tango Therapeutics, Inc.

(Tango) to enable the evaluation of ERAS-0015 with Tango's PRMT5 inhibitor, vopimetostat, in a Phase 1 clinical trial sponsored by Tango (the Tango CTCSA).

Under the terms of the Tango CTCSA, we are providing ERAS-0015 to Tango at no cost and Tango is sponsoring and funding the clinical trial.

In May 2026, we announced that we had entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside of the United States and Canada) in connection with the AURORAS-1 trial (the Merck CTCSA).

Under the terms of the Merck CTCSA, we are sponsoring and funding the clinical trial and Merck is providing its anti-PD-1 therapy, KEYTRUDA ® (pembrolizumab), at no cost.

On April 27, 2026, we announced positive preliminary Phase 1 dose escalation data for ERAS-0015 from our AURORAS-1 trial and the Joyo JYP0015M101 trial.

Both our AURORAS-1 trial and Joyo’s JYP0015M101 trial include patients with RAS-mutant solid tumors, including colorectal cancer (CRC), non-small-cell lung cancer (NSCLC), and pancreatic adenocarcinoma (PDAC).

The estimated incidence of the number of patients in the United States with KRAS-mutant tumors in CRC, NSCLC, and PDAC are approximately 74,000, 55,000, and 50,000 patients, respectively.

The trial designs are depicted below:

ATD= Accelerated Titration Design;

BOIN= Bayesian Optimal Interval;

DCR=disease control rate;

DLT=dose limiting toxicity;

DOR=duration of response;

NSCLC=non-small-cell lung cancer;

ORR=objective response rate;

OS=overall survival;

PDAC=pancreatic adenocarcinoma;

PK=pharmacokinetics;

PFS=progression free survival;

QD=once daily;

RASi=RAS inhibitor;

SOC=standard of care;

TTR=time to response.

A summary of the data in the announcement is as follows:

Highlights of Phase 1 Preliminary Results

• PK in AURORAS-1:

o 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.

o 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) in AURORAS-1:

o 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 in AURORAS-1 and JYP0015M101 trials:

Robust monotherapy overall response rates (ORR) in patients with KRAS G12X NSCLC and with KRAS G12X PDAC, in each case as of the relevant data cut off (DCO) 1,2 :

▪ At PADs of 16-32 mg QD, 62% uORR 8wk (N=37) in second line or greater (2L+) KRAS G12X NSCLC, which exceeded comparator by 24 percentage points 3,4

▪ At PADs of 16-32 mg QD, 75% uORR 8wk (N=16) in post-ICI/platinum (2/3L) KRAS G12X NSCLC, which exceeded comparator by 37 percentage points 3,4

▪ At recommended doses for expansion (RDEs) of 24-32 mg QD, 64% uORR 8wk (N=25) in 2L+ KRAS G12X NSCLC 3

▪ At PADs of 16-32 mg QD, 40% uORR 14wk (N=20) in 2L KRAS G12X PDAC, which exceeded comparator by 11 percentage points 5,6

▪ At RDEs of 24-32 mg QD, 42% uORR 14wk (N=12) in 2L KRAS G12X PDAC, which exceeded comparator by 13 percentage points 5,6

▪ At RDE of 32 mg QD, 50% uORR 14wk (N=2) in 2L KRAS G12X PDAC, which exceeded comparator by 15 percentage points 5,7

• Multiple ongoing responses:

Nearly all responding patients—including all unconfirmed responders—remain on treatment as of the DCO:

▪ 23 out of 24 responding patients remain on treatment, including all responders treated at 24-32 mg QD RDEs

▪ 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)

o No DLTs observed through the 31Mar2026 DCO (N=3) with 1 uPR in 1 efficacy-evaluable patient with metastatic CRC

1 AURORAS-1 data cutoff (DCO) 4Apr2026;

JYP0015M101 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 uORR 8wk is the ORR (confirmed and unconfirmed responses) for patients who received first dose of ERAS-0015 at least 8 weeks prior to DCO (US trial) or at least one post-dose tumor assessment (CN trial)

4 Comparator as used in this report, RMC-6236.

Punekar et al.

Journal of Thoracic Oncology 2025;

DCO 30Sep2024

5 The uORR 14wk is the ORR (confirmed and unconfirmed responses) for patients who received first dose of ERAS-0015 (US, CN) at least 14 weeks prior to DCO

6 Wolpin et al.

EORTC-NCI-AACR 2024;

DCO 23Jul2024

7 Revolution Medicines Press Release (10Sep2025);

DCO 30Jun2025

Additional AURORAS-1 Safety Data

The following table summarizes all treatment-related adverse events occurring in 10% or more of patients in the AURORAS-1 trial as of the April 4, 2026 data cutoff date:

1 One Grade 3 TRAE of pneumonitis progressed to Grade 5 after withdrawal of supportive care per patient decision.

The patient was a 66 year-old male with heavily pretreated metastatic pancreatic adenocarcinoma who received 24 mg of ERAS-0015.

The patient had pulmonary metastases, a history of right lung cryoablation and no history of lung radiation.

The patient presented to the ER approximately a month after starting ERAS-0015 with Grade 3 pneumonitis that was treated aggressively with immediate discontinuation of ERAS-0015, high dose steroids and infliximab.

The patient requested withdrawal of supportive care and ultimately died of the event.

2 Rash events are identified using following preferred term rash pustular, rash papular, rash maculo-papular, rash macular, rash, erythema and dermatitis acneiform (uncoded terms rash acneiform and rash, are also included).

The following tables summarize the baseline characteristics for the JYP0015M101 and AURORAS-1 trials in patients with PDAC and NSCLC:

1 2 and 8 mg cohorts did not enroll patients with NSCLC.

2 Safety analysis set:

all patients with PDAC or NSCLC that received at least one dose of ERAS-0015.

3 2 and 4 mg cohorts did not enroll patients with NSCLC.

NA = not available

ERAS-4001 is a potential first-in-class pan-KRAS inhibitor in clinical development for the treatment of patients with KRAS-mutated solid tumors.

The preclinical in vitro potency of ERAS-4001 showed good activity against KRAS G12X mutations, as well as KRAS wildtype amplifications, with no activity observed against HRAS or NRAS wildtype proteins.

We believe sparing wildtype HRAS and NRAS has the potential to provide a wider therapeutic window in the clinic.

We believe sparing wildtype HRAS and NRAS has the potential to provide a wider therapeutic window in the clinic compared to the other pan-RAS molecular glues in development.

ERAS-4001 demonstrated activity against both GDP-bound (“inactive state”) and GTP-bound (“active state”) KRAS G12D with single digit nanomolar IC 50 (a measure of the drug concentration needed to achieve half-maximal inhibition) values in a biochemical RAS – RAF1 RBD (RAS Binding Domain) assay.

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In combination with an anti-PD-1 antibody, ERAS-4001 was able to achieve complete disappearance of tumors in mice on day 31.

The combination of ERAS-4001 plus the anti-EGFR antibody cetuximab induced significant tumor growth inhibition and demonstrated the combination benefit of blocking both oncogenic drivers.

The initial clinical trial for ERAS-4001 is BOREALIS-1.

We anticipate a Phase 1 monotherapy data readout from the BOREALIS-1 trial in 2026.

The combination of ERAS-4001 plus the anti-EGFR antibody cetuximab induced significant tumor growth inhibition and demonstrated the potential combination benefit of blocking both oncogenic drivers.

The initial clinical trial for ERAS-4001 is called BOREALIS-1.

The IND for BOREALIS-1 was cleared by the FDA in May 2025.

We anticipate a Phase 1 monotherapy data readout from the BOREALIS-1 trial in the second half of 2026.

In addition, we anticipate the initiation of monotherapy expansion cohorts and combination dose escalation cohorts in 2027.

We believe ERAS-0015 has the potential to address unmet medical needs in approximately 2.7 million patients who are diagnosed annually worldwide with RAS-mutant tumors, including the more than 2.2 million patients with KRAS-mutant tumors whom ERAS-4001 could also address.

Our most advanced clinical stage product candidate is naporafenib, for which we initiated two trials to evaluate the naporafenib plus trametinib (MEKINIST) combination (neither of which is enrolling patients currently), the SEACRAFT-2 pivotal Phase 3 trial for patients with NRAS-mutated (NRASm) melanoma and the SEACRAFT-1 Phase 1b trial for patients with RAS Q61X solid tumors.

Naporafenib is a pan-RAF inhibitor with first-in-class and best-in-class potential for patients with NRASm melanoma and other RAS/MAPK pathway-driven tumors.

RAF proteins are ubiquitously expressed serine-threonine kinases that constitute a key node of the RAS/MAPK pathway downstream of RAS and upstream of MEK.

The RAF protein family consists of ARAF, BRAF, and CRAF (RAF1) that are activated through dimerization.

Mutations in RAF proteins have been observed in many cancers, such as melanoma, colorectal cancer (CRC), non-small cell lung cancer (NSCLC), and thyroid cancer.

We in-licensed naporafenib from Novartis Pharma AG (Novartis) in December 2022.

Naporafenib has been dosed in over 600 patients to date, whereby safety, tolerability, and acceptable pharmacokinetics (PK) and pharmacodynamics have been established in both monotherapy and select combinations, with clinical proof-of-concept (PoC) data in combination with trametinib for patients with NRASm melanoma, which includes NRAS Q61X melanoma.

In December 2023, we announced that the FDA granted Fast Track Designation (FTD) to naporafenib in combination with trametinib for the treatment of adult patients with unresectable or metastatic melanoma who have progressed on, or are intolerant to, an anti‑programmed death-1 (ligand 1) (PD‑(L)1)-based regimen, and whose tumors contain an NRAS mutation.

Programs that receive FTD may benefit from early and frequent interactions with the FDA during the clinical development process and, if relevant criteria are met, the FDA may consider reviewing portions of a marketing application before the sponsor submits the complete application.

In connection with our SEACRAFT-2 trial, we have entered into a clinical trial collaboration and supply agreement (CTCSA) with Novartis for its MEK inhibitor, trametinib.

Pursuant to the CTCSA, we are sponsoring and funding the clinical trial and Novartis is providing its drug to us free of charge.

In addition, we are evaluating additional combinations of naporafenib with our other RAS/MAPK pathway targeting agents and/or external agents in preclinical models.

On October 24, 2024, we announced preliminary data from our SEACRAFT-1 trial in an oral presentation at the 36th EORTC-NCI-AACR (ENA) Symposium.

The preliminary clinical activity of naporafenib plus trametinib in the melanoma cohort of SEACRAFT-1 include, as of the efficacy cutoff date*:

• 40% (4/10) response rate observed in the efficacy-evaluable patients with NRAS Q61X melanoma, including three confirmed partial responses and one unconfirmed partial response;

the melanoma cohort in SEACRAFT-1 is generally representative of the patient population currently being enrolled in the pivotal SEACRAFT-2 trial

• 70% (7/10) of patients remained on treatment as of the data cutoff, including all four responders

In addition, we reported that naporafenib plus trametinib was generally well tolerated as of the safety cutoff date*, with mostly low-grade adverse events in the majority of patients.

We believe that the use of mandatory primary rash prophylaxis helped reduce the frequency and severity of skin toxicities, reduced the drug discontinuation rate due to skin-related adverse events, and improved the observed tolerability results as measured by the increased relative dose intensity, as compared to the prior clinical trials of naporafenib plus trametinib conducted by Novartis, which did not include the use of mandatory primary rash prophylaxis.

* Efficacy data cutoff date was September 5, 2024.

Safety data cutoff date was September 3, 2024.

In May 2025, in connection with our expectation that ERAS-0015 and ERAS-4001 would both become clinical stage programs, we conducted a strategic pipeline review.

Following this review, in order to prioritize organizational focus and resources to rapidly advance our differentiated RAS-targeting franchise, we decided to evaluate strategic alternatives for the Stage 2 portion of the naporafenib Phase 3 trial, including pursuing potential partnership opportunities.

As a result of this decision, we will not read out data from Stage 1 of the SEACRAFT-2 trial in the second half of 2025.

Our next program is ERAS-12, our investigational EGFR D2/D3 biparatopic antibody (bpAb).

ERAS-12 is a potential best-in-class biologic that is designed to inhibit EGFR through multiple proposed mechanisms of action.

ERAS-12 is a potential best-in-class biologic, for which we have identified a lead candidate, that is designed to inhibit EGFR through multiple proposed mechanisms of action.

In tumors where EGFR signaling is thought to be a primary driver of tumor growth, an antibody-based approach has been shown to be an effective way to target the receptor.

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By combining novel cell signal inhibition with enhancements to the Fc, we aim to create a potent multi-modal BIC anti-EGFR biologic which we believe could function as a targeted therapy with immunomodulatory activity.

In May 2025, in connection with our expectation that ERAS-0015 and ERAS-4001 would both become clinical stage programs, we conducted a broader pipeline review.

Following this review, in order to prioritize organizational focus and resources to advance our differentiated RAS-targeting franchise, we decided to evaluate strategic alternatives for our naporafenib program, which we in-licensed from Novartis Pharma AG (Novartis).

After evaluating the clinical progress of our RAS franchise, we made a decision to stop development of naporafenib.

In March 2026, we sent a notice to Novartis to terminate our exclusive license agreement with Novartis (as amended, the Novartis Agreement) pursuant to which we acquired exclusive rights to develop naporafenib.

The effective date of the termination of the Novartis Agreement is June 3, 2026.

In connection with such termination, we and Novartis have agreed that we shall continue to ensure that the patients currently enrolled in the SEACRAFT-1 and SEACRAFT-2 trials will be permitted to continue to receive treatment for the foreseeable future.

We do not own or operate, and currently have no plans to establish, any manufacturing facilities.

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We believe that this strategy allows us to maintain a more efficient infrastructure by eliminating the need for us to invest in our own manufacturing facilities, equipment, and personnel while also enabling us to focus our expertise and resources on the design and development of our product candidates.

In December 2022, we completed the sale and issuance of 15,384,616 shares of our common stock at a price to the public of $6.50 per share (the 2022 Offering).

Proceeds from the 2022 Offering were $94.9 million, net of underwriting discounts and commissions and offering costs of $5.1 million.

In March 2024, we entered into a stock purchase agreement with the purchasers named therein for the private placement of 21,844,660 shares of our common stock at a price of $2.06 per share, which closed on April 2, 2024 (the 2024 Private Placement).

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Proceeds from the 2024 Offering were $174.4 million, net of underwriting discounts and commissions and offering costs of $9.6 million.

In August 2022, we entered into an Open Market Sale Agreement (the Sale Agreement) with Jefferies LLC (the Agent), pursuant to which we could offer and sell shares of our common stock having an aggregate offering price of up to $200 million from time to time, in an “at-the-market offering” (ATM Offering) through the Agent.

Sales of the shares of common stock were made at prevailing market prices at the time of sale, or as otherwise agreed with the Agent.

Pursuant to the Sale Agreement, the Agent received a commission from us of up to 3.0% of the gross proceeds of shares of common stock sold under the Sale Agreement.

During the three and nine months ended September 30, 2024, we sold 9,231,114 shares of our common stock at a weighted-average price of $2.37 per share under the Sale Agreement with the Agent.

Proceeds from the ATM Offerings during the three and nine months ended September 30, 2024 were $21.0 million, net of commissions and expenses of $0.8 million.

In August 2025, we entered into an Amended and Restated Open Market Sale Agreement (the 2025 Sale Agreement) with the Agent, pursuant to which we may offer and sell shares of our common stock having an aggregate offering price of up to $200 million from time to time, in ATM Offerings through the Agent.

During the year ended December 31, 2024, we sold 9,231,114 shares of our common stock under the Sale Agreement at a weighted-average price of $2.37 per share.

Proceeds from the ATM Program during the year ended December 31, 2024 were $21.0 million, net of commissions and expenses of $0.8 million.

Sales of the shares of common stock, if any, will be made at prevailing market prices at the time of sale, or as otherwise agreed with the Agent.

The Agent will receive a commission from us of up to 3.0% of the gross proceeds of any shares of common stock sold under the 2025 Sale Agreement.

As of September 30, 2025, we had $200.0 million of shares available for sale under the ATM program.

As of March 31, 2026, we had $200.0 million of shares available for sale under the ATM Program.

In January 2026, we completed the sale and issuance of 25,875,000 shares of our common stock, including the exercise in full by the underwriters of their option to purchase 3,375,000 shares of our common stock, at a price to the public of $10.00 per share (the January 2026 Offering).

Our aggregate net proceeds from the January 2026 Offering were $242.7 million, net of underwriting discounts and commissions of $15.5 million and offering costs of $0.5 million.

Since our inception in 2018, we have devoted substantially all of our resources to organizing and staffing our company, business planning, raising capital, identifying, acquiring, and in-licensing our product candidates, establishing our intellectual property portfolio, conducting research, preclinical studies and clinical trials, establishing arrangements with third parties for the manufacture of our product candidates and related raw materials, and providing general and administrative support for these operations.

We do not have any products approved for sale and have not generated any revenue.

As of September 30, 2025, we have raised a total of $1.0 billion to fund our operations, comprised primarily of gross proceeds from our IPO, underwritten offerings, a private placement of our common stock and the sale and issuance of convertible preferred stock.

As of September 30, 2025, we had cash, cash equivalents and marketable securities of $362.4 million.

As of March 31, 2026, we have raised a total of $1.3 billion to fund our operations, comprised primarily of gross proceeds from our IPO, underwritten offerings, a private placement of our common stock, and the sale and issuance of convertible preferred stock.

As of March 31, 2026, we had cash, cash equivalents, and marketable securities of $408.5 million.

We have incurred significant operating losses since inception.

Our net losses were $30.6 million and $31.2 million for the three months ended September 30, 2025 and 2024, respectively, and $95.5 million and $129.4 million for the nine months ended September 30, 2025 and 2024, respectively.

As of September 30, 2025, we had an accumulated deficit of $863.1 million.

Our net losses were $183.4 million and $31.0 million for the three months ended March 31, 2026 and 2025, respectively.

As of March 31, 2026, we had an accumulated deficit of $1.1 billion.

We expect our expenses and operating losses will increase substantially for the foreseeable future, particularly if and as we conduct our ongoing and planned clinical trials and preclinical studies;

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If we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing, and distribution.

In addition, as our product candidates progress through development and toward commercialization, we will need to make milestone payments to the licensors and other third parties from whom we have in-licensed or acquired our product candidates.

Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and preclinical studies and our expenditures on other research and development activities.

Based upon our current operating plans, we believe that our cash, cash equivalents and marketable securities as of September 30, 2025 will be sufficient to fund our operations into the second half of 2028.

Based upon our current operating plans, we believe that our cash, cash equivalents, and marketable securities as of March 31, 2026 will be sufficient to fund our operations into the second half of 2028.

We do not expect to generate any revenues from product sales until we successfully complete development and obtain regulatory approval for one or more of our product candidates, which we expect will take a number of years and may never occur.

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Our financial condition and results of operations may also be impacted by other factors we may not be able to control, such as geopolitical and economic events.

We do not believe that such factors had a material adverse impact on our results of operations during the three months ended September 30, 2025.

We do not believe that such factors had a material adverse impact on our results of operations during the three months ended March 31, 2026.

Our acquisition and license agreements

We have entered into in-license and acquisition agreements pursuant to which we in-licensed or acquired certain intellectual property rights related to our product candidates and development programs.

Asana BioSciences, LLC

In November 2020, we entered into the Asana Merger Agreement, pursuant to which ASN became its wholly-owned subsidiary.

Asana and ASN had previously entered into a license agreement, which was amended and restated prior to the closing of the merger transaction (the Asana License Agreement), pursuant to which ASN acquired an exclusive, worldwide license to certain intellectual property rights relating to inhibitors of ERK1 and ERK2 owned or controlled by Asana to develop and commercialize ERAS-007 and certain other related compounds for all applications.

In May 2024, we announced a strategic reprioritization that included deprioritizing the final trial in the HERKULES series of clinical trials that was evaluating ERAS-007.

In September 2025, we sent a notice to Asana to terminate the Asana License Agreement, with an effective termination date of November 8, 2025.

In connection with such termination, the Company and Asana have agreed that we shall continue to ensure that the patients currently enrolled in the HERKULES series of trials will be permitted to continue to participate in such trials for the foreseeable future.

NiKang Therapeutics, Inc.

In February 2020, we entered into a license agreement (the NiKang License Agreement) with NiKang Therapeutics, Inc.

(NiKang) under which we were granted an exclusive, worldwide license to certain intellectual property rights owned or controlled by NiKang related to certain SHP2 inhibitors to develop and commercialize ERAS-601 and certain other related compounds for all applications.

In November 2023, we announced a strategic reprioritization that included deprioritizing the FLAGSHP-1 clinical trial that was evaluating ERAS-601.

In September 2025, we sent a notice to NiKang to terminate the NiKang License Agreement, with an effective termination date of October 9, 2025.

In connection with such termination, the Company and NiKang have agreed that we shall continue to ensure that the patients currently enrolled in the FLAGSHP-1 trial and an investigator-initiated trial of ERAS-601 will be permitted to continue to participate in such trials for the foreseeable future.

Katmai Pharmaceuticals, Inc.

In May 2024, we announced a strategic reprioritization which included deprioritizing our THUNDERBBOLT-1 clinical trial evaluating ERAS-801 in patients with recurrent glioblastoma.

In April 2025, we entered into a Termination Agreement (the Katmai Termination Agreement) with Katmai Pharmaceuticals, Inc.

The Katmai Termination Agreement terminated the license agreement, dated March 12, 2020, between us and Katmai in which we obtained an exclusive worldwide license from Katmai to develop and commercialize ERAS-801 (the Katmai License Agreement).

Pursuant to the Katmai Termination Agreement, the Katmai License Agreement was terminated as of April 1, 2025.

Under the Katmai Termination Agreement, we assigned to Katmai certain know-how, intellectual property rights, third-party vendor agreements, regulatory filings, and materials that we developed in connection with the development of ERAS-801 under the Katmai License Agreement, and Katmai is obligated to make payments to us upon the occurrence of specific events related to Katmai’s future development and commercialization of ERAS-801.

In addition, we provided certain transition services to Katmai for a 90-day period, for which Katmai reimbursed us for our internal costs related to such services.

For additional information regarding our other in-license and acquisition agreements, see the section titled “Business—Our acquisition and license agreements” in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 20, 2025.

For additional information regarding our in-license and acquisition agreements, see the section titled “Business—Our acquisition and license agreements” in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 12, 2026.

Components of results of operations

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• internal costs, including:

employee-related expenses, including salaries, benefits, and stock-based compensation for those individuals involved in research and development efforts;

the costs of laboratory supplies and acquiring, developing and manufacturing preclinical study materials;

facilities and depreciation, which include direct and allocated expenses for rent of facilities and depreciation.

o employee-related expenses, including salaries, benefits, and stock-based compensation for those individuals involved in research and development efforts;

o the costs of laboratory supplies and acquiring, developing, and manufacturing preclinical study materials;

o facilities and depreciation, which include direct and allocated expenses for rent of facilities and depreciation.

The following table summarizes our research and development expenses incurred for the following periods (in thousands):

Three Months Ended September 30,

Nine Months Ended September 30,

ERAS-0015 (1)

ERAS-4001 (1)

Three Months Ended March 31,

Other clinical programs (1)

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Total research and development expenses

(1) We in-licensed ERAS-0015 and ERAS-4001 in May 2024.

(1) Other clinical programs include naporafenib.

We expect our research and development expenses to increase substantially for the foreseeable future as we continue to conduct our ongoing research and development activities, conduct clinical trials, and advance our preclinical research programs toward clinical development, particularly as more of our product candidates move into later stages of development, which typically cost more.

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We may never succeed in achieving marketing approval for any of our product candidates.

The timelines and costs with research and development activities are uncertain, can vary significantly for each product candidate and program and are difficult to predict.

The timelines and costs associated with research and development activities are uncertain, can vary significantly for each product candidate and program and are difficult to predict.

We anticipate we will make determinations as to which product candidates and programs to pursue and how much funding to direct to each product candidate and program on an ongoing basis in response to preclinical and clinical results, regulatory developments, ongoing assessments as to each product candidate’s and program’s commercial potential, and our ability to enter into collaborations, licenses, or other similar agreements to the extent we determine the resources or expertise of a third-party would be beneficial for a given product candidate or program.

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Results of operations

Comparison of the three months ended September 30, 2025 and 2024

The following table summarizes our results of operations for the three months ended September 30, 2025 and 2024 (in thousands):

Three Months Ended September 30,

Operating expenses:

Research and development

In-process research and development

General and administrative

Total operating expenses

Loss from operations

Total other income (expense), net

Research and development expenses

Research and development expenses were $22.5 million for the three months ended September 30, 2025 compared to $27.6 million for the three months ended September 30, 2024.

The decrease of $5.2 million was primarily driven by decreases of $2.8 million in expenses incurred in connection with clinical trials, preclinical studies and discovery activities and $2.4 million in outsourced services and consulting fees.

In-process research and development expenses

In-process research and development expenses were $2.0 million for the three months ended September 30, 2025 compared to $0 for the three months ended September 30, 2024.

In-process research and development expenses for the three months ended September 30, 2025 were related to the achievement of milestones in connection with our license agreement with Medshine.

General and administrative expenses

General and administrative expenses were $10.1 million for the three months ended September 30, 2025 compared to $9.6 million for the three months ended September 30, 2024.

The increase of $0.5 million was primarily driven by increases of $0.3 million in legal fees and $0.2 million in personnel costs, including stock-based compensation expense.

Other income (expense), net

Other income (expense), net was $3.9 million for the three months ended September 30, 2025 compared to $6.0 million for the three months ended September 30, 2024.

The decrease of $2.1 million was primarily related to a decrease in interest earned on our cash, cash equivalents and marketable securities of $1.9 million during the three months ended September 30, 2025.

Comparison of the nine months ended September 30, 2025 and 2024

The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024 (in thousands):

Nine Months Ended September 30,

Comparison of the three months ended March 31, 2026 and 2025

The following table summarizes our results of operations for the three months ended March 31, 2026 and 2025 (in thousands):

Three Months Ended March 31,

Operating expenses:

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Research and development expenses

Research and development expenses were $69.6 million for the nine months ended September 30, 2025 compared to $89.2 million for the nine months ended September 30, 2024.

The decrease of $19.6 million was primarily driven by decreases of $5.8 million in expenses incurred in connection with clinical trials, preclinical studies and discovery activities, $4.9 million in outsourced services and consulting fees, $3.5 million in personnel costs, including stock-based compensation expense, and $2.0 million in facilities-related expenses and depreciation, and an impairment charge of $3.0 million on operating lease assets, leasehold improvements, and furniture related to the sublease plan of the first floor of our San Diego facility during the nine months ended September 30, 2024.

Research and development expenses were $27.3 million for the three months ended March 31, 2026 compared to $26.0 million for the three months ended March 31, 2025.

The increase of $1.3 million was primarily driven by increases of $1.7 million in personnel costs, including stock-based compensation expense, and $1.0 million in expenses incurred in connection with clinical trials, preclinical studies, and discovery activities, partially offset by decreases of $1.1 million in outsourced services and consulting fees and $0.4 million in facilities-related expenses and depreciation.

In-process research and development expenses

In-process research and development expenses were $9.5 million for the nine months ended September 30, 2025 compared to $22.5 million for the nine months ended September 30, 2024.

In-process research and development expenses for the nine months ended September 30, 2025 were related to the achievement of milestones in connection with our license agreements with Joyo and Medshine.

In-process research and development expenses for the nine months ended September 30, 2024 were related to upfront payments in connection with our license agreements with Joyo and Medshine.

In-process research and development expenses were $150.0 million for the three months ended March 31, 2026 compared to $0 for the three months ended March 31, 2025.

In-process research and development expenses for the three months ended March 31, 2026 were related to our exercise of the option to expand our territory under the license agreement with Joyo.

General and administrative expenses

General and administrative expenses were $29.2 million for the nine months ended September 30, 2025 compared to $32.1 million for the nine months ended September 30, 2024.

The decrease of $3.0 million was primarily driven by an impairment charge of $1.7 million on operating lease assets, leasehold improvements, and furniture related to the sublease plan of the first floor of our San Diego facility during the nine months ended September 30, 2024, and decreases of $0.6 million in legal fees, $0.4 million in facilities and office-related expenses, and $0.4 million in insurance costs.

General and administrative expenses were $10.6 million for the three months ended March 31, 2026 compared to $9.7 million for the three months ended March 31, 2025.

The increase of $1.0 million was primarily driven by an increase of $0.9 million in personnel costs, including stock-based compensation expense.

Other income (expense), net

Other income (expense), net was $12.8 million for the nine months ended September 30, 2025 compared to $14.5 million for the nine months ended September 30, 2024.

The decrease of $1.6 million was primarily related to a decrease in interest earned on our cash, cash equivalents and marketable securities of $1.8 million during the nine months ended September 30, 2025, partially offset by a $0.4 million impairment charge on our investment in equity securities during the nine months ended September 30, 2024.

Other income (expense), net was $4.5 million for the three months ended March 31, 2026 compared to $4.7 million for the three months ended March 31, 2025.

The decrease of $0.2 million was primarily related to a decrease in interest earned on our cash, cash equivalents, and marketable securities during the three months ended March 31, 2026.

Liquidity and capital resources

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Proceeds from the 2024 Offering were $174.4 million, net of underwriting discounts and commissions and offering costs of $9.6 million.

In August 2022, we entered into the Sale Agreement with the Agent, pursuant to which, we could offer and sell shares of our common stock having an aggregate offering price of up to $200 million from time to time, in an ATM Offering through the Agent.

In August 2022, we entered into the Sale Agreement with the Agent, pursuant to which we could offer and sell shares of our common stock having an aggregate offering price of up to $200 million from time to time, in an ATM Program through the Agent.

Sales of the shares of common stock were made at prevailing market prices at the time of sale, or as otherwise agreed with the Agent.

Pursuant to the Sale Agreement, the Agent received a commission from us of up to 3.0% of the gross proceeds of shares of common stock sold under the Sale Agreement.

During the three and nine months ended September 30, 2024, we sold 9,231,114 shares of our common stock at a weighted-average price of $2.37 per share under the Sale Agreement with the Agent.

Proceeds from the ATM Offerings during the three and nine months ended September 30, 2024 were $21.0 million, net of commissions and expenses of $0.8 million.

In August 2025, we entered into the 2025 Sale Agreement with the Agent, pursuant to which we may offer and sell shares of our common stock having an aggregate offering price of up to $200 million from time to time, in ATM Offerings through the Agent.

During the year ended December 31, 2024, we sold 9,231,114 shares of our common stock under the Sale Agreement at a weighted-average price of $2.37 per share.

Proceeds from the ATM Program during the year ended December 31, 2024 were $21.0 million, net of commissions and expenses of $0.8 million.

Sales of the shares of common stock, if any, will be made at prevailing market prices at the time of sale, or as otherwise agreed with the Agent.

The Agent will receive a commission from us of up to 3.0% of the gross proceeds of any shares of common stock sold under the 2025 Sale Agreement.

As of September 30, 2025, we had $200.0 million of shares available for sale under the ATM program.

As of March 31, 2026, we had $200.0 million of shares available for sale under the ATM Program.

Our aggregate net proceeds from the January 2026 Offering were $242.7 million, net of underwriting discounts and commissions of $15.5 million and offering costs of $0.5 million.

Future capital requirements

As of September 30, 2025, we had cash, cash equivalents and marketable securities of $362.4 million.

As of March 31, 2026, we had cash, cash equivalents, and marketable securities of $408.5 million.

Based upon our current operating plans, we believe that our cash, cash equivalents, and marketable securities will be sufficient to fund our operations into the second half of 2028.

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• the costs associated with hiring additional personnel, consultants, and CROs as our preclinical and clinical activities increase;

the timing and amount of the milestone or other payments we must make to the licensors and other third parties from whom we have in-licensed or acquired our product candidates or technologies;

• the timing and amount of the milestone or other payments we must make to the licensors and other third parties from whom we have in-licensed our product candidates or technologies;

• the costs and timing of establishing or securing sales and marketing capabilities if any product candidate is approved;

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The following table shows a summary of our cash flows for the periods presented (in thousands):

Nine Months Ended September 30,

Three Months Ended March 31,

Net cash (used in) provided by:

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Financing activities

Net increase (decrease) in cash, cash equivalents and restricted cash

Net (decrease) increase in cash, cash equivalents, and restricted cash

Operating activities

Cash used in operating activities was $73.7 million during the nine months ended September 30, 2025, primarily resulting from a net loss of $95.5 million, changes in operating assets and liabilities of $4.7 million and accretion on marketable securities of $4.5 million, partially reduced by stock-based compensation expense of $19.1 million, in-process research and development expenses of $9.5 million, which are reflected in investing activities, and depreciation and amortization expense of $2.4 million.

Net cash used from changes in operating assets and liabilities consisted primarily of decreases in accrued expenses and other current and long-term liabilities of $5.4 million and operating lease assets and liabilities, net of $1.5 million and an increase in prepaid expenses and other current and long-term assets of $0.4 million, partially offset by an increase in accounts payable of $2.6 million.

Cash used in operating activities was $84.9 million during the nine months ended September 30, 2024, primarily resulting from a net loss of $129.4 million and accretion on marketable securities of $7.2 million, partially reduced by in-process research and development expenses of $22.5 million in connection with our license agreements with Joyo and Medshine, which are reflected in investing activities, stock-based compensation expense of $20.7 million, an impairment charge of $4.7 million on operating lease assets, leasehold improvements and furniture, depreciation and amortization expense of $3.0 million, and changes in operating assets and liabilities of $0.6 million.

Net cash provided by changes in operating assets and liabilities consisted primarily of an increase in accounts payable, accrued expenses and other current and long-term liabilities of $3.6 million, partially offset by an increase in prepaid expenses and other current and long-term assets of $2.6 million.

Cash used in operating activities was $27.4 million during the three months ended March 31, 2026, primarily resulting from a net loss of $183.4 million, changes in operating assets and liabilities of $2.3 million, and accretion on marketable securities of $0.7 million, partially reduced by in-process research and development expenses of $150.0 million related to our exercise of the option to expand our territory under the license agreement with Joyo which are reflected in investing activities, stock-based compensation expense of $8.5 million, and depreciation and amortization expense of $0.7 million.

Net cash used from changes in operating assets and liabilities consisted primarily of a decrease in accrued expenses and other current and long-term liabilities of $3.3 million, partially offset by an increase in accounts payable of $1.2 million.

Cash used in operating activities was $31.6 million during the three months ended March 31, 2025, primarily resulting from a net loss of $31.0 million, changes in operating assets and liabilities of $6.1 million, and accretion on marketable securities of $2.0 million, partially reduced by stock-based compensation expense of $6.7 million and depreciation and amortization expense of $0.8 million.

Net cash used from changes in operating assets and liabilities consisted primarily of a decrease in accrued expenses and other current and long-term liabilities of $8.0 million, partially offset by an increase in accounts payable of $1.8 million.

Investing activities

Net cash provided by investing activities was $75.7 million during the nine months ended September 30, 2025 as compared to net cash used in investing activities of $179.2 million during the nine months ended September 30, 2024.

The increase in cash provided by investing activities of $254.9 million was primarily the result of a decrease in purchases of marketable securities of $227.3 million, an increase in maturities of marketable securities of $14.5 million and a decrease in in-process research and development of $13.0 million.

Net cash used in investing activities was $243.8 million during the three months ended March 31, 2026 as compared to net cash provided by investing activities of $34.3 million during the three months ended March 31, 2025.

The increase in cash used in investing activities of $278.1 million was primarily the result of increases in purchases of marketable securities of $242.5 million and in-process research and development of $150.0 million, partially offset by increases in sales of marketable securities of $100.8 million and maturities of marketable securities of $13.6 million.

Financing activities

Net cash provided by financing activities was $0.5 million during the nine months ended September 30, 2025 as compared to $239.9 million during the nine months ended September 30, 2024.

During the nine months ended September 30, 2025, we received $0.4 million from the issuance of common stock under our ESPP and $0.1 million from the exercise of stock options.

During the nine months ended September 30, 2024, we received $174.4 million of net proceeds for the issuance of common stock from the 2024 Offering, $43.6 million in net proceeds for the issuance of common stock from the 2024 Private Placement, $21.0 million in net proceeds for the issuance of common stock from the ATM Offerings, $0.4 million from the issuance of common stock under our ESPP and $0.4 million from the exercise of stock options.

Net cash provided by financing activities was $244.7 million during the three months ended March 31, 2026 and less than $0.1 million during the three months ended March 31, 2025.

During the three months ended March 31, 2026, we received $242.7 million in net proceeds for the issuance of common stock from the 2026 Offering and $2.0 million from the exercise of stock options.

Contractual obligations and commitments

As of September 30, 2025, there have been no material changes outside the ordinary course of our business to the contractual obligations we reported in “Management’s discussion and analysis of financial condition and results of operations – Cash requirements due to contractual obligations and other commitments,” included in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 20, 2025.

As of March 31, 2026, there have been no material changes outside the ordinary course of our business to the contractual obligations we reported in “Management’s discussion and analysis of financial condition and results of operations – Cash requirements due to contractual obligations and other commitments,” included in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 12, 2026.

Critical accounting policies and estimates

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Actual results may differ materially from these estimates.

As of September 30, 2025, there have been no material changes to our critical accounting policies and estimates from those disclosed in “Management’s discussion and analysis of financial condition and results of operations – Critical accounting policies and estimates,” included in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 20, 2025.

As of March 31, 2026, there have been no material changes to our critical accounting policies and estimates from those disclosed in “Management’s discussion and analysis of financial condition and results of operations – Critical accounting policies and estimates,” included in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 12, 2026.

Recently issued and adopted accounting pronouncements

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis