Black Diamond Therapeutics, Inc.

Previous wording

We are a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, including silevertinib, a potential best-in-class brain-penetrant epidermal growth factor receptor (EGFR) inhibitor. The foundation of our company is built upon a deep understanding of cancer genetics, onco-protein structure and function, and medicinal chemistry. Our MasterKey therapies are designed to address a broad spectrum of genetically defined tumors, overcome resistance, minimize wild-type mediated toxicities, and be brain-penetrant to treat central nervous system (CNS) disease. Our compounds target families of oncogenic mutations in clinically validated pathways. Our lead clinical-stage program, silevertinib (formerly BDTX-1535), is a brain-penetrant, covalent, fourth-generation epidermal growth factor receptor (EGFR) MasterKey inhibitor targeting epidermal growth factor receptor mutant (EGFRm) non-small cell lung cancer (NSCLC) and glioblastoma (GBM). We are advancing a Phase 2 trial in EGFRm NSCLC patients and initiated a randomized Phase 2 trial of silevertinib in newly diagnosed patients with EGFRvIII+ glioblastoma (GBM), with the first patient dosed in May 2026.

Current wording

We are a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, including silevertinib, a potential best-in-class brain-penetrant epidermal growth factor receptor (EGFR) inhibitor. The foundation of our company is built upon a deep understanding of cancer genetics, onco-protein structure and function, and medicinal chemistry. Our MasterKey therapies are designed to address a broad spectrum of genetically defined tumors, overcome resistance, minimize wild-type mediated toxicities, and be brain-penetrant to treat central nervous system (CNS) disease. Our compounds target families of oncogenic mutations in clinically validated pathways. Our lead clinical-stage program, silevertinib (formerly BDTX-1535), is a brain-penetrant, covalent, fourth-generation epidermal growth factor receptor (EGFR) MasterKey inhibitor targeting epidermal growth factor receptor mutant (EGFRm) non-small cell lung cancer (NSCLC) and glioblastoma (GBM). We are advancing silevertinib in EGFRm NSCLC patients through an ongoing Phase 2 trial and are planning a Phase 3 trial in frontline NSCLC patients with EGFR non-classical mutations (NCMs) with the potential to initiate in the second quarter of 2027. We are also enrolling newly diagnosed patients with EGFRvIII+ glioblastoma (GBM)in a randomized Phase 2 trial of silevertinib, with the first patient dosed in the randomized portion of the trial in the fourth quarter of 2026.

Previous wording

We believe that our clinical-stage lead product candidate, silevertinib, has the potential to treat newly diagnosed patients with EGFRm NSCLC, as well as those with recurrent disease, based upon silevertinib’s ability to address greater than 50 classical and non-classical oncogenic driver mutations with greater potency than other EGFR tyrosine kinase inhibitors (TKIs), as well as uniquely target the C797S resistance mutation which can be acquired after treatment with osimertinib. Silevertinib was shown to be well tolerated and achieve durable clinical responses in our Phase 1 trial in patients with recurrent EGFRm NSCLC whose tumors expressed a range of mutation subtypes, including the acquired C797S resistance mutation and a broad spectrum of non-classical mutations. At the American Society of Clinical Oncology (ASCO) Annual Meeting in May 2026, final clinical data from a Phase 2 trial of 83 patients with EGFRm NSCLC in the second- and third-line settings demonstrated encouraging clinical responses, robust EGFRm target coverage, and a favorable tolerability profile with no new safety signals observed.

Current wording

We believe that our clinical-stage lead product candidate, silevertinib, has the potential to treat newly diagnosed patients with EGFRm NSCLC, as well as those with recurrent disease, based upon silevertinib’s ability to address greater than 50 classical and non-classical oncogenic driver mutations with greater potency than other EGFR tyrosine kinase inhibitors (TKIs) and the C797S resistance mutation (which can be acquired after treatment with osimertinib), and its potential best-in-class CNS activity. Silevertinib was shown to be well tolerated and achieve durable clinical responses in our Phase 1 trial in patients with recurrent EGFRm NSCLC whose tumors expressed a range of mutation subtypes, including the acquired C797S resistance mutation and a broad spectrum of non-classical mutations. At the American Society of Clinical Oncology (ASCO) Annual Meeting in May 2026, final clinical data from a Phase 2 trial of 83 patients with EGFRm NSCLC in the second- and third-line settings demonstrated encouraging clinical responses, robust EGFRm target coverage, and a favorable tolerability profile with no new safety signals observed.

Previous wording

On May 30, 2026, data from our Phase 2 trial of silevertinib in frontline EGFRm NSCLC patients were presented at the ASCO Annual Meeting. As of an April 11, 2026 data cutoff date, 43 frontline patients presenting with a broad spectrum of EGFR non-classical mutations (NCMs), including compound and P-Loop and C-Helix Compressing (PACC) mutations, were enrolled at a dose of 200 mg once daily (QD). 19 patients presented with brain metastases, 7 of whom had measurable central nervous system (CNS) target lesions. At a median follow-up of 11.2 months, preliminary median progression-free survival (mPFS) was 15.2 months (95% CI: 10.8, NE) and median duration of response (DOR) had not been reached (95% CI: 7.0, NE). As of the data cutoff date, 23 of 43 patients (53%) remained on therapy, with the longest at 23.5 months. No patients developed de novo brain metastases. The previously disclosed CNS objective response rate (ORR by RANO-BM) of 86%, objective response rate (ORR by RECIST 1.1) of 60%, and disease control rate (DCR) of 91% each remained unchanged. Reductions in variant allele frequency (VAF) were observed in all evaluable patients across 25 unique EGFR-NCMs, including PACC mutations. No new safety signals were observed. Adverse events (AEs) experienced by a majority of patients included rash, stomatitis, diarrhea, and paronychia and were managed with standard supportive care and dose interruptions or reductions without compromising response depth or durability. Following dose reductions, the rate of Grade 3 or higher treatment-related AEs was reduced to 28%. Collectively, safety, pharmacokinetics, pharmacodynamics and efficacy data support the selection of a 150 mg QD dose for pivotal development.

Current wording

On November 10, 2026, we announced updated results from our Phase 2 trial of silevertinib in frontline EGFRm NSCLC patients. As of an October 7, 2026 data cutoff date, 43 frontline patients presenting with a broad spectrum of EGFR NCMs were enrolled at a dose of 200 mg once daily (QD). 19 patients presented with brain metastases, (including 16 patients with untreated brain metastases) 7 of whom had measurable CNS target lesions. Median follow-up time was 15.9 months. In our Intent-to-Treat (ITT) population, median progression-free survival (mPFS) was 15.0 months (95% confidence interval (CI): 11.0, 23.5) and median duration of response (DOR) was 13.8 months (95% CI: 9.2, 22.3). As of the data cutoff date, 18 of 43 patients (42%) remained on therapy, with the longest at 26.2 months and the disease control rate (DCR) was 93%. The previously disclosed objective response rate (ORR by RECIST 1.1) of 60% remained unchanged. In the 24 patients without brain metastases at baseline, mPFS was 23.5 months (95% CI: 11.0, not estimable (NE)), and no patients developed de novo brain metastases. In patients with untreated brain metastases, mPFS was 12.2 months (95% CI: 8.1, NE) and median DOR was 13.8 months (95% CI: 4.4, NE). As of the data cutoff date, 8 of 16 patients (50%) with untreated brain metastases remained on therapy, with the longest at 21.3 months. In the 7 patients with untreated measurable brain metastases, the CNS objective response rate (CNS ORR by RANO-BM) of 86% remained unchanged, and in 4 of the 9 patients with untreated non-measurable brain metastases, complete disappearance of brain metastases was observed. Among the 19 patients with baseline brain metastases, only 4 had the brain as a site of progression. No new safety signals were observed. Most patients experienced dose interruption and/or reduction, and only 19% of patients discontinued due to adverse events (AEs). AEs experienced by a majority of patients included rash, stomatitis, diarrhea, and paronychia and were managed with standard supportive care and dose interruptions or reductions without compromising response depth or durability. Following dose reductions, the rate of Grade 3 or higher treatment-related AEs was reduced to 28%. Based on the totality of safety, pharmacokinetics, pharmacodynamics and efficacy data available to date, we have selected 150 mg QD as the dose for pivotal development. In support of our pivotal development plan, in the third quarter of 2026 we began enrollment of frontline EGFR-NCM NSCLC patients at a dose of 150 mg QD in a new Cohort 4 (n=20) in our Phase 2 trial.

Previous wording

Silevertinib has demonstrated encouraging CNS activity in multiple trials across NSCLC and GBM. In our Phase 2 in frontline patients with EGFRm NSCLC 86% of patients achieved a confirmed CNS response. The results from our Phase 1 trial of silevertinib in patients with relapsed/recurrent GBM (presented at ASCO in 2024) showed encouraging duration of treatment and clinical activity, and a tolerability profile consistent with the initial safety data seen in patients with recurrent NSCLC. A Phase 0/1 “window of opportunity” study sponsored by the Ivy Brain Tumor Center in Phoenix, Arizona in patients with recurrent high-grade glioma (HGG) with EGFR alterations and/or fusions at initial diagnosis demonstrated that silevertinib exceeded the pre-specified threshold for drug concentration in the brain tumor tissue and was generally well tolerated. It also showed that silevertinib penetrates non-contrast enhancing regions of glioblastoma and suppresses EGFR signaling in patient tumors. Based on these data and together with the robust CNS ORR demonstrated by silevertinib to date in our Phase 2 trial in frontline EGFRm NSCLC patients, we believe that silevertinib is uniquely positioned as a potential treatment for patients with newly diagnosed EGFR-altered GBM. Following feedback on the study design received from the FDA in January 2026, we initiated a randomized Phase 2 trial in this patient population and dosed the first patient in May 2026. After a combination safety lead-in of silevertinib plus temozolomide (TMZ), the trial is expected to enroll approximately 150 newly diagnosed patients, randomized to receive TMZ (as the control arm) or silevertinib plus TMZ (as the experimental arm). The eligible patient population will be EGFRvIII-positive patients (approximately 30% of GBM patients) who are O-6-methylguanine-DNA methyltransferase (MGMT) -negative (unmethylated). Randomization and treatment will begin after patients have had surgical resection and radiation and are eligible for maintenance TMZ. The primary endpoint of the trial will be PFS (RANO by blinded independent committee review, or BICR), with a planned futility analysis, and an interim PFS analysis anticipated in the first half of 2028. The secondary endpoint of the trial will be overall survival (OS). The trial will be governed by an independent data monitoring committee (IDMC).

Current wording

The results from our Phase 1 trial of silevertinib in patients with relapsed/recurrent GBM (presented at ASCO in 2024) showed prolonged stable disease in multiple patients, confirmed partial response in a patient with EGFRvIII/EGFRamp, and a tolerability profile consistent with the initial safety data seen in patients with recurrent NSCLC. A Phase 0/1 “window of opportunity” study sponsored by the Ivy Brain Tumor Center in Phoenix, Arizona in patients with recurrent high-grade glioma (HGG) with EGFR alterations and/or fusions at initial diagnosis demonstrated that silevertinib exceeded the pre-specified threshold for drug concentration in the brain tumor tissue and was generally well tolerated. It also showed that silevertinib penetrates non-contrast enhancing regions of glioblastoma and suppresses EGFR signaling in patient tumors. Based on these data and together with the robust CNS activity demonstrated by silevertinib to date in our Phase 2 trial in frontline EGFRm NSCLC patients, we believe that silevertinib is uniquely positioned as a potential treatment for patients with newly diagnosed EGFR-altered GBM. Following feedback on the study design received from the FDA in January 2026, we initiated a randomized Phase 2 trial in this patient population. In September 2026 we completed the combination safety lead-in portion of the study evaluating silevertinib plus temozolomide (TMZ). Based on data from six patients treated with silevertinib at 150 mg QD in combination with TMZ with no dose-limiting toxicities observed, 150 mg QD was selected for the randomized portion of the study by the independent data monitoring committee (IDMC) overseeing the trial. The first patient was dosed in the randomized portion of the study in the fourth quarter of 2026. The randomized portion of the trial is expected to enroll approximately 150 newly diagnosed patients, randomized to receive TMZ (as the control arm) or silevertinib plus TMZ (as the experimental arm). The eligible patient population will be EGFRvIII-positive patients (approximately 30% of GBM patients) who are O-6-methylguanine-DNA methyltransferase (MGMT) -negative (unmethylated). Randomization and treatment begin after patients have had surgical resection and radiation and are eligible for maintenance TMZ. The primary endpoint of the trial is PFS (RANO by BICR), with a planned futility analysis, and an interim PFS analysis anticipated in the first half of 2028. The secondary endpoint of the trial is overall survival (OS).

Previous wording

We are also continuing to explore potential partnership opportunities to advance silevertinib into pivotal development.

Current wording

We are continuing to explore partnership opportunities to advance silevertinib through approval and commercialization.

Previous wording

Our second clinical-stage asset, BDTX-4933 (also known as S241656), was outlicensed to Servier Pharmaceuticals LLC (Servier) in the first quarter of 2025. Pursuant to the license agreement, we granted to Servier a global license to develop and commercialize BDTX-4933. Under the terms of the license agreement, Servier will lead the development activities and the global commercialization of BDTX-4933 across multiple indications, including NSCLC, with potential applications in other solid tumors. In consideration for the license granted to Servier, we received an upfront payment of $70.0 million in March 2025 and will be eligible to receive up to $710.0 million in development and commercial sales milestone payments, along with tiered royalties based on global net sales. See Note 14, License Revenue, to the consolidated financial statements included elsewhere in this Quarterly Report for additional information.

Current wording

Our second clinical-stage asset, BDTX-4933 (also known as S241656), was outlicensed to Servier Pharmaceuticals LLC (Servier) in the first quarter of 2025. Pursuant to the license agreement, we granted to Servier a global license to develop and commercialize BDTX-4933. Under the terms of the license agreement, Servier will lead the development activities and the global commercialization of BDTX-4933 across multiple indications, including NSCLC, with potential applications in other solid tumors. In consideration for the license granted to Servier, we received an upfront payment of $70.0 million in March 2025 and will be eligible to receive up to $710.0 million in development and commercial sales milestone payments, along with tiered royalties based on global net sales. See Note 14, License Revenue, to the condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information.

Previous wording

To date, we have funded our operations primarily with proceeds from sales of our common stock and preferred stock, and through the $70.0 million upfront payment received under the Servier Agreement in March 2025. Since inception, we have incurred significant operating losses. Our net loss was $18.9 million and our net income was $46.0 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $483.7 million. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of our current or future product candidates. We expect that our expenses and capital requirements will increase substantially in connection with our ongoing activities, particularly if and as we:

Current wording

To date, we have funded our operations primarily with proceeds from sales of our common stock and preferred stock, and through the $70.0 million upfront payment received under the Servier Agreement in March 2025. Since inception, we have incurred significant operating losses. Our net loss was $29.0 million and our net income was $37.5 million for the nine months ended September 30, 2026 and 2025, respectively. As of September 30, 2026, we had an accumulated deficit of $493.7 million. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of our current or future product candidates. We expect that our expenses and capital requirements will increase substantially in connection with our ongoing activities, particularly if and as we:

Previous wording

As of June 30, 2026, we had cash, cash equivalents and investments of approximately $110.5 million, which we believe will enable us to fund our operating expenses and capital expenditure requirements into the second half of 2028. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “—Liquidity and capital resources.” To finance our operations beyond that point, we will need to raise additional capital, which cannot be assured. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of our product candidates or other research and development initiatives.

Current wording

As of September 30, 2026, we had cash, cash equivalents and investments of approximately $102.0 million, which we believe will enable us to fund our operating expenses and capital expenditure requirements into the second half of 2028. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “—Liquidity and capital resources.” To finance our operations beyond that point, we will need to raise additional capital, which cannot be assured. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of our product candidates or other research and development initiatives.

Previous wording

Other income (expense) consists primarily of interest income earned on our cash equivalents and investment balances, sublease income, and realized and unrealized foreign currency transaction gains and losses.

Current wording

Other income (expense) consists primarily of interest income earned on our cash equivalents and investment balances, sublease income, (accretion) amortization on investments, and realized and unrealized foreign currency transaction gains and losses.

Previous wording

Research and development expenses were $7.4 million for the three months ended June 30, 2026, compared to $9.3 million for the three months ended June 30, 2025. The following table summarizes our research and development expenses for the three months ended June 30, 2026 and 2025:

Current wording

Research and development expenses were $7.0 million for the three months ended September 30, 2026, compared to $7.4 million for the three months ended September 30, 2025. The following table summarizes our research and development expenses for the three months ended September 30, 2026 and 2025:

Previous wording

The decrease of $1.9 million for the three months ended June 30, 2026 was primarily due to a decrease of $3.3 million related to the progression of our Phase 2 clinical trial for silevertinib in NSCLC, partially offset by an increased spend of $2.6 million related to the start up activities for our Phase 2 clinical trial for silevertinib in GBM, compared to the three months ended June 30, 2025. In addition, personnel expenses decreased by $0.4 million as we continue to capitalize on workforce efficiencies and focus on our development program, and facilities expenses decreased by $0.4 million due to the sublease of the remaining floor of our Cambridge, Massachusetts office space in December 2025.

Current wording

The decrease of $0.5 million for the three months ended September 30, 2026 was primarily due to a decrease of $1.7 million related to the progression of our Phase 2 clinical trial for silevertinib in NSCLC and a decrease of $0.4 million in other research programs and development expenses due to focusing on silevertinib, partially offset by an increase of $2.5 million related to the start-up and conduct of our Phase 2 clinical trial for silevertinib in GBM, compared to the three months ended September 30, 2025. In addition, personnel expenses decreased by $0.3 million as we continue to capitalize on workforce efficiencies and focus on our development program, and facilities expenses decreased by $0.4 million due to the sublease of the remaining floor of our Cambridge, Massachusetts office space in December 2025.

Previous wording

General and administrative expenses were $4.7 million for the three months ended June 30, 2026 compared to $4.1 million for the three months ended June 30, 2025. The increase was primarily a result of higher IP-related costs.

Current wording

General and administrative expenses were $5.1 million for the three months ended September 30, 2026 compared to $3.5 million for the three months ended September 30, 2025. The increase was primarily a result of higher IP-related costs and higher non-income tax expense.

Previous wording

Other income was $2.2 million for the three months ended June 30, 2026, compared to $2.9 million for the three months ended June 30, 2025. The decrease was primarily attributable to a decrease in interest income and a decrease in accretion on investments in 2026 compared to 2025.

Current wording

Other income was $2.1 million for the three months ended September 30, 2026, compared to $2.5 million for the three months ended September 30, 2025. The decrease was primarily attributable to a decrease in interest income and a decrease in accretion on investments in 2026 compared to 2025.

Previous wording

The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025:

Current wording

The following table summarizes our results of operations for the nine months ended September 30, 2026 and 2025:

Previous wording

No revenue was recorded for the six months ended June 30, 2026 compared to $70.0 million for the six months ended June 30, 2025. The decrease was a result of the upfront payment we received from Servier in the first quarter of 2025 under the Servier Agreement.

Current wording

No revenue was recorded for the nine months ended September 30, 2026 compared to $70.0 million for the nine months ended September 30, 2025. The decrease was a result of the upfront payment we received from Servier in the first quarter of 2025 under the Servier Agreement.

Previous wording

Research and development expenses were $14.4 million for the six months ended June 30, 2026, compared to $19.8 million for the six months ended June 30, 2025. The following table summarizes our research and development expenses for the six months ended June 30, 2026 and 2025:

Current wording

Research and development expenses were $21.4 million for the nine months ended September 30, 2026, compared to $27.3 million for the nine months ended September 30, 2025. The following table summarizes our research and development expenses for the nine months ended September 30, 2026 and 2025:

Previous wording

The decrease of $5.4 million for the six months ended June 30, 2026 was primarily due to a decrease of $5.7 million related to the progression of our Phase 2 clinical trial for silevertinib in NSCLC and a decrease of $1.0 million related to the deprioritization of the BDTX-4933 program and subsequent licensing to Servier, partially offset by an increase of $4.0 million for silevertinib GBM due to the initiation of a Phase 2 GBM trial, compared to the six months ended June 30, 2025. In addition, personnel expenses decreased by $0.7 million as we continue to capitalize on workforce efficiencies and focus on advancing and optimizing development for silevertinib, and facilities expenses decreased by $0.9 million due to the sublease of the remaining floor of our Cambridge, Massachusetts office space in December 2025.

Current wording

The decrease of $5.9 million for the nine months ended September 30, 2026 was primarily due to a decrease of $7.4 million related to the progression of our Phase 2 clinical trial for silevertinib in NSCLC and a decrease of $1.0 million related to the deprioritization of the BDTX-4933 program and subsequent licensing to Servier and a decrease of $1.4 million in other research programs and development expenses, partially offset by an increase of $6.5 million for silevertinib GBM due to the initiation of a Phase 2 GBM trial, compared to the nine months ended September 30, 2025. In addition, personnel expenses decreased by $1.0 million as we continue to capitalize on workforce efficiencies and focus on advancing and optimizing development for silevertinib, and facilities expenses decreased by $1.3 million due to the sublease of the remaining floor of our Cambridge, Massachusetts office space in December 2025.

Previous wording

General and administrative expenses were $8.9 million for the six months ended June 30, 2026 compared to $9.1 million for the six months ended June 30, 2025. The decrease was primarily a result of continued operational efficiencies.

Current wording

General and administrative expenses were $14.1 million for the nine months ended September 30, 2026 compared to $12.6 million for the nine months ended September 30, 2025. The increase was primarily a result of higher IP-related costs and higher non-income tax expense.

Previous wording

Other income was $4.4 million for the six months ended June 30, 2026, compared to $4.9 million for the six months ended June 30, 2025. The decrease was primarily attributable to a decrease in accretion on investments in 2026, partially offset by an increase in interest income compared to 2025.

Current wording

Other income was $6.5 million for the nine months ended September 30, 2026, compared to $7.4 million for the nine months ended September 30, 2025. The decrease was primarily attributable to a decrease in accretion on investments in 2026.

Previous wording

On November 13, 2025, we filed a new shelf registration statement on Form S-3 (the New Shelf Registration Statement) with the SEC, which covers the offering, issuance and sale of our common stock, preferred stock, debt securities, warrants and/or units of any combination thereof up to a maximum price of $500.0 million, including up to $150.0 million of shares of our common stock (the Shares) that may be offered, issued and sold under an Open Market Sale Agreement SM(the Sales Agreement) previously entered into with Jefferies LLC (Jefferies), as sales agent, on November 13, 2022 (the ATM Program). The New Registration Statement was filed to replace our prior shelf registration statement on Form S-3 (the Prior Shelf Registration Statement), originally filed with the SEC on November 14, 2022 and declared effective on November 22, 2022, which was set to expire on November 22, 2025, in accordance with applicable SEC regulations. The New Shelf Registration Statement became effective on December 3, 2025, and in accordance with Rule 415(a)(6) under the Securities Act, the offering of securities under the Prior Shelf Registration Statement is deemed terminated as of the date of effectiveness of the New Shelf Registration Statement. Any Shares will be sold pursuant to the New Shelf Registration Statement and the sales agreement prospectus filed therewith. Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, Jefferies may sell the Shares by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act. We may sell the Shares in amounts and at times to be determined by us from time to time subject to the terms and conditions of the Sales Agreement, but we have no obligation to sell any Shares under the Sales Agreement. We or Jefferies may suspend or terminate the offering of Shares upon notice to the other party and subject to other conditions. As of June 30, 2026, we sold 4,490,853 shares of our common stock pursuant to the ATM Program, resulting in gross proceeds to us of approximately $25.0 million ($24.5 million net of offering costs).

Current wording

On November 13, 2025, we filed a new shelf registration statement on Form S-3 (the New Shelf Registration Statement) with the SEC, which covers the offering, issuance and sale of our common stock, preferred stock, debt securities, warrants and/or units of any combination thereof up to a maximum price of $500.0 million, including up to $150.0 million of shares of our common stock (the Shares) that may be offered, issued and sold under an Open Market Sale Agreement SM(the Sales Agreement) previously entered into with Jefferies LLC (Jefferies), as sales agent, on February 1, 2021 (the ATM Program). The New Shelf Registration Statement was filed to replace our prior shelf registration statement on Form S-3 (the Prior Shelf Registration Statement), originally filed with the SEC on November 14, 2022 and declared effective on November 22, 2022, which was set to expire on November 22, 2025, in accordance with applicable SEC regulations. The New Shelf Registration Statement became effective on December 3, 2025, and in accordance with Rule 415(a)(6) under the Securities Act, the offering of securities under the Prior Shelf Registration Statement was deemed terminated as of the date of effectiveness of the New Shelf Registration Statement. Any Shares will be sold pursuant to the New Shelf Registration Statement and the sales agreement prospectus filed therewith. Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, Jefferies may sell the Shares by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act. We may sell the Shares in amounts and at times to be determined by us from time to time subject to the terms and conditions of the Sales Agreement, but we have no obligation to sell any Shares under the Sales Agreement. We or Jefferies may suspend or terminate the offering of Shares upon notice to the other party and subject to other conditions. As of September 30, 2026, we sold 4,490,853 shares of our common stock pursuant to the ATM Program, resulting in gross proceeds to us of approximately $25.0 million ($24.5 million net of offering costs).

Previous wording

During the six months ended June 30, 2026, we had cash used in operating activities of $18.2 million, primarily resulting from our net loss of $18.9 million, along with changes in our operating assets and liabilities of $3.0 million, partially offset by $3.8 million of non-cash items.

Current wording

During the nine months ended September 30, 2026, we had cash used in operating activities of $26.5 million, primarily resulting from our net loss of $29.0 million, along with changes in our operating assets and liabilities of $3.9 million, partially offset by $6.3 million of non-cash items.

Previous wording

During the six months ended June 30, 2025, we had cash provided by operating activities of $44.3 million, primarily resulting from our net income of $46.0 million, along with $4.3 million of non-cash items, partially offset by changes in our operating assets and liabilities of $6.1 million.

Current wording

During the nine months ended September 30, 2025, we had cash provided by operating activities of $36.4 million, primarily resulting from our net income of $37.5 million, along with $6.7 million of non-cash items, partially offset by changes in our operating assets and liabilities of $7.7 million.

Previous wording

During the six months ended June 30, 2026, we had cash provided by investing activities of $16.4 million primarily from the sales and maturities of investments, netted against our purchase of investments.

Current wording

During the nine months ended September 30, 2026, we had cash provided by investing activities of $20.6 million primarily from the sales and maturities of investments, netted against our purchase of investments.

Previous wording

During the six months ended June 30, 2025, we had cash used in investing activities of $50.6 million primarily from the sales and maturities of investments, netted against our purchase of investments.

Current wording

During the nine months ended September 30, 2025, we had cash used in investing activities of $42.0 million primarily from the sales and maturities of investments, netted against our purchase of investments.

Previous wording

During the six months ended June 30, 2025, we had cash used in financing activities of less than $0.1 million, consisting of proceeds from the participation in the 2020 Employee Stock Purchase Plan offset by the shares surrendered to cover taxes from a restricted stock unit vesting.

Current wording

During the nine months ended September 30, 2026, we had cash provided by financing activities of less than $0.1 million, consisting of proceeds from exercises of stock options and the participation in the 2020 Employee Stock Purchase Plan (ESPP) offset by the shares surrendered to cover taxes from a restricted stock unit vesting.

Previous wording

During the six months ended June 30, 2026, we had cash provided by financing activities of less than $0.1 million, consisting of proceeds from the exercises of common stock options offset by the shares surrendered to cover taxes from a restricted stock unit vesting.

Current wording

During the nine months ended September 30, 2025, we had cash provided by financing activities of less than $0.1 million, consisting of proceeds from exercises of stock options and the participation in the ESPP offset by the shares surrendered to cover taxes from a restricted stock unit vesting.

Previous wording

We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance clinical trials of silevertinib. In addition, we expect to incur additional costs associated with operating as a public company, including significant legal, accounting, investor relations and other expenses. The timing and amount of our operating expenditures will depend largely on our ability to:

Current wording

We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance clinical trials of silevertinib, including our planned Phase 3 trial in frontline EGFR-NCM NSCLC. In addition, we expect to incur additional costs associated with operating as a public company, including significant legal, accounting, investor relations and other expenses. The timing and amount of our operating expenditures will depend largely on our ability to:

Previous wording

As of June 30, 2026, we had cash, cash equivalents and investments of $110.5 million. We believe that our existing cash, cash equivalents and investments will enable us to fund our operating expenses and capital expenditure requirements into the second half of 2028. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. We anticipate that we will require additional capital as we seek regulatory approval of our product candidates and if we choose to pursue in-licenses or acquisitions of other product candidates. If we receive regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize.

Current wording

As of September 30, 2026, we had cash, cash equivalents and investments of $102.0 million. We believe that our existing cash, cash equivalents and investments, will enable us to fund our operating expenses and capital expenditure requirements into the second half of 2028. We will need to raise substantial additional capital to initiate and complete the Phase 3 trial and to fund any potential marketing approval and commercialization of silevertinib. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. We anticipate that we will require additional capital as we seek regulatory approval of our product candidates and if we choose to pursue in-licenses or acquisitions of other product candidates. If we receive regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize.

Previous wording

To the extent that we raise additional capital through the sale of private or public equity or convertible debt securities, the ownership interest of our stockholders may be materially diluted, and the terms of such securities could include liquidation or other preferences and anti-dilution protections that could adversely affect the rights of our common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include restrictive covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends, that could adversely impact our ability to conduct our business. In addition, debt financing may involve significant cash payment obligations and specific financial ratios that may restrict our ability to operate our business would result in fixed payment obligations.

Current wording

To the extent that we raise additional capital through the sale of private or public equity or convertible debt securities, the ownership interest of our stockholders may be materially diluted, and the terms of such securities could include liquidation or other preferences and anti-dilution protections that could adversely affect the rights of our common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include restrictive covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends, that could adversely impact our ability to conduct our business. In addition, debt financing would result in fixed payment obligations and may involve specific financial ratios that may restrict our ability to operate our business.

Previous wording

Our critical accounting policies are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations— Critical Accounting Policies and Use of Estimates” in our Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the SEC on March 16, 2026. During the six months ended June 30, 2026, there were no material changes to our critical accounting policies from those previously disclosed.

Current wording

Our critical accounting policies are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Use of Estimates” in our Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the SEC on March 16, 2026. During the nine months ended September 30, 2026, there were no material changes to our critical accounting policies from those previously disclosed.