What changed in this filing

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Item 7. Management’s Discussion and Analysis

2026-03-16 compared with 2025-03-06 · 85 added, 64 removed, 206 unchanged (42% of the section changed)

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Our compounds target families of oncogenic mutations in clinically validated pathways.

Our lead clinical-stage program, BDTX-1535, is a brain-penetrant, 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).

In October 2024, we announced a corporate restructuring plan to prioritize our resources on advancing BDTX-1535 into pivotal development.

We are actively evaluating partnership opportunities for a second clinical-stage program, BDTX-4933, a brain-penetrant, RAF MasterKey inhibitor targeting KRAS, NRAS and BRAF alterations in solid tumors.

We believe that our clinical-stage lead product candidate, BDTX-1535, has the potential to treat newly diagnosed patients with EGFRm NSCLC, as well as those with recurrent disease, based upon BDTX-1535’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.

BDTX-1535 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.

We are currently evaluating BDTX-1535 in a Phase 2 clinical trial in the first-line setting in patients with EGFRm NSCLC harboring non-classical EGFR mutations.

Initial results from the first-line cohort are anticipated in the second quarter of 2025.

We recently completed enrollment of BDTX-1535 in a Phase 2 clinical trial of 83 patients with EGFRm NSCLC in the second- and third-line settings.

In September 2024, we announced initial Phase 2 data from this trial demonstrating encouraging clinical responses and durability of BDTX-1535.

The 200 mg daily dose of BDTX-1535 was selected for pivotal development, showing robust EGFRm target coverage and a favorable tolerability profile with no new safety signals observed.

Based on an August 2024 data cutoff, a preliminary overall response rate (ORR) of 42% was seen in 19 patients with known osimertinib resistance EGFR mutations (PACC “P-loop αC-helix compressing” and C797S mutations).

Acquisition of C797S was frequently observed in patients who progressed following treatment with osimertinib.

PACC mutations represent a structure-function group of non-classical oncogenic driver mutations which may accumulate or be acquired following treatment with osimertinib.

Encouraging durability was noted with a duration of response (DOR) of approximately eight months or more in the first three patients who achieved a partial response (PR), while 14 of the 19 patients remained on treatment.

We expect to present updated results from this trial in the second half of 2025 and are exploring potential combination opportunities for BDTX-1535 in the recurrent setting.

In June 2024, at the American Society of Clinical Oncology (ASCO) Annual Meeting, we presented preliminary data from the Phase 1 trial of BDTX-1535 in patients with relapsed/recurrent GBM, demonstrating encouraging duration of treatment and clinical activity, and a tolerability profile consistent with the initial safety data from the dose escalation portion of the Phase 1 trial presented in 2023.

At the June 2024 ASCO meeting, our collaborators at the Ivy Brain Tumor Center also presented initial intratumoral pharmacokinetic data from a “window of opportunity” study in patients with recurrent high-grade glioma (HGG) with EGFR alterations and/or fusions at initial diagnosis.

This study, also known as a Phase 0/1 “Trigger” trial, is sponsored by the Ivy Brain Tumor Center.

Initial results from this trial demonstrated that BDTX-1535 exceeded the pre-specified threshold for drug concentration in the brain tumor tissue and was generally well tolerated with expected EGFR-mediated side effects.

Additional promising results from this trial were presented by the Ivy Brain Tumor Center at the European Association of Neuro-Oncology (EANO) meeting in October 2024 and at the Society of Neuro-Oncology (SNO) Annual Meeting in November 2024.

The data demonstrated that BDTX-1535 penetrates rarely accessible regions of glioblastoma and suppresses EGFR signaling in patient tumors.

In the first quarter of 2025, the program is expected to expand into a Phase 0/2 “window of opportunity” trial in newly diagnosed glioblastoma patients with EGFR aberrations.

Our second clinical-stage asset, BDTX-4933, is designed to be a potent and selective, reversible oral inhibitor that targets broad families of oncogenic BRAF, KRAS and NRAS alterations.

BDTX-4933 selectively targets constitutively active RAF dimers resulting from either BRAF mutations or other upstream oncogenic MAPK pathway alterations, such as KRAS and NRAS alterations.

In preclinical tumor models, we observed that BDTX-4933 demonstrated brain-penetrant activity and achieved regression of tumors carrying a broad spectrum of KRAS mutations, NRAS alterations, as well as BRAF Class I, II, and III mutations.

We initiated a Phase 1 clinical trial for BDTX-4933 in the second quarter of 2023 in patients with BRAF and select KRAS and NRAS mutation-positive cancers, with an emphasis on patients with non-G12C KRAS mutant NSCLC.

In October 2024, we announced we are actively seeking partnerships for this asset as we deprioritize the BDTX-4933 program in RAF/RAS-mutant solid tumors and focus resources on our lead program BDTX-1535.

Our lead clinical-stage program, silevertinib (formerly BDTX-1535), is a brain-penetrant, 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 NSCLC patients and plan to initiate a randomized Phase 2 trial of silevertinib in newly diagnosed patients with EGFR altered glioblastoma (GBM) in the second quarter of 2026.

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.

Initial 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, a favorable tolerability profile with no new safety signals observed, and durability of silevertinib.

We are currently evaluating silevertinib in a Phase 2 clinical trial in the first-line setting in patients with EGFRm NSCLC harboring non-classical EGFR mutations and in the fourth quarter of 2025, we announced initial data from our Phase 2 trial of 43 frontline NSCLC patients harboring a broad spectrum of 35 distinct non-classical EGFR mutations, including 16 patients with brain metastases (7 of whom had measurable CNS target lesions).

All patients were enrolled at a 200mg oral daily dose of silevertinib.

Efficacy and safety were assessed with a November 3, 2025 data cutoff and median follow-up time as of this date was 7.2 months, the study is fully enrolled and remains ongoing.

The initial data from this trial was encouraging with 25 confirmed partial responses and 1 confirmed complete response equating to a 60% Objective Response Rate (ORR by RECIST 1.1).

CNS ORR (by RANO-BM) was 86% and the disease control rate (DCR) was 91%.

No new safety signals were observed.

Adverse events (AEs) experienced by a majority of patients include rash, stomatitis, diarrhea and paronychia and were managed with standard supportive care and dose interruptions or reductions without compromising response depth or durability.

As of the November 3, 2025 data cutoff, 29 patients remained on therapy (5 of 29 after progression) with one patient having been on therapy for more than 19 months.

We plan to present updated results from the Phase 2 NSCLC trial, including preliminary duration of response (DOR) and progression-free survival (PFS) data in the frontline setting (43 patients) as well as updated clinical results in the recurrent setting (83 patients), at a medical meeting in the second quarter of 2026.

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 patents, 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 are preparing to initiate a randomized Phase 2 trial in this patient population in the second quarter of 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 on 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 2028.

The secondary endpoint of the trial will be overall survival (OS).

The trial will be governed by an independent data monitoring committee (IDMC).

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

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 15, License Revenue , to the consolidated financial statements included elsewhere in this Annual Report for additional information.

Since our inception in 2014, we have devoted substantially all of our efforts and financial resources to organizing and staffing our company, business planning, raising capital, discovering product candidates and securing related intellectual property rights while conducting research and development activities for our programs.

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Since inception, we have incurred significant operating losses.

Our net losses were $69.7 million and $82.4 million for the years ended December 31, 2024 and 2023, respectively.

Our net income was $22.4 million and our net loss was $69.7 million for the years ended December 31, 2025 and 2024, respectively.

As of December 31, 2025, we had an accumulated deficit of $464.7 million.

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We expect that our expenses and capital requirements will increase substantially in connection with our ongoing activities, particularly if and as we:

• advance clinical development of BDTX-1535;

• advance clinical development of silevertinib;

• obtain, maintain, expand, enforce and protect our intellectual property portfolio;

• maintain existing collaborations or strategic relationships and identify and enter into future license agreements and collaborations with third parties;

• attract and retain key clinical, scientific, management and commercial personnel;

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As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy.

Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the sale of equity, debt financings or other capital sources, which may include collaborations with other companies or other strategic transactions.

Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of private and public equity offerings, debt financings or other capital sources, which may include collaborations and licensing arrangements with other companies or other strategic transactions.

We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all.

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If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.

Additionally, we continue to actively monitor macroeconomic conditions and market volatility resulting from global economic developments, political unrest, high inflation, disruptions in capital markets, changes in international trade relationships and military conflicts, and health crises.

Additionally, we continue to actively monitor macroeconomic conditions and market volatility resulting from global and national economic developments, political unrest, new or increased international tariffs and retaliatory tariffs, high inflation, disruptions in capital markets, changes in international trade relationships, changes in U.S.

governmental agencies, new laws and regulations or amendments to existing laws and regulations in the U.S.

and foreign countries, and military conflicts.

While we believe such factors have had no significant impact on our business or financial results during the periods presented, future developments and potential impacts on our business are uncertain and cannot be predicted with confidence.

As of December 31, 2024, we had cash, cash equivalents and investments of $98.6 million, which we believe will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2026.

As of December 31, 2025, we had cash, cash equivalents and investments of $128.7 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.

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Components of our results of operations

To date, we have not generated any revenue from any sources, including from product sales, and we do not expect to generate any revenue from the sale of products in the foreseeable future.

If our development efforts for our product candidates are successful and result in regulatory approval, or license agreements with third parties, we may generate revenue in the future from product sales.

To date, we have not generated any product revenue and do not expect to generate any revenue from the sale of products for the foreseeable future.

To date, we have generated revenue solely from licensing of intellectual property.

If our development efforts for our product candidates are successful and result in regulatory approval, or if we enter into collaboration or license agreements with third parties, we may generate revenue in the future from a combination of product sales or payments from such collaboration or license agreements.

However, there can be no assurance as to when we will generate such revenue, if at all.

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Research and development expenses

Research and development expenses consist primarily of costs incurred for our research activities, including our drug discovery efforts and the development of our product candidates.

Research and development expenses consist primarily of costs incurred for our research activities, including the development of our product candidates.

We expense research and development costs as incurred, which include:

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Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials.

As a result, we expect that our research and development expenses will increase substantially over the next several years as we continue our clinical development of BDTX-1535.

As a result, we expect that our research and development expenses will increase substantially over the next several years as we continue our clinical development of silevertinib.

In addition, we may incur additional expenses related to milestone and royalty payments payable to third parties with whom we may enter into license, acquisition and option agreements to acquire the rights to future product candidates.

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Additionally, if and when we believe a regulatory approval of a product candidate appears likely, we anticipate an increase in payroll and other employee-related expenses as a result of our preparation for commercial operations, especially as it relates to the sales and marketing of that product candidate.

Impairment of right-of-use assets and property and equipment

Impairment of right-of-use assets and property and equipment expenses consists of impairment losses relating to our operating leases.

Other income (expense)

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(in thousands)

License revenue $ 70,000 $ — $ 70,000

Operating expenses:

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General and administrative 16,572 27,469 (10,897)

Impairment of right-of-use assets and property and equipment 7,348 — 7,348

Total operating expenses 57,478 78,781 (21,303)

Loss from operations (78,781) (86,460) 7,679

Income (loss) from operations 12,522 (78,781) 91,303

Other income (expense):

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Total other income (expense), net 9,845 9,105 740

Net loss $ (69,676) $ (82,442) $ 12,766

Net income (loss) $ 22,367 $ (69,676) $ 92,043

Research and development

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(in thousands)

BDTX-1535 research and development expenses $ 24,378 $ 21,141 $ 3,237

Silevertinib (NSCLC) research and development expenses $ 17,469 $ 24,378 $ (6,909)

Silevertinib (GBM) research and development expenses 138 — 138

BDTX-4933 research and development expenses 1,018 4,613 (3,595)

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$ 33,558 $ 51,312 $ (17,754)

The decrease of $8.0 million was primarily due to an increase of $3.2 million related to the progression of our clinical trial for BDTX-1535, offset by decreased spend relating to BDTX-4933 of $1.7 million as clinical startup and non-clinical activities completed as well as a decrease in other research and development of $5.4 million due to reduced spending on early discovery projects as we deepened our focus on our clinical-stage assets, compared to the year ended December 31, 2023.

In addition, personnel expenses decreased by $3.1 million as we continue to capitalize on workforce efficiencies to focus on advancing and optimizing development plans for BDTX-1535.

The decrease of $17.8 million was primarily due to a decrease of $6.9 million related to operational efficiencies gained as we progressed our clinical trial for silevertinib in NSCLC, combined with decreased spend related to BDTX-4933 of $3.6 million as a result of its outlicensing to Servier in the first quarter of 2025, compared to the year ended December 31, 2024.

In addition, personnel expenses decreased by $5.9 million as we continue to capitalize on workforce efficiencies and focus on our development program.

General and administrative

General and administrative expenses were $16.6 million for the year ended December 31, 2025, compared to $27.5 million for the year ended December 31, 2024.

The increase of $0.4 million was primarily related to one-time restructuring costs.

The decrease of $10.9 million was primarily a result of operational and workforce efficiencies from our corporate restructuring announced in the fourth quarter of 2024.

Other income (expense)

Other income was $9.8 million for the year ended December 31, 2025, compared to $9.1 million for the year ended December 31, 2024.

The increase of $5.1 million was primarily attributable to accretion on investments increasing at a higher rate in 2024 compared to 2023 as well as an increase in sublease income due to signing an additional sublease in 2024.

The increase of $0.7 million was primarily attributable to an increase in interest income, a decrease in accretion on investments, as well as an increase in sublease income due to signing an additional sublease in 2024.

Liquidity and capital resources

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Through December 31, 2025, we had received net cash proceeds of $200.6 million from previous sales of our preferred stock and as of December 31, 2025, we had cash, cash equivalents and investments of $128.7 million.

On November 14, 2022, we filed a shelf registration statement on Form S-3 (the 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.

We simultaneously entered into an Open Market Sale Agreement SM (the Sales Agreement) with Jefferies LLC (Jefferies), as sales agent, to provide for the issuance and sale by us of up to $150.0 million of our common stock, or the Shares, from time to time through Jefferies as our sales agent (the ATM Program).

The Shelf Registration Statement became effective on November 22, 2022.

On November 14, 2022, we entered into an Open Market Sale Agreement SM (the Sales Agreement) with Jefferies LLC (Jefferies), as sales agent, to provide for the issuance and sale by us of up to $150.0 million of our common stock, or the Shares, from time to time through Jefferies as our sales agent (the ATM Program).

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.

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As of December 31, 2025, 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).

On November 13, 2025, we filed a new shelf registration statement on Form S-3, including a base prospectus and sales agreement prospectus (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 that may be offered, issued and sold under the Sales Agreement.

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.

On July 5, 2023, we completed an underwritten public offering (the Follow-on Offering) of 15,000,000 shares of our common stock at a price to the public of $5.00 per share.

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The underwriters did not exercise any portion of their 30-day overallotment option to purchase up to an additional 2,250,000 shares of our common stock at the public offering price, which expired on July 29, 2023, and therefore no additional proceeds from the Follow-on Offering were received.

On March 18, 2025, we entered into the Servier Agreement with Servier for BDTX-4933, a small molecule designed to address unmet medical needs in RAF/RAS-mutant solid tumors, pursuant to which we granted to Servier a global license to develop and commercialize BDTX-4933.

Under the terms of the Servier 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.

See Note 15, License Revenue , to the consolidated financial statements included elsewhere in this Annual Report for additional information.

The following table summarizes our sources and uses of cash for each of the periods presented (in thousands):

Year ended December 31,

Cash used in operating activities $ (62,303)

Cash provided by investing activities

Cash provided by financing activities 25,547

Cash provided by (used in) operating activities

Cash provided by (used in) investing activities

Cash provided by (used in) financing activities

Net increase (decrease) in cash and cash equivalents $ (15,437)

Operating activities

During the year ended December 31, 2025, we had cash provided by operating activities of $29.6 million, primarily resulting from our net income of $22.4 million, along with $16.0 million of non-cash items, partially offset by changes in our operating assets and liabilities of $8.7 million.

During the year ended December 31, 2024, we used cash in operating activities of $62.3 million, primarily resulting from our net loss of $69.7 million, partially offset by the non-cash charge related to stock compensation expense of $10.6 million, an increase in accretion on investments, and an increase in accounts payable.

During the year ended December 31, 2023, we used cash in operating activities of $66.7 million, primarily resulting from our net loss of $82.4 million, partially offset by the non-cash charge related to stock compensation expense of $9.6 million, a decrease in prepaid expenses and other current assets as development services were performed, and an increase in accounts payable, accrued expenses and other current liabilities.

Changes in accounts payable and accrued expenses in all periods were generally due to ongoing development of our product candidates and the timing of vendor invoicing and payments.

Investing activities

During the year ended December 31, 2025, we had cash used investing activities of $44.9 million primarily from the purchase of investments offset by sales and maturities of investments.

During the year ended December 31, 2024, we had cash provided by investing activities of $17.0 million primarily from the sales and maturities of investments, netted against our purchase of investments.

During the year ended December 31, 2023, we had cash provided by investing activities of $16.3 million primarily from the sales and maturities of investments.

Financing activities

During the year ended December 31, 2025, we had cash used in financing activities of $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.

During the year ended December 31, 2024, we had cash provided by financing activities of $25.5 million, consisting of proceeds from the sale of shares of our common stock pursuant to the ATM Program as well as exercises of stock options and participation in the employee stock purchase plan.

During the year ended December 31, 2023, we had cash provided by financing activities of $71.9 million, consisting of proceeds from the Follow-on Offering in July 2023 as well as participation in the employee stock purchase plan.

Funding requirements

We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance clinical trials of BDTX-1535.

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:

• advance BDTX-1535 through clinical trials;

• advance silevertinib through clinical trials, either independently or with a partner;

• manufacture, or have manufactured on our behalf, our drug material and develop processes for late stage and commercial manufacturing;

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• obtain, maintain, expand, enforce and protect our intellectual property portfolio.

As of December 31, 2024, we had cash, cash equivalents and investments of $98.6 million, which we believe will fund our operating expenses and capital expenditure requirements into the fourth quarter of 2026.

As of December 31, 2025, we had cash, cash equivalents and investments of $128.7 million, which we believe will 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.

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• the costs, timing and ability to manufacture our product candidates to supply our clinical development efforts and our clinical trials;

• Servier’s ability to develop and commercialize BDTX-4933 and the receipt of potential milestone and royalty payments from commercial product sales, along with tiered royalties based on global net sales, if any, under the Servier Agreement;

• the costs of future activities, including product sales, medical affairs, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval;

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• the costs of preparing, filing and prosecuting patent applications, obtaining, maintaining, expanding and enforcing our intellectual property rights and defending intellectual property-related claims;

• our ability to establish and maintain collaborations on favorable terms, if at all;

• our ability to establish and maintain additional collaborations and license agreements on favorable terms, if at all, and the ability and willingness of our third-party strategic collaborators to undertake research and development activities relating to our product candidates, and the success of those collaborations and license agreements;

• the extent to which we acquire or in-license other product candidates and technologies;

• the costs of operating as a public company.

• the ongoing costs of operating as a public company;

• general macroeconomic, geopolitical, industry and market conditions, including increases in inflationary rates, tariffs, interest rates and supply chain constraints.

As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy.

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While our significant accounting policies are described in more detail in Note 2 to our consolidated financial statements, we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our financial statements.

Accrued research and development expenses

Accrued research and development costs

As part of the process of preparing our consolidated financial statements, we are required to estimate our accrued research and development expenses.

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A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our consolidated financial statements appearing elsewhere in this Annual Report.

Emerging growth company and smaller reporting company status

The Jumpstart Our Business Startups Act of 2012 (the JOBS Act) permits an “emerging growth company” such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies.

We have elected to not “opt out” of this provision and, as a result, we will adopt new or revised accounting standards at the time private companies adopt the new or revised accounting standard and will do so until such time that we either (i) irrevocably elect to “opt out” of such extended transition period or (ii) no longer qualify as an emerging growth company.

We are also a “smaller reporting company” meaning that the market value of our stock held by non-affiliates is less than $700 million and our annual revenue was less than $100 million during the most recently completed fiscal year.

Smaller reporting company status

Effective as of December 31, 2025, the fifth anniversary of the closing of our IPO, we no longer qualify as an “emerging growth company.” As a result, commencing with this Annual Report, we are no longer eligible to take advantage of certain exemptions from various reporting requirements that are applicable to emerging growth companies.

We are still a “smaller reporting company” meaning that the market value of our stock held by non-affiliates is less than $700 million and our annual revenue was less than $100 million during the most recently completed fiscal year.

We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250 million or (ii) our annual revenue was less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million.

If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies.

As a smaller reporting company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies despite the loss of emerging growth company status.

Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.

Effective as of December 31, 2025, the fifth anniversary of the closing of our IPO, we will no longer qualify as an “emerging growth company.” As a result, commencing with our Annual Report on Form 10-K for the fiscal year ending December 31, 2025, we will no longer be eligible to take advantage of certain exemptions from various reporting requirements that are applicable to emerging growth companies.

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-K

Item 7. Management’s Discussion and Analysis